[go: up one dir, main page]

WO2025122878A1 - Modèles de forme statistique pour procédures guidées par image - Google Patents

Modèles de forme statistique pour procédures guidées par image Download PDF

Info

Publication number
WO2025122878A1
WO2025122878A1 PCT/US2024/058882 US2024058882W WO2025122878A1 WO 2025122878 A1 WO2025122878 A1 WO 2025122878A1 US 2024058882 W US2024058882 W US 2024058882W WO 2025122878 A1 WO2025122878 A1 WO 2025122878A1
Authority
WO
WIPO (PCT)
Prior art keywords
model
processor
points
fit
data
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/US2024/058882
Other languages
English (en)
Inventor
Rahul Khare
Toby FRANCIS
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 Asia Pacific Pte Ltd
Smith and Nephew Inc
Original Assignee
Smith and Nephew Orthopaedics AG
Smith and Nephew Asia Pacific Pte Ltd
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 Asia Pacific Pte Ltd, Smith and Nephew Inc filed Critical Smith and Nephew Orthopaedics AG
Publication of WO2025122878A1 publication Critical patent/WO2025122878A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • G—PHYSICS
    • G06—COMPUTING OR CALCULATING; COUNTING
    • G06T—IMAGE DATA PROCESSING OR GENERATION, IN GENERAL
    • G06T7/00—Image analysis
    • G06T7/30—Determination of transform parameters for the alignment of images, i.e. image registration
    • G06T7/33—Determination of transform parameters for the alignment of images, i.e. image registration using feature-based methods
    • G06T7/344—Determination of transform parameters for the alignment of images, i.e. image registration using feature-based methods involving models
    • G—PHYSICS
    • G06—COMPUTING OR CALCULATING; COUNTING
    • G06T—IMAGE DATA PROCESSING OR GENERATION, IN GENERAL
    • G06T2207/00—Indexing scheme for image analysis or image enhancement
    • G06T2207/30—Subject of image; Context of image processing
    • G06T2207/30004—Biomedical image processing
    • G06T2207/30008—Bone

Definitions

  • a pre-segmented bone surface model is available from pre-operative imaging and planning.
  • the imagery is acquired from scans (e.g., CT or MRI) taken before the procedure.
  • scans e.g., CT or MRI
  • important information about the bone that assists in planning the implant positioning can be derived from the pre-segmented bone surface.
  • pre-segmented bone it has to be registered to the intraoperative reference frame.
  • Existing approaches for registration involve identifying equivalent points on the pre-segmented surface and in the intra-operative space. However, this process is time intensive for the surgeon.
  • a method of registration includes importing, by a processor, a pre-operative patient model and a statistical shape model, wherein the pre-operative patient model is associated with a patient’s bony anatomy, pre-fitting, by the processor, the statistical shape model to the pre-operative patient model to generate a pre-fit model, and determining, by the processor, a transformation between the pre-fit model and the statistical shape model.
  • the pre-operative patient model is converted to a converted pre-operative patient model in an anatomic reference frame of the statistical shape model.
  • a plurality of points on the bony anatomy are collected in a tracker reference frame and based on the plurality of points, the pre-fit model is registered to the tracker reference frame.
  • the method includes determining, by the processor, whether the statistical shape model is sufficiently matched to the pre-operative patient model.
  • the method includes converting, by the processor, the pre-fit model to the anatomic reference frame of the statistical shape model based on the determined transformation.
  • the method includes visualizing, on a display, the pre- fit model.
  • the method includes evaluating, by the processor, a distance between the plurality of points and one or more sampled points in the pre-fit model and determining, by the processor, a confidence level of the registering based on the distance.
  • the method includes in response to the confidence level being low: collecting, by the sensor, a plurality of additional points on the bony anatomy in the tracker reference frame. ACTIVE ⁇ 1604724607.3 Attorney Docket No. PT-6046-WO-PCT/D030902 [0011]
  • registering the pre-fit model to the tracker reference frame includes registering with an iterative closest points algorithm.
  • registering with an iterative closest points algorithm includes determining a registration which minimizes least-square error between the plurality of points and one or more sampled points in the pre-fit model.
  • the pre-fit model includes a mesh.
  • pre-fitting further includes pre-fitting with a radial basis function neural network.
  • the method includes determining whether a portion of the plurality of points on the bony anatomy in the tracker reference frame represent a change in the bony anatomy in comparison to the converted pre-operative patient model and modifying the converted pre-operative patient model based on the portion of the plurality of points.
  • a system for registration includes a processor and a non-transitory, processor-readable storage medium, wherein the non-transitory, processor- readable storage medium comprises one or more programming instructions.
  • the one or more programming instructions when executed, cause the processor to import a pre-operative patient model and a statistical shape model, wherein the pre-operative patient model is associated with a patient’s bony anatomy, pre-fit the statistical shape model to the pre-operative patient model to generate a pre-fit model, determine a transformation between the pre-fit model and the statistical shape model, based on the determined transformation, convert the pre-operative patient model to a converted pre-operative patient model in an anatomic reference frame of the statistical shape model, collect, via a sensor, a plurality of points on the bony anatomy in a tracker reference frame, and, based on the plurality of points, register the pre-fit model to the tracker reference frame.
  • the one or more programming instructions further cause the processor to determine if the statistical shape model is sufficiently matched to the pre-operative patient model. [0018] In some embodiments, the one or more programming instructions further cause the processor to convert the pre-fit model to the anatomic reference frame of the statistical shape model based on the determined transformation. [0019] In some embodiments, the system further includes a display, wherein the one or more programming instructions further cause the processor to visualize, on the display, the pre-fit model.
  • the one or more programming instructions further cause the processor to evaluate a distance between the plurality of points and one or more sampled points in the pre-fit model and determine a confidence level of the registering based on the distance.
  • the one or more programming instructions further cause the processor to in response to the confidence level being low, collect, via the sensor, a plurality of additional points on the bony anatomy in the tracker reference frame.
  • the one or more programming instructions which cause the processor to register the pre-fit model to the tracker reference frame register with an iterative closest points algorithm further cause the processor to determine a registration that minimizes a least-square error between the plurality of points and one or more sampled points in the pre-fit model.
  • the pre-fit model includes a mesh. ACTIVE ⁇ 1604724607.3 Attorney Docket No.
  • FIG.1 depicts an operating theatre including an illustrative computer-assisted surgical system (CASS) in accordance with an embodiment.
  • 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.3 depicts a flow diagram for a method of registration in accordance with an embodiment.
  • FIG. 4 illustrates an illustrative flowchart for image-based registration in accordance with an embodiment.
  • FIG. 5A illustrates sampled points on a segmented mesh in accordance with an embodiment.
  • FIG. 5B illustrates an atlas fit mesh overlayed with the original segmented mesh 514 in accordance with an embodiment.
  • ACTIVE ⁇ 1604724607.3 Attorney Docket No. PT-6046-WO-PCT/D030902
  • FIGS. 6A and 6B compare sampled points on a Nelder-Mead atlas fit mesh with an radial bias fit atlas mesh in accordance with an embodiment .
  • FIG. 7 illustrate the correction of the mechanical axis in the sagittal plane provided by pre-fitting the original mesh to the fitted mesh in accordance with embodiment.
  • FIG. 7 illustrate the correction of the mechanical axis in the sagittal plane provided by pre-fitting the original mesh to the fitted mesh in accordance with embodiment.
  • FIG. 8A illustrates a defined initial placement position, for a total knee arthroplasty (TKA), on entry to the free collection state in accordance with an embodiment.
  • FIG. 8B illustrates an example user interface for femur-free collection in a unicondylar knee arthroplasty (UKA) in accordance with an embodiment.
  • FIGS.9A-9B illustrate sample points in example critical regions on the femur in a posterior view and anterior view in accordance with an embodiment.
  • FIG. 10 illustrates sample points in example critical regions on the tibia in accordance with an embodiment.
  • FIGS. 11A-11B illustrate sample points in example critical regions on the femur in a medial view and lateral view in accordance with an embodiment.
  • FIGS. 12A-12B illustrate sample points in example critical regions on the tibia in a medial view and lateral view in accordance with an embodiment.
  • FIGS.13A-13B illustrate example osteophytic regions for a TKA in the femur and tibia in accordance with an embodiment.
  • FIGS.14A-14B illustrate example osteophytic regions for a UKA in the femur and tibia in accordance with an embodiment.
  • FIG. 15 illustrates an example morphed mesh overlaid with an original mesh in accordance with an embodiment.
  • FIG.16 illustrates a block diagram of an exemplary data processing system in which embodiments are implemented.
  • ACTIVE ⁇ 1604724607.3 Attorney Docket No. PT-6046-WO-PCT/D030902 DETAILED DESCRIPTION
  • This disclosure is not limited to the particular systems, devices and methods described, as these may vary.
  • the terminology used in the description is for the purpose of describing the particular versions or embodiments only and is not intended to limit the scope.
  • the singular forms “a,” “an,” and “the” include plural references unless the context clearly dictates otherwise. Unless defined otherwise, all technical and scientific terms used herein have the same meanings as commonly understood by one of ordinary skill in the art.
  • the term “comprising” means “including, but not limited to.” Definitions [0049]
  • the term “implant” is used to refer to a prosthetic device or structure manufactured to replace or enhance a biological structure. For example, in a total hip replacement procedure a prosthetic acetabular cup (implant) is used to replace or enhance a patients worn or damaged acetabulum.
  • an implant can include a biological tissue or material transplanted to replace or enhance a biological structure.
  • real-time is used to refer to calculations or operations performed on-the-fly as events occur or input is received by the operable system.
  • real-time is not intended to preclude operations that cause some latency between input and response, so long as the latency is an unintended consequence induced by the performance characteristics of the machine.
  • PT-6046-WO-PCT/D030902 the terms “distract,” “distracting,” or “distraction” are used to refer to displacement of a first point with respect to a second point.
  • the 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.
  • FIG. 1 provides an illustration of an example computer-assisted surgical system (CASS) 100, according to some embodiments.
  • the CASS uses computers, robotics, and imaging technology to aid surgeons in performing orthopedic surgery procedures such as total knee arthroplasty (TKA), unicondylar knee arthroplasty (UKA) , or total hip arthroplasty (THA).
  • TKA total knee arthroplasty
  • UKA unicondylar knee arthroplasty
  • TKA total hip arthroplasty
  • surgical navigation systems can aid surgeons in locating patient anatomical structures, guiding surgical instruments, and implanting medical devices with a high degree of accuracy.
  • Surgical navigation systems such as the CASS 100 often employ various forms of computing technology to perform a wide variety of standard and minimally invasive surgical procedures and techniques. Moreover, these systems allow surgeons to more accurately plan, track and navigate the placement of instruments and implants relative to the body of a patient, as well as conduct pre-operative and intra-operative body imaging.
  • 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 floor platform may be fixed or moveable.
  • the robotic arm 105A is mounted on a floor-to-ceiling pole located between the patient's legs or feet.
  • the End Effector 105B may include a suture holder or a stapler to assist in closing wounds.
  • the surgical computer 150 can drive the robotic arms 105A to work together to suture the wound at closure.
  • the surgical computer 150 can drive one or more robotic arms 105A to staple the wound at closure.
  • the Effector Platform 105 can include a Limb Positioner 105C for positioning the patient's limbs during surgery.
  • a Limb Positioner 105C is the SMITH AND NEPHEW SPIDER2 system.
  • the Limb Positioner 105C may be operated manually by the surgeon or alternatively change limb positions based on instructions received from the Surgical Computer 150 (described below). While one Limb Positioner 105C is illustrated in FIG.1, in some embodiments there may be multiple devices. As examples, there may be one Limb Positioner 105C on each side of the operating table T or two devices on one side of the table T.
  • the Limb Positioner 105C may be mounted directly to the table T, be located next to the table T on a floor platform (not shown), mounted on a pole, or mounted on a wall or ceiling of an operating room.
  • the Limb Positioner 105C can be used in non- conventional ways, such as a retractor or specific bone holder.
  • the Limb Positioner 105C may include, as examples, an ankle boot, a soft tissue clamp, a bone clamp, or a soft-tissue retractor spoon, such as a hooked, curved, or angled blade.
  • the Limb Positioner 105C may include a suture holder to assist in closing wounds.
  • 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 ACTIVE ⁇ 1604724607.3 Attorney Docket No. PT-6046-WO-PCT/D030902 Resection Equipment 110 include drilling devices, burring devices, oscillatory sawing devices, vibratory impaction devices, reamers, ultrasonic bone cutting devices, radio frequency ablation devices, reciprocating devices (such as a rasp or broach), and laser ablation systems.
  • the Resection Equipment 110 is held and operated by the surgeon during surgery.
  • the Effector Platform 105 may be used to hold the Resection Equipment 110 during use.
  • the Effector Platform 105 also can include a cutting guide or jig 105D that is used to guide saws or drills used to resect tissue during surgery.
  • Such cutting guides 105D can be formed integrally as part of the Effector Platform 105 or robotic arm 105A or cutting guides can be separate structures that can be matingly and/or removably attached to the Effector Platform 105 or robotic arm 105A.
  • the Effector Platform 105 or robotic arm 105A can be controlled by the CASS 100 to position a cutting guide or jig 105D adjacent to the patient's anatomy in accordance with a pre-operatively or intraoperatively developed surgical plan such that the cutting guide or jig will produce a precise bone cut in accordance with the surgical plan.
  • the Tracking System 115 uses one or more sensors to collect real-time position data that locates the patient's anatomy and surgical instruments. For example, for TKA procedures, the Tracking System may provide a location and orientation of the End Effector 105B during the procedure. In addition to positional data, data from the Tracking System 115 also can be used to infer velocity/acceleration of anatomy/instrumentation, which can be used for tool control.
  • 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 ACTIVE ⁇ 1604724607.3 Attorney Docket No. PT-6046-WO-PCT/D030902 systems may be used in various embodiments of the present invention including, without 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.
  • 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 infrared/time of flight sensor data which is predominantly used for hand/gesture detection, can build correspondence between the AR headset and the tracking system of the robotic system using sensor fusion techniques. This can be used to calculate a calibration matrix that relates the optical camera coordinate frame to the fixed holographic world frame.
  • certain features of objects can be tracked by registering physical properties of the object and associating them with objects that can be tracked, such as fiducial marks fixed to a tool or bone. For example, a surgeon may perform a manual registration process whereby a tracked tool and a tracked bone can be manipulated relative to one another.
  • a three- dimensional surface can be mapped for that bone that is associated with a position and ACTIVE ⁇ 1604724607.3 Attorney Docket No. PT-6046-WO-PCT/D030902 orientation relative to the frame of reference of that fiducial mark.
  • a model of that surface can be tracked with an environment through extrapolation.
  • the registration process that registers the CASS 100 to the relevant anatomy of the patient also can involve the use of anatomical landmarks, such as landmarks on a bone or cartilage.
  • 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.1) provides the surgeon with intraoperative, real-time visualization for the patient's bone, cartilage, muscle, nervous, and/or vascular tissues surrounding the surgical area. Examples of systems that may be employed for tissue navigation include fluorescent imaging systems and ultrasound systems. [0067]
  • 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 ACTIVE ⁇ 1604724607.3 Attorney Docket No. PT-6046-WO-PCT/D030902 surgery.
  • the Display 125 overlays image information collected from various modalities (e.g., CT, MRI, X-ray, fluorescent, ultrasound, etc.) collected pre-operatively or intra-operatively to give the surgeon various views of the patient's anatomy as well as real-time conditions.
  • the Display 125 may include, for example, one or more computer monitors.
  • one or more members of the surgical staff may wear an Augmented Reality (AR) Head Mounted Device (HMD).
  • AR Augmented Reality
  • HMD Head Mounted Device
  • 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.
  • Various example uses of the AR HMD 155 in surgical procedures are detailed in the sections that follow.
  • Surgical Computer 150 provides control instructions to various components of the CASS 100, collects data from those components, and provides general processing for ACTIVE ⁇ 1604724607.3 Attorney Docket No. PT-6046-WO-PCT/D030902 various data needed during surgery.
  • the Surgical Computer 150 is a 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.
  • Surgical Computer 150 can connect 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).
  • ACTIVE ⁇ 1604724607.3 Attorney Docket No.
  • 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 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 ACTIVE ⁇ 1604724607.3 Attorney Docket No. PT-6046-WO-PCT/D030902 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 surgical plan tracked by the Surgical Computer 150.
  • a robotic arm 105A is internally powered through hydraulics or motors or provides resistance to external manual motion through similar means can be described as powered robotic arms, while arms that are manually manipulated without power feedback, but which may be manually or automatically locked in place, may be described as passive robotic arms.
  • 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.
  • PT-6046-WO-PCT/D030902 controlled end effector 105B can be controlled remotely by a surgeon or other medical professional using a control mechanism separate from the robotic arm or robotically controlled end effector device, for example using a joystick or interactive monitor or display control device.
  • a robotic arm 105A may be used for holding the retractor. For example, in one embodiment, 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. In some embodiments, 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 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 ACTIVE ⁇ 1604724607.3 Attorney Docket No. PT-6046-WO-PCT/D030902 been achieved, the robotic arm 105A may prevent any further seating to prevent damage to the pelvis.
  • 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.).
  • 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.
  • 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.
  • data is collected or generated that can be used to analyze the episode of care in order to understand various features of the procedure and identify patterns that may be used, for example, in training models to make decisions with minimal human intervention.
  • the data collected over the episode of care may be stored at the Surgical Computer 150 or the Surgical Data Server 180 as a complete dataset.
  • a dataset exists that comprises all of the data collectively pre-operatively about the patient, all of the data collected or stored by the CASS 100 intra-operatively, and any 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.
  • the Surgical Computer 150 can be queried for a recommendation.
  • the pre-operative and intra-operative planning approaches can be combined such that a robust pre-operative plan can be dynamically modified, as necessary or desired, during the surgical procedure.
  • a biomechanics-based model of patient anatomy contributes simulation data to be considered by ACTIVE ⁇ 1604724607.3 Attorney Docket No. PT-6046-WO-PCT/D030902 the CASS 100 in developing preoperative, intraoperative, and post-operative/rehabilitation procedures to optimize implant performance outcomes for the patient.
  • implants can be designed using episode of care data.
  • 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.
  • the data can be used for educational, training, or research purposes.
  • other doctors or students can remotely view surgeries in interfaces that allow them to selectively view data as it is collected from the various components of the CASS 100.
  • similar interfaces may be used to "playback" a surgery for training or other educational purposes, or to identify the source of any issues or complications with the procedure.
  • Data acquired during the pre-operative phase generally includes all information collected or generated prior to the surgery.
  • information about the patient may be acquired from a patient intake form or electronic medical record (EMR).
  • patient information that may be collected include, without limitation, patient demographics, diagnoses, medical histories, progress notes, vital signs, medical history information, allergies, and lab results.
  • the pre-operative data may also include images related ACTIVE ⁇ 1604724607.3 Attorney Docket No. PT-6046-WO-PCT/D030902 to the anatomical area of interest. These images may be captured, for example, using Magnetic Resonance Imaging (MRI), Computed Tomography (CT), X-ray, ultrasound, or any other modality known in the art.
  • the pre-operative data may also comprise quality of life data captured from the patient.
  • 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. For example, certain cultures or demographics may be more likely to use a toilet that requires squatting on a daily basis.
  • FIGS. 2A and 2B provide examples of data that may be acquired during the intra-operative phase of an episode of care.
  • 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. In embodiments where a component is manually controlled by the Surgeon 111, instructions may be provided on the Display 125 or AR HMD 155 instructing the Surgeon 111 how to move the component.
  • the various components included in the Effector Platform 105 are controlled by the Surgical Computer 150 providing position commands that instruct the component where to move within a coordinate system.
  • the Surgical Computer 150 provides the Effector Platform 105 with instructions defining how to react when a component of the Effector Platform 105 deviates from a surgical plan. These commands are referenced in ACTIVE ⁇ 1604724607.3 Attorney Docket No. PT-6046-WO-PCT/D030902 FIG. 2A as "haptic" commands.
  • the End Effector 105B may provide a force to resist movement outside of an area where resection is planned.
  • Other commands that may be used by the Effector Platform 105 include vibration and audio cues.
  • 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. This can reduce the likelihood of error, allowing the vision system and a processor utilizing that vision system to implement the surgical plan to place a cutting guide 105D at the precise location and orientation relative to the tibia or femur to align a cutting slot of the cutting guide with the cut to be performed according to the surgical plan.
  • the cutting guide 105D may include one or more pin holes that are used by a surgeon to drill and screw or pin the cutting guide into place before performing a resection of the patient tissue using the cutting guide. This can free the robotic arm 105A or ensure that the cutting guide 105D is fully affixed without moving relative to the bone to be resected. For example, this procedure can be used to make the first distal cut of the femur during a total knee arthroplasty.
  • cutting guide 105D can be fixed to the femoral head or the acetabulum for the respective hip arthroplasty resection. It should be understood that any arthroplasty that utilizes precise cuts can use the robotic arm 105A and/or cutting guide 105D in this manner.
  • the Resection Equipment 110 is provided with a variety of commands to perform bone or tissue operations. As with the Effector Platform 105, position information may ACTIVE ⁇ 1604724607.3 Attorney Docket No. PT-6046-WO-PCT/D030902 be provided to the Resection Equipment 110 to specify where it should be located when performing resection.
  • commands provided to the Resection Equipment 110 may be dependent on the type of resection equipment.
  • the commands may specify the speed and frequency of the tool.
  • the commands may specify intensity and pulse duration.
  • Some components of the CASS 100 do not need to be directly controlled by the Surgical Computer 150; rather, the Surgical Computer 150 only needs to activate the component, which then executes software locally specifying the manner in which to collect data and provide it to the Surgical Computer 150. In the example of FIG. 2A, there are two components that are operated in this manner: the Tracking System 115 and the Tissue Navigation System 120.
  • the Surgical Computer 150 provides the Display 125 with any visualization that is needed by the Surgeon 111 during surgery.
  • 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. During the registration process, for example, the display 125 can show a preoperatively constructed 3D bone model and depict the locations of the probe as the surgeon uses the probe to collect locations of anatomical landmarks on the patient.
  • the display 125 can include information about the surgical target area. For example, in connection with a TKA, the display 125 can depict the mechanical and anatomical axes of the femur and tibia.
  • the display 125 can depict varus and valgus angles for the knee joint based on a surgical plan, and the CASS 100 can depict how such angles will be affected if contemplated revisions to the surgical plan are made. Accordingly, the display 125 is an interactive interface that can dynamically update and display ACTIVE ⁇ 1604724607.3 Attorney Docket No. PT-6046-WO-PCT/D030902 how changes to the surgical plan would impact the procedure and the final position and orientation of implants installed on bone. [0094] As the workflow progresses to preparation of bone cuts or resections, the display 125 can depict the planned or recommended bone cuts before any cuts are performed.
  • the surgeon 111 can manipulate the image display to provide different anatomical perspectives of the target area and can have the option to alter or revise the planned bone cuts based on intraoperative evaluation of the patient.
  • the display 125 can depict how the chosen implants would be installed on the bone if the planned bone cuts are performed. If the surgeon 111 choses to change the previously planned bone cuts, the display 125 can depict how the revised bone cuts would change the position and orientation of the implant when installed on the bone. [0095]
  • the display 125 can provide the surgeon 111 with a variety of data and information about the patient, the planned surgical intervention, and the implants. Various patient-specific information can be displayed, including real-time data concerning the patient's health such as heart rate, blood pressure, etc.
  • the display 125 also can include information about the anatomy of the surgical target region including the location of landmarks, the current state of the anatomy (e.g., whether any resections have been made, the depth and angles of planned and executed bone cuts), and future states of the anatomy as the surgical plan progresses.
  • the display 125 also can provide or depict additional information about the surgical target region.
  • the display 125 can provide information about the gaps (e.g., gap balancing) between the femur and tibia and how such gaps will change if the planned surgical plan is carried out.
  • the display 125 can provide additional relevant information about the knee joint such as data about the joint's tension (e.g., ligament laxity) and information concerning rotation and alignment of the joint.
  • the display 125 can depict how the planned implants' locations and positions will affect the patient as the knee joint is flexed.
  • the display 125 can depict how the use of different implants or the use of different sizes of the same implant ACTIVE ⁇ 1604724607.3 Attorney Docket No. PT-6046-WO-PCT/D030902 will affect the surgical plan and preview how such implants will be positioned on the bone.
  • the CASS 100 can provide such information for each of the planned bone resections in a TKA or THA. In a TKA, the CASS 100 can provide robotic control for one or more of the planned bone resections.
  • the CASS 100 can provide robotic control only for the initial distal femur cut, and the surgeon 111 can manually perform other resections (anterior, posterior and chamfer cuts) using conventional means, such as a 4-in-1 cutting guide or jig 105D.
  • the display 125 can employ different colors to inform the surgeon of the status of the surgical plan. For example, un-resected bone can be displayed in a first color, resected bone can be displayed in a second color, and planned resections can be displayed in a third color. Implants can be superimposed onto the bone in the display 125, and implant colors can change or correspond to different types or sizes of implants.
  • the information and options depicted on the display 125 can vary depending on the type of surgical procedure being performed. Further, the surgeon 111 can request or select a particular surgical workflow display that matches or is consistent with his or her surgical plan preferences. For example, for a surgeon 111 who typically performs the tibial cuts before the femoral cuts in a TKA, the display 125 and associated workflow can be adapted to take this preference into account. The surgeon 111 also can preselect that certain steps be included or deleted from the standard surgical workflow display.
  • the surgical workflow display can be organized into modules, and the surgeon can select which modules to display and the order in which the modules are provided based on the surgeon's preferences or the circumstances of a particular surgery.
  • Modules directed to ligament and gap balancing can include pre- and post-resection ligament/gap balancing, and the surgeon 111 can select which modules to 27 ACTIVE ⁇ 1604724607.3
  • Attorney Docket No. PT-6046-WO-PCT/D030902 include in their default surgical plan workflow depending on whether they perform such ligament and gap balancing before or after (or both) bone resections are performed.
  • the Surgical Computer 150 may provide images, text, etc. using the data format supported by the equipment.
  • the Display 125 is a holography device such as the Microsoft HoloLensTM or Magic Leap OneTM
  • the Surgical Computer 150 may use the HoloLens Application Program Interface (API) to send commands specifying the position and content of holograms displayed in the field of view of the Surgeon 111.
  • one or more surgical planning models may be incorporated into the CASS 100 and used in the development of the surgical plans provided to the surgeon 111.
  • the term "surgical planning model” refers to software that simulates the biomechanics performance of anatomy under various scenarios to determine the optimal way to perform cutting and other surgical activities. For example, for knee replacement surgeries, the surgical planning model can measure parameters for functional activities, such as deep knee bends, gait, etc., and select cut locations on the knee to optimize implant placement.
  • One example of a surgical planning model is the 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, ACTIVE ⁇ 1604724607.3 Attorney Docket No. PT-6046-WO-PCT/D030902 filed August 19, 2019, entitled "Patient Specific Surgical Method and System," the entirety of which is incorporated herein by reference.
  • 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. [0102]
  • 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.
  • Example tracking data types include position values for tracked items (e.g., anatomy, tools, etc.), ultrasound images, and surface or landmark collection points or axes.
  • the Tissue Navigation System 120 provides the Surgical Computer 150 with anatomic locations, shapes, etc. as the system operates. ACTIVE ⁇ 1604724607.3 Attorney Docket No. PT-6046-WO-PCT/D030902 [0103]
  • the Display 125 generally is used for outputting data for presentation to the user, it may also provide data to the Surgical Computer 150.
  • the Surgeon 111 may interact with a GUI to provide inputs which are sent to the Surgical Computer 150 for further processing.
  • 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.
  • a hip replacement surgery may include the Oxford Hip Score, Harris Hip Score, and WOMAC (Western Ontario and McMaster Universities Osteoarthritis index).
  • Such questionnaires can be administered, for example, by a healthcare professional directly in a clinical setting or using a mobile app that allows the patient to respond to questions directly.
  • the patient may be outfitted with one or more wearable devices that collect data relevant to the surgery.
  • the patient may be outfitted with a knee brace that includes sensors that monitor knee positioning, flexibility, etc. This information can be collected and transferred to the patient's mobile device for review by the surgeon to evaluate the outcome of the surgery and address any issues.
  • 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.
  • ACTIVE ⁇ 1604724607.3 Attorney Docket No. PT-6046-WO-PCT/D030902 [0105]
  • the post-operative stage of the episode of care can continue over the entire life of a patient.
  • the Surgical Computer 150 or other components comprising the CASS 100 can continue to receive and collect data relevant to a surgical procedure after the procedure has been performed.
  • This data may include, for example, images, answers to questions, "normal" patient data (e.g., blood type, blood pressure, conditions, medications, etc.), biometric data (e.g., gait, etc.), and objective and subjective data about specific issues (e.g., knee or hip joint pain).
  • This data may be explicitly provided to the Surgical Computer 150 or other CASS component by the patient or the patient's physician(s). Alternatively, or additionally, the Surgical Computer 150 or other CASS component can monitor the patient's EMR and retrieve relevant information as it becomes available. This longitudinal view of the patient's recovery allows the Surgical Computer 150 or other CASS component to provide a more objective analysis of the patient's outcome to measure and track success or lack of success for a given procedure.
  • a condition experienced by a patient long after the surgical procedure can be linked back to the surgery through a regression analysis of various data items collected during the episode of care. This analysis can be further enhanced by performing the analysis on groups of patients that had similar procedures and/or have similar anatomies.
  • data is collected at a central location to provide for easier analysis and use. Data can be manually collected from various CASS components in some instances. For example, a portable storage device (e.g., USB stick) can be attached to the Surgical Computer 150 into order to retrieve data collected during surgery. The data can then be transferred, for example, via a desktop computer to the centralized storage.
  • a portable storage device e.g., USB stick
  • 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.
  • the Patient 160 can send pre-operative and post-operative data to the Surgical Data Server 180, for example, using a mobile app.
  • the Healthcare Professional(s) 165 includes the surgeon and his or her staff as well as any other professionals working with Patient 160 (e.g., a personal physician, a rehabilitation specialist, etc.).
  • the EMR Database 170 may be used for both pre-operative and post-operative data. For example, assuming that the Patient 160 has given adequate permissions, the Surgical Data Server 180 may collect the EMR of the Patient pre-surgery. Then, the Surgical Data Server 180 may continue to monitor the EMR for any updates post- surgery.
  • 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., ACTIVE ⁇ 1604724607.3 Attorney Docket No. PT-6046-WO-PCT/D030902 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 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., ACTIVE ⁇ 1604724607.3 Attorney Docket No. PT-6046-WO-PCT/D030902 MongoDB
  • key-value based data models e.g., Redis
  • graph-based data models e
  • 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. [0110] 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 ACTIVE ⁇ 1604724607.3 Attorney Docket No. PT-6046-WO-PCT/D030902 Computer 150 or at the Surgical Data Server 180.
  • a robust database of episode of care data allows the generation of optimized values, measurements, distances, or other parameters and other recommendations related to the surgical procedure.
  • 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.
  • 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.
  • Image-Based Registration An image-based registration may be used to incorporate a pre-operatively generated bone model into the coordinate system of a navigation and/or robotic system.
  • a platform for image-based registration may be configured to minimize deviation from an image-free platform.
  • Image-free platforms may rely on the definition of critical regions requiring data locational data collection (e.g., using a probe interfaced to the CASS 100). The user may be notified visually of the critical regions during free collection. A coverage of these regions may be calculated after every registration, indicating to the user whether they need to collect more points.
  • the collection regions ACTIVE ⁇ 1604724607.3 Attorney Docket No. PT-6046-WO-PCT/D030902 may be critical to maintain accuracy in resection depth.
  • FIG.3 depicts a flow diagram for a method 300 of registration in accordance with an embodiment.
  • the method may include receiving 302 a pre-operative model of the patient’s anatomy.
  • the model may be generated using a variety of imaging modalities (e.g., CT, MRI, X-ray, fluorescent, ultrasound, etc.).
  • the imaging modality directly produces three-dimensional images.
  • the imaging modality produces one or more two-dimensional images that can be projected into a three-dimensional space.
  • multiple imaging and sensing modalities may be used in combination to generate the model.
  • the resulting three-dimensional model may be formatted as a mesh (e.g., data capturing a collection of vertices, edges, and faces that form a three- dimensional model) and/or as point cloud data.
  • the method 300 may include fitting 304 the model to an atlas (i.e., atlas pre- fitting).
  • an atlas is a statistical model of the shape of an object (e.g., a bone).
  • the atlas may include the principal components (e.g., eigenvector/eigenvalue pairs) of the vertices of CT segmentations after being mapped to a common number of vertices by thin-plate splines.
  • Fitting 304 may include transforming the atlas model’s principal components to minimize the difference between an atlas-generated model and a received 302 bone model.
  • the determined 306 coarse transformation may be stored in a non-transitory medium.
  • the coarse transformation is a matrix that maps the atlas model to the atlas-generated model with a minimized difference between the atlas-generated model and the received 302 bone model.
  • the atlas-generated model is in an approximate anatomic frame. Because the determined 306 coarse transformation matrix converts from the ACTIVE ⁇ 1604724607.3 Attorney Docket No.
  • the method 300 may include refining 308 the transformation to generate finer registration through techniques disclosed herein.
  • the CASS 100 may use the atlas (i.e., pre-fit) model, the atlas-generated model, or the received model as best suited for visualization and/or calculations.
  • the CASS 100 may use the atlas model for visualization to provide a consistent topology with known behavior in the software, thereby enabling the use of critical regions and autorotation in free collection.
  • all internal calculations may be performed on the received bone model placed in the appropriate space (e.g., the tracker reference frame or CASS 100 anatomic reference frame) to provide the highest fidelity possible to the calculation (e.g., pre-operatively determined implant placement).
  • the resulting registration may provide a technical advantage over traditional systems by the decomposition of the errors to provide a minimal difference between the accuracy of image-free and image- based CASS 100.
  • FIG. 4 illustrates an illustrative system 400 flowchart for image-based registration in accordance with an embodiment.
  • the system 400 may be configured to load 402 atlas data and load 404 patient data.
  • the atlas and patient data may be loaded 402/404 from any non-transitory storage medium (e.g., local media storage, a database, a cloud device, or any combination thereof).
  • the atlas data may be loaded 402 from a database, and the patient data may be loaded 404 from local media storage.
  • the atlas data may be limited to relevant data.
  • the system 400 may only load 402 atlas data for the only relevant anatomy (e.g., femur and/or tibia atlas models for a total knee ACTIVE ⁇ 1604724607.3 Attorney Docket No.
  • the system 400 may further limit the loaded 402 atlas data based on patient parameters (e.g., height, weight, gender, etc.).
  • patient parameters e.g., height, weight, gender, etc.
  • the system 400 may be configured to determine 408 whether sufficient data (e.g., atlas and/or patient data) is available for image-based registration. In certain embodiments, the determination 408 is based on the availability of relevant atlas data (e.g., relevant anatomy that may or may not match patient parameters).
  • the system 400 may revert to an image-free workflow 410.
  • the system 400 may continue with an image-based workflow.
  • the system 400 may be configured to convert 412 the loaded 404 patient data into a proper format.
  • the patient data may be transformed into segmented mesh data.
  • FIG. 5A illustrates sampled points on a segmented mesh 500 in accordance with an embodiment.
  • the system 400 may pre-fit 414 the atlas parameters to the vertices sampled from the segmented mesh.
  • vertices may be sampled in decreasing order of absolute Gauss curvature (i.e., excluding vertices with no angle defect), which tend to not favor the shaft.
  • pre-fitting 414 includes applying a non-linear optimization algorithm to the atlas parameters.
  • the non-linear optimization algorithm may generate optimized atlas parameters that can be used to generate an atlas-generated mesh.
  • the optimization algorithm is the Nelder-Mead simplex optimization. Optimization may be performed on sampled points from the mesh. In some embodiments, the shaft of the bone may be omitted from the sampled points.
  • sampling may include randomly selecting (e.g., weighted by the area of the triangle) a plurality of triangles (e.g., 2000) on the mesh, randomly selecting a point in each triangle, and randomly selecting a subset of the points.
  • sampling may include selecting the top vertices within a given percentile of a Gauss curvature (e.g., 50%) and then randomly subsampling a portion of these vertices (e.g., 400).
  • the first sampling method may produce a stable fitting for femurs.
  • the second sampling method may produce a stable fitting for tibias.
  • pre-fitting includes applying Radial Basis Fitting (RBF) to the atlas-generated mesh.
  • RBF is defined by a kernel that determines how the atlas- generated mesh is mapped to a set of points as a function of the distance between a point on the atlas-generated mesh and an input point (e.g., points collected in the free collection state).
  • an exponential kernel may be used with 10 to smooth noise from free collection.
  • the thin-plate-splines kernel defined by 2 log , where is a regularization parameter, may be used to prevent the value of the logarithm from going to infinity.
  • the thin-plate-splines kernel may provide the smallest error for mesh-to-mesh mapping.
  • Thin-plate splines may be preconditioned with a lower-order harmonic spline to provide a relatively differentiable surface.
  • points are randomly sampled from the surface as point constraints by selecting a triangle at random (e.g., weighted by the area of the triangle) and generating a random point inside the chosen triangle.
  • points which are closer than a threshold percentage e.g., 30% of the total Z-axis length of the mesh to the minimum/maximum Z-value vertex of the shaft are removed from sampling.
  • the atlas-generated mesh may be placed in the CASS 100 anatomic reference frame 416.
  • the atlas-generated mesh may be cropped along the Z-axis such that points within a threshold (e.g.,10mm) of the minimum (e.g., for a ACTIVE ⁇ 1604724607.3 Attorney Docket No. PT-6046-WO-PCT/D030902 femur) or maximum (e.g., for a tibia) Z-component of the bone model are not used in RBF to prevent RBF artifacts at the bottom of the shaft.
  • a threshold e.g.,10mm
  • the minimum e.g., for a ACTIVE ⁇ 1604724607.3
  • maximum e.g., for a tibia
  • 6A and 6B compare sampled points on a Nelder-Mead atlas fit mesh 600 with an RBF atlas fit mesh 610 in accordance with an embodiment. [0128] If the pre-fitting 414 results in spikes or self-intersection of the mesh, then the pre-fitting may be restarted. [0129] Referring back to FIG.4, the resulting mesh (e.g., non-linear optimized, RBF fit, or a combination thereof) may be cropped and stored for visualization purposes.
  • the resulting mesh e.g., non-linear optimized, RBF fit, or a combination thereof
  • the imported mesh is aligned to the RBF fit mesh, thereby placing the imported mesh in an approximate CASS 100 anatomic frame 418 as used in an image-free atlas methodology, which can reduce the amount of rotation and translation from the coarse transformation matrix over traditional methods.
  • This correction is most prominent in the sagittal plane, in which the location of the hip/ankle centers are poorly defined, being derived from coronal plane (i.e., two-dimensional) X-rays.
  • the anatomic frame may be configured such that the origin is at the intercondylar notch/eminence ridge for the femur/tibia, the medial-lateral (ML) axis is defined as the x-axis positively pointing patient- left, the anterior-posterior (AP) axis is defined as the y-axis positively pointing anterior, and the mechanical axis of the corresponding anatomy is defined as the z-axis pointing superior.
  • ML medial-lateral
  • AP anterior-posterior
  • the mechanical axis of the corresponding anatomy is defined as the z-axis pointing superior.
  • the coordinate frame may be measured intraoperatively as a part of CASS’s 100 landmarking procedure prior to free collection, using landmarks such as the intercondylar groove, eminence ridge, medial/lateral malleoli, and hip center, where the hip center landmark is calculated as the center of rotation of the femur tracker.
  • the definition of this reference frame in the optical tracking space may form a coarse transformation matrix.
  • the registration problem may be formulated between the atlas coordinate frame and the intraoperatively measured CASS 100 anatomic frame. ACTIVE ⁇ 1604724607.3 Attorney Docket No. PT-6046-WO-PCT/D030902 [0130] FIG.
  • FIG. 7 illustrates the correction of the mechanical axis in the sagittal plane provided by pre-fitting the original mesh 702 to the fitted mesh 704 in accordance with an embodiment.
  • Either the atlas pre-fit 416 or the original mesh 418 in the anatomic frame may be used as a basis for registering the original mesh to the tracker space as described herein.
  • a coarse registration matrix has been determined from the tracker frame to the CASS 100 anatomic reference frame (e.g., defined by the kinematic axis, knee centers, ankle/hip centers, etc.).
  • the atlas anatomic frame is statistically close to this CASS 100 anatomic frame, as in a standard image-free workflow.
  • the atlas anatomic frame may facilitate the use of the coarse transformation to place the mesh in the tracker space, thereby defining the initial placement 800 illustrated in FIG.8A on entry to the free collection state.
  • this does not define the pose of the bone in the tracker space with sufficient accuracy for resection depth measurement.
  • the user may be instructed to collect (426) points on the surface of the bone, particularly in regions that are relevant to such measurement.
  • the user may be presented with a visual representation of the atlas pre-fit surface in the tracker space using the coarse transformation matrix along with an indication of the critical regions defined for the particular anatomy on the atlas.
  • the critical regions are automatically defined by the system.
  • the user interface 810 may highlight collection points 812 and/or critical regions 814.
  • critical regions may be identified through virtual testing by reversing the registration process, randomly subsampling the vertices to a threshold coverage, and adding noise to the positions. The critical regions described herein may minimize registration error based on this identification process. ACTIVE ⁇ 1604724607.3 Attorney Docket No.
  • critical regions of the femur may be located on some combination of the medial and lateral distal femur, the medial and lateral posterior femur, the anterior notch, and the intercondylar notch.
  • FIGS.9A-9B illustrate sample points in example critical regions on the femur in a posterior view 900 and an anterior view 910 in accordance with an embodiment.
  • Critical regions of the tibia may be located on some combination of the medial and lateral plateaus and the anterior cortex.
  • FIG. 10 illustrates sample points in example critical regions on the tibia 1000 in accordance with an embodiment.
  • the posterior regions may constrain varus-valgus movement
  • the distal regions may constrain internal-external rotation
  • the anterior notch along with the intercondylar notch may constrain flexion.
  • the plateaus and anterior cortex together may constrain the posterior slope, while the plateaus together may constrain varus-valgus movement.
  • the extension of the anterior cortex region onto the medial cortical rim may constrain internal-external rotation.
  • critical regions of the femur may be located on some combination of the operative condyle of the distal femur, the operative condyle of the anterior femur, the operative condyle of the posterior femur, the operative condyle of the cortical rim, and the intercondylar notch.
  • FIGS.11A-11B illustrate sample points in example critical regions on the femur in a medial view 1100 and a lateral view 1110 in accordance with an embodiment.
  • Critical regions of the tibia may be located on some combination of the operative side of the plateau, the operative side of the anterior cortex, and the operative side of the cortical rim.
  • FIGS. 12A-12B illustrate sample points in example critical regions on the tibia in a medial view 1200 and lateral view 1210 in accordance with an embodiment.
  • the issue of angular constraint may be more complex.
  • the intercondylar notch as well as the cortical rim may constrain the varus-valgus movement
  • the distal region as well as the intercondylar notch and cortical rim may constrain internal-external ACTIVE ⁇ 1604724607.3
  • the anterior and the posterior regions may constrain flexion.
  • the plateau and anterior cortex together may constrain the posterior slope
  • the plateau and cortical rim may constrain varus-valgus movement
  • the cortical rim combined with the anterior cortex may constrain internal-external rotation.
  • additional or alternative critical regions may be identified with varying effects on the accuracy of registration.
  • the vertices of the atlas may be used to indicate where osteophytes tend to be present.
  • a bounding box tree may be constructed for the osteophytic region, and points may be filtered before registration if such points are too close to the surface given the current registration matrix.
  • FIGS. 13A-13B illustrate example osteophytic regions for a TKA in the femur 1300 and tibia 1310 in accordance with an embodiment.
  • FIGS. 14A-14B illustrate example osteophytic regions for a UKA in the femur 1400 and tibia 1410 in accordance with an embodiment.
  • the mesh may be deformed in real-time based on the collection 426 of points in the tracker frame. The deformity may capture any modifications to the bone surface that have occurred between initial imaging and the start of the procedure.
  • registration 422 may be triggered.
  • Registration 422 may follow an Iterative Closet Points (ICP) method.
  • ICP methods determine a point-to-point correspondence by minimizing the current point-to- point distances including minimizing a least-square error between two corresponding point sets (e.g., Horn’s method) to solve for the registration using the correspondence.
  • the registration algorithm may include iteratively (e.g., for 4 iterations) filtering the collection points outside ACTIVE ⁇ 1604724607.3 Attorney Docket No. PT-6046-WO-PCT/D030902 an outlier detection threshold, perturbing the surface, and transforming the points to be in alignment with the surface.
  • the parameters may be linearly ramped down from an initial set of parameters to a final set of parameters. These parameters as well as the parameters used for atlas pre-fitting may minimize the rotational and translational error in registering the bone model to point clouds.
  • the vertices may be evaluated 424 based on their distance to the collected points. The vertices sufficiently close to the collected points are marked as high confidence, providing feedback as to where the user should collect next 426.
  • Collected points may easily be translated 420 to the CASS 100 anatomic frame using by inversing the coarse transformation.
  • the registration process may be completed 428.
  • the operative bone may have changed significantly over the lead-time from the imaging to the time of operation.
  • it may be beneficial to fit the bone model to the points that were collected on the intraoperative bone surface.
  • Example reasons for change in the operative bone may include intraoperative osteophyte removal and cartilage degradation from wear on the knee.
  • points within a threshold e.g., 2.5mm
  • the principal constraint for image-to-point surface interpolation may be that the deformations applied to the surface should be local. When no points are near a vertex, no deformation may be applied to that vertex.
  • the constraint may be achieved by using a kernel with compact support and applying only the non-affine portion ACTIVE ⁇ 1604724607.3 Attorney Docket No. PT-6046-WO-PCT/D030902 of the determined RBF transformation.
  • the kernel may be the Wendland C6 kernel, which provides a differentiable polynomial interpolation within the determined support radius.
  • the affine deformation may be applied to the surface, and the non-affine portion of the per-vertex displacement may be found as the difference between the affinely-deformed vertex positions and the fully deformed vertex positions.
  • the non-affine portion may be applied to the original surface.
  • Vertices that are deformed by more than a threshold e.g., 1 micron
  • Curvature smoothing may be applied to the vertices that were deformed, thereby acting as a low-pass filter on the deformed regions. For example, ridges may form when a large local deformation results from fitting the surface where osteophytes have been removed. These ridges may then be smoothed.
  • FIG. 15 illustrates an example morphed mesh 1502 overlaid with an original mesh 1504 in accordance with an embodiment.
  • image-based registration methods may produce a transform from the anatomic reference frame to tracking reference frame.
  • the transform may be used to move between reference frames throughout a procedure.
  • the anatomic reference frame may be used by a system utilizing physical cut guides while the tracking reference frame may be used by the navigation system 115.
  • FIG. 16 illustrates a block diagram of an exemplary data processing system 1600 in which embodiments are implemented.
  • the data processing system 1600 is an example of a computer, such as a server or client, in which computer usable code or instructions implementing the process for illustrative embodiments of the present invention are located.
  • the data processing system 1600 may be a server computing device.
  • the data processing system 1600 may be implemented in a server or another similar computing device operably connected to a surgical system 100 as described above.
  • the data ACTIVE ⁇ 1604724607.3 Attorney Docket No. PT-6046-WO-PCT/D030902 processing system 1600 may be configured to, for example, transmit and receive information related to a patient and/or a related surgical plan with the surgical system 100.
  • the data processing system 1600 may employ a hub architecture including a north bridge and memory controller hub (NB/MCH) 1601 and south bridge and input/output (I/O) controller hub (SB/ICH) 1602.
  • a processing unit 1603, a main memory 1604, and a graphics processor 1605 may be connected to the NB/MCH 1601.
  • the graphics processor 1605 may be connected to the NB/MCH 1601 through, for example, an accelerated graphics port (AGP).
  • AGP accelerated graphics port
  • a network adapter 1606 connects to the SB/ICH 1602.
  • An audio adapter 1607, a keyboard and mouse adapter 1608, a modem 1609, a read only memory (ROM) 1610, a hard disk drive (HDD) 1611, an optical drive (e.g., CD or DVD) 1612, a universal serial bus (USB) ports and other communication ports 1613, and PCI/PCIe devices 1614 may connect to the SB/ICH 1602 through a bus system 1616.
  • the PCI/PCIe devices 1614 may include Ethernet adapters, add-in cards, and/or PC cards for notebook computers.
  • the ROM 1610 may be, for example, a flash basic input/output system (BIOS).
  • BIOS basic input/output system
  • the HDD 1611 and the optical drive 1612 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 1615 may be connected to the SB/ICH 1602.
  • An operating system may run on the processing unit 1603. The operating system may coordinate and provide control of various components within the data processing system 1600.
  • 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 from the object-oriented programs or applications executing on the data processing system 1600.
  • the data processing system 1600 may be an IBM® eServer TM System® ACTIVE ⁇ 1604724607.3 Attorney Docket No. PT-6046-WO-PCT/D030902 running the Advanced Interactive Executive operating system or the Linux operating system.
  • the data processing system 1600 may be a symmetric multiprocessor (SMP) system that includes a plurality of processors in the processing unit 1603. Alternatively, a single processor system may be employed.
  • SMP symmetric multiprocessor
  • Instructions for the operating system, the object-oriented programming system, and applications or programs are located on storage devices, such as the HDD 1611, and are loaded into the main memory 1604 for execution by the processing unit 1603.
  • the processes for embodiments described herein may be performed by the processing unit 1603 using computer usable program code, which can be located in a memory such as, for example, main memory 1604, ROM 1610, or in one or more peripheral devices.
  • a bus system 1616 may comprise one or more busses.
  • the bus system 1616 may be implemented using any type of communication fabric or architecture that provides for a transfer of data between different components or devices attached to the fabric or architecture.
  • a communication unit such as the modem 1609 or the network adapter 1606 may include one or more devices that can be used to transmit and receive data.
  • the hardware depicted in FIG. 16 may vary depending on the implementation.
  • Other internal hardware or peripheral devices such as flash memory, equivalent non-volatile memory, or optical disk drives may be used in addition to or in place of the hardware depicted.
  • the data processing system 1600 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.
  • data processing system 1600 can be any known or later developed data processing system without architectural limitation.
  • ACTIVE ⁇ 1604724607.3 Attorney Docket No. PT-6046-WO-PCT/D030902 [0152] While various illustrative embodiments incorporating the principles of the present teachings have been disclosed, the present teachings are not limited to the disclosed embodiments. Instead, this application is intended to cover any variations, uses, or adaptations of the present teachings and use its general principles.
  • 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. [0157] 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).
  • PT-6046-WO-PCT/D030902 and/or phrase presenting two or more alternative terms, whether in the description, sample embodiments, or drawings, should be understood to contemplate the possibilities of including one of the terms, either of the terms, or both terms.
  • the phrase “A or B” will be understood to include the possibilities of “A” or “B” or “A and B.”
  • 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 means greater or lesser than the value or range of values stated by 1/10 of the stated values, e.g., ⁇ 10%.

Landscapes

  • Engineering & Computer Science (AREA)
  • Computer Vision & Pattern Recognition (AREA)
  • Physics & Mathematics (AREA)
  • General Physics & Mathematics (AREA)
  • Theoretical Computer Science (AREA)
  • Prostheses (AREA)

Abstract

Des systèmes et des procédés d'alignement basé sur une image sont divulgués. Un procédé peut comprendre l'importation d'un modèle de patient préopératoire et d'un modèle de forme statistique, le modèle de patient préopératoire étant associé à l'anatomie osseuse d'un patient, le pré-ajustement du modèle de forme statistique au modèle de patient préopératoire pour générer un modèle pré-ajusté, et la détermination d'une transformation entre le modèle pré-ajusté et le modèle de forme statistique. Sur la base de la transformation déterminée, le modèle de patient préopératoire peut être converti en un modèle de patient préopératoire converti dans une image de référence anatomique du modèle de forme statistique. Une pluralité de points sur l'anatomie osseuse dans une image de référence de dispositif de suivi peuvent être collectés par un capteur et, sur la base de la pluralité de points, le modèle de patient préopératoire pré-ajusté ou converti peut être aligné sur l'image de référence de dispositif de suivi.
PCT/US2024/058882 2023-12-07 2024-12-06 Modèles de forme statistique pour procédures guidées par image Pending WO2025122878A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US202363607180P 2023-12-07 2023-12-07
US63/607,180 2023-12-07

Publications (1)

Publication Number Publication Date
WO2025122878A1 true WO2025122878A1 (fr) 2025-06-12

Family

ID=94216760

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2024/058882 Pending WO2025122878A1 (fr) 2023-12-07 2024-12-06 Modèles de forme statistique pour procédures guidées par image

Country Status (1)

Country Link
WO (1) WO2025122878A1 (fr)

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8078440B2 (en) 2008-09-19 2011-12-13 Smith & Nephew, Inc. Operatively tuning implants for increased performance
US10064686B2 (en) 2010-08-13 2018-09-04 Smith & Nephew, Inc. Systems and methods for optimizing parameters of orthopaedic procedures
US10102309B2 (en) 2011-07-20 2018-10-16 Smith & Nephew, Inc. Systems and methods for optimizing fit of an implant to anatomy
US10342636B2 (en) 2015-08-12 2019-07-09 Medineering Gmbh Medical holding arm having annular LED display means
WO2020037308A1 (fr) 2018-08-17 2020-02-20 Smith & Nephew, Inc. Procédé et système chirurgicaux spécifiques d'un patient
US11532402B2 (en) 2018-12-21 2022-12-20 Smith & Nephew, Inc. Methods and systems for providing an episode of care

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8078440B2 (en) 2008-09-19 2011-12-13 Smith & Nephew, Inc. Operatively tuning implants for increased performance
US10064686B2 (en) 2010-08-13 2018-09-04 Smith & Nephew, Inc. Systems and methods for optimizing parameters of orthopaedic procedures
US10102309B2 (en) 2011-07-20 2018-10-16 Smith & Nephew, Inc. Systems and methods for optimizing fit of an implant to anatomy
US10342636B2 (en) 2015-08-12 2019-07-09 Medineering Gmbh Medical holding arm having annular LED display means
WO2020037308A1 (fr) 2018-08-17 2020-02-20 Smith & Nephew, Inc. Procédé et système chirurgicaux spécifiques d'un patient
US11532402B2 (en) 2018-12-21 2022-12-20 Smith & Nephew, Inc. Methods and systems for providing an episode of care

Non-Patent Citations (4)

* Cited by examiner, † Cited by third party
Title
ANAS EMRAN MOHAMMAD ET AL: "Registration of a statistical model to intraoperative ultrasound for scaphoid screw fixation", INTERNATIONAL JOURNAL OF COMPUTER ASSISTED RADIOLOGY AND SURGERY, SPRINGER, DE, vol. 11, no. 6, 16 March 2016 (2016-03-16), pages 957 - 965, XP035863008, ISSN: 1861-6410, [retrieved on 20160316], DOI: 10.1007/S11548-016-1370-Y *
HONG XU ET AL: "Image2SSM: Reimagining Statistical Shape Models from Images with Radial Basis Functions", ARXIV.ORG, CORNELL UNIVERSITY LIBRARY, 201 OLIN LIBRARY CORNELL UNIVERSITY ITHACA, NY 14853, 19 May 2023 (2023-05-19), XP091513660 *
RASOULIAN ABTIN ET AL: "Lumbar Spine Segmentation Using a Statistical Multi-Vertebrae Anatomical Shape+Pose Model", IEEE TRANSACTIONS ON MEDICAL IMAGING, IEEE, USA, vol. 32, no. 10, 31 October 2013 (2013-10-31), pages 1890 - 1900, XP011528122, ISSN: 0278-0062, [retrieved on 20130927], DOI: 10.1109/TMI.2013.2268424 *
SINKO MARTIN ET AL: "3D registration of the point cloud data using ICP algorithm in medical image analysis", 2018 ELEKTRO, IEEE, 21 May 2018 (2018-05-21), pages 1 - 6, XP033365669, DOI: 10.1109/ELEKTRO.2018.8398245 *

Similar Documents

Publication Publication Date Title
US20250359939A1 (en) Patient-specific surgical method and system
AU2019332975B2 (en) Robotic assisted ligament graft placement and tensioning
US11832893B2 (en) Methods of accessing joints for arthroscopic procedures
US20250200921A1 (en) Three-dimensional selective bone matching from two-dimensional image data
US20230363831A1 (en) Markerless navigation system
US20220087749A1 (en) Augmented reality ready optical tracking system
US20230065449A1 (en) Improved and cass assisted osteotomies
US20210244481A1 (en) Multi-level positional tracking
JP2023545257A (ja) 膝蓋骨に対する置換術を計画するコンピュータ実装方法
EP3930584B1 (fr) Mesure d'une force à l'aide d'un système de suivi
US20220265362A1 (en) Optical tracking device with built-in structured light module
US11931107B1 (en) Intraoperative three-dimensional bone model generation
US12144551B1 (en) Computer-assisted tissue navigation
US20220183762A1 (en) Small form modular tracking device for computer assisted surgery
WO2024238453A1 (fr) Méthode de planification chirurgicale et caractérisations pour des résultats optimisés
WO2024254421A1 (fr) Ensembles marqueurs de repère pour systèmes de navigation chirurgicale
WO2024072886A1 (fr) Systèmes et procédés de configuration de systèmes chirurgicaux pour effectuer une intervention spécifique à un patient avec des préférences de chirurgien
US20250302538A1 (en) Virtual alignment of patient anatomy
WO2025122878A1 (fr) Modèles de forme statistique pour procédures guidées par image
US20250143797A1 (en) Augmented reality registration device for navigated surgery
US20250302546A1 (en) Systems and methods for recalling tracking information via applied landmarks
US20240315906A1 (en) Devices and systems for assessing laxity in a joint
US12502222B2 (en) Systems and methods for fusing arthroscopic video data
WO2025153723A1 (fr) Approche pour enregistrement sans correspondance en arthroplastie
US20240000513A1 (en) Systems and methods for fusing arthroscopic video data

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 24834512

Country of ref document: EP

Kind code of ref document: A1