Patella tracking method and system

Abstract

A computer-implemented method for improving patello-femoral response is described. A computing system characterizes anterior geometry of the patella and determines a position of a posterior apex of the patella relative to one or more features of the anterior geometry of the patella. The computing system also receives positioning information about the patella as the knee moves through a range of motion. The computing system provides one or more recommendations for improving the patello-femoral response.

Description

[0001] Priority declaration

[0002] This application claims the benefit of priority to U.S. Provisional Application No. 62 / 715,558, filed on August 7, 2018, entitled “Patella Tracking Method and System,” which is incorporated herein by reference in its entirety. Technical Field

[0003] The present disclosure generally relates to methods, systems and apparatus related to computer-assisted surgery systems, which include various hardware and software components that work together to enhance surgical workflow. The disclosed techniques can be applied, for example, to shoulder, hip and knee arthroplasties, as well as other surgical interventions, such as arthroscopic surgery, spinal surgery, maxillofacial surgery, rotator cuff surgery, ligament repair and replacement surgery. More specifically, the present disclosure relates to tracking the patella during knee replacement surgery using an optical surgical navigation system to ensure proper joint function. Background Art

[0004] The use of computers, robots and imaging to assist orthopedic surgery is known in the art. There has been a great deal of research and development into computer-assisted navigation and robotic systems for guiding surgical procedures. For example, surgical navigation systems can help surgeons locate patient anatomical structures, guide surgical instruments and implant medical devices with high accuracy. Surgical navigation systems typically employ various forms of computing technology to perform various standard and minimally invasive surgical procedures and techniques. In addition, these systems allow surgeons to more accurately plan, track and navigate the placement of instruments and implants relative to the patient's body, as well as perform preoperative and intraoperative body imaging.

[0005] Surgeons often use a "tracking array" attached to surgical components in conjunction with a surgical navigation system when performing implant surgeries, such as knee replacements and revision knee replacements. The tracking array allows the surgeon to accurately track the position of the surgical components as well as the patient's anatomy during surgery. By knowing the physical location of the tracking array, the tracking system and its associated software are able to detect and calculate the position of the tracked component relative to the surgical planning image.

[0006] Patellofemoral pain is a common complication associated with knee replacement and revision knee replacement. Current technology does not take into account patellar function and position prior to removal of the implant, cement, and tissue. The result is often a misaligned or improperly positioned patella, which may require further surgical intervention. Additionally, without an understanding of patellar function, it is difficult for surgeons to assess the need for patellar replacement. Summary of the invention

[0007] The present invention provides a computer-implemented method for improving patello-femoral response. The method includes: characterizing the anterior geometry of the patella; determining the position of the posterior apex of the patella relative to one or more features of the anterior geometry of the patella; receiving positioning information related to the patella as the knee joint moves through a range of motion; and providing one or more recommendations for improving the patello-femoral response.

[0008] According to some embodiments, characterizing anterior geometry of the patella includes: receiving, by a probe tracking system, a plurality of locations of a probe as the probe moves across an anterior surface of the patella; and storing position information about the plurality of locations to form the anterior geometry of the patella.

[0009] According to certain embodiments, determining the position of the posterior apex of the patella includes: receiving the position of the probe by a probe tracking system when the probe is placed on the posterior apex of the patella; storing the position as the location of the posterior apex; and determining the spatial relationship between the location of the posterior apex and one or more features of the anterior portion of the patella.

[0010] According to some embodiments, receiving positioning information related to the patella includes: detecting the positioning of the patella at each of a plurality of discrete flexion increments of the knee; and storing the positioning of the patella for each discrete flexion increment. According to certain other embodiments, storing the positioning of the patella for each discrete flexion increment includes converting the positioning of the patella into a model representing movement of the patella. According to still other embodiments, receiving positioning information related to the patella also includes: determining whether the positioning information is sufficient to define patellar motion; and in response to determining that the positioning information is insufficient, detecting the positioning of the patella at each of one or more supplemental discrete flexion increments of the knee.

[0011] According to some embodiments, providing one or more recommendations includes: simulating predicted post-operative patellar movement information; comparing the positioning information with the predicted post-operative patellar movement information; and updating the surgical plan to coordinate the positioning information and the predicted post-operative patellar movement information.

[0012] According to some embodiments, updating the surgical plan includes one or more of: changing the location at which the surgical implant is placed; changing the orientation at which the surgical implant is placed; and changing the selection of the surgical implant to be placed.

[0013] According to some embodiments, the one or more recommendations reduce post-operative offset of the patella.

[0014] A method for tracking a posterior apex of a patella during a surgical procedure is also provided. The method includes: drilling a cavity between the posterior apex of the patella and an anterior side of the patella; inserting a marker into the cavity from the anterior side of the patella; determining a relative position of the marker relative to the posterior apex; receiving positioning information of the marker during the surgical procedure; and determining a position of the posterior axis based on the positioning information and the relative position of the marker relative to the posterior apex.

[0015] According to some embodiments, drilling the cavity includes: cutting at least a portion of the patellar tendon to enable rotation of the patella; and drilling the cavity from a posterior apex of the patella to an anterior side of the patella.

[0016] According to some embodiments, drilling a cavity includes: locating the posterior axis of the patella using a drill guide; and drilling a cavity from the anterior side of the patella to the posterior apex of the patella using the drill guide. According to some other embodiments, the drill guide also determines the thickness of the patella. According to some other embodiments, the drill guide reduces the progress of the drill for drilling a cavity substantially at the posterior apex of the patella.

[0017] According to some embodiments, the longitudinal axis of the mark intersects the posterior apex.

[0018] A method for tracking a posterior apex of a patella during a surgical procedure is also provided. The method includes: drilling a cavity between an anterior side and a posterior side of the patella; determining a relative position of the posterior side of the cavity relative to the posterior apex of the patella; inserting a marker into the cavity from the anterior side of the patella; determining a relative position of the marker relative to the posterior apex; receiving location information of the marker during the surgical procedure; and determining a location of the posterior axis based on the location information and the relative position of the marker relative to the posterior apex.

[0019] According to some embodiments, drilling the cavity includes: cutting at least a portion of the patellar tendon to enable rotation of the patella; and drilling the cavity from a posterior side of the patella to an anterior side of the patella.

[0020] According to some embodiments, drilling a cavity includes: placing a drill guide in contact with the posterior side of the patella; and using the drill guide to drill a cavity from the anterior side of the patella to the posterior side of the patella. According to some other embodiments, the drill guide also determines the thickness of the patella. According to some other embodiments, the drill guide reduces the progress of the drill for drilling a cavity substantially on the posterior side of the patella. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] The accompanying drawings, which are incorporated in and form a part of this specification, illustrate embodiments of the present disclosure and, together with the written description, serve to explain the principles, characteristics, and features of the present invention. In the drawings:

[0022] Figure 1 An operating room including an illustrative computer assisted surgery system (CASS) is depicted in accordance with an embodiment.

[0023] Figure 2A Depicted are illustrative control instructions provided by the surgical computer to other components of CASS according to an embodiment.

[0024] Figure 2B Depicted are illustrative control instructions provided to a surgical computer by components of CASS according to an embodiment.

[0025] Figure 2C An illustrative implementation is depicted in which a surgical computer is connected to a surgical data server via a network in accordance with an embodiment.

[0026] Figure 3 A surgical patient care system and illustrative data sources are depicted in accordance with an embodiment.

[0027] Figure 4A An illustrative flow chart for determining a preoperative surgical plan is depicted in accordance with an embodiment.

[0028] Figure 4B An illustrative flow chart for determining a care episode including pre-operative, intra-operative, and post-operative actions is depicted in accordance with an embodiment.

[0029] Figure 4C An illustrative graphical user interface including an image depicting implant placement is depicted in accordance with an embodiment.

[0030] Figure 5A is a block diagram depicting a system according to some embodiments of the present invention.

[0031] Figure 5B is a perspective view of a probe according to some embodiments of the present invention.

[0032] Figure 5C An exemplary output of a knee extended and measured in discrete increments is shown in accordance with certain embodiments of the present invention.

[0033] Figure 5D An exemplary output of a knee being bent and measured in discrete increments is shown in accordance with some embodiments of the present invention.

[0034] Figure 6 is a block diagram depicting a method according to one embodiment of the present invention.

[0035] Figure 7 is a block diagram depicting a system according to some embodiments of the present invention.

[0036] Fig. 8ADepicted is a sample procedure for preparing a patella for a tracker device according to some embodiments of the present invention.

[0037] Figure 8B An alternative sample process for preparing a patella for a tracker device according to some embodiments of the present invention is depicted.

[0038] Fig. 9A Depicted is an anatomical representation of the patella including a cavity for inserting a tracker device according to some embodiments of the present invention.

[0039] Figure 9B-9E A tracker device attached to the patella is depicted according to some embodiments of the present invention.

[0040] Fig.10 A tracker device is shown attached to a prepared patella according to some embodiments of the present invention. DETAILED DESCRIPTION

[0041] The present disclosure describes an exemplary system and method for tracking the patella during surgery using an optical surgical navigation system. By tracking the patella during surgery, appropriate measures can be taken to ensure proper joint function. In the following description, for the purpose of explanation, many specific details are set forth in order to provide a thorough understanding of the example embodiments. However, it will be apparent to those skilled in the art that the embodiments may be practiced without these specific details.

[0042] The present disclosure is not limited to the specific systems, devices, and methods described, as these systems 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.

[0043] As used in this document, the singular forms "a", "an", and "the" include plural references unless the context clearly dictates otherwise. Unless otherwise defined, all scientific and technical terms used herein have the same meaning as commonly understood by those of ordinary skill in the art. Nothing in this disclosure should be construed as an admission that the embodiments described in this disclosure are not entitled to antedate the date of this disclosure due to prior invention. As used in this document, the term "including" means "including but not limited to."

[0044] definition

[0045] For the purposes of this disclosure, the term "implant" is used to refer to a prosthetic device or structure manufactured to replace or enhance a biological structure. For example, in total hip replacement surgery, a prosthetic acetabular cup (implant) is used to replace or enhance a patient's worn or damaged acetabulum. Although the term "implant" is generally considered to mean an artificial structure (in contrast to a transplant), for the purposes of this specification, an implant may include biological tissue or material transplanted to replace or enhance a biological structure.

[0046] For purposes of this disclosure, the term "real time" is used to refer to calculations or operations that are performed on the fly as events occur or inputs are received by the surgical system. However, the use of the term "real time" is not intended to exclude operations that incur some delay between input and response, as long as the delay is an unintended consequence of the performance characteristics of the machine.

[0047] Although much of the disclosure relates to surgeons or other medical personnel by specific titles or roles, nothing in the disclosure is intended to be limited to specific titles or functions. A surgeon or medical personnel may include any doctor, nurse, medical staff, or technician. Unless otherwise explicitly defined, any of these terms or titles may be used interchangeably with users of the system disclosed herein. For example, in some embodiments, references to surgeons may also apply to technicians or nurses.

[0048] CASS Ecosystem Overview

[0049] Figure 1 An illustration of an exemplary computer-assisted surgery system (CASS) 100 is provided according to some embodiments. As described in further detail in the following sections, CASS uses computers, robotics, and imaging technology to assist surgeons in performing orthopedic surgical procedures, such as total knee arthroplasty (TKA) or total hip arthroplasty (THA). For example, a surgical navigation system can assist surgeons in locating patient anatomy, guiding surgical instruments, and implanting medical devices with a high degree of accuracy. Surgical navigation systems such as CASS 100 typically employ various forms of computing technology to perform a variety of standard and minimally invasive surgical procedures and techniques. In addition, these systems allow surgeons to more accurately plan, track, and navigate the placement of instruments and implants relative to the patient's body, as well as perform preoperative and intraoperative body imaging.

[0050] The effector platform 105 positions the surgical tools relative to the patient during surgery. The exact components of the effector platform 105 will vary depending on the embodiment being employed. For example, for knee surgery, the effector platform 105 may include an end effector 105B that holds the surgical tools or instruments during their use. The end effector 105B may be a handheld device or instrument used by the surgeon (e.g., handpiece or cutting guide or clamp), or, alternatively, the end effector 105B may include a device or instrument held or positioned by the robotic arm 105A.

[0051] The actuator platform 105 may include a limb positioner 105C for positioning a patient's limb during surgery. An example of a limb positioner 105C is the SMITH AND NEPHEW SPIDER2 system. The limb positioner 105C may be manually operated by the surgeon, or alternatively change the limb position based on instructions received from the surgical computer 150 (described below).

[0052] Resection device 110 ( Figure 1 The resection device 110 is a device that is used to perform bone or tissue resection (not shown) using, for example, mechanical, ultrasonic, or laser techniques. Examples of the resection device 110 include drilling devices, deburring devices, oscillating sawing devices, vibrating impact devices, reamer, ultrasonic bone cutting devices, radiofrequency ablation devices, and laser ablation systems. In some embodiments, the resection device 110 is held and operated by the surgeon during surgery. In other embodiments, the actuator platform 105 can be used to hold the resection device 110 during use.

[0053] The effector platform 105 may also include a cutting guide or fixture 105D for guiding a saw or drill used to remove tissue during surgery. Such a cutting guide 105D may be integrally formed as part of the effector platform 105 or robotic arm 105A, or the cutting guide may be a separate structure that can be matably and / or removably attached to the effector platform 105 or robotic arm 105A. The effector platform 105 or robotic arm 105A may be controlled by CASS 100 to position the cutting guide or fixture 105D proximate to the patient's anatomical structure according to a surgical plan developed preoperatively or intraoperatively, so that the cutting guide or fixture will produce precise bone cuts according to the surgical plan.

[0054] The tracking system 115 uses one or more sensors to collect real-time position data of the patient's anatomical structures and surgical instruments. For example, for TKA surgery, the tracking system can provide the position and orientation of the end effector 105B during operation. In addition to the positioning data, the data from the tracking system 115 can also be used to infer the speed / acceleration of the anatomical structure / instrument, which can be used for tool control. In some embodiments, the tracking system 115 can use a tracker array attached to the end effector 105B to determine the position and orientation of the end effector 105B. The position of the end effector 105B can be inferred based on the position and orientation of the tracking system 115 and the known relationship in three-dimensional space between the tracking system 115 and the end effector 105B. Various types of tracking systems can be used in various embodiments of the present invention, including but not limited to infrared (IR) tracking systems, electromagnetic (EM) tracking systems, video or image-based tracking systems, and ultrasound registration tracking systems.

[0055] Any suitable tracking system can be used to track surgical objects and patient anatomy in the operating room. For example, a combination of IR and visible light cameras can be used in an array. Various illumination sources, such as IR LED light sources, can illuminate the scene, thereby allowing three-dimensional imaging. In some embodiments, this may include stereoscopic imaging, tri-scopic imaging, quad-scopic imaging, etc. In addition to the camera array being attached to the cart in some embodiments, additional cameras can be placed throughout the operating room. For example, a handheld tool or a headset worn by an operator / surgeon may include imaging capabilities that transmit images back to a central processor to associate these images with images captured by the camera array. This can give a more robust image for an environment modeled using multiple perspectives. In addition, some imaging devices may have a suitable resolution or a suitable perspective for the scene to pick up information stored in a quick response (QR) code or barcode. This can help identify specific objects that are not manually registered in the system.

[0056] In some embodiments, specific objects can be manually registered in the system by the surgeon before or during surgery. For example, by interacting with a user interface, the surgeon can identify the starting position of a tool or bone structure. By tracking fiducial markers associated with the tool or bone structure, or by using other conventional image tracking modes, the processor can track the tool or bone in the three-dimensional model as the tool or bone moves through the environment.

[0057] In some embodiments, certain marks, such as fiducial marks that identify individuals, important tools, or bones in the operating room, can include passive or active identifiers that can be picked up by a camera or camera array associated with the tracking system. For example, an IRLED can flash a pattern, transmitting a unique identifier to the source of the pattern, thereby providing a dynamic identification mark. Similarly, one-dimensional or two-dimensional optical codes (barcodes, QR codes, etc.) can be attached to objects in the operating room to provide passive identification that can occur based on image analysis. If these codes are placed asymmetrically on the object, they can also be used to determine the orientation of the object by comparing the position of the identifier with the range of the object in the image. For example, a QR code can be placed in the corner of a tool tray, thereby allowing the orientation and features of the tray to be tracked. Other tracking modes are explained in various places in the text. For example, in some embodiments, surgeons and other staff can wear augmented reality headsets to provide additional camera angles and tracking capabilities.

[0058] In addition to optical tracking, certain features of an object, such as a fiducial marker fixed to a tool or bone, can be tracked by recording the physical properties of the object and associating it with the object that can be tracked. For example, a surgeon can perform a manual registration process whereby the tracked tool and the tracked bone can be manipulated relative to each other. By striking the tip of the tool against the surface of the bone, a three-dimensional surface can be drawn for the bone, which is associated with the position and orientation of the reference frame relative to the fiducial marker. By optically tracking the position and orientation (posture) of the fiducial marker associated with the bone, a model of the surface can be tracked with the environment by extrapolation.

[0059] The registration process of registering CASS 100 to the relevant anatomical structure of the patient can also involve the use of anatomical landmarks, such as landmarks on bones or cartilage. For example, CASS 100 can include a 3D model of the relevant bones or joints, and the surgeon can use a probe connected to CASS to collect data about the positioning of bone landmarks on the patient's actual bones during surgery. Bone landmarks may include, for example, the medial and lateral tibia, the proximal femur and the distal tibia, and the center of the hip joint. CASS 100 can compare and register the position data of the bone landmarks collected by the surgeon with the position data of the same landmarks in the 3D model. Alternatively, CASS 100 can build a 3D model of the bone or joint without preoperative image data by using the position data of the bone landmarks and bone surfaces collected by the surgeon using the CASS probe or other means. The registration process may also include determining various axes of the joint. For example, for TKA, the surgeon can use CASS 100 to determine the anatomical axis and mechanical axis of the femur and tibia. The surgeon and CASS 100 can identify the center of the hip joint by moving the patient's leg in a spiral direction (ie, circular) so that CASS can determine where the center of the hip joint is located.

[0060] Organizational Navigation System 120 ( Figure 1 The system (not shown) provides the surgeon with intraoperative real-time visualization of the patient's bone, cartilage, muscle, nerve and / or vascular tissue surrounding the surgical area. Examples of systems that can be used for tissue navigation include fluorescent imaging systems and ultrasound systems.

[0061] The display 125 provides a graphical user interface (GUI) that displays images acquired by the tissue navigation system 120 and other information related to the procedure. For example, in one embodiment, the display 125 overlays image information acquired from various modalities (e.g., CT, MRI, X-ray, fluorescence, ultrasound, etc.), acquired preoperatively or intraoperatively, to provide the surgeon with various views of the patient's anatomy as well as real-time conditions. The display 125 may include, for example, one or more computer monitors. As an alternative or in addition to the display 125, one or more members of the surgical staff may wear an augmented reality (AR) head mounted device (HMD). For example, in Figure 1 In FIG. 1 , surgeon 111 wears an AR HMD 155, which can, for example, overlay pre-operative image data on the patient or provide surgical planning suggestions. Various exemplary uses of the AR HMD 155 in surgical procedures are detailed in the following sections.

[0062] The surgical computer 150 provides control instructions to the various components of the CASS 100, collects data from those components, and provides general processing for the various data required during surgery. In some embodiments, the surgical computer 150 is a general-purpose computer. In other embodiments, the surgical computer 150 can be a parallel computing platform that uses multiple central processing units (CPUs) or graphics processing units (GPUs) to perform processing. In some embodiments, the surgical computer 150 is connected to a remote server via one or more computer networks (e.g., the Internet). For example, the remote server can be used to store data or perform computationally intensive processing tasks.

[0063] Various techniques generally known in the art may be used to connect the surgical computer 150 to the other components of the CASS 100. Furthermore, the computer may be connected to the surgical computer 150 using a mix of techniques. For example, the end effector 105B may be connected to the surgical computer 150 via a wired (i.e., serial) connection. The tracking system 115, tissue navigation system 120, and display 125 may similarly be connected to the surgical computer 150 using wired connections. Alternatively, the tracking system 115, tissue navigation system 120, and display 125 may be connected to the surgical computer 150 using wireless technologies, such as, but not limited to, Wi-Fi, Bluetooth, near field communication (NFC), or ZigBee.

[0064] Electric impact and acetabular reamer device

[0065] The above article about Figure 1Part of the flexibility of the described CASS design is that additional or alternative devices can be added to the CASS 100 as needed to support specific surgical procedures. For example, in the context of hip surgery, the CASS 100 may include an electric impact device. The impact device is designed to repeatedly apply impact forces, which the surgeon can use to perform activities such as implant alignment. For example, in total hip arthroplasty (THA), the surgeon will often use the impact device to insert the prosthetic acetabular cup into the acetabulum of the implant host. Although the impact device can be manual in nature (e.g., operated by the surgeon striking the impactor with a hammer), it is generally easier and faster to use an electric impact device in a surgical environment. For example, a battery attached to the device can be used to power the electric impact device. Various attachments can be connected to the electric impact device to allow the impact force to be directed in various ways as needed during surgery. Also in the context of hip surgery, the CASS 100 may include an electric robot-controlled end effector for reaming the acetabulum to accommodate an acetabular cup implant.

[0066] In robotic-assisted THA, the patient's anatomy can be registered to CASS 100 using CT or other image data, identification of anatomical landmarks, a tracker array attached to the patient's bones, and one or more cameras. The tracker array can be mounted on the iliac spine using clamps and / or bone pins, and such trackers can be installed externally through the skin, or internally (posterolateral or anterolateral) through an incision made for THA. For THA, CASS 100 can utilize one or more femoral cortical screws inserted into the proximal femur as checkpoints to assist in the registration process. CASS 100 can also utilize one or more checkpoint screws inserted into the pelvis as additional checkpoints to assist in the registration process. The femoral tracker array can be fixed to or mounted in the femoral cortical screw. CASS 100 can employ a step of using a probe to verify registration, with the surgeon placing the probe precisely on key areas of the proximal femur and pelvis identified for the surgeon on display 125. A tracker may be located on the robotic arm 105A or end effector 105B to register the arm and / or end effector to CASS 100. The verification step may also utilize proximal and distal femoral checkpoints. CASS 100 may utilize color cues or other cues to inform the surgeon that the registration process of the associated bone and the robotic arm 105A or end effector 105B has been verified to a certain accuracy (e.g., within 1 mm).

[0067] For THA, CASS 100 may include a pin tracking option using a femoral array to allow the surgeon to capture the pin position and orientation during surgery and calculate the patient's hip length and offset values. Based on the information provided about the patient's hip and the planned implant position and orientation after pin tracking is completed, the surgeon can modify or adjust the surgical plan.

[0068] For robot-assisted THA, CASS 100 may include one or more electric reamers connected or attached to a robotic arm 105A or an end effector 105B that prepares the pelvis to receive an acetabular implant according to a surgical plan. The robotic arm 105A and / or the end effector 105B may notify the surgeon and / or control the power of the reamer to ensure that the acetabulum is being resected (reamed) according to the surgical plan. For example, if the surgeon attempts to resect the bone outside the boundary of the bone to be resected according to the surgical plan, CASS 100 may turn off the reamer or instruct the surgeon to turn off the reamer. CASS 100 may provide the surgeon with the option of turning off or releasing the robotic control of the reamer. The display 125 may depict the progress of the bone being resected (reamed) compared to the surgical plan using different colors. The surgeon may view the display of the bone being resected (reamed) to guide the reamer to complete the reaming according to the surgical plan. CASS 100 can provide visual or audible cues to the surgeon to alert the surgeon that a resection is being performed that is not in accordance with the surgical plan.

[0069] After reaming, CASS 100 can use a manual or electric impactor attached to or connected to the robotic arm 105A or the end effector 105B to impact the trial implant and the final implant into the acetabulum. The robotic arm 105A and / or the end effector 105B can be used to guide the impactor to impact the trial implant and the final implant into the acetabulum according to the surgical plan. CASS100 can display the position and orientation of the trial implant and the final implant relative to the bone to inform the surgeon about the orientation and position of the trial implant and the final implant compared to the surgical plan, and the display 125 can display the position and orientation of the implant as the surgeon manipulates the leg and hip joint. If the surgeon is not satisfied with the original implant position and orientation, CASS 100 can provide the surgeon with the option of replanning and re-reaming and implant impact by preparing a new surgical plan.

[0070] Preoperatively, CASS 100 can develop the proposed surgical plan based on the three-dimensional model of the hip joint and other patient-specific information, such as the mechanical and anatomical axis of the leg bone, the epicondylar axis, the femoral neck axis, the size (e.g., length) of the femur and hip joint, the midline axis of the hip joint, the ASIS axis of the hip joint, and the position of anatomical landmarks, such as the lesser trochanter landmark, the distal landmark and the rotation center of the hip joint. The surgical plan developed by CASS can provide recommended optimal implant size and implant position and orientation based on the three-dimensional model of the hip joint and other patient-specific information. The surgical plan developed by CASS can include details of suggestions on offset value, tilt and anteversion value, rotation center, cup size, median value, upper-lower fitting value, femoral stem size and length.

[0071] For THA, the surgical plan developed by CASS can be viewed preoperatively and intraoperatively, and the surgeon can modify the surgical plan developed by CASS preoperatively or intraoperatively. The surgical plan developed by CASS can show the planned resection of the hip joint and superimpose the planned implant on the hip joint based on the planned resection. CASS 100 can provide the surgeon with the option of different surgical workflows presented to the surgeon based on the surgeon's preferences. For example, the surgeon can choose from different workflows based on the number and type of anatomical landmarks examined and captured and / or the location and number of tracker arrays used in the registration process.

[0072] According to some embodiments, the electric impact device used with CASS 100 can operate with a variety of different settings. In some embodiments, the surgeon adjusts the settings by a manual switch or other physical mechanism on the electric impact device. In other embodiments, a digital interface can be used that allows, for example, touch screen settings input via the electric impact device. Such a digital interface can allow the available settings to be changed based on, for example, the type of attachment connected to the electric attachment device. In some embodiments, instead of adjusting the settings on the electric impact device itself, the settings can be changed by communicating with a robot or other computer system within CASS 100. Such a connection can be established using, for example, a Bluetooth or Wi-Fi network module on the electric impact device. In another embodiment, the impact device and the end piece can include features that allow the impact device to know which end piece (cup impactor, medullary needle handle, etc.) is attached without the surgeon having to take action, and adjust the settings accordingly. This can be achieved, for example, by a QR code, a barcode, an RFID tag, or other methods.

[0073] Examples of settings that can be used include cup impact settings (e.g., unidirectional, specified frequency range, specified force and / or energy range); medullary pin impact settings (e.g., bidirectional / oscillating at a specified frequency range, specified force and / or energy range); femoral head impact settings (e.g., unidirectional / single puff at a specified force or energy); and stem impact settings (e.g., unidirectional at a specified force or energy at a specified frequency). Additionally, in some embodiments, the electric impact device includes settings associated with acetabular liner impact (e.g., unidirectional / single puff at a specified force or energy). There can be multiple settings for each type of liner, such as polymeric materials, ceramic materials, black crystal materials, or other materials. Additionally, the electric impact device can provide settings for different bone qualities based on the surgeon's preoperative testing / imaging / knowledge and / or intraoperative evaluation.

[0074] In some embodiments, the electric impact device includes a feedback sensor that collects data during use of the instrument and sends the data to a computing device, such as a controller within the device or surgical computer 150. This computing device can then record the data for later analysis and use. Examples of data that can be collected include, but are not limited to, sound waves, a predetermined resonant frequency of each instrument, reaction forces or rebound energies from the patient's bone, the position of the device relative to the bone anatomy registered with imaging (e.g., fluorescence, CT, ultrasound, MRI, etc.), and / or external strain gauges on the bone.

[0075] Once the data is collected, the computing device can execute one or more algorithms in real time or near real time to assist the surgeon in performing the surgical procedure. For example, in some embodiments, the computing device uses the collected data to derive information such as the appropriate final medullary pin size (femoral); the time when the stem is fully seated (femoral side); or for THA, the time when the cup is in place (depth and / or orientation). Once the information is known, the information can be displayed for the surgeon to view, or it can be used to activate haptic or other feedback mechanisms to guide the surgical procedure.

[0076] In addition, the data derived from the aforementioned algorithm can be used to drive the operation of the device. For example, during the insertion of a prosthetic acetabular cup with an electric impact device, once the implant is fully in place, the device can automatically extend the impact head (e.g., end effector) to move the implant to the appropriate position, or shut down the device power. In one embodiment, the derived information can be used to automatically adjust the setting of the bone quality, where the electric impact device should use less power to reduce the femoral / acetabulum / pelvic fracture or damage to surrounding tissue.

[0077] Robotic Arm

[0078] In some embodiments, CASS 100 includes a robotic arm 105A that acts as an interface for stabilizing and holding various instruments used during surgical procedures. For example, in the context of hip surgery, these instruments may include, but are not limited to, retractors, sagittal or reciprocating saws, reamer handles, cup impactors, medullary needle handles, and stem inserters. The robotic arm 105A may have multiple degrees of freedom (such as a spider device) and have the ability to lock into place (e.g., by pressing a button, voice activation, the surgeon removing the hand from the robotic arm, or other methods).

[0079] In some embodiments, the movement of the robotic arm 105A can be achieved by using a control panel built into the robotic arm system. For example, the display screen can include one or more input sources, such as physical buttons or a user interface with one or more icons, that direct the movement of the robotic arm 105A. The surgeon or other medical personnel can engage with the one or more input sources to position the robotic arm 105A when performing a surgical procedure.

[0080] The tools or end effectors 105B attached or integrated into the robotic arm 105A may include, but are not limited to, deburring devices, scalpels, cutting devices, retractors, joint tensioning devices, etc. In embodiments using end effectors 105B, the end effectors may be positioned at the end of the robotic arm 105A such that any motor control operations are performed within the robotic arm system. In embodiments using tools, the tools may be fixed at the distal end of the robotic arm 105A, but the motor control operations may reside within the tool itself.

[0081] The robotic arm 105A can be maneuvered internally to stabilize the robotic arm, thereby preventing it from falling and hitting the patient, the operating table, surgical staff, etc., and allowing the surgeon to move the robotic arm without having to fully support its weight. As the surgeon moves the robotic arm 105A, the robotic arm can provide some resistance to prevent the robotic arm from moving too quickly or activating too many degrees of freedom at once. The position and locking state of the robotic arm 105A can be tracked, for example, by a controller or surgical computer 150.

[0082] In some embodiments, the robotic arm 105A can be moved manually (e.g., by a surgeon) or moved to its ideal position and orientation for the task being performed using an internal motor. In some embodiments, the robotic arm 105A can be enabled to operate in a "free" mode that allows the surgeon to position the arm in a desired position without restriction. When in free mode, the position and orientation of the robotic arm 105A can still be tracked as described above. In one embodiment, during a specified portion of a surgical plan tracked by a surgical computer 150, certain degrees of freedom can be selectively released upon input by a user (e.g., a surgeon). A design in which the robotic arm 105A is internally powered by hydraulics or a motor or by similar means to provide resistance to external manual motion can be described as an electric robotic arm, while an arm that is manually manipulated without power feedback but can be manually or automatically locked in place can be described as a passive robotic arm.

[0083] The robotic arm 105A or the end effector 105B may include a trigger or other device for controlling the power of the saw or drill. The surgeon engages the trigger or other device to cause the robotic arm 105A or the end effector 105B to change from the electric alignment mode to the mode in which the saw or drill is engaged and powered. In addition, CASS 100 may include a foot pedal (not shown) that enables the system to perform certain functions when activated. For example, the surgeon may activate the foot pedal to instruct CASS 100 to place the robotic arm 105A or the end effector 105B in an automatic mode that places the robotic arm or the end effector in an appropriate position relative to the patient's anatomical structure in order to perform necessary resection. CASS 100 may also place the robotic arm 105A or the end effector 105B in a collaborative mode that allows the surgeon to manually manipulate the robotic arm or the end effector and position it in a specific position. The collaborative mode may be configured to allow the surgeon to move the robotic arm 105A or the end effector 105B inside or outside while limiting movement in other directions. As discussed, the robotic arm 105A or end effector 105B may include a cutting device (saw, drill, and round head file) or a cutting guide or fixture 105D to guide the cutting device. In other embodiments, the movement of the robotic arm 105A or the robotically controlled end effector 105B may be completely controlled by CASS 100 without any assistance or input from the surgeon or other medical personnel, or with minimal assistance or input. In still other embodiments, the movement of the robotic arm 105A or the robotically controlled end effector 105B may be remotely controlled by the surgeon or other medical personnel using a control mechanism separate from the robotic arm or robotically controlled end effector device, such as using a joystick or an interactive monitor or display control device.

[0084] The following example describes the use of a robotic device in the context of hip surgery; however, it should be understood that the robotic arm may have other applications for surgical procedures involving knees, shoulders, etc. One example of the use of a robotic arm in the context of forming an anterior cruciate ligament (ACL) graft tunnel is described in U.S. Provisional Patent Application No. 62 / 723,898, filed on August 28, 2018, entitled “Robotic Assisted Ligament Graft Placement and Tressing,” which is incorporated herein by reference in its entirety.

[0085] The robotic arm 105A can be used to hold a retractor. For example, in one embodiment, the robotic arm 105A can be moved by the surgeon to a desired position. At this point, the robotic arm 105A can be locked into position. In some embodiments, data about the patient's position is provided to the robotic arm 105A so that if the patient moves, the robotic arm can adjust the retractor position accordingly. In some embodiments, multiple robotic arms can be used, thereby allowing multiple retractors to be held or more than one activity to be performed simultaneously (e.g., retractor holding and reaming).

[0086] The robotic arm 105A can also be used to help stabilize the surgeon's hand while performing a femoral neck cut. In this application, the control of the robotic arm 105A can impose certain restrictions to prevent soft tissue damage from occurring. For example, in one embodiment, the surgical computer 150 tracks the position of the robotic arm 105A as it operates. If the tracked position is close to an area where tissue damage is predicted, a command can be sent to the robotic arm 105A to stop it. Alternatively, in the case where the robotic arm 105A is automatically controlled by the surgical computer 150, the surgical computer can ensure that no instructions are given to the robotic arm that cause it to enter an area where soft tissue damage may occur. The surgical computer 150 can impose certain restrictions on the surgeon to prevent the surgeon from reaming too far in the medial wall of the acetabulum or reaming at an incorrect angle or orientation.

[0087] In some embodiments, the robotic arm 105A can be used to hold the cup impactor at a desired angle or orientation during cup impaction. When the final position has been reached, the robotic arm 105A can prevent any further expansion to prevent damage to the pelvis.

[0088] The surgeon can use the robotic arm 105A to position the needle handle in a desired position and allow the surgeon to impact the needle into the femoral canal at the desired orientation. In some embodiments, once the surgical computer 150 receives feedback that the needle is fully in place, the robotic arm 105A can limit the handle to prevent further advancement of the needle.

[0089] The robotic arm 105A can also be used for resurfacing applications. For example, the robotic arm 105A can stabilize the surgeon while using conventional instruments and provide certain limitations or constraints to allow for proper placement of implant components (e.g., guidewire placement, chamfer cutters, sleeve cutters, planning cutters, etc.). In the case of using only round-head burrs, the robotic arm 105A can stabilize the surgeon's handpiece and can impose limitations on the handpiece to prevent the surgeon from removing unintended bone in violation of the surgical plan.

[0090] Surgical procedure data generation and acquisition

[0091] The various services provided by medical personnel to treat clinical conditions are collectively referred to as "care episodes." For a particular surgical procedure, an episode of care may include three stages: preoperative, intraoperative, and postoperative. During each stage, data that can be used to analyze the care episode is collected or generated in order to understand various aspects of the operation and identify patterns that can be used, for example, in training models to make decisions with minimal human intervention. The data collected in the care episode can be stored in the surgical computer 150 or the surgical data server 180 as a complete data set. Therefore, for each care episode, there is a data set that includes all data about the patient, collectively referred to as preoperative, all data collected or stored by CASS 100 during the operation, and any postoperative data provided by the patient or by medical personnel monitoring the patient.

[0092] As further explained in detail, the data collected during the care segment can be used to enhance the performance of the surgical procedure or provide an overall understanding of the surgical procedure and patient results. For example, in some embodiments, the data collected in the care segment can be used to generate a surgical plan. In one embodiment, as data is collected during surgery, the high-level preoperative plan is improved intraoperatively. In this way, as the components of CASS 100 collect new data, the surgical plan can be viewed as dynamically changing in real time or near real time. In other embodiments, preoperative images or other input data can be used to develop a solid plan that is only executed during surgery before surgery. In this case, the data collected by CASS 100 during surgery can be used to make suggestions to ensure that the surgeon remains within the preoperative surgical plan. For example, if the surgeon is not sure how to achieve a specific prescribed cut or implant alignment, the surgical computer 150 can be queried for advice. In other embodiments, preoperative and intraoperative planning methods can be combined so that a robust preoperative plan can be dynamically modified as needed or desired during the surgical procedure. In some embodiments, a biomechanically based model of the patient's anatomy provides simulation data for consideration by CASS 100 in developing preoperative, intraoperative, and postoperative / rehabilitation procedures to optimize implant performance outcomes for the patient.

[0093] Except changing the surgical procedure itself, the data collected during the nursing segment can be used as the input of other surgical auxiliary programs.For example, in some embodiments, the nursing segment data can be used to design implants.The U.S. Patent Application No. 13 / 814,531,753,763,773 filed on August 15, 2011, the U.S. Patent Application No. 14 / 232,958,763,773 filed on July 20, 2012, and the U.S. Patent Application No. 12 / 234,444,958,763,773 filed on September 19, 2008, for designing, determining implant size, and installing an exemplary data-driven technology for implants, the full content of each in the application is incorporated by reference into this patent application at this time.

[0094] In addition, the data may be used for educational, training or research purposes. Figure 2C Using the web-based approach described in , other physicians or students can remotely view the surgery in an interface that allows them to selectively view data acquired from various components of the CASS 100. After the surgical procedure, a similar interface can be used to "play back" the surgery for training or other educational purposes, or to determine the source of any problems or complications in the operation.

[0095] The data acquired during the preoperative phase typically includes all information collected or generated before the operation. Thus, for example, information about the patient can be obtained from a patient intake form or an electronic medical record (EMR). Examples of patient information that can be collected include, but are not limited to, patient demographics, diagnosis, medical history, progress notes, vital signs, medical history information, allergies, and laboratory results. Preoperative data may also include images related to the anatomical region of interest. These images may be captured, for example, using magnetic resonance imaging (MRI), computed tomography (CT), X-rays, ultrasound, or any other mode known in the art. Preoperative data may also include quality of life data captured from the patient. For example, in one embodiment, the patient uses a mobile application ("app") to answer a questionnaire about his current quality of life before surgery. In some embodiments, the preoperative data used by CASS 100 includes demographics, anthropometrics, culture, or other specific features that may be consistent with activity levels and specific patient activities about the patient to customize the surgical plan for the patient. For example, certain cultures or demographics may be more likely to use toilets that require squatting every day.

[0096] Figure 2A and 2B Examples of data that can be acquired during the intraoperative phase of a care episode are provided. These examples are based on the above reference Figure 1 Various components of CASS 100 are described; however, it should be understood that other types of data may be used based on the type of equipment used during the procedure and its use.

[0097] Figure 2A 1 shows some examples of control instructions provided by the surgical computer 150 to other components of the CASS 100 according to some embodiments. Note that Figure 2A The example assumes that the components of the effector platform 105 are each directly controlled by the surgical computer 150. In embodiments where the components are 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 components.

[0098] The various components included in the effector platform 105 are controlled by a surgical computer 150, which provides position commands that indicate where the components are to move within a coordinate system. In some embodiments, the surgical computer 150 provides instructions to the effector platform 105 that define how to react when components of the effector platform 105 deviate from the surgical plan. These commands are Figure 2A As referred to in the "haptic" commands. For example, the end effector 105B can provide a force that resists movement outside the area planned for resection. Other commands that can be used by the actuator platform 105 include vibration and audio prompts.

[0099] In some embodiments, the end effector 105B of the robot arm 105A is operatively connected to the cutting guide 105D. In response to the anatomical model of the surgical scene, the robot arm 105A can move the end effector 105B and the cutting guide 105D to the appropriate position to match the position of the femur or tibia cut performed according to the surgical plan. This can reduce the possibility of error, thereby allowing the visual system and the processor using the visual system to implement the surgical plan to place the cutting guide 105D at the precise position and orientation relative to the tibia or femur to align the cutting slot of the cutting guide with the cutting performed according to the surgical plan. The surgeon can then use any suitable tool, such as an oscillating or rotating saw or drill, to perform a cut (or drill) with perfect placement and orientation because the tool is mechanically limited by the features of the cutting guide 105D. In some embodiments, the cutting guide 105D may include one or more pin holes that are used by the surgeon to drill holes before using the cutting guide to perform the excision of the patient's tissue, or to screw or nail the cutting guide into the appropriate position. This can free the robotic arm 105A or ensure that the cutting guide 105D is completely fixed and does not move relative to the bone to be resected. For example, this operation can be used to make a first distal cut of the femur during a total knee arthroplasty. In some embodiments where the arthroplasty is a hip arthroplasty, the cutting guide 105D can be fixed to the femoral head or acetabulum for a corresponding hip arthroplasty resection. It should be understood that any arthroplasty utilizing precision cutting can use the robotic arm 105A and / or cutting guide 105D in this manner.

[0100] The ablation device 110 is provided with various commands for performing bone or tissue operations. As with the actuator platform 105, positioning information can be provided to the ablation device 110 to specify where it should be located when performing ablation. Other commands provided to the ablation device 110 may depend on the type of ablation device. For example, for mechanical or ultrasonic ablation tools, the commands may specify the speed and frequency of the tool. For radiofrequency ablation (RFA) and other laser ablation tools, the commands may specify the intensity and pulse duration.

[0101] Certain components of CASS 100 need not be directly controlled by surgical computer 150; instead, surgical computer 150 need only activate the component, which then executes software locally that specifies how data is to be acquired and provided to surgical computer 150. Figure 2A In the example of , two components are operated in this manner: the tracking system 115 and the tissue navigation system 120.

[0102] The surgical computer 150 provides the display 125 with any visualization required by the surgeon 111 during the operation. For the monitor, the surgical computer 150 can provide instructions for displaying images, GUIs, etc. using techniques known in the art. The display 125 may include various aspects of the workflow of the surgical plan. For example, during the registration process, the display 125 can display the 3D bone model constructed before surgery, and depict the position of the probe when the surgeon uses the probe to collect the position of the anatomical landmarks on the patient. The display 125 may include information about the surgical target area. For example, in conjunction with TKA, the display 125 can depict the mechanical and anatomical axes of the femur and tibia. The display 125 can depict the varus and valgus angles of the knee joint based on the surgical plan, and CASS 100 can depict how these angles will be affected if the surgical plan is modified as envisioned. Therefore, the display 125 is an interactive interface that can dynamically update and display how changes in the surgical plan will affect the surgery and the final position and orientation of the implant installed on the bone.

[0103] When the workflow progresses to preparing for bone cutting or resection, the display 125 can depict the planned or recommended bone cutting before any cutting is performed. The surgeon 111 can manipulate the image display to provide different anatomical perspectives of the target area, and can have the option of changing or modifying the planned bone cutting based on the patient's intraoperative assessment. The display 125 can depict how the selected implant will be installed on the bone if the planned bone cutting is performed. If the surgeon 111 chooses to change the previously planned bone cutting, the display 125 can depict how the modified bone cutting will change the position and orientation of the implant when installed on the bone.

[0104] The display 125 can provide the surgeon 111 with various data and information about the patient, the planned surgical operation and the implant. Various patient-specific information can be displayed, including real-time data about the patient's health, such as heart rate, blood pressure, etc. The display 125 can also include information about the anatomical structure of the surgical target area, including the location of the landmark, the current state of the anatomical structure (e.g., whether any resection has been performed, the depth and angle of the planned and executed bone cutting), and the future state of the anatomical structure as the surgical plan progresses. The display 125 can also provide or depict additional information about the surgical target area. For TKA, the display 125 can provide information about the gap between the femur and the tibia (e.g., gap balance) and information about how these gaps will be changed if the planned surgical plan is executed. For TKA, the display 125 can provide other relevant information about the knee joint (e.g., data about joint tension (e.g., ligament laxity)) and information about the rotation and alignment of the joint. The display 125 can depict how the positioning and position of the planned implant will affect the patient when the knee joint is bent. The display 125 can depict how the use of different implants or the use of different sizes of the same implant will affect the surgical plan, and preview how these implants will be positioned on the bone. CASS 100 can provide such information for each planned bone resection in TKA or THA. In TKA, CASS 100 can provide robotic control for one or more of the planned bone resections. For example, CASS 100 can provide robotic control only for the initial distal femoral cut, and the surgeon 111 can use conventional means, such as 4-in-1 cutting guides or fixtures 105D, to manually perform other resections (front cuts, back cuts, and chamfer cuts).

[0105] The display 125 may employ different colors to inform the surgeon of the status of the surgical plan. For example, unresected bone may be displayed in a first color, resected bone may be displayed in a second color, and planned resection may be displayed in a third color. Implants may be superimposed on the bone in the display 125, and the implant colors may change or may correspond to implants of different types or sizes.

[0106] The information and options depicted on the display 125 can vary depending on the type of surgical procedure being performed. In addition, the surgeon 111 can request or select a specific surgical workflow display that matches or is consistent with its surgical plan preferences. For example, for the surgeon 111 who usually performs tibial cutting before the femoral cutting in TKA, the display 125 and the associated workflow can be adapted to take this preference into account. The surgeon 111 can also display certain steps of pre-selection inclusion or deletion from the standard surgical workflow. For example, if the surgeon 111 uses the resection measurement to finalize the implantation plan, but does not analyze the ligament gap balance when finalizing the implantation plan, the surgical workflow display can be organized into modules, and the surgeon can select the modules to be displayed and the order in which the modules are provided based on the surgeon's preferences or the situation of a specific operation. For example, the module for ligament and gap balance can include ligament / gap balance before / after resection, and the surgeon 111 can select which modules to include in their default surgical plan workflow according to whether they perform such ligament and gap balance before or after bone resection (or, both before and after).

[0107] For more specialized display devices, such as an AR HMD, the surgical computer 150 may use data formats supported by the device to provide images, text, etc. For example, if the display 125 is a holographic device, such as a Microsoft HoloLens™ or Magic Leap One™, the surgical computer 150 may use the HoloLens application programming interface (API) to send commands specifying the location and content of the hologram displayed in the surgeon's 111 field of view.

[0108] In some embodiments, one or more surgical planning models may be incorporated into CASS 100 and used to develop a surgical plan that is provided to surgeon 111. The term "surgical planning model" refers to software that simulates the biomechanical properties of anatomical structures in various scenarios to determine the best way to perform cutting and other surgical activities. For example, for knee replacement surgery, a surgical planning model may measure parameters of functional activity, such as deep knee flexion, gait, etc., and select cutting locations on the knee to optimize implant placement. An example of a surgical planning model is the LIFEMOD® from SMITH AND NEPHEW, INC. TM In some embodiments, surgical computer 150 includes a computing architecture that allows the surgical planning model to be fully executed during surgery (e.g., a GPU-based parallel processing environment). In other embodiments, surgical computer 150 can be connected via a network to a remote computer that allows this execution, such as surgical data server 180 (see Figure 2C). As an alternative to fully executing the surgical planning model, in some embodiments, a set of transfer functions is derived that simplifies the mathematical operations captured by the model into one or more prediction equations. Then, rather than performing a full simulation during surgery, the prediction equations are used. Further details on the use of transfer functions are described in U.S. Provisional Patent Application No. 62 / 719,415, entitled "Patient Specific Surgical Method and System," the entire contents of which are incorporated herein by reference.

[0109] Figure 2B Examples of some of the types of data that may be provided from the various components of CASS 100 to the surgical computer 150 are shown. In some embodiments, the components may stream data to the surgical computer 150 in real time or near real time during surgery. In other embodiments, the components may queue the data and send it to the surgical computer 150 at set intervals (e.g., every second). The data may be transmitted using any format known in the art. Thus, in some embodiments, the components all transmit data to the surgical computer 150 in a common format. In other embodiments, each component may use a different data format, and the surgical computer 150 may be configured with one or more software applications that enable data interpretation.

[0110] In general, the surgical computer 150 can serve as a central point for collecting CASS data. The exact content of the data will vary depending on the source. For example, each component of the actuator platform 105 provides a measured position to the surgical computer 150. Thus, by comparing the measured position with the position originally specified by the surgical computer 150 (see Figure 2B ), the surgical computer can identify deviations that occur during surgery.

[0111] Depending on the type of device used, the resection device 110 can send various types of data to the surgical computer 150. Example data types that can be sent include measured torques, audio signatures, and measured displacement values. Similarly, the tracking technology 115 can provide different types of data depending on the tracking method used. Exemplary tracking data types include position values ​​of tracked items (e.g., anatomical structures, tools, etc.), ultrasound images, and surface or landmark acquisition points or axes. When the system is operating, the tissue navigation system 120 provides anatomical positions, shapes, etc. to the surgical computer 150.

[0112] Although the display 125 is typically used to output data for presentation to a user, the display may also provide data to the surgical computer 150. For example, for embodiments where a monitor is used as part of the display 125, the surgeon 111 may interact with the GUI to provide input that is sent to the surgical computer 150 for further processing. For AR applications, the measured position and displacement of the HMD may be sent to the surgical computer 150 so that it may update the presented view as needed.

[0113] During the postoperative phase of the care segment, various types of data can be collected to quantify the overall improvement or deterioration of the patient's condition due to the surgery. The data can take the form of self-reported information reported by the patient through a questionnaire, for example. For example, in the context of knee replacement, the functional status can be measured with the Oxford Knee Score questionnaire, and the postoperative quality of life can be measured with the EQ5D-5L questionnaire. Other examples in the context of hip replacement may include Oxford HipScore, Harris Hip Score, and WOMAC (Western Ontario and McMaster Universities Osteoarthritis index). For example, such questionnaires can be directly applied by medical staff in a clinical setting or applied using a mobile app that allows patients to directly answer questions. In some embodiments, the patient can be equipped with one or more wearable devices that collect data related to the surgery. For example, after knee surgery, the patient can be equipped with a knee brace that includes sensors for monitoring knee positioning, flexibility, etc. This information can be collected and transmitted to the patient's mobile device for the surgeon to view, to evaluate the results of the operation and solve any problems. In some embodiments, one or more cameras can capture and record the motion of the patient's body segment during designated activities after surgery. This motion capture can be compared with a biomechanical model to better understand the function of the patient's joint, better predict the progress of recovery, and identify any possible revisions that may be needed.

[0114] The postoperative phase of the care segment can last for the entire life of the patient. For example, in some embodiments, after the operation has been performed, the surgical computer 150 or other components including CASS 100 can continue to receive and collect data related to the surgical procedure. These data may include, for example, images, answers to questions, "normal" patient data (e.g., blood type, blood pressure, condition, medication, etc.), biometric data (e.g., gait, etc.), and objective and subjective data about specific problems (e.g., knee or hip pain). This data can be explicitly provided to the surgical computer 150 or other CASS components by the patient or the patient's doctor. Alternatively or in addition, the surgical computer 150 or other CASS components can monitor the patient's EMR and retrieve relevant information when relevant information is available. This longitudinal view of patient recovery allows the surgical computer 150 or other CASS components to provide a more objective analysis of patient results to measure and track the success or failure of a given operation. For example, long after the surgical procedure, the symptoms experienced by the patient can be traced back to the surgery by regression analysis of various data items collected during the care segment. This analysis can be further enhanced by analyzing a group of patients who undergo similar operations and / or have similar anatomical structures.

[0115] In some embodiments, data is collected at a central location to provide easier analysis and use. In some cases, data may be collected manually from the various CASS components. For example, a portable storage device (e.g., a USB stick) may be attached to the surgical computer 150 to retrieve data collected during surgery. The data may then be transferred to the central storage device, for example, via a desktop computer. Alternatively, in some embodiments, the surgical computer 150 is directly connected to the central storage device via a network 175, such as a computer that can store data directly to the surgical computer 150. Figure 2C as shown in .

[0116] Figure 2C A "cloud-based" embodiment is shown, in which the surgical computer 150 is connected to a surgical data server 180 via a network 175. This network 175 can be, for example, a private intranet or the Internet. In addition to data from the surgical computer 150, other sources can transmit relevant data to the surgical data server 180. Figure 2CThe example of shows three additional data sources: patient 160, medical staff 165, and EMR database 170. Thus, patient 160 can send pre-operative and post-operative data to surgical data server 180, for example using a mobile application. Medical staff 165 includes the surgeon and his or her staff, as well as any other professionals working with patient 160 (e.g., personal physician, rehabilitation specialist, etc.). It should also be noted that EMR database 170 can be used for pre-operative and post-operative data. For example, assuming that patient 160 has been given sufficient permissions, surgical data server 180 can collect the patient's pre-operative EMR. The surgical data server 180 can then continue to monitor the EMR for any updates after the surgery.

[0117] At the surgical data server 180, the care fragment database 185 is used to store various data collected on the patient's care fragments. The care fragment database 185 can be implemented using any technology known in the art. For example, in some embodiments, a SQL-based database can be used, in which all various data items are constructed in a way that allows them to be easily incorporated into two SQL rows and columns. However, in other embodiments, a No-SQL database can be used to allow unstructured data while providing the ability to quickly process and respond to queries. As understood in the art, the term "No-SQL" is used to define a class of data storage that is non-relational in its design. Various types of No-SQL databases can generally be grouped according to their underlying data models. These groups may include databases using column-based data models (e.g., Cassandra), document-based data models (e.g., MongoDB), key-value-based data models (e.g., Redis) and / or graph-based data models (e.g., Allego). Any type of No-SQL database can be used to implement the various embodiments described herein, and in some embodiments, different types of databases can support the care fragment database 185.

[0118] Data may be transmitted between the various data sources and the surgical data server 180 using any data format and transmission technology known in the art. Figure 2C The architecture shown in allows data to be transmitted from a data source to, and retrieved from, the surgical data server 180. 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.

[0119] In some embodiments, the surgical computer 150 or surgical data server 180 may perform a de-identification process to ensure that the data stored in the care episode database 185 complies with Health Insurance Portability and Accountability Act (HIPAA) standards or other requirements imposed by law. HIPAA provides a list of certain identifiers that must be removed from the data during de-identification. The aforementioned de-identification process can scan these identifiers in the data transmitted to the care episode database 185 for storage. For example, in one embodiment, the surgical computer 150 performs a de-identification process before initiating the transmission of a particular data item or set of data items to the surgical data server 180. In some embodiments, a unique identifier is assigned to the data from a particular care episode to allow the data to be re-identified when necessary.

[0120] although Figure 2A –2C discusses data collection in the context of a single care episode, and it should be understood that the general concepts can be extended to data collected from multiple care episodes. For example, surgical data can be collected throughout the care episode each time a surgery is performed with CASS 100 and stored at the surgical computer 150 or surgical data server 180. As explained in further detail below, a robust database of care episode data allows the generation of optimization values, measurements, distances or other parameters, and other recommendations related to surgical procedures. In some embodiments, various data sets are indexed in a database or other storage medium in a manner that allows rapid retrieval of relevant information during the surgical procedure. For example, in one embodiment, a patient-centric index set can be used so that data related to a specific patient or a group of patients similar to a specific patient can be easily extracted. The concept can be similarly applied to surgeons, implant features, CASS component versions, and the like.

[0121] Further details of the management of care episode data are described in U.S. patent application Ser. No. 62 / 783,858, filed on Dec. 21, 2018, and entitled “Methods and Systems for Providing an Episode of Care,” which is incorporated herein by reference in its entirety.

[0122] Open vs. Closed Digital Ecosystems

[0123] In some embodiments, CASS 100 is designed to operate as a standalone or "closed" digital ecosystem. Each component of CASS 100 is specifically designed for use in a closed ecosystem, and data is generally not accessible by devices outside the digital ecosystem. For example, in some embodiments, each component includes software or firmware that implements proprietary protocols for activities such as communication, storage, security, etc. The concept of a closed digital ecosystem may be desirable for companies that wish to control all components of CASS 100 to ensure that certain compatibility, security, and reliability standards are met. For example, CASS 100 can be designed so that new components cannot be used with CASS unless they are certified by the company.

[0124] In other embodiments, CASS 100 is designed to operate as an "open" digital ecosystem. In these embodiments, components can be produced by a variety of different companies according to standards for activities such as communication, storage, and security. Therefore, by using these standards, any company is free to build independent, compliant components of the CASS platform. Data can be transferred between components using publicly available application programming interfaces (APIs) and open, shareable data formats.

[0125] To illustrate one type of recommendation that can be performed with CASS 100, a technique for optimizing surgical parameters is disclosed below. In this context, the term "optimization" means selecting optimal parameters based on some specified criteria. In the extreme case, optimization can refer to selecting optimal parameters based on data from the entire care episode, including any preoperative data, the state of the CASS data at a given point in time, and the postoperative goals. In addition, optimization can be performed using historical data, such as data generated during past surgeries involving, for example, the same surgeon, past patients with physical characteristics similar to the current patient, etc.

[0126] Optimization parameters can depend on the part of the patient's anatomical structure to be operated.For example, for knee surgery, surgical parameters can include the positioning information of femur and tibial component (including but not limited to rotation alignment, such as varus / valgus rotation, external rotation, the flexion rotation of femoral component, the posterior tilt angle of tibial component), excision depth (such as, genu varum, genu valgum), and implant type, size and position. Positioning information can also include the surgical parameters for modular implants, such as overall limb alignment, combined tibia-femoral hyperextension and combined tibia-femoral resection.Other examples of parameters that can be optimized for a given TKA femur implant by CASS 100 include the following:

[0127]

[0128]

[0129] Additional examples of parameters that may be optimized by the CASS 100 for a given TKA tibial implant include the following:

[0130]

[0131] For hip surgery, surgical parameters may include femoral neck resection location and angle, cup inclination, cup anteversion, cup depth, femoral stem design, femoral stem size, fit of the femoral stem within the canal, femoral offset, leg length, and femoral form of the implant.

[0132] Shoulder parameters may include, but are not limited to, humeral resection depth / angle, humeral stem form, humeral offset, glenoid form and inclination, and reverse shoulder parameters such as humeral resection depth / angle, humeral stem form, glenoid inclination / form, glenosphere orientation, glenosphere offset, and offset direction.

[0133] There are various conventional techniques for optimizing surgical parameters. However, these techniques are often computationally intensive, and therefore, often require the parameters to be determined preoperatively. Therefore, the surgeon's ability to modify the optimization parameters based on problems that may arise during surgery is limited. In addition, conventional optimization techniques often operate in a "black box" manner, with little or no explanation of the recommended parameter values. Therefore, if the surgeon decides to deviate from the recommended parameter values, the surgeon often does so without fully understanding the impact of the deviation on the rest of the surgical workflow, or the impact of the deviation on the patient's quality of life after surgery.

[0134] Surgical Patient Care Systems

[0135] The general concept of optimization can be extended to the entire care episode using a surgical patient care system 320 that uses surgical data as well as other data from the patient 305 and medical staff 330 to optimize outcomes and patient satisfaction, such as Figure 3 Described in.

[0136] Conventionally, preoperative diagnosis, preoperative surgical planning, intraoperative execution of prescribed plans, and postoperative management of total joint arthroplasty are based on individual experience, published literature, and the surgeon's training knowledge base (ultimately, the tribal knowledge and journal publications of individual surgeons and their "network" of peers), and their instincts for accurate intraoperative tactile discrimination and accurate manual execution of plane resections using guides and visual cues for "balance." This existing knowledge base and execution are limited in terms of optimizing the outcomes provided to patients in need of care. For example, there are limitations with respect to: accurately diagnosing patients to obtain appropriate, minimally invasive prescribed care; aligning dynamic patient, healthcare economic, and surgeon preferences with patient desired outcomes; executing surgical plans that produce appropriate skeletal alignment and balance, etc.; and receiving data from disconnected sources with varying biases that are difficult to reconcile into a holistic patient framework. Therefore, data-driven tools that more accurately simulate anatomical responses and guide surgical planning could improve upon existing approaches.

[0137] The surgical patient care system 320 is designed to utilize patient-specific data, surgeon data, healthcare facility data, and historical outcome data to develop algorithms that suggest or recommend the best overall treatment plan for the patient's entire care episode (preoperative, surgical, and postoperative) based on the desired clinical outcomes. For example, in one embodiment, the surgical patient care system 320 tracks compliance with the suggested or recommended plan and adjusts the plan based on patient / care provider performance. Once the surgical treatment plan is completed, the collected data is recorded by the surgical patient care system 320 in a historical database. The database is accessible to future patients and can be used to develop future treatment plans. In addition to utilizing statistical and mathematical models, simulation tools (e.g., ) can be used to simulate outcomes, alignment, kinematics, etc. based on a preliminary or proposed surgical plan, and to reconfigure the preliminary or proposed plan to achieve a desired outcome or optimal outcome based on the patient's profile or surgeon's preferences. The surgical patient care system 320 ensures that each patient receives personalized surgical and rehabilitation care, thereby increasing the chances of a successful clinical outcome and reducing the financial burden on the facility associated with recent renovations.

[0138] In some embodiments, the surgical patient care system 320 employs a data collection and management method to provide a detailed surgical case plan with different steps monitored and / or performed using CASS 100. User performance is calculated as each step is completed and can be used to suggest changes to subsequent steps of the case plan. Case plan generation relies on a series of input data stored on a local or cloud storage database. The input data can be related to both the current patient being treated and historical data of patients who have received similar treatments.

[0139] The patient 305 provides input to the surgical patient care system 320, such as current patient data 310 and historical patient data 315. Various methods generally known in the art can be used to collect such input from the patient 305. For example, in some embodiments, the patient 305 fills out a paper or digital survey, which is parsed by the surgical patient care system 320 to extract patient data. In other embodiments, the surgical patient care system 320 can extract patient data from existing information sources (such as electronic medical records (EMR), health history files, and payer / provider history files). In other embodiments, the surgical patient care system 320 can provide an application program interface (API) that allows external data sources to push data to the surgical patient care system. For example, the patient 305 can have a mobile phone, wearable device, or other mobile device collect data (e.g., heart rate, pain or discomfort level, movement or activity level, or patient-submitted answers to the patient's compliance with any number of preoperative planning standards or conditions) and provide the data to the surgical patient care system 320. Similarly, the patient 305 may have a digital application on his or her mobile or wearable device that enables data to be collected and transmitted to the surgical patient care system 320 .

[0140] Current patient data 310 may include, but is not limited to: activity level, pre-existing conditions, comorbidities, prosthetic performance, health and fitness level, pre-operative expectation level (related to hospital, surgery, and recovery), metropolitan statistical area (MSA) driver score, genetic background, previous injuries (sports, trauma, etc.), previous arthroplasty, previous trauma surgery, previous sports medicine surgery, treatment of the contralateral joint or limb, gait or biomechanical information (back and ankle problems), degree of pain or discomfort, care infrastructure information (payer coverage type, home healthcare infrastructure level, etc.), and an indication of the expected ideal outcome of the procedure.

[0141] Historical patient data 315 may include, but is not limited to: activity level, pre-existing conditions, comorbidities, recovery performance, health and fitness level, pre-operative expectation level (related to hospital, surgery, and recovery), MSA driver score, genetic background, previous injuries (sports, trauma, etc.), previous arthroplasty, previous trauma surgery, previous sports medicine surgery, treatment of contralateral joint or limb, gait or biomechanical information (back and ankle problems), degree or pain or discomfort, care infrastructure information (payer coverage type, level of home healthcare infrastructure, etc.), expected ideal outcome of the surgery, actual outcomes of the surgery (patient reported outcomes [PRO], implant survival, pain level, activity level, etc.), implant size used, location / orientation / alignment of implant used, soft tissue balance achieved, etc.

[0142] The medical staff 330 performing the operation or treatment can provide various types of data 325 to the surgical patient care system 320. This medical staff data 325 may include, for example, known or preferred surgical techniques (e.g., cruciate retention (CR) versus posterior stabilization (PS), scale-up versus scale-down, tourniquet versus no tourniquet, femoral stem type, preferred method of THA, etc.), the training level of the medical staff 330 (e.g., years in practice, training qualifications, training location, whose technique to emulate), previous success levels (outcomes, patient satisfaction) including historical data, and expected ideal results with respect to range of motion, recovery days, and device survival. The medical staff data 325 can be captured, for example, by providing a paper or digital survey to the medical staff 330, by the medical staff inputting into a mobile application, or by extracting relevant data from an EMR. In addition, CASS 100 can provide data describing the use of CASS during surgery, such as profile data (e.g., a patient-specific knee instrument profile) or a historical log.

[0143] Information about the facility where the procedure or treatment will be performed may be included in the input data. This data may include, but is not limited to, the following: ambulatory surgical center (ASC) versus hospital, facility impairment level, Comprehensive Care Program for Joint Replacement (CJR) or bundle candidacy, MSA driver score, community versus medical, academic versus non-academic, post-operative network access (skilled nursing facility [SNF] only, home monitoring, etc.), medical staff availability, implant availability, and surgical equipment availability.

[0144] These facility inputs may be captured through, for example, but not limited to, surveys (paper / digital), surgery scheduling tools (e.g., apps, websites, electronic medical records [EMR], etc.), hospital information databases (on the Internet), etc. Input data related to the associated healthcare economics, including but not limited to the patient's socioeconomic status, the expected level of reimbursement the patient will receive, and if the treatment is patient-specific, may also be captured.

[0145] These healthcare economic inputs can be obtained through, for example, but not limited to, surveys (paper / digital), direct payer information, socioeconomic status databases (on the Internet with zip codes), etc. Finally, data from the simulation operation is captured. Simulation inputs include implant size, location, and orientation. Custom or commercially available anatomical modeling software programs (e.g., It should be noted that the above data inputs may not be available for every patient and the treatment plan will be generated using the available data.

[0146] Prior to surgery, patient data 310, 315 and medical staff data 325 may be captured and stored in a cloud-based or online database (e.g., Figure 2C The information related to the surgery is provided to the computing system via wireless data transmission or manually by using a portable media storage device. The computing system is configured to generate a case plan for CASS 100. The case plan generation will be described below. It should be noted that the system is able to access historical data from previous patients treated, including implant size, placement and orientation automatically generated by a computer-assisted, patient-specific knee instrument (PSKI) selection system or by CASS 100 itself. To achieve this, a surgical sales representative or case engineer uploads case log data to a historical database using an online portal. In some embodiments, data transmission to the online database is wireless and automatic.

[0147] The historical data set from the online database is used as the input of the machine learning model, for example, a recursive neural network (RNN) or other forms of artificial neural network. As generally understood in the art, the artificial neural network function is similar to a biological neural network, and is composed of a series of nodes and connections. The machine learning model is trained to predict one or more values ​​based on the input data. For subsequent parts, it is assumed that the machine learning model is trained to generate prediction equations. These prediction equations can be optimized to determine the optimal size, position and orientation of the implant, to achieve optimal results or satisfaction.

[0148] Once the procedure is complete, all patient data and available outcome data, including implant size, position and orientation determined by CASS 100, is collected and stored in a historical database. Any subsequent calculation of the objective equation via the RNN will include data from previous patients in this manner, allowing for continuous improvement of the system.

[0149] In addition to determining implant positioning or as an alternative to determining implant positioning, in some embodiments, prediction equations and associated optimizations can be used to generate resection planes for the PSKI system. When used in conjunction with the PSKI system, prediction equation calculations and optimizations are completed before surgery. Patient anatomical structures are estimated using medical image data (x-rays, CT, MRI). Global optimization of prediction equations can provide the ideal size and position of implant components. The Boolean intersection of implant components and patient anatomical structures is defined as the resection volume. PSKI can be generated to remove the optimized resection envelope. In this embodiment, the surgeon cannot change the surgical plan during surgery.

[0150] The surgeon may choose to change the surgical case plan at any time before or during surgery. If the surgeon chooses to deviate from the surgical case plan, changes to the size, position, and / or orientation of the components are locked and the global optimization is refreshed based on the new size, position, and / or orientation of the components (using the techniques previously described) to find new ideal positions for the other components and to perform the corresponding resections required to achieve the new optimized size, position, and / or orientation of the components. For example, if the surgeon determines that the size, position, and / or orientation of the femoral implant in a TKA needs to be updated or modified intraoperatively, the femoral implant position is locked relative to the anatomy and a new optimal position for the tibia will be calculated (via global optimization) taking into account the surgeon's changes to the femoral implant size, position, and / or orientation. Additionally, if the surgical system used to implement the case plan is robotically assisted (e.g., with a or MAKO Rio), bone removal and bone morphology during surgery can be monitored in real time. If the resection made during the operation deviates from the surgical plan, the processor can take into account the actual resection that has been made to optimize the subsequent placement of additional components.

[0151] Figure 4AHow to make the surgical patient care system 320 suitable for performing case plan matching services is shown. In this example, data related to the current patient 310 is captured and compared with all or part of a historical database of patient data and related results 315. For example, the surgeon can choose to compare the plan of the current patient with a subset of the historical database. The data in the historical database can be filtered to include only, for example, a data set with favorable results, a data set corresponding to historical surgeries of patients with the same or similar profile as the current patient profile, a data set corresponding to a specific surgeon, a data set corresponding to a specific aspect of the surgical plan (e.g., surgery that only retains a specific ligament), or any other criteria selected by the surgeon or medical staff. For example, if the current patient data matches or correlates with the data of a previous patient who experienced a good result, the case plan from the previous patient can be accessed and modified or used for the current patient. The prediction equation can be used in conjunction with an intraoperative algorithm that identifies or determines the actions associated with the case plan. Based on relevant and / or pre-selected information from the historical database, the intraoperative algorithm determines a series of recommended actions for the surgeon to perform. Each execution of the algorithm generates the next action in the case plan. If the surgeon performs the action, the result is evaluated. The results of the actions performed by the surgeon are used to refine and update the input to the intraoperative algorithm used to generate the next step in the case plan. Once the case plan has been fully executed, all data associated with the case plan, including any deviations from the recommended actions performed by the surgeon, are stored in a historical data database. In some embodiments, the system utilizes preoperative, intraoperative, or postoperative modules in a piecemeal manner, as opposed to an entire continuum of care. In other words, the caregiver can specify any permutation or combination of treatment modules, including the use of a single module. These concepts are described in detail in the literature. Figure 4B and may be applied to any type of surgery utilizing CASS 100.

[0152] Surgical Procedure Monitor

[0153] As mentioned above about Figure 1-2CAs described, the various components of CASS 100 generate detailed data records during surgery. CASS 100 can track and record the various actions and activities of the surgeon during each step of the operation, and compare the actual activities with the preoperative or intraoperative surgical plan. In some embodiments, software tools can be used to process these data into a format in which the surgery can be effectively "played back". For example, in one embodiment, one or more GUIs can be used to depict all the information presented on the display 125 during surgery. This can be supplemented with graphics and images depicting the data collected by different tools. For example, a GUI that provides a visual depiction of the knee during tissue resection can provide the torque and displacement of the resection device measured adjacent to the visual depiction to better provide an understanding of any deviation from the planned resection area. The ability to view the playback of the surgical plan or to switch between different aspects of the actual surgery and the surgical plan can provide benefits for surgeons and / or surgical personnel, allowing such personnel to identify any defects or challenging aspects of the surgery so that modifications can be made in future surgeries. Similarly, in an academic environment, the above-mentioned GUI can be used as a teaching tool for training future surgeons and / or surgical personnel. Additionally, because the dataset effectively records many aspects of a surgeon's activities, it may also be used as evidence of the correct or incorrect performance of a particular surgical procedure for other reasons (eg, legal or compliance reasons).

[0154] Over time, as more and more surgical data is collected, a rich database can be acquired that describes surgical procedures performed by different surgeons on different patients for various types of anatomical structures (knee, shoulder, hip, etc.). In addition, aspects such as implant type and size, patient demographics, etc. can be further used to enhance the overall dataset. Once the dataset has been established, it can be used to train a machine learning model (e.g., RNN) to predict how the surgery will proceed based on the current state of CASS100.

[0155] Training of the machine learning model can be performed as follows. The overall state of CASS 100 can be sampled over multiple time periods over the duration of the operation. The machine learning model can then be trained to transform the current state at the first time period into a future state at a different time period. By analyzing the entire state of CASS 100 rather than a single data item, any causal relationships of the interactions between the different components of CASS 100 can be captured. In some embodiments, multiple machine learning models can be used instead of a single model. In some embodiments, the machine learning model can be trained not only with the state of CASS 100, but also with patient data (e.g., captured from EMR) and identification of members of the surgical staff. This allows the model to make predictions with greater specificity. In addition, if necessary, it allows the surgeon to selectively make predictions based solely on his or her own surgical experience.

[0156] In some embodiments, the predictions or recommendations made by the aforementioned machine learning models can be directly integrated into the surgical workflow. For example, in some embodiments, the surgical computer 150 can execute a machine learning model in the background to predict or recommend upcoming actions or surgical conditions. Thus, multiple states can be predicted or recommended for each time period. For example, the surgical computer 150 can predict or recommend states for the next 5 minutes in 30 second increments. Using this information, the surgeon can utilize a "process display" view of the surgery that allows visualization of future states. For example, Figure 4C A series of images that can be displayed to the surgeon are depicted, which depict the implant placement interface. The surgeon can cycle through these images, for example, by inputting a specific time into the display 125 of CASS 100 or instructing the system to advance or retract the display in specific time increments using tactile, verbal or other instructions. In one embodiment, the process display can be presented in the upper portion of the surgeon's field of view in the AR HMD. In some embodiments, the process display can be updated in real time. For example, when the surgeon moves the resection tool around the planned resection area, the process display can be updated so that the surgeon can see how his action is affecting other aspects of the operation.

[0157] In some embodiments, rather than simply using the current state of CASS 100 as the input of the machine learning model, the input of the model may include the planned future state. For example, a surgeon may indicate that he is planning to perform a specific bone resection of the knee joint. The indication may be manually entered into the surgical computer 150, or the surgeon may provide the indication verbally. The surgical computer 150 may then generate a film strip showing the impact of the predicted cutting on the surgery. This film strip may describe how the surgery will be affected at a specific time increment, including, for example, changes in the patient's anatomical structure, implant position and orientation, and changes in surgical intervention and instruments if the envisioned course of action is to be performed. A surgeon or medical staff member may call or request this type of film strip at any time point during the surgery to preview how the envisioned course of action will affect the surgical plan if the envisioned action is to be performed.

[0158] It should also be noted that, with fully trained machine learning models and robot CASS, various aspects of surgery can be automated so that the surgeon only needs to minimally participate, for example, by only providing consent to the various steps of the surgery. For example, over time, robotic control using arms or other devices can be gradually integrated into the surgical workflow, where the surgeon gradually participates less and less in manual interaction compared to robotic operations. In this case, the machine learning model can learn which robot commands are needed to reach certain states of implementing the CASS plan. Ultimately, the machine learning model can be used to generate a film strip or similar view or display that predicts and can preview the entire operation from an initial state. For example, an initial state can be defined that includes patient information, surgical plans, implant features, and surgeon preferences. Based on this information, the surgeon can preview the entire operation to confirm that the plan recommended by CASS meets the surgeon's expectations and / or requirements. In addition, since the output of the machine learning model is the state of CASS 100 itself, commands can be derived to control the components of CASS to achieve each predicted state. In extreme cases, the entire operation can therefore be automated based only on the initial state information.

[0159] Using a point probe to acquire high-resolution images of critical areas during hip surgery

[0160] The use of a point probe is described in U.S. Patent Application No. 14 / 955,742, entitled "Systems and Methods for Planning and Performing Image Free Implant Revision Surgery," the entire contents of which are incorporated herein by reference. In short, an optically tracked point probe can be used to depict the actual surface of a target bone that requires a new implant. Drawing is performed after defective or worn implants are removed, and after any diseased or unwanted bone is removed. Multiple points are collected on the bone surface by brushing or scraping all of the remaining bone with the tip of the point probe. This is called tracing or "painting" the bone. The collected points are used to create a three-dimensional model or surface map of the bone surface in a computerized planning system. The 3D model of the remaining bone created is then used as a basis for planning surgery and the necessary implant size. An alternative technique for using X-rays to determine a 3D model is described in U.S. Provisional Patent Application No. 62 / 658,988, filed on April 17, 2018, entitled “Three Dimensional Guide with Selective Bone Matching,” which is incorporated herein by reference in its entirety.

[0161] For hip applications, point probe painting can be used to obtain high-resolution data of key areas, such as the acetabular rim and acetabular fossa. This can allow the surgeon to obtain detailed views before starting reaming. For example, in one embodiment, a point probe can be used to identify the bottom surface (fossa) of the acetabulum. As is well known in the art, in hip surgery, it is important to ensure that the bottom surface of the acetabulum is not damaged during reaming to avoid damaging the medial wall. If the medial wall is inadvertently damaged, the surgery will require an additional step of bone transplantation. With this in mind, information from the point probe can be used to provide operating guidance to the acetabular reamer during the surgical procedure. For example, the acetabular reamer can be configured to provide tactile feedback to the surgeon when the surgeon reaches the bottom surface or otherwise deviates from the surgical plan. Alternatively, when the bottom surface is reached or when the reamer is within a threshold distance, CASS 100 can automatically stop the reamer.

[0162] As an added safeguard, the thickness of the area between the acetabulum and the medial wall can be estimated. For example, once the acetabular rim and acetabular socket have been painted and registered to the preoperative 3D model, the thickness can be easily estimated by comparing the position of the acetabular surface to the position of the medial wall. Using this knowledge, the CASS 100 can provide an alarm or other response if any surgical activity is predicted to protrude through the acetabular wall during reaming.

[0163] The point probe can also be used to acquire high-resolution data used to orient the 3D model to a common reference point for the patient. For example, for pelvic plane landmarks such as the ASIS and pubic symphysis, the surgeon can use the point probe to paint the bones to represent the true pelvic plane. Given a more complete view of these landmarks, the registration software has more information to orient the 3D model.

[0164] Point probes can also be used to collect high-resolution data describing proximal femoral reference points, which can be used to improve the accuracy of implant placement. For example, the relationship between the tip of the greater trochanter (GT) and the center of the femoral head is often used as a reference point for aligning femoral components during hip arthroplasty. Alignment is highly dependent on the proper position of the GT; therefore, in some embodiments, the point probe is used to paint the GT to provide a high-resolution view of the area. Similarly, in some embodiments, it may be useful to have a high-resolution view of the lesser trochanter (LT). For example, during hip arthroplasty, the Dorr classification helps to select a handle that will maximize the ability to achieve a press fit during surgery to prevent postoperative micromotion of the femoral component and ensure optimal bone ingrowth. As understood in the art, the Dorr classification measures the ratio between the tube width at the LT and the tube width 10 cm below the LT. The accuracy of the classification is highly dependent on the correct position of the relevant anatomical structure. Therefore, it may be advantageous to paint the LT to provide a high-resolution view of the area.

[0165] In some embodiments, a point probe is used to paint the femoral neck to provide high-resolution data that allows the surgeon to better understand where to make a neck cut. The navigation system can then guide the surgeon as the surgeon performs the neck cut. For example, as understood in the art, the femoral neck angle is measured by placing a line along the center of the femoral shaft and a second line along the center of the femoral neck. Therefore, a high-resolution view of the femoral neck (and possibly the femoral shaft) will provide a more accurate calculation of the femoral neck angle.

[0166] High-resolution femoral head and neck data can also be used to navigate resurfacing procedures, where software / hardware assists the surgeon in preparing the proximal femur and placing the femoral component. As is generally understood in the art, during hip resurfacing, the femoral head and neck are not removed; rather, the head is trimmed and capped with a smooth metal covering. In this case, it would be advantageous for the surgeon to paint the femoral head and cap so that the trimming and placement of the femoral component can be guided by an accurate assessment of its corresponding geometry.

[0167] Register preoperative data to patient anatomy using a point probe

[0168] As described above, in some embodiments, a 3D model is developed during the preoperative phase based on a 2D or 3D image of the anatomical region of interest. In such embodiments, registration between the 3D model and the surgical site is performed prior to the surgical procedure. The registered 3D model can be used to track and measure the patient's anatomical structure and surgical tools during surgery.

[0169] During the surgical procedure, landmarks are acquired to facilitate registration of the preoperative 3D model to the patient's anatomy. For knee surgery, these points may include the center of the femoral head, the distal femoral axis point, the medial and lateral epicondyles, the medial and lateral condyles, the proximal tibial mechanical axis point, and the tibial A / P direction. For hip surgery, these points may include the anterior superior iliac spine (ASIS), the pubic symphysis, points along the acetabular rim and within the hemisphere, the greater trochanter (GT), and the lesser trochanter (LT).

[0170] In revision surgery, the surgeon can paint certain areas containing anatomical defects to allow better visualization and navigation of implant insertion. These defects can be identified based on analysis of preoperative images. For example, in one embodiment, each preoperative image is compared with an image library showing "healthy" anatomical structures (i.e., without defects). Any significant deviation between the patient's image and the healthy image can be marked as a potential defect. Then, during surgery, the surgeon can be warned of possible defects via a visual alarm on the display 125 of CASS100. The surgeon can then paint the area to provide further details about the potential defect to the surgical computer 150.

[0171] In some embodiments, the surgeon can use a non-contact method to register the incisions within the bone anatomy. For example, in one embodiment, laser scanning is used for registration. Laser stripes are projected over the anatomical region of interest, and changes in the height of the region are detected as changes in the line. Other non-contact optical methods, such as white light extrapolation or ultrasound, can alternatively be used to measure surface heights or register anatomical structures. For example, when there is soft tissue between the registration point and the bone being registered (e.g., ASIS, pubic symphysis in hip surgery), ultrasound technology may be beneficial, thereby providing a more precise definition of the anatomical plane.

[0172] refer to Figures 5A-5D , and with continued reference to the previous figures, an exemplary surgical system, generally indicated as 500, is shown. The exemplary surgical system 500 can be configured to obtain intraoperative position data related to the range of motion of a knee that is to undergo a surgical procedure. This position data can correspond to discrete flexion or extension angles of the surgical knee joint. In certain embodiments, the system 500 can include a surgical navigation system 510 and a probe 520. In operation, the patient's knee is moved through a range of motion so that the positions of various anatomical components, such as the femur, tibia, and patella, can be tracked.

[0173] In certain embodiments, the surgical navigation system 510 can be configured to employ a patella tracking component 530. The patella tracking component 530 can be constructed and implemented as an integral system or component within the surgical navigation system 510 or as a separate component connected to the surgical navigation system 510. It should be appreciated that embodiments of the described subject matter can be implemented by various types of operating environments, computer networks, platforms, frameworks, computer architectures, and / or computing devices.

[0174] The surgical navigation system 510 and / or patella tracking component 530 may include one or more processors and memory devices, as well as various input devices, output devices, communication interfaces, and / or other types of devices. The surgical navigation system 510 and / or patella tracking component 530 may include a combination of hardware and software.

[0175] The surgical navigation system 510 and / or the patella tracking component 530 may implement and utilize one or more program modules. Generally, program modules include routines, programs, objects, components, data structures, etc. that perform specific tasks or implement specific abstract data types.

[0176] The surgical navigation system 510 and / or patella tracking component 530 may be implemented by one or more computing devices configured to provide various types of services and / or data storage in accordance with aspects of the described subject matter. Exemplary computing devices may include, but are not limited to, personal computing devices, network servers, front-end servers, application servers, database servers, domain controllers, domain name servers, directory servers, and / or other suitable computers. Components of the surgical navigation system 510 and / or patella tracking component 530 may be implemented by software, hardware, firmware, or a combination thereof.

[0177] Patella tracking component 530 may include a processor 532, a memory 534, an input device 536, a stylet interface 538, a measurement database 540, and an output device 542. Input device 536 may be configured and implemented to receive instructions from a surgeon prior to implementing a surgical plan.

[0178] The patella tracking component 530 can be configured to characterize the anterior surface of the patella with the probe 520 to correlate the anterior geometry with the position of the posterior apex. The patella tracking component 530 can implement a processor 532 to communicate with the probe 520 via a probe interface 538 to obtain measurements of the patella position at discrete increments. The increments can represent discrete amounts of flexion and extension measured in degrees or other suitable units.

[0179] The processor 532 can be configured to execute software instructions stored in the memory 534 to determine the posterior apex of the patella, for example, prior to assessing patellar movement by the patellar tracking component 530 using measurements from the probe 520. In some embodiments, the posterior apex of the patella can be determined using the probe 520, and thus the relative position of the posterior apex to the anterior patellar geometry can be recorded in the measurement database 540.

[0180] Probe 520 may be a hand-held point probe, for example, Figure 5B . The probe 520 is used to identify certain landmarks and characterize the surface. Alternatively, the probe 520 can be a point probe that terminates in a curved tip to identify difficult-to-reach landmarks that would otherwise be covered or blocked by, for example, soft tissue. The probe 520 can be used to correlate the location of the posterior apex with the anterior geometry.

[0181] In some embodiments, the processor 532 can approximate the motion of the posterior apex during full flexion and extension by locating specific anatomical features on the anterior patella or by probing the anterior patella surface at different increments. For example, the increments can include 30°, 60°, and 90° flexion.

[0182] The output device 542 can generate position measurements of the patella during various stages of extension and flexion. Figure 5C and 5D Depicts a display, which is illustrated from Figure 5C Almost full extension of 550 to Figure 5D Acquisition of position data related to the positioning and orientation of the patella through a nearly full flexion 552 range of motion.

[0183] refer to Figure 6 , and continuing to refer to the previous figures, an exemplary method 600 is illustrated as an embodiment of a patella tracking process according to aspects of the described subject matter. The method 600 or portions thereof can be performed or assisted by one or more computing devices, computer systems, computer executable instructions, software, hardware, firmware, or a combination thereof in various embodiments. For example, the method 600 can be performed by CASS 100, surgical system 500, or any other suitable system.

[0184] like Figure 6 As shown in , the computing system can characterize 601 the anterior geometry of the patella. In this sample implementation, as Figure 5A The patella tracking component 530 shown in FIG. 5 can be configured and implemented with a probe interface 538 to collect sufficient positioning and position data to characterize the anterior portion of the patella using the probe 520. In some embodiments, such collection is accomplished by the surgeon scraping or "painting" the patella with the probe, and the computing system collecting a large number of positioning data points related to, for example, the current position and orientation of the patella.

[0185] The computing system can identify 602 the location of the posterior apex relative to the anterior features determined during the previous step by, for example, using additional information determined by measuring position information associated with the probe 520. In a sample embodiment as described herein, the patella tracking component 530 can receive information associated with the posterior apex of the patella from the probe 520 via the probe interface 538. The processor 532 can process the information to identify 602 the location information and store the location information in, for example, the memory 542 and / or the measurement database 540.

[0186] The computing system may collect 603 additional data regarding the positioning of the patella as the knee joint moves through a range of motion. In some embodiments, the range of motion may be from full leg extension to full leg flexion. In a sample embodiment as described herein, data is collected 603 from the probe 520 in discrete flexion increments to obtain additional information about the patella. The movement may be depicted by the output device 542 as, for example, Figure 5C and 5D The output shown in . The processor 532 can process the movement data to determine the change in the position of the patella when the leg moves from full extension to full flexion. The processor 532 can store the movement data in, for example, the memory 542 and / or the measurement database 540 as a set of discrete points, or in some embodiments, the movement data can be stored as a model representing the movement of the patella.

[0187] After processing the movement data, the computing system may determine 604 whether the movement data is sufficient to define patellar motion. In a sample embodiment as described herein, the processor 532 may determine 604 whether the data is sufficient within a reasonable degree of error. For example, the processor 532 may determine 604 whether the data indicates that enough points were collected during the leg movement to accurately estimate patellar position information at all points from full leg extension to full leg flexion. If the data is insufficient, the processor 532 may collect additional data, such as Figure 6 as shown in .

[0188] If computing device determines that 604 collected data are enough, computing device can generate 605 suggestions to improve patella-femur relationship. For example, computing system can analyze the postoperative patellar movement information of collected movement data and model prediction based on current operation plan (for example, current implant component selection and position information). By comparing the collected movement data with postoperative movement information, computing system can determine one or more changes of operation plan, and the change can change postoperative model to be more closely consistent with the movement information collected. Based on one or more changes determined, computing system can generate 605 suggestions.

[0189] In a sample embodiment as described herein, processor 532 can generate one or more recommendations and transmit those recommendations to surgical navigation system 510 for potential consideration in creating or modifying a surgical plan. For example, the recommendations can include changes to the placement of a femoral implant component, changes to the size of a femoral implant component, resection of at least a portion of the patella including a patellar implant component, and other similar recommendations.

[0190] In some embodiments, the surgical navigation system 510 can make recommendations about the placement and orientation of the implant to ensure smooth patellar tracking. In normal anatomy, the flexion or extension of the knee causes the posterior apex of the patella to slide between the condyles of the distal femur. In a knee replacement procedure, the surgical navigation system 510 can recommend the angle and orientation at which the implant should be placed to best maintain good patellar motion.

[0191] In other embodiments, surgical navigation system 510 can make suggestions about the impact of assessment joint line change on patellar offset. Joint line change may be due to the near end / distal end positioning of implant affecting the movement of implant components and the interface surface causing. In this exemplary embodiment, surgical navigation system 510 can utilize the information obtained by the execution of method 600 to make this type of suggestions to the position of implant components, to reduce the postoperative offset of potential patella.

[0192] refer to Figure 7 , and with continued reference to the previous figures, another exemplary surgical system is shown, generally indicated as system 700. Figure 5A , system 700 may be configured to collect data reflecting the position and movement of the patella through the range of motion of a knee undergoing a surgical procedure. System 700 may include a surgical navigation system 710 and a landmark reader 720, such as a camera.

[0193] In certain embodiments, the surgical navigation system 710 may be configured and implemented with a patella tracking component 730, which may include a processor 732, a memory 734, an input device 736, a marker reader interface 738, a measurement database 740, and an output device 742. The processor 732, the memory 734, the input device 736, the measurement database 740, and the output device 742 may be implemented in a manner similar to Figure 5A The processor 532, memory 534, input device 536, measurement database 540 and output device 542 shown in FIG. 5 are configured in the manner shown in FIG.

[0194] and Figure 5AUnlike the embodiment shown in , system 700 utilizes a marker reader 720 to read a plurality of reflective markers (ie, a marker array) placed in the patient's knee. The marker reader 720 may interface with a marker reader interface 738 to provide data to a processor 732 as the knee moves.

[0195] Fig. 8A An alternative embodiment is shown in view 800. At 800, a hole or cavity 802 is created in a patella 804 at a posterior apex 806 by a drill 808 having a relatively small diameter drill bit 810. For example, in some embodiments, the drill bit 810 has a diameter of approximately 1 mm.

[0196] like Fig. 8A As shown in , preparing the patella can include cutting at least a portion of the patellar tendon 812 to rotate the patella to a position for drilling. Alternative preparation techniques can also be used. After the surgical procedure, the replacement ligament material can be used to replace or otherwise repair the patellar tendon.

[0197] Once cavity 802 is created, a marker or array of markers can be inserted therein from the anterior side. When the axis of the marker is aligned with apex 806, the movement of apex 806 can be tracked to gather information about the movement of patella 804 during knee flexion.

[0198] Figure 8B Another alternative embodiment is shown in view 820. Figure 8B 824 of the patella 826. Drilling is then performed from the front side of the patella. The drill guide 822 is used to determine the thickness of the patella 826 so that the surgeon does not accidentally drill all the way to the bottom. In certain embodiments, the drill guide 822 can physically prevent the drill 828 from traveling far enough to accidentally pierce the posterior joint surface 830. In an embodiment, the drill guide 822 also ensures that the drill 828 can create a cavity 832 along an axis that intersects the posterior apex 824 of the patella 826, so that accurate tracking of the movement of the posterior apex 824 through the range of motion is achieved.

[0199] Figures 9A-9C A tracking device, such as marker 900 , is shown inserted into a cavity 902 in a patella 904 . Fig. 9A Alignment of cavity 902 in patella 904 is shown. Fig. 9B and 9C A marker 900 is shown positioned within cavity 902. In this exemplary embodiment, the mounted marker 900 is a position tracker that can be used to track the position of the patella 904 within the range of motion of the knee 906. Fig. 9BAs shown in , the marker 900 may include at least an extension 908 that is configured to fit within the cavity 902 and form a friction fit to hold the marker in place. For example, the extension 908 may include threads configured to cut or otherwise engage the cavity 902. In some embodiments, the extension 908 may be slightly larger than the cavity 902 to create a pressure or force fit within the cavity. Fig. 9B and 9C In the illustrated embodiment, cavity 902 may be positioned "on axis" relative to the apex of the patella.

[0200] Fig.9D An alternative embodiment is shown for attaching a tracker device such as a marker 900 to a plurality of cavities 902 in a patella 904. Fig.9D As shown in , the mounted marker 900 may include a plurality of extensions 908. Each extension 908 may be configured to fit within a corresponding cavity 902 and form a friction fit, thereby holding the marker in place. For example, each extension 908 may include threads that are configured to cut or otherwise engage a corresponding cavity 902. In some embodiments, the extension 908 may be sized slightly larger than the cavity 902 to create a pressure or force fit within the cavity. Fig.9D In the illustrated embodiment, the corresponding cavity 902 can be positioned "around the axis" relative to the apex of the patella. Other orientations of the cavity can also be used within the scope of the present disclosure.

[0201] Fig.9E An alternative embodiment is shown for attaching a tracker device such as marker 900 to a cavity 902 in a patella 904. Fig.9E As shown in , the mounted marker 900 may include an extension 908 configured to fit within the cavity 902 and form a friction fit to hold the marker in place. For example, each extension 908 may include threads configured to cut or otherwise engage the corresponding cavity 902. In some embodiments, the extension 908 may be sized slightly larger than the cavity 902 to create a pressure or force fit within the cavity. Fig.9E In the illustrated embodiment, cavity 902 may be "off-axis" relative to the apex of the patella. In such embodiments, cavity 902 may be positioned at a known orientation relative to the apex.

[0202] Fig.10 A sample clamping device for preparing the patella and attaching tracking markers is shown. Fig.10As shown in , the surgeon can use the clamp 1002 to clamp onto the patella 1004. Then, the drill can be used to prepare the cavity in the patella in the manner described above. The reflection tracker 1006 can then be inserted into the prepared cavity of the patella 1004. Alternatively, the reflection tracker 1006 can be directly attached to the clamp 1002, thereby eliminating the need to prepare the patella to include a cavity for receiving at least a portion of the reflection tracker.

[0203] It should be noted that the attachment tracking markers as shown herein are provided by way of example only. Additional techniques can be used to associate the markers with the patella. For example, once exposed, a portion of the patella can be painted or otherwise marked with infrared paint. An infrared camera system can be used to track the movement of the patella by measuring changes in the position of the infrared paint.

[0204] Although various illustrative embodiments incorporating the principles of the present teachings have been disclosed, the present teachings are not limited to the disclosed embodiments. Rather, the present application is intended to cover any variation, use or adaptation of the present teachings and use of their general principles. In addition, the present application is intended to cover such deviations from the present disclosure that are known or customary practices in the field to which these teachings belong.

[0205] In the above detailed description, reference is made to the accompanying drawings which form a part thereof. In the accompanying drawings, similar symbols generally identify similar parts unless the context otherwise dictates. The illustrative embodiments described in the present disclosure are not meant to be restrictive. Other embodiments may be used, and other changes may be made without departing from the spirit or scope of the subject matter presented herein. It is readily understood that the various features of the present disclosure (as generally described herein and illustrated in the accompanying drawings) may be arranged, substituted, combined, separated and designed into a variety of different configurations, all of which are expressly contemplated herein.

[0206] The present disclosure is not limited to the specific embodiments described in the present application, which are intended to be an illustration of various features. Without departing from the spirit and scope that are clearly understood by those skilled in the art, many modifications and changes can be made. According to the foregoing description, functionally equivalent methods and devices (except those listed herein) within the scope of the present disclosure will be apparent to those skilled in the art. It should be understood that the present disclosure is not limited to specific methods, reagents, compounds, compositions or biological systems, which can certainly change. It should also be understood that the terms used herein are only used to describe the purpose of specific embodiments, and are not intended to be restrictive.

[0207] With respect to the use of substantially any plural and / or singular terms herein, those skilled in the art may translate from the plural to the singular and / or from the singular to the plural, as appropriate, depending on the context and / or application. For clarity, various singular / plural permutations may be expressly set forth herein.

[0208] Those skilled in the art will understand that, in general, the terms used herein are generally intended to be "open" terms (e.g., the term "including" should be interpreted as "including but not limited to", the term "having" should be interpreted as "having at least", the term "comprising" should be interpreted as "including but not limited to", etc.). Although various compositions, methods, and apparatus are described in terms of "comprising" various components or steps (interpreted to mean "including but not limited to"), the compositions, methods, and apparatus may also "consist essentially of" or "consist of" the various components and steps, and such terms should be interpreted as defining substantially closed groups of components.

[0209] In addition, even if a specific number is explicitly recited, one skilled in the art will recognize that such a recitation should be interpreted as meaning at least the recited number (e.g., reciting "two items" without other modifiers means at least two items or two or more items). In addition, in those cases where phrases similar to "at least one of A, B, and C" are used, generally, such construction is intended that a person skilled in the art will understand the meaning of the phrase (e.g., "a system having at least one of A, B, and C" will include but is not limited to systems having only A, only B, only C, A and B together, A and C together, B and C together, and / or A, B, and C together, etc.). In those cases where phrases similar to "at least one of A, B, or C, etc." are used, generally, such construction is intended that a person skilled in the art will understand the meaning of the phrase (e.g., "a system having at least one of A, B, or C" will include but is not limited to systems having only A, only B, only C, A and B together, A and C together, B and C together, and / or A, B, and C together, etc.). Those skilled in the art will also understand that, whether in the specification, sample embodiments or drawings, almost any transition word and / or phrase presenting two or more alternative terms should be understood to include the possibility of one of the terms, any one of the terms, or both of the terms. For example, the phrase "A or B" will be understood to include the possibility of "A" or "B" or "A and B".

[0210] In addition, where features of the disclosure are described in terms of Markush groups, those skilled in the art will recognize that the disclosure is also described in terms of any individual member or subgroup of members of the Markush group.

[0211] It will be appreciated by those skilled in the art that for any and all purposes, for example, with respect to providing a written description, all scopes disclosed herein also encompass any possible sub-ranges and all possible sub-ranges and combinations of sub-ranges thereof.Any listed scope can be easily considered to fully describe and realize the same scope of being decomposed into at least equal half, one-third, one-quarter, one-fifth, one-tenth, etc. As a non-limiting example, each scope discussed herein can be easily decomposed into lower third, middle third and upper third, etc. It will also be appreciated by those skilled in the art that all languages ​​such as "up to", "at least", etc. include the numerals of narration, and refer to the scope that can be subsequently decomposed into sub-ranges as described above.Finally, it will be appreciated by those skilled in the art that scope includes each individual member.Therefore, for example, a group with 1-3 cells refers to a group with 1, 2 or 3 cells.Similarly, a group with 1-5 cells refers to a group with 1, 2, 3, 4 or 5 cells, and so on.

[0212] As used herein, the word "about" refers to a change in the amount of a value, such as it can occur through measurement or processing procedures in the real world; through unintentional errors in these procedures; through differences in manufacturing, source, or purity of compositions or reagents; and the like. Typically, as used herein, the word "about" means that the ratio or range of values ​​is 1 / 10 greater or less than the stated value, for example, ±10%. The word "about" also refers to changes that a person skilled in the art would consider to be equivalent, as long as such changes do not cover known values ​​practiced in the prior art. Each value or range of values ​​following the term "about" is also intended to cover embodiments of the stated absolute value or range of values. Whether or not modified by the word "about", the quantitative values ​​stated in the present disclosure include equivalents of the stated values, such as changes in the amount of the value of the value that may occur but that a person skilled in the art would recognize as equivalent.

[0213] The various features and functions disclosed above and their alternatives may be combined into many other different systems or applications. A variety of currently unforeseeable or unexpected alternatives, modifications, changes or improvements may subsequently be made by those skilled in the art, each of which is also intended to be covered by the disclosed embodiments.

Claims

1. A computer-assisted surgery system for improving patella-femoral response, the computer-assisted surgery system being configured as follows: receiving position information related to a plurality of locations of the anterior surface of the patella; characterizing an anterior geometry of the patella based on the received position information; receiving information related to the location of the posterior apex of the patella; determining, based on the information regarding the location of the posterior apex of the patella and the characterized anterior geometry of the patella, a position of the posterior apex of the patella relative to one or more anatomical features of the anterior geometry of the patella; receiving positioning information related to the positioning of the patella corresponding to a plurality of discrete flexion increments of the knee joint as the knee joint moves through a range of motion; as well as One or more recommendations for improving patello-femoral response are provided based on the positioning information.

2. The computer-assisted surgery system of claim 1, comprising converting the positioning of the patella into a model representing patellar movement.

3. The computer-assisted surgery system of claim 1 , wherein receiving positioning information related to the patella further comprises: determining whether the positioning information is sufficient to limit patellar motion; as well as In response to determining that the positioning information is insufficient, supplemental positioning information related to the positioning of the patella is received at each of one or more supplemental discrete flexion increments of the knee joint.

4. The computer-assisted surgery system of any one of claims 1-3, wherein providing one or more suggestions comprises: Information on post-operative patellar movement predicted by simulation; comparing the positioning information with the predicted post-operative patellar movement information; as well as The surgical plan is updated to coordinate the positioning information and the predicted post-operative patellar translation information.

5. The computer-assisted surgery system of claim 4, wherein updating the surgical plan comprises one or more of the following: Changes in positioning of surgical implants; Changing the orientation of placed surgical implants; and Change the choice of surgical implant to be placed.

6. The computer-assisted surgery system of any one of claims 1-3, wherein the one or more recommendations reduce post-operative deviation of the patella.

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