Registration of intramedullary canal during revision total knee arthroplasty

Abstract

Methods and systems for identifying and determining the size and orientation of a reamed portion of a patient's bone are disclosed. A tracking array and / or a point probe can be inserted into an adapter device. The adapter device includes a plurality of openings with various connection means therein such that when a tracking array is inserted into the adapter, a secure and stable connection is created. A reamer, a handle, or similar tool can then be inserted into the opposite side of the adapter during which a secure and stable connection is established between the adapter and the tool. Thus, a more accurate representation of a patient's anatomy can be obtained through the use of a computer-assisted surgical system.

Description

[0001] Cross Reference to Related Applications

[0002] This application claims priority to U.S. Provisional Application No. 62 / 910,153, filed October 3, 2019, entitled “REGISTRATION OF INTRAMEDULLARY CANAL DURING REVISION TOTAL KNEE ARTHROPLASTY,” which is incorporated herein by reference in its entirety. TECHNICAL FIELD

[0003] The present disclosure relates generally to methods, systems, and devices related to computer-assisted surgical systems, which include various hardware and software components that work together to enhance surgical procedures. The disclosed technology can be applied, for example, to shoulder, hip, and knee arthroplasty, as well as other surgical procedures, such as arthroscopic surgery, spinal surgery, maxillofacial surgery, rotator cuff surgery, ligament repair and replacement surgery. BACKGROUND

[0004] A knee arthroplasty procedure involves installing a femoral component on a patient’s femur, and installing a tibial component on a patient’s tibia. The tibial component typically includes a tibial stem that is attachable to a tibial tray. The tibial stem is designed to be installed within the intramedullary canal of the tibia, while the tibial tray is installed on a prepared surface on the tibial head. A tibial bearing member articulating with the femoral component is typically installed on the tibial tray.

[0005] Variations in human anatomy from patient to patient, particularly variations in bones such as the tibia, create a need for a variety of implant sizes and configurations. In some cases, the longitudinal axis of a stem component, such as a tibial stem, can not need to be laterally offset from the longitudinal axis of another prosthetic component, such as a tibial tray. However, in many individuals, these axes must be offset relative to one another to ensure proper implantation. Even where an offset is needed, the degree or direction of the offset is not uniform.

[0006] Further, some patients require angling of the stem to account for the bow of the intramedullary canal. For example, in a patient population, the tibia can bow outwardly by about 1.63 + / - 1.57 degrees relative to the mechanical axis. Similarly, the femoral canal can bow posteriorly relative to the mechanical axis. Such impingement can prevent the stem from penetrating the canal sufficiently, resulting in improper positioning of the tibial and femoral components in the knee, and potentially causing pain.

[0007] Accordingly, there is a need for a tracking system that can improve the alignment and orientation of implants based on various knee prosthesis factors. BRIEF DESCRIPTION OF DRAWINGS

[0008] The accompanying drawings, which are incorporated in and form a part of the specification, illustrate embodiments of the present disclosure and, together with the written description, serve to explain the principles, characteristics, and features of the application. In the drawings:

[0009] Figure 1 A surgical theater including an example computer-assisted surgical system (CASS) is shown in accordance with an embodiment.

[0010] Figure 2 An example of an electromagnetic sensor device is shown in accordance with some embodiments.

[0011] Figure 3A An alternative example of an electromagnetic sensor device having three perpendicular coils is shown in accordance with some embodiments.

[0012] Figure 3B An alternative example of an electromagnetic sensor device having two non-parallel fixed coils is shown in accordance with some embodiments.

[0013] Figure 3C An alternative example of an electromagnetic sensor device having two non-parallel split coils is shown in accordance with some embodiments.

[0014] Figure 4 An example of an electromagnetic sensor device and a patient bone is shown in accordance with some embodiments.

[0015] Figure 5A Illustrative control instructions provided by a surgical computer to other components of a CASS are shown in accordance with an embodiment.

[0016] Figure 5B Illustrative control instructions provided by components of a CASS to a surgical computer are shown in accordance with an embodiment.

[0017] Figure 5C Illustrative implementations of a surgical computer connected to a surgical data server over a network are shown in accordance with an embodiment.

[0018] Figure 6 A surgical patient care system and illustrative data sources are shown in accordance with an embodiment.

[0019] Figure 7A An example flowchart for determining a pre-operative surgical plan is shown in accordance with an embodiment.

[0020] Figure 7B An example flowchart for determining a care period, including pre-operative, intra-operative, and post-operative actions is shown in accordance with an embodiment.

[0021] Figures 7C-7E Illustrative graphical user interfaces including images depicting implant placement are shown in accordance with an embodiment.

[0022] Figure 8 Exploded views of illustrative trackers, adapters, and objects according to embodiments are depicted.

[0023] Figure 9 Detailed views of illustrative trackers according to embodiments are depicted.

[0024] Figure 10 Detailed views of illustrative adapters according to embodiments are depicted.

[0025] Figure 11 Illustrative views of trackers coupled to reamers using adapters according to embodiments are depicted.

[0026] Figure 12 Illustrative views of implants with offset couplers according to embodiments are depicted.

[0027] Figure 13 Illustrative methods of tracking reamer position and installing appropriate implants according to embodiments are depicted.

[0028] Figure 14 A block diagram of an illustrative data processing system in which features of illustrative embodiments are implemented is shown. DETAILED DESCRIPTION

[0029] The present disclosure describes methods of approaching a joint for arthroscopic procedures. These methods can be used in conjunction with a surgical navigation system. In the following description, for the purposes of explanation, numerous specific details are set forth in order to provide a thorough understanding of the example embodiments. It will be apparent, however, to one skilled in the art that the embodiments can be practiced without some or all of these specific details.

[0030] The present disclosure is not limited to the particular systems, devices, and methods described, as these can vary. The terminology used in the description is for the purpose of describing particular versions or embodiments only and is not intended to limit the scope of the disclosure.

[0031] As used in this document, the singular forms "a," "an," and "the" include plural references unless the context clearly dictates otherwise. Unless defined otherwise, all technical and scientific terms used herein have the same meanings as commonly understood by one of ordinary skill in the art. Nothing herein is to be construed as an admission that the embodiments described in this disclosure are not entitled to antedate claim to the benefit of an earlier date than the date that a particular version or embodiment is described. As used in this document, the term "comprising" means "including, but not limited to."

[0032] Definitions

[0033] For purposes of this disclosure, the term "implant" is used to refer to a prosthetic device or structure manufactured to replace or augment a biological structure. For example, in a total hip arthroplasty procedure, a prosthetic acetabular cup (implant) is used to replace or augment a patient's worn or damaged acetabulum. While the term "implant" is generally considered to denote an artificial structure (as opposed to a graft), for purposes of this specification, an implant can include biological tissue or material grafted to replace or augment a biological structure.

[0034] For purposes of this disclosure, the term "real-time" is used to refer to a computation or operation performed at the time an event occurs or an input is received by an operable system. However, the use of the term "real-time" is not intended to exclude operations that cause some delay between the input and the response, so long as the delay is an incidental result of the performance characteristics of the machine.

[0035] While much of the disclosure herein refers to surgeons or other medical professionals in particular titles or roles, nothing in the disclosure is intended to be limited to a particular title or function. Surgeons or medical professionals can include any doctor, nurse, medical professional, or technician. Any of these terms or positions can be used interchangeably with a user of the systems disclosed herein, unless otherwise expressly specified. For example, in some embodiments, a reference to a surgeon can also apply to a technician or nurse.

[0036] The various embodiments discussed herein address the problems discussed above by providing an intermediate stem extension or coupler that couples a femoral or tibial articular component (e.g., a tibial tray and articular insert) with a stem extension and / or a tracking component. Moreover, the coupler stem connection device can be offset from the articular component or tracking component at a known distance and orientation, and angled relative to the required angular orientation of the varus / valgus (V / V) and / or flexion / extension (F / E) of the articular component and the required angular orientation of the stem. The present invention allows for variable alignment to anatomic or kinematic alignment or surgeon prescribed alignment, such as human bone deformity, muscle structure, and / or flexion / extension balance.

[0037] In knee revision arthroplasty, a typical femoral component is usually supported by an attached intramedullary (IM) stem. Most revision femoral component stem attachment means are usually coronally fixed with a set varus / valgus (V / V) angle; typically, about six (6) degrees. However, this varus / valgus (V / V) angle can vary from patient to patient due to variations in bone anatomy. In another embodiment, this variation in bone anatomy also varies sagittally with respect to joint cartilage geometry (i.e., the distal outer face / exterior portion of the bone) and the location of the IM canal (the inner face / interior portion of the bone). It is desirable to coronally place the joint portion of the femoral component in the optimal position for a given patient with respect to the V / V angle about the mechanical or anatomical axis, while optimally positioning the A / P position, the M / L position, and to a lesser extent, the internal / external rotation (in the transverse plane), while rigidly fixing the stem to the femoral component in one position such that the stem fits centrally within the intermedullary canal. The intermediate stem coupler of the present invention accomplishes all of these goals.

[0038] The systems, methods, and devices disclosed herein are particularly well suited for surgical procedures utilizing a surgical navigation system, such as the NAVIO® surgical navigation system. NAVIO is a registered trademark of BLUE BELT TECHNOLOGIES, INC., of Pittsburgh, PA, which is a subsidiary of SMITH & NEPHEW, INC., of Memphis, TN.

[0039] Overview of the CASS Ecosystem

[0040] Figure 1 An illustration of an example computer-assisted surgery system (CASS) 100 according to some embodiments is provided. As described in further detail in the following sections, the 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 positioning a patient’s anatomy with high precision, guiding surgical instruments, and implanting medical devices. Surgical navigation systems such as the CASS 100 often employ various forms of computing technology to perform a wide variety of standard and minimally invasive surgical procedures and techniques. Moreover, these systems allow surgeons to more accurately plan, track, and navigate the position of instruments and implants relative to a patient’s body, as well as perform preoperative and intraoperative body imaging.

[0041] The effector platform 105 positions surgical tools relative to the patient during surgery. The exact components of the effector platform 105 will vary depending on the embodiment employed. For example, for a knee surgery, the effector platform 105 can include an end effector 105B that holds a surgical tool or instrument during its use. The end effector 105B can be a handheld device or instrument used by the surgeon (e.g., a NAVIO® handpiece or a cutting guide or clamp), or alternatively, the end effector 105B can include a device or instrument held or positioned by a robotic arm 105A. Although one robotic arm 105A is shown in Figure 1

[0042] The effector platform 105 can include a limb positioner 105C for positioning a limb of the patient during surgery. One example of a limb positioner 105C is the SMITH AND NEPHEW SPIDER2 system. The limb positioner 105C can be manually operated by the surgeon, or alternatively, change the limb position based on instructions received from the surgical computer 150 (described below). Although one limb positioner 105C is shown in Figure 1 The effector platform 105 can include a limb positioner 105C for positioning a limb of the patient during surgery. One example of a limb positioner 105C is the SMITH AND NEPHEW SPIDER2 system. The limb positioner 105C can be manually operated by the surgeon, or alternatively, change the limb position based on instructions received from the surgical computer 150 (described below). Although one limb positioner 105C is shown in

[0043] The effector platform 105 can include tools such as a screwdriver, a light or laser indicating an axis or plane, a level, a pin driver, a pin puller, a planar checker, an indicator, a finger, or some combination thereof.

[0044] The resection device 110 (not shown in FIG. 1) performs bone or tissue resection using, for example, mechanical, ultrasonic, or laser technology. Examples of resection devices 110 include a drilling device, a deburring device, an oscillating sawing device, a vibrating impact device, a reamer, an ultrasonic bone cutting device, a radiofrequency ablation device, a reciprocating device (e.g., a file or broach), and a laser ablation system. In some embodiments, the resection device 110 is held and operated by a surgeon during a procedure. In other embodiments, the effector platform 105 can be used to hold the resection device 110 during use. Figure 1 The effector platform 105 can also include a cutting guide or jig 105D that is used to guide a saw or drill used to resect tissue during a procedure. Such a cutting guide 105D can be integrally formed as part of the effector platform 105 or the robotic arm 105 A, or the cutting guide can be a separate structure that can be matingly and / or removably attached to the effector platform 105 or the robotic arm 105 A. The effector platform 105 or the robotic arm 105 A can be controlled by the CASS 100 to position the cutting guide or jig 105D near the patient’s anatomy in accordance with a preoperatively or intraoperatively developed surgical plan such that the cutting guide or jig will produce precise bone cuts in accordance with the surgical plan.

[0045]

[0046] The tracking system 115 uses one or more sensors to collect real-time position data that localizes the patient’s anatomy and surgical instruments. For example, for a TKA procedure, the tracking system can provide the position and orientation of the end effector 105B during the procedure. In addition to position data, data from the tracking system 115 can be used to infer velocity / acceleration of the anatomy / instruments, 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 a 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 application, including but not limited to infrared (IR) tracking systems, electromagnetic (EM) tracking systems, video or image-based tracking systems, and ultrasound registration and tracking systems. Using data provided by the tracking system 115, the surgical computer 150 can detect objects and prevent collisions. For example, the surgical computer 150 can prevent the robotic arm 105 A and / or the end effector 105B from colliding with soft tissue.​

[0047] Any suitable tracking system can be used to track surgical objects and patient anatomy in the operating room. For example, a combination of infrared and visible light cameras can be used in an array. Various illumination sources, such as infrared LED lights, can illuminate the scene so that three-dimensional imaging can be performed. In some embodiments, this can include stereo, trinocular, tetranocular, etc. imaging. In addition to the camera array, which in some embodiments is fixed to a cart, additional cameras can be placed throughout the operating room. For example, handheld tools or headwear worn by the operator / surgeon can include imaging functionality that transmits images back to a central processor to correlate those images with images acquired by the camera array. This can provide a more robust image for the environment being modeled using multiple perspectives. Additionally, some imaging devices can have suitable resolution on the scene or have a suitable perspective to pick up information stored in a quick response (QR) code or barcode. This helps to identify specific objects that are not manually registered with the system. In some embodiments, cameras can be mounted on the robotic arm 105A.

[0048] As discussed herein, while most tracking and / or navigation techniques utilize image-based tracking systems (e.g., IR tracking systems, video or image-based tracking systems, etc.). However, electromagnetic (EM)-based tracking systems are becoming more common for various reasons. For example, implantation of standard optical trackers requires tissue resection (e.g., down to the cortex) and subsequent drilling and driving of a cortical pin. Additionally, because optical trackers require a direct line of sight with the tracking system, placement of such trackers can need to be kept away from the surgical site to ensure that they do not limit the movement of the surgeon or medical professional.

[0049] Generally, EM-based tracking devices include one or more coils and a reference field generator. The one or more coils can be energized (e.g., via a wired or wireless power source). Once energized, the coils generate electromagnetic fields that can be detected and measured (e.g., by the reference field generator or additional devices) in a manner that allows for determination of the position and orientation of the one or more coils. As will be understood by one of ordinary skill in the art, a single coil, such as shown in FIG. 1 A, is limited to detecting five (5) total degrees of freedom (DOF). For example, the sensor 200 is capable of tracking / determining movement in the X, Y, or Z directions, as well as rotation about the Y axis 202 or the Z axis 201. However, due to the electromagnetic properties of the coil, it is not possible to properly track rotational motion about the X axis. Figure 2

[0050] Thus, in most electromagnetic tracking applications, such as Figure 3A ​The three-coil system shown in FIG. 3 is used to enable tracking in all six degrees of freedom that can cause a rigid body to move in three-dimensional space (i.e., forward / back 310, up / down 320, left / right 330, roll 340, pitch 350, and yaw 360). However, the 90° offset angle including two additional coils and their positioning can require a much larger tracking device. Alternatively, as known to those skilled in the art, less than three complete coils can be used to track all 6DOF. In some EM-based tracking devices, two coils can be fixed to each other, for example Figure 3B as shown in FIG. 3. Since the two coils 301B, 302B are rigidly fixed to each other, not completely parallel, and have a known position relative to each other, the sixth degree of freedom 303B can be determined using this arrangement.

[0051] Although the use of two fixed coils (e.g., 301B, 302B) allows for EM-based tracking in 6DOF, the diameter of the sensor device is much larger than a single coil due to the additional coils. Thus, practical applications of using EM-based tracking systems in a surgical environment can require tissue resection and drilling a hole into a portion of the patient’s bone to allow insertion of the EM tracker. Alternatively, in some embodiments, a single coil or 5DOF EM tracking device can be implanted / inserted into the patient’s bone using only a pin (e.g., without the need to drill a hole or resect a large amount of bone).

[0052] Thus, as described herein, a solution is needed that can limit the use of EM tracking systems to devices that are small enough to be inserted / embedded using a small diameter needle or pin (i.e., without the need to make a new incision or large diameter opening in the bone). Thus, in some embodiments, a second 5DOF sensor that is not attached to the first sensor and thus has a small diameter can be used to track all 6DOF. Referring now to Figure 3C In some embodiments, two 5DOF EM sensors (e.g., 301C, 302C) can be inserted into the patient (e.g., into the patient’s bone) at different locations with different angular orientations (e.g., angle 303C is non-zero).

[0053] Referring now to Figure 4Figure 4B shows an example embodiment of inserting first 5DOF EM sensor 401 and second 5DOF EM sensor 402 into a patient bone 403 using a standard hollow needle 405 typical in most ORs. In another embodiment, the first sensor 401 and second sensor 402 can have an angular offset of "a" 404. In some embodiments, the offset angle "a" 404 can need to be greater than a predetermined value (e.g., a minimum angle of 0.50°, 0.75°, etc.). In some embodiments, this minimum value can be determined by the CASS and provided to the surgeon or medical professional during the surgical planning. In some embodiments, the minimum value can be based on one or more factors, e.g., the directional accuracy of the tracking system, the distance between the first EM sensor and the second EM sensor, the location of the field generator, the location of the field detector, the type of EM sensor, the mass of the EM sensor, the patient anatomy, etc.

[0054] Thus, as discussed herein, in some embodiments, a pin / needle (e.g., a cannula mounted needle, etc.) can be used to insert one or more EM sensors. Typically, the pin / needle will be a disposable component, while the sensor itself can be reusable. However, it should be understood that this is merely one possible system, and various other systems can be used in which the pin / needle and / or EM sensor are independent, single use, or reusable. In another embodiment, the EM sensor can be secured to the mounting pin / needle (e.g., using a luer lock fitting, etc.), which can allow for quick assembly and disassembly. In further embodiments, the EM sensor can utilize an alternative sleeve and / or anchoring system that allows for minimally invasive placement of the sensor.

[0055] In another embodiment, the above-described system can allow for a multi-sensor navigation system that can detect and correct for field distortions that plague electromagnetic tracking systems. It should be understood that field distortions can be caused by the movement of any ferromagnetic material within the reference field. Thus, as is known to those of ordinary skill in the art, a typical OR has a large number of devices that can cause interference (e.g., surgical table, LCD displays, lighting, imaging systems, surgical instruments, etc.). Moreover, it is well known that field distortions are difficult to detect. The use of multiple EM sensors allows the system to accurately detect field distortions, and / or alert the user that the current position measurements can not be accurate. Because the sensors are securely fixed to the bone anatomy (e.g., via the pin / needle), the relative measurements of the sensor positions (X, Y, Z) can be used to detect field distortions. As a non-limiting example, in some embodiments, after the EM sensors are fixed to the bone, the relative distance between the two sensors is known and should remain constant. Thus, any change in this distance can be indicative of the presence of a field distortion.

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

[0057] In some embodiments, certain markers such as fiducial markers identifying individuals, important tools, or bones in the operating room can include passive or active identification that can be picked up by cameras or camera arrays associated with the tracking system. For example, infrared LEDs can flash a pattern that conveys a unique identification to the source of the pattern, providing a dynamic identification marker. Similarly, one- or two-dimensional optical codes (barcodes, QR codes, etc.) can be affixed 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 objects, they can also be used to determine the orientation of the objects by comparing the location of the identification to the extent of the object in the image. For example, a QR code can be placed in a corner of a tool tray, allowing the direction and identification of the tray to be tracked. Other tracking modalities will be described throughout. For example, in some embodiments, the surgeon and other personnel can wear augmented reality headsets to provide additional camera angles and tracking capabilities.

[0058] In addition to optical tracking, certain features of objects can also be tracked by registering physical properties of the objects and associating them with objects that can be tracked, such as fiducial markers affixed to tools or bones. For example, the surgeon can perform a manual registration process whereby a tracked tool and a tracked bone can be manipulated relative to one another. By striking the tip of the tool against the surface of the bone, a three-dimensional surface can be mapped for the bone, associated with a position and orientation relative to the frame of reference of the fiducial marker. By tracking the position and orientation (pose) of the fiducial marker associated with the bone optically, a model of the surface can be tracked in the environment by extrapolation.

[0059] The registration process of registering the CASS 100 to relevant anatomy of a patient can also involve the use of anatomical landmarks, such as landmarks on bones or cartilage. For example, the CASS 100 can include a 3D model of the relevant bones or joint, and the surgeon can use a probe connected to the CASS to collect data about the location of bone landmarks on the patient’s actual bones intraoperatively. Bone landmarks can include, for example, the medial and lateral malleolus, the ends of the proximal femur and distal tibia, and the center of the hip joint. The CASS 100 can compare and register the location data of the bone landmarks collected by the surgeon with the probe to the location data of the same landmarks in the 3D model. Alternatively, the CASS 100 can construct a 3D model of a bone or joint without preoperative image data by using the location data of bone landmarks and bone surfaces collected by the surgeon using the CASS probe or other means. The registration process can also include determining the various axes of the joint. For example, for a TKA, the surgeon can use the CASS 100 to determine the anatomical and mechanical axes of the femur and tibia. The surgeon and the CASS 100 can identify the center of the hip joint by moving the patient’s leg in a helical direction (i.e., circumduction) so that the CASS can determine the location of the hip joint center.

[0060] The tissue navigation system 120 (not shown in Figure 1 provides intraoperative real-time visualization of the patient’s bony, cartilaginous, muscular, neural, and / or vascular tissue around the surgical area for the surgeon. Examples of systems that can be used for tissue navigation include a fluorescent imaging system and an ultrasound system.

[0061] The display 125 provides a graphical user interface (GUI) that displays images collected by the tissue navigation system 120 as well as other information relevant to the surgery. For example, in one embodiment, the display 125 overlays image information collected from various modalities (e.g., CT, MRI, X-ray, fluorescence, ultrasound, etc.) collected preoperatively or intraoperatively to provide the surgeon with various views of the patient’s anatomy as well as real-time conditions. The display 125 can include, for example, one or more computer monitors. As an alternative or supplement to the display 125, one or more of the surgical personnel can wear an augmented reality (AR) head-mounted device (HMD). For example, in Figure 1 the surgeon 111 wears an AR HMD 155, which can, for example, overlay preoperative image data over the patient or provide surgical plan suggestions. Various exemplary uses of the AR HMD 155 in the surgical procedure are described in detail in the following sections.

[0062] The surgical computer 150 provides control instructions to various components of the CASS 100, collects data from those components, and provides general processing for various data required during surgery. In some embodiments, the surgical computer 150 is a general-purpose computer. In other embodiments, the surgical computer 150 may 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). The remote server may be used for, for example, data storage or the execution of computationally intensive processing tasks.

[0063] Various techniques known in the art can be used to connect the surgical computer 150 to other components of the CASS 100. Furthermore, the computer can be connected to the surgical computer 150 using a variety of technologies. For example, the end effector 105B can 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 can similarly be connected to the surgical computer 150 using wired connections. Alternatively, the tracking system 115, tissue navigation system 120, and display 125 can 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] Powered Impactor and Reamer Device

[0065] The above is about Figure 1 Part of the flexibility of the described CASS design lies in the ability to add additional or alternative devices to the CASS 100 as needed to support specific surgical procedures. For example, in the case of hip surgery, the CASS 100 may include a powered impact device. The impact device is designed to repeatedly apply impact forces that a surgeon can use to perform activities such as implant alignment. For instance, in total hip replacement (THA), surgeons typically use an impact device to insert a prosthetic acetabular cup into the acetabulum of the implant host. While impact devices can be inherently manual (e.g., operated by a surgeon striking the impactor with a hammer), powered impact devices are generally easier and faster to use in the surgical setting. Powered impact devices can be powered, for example, using a battery attached to the device. Various attachments can be connected to the powered impact device to allow the impact forces to be directed in various ways as needed during surgery. Also in the case of hip surgery, the CASS 100 may include a powered, robotically controlled end effector to dilate the acetabulum to accommodate the acetabular cup implant.

[0066] In a robot-assisted THA, the patient’s anatomy can be registered to the 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 installed using clamps and / or bone pins on the iliac crest, and can be installed externally through the skin or internally (posterolaterally or anterolaterally) through an incision made for performing the THA. For a THA, the CASS 100 can utilize one or more femoral cortical screws inserted into the proximal femur as checkpoints to aid the registration process. The CASS 100 can also utilize one or more checkpoint screws inserted into the pelvis as additional checkpoints to aid the registration process. A femoral tracker array can be secured or mounted in the femoral cortical screws. The CASS 100 can employ the following steps, where a probe that the surgeon places precisely on key areas of the proximal femur and pelvis, which are identified for the surgeon on the display 125, is used for verification. Trackers can be located on the robotic arm 105 A or end effector 105B to register the arm and / or end effector to the CASS 100. The verification steps can also utilize proximal and distal femoral checkpoints. The CASS 100 can utilize color cues or other cues to inform the surgeon that the registration process for the bones and the robotic arm 105 A or end effector 105B has been verified to a certain degree of accuracy (e.g., within 1 mm).

[0067] For a THA, the CASS 100 can include a broach tracking option using the femoral array to allow the surgeon to intraoperatively capture the position and orientation of the broach and to calculate the patient’s hip length and offset values. Based on the information provided about the patient’s hip joint and the information about the planned implant position and orientation after the broach tracking is complete, the surgeon can make modifications or adjustments to the surgical plan.

[0068] For robot-assisted THA, the CASS 100 can include one or more powered reamers connected or attached to the robotic arm 105 A or end effector 105B that prepare the pelvic bone to receive the acetabular implant according to the surgical plan. The robotic arm 105 A and / or end effector 105B can notify the surgeon and / or control the power of the reamers to ensure that the acetabulum is resected (reamed) according to the surgical plan. For example, if the surgeon attempts to resect bone outside of the boundaries of the bone to be resected according to the surgical plan, the CASS 100 can shut off power to the reamers or instruct the surgeon to shut off power to the reamers. The CASS 100 can provide the surgeon with the option to turn off or disengage robotic control of the reamers. The display 125 can show the progress of the bone being resected (reamed) compared to the use of different colored surgical plans. The surgeon can view the display of the bone being resected (reamed) to guide the reamers to complete the reaming according to the surgical plan. The CASS 100 can provide visual or audible cues to the surgeon to warn the surgeon that resection is being performed that does not conform to the surgical plan.

[0069] After reaming, the CASS 100 can employ a manual or powered impactor attached or connected to the robotic arm 105 A or end effector 105B to impact trial implants and final implants into the acetabulum. The robotic arm 105 A and / or end effector 105B can be used to guide the impactor to impact trial implants and final implants into the acetabulum according to the surgical plan. The CASS 100 can cause the position and orientation of the trial implants and final implants relative to the bone to be displayed to inform the surgeon how to compare the orientation and position of the trial implants and final implants to the surgical plan. The display 125 can display the position and orientation of the implants as the surgeon manipulates the leg and hip. If the surgeon is not satisfied with the initial implant position and orientation, the CASS 100 can provide the surgeon with the option to re-plan and redo the reaming and implant impacting by preparing a new surgical plan.

[0070] Prior to surgery, the CASS 100 can develop a proposed surgical plan based on a three-dimensional model of the hip joint and other patient-specific information, such as the mechanical and anatomical axes of the leg bones, the epicondylar axis, the femoral neck axis, the dimensions (e.g., length) of the femur and hip, the midline axis of the hip joint, the ASIS axis of the hip joint, and the locations of anatomical landmarks such as the lesser trochanter landmark, the distal landmark, and the center of rotation of the hip joint. The CASS-developed surgical plan can provide recommended optimal implant sizes as well as the position and orientation of the implants based on the three-dimensional model of the hip joint and other patient-specific information. The CASS-developed surgical plan can include recommended details about offset values, anteversion and anteversion values, center of rotation, cup size, medialization values, fit- up values, femoral stem size and length.

[0071] For THA, the CASS-developed surgical plan can be viewed preoperatively and intraoperatively, and the surgeon can modify the CASS-developed surgical plan preoperatively or intraoperatively. The CASS-developed surgical plan can show the planned resection of the hip joint and superimpose the planned implants onto the hip joint according to the planned resection. The CASS 100 can provide the surgeon with a choice of different surgical workflows, which will be displayed to the surgeon according to the surgeon’s preferences. For example, the surgeon can choose from different workflows based on the number and type of anatomical landmarks examined and acquired and / or the position and number of tracker arrays used in the registration process.

[0072] According to some embodiments, the powered impaction device used with the CASS 100 can be operated in a variety of different settings. In some embodiments, the surgeon adjusts the settings through a manual switch or other physical mechanism on the powered impaction device. In other embodiments, a digital interface can be used that allows for setting input, for example, via a touchscreen on the powered impaction device. Such a digital interface can allow the available settings to vary based on, for example, the type of attachment connected to the power attachment device. In some embodiments, the settings can be changed by communicating with the robot or other computer system within the CASS 100, rather than adjusting the settings on the powered impaction device itself. Such a connection can be established using, for example, a Bluetooth or Wi-Fi networking module on the powered impaction device. In another embodiment, the impaction device and end piece can contain features that allow the impaction device to know what end piece (cup impactor, broach handle, etc.) is attached without the surgeon needing to take any action and adjust the settings accordingly. This can be accomplished, for example, through a QR code, bar code, RFID tag, or other method.

[0073] Examples of settings that can be used include cup impaction settings (e.g., one-way, specified frequency range, specified force and / or energy range); broach impaction settings (e.g., two-way / oscillating within a specified frequency range, specified force and / or energy range); femoral head impaction settings (e.g., one-way / single strike at a specified force or energy); and dry impaction settings (e.g., one-way at a specified force or energy at a specified frequency). Additionally, in some embodiments, the powered impaction device includes settings related to acetabular liner impaction (e.g., one-way / single strike at a specified force or energy). There can be multiple settings for each type of liner (e.g., poly, ceramic, oxinium, or other materials). Furthermore, the powered impaction device can provide settings for different bone qualities based on preoperative testing / imaging / knowledge and / or intraoperative assessment by the surgeon. In some embodiments, the powered impaction device can have dual functionality. For example, the powered impaction device can not only provide reciprocation to provide impaction forces, but can also provide reciprocation for a broach or a rasp.

[0074] In some embodiments, the powered impaction device includes feedback sensors that collect data during instrument use and send the data to a computing device, such as a controller within the device or a surgical computer 150. The 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, predetermined resonant frequencies for each instrument, reaction forces or rebound energy from the patient’s bone, the device’s position relative to imaging (e.g., fluoroscopy, CT, ultrasound, MRI, etc.) of the registered bone anatomy, and / or external strain gauges on the bone.

[0075] Once 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 correct final reamer size (femur); when the stem is fully seated (femur side); or when the cup is seated (depth and / or orientation) for THA. Once this information is known, it 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] Further, data derived from the aforementioned algorithms can be used to drive the operation of the device. For example, during the insertion of a prosthetic acetabular cup with a powered impaction device, the device can automatically extend the impaction head (e.g., end effector), move the implant into position, or shut off power to the device once the implant is fully seated. In one embodiment, the derived information can be used to automatically adjust the settings for bone quality, where less power should be used by the powered impaction device to mitigate damage to the femur / acetabulum / pelvic bone or surrounding tissue.

[0077] Robotic Arm

[0078] In some embodiments, the CASS 100 includes a robotic arm 105 A that serves as an interface to stabilize and hold various instruments used during a surgical procedure. For example, in the case of a hip surgery, these instruments can include, but are not limited to, retractors, sagittal or reciprocating saws, reamer handles, cup impactors, reamer bars, and stem inserters. The robotic arm 105 A can have multiple degrees of freedom (similar to a Spider device) and have the ability to lock into place (e.g., by pressing a button, voice activation, the surgeon moving his hand away from the robotic arm, or other methods).

[0079] In some embodiments, movement of the robotic arm 105 A can be achieved through the use of a control panel built into the robotic arm system. For example, a 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 robotic arm 105 A to move. A surgeon or other healthcare professional can interface with the one or more input sources to position the robotic arm 105 A during performance of a surgical procedure.

[0080] Tools or end effectors 105B attached or integrated to the robotic arm 105 A can 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 can be positioned at the end of the robotic arm 105 A such that any motor control operations are performed within the robotic arm system. In embodiments using tools, the tools can be fixed at the distal end of the robotic arm 105 A, but motor control operations can be located within the tool itself.

[0081] The robotic arm 105 A can be motorized internally to stabilize the robotic arm, preventing it from falling and hitting the patient, surgical table, surgical personnel, etc., and to allow the surgeon to move the robotic arm without having to fully support its weight. While the surgeon moves the robotic arm 105 A, 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 locked state of the robotic arm 105 A can be tracked, for example, by a controller or surgical computer 150.

[0082] In some embodiments, the robotic arm 105 A can be moved to its desired position and orientation for the task being performed, either by hand (e.g., by a surgeon) or with internal motors. In some embodiments, the robotic arm 105 A can be capable of operating in a“free” mode, allowing the surgeon to position the arm in a desired position without restriction. In free mode, the position and orientation of the robotic arm 105 A can still be tracked, as described above. In one embodiment, certain degrees of freedom can be selectively released upon input from a user (e.g., a surgeon) during a specified portion of a surgical plan tracked by the surgical computer 150. Designs in which the robotic arm 105 A is powered internally by hydraulics or motors or provides resistance to external manual motion by similar means can be described as powered robotic arms, while arms that are manually manipulated without powered feedback but can be manually or automatically locked in place can be described as passive robotic arms.

[0083] The robotic arm 105A or end effector 105B can include a trigger or other device to control the power of the saw or drill. Engagement of the trigger or other device by the surgeon can cause the robotic arm 105A or end effector 105B to transition from a motorized alignment mode to a mode in which the saw or drill is engaged and powered. Additionally, the CASS 100 can include a foot pedal (not shown) that, when activated, causes the system to perform certain functions. For example, the surgeon can activate the foot pedal to instruct the CASS 100 to place the robotic arm 105A or end effector 105B in an automatic mode that positions the robotic arm or end effector in the appropriate position relative to the patient’s anatomy in order to perform the necessary resection. The CASS 100 can also place the robotic arm 105A or end effector 105B in a cooperative mode that allows the surgeon to manually manipulate and position the robotic arm or end effector in a particular location. The cooperative mode can be configured to allow the surgeon to move the robotic arm 105A or end effector 105B medially or laterally while limiting motion in other directions. As discussed, the robotic arm 105A or end effector 105B can include a cutting device (saw, drill, and bur) or a cutting guide or clamp 105D that will guide the cutting device. In other embodiments, the motion of the robotic arm 105A or robotically controlled end effector 105B can be controlled entirely by the CASS 100 without any assistance or input from a surgeon or other medical professional, or with only minimal assistance or input. In still other embodiments, a surgeon or other medical professional can remotely control the motion of the robotic arm 105A or robotically controlled end effector 105B using a control mechanism separate from the robotic arm or robotically controlled end effector device, such as using a joystick or interactive monitor or display control device.

[0084] The following examples describe the use of the robotic device in the context of hip surgery; however, it should be understood that the robotic arm can have other applications in surgical procedures involving the knee, shoulder, etc. One example of the use of the 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 August 28, 2018, entitled “Robotic Assisted Ligament Graft Placement and Tensioning,” the entirety of which is incorporated by reference herein.

[0085] The robotic arm 105 A can be used to hold a retractor. For example, in one embodiment, the surgeon can move the robotic arm 105 A to a desired position. At that point, the robotic arm 105 A can lock into place. In some embodiments, the robotic arm 105 A is provided with data regarding the position of the patient, 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 action to be performed simultaneously (e.g., retractor holding and reaming).

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

[0087] In some embodiments, the robotic arm 105 A 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 105 A can prevent any further seating to prevent damage to the pelvis.

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

[0089] The robotic arm 105 A can also be used for resurfacing applications. For example, the robotic arm 105 A can stabilize the surgeon while using traditional instruments and provide certain constraints or restrictions to allow for proper placement of implant components (e.g., guide wire placement, chamfer cutters, sleeve cutters, planar cutters, etc.). In the case of using only a bone drill, the robotic arm 105 A can stabilize the surgeon's handpiece and can impose restrictions on the handpiece to prevent the surgeon from removing undesired bone in violation of the surgical plan.

[0090] The robotic arm 105A can be a passive arm. As an example, the robotic arm 105A can be a CIRQ robotic arm available from Brainlab AG. CIRQ is a registered trademark of Brainlab AG, Olof-Palme-Str. 9 81829, Munich, Germany. In one particular embodiment, the robotic arm 105A is a smart holding arm as disclosed in U.S. Patent Application No. 15 / 525,585 to Krinninger et al., U.S. Patent Application No. 15 / 561,042 to Nowatschin et al., U.S. Patent No. 15 / 561,048 to Nowatschin et al., and U.S. Patent No. 10,342,636 to Nowatschin et al., the entire contents of each of the above patents are incorporated herein by reference.

[0091] Generation and Collection of Surgical Procedure Data

[0092] Various services provided by medical professionals for treating a clinical condition are collectively referred to as a “care episode.” For a particular surgical procedure, the care episode can include three phases: pre-operative, intra-operative, and post-operative. During each phase, data is collected or generated that can be used to analyze the care episode in order to understand various characteristics of the procedure and identify patterns that can be used, for example, in training models to make decisions with minimal human intervention. The data collected during a care episode can be stored as a complete data set at the surgical computer 150 or the surgical data server 180. Thus, for each care episode, there is a data set that includes all data collected about the patient pre-operatively, all data collected or stored by the CASS 100 intra-operatively, and any post-operative data provided by the patient or by medical professionals monitoring the patient.

[0093] As explained in further detail, data collected during the episode of care can be used to enhance the execution of the surgical procedure or provide an overall understanding of the surgical procedure and patient outcomes. For example, in some embodiments, data collected during the episode of care can be used to generate a surgical plan. In one embodiment, as data is collected during surgery, a high-level pre-operative plan is refined intraoperatively. In this manner, the surgical plan can be viewed as dynamically changing in real-time or near real-time as new data is collected by the components of the CASS 100. In other embodiments, a robust plan can be pre-operatively formulated using pre-operative images or other input data that is simply executed during surgery. In this case, data collected by the CASS 100 during surgery can be used to make recommendations to ensure that the surgeon stays within the pre-operative surgical plan. For example, if the surgeon is unsure how to achieve certain prescribed cuts or implant alignments, the surgical computer 150 can be queried for recommendations. In still other embodiments, a combination of pre-operative and intra-operative planning approaches can be used such that a refined pre-operative plan can be dynamically modified during the surgical procedure as needed or desired. In some embodiments, biomechanically-based models of patient anatomy contribute simulation data to be considered by the CASS 100 in formulating pre-operative, intra-operative, and post-operative / rehabilitation procedures to optimize implant performance outcomes for the patient.

[0094] In addition to altering the surgical procedure itself, data collected during the episode of care can also be used as input for other surgical ancillary procedures. For example, in some embodiments, the episode of care data can be used to design implants. Example data-driven techniques for designing, sizing, and fitting implants are described in U.S. Patent Application No. 13 / 814,531, filed August 15, 2011, entitled “Systems and Methods for Optimizing Parameters for Orthopaedic Procedures”; U.S. Patent Application No. 14 / 232,958, filed July 20, 2012, entitled “Systems and Methods for Optimizing Fit of an Implant to Anatomy”; and U.S. Patent Application No. 12 / 234,444, filed September 19, 2008, entitled “Operatively Tuning Implants for Increased Performance,” the entire contents of each of the foregoing are hereby incorporated by reference into this patent application.

[0095] Further, data can be used for educational, training, or research purposes. For example, using the below inFigure 5C The network-based approach described in the middle, other doctors or students can remotely view a surgery in an interface that allows them to selectively view data collected from various components of the CASS 100. After the surgical procedure, a similar interface can be used to “replay” the surgery for training or other educational purposes, or to find the root of any problems or complications in the surgery.

[0096] Data acquired during the pre-operative phase generally includes all information collected or generated prior to the surgery. Thus, for example, information about the patient can be acquired from a patient intake form or electronic medical record (EMR). Examples of patient information that can be collected include, but are not limited to, patient demographics, diagnoses, medical history, medical records, vital signs, medical history information, allergies, and laboratory test results. Pre-operative data can also include images related to the anatomical region of interest. These images can be acquired, for example, using magnetic resonance imaging (MRI), computed tomography (CT), X-ray, ultrasound, or any other means known in the art. Pre-operative data can also include quality of life data acquired from the patient. For example, in one embodiment, pre-operative patients use a mobile application (“app”) to answer a questionnaire about their current quality of life. In some embodiments, pre-operative data used by the CASS 100 includes information about patient demographics, anthropometrics, cultural, or other specific characteristics that can be aligned with activity levels and specific patient activities to customize a surgical plan for the patient. For example, certain cultures or demographics of people can be more comfortable using a toilet for bowel movements each day.

[0097] Figure 5A And 5B Examples of data that can be acquired during the intra-operative phase of the care episode are provided. These examples are based on the various components of the CASS 100 described above with reference to Figure 1 It should be appreciated, however, that other types of data can be used based on the types of equipment used during the surgery and their use.

[0098] Figure 5A Examples of some control instructions provided by the Surgical Computer 150 to other components of the CASS 100 according to some embodiments are shown. Note that Figure 5A Examples of the Surgical Computer 150 assume that components of the Effector Platform 105 are all controlled directly by the Surgical Computer 150. In embodiments where components are manually controlled by the Surgeon 111, instructions can be provided on the Display 125 or AR HMD 155 to instruct the Surgeon 111 how to move the components.

[0099] The various components included in the effector platform 105 are controlled by a surgical computer 150, which provides position instructions that dictate 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 the components of the effector platform 105 are to react when they deviate from a surgical plan. These commands are referred to in Figure 5A as "haptic" commands. For example, the end effector 105B can provide a force to resist motion outside of a planned resection area. Other commands that can be used by the effector platform 105 include vibrations and audio cues.

[0100] In some embodiments, the end effector 105B of the robotic arm 105A is operably coupled with a cutting guide 105D. In response to an anatomical model of the surgical scene, the robotic arm 105A can move the end effector 105B and the cutting guide 105D into position to match the location of a femoral or tibial cut to be made according to the surgical plan. This can reduce the likelihood of error, allowing the vision system and processor utilizing the vision system to implement the surgical plan to place the cutting guide 105D in a precise position and orientation relative to the tibia or femur to align the cutting slot of the cutting guide with the cut to be performed according to the surgical plan. The surgeon can then use any suitable tool, such as a vibrating or rotating saw or drill, to perform the cut (or drill hole) with perfect placement and orientation, as the tool is mechanically limited by the features of the cutting guide 105D. In some embodiments, the cutting guide 105D can include one or more pin holes that the surgeon uses to drill and tighten or pin the cutting guide into place before performing a resection of patient tissue using the cutting guide. This can free the robotic arm 105A or ensure that the cutting guide 105D is fully secured from moving relative to the bone to be resected. For example, this procedure 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 secured to the femoral head or acetabulum for a corresponding hip arthroplasty resection. It will be appreciated that any arthroplasty that utilizes a precise cut can use the robotic arm 105A and / or cutting guide 105D in this manner.

[0101] The resection device 110 is provided with a variety of commands to perform bone or tissue operations. As with the effector platform 105, position information can be provided to the resection device 110 to specify where it should be positioned in performing a resection. Other commands provided to the resection device 110 can depend on the type of resection device. For example, for mechanical or ultrasonic resection tools, the commands can specify the speed and frequency of the tool. For radiofrequency ablation (RFA) and other laser ablation tools, the commands can specify the intensity and pulse duration.

[0102] Some components of the CASS 100 do not need to be controlled directly by the surgical computer 150; rather, the surgical computer 150 only needs to activate the components, which then execute software locally to specify the way in which data is collected and provided to the surgical computer 150. In the example of the CASS 100, there are two components that operate in this manner: the tracking system 115 and the tissue navigation system 120. Figure 5A

[0103] The surgical computer 150 provides any visualization required by the surgeon 111 during the surgery to the display 125. For a monitor, the surgical computer 150 can provide instructions for displaying images, GUIs, etc. using techniques known in the art. The display 125 can include various features of the workflow of the surgical plan. For example, during the registration process, the display 125 can display the preoperatively constructed 3D bone model and show the position of a probe as the surgeon collects the locations of anatomical landmarks on the patient. The display 125 can include information about the target region of the surgery. For example, in connection with a TKA, the display 125 can show the mechanical and anatomical axes of the femur and tibia. The display 125 can show the varus and valgus angles of the knee based on the surgical plan, and the CASS 100 can show how such angles would be affected if the contemplated modifications to the surgical plan were made. Thus, the display 125 is an interactive interface that can dynamically update and display how changes to the surgical plan would affect the procedure and the final position and orientation of the implants installed on the bone.

[0104] As the workflow progresses to the preparation of bone cuts or resections, the display 125 can show the planned or recommended bone cuts prior to any cuts being performed. The surgeon 111 can manipulate the image display to provide different anatomical perspectives of the target region and can have the option to change or modify the planned bone cuts based on intraoperative assessment of the patient. The display 125 can show how the selected implants would be installed on the bone if the planned bone cuts were performed. If the surgeon 111 elects to change a previously planned bone cut, the display 125 can show how the revised bone cut would change the position and orientation of the implants when installed on the bone.

[0105] ​The display 125 can provide various data and information to the surgeon 111 regarding the patient, the planned surgical procedure, and the implants. Various patient-specific information can be displayed, including real-time data regarding the patient’s health, such as heart rate, blood pressure, etc. The display 125 can also include information regarding the anatomy of the surgical target region, including the location of landmarks, the current state of the anatomy (e.g., whether any resections have been made, the depth and angle of planned and executed bone cuts), and the future state of the anatomy as the surgical plan progresses. The display 125 can also provide or illustrate additional information regarding the surgical target region. For TKA, the display 125 can provide information regarding the gap between the femur and tibia (e.g., gap balancing) and how such a gap will change if the planned surgical plan is executed. For TKA, the display 125 can provide additional relevant information regarding the knee joint, such as data regarding the tension of the joint (e.g., ligament laxity) and information regarding the rotation and alignment of the joint. The display 125 can illustrate how the planned implants will be positioned and located when the knee joint is flexed. The display 125 can illustrate how the use of different implants or the use of the same implant in different sizes will affect the surgical plan and preview how such implants will be positioned on the bone. The CASS 100 can provide such information for each planned bone resection in TKA or THA. In TKA, the CASS 100 can provide robotic control for one or more planned bone resections. For example, the CASS 100 can only provide robotic control for the initial femoral distal cut, and the surgeon 111 can manually perform the other resections (anterior, posterior, and chamfer cuts) using conventional means (e.g., a 4-in-l cutting guide or jig 105D).

[0106] The display 125 can employ different colors to inform the surgeon of the status of the surgical plan. For example, un-resected bone can be displayed in a first color, resected bone can be displayed in a second color, and planned resections can be displayed in a third color. Implants can be superimposed on the bone in the display 125, and the implant colors can change or correspond to different types or sizes of implants.

[0107] The information and options shown on display 125 can vary depending on the type of surgical procedure being performed. In addition, surgeon 111 can request or select a particular surgical procedure display that matches or is consistent with his or her surgical planning preferences. For example, for a surgeon 111 who typically performs tibial cuts prior to femoral cuts in a TKA, display 125 and the associated workflow can be adapted to account for that preference. Surgeon 111 can also pre-select certain steps to be included or deleted from a standard surgical procedure display. For example, if surgeon 111 uses resection measurements to finalize an implant plan, but does not analyze ligament gap balancing when finalizing the implant plan, the surgical procedure display can be organized into modules, and the surgeon can select which modules to display and the order in which the modules are provided, according to the surgeon’s preferences or the specifics of the surgery. For example, modules related to ligament and gap balancing can include pre- and post-resection ligament / gap balancing, and surgeon 111 can select which of those modules to include in his or her default surgical planning workflow, depending on whether such ligament and gap balancing is performed before or after (or both) performing bone resections.

[0108] For more specialized display devices, such as AR HMDs, surgical computer 150 can use data formats supported by the device to provide images, text, etc. For example, if display 125 is a holographic device such as Microsoft HoloLens™ or Magic Leap One™, surgical computer 150 can use the HoloLens Application Program Interface (API) to send commands specifying the location and content of holograms to be displayed in the field of view of surgeon 111.

[0109] In some embodiments, one or more surgical planning models can be incorporated into CASS 100 and used in the formulation of surgical plans provided to surgeon 111. The term “surgical planning model” refers to software that simulates the biomechanical performance of anatomical structures in various scenarios to determine the best way to perform cuts and other surgical activities. For example, for a knee replacement surgery, a surgical planning model can measure parameters of functional activities, such as deep knee flexion, gait, etc., and select cut locations on the knee to optimize implant placement. One example of a surgical planning model is the LIFEMOD™ simulation software from SMITH AND NEPHEW, INC. In some embodiments, surgical computer 150 includes a computational architecture that allows for full execution of a surgical planning model during surgery (e.g., a GPU-based parallel processing environment). In other embodiments, surgical computer 150 can be connected over a network to a remote computer that allows for such execution, such as surgical data server 180 (see FIG. 1). In some embodiments, the surgical planning model is executed on a remote computer, and the results are provided to surgical computer 150 for use in the formulation of surgical plans. Figure 5C). As an alternative to full execution of the surgical planning model, in some embodiments, a set of transfer functions are derived that simplify the mathematical operations taken by the model into one or more predictive equations. Then, rather than executing a full simulation during surgery, the predictive equations are used. Further details regarding the use of transfer functions are described in International Patent Application No. WO 2020 / 037308, titled “Patient Specific Surgical Method and System,” filed August 19, 2019, the entirety of which is incorporated by reference herein.

[0110] Figure 5B Examples of some types of data that can be provided to the Surgical Computer 150 from the various components of the CASS 100 are shown. In some embodiments, the components can stream data to the Surgical Computer 150 in real-time or near real-time during surgery. In other embodiments, the components can queue data and send it to the Surgical Computer 150 at set intervals (e.g., every second). The data can be transmitted using any format known in the art. Thus, in some embodiments, all components transmit data to the Surgical Computer 150 in a universal format. In other embodiments, each component can use a different data format, and the Surgical Computer 150 is configured with one or more software applications that are capable of converting the data.

[0111] In general, the Surgical Computer 150 can serve as a central point for collecting CASS data. The exact content of the data will depend on the source. For example, each component of the Effector Platform 105 provides a measured position to the Surgical Computer 150. Thus, by comparing the measured position to the position originally specified by the Surgical Computer 150 (see Figure 5B ), the Surgical Computer can identify deviations that occur during surgery.

[0112] The Resection Device 110 can send various types of data to the Surgical Computer 150 depending on the type of device used. Example data types that can be sent include measured torque, audio signatures, and measured displacement values. Similarly, the Tracking Technology 115 can provide different types of data depending on the tracking method employed. Example tracking data types include tracked items (e.g., anatomical structures, tools, etc.), ultrasound images, and position values for surface or landmark collection points or axes. The Organizational Navigation System 120 provides anatomical positions, shapes, etc. to the Surgical Computer 150 as the system operates.

[0113] While the display 125 is generally used to output data for presentation to a user, it can also provide data to the surgical computer 150. For example, for embodiments in which a monitor is used as part of the display 125, the surgeon 111 can 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 can be sent to the surgical computer 150 so that it can update the presented view as needed.

[0114] During the post-operative phase of the care episode, various types of data can be collected to quantify the overall improvement or deterioration in the patient’s condition as a result of the surgery. The data can take the form of self-reported information, for example, reported by the patient through a questionnaire. For example, in the case of a knee replacement surgery, the Oxford Knee Score questionnaire can be used to measure functional status, and the post-operative quality of life can be measured through the EQ5D-5L questionnaire. Other examples in the case of hip replacement surgery can include the Oxford Hip Score, the Harris Hip Score, and the WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index). Such questionnaires can be administered, for example, directly by a healthcare professional in a clinical setting, or using a mobile application that allows the patient to answer the questions directly. In some embodiments, the patient can be equipped with one or more wearable devices that collect data related to the surgery. For example, after a knee surgery, the patient can be equipped with a knee brace that includes sensors to monitor the position of the knee, flexibility, etc. This information can be collected and transmitted to the patient’s mobile device for review by the surgeon to assess the results of the surgery and address any issues. In some embodiments, one or more cameras can acquire and record the motion of the patient’s body part during specified activities post-surgery. This motion acquisition can be compared to biomechanical models to better understand the function of the patient’s joint, and to better predict rehabilitation progress and determine any modifications that can be needed.

[0115] The postoperative phase of the care period can continue throughout the patient's lifespan. For example, in some embodiments, the surgical computer 150 or other components including CASS 100 can continue to receive and collect data related to the surgical procedure after it has been performed. This data may include, for example, images, question answers, “normal” patient data (e.g., blood type, blood pressure, condition, medications, etc.), biometric data (e.g., gait, etc.), and objective and subjective data on specific issues (e.g., knee or hip pain). This data may be explicitly provided to the surgical computer 150 or other CASS components by the patient or the patient's physician. Alternatively or additionally, the surgical computer 150 or other CASS components may monitor the patient's EMR and retrieve relevant information when available. This longitudinal view of patient recovery allows the surgical computer 150 or other CASS components to provide a more objective analysis of patient outcomes to measure and track the success or failure of a given procedure. For example, regression analysis of various data items collected during the care period can link the patient's condition long after the surgical procedure to the surgery. This analysis can be further enhanced by analyzing patient groups with similar procedures and / or similar anatomy.

[0116] In some embodiments, data is collected at a central location to provide easier analysis and use. In some cases, data can be collected manually from various CASS components. For example, a portable storage device (e.g., a USB stick) can be attached to the surgical computer 150 to retrieve data collected during surgery. The data can then be transferred, for example, via a desktop computer to a centralized storage device. Alternatively, in some embodiments, the surgical computer 150 is directly connected to a centralized storage device via a network 175, such as... Figure 5C As shown in the image.

[0117] Figure 5C A cloud-based implementation is illustrated, in which surgical computer 150 is connected to surgical data server 180 via network 175. This network 175 can be, for example, a private intranet or the Internet. In addition to data from surgical computer 150, relevant data can also be transferred to surgical data server 180 from other sources. Figure 5CThe example shown in FIG. 1 illustrates three additional data sources: a patient 160, a healthcare professional 165, and an EMR database 170. Thus, the patient 160 can send preoperative and postoperative data to the surgical data server 180, for example, using a mobile application. The healthcare professional 165 includes the surgeon and his or her staff, as well as any other professionals working with the patient 160 (e.g., a private physician, a rehabilitation specialist, etc.). It should also be noted that the EMR database 170 can be used for preoperative and postoperative data. For example, assuming the patient 160 has given sufficient permission, the surgical data server 180 can collect the patient’s preoperative EMR. The surgical data server 180 can then continue to monitor the EMR for any updates postoperatively.

[0118] At the surgical data server 180, a care period database 185 is used to store various data collected during a patient’s care period. The care period database 185 can be implemented using any technology known in the art. For example, in some embodiments, an SQL-based database can be used in which all of the various data items are structured in a way that allows them to be easily incorporated into two SQL collections that allow them to be easily incorporated into rows and columns. However, in other embodiments, a No-SQL database can be employed 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 databases that are not related in their design. Various types of No-SQL databases can generally be grouped according to their underlying data model. These groupings can include databases that use a column-based data model (e.g., Cassandra), a document-based data model (e.g., MongoDB), a key-value based data model (e.g., Redis), and / or a graph-based data model (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 period database 185.

[0119] Data can be transmitted between the various data sources and the surgical data server 180 using any data format and transmission technology known in the art. It should be noted that, Figure 5C The architecture shown in FIG. 1 allows for transmission from the data sources to the surgical data server 180, as well as retrieval of data by the data sources from the surgical data server 180. For example, as explained in detail below, in some embodiments, the surgical computer 150 can use data from past surgeries, machine learning models, etc. to help guide the surgical procedure.

[0120] In some embodiments, the surgical computer 150 or the surgical data server 180 can perform a de-identification process to ensure that the data stored in the episode of care database 185 meets Health Insurance Portability and Accountability Act (HIPAA) standards or other requirements mandated by law. HIPAA provides a list of certain identifiers that must be removed from data during de-identification. The aforementioned de-identification process can scan for these identifiers in data being transmitted to the episode of care database 185 for storage. For example, in one embodiment, the surgical computer 150 performs the de-identification process just before it begins transmitting a particular data item or set of data items to the surgical data server 180. In some embodiments, unique identifiers are assigned to data from a particular episode of care in order to re-identify the data if necessary.

[0121] Although Figure 5A While

[0122] More details on managing episode of care data are described in International Patent Application No. WO 2020 / 132439, filed December 20, 2019, entitled “Methods and Systems for Providing an Episode of Care,” the entire contents of which are incorporated herein by reference.

[0123] Open vs. Closed Digital Ecosystem

[0124] In some embodiments, the CASS 100 is designed to function as a standalone or “closed” digital ecosystem. Each component of the CASS 100 is specifically designed to be used in a closed ecosystem, and data is generally not accessible to devices outside of the digital ecosystem. For example, in some embodiments, each component includes software or firmware that implements a proprietary protocol for activities such as communication, storage, security, etc. The concept of a closed digital ecosystem can be desirable for a company that wants to control all components of the CASS 100 to ensure that certain compatibility, security, and reliability standards are met. For example, the CASS 100 can be designed such that new components cannot be used with the CASS unless they are certified by the company.

[0125] In other embodiments, the CASS 100 is designed to function 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. Thus, 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.

[0126] To illustrate one type of recommendation that can be performed with the CASS 100, a technique for optimizing surgical parameters is disclosed below. The term “optimize” in this context means to select the best parameters based on certain specified criteria. In an extreme case, optimization can mean selecting the best parameters based on data from the entire episode of care, including any pre-operative data, the CASS data state at a given point in time, and post-operative goals. Also, optimization can be performed using historical data, e.g., data generated during past surgeries involving, e.g., the same surgeon, past patients with similar physical characteristics as the current patient, etc.

[0127] The parameters that are optimized can depend on the portion of the patient anatomy to be operated on. For example, for a knee surgery, the surgical parameters can include positioning information for femoral and tibial components, including but not limited to rotational alignment (e.g., varus / valgus rotation, external rotation, flexion rotation of femoral component, posterior slope angle of tibial component), resection depth (e.g., varus knee, valgus knee), and type, size, and position of implants. The positioning information can also include surgical parameters for combining implants, such as overall limb alignment, combined tibiofemoral overextension, and combined tibiofemoral resection. Other examples of parameters that the CASS 100 can optimize for a given TKA femoral implant include the following:

[0128] .

[0129] Other examples of parameters that the CASS 100 can optimize for a given TKA tibial implant include the following:

[0130] .

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

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

[0133] Various conventional techniques exist for optimizing surgical parameters. However, these techniques often require significant computation, and thus, often require the parameters to be determined preoperatively. As a result, the ability of the surgeon to modify the optimized parameters based on issues that can arise during surgery is limited. Moreover, conventional optimization techniques often operate in a“black box” manner, with little or no explanation of the recommended parameter values. Thus, if the surgeon decides to deviate from the suggested parameter values, the surgeon often does so without fully understanding the impact of the deviation on the rest of the surgical procedure or the impact of the deviation on the patient’s quality of life post-surgery.

[0134] Surgical Patient Care System

[0135] The general concept of optimization can be extended to the entire episode of care using a surgical patient care system 620 that uses surgical data as well as other data from the patient 605 and healthcare professionals 630 to optimize outcomes and patient satisfaction, as shown in Figure 6 .

[0136] Conventionally, pre-operative diagnosis, pre-operative surgical planning, intra-operative execution of the established plan, and post-operative total joint arthroplasty management are based on personal experience, published literature, and the surgical physician's training knowledge base (ultimately, the individual surgeon's tribal knowledge and their peer "network" and journal publications) and their instinct to accurately intra-operative haptics discernment of "balance" and accurate manual execution of planar resections using guidance and visual cues. This existing knowledge base and execution is limited in optimizing the outcomes provided to the patients in need of care. For example, there are limitations in accurately diagnosing the patient for the appropriate, minimally invasive, established care; reconciling the dynamic patient, medical economic, and surgeon's preferences with the patient's desired outcomes; executing the surgical plan to properly align the bones and maintain balance; and receiving data from disconnected sources with different biases that are difficult to reconcile into the overall patient framework. Thus, a data-driven tool that more accurately simulates anatomical responses and guides the surgical plan can improve the existing approach.

[0137] The surgical patient care system 620 is designed to utilize patient-specific data, surgeon data, medical facility data, and historical outcomes data to develop algorithms that recommend or suggest the best overall treatment plan for the patient's entire period of care (pre-operative, intra-operative, and post-operative) based on the desired clinical outcomes. For example, in one embodiment, the surgical patient care system 620 tracks adherence to the suggested or recommended plan and adjusts the plan based on the patient / care provider's performance. Once the surgical treatment plan is complete, the surgical patient care system 620 records the collected data in a historical database. This database is available for future patients to access and develop future treatment plans. In addition to utilizing statistical and mathematical models, simulation tools (such as LIFEMOD®) can be used to simulate outcomes, alignment, kinematics, etc. based on the preliminary or suggested surgical plan and reconfigure the preliminary or suggested plan to achieve the desired or optimal outcomes according to the patient's profile or the surgeon's preferences. The surgical patient care system 620 ensures that each patient is receiving individualized surgical and rehabilitation care, thereby improving the chances of successful clinical outcomes and reducing the economic burden on the facility associated with near-term revision.

[0138] In some embodiments, the surgical patient care system 620 employs a data collection and management method to provide a detailed surgical case plan with different steps that are monitored and / or executed using the CASS 100. The user's execution is computed at the completion of each step and used to suggest changes to the subsequent steps of the case plan. The generation of the case plan relies on a series of input data stored in a local or cloud storage database. The input data can be related to the patient currently receiving treatment or historical data from patients who have received similar treatment.

[0139] The patient 605 provides input to the surgical patient care system 620 such as current patient data 610 and historical patient data 615. Various methods generally known in the art can be used to collect such input from the patient 605. For example, in some embodiments, the patient 605 fills out a paper or digital survey that the surgical patient care system 620 parses to extract patient data. In other embodiments, the surgical patient care system 620 can extract patient data from existing sources of information such as electronic medical records (EMRs), health history files, and payer / provider history files. In still other embodiments, the surgical patient care system 620 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 605 can have a mobile phone, wearable device, or other mobile device that collects data (e.g., heart rate, pain or discomfort level, level of motion or activity, or patient-submitted responses to patient adherence to any number of preoperative plan criteria or conditions) and provides that data to the surgical patient care system 620. Similarly, the patient 605 can have a digital application on their mobile or wearable device that can collect data and transmit it to the surgical patient care system 620.

[0140] The current patient data 610 can include, but is not limited to, level of activity, preexisting conditions, comorbidities, pre-rehabilitation performance, health and fitness level, preoperative expectation level (related to hospital, surgery, and rehabilitation), metropolitan statistical area (MSA) driven score, genetic background, previous injuries (sports, trauma, etc.), previous joint replacements, previous trauma surgery, previous sports medicine surgery, treatment of contralateral joint or limb, gait or biomechanics information (back and ankle tissue), pain or discomfort level, care infrastructure information (payer coverage type, home medical infrastructure level, etc.), and an indication of the desired outcome of the surgery.

[0141] The historical patient data 615 can include, but is not limited to, level of activity, preexisting conditions, comorbidities, pre-rehabilitation performance, health and fitness level, preoperative expectation level (related to hospital, surgery, and rehabilitation), MSA driven score, genetic background, previous injuries (sports, trauma, etc.), previous joint replacements, previous trauma surgery, previous sports medicine surgery, treatment of contralateral joint or limb, gait or biomechanics information (back and ankle tissue), pain or discomfort level, care infrastructure information (payer coverage type, home medical infrastructure level, etc.), desired outcome of the surgery, actual outcome of the surgery (patient reported outcomes [PROs], implant survival, pain level, activity level, etc.), size of implant used, position / orientation / alignment of implant used, soft tissue balance achieved, etc.

[0142] A healthcare professional 630 performing the surgery or treatment can provide various types of data 625 to the surgical patient care system 620. This healthcare professional data 625 can include, for example, a description of known or preferred surgical techniques (e.g., cruciate retaining (CR) vs. posterior stabilized (PS), size up vs. size down, with tourniquet vs. without tourniquet, femoral stem style, preferred approach for THA, etc.), training level of the healthcare professional 630 (e.g., years in practice, positions trained, where trained, techniques emulated), previous success level including historical data (outcomes, patient satisfaction), and expected ideal outcomes regarding range of motion, days to recovery, and survival of the device. The healthcare professional data 625 can be obtained, for example, through paper or digital surveys provided to the healthcare professional 630, via the healthcare professional’s input to a mobile application, or by extracting relevant data from an EMR. Additionally, the CASS 100 can provide data such as profile data (e.g., patient-specific knee instrumentation profile) or historical records describing use of the CASS during surgery.

[0143] Information related to the facility in which the surgery or treatment is to be performed can be included in the input data. This data can include, but is not limited to, the following: ambulatory surgery center (ASC) vs. hospital, facility trauma level, joint replacement comprehensive care program (CJR) or bundle candidacy, MSA driven score, community vs. urban, academic vs. non-academic, post-operative network access (skilled nursing facility [SNF] only, home health, etc.), availability of medical professionals, availability of implants, and availability of surgical equipment.

[0144] These facility inputs can be obtained, for example, but not limited to, through surveys (paper / digital), surgical planning tools (e.g., applications, websites, electronic medical records [EMRs], etc.), hospital information databases (on the internet), etc. Input data related to the associated healthcare economy can also be obtained, including but not limited to, the patient’s socioeconomic profile, the expected level of reimbursement the patient will receive, and whether the treatment is patient-specific.

[0145] These healthcare economy inputs can be obtained, for example, but not limited to, through surveys (paper / digital), direct payer information, socioeconomic status databases (available on the internet by zip code), etc. Finally, data derived from a simulation of the procedure is obtained. The simulation inputs include implant size, position, and orientation. The simulation can be performed using custom or commercially available anatomical modeling software programs (e.g., LIFEMOD®, AnyBody, or OpenSIM). It should be noted that the above data inputs can not be available for every patient, and the treatment plan will be generated using the available data.

[0146] Prior to surgery, patient data 610, 615 and healthcare professional data 625 can be acquired and stored in a cloud-based database or online database (e.g., Figure 5C The surgical data server 180 shown is used. Information related to the procedure is provided to the computing system via wireless data transmission or manually using portable media storage. The computing system is configured to generate case plans for the CASS 100. The generation of case plans will be described below. It should be noted that the system can access historical data of previously treated patients, including implant size, location, and orientation automatically generated by a computer-assisted patient-specific knee device (PSKI) selection system or by the CASS 100 itself. For this purpose, a surgical sales representative or case engineer uploads case log data to the historical database using an online portal. In some embodiments, data transmission to the online database is wireless and automated.

[0147] Historical datasets from online databases are used as input to machine learning models, such as recurrent neural networks (RNNs) or other forms of artificial neural networks. As is generally understood in the art, artificial neural networks function similarly to biological neural networks and consist 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 the following sections, it is assumed that the machine learning model is trained to generate predictive equations. These predictive equations can be optimized to determine the optimal size, location, and orientation of the implant for best results or satisfaction.

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

[0149] In addition to, or as an alternative to, determining implant location, in some embodiments, the predictive equations and associated optimizations can be used to generate a resection plane for use with a PSKI system. When used with a PSKI system, the computation and optimization of the predictive equations are performed preoperatively. The patient's anatomy is estimated using medical imaging data (X-ray, CT, MRI). Global optimization of the predictive equations can provide the ideal size and location of the implant component. The Boolean intersection of the implant component and the patient's anatomy is defined as the resection volume. A PSKI can be generated to remove the optimized resection envelope. In this embodiment, the surgeon cannot change the surgical plan intraoperatively.

[0150] The surgeon can choose to change the surgical case plan at any time before or during the surgery. If the surgeon chooses to deviate from the surgical case plan, the dimensions, position, and / or orientation of the changed component are locked and the global optimization is refreshed (using the previously described techniques) to find new ideal positions for other components, and the corresponding resections needed to achieve the new optimized dimensions, positions, and / or orientations of the components, according to the new dimensions, positions, and / or orientations of the components. For example, if the surgeon determines that the dimensions, position, and / or orientation of the femoral implant in a TKA need to be updated or modified intraoperatively, the position of the femoral implant will be locked relative to the anatomy and the new optimal position of the tibia will be calculated (by the global optimization) taking into account the surgeon's changes to the femoral implant dimensions, position, and / or orientation. Furthermore, if the surgical system used to implement the case plan is robotically assisted (e.g., using NAVIO® or MAKO Rio), the bone removal and bone morphology during the surgery can be monitored in real-time. If the resections made during the procedure deviate from the surgical plan, the processor can optimize the subsequent placement of additional components taking into account the actual resections that have been made.

[0151] Figure 7AThe surgical patient care system 620 is shown as can be adapted to perform a case plan matching service. In this example, data related to the current patient 610 is acquired and compared to all or a portion of a historical database of patient data and related outcomes 615. For example, the surgeon can choose to compare the current patient's plan to a subset of the historical database. Data in the historical database can be filtered to include, for example, only data sets with good outcomes, data sets corresponding to historical surgeries of patients with a profile identical or similar to the current patient's profile, data sets corresponding to a particular surgeon, data sets corresponding to particular features of the surgical plan (e.g., only surgeries of particular ligaments), or any other criteria selected by the surgeon or medical professional. For example, if the current patient data matches or correlates with data of a previous patient who experienced a good outcome, the case plan of the previous patient can be accessed and adapted or adopted for the current patient. The predictive equation can be used in conjunction with an intraoperative algorithm that identifies or determines actions related to the case plan. Based on the relevant information from the historical database and / or pre-selected information, the intraoperative algorithm determines a series of recommended operations for the surgeon to perform. Each execution of the algorithm produces the next action in the case plan. If the surgeon performs the action, the outcome is assessed. The outcome of the surgeon performing the action is used to refine and update the inputs to the intraoperative algorithm for generating the next step in the case plan. Once the case plan has been fully executed, all data related to the case plan, including any deviations by the surgeon from the recommended actions, is stored in the database of historical data. In some embodiments, the system uses preoperative, intraoperative, or postoperative modules in a segmented fashion, rather than the 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 illustrated in Figure 7B and can be applied to any type of surgery using the CASS 100.

[0152] Surgical Procedure Display

[0153] As described above with respect to Figure 1 and Figures 5A-5CAs noted, the various components of the CASS 100 generate detailed data records during surgery. The CASS 100 can track and record the various actions and activities of the surgeon during each step of the surgery and compare the actual activities to the preoperative or intraoperative surgical plan. In some embodiments, software tools can be employed to process this data into a format that can effectively “replay” the surgery. For example, in one embodiment, one or more GUIs can be used that show all of the information presented on the display 125 during the surgery. This can be supplemented with graphs and images that show the data collected by the different tools. For example, a GUI that provides a visual illustration of the knee during a tissue resection can provide the measured torque and displacement of the resection device adjacent to the visual illustration to better provide an understanding of any deviations from the planned resection area that occurred. The ability to view a replay of the surgical plan or to toggle between different steps of the actual surgery and the surgical plan can provide benefits to the surgeon and / or surgical staff, allowing such personnel to identify any deficient or challenging portions of the surgery that can be modified in future surgeries. Similarly, in an academic setting, the aforementioned GUIs can be used as teaching tools to train future surgeons and / or surgical staff. Additionally, since the data set effectively records many elements of the surgeon’s activities, it can also be used as evidence of the proper or improper performance of a particular surgical procedure for other reasons (e.g., legal or compliance reasons).

[0154] Over time, as more and more surgical data is collected, a rich database can be acquired that describes the performance of surgical procedures by different surgeons for different patients for various types of anatomy (knee, shoulder, hip, etc.). Moreover, features such as implant type and size, patient demographics, etc. can be further used to enhance the overall data set. Once the data set has been established, it can be used to train a machine learning model (e.g., an RNN) to predict how a surgery will proceed based on the current state of the CASS 100.

[0155] The training of the machine learning model can proceed as follows. During a surgery, the overall state of the CASS 100 can be sampled at multiple time periods. The machine learning model can then be trained to convert the current state at a first time period to a future state at a different time period. By analyzing the overall state of the CASS 100 rather than individual data items, any causal effects of the interactions between the different components of the CASS 100 can be captured. In some embodiments, rather than a single model, multiple machine learning models can be used. In some embodiments, not only can the state of the CASS 100 be utilized, but patient data (e.g., acquired from an EMR) and the identity of the surgical staff can be utilized to train the machine learning model. This allows the model to make predictions with greater specificity. Moreover, if desired, it allows the surgeon to selectively make predictions based only on their own surgical experience.

[0156] In some embodiments, predictions or recommendations made by the aforementioned machine learning models can be directly integrated into the surgical procedure. For example, in some embodiments, the surgical computer 150 can execute the machine learning models in the background, making predictions or recommendations for upcoming actions or surgical conditions. Thus, multiple states can be predicted or recommended for each epoch. 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 to allow visualization of future states. For example, Figures 7C-7E A series of images are shown that can be displayed to the surgeon showing the implant placement interface. The surgeon can traverse through these images, for example, by entering a specific time or instructing the system to advance or rewind the display using haptic, verbal, or other commands in the display 125 of the CASS 100 in specific time increments. In one embodiment, the process display can be presented in the upper portion of the surgeon’s field of view in an AR HMD. In some embodiments, the process display can be updated in real time. For example, as 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 or her actions are affecting other parts of the surgery.

[0157] In some embodiments, rather than simply using the current state of the CASS 100 as input to the machine learning models, the input to the models can include planned future states. For example, the surgeon can indicate that he or she is planning a particular bone resection of the knee joint. This indication can be entered manually into the surgical computer 150, or the surgeon can provide the indication verbally. The surgical computer 150 can then produce a film showing the expected effects of the incision on the surgery. Such a film can show, over specific time increments, how the surgery will be affected if the expected course of action is performed, including, for example, changes to the patient anatomy, changes to implant position and orientation, and changes to the surgical procedure and instruments. The surgeon or medical professional can invoke or request this type of film at any time during the surgery to preview how the expected course of action will affect the surgical plan if the expected actions are performed.

[0158] It should be further noted that using a well-trained machine learning model and a robotic CASS, various portions of a surgery can be automated, requiring only minimal involvement from the surgeon, e.g., only providing approval for various steps of the surgery. For example, over time, robotic control using arms or other means can be gradually integrated into the surgical procedure, with the surgeon interacting with the robot less and less over time. In this case, the machine learning model can learn what robot commands are needed to achieve certain states of the CASS implementation plan. Eventually, the machine learning model can be used to produce a film or similar view or display that can predict and can preview the entire surgery from an initial state. For example, an initial state can be defined that includes patient information, a surgical plan, implant characteristics, and surgeon preferences. Based on this information, the surgeon can preview the entire surgery to confirm that the CASS-recommended plan meets the surgeon’s expectations and / or requirements. Moreover, since the output of the machine learning model is a state of the CASS 100 itself, commands can be derived to control the components of the CASS to achieve each predicted state. Thus, in the extreme case, the entire surgery can be automated based on the initial state information alone.

[0159] Acquiring High Resolution of Key Areas Using a Point Probe During Hip Surgery

[0160] The use of a point probe is described in International Patent Application No. 2016 / 089870, filed December 1, 2015, entitled “Systems and Methods for Planning and Performing Image Free Implant Revision Surgery,” the entire contents of which are incorporated herein by reference. Briefly, an optically tracked point probe can be used to map the actual surface of the target bone that needs a new implant. The mapping is performed after the removal of the defective or worn implant, and after the removal of any diseased or otherwise unwanted bone. By brushing or scraping the entire bone remaining with the tip of the point probe, a plurality of points can be collected on the bone surface. This is called tracking or “painting” the bone. The collected points are used to create a three-dimensional model or surface map of the bone surface in a computer planning system. The created 3D model of the remaining bone is then used as a basis for planning the surgery and the necessary implant size. An alternative technique for determining the 3D model using X-rays is described in U.S. Provisional Patent Application No. 16 / 387,151, filed April 17, 2019, entitled “Three Dimensional Guide with Selective Bone Matching,” the entire contents of which are incorporated herein by reference.

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

[0162] As an additional safeguard, the thickness of the area between the acetabulum and the medial wall can be estimated. For example, once the acetabular rim and acetabular fossa are mapped and registered to the preoperative 3D model, the thickness can be easily estimated by comparing the location of the acetabular surface to the location of the medial wall. Using this knowledge, the CASS 100 can provide an alert or other response in the event that any surgical activity is predicted to protrude through the acetabular wall upon reaming.

[0163] The point probe can also be used to collect high resolution data of common reference points used when orienting the 3D model to the patient. For example, for pelvic plane landmarks like the ASIS and the pubic symphysis, the surgeon can use the point probe to map the bone to represent the true pelvic plane. With a more complete view of these landmarks, the registration software will have more information to orient the 3D model.

[0164] The point probe can also be used to collect high resolution data of proximal femur reference points that 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 to align the femoral component during hip arthroplasty. The alignment is highly dependent on the correct location of the GT; therefore, in some embodiments, the point probe is used to map the GT to provide a high resolution view of the area. Similarly, in some embodiments, a high resolution view of the lesser trochanter (LT) can be useful. For example, during hip arthroplasty, the Dorr classification helps to select a stem that will maximize the ability to achieve a press fit during surgery, thereby preventing post-operative femoral component micromotion and ensuring optimal bone ingrowth. As is understood in the art, the Dorr classification measures the ratio between the canal width at the LT and the canal width 10 cm below the LT. The accuracy of the classification is highly dependent on the correct location of the relevant anatomy. Therefore, it can be advantageous to map the LT to provide a high resolution view of the area.

[0165] In some embodiments, a point probe is used to map the femoral neck to provide high resolution data, allowing the surgeon to better understand where to make the neck cut. The navigation system can then guide the surgeon as they make the neck cut. For example, as is understood in the art, the femoral neck angle is measured by placing one line under the center of the femoral stem and a second line under the center of the femoral neck. Thus, a high resolution view of the femoral neck (and possibly the femoral stem as well) will provide a more accurate calculation of the femoral neck angle.

[0166] High resolution femoral head and neck data can also be used for navigated resurfacing procedures, where the software / hardware helps the surgeon prepare the proximal femur and place a 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 covered with a smooth metal cap. In this case, it would be advantageous for the surgeon to have a map of the femur and cap so that an accurate assessment of their respective geometries can be understood and used to guide the trimming and placement of the femoral component.

[0167] Registering Preoperative Data to Patient Anatomy Using a Point Probe

[0168] As noted above, in some embodiments, a 3D model is developed during the preoperative phase based on 2D or 3D images of the anatomical region of interest. In such embodiments, a 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 anatomy and surgical tools intraoperatively.

[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 can include the femoral head center, the distal femoral epicondylar axis points, the medial and lateral epicondyles, the medial and lateral malleoli, the tibial proximal mechanical axis points, and the tibial A / P direction. For hip surgery, these points can include the anterior superior iliac spine (ASIS), the pubic symphysis, points along the rim and hemi-sphere of the acetabulum, the greater trochanter (GT), and the lesser trochanter (LT).

[0170] In revision surgery, the surgeon can map certain areas containing anatomical defects for better visualization and navigation of implant insertion. These defects can be identified based on analysis of the preoperative images. For example, in one embodiment, each preoperative image is compared to a library of images showing “healthy” anatomy (i.e., without defects). Any significant deviations between the patient’s images and the healthy images can be flagged as potential defects. Then, during the surgery, the surgeon can be alerted to the potential defects through visual alerts on the display 125 of the CASS 100. The surgeon can then map the areas to provide the surgical computer 150 with more detailed information about the potential defects.

[0171] In some embodiments, a surgeon can use a non-contact method to perform registration of intraosseous cuts in bone anatomy. For example, in one embodiment, registration is performed with a laser scan. A laser stripe is projected on the anatomical region of interest, and the height variations of the region are detected as variations in the line. Other non-contact optical methods, such as white light interferometry or ultrasound, can alternatively be used for surface height measurement or registration of the anatomical structure. For example, where there is soft tissue between the registration point and the bone being registered (e.g., ASIS, pubic symphysis in hip surgery), ultrasound technology can be beneficial, providing a more accurate definition of the anatomical plane.

[0172] As discussed herein, during certain surgeries, particularly revision total knee arthroplasty (rTKA), the intramedullary (IM) canal of the femur and / or tibia can be referenced when placing one or more implant components. Further, once a component is implanted (e.g., by attaching a stem to a femoral or tibial implant), conventional implant systems can utilize the IM canal as a primary fixation and / or attachment mode. As has been discussed, when using implants that include stems, the stem can generally limit the position of the implant relative to the native anatomy in several degrees of freedom, namely, flexion / extension rotation, varus / valgus rotation, and potentially M / L and A / P position. In some embodiments, known factors about the existing component can be used to obtain a more accurate estimate of the size, shape, etc. of a selected implant (e.g., stem).

[0173] Accordingly, if the CASS is employed, the surgical plan and / or IM canal information can be known to one or more navigation systems. Further, the information collected (e.g., surgical plan, patient information, etc.) can be used and / or supplemented by the CASS system during implant position planning. Currently, most revision TKA procedures are completed using manual instruments and / or planning tools. Generally, when manual instruments are used, the workflow includes removing the primary implant, reaming the IM canal (e.g., using progressively larger reamer diameters until cortical bone is contacted), and referencing the reamer axis to guide positioning of a cutting guide. The cutting planes are generally defined relative to the IM canal.

[0174] Referring now to Figure 8 , for example, the illustrated embodiment can have a coupler device 801 that enables the tracking array 802 to be attached to an existing component 803 (e.g., a reamer, femoral / tibial joint component, etc.). The tracking system (e.g., 115 of Figure 1 may use one or more sensors to collect position data (e.g., real-time position data) of a patient’s anatomy and / or surgical instruments (e.g., the tracking array 802) that are positioned. For example, for a TKA procedure, the tracking system 115 can provide the position and / or orientation of the tracking array 802 prior to and / or during the procedure.

[0175] In another embodiment, the position of the tracking array 802 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 and the tracking array. In additional embodiments, the position data (e.g., from the tracking system 115) can also be used to infer the patient’s anatomy and / or can be used for speed / acceleration of various instruments for tool control. In other embodiments, the tracking system 115 can use the tracking array 802 to determine the 3D geometry of the patient’s anatomy and / or the axis of the patient’s anatomy. In another embodiment, the tracking system 115 can use the tracking array 802 to determine the 3D geometry of a tool or object and / or the axis of the tool or object.

[0176] As shown in FIG. 8A, the tracking array 802 can also be a standalone tool, such as a point probe. Referring now to FIG. 8B, a point probe 801 is shown having one or more trackable tags 901, a point 902, and a handle 903. It should be understood that although a point probe is shown in the figures, any feasible tool (e.g., a tracked and couplable tool) can be used for the purpose of imparting a tracking array to a non-tracked device, such as an end effector (e.g., 105B), a robotic arm (e.g., 105A), or any known and couplable tracked device. Figure 8 Figure 9 Referring back to FIG. 8A, a tool (e.g., a point probe) having an attached tracking array 802 can be inserted into a coupling device 801. It should be understood that the coupling mechanism 801 can be any mechanism capable of securely affixing an existing component and / or tracked device 803 to the tracked device 802. Illustrative coupling devices can include, but are not limited to, threaded fasteners, mechanical fasteners, magnetic couplers, electromagnetic couplers, expansion / contraction couplers, or any combination of the like. In another embodiment, the coupler can have a locking mechanism that, once in place, secures the connection and reduces any accidental decoupling.

[0177] Referring back to FIG. 8A, a tool (e.g., a point probe) having an attached tracking array 802 can be inserted into a coupling device 801. It should be understood that the coupling mechanism 801 can be any mechanism capable of securely affixing an existing component and / or tracked device 803 to the tracked device 802. Illustrative coupling devices can include, but are not limited to, threaded fasteners, mechanical fasteners, magnetic couplers, electromagnetic couplers, expansion / contraction couplers, or any combination of the like. In another embodiment, the coupler can have a locking mechanism that, once in place, secures the connection and reduces any accidental decoupling. Figure 8 Thus, in some embodiments, the adapter 801 can interface between the tracking array 802 (e.g., a point probe tool as shown) and the tracked device 803 (e.g., a reamer, a trial handle, an implant, etc.) via a quick connect mechanism. This embodiment allows for the use of an existing array (e.g., a point probe) to be reutilized and / or quickly reused during a surgical procedure, thus the tracked device 803 does not need a separate tracking array. In some embodiments, the system can (1) ream until the desired reamer size is reached, (2) remove the t-handle and / or drill from the reamer, (3) connect the adapter 801 to the end of the reamer, (4) insert the tracking array 802 (e.g., a point probe) into the adapter, and collect the axis of the tube.

[0178] Thus, in some embodiments, the adapter 801 can interface between the tracking array 802 (e.g., a point probe tool as shown) and the tracked device 803 (e.g., a reamer, a trial handle, an implant, etc.) via a quick connect mechanism. This embodiment allows for the use of an existing array (e.g., a point probe) to be reutilized and / or quickly reused during a surgical procedure, thus the tracked device 803 does not need a separate tracking array. In some embodiments, the system can (1) ream until the desired reamer size is reached, (2) remove the t-handle and / or drill from the reamer, (3) connect the adapter 801 to the end of the reamer, (4) insert the tracking array 802 (e.g., a point probe) into the adapter, and collect the axis of the tube.​

[0179] Figure 10 An exemplary embodiment of adapter 801 is shown. In some embodiments, adapter 801 may have a top opening 1001 and a bottom opening 1002 to accommodate tools and / or trackers (e.g., tracking array 802 or tracked device 803). Although Figure 10 The top opening 1001 and the bottom opening 1002 are shown as having different sizes and / or geometries, but it should be understood that... Figure 10 Only one embodiment is depicted, and the top / bottom openings may have the same size / shape. Alternatively, in some embodiments, the top opening 1001 may be larger than the bottom opening 1002. In other embodiments, the bottom opening may be larger than the top opening 1001.

[0180] Brief Reference Figure 9 In some embodiments, the point probe 802 may have one or more fastening mechanisms (e.g., 904 and 905). For example, in some embodiments, the point probe may have a coupling surface 904. The coupling surface 904 may be made of, for example, a magnetic or electromagnetic material. In another embodiment, the shape and / or size of the coupling surface 904 may be configured to be complementary to one or more of the openings (e.g., 1001 and 1002) in the adapter 801. In another embodiment, the coupling surface 904 or any part of the tracking device may include a smart connector (not shown). In some embodiments, the smart connector may detect when an object or tool is placed in the adapter 801. In another embodiment, the reamer and / or handle may also contain a smart connector.

[0181] It should be understood that the detection of the smart connector may be based on, but is not limited to, RFID tags, microelectromechanical systems (MEMS), magnetometers, or any other detection mechanism capable of detecting a connection. In another embodiment, the smart connector may transmit and / or communicate the connection with adapter 801 to CASS. In another embodiment, the smart connector may be able to identify the type of device (e.g., tracking array, handle, implant, enlarger, etc.) inserted into the connector.

[0182] In another embodiment, and as Figure 9 and Figure 10 As shown, the dot probe 802 may have a physical attachment device 905. In some embodiments, the physical attachment device may be a raised edge, a groove, and / or a recess that connects to or is coupled to a complementary physical attachment 1004 within the adapter 801. In some embodiments, the adapter 801 may have an adjustment mechanism 1003 that allows for fine adjustments to the alignment, size, and / or orientation of the adapter 801.

[0183] Figure 11An illustrative example is shown where the tracking array 802 is connected to the tracked device 803 and inserted into the patient's femur. Therefore, in some embodiments, because the CASS can track and locate the tracking array 802 and knows the exact physical dimensions of the adapter 801 and the tracked device 803, the CASS can infer various information about the patient, such as the angle, location, and size of the reamer portion of the femur.

[0184] This article discusses various systems and methods for better tracking of patient anatomy. Therefore, by using more accurate tracking, physicians / surgeons will have a more precise understanding of the stem and implant location. Differences in human anatomy among patients, particularly variations in bone such as the tibia, not only create a need for various implant sizes and constructions, but also, in some cases, require the longitudinal axis of the stem component, such as the tibial stem, to be laterally offset from the longitudinal axis of other prosthetic components (e.g., the tibial tray). Therefore, by using improved tracking and / or preoperative planning, a more precise determination of the patient's anatomy and / or the shape, orientation, size, and location of the implant can be made.

[0185] In some embodiments, an intermediate stem extension (e.g., a connector or offset connector) can connect the stem to the tibial and / or femoral load-bearing component of a tibial / femoral orthopedic implant. In some embodiments, the intermediate stem extension may have a first end portion engaging the tibial and / or femoral load-bearing component and a second end portion engaging the stem and offset from the first end portion and angled relative to the first end portion to orient the stem. Therefore, some embodiments may require an offset connector to facilitate reception of the stem in curved or angled tibial or femoral canals. In another embodiment, CASS may make one or more determinations as to whether a connector should be used, and if so, provide a recommendation for a particular connector (e.g., a connector with a specific offset). In another embodiment, CASS may determine or obtain relative angular information relating to each end of the offset connector based on collected location information. Additionally or alternatively, in some embodiments, if a typical 6-degree eversion is suboptimal, a patient-specific implant may be required.

[0186] Now for reference Figure 12 Embodiments of the femoral implant 1200 include a femoral load-bearing component 1203 (e.g., a condylar component), an intramedullary stem 1202, and an intermediate stem extension (i.e., a connector) 1201. In some embodiments, the connector 1201 may be omitted. Furthermore, in some embodiments, the stem 1202 and the connector 1201 may be essentially integral. In one embodiment, for example... Figure 12 As depicted, the intermediate shank connector 901 can connect the femoral load-bearing component 903 and the shank 902.

[0187] Therefore, for example Figure 13Some embodiments illustrated in FIG. 13 can involve first reaming 1301 a patient's bone (e.g., femur) with a reamer device, such as those illustrated in FIGS. 8-12, for example, in Figure 8 Once the patient's bone is properly reamed (i.e., to the appropriate depth and size), the drill or tool used to power the reamer can be removed or disassembled 1302. Thus, in this embodiment, the reamer device can remain in the patient's anatomy when the tracking array is fixed 1303. In alternative embodiments, the reaming device of, for example, 803 can be removed from the patient prior to attaching the tracking array 1303. It should also be understood that the attachment 1303 of the tracking array can be through the use of any attachment method disclosed herein or discovered in the future.

[0188] Once the reamer is properly attached to the tracking array 1303, the CASS can accurately obtain position and / or orientation information of the reamer 1304. As discussed further herein, in some cases, the reamer angle, the patient's anatomy, or other circumstances can cause the reaming cavity to be offset or misaligned from the selected and / or recommended implant. Thus, in some embodiments, the CASS or surgeon can determine that an offset 1305 is needed. If an offset setup is needed, the CASS or surgeon can calculate or determine the offset distance and / or angle 1307. Thereafter, an offset coupler or the like can be attached and or installed on the implant 1308 to ensure proper alignment and fit. In some embodiments, no offset 1305 is needed and thus the appropriate implant (e.g., with or without a femoral stem) can be inserted directly.

[0189] It should be understood that the systems and / or methods described herein can involve revision knee surgeries as well as those surgical methods discussed herein. Specifically, in some embodiments, with brief reference to Figure 8 , the tracking array 802 can be fixed to an existing implant stem (e.g., at 803 instead of the tool or reamer) so that the CASS system obtains position information relative to the existing stem implant. Thus, in some embodiments, the user can attach the tracking array 802 and coupler 801 to the existing / old stem prior to removing the existing / old stem from the patient's anatomy. In another embodiment, because the CASS system knows the shape, size, orientation, etc. of the existing stem implant, various modifications to one or more surgical plans can be possible. For example, in some embodiments, an angular adjustment of the distal femoral cut and / or the proximal tibial cut can be identified based on the additional information about the previous stem implant.

[0190] In other embodiments, a plate probe (not shown) can be attached to the tracking array 802 (e.g., via the coupler 801) after surgical cuts, drillings, grinding, etc. to verify one or more cut planes. Thus, it should be understood that while the discussion herein is around the use of the coupler 801 and the tracking array 802 for reamers and / or implant stems, implementation in various other scenarios is possible. For example, where a surgical procedure or process can benefit from having point probes or a universal tracking array quickly coupled to surgical tools and / or patient anatomy.

[0191] Figure 14 A block diagram of an illustrative data processing system 1400 is shown in which illustrative embodiments, features, methods, and / or operations can be implemented. The data processing system 1400 is an example of a computer, such as a server or client, in which computer usable code or instructions implementing the processes for illustrative embodiments of the present application are located. In some embodiments, the data processing system 1400 can be a server computing device. For example, the data processing system 1400 can be implemented in a server or another similar computing device operably connected to the surgical system 100 as described above. The data processing system 1400 can be configured to, for example, transmit and receive information related to a patient and / or a surgical plan related to the surgical system 100.

[0192] In the depicted example, data processing system 1400 can employ a hub architecture including a north bridge and memory controller hub (NB / MCH) 1401 and a south bridge and input / output (I / O) controller hub (SB / ICH) 1402. Processing unit 1403, main memory 1404, and graphics processor 1405 can be connected to the NB / MCH 1401. Graphics processor 1405 can be connected to the NB / MCH 1401 through, for example, an accelerated graphics port (AGP).

[0193] In the depicted example, network adapter 1406 is connected to SB / ICH 1402. Audio adapter 1407, keyboard and mouse adapter 1408, modem 1409, read-only memory (ROM) 1410, hard disk drive (HDD) 1411, optical drive (e.g., CD or DVD) 1412, Universal Serial Bus (USB) port and other communication ports 1413, and PCI / PCIe device 1414 can be connected to SB / ICH 1402 via bus system 1416. PCI / PCIe device 1414 may include Ethernet adapters, add-in cards, and PC cards for laptops. ROM 1410 may be, for example, a flash-based basic input / output system (BIOS). HDD 1411 and optical drive 1412 may use Integrated Drive Electronics (IDE) or Serial Advanced Technology Attachment (SATA) interfaces. Super I / O (SIO) device 1415 may be connected to SB / ICH 1402.

[0194] An operating system can run on the processing unit 1403. The operating system can coordinate and provide control over various components within the data processing system 1400. As a client, the operating system can be a commercially available operating system, such as Java. TM The object-oriented programming system, such as the programming system, can run alongside the operating system and make calls to the operating system from the object-oriented program or the application running on the data processing system 1400. As a server, the data processing system 1400 can be an IBM® eServer running an advanced interactive operating system or a Linux operating system. TM System p ® The data processing system 1400 can be a symmetric multiprocessor (SMP) system, which may include multiple processors in the processing unit 1403. Alternatively, a single-processor system may be used.

[0195] Instructions for operating systems, object-oriented programming systems, and applications or programs reside on a storage device such as HDD 1411 and are loaded into main memory 1404 for execution by processing unit 1403. The processes of the embodiments described herein can be executed by processing unit 1403 using computer-usable program code, which may reside in memory such as main memory 1404, ROM 1410, or in one or more peripheral devices.

[0196] The bus system 1416 can be comprised of one or more buses. The bus system 1416 can be implemented using any type of communication fabric or architecture that provides for data transfer between different components or devices attached to the fabric or architecture. The communication units, such as the modem 1409 or the network adapter 1406, can include one or more devices that can be used to transmit and receive data.

[0197] Those of ordinary skill in the art will appreciate that Figure 14 The hardware depicted in the preceding figures can vary depending on the implementation. Other internal hardware or peripheral devices can be used in addition to or instead of the hardware depicted. For example, a flash memory, equivalent nonvolatile storage, or disk drives can be used in some implementations for mass storage. Also, any of the devices illustrated in the figures can be used in other embodiments or exist in variations of the devices. A data processing system 1400 can also include a variety of other components not specifically depicted in the figures. Furthermore, the data processing system 1400 can take many different forms, as described in more detail below. Essentially, the data processing system 1400 can be any known or later developed data processing system without architectural limitation.

[0198] While various exemplary embodiments in connection with 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 using its general principles. Further, the present application is intended to cover such departures from the present disclosure as come within known or customary practice in the art to which the present teachings pertains.

[0199] In the above detailed description, reference is made to the accompanying drawings, which form a part hereof. In the drawings, similar symbols typically identify similar components, unless context dictates otherwise. The illustrative embodiments described in the present disclosure are not meant to be limiting. Other embodiments can be used, and other changes can be made, without departing from the spirit or scope of the subject matter presented herein. It will be readily understood to those skilled in the art that the various features of the present disclosure, as described herein, and illustrated in the accompanying drawings, can be arranged, substituted, combined, separated, and designed in various different configurations, all of which arrangements will result in like features and functions as described herein.

[0200] The present disclosure is not limited to the particular embodiments described herein, which are intended as illustrative only rather than as limiting. Numerous modifications and variations are possible in light of the above teachings without departing from the spirit and scope of the present disclosure. Functionally equivalent methods and apparatuses within the scope of the present disclosure, in addition to those enumerated herein, will be apparent to those skilled in the art from the foregoing descriptions and accompanying drawings. It is to be understood that the present disclosure is not limited to particular methods, reagents, compounds, compositions or biological systems, which can, of course, vary. It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments only, and is not intended to be limiting.

[0201] With respect to use of substantially any plural and / or singular terms herein, those having skill in the art can translate the authentication as being singular or plural as appropriate to the disclosure. Specifically, where any singular / plural elements can be described herein, those having skill in the art will understand that we contemplate both the singular and the plural possibilities in the disclosure.

[0202] Those skilled in the art will appreciate that, in general, the terms used herein are generally intended to be "open" terms (e.g., the term "including" is to be interpreted as "including but not limited to" ; the term "having" is to be interpreted as "having at least" ; the term "includes" is to be interpreted as "includes, but is not limited to" ; etc.). While various compositions, methods, and devices are described in terms of "comprising" various components or steps (interpreted as meaning "including, but not limited to", "consisting essentially of" or "consisting of", and the like), the compositions, methods, and devices can also "consist of" various components or steps, and such terminology should be interpreted as defining essentially closed member groups.

[0203] Additionally, even if a specific number of an element is explicitly recited, those skilled in the art will recognize that such recitation should be interpreted to mean at least the number recited (e.g., reciting "two recitations" without further qualification means at least two recitations or two or more recitations). Additionally, where terms like "at least one of A, B, and C" are used in the detailed description, those skilled in the art will understand that the phrase is intended to mean A alone, B alone, C alone, any two of the items A, B, and C in combination, or all of the items A, B, and C in combination. Further, where the use of the term "at least one of A, B, or C" is used in the detailed description, those skilled in the art will understand that the phrase is intended to mean A alone, B alone, C alone, any two of the items A, B, and C in combination, or all of the items A, B, and C in combination. Additionally, those skilled in the art will recognize that virtually any disjunctive word and / or phrase presenting two or more alternative terms is intended to cover the possibility of including at least one of the terms, either individually or in combination with other terms in the set of terms. For example, the phrase "A or B" will be understood to include "A" or "B" or "A and B".

[0204] Further, where features of the disclosure are described in terms of Markush groups, those skilled in the art will recognize that the disclosure is also thereby described in terms of any individual member or subgroup of members of the Markush group.

[0205] Those skilled in the art will appreciate that the disclosure of all ranges herein also encompasses any possible subranges and every possible sub-range therebetween, for any and all purposes, e.g., provided that the sub-range lies within the larger range. Any listed range can be easily reduced to at least equal halves, thirds, quarters, fifths, tenths, etc. of the same range. Every statement of a range herein is intended to include the reverse and complementing range as well. Thus, for example, a range of 1-3 cells is intended to include a range of 3-1 cells. Similarly, a range of 1-5 cells is intended to include a range of 5-1 cells, and so on. Finally, those skilled in the art will appreciate that the dimensions include each individual member. Thus, for example, a group of 1-3 cells refers to a group of 1, 2, or 3 cells. Similarly, a group of 1-5 cells refers to a group of 1, 2, 3, 4, or 5 cells, and so on.

[0206] As used herein, the term "about" is a variation of a numerical value amount that can occur, for example, through measurement or processing procedures in the real world, through inadvertent error in those procedures, through differences in composition or reagent manufacturing, sourcing, or purity, and the like. Generally, the term "about" as used herein means a value or range of values greater than or less than the value represented by 1 / 10 of the stated value (e.g., ±10%). The term "about" also refers to variants that one of skill in the art would understand to be equivalent, so long as such variants do not encompass values that are known in the art practice. Each value or range of values following the term "about" is also intended to encompass embodiments of the stated absolute value or range of values. Whether or not modified by the term "about," quantitative values cited in the present disclosure include equivalents of the cited value, e.g., numerical variations of such values that could occur in the real world, but a skilled artisan will recognize equivalents.

[0207] The various features and functions discussed above as well as alternatives thereof can be combined into many other different systems or applications. Various presently unforeseen or unanticipated alternatives, modifications, variations or improvements can be made by those skilled in the art using the concepts disclosed in this disclosure, each of which is also intended to fall within the scope of the disclosed embodiments.

Claims

1. A system for adapting to deviations based on patient-specific intramedullary canal registration, comprising: A navigation system, comprising one or more processors coupled to a memory, the memory including instructions that, when executed, cause the one or more processors to: Obtain a surgical plan; Obtain position data associated with the reaming device, wherein the position data is obtained after reaming the femur; Based on the location data and the surgical plan, an offset factor is identified. The offset factor is selected from the group consisting of the offset distance and offset angle between the longitudinal axis of the femoral stem and the longitudinal axis of the femoral load-bearing component of the implant. Based on the offset factor, an offset connection device is selected, which connects the femoral load-bearing component and the femoral stem of the implant and corrects the offset factor to ensure proper alignment and fit. as well as The user interface provides information associated with the offset coupling device.

2. The system of claim 1, further comprising at least one tracking array, wherein the instructions for obtaining the location data, when executed, cause the one or more processors to: Obtain the position of at least one tracking array, wherein the at least one tracking array is coupled to the aperture enlarging device; and Based on the position of the at least one tracking array, position data associated with the aperture enlarging device is determined.

3. The system of claim 2, wherein the at least one tracking array is connected to the aperture enlarging device via the offset coupling device.

4. The system of claim 2, wherein the at least one tracking array comprises a point probe.

5. The system of claim 2, wherein the at least one tracking array is rigidly fixed to the surgical instrument, and wherein, The surgical tool is connected to the reaming device.

6. The system of claim 1, wherein the instructions for providing information associated with the offset coupling device, when executed, also cause the one or more processors to: Provide information associated with selecting the offset coupling device; and Provides information associated with modifying the appropriate offset connector.

7. A system for registering a patient's intramedullary canal, comprising: At least one tracking array; A navigation system, comprising one or more processors coupled to a memory, the memory including instructions that, when executed by the one or more processors, cause the implant to locate the device. Obtain a surgical plan; Obtaining position data associated with the reaming device, wherein obtaining the position data after reaming the femur includes: The position of the at least one tracking array is obtained, wherein the at least one tracking array is coupled to the aperture enlarging device; and Based on the position of the at least one tracking array, determine the position data associated with the aperture enlarging device; Based on the location data and the surgical plan, an offset factor is identified, wherein the offset factor is selected from the group consisting of the offset distance and offset angle between the longitudinal axis of the femoral stem and the longitudinal axis of the femoral load-bearing component of the implant; Based on the offset factor, an offset connection device is selected, which connects the femoral load-bearing component and the femoral stem of the implant and corrects the offset factor to ensure proper alignment and fit. The user interface is used to provide information associated with the offset coupling device; and The user interface is used to provide information associated with modifying the offset coupling device.

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