Primary trial measurement device for use during total knee arthroplasty revision

Abstract

A trial guide for temporary placement on the distal end of a femur during revision of a knee joint includes instrument components that allow a surgeon to determine distal extension gaps and posterior extension gaps for balancing the revised implant, and adjustable handle components that allow the surgeon to translate a trial stem (830) and rotate using selected offset couplings (836) for the trial stem to ensure proper trial placement prior to the revision procedure. Reference markers (824) can be affixed to the body (802) or components of the trial guide to allow a surgical system to map the trial guide onto a reference frame of the surgery, such as a femoral reference frame, thereby allowing the surgical system to update a surgical plan and assist the surgeon in implementing the plan for the revision of the joint replacement.

Description

[0001] Cross Reference to Related Applications

[0002] This application claims the benefit of priority to U.S. Provisional Application No. 62 / 961,304, filed January 15, 2020, entitled “Trial-First Measuring Device for Use During Revision Total Knee Arthroplasty,” which is incorporated herein by reference in its entirety. Technical Field

[0003] This disclosure generally relates to methods, systems, and apparatus related to implant planning for joint revision surgery. More specifically, this disclosure relates to a trial guide system for selecting implants and planning bone resection when pre-existing holes are used for the implant stem. The disclosed techniques can be applied to, for example, shoulder, hip, and knee replacement surgeries, as well as other surgical procedures such as arthroscopic surgery, spinal surgery, maxillofacial surgery, rotator cuff surgery, ligament repair and replacement surgery. Background Technology

[0004] Knee replacement surgery involves mounting a femoral component onto the patient's femur and a tibial component onto the patient's tibia. The tibial component typically includes a tibial stem that attaches to a tibial tray. The tibial stem is designed to rest within the intramedullary canal of the tibia, while the tibial tray rests on a prepared surface on the tibial head. A tibial load-bearing member, articulated with the femoral component, is typically mounted on the tibial tray.

[0005] Variations in human anatomy among patients, particularly in bone structures such as the tibia, create a need for various implant sizes and constructions. In some cases, the longitudinal axis of the stem component (e.g., the tibial stem) may not need to be laterally offset from the longitudinal axis of other prosthetic components (e.g., the tibial tray). However, in many individuals, these axes must be offset relative to each other to ensure proper implantation. Even when offset is necessary, the degree or direction of the offset is inconsistent.

[0006] In addition, some patients require the stem to be angled to correct varus curvature of the intramedullary canal. For example, in the general patient population, valgus curvature of the tibia relative to the mechanical axis is typically within the range of approximately 1.63 + / - 1.57 degrees. Similarly, the femoral canal can be posteriorly varus relative to the mechanical axis. Such impact can prevent the stem from fully penetrating the canal, leading to misalignment of the tibial and femoral components in the knee and potentially causing pain.

[0007] For many patients, once the initial knee replacement surgery is performed, the implant may wear out and eventually need replacement, or the initial implant may result in less than ideal performance during healing. In these cases, a knee replacement revision may be necessary. During a knee replacement revision, additional bone is removed from the patient, and typically, a rigid stem of the femoral implant is used to provide additional stability. This stem passes through a hole drilled into the intramedullary canal of the femur at the distal end of the femur. Typically, during the revision procedure, temporary hardware, called the initial trial hardware, is temporarily placed in the distal femur, allowing the surgeon to determine what changes might need to be made to the existing distal femoral geometry to receive a revision implant with the desired balance. This temporary hardware is usually a modular system with components designed similarly to the final revision implant, and this procedure relies heavily on the surgeon's guesswork and examination, or "visual inspection." Summary of the Invention

[0008] A trial guide system is provided for planning a patient's joint replacement revision surgery. The trial guide system includes: a body having a hinged surface, a posterior surface substantially orthogonal to the hinged surface, and an array of body trackers, wherein the body is configured to be coupled to an end surface of a resected bone of the joint; a trial handle having a longitudinal axis, wherein the trial handle is configured to be received through a longitudinal hole in the bone and received into an intramedullary canal of the bone; a handle adapter that engages the trial handle with the hinged surface relative to the body, wherein the handle adapter is configured to translate relative to the posterior surface of the body to adjust the anterior-posterior alignment of the trial handle with the hinged surface; one or more offset connectors configured to engage the handle adapter with the trial handle, each offset connector being configured to adjust at least one of: the lateral alignment of the trial handle and the hinged surface, and the trial... The angular offset between the longitudinal axis of the handle and the hinge surface; a patient tracker array configured to be coupled to the bone; a tracking system including one or more sensors configured to detect the position and orientation of each of the main body tracker array and the patient tracker array; a processor; and a non-transitory computer-readable medium storing instructions that, when executed, cause the processor to: receive the position and orientation of each of the main body tracker array and the patient tracker array when the selected offset connector of the one or more offset connectors is coupled to the handle adapter and the test handle; determine the geometry between the test handle and the main body based on the position of the main body tracker array and the position of the patient tracker array; and generate a surgical plan including a selected revision implant based on the geometry between the test handle and the main body.

[0009] According to some embodiments, the selected offset connector is chosen from one or more offset connectors based on at least one of the lateral alignment and the angular offset.

[0010] According to some embodiments, each offset connector may be interchangeable relative to the handle adapter and the test handle to adjust at least one of the lateral alignment and the angular offset.

[0011] According to some embodiments, each offset connector is configured to rotate relative to the cut-off end surface to adjust the lateral alignment.

[0012] According to some embodiments, each offset connector is configured to adjust the lateral alignment by a predetermined distance, wherein the predetermined distance for each offset connector is different from at least one of the one or more offset connectors.

[0013] According to some embodiments, each offset connector is configured to adjust the angular offset by a predetermined angle, wherein the predetermined angle for each offset connector is different from at least one of the one or more offset connectors.

[0014] According to some embodiments, the test guide system further includes a lead screw coupled to the handle adapter, wherein rotation of the lead screw adjusts the front-to-back alignment of the test handle with the hinged surface.

[0015] According to some embodiments, the geometry between the test handle and the body includes one or more of the front-to-back alignment, the lateral alignment, and the angular offset.

[0016] According to some embodiments, the selected revision implant in the surgical plan includes one or more of the selected implant size and the selected implant geometry.

[0017] According to some embodiments, the surgical plan may also include one or more resections of the bone.

[0018] According to some embodiments, the test guidance system further includes a distal spacer coupled to the body and including one or more distal references, wherein the distal spacer is configured to translate relative to the hinge surface to adjust a first gap between the distal spacer and the hinge surface; and a rear spacer coupled to the body and including one or more rear references, wherein the rear spacer is configured to translate relative to the rear surface to adjust a second gap between the rear spacer and the rear surface. According to an additional embodiment, the one or more sensors are further configured to the position of each of the one or more distal references and the one or more rear references, and the instructions, when executed, also cause the processor to: receive the position of each of the one or more distal references and the one or more rear references; determine a first gap distance based on the position of the body tracker array and the position of the one or more distal references; and determine a second gap distance based on the position of the body tracker array and the position of the one or more rear references, wherein the surgical plan is also based on the first gap distance and the second gap distance. According to an additional embodiment, the test guide system further includes: a distal post connecting the distal spacer to the hinged surface, wherein the distal post is movable to adjust the first gap; and a rear post connecting the rear spacer to the rear surface, wherein the rear post is movable to adjust the second gap. According to another embodiment, the test guide system further includes: a distal adjustment knob connected to the distal post, wherein actuation of the distal adjustment knob moves the distal post; and a rear adjustment knob connected to the rear post, wherein actuation of the rear adjustment knob moves the rear post. According to an additional embodiment, the test guide system further includes: a distal locking mechanism configured to selectively lock the distal spacer relative to the hinged surface; and a rear locking mechanism configured to selectively lock the rear spacer relative to the rear surface.

[0019] Also provided is a trial guide system for planning a patient's joint replacement revision surgery. The trial guide system includes: a body having a hinged surface and a posterior surface substantially orthogonal to the hinged surface, wherein the body is configured to be coupled to an end surface of a resected bone of the joint; a distal spacer coupled to the body and configured to translate relative to the hinged surface to adjust a first gap between the distal spacer and the hinged surface; a posterior spacer coupled to the body and configured to translate relative to the posterior surface to adjust a second gap between the posterior spacer and the posterior surface; and a trial handle configured to pass through a longitudinal hole in the bone. Received and received into the intramedullary canal of the bone; a handle adapter that connects the test handle and the distal spacer to the body, wherein the handle adapter is configured to translate relative to the posterior surface of the body to adjust the anteroposterior alignment of the test handle with the hinge surface; and one or more offset connectors configured to engage the handle adapter with the test handle, each offset connector being configured to adjust at least one of: the lateral alignment of the test handle and the hinge surface, and the angular offset between the longitudinal axis of the test handle and the hinge surface.

[0020] According to some embodiments, the offset connector is configured to rotate relative to the cut-off end surface to adjust the lateral alignment.

[0021] According to some embodiments, each offset connector is configured to adjust the lateral alignment by a predetermined distance, wherein the predetermined distance for each offset connector is different from at least one of the one or more offset connectors.

[0022] According to some embodiments, each offset connector is configured to adjust the angular offset by a predetermined angle, wherein the predetermined angle for each offset connector is different from at least one of the one or more offset connectors.

[0023] According to some embodiments, the test guide system further includes a distal post connecting the distal spacer to a hinged surface, wherein the distal post is movable to adjust the first gap; and a rear post connecting the rear spacer to the rear surface, wherein the rear post is movable to adjust the second gap. According to an additional embodiment, the test guide system further includes: a distal adjustment knob connected to the distal post, wherein actuation of the distal adjustment knob causes movement of the distal post; and a rear adjustment knob connected to the rear post, wherein actuation of the rear adjustment knob causes movement of the rear post. According to another embodiment, the distal adjustment knob extends through a first slot in the body, wherein the position of the distal adjustment knob within the first slot corresponds to a distance of the first gap. According to yet another embodiment, the body includes one or more first marks adjacent to the first slot, wherein each of the one or more first marks corresponds to a gap distance of the first gap.

[0024] According to another embodiment, the rear adjustment knob extends through a second slot in the body, wherein the position of the rear adjustment knob within the second slot corresponds to the distance of the second gap. According to yet another embodiment, the body includes one or more second marks adjacent to the second slot, wherein each of the one or more second marks corresponds to the gap distance of the second gap.

[0025] According to some embodiments, the test guide system further includes: a distal locking mechanism configured to selectively lock the distal spacer relative to the hinged surface; and a rear locking mechanism configured to selectively lock the rear spacer relative to the rear surface.

[0026] According to some embodiments, the test guidance system further includes: a body tracker array coupled to the body; one or more distal references coupled to the distal spacer; and one or more posterior references coupled to the posterior spacer. According to an additional embodiment, the test guidance system further includes: a patient tracker array configured to be coupled to the bone; and a tracking system including one or more sensors configured to detect the position of each of the body tracker array, the one or more distal references, the one or more posterior references, and the patient tracker array. According to another embodiment, the test guidance system further includes: a processor; and a non-transitory computer-readable medium storing instructions that, when executed, cause the processor to: receive the position of each of the body tracker array, the one or more distal references, the one or more posterior references, and the patient tracker array; determine a first gap distance based on the position of the body tracker array and the position of the one or more distal references; determine a second gap distance based on the position of the body tracker array and the position of the one or more posterior references; and determine the geometry between the test handle and the body based on the position of the body tracker array and the position of the patient tracker array. According to some other embodiments, the geometry between the test handle and the body includes one or more of the front-to-back alignment, the lateral alignment, and the angular offset. According to some other embodiments, the instructions, when executed, also cause the processor to generate a surgical plan based on one or more of the first gap distance, the second gap distance, and the geometry between the test handle and the body. According to some other embodiments, the surgical plan includes one or more of the selected revision implant size, the selected revision implant geometry, and one or more planned resections. Attached Figure Description

[0027] The accompanying drawings, which are incorporated in and form a part of this specification, illustrate embodiments of the present disclosure and, together with the written description, serve to explain the principles, features, and characteristics of the invention. In the drawings:

[0028] Figure 1 An operating room including an exemplary computer-assisted surgical system (CASS) according to an embodiment is shown.

[0029] Figure 2 An example of an electromagnetic sensor device according to some embodiments is shown.

[0030] Figure 3A Alternative examples of electromagnetic sensor devices with three vertical coils according to some embodiments are shown.

[0031] Figure 3B Alternative examples of electromagnetic sensor devices with two non-parallel fixed coils according to some embodiments are shown.

[0032] Figure 3C Alternative examples of electromagnetic sensor devices with two non-parallel, separate coils according to some embodiments are shown.

[0033] Figure 4 Examples of an electromagnetic sensor device and a patient's bone according to some embodiments are shown.

[0034] Figure 5A Illustrative control instructions provided by the surgical computer to other components of CASS according to an embodiment are shown.

[0035] Figure 5B Illustrative control instructions provided by components of a CASS according to an embodiment to a surgical computer are shown.

[0036] Figure 5C An illustrative embodiment is shown in which a surgical computer, according to an embodiment, is connected to a surgical data server via a network.

[0037] Figure 6 A surgical patient care system and illustrative data source according to an embodiment are shown.

[0038] Figure 7A An exemplary flowchart for determining a preoperative surgical plan is shown according to an embodiment.

[0039] Figure 7B An exemplary flowchart is shown for determining the care period, including preoperative, intraoperative, and postoperative actions, according to an embodiment.

[0040] Figure 7C An illustrative graphical user interface according to an embodiment is shown, including images depicting implant placement.

[0041] Figures 8A-8B A perspective view of an illustrative test guide according to an embodiment is shown.

[0042] Figure 9 A perspective view of an illustrative test guide according to an embodiment is shown.

[0043] Figure 10 A side view of an illustrative test guide according to an embodiment is shown.

[0044] Figure 11 A perspective view of an illustrative test guide according to an embodiment is shown.

[0045] Figure 12A A perspective view of an illustrative test guide according to an embodiment is shown.

[0046] Figure 12B A close-up view of illustrative markings on an illustrative test guide according to an embodiment is shown.

[0047] Figure 13A A perspective view of an illustrative test guide according to an embodiment is shown.

[0048] Figure 13B A close-up view of an illustrative lead screw on an illustrative test guide according to an embodiment is shown.

[0049] Figures 14A-14B A perspective view of an illustrative test guide with a cam-shaped insert according to an embodiment is shown.

[0050] Figure 15 A top view of an illustrative test guide according to an embodiment is shown.

[0051] Figure 16 A block diagram of an exemplary data processing system in which embodiments are implemented is shown. Detailed Implementation

[0052] This disclosure is not limited to the specific systems, apparatus, and methods described, as they can vary. The terminology used in the description is for the purpose of describing a particular version or embodiment only and is not intended to be limiting.

[0053] As used herein, unless the context clearly indicates otherwise, the singular forms “a,” “an,” and “the / described” include plural references. Unless otherwise defined, all technical terms used herein have the same meaning as commonly understood by one of ordinary skill in the art. Nothing in this disclosure should be construed as an admission that the embodiments described herein are not entitled to bring forward the date of this disclosure due to prior inventions. As used herein, the term “comprising” means “including, but not limited to,” “including.”

[0054] definition

[0055] For the purposes of this disclosure, the term "implant" is used to refer to a prosthetic device or structure manufactured to replace or enhance a biological structure. For example, in a total hip replacement procedure, a prosthetic acetabular cup (implant) is used to replace or enhance a patient's worn or damaged acetabulum. While the term "implant" is generally considered to refer to an artificial structure (in contrast to a transplant), for the purposes of this specification, an implant may include biological tissue or material transplanted to replace or enhance a biological structure.

[0056] For the purposes of this disclosure, the term "real-time" is used to refer to computations or operations performed immediately upon the occurrence of an event or the receipt of input by an operating system. However, the use of the term "real-time" is not intended to exclude operations that introduce some delay between input and response, provided that the delay is an unintended consequence of the machine's performance characteristics.

[0057] While much of this disclosure refers to surgeons or other medical professionals by specific titles or roles, nothing in this disclosure is intended to be limited to any particular title or function. A surgeon or medical professional can include any physician, nurse, medical professional, or technician. Any of these terms or titles may be used interchangeably with the systems disclosed herein, unless otherwise expressly stated. For example, in some embodiments, references to surgeons may also apply to technicians or nurses.

[0058] The systems, methods, and apparatus disclosed herein are particularly well-suited for use with surgical navigation systems (e.g., Surgical procedures using a surgical navigation system. NAVIO is a registered trademark of BLUE BELTTECHNOLOGIES, Inc., Pittsburgh, Pennsylvania, a subsidiary of SMITH & NEPHEW, Inc., Memphis, Tennessee.

[0059] CASS Ecosystem Overview

[0060] Figure 1 Illustrations of an example computer-assisted surgical system (CASS) 100 according to some embodiments are provided. As described in further detail in the following sections, CASS uses computers, robotics, and imaging technologies to assist surgeons in performing orthopedic surgical procedures such as total knee replacement (TKA) or total hip replacement (THA). For example, surgical navigation systems can help surgeons locate the patient's anatomy, guide surgical instruments, and implant medical devices with high precision. Surgical navigation systems such as CASS 100 often employ various forms of computing technology to perform a wide range 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 the patient's body, as well as to perform preoperative and intraoperative body imaging.

[0061] The actuator platform 105 positions surgical instruments relative to the patient during surgery. The exact components of the actuator platform 105 will vary depending on the embodiment employed. For example, for knee surgery, the actuator platform 105 may include an end effector 105B that holds the surgical instruments or apparatus during its use. The end effector 105B may be a handheld device or instrument used by the surgeon (e.g., ...). (Handheld component, cutting guide, or clamp), or alternatively, the end effector 105B may include a device or instrument held or positioned by the robotic arm 105A. Although in Figure 1 A single robotic arm 105A is shown, but in some embodiments, multiple devices may be present. For example, there may be one robotic arm 105A on each side of the operating table T, or two devices on one side of the operating table T. The robotic arm 105A may be mounted directly to the operating table T, located on a floor platform (not shown) adjacent to the operating table T, mounted on a floor bar, or mounted on a wall or ceiling of the operating room. The floor platform may be fixed or movable. In one particular embodiment, the robotic arm 105A is mounted on a floor bar located between the patient's legs or feet. In some embodiments, the end effector 105B may include a suture retainer or stapler to aid in wound closure. Furthermore, in the case of two robotic arms 105A, the surgical computer 150 may drive the robotic arms 105A to work together to suture the wound upon closure. Alternatively, the surgical computer 150 may drive one or more robotic arms 105A to suture the wound upon closure.

[0062] The actuator platform 105 may include a limb locator 105C for positioning a patient's limb during surgery. An example of the limb locator 105C is the Smith and Nephew Spider2 system. The limb locator 105C can be manually operated by the surgeon, or alternatively, the limb position can be changed based on instructions received from the surgical computer 150 (described below). Although in Figure 1 A limb locator 105C is shown, but in some embodiments, multiple devices may be present. As an example, there may be one limb locator 105C on each side of the operating table T, or two devices on one side of the operating table T. The limb locator 105C may be mounted directly to the operating table T, located on a floor platform (not shown) next to the operating table T, mounted on a pole, or mounted on the wall or ceiling of the operating room. In some embodiments, the limb locator 105C may be used in unconventional ways, such as as a retractor or a specific bone retainer. As an example, the limb locator 105C may include an ankle boot, soft tissue clip, bone clip, or soft tissue retractor key, such as a hook-shaped, curved, or angled blade. In some embodiments, the limb locator 105C may include a suture retainer to assist in wound closure.

[0063] The actuator platform 105 may include tools such as screwdrivers, light or lasers indicating axes or planes, levels, pin drivers, pin pullers, plane checkers, indicators, fingers, or some combination thereof.

[0064] Resection device 110 ( Figure 1(Not shown) Bone or tissue resection is performed using techniques such as mechanical, ultrasonic, or laser methods. Examples of resection devices 110 include drilling devices, deburring devices, vibratory sawing devices, vibratory impact devices, reamers, ultrasonic bone cutting devices, radiofrequency ablation devices, reciprocating motion devices (e.g., files or broaches), and laser ablation systems. In some embodiments, the resection device 110 is held and operated by a surgeon during surgery. In other embodiments, an actuator platform 105 may be used to hold the resection device 110 during use.

[0065] The actuator platform 105 may also include a cutting guide or clamp 105D for guiding a saw or drill used to remove tissue during surgery. Such a cutting guide 105D may be integrally formed as part of the actuator platform 105 or the robotic arm 105A, or the cutting guide may be a separate structure that can be mateably and / or removably attached to the actuator platform 105 or the robotic arm 105A. The actuator platform 105 or the robotic arm 105A may be controlled by the CASS 100 to position the cutting guide or clamp 105D near the patient's anatomy according to a preoperative or intraoperative surgical plan, such that the cutting guide or clamp will produce precise bone cuts according to the surgical plan.

[0066] Tracking system 115 uses one or more sensors to collect real-time positional data for locating patient anatomy and surgical instruments. For example, for TKA procedures, the tracking system can provide the position and orientation of end effector 105B during the procedure. In addition to positional data, data from tracking system 115 can also be used to infer the velocity / acceleration of the anatomy / instrument, which can be used for tool control. In some embodiments, tracking system 115 can use an array of trackers attached to end effector 105B to determine the position and orientation of end effector 105B. The position of end effector 105B can be inferred based on the position and orientation of tracking system 115 and a known relationship in three-dimensional space between tracking system 115 and end effector 105B. Various types of tracking systems can be used in various embodiments of the invention, 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 the data provided by tracking system 115, surgical computer 150 can detect objects and prevent collisions. For example, surgical computer 150 can prevent robotic arm 105A and / or end effector 105B from colliding with soft tissue.

[0067] 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 (e.g., infrared LED light sources) can illuminate the scene, enabling three-dimensional imaging. In some embodiments, this can include stereo, three-view, four-view, etc., imaging. In addition to camera arrays fixed to a trolley in some embodiments, additional cameras can be placed throughout the operating room. For example, handheld tools or headgear worn by the operator / surgeon can include imaging capabilities that transmit images back to a central processor to correlate those images with those acquired by the camera array. This can provide more robust images for environments modeled using multiple perspectives. Furthermore, some imaging devices can have appropriate resolution on the scene or appropriate viewing angles to pick up information stored in quick response (QR) codes or barcodes. This helps identify specific objects that have not been manually registered with the system. In some embodiments, the cameras can be mounted on a robotic arm 105A.

[0068] As discussed in this paper, while most tracking and / or navigation technologies utilize image-based tracking systems (e.g., IR tracking systems, video or image-based tracking systems, etc.), electromagnetic (EM)-based tracking systems are becoming increasingly 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 cortical pins. Additionally, because optical trackers require a direct line of sight to the tracking system, placement of such trackers may need to be away from the surgical site to ensure they do not restrict the movement of surgeons or medical professionals.

[0069] Typically, 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 an electromagnetic field that can be detected and measured (e.g., by the reference field generator or additional devices) in a manner that allows the position and orientation of the one or more coils to be determined. As will be understood by one of ordinary skill in the art, for example... Figure 2 The single coil shown is limited to detecting five (5) total degrees of freedom (DOF). For example, sensor 200 is able to track / determine 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 accurately track rotational motion about the X-axis.

[0070] Therefore, in most electromagnetic tracking applications, such as Figure 3AThe three-coil system shown is used to achieve tracking in all six degrees of freedom (i.e., forward / backward 310°, up / down 320°, left / right 330°, roll 340°, pitch 350°, and yaw 360°) that allow a rigid body to move in three-dimensional space. However, including two additional coils and their 90° offset angle of positioning may require a much larger tracking device. Alternatively, as those skilled in the art will know, fewer 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 the diagram. Since the two coils 301B and 302B are rigidly fixed to each other, not perfectly parallel, and have known positions relative to each other, this arrangement can be used to determine the sixth degree of freedom 303B.

[0071] While using two fixed coils (e.g., 301B, 302B) allows for EM-based tracking at 6DOF, the sensor device has a significantly larger diameter than a single coil due to the additional coils. Therefore, practical application of an EM-based tracking system in a surgical setting may require tissue removal and drilling 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 drilling or extensive bone removal).

[0072] Therefore, as described herein, there is a need for a solution that limits the use of the EM tracking system to devices small enough to be inserted / embedded using small-diameter needles or pins (i.e., without requiring new incisions or large-diameter openings in the bone). Thus, in some embodiments, a second 5DOF sensor, not attached to the first sensor and therefore having a small diameter, can be used to track all 6DOF. Now refer to... Figure 3C In some embodiments, two 5DOF EM sensors (e.g., 301C and 302C) may be inserted into the patient (e.g., in the patient's bone) at different locations with different angular orientations (e.g., angle 303C is non-zero).

[0073] Now for reference Figure 4This illustrates an example embodiment of inserting a first 5DOF EM sensor 401 and a second 5DOF EM sensor 402 into the patient's bone 403 using a standard hollow needle 405 typical in most orthopedic procedures. In another embodiment, the first sensor 401 and the second sensor 402 may have an angular offset of "α" 404. In some embodiments, the offset angle "α" 404 may 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 may be determined by the CASS during surgical planning and provided to the surgeon or medical professional. In some embodiments, the minimum value may be based on one or more factors, such as the orientation accuracy of the tracking system, the distance between the first and second EM sensors, the location of the field generator, the location of the field detector, the type of EM sensor, the quality of the EM sensor, the patient's anatomy, etc.

[0074] Therefore, as discussed herein, in some embodiments, pins / needles (e.g., sleeve mounting pins, etc.) may be used to insert one or more EM sensors. Typically, the pins / needles will be disposable components, while the sensor itself may be reusable. However, it should be understood that this is only one possible system, and various other systems may be used where the pins / needles and / or EM sensors are either single-use or reusable. In another embodiment, the EM sensor may be secured to a mounting pin / needle (e.g., using Luer lock fittings, etc.), which may allow for quick assembly and disassembly. In yet another embodiment, the EM sensor may utilize alternative sleeves and / or anchoring systems that allow for minimal intrusion into the sensor's placement.

[0075] In another embodiment, the system described above can allow for a multi-sensor navigation system that can detect and correct field distortions that plague electromagnetic tracking systems. It should be understood that field distortions can be caused by movement of any ferromagnetic material within the reference field. Therefore, as is known to those skilled in the art, a typical operating system (OR) has numerous devices that can cause interference (e.g., operating tables, LCD displays, lighting equipment, imaging systems, surgical instruments, etc.). Furthermore, field distortions are known to be difficult to detect. Using multiple EM sensors enables the system to accurately detect field distortions and / or alert the user that measurements of the current position may be inaccurate. Because the sensors (e.g., via pins / needles) are securely attached to the bone anatomy, 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 attached to the bone, the relative distance between the two sensors is known and should be kept constant. Therefore, any change in this distance can indicate the presence of field distortion.

[0076] In some embodiments, surgeons can manually register specific objects using the system before or during surgery. For example, by interacting with a user interface, a surgeon can identify the starting position of a tool or bone structure. By tracking reference markers associated with the tool or bone structure, or by using other conventional image tracking methods, the processor can track the tool or bone as it moves through the environment in a 3D model.

[0077] In some embodiments, certain markers, such as reference marks for identifying individuals, vital instruments, or bones in an operating room, may include passive or active identifiers that can be picked up by a camera or camera array associated with a tracking system. For example, an infrared LED may flash a pattern that conveys a unique identifier to the source of the pattern, thus providing dynamic identification marking. Similarly, one-dimensional or two-dimensional optical codes (barcodes, QR codes, etc.) may 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 object, they can also be used to determine the object's orientation by comparing the location of the identifier to the extent of the object in an image. For example, a QR code may be placed in the corner of a tool tray, allowing tracking of the tray's orientation and identifier. Other tracking methods will be described throughout the text. For example, in some embodiments, surgeons and other personnel may wear augmented reality headsets to provide additional camera angles and tracking capabilities.

[0078] Besides optical tracking, certain features of an object can also be tracked by registering its physical properties and associating them with a trackable object (e.g., a reference marker fixed to a tool or bone). For example, a surgeon can perform a manual registration process, whereby the tracked tool and the tracked bone can be manipulated relative to each other. By striking the surface of the bone with the tip of the tool, a three-dimensional surface can be mapped onto the bone, which is associated with its position and orientation relative to the reference marker. By optically tracking the position and orientation (pose) of the reference marker associated with the bone, a model of the surface can be tracked in the environment via extrapolation.

[0079] The registration process of CASS 100 to a patient's relevant anatomical structures can also involve the use of anatomical landmarks, such as those on bone or cartilage. For example, CASS 100 can include a 3D model of the relevant bone or joint, and the surgeon can use probes attached to CASS to collect data intraoperatively on the location of bone landmarks on the patient's actual bones. Bone landmarks can include, for example, the medial and lateral malleoli, the ends of the proximal femur and distal tibia, and the center of the hip joint. CASS 100 can compare and register the location data of the bone landmarks collected by the surgeon with the probes with the location data of the same landmarks in the 3D model. Alternatively, CASS 100 can construct a 3D model of a bone or joint without preoperative image data by using location data of bone landmarks and bone surfaces collected by the surgeon using CASS probes or other means. The registration process can also include determining the individual axes of the joint. For example, for TKA, the surgeon can use CASS 100 to determine the anatomical and mechanical axes of the femur and tibia. Surgeons and CASS 100 can identify the center of the hip joint by moving the patient's legs in a spiral direction (i.e., circumferentially) so that CASS can determine the location of the hip joint center.

[0080] Organizational Navigation System 120 ( Figure 1 (Not shown) provides surgeons with real-time intraoperative visualization of the patient's bone, cartilage, muscle, nerves, and / or blood vessels surrounding the surgical area. Examples of systems that can be used for tissue navigation include fluorescence imaging systems and ultrasound systems.

[0081] Display 125 provides a graphical user interface (GUI) that displays images collected by the tissue navigation system 120, as well as other surgery-related information. For example, in one embodiment, display 125 overlays image information collected preoperatively or intraoperatively from various modalities (e.g., CT, MRI, X-ray, fluorescence, ultrasound, etc.) to provide the surgeon with various views of the patient's anatomy and real-time status. Display 125 may include, for example, one or more computer monitors. As an alternative to or supplement to display 125, one or more surgical personnel may wear an augmented reality (AR) head-mounted device (HMD). For example, in Figure 1 In this case, the surgeon 111 wears an AR HMD 155, which can, for example, overlay preoperative image data onto the patient or provide surgical planning advice. Various exemplary uses of the AR HMD 155 in surgical procedures are described in detail in the following sections.

[0082] 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.

[0083] 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.

[0084] Dynamic impact and acetabular reamer device

[0085] 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. The powered impact device may be powered, for example, by a battery attached to it. 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. Similarly, 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.

[0086] In 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 mounted on the iliac crest using clamps and / or bone pins, and can be mounted externally through the skin or internally (posterolaterally or anterolaterally) through an incision made for performing the THA. For 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. The femoral tracker array can be fixed or mounted in the femoral cortical screws. The CASS 100 can employ the following steps, wherein verification is performed using probes precisely placed on the monitor 125 by the surgeon on key areas of the proximal femur and pelvis identified by the surgeon. The tracker can be located on the robotic arm 105A or end effector 105B to register the arm and / or end effector to the CASS 100. The verification process can also utilize proximal and distal femoral checkpoints. The CASS 100 can use color cues or other cues to inform the surgeon that the registration process between the bone and the robotic arm 105A or end effector 105B has been verified with a certain level of accuracy (e.g., within 1 mm).

[0087] For THA, the CASS 100 may include a puller tracking option using a femoral array, allowing the surgeon to obtain the puller's position and orientation intraoperatively and calculate the patient's hip length and offset values. Based on the information provided about the patient's hip joint and the planned implant position and orientation after puller tracking is completed, the surgeon can modify or adjust the surgical plan.

[0088] For robot-assisted THA, CASS 100 may include one or more powered reamers connected to or attached to a robotic arm 105A or an end effector 105B, which prepare the pelvic bone according to the surgical plan to receive the acetabular implant. The robotic arm 105A and / or the end effector 105B may 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 the boundaries of the bone to be resected according to the surgical plan, CASS 100 may disconnect the power to the reamers or instruct the surgeon to disconnect the power to the reamers. CASS 100 may provide the surgeon with the option to turn off or disengage the robotic control of the reamers. Instead of using a surgical plan in different colors, the display 125 may show the progress of the bone being resected (reamed). 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. CASS 100 may provide the surgeon with visual or auditory cues to warn the surgeon that a resection is not in accordance with the surgical plan.

[0089] After reaming, the CASS 100 can use a manual or powered impactor attached to or connected to the robotic arm 105A or end effector 105B to impact the test and final implants into the acetabulum. The robotic arm 105A and / or end effector 105B can be used to guide the impactor to impact the test and final implants into the acetabulum according to the surgical plan. The CASS 100 can display the position and orientation of the test and final implants relative to the bone to inform the surgeon how to compare the orientation and position of the test and final implants with 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 replan and redo the reaming and implant impact by preparing a new surgical plan.

[0090] Preoperatively, the CASS 100 can develop a proposed surgical plan based on a 3D model of the hip joint and other patient-specific information, such as the mechanical and anatomical axes of the leg bones, the epicondyle 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 location of anatomical landmarks such as the lesser trochanter landmark, the distal landmark, and the center of rotation of the hip joint. The surgical plan developed by CASS can provide recommended optimal implant size, as well as implant location and orientation, based on the 3D model of the hip joint and other patient-specific information. The surgical plan developed by CASS can include recommended details regarding offset values, tilt and anteversion values, center of rotation, cup size, mid-range value, superior-inferior fit, femoral stem size, and length.

[0091] For THA, the surgical plan developed by CASS 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 display the planned hip resection and, based on the planned resection, the planned implant is superimposed onto the hip joint. CASS 100 can provide the surgeon with a choice of different surgical procedures, which will be displayed to the surgeon according to their 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 location and number of tracker arrays used during registration.

[0092] According to some embodiments, the powered impact device used with the CASS 100 can operate in a variety of different settings. In some embodiments, the surgeon adjusts the settings via a manual switch or other physical mechanism on the powered impact device. In other embodiments, a digital interface can be used, allowing setting input, for example, via a touchscreen on the powered impact device. Such a digital interface can allow available settings to vary based on, for example, the type of attachment connected to an electrical attachment device. In some embodiments, the settings can be changed by communicating with a robot or other computer system within the CASS 100, rather than adjusting the settings on the powered impact device itself. Such a connection can be established using, for example, a Bluetooth or Wi-Fi networking module on the powered impact device. In another embodiment, the impact device and end components can include features that allow the impact device to know which end components (cup impactor, puller handle, etc.) are attached without requiring any action from the surgeon, and adjust the settings accordingly. This can be achieved, for example, via QR codes, barcodes, RFID tags, or other methods.

[0093] Examples of possible settings include cup impact settings (e.g., unidirectional, specified frequency range, specified force and / or energy range); puller impact settings (e.g., bidirectional / oscillating within a specified frequency range, specified force and / or energy range); femoral head impact settings (e.g., unidirectional / single-shot impact with specified force or energy); and dry impact settings (e.g., unidirectional impact with specified force or energy at a specified frequency). Additionally, in some embodiments, the dynamic impact device includes settings related to acetabular liner impact (e.g., unidirectional / single-shot impact with specified force or energy). Multiple settings may be available for each type of liner (e.g., polymer, ceramic, oxinium, or other materials). Furthermore, the dynamic impact 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 dynamic impact device can have dual functionality. For example, the dynamic impact device can not only provide reciprocating motion to deliver impact force but also provide reciprocating motion for a puller or file.

[0094] In some embodiments, the dynamic impact device includes a feedback sensor that collects data during instrument use and transmits the data to a computing device, such as a controller or surgical computer 150 within the device. 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 of each instrument, reaction forces or rebound energy from the patient's bone, the position of the device relative to an image (e.g., fluorescence, CT, ultrasound, MRI, etc.) of a registered bone anatomy, and / or external strain gauges on the bone.

[0095] Once the data is collected, the computing device can execute one or more algorithms in real time or near real time to assist the surgeon in performing surgical procedures. For example, in some embodiments, the computing device uses the collected data to derive information such as the correct final retractor size (femur); when the shaft is fully in place (femoral side); or when the cup is in place relative to the THA (depth and / or orientation). 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.

[0096] Furthermore, the data derived from the aforementioned algorithm can be used to operate the drive device. For example, during insertion of the prosthetic acetabular cup using a powered impact device, the device can automatically extend the impact head (e.g., an end effector) to move the implant into place, or shut off the device's power once the implant is fully in place. In one embodiment, the derived information can be used to automatically adjust bone quality settings, where the powered impact device should use less power to mitigate femoral / acetabular / pelvic fractures or damage to surrounding tissues.

[0097] robotic arm

[0098] In some embodiments, the CASS 100 includes a robotic arm 105A, which serves as an interface for stabilizing and holding various instruments used during surgical procedures. For example, in the case of hip surgery, these instruments may include, but are not limited to, retractors, sagittal or reciprocating saws, reamer handles, cup impactors, puller handles, and dry inserters. The robotic arm 105A may have multiple degrees of freedom (similar to a spider device) and the ability to lock into place (e.g., by pressing a button, voice activation, the surgeon removing their hand from the robotic arm, or other methods).

[0099] In some embodiments, movement of the robotic arm 105A can be achieved using a control panel built into the robotic arm system. For example, the display screen may include one or more input sources, such as physical buttons that guide the movement of the robotic arm 105A or a user interface with one or more icons. Surgeons or other healthcare professionals can engage with one or more input sources to position the robotic arm 105A during surgical procedures.

[0100] Tools or end effectors 105B attached to or integrated into the robotic arm 105A may include, but are not limited to, deburring devices, scalpels, cutting devices, retractors, joint tensioners, etc. In embodiments using the end effector 105B, the end effector may be positioned at the end of the robotic arm 105A, enabling any motor-controlled operation to be performed within the robotic arm system. In embodiments using the tool, the tool may be fixed at the distal end of the robotic arm 105A, but the motor-controlled operation may be located within the tool itself.

[0101] The robotic arm 105A can be internally motorized to stabilize it, preventing it from falling and impacting patients, operating tables, surgical personnel, etc., and allowing the surgeon to move the robotic arm without having to fully support its weight. While the surgeon moves the robotic arm 105A, it provides some resistance to prevent it from moving too quickly or activating too many degrees of freedom at once. The position and locked state of the robotic arm 105A can be tracked, for example, by a controller or surgical computer 150.

[0102] In some embodiments, the robotic arm 105A can be moved to its ideal position and orientation by hand (e.g., by a surgeon) or by internal motors to perform the task at hand. In some embodiments, the robotic arm 105A may be able to operate in a “free” mode, allowing the surgeon to position the arm in a desired location without restriction. In free mode, as described above, the position and orientation of the robotic arm 105A can still be tracked. In one embodiment, during a designated portion of the surgical plan tracked by the surgical computer 150, certain degrees of freedom can be selectively released upon input from a user (e.g., a surgeon). A design in which the robotic arm 105A is internally powered by hydraulics or motors or provides resistance to external manual movement by similar means can be described as a powered robotic arm, while an arm that is manually manipulated without power feedback but can be manually or automatically locked in place can be described as a passive robotic arm.

[0103] The robotic arm 105A or end effector 105B may include triggers or other devices to control the power of the saw or drill. Engagement of the trigger or other device by the surgeon can transition the robotic arm 105A or end effector 105B from a motorized alignment mode to a mode where the saw or drill is engaged and energized. Additionally, the CASS 100 may include a foot pedal (not shown) that, when activated, causes the system to perform certain functions. For example, the surgeon may activate the foot pedal to instruct the CASS 100 to place the robotic arm 105A or end effector 105B in an automatic mode, which positions the robotic arm or end effector relative to the patient's anatomy to perform necessary resections. The CASS 100 may also place the robotic arm 105A or end effector 105B in a cooperative mode, which allows the surgeon to manually manipulate the robotic arm or end effector and position it in a specific 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 restricting movement in other directions. As discussed, the robotic arm 105A or end effector 105B may include a cutting device (saw, drill, and sharpener) or a cutting guide or clamp 105D that guides the cutting device. In other embodiments, the movement of the robotic arm 105A or the robot-controlled end effector 105B may be entirely controlled by the CASS 100 without any assistance or input from a surgeon or other medical professional, or with very little assistance or input. In still other embodiments, a surgeon or other medical professional may remotely control the movement of the robotic arm 105A or the robot-controlled end effector 105B using a control mechanism separate from the robotic arm or robot-controlled end effector device, such as a joystick or interactive monitor or display control device.

[0104] The following examples describe the use of robotic devices in hip surgery; however, it should be understood that robotic arms may have other applications in surgical procedures involving the knee, shoulder, etc. An example of the use of a robotic arm in creating anterior cruciate ligament (ACL) graft tunnels is described in WIPO Publication No. WO 2020 / 047051, filed August 28, 2019, entitled "Robotic Assisted Ligament Graft Placement and Tensioning," the entire contents of which are incorporated herein by reference.

[0105] The robotic arm 105A can be used to hold a retractor. For example, in one embodiment, the surgeon can move the robotic arm 105A to a desired position. At this point, the robotic arm 105A can lock into place. In some embodiments, the robotic arm 105A is provided with data about the patient's position 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 dilation).

[0106] The robotic arm 105A can also be used to help stabilize the surgeon's hand when making a femoral neck incision. In this application, certain limitations can be imposed on the control of the robotic arm 105A to prevent soft tissue injury. For example, in one embodiment, the surgical computer 150 tracks the position of the robotic arm 105A as it operates. If the tracked position approaches an area where tissue damage is predicted, a command can be sent to the robotic arm 105A to stop it. Alternatively, in the case where the robotic arm 105A is automatically controlled by the surgical computer 150, the surgical computer can ensure that it does not provide any instructions to the robotic arm that would cause it to enter an area where soft tissue injury may occur. The surgical computer 150 can impose certain limitations on the surgeon to prevent the surgeon from digging too deep into the medial wall of the acetabulum or digging at an incorrect angle or orientation.

[0107] In some embodiments, the robotic arm 105A can be used to hold the cup impactor at a desired angle or orientation during cup impact. Once the final position has been reached, the robotic arm 105A can prevent any further positioning to avoid damage to the pelvis.

[0108] The surgeon can use the robotic arm 105A to position the retractor handle in the desired location, allowing the surgeon to impact the retractor into the femoral canal in the desired orientation. In some embodiments, once the surgical computer 150 receives feedback that the retractor is fully in place, the robotic arm 105A can restrict the handle to prevent further advance of the retractor.

[0109] The robotic arm 105A can also be used in surface resurfacing applications. For example, the robotic arm 105A can stabilize the surgeon while using conventional instruments and provide certain constraints or limitations to allow for the proper placement of implanted components (e.g., guidewire placement, chamfering cutter, sleeve cutter, planar cutter, etc.). When using only a bone drill, the robotic arm 105A can stabilize the surgeon's handpiece and impose restrictions on it to prevent the surgeon from deviating from the surgical plan and removing unwanted bone.

[0110] Robotic arm 105A may be a passive arm. As an example, robotic arm 105A may be a CIRQ robotic arm available from Brainlab AG. CIRQ is a registered trademark of Brainlab AG, Olof-Palme-Str. 981829, Munich, Germany. In one particular embodiment, robotic arm 105A is an intelligent gripping 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 which are incorporated herein by reference.

[0111] Generation and collection of surgical procedure data

[0112] The various services provided by healthcare professionals to treat a clinical condition are collectively referred to as the "care period." For a specific surgical procedure, the care period may include three phases: preoperative, intraoperative, and postoperative. During each phase, data is collected or generated that can be used to analyze the care period in order to understand the various characteristics of the procedure and identify patterns that can be used, for example, to make decisions with minimal human intervention in a training model. The data collected during the care period may be stored as a complete dataset at the surgical computer 150 or the surgical data server 180. Thus, for each care period, there exists a dataset that includes all data collected collectively about the patient preoperatively, all data collected or stored intraoperatively by CASS 100, and any postoperative data provided by the patient or by the healthcare professionals monitoring the patient.

[0113] As explained in further detail, data collected during the care period can be used to enhance the execution of surgical procedures or provide a holistic understanding of surgical procedures and patient outcomes. For example, in some embodiments, data collected during the care period can be used to generate surgical plans. In one embodiment, advanced preoperative planning is refined intraoperatively while data is collected during surgery. In this way, the surgical plan can be viewed as dynamically changing in real-time or near real-time as new data is collected through components of CASS 100. In other embodiments, preoperative images or other input data can be used to develop a robust plan that is easy to execute during surgery. In this case, data collected by CASS 100 during surgery can be used to make recommendations to ensure the surgeon stays within the preoperative surgical plan. For example, if the surgeon is unsure how to achieve certain prescribed cuts or implant alignments, they can consult the surgical computer 150 for recommendations. In still other embodiments, preoperative and intraoperative planning schemes can be combined so that the refined preoperative plan can be dynamically modified as needed or desired during the surgical procedure. In some embodiments, biomechanical models of the patient's anatomy contribute simulation data to be considered by CASS 100 in developing preoperative, intraoperative, and postoperative / rehabilitation procedures to optimize the patient's implant performance outcomes.

[0114] Besides altering the surgical procedure itself, data collected during the care period can also be used as input for other surgical aids. For example, in some embodiments, care period 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 these patents are incorporated herein by reference.

[0115] Furthermore, the data can be used for educational, training, or research purposes. For example, using the following...Figure 5C The web-based approach described herein allows other doctors or students to remotely view surgeries through an interface that allows them to selectively view data collected from the 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 identify the root cause of any problems or complications that occurred during the procedure.

[0116] Data acquired during the preoperative phase typically includes all information collected or generated prior to surgery. Thus, information about the patient can be obtained, for example, from a patient entry form or electronic medical record (EMR). Examples of patient information that can be collected include, but are not limited to, patient demographics, diagnosis, medical history, medical records, vital signs, medical history information, allergies, and laboratory test results. Preoperative data may also include images relating to the anatomical region of interest. These images may be acquired, for example, using magnetic resonance imaging (MRI), computed tomography (CT), X-ray, ultrasound, or any other means known in the art. Preoperative data may also include quality-of-life data obtained from the patient. For example, in one embodiment, the patient uses a mobile application (“app”) to answer a questionnaire about their current quality of life. In some embodiments, the preoperative data used by CASS100 includes demographics, anthropometry, culture, or other specific characteristics of the patient that may be correlated with activity levels and specific patient activities to tailor surgical plans for the patient. For example, people of certain cultures or demographics may prefer to use a squat toilet daily.

[0117] Figure 5A and 5B Examples of data that can be obtained during the intraoperative phase of the nursing period are provided. These examples are based on the above references. Figure 1 The various components of the CASS 100 are described; however, it should be understood that other types of data may be used based on the type of equipment used during the operation and its usage.

[0118] 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 The example assumes that all components of the actuator platform 105 are directly controlled 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 on how to move the components.

[0119] Various components included in the actuator platform 105 are controlled by a surgical computer 150, which provides position commands indicating the location of the component within a coordinate system. In some embodiments, the surgical computer 150 provides commands to the actuator platform 105 defining how to react when a component of the actuator platform 105 deviates from the surgical plan. These commands are in... Figure 5A The term "tactile" is used as a reference. For example, the end effector 105B can provide force to resist movement outside the planned area to be removed. Other commands that the actuator platform 105 can use include vibration and audio cues.

[0120] In some embodiments, the end effector 105B of the robotic arm 105A is operatively coupled to the cutting guide 105D. In response to an anatomical model of the surgical scenario, the robotic arm 105A can move the end effector 105B and the cutting guide 105D to the appropriate position to match the location of the femoral or tibial cut to be performed according to the surgical plan. This reduces the possibility of errors, allowing the vision system and the processor utilizing that vision system to implement the surgical plan, positioning the cutting guide 105D in a precise location and orientation relative to the tibia or femur to align the cutting groove 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 vibratory or rotary saw or drill, to perform the cut (or drill) with perfect placement and orientation, as the tool is mechanically limited by the characteristics of the cutting guide 105D. In some embodiments, the cutting guide 105D may include one or more pin holes, which the surgeon uses to drill and tighten or pin the cutting guide into the appropriate position before performing the resection of patient tissue using the cutting guide. This allows the robotic arm 105A to be released or ensures that the cutting guide 105D is fully fixed without moving relative to the bone to be removed. For example, this procedure can be used to create a first distal incision in the femur during total knee arthroplasty. In some embodiments, where the joint replacement is a hip replacement, the cutting guide 105D can be fixed to the femoral head or acetabulum for the corresponding hip replacement resection. It should be understood that any joint replacement utilizing a precise incision can employ the robotic arm 105A and / or the cutting guide 105D in this manner.

[0121] The resection device 110 provides a variety of commands to perform bone or tissue manipulations. Similar to the actuator platform 105, position information can be provided to the resection device 110 to specify where it should be positioned during resection. Other commands provided to the resection device 110 may vary depending on the type of resection device. For example, for mechanical or ultrasonic resection tools, commands may specify the tool's speed and frequency. For radiofrequency ablation (RFA) and other laser ablation tools, these commands may specify intensity and pulse duration.

[0122] Some components of the CASS 100 do not require direct control by the surgical computer 150; instead, the surgical computer 150 only needs to activate the components, which then execute software locally to specify how data is collected and provided to the surgical computer 150. Figure 5A In the example, two components operate in this manner: the tracking system 115 and the organization navigation system 120.

[0123] The surgical computer 150 provides the display 125 with any visualizations required by the surgeon 111 during surgery. For the monitor, the surgical computer 150 can use techniques known in the art to provide instructions for displaying images, a GUI, etc. The display 125 can include various parts of the surgical planning workflow. For example, during the registration process, the display 125 can display a preoperatively constructed 3D bone model and show the location of probes as the surgeon uses probes to collect anatomical landmarks on the patient. The display 125 can include information about the target surgical area. For example, in conjunction with 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 joint based on the surgical plan, and the CASS 100 can show how such angles would be affected if anticipated modifications to the surgical plan were made. Therefore, the display 125 is an interactive interface that can dynamically update and display how changes to the surgical plan will affect the procedure and the final position and orientation of the implant mounted on the bone.

[0124] As the workflow progresses to preparation for bone cutting or resection, the display 125 can show the planned or recommended bone cut before any cut is performed. The surgeon 111 can manipulate the image display to provide different anatomical views of the target area and may have the option to change or modify the planned bone cut based on the patient's intraoperative assessment. The display 125 can show how the selected implant will be placed on the bone if the planned bone cut is performed. If the surgeon 111 chooses to change the previously planned bone cut, the display 125 can show how the modified bone cut will change the position and orientation of the implant when placed on the bone.

[0125] The display 125 can provide the surgeon 111 with various data and information about the patient, the planned surgical procedure, and the implant. Various patient-specific information can be displayed, including real-time data on the patient's health, such as heart rate, blood pressure, etc. The display 125 can also include information about the anatomy of the surgical target area (including the location of landmarks), the current state of the anatomy (e.g., whether any resections have been performed, the depth and angle of planned and performed bone cuts), and the future state of the anatomy as the surgical plan progresses. The display 125 can also provide or show additional information about the surgical target area. For TKA, the display 125 can provide information about the gap between the femur and tibia (e.g., gap balance) and how such a gap will change if the planned surgical procedure is performed. For TKA, the display 125 can provide additional relevant information about the knee joint, such as data about joint tension (e.g., ligament laxity) and information about joint rotation and alignment. The display 125 can show how the planned implant placement and location will affect the patient when the knee is flexed. The display 125 can show how the use of different implants or the use of the same implant of 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 osteotomy in either a TKA or THA. In a TKA, the CASS 100 can provide robotic control for one or more planned osteotomies. For example, the CASS 100 can only provide robotic control for the initial distal femoral resection, and the surgeon 111 can manually perform other resections (anterior, posterior, and chamfered cuts) using conventional means such as a 4-in-1 cutting guide or clamp 105D.

[0126] The display 125 can use different colors to inform the surgeon of the status of the surgical plan. For example, unremoved bone can be displayed in a first color, removed bone in a second color, and planned removal in a third color. Implants can be superimposed on the bone in the display 125, and the implant color can be changed or correspond to different types or sizes of implants.

[0127] The information and options displayed on monitor 125 can vary depending on the type of surgical procedure being performed. Furthermore, surgeon 111 can request or select a specific surgical workflow display that matches or is consistent with his or her surgical planning preferences. For example, for surgeon 111 who typically performs a tibialis resection before a femoral resection in TKA, monitor 125 and the associated workflow can be adapted to take that preference into account. Surgeon 111 can also pre-select to include or remove certain steps from the standard surgical workflow display. For example, if surgeon 111 uses resection measurements to finalize the implantation plan but does not analyze ligament-space balance when finalizing the implantation plan, the surgical workflow display can be organized into modules, and the surgeon can select which modules to display and the order in which the modules are presented based on the surgeon's preferences or the specific surgical circumstances. For example, modules involving ligament and space balance can include pre- and post-resection ligament / space balance, and surgeon 111 can select which modules to include in their default surgical planning workflow depending on whether such ligament and space balance is performed before or after (or before and after) the osteotomy.

[0128] For more specialized display devices, such as AR HMDs, the surgical computer 150 can use data formats supported by the device to provide images, text, etc. For example, if the display 125 is such as a Microsoft HoloLens... TM Or Magic LeapOne TM If the holographic device is used, the surgical computer 150 can use the HoloLens application programming interface (API) to send commands specifying the location and content of the hologram displayed in the surgeon 111's field of vision.

[0129] In some embodiments, one or more surgical planning models may be incorporated into CASS 100 and used in the development of surgical plans provided to surgeon 111. The term "surgical planning model" refers to software that simulates the biomechanical properties of anatomical structures under various conditions to determine the optimal manner of performing incisions and other surgical activities. For example, for knee replacement surgery, a surgical planning model can measure parameters of functional activities, such as deep knee flexion, gait, etc., and select incision locations on the knee to optimize implant placement. An example of a surgical planning model is LIFEMOD from Smith and Nephew. TM Simulation software. In some embodiments, the surgical computer 150 includes a computational architecture (e.g., a GPU-based parallel processing environment) that allows the full execution of a surgical planning model during surgery. In other embodiments, the surgical computer 150 may be connected via a network to a remote computer that allows such execution, such as a surgical data server 180 (see [link to surgical data server]). Figure 5CAs an alternative to a full execution of the surgical planning model, in some embodiments, a set of transfer functions is derived that simplifies the mathematical operations acquired by the model into one or more predictive equations. These predictive equations are then used instead of performing a full simulation during surgery. Further details regarding the use of transfer functions are described in WIPO Publication No. 2020 / 037308, filed August 19, 2019, entitled “Patient Specific Surgical Method and System,” the entire contents of which are incorporated herein by reference.

[0130] Figure 5B Examples of some types of data that can be provided from the various components of CASS 100 to the surgical computer 150 are shown. In some embodiments, components may stream data to the surgical computer 150 in real time or near real time during surgery. In other embodiments, components may queue data and send it to the surgical computer 150 at set intervals (e.g., per second). 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 common format. In other embodiments, each component may use a different data format, and the surgical computer 150 may be configured with one or more software applications capable of converting the data.

[0131] Typically, the surgical computer 150 can be used 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 actuator platform 105 provides a measurement location to the surgical computer 150. Therefore, by comparing the measurement location with the location initially specified by the surgical computer 150 (see...), the data is collected and analyzed. Figure 5B By comparing these parameters, the surgical computer can identify deviations that occur during the procedure.

[0132] The resection device 110 can send various types of data to the surgical computer 150 depending on the type of device used. Exemplary 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. Exemplary tracking data types include tracked items (e.g., anatomical structures, tools, etc.), ultrasound images, and position values ​​of surface or marker collection points or axes. When the system is operating, the tissue navigation system 120 provides the surgical computer 150 with anatomical locations, shapes, etc.

[0133] While the display 125 is typically used to output data for presentation to a user, it can also provide data to the surgical computer 150. For example, in an embodiment where a monitor is used as part of the display 125, the surgeon 111 can interact with a GUI to provide input, which is then 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, allowing it to update the presented view as needed.

[0134] During the postoperative phase of the care period, various types of data can be collected to quantify the overall improvement or deterioration of the patient's condition as a result of the surgery. Data can take the form of, for example, self-reported information from patients through questionnaires. For instance, in the case of knee replacement surgery, the Oxford Knee Score can be used to measure functional status, and the EQ5D-5L questionnaire can be used to measure postoperative quality of life. Other examples in the case of hip replacement surgery may include the Oxford Hip Score, the Harris Hip Score, and the WOMAC (Western University and McMaster University Osteoarthritis Index). Such questionnaires can be administered, for example, by healthcare professionals directly in a clinical setting, or using mobile applications that allow patients to answer questions directly. In some embodiments, patients may be equipped with one or more wearable devices to collect data related to the surgery. For example, after knee surgery, patients may be equipped with a knee brace that includes sensors for monitoring knee position, flexibility, etc. This information can be collected and transmitted to the patient's mobile device for the surgeon to review in order to assess the surgical outcome and address any issues. In some embodiments, one or more cameras may acquire and record movement of the patient's body parts during designated postoperative activities. This motion can be compared with biomechanical models to better understand the function of the patient's joints, and to better predict rehabilitation progress and identify any necessary corrections.

[0135] 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.

[0136] 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.

[0137] 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 illustrates three additional data sources: patient 160, healthcare professionals 165, and an EMR database 170. Therefore, patient 160 can, for example, use a mobile application to send pre- and post-operative data to surgical data server 180. Healthcare professionals 165 include the surgeon and his or her staff, as well as any other professionals working with patient 160 (e.g., private physicians, rehabilitation specialists, etc.). It should also be noted that the EMR database 170 can be used for pre- and post-operative data. For example, assuming patient 160 has given sufficient permission, surgical data server 180 can collect the patient's pre-operative EMR. Surgical data server 180 can then continue to monitor the EMR for any post-operative updates.

[0138] At surgical data server 180, a nursing period database 185 is used to store various data collected during a patient's nursing period. The nursing 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, where all various data items are structured in a way that allows them to be easily incorporated into two sets of SQL rows and columns. However, in other embodiments, a No-SQL database can be employed to allow unstructured data while providing the ability to process and respond to queries quickly. 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 using column-based data models (e.g., Cassandra), document-based data models (e.g., MongoDB), key-value-based data models (e.g., Redis), and / or graph-based data models (e.g., Allego). The various embodiments described herein can be implemented using any type of No-SQL database, and in some embodiments, different types of databases can support the nursing period database 185.

[0139] Data can be transferred between various data sources and 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 allows for the transfer of data from a data source to the surgical data server 180, as well as the retrieval of data from the surgical data server 180 by the data source. 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.

[0140] In some embodiments, the surgical computer 150 or surgical data server 180 may perform a deidentification process to ensure that data stored in the care period database 185 meets Health Insurance Portability and Accountability Act (HIPAA) standards or other legal requirements. HIPAA provides a list of certain identifiers that must be removed from data during the deidentification process. The aforementioned deidentification process may scan for these identifiers in the data transferred to the care period database 185 for storage. For example, in one embodiment, the surgical computer 150 performs the deidentification process before initially transferring a specific data item or set of data items to the surgical data server 180. In some embodiments, unique identifiers are assigned to data from a specific care period for reidentification if necessary.

[0141] although Figure 5A –5C discusses data collection in the context of a single care period; however, it should be understood that the general concept can be extended to data collection across multiple care periods. For example, surgical data can be collected throughout the care period each time a surgery is performed using the CASS 100 and stored at the surgical computer 150 or surgical data server 180. As explained in further detail below, a robust database of care period data allows for the generation of optimized values, measurements, distances or other parameters, and other recommendations related to the surgical procedure. In some embodiments, various datasets are indexed in a database or other storage medium in a manner that allows for rapid retrieval of relevant information during the surgical procedure. For example, in one embodiment, a patient-centric set of indexes can be used so that data can be easily extracted from a specific patient or a group of patients similar to a specific patient. This concept can be similarly applied to surgeons, implant characteristics, CASS component types, etc.

[0142] Further details regarding the management of care period data are described in U.S. Patent Application No. 62 / 783,858, filed December 21, 2018, entitled “Methods and Systems for Providing an Episode of Care,” the entire contents of which are incorporated herein by reference.

[0143] Open and Closed Digital Ecosystems

[0144] 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 for use within a closed ecosystem, and devices outside the digital ecosystem typically cannot access the data. For example, in some embodiments, each component includes software or firmware implementing proprietary protocols for activities such as communication, storage, and security. The concept of a closed digital ecosystem may be ideal for companies that want to control all components of the CASS 100 to ensure compliance with certain compatibility, security, and reliability standards. For example, the CASS 100 may be designed such that new components cannot be used with the CASS without the company’s certification.

[0145] In other embodiments, CASS 100 is designed as an “open” digital ecosystem. In these embodiments, components can be manufactured by a variety of different companies according to standards for activities such as communication, storage, and security. Therefore, by using these standards, any company is free to build independent, compliant components of the CASS platform. Data can be transferred between components using publicly available application programming interfaces (APIs) and open, shareable data formats.

[0146] To illustrate one type of recommendation that can be performed using CASS 100, a technique for optimizing surgical parameters is disclosed below. In this document, the term "optimization" refers to selecting the optimal parameters based on certain specified criteria. In extreme cases, optimization can refer to selecting the optimal parameters based on data from the entire period of care (including any preoperative data, CASS data status at a given time point, and postoperative goals). Furthermore, historical data can be used to perform optimization, such as data generated during past surgeries involving, for example, the same surgeon, past patients with similar physical characteristics to the current patient, etc.

[0147] Optimized parameters can be dependent on parts of the patient's anatomy to be operated on. For example, for knee surgery, surgical parameters may include positioning information for the femoral and tibial components, including but not limited to rotational alignment (e.g., varus / valgus rotation, external rotation, flexion rotation of the femoral component, posterior tilt angle of the tibial component), resection depth (e.g., varus knee, valgus knee), and the type, size, and location of the implant. Positioning information may also include surgical parameters for combining implants, such as overall limb alignment, combined tibiofemoral hyperextension, and combined tibiofemoral resection. Other examples of parameters that CASS 100 can optimize for a given TKA femoral implant include the following:

[0148]

[0149] Other examples of parameters that CASS 100 can optimize for a given TKA tibial implant include the following:

[0150]

[0151] for

[0152] For hip surgery, surgical parameters may include femoral neck resection location and angle, cup tilt angle, cup anteversion angle, cup depth, femoral stem design, femoral stem size, femoral stem fit within the canal, femoral offset, leg length, and femoral type of implant.

[0153] Shoulder parameters may include, but are not limited to, humeral resection depth / angle, humeral shaft type, humeral deviation, glenoid type and tilt, as well as reverse shoulder parameters, such as humeral resection depth / angle, humeral shaft type, glenoid tilt / type, glenoid ball orientation, glenoid ball deviation and deviation direction.

[0154] Various routine techniques exist for optimizing surgical parameters. However, these techniques typically require extensive computation, thus necessitating preoperative parameter determination. Consequently, surgeons' ability to modify optimized parameters based on potential problems during surgery is limited. Moreover, routine optimization techniques often operate in a "black box" manner, with little or no explanation of the recommended parameter values. Therefore, if a surgeon decides to deviate from the recommended parameter values, they often do so without fully understanding the impact of that deviation on the remainder of the surgical procedure or on the patient's postoperative quality of life.

[0155] Surgical patient care system

[0156] Using the surgical patient care system 620, the general concept of optimization can be extended to the entire period of care. This system uses surgical data, along with other data from the patient 605 and healthcare professionals 630, to optimize outcomes and patient satisfaction, such as... Figure 6 As shown in the image.

[0157] Conventionally, preoperative diagnosis, preoperative surgical planning, intraoperative execution of the established plan, and postoperative management of total joint replacement surgery are all based on individual experience, published literature, and the surgeon's training knowledge base (ultimately, the tribal knowledge of individual surgeons and their peer "networks" and journal publications), as well as their instinct for accurate intraoperative tactile discrimination of "balance" using guidance and visual cues, and accurate manual execution of plane resections. This existing knowledge base and mode of execution are limited in their ability to optimize outcomes for patients requiring care. For example, limitations exist in: accurately diagnosing patients for appropriate, minimally invasive pre-established care; aligning dynamic patient, medical economic, and surgeon preferences with the patient's desired outcome; executing the surgical plan to ensure proper bone alignment and balance, etc.; and receiving data from disconnected sources with varying deviations that are difficult to reconcile into the overall patient framework. Therefore, data-driven tools that more accurately simulate anatomical responses and guide surgical planning can improve existing methods.

[0158] The surgical patient care system 620 is designed to utilize patient-specific data, surgeon data, healthcare institution data, and historical outcome data to develop algorithms that suggest or recommend optimal overall treatment plans for the patient throughout their entire care period (preoperative, intraoperative, and postoperative) based on 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 patient / care provider performance. Once the surgical treatment plan is finalized, the surgical patient care system 620 records the collected data in a historical database. This database is accessible for future patients and for developing future treatment plans. In addition to utilizing statistical and mathematical models, simulation tools (e.g., Based on the preliminary or recommended surgical plan, the outcome, alignment, kinematics, etc., are simulated, and the preliminary or recommended plan is reconfigured according to the patient profile or surgeon's preferences to achieve the desired or optimal outcome. The Surgical Patient Care System 620 ensures that each patient is receiving personalized surgical and rehabilitation care, thereby increasing the chances of successful clinical outcomes and reducing the financial burden on facilities associated with near-term modifications.

[0159] In some embodiments, the surgical patient care system 620 employs a data collection and management approach to provide a detailed surgical case plan, which has different steps monitored and / or performed using CASS 100. User execution is calculated upon completion of each step and used to suggest changes to subsequent steps in 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 may be related to the patient currently receiving treatment or to historical data from patients who have received similar treatment.

[0160] Patient 605 provides inputs such as current patient data 610 and historical patient data 615 to surgical patient care system 620. Various methods generally known in the art can be used to collect such inputs from patient 605. For example, in some embodiments, patient 605 completes a paper or digital survey parsed by surgical patient care system 620 to extract patient data. In other embodiments, surgical patient care system 620 may extract patient data from existing information sources such as electronic medical records (EMRs), health history files, and payer / provider history files. In still other embodiments, surgical patient care system 620 may provide an application programming interface (API) that allows external data sources to push data to the surgical patient care system. For example, patient 605 may have a mobile phone, wearable device, or other mobile device that collects data (e.g., heart rate, pain or discomfort level, exercise or activity level, or patient-submitted responses to any number of preoperative planning criteria or conditional compliance) and provides that data to surgical patient care system 620. Similarly, patient 605 may have a digital application on their mobile or wearable device that can collect data and transmit it to surgical patient care system 620.

[0161] Current patient data 610 may include, but is not limited to: activity level, past medical history, comorbidities, pre-rehabilitation performance, health and fitness level, preoperative expected level (related to hospital, surgery, and rehabilitation), Metropolitan Statistical Area (MSA) driven score, genetic background, previous injuries (sports, trauma, etc.), previous joint replacement surgery, previous trauma surgery, previous sports medicine surgery, treatment of contralateral joints or limbs, gait or biomechanical information (back and ankle tissues), level of pain or discomfort, nursing infrastructure information (payer coverage type, level of home medical infrastructure, etc.), and indications of the expected ideal surgical outcome.

[0162] Historical patient data 615 may include, but is not limited to: activity level, past medical history, comorbidities, pre-rehabilitation performance, health and fitness level, preoperative expected level (related to hospital, surgery, and rehabilitation), MSA-driven score, genetic background, previous injuries (sports, trauma, etc.), previous joint replacement surgery, previous trauma surgery, previous sports medicine surgery, treatment of contralateral joints or limbs, gait or biomechanical information (back and ankle tissues), pain or discomfort level, nursing infrastructure information (payer coverage type, level of home medical infrastructure, etc.), expected desired surgical outcome, actual surgical outcome (patient-reported outcome [PRO], implant survival, pain level, activity level, etc.), size of the implant used, position / orientation / alignment of the implant used, and soft tissue balance achieved, etc.

[0163] The 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 may include, for example, descriptions of known or preferred surgical techniques (e.g., cruciate retention (CR) vs. posterior stabilization (PS), size increase vs. size decrease, with and without a tourniquet, femoral stem style, preferred THA options, etc.), the healthcare professional 630's training level (e.g., years of experience, position trained, place of training, techniques imitated), previous success levels including historical data (outcomes, patient satisfaction), and expected desired outcomes regarding range of motion, recovery days, and device survival. The healthcare professional data 625 can be obtained, for example, through paper or digital surveys provided to the healthcare professional 630, via input from the healthcare professional into a mobile application, or by extracting relevant data from the EMR. Additionally, the CASS 100 can provide data such as profile data (e.g., patient-specific knee device profile) or a historical record describing the use of the CASS during surgery.

[0164] Information related to the facility where the surgery or treatment will be performed can be included in the input data. This data may include, but is not limited to, the following: outpatient surgery center (ASC) vs. hospital, facility trauma level, Joint Replacement Comprehensive Medical Plan (CJR) or bundled candidate, MSA-driven score, community vs. metropolitan, academic vs. non-academic, postoperative network access (skilled care facilities only [SNF], family health, etc.), availability of medical professionals, availability of implants, and availability of surgical equipment.

[0165] These facility inputs can be, for example, but not limited to, surveys (paper / digital), surgical planning tools (e.g., apps, websites, electronic medical records [EMR], etc.), hospital information databases (on the Internet), etc. Input data related to the associated healthcare economics may also be obtained, including but not limited to the patient's socioeconomic profile, the level of reimbursement the patient expects to receive, and whether the treatment is patient-specific.

[0166] These healthcare economic inputs can be obtained (e.g., but not limited to) through surveys (paper / digital), direct payer information, socioeconomic databases (providing postal codes online), etc. Finally, data derived from the simulation of the program is obtained. Simulation inputs include implant size, location, and orientation. Custom or commercially available anatomical modeling software programs (e.g.) can be used. Simulations can be performed using AnyBody or OpenSIM. It should be noted that the above data inputs may not be available for every patient, and the available data will be used to generate the treatment plan.

[0167] 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.

[0168] 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.

[0169] 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.

[0170] In addition to, or as an alternative to, determining implant location, in some embodiments, 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.

[0171] Surgeons may choose to change the surgical case plan at any time before or during surgery. If a surgeon chooses to deviate from the surgical case plan, the size, position, and / or orientation of the changed components are locked, and global optimization (using previously described techniques) is refreshed based on the new size, position, and / or orientation of the components to find new ideal positions for other components, and the corresponding resections required to achieve the new optimized size, position, and / or orientation of the components. For example, if the surgeon determines that the size, position, and / or orientation of the femoral implant in a TKA needs to be updated or modified intraoperatively, the position of the femoral implant will be locked relative to the anatomy, and a new optimal position for the tibia will be calculated (through global optimization) by taking into account the surgeon's changes to the size, position, and / or orientation of the femoral implant. Furthermore, if the surgical system used to perform the case plan is robot-assisted (e.g., using...), Alternatively, a device like MAKO Rio can monitor bone removal and morphology in real time during surgery. If the resection performed during the procedure deviates from the surgical plan, the processor can take the actual resections performed into account to optimize the subsequent placement of additional components.

[0172] Figure 7AThis illustrates how a surgical patient care system 620 can be adapted to perform a case plan matching service. In this example, data related to the current patient 610 is acquired and compared, in whole or in part, with a historical database of patient data and related outcomes 615. For example, the surgeon may choose to compare the current patient's plan with a subset of the historical database. The data in the historical database can be filtered to include, for example, datasets with only good outcomes, datasets corresponding to historical surgeries of patients with profiles identical or similar to the current patient's profile, datasets corresponding to specific surgeons, datasets corresponding to specific elements of the surgical plan (e.g., surgery that preserves only specific ligaments), or any other criteria chosen by the surgeon or medical professional. For example, if the current patient data matches or correlates with data from a previous patient who experienced a good outcome, the previous patient's case plan can be accessed and adapted or adopted for the current patient. Predictive equations can be used in conjunction with intraoperative algorithms that identify or determine actions associated with the case plan. Based on relevant information from the historical database and / or pre-selected information, the intraoperative algorithm determines a set of recommended actions for the surgeon to perform. Each execution of the algorithm generates the next action in the case plan. If the surgeon performs the action, the outcome is evaluated. The results of the surgeon's actions are used to refine and update the inputs to the intraoperative algorithm, which generates the next step in the case plan. Once the case plan has been fully executed, all data related to it (including any deviations by the surgeon from the recommended actions) is stored in a database of historical data. In some embodiments, the system uses preoperative, intraoperative, or postoperative modules in a segmented manner, rather than the entire continuous care. In other words, caregivers can specify any arrangement or combination of treatment modules, including the use of a single module. These concepts are... Figure 7B As shown in the diagram, it can be applied to any type of surgery using CASS100.

[0173] Surgical procedure showed

[0174] As mentioned above Figure 1 and Figures 5A-5CThe various components of the CASS 100 generate detailed data logs during surgery. The CASS 100 can track and record various actions and activities of the surgeon during each step of the surgery and compare the actual activities with the preoperative or intraoperative surgical plan. In some embodiments, software tools can be used to process this data into a format that allows for efficient “replay” of the surgery. For example, in one embodiment, one or more GUIs can be used, displaying all information presented on the display 125 during surgery. This can be supplemented with graphics and images showing data collected by different tools. For example, a GUI providing a visual illustration of the knee during tissue removal can provide measured torque and displacement of the resection equipment adjacent to the visual illustration to better provide an understanding of any deviations that occur from the planned resection area. The ability to review the replay of the surgical plan or switch between different stages of the actual surgery and the surgical plan can benefit surgeons and / or surgical personnel, allowing them to identify any deficiencies or challenging phases of the surgery that can be modified in future surgeries. Similarly, in an academic setting, the aforementioned GUI can be used as a teaching tool to train future surgeons and / or surgical personnel. In addition, because the dataset effectively records many elements of a surgeon's activities, it can also be used as evidence of whether a particular surgical procedure was performed correctly or incorrectly for other reasons (e.g., legal or compliance reasons).

[0175] Over time, as more surgical data is collected, a rich database may be acquired, describing surgical procedures performed by different surgeons on various types of anatomy (knee, shoulder, hip, etc.) for different patients. Furthermore, information such as implant type and size, patient demographics, etc., can be further used to augment the overall dataset. Once the dataset is established, it can be used to train machine learning models (e.g., RNNs) to predict how surgery will proceed based on the current state of CASS 100.

[0176] The training of the machine learning model can be performed as follows. During surgery, the overall state of the CASS 100 can be sampled over multiple time periods. The machine learning model can then be trained to transform the current state of the first time period into future states for different time periods. By analyzing the entire state of the CASS 100 rather than individual data items, any causal effects of interactions between the different components of the CASS 100 can be obtained. In some embodiments, multiple machine learning models can be used instead of a single model. In some embodiments, the machine learning model can be trained not only using the state of the CASS 100, but also using patient data (e.g., obtained from EMR) and the identity of the surgeon. This allows the model to make predictions with greater specificity. Moreover, if needed, it allows surgeons to make predictions selectively based solely on their own surgical experience.

[0177] In some embodiments, predictions or recommendations made by the aforementioned machine learning model can be directly integrated into the surgical procedure. For example, in some embodiments, the surgical computer 150 can execute a machine learning model in the background to make predictions or recommendations for upcoming actions or surgical conditions. Thus, multiple states can be predicted or recommended for each period. For example, the surgical computer 150 can predict or recommend states for the next 5 minutes in 30-second increments. Using this information, the surgeon can utilize a "process display" view of the surgery to allow visualization of future states. For example, Figure 7C A series of images illustrating the implant placement interface are shown and can be displayed to the surgeon. The surgeon can navigate these images, for example, by entering a specific time in the display 125 of the CASS 100 or instructing the system to advance or rewind the display in specific time increments using tactile, verbal, or other commands. In one embodiment, the process display may be presented at the top of the surgeon's field of vision in the 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, allowing the surgeon to see how his or her movements affect other factors of the procedure.

[0178] In some embodiments, instead of simply using the current state of CASS 100 as input to the machine learning model, the model's input can include the planned future state. For example, a surgeon may instruct that he or she is planning to perform a specific bone resection of the knee joint. This instruction can be manually entered into the surgical computer 150, or the surgeon can provide the instruction verbally. The surgical computer 150 can then generate films showing the expected effects of the incision on the surgery. Such films can show, over specific time increments, how the surgery will be affected if the expected procedures are performed, including, for example, changes in patient anatomy, changes in implant position and orientation, and changes in surgical procedures and instruments. Surgeons or medical professionals can recall or request this type of film at any time during the surgery to preview how the expected procedures will affect the surgical plan if the expected procedures are performed.

[0179] It should be further noted that using a well-trained machine learning model and the CASS robot can automate various elements of the surgery, requiring minimal intervention from the surgeon, for example, by providing approval only for each step of the procedure. For instance, over time, robotic control using arms or other means can be gradually integrated into the surgical process, with less manual interaction between the surgeon and the robot's operation. In this case, the machine learning model can learn which robotic commands are needed to achieve certain states of the CASS implementation plan. Ultimately, the machine learning model can be used to generate films or similar views or displays that can predict and preview the entire surgery from its initial state. For example, an initial state including patient information, surgical plan, implant characteristics, and surgeon preferences can be defined. 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 the state of the CASS 100 itself, commands can be derived to control the components of the CASS to achieve each predicted state. Therefore, in extreme cases, the entire surgery can be automated based solely on initial state information.

[0180] High-resolution imaging of critical areas is achieved using a point probe during hip surgery.

[0181] The use of point probes is described in U.S. Patent Application No. 14 / 955,742, entitled "Systems and Methods for Planning and Performing Image-Free Implant Revision Surgery," the entire contents of which are incorporated herein by reference. In short, optically tracked point probes can be used to map the actual surface of the target bone where a new implant is needed. Mapping is performed after the removal of defective or worn implants, and after the removal of any diseased or otherwise unwanted bone. Multiple points can be collected on the bone surface by brushing or scraping the remaining bone with the tip of the point probe. This is called tracking or "mapping" 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 the basis for planning the surgery and determining the necessary implant dimensions. Alternative techniques for determining 3D models using X-rays are described in U.S. Patent Application No. 16 / 387,151, filed April 17, 2019, entitled "Three-Dimensional Selective Bone Matching," and U.S. Patent Application No. 16 / 789,930, filed February 13, 2020, entitled "Three-Dimensional Selective Bone Matching," the entire contents of each of which are incorporated herein by reference.

[0182] 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 allows the surgeon to obtain a detailed view before initiating reaming. For example, in one embodiment, the point probe can be used to identify the floor (fossa) of the acetabulum. 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 destroying the medial wall. If the medial wall is unintentionally damaged, the surgery will require additional bone grafting steps. 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 tactile feedback to the surgeon when the surgeon reaches the floor or otherwise deviates from the surgical plan. Alternatively, the CASS100 can automatically stop the reamer when the floor is reached or when the reamer is within a threshold distance.

[0183] 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 drawn and registered to the preoperative 3D model, the thickness can be easily estimated by comparing the position of the acetabular surface with that of the medial wall. Using this knowledge, the CASS100 can provide alerts or other responses in case any surgical activity during reaming is anticipated to protrude through the acetabular wall.

[0184] Point probes can also be used to collect high-resolution data of common reference points used when orienting a 3D model to a patient. For example, for pelvic plane landmarks like the ASIS and pubic symphysis, surgeons can use point probes to map the bone to represent the actual pelvic plane. With a more complete view of these landmarks, the registration software will have more information to orient the 3D model.

[0185] Point probes can also be used to collect high-resolution data describing proximal femoral 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 commonly used as a reference point for aligning the femoral components during hip replacement surgery. Alignment height depends on the correct location of the GT; therefore, in some embodiments, point probes are 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) may be useful. For example, during hip replacement surgery, Dorr classification helps to select the trunk that will maximize the ability to achieve compression fit during surgery, thereby preventing micromovement of the femoral components postoperatively and ensuring optimal bone ingrowth. As understood in the art, Dorr classification measures the ratio between the canal width at the LT and the canal width 10 cm below the LT. The accuracy of classification is highly dependent on the correct location of the relevant anatomical structures. Therefore, mapping the LT to provide a high-resolution view of the area may be advantageous.

[0186] In some embodiments, a point probe is used to map the femoral neck to provide high-resolution data, allowing surgeons to better understand where to make the neck incision. A navigation system can then guide the surgeon as they make the neck incision. For example, as understood in the art, the femoral neck angle is measured by placing a line below the center of the femoral stem and a second line below the center of the femoral neck. Therefore, a high-resolution view of the femoral neck (and possibly the femoral stem) will provide a more accurate calculation of the femoral neck angle.

[0187] High-resolution femoral head and neck data can also be used to navigate resurfacing procedures, where software / hardware assists the surgeon in preparing the proximal femur and placing femoral components. As is generally understood in the art, during hip resurfacing, the femoral head and neck are not removed; instead, the head is trimmed and covered with a smooth metal cap. In this case, it is advantageous for the surgeon to map the femur and cap, allowing for a precise assessment of their respective geometries and its use to guide the trimming and placement of femoral components.

[0188] Preoperative data was registered to the patient's anatomical structures using a point probe.

[0189] As described above, in some embodiments, a 3D model is developed based on 2D or 3D images of the anatomical region of interest during the preoperative phase. In such embodiments, registration between the 3D model and the surgical site is performed prior to the surgical procedure. The registered 3D model can be used to track and measure the patient's anatomy and surgical instruments during surgery.

[0190] During the surgical procedure, landmarks are acquired to facilitate the registration of the preoperative 3D model to the patient's anatomy. For knee surgery, these points may include the femoral head center, distal femoral axis, medial and lateral epicondyles, medial and lateral malleoli, proximal tibial mechanical axis, and tibial A / P direction. For hip surgery, these points may include the anterior superior iliac spine (ASIS), pubic symphysis, points along the acetabular rim and within the hemisphere, greater trochanter (GT), and lesser trochanter (LT).

[0191] In revision surgery, the surgeon may map certain areas containing anatomical defects to better visualize and navigate implant insertion. These defects can be identified based on analysis of preoperative images. For example, in one embodiment, each preoperative image is compared to a library of images showing “healthy” anatomy (i.e., defect-free). Any significant deviation between the patient image and the healthy image can be flagged as a potential defect. During surgery, the surgeon can then be alerted to the potential defect via a visual alert on the CASS 100’s display 125. The surgeon can then map the area to provide the surgical computer 150 with more detailed information about the potential defect.

[0192] In some embodiments, surgeons may use non-contact methods to register incisions within the bone anatomy. For example, in one embodiment, laser scanning is used for registration. A laser strip is projected onto the anatomical region of interest, and changes in the height of that region are detected as changes in the line. Other non-contact optical methods, such as white light interferometry or ultrasound, may also be used alternatively for surface height measurement or registration of anatomical structures. For example, ultrasound may be beneficial where soft tissue exists between the registration point and the bone being registered (e.g., ASIS, pubic symphysis in hip surgery), providing a more precise definition of the anatomical plane.

[0193] Trial guidance system for joint revision surgery

[0194] As discussed herein, during certain surgical procedures, 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. Furthermore, once a component is implanted (e.g., by attaching a stem to a femoral or tibial implant), conventional implantation systems can utilize the IM canal as the primary fixation and / or attachment mode. As already discussed, when using implants containing a stem, the stem can typically restrict the implant's position relative to the natural anatomy in several degrees of freedom, namely flexion / extension rotation, varus / valgus rotation, and potential M / L and A / P positions. In some embodiments, known factors regarding existing components can be used to obtain a more accurate estimate of the size, shape, etc., of the selected implant (e.g., the stem).

[0195] Therefore, if CASS is used, the surgical plan and / or IM tube information can be known to one or more navigation systems. Furthermore, the collected information (e.g., surgical plan, patient information, etc.) can be used and / or supplemented by the CASS system during implantation site planning. Currently, most revision TKA procedures are performed using manual instruments and / or planning tools. Typically, when using manual instruments, the workflow includes removing the primary implant, reaming the IM tube (e.g., using a gradually increasing reamer diameter until contact with the cortical bone), and referencing the reamer axis to guide the positioning of the cutting guide. The cutting plane is typically defined relative to the IM tube.

[0196] Figure 8AThis is a perspective view of an illustrative test guide 800 used in a primary knee revision surgery procedure. Once the previously implanted distal femoral implant has been removed, the test guide 800 can be placed on the patient's femur. Generally, the primary test procedure also requires longitudinal drilling into the intramedullary canal of a pre-existing or concurrently formed hole to allow for reaming and insertion of a stalk from the revision implant. The test guide 800 includes a body 802, a movable distal spacer 804 movably coupled to the body 802, and a movable posterior spacer 806 movably coupled to the body 802. The distal spacer 804 and the posterior spacer 806 are generally orthogonal along their axes of travel, with the distal spacer 804 moving distally approximately along the axis of the femur and the posterior spacer 806 moving posteriorly. By making the distal spacer 804 and the posterior spacer 806 movable, these spacers can be adjusted relative to the body 802 to measure the appropriate spacing of the final prosthesis to be implanted to balance the knee joint. Specifically, translation of the distal spacer 804 defines a measurable extension space 805, while translation of the posterior spacer defines a flexion space 807, which can also be measured once the test guide is adjusted. The extension space 805 is driven by the femoral position distal to the tibial tray / insertion. Similarly, when the knee is flexed, the flexion space 807 is defined by the distance between the femur and the tibial tray.

[0197] In some embodiments, the distal spacer 804 and the rear spacer 806 are manually adjusted in a similar manner. A post 808 positions the distal spacer 804 distally / proximally, while a post 810 positions the rear spacer 806 frontally / rearly. The method of actuating these posts can be any suitable mechanism known in the art. For example, post 808 can be actuated by an adjusting knob 812 coupled to a rack and pinion, worm gear, or lead screw. Once adjustment is complete, a locking knob 814 can be engaged to lock the distal spacer 804 in place. Similarly, post 810 can be actuated by a similar adjusting knob 816 and locked by a locking knob 818.

[0198] The movable handle adapter 820 is movably coupled to the body 802 to allow for back-and-forth adjustment of the test handle for insertion into a hole in the intramedullary canal of the femur. This movement allows the movable handle adapter 820 (and any test handle coupled thereto) to be manipulated to a position near a predetermined point between the body 802 and the posterior spacer 806, and then adjusted to account for a specific position of the hole entering the intramedullary cavity, which may deviate from the predetermined ideal position of the hole.

[0199] During a normal trial insertion, adjustments are made based on the fixed position of the longitudinal hole entering the intramedullary canal (which may be pre-existing or drilled during the trial insertion). The movable shank adapter 820 is adjusted (including selecting a suitable offset connector and rotating it to achieve an acceptable offset between the body 802 and the shank) so that the body 802 is approximately positioned as desired. The shank is then inserted into the intramedullary canal. The shank offset can then be adjusted to achieve the final desired placement of the body 802. The distal spacer 804 and the posterior spacer 806 can be adjusted in both extended and flexed knee positions to achieve a balanced spacing, thereby determining the appropriate implant size. The surgeon, CASS, or a combination thereof can then determine the shank-body offset and implant size, and the surgical plan can then be updated to identify the geometry of the revision prosthesis to be implanted and any revision resections required to achieve the desired placement of the prosthesis.

[0200] In some embodiments, the test guide 800 is designed to work seamlessly with the CASS 100 and may include one or more reference tracking arrays, such as a tracking array 824 fixed to the body 802 at attachment point 822. Once the exact location and orientation of the body 802 are known, prior knowledge of the geometry of the test guide 800 allows for tracking of the extension space 805 and the buckling space 807 by fixing one or more reference marks 826 to the distal spacer 804 and one or more reference marks 828 to the posterior spacer 806. The extension space 805 and the buckling space 807 define the dimensional requirements of the prosthesis to be implanted, and these spaces should be balanced so that, once implanted, the medial and lateral compartmental gaps of the prosthesis will be consistent throughout the range of motion.

[0201] Figure 8BThis is another view of the trial guide 800, depicting the illustrative placement of reference markers, thereby allowing seamless integration of the trial guide into the surgical workflow using the CASS 100's vision system. In this example, the tracking array 824 includes at least three reference markers (with additional markers that provide extra robustness in determining posture) to allow the vision system to determine a specific posture (position and orientation) of the subject 802. This allows the surgical system to update a 3D model of the surgical scene to include the position and orientation of the trial guide 800 relative to the reference markers indicating the posture of the patient's femur. This allows all measurements performed using the trial guide 800 to be stored in the surgical system in a manner that allows CASS to generate a surgical plan based on said measurements. These specific measurements may include relative offsets in the position or orientation of the extension space 805, the flexion space 807, and the stem inserted into the intramedullary canal of the femur, as discussed below. Based on these measurements and the posture of the subject 802 relative to the patient's femoral reference frame, CASS can create a surgical plan to determine the specific treatment resections and reaming required to complete a successful revision joint replacement. Additionally, CASS can determine the appropriate revision implant for the patient. In some embodiments, once the test guide has been adjusted, the surgeon can use a hand tool with reference markings to register the position of each relevant component of the test guide 800 to mark the position of these components.

[0202] Figure 9 This is a perspective view of the test guide 800 used in conjunction with a test handle 830 and a screwdriver tool 832, such as a hexagonal screwdriver (the patient's bone and tissue are not depicted for illustrative purposes). The test guide 800 is positioned on the distal end of the patient's femur by inserting the removable test handle 830 into an existing or simultaneously formed hole through the distal end into the intramedullary canal of the femur. The manual (or automatic) screwdriver tool 832 can be used to adjust the test handle 830 to ensure proper positioning relative to the body 802. When used with an offset connector, proper positioning can produce an anterior / posterior offset of the movable handle adapter 820 and may produce an arcuate rotation of the test handle 830 relative to the movable handle adapter 820. In some embodiments, the body 802 may be secured to the anterior end of the distal femur using temporary pins or screws, which, for revision procedures, will have a generally flat surface of the previously resected area.

[0203] Figure 10This is a side view of the test guide 800, showing the connection between the test handle and the movable handle adapter 820. In this example, an offset handle connector 836 is selected. The offset handle connector 836 can be used when the center of the hole entering the intramedullary cavity is not aligned with the intended lateral placement of the hole. By using the offset handle connector 836, the test handle 830 can be rotated in an arc relative to the position of the movable handle adapter 820, thereby allowing a limited range of lateral movement while allowing for forward / backward adjustment by moving the position of the movable handle adapter 820 relative to the body 802. In some embodiments, multiple connectors, such as the offset handle connector 836, are provided to the surgeon in the kit along with the test guide 800 and the test handle 830. This allows the surgeon to select an appropriate offset for the connector from zero to a distance that will cover all reasonable cases. In some embodiments, selecting the offset connector 836 includes multiple offset angles between the handle adapter 820 and the test handle 830, thereby allowing the two components to be decoupled from parallel by selecting an appropriate offset connector.

[0204] In some embodiments, the prosthesis for implantation may be selected to include a stalk having both translational offset and angular offset from a predetermined point on the dorsal side of the articulation surface. By selecting both angular offset and translational offset for the implant, this allows the implant stalk to align with the reamer entering the intramedullary canal without limiting the position and orientation of the implant's articulation surface. Figure 10 The example shown illustrates an offset handle connector 836 with a translational offset between an offset handle adapter 820 and a handle 830, but without an angle between these components. This allows for forward / backward and inward / outward translation of the handle 830 by translating the offset handle adapter 820 forward / backward relative to the body 802 and by rotating the offset handle connector 836. Some embodiments utilize an offset handle connector 836 with a fixed translational offset (e.g., Figure 10(as shown in the diagram) and a fixed angular offset that introduces an angular offset between the handle adapter 820 and the test handle 830. Any orientation offset between the test handle 830 and the body 802 can be achieved by selecting the correct angular and translational offset for the offset handle connector 836. Once the appropriate orientation offset of the body 802 has been achieved, the selection of the offset handle connector 836, the translation of the handle adapter 820, and the rotation of the offset handle connector 836 relative to the handle adapter 820 can be recorded and used by CASS to select an implant with appropriate translational and angular offsets between the handle and the hinge surface. The extension space 805 and the buckling space 807, determined by the movement of the spacers 804 and 806, can be used to select the appropriate dimensions of the hinge surface of the implant. An exemplary implant with angular and translational offset between the articulated surface and the stem is described in international patent application number PCT / US2020 / 044273, filed on July 30, 2020, entitled “Orthopaedic Implant”, which is incorporated herein by reference in its entirety.

[0205] In some embodiments, the surgeon can adjust the spacers 804 / 806, the step adapter 820, and the offset handle connector 836 to achieve a suitable orientation of the body 802. For example, the surgeon can translate the spacers 804 and / or 806 relative to the body 802 to indicate an appropriate size for the implant. In another example, the surgeon can translate the handle adapter 820 relative to the body to achieve a suitable front-to-back alignment between the hinge surface and the test handle 830. In another example, the surgeon can rotate the offset handle connector 836 to achieve a suitable lateral offset between the hinge surface and the test handle 830. In some embodiments, the surgeon can test multiple offset handle connectors 836 to achieve the desired lateral and / or angular offset. For example, the surgeon can apply a first offset handle connector 836 and then exchange the first offset handle connector 836 for a second offset handle connector 836 with a different offset distance to adjust the lateral offset. In another example, the surgeon may apply a first offset handle connector 836 and then exchange the first offset handle connector 836 for a second offset handle connector 836 with a different offset angle to adjust the offset angle. A series of adjustments and / or exchanges may be performed until the surgeon is satisfied with the attitude offset of the body 802 relative to the test handle 830.

[0206] Once the surgeon has determined the postural offset, various parameters can be recorded manually or by the CASS, including the spacing of spacers 804 / 806, the translation of the handle adapter 820, the selection of the offset handle connector 836, and the rotation of the offset handle connector 836. In some embodiments, the surgeon may provide input to the CASS (e.g., button input, voice command input, and / or gesture input) to trigger recording upon achieving the postural offset. In some embodiments, the CASS's tracking system may use a tracking array and a reference to evaluate the posture of the articulated surface relative to the test handle 830 and / or the position of the spacers 804 / 806 relative to the body 802. In some embodiments, the CASS may select an implant with an appropriate size and / or with appropriate translational and angular offsets between the handle and the articulated surface based on the recorded parameters.

[0207] Figure 11 This is another perspective view of the test guide 800, illustrating an exemplary means by which a surgeon can rotatably adjust the test handle (e.g., test handle 530) relative to the test guide body 802 using a tool (e.g., a screwdriver tool 832). An adjustment coupling 840 is positioned at the top of the movable handle adapter 820. In some embodiments, this is simply a through-hole allowing a tool to be inserted through the movable handle adapter 820 to engage a suitable interface of the test handle or offset handle coupling 836. For example, the offset handle coupling 836 may include a hexagonal, Phillips, or star-shaped head that allows the offset handle coupling 836 to rotate relative to the movable handle adapter 820. This allows the surgeon to adjust the position of the movable handle adapter 820 relative to the body 802 before and after surgery, while adjusting the rotation of the offset handle connector 836 to position the test handle at any location within an elongated defining region defined by a usable linear translation of the handle adapter 820 relative to the test handle 830 and a usable rotational arc of the handle adapter 820 defined by the geometry of the selected offset connector 836.

[0208] In some embodiments, the adjusting connector 840 includes a hexagonal, cross-shaped, or star-shaped head rigidly fixed to (or integrated into) the movable handle adapter 820 to allow rotation of the cylindrical portion of the movable handle adapter 820 relative to the carrier portion. In this embodiment, the movable handle adapter 820 includes two main components: a carrier portion movably fitted to the body 802, traveling forward or backward, and capturing a rotating portion with an elongated body (a precisely elongated shape with any suitable profile, such as a cylinder rotatable relative to the carrier) to alter the rotation of the offset handle connector 836 mounted to the movable handle adapter 820 (this rotation is performed under tool control via a hexagonal, cross-shaped, star-shaped, etc., head). This simplifies the interface between the movable handle adapter 820 and the offset handle connector 836. For example, the offset handle connector 836 can be simply locked onto the rotatable cylindrical portion of the movable handle adapter 820. In some other embodiments, the movable handle adapter 820 is monolithic or rigid, and the offset handle connector 836 is attached to the base of the movable handle adapter 820 but rotates freely relative to it when driven by the tool.

[0209] Figure 12A and Figure 12B The movable handle adapter 820 is shown to be used to measure the extension space 805, the flexion space 807, and the offset of the test handle relative to the body 802 (once properly adjusted). These measurements can be used to determine the final surgical plan for supplementary resection and final enlargement of the test handle to receive the final implant. Figure 12A This is a perspective view showing various measurement scales that can be used by a surgeon to visually indicate the measurements of extension space 805 and flexion space 807. In some embodiments, a CASS vision system (e.g., via...) can be used. Figure 5B These measurements are performed automatically; however, finer measurements can be taken using a direct scale indicator, which allows the surgeon to view the readings and manually update the measurements to the CASS. The extension space 805 can be measured using a telescopic scale 842. The telescopic scale 842 may include markings etched or painted along a visual window / opening that aligns with the base of the column 808. Figure 8A Reference marks in the base of column 808 (or, in embodiments where locking knob 814 moves with column 808), aligned with the numbering of telescopic scale 842, indicate a specific telescopic scale 842 (in millimeters or fractions thereof, or any suitable unit). Thus, during the trial procedure, the surgeon can adjust the extension of column 808 to engage the distal spacer 804 in place and then visually read the precise amount of the extended gap using telescopic scale 842. This can then be used to supplement any measurements taken using the visual system of CASS 100.

[0210] The flexure clearance (or femoral size) can be determined in a similar manner. A femoral size scale 844 can be etched into or painted onto the distal spacer 804 (in embodiments where the distal spacer 804 substantially covers the entire top of the body 802) or onto the top or side of the body 802. When the surgeon adjusts the posterior extension of the column 810, a visual reference mark moving with the column can be read relative to the femoral size scale 844 to indicate the posterior extension of the posterior spacer 806 (in millimeters or fractions thereof, or any suitable unit).

[0211] Additional femoral size selector markings 846 are etched or painted into the distal spacer 804 or body 802. For example... Figure 12B As shown, these femoral size selector marks 846 are used to identify appropriate offset measurements on the handle carrier 848 (or approximately the top of the movable handle adapter 820). When the movable handle adapter 820 has been moved into position to position the body relative to the test handle as needed, the surgeon can view the handle offset scale 850 on top of the handle carrier 848 or the movable handle adapter 820. In some embodiments, the handle offset scale 850 includes a plurality of additionally painted marks aligned in a row with appropriate marks indicating the size of the femur in the femoral size selector marks 846 (which can be determined according to the femoral size scale 844). This allows the handle offset to be centered between the face of the body 802 and the face of the posterior spacer 806.

[0212] In some embodiments, the movable handle adapter 820 can be manually moved (e.g., by manually moving the test handle 830) before insertion into the patient during trial fitting. However, in some embodiments, the adjustable handle carrier 848 can be adjusted via a lead screw. Figure 13A and 13B An exemplary embodiment illustrating this is depicted (for illustrative purposes, the distal spacer 804 is depicted as partially transparent herein). Figure 13A In this design, the test guide 800 includes a lead screw 854 that can be adjusted via the surface of the body 802. For example, the end of the lead screw 854 may have a hexagonal, Phillips, or star-shaped head that can be adjusted using a corresponding screwdriver. Figure 13BAs shown, a lead screw 854 passes through the top portion of the body 802 to engage the threaded portion 856 of the adjustable handle carrier 848. By rotating the lead screw 854, the threaded portion 856 moves the adjustable handle carrier 848 forward or backward until the adjustable handle carrier (and by extending the test handle 830) is properly positioned. This adjustment can be combined with rotation of the offset handle connector 836 to fully adjust the test handle 830. As described above, different offset amounts can be selected (e.g., by selecting one of several offset connectors provided in the revision test kit) to define the range of areas where the test handle 830 can be adjusted for the test kit. Both the forward / rear position of the top portion of the offset connector and the rotation of the offset connector 836 can be adjusted to select the ideal test handle placement, which can then be provided to the CASS to update the surgical plan, thereby selecting and facilitating the revision of the plan.

[0213] Figures 14A-14B and Figure 15 An alternative embodiment that does not require an offset coupling is shown (the distal spacer 804 is depicted as partially transparent herein for illustrative purposes). The modified adjustable handle carrier 858 includes a stepped disc-shaped recess for receiving a carrier insert 860. The carrier insert 860 includes a disc-shaped cam 862 for receiving an offset coupling member 864. The coupling member 864 includes a face with a quincunx / star, cross, or hexagonal head, a shaft 866, and two or more locking tabs 868 for locking the shaft 866 into a handle adapter 870. The handle adapter 870 includes a slotted recess into which the shaft and tabs of the coupling member 864 can be inserted, the slotted recess terminating with a circumferential keyway to lock the locking tabs 868 into place when the shaft 866 is rotated after being inserted into the recess. This rigidly connects the handle coupling member 870 to the carrier insert 860 in an eccentric manner (based on the offset of the coupling member 864 within the disc cam 862). In some embodiments, different carrier inserts 860 with different offsets can be provided in the kit, thereby allowing the surgeon to select various offsets for the handle coupling member 870. This allows for greater freedom in selecting lateral balance and the placement of the test handle. In these embodiments, the disc cam 862 can be effectively used as an offset coupling.

[0214] like Figure 15 As shown, as Figure 13BThe lead screw 854 shown can be used to adjust the forward and backward placement of the adjustable handle carrier 858. Precise placement of the test handle can be achieved by adjusting the specific rotation of the carrier insert 860. In some embodiments, an indicator 872 can be etched into or painted onto the surface of the carrier insert 862 to indicate the adjusted angular placement of the test handle, while forward / backward placement indicators can be etched into or painted onto the threaded portion 874 of the adjustable handle carrier 858, which is controlled by rotating the lead screw 854.

[0215] It should be noted that in various embodiments, an additional indicator (e.g., indicator 872) may be applied to one embodiment to display the angular orientation of the test handle once the test guide has been adjusted. Thus, the surgeon is able to obtain precise measurements of the extension gap and posterior gap, the posterior offset of the test handle, and the angular offset of any offset connector of the test handle. In various embodiments, any of these measurements may be determined optically by CASS or by the surgeon's reading. In some embodiments, the test guide may include an active component, such as a sensor, that automatically identifies distance and measurements and reports this information to CASS. It should also be noted that the test guide 800 may be integrated into the CASS workflow and controlled by CASS in a manner similar to... Figure 1 The cutting guide 105D is used in this way.

[0216] Figure 16 This is a block diagram of an exemplary data processing system 1600 in which embodiments of the invention are implemented. The data processing system 1600 is an example of a computer, such as a server or client, in which computer-usable code or instructions for implementing processes of exemplary embodiments of the invention are located. In some embodiments, the data processing system 1600 may be a server computing device. For example, the data processing system 1600 may be implemented in a server or another similar computing device operatively connected to the surgical system 100 as described above. The data processing system 1600 may be configured, for example, to transmit and receive patient-related information and / or surgical plans associated with the surgical system 100.

[0217] In the depicted example, the data processing system 1600 may employ a hub architecture including a northbridge and memory controller hub (NB / MCH) 1601 and a southbridge and input / output (I / O) controller hub (SB / ICH) 1602. A processing unit 1603, main memory 1604, and graphics processor 1605 may be connected to the NB / MCH 1601. The graphics processor 1605 may be connected to the NB / MCH 1601 via, for example, an Accelerated Graphics Port (AGP).

[0218] In the depicted example, network adapter 1606 is connected to SB / ICH 1602. Audio adapter 1607, keyboard and mouse adapter 1608, modem 1609, read-only memory (ROM) 1610, hard disk drive (HDD) 1611, optical drive (e.g., CD or DVD) 1612, Universal Serial Bus (USB) port and other communication ports 1613, and PCI / PCIe device 1614 can be connected to SB / ICH 1602 via bus system 1616. PCI / PCIe device 1614 may include Ethernet adapters, add-in cards, and PC cards for laptops. ROM 1610 may be, for example, a flash-based basic input / output system (BIOS). HDD 1611 and optical drive 1612 can use Integrated Drive Electronics (IDE) or Serial Advanced Technology Attachment (SATA) interfaces. Super I / O (SIO) device 1615 can be connected to SB / ICH 1602.

[0219] An operating system can run on the processing unit 1603. The operating system can coordinate and provide control over the various components within the data processing system 1600. As a client, the operating system can be a commercially available operating system. An object-oriented programming system, such as the Java™ programming system, can run alongside the operating system and make calls to the operating system from object-oriented programs or applications executing on the data processing system 1600. As a server, the data processing system 1600 can run an advanced interactive executive operating system or a Linux operating system. eServerTM The data processing system 1600 can be a symmetric multiprocessor (SMP) system, which may include multiple processors in the processing unit 1603. Alternatively, a single-processor system may be used.

[0220] Instructions for operating systems, object-oriented programming systems, and applications or programs reside on a storage device such as HDD 1611 and are loaded into main memory 1604 for execution by processing unit 1603. The processes described in the embodiments herein can be executed by processing unit 1603 using computer-usable program code, which may reside in memory such as main memory 1604, ROM 1610, or in one or more peripheral devices.

[0221] The bus system 1616 may consist of one or more buses. The bus system 1616 can be implemented using any type of communication construct or architecture that can provide data transmission between different components or devices attached to that construct or architecture. Communication units such as modem 1609 or network adapter 1606 may include one or more devices for transmitting and receiving data.

[0222] Those skilled in the art will understand that Figure 16 The hardware depicted can vary depending on the implementation. Other internal hardware or peripheral devices, such as flash memory, equivalent non-volatile memory, or optical disc drives, can be used in addition to or in place of the hardware shown. Furthermore, the data processing system 1600 can take the form of any of many different data processing systems, including but not limited to client computing devices, server computing devices, tablet computers, laptop computers, telephones or other communication devices, personal digital assistants, and so on. Essentially, the data processing system 1600 can be any known or subsequently developed data processing system, without architectural limitations.

[0223] While various exemplary embodiments incorporating the principles of this teaching have been disclosed, this teaching is not limited to the disclosed embodiments. Rather, this application is intended to cover any variations, uses, or modifications of this teaching and its general principles. Furthermore, this application is intended to cover deviations from this disclosure that fall within the scope of known or customary practices in the field to which these teachings pertain.

[0224] In the above detailed description, reference is made to the accompanying drawings, which form a part thereof. In the drawings, like symbols generally identify like parts unless the context otherwise requires. The illustrative embodiments described in this disclosure are not intended to be limiting. Other embodiments may be used, and other changes may be made without departing from the spirit or scope of the subject matter presented herein. It will be readily understood that various features of this disclosure (as generally described herein and illustrated in the accompanying drawings) may be arranged, replaced, combined, separated, and designed into a wide variety of different configurations, all of which are expressly contemplated herein.

[0225] This disclosure is not limited to the specific embodiments described herein, which are intended as illustrations of various features. Many modifications and variations can be made without departing from the spirit and scope that will be apparent to those skilled in the art. Functionally equivalent methods and apparatuses within the scope of this disclosure (in addition to those listed herein) will be apparent to those skilled in the art based on the foregoing description. It should also be understood that the terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting.

[0226] Regarding the use of virtually any plural and / or singular terms in this document, those skilled in the art may, at their discretion, convert from plural to singular and / or from singular to plural depending on the context and / or application. For clarity, various singular / plural permutations are explicitly described herein.

[0227] Those skilled in the art will understand that, in general, the terms used herein are intended to be “open-ended” terms (e.g., the term “comprising” should be interpreted as “including but not limited to”, the term “having” should be interpreted as “having at least”, the term “including” should be interpreted as “including but not limited to”, etc.). While various compositions, methods, and apparatuses are described as “comprising” individual components or steps (interpreted as meaning “including but not limited to”), compositions, methods, and apparatuses may also be “substantially composed of individual components and steps” or “consisting of individual components and steps,” and such terms should be interpreted as defining a substantially closed group of components.

[0228] Furthermore, even when a specific number is explicitly stated, those skilled in the art will recognize that such a statement should be interpreted as referring to at least the stated number (e.g., stating "two narratives" without other modifiers means at least two narratives or two or more narratives). Additionally, in cases where terms like "at least one of A, B, and C" are used, this construction is generally intended for those skilled in the art to understand the meaning of the term (e.g., "a system having at least one of A, B, and C" includes, but is not limited to, systems having only A, only B, only C, A and B together, A and C together, B and C together, and / or A, B, and C together, etc.). In cases where terms like "at least one of A, B, or C" are used, this construction is generally intended for those skilled in the art to understand the meaning of the term (e.g., "a system having at least one of A, B, or C" includes, but is not limited to, systems having only A, only B, only C, A and B together, A and C together, B and C together, and / or A, B, and C together, etc.). Those skilled in the art will also understand that virtually any transition words and / or phrases presenting two or more alternative terms, whether in the specification, sample embodiments, or drawings, should be understood to account for the possibility of including one, any one, or both of the terms. For example, the phrase "A or B" will be understood to include the possibility of including "A" or "B" or "A and B".

[0229] Furthermore, in the context of the features of this disclosure being described in accordance with the Markush Group, those skilled in the art will recognize that this disclosure is also based on any individual member of the Markush Group or a subgroup of its members.

[0230] Those skilled in the art will understand that, for any and all purposes, such as for providing a written description, all scopes disclosed herein also cover any possible subscopes and all possible combinations of subscopes and their subscopes. Any listed scope can be readily considered sufficiently descriptive and realized by decomposition into at least equal halves, thirds, quarters, fifths, tenths, etc. As a non-limiting example, each scope discussed herein can be readily decomposed into a lower third, a middle third, and an upper third, etc. Those skilled in the art will also understand that all language such as “up to,” “at least,” etc., includes the stated number and refers to a scope that can subsequently be decomposed into subscopes as described above. Finally, those skilled in the art will understand that a scope includes each individual member. Thus, for example, a group having 1-3 cells means a group having 1, 2, or 3 cells. Similarly, a group having 1-5 cells means a group having 1, 2, 3, 4, or 5 cells, and so on.

[0231] As used herein, the term "about" refers to a change in a numerical quantity that can occur, for example, through measurement or processing procedures in the real world, through unintentional errors in these procedures, through differences in the manufacture, origin, or purity of the composition or reagent, etc. Generally, the term "about" as used herein refers to a value or range of values ​​that is greater than or less than 1 / 10 (e.g., ±10%) of the stated value. The term "about" also refers to variations that will be understood by those skilled in the art as equivalents, provided that such variations do not contain values ​​known in prior art practice. Each value or range of values ​​following the term "about" is also intended to cover embodiments of the absolute value or range of values. Whether or not modified by the term "about," numerical values ​​referenced in this disclosure include equivalents to the referenced values, such as possible numerical variations of such values, but those skilled in the art will recognize the equivalents.

[0232] The various features and functions disclosed above, as well as their alternatives, can be combined into many other different systems or applications. Those skilled in the art can then make various currently unforeseen or unintended alternatives, modifications, variations, or improvements, each of which is also intended to be covered by the disclosed embodiments.

Claims

1. A trial guidance system for planning a patient's joint replacement revision surgery, the trial guidance system comprising: A body having a hinged surface, a rear surface substantially orthogonal to the hinged surface, and a body tracker array, wherein the body is configured to connect to the resected end surface of the bone of the joint; A test handle having a longitudinal axis, wherein the test handle is configured to be received through a longitudinal hole in the bone and received into the intramedullary canal of the bone; A handle adapter that attaches the test handle to the body opposite to the hinge surface, wherein the handle adapter is configured to translate relative to the rear surface of the body to adjust the front-to-back alignment of the test handle with the hinge surface; One or more offset connectors, said one or more offset connectors being configured to engage the handle adapter to the test handle, each offset connector being configured to adjust at least one of the following: The lateral alignment of the test handle and the hinged surface, and The angular offset between the longitudinal axis of the test handle and the hinge surface; A patient tracker array configured to be coupled to the bone; A tracking system comprising one or more sensors configured to detect the position and orientation of each of the subject tracker array and the patient tracker array; processor; as well as A non-transitory computer-readable medium storing instructions that, when executed, cause the processor to: When a selected offset connector in one or more of the offset connectors is combined with the handle adapter and the test handle, it receives the position and orientation of each of the main tracker array and the patient tracker array. The geometry between the test handle and the body is determined based on the positions of the main body tracker array and the patient tracker array. A surgical plan, including the selected revision implant, is generated based on the geometry between the test handle and the body.

2. The test guide system of claim 1, wherein the selected offset connector is selected from the one or more offset connectors based on at least one of the lateral alignment and the angular offset.

3. The test guide system according to any one of claims 1-2, wherein each offset connector is replaceable relative to the handle adapter and the test handle to adjust at least one of the lateral alignment and the angular offset.

4. The test guide system of claim 1 or 2, wherein each offset connector is configured to rotate relative to the cut-off end surface to adjust the lateral alignment.

5. The test guide system of claim 1 or 2, wherein each offset connector is configured to adjust the lateral alignment by a predetermined distance, wherein the predetermined distance for each offset connector is different from at least one of the one or more offset connectors.

6. The test guide system of claim 1 or 2, wherein each offset connector is configured to adjust the angular offset by a predetermined angle, wherein the predetermined angle for each offset connector is different from at least one of the one or more offset connectors.

7. The test guide system according to claim 1 or 2, further comprising a lead screw coupled to the handle adapter, wherein rotation of the lead screw adjusts the front-to-back alignment of the test handle with the hinge surface.

8. The test guide system according to claim 1 or 2, wherein the geometry between the test handle and the body includes one or more of the front-to-back alignment, the lateral alignment, and the angular offset.

9. The experimental guide system of claim 1 or 2, wherein the selected revision implant of the surgical plan includes one or more of the selected implant size and the selected implant geometry.

10. The experimental guide system of claim 1 or 2, wherein the surgical plan further includes one or more resections of the bone plan.

11. The test guide system according to claim 1 or 2, further comprising: A distal spacer, the distal spacer being coupled to the body and including one or more distal references, wherein the distal spacer is configured to translate relative to the hinge surface to adjust a first gap between the distal spacer and the hinge surface; as well as A rear spacer, the rear spacer being coupled to the body and including one or more rear references, wherein the rear spacer is configured to translate relative to the rear surface to adjust a second gap between the rear spacer and the rear surface.

12. The test guide system according to claim 11, The one or more sensors are further configured at the location of each of the one or more distal references and the one or more rear references, and The instructions, when executed, also cause the processor to: Receive the position of each of the one or more distal references and the one or more rear references. The first gap distance is determined based on the position of the main tracker array and the positions of the one or more distal references, and The second gap distance is determined based on the position of the main tracker array and the position of the one or more rear references. The surgical plan is also based on the first gap distance and the second gap distance.

13. The test guide system according to claim 11, further comprising: A distal post that connects the distal spacer to the hinged surface, wherein the distal post is movable to adjust the first gap; as well as A rear post that connects the rear spacer to the rear surface, wherein the rear post is movable to adjust the second gap.

14. The test guide system according to claim 13, further comprising: A distal adjustment knob is connected to the distal column, wherein actuation of the distal adjustment knob causes the distal column to move; as well as A rear adjustment knob is connected to the rear column, wherein actuation of the rear adjustment knob causes the rear column to move.

15. The test guide system according to claim 11, further comprising: A distal locking mechanism configured to selectively lock the distal spacer relative to the hinge surface; as well as A rear locking mechanism configured to selectively lock the rear spacer relative to the rear surface.

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