Electrical stimulation methods and systems for surgical planning

Abstract

Disclosed herein are systems and methods for planning a knee arthroplasty procedure. In one example, a surgical method includes intraoperative measurement of patient anatomical information of the knee and / or movement of the knee of a patient resulting from electrical stimulation of nerves or muscles to cause articulation of the knee. An electrical stimulation system may be attached to a patient to cause contraction / relaxing of muscles operative to cause articulation of the knee. Tracking elements may be associated with relevant knee anatomical structures, such as the proximal tibia, the distal femur, and / or the patella to track the movement of the knee components resulting from the electrical stimulation. Implant components may be selected, positioned, and / or orientated using the tracking information resulting from the electrical stimulation, thereby allowing for determination of a surgical plan based on intraoperative muscle-activated knee articulation, configured to emulate natural patient anatomy and kinematics.

Description

ELECTRICAL STIMULATION METHODS AND SYSTEMS FOR SURGICALPLANNINGRELATED APPLICATIONS

[0001] This application claims the benefit of U.S. Provisional Patent Application No. 63 / 694,960, filed September 16, 2024, entitled “ELECTRICAL STIMULATION METHODS AND SYSTEMS FOR SURGICAL PLANNING”, the contents of which are incorporated herein in their entirety.FIELD OF THE DISCLOSURE

[0002] The present disclosure generally relates to methods, systems, and apparatuses related to a computer-assisted surgical system that includes various hardware and software components that work together to enhance surgical workflows. More specifically, the present disclosure relates to methods, systems, and apparatuses for determining at least a portion of a knee arthroplasty surgical plan using patient information generated based on electrical stimulation techniques.BACKGROUND

[0003] The ultimate goal of a knee replacement procedure, such as a total knee arthroplasty (TKA) procedure, is to restore knee function and alleviate pain by matching the size and orientation of implant components to optimally match and reproduce the patient's original, pre-surgical anatomy. However, the knee is a sophisticated joint formed of multiple components (i.e., femur, tibia, and patella operating via a specific group of muscles andAttorney Docket No.: 8178.6101WO tendons) that flexes, extends, rotates, and translates during movement and, as such, makes characterization and surgical reproduction of the movement difficult.

[0004] The use of computers, robotics, and imaging to aid knee replacement surgery has improved surgical outcomes for patients, for instance, through computer-aided navigation and robotic systems. For example, surgical navigation systems can aid surgeons in locating and tracking patient anatomical structures, guiding surgical instruments, and implanting medical devices with a high degree of accuracy. These systems allow surgeons to plan, track, and navigate the placement of instruments and implants relative to the body of a patient, as well as conduct pre-operative and intra-operative body imaging. However, even with such advances, the biomechanics of a complex system such as the knee is difficult to accurately and completely characterize by intraoperative observation using existing systems and techniques.SUMMARY

[0005] This Summary is provided to introduce a selection of concepts in a simplified form that are further described below in the Detailed Description. This Summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended as an aid in determining the scope of the claimed subject matter.

[0006] Disclosed herein are improved systems and methods for planning a knee arthroplasty procedure, including determining patient anatomical information via intraoperative electrical stimulation of a sedated patient that activates muscles that cause articulation of the knee joint. The patient knee anatomy may be tracked by a surgicalAttorney Docket No.: 8178.6101WO tracking system during the movement (i.e., flexion and extension) induced by the electrical stimulation. Accordingly, patient anatomical information relating to the patella-femoral and / or tibia-femoral articulations may be determined and used to form a surgical plan, including implant component selection and / or positioning, under conditions the same as or substantially similar to natural patient movement.

[0007] In any preceding or subsequent example, the electrical stimulation facilitates the determination of the quad muscle mechanisms or Q-angle / quad vector and its effects on the patellofem oral joint and / or the tibiofemoral joint. Assessing, by stimulating quadricep muscle contractions (along with any other contributing muscular structures), the patellafemoral articulations and / or tibiofemoral articulations, under natural conditions allows for improved and optimized implant component selection and placement.

[0008] In any preceding or subsequent example, the stimulated muscles include any muscle or muscle group that may cause or may affect the articulation of the knee joint. In any preceding or subsequent example, the stimulated muscles include one or more muscles of the quadricep muscle group. In any preceding or subsequent example, the stimulated muscles include one or more of the rectus femoris, the vastus lateralis, the vastus medialis, and / or the vastus intermedins. In any preceding or subsequent example, the stimulated muscles include one or more muscles of the hamstring muscle group. In any preceding or subsequent example, the stimulated muscles include the biceps femoris, the semimembranosus, and / or the semitendinosus. In any preceding or subsequent example, the stimulated muscles include one or more of the calf muscles. In any preceding orAttorney Docket No.: 8178.6101WO subsequent example, the stimulated muscles include the anterior tibialis, the gastrocnemius, and / or the Soleus.

[0009] In any preceding or subsequent example, stimulation, including electrical stimulation and / or non-electrical stimulation or forces, may be applied to the patella tendon and / or quadriceps tendon to articulate the knee joint.

[0010] In any preceding or subsequent example, the electrical stimulation may be configured to directly stimulate the muscle. In any preceding or subsequent example, the electrical stimulation may be configured to stimulate a nerve or other nervous system component to stimulate the muscle.

[0011] In any preceding or subsequent example, the electrical stimulation is provided using one or more techniques including, without limitation, electrical muscle stimulation (EMS), functional electrical stimulation (FES), functional electrical therapy (FET), transcutaneous electrical stimulation (TES), and neuromuscular electrical stimulation (NMES). The present disclosure is not limited to the aforementioned muscle stimulation techniques, which are provided for illustrative purposes. In any preceding or subsequent example, the muscle stimulation may be provided by any existing or future-developed technique capable of operating with the described examples.

[0012] In any preceding or subsequent example, the electrical stimulation is provided via one or more electrodes configured and arranged to activate targeted muscles and / or nerves. The electrodes can be placed epidermal (above the skin) or hypodermic (subcutaneous, percutaneous, or below the skin). Hypodermic placement may include attaching electrodes directly under the skin (percutaneous) or fully embedded deeper into the muscle or theAttorney Docket No.: 8178.6101WO areas surrounding a targeted nerve. In any preceding or subsequent example, the electrodes may be configured to stimulate nerves of the spinal cord to effectuate muscle contraction.

[0013] In any preceding or subsequent example, the patient anatomical information may include any information capable of being used to select an implant component and / or to determine the positioning of an implant component. An implant component may include a femoral component and / or a tibial component of an implant system. An implant component may include a patella component, which may include or may be a patella implant and / or a reshaped native patella of the patient.

[0014] In any preceding or subsequent example, the patient anatomical information may include femoral implant parameters such as femoral component size, type, brand, spatial orientation and / or the like. In any preceding or subsequent example, the patient anatomical information may include femoral joint line orientation, femoral varus / valgus orientation, femoral internal and external rotation orientation, femoral flexion / extension orientation, and / or other femoral spatial orientations that may be used to “tune” a femoral component position for optimum results either alone or in combination with a tibial component and / or patella component.

[0015] In any preceding or subsequent example, the patient anatomical information may include tibial implant parameters such as tibial component size, type, brand, spatial orientation, and / or the like. In any preceding or subsequent example, the patient anatomical information may include tibial internal and external rotation, tibial posterior slope, tibial A-P positioning, tibial varus / valgus orientation, and / or other tibial spatial orientations (or tibial construct and / or assembly (e.g. compartmental inserts varying in thickness, slope,Attorney Docket No.: 8178.6101WO rotation, etc.) that may be used to “tune” a tibial component position for optimum results either alone or in combination with a femoral component and / or patella component.

[0016] In any preceding or subsequent example, the patient anatomical information may include patella component parameters such as patellar component size, shape, type, brand, spatial orientation relative to the femoral component and / or tibial component, and / or the like. Patient-specific patella information may include native patella size, thickness and shape, patella orientation and position relative to the femur, including, for instance, superior-inferior or medial-lateral position, internal-external (transverse) rotation, flexionextension at full extension, 30° knee flexion, and / or other clinically relevant positions, patella mobility, patella tendon length, patella positioning, and / or the like.

[0017] In any preceding or subsequent example, the patient anatomical information may be or may include kinematic information relating to the pattern of motion having six degrees of freedom. In any preceding or subsequent example, the patient anatomical information may be or may include knee performance information.

[0018] In any preceding or subsequent example, the patient anatomical information may be or may include information mapping patella tracking relative to the femur and / or tibia, for example, under quad-loading conditions provided via the electrical stimulation.

[0019] In any preceding or subsequent example, a portion of the patient anatomical information may be or may be determined via pre-operative or intraoperative medical imaging or scanning of portions of the knee anatomy, including the patella, tibia, and femur, as well as muscle and tendon structures. Non-limiting examples of medical imaging may include diagnostic imaging techniques such as MRI, CT, X-Ray, ultrasound, etc.Attorney Docket No.: 8178.6101WOPatient anatomical information may include pre-operative diagnostic imaging, intraoperative scans, for instance, via diagnostic imaging equipment, CASS robotic scanning / imaging systems (e.g., camera array), sensor arrays, landmarking systems, and / or the like. Patient anatomical information may include patient factors such as varus / valgus knee alignment, joint line, quadriceps angle (Q-angle), native femur anatomy and size, femoral trochlear groove positioning and shape, native tibia anatomy and size, position of the tibial tubercle, tibial posterior slope, and / or the like.

[0020] In any preceding or subsequent example, the surgical method may include generating patient models. For example, two-dimensional (2D) and / or three-dimensional (3D) models of the patient anatomy may be generated based on the patient anatomical information. In any preceding or subsequent example, the boney and soft tissue anatomy of the patient knee may be segmented and used to generate anatomical models. In any preceding or subsequent example, the models may include the tibia, femur, and patella bones, along with ligament, tendon, and muscle models that are direct contributors to knee anatomy and function. In any preceding or subsequent example. The anatomical models may include models of the patella, femur, tibia, a patella implant component, a femur implant component, and / or a tibial implant component alone or in combination.

[0021] In any preceding or subsequent example, the results of stimulating patient anatomy and tracking the resultant patient anatomical information may be stored as correlation information. In any preceding or subsequent example, correlation information may correlate electrical signals with resulting knee anatomy information to relate electrical stimulation with patient movement. In some examples, the correlation information may beAttorney Docket No.: 8178.6101WO or may include information to map patella tracking relative to the femur and / or tibia with quad-loading conditions (or other loading conditions) provided via the electrical stimulation.

[0022] In one example, a surgical system includes a stimulation control system configured to electrically stimulate target anatomy of a patient to cause articulation of a knee joint of a patient, a tracking system configured to generate patient anatomical information responsive to tracking at least one component of the knee joint articulated via the stimulation control system, and a computing device operative to generate a surgical plan based on the patient anatomical information, the surgical plan including selecting at least one of an implant size, placement, or orientation.

[0023] In one example, a surgical method includes attaching electrical stimulation elements to target anatomy of a patient to cause articulation of a knee joint of a patient, attaching tracking elements to generate patient anatomical information responsive to tracking at least one component of the knee joint articulated via the stimulation control system, manipulating patient anatomy via applying electrical signals to the electrical stimulation elements, receiving tracking information from the tracking elements, generating patient anatomical information based on the tracking information, and generating a surgical plan based on the patient anatomical information, the surgical plan including selecting at least one of an implant size, placement, or orientation.

[0024] In one example, a surgical method includes installing implant components or trial components determined via surgical plan, generating patient anatomical information via electrical stimulation for the implant components or trial components, comparing theAttorney Docket No.: 8178.6101WO patient anatomical information for the implant components or trial components to patient anatomical information for natural or pre-surgical patient anatomy, and generating an updated surgical plan based on the updated patient anatomical information for the implant components or trial components.

[0025] Examples described in the present disclosure provide numerous advantages over conventional systems and methods. In one non-limiting example advantage, electrical stimulation of patient anatomy allows for intraoperative monitoring or measurement of patient anatomy of a sedated patient that corresponds with natural patient movement, including the effects of muscles and tendons on knee component orientation and positioning, particularly the patella and patella tracking. Accordingly, a surgical plan may be determined based on accurate, natural patient movement, instead of passive, manual articulation of the patient which fails to accurately capture knee joint movement.

[0026] Further features and advantages of at least some of the examples described in the present disclosure, as well as the structure and operation of any preceding or subsequent example of the present disclosure, are described in detail below with reference to the accompanying drawings.BRIEF DESCRIPTION OF THE DRAWINGS

[0027] By way of example, specific examples of the disclosed device will now be described, with reference to the accompanying drawings, in which:

[0028] FIG. 1 depicts an operating theatre including an illustrative computer-assisted surgical system (CASS) in accordance with one or more features of the present disclosure;Attorney Docket No.: 8178.6101WO

[0029] FIG. 2 is a block diagram depicting a system for performing a surgery planning process in accordance with one or more features of the present disclosure;

[0030] FIG. 3 depicts an operating environment in accordance with one or more features of the present disclosure;

[0031] FIG. 4 depicts operation of a surgical system in accordance with one or more features of the present disclosure;

[0032] FIG. 5 depicts correlation information in accordance with one or more features of the present disclosure;

[0033] FIG. 6 illustrates an example of a first surgical workflow in accordance with one or more features of the present disclosure; and

[0034] FIG. 7 illustrates an example of a second surgical workflow in accordance with one or more features of the present disclosure.

[0035] It should be understood that the drawings are not necessarily to scale and that the disclosed examples are sometimes illustrated diagrammatically and in partial views. In certain instances, details which are not necessary for an understanding of the disclosed methods and devices, or which render other details difficult to perceive may have been omitted. It should be further understood that this disclosure is not limited to the particular examples illustrated herein. In the drawings, like numbers refer to like elements throughout unless otherwise noted.DETAILED DESCRIPTIONAttorney Docket No.: 8178.6101WO

[0036] This disclosure is not limited to the particular systems, devices and methods described, as these may vary. The terminology used in the description is for the purpose of describing the particular versions or examples only and is not intended to limit the scope.

[0037] As used in this document, the singular forms “a,” “an,” and “the” include plural references unless the context clearly dictates otherwise. Unless defined otherwise, all technical and scientific terms used herein have the same meanings as commonly understood by one of ordinary skill in the art. Nothing in this disclosure is to be construed as an admission that the examples described in this disclosure are not entitled to antedate such disclosure by virtue of prior invention. As used in this document, the term “comprising” means “including, but not limited to.”

[0038] The described technology generally relates to surgical processes, for example, knee arthroplasty procedures including, without limitation, a total knee arthroplasty (TKA) procedure, a revision knee arthroplasty procedure, a partial (unicondylar or unicompartmental) knee arthroplasty procedure, and / or the like. Although knee arthroplasty, and TKA in particular, is used in some examples, the present disclosure is not limited to knee arthroplasty, as processes according to some examples may operate with other orthopedic procedures (e.g., hip arthroplasty for example, which could include abductor(s) and / or adductor(s) stimulation).

[0039] In some examples, a surgical process may include a method for optimizing implant selection and / or positioning during a knee arthroplasty procedure. The surgical process may include determining patient information via intraoperative electrical stimulation of a sedated patient that activates muscles that cause articulation of the knee joint. The patientAttorney Docket No.: 8178.6101WO knee anatomy may be tracked by a surgical tracking system during the movement (i.e., flexion and extension) induced by the electrical stimulation. Accordingly, patient information relating to the patella-femoral and / or tibia-femoral articulations may be determined and used to form a surgical plan, including implant component selection and / or positioning, under conditions the same as or substantially similar to natural patient movement or a prescribed alternative (e.g., a correction to a deformity or trauma).

[0040] In order to ensure proper post-operative functioning of a prosthetic knee, optimal selection (i.e., component size, shape, and / or other parameters), positioning, and alignment of the prosthetic knee components and proper balancing, including any necessary surgical release or contraction, of the knee ligaments, during knee arthroplasty surgery are necessary. Improper selection, positioning, and / or misalignment of the prosthetic knee components commonly cause prosthetic knees to fail.

[0041] Traditionally, surgeons relied heavily on their experience to determine where the bone should be cut, to select, align, and place the knee prosthetic components, and to judge how the knee ligaments should be contracted or released to ensure proper ligament balancing. Surgeons typically use computer-assisted surgery functions to determine or estimate surgical cutting planes and / or component selection, alignment, and positioning.

[0042] Conventional knee arthroplasty procedures have typically focused on femoral and tibial component placement, with the patella (un-resurfaced) or patella component often placed later in priority. For example, the patella is usually assessed at the end of the procedure for patella femoral tracking / kinematics, which often leads to suboptimal adjustments, such as bone resection reliefs (e.g., lateral facetectomy) and / or soft tissueAttorney Docket No.: 8178.6101WO releases (e g., lateral retinaculum). However, the patella-femoral joint is a significant contributing factor to the success of a knee arthroplasty procedure.

[0043] Conventional assessments of the patellofemoral joint and the tibiofemoral joint are either via pre-operative medical imaging or through intraoperative passive motion (i.e., manual movement of sedated patient anatomy). Accordingly, intraoperative examination of the patient is not able to provide the same mechanics as natural patient movement via contraction / relaxing of the knee muscles, tendons, and / or the like. As a result, surgeons are not able to achieve an accurate examination of patient post-operative knee articulation. For example, conventional surgical techniques do not allow a surgeon to intraoperatively examine quad mechanism mechanics or Q-angle / quad vector and its effects on the patellofemoral joint and / or the tibiofemoral joint.

[0044] Accordingly, systems, methods, and processes according to various examples of the present disclosure can provide patient information for implant component selection, positioning, balancing, and / or other parameters relevant to achieving optimal kinematics of a post-operative knee joint. As used herein, the term “kinematics” relates to the pattern of motion having six degrees of freedom. More particularly, the term “kinematics” in reference to a knee joint is used to denote the motion, or articulation, of the knee joint in six degrees of freedom. The knee has generally six degrees of freedom or motion during dynamic activities: three rotations (flexion / extension angulations, axial rotation along the long axis of a large tubular bone, also referred to as intemal / extemal rotation, and varus / valgus angulations); and three translations (anterior / posterior, medial / lateral, and superior / inferior).Attorney Docket No.: 8178.6101WO

[0045] In some examples, surgical processes may be or may include a surgical workflow for computer-assisted or navigated knee arthroplasty procedures. A surgical workflow may include registering the patient’s anatomy pre-operatively and / or intra-operatively in order to create a three-dimensional (3D) representation of the femur, tibia, and patellar anatomy. The patient’s anatomy may be automatically landmarked and measured in order to characterize the anatomy, including the femur, tibia, and patellar anatomy. Electrical stimulation may be applied intraoperative to one or more muscles (or to nerves that affect the muscles) of a sedated patient to cause contraction and / or relaxation of the muscles to induce articulation of the knee, thereby facilitating measurement of patient anatomical information during natural movement of the knee in a sedated patient.

[0046] Introducing the electrical stimulation steps of various examples of the present disclosure into the surgical workflow, to more accurately capture knee anatomy during natural patient motion and predict clinical outcomes, is critical in providing a surgeon with a better understanding as to how an implant system can be optimized and to reduce the risk of poor outcomes.

[0047] Accordingly, various examples may include technologies and processes for determining patient information to optimize implant component selection and / or positioning to improve post-operative biomechanics and performance of the implant system.

[0048] Processes according to some examples may provide a technological feature and advantage of determining recommendations on selecting implant components and implant component positioning, and intraoperative testing of implant components (or trials) usingAttorney Docket No.: 8178.6101WO induced muscle contractions, simulating natural patient movement. Processes according to some examples may also provide possible clinical benefits including, without limitation, reduced anterior knee pain and implant failure.

[0049] As a result, surgical processes including electrical stimulation according to any preceding or subsequent example may provide surgeons with improved surgical methods that are more accurate, personalized for each patient, and reduce complexity and cognitive load (particularly during an active surgery), while also improving patient outcomes.

[0050] FIG. 1 provides an illustration of an example computer-assisted surgical system (CASS) 100 according to any preceding or subsequent example. As described in further detail in the sections that follow, the CASS uses computers, robotics, and imaging technology to aid surgeons in performing orthopedic surgery procedures such as knee arthroplasty (e.g., total knee arthroplasty (TKA)) or total hip arthroplasty (THA). For example, surgical navigation systems can aid surgeons in locating patient anatomical structures, guiding surgical instruments, and implanting medical devices with a high degree of accuracy. Surgical navigation systems such as the CASS 100 often employ various forms of computing technology to perform a wide variety of standard and minimally invasive surgical procedures and techniques. Moreover, these systems allow surgeons to more accurately plan, track, and navigate the placement of instruments and implants relative to the body of a patient, as well as conduct pre-operative and intra-operative body imaging.

[0051] As shown in FIG. 1, an Effector Platform 105 positions surgical tools relative to a patient during surgery. The exact components of the Effector Platform 105 will vary,Attorney Docket No.: 8178.6101WO depending on the example employed. For example, for a knee surgery, the Effector Platform 105 may include an End Effector 105B that holds surgical tools or instruments during their use. The End Effector 105B may be a handheld device or instrument used by the surgeon (e.g., a hand piece or a cutting guide or jig of a surgical system, such as the Navio® Surgical System from Blue Belt Technologies of Plymouth, Minnesota, United States of America) or, alternatively, the End Effector 105B can include a device or instrument held or positioned by a Robotic Arm 105 A.

[0052] The Effector Platform 105 can include a Limb Positioner 105C for positioning the patient’s limbs during surgery. One example of a Limb Positioner 105C may be the SPIDER2 system manufactured and sold by Smith & Nephew, Inc. of Cordova, Tennessee, United States of America. The Limb Positioner 105C may be operated manually by the surgeon or alternatively change limb positions based on instructions received from the Surgical Computer 150 (described below).

[0053] Resection Equipment 110 (not shown in FIG. 1) performs bone or tissue resection using, for example, mechanical, ultrasonic, or laser techniques. Examples of Resection Equipment 110 may include drilling devices, burring devices, oscillatory sawing devices, vibratory impaction devices, reamers, ultrasonic bone cutting devices, radio frequency ablation devices, and laser ablation systems. In some examples, the Resection Equipment 110 is held and operated by the surgeon during surgery. In other examples, the Effector Platform 105 may be used to hold the Resection Equipment 110 during use.

[0054] The Effector Platform 105 can also include a cutting guide or jig 105D that is used to guide saws or drills used to resect tissue during surgery. Such cutting guides 105D canAttorney Docket No.: 8178.6101WO be formed integrally as part of the Effector Platform 105 or Robotic Arm 105 A, or cutting guides can be separate structures that can be matingly and / or removably attached to the Effector Platform 105 or Robotic Arm 105 A. The Effector Platform 105 or Robotic Arm 105 A can be controlled by the CASS 100 to position a cutting guide or jig 105D adjacent to the patient’ s anatomy in accordance with a pre-operatively or intraoperatively developed surgical plan such that the cutting guide or jig will produce a precise bone cut in accordance with the surgical plan.

[0055] The Tracking System 115 uses one or more sensors to collect real-time position data that locates the patient’s anatomy and surgical instruments. For example, for TKA procedures, the Tracking System may provide a location and orientation of the End Effector 105B during the procedure. In addition to positional data, data from the Tracking System 115 can also be used to infer velocity / acceleration of anatomy / instrumentation, which can be used for tool control. In some examples, the Tracking System 115 may use a tracker array attached to the End Effector 105B to determine the location and orientation of the End Effector 105B. The position of the End Effector 105B may be inferred based on the position and orientation of the Tracking System 115 and a known relationship in three- dimensional space between the Tracking System 115 and the End Effector 105B. Various types of tracking systems may be used in some examples of the present disclosure including, without limitation, Infrared (IR) tracking systems, electromagnetic (EM) tracking systems, video or image-based tracking systems, and ultrasound registration and tracking systems.Attorney Docket No.: 8178.6101WO

[0056] Any suitable tracking system can be used for tracking surgical objects and patient anatomy in the surgical theatre. For example, a combination of infrared (IR) and visible light cameras can be used in an array. Various illumination sources, such as an IR light emitting diode (LED) light source, can illuminate the scene allowing three-dimensional imaging to occur. In some examples, this can include stereoscopic, tri-scopic, quad-scopic, etc. imaging. In addition to the camera array, which in some examples is affixed to a cart, additional cameras can be placed throughout the surgical theatre. For example, handheld tools or headsets worn by operators / surgeons can include imaging capability that communicates images back to a central processor to correlate those images with images captured by the camera array. This can give a more robust image of the environment for modeling using multiple perspectives. Furthermore, some imaging devices may be of suitable resolution or have a suitable perspective on the scene to pick up information stored in quick response (QR) codes or barcodes. This can be helpful in identifying specific objects not manually registered with the system.

[0057] In some examples, specific objects can be manually registered by a surgeon with the system preoperatively or intraoperatively. For example, by interacting with a user interface, a surgeon may identify the starting location for a tool or a bone structure. By tracking fiducial marks associated with that tool or bone structure, or by using other conventional image tracking modalities, a processor may track that tool or bone as it moves through the environment in a three-dimensional model.

[0058] In some examples, certain markers, such as fiducial marks that identify individuals, important tools, or bones in the theater may include passive or active identifiers that canAttorney Docket No.: 8178.6101WO be picked up by a camera or camera array associated with the tracking system. For example, an IR LED can flash a pattern that conveys a unique identifier to the source of that pattern, providing a dynamic identification mark. Similarly, one- or two-dimensional optical codes (e.g., barcode, QR code, etc.) can be affixed to objects in the theater to provide passive identification that can occur based on image analysis. If these codes are placed asymmetrically on an object, they can also be used to determine an orientation of an object by comparing the location of the identifier with the extents of an object in an image. For example, a QR code may be placed in a corner of a tool tray, allowing the orientation and identity of that tray to be tracked. Other tracking modalities are explained throughout. For example, in some examples, augmented reality headsets can be worn by surgeons and other staff to provide additional camera angles and tracking capabilities.

[0059] In addition to optical tracking, certain features of objects can be tracked by registering physical properties of the object and associating them with objects that can be tracked, such as fiducial marks fixed to a tool or bone. For example, a surgeon may perform a manual registration process whereby a tracked tool and a tracked bone can be manipulated relative to one another. By impinging the tip of the tool against the surface of the bone, a three-dimensional surface can be mapped for that bone that is associated with a position and orientation relative to the frame of reference of that fiducial mark. By optically tracking the position and orientation (pose) of the fiducial mark associated with that bone, a model of that surface can be tracked with an environment through extrapolation.

[0060] The registration process that registers the CASS 100 to the relevant anatomy of the patient can also involve the use of anatomical landmarks, such as landmarks on a bone orAttorney Docket No.: 8178.6101WO cartilage. For example, the CASS 100 can include a 3D model of the relevant bone or joint and the surgeon can intraoperatively collect data regarding the location of bony landmarks on the patient’s actual bone using a probe that is connected to the CASS. Bony landmarks can include, for example, the medial malleolus and lateral malleolus, the ends of the proximal femur and distal tibia, and the center of the hip joint. The CASS 100 can compare and register the location data of bony landmarks collected by the surgeon with the probe with the location data of the same landmarks in the 3D model. Alternatively, the CASS 100 can construct a 3D model of the bone or joint without pre-operative image data by using location data of bony landmarks and the bone surface that are collected by the surgeon using a CASS probe or other means. The registration process can also include determining various axes of a joint. For example, for a TKA the surgeon can use the CASS 100 to determine the anatomical and mechanical axes of the femur and tibia. The surgeon and the CASS 100 can identify the center of the hip joint by moving the patient’s leg in a spiral direction (i.e., circumduction) so the CASS can determine where the center of the hip joint is located.

[0061] A Tissue Navigation System 120 provides the surgeon with intraoperative, realtime visualization for the patient’s bone, cartilage, muscle, nervous, and / or vascular tissues surrounding the surgical area. Examples of systems that may be employed for tissue navigation include fluorescent imaging systems and ultrasound systems.

[0062] The Display 125 provides graphical user interfaces (GUIs) that display images collected by the Tissue Navigation System 120 as well other information relevant to the surgery. For example, in some examples, the Display 125 overlays image informationAttorney Docket No.: 8178.6101WO collected from various modalities (e.g., CT, MRI, X-ray, fluorescent, ultrasound, etc.) collected pre-operatively or intra-operatively to give the surgeon various views of the patient’s anatomy as well as real-time conditions. The pre-operative image information can include data such as muscle activities relative to limb motion(s) (e.g., muscle contraction sensors in combination with prescribed activities and / or fluoroscopic imaging of joint activity) for intraoperative comparisons including contralateral limb (e.g., often the contralateral X-ray is used in joint replacements for anatomic references for implant sizing, positioning, placement, including joint line, leg length, etc.). The Display 125 may include, for example, one or more computer monitors. As an alternative or supplement to the Display 125, one or more members of the surgical staff may wear an Augmented Reality (AR) Head Mounted Device (HMD). For example, in FIG. 1 the Surgeon I l l is wearing an AR HMD 155 that may, for example, overlay pre-operative image data on the patient or provide surgical planning suggestions. Various example uses of the AR HMD 155 in surgical procedures are detailed in the sections that follow.

[0063] Surgical Computer 150 provides control instructions to various components of the CASS 100, collects data from those components, and provides general processing for various data needed during surgery. In some examples, the Surgical Computer 150 is a general -purpose computer. In some examples, the Surgical Computer 150 may be a parallel computing platform that uses multiple central processing units (CPUs) or graphics processing units (GPU) to perform processing. In some examples, the Surgical Computer 150 is connected to a remote server over one or more computer networks (e.g., the Internet).Attorney Docket No.: 8178.6101WOThe remote server can be used, for example, for storage of data or execution of computationally intensive processing tasks.

[0064] Various techniques generally known in the art can be used for connecting the Surgical Computer 150 to the other components of the CASS 100. Moreover, the computers can connect to the Surgical Computer 150 using a mix of technologies. For example, the End Effector 105B may connect to the Surgical Computer 150 over a wired (i.e., serial) connection. The Tracking System 115, Tissue Navigation System 120, and Display 125 can similarly be connected to the Surgical Computer 150 using wired connections. Alternatively, the Tracking System 115, Tissue Navigation System 120, and Display 125 may connect to the Surgical Computer 150 using wireless technologies such as, without limitation, Wi-Fi, Bluetooth, Near Field Communication (NFC), and / or ZigBee.

[0065] Part of the flexibility of the CASS design described above with respect to FIG. 1 is that additional or alternative devices can be added to the CASS 100 as necessary to support particular surgical procedures.

[0066] In some examples, the CASS 100 includes a robotic arm 105A that serves as an interface to stabilize and hold a variety of instruments used during the surgical procedure. The robotic arm 105 A may have multiple degrees of freedom (e.g., like a SPIDER2 device) and have the ability to be locked in place (e.g., by a press of a button, voice activation, a surgeon removing a hand from the robotic arm, or other method).

[0067] In some examples, movement of the robotic arm 105 A may be effectuated by use of a control panel built into the robotic arm system. For example, a display screen mayAttorney Docket No.: 8178.6101WO include one or more input sources, such as physical buttons or a user interface having one or more icons, that direct movement of the robotic arm 105 A. The surgeon or other healthcare professional may engage with the one or more input sources to position the robotic arm 105 A when performing a surgical procedure.

[0068] A tool or an end effector 105B attached or integrated into a robotic arm 105 A may include, without limitation, a burring device, a scalpel, a cutting device, a retractor, a joint tensioning device, or the like. In some examples in which an end effector 105B is used, the end effector may be positioned at the end of the robotic arm 105 A such that any motor control operations are performed within the robotic arm system. In some examples in which a tool is used, the tool may be secured at a distal end of the robotic arm 105 A, but motor control operation may reside within the tool itself.

[0069] The robotic arm 105 A may be motorized internally to both stabilize the robotic arm, thereby preventing it from falling and hitting the patient, surgical table, surgical staff, etc., and to allow the surgeon to move the robotic arm without having to fully support its weight. While the surgeon is moving the robotic arm 105 A, the robotic arm may provide some resistance to prevent the robotic arm from moving too fast or having too many degrees of freedom active at once. The position and the lock status of the robotic arm 105 A may be tracked, for example, by a controller or the Surgical Computer 150.

[0070] In some examples, the robotic arm 105A can be moved by hand (e.g., by the surgeon) or with internal motors into its ideal position and orientation for the task being performed. In some examples, the robotic arm 105 A may be enabled to operate in a “free” mode that allows the surgeon to position the arm into a desired position without beingAttorney Docket No.: 8178.6101WO restricted. While in the free mode, the position and orientation of the robotic arm 105 A may still be tracked as described above. In some examples, certain degrees of freedom can be selectively released upon input from user (e.g., surgeon) during specified portions of the surgical plan tracked by the Surgical Computer 150. Designs in which a robotic arm 105 A is internally powered through hydraulics or motors or provides resistance to external manual motion through similar means can be described as powered robotic arms, while arms that are manually manipulated without power feedback, but which may be manually or automatically locked in place, may be described as passive robotic arms.

[0071] A robotic arm 105 A or end effector 105B can include a trigger or other means to control the power of a saw or drill. Engagement of the trigger or other means by the surgeon can cause the robotic arm 105 A or end effector 105B to transition from a motorized alignment mode to a mode where the saw or drill is engaged and powered on. Additionally, the CASS 100 can include a foot pedal (not shown) that causes the system to perform certain functions when activated. For example, the surgeon can activate the foot pedal to instruct the CASS 100 to place the robotic arm 105 A or end effector 105B in an automatic mode that brings the robotic arm or end effector into the proper position with respect to the patient’s anatomy in order to perform the necessary resections. The CASS 100 can also place the robotic arm 105 A or end effector 105B in a collaborative mode that allows the surgeon to manually manipulate and position the robotic arm or end effector into a particular location. The collaborative mode can be configured to allow the surgeon to move the robotic arm 105 A or end effector 105B medially or laterally, while restricting movement in other directions. As discussed, the robotic arm 105 A or end effector 105BAttorney Docket No.: 8178.6101WO can include a cutting device (saw, drill, and burr) or a cutting guide or jig 105D that will guide a cutting device. In some examples, movement of the robotic arm 105 A or robotically controlled end effector 105B can be controlled entirely by the CASS 100 without any, or with only minimal, assistance or input from a surgeon or other medical professional. In still any preceding or subsequent example, the movement of the robotic arm 105 A or robotically controlled end effector 105B can be controlled remotely by a surgeon or other medical professional using a control mechanism separate from the robotic arm or robotically controlled end effector device, for example using a joystick or interactive monitor or display control device.

[0072] The examples below describe uses of the robotic device in the context of a hip surgery; however, it should be understood that the robotic arm may have other applications for surgical procedures involving knees, shoulders, etc.

[0073] A robotic arm 105 A may be used for holding the retractor. For example, in some examples, the robotic arm 105 A may be moved into the desired position by the surgeon. At that point, the robotic arm 105 A may lock into place. In some examples, the robotic arm 105 A is provided with data regarding the patient’s position, such that if the patient moves, the robotic arm can adjust the retractor position accordingly. In some examples, multiple robotic arms may be used, thereby allowing multiple retractors to be held or for more than one activity to be performed simultaneously (e.g., retractor holding & reaming).

[0074] The robotic arm 105 A may also be used to help stabilize the surgeon’s hand while making a femoral neck cut. In this application, control of the robotic arm 105 A may impose certain restrictions to prevent soft tissue damage from occurring. For example, in someAttorney Docket No.: 8178.6101WO examples, the Surgical Computer 150 tracks the position of the robotic arm 105 A as it operates. If the tracked location approaches an area where tissue damage is predicted, a command may be sent to the robotic arm 105 A causing it to stop. Alternatively, where the robotic arm 105 A is automatically controlled by the Surgical Computer 150, the Surgical Computer may ensure that the robotic arm is not provided with any instructions that cause it to enter areas where soft tissue damage is likely to occur. The Surgical Computer 150 may impose certain restrictions on the surgeon to prevent the surgeon from reaming too far into the medial wall of the acetabulum or reaming at an incorrect angle or orientation.

[0075] The robotic arm 105 A may also be used for resurfacing applications. For example, the robotic arm 105 A may stabilize the surgeon while using traditional instrumentation and provide certain restrictions or limitations to allow for proper placement of implant components (e.g., guide wire placement, chamfer cutter, sleeve cutter, plan cutter, etc.). Where only a burr is employed, the robotic arm 105 A may stabilize the surgeon’s handpiece and may impose restrictions on the handpiece to prevent the surgeon from removing unintended bone in contravention of the surgical plan.

[0076] The various services that are provided by medical professionals to treat a clinical condition are collectively referred to as an “episode of care.” For a particular surgical intervention, the episode of care can include three phases: pre-operative, intra-operative, and post-operative. During each phase, data is collected or generated that can be used to analyze the episode of care in order to understand various features of the procedure and identify patterns that may be used, for example, in training models to make decisions with minimal human intervention. The data collected over the episode of care may be stored atAttorney Docket No.: 8178.6101WO the Surgical Computer 150 or the Surgical Data Server 180 as a complete dataset. Thus, for each episode of care, a dataset exists that includes all of the data collectively pre- operatively about the patient, all of the data collected or stored by the CASS 100 intra- operatively, and any post-operative data provided by the patient or by a healthcare professional monitoring the patient.

[0077] As explained in further detail, the data collected during the episode of care may be used to enhance performance of the surgical procedure or to provide a holistic understanding of the surgical procedure and the patient outcomes. For example, in some examples, the data collected over the episode of care may be used to generate a surgical plan. In some examples, a high-level, pre-operative plan is refined intra-operatively as 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 by the components of the CASS 100. In some examples, pre-operative images or other input data may be used to develop a robust plan preoperatively that is simply executed during surgery. In this case, the data collected by the CASS 100 during surgery may be used to make recommendations that ensure that the surgeon stays within the pre-operative surgical plan. For example, if the surgeon is unsure how to achieve a certain prescribed cut or implant alignment, the Surgical Computer 150 can be queried for a recommendation. In still any preceding or subsequent example, the pre-operative and intra-operative planning approaches can be combined such that a robust pre-operative plan can be dynamically modified, as necessary or desired, during the surgical procedure. In some examples, a biomechanics-based model of patient anatomy contributes simulation data to be considered by the CASS 100 inAttorney Docket No.: 8178.6101WO developing preoperative, intraoperative, and post-operative / rehabilitation procedures to optimize implant performance outcomes for the patient.

[0078] Aside from changing the surgical procedure itself, the data gathered during the episode of care may be used as an input to other procedures ancillary to the surgery. For example, in some examples, implants can be designed using episode of care data. Example data-driven techniques for designing, sizing, and fitting implants are described in U.S. Patent Application No. 13 / 814,531 filed August 15, 2011 and entitled “Systems and Methods for Optimizing Parameters for Orthopaedic Procedures”; U.S. Patent Application No. 14 / 232,958 filed July 20, 2012 and entitled “Systems and Methods for Optimizing Fit of an Implant to Anatomy”; U.S. Patent Application No. 12 / 234,444 filed September 19, 2008 and entitled “Operatively Tuning Implants for Increased Performance,” and U.S. Patent Application No. 17 / 265,675 filed February 3, 2021 and entitled “Patella Tracking Method and System” the entire contents of each of which are hereby incorporated by reference into the present disclosure.

[0079] Data acquired during the pre-operative phase generally includes all information collected or generated prior to the surgery. Thus, for example, information about the patient may be acquired from a patient intake form or electronic medical record (EMR). Examples of patient information that may be collected include, without limitation, patient demographics, diagnoses, medical histories, progress notes, vital signs, medical history information, allergies, and lab results. The pre-operative data may also include images related to the anatomical area of interest. These images may be captured, for example, using Magnetic Resonance Imaging (MRI), Computed Tomography (CT), X-ray, ultrasound, orAttorney Docket No.: 8178.6101WO any other modality known in the art. The pre-operative data may also include quality of life data captured from the patient. For example, in some examples, pre-surgery patients use a mobile application (“app”) to answer questionnaires regarding their current quality of life. In some examples, preoperative data used by the CASS 100 includes demographic, anthropometric, cultural, or other specific traits about a patient that can coincide with activity levels and specific patient activities to customize the surgical plan to the patient.

[0080] FIG. 2 is a block diagram depicting a system for performing a surgery planning process in accordance with one or more features of the present disclosure. A non-limiting example of a surgical procedure may include an orthopedic or arthroplasty procedure.

[0081] As shown in FIG. 2, operating environment 200 may include a surgical system 205. In any preceding or subsequent example, surgical system 205 may include a computing device 210 communicatively coupled to network 260 via a communication interface (for instance, a transceiver) 240. Computing device 210 may be or may include one or more logic devices, including, without limitation, a server computer, a client computing device, a personal computer (PC), a workstation, a laptop, a notebook computer, a smart phone, a tablet computing device, and / or the like. Although a single computing device 210 is depicted in FIG. 2, preceding or subsequent examples are not so limited, as surgical system 205 may include and / or operably communicate with, and surgery planning processes according to any preceding or subsequent example may be performed using, a plurality of computing devices 210. In addition, components of computing device 210 depicted in FIG. 2 may be arranged within a plurality of different computing devices. In any preceding orAttorney Docket No.: 8178.6101WO subsequent example, surgical system 205 may be or may be a part of system 100 of FIG. 1.

[0082] In any preceding or subsequent example, surgical system 205 may include computing device 210 operating as or operating as part of a control system (for instance, system 100), a tracking system 115, a surgical instrument, and / or the like. Optionally, in any preceding or subsequent example, surgical system 205 may also include or may be operatively coupled to a display device 242 and / or a one or more data sources (for instance, databases) 262a-n.

[0083] In any preceding or subsequent example, display device 242 and / or databases 262a- n may be used to provide navigation and control of a surgical instrument, which may include navigation and control of a cutting tool, a point probe, a bur, a bone saw, a reamer, or other tools / instruments, that may be used during an arthroplasty procedure, such as an orthopedic (or similar) prosthetic implant surgery.

[0084] In any preceding or subsequent example, display device 242 and / or databases 262a- n may be used to provide control of an electrical stimulation system 310 (see, for example, FIG. 3), which may include control of one or more stimulation elements used to stimulate a nerve or muscle of a sedated patient.

[0085] Computing device 210 may include one or more computing devices configured to coordinate information received from tracking system 115 and provide control to an electrical stimulation system. In any preceding or subsequent example, computing device 210 may include a planning module 212, a navigation module 214, a control module 216, and a communication interface 240.Attorney Docket No.: 8178.6101WO

[0086] In an example, such as for a total knee arthroplasty (TKA) procedure, planning module 212 may be used to generate and / or present a virtual model of a patient anatomy, such as a knee joint and / or components thereof, such as a patella, femur (distal end of the femur), and / or tibia (proximal end of the tibia). In some examples, the virtual model may include prepared knee anatomy and / or implant components. In various examples, the virtual model may be created through use of a point probe or similar instrument tracked by tracking system 115.

[0087] Planning module 212 may be used to collect patient information from surfaces of the knee anatomy a virtual model of the patient's actual anatomical structure. This method may, among other things, increase the accuracy of the planning process by using data collected from the patient’s actual anatomy to allow for, among other things, the accurate and / or iterative shaping / preparation of knee anatomy and / or component selection and positioning.

[0088] In an example, navigation module 214 may coordinate tracking the location and orientation of the implant components, the implant host (for instance, the patient patella, femur, tibia, and / or the like), and / or surgical instruments. In certain examples, navigation module 214 may also coordinate tracking of the virtual models used during pre-operative or intraoperative planning within planning module 212. Tracking the virtual models may include operations such as alignment of the virtual models with the implant host, generating predicted performance information, through data obtained via tracking system 115. In these examples, navigation module 214 receives input from tracking system 115 regarding the physical location and orientation of surgical instrument and the anatomical kneeAttorney Docket No.: 8178.6101WO components of the patient. Tracking of the implant host may include tracking multiple individual bone structures, such as with tracking arrays. For example, during a TKA procedure, tracking system 115 may track the femur, tibia, and / or patella using individual tracking devices engaged with each of the femur, tibia, and / or patella.

[0089] In some examples, navigation module 214 may operate to produce visual elements or animations to assist the surgeon during an operative procedure. Visual elements or animations may be displayed via a display device, such as display device 242. In an example, the visual animations may include real-time or substantially real-time 3D representations of the implant, the patella, the femur, the tibia, muscles, tendons, and / or surgical instrument, among other things.

[0090] In some examples, control module 216 may operate to control stimulation system 310 to cause stimulation of muscles of a patient. FIG. 3 depicts an operating environment in accordance with one or more features of the present disclosure. As shown in FIG. 3, operating environment 300 includes a stimulation control system 311 having a signal generator 311 and a signal transmitter 312. Stimulation control system 311 may be configured to electrically stimulate the nerves and / or muscles of a patient 360 to cause contraction and / or relaxation of muscles of target stimulation anatomy 350. Stimulation control system 311 may be configured to perform various stimulation techniques including, without limitation, electrical muscle stimulation (EMS), functional electrical stimulation (FES), functional electrical therapy (FET), transcutaneous electrical stimulation (TES), and neuromuscular electrical stimulation (NMES).Attorney Docket No.: 8178.6101WO

[0091] Non-limiting examples of electrical stimulation and stimulation parameters include Maffiuletti et al., “Neuromuscular Electrical Stimulation for Preventing Skeletal-Muscle Weakness and Wasting in Critically Ill Patients: A Systematic Review,” BMC Medicine, Volume 11, Article number: 137 (2013) and Makssoud et al., “Multiscale Modeling of Skeletal Muscle Properties and Experimental Validations in Isometric Conditions,” Biol. Cybernet, Vol. 105 (2), pp. 121-138 (2011), the entire contents of each of which are hereby incorporated by reference into the present disclosure.

[0092] Stimulation control system 311 may be communicatively coupled to one or more stimulation elements 320a-n in contact with (or in contact with structures to stimulate) patient target stimulation anatomy 350. In some examples, stimulation elements 320a-n may include electrodes, pads, fabrics, meshes, and / or the like operative to provide electrical energy to patient anatomy. Stimulation elements 320a-n can be placed epidermal (above the skin) or hypodermic (subcutaneous, percutaneous, or below the skin). Hypodermic placement may include attaching stimulation elements 320a-n directly under the skin (percutaneous) or fully embedded deeper into the muscle or the areas surrounding a targeted nerve. In any preceding or subsequent example, stimulation elements 320a-n may be configured to stimulate nerves of the spinal cord to effectuate muscle contraction and / or relaxation.

[0093] In some examples, target stimulation anatomy 350 may include any muscle or muscle group (or nerves that may stimulate a muscle or muscle group) and / or tendon (e.g., patella tendon or quadriceps tendon) that may cause or may affect the articulation of the knee joint. In some examples, target stimulation anatomy 350 includes one or more musclesAttorney Docket No.: 8178.6101WO of the quadri cep muscle group. In various examples, target stimulation anatomy 350 includes one or more of the rectus femoris, the vastus lateralis, the vastus medialis, and / or the vastus intermedius. In some examples, target stimulation anatomy 350 includes one or more muscles of the hamstring muscle group. In various examples, target stimulation anatomy 350 includes the biceps femoris, the semimembranosus, and / or the semitendinosus. In some examples, target stimulation anatomy 350 includes one or more of the calf muscles. In some examples, target stimulation anatomy 350 includes the anterior tibialis, the gastrocnemius, and / or the Soleus.

[0094] In some examples, the electrical stimulation may be configured to directly stimulate the target stimulation anatomy 350. In various examples, the electrical stimulation may stimulate target stimulation anatomy 350 indirectly, for example, via stimulation of a nerve or other nervous system component to stimulate target stimulation anatomy 350.

[0095] In various examples, the stimulation may cause articulation of the knee in various directions, including through degrees of flexion / extension, applying force with medial and lateral variances, and / or the like.

[0096] In some examples, signal generator 311 may be configured to generate an electrical signal that may be transmitted via a signal transmitter 312 to stimulation elements 320a-n to cause the electrical signal to affect a muscle or nerve of target stimulation anatomy 350. The signal generated by signal transmitter 312 may have various signal properties, such as a voltage, an amperage, a frequency, an amplitude, pulses, pulse patterns, pulse width, burst duration, burst pattern, cycles, and / or the like.Attorney Docket No.: 8178.6101WO

[0097] In some examples, the electrical stimulation may include a current amplitude of about 0 to about 500 mA, a pulse width of about 0 to about 500 ms, and a pulse frequency of about 0 to about 500 Hz. An operator may control the signal properties, for instance, via computing device 210 and / or control module 216.

[0098] One or more tracking elements 330a-n of tracking system 115 may be coupled to or otherwise associated with target tracking anatomy 351. In some examples, the one or more tracking elements 330a-n may include one or more discs (e.g., reflective discs) attached to a structure for holding the discs. Alternatively, the one or more tracking elements 330a-n may be of any shape or form factor. This may include adhesive tags, magnetic mounts, embedded sensors, clip on modules, leg or arm bands, clip-on devices, smart clothing, skin patches, implantable devices, or other suitable tracking elements 330a- n suitable for the tracking system 115 to track movement of the tracking elements 330a-n and thereby the anatomy of the patient. In some examples, target tracking anatomy 351 may include any anatomy to be tracked as part of a surgical process, including, without limitation, a tibia, a femur, a patella, a tibial implant component (or trial), a femoral implant component (or trial), a patella implant component (or trial), and / or the like.

[0099] Accordingly, operating environment 300 may be configured to allow for electrical stimulation of target stimulation anatomy 350 (e.g., quad muscles, hamstring muscles, and / or calf muscles) of patient 360 and tracking of target tracking anatomy 351 (e.g., tibia, femur, and / or patella) to generate patient anatomical information (patient information 232) resulting from natural (i.e., muscle-induced) movement of the knee on a sedated patient intraoperatively.Attorney Docket No.: 8178.6101WO

[0100] Referring back to FIG. 2, in some examples, communication interface 240 may facilitate communication between computing device system 210 and external systems and devices. Communication interface 240 may include both wired and wireless communication interfaces, such as Ethernet, IEEE 802.11 wireless, or Bluetooth, among others. As illustrated in FIG. 2, in this example, the primary external systems connected via the communication interface 240 may include tracking system 115 and stimulation system 310.

[0100] In some examples, computing device 210 may operate to generate and / or access virtual or anatomical models of a patient. For example, computing device 210 may operate to generate anatomical models of a patient via an anatomical model generation process the same or similar to the methods described in U.S. Patent Application Publication No. 2019 / 0365474, titled “Systems and Methods for Planning and Performing Image Free Implant Revision Surgery,” and / or PCT International Application No. PCT / US2020 / 054231, titled “Registration of Intramedullary Canal During Revision Total Knee Arthroplasty,” both of which are incorporated by reference in the present disclosure as if fully written herein. Preceding or subsequent examples are not limited in this context. For example, surgical planning processes according to any preceding or subsequent example may generate and / or access anatomical models created via various other processes (for instance, image-based processes) capable of operating with any preceding or subsequent example described in the present disclosure.

[0101] The anatomical models may be or may include virtual representations of portions of the patient, such as the tibia, femur, patella, and / or implant components thereof, forAttomey Docket No.: 8178.6101WO example, the same or similar to the computer models of patient anatomy provided in the Cori® and / or Navio® surgical systems. The anatomical models may be graphically depicted via display device 242 and visually manipulated (for instance, rotated, moved, viewed wholly or partially transparent or semi-transparent, viewed as wireframe or similar images, and / or the like).

[0102] In one non-limiting example, the anatomical model generation process may include an image-free process using a point probe (for instance, an optically tracked point probe) to map the actual surface of the target bone(s) that need a new implant. Mapping may be performed after removal of the defective or worn-out implant, as well as after removal of any diseased or otherwise unwanted bone. Points may be collected on the bone surfaces via “painting” by brushing or scraping the entirety of the remaining bone with the tip of the point probe. The collected points may be used to create a three-dimensional model or surface map of the bone surfaces in the computerized planning system. In another nonlimiting example, an anatomical model may be mathematically accomplished by capturing a series of Cartesian coordinates that represent the tissue surface, for instance, to generate a model file (for instance, without limitation, *.stl, *.obj., *.fea, *.stp, *.sur, *.igs, *.wrl, *.xyz, and / or the like file formats). In an additional non-limiting example, the anatomical model generation process may include an image-based process based on diagnostic images of the subject anatomy of a patient, such as X-ray images, CT images, and / or the like. Image analysis software may be used to analyze the diagnostic images to generate anatomical models, such as 3D models. In any preceding or subsequent example, the anatomical model generation process may use a combination of image-free and image-Attorney Docket No.: 8178.6101WO based processes. In any preceding or subsequent example, at least a portion of the information used to generate a patella model may include information manually entered by a surgeon (for instance, dimensions). In general, anatomical models according to any preceding or subsequent example may be generated using various processes, including, without limitation, traditional probe painting, 3D imaging mapped with references, visual edge detection, combinations thereof, and / or the like.

[0103] For a particular surgical procedure, such as a TKA procedure, the procedure or episode of care can include three phases: pre-operative, intra-operative, and post-operative. During each phase, data may be collected or generated that can be used to analyze the episode of care. Accordingly, display device 242 may operate as an interactive interface that can dynamically update and display how changes to the surgical plan (for instance, visualization of cuts or other patella preparations) would impact the procedure and the final performance of the implant and / or patella.

[0104] Computing device (or control system) 210 may include a processor circuitry 220 that may include and / or may access various logics for performing processes according to any preceding or subsequent example, for example, a surgical planning process. For instance, processor circuitry 220 may include and / or may access a computer-assisted surgery logic 222. Processing circuitry 220 and / or computer-assisted surgery logic 222, and / or portions thereof may be implemented in hardware, software, or a combination thereof. As used in this application, the terms “logic,” “component,” “layer,” “system,” “circuitry,” “decoder,” “encoder,” “control loop,” and / or “module” are intended to refer to a computer-related entity, either hardware, a combination of hardware and software,Attorney Docket No.: 8178.6101WO software, or software in execution, examples of which may be provided by exemplary computing architecture. For example, a logic, circuitry, or a module may be and / or may include, but are not limited to, a process running on a processor, a processor, a hard disk drive, multiple storage drives (of optical and / or magnetic storage medium), an object, an executable, a thread of execution, a program, a computer, hardware circuitry, integrated circuits, application specific integrated circuits (ASIC), programmable logic devices (PLD), digital signal processors (DSP), field programmable gate array (FPGA), a system- on-a-chip (SoC), memory units, logic gates, registers, semiconductor device, chips, microchips, chip sets, software components, programs, applications, firmware, software modules, computer code, a control loop, a computational model or application, an Al model or application, an ML model or application, a proportional-integral-derivative (PID) controller, FG circuitry, variations thereof, combinations of any of the foregoing, and / or the like.

[0105] Although computer-assisted surgery logic 222 is depicted as being within processor circuitry 220 in FIG. 1, any preceding or subsequent examples are not so limited. For example, computer-assisted surgery logic 222 and / or any component thereof may be located within an accelerator, a processor core, an interface, an individual processor die, a memory, a storage device, a data store, a database, implemented entirely or partially as a software application (for instance, a computer-assisted surgery application 236), and / or the like.

[0106] Memory unit 230 may include various types of computer-readable storage media and / or systems in the form of one or more higher speed memory units, such as read-onlyAttorney Docket No.: 8178.6101WO memory (ROM), random-access memory (RAM), dynamic RAM (DRAM), Double-Data- Rate DRAM (DDRAM), synchronous DRAM (SDRAM), static RAM (SRAM), programmable ROM (PROM), erasable programmable ROM (EPROM), electrically erasable programmable ROM (EEPROM), flash memory, polymer memory such as ferroelectric polymer memory, ovonic memory, phase change or ferroelectric memory, silicon-oxide-nitride-oxide-silicon (SONOS) memory, magnetic or optical cards, an array of devices such as Redundant Array of Independent Disks (RAID) drives, solid state memory devices (e.g., USB memory, solid state drives (SSD) and any other type of storage media suitable for storing information. In addition, memory unit 230 may include various types of computer-readable storage media in the form of one or more lower speed memory units, including an internal (or external) hard disk drive (HDD), a magnetic floppy disk drive (FDD), and an optical disk drive to read from or write to a removable optical disk (e.g., a CD-ROM or DVD), a solid-state drive (SSD), and / or the like.

[0107] Memory unit 230 may store various types of information and / or applications for performing features and processes according to any preceding or subsequent example, for instance, a surgical planning process according to any preceding or subsequent example. For example, memory unit 230 may store patient information 232, surgical plans 234, and / or computer-assisted surgery application 236. In any preceding or subsequent example, all or some of the information depicted as being stored in memory unit 230 may be, in whole or in part, stored in data sources 262a-n and accessible to computing device 210.

[0108] In any preceding or subsequent example, patient information 232 may include information for a patient undergoing a surgical procedure being performed via surgicalAttorney Docket No.: 8178.6101WO system. Patient information 232 may include personal information (for instance, name, address, and / or the like), physical characteristics (for instance, height, weight, and / or the like), medical information (for instance, health history, health record identifiers, procedure information, and / or the like), and / or any other type of information that may be associated with a patient.

[0109] In various, patient information 232 may include patient anatomical information determined via tracking system 115. For example, information determined using tracking elements 330a-n via tracking system 115 resulting from articulation of the knee joint induced by electrical stimulation using stimulation system 310 may be stored as patient anatomical information of patient information 232. In any preceding or subsequent example, the patient anatomical information may be or may include kinematic information relating to the pattern of motion having six degrees of freedom. In any preceding or subsequent example, the patient anatomical information may be or may include knee performance information.

[0110] In various examples, a surgical plan 250 may include instructions, method, steps, workflows, and / or the like for performing a surgical procedure. In any preceding or subsequent example, surgical system 205 may develop a surgical plan 250 based on anatomical models and other information specific to the patient (for instance, patient information 232), including patient anatomical information generated via electrical stimulation of target stimulation anatomy 350. In some examples, surgical plans 250 may include implant (or implant trial) selections (e.g., size, shape, type, and / or the like) and / or positioning.Attorney Docket No.: 8178.6101WO

[0111] Surgical plans 250 may be administered, in whole or in part, manually by a surgeon, automatically (for instance, computer- or robot-assisted) via computer-controlled surgical instruments 150, and / or combinations thereof. Preceding or subsequent examples are not limited in this context.

[0112] In some examples, computer-assisted surgery logic 222 may operate to perform, implement, or otherwise provide computer-assisted surgery processes for surgical system 205 according to any preceding or subsequent example. For instance, in any preceding or subsequent example, computer-assisted surgery logic 222 may operate to manage or control operational features of planning module 212, navigation module 214, control module 216, tracking system 115, and / or stimulation system 310 described in the present disclosure. In another example, computer-assisted surgery logic 222 may perform, implement, or otherwise provide surgical planning processes according to any preceding or subsequent example.

[0113] In any preceding or subsequent example, computer-assisted surgery application 236 may be or may include a software application that includes and / or operates in combination with computer-assisted surgery logic 222 to perform features of surgical system 205 described in the present disclosure. For example, computer-assisted surgery application 236 may operate to present user interfaces via display device 242.

[0100] FIG. 4 depicts operation of a surgical system in accordance with one or more features of the present disclosure. In certain examples, FIG. 4 depicts the collection of position data relating to the location and orientation of target tracking anatomy 351 monitored via tracking element(s) 330 of tracking system 115 through a range of motionAttorney Docket No.: 8178.6101WO from nearly full extension 401 to nearly full flexion 402 caused by electrical stimulation of target stimulation anatomy 350 via stimulation control system 310 as instructed by control module 216 of computing device 310.

[0101] In various examples, target tracking anatomy 351 may be or may include native patient anatomy (i.e., original patient proximal tibia, distal femur, and / or patella). In some examples, target tracking anatomy 351 may be or may include implant components and / or trials thereof. For example, a surgeon may determine implant or implant trial components as part of a surgical procedure. The implant or implant trial components may be implanted into the patient and electrical stimulation applied to determine patient anatomical information, including, without limitation, parameters, measurements, kinematics, performance, and / or the like.

[0102] FIG. 5 depicts correlation information in accordance with one or more features of the present disclosure. In some examples, the results of stimulating patient anatomy and tracking the resultant patient anatomical information may be stored as correlation information 505. In various examples, correlation information 505 may correlate electrical signals with resulting knee anatomy information to relate electrical stimulation with patient movement. For example, planning module 212 may access the stimulation information provided to control stimulation system 310 and the resulting tracking information of the anatomical tracking information and correlate them for storage as correlation information 505.Attorney Docket No.: 8178.6101WO

[0103] In some examples, correlation information 505 may be or may include information to map patella tracking relative to the femur and / or tibia with quad-loading conditions provided via the electrical stimulation.

[0104] In one example, a patient may have an anatomical information set X (e.g., degree of flexion / extension, kinematics, six degrees of freedom information, joint lines, femur location, tibia location, patella location, and / or the like) for native knee anatomy. Application of electrical signals having property set Y (e.g., current amplitude, pulse width, pulse frequency, and / or the like) may cause the patient to have anatomical information set X-l for the native knee anatomy. If an implant component or trial is implanted into the patient, application of electrical signal property set Y for anatomical information set X (i.e., the knee with the trial component is put in the same or substantially the same position to obtain anatomical information set X) should cause the patient to have anatomical information set X-l (for instance, within a threshold amount). In this manner, the movement of the knee induced by electrical stimulation according to some examples may facilitate monitoring whether an implant component or trial may operate the same or substantially similar as native patient anatomy.

[0105] Correlation information 505 may include stimulation information 510 having information elements 51 la-n. In some examples, information elements 51 la-n may include electrical signal or stimulation parameters, such as a voltage, an amperage, a frequency, an amplitude, pulses, pulse patterns, pulse width, burst duration, burst pattern, cycles, and / or the like. In various examples, correlation information 505 may include patient anatomical information 520 having information elements 52 la-n. In some examples, informationAttorney Docket No.: 8178.6101WO elements 521a-n may include patient anatomical information such as degree of flexion / extension, kinematics, six degrees of freedom information, joint lines, femur location, tibia location, patella location, and / or the like. In various examples, information elements 521a-n may indicate a particular position or state of knee anatomy (for instance, degree of flexion and / or degree of freedom information).

[0106] In various examples, stimulation information 510 (or information sets thereof) may be stored to corresponding to certain states or information sets of patient anatomical information 520. In various examples, stimulation information 510 (or information sets thereof) may be stored to corresponding to certain state transitions (as indicated by patient anatomical information 520) resulting from stimulation according to a stimulation information set. For example, stimulation information set A (current amplitude = 100, pulse width = 100, pulse frequency = 100) caused patient native knee anatomy to transition from knee state B (information set B: flexion = 30 degrees, degree of freedom 1 = 10, degree of freedom 2 = 20, and so on) to knee state C (information set C: flexion = 35 degrees, degree of freedom 1 = 15, degree of freedom 2 = 25, and so on).

[0107] Included herein are one or more workflows representative of exemplary methodologies for performing novel features of the disclosed examples. While, for purposes of simplicity of explanation, the one or more methodologies shown herein are shown and described as a series of acts, those skilled in the art will understand and appreciate that the methodologies are not limited by the order of acts. Some acts may, in accordance therewith, occur in a different order and / or concurrently with other acts from that shown and described herein. For example, those skilled in the art will understand andAttorney Docket No.: 8178.6101WO appreciate that a methodology could alternatively be represented as a series of interrelated states or events, such as in a state diagram. Moreover, not all acts illustrated in a methodology may be required for a novel implementation. Blocks designated with dotted lines may be optional blocks of a workflow.

[0108] A workflow or portions (or steps) thereof may be implemented manually and / or via software, firmware, hardware, or any combination thereof. In software and firmware examples, one or more workflow steps (or logic flow) may be implemented by computer executable instructions stored on a non-transitory computer readable medium or machine readable medium (for instance, executed by CASS 100 or similar system). The examples are not limited in this context.

[0109] FIG. 6 illustrates an example of a surgical workflow 600 in accordance with one or more features of the present disclosure. Workflow 600 may be representative of some or all of the operations executed by or according to any preceding or subsequent example described in the present disclosure to determine a surgical plan.

[0110] At block 601, workflow 600 may include starting the surgical procedure, such as a knee arthroplasty procedure. Starting the surgical procedure may include sedating the patient, making initial incisions (for instance, to expose knee anatomy and / or to place tracking markers or stimulation elements), and / or the like. The steps of starting the surgical procedure may depend on surgeon preference and / or surgical approaches (e.g., medial parapatellar (MP), quadriceps-sparing (QS), and / or the like).[OHl] Workflow 600 may include attaching stimulation elements at block 602. For instance, a set of stimulation elements 320a-n of a stimulation system 310 may be attachedAttorney Docket No.: 8178.6101WO to target anatomy of the patient according to various examples, such as on the skin surface, subcutaneously, and / or the like. The stimulation elements 320a-n may be attached to the patient to stimulate target stimulation anatomy 350 or cause articulation of the knee joint of the patient.

[0112] At block 603, workflow 600 may include attaching a set of tracking elements to the patient. For example, a set of tracking elements 330a-n of tracking system 115 may be attached to the patient (e.g., the knee joint of the patient). In some examples, tracking elements may not be attached to the patient, for instance, if patient information will be determined via a probe or visual processing device. The set of tracking elements are configured to provide patient anatomical information responsive to tracking at least one component of the knee joint articulated via the set of electrical stimulation elements.

[0113] At block 604, workflow 600 may include manipulating patient (e.g., target) anatomy via the stimulation system. For example, an operator may use control module 216 (for instance, via a graphical user interface (GUI) implemented via execution of computer- assisted surgery application 236) to control signal generator 311 of stimulation control system 310. The operator may stimulate target stimulation anatomy, such as the quadriceps muscles, based on one or more signal parameters, such as amplitude, pulse properties, and / or the like. In various examples, the electrical stimulation may cause and / or may be used through various levels of flexion / extension of the patient knee joint. In other words, block 604 includes applying electrical signals to the electrical stimulation elements to manipulate the target anatomy of the patient.Attorney Docket No.: 8178.6101WO

[0114] Workflow 600 may include receiving tracking information at block 605. For example, tracking system 115 may provide tracking information for target tracking anatomy 351 to computer-assisted surgery application 236, for instance, which may be stored as patient anatomical information of patient information 232. In some examples, this includes receiving tracking information from the set of tracking elements. In some examples, the tracking information may be correlated with the electrical stimulation information (see, for example, FIG. 5). The workflow 600 also includes determining patient anatomical information based on the tracking information. The patient anatomical information may include any of the anatomical information discussed herein.

[0115] At block 606, workflow 600 may determine surgical plan information. For example, a surgeon, computer-assisted surgery application 236, and / or a combination thereof, may determine various features of a surgical plan based on the patient anatomical information resulting from the electrical stimulation. Non-limiting features of a surgical plan may include resection information, implant component size, positioning, placement, orientation of a femoral, patella, or tibial component of an implant system for the knee joint of the patient, and / or the like.

[0116] Workflow 600 may include continuing the surgical process at block 607. For example, a surgeon, surgical system 100, and / or a combination thereof may continue with the surgical system to implement the surgical plan, including patient incisions, removal / modification of patient anatomy, insertion of implant components or trials, and / or the like.Attorney Docket No.: 8178.6101WO

[0117] FIG. 7 illustrates an example of a surgical workflow 700 in accordance with one or more features of the present disclosure. Workflow 700 may be representative of some or all of the operations executed by or according to any preceding or subsequent example described in the present disclosure to determine a surgical plan, including testing implant components or trials.

[0118] At block 701, workflow 700 may include installing implant components. For example, implant components and / or implant trials determined based on a surgical plan may be installed in a patient. In various example, the implant components and / or implant trials may be determined, positioned, orientated, and / or the like according to a surgical plan determined using an electrical stimulation process according to some examples, such as via workflow 600.

[0119] Workflow 700 may include attaching stimulation elements at block 702. For instance, stimulation elements 320a-n of a stimulation system 310 may be attached to the patient according to various examples, such as on the skin surface, subcutaneously, and / or the like. The stimulation elements 320a-n may be attached to the patient to stimulate target stimulation anatomy 350.

[0120] At block 703, workflow 700 may include attaching tracking elements to the patient. For example, tracking elements 330a-n of tracking system 115 may be attached to, at least a portion of tracking elements 330a-n may be arranged to track the installed implant components or trials. At block 704, workflow 700 may include manipulating patient anatomy via the stimulation system. Workflow 700 may include receiving tracking information at block 705.Attorney Docket No.: 8178.6101WO

[0121] At block 706, workflow 700 may compare the implant tracking information with patient anatomy tracking information. For example, computer-assisted surgery application 236 may access correlation information 505 to compare how the native patient anatomy compares with the modified anatomy, for instance, implanted with an implant component or trial.

[0122] Workflow 700 may include updating a surgical plan at block 707. For example, a property of the surgical plan, such as resection information and / or component sizing, shape, position, or orientation may be modified based on the comparison of the operation of the native patient anatomy with the modified anatomy. For example, a different size implant or a different position of an implant may be determined for the surgical plan to better correlate the post-surgical knee structure and / or kinematics with pre-surgical knee structure and / or kinematics. In another example, a surgical plan may be updated to provide improved or optimized patella location, position, and / or tracking in a knee arthroplasty procedure.

[0123] In some examples, revised implant components or implant positioning / orientation may be implemented and workflow 700 repeated until a satisfactory correlation between surgically-modified knee structure and / or kinematics matches pre-surgical, native knee structure and / or kinematics.

[0124] The foregoing description has broad application. While the present disclosure refers to certain some examples, numerous modifications, alterations, and changes to the described examples are possible without departing from the sphere and scope of the present disclosure, as defined in the appended claim(s). Accordingly, it is intended that the present disclosure not be limited to the described examples. Rather these examples should beAttorney Docket No.: 8178.6101WO considered as illustrative and not restrictive in character. All changes and modifications that come within the spirit of the disclosure are to be considered within the scope of the disclosure. The present disclosure should be given the full scope defined by the language of the following claims, and equivalents thereof. The discussion of any example is meant only to be explanatory and is not intended to suggest that the scope of the disclosure, including the claims, is limited to these examples. In other words, while illustrative examples of the disclosure have been described in detail herein, it is to be understood that the inventive concepts may be otherwise variously embodied and employed, and that the appended claims are intended to be construed to include such variations, except as limited by the prior art. Unless otherwise defined, all technical terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the disclosure belongs.

[0125] Directional terms such as top, bottom, superior, inferior, medial, lateral, anterior, posterior, proximal, distal, upper, lower, upward, downward, left, right, longitudinal, front, back, above, below, vertical, horizontal, radial, axial, clockwise, and counter-clockwise) and the like may have been used herein. Such directional references are only used for identification purposes to aid the reader’s understanding of the present disclosure. For example, the term “distal” may refer to the end farthest away from the medical professional / operator when introducing a device into a patient, while the term “proximal” may refer to the end closest to the medical professional when introducing a device into a patient. Such directional references do not necessarily create limitations, particularly as to the position, orientation, or use of this disclosure. As such, directional references shouldAttorney Docket No.: 8178.6101WO not be limited to specific coordinate orientations, distances, or sizes, but are used to describe relative positions referencing particular examples. Such terms are not generally limiting to the scope of the claims made herein. Any example or feature of any section, portion, or any other component shown or particularly described in relation to any preceding or subsequent example of similar sections, portions, or components herein may be interchangeably applied to any other similar example or feature shown or described herein.

[0126] It should be understood that, as described herein, an “example” (such as illustrated in the accompanying Figures) or “example” (such as “in some examples”) may refer to an illustrative representation of an environment or article or component in which a disclosed concept or feature may be provided or embodied, or to the representation of a manner in which just the concept or feature may be provided or embodied. However, such illustrated examples are to be understood as examples (unless otherwise stated), and other manners of embodying the described concepts or features, such as may be understood by one of ordinary skill in the art upon learning the concepts or features from the present disclosure, are within the scope of the disclosure. Furthermore, references to “one example” of the present disclosure are not intended to be interpreted as excluding the existence of additional implementations, configurations, and / or examples that also incorporate the recited features.

[0127] In addition, it will be appreciated that while the Figures may show one or more examples of concepts or features together in a single example of an environment, article, or component incorporating such concepts or features, such concepts or features are to be understood (unless otherwise specified) as independent of and separate from one anotherAttorney Docket No.: 8178.6101WO and are shown together for the sake of convenience and without intent to limit to being present or used together. For instance, features illustrated or described as part of one example can be used separately, or with another example to yield a still further example. Thus, it is intended that the present subject matter covers such modifications and variations as come within the scope of the appended claims and their equivalents.

[0128] As used herein, an element or step recited in the singular and proceeded with the word “a” or “an” should be understood as not excluding plural elements or steps, unless such exclusion is explicitly recited. It will be further understood that the terms “comprises” and / or “comprising,” or “includes” and / or “including” when used herein, specify the presence of stated features, regions, steps, elements and / or components, but do not preclude the presence or addition of one or more other features, regions, integers, steps, operations, elements, components and / or groups thereof.

[0129] The phrases “at least one,” “one or more,” and “and / or,” as used herein, are open- ended expressions that are both conjunctive and disjunctive in operation. The terms “a” (or “an”), “one or more” and “at least one” can be used interchangeably herein.

[0130] Connection references (e.g., engaged, attached, coupled, connected, and joined) are to be construed broadly and may include intermediate members between a collection of elements and relative to movement between elements unless otherwise indicated. As such, connection references do not necessarily infer that two elements are directly connected and in fixed relation to each other. Identification references (e g., primary, secondary, first, second, third, fourth, etc.) are not intended to connote importance or priority but are used to distinguish one feature from another. The drawings are for purposes of illustration onlyAttorney Docket No.: 8178.6101WO and the dimensions, positions, order and relative to sizes reflected in the drawings attached hereto may vary.

[0131] The foregoing discussion has been presented for purposes of illustration and description and is not intended to limit the disclosure to the form or forms disclosed herein. For example, various features of the disclosure are grouped together in one or more examples or configurations for the purpose of streamlining the disclosure. However, it should be understood that various features of the certain some examples or configurations of the disclosure may be combined in alternate examples or configurations. Moreover, the following claims are hereby incorporated into this Detailed Description by this reference, with each claim standing on its own as a separate example of the present disclosure.

Claims

Attorney Docket No.: 8178.6101WOCLAIMSWhat is claimed is:

1. A method comprising: attaching a set of electrical stimulation elements to target anatomy of a patient, the set of electrical stimulation elements configured to cause articulation of a knee joint of the patient; attaching a set of tracking elements to the knee joint of the patient, the set of tracking elements configured to provide patient anatomical information responsive to tracking at least one component of the knee joint articulated via the set of electrical stimulation elements; applying electrical signals to the electrical stimulation elements to manipulate the target anatomy of the patient; receiving tracking information from the set of tracking elements; determining patient anatomical information based on the tracking information; and generating a surgical plan for the knee joint of the patient based on the patient anatomical information.

2. The method of claim 1, wherein generating the surgical plan includes selecting at least one of an implant size, placement, or orientation of a femoral, patella, or tibial component of an implant system for the knee joint.

3. The method of claim 1, wherein the target anatomy of the patient includes one or more of: a quadricep muscle group, including one or more of a rectus femoris, a vastus lateralis, a vastus medialis, a vastus intermedius of the patient; a hamstring muscle group, including one or more of a biceps femoris, a semimembranosus, or a semitendinosus of the patient; orAttorney Docket No.: 8178.6101WO a calf muscle group, including one or more of an anterior tibialis, a gastrocnemius, or a soleus of the patient.

4. The method of claim 1, further comprising applying electrical stimulation, via the set of electrical stimulation elements, non-electrical stimulation, or a force to one or more of a patella tendon or quadriceps tendon of the patient to articulate the knee joint.

5. The method of claim 1, further comprising applying electrical stimulation, via the set of electrical stimulation elements, to one or more nerves of the patient.

6. The method of claim 1, wherein the electrical signals are applied in accordance with one or more of electrical muscle stimulation (EMS), functional electrical stimulation (FES), functional electrical therapy (FET), transcutaneous electrical stimulation (TES), or neuromuscular electrical stimulation (NMES).

7. The method of claim 1, wherein the patient anatomical information includes one or more of a femoral joint line orientation, a femoral varus or valgus orientation, a femoral internal and external rotation orientation, or a femoral flexion or extension orientation; wherein the patient anatomical information includes one or more of a tibial internal and external rotation, a tibial posterior slope, a tibial A-P positioning, or a tibial varus or valgus orientation; or wherein the patient anatomical information includes one or more of a native patella size, a patella thickness and shape, a patella orientation and position relative to the femur, a patella internal -external rotation, at full extension, 30° knee flexion.

8. The method of claim 1, wherein the patient anatomical information includes patella tracking relative to a femur or tibia of the patient under quad-loading conditions provided by the electrical signals.Attorney Docket No.: 8178.6101WO9. The method of claim 1, further comprising installing implant components or trial components to the patient knee joint based on the surgical plan.

10. The method of claim 9, wherein a first set of patient anatomical information is determined before the implant components are installed and a second set of patient anatomical information is determined after the implant components are installed, the method further comprising: performing a comparison of the first set of patient anatomical information and the second set of patient anatomical information; and generating an updated surgical plan based on the comparison.

11. A system comprising: a stimulation control system including a set of electrical stimulation elements configured to electrically stimulate target anatomy of a patient to cause articulation of a knee joint of the patient; a tracking system comprising a set of tracking elements configured to provide patient anatomical information responsive to tracking at least one component of the knee joint articulated via the stimulation control system; and a computing device comprising a processing circuit in communication with the stimulation control system and the tracking system, the processing circuit configured to generate a surgical plan based on the patient anatomical information.

12. The system of claim 11, wherein the surgical plan includes a selection of at least one of a size, a placement, or an orientation of a femoral, patella, or tibial component of an implant system for the knee joint.

13. The system of claim 11, wherein the target anatomy of the patient includes one or more of:Attorney Docket No.: 8178.6101WO a quadricep muscle group, including one or more of a rectus femoris, a vastus lateralis, a vastus medialis, a vastus intermedius of the patient; a hamstring muscle group, including one or more of a biceps femoris, a semimembranosus, or a semitendinosus of the patient; or a calf muscle group, including one or more of an anterior tibialis, a gastrocnemius, or a soleus of the patient.

14. The system of claim 11, wherein the stimulation control system is configured to apply electrical stimulation, via the set of electrical stimulation elements, non-electrical stimulation, or a force to one or more of a patella tendon or quadriceps tendon of the patient to articulate the knee joint.

15. The system of claim 11, wherein the stimulation control system is configured to apply electrical stimulation, via the set of electrical stimulation elements, to one or more nerves of the patient.

16. The system of claim 11, wherein the stimulation control system is activated in accordance with one or more of electrical muscle stimulation (EMS), functional electrical stimulation (FES), functional electrical therapy (FET), transcutaneous electrical stimulation (TES), or neuromuscular electrical stimulation (NMES).

17. The system of claim 11, wherein the patient anatomical information includes one or more of a femoral joint line orientation, a femoral varus or valgus orientation, a femoral internal and external rotation orientation, or a femoral flexion or extension orientation; wherein the patient anatomical information includes one or more of a tibial internal and external rotation, a tibial posterior slope, a tibial A-P positioning, or a tibial varus or valgus orientation; orAttorney Docket No.: 8178.6101WO wherein the patient anatomical information includes one or more of a native patella size, a patella thickness and shape, a patella orientation and position relative to the femur, a patella internal -external rotation, at full extension, 30° knee flexion.

18. The system of claim 11, wherein the patient anatomical information includes patella tracking relative to a femur or tibia of the patient under quad-loading conditions provided by the electrical signals.

19. The system of claim 11, wherein implant components or trial components are installed to the patient knee joint based on the surgical plan.

20. The system of claim 19, wherein a first set of patient anatomical information is determined before the implant components are installed and a second set of patient anatomical information is determined after the implant components are installed; and wherein the computing device is further configured to: perform a comparison of the first set of patient anatomical information and the second set of patient anatomical information; and generate an updated surgical plan based on the comparison.

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