METHODS FOR ALIGNING SENSOR-ENABLED PROSTHESIS DURING ROBOTICALLY-ASSISTED ARTHROPLASTY

A method for registering output of sensor-enabled implants with a bone axis during robotically-assisted arthroplasty procedures comprises registering anatomy of a patient to a surgical tracking system, determining a bone axis of a bone of the anatomy using the surgical tracking system, preparing the bone to receive a prosthetic implant including an orientation sensor, inserting the prosthetic implant into the bone, obtaining orientation output from the orientation sensor, and shifting the orientation output from the orientation sensor to align with the bone axis. A system for registering output of sensor-enabled implants with a bone axis during robotically-assisted arthroplasty procedures comprises a surgical robot comprising an arm configured to move within a coordinate system, a tracking system configured determine locations of one or more trackers in the coordinate system, a sensor-enabled implant configured to implanted into anatomy and output orientation data, and a controller for the surgical robot.

TECHNICAL FIELD

The present disclosure is directed to devices and methods for use in performing a joint arthroplasty, such as knee, hip and shoulder replacement procedures. In examples, the devices and methods can be used to facilitate alignment of sensor-enabled orthopedic implants with anatomy of a patient.

BACKGROUND

Arthroplasty procedures involve the implantation of medical devices, e.g., orthopedic implants, into anatomy of a patient. Typically, once the medical device is implanted into the patient, or even while it is being implanted, it is difficult to obtain feedback regarding the effectiveness of the implant or the implant procedure. Attempts have been made to obtain data from orthopedic implants using sensors.

Pub. No. US 2018/0125365 to Hunter et al. is titled “Devices, Systems and Methods for Using and Monitoring Medical Devices.”

Pub. No. US 2019/0350518 to Bailey et al. is titled “Implantable Reporting Processor for an Implant.”

Overview

The present inventor has recognized, among other things, that problems to be solved with sensor-enabled implants involve positioning of the sensor relative to the anatomy. Sensor-enabled implants can include sensors configured to provide motion output relative to an internal frame of reference. For example, sensors included within sensor modules of various prosthetic devices can include one or more 3-axis sensors or accelerometers configured to provide output of movement of the sensor module. It is desirable to implant the sensor module within a known frame of reference such that output of the sensor module can be correlated to kinematic movement of the patient. Typically, the sensor module can be registered to the anatomy of the patient via alignment to the prosthetic device in a known manner. However, due to a variety of factors, the intended orientation of the sensor module can be skewed relative to the anatomy such that data output of the sensor module can be inaccurate or shifted from the desired frame of reference. For example, misalignment of the sensor module to the prosthetic device, misalignment of the prosthetic device to the anatomy, imperfections in resection planes and the like can result in sensor module output being offset from the desired reference frame. The skewed sensor data can be corrected post-operatively. But such post-operative adjustment of the sensor module output can sometimes occur after a period of time before the misalignment is detected, can take multiple recalibration attempts and can be less accurate than if properly aligned from the outset.

The present inventor has recognized that robotic surgical systems can be used to solve problems associated with sensor-enabled implants. In robotic surgical systems, the shape of the anatomy of a patient obtained from patient imaging can be registered with another frame of reference, such as the physical space of an operating room where the robotic surgical system is located, which can be associated with surgical landmarks such as bone landmarks in the anatomy to, for example, help estimate anatomical and kinematic axes. The surgical system can utilize an optical tracking system that can track the location and position of tracking arrays attached to various objects, such as instruments, anatomy and the robotic surgical arm. Robotic surgical arms can be used to hold various instruments in place in a desired orientation relative to both the anatomy and operating room during a procedure so that movement of an instrument in the operating room relative to the anatomy can be tracked on the anatomic imaging based on movement of the robotic surgical arm. As such, robotic surgical systems include a robotic frame of reference in which an anatomic frame of reference of a patient is known. With the present disclosure, the robotic frame of reference of a robotic surgical system can be used to align output of a sensor module to the anatomic frame of reference of the patient. For example, output of a sensor-enabled implant and orientation output from tracking arrays associated with bones and/or kinematic axes can be correlated to register output of the sensor-enabled implant to the anatomic reference frame.

In an example, a method for registering output of a sensor-enabled implant with a bone axis during a robotically-assisted arthroplasty procedure can comprise registering anatomy of a patient to a surgical tracking system, determining a bone axis of a bone of the anatomy using the surgical tracking system, preparing the bone to receive a prosthetic implant including an orientation sensor, inserting the prosthetic implant into the bone, obtaining orientation output from the orientation sensor, and shifting the orientation output from the orientation sensor to align with the bone axis.

In an additional example, a system for registering output of a sensor-enabled implant with a bone axis during a robotically-assisted arthroplasty procedure can comprise a surgical robot comprising an articulating arm configured to move within a coordinate system for the surgical robot, a tracking system configured determine locations of one or more trackers in the coordinate system, a sensor-enabled implant configured to be implanted into anatomy and output orientation data, and a controller for the surgical robot comprising a communication device configured to receive data from and transmit data to the surgical robot, the tracking system and the sensor-enabled implant, a display device for outputting visual information from the surgical robot, the tracking system and the sensor-enabled implant and a non-transitory storage medium having computer-readable instructions stored therein comprising registering anatomy of a patient to a surgical tracking system, determining a bone axis of a bone of the anatomy using the surgical tracking system, obtaining orientation output from an orientation sensor of a sensor-enabled prosthetic implant implanted into bone, and shifting the orientation output from the orientation sensor to align with the bone axis.

DETAILED DESCRIPTION

FIG.1is a diagrammatic view of surgical system100for operation on surgical area105of patient110in accordance with at least one example of the present disclosure. Surgical area105in one example can include a joint and, in another example, can be a bone. Surgical area105can include any surgical area of patient110, including but not limited to the shoulder, knee, hip, head, elbow, thumb, spine, and the like. Surgical system100can also include robotic system115with one or more robotic arms, such as robotic arm120. As illustrated, robotic system115can utilize only a single robotic arm. Robotic arm120can be a 6 degree-of-freedom (DOF) robot arm, such as the ROSA® robot from Medtech, a Zimmer Biomet Holdings, Inc. company. In some examples, robotic arm120is cooperatively controlled with surgeon input on the end effector or surgical instrument, such as surgical instrument125. In other examples, robotic arm120can operate autonomously. While not illustrated inFIG.1, one or more positionable surgical support arms can be incorporated into surgical system100to assist in positioning and stabilizing instruments or anatomy during various procedures.

Each robotic arm120can rotate axially and radially and can receive an end effector, such as surgical instrument125, at distal end130. Surgical instrument125can be any surgical instrument adapted for use by the robotic system115, including, for example, a guide tube, a holder device, a gripping device such as a pincer grip, a burring device, a reaming device, an impactor device such as a humeral head impactor, a pointer, a probe, a cutting guide, an instrument guide, an instrument holder or a universal instrument adapter device as described herein or the like. Surgical instrument125can be positionable by robotic arm120, which can include multiple robotic joints, such as joints135, that allow surgical instrument125to be positioned at any desired location adjacent or within a given surgical area105. As discussed below, robotic arm120can be used with resection guide instrument200ofFIGS.2and6to perform a proximal tibial resection for a total knee arthroplasty. Robotic arm120can additionally be used with sensor-enabled implants, such as sensor-enabled implant241ofFIGS.3and4.

Robotic system115can also include computing system140that can operate robotic arm120and surgical instrument125. Computing system140can include at least memory, a processing unit, and user input devices, as will be described herein. Computing system140and tracking system165can also include human interface devices145for providing images for a surgeon to be used during surgery. Computing system140is illustrated as a separate standalone system, but in some examples computing system140can be integrated into robotic system115. Human interface devices145can provide images, including but not limited to three-dimensional images of bones, glenoids, knees, joints, and the like. In examples, human interface device145can be used to display an axis of a sensor module for a sensor-enabled implant, such as sensor module axis264ofFIG.3A. Human interface devices145can include associated input mechanisms, such as a touch screen, foot pedals, or other input devices compatible with a surgical environment. As discussed below, computing system140can interact with base station230ofFIG.2and surgical helmet340ofFIG.8.

Computing system140can receive pre-operative, intra-operative and post-operative medical images. These images can be received in any manner and the images can include, but are not limited to, computed tomography (CT) scans, magnetic resonance imaging (MRI), two-dimensional x-rays, three-dimensional x-rays, ultrasound, and the like. These images in one example can be sent via a server as files attached to an email. In another example the images can be stored on an external memory device such as a memory stick and coupled to a USB port of the robotic system to be uploaded into the processing unit. In yet other examples, the images can be accessed over a network by computing system140from a remote storage device or service.

After receiving one or more images, computing system140can generate one or more virtual models related to surgical area105. Alternatively, computing system140can receive virtual models of the anatomy of the patient prepared remotely. Specifically, a virtual model of the anatomy of patient110can be created by defining anatomical points within the image(s) and/or by fitting a statistical anatomical model to the image data. The virtual model, along with virtual representations of implants, can be used for calculations related to the desired location, height, depth, inclination angle, or version angle of an implant, stem, acetabular cup, glenoid cup, total ankle prosthetic, total and partial knee prosthetics, surgical instrument, or the like to be utilized in surgical area105. As discussed below, digital model304D of tibia304is shown inFIG.9A. In another procedure type, the virtual model can be utilized to determine resection locations on femur and tibia bones for a partial knee arthroplasty. In a specific example, the virtual model can be used to determine the orientation of a sensor-enabled implant relative to anatomic landmarks. The virtual model can also be used to determine bone dimensions, implant dimensions, bone fragment dimensions, bone fragment arrangements, and the like. Any model generated, including three-dimensional models, can be displayed on human interface devices145for reference during a surgery or used by robotic system115to determine motions, actions, and operations of robotic arm120or surgical instrument125. Known techniques for creating virtual bone models can be utilized, such as those discussed in U.S. Pat. No. 9,675,461, titled “Deformable articulating templates” or U.S. Pat. No. 8,884,618, titled “Method of generating a patient-specific bone shell” both by Mohamed Rashwan Mahfouz, as well as other techniques known in the art.

Computing system140can also communicate with tracking system165that can be operated by computing system140as a stand-alone unit. Surgical system100can utilize the Polaris optical tracking system from Northern Digital, Inc. of Waterloo, Ontario, Canada. Additionally, tracking system165can comprise the tracking system shown and described in Pub. No. US 2017/0312035, titled “Surgical System Having Assisted Navigation” to Brian M. May, which is hereby incorporated by this reference in its entirety. Tracking system165can monitor a plurality of tracking elements, such as tracking elements170, affixed to objects of interest to track locations of multiple objects within the surgical field using a tracker, such as a camera. Tracking system165can interact with tracking element348and tracking element350ofFIG.8to determine the relative positions and orientations of tibia304and femur302. Tracking system165can function to create a virtual three-dimensional coordinate system within the surgical field for tracking patient anatomy, surgical instruments, or portions of robotic system115. Tracking elements170can be tracking frames including multiple IR reflective tracking spheres, or similar optically tracked marker devices. In one example, tracking elements170can be placed on or adjacent one or more bones of patient110. In other examples, tracking elements170can be placed on robotic arm120, surgical instrument125, and/or an implant to accurately track positions within the virtual coordinate system associated with surgical system100. In each instance tracking elements170can provide position data, such as patient position, bone position, joint position, robotic arm position, implant position, or the like.

Robotic system115can include various additional sensors and guide devices. For example, robotic system115can include one or more force sensors, such as force sensor180. Force sensor180can provide additional force data or information to computing system140of robotic system115. Force sensor180can be used by a surgeon to cooperatively move robotic arm120. For example, force sensor180can be used to monitor impact or implantation forces during certain operations, such as insertion of an implant stem into a humeral canal. Monitoring forces can assist in preventing negative outcomes through force fitting components. In other examples, force sensor180can provide information on soft-tissue tension in the tissues surrounding a target joint. In examples, robotic system115can also include laser pointer185that can generate a laser beam that is used for alignment of implants during surgical procedures. In examples, laser pointer185can be used to generate images of sensor module axis264(FIG.3A) and tibial axis308(FIG.5) onto a tibia of patient110.

In order to ensure that computing system140is moving robotic arm120in a known and fixed relationship to surgical area105and patient110, the space of surgical area105and patient110can be registered to computing system140via a registration process involving registering fiducial markers attached to patient110with corresponding images of the markers in patient110recorded preoperatively or just prior to a surgical procedure. For example, a plurality of fiducial markers can be attached to patient110, images of patient110with the fiducial markers can be taken or obtained and stored within a memory device of computing system140. Subsequently, patient110with the fiducial markers can be moved into, if not already there because of the imaging, surgical area105and robotic arm120can touch each of the fiducial markers. Engagement of each of the fiducial markers can be cross-referenced with, or registered to, the location of the same fiducial marker in the images. In additional examples, patient110and medical images of the patient can be registered in real space using contactless methods, such as by using a laser rangefinder held by robotic arm120and a surface matching algorithm that can match the surface of the patient from scanning of the laser rangefinder and the surface of the patient in the medical images. As such, the real-world, three-dimensional geometry of the anatomy attached to the fiducial markers can be correlated to the anatomy in the images and movements of surgical instrument125attached to robotic arm120based on the images will correspondingly occur in surgical area105.

Subsequently, other instruments and devices attached to surgical system100can be positioned by robotic arm120into a known and desired orientation relative to the anatomy. For example, robotic arm120can be coupled to resection guide instrument200ofFIG.2, that can be used to guide resections on multiple bones (e.g., proximal tibia and distal femur) and that allows other instruments (e.g., a finishing guide or posterior cut guide) to be attached to robotic arm without having to individually couple each instrument to robotic arm in succession and without the need for individually registering each attached instrument with the coordinate system. Robotic arm120can move resection guide instrument200relative to anatomy of the patient such that the surgeon can, after adding and removing another instrument to the guide instrument as needed, perform the desired interaction with the patient at specific locations called for by the surgical plan with the attached instrument.

In the present application, surgical system100can be configured to operate with sensor-enabled implants such that the three-dimensional space of surgical area105can be correlated to orientation and motion data of the sensor-enabled implant to allow a surgeon to ensure alignment of the data of the sensor-enabled implant with the anatomy of the patient.

FIG.2is a schematic view of robotic arm120ofFIG.1including resection guide instrument200, which can be positioned by robotic arm120relative to surgical area105(FIG.1) in a desired orientation according to a surgical plan, such as a plan based on preoperative imaging or based, at least partially, on intra-operative planning. Resection guide instrument200can comprise tool base202, extension arm204and guide block206. Extension arm204can comprise first segment208and second segment210, as well as additional segments in other examples. Guide block206can comprise body212, guide surface214and interface216. In an example, guide block206can be configured as a resection block for use in a partial knee arthroplasty and, as such, guide block206can be used to perform a proximal resection of a tibial plateau, as shown inFIG.6, and a distal resection of a femoral condyle.

Robotic arm120can include joint135A that permits rotation about axis216A, joint135B that can permit rotation about axis216B, joint135C that can permit rotation about axis216C and joint135D that can permit rotation about axis216D.

In order to position resection guide instrument200relative to anatomy of patient110(FIG.1), surgical system100(FIG.1) can manipulate robotic arm120automatically by computing system140or a surgeon manually operating computing system140to move resection guide instrument200to the desired location, e.g., a location called for by a surgical plan to align an instrument relative to the anatomy. For example, robotic arm120can be manipulated along axis216A to axis216D to position resection guide instrument200such that guide block206is located in a desired location relative to the anatomy. As such, a step of a surgical procedure can be performed, such as by using guide surface214. However, subsequent steps of the surgical procedure can be performed with resection guide instrument200without having to uncouple resection guide instrument200from robotic arm120. For example, other instruments can be attached to guide block206at interface216. Other instruments attached at interface216can be used without having to re-register an additional instrument to the coordinate system because the dimensions and geometries of resection guide instrument200and other instruments to be used therewith can be known by surgical system100(FIG.1) such that the locations of guide block206and instruments attached thereto can be calculated by surgical system100as robotic arm120moves throughout the coordinate system.

Robotic arm120can be separately registered to the coordinate system of surgical system100, such via use of a tracking element170(FIG.1). Fiducial markers can additionally be separately registered to the coordinate system of surgical system100via engagement with a probe having a tracking element170attached thereto. Resection guide instrument200can be registered to the coordinate system via coupling with robotic arm. Furthermore, output of sensor-enabled implant241(FIGS.3A and4) can be registered to the coordinate system of surgical system100via base station230. Base station230can comprise a wireless communication device232for receiving output of sensor module240. Base station230can comprise cable or wire234for connecting to computing system140of surgical system100. As such, some or all of the components of surgical system100can be individually registered to the coordinate system (with or without the aid of tracking elements) and, if desired, movement of such components can be continuously or intermittently tracked with a tracking element170.

In some robotic procedures, instruments can be separately and individually tracked using an optical navigation system that, under ideal conditions, alleviate the need for precisely maintaining axis216D and the location of an instrument along axis216D through a surgical procedure or surgical task, as the optical navigation system can provide the surgical computer system information to compensate for any changes. However, as optical navigation systems require line-of-sight with the instruments to be maintained, there is a significant advantage in not requiring instruments to be navigated (or at least not constantly navigated). Resection guide instrument200allows multiple instruments to be registered to robotic system115without the need for individually tracking each instrument. Robotic system115can know the precise location of robotic arm120, and the geometry and dimensions of resection guide instrument200can be registered to robotic system115. As such, the location of guide block206in the surgical space can be determined as robotic arm120moves guide block206within the surgical space. Furthermore, robotic system115can be provided with, such as within a non-transient computer-readable storage medium, the geometry and dimensions of instruments configured to be attached to guide block206such that the locations of attachment instruments can also be tracked as robotic arm120moves. Thus, individual tracking or registration of the attachment instruments can be avoided if desired. Additionally, robotic system115can be provided with, such as within a non-transient computer-readable storage medium, the geometry and dimensions of sensor-enabled implant241(FIG.4) and tibial component270(FIG.5) such that the geometry and location of tibial component270and sensor-enabled implant241including sensor module240can be registered to the anatomy when implanted.

FIG.3Ais a perspective view of sensor module240for sensor-enabled implant241. Sensor module240can comprise outer casing242, battery244, electronics assembly246, and antenna248. Outer casing242can comprise radome250that can be used to cover and protect antenna248to allow sensor module240to receive and transmit information via a wireless signal. Outer casing242can include set-screw engagement hole252, which can be utilized to physically attach sensor module240to tibial plate272(FIG.4). In the example ofFIG.3A, sensor-enabled implant241comprises a tibial stem such that outer casing242comprises an elongate cylinder-like body that can be inserted into a tibia when attached to tibial plate272(FIG.4).

FIG.3Bis an exploded view of electronics assembly246that can be used with sensor module240ofFIG.3A. Electronics assembly246includes a printed circuit assembly (PCA), such as PCA254, which can be physically attached and electrically connected to header assembly256. For the illustrated example, PCA254includes three rigid printed circuit boards (PCBs) with electronic components (e.g., integrated circuit chips) mounted thereon and electrically interconnected utilizing flexible conductive wiring, such as, for example, flexible flat cable fabricated as an inner layer of the PCB (e.g., rigid-flex). The three rigid printed circuit boards of PCA254, which can be folded over so as to overlap each other and thus save physical space, can be characterized as a tri-fold printed circuit assembly. Electronics assembly246can also include printed circuit assembly clip258, which can be utilized to physically affix PCA254to one side of the header assembly256. Printed circuit assembly clip258can be made of a suitable sturdy and corrosion-resistant material, such as, for example, titanium (Ti) and the like. The side of header assembly256opposite PCA254can include two antenna connections260, which can be utilized as mounting points and electrical connections for an antenna. Thus, header assembly256can function to electrically and physically connect an antenna to, for example, a radio transmitter circuit mounted on one of the printed circuit boards of the PCA254. Electronics assembly246can also include case262, which can be physically affixed to header assembly256and thereby utilized to enclose and hermetically seal PCA254and printed circuit assembly clip258within. For example, case262can be made of a suitable sturdy and corrosion-resistant material, such as titanium (Ti) and the like. Outer casing242and radome250can be attached in an end-to-end configuration such that both components extend along sensor module axis264.

Electronics assembly246can include, circuits, pressure sensors, temperature sensors, pedometers, on-board volatile memory (e.g., random-access memory (RAM), dynamic RAM (DRAM), or static RAM (SRAM)) and nonvolatile memory (e.g., read-only memory (ROM), programmable ROM (PROM, electrically programmable ROM (EPROM), and electrically erasable and programmable ROM (EEPROM)). Electronics assembly246can include switches to couple these components. Electronics assembly246can comprise a microcontroller, a microprocessor, or any other computing circuit, such as a Silicon Labs® EFM32HG microcontroller IC.

Electronics assembly246can include an inertial measurement circuit that includes one or more sensors for acquiring data related to the motion of sensor module240and a prosthesis attached thereto, such as tibial component270(FIG.4). In examples, the inertial measurement circuit can include one or more accelerometers, gyroscopes, pedometers, and magnetometers that are respectively configured to sense and measure linear and rotational accelerations, step counts, and magnetic fields that the prosthesis experiences or to which the prosthesis is exposed. In examples, the inertial measurement circuit can include three accelerometers and three gyroscopes, one accelerometer and gyroscope for each dimension of linear (X, Y, Z) and rotational (rotation about X axis, rotation about Y axis, rotation about Z axis) freedom, respectively, that the implanted prosthesis possesses, or is configured to possess. By analyzing the information generated by these sensors while a patient, or other subject, in which the prosthesis is implanted, is moving, one can determine whether the prosthesis is functioning properly, and can predict when the prosthesis should be replaced.

In examples, sensor module240can be constructed according to the teachings of US 20190350518 A1 to Bailey et al., titled “Implantable Reporting Processor for an Alert Implant,” the contents of which are hereby incorporated into the present application in their entirety.

Output of sensor module240is thus correlated to an internal X, Y, Z frame of reference or a sensor frame of reference. In examples, one of the axes can extend along sensor module axis264, with the other two axes extending in a plane orthogonal thereto. As shown inFIG.4, outer casing242can be provided with hash mark278to provide an indication of the direction of one of the axes relative to sensor module axis264. As such, the direction of each of the X, Y and Z axes can be physically determined from the exterior of sensor-enabled implant241.

FIG.4is a perspective view of tibial component270that can be utilized with sensor-enabled implant241having sensor module240ofFIGS.3A and3B. The present application is described with reference to tibial component270, but can be utilized with other prosthetic implants, such as shoulder implants (including humeral and scapular implants), hip implants (including pelvic and femoral implants), knee implants (including femoral and tibial implants), as well as others. The illustrated example of sensor-enabled implant241works particularly well with implants having stem configured for insertion into long bones, such as tibial implants for knee prosthetics, femoral implants for knee prosthetic and humeral implants for shoulder prosthetics. However, sensor-enabled implant241can have other form factors for use in other prosthetic constructs. Tibial component270can comprise tibial plate272, keel274and tibial extension276. Tibial component270can be attached to tibia304, which can be reamed to form bone socket279.

Tibial plate272can be a base plate section of an artificial knee joint (prosthesis) that can be implanted during a surgical procedure, such as a total knee arthroplasty (TKA). Prior to, or during the surgical procedure, sensor-enabled implant241can be physically attached to tibial plate272via coupling to tibial extension276via suitable means, such as threaded engagement, snap fit and the like. Outer casing242can include set-screw engagement hole252, which can be utilized to physically attach sensor-enabled implant241to tibial plate272. It is understood that the mechanism for affixing sensor module240to tibial component270or other implant can also include threaded fasteners as well as a variety of clips and locking mechanisms. In examples, sensor-enabled implant241can be attached to tibial component270such that sensor module axis264aligns with stem axis314. A surgical plan for patient110(FIG.1) can be prepared to implant tibial component270into tibia304such that stem axis314aligns with the anatomic axis of tibia304.

In order to facilitate registration of the output of sensor module240with tibial component270, alignment marks or indicia can be included on each component. For example, outer casing242can include hash mark266and tibial extension276can include hash mark278. Hash mark266and hash mark278can extend parallel to sensor module axis264. Hash mark266and hash mark278can comprise markings, such as ink or paint added to the exterior of outer casing242and tibial extension276. In additional examples, hash mark266and hash mark278can comprise etchings or depressions extending into outer casing242and tibial extension276or build-ups or protrusions extending from outer casing242and tibial extension276. Hash mark266and hash mark278can be oriented relative to each other such that output of sensor module240is referenced to an orientation of tibial component270. In examples, hash mark278can be located on the anterior-most portion of tibial extension276. Thus, hash mark278can be aligned with hash mark266to ensure that the anterior-posterior axis of tibial component270is aligned with the axis of sensor module extending in the direction of hash mark266as described with reference toFIGS.3A and3B. As such, in examples, x-axis output of sensor module240can be configured to align with hash mark266to provide forward (anterior-posterior) movements of tibial component270and y-axis and z-axis outputs can be appropriately oriented in orthogonal directions to provide upward (superior-inferior) movements and sideways (medial-lateral) movements, when tibial component270is implanted into tibia304. Tibial plate272can include anterior surface or indicator277that can align with hash mark278at the anterior-most portions of tibial component270. As such, the orientation of tibial component270relative to tibia304can be visualized by a surgeon during implantation. Indicator277can provide visual feedback as to the location of hash mark278when tibial extension276is obscured or concealed within tibia304.

FIG.5is a schematic view of knee joint300comprising femur302and tibia304extending along femoral axis306and tibial axis308, respectively. Femur302and tibia304can comprise anatomy of patient110(FIG.1). Knee joint300is disposed relative to tibial component270and sensor module240ofFIGS.3A-4. In order to perform a total knee arthroplasty, a distal resection is performed on femur302to produce distal resection plane310and a proximal resection is performed on tibia304to produce proximal resection plane312. Femoral axis306can be disposed at an angle to distal resection plane310and tibial axis308can be disposed at an angle to proximal resection plane312. Femoral axis306and tibial axis308can be disposed at angle σ relative to each other. Tibial component270is implanted in tibia304such that tibial plate272mates flush with proximal resection plane312. Tibial extension276extends distally from tibial plate272along stem axis314. Stem axis314can extend non-parallel to the bottom or inferior surface of tibial plate272. When tibial component270is implanted in tibia304, stem axis314can be offset and angled relative to tibial axis308.

As discussed above, sensor module240can be configured to output three-dimensional orientation information in an X, Y, Z coordinate system relative to sensor module axis264. Output of sensor module240can be registered to the orientation of tibial component270, such as via the alignment of hash mark266with hash mark278, as shown inFIG.4. Tibial component270can be registered to the anatomy of tibia304via flush engagement of tibial plate272with proximal resection plane312, as well as by positioning of indicator277relative to anatomic landmarks on tibia304, such as the tibial tuberosity or soleal line.

It can be desirable for tibial component270and sensor module240to align with tibia304in a known orientation so that output of sensor module240is properly registered with the kinematic reference from of knee joint300defined by tibial axis308and femoral axis306. Proper positioning of tibial component270can be desirable to allow for natural kinematic interaction between tibia304and femur302. Understanding of the kinematic interaction between tibia304and femur302can be obtained by output of sensor module240. As such, it is important for the output of sensor module240to be suitably referenced relative to tibial axis308so that the kinematic analysis of knee joint300is properly understood. As mentioned above, the alignment of sensor module240with tibial component270and the alignment of tibial component270can be interfered with or altered by various factors including misalignment between hash mark266and hash mark278, misalignment of tibial plate272with proximal resection plane312, the imperfection on or the location of proximal resection plane312and others. With the present disclosure, sensor output of sensor module240can be communicated to surgical system100(FIG.1) so that output of sensor module240can be registered to the frame of reference of surgical system100, which is registered to the anatomy of patient110(FIG.1). Output of sensor module240can thereafter be registered to tibial axis308physically or digitally. Physical registration of sensor module240to tibial axis308can involve physically moving sensor module240via movement of tibial component270to obtain the desired output orientation of sensor module240. Digital registration of sensor module240can involve digitally shifting the output of sensor module240, such as by applying a registration factor (e.g., a numerical correction along the X, Y and Z axes), to obtain the desired output orientation of sensor module240. The numerical correction can be automatically determined by computing system140, such as by moving tibia304through a series of movements to provide computing system140of surgical system with a set of reference data points, or manually by a surgeon by movement of a virtual representation of sensor module axis264with virtual representation of tibial axis308, such as by using human interface device145(FIG.1) or surgical helmet340(FIG.9A). The desired output orientation of sensor module240can be when sensor module axis264aligns with tibial axis308, as discussed herein.

FIG.6illustrates resection guide instrument200that can be used to perform a proximal tibial resection in accordance with some examples of the present disclosure. In examples, resection guide instrument200can include guide surface214to perform a first cut and guide surface215to perform a second cut. Resection guide instrument200can be affixed to a distal end of robotic arm120(FIG.2). In examples, cutting device280can perform the tibial resection as shown inFIG.6. Cutting device280can comprise a reciprocating and oscillating blade having cutting teeth at the distal end thereof. Robotic arm120can position resection guide instrument200into a specific orientation relative to tibia304as discussed herein. Cutting device280can be used to produce proximal resection plane312ofFIG.5. In examples, resection guide instrument200can positioned so that proximal resection plane312is orthogonal to tibial axis308(FIG.5). However, as mentioned, it can be possible for proximal resection plane312to be slightly skewed from being orthogonal to tibial axis308due to imperfections in the planning process, imperfections in the anatomy, imperfections in executing the surgical plan and the like. Nonetheless, the surgical procedure can proceed to the next step of preparing tibia304for tibial component270.

FIG.7is a perspective view of tibia304ofFIG.6shown relative to tibial drill guide320. Tibial drill guide320can comprise trial plate322and guide sleeve324having guide aperture326. Tibial drill guide320can be used to form a passage within tibia304into which sensor module240and tibial extension276can be inserted. Tibial drill guide320can be used to produce bone socket279ofFIG.4. Tibial drill guide320can be shaped to allow tibial component270to assemble with tibia304in a known orientation such that stem axis314will be disposed relative to tibial axis308in a known relationship, which helps correlate the output of sensor module240with anatomic movements of tibia304. For example, the bottom of trial plate322can be planar to mate flush with proximal resection plane312. Likewise, the anterior-most point of trial plate322can be positioned at the anterior-most point of tibia304. However, as mentioned, it can be possible for tibial drill guide320to be slightly skewed from being aligned with proximal resection plane312due to imperfections in the planning process, imperfections in the anatomy, imperfections in executing the surgical plan and the like. Nonetheless, the surgical procedure can proceed to the next step of assembling tibial component270and sensor module240with tibia304.

FIG.8is a schematic view of surgical helmet340including augmented reality headset342. Surgical helmet340can comprise projector344(a helmet-mounted projector) and optical locator346(a helmet-mounted optical locator). Surgical helmet340can be configured to interact with surgical system100(FIG.1).

In examples, projector344can comprise a so-called pico projector, or pocket projector, which may be any hand-held sized, commercially available projector capable of emitting a light source, such as a laser or LED light. Optical locator346can operate to determine the three-dimensional position of tracking element348and tracking element350within surgical area105(FIG.1) as has been described herein. Optical locator346can additionally be used to track movement of hands of the wearer of surgical helmet340. In examples, the hands can be tracked with or without the use of optical tracking elements, similar to tracking element348and tracking element350, but miniaturized for incorporation on gloves or the like. As such, hands of a user can be moved to provide input to surgical system to, for example, adjust the position of sensor module axis264, as well as to achieve other interactions with surgical system100.

Positioning or locating optical locator346directly on surgical helmet340can ensure that arrays or tracking elements within the field of view of a surgeon wearing surgical helmet340will always be recognized by the navigation system, thus allowing the navigation system to be looking up information relevant to those arrays, and the instruments and tools connected to those arrays, in memory of computing system140. Positioning or locating projector344directly on surgical helmet340can ensure that the instructions generated by beam352will always remain in the field of view of the surgeon and that the orientation of the instructions will be correlated to the point of view of the surgeon, e.g., any letters or text produced by beam352will not be upside down.

Projector344can use beam352to project various instructions from the surgical plan based on, for example, the instrument that surgeon is holding in his or her hand, such as cutting device280(FIG.6) and tibial drill guide320(FIG.7). The instructions depicted by beam352can include various landmarks, alignment axis, and resection planes for projection onto femur302and tibia304of patient110(FIG.1) to provide visual instructions to a surgeon based on the surgical plan using information stored in the navigation system for each tool or instrument based on the location of each tool or instrument determined by an optical locator and the appropriately correlated array for that particular tool or instrument. Projector344can operate to project an indication of tibial axis308for tibia304(FIG.5) and an indication of sensor module axis264of sensor module240(FIG.5) onto tibia304to provide visual instructions to a surgeon as to the orientation of the output of sensor module240relative to tibia304, similar to what is shown for augmented reality headset342inFIG.9. Additionally, augmented reality headset342can include goggles360having heads-up display screen362to provide virtual indicia on tibia304, as shown inFIG.9A, that can be used to provide similar indicia for the surgeon as just described.

FIG.9Ais a schematic illustration of a display output364of augmented reality headset342ofFIG.8. Goggles360can comprise a frame for supporting heads-up display screen362. Goggles360can be supported by a frame of surgical helmet340or can be directly supported by a head of a user, e.g., a surgeon, via appropriate earpieces or head straps. Heads-up display screen362can comprise a lens, e.g., glass or polycarbonate, upon which an image can be projected. One or more cameras attached to goggles360or surgical helmet340can be used to view the surrounding environment, e.g., the reality, in the field of view of surgical helmet340. The surrounding environment can be projected onto heads-up display screen362. In examples, the camera comprising optical locator346can be used to record the environment for providing a video transmission to heads-up display screen362. Additionally, goggles360or surgical helmet340can include one or more projectors that can project output, e.g., the augmentation, onto heads-up display screen362. In examples, projector344can be used to project the augmented reality output or indicia. In examples, projectors or other components can be included within goggles360to generate augmented reality output, e.g., virtual axes, onto display screen. As such, the augmented reality of the one or more projectors can be displayed on top of the video output of the one or more cameras. In additional examples, heads-up display screen362can allow for a user, e.g., a surgeon to see the surrounding environment, e.g., the reality, through heads-up display screen362without the use of projected video images. However, in such configurations, heads-up display screen362can having coatings or other features to allow projected or electronic indicia to be visible on heads-up display screen362to provide the augmented reality output.

Display output364can comprise video display366and augmented reality display368. Video display366can comprise video representations of tibia304, sensor module240and tibial component270, shown as digital tibia304D, digital sensor module240D and digital tibial component270D, respectively. However, as discussed above, heads-up display screen362can be configured to allow a wearer to see-through heads-up display screen362to view tibia304, sensor module240and tibial component270directly. Augmented reality display368can comprise digital representations of tibial axis308for tibia304(FIG.5) and sensor module axis264of sensor module240(FIG.5). Additionally, digital representations of tibial component270and sensor module240can be displayed to facilitate visualization since tibial component270and sensor module240can be obscured by tissue.

As discussed herein, a surgeon can 1) physically manipulate sensor module240relative to tibial component270to change the orientation of sensor module axis264(such as by removing tibial component270from tibia304and adjusting the position or coupling of sensor module240), 2) physically manipulate tibial component270relative to tibia304, and 3) digitally moving sensor module axis264using computing system140(FIG.1). Options 1) and 2) can be performed to ensure proper assembly of sensor module240with tibial component270and proper insertion of tibial component270according to the surgical plan, respectively. However, the assembly of sensor module240and tibial component270may be acceptable and it may not be possible to alter the position of tibial component270due to the surgical plan. Thus, option 3) can be performed to digitally offset or calibrate the output of sensor module240to match the desired reference frame, e.g., tibial axis308. Option 3) can be performed by a user or surgeon utilizing a human interface device to manipulate the position of sensor module axis264displayed as described herein, such as on a display screen, using projected illumination light, or virtually using heads-up display screen362. For example, a user can do one or both of pivoting or rotating a representation of sensor module axis264on human interface device145(FIG.1) or by using hand gestures in conjunction with surgical helmet340, and inputting values for X, Y and Z axis numerical offsets into human interface device145. As a user manipulates the representation of sensor module308on a display screen or enters different values for the X, Y and Z axis numerical offsets the position of the representation of sensor module axis264can change. A user can continue to digitally manipulate the representation of sensor module axis264until sensor module axis264aligns with tibial axis308or another landmark or reference potin. For example, rather than aligning sensor module axis264with tibial axis308, sensor module axis264can be aligned with anatomic features on tibia304, such as the tibial tuberosity or soleal line. In additional examples, computing system140can automatically align sensor module axis264with tibial axis308. Once sensor module axis264is positioned in the desired orientation, a correction factor can be supplied to sensor module240, such as by computing system140sending a wireless signal to sensor module240through base station230(FIG.2). The correction factor can be stored in memory of electronics assembly246(FIG.3B) so that output of sensor module240can be customized for a specific patient.

FIG.9Bis a schematic illustration of user interface370that can be used to adjust the position of a sensor module axis264. In examples, user interface370can comprise one of human interface devices145(FIG.1). In examples, user interface370can comprise a touch-screen display. User interface370can display coordinate system icon372having an x-axis, a y-axis and a z-axis. User interface370can display numerical values for the orientation of each axis, such as x-axis values380, y-axis values382and z-axis values384. User interface370can display user inputs to allow for the adjustment of the x-axis values, the y-axis values and the z-axis values. In examples, user interface370can include x-axis slider374, y-axis slider376and z-axis slider378. Coordinate system icon272can provide an indication of the orientation of sensor module axis264ofFIG.9A. A user can utilize various inputs to adjust x-axis values380, y-axis values382and z-axis values384. For example, an input device such as a keyboard can be used to type values for x-axis values380, y-axis values382and z-axis values384; x-axis slider374, y-axis slider376and z-axis slider378can be manipulated to increase or decrease x-axis values380, y-axis values382and z-axis values384; and coordinate system icon372can be manipulated, e.g., rotated, to adjust x-axis values380, y-axis values382and z-axis values384. As x-axis values380, y-axis values382and z-axis values384are adjusted, the position of sensor module axis264relative to tibial axis308(FIG.9A) can be adjusted on heads-up display screen362or another video display output. Thereafter, a controller for robotic system115can adjust the initial output of sensor module240after being implanted into the patient to align with tibial axis308. A correction factor can be applied so that, for example, the x-axis values380will align with tibial axis308and y-axis values382and z-axis values384are orthogonal to the y-axis values, as discussed herein, so that the output of sensor module240is consistent with the anatomic frame of reference of the patient, e.g., the kinematic frame of reference defined by tibia304. In other words, the coordinate system origin of sensor module240can be aligned with the coordinate system origin for the anatomy of the patient. Additionally, the x, y and z values for sensor module axis264can be adjusted electronically by tracking system165by tracking hand gestures using a motion-tracking system. For example, a user can pinch a virtual representation of sensor module axis264displayed by goggles360(FIG.9A) and then make wrist or hand movements to rotate the representation of sensor module axis264to align with tibial axis308. In examples, virtual “buttons” can be depressed via prescribed gestures to grab, rotate and release sensor module axis264. In other examples, a handpiece can be held having buttons that electronically provide instructions to tracking system165for when a user grasps and releases sensor module axis264.

FIG.10is a block diagram of method400including various operations for exemplary methods of aligning sensor module240of tibial component270with tibia304. Method400is described with reference to a tibia bone and a tibial implant for a total knee arthroplasty. However, method400can be adapted for implanting, aligning and calibrating sensor modules of other implants with other anatomy. Method400is described with reference to operation402-operation428. However, some of operation402-operation428can be omitted and operation402-operation428can be performed in other sequences.

At operation402, anatomy of a patient can be registered to a tracking system for a surgical system, such as a robotic surgical system. For example, the anatomy of patient110(FIG.1) can be registered to the three-dimensional space of surgical area105. Tracking element348(FIG.8) and tracking element350(FIG.8) can be attached to the anatomy of patient110, such as femur302(FIG.8) and tibia304(FIG.8). Thus, as described herein, the location and orientation of femur302and tibia304can be determined relative to a coordinate system of surgical area105.

At operations404and406, a bone can be prepared for receiving an implant having a sensor module. For example, at operation404, the proximal end of tibia304can be resected to form proximal resection plane312. As shown inFIG.6, robotic arm120can be used to move resection guide instrument200proximate the proximal end of tibia304so that cutting device280can be engaged with guide surface214to form proximal resection plane312in a specific location and orientation on tibia304. For example, at operation406, proximal resection plane312can be prepared to receive tibial extension276and sensor module240. As shown inFIG.7, tibial drill guide320can be attached to tibia304so that a drill or reamer can be inserted into guide aperture326to form a bone channel or bone socket279(FIG.4) to provide space for tibial extension276and sensor module240in a specific location and orientation on tibia304. As such, proximal resection plane312and the bone channel or bone socket279can be formed within the three-dimensional space of surgical area105in such a manner that the orientation of tibial component270will be known to surgical system100.

At operation408, trial implants can be engaged with the prepared anatomy of the patient to determine, for example, the size and shape of the final construct. For example, a trial implant having the shape of tibial plate272, keel274and tibial extension276can be engaged with tibia304at proximal resection plane312and bone socket279. After trialing, a surgeon can determine the desired size of the implants for implanting into the patient to perform the prosthetic functionality.

At operation410, sensor module240can be assembled with tibial component270. For example, sensor module240can be connected to tibial extension276via suitable methods, such as force fit, snap fit and threaded engagement. Sensor module240can be rotated so that hash mark266(FIG.4) aligns with hash mark278(FIG.4).

At operation412, sensor module240can be registered with surgical system100. For example, sensor module240can be activated to communicate with base station230(FIG.2). Orientation output of various sensors, e.g., accelerometers, gyroscopes and multi-axis sensors, of sensor module240can be integrated with the three-dimensional space of surgical area105. That is three-dimensional x, y, z output of the orientation sensors can be superposed to the x, y, z coordinate system of surgical system115, which can then be extrapolated and applied to the axis of tibia304.

At operation414, tibial component270can be implanted into tibia304as prepared in operation404and operation406. Sensor module240and tibial extension276can be inserted into bone socket279and tibial plate272can be engaged with proximal resection plane312. Bone cement or other material can be used to facilitate coupling of tibial component270to the anatomy.

At operation416, tibial axis308can be displayed along tibia304for observation by a surgeon. Tibial axis308can be generated by the use of tracking element348and tracking element350(FIG.8). In examples, tibial axis308can be displayed on one or both of human interface devices145(FIG.1). In examples, tibial axis308can be projected onto tibia304via projector344(FIG.8). In examples, tibial axis308can be displayed against an image of tibia304on heads-up display screen362.

At operation418, sensor module axis264can be displayed along sensor module240for observation by a surgeon. Sensor module axis264can be generated by the use of output of sensor module240being communicated to surgical system115via base station230(FIG.2). In example, sensor module axis264can be displayed on one or both of human interface devices145(FIG.1). In examples, sensor module axis264can be projected onto tibia304via projector344(FIG.8). In examples, sensor module axis264can be displayed against an image of tibia304on heads-up display screen362.

At operation420, the position of sensor module axis264can be adjusted. Sensor module axis264can be adjusted by A) physically moving sensor module240either a) directly or b) via movement of tibial component270and B) digitally moving stem axis314. As discussed with reference toFIG.9B, sensor module axis264can be digitally adjusted by manipulating stem axis314; coordinate system icon372; x-axis values380, y-axis values382and z-axis values384; and x-axis slider374, y-axis slider376and z-axis slider378on user interface370or by using motion-tracking of a surgeon in conjunction with a virtual representation of sensor module axis264.

At operation422, sensor module axis264can be adjusted to align with tibial axis308. For example, the x-axis values380(FIG.9B) can be aligned with tibial axis308and y-axis values382and z-axis values384are orthogonal to the y-axis values, as discussed herein, so that the output of sensor module240is consistent with the anatomic frame of reference of the patient, e.g., the kinematic frame of reference defined by tibia304. For example, intended forward or anterior direction of sensor module240, such as indicated by hash mark266, can be aligned to the true forward or anterior direction of tibia304via a conversion of the output data of sensor module240.

Operation418and operation420can be repeated until stem axis314is aligned with tibial axis308. Once sensor module axis264is adjusted to the desired location. A correction factor can be applied to the output of sensor module264to shift the output as predisposed based on the implanted relationship to tibia304to align with tibial axis308. The correction factor can be stored in memory of sensor module264so that future output of sensor module240communicated to base station230or another base station at the home of a patient can maintain the corrected or registered output.

At operation424, tibial component270can be immobilized. For example, bone cement, which can be dispensed at operation414, can be set so that tibial component270does not move and output of sensor module240will remain as registered.

At operation426, sensor module240can be deactivated to preserve battery life. For example, an input into surgical system115can be communicated via base station230to sensor module240. Additionally, other computing systems or handheld devices operating software for the control of sensor module240can be used to communicate with sensor module240via base station230.

At operation428, the surgical procedure can be continued and completed, leaving tibial component270along with sensor module240inside the patient. Incisions or access points within the anatomy can be closed to dispose tibial component270and sensor module240within the anatomy.

FIG.11illustrates system500for performing the methods, operations and techniques described herein, in accordance with some embodiments. System500is an example of a system that can incorporate surgical system100ofFIG.1. System500can include sensor-enabled implant502, which can interact with tracking system506. Sensor-enabled implant502can comprise prosthetic implant512(e.g., tibial component270) and sensor module514(e.g., sensor module240). In other examples, sensor-enabled implant502can be used without tracking system506. Tracking system506can include tracking element508(e.g., tracking element170) and tracker device510(e.g., a camera of tracking system165). System500can include display device516(e.g., human interface device145, a computer monitor or video display screen), which can be used with user interface518(e.g., a touchscreen, mouse or keyboard). System500can include control system520(e.g., a robotic controller or computing system140ofFIG.1), including processor522and memory524. In an example, display device516can be coupled to one or more of sensor-enabled implant502, tracking system506, and control system520. As such, data generated by sensor-enabled implant502can be shared with control system520, tracking system506and an operator of system500via display device516. In examples, sensor-enabled implant502can communicate with control system520via an external device, such as base station230. In examples, sensor-enabled implant502can be operated without input from tracking system506, after a registration process, such that sensor-enabled implant502can be positioned and tracked by movement of robotic arm120within the native coordinate system of robotic arm120. Display device516can be used to visualize an axis of a bone determined by tracking system506and an axis of sensor module514determined by sensor module514and display both axes in a common frame of reference so that an operator of system500can ensure alignment of the axis either by physically moving prosthetic implant512and sensor module514to achieve alignment or by recalibrating the output of sensor module514to align the sensor axis with the anatomic axis. User interface518can be used to manipulate the orientation of the axis of sensor module514. Control system520can be used to apply a correction factor to the output of sensor module514such as by programming or uploading the correction factor to sensor module514.

FIG.12illustrates a block diagram of example machine600upon which any one or more of the techniques discussed herein may be performed in accordance with some embodiments. For example, machine600can comprise computing system140ofFIG.1. Machine600can comprise an example of a controller for robotic system115and a sensor-enabled implant, such as the combination of tibial component270and sensor module240, tracking element348and tracking element350and base station230. As such instructions624can be executed by processor602to generate and correlate position and orientation information to determine the position and orientation of femur302and tibia304relative to robotic arm120and the position and orientation of sensor module240relative to robotic arm120. Position and geometric information of sensor module240can be determined via implantation of tibial component270into tibia304in a known relationship according to a surgical plan. Geometric information, such as shapes, geometries and dimensions, for instruments connected to surgical arm and prosthetic implants can be stored in main memory604and accessed by processor602. Furthermore, output of sensor module240can be provided to surgical system100, e.g., at computing system140via connection to base station230. Processor602can also receive input (such as at alphanumeric input device612) relating to the position of tibia304relative to robotic arm120via tracking element348and tracking element350, which can be stored in main memory604. Processor602can further relate position information of sensor module240to the position information of robotic arm120by registering the spatial information output of sensor module240to the three-dimensional coordinate system of surgical system100. Output of sensor module240can be additionally registered to the anatomy and specifically the bone into which tibial component270is implanted. Thus, as femur302and tibia304move through a range of motion, machine600can continuously track and update the location of sensor module240relative to the three-dimensional space of surgical system100. Machine600can additionally display the positions of femur302, tibia304, sensor module240and axes thereof on display unit610(e.g., human interface devices145), as well as the location of features included thereon, such as cutting guide features. User interface navigation device614can be used to adjust the output of sensor module240to that sensor module axis240aligns with tibial axis308.

Machine (e.g., computer system)600may include processor602(e.g., a central processing unit (CPU), a graphics processing unit (GPU), a hardware processor core, or any combination thereof), main memory604and static memory606, some or all of which may communicate with each other via interlink608(e.g., a bus). Machine600may further include display unit610, alphanumeric input device612(e.g., a keyboard), and user interface navigation device614(e.g., a mouse). In an example, display unit610, alphanumeric input device612and user interface navigation device614may be a touch screen display. Machine600may additionally include storage device616(e.g., a drive unit), signal generation device618(e.g., a speaker), network interface device620, and one or more sensors621, such as a global positioning system (GPS) sensor, compass, accelerometer, or other sensor. Machine600may include output controller628, such as a serial (e.g., Universal Serial Bus (USB), parallel, or other wired or wireless (e.g., infrared (IR), near field communication (NFC), etc.) connection to communicate or control one or more peripheral devices (e.g., a printer, card reader, etc.).

Storage device616may include machine readable medium622on which is stored one or more sets of data structures or instructions624(e.g., software) embodying or utilized by any one or more of the techniques or functions described herein. Instructions624may also reside, completely or at least partially, within main memory604, within static memory606, or within processor602during execution thereof by machine600. In an example, one or any combination of processor602, main memory604, static memory606, or storage device616may constitute machine readable media.

While machine readable medium622is illustrated as a single medium, the term “machine readable medium” may include a single medium or multiple media (e.g., a centralized or distributed database, and/or associated caches and servers) configured to store the one or more instructions624. The term “machine readable medium” may include any medium that is capable of storing, encoding, or carrying instructions for execution by machine600and that cause machine600to perform any one or more of the techniques of the present disclosure, or that is capable of storing, encoding or carrying data structures used by or associated with such instructions. Non-limiting machine readable medium examples may include solid-state memories, and optical and magnetic media.

The systems, devices and methods discussed in the present application can be useful in performing robotic-assisted surgical procedures that utilize robotic surgical arms that can be used to position devices relative to a patient to perform arthroplasty procedures, such as partial knee arthroplasties. In particular, the systems, devices and methods disclosed herein are useful in registering output of sensor-enabled implants to the three-dimensional space of robotic surgical systems to determine, verify, offset and calibrate output of the sensor-enabled implant to the anatomy of a patient so that the output of the sensor-enabled implant is reflective or indicative of real-world kinematic movements of the anatomy of the patient. The systems, devices and methods disclosed herein can reduce or eliminate errors from sensor output that is skewed from anatomy of a patient that can arise from improperly assembled sensor modules and prosthetic devices, improperly implanted prosthetic devices or slight deviations from surgical plans due to operator variance or anatomic imperfections or anomalies. As such, output of the sensor-enabled implant can be utilized to provide accurate feedback to a patient and a surgeon regarding the operation or movements of a joint in which a sensor-enabled implant is implanted to verify or determine the effectiveness of the implant and to prescribe actions for the patient to overcome or avoid pain, discomfort and the like.

Examples

Example 1 is a method for registering output of a sensor-enabled implant with a bone axis during a robotically-assisted arthroplasty procedure, the method comprising: registering anatomy of a patient to a surgical tracking system; determining a bone axis of a bone of the anatomy using the surgical tracking system; preparing the bone to receive a prosthetic implant including an orientation sensor; inserting the prosthetic implant into the bone; obtaining orientation output from the orientation sensor; and shifting the orientation output from the orientation sensor to align with the bone axis.

In Example 2, the subject matter of Example 1 optionally includes wherein shifting the orientation output from the orientation sensor to align with the bone axis comprises: aligning one axis of a three-dimensional coordinate system of the orientation sensor to align with the bone axis.

In Example 3, the subject matter of any one or more of Examples 1-2 optionally include wherein shifting the orientation output from the orientation sensor comprises: manually adjusting a position of the prosthetic implant in the bone.

In Example 4, the subject matter of any one or more of Examples 2-3 optionally include wherein shifting the orientation output from the orientation sensor comprises: manually adjusting a position of the orientation sensor relative to the prosthetic implant.

In Example 5, the subject matter of any one or more of Examples 1-4 optionally include wherein shifting the orientation output from the orientation sensor comprises: digitally adjusting the orientation output to align with the bone axis.

In Example 6, the subject matter of Example 5 optionally includes wherein digitally adjusting the orientation output to align with the bone axis: applying a mathematical correction factor to the orientation output.

In Example 7, the subject matter of Example 6 optionally includes wherein applying a mathematical correction factor to the orientation output comprises: automatically applying the mathematical correction factor with a controller of the surgical tracking system.

In Example 8, the subject matter of Example 7 optionally includes wherein applying a mathematical correction factor to the orientation output comprises: displaying a digital representation of the bone axis on an output device of the surgical tracking system; displaying a digital representation of a sensor axis of the orientation sensor on the output device of the surgical tracking system; and manually shifting orientation of the digital representation of the sensor axis to align with the digital representation of the bone axis using an input device of the surgical tracking system.

In Example 9, the subject matter of Example 8 optionally includes wherein manually shifting orientation of the digital representation of the sensor axis to align with the digital representation of the bone axis using an input device of the surgical tracking system comprises: using a touchscreen to adjust a position of the digital representation of the sensor axis.

In Example 10, the subject matter of any one or more of Examples 8-9 optionally include wherein manually shifting orientation of the digital representation of the sensor axis to align with the digital representation of the bone axis using an input device of the surgical tracking system comprises: using a touchscreen to adjust numerical values associated with an X, Y and Z position of the digital representation of the sensor axis.

In Example 11, the subject matter of any one or more of Examples 8-10 optionally include wherein the output device comprises an augmented reality headset.

Example 12 is a system for registering output of a sensor-enabled implant with a bone axis during a robotically-assisted arthroplasty procedure, the system comprising: a surgical robot comprising an articulating arm configured to move within a coordinate system for the surgical robot; a tracking system configured determine locations of one or more trackers in the coordinate system; a sensor-enabled implant configured to be implanted into anatomy and output orientation data; and a controller for the surgical robot, the controller comprising: a communication device configured to receive data from and transmit data to the surgical robot, the tracking system and the sensor-enabled implant; a display device for outputting visual information from the surgical robot, the tracking system and the sensor-enabled implant; and a non-transitory storage medium having computer-readable instructions stored therein comprising: registering anatomy of a patient to a surgical tracking system; determining a bone axis of a bone of the anatomy using the surgical tracking system; obtaining orientation output from an orientation sensor of a sensor-enabled prosthetic implant implanted into bone; and shifting the orientation output from the orientation sensor to align with the bone axis.

In Example 13, the subject matter of Example 12 optionally includes wherein shifting the orientation output from the orientation sensor to align with the bone axis comprises: aligning one axis of a three-dimensional coordinate system of the orientation sensor to align with the bone axis.

In Example 14, the subject matter of any one or more of Examples 12-13 optionally include wherein shifting the orientation output from the orientation sensor comprises: digitally adjusting the orientation output to align with the bone axis.

In Example 15, the subject matter of Example 14 optionally includes wherein digitally adjusting the orientation output to align with the bone axis: applying a mathematical correction factor to the orientation output.

In Example 16, the subject matter of Example 15 optionally includes wherein applying a mathematical correction factor to the orientation output comprises: automatically applying the mathematical correction factor with a controller of the surgical tracking system.

In Example 17, the subject matter of Example 16 optionally includes wherein applying a mathematical correction factor to the orientation output comprises: displaying a digital representation of the bone axis on an output device of the surgical tracking system; displaying a digital representation of a sensor axis of the orientation sensor on the output device of the surgical tracking system; and receiving a manual shift in orientation of the digital representation of the sensor axis to align with the digital representation of the bone axis using an input device of the surgical tracking system.

In Example 18, the subject matter of Example 17 optionally includes wherein receiving a manual shift in orientation of the digital representation of the sensor axis to align with the digital representation of the bone axis using an input device of the surgical tracking system comprises: receiving an input from a touchscreen or a gesture-tracking system to adjust a position of the digital representation of the sensor axis.

In Example 19, the subject matter of any one or more of Examples 17-18 optionally include wherein receiving a manual shift in orientation of the digital representation of the sensor axis to align with the digital representation of the bone axis using an input device of the surgical tracking system comprises: receiving an input from a touchscreen or a gesture-tracking system to adjust numerical values associated with an X, Y and Z position of the digital representation of the sensor axis.

In Example 20, the subject matter of any one or more of Examples 12-19 optionally include wherein the display device comprises an augmented reality headset.

Various Notes