CN112867460B - Dual position tracking hardware mount for surgical navigation - Google Patents

Abstract

A system for performing computer-assisted surgical procedures is disclosed. Using a computer program, an optical sensor detects and records the positioning of one or more optical tracking devices. The computer program then generates navigation reference information regarding position and orientation information of one or more specific body parts of the patient. The tracking device is mounted to the patient using a tracking frame and a coupler base, wherein the coupler base has multiple surfaces and the tracking frame is configured to be removably attached to the multiple surfaces. Because the characteristics of the coupler base are known to the computer program, all possible positioning of the tracking frame when attached to the coupler base are known. Therefore, the axis and orientation of the tracking frame can be changed to allow the patient to be moved during the surgical procedure without compromising the position and orientation information of the body parts.

Description

Dual Position Tracking Hardware Mount for Surgical Navigation

Priority declaration

This application claims the benefit of priority to U.S. Provisional Application No. 62/741,280, filed on October 4, 2018, entitled “Dual-Position Tracking Hardware Mount for Surgical Navigation,” which is incorporated herein by reference in its entirety.

Technical Field

The present disclosure generally relates to methods, systems and apparatus related to computer-assisted surgical systems, which include various hardware and software components that work together to enhance surgical workflow. The disclosed techniques can be applied, for example, to shoulder, hip and knee arthroplasties, as well as other surgical interventions such as arthroscopic surgery, spinal surgery, maxillofacial surgery, rotator cuff surgery, ligament repair and replacement surgery. Specifically, the present disclosure generally relates to a tracker array for surgical procedures, and more specifically to a tracker array used during joint replacement surgery.

Background Art

The use of computers, robots and imaging to assist orthopedic surgery is well known in the art. There has been a lot of research and development on computer-assisted navigation and robotic systems used to guide surgical procedures. Two general types of semi-active surgical robots have emerged and have been used in orthopedic surgery, such as arthroplasty. The first type of semi-active robot attaches surgical tools to a robotic arm that resists the movement of the surgeon away from the planned procedure (e.g., bone resection). This first type is generally referred to as a tactile system, which is derived from the Greek word for contact. The second type of semi-active robot focuses on controlling various aspects of the surgical tool, such as the speed of a cutting drill. This second type of semi-active robot is sometimes referred to as a free-arm robot because the user is not restricted when moving the tool.

Both types of surgical robots include a navigation or tracking system that closely monitors the surgical tools and the patient during surgery. The navigation system can be used to establish a virtual three-dimensional (3-D) coordinate system in which both the patient and the surgical device will be tracked.

Hip replacement is a type of surgical procedure that is gaining acceptance using surgical robots, advanced imaging and computer-assisted navigation. Since the early 1960s, total hip replacement (THR) or arthroplasty (THA) surgery has been performed to repair the acetabulum and the area around it and replace the degenerated hip joint components, such as the femoral head. Currently, only about 200,000 THR operations are performed each year in the United States, of which about 40,000 are revision surgeries. Due to any of the many problems that may occur during the life of the implanted components, such as dislocation, component wear and degradation, and implant loosening from the bone, revisions are required.

Dislocation of the femoral head from the acetabular component or cup is considered one of the most common early problems associated with THR because of the sudden physical and emotional difficulties that dislocation can bring. Dislocation occurs in approximately 2-6% of cases after primary THR surgery and at even higher rates after revision surgery. While dislocation can be attributed to a variety of causes, such as soft tissue laxity and loosening of the implant, the most common cause is impingement of the femoral neck with the rim of the acetabular cup implant or with the soft tissue or bone surrounding the implant. Impingement most often occurs due to inaccurate positioning of the acetabular cup component within the pelvis.

BRIEF DESCRIPTION OF THE DRAWINGS

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

FIG. 1 depicts an operating room including an illustrative computer assisted surgery system (CASS), according to an embodiment.

FIG. 2A depicts illustrative control instructions provided by the surgical computer to other components of CASS, according to an embodiment.

2B depicts illustrative control instructions provided to a surgical computer by components of CASS, according to an embodiment.

2C depicts an illustrative implementation of a surgical computer connected to a surgical data server via a network, according to an embodiment.

3 depicts a surgical patient care system and illustrative data sources, according to an embodiment.

4A depicts an illustrative flow chart for determining a pre-operative surgical plan, according to an embodiment.

4B depicts an illustrative flow chart for determining a care episode including pre-operative, intra-operative, and post-operative actions, according to an embodiment.

4C depicts an illustrative graphical user interface including an image depicting implant placement, according to an embodiment.

FIG. 5 depicts a tracking frame and coupler mount in accordance with an illustrative embodiment.

6 depicts a tracking frame and coupler mount attached to a bone structure in accordance with an illustrative embodiment.

7 depicts a tracking frame and a coupler mount having multiple surfaces in accordance with an illustrative embodiment.

8 depicts a tracking frame and a coupler mount having multiple surfaces and one or more magnetic connections in accordance with an illustrative embodiment.

9 depicts a tracking frame and a coupler mount having multiple surfaces and one or more divots in accordance with an illustrative embodiment.

10 depicts a tracking frame and a coupler mount having multiple surfaces and one or more recesses according to another illustrative embodiment.

11 depicts a block diagram of an exemplary system for providing navigation and control for implant positioning in accordance with an illustrative embodiment.

12 depicts a block diagram of an exemplary environment for operating a system for navigating and controlling an implant positioning device in accordance with an illustrative embodiment.

Summary of the invention

A computer-assisted surgical navigation system is provided. The system comprises: a computer program adapted to generate navigation reference information regarding the position and orientation of a patient's body part; a tracking device mounted to the patient, the tracking device comprising a tracking frame and a coupling mount having a plurality of surfaces, wherein the tracking frame is configured to removably engage each of the plurality of surfaces; a sensor configured to identify the position of the tracking frame; and a computer configured to store the navigation reference information and receive the position of the tracking frame from the sensor so as to track the position and orientation of at least one surgical reference relative to the body part.

According to some embodiments, the system further comprises a monitor configured to receive and display the navigation reference information and one or more of the position and orientation of the at least one surgical reference.

According to some embodiments, each of the plurality of surfaces includes a pit. According to further embodiments, the system further includes a tracking probe, wherein the sensor is further configured to identify a position of the tracking probe, and wherein the computer is further configured to receive the position of the tracking probe and determine whether the tracking probe is located in a pit of one of the plurality of surfaces.

According to some embodiments, the system further comprises a robotic arm, wherein the computer is further configured to notify a user to reposition the tracking frame when the robotic arm blocks the sensor's line of sight to the tracking frame.

According to some embodiments, the sensor is adapted to sense at least one of: an electrical signal, a magnetic field, an electromagnetic field, sound, body, radio frequency, x-rays, light, an active signal or a passive signal.

According to some embodiments, the sensor comprises at least two optical tracking cameras for sensing at least one surgical reference associated with a body part of the patient.

According to some embodiments, the body part is at least one of a bone, a tissue, a femur and a head of the patient.

According to some embodiments, the navigation reference information relates to a bone of the patient. According to further embodiments, the tracking device is mounted to the bone.

According to some embodiments, the navigation reference information is a mechanical axis of the body part.

According to some embodiments, the surgical reference is the anterior pelvic plane.

According to some embodiments, the system further comprises an imager for obtaining an image of the patient's body part, and wherein the computer is adapted to store the image.

A repositionable surgical tracking assembly is also provided. The assembly includes a base and a tracking frame, the base including: a first surface, the first surface including one or more first coupling features; a second surface different from the first surface, the second surface including one or more second coupling features; and one or more bone coupling features, the one or more bone coupling features configured to fix the coupling device to the bone; the tracking frame including: one or more optical tracking markers; and one or more complementary coupling features, the one or more complementary coupling features configured to cooperate with the one or more first coupling features to engage the tracking frame on the first surface, and configured to cooperate with the one or more second coupling features to engage the tracking frame on the second surface, wherein each of the one or more first coupling features and the one or more second coupling features is configured to require a specific orientation of the tracking frame based on the one or more complementary coupling features.

According to some embodiments, the one or more first coupling features include a first dimple, the one or more second coupling features include a second dimple, and the one or more complementary coupling features include a protrusion complementary to each of the first dimple and the second dimple. According to further embodiments, when the tracking frame is engaged with the first surface, a probe may be received in a dimple of the second surface, thereby indicating to a tracking system that the tracking frame is engaged with the first surface.

A coupling device for securing a tracking frame to a bone of a patient during a surgical procedure is also provided. The coupling device comprises: a plurality of surfaces, wherein each surface comprises one or more coupling features, wherein the one or more coupling features are configured to engage the tracking frame thereto by mating with one or more complementary coupling features of the tracking frame; and one or more bone coupling features, wherein the one or more bone coupling features are configured to secure the coupling device to the bone, wherein the one or more coupling features are configured to require a specific orientation of the tracking frame based on the one or more complementary coupling features.

According to some embodiments, the one or more coupling features include one or more magnets.

According to some embodiments, the one or more complementary coupling features include one or more magnets.

According to some embodiments, the one or more coupling features include recesses and the one or more complementary coupling features include protrusions that are complementary to the recesses.

DETAILED DESCRIPTION

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

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

definition

For the purposes of this disclosure, the term "implant" is used to refer to a prosthetic device or structure that is manufactured to replace or enhance a biological structure. For example, in a total hip replacement procedure, a prosthetic acetabular cup (implant) is used to replace or enhance a patient who has a damaged acetabulum or acetabulum. Although the term "implant" is generally considered to mean an artificial structure (in contrast to a graft), for the purposes of this specification, an implant may include biological tissue or material that is transplanted to replace or enhance a biological structure.

For the purpose of this disclosure, the term "implant host" is used to refer to a patient. In some cases, the term "implant host" can also be used to refer more specifically to a specific joint or position of an intended implant in a specific patient's anatomical structure. For example, in total hip replacement surgery, the implant host can refer to the hip joint of a replaced or repaired patient.

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

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

CASS Ecosystem Overview

FIG1 provides an illustration of an exemplary computer-assisted surgery system (CASS) 100 according to some embodiments. As described in further detail in the following sections, CASS uses computers, robotics, and imaging technology to assist surgeons in performing orthopedic surgical procedures, such as total knee arthroplasty (TKA) or total hip arthroplasty (THA). For example, a surgical navigation system can assist surgeons in locating patient anatomy, guiding surgical instruments, and implanting medical devices with a high degree of accuracy. Surgical navigation systems such as CASS 100 typically employ various forms of computing technology to perform a variety of standard and minimally invasive surgical procedures and techniques. In addition, these systems allow surgeons to more accurately plan, track, and navigate the placement of instruments and implants relative to the patient's body, as well as perform preoperative and intraoperative body imaging.

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

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

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

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

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

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

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

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

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

The registration process of registering CASS 100 to the relevant anatomical structure of the patient can also involve the use of anatomical landmarks, such as landmarks on bones or cartilage. For example, CASS 100 can include a 3D model of the relevant bones or joints, and the surgeon can use a probe connected to CASS to collect data about the position of the bone landmarks on the patient's actual bones during surgery. Bone landmarks can include, for example, the ends of the medial and lateral malleolus, the proximal femur and the distal tibia, and the center of the hip joint. CASS100 can compare and register the position data of the bone landmarks collected by the surgeon with the position data of the same landmarks in the 3D model. Alternatively, CASS 100 can build a 3D model of the bone or joint without preoperative image data by using the position data of the bone landmarks and bone surfaces collected by the surgeon using CASS probes or other means. The registration process can also include determining various axes of the joint. For example, for TKA, the surgeon can use CASS 100 to determine the anatomical axis and mechanical axis of the femur and tibia. The surgeon and CASS 100 can identify the center of the hip joint by moving the patient's leg in a spiral direction (ie, circular) so that CASS can determine where the center of the hip joint is located.

Tissue navigation system 120 (not shown in FIG. 1 ) provides the surgeon with intraoperative real-time visualization of the patient's bone, cartilage, muscle, nerve and/or vascular tissue surrounding the surgical area. Examples of systems that can be used for tissue navigation include fluorescence imaging systems and ultrasound systems.

The display 125 provides a graphical user interface (GUI) that displays images collected by the tissue navigation system 120 and other information related to the surgery. For example, in one embodiment, the display 125 covers image information collected from various modes (e.g., CT, MRI, X-ray, fluorescence, ultrasound, etc.), preoperatively or intraoperatively to provide the surgeon with various views of the patient's anatomical structure and real-time conditions. 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 Figure 1, the surgeon 111 wears an AR HMD 155, which can, for example, overlay preoperative image data on the patient or provide surgical planning suggestions. Various exemplary uses of the AR HMD 155 in surgical procedures are detailed in the following sections.

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

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

Electric impact and acetabular reamer device

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

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

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

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

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

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

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

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

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

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

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

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

Robotic Arm

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

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

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

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

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

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

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

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

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

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

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

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

Surgical procedure data generation and acquisition

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

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

Except changing the surgical procedure itself, the data collected during the nursing segment can be used as the input of other surgical auxiliary programs.For example, in some embodiments, the nursing segment data can be used to design implants.The name submitted on August 15, 2011 is called the U.S. Patent Application No. 13/814,531 of " Systems and Methods for Optimizing Parameters for Orthopaedic Procedures ", the name submitted on July 20, 2012 is called the U.S. Patent Application No. 14/232 of " Systems and Methods for Optimizing Fit of an Implant to Anatomy ", the name submitted on September 19, 2008 is called the U.S. Patent Application No. 12/234 of " Operatively Tuning Implants for Increased Performance ", 444 describes the exemplary data-driven technology for designing implants, determining implant size and installing implants, and the full content of each in the described application is incorporated to this patent application by reference at this time.

In addition, the data may be used for educational, training, or research purposes. For example, using the web-based approach described in FIG. 2C below, other physicians or students may remotely view the surgery in an interface that allows them to selectively view data collected from various components of the CASS 100. Following the surgical procedure, a similar interface may be used to "play back" the surgery for training or other educational purposes, or to determine the source of any problems or complications with the procedure.

The data acquired during the preoperative phase typically includes all information collected or generated before the operation. Therefore, for example, information about the patient can be obtained from a patient intake table or an electronic medical record (EMR). Examples of patient information that can be collected include, but are not limited to, patient demographics, diagnosis, medical history, progress notes, vital signs, medical history information, allergies, and laboratory results. Preoperative data may also include images related to the anatomical region of interest. These images can be captured, for example, using magnetic resonance imaging (MRI), computed tomography (CT), X-rays, ultrasound, or any other mode known in the art. Preoperative data may also include quality of life data captured from the patient. For example, in one embodiment, the patient uses a mobile application ("app") to answer a questionnaire about his current quality of life before surgery. In some embodiments, the preoperative data used by CASS100 includes demographics, anthropometrics, culture, or other specific features that can be consistent with activity levels and specific patient activities about the patient to customize the surgical plan for the patient. For example, certain cultures or demographics may be more likely to use toilets that require squatting every day.

Figures 2A and 2B provide examples of data that can be acquired during the intraoperative phase of a care segment. These examples are based on the various components of CASS 100 described above with reference to Figure 1; however, it should be understood that other types of data can be used based on the type of equipment used during surgery and its use.

FIG2A shows an example of some control instructions provided by the surgical computer 150 to other components of the CASS 100 according to some embodiments. Note that the example of FIG2A assumes that the components of the effector platform 105 are each directly controlled by the surgical computer 150. In embodiments where the components are manually controlled by the surgeon 111, instructions may be provided on the display 125 or AR HMD 155 instructing the surgeon 111 how to move the components.

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

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

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

Certain components of CASS 100 need not be directly controlled by surgical computer 150; instead, surgical computer 150 need only activate the component, which then executes software locally that specifies the manner in which data is acquired and provided to surgical computer 150. In the example of FIG2A, two components are operated in this manner: tracking system 115 and tissue navigation system 120.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

FIG. 2C shows a "cloud-based" implementation in which the surgical computer 150 is connected to the surgical data server 180 via a network 175. This network 175 can be, for example, a dedicated intranet or the Internet. In addition to the data from the surgical computer 150, other sources can transmit relevant data to the surgical data server 180. The example of FIG. 2C shows three additional data sources: the patient 160, the medical staff 165, and the EMR database 170. Thus, the patient 160 can send preoperative and postoperative data to the surgical data server 180, for example, using a mobile application. The medical staff 165 includes the surgeon and his staff and any other professional working with the patient 160 (e.g., a personal physician, a rehabilitation specialist, etc.). It should also be noted that the EMR database 170 can be used for preoperative and postoperative data. For example, assuming that the patient 160 has been given sufficient permissions, the surgical data server 180 can collect the patient's preoperative EMR. The surgical data server 180 can then continue to monitor the EMR to understand any updates after the operation.

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

Data may be transmitted between the various data sources and the surgical data server 180 using any data format and transmission technology known in the art. It should be noted that the architecture shown in FIG2C allows for data to be transmitted from the data sources to the surgical data server 180, and retrieved by the data sources from the surgical data server 180. For example, as explained in detail below, in some embodiments, the surgical computer 150 may use data from past surgeries, machine learning models, etc. to help guide the surgical procedure.

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

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

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

Open vs. Closed Digital Ecosystems

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

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

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

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

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

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

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

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

Surgical Patient Care Systems

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

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

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

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

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

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

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

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

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

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

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

Before surgery, patient data 310,315 and medical staff data 325 can be captured and stored in a cloud-based or online database (e.g., the surgical data server 180 shown in Fig. 2C). Information related to surgery is provided to the computing system manually via wireless data transmission or by using a portable media storage device. The computing system is configured to generate a case plan for CASS 100. The case plan generation will be described below. It should be noted that the system can access historical data from previous patients receiving treatment, including implant size, placement and orientation automatically generated by a computer-assisted, patient-specific knee instrument (PSKI) selection system or by CASS 100 itself. To achieve this, a surgical sales representative or case engineer uses an online portal to upload case log data to a historical database. In certain embodiments, the data transmission to the online database is wireless and automatic.

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

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

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

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

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

Surgical Procedure Monitor

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

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

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

In some embodiments, the predictions or recommendations made by the aforementioned machine learning model can be directly integrated into the surgical workflow. For example, in some embodiments, the surgical computer 150 can execute the machine learning model in the background to predict or recommend upcoming actions or surgical conditions. Therefore, multiple states can be predicted or recommended for each time period. For example, the surgical computer 150 can predict or recommend the state of the next 5 minutes in 30-second increments. With this information, the surgeon can use a "process display" view of the operation that allows visualization of future states. For example, FIG. 4C depicts a series of images that can be displayed to the surgeon, which depicts the implant placement interface. The surgeon can, for example, cycle through these images by inputting a specific time into the display 125 of CASS100 or instructing the system to use tactile, verbal or other instructions to advance or retract the display in specific time increments. In one embodiment, the process display can be presented in the upper part of the surgeon's field of view in the AR HMD. In some embodiments, the process display can be updated in real time. For example, when the surgeon moves the resection tool around the planned resection area, the process display can be updated so that the surgeon can see how his actions are affecting other aspects of the operation.

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

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

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

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

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

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

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

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

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

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

Register preoperative data to patient anatomy using a point probe

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

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

In revision surgery, the surgeon can paint certain areas containing anatomical defects to allow better visualization and navigation of implant insertion. These defects can be identified based on analysis of preoperative images. For example, in one embodiment, each preoperative image is compared with an image library showing "healthy" anatomical structures (i.e., no defects). Any significant deviation between the patient's image and the healthy image can be marked as a potential defect. Then, during surgery, the surgeon can be warned of possible defects via a visual alarm on the display 125 of CASS100. The surgeon can then paint the area to provide further details about the potential defect to the surgical computer 150.

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

The present disclosure describes exemplary systems and methods for tracking specific portions of a patient's skeletal structure during surgery using an optical surgical navigation system. By tracking the skeletal structure during surgery, appropriate measures can be taken to ensure proper joint function. In the following description, for purposes of explanation, numerous specific details are set forth in order to provide a thorough understanding of the exemplary embodiments. However, it will be apparent to those skilled in the art that the embodiments may be practiced without these specific details.

The disclosed tracking system is particularly suitable for use with surgical navigation systems (e.g., NAVIO is a registered trademark of BLUEBELT TECHNOLOGIES, Inc. of Pittsburgh, Pennsylvania, which is now a subsidiary of SMITH & NEPHEW, Inc. of Memphis, Tennessee.

In current implementations of surgical navigation using optical tracking, tracking arrays (i.e., "trackers") are mounted to various body parts and must remain visible to one or more optical tracking cameras. In order for the system to maintain accuracy, the trackers must remain in the appropriate field of view. For example, each tracker must have a reflective or emissive marking feature that is substantially facing the camera or image capture device. As a specific example, the NAVIO system may require that its trackers face the Aurora Spectrum Camera at an angle of no more than 45 degrees. Other systems or embodiments may allow the "face" of the tracker to deviate from the viewing direction (i.e., face angle) of one or more optical tracking cameras by up to 75 degrees.

In some current embodiments, the surgeon performing hip replacement surgery can use a tracked probe to locate landmarks on the pelvis and establish an anatomical coordinate system. Typically, due to proximity constraints and aseptic constraints, the patient first lies down. The landmarks are then collected with the patient in a supine position. However, most surgeons use a lateral surgical approach. Therefore, the patient must be placed on his side after collecting the landmark data in order to proceed with the surgery. During acetabular component placement, changing the patient's orientation may cause pelvic tracking problems.

Therefore, with current pelvic tracker mount designs, the surgeon must position the mount so that the pelvic tracker will be in the field of view of the navigation camera in both the supine and lateral positions. This positioning can be difficult due to the limited face angle of the tracking device. In the operating room (OR), the difficulty of properly positioning the patient is exacerbated by the limited set of available camera positions. Since the rotation from supine to lateral is approximately a 90 degree rotation, each position (e.g., supine and lateral) may place the tracker (i.e., reflective markers on the tracker) at the limit of the field of view or detection range of one or more cameras.

Referring now to FIGS. 5 and 6 , current systems typically have a tracking frame 501, a connector body 502, one or more screws 503, and a connector base 504. As shown in FIG. 5 , the tracking frame 501 can be removably coupled to the connector base 504. One or more screws 503 can be used to attach the connector base 504 to the bone 505. If desired, the tracker 501 can be removed from the connector base 504 during surgery. However, the positioning of the tracker 501 cannot be modified (i.e., if it is removed and replaced, it will remain in the same orientation).

As described herein, a single tracker mounting fixture is typically designed with multiple joints (e.g., a coupler body 502 and a coupler base 504) that can allow the coupler to be initially mounted to the bone and then adjusted to align the tracker to optimally face the camera. However, when one or more patient bones are placed in two significantly different positions (e.g., for a lateral pelvis versus a supine pelvis), the challenge remains finding an optimal position for the tracker while still maintaining acceptable vision for the tracker.

A possible solution may be to use two trackers per bone. In this solution, it would be required that during at least a portion of the registration process, the positions of both trackers be registered identically to the patient, or that both trackers be visible to the tracker at the same time. In addition, such embodiments would require additional bone fixation hardware (e.g., screws 503 and couplers 504), thereby increasing the invasiveness of the procedure.

Thus, a system is presented herein wherein each tracker has at least two coupler locations on a single tracker mount (e.g., coupler), thereby allowing the tracker to be securely and repeatably mounted in multiple locations. In some embodiments, the system may utilize a dual coupler assembly (i.e., a single coupler device having dual coupling surfaces). In a dual coupler assembly, the coupler may be constructed based on predetermined positioning constraints (e.g., the exact positioning and dimensions (i.e., positions) of the two surfaces are known relative to each other).

Referring now to FIG. 7 , a dual coupler assembly 701 may have two or more coupler features 702 (e.g., protrusions). In another embodiment, the two features 702 may be oriented at approximately a 90 degree angle relative to each other. Thus, in some embodiments, the tracker 703 may be mounted in more than one position (e.g., position 1 and position 2 as shown in FIG. 7 ) using the coupler features 702. As discussed herein, the precise machining of the coupler allows the tracking system to know the precise location of the tracking array 704, regardless of where it is located.

The coupler feature 702 ensures that the position of the tracker 703 is known relative to the coupler 701. Since the positions of the coupler features 702 are known relative to each other, the position of the tracker 703 is known when attached to either coupler feature. Therefore, once the navigation system identifies the coupler feature 702 (i.e., the coupler surface) of the dual coupler assembly with the tracker mounted/attached thereto, then when the tracker 703 is placed in the auxiliary position, the landmarks on the bone or skeletal structure registered relative to the tracker position can be transformed. In some embodiments, a coordinate transformation algorithm can be used to make these relative positioning determinations.

As discussed herein, it should be understood that the methods and procedures discussed herein are broadly applicable to various types of surgeries and operating room (OR) environments. However, for purposes of explanation, some specific exemplary embodiments are discussed herein. For example, in some embodiments, the pins can be placed in the iliac ala in a supine position on an operating table. The dual coupler assembly, which can have an integrated latch port, can slide on the pins without tightening. As discussed herein, the tracker can be placed in a first position of the coupler.

In some embodiments, the dual coupler assembly may include one or more markings. The markings may assist the surgeon in orienting the tracker. For example, a first marking may indicate an "up" orientation, and a second marking may indicate a "sideways" orientation. Such markings may allow the surgeon to generally understand how the dual coupler assembly should be attached so that multiple attachment locations are oriented in the proper position.

In further embodiments, the surgeon can adjust the position of the tracker and/or the dual coupling assembly on the bone so that the tracker faces the imaging device (e.g., camera) directly. In another embodiment, the surgeon can also consider the direction in which the patient can be moved (e.g., turned over) during adjustment in order to orient the patient to the surgical lateral position.

Once the orientation is optimized or satisfactory to the surgeon, the latch port can be tightened. In some embodiments, as discussed herein, a tracker can be used to collect pelvic landmarks, such as the anterior superior iliac spine and the pubic spine. The tracker can register the landmark positions relative to the dual coupler assembly. As a specific example, a tracking system (e.g., System) can use one or more landmarks to define the anterior pelvic plane relative to the tracker.

In some embodiments, the anterior pelvic plane can be used as an anatomical reference for surgical navigation. Once the anterior pelvic plane is registered, the anterior pelvic plane can be used as an anatomical reference, which can be more easily done when the patient is in the supine position. Therefore, in another embodiment, once the anterior pelvic plane is registered, the surgeon can remove the tracker from the first coupler position, turn the patient to the surgical lateral position, and attach the tracker to a second or additional coupler position.

Based on the known factors and relative coordinates, when the surgeon is ready to navigate the acetabular component orientation, the surgeon can attach a tracker to the second coupling location and notify the system (e.g., via user input, such as a GUI input, a tactile input (e.g., on a hand tool or foot pedal), a voice command, a gesture, etc.) that the second coupling location is being used. During navigation, the system can track the acetabular locator guide to which the second tracker can be attached to determine the orientation of the guide relative to the tracker.

In some embodiments, the system can report the orientation of the acetabular guide relative to the anterior pelvic plane coordinate system. Such reporting is achieved by understanding the position of the couplers relative to each other. Therefore, although the position information of the anterior pelvic plane can be collected with the tracker installed on the first coupler position, such position information can be transformed when the tracker is in the second position, and the second position is arranged to directly face the camera when the patient is positioned laterally. Using the second coupler position enables all trackers to be seen by the navigation camera at the same time.

In another embodiment, if the tracker is out of the field of view of one or more sensor devices, the system can notify the user (e.g., via a GUI, one or more notification lights, one or more audible tones, etc.). Thus, in some embodiments, the system itself can request a modification or update of the tracker position. As discussed herein, in some embodiments, the system may be able to automatically determine where the tracker is located based on orientation or through some form of user input (e.g., inserting a probe tracker into an open pit).

As shown in FIG8 , some embodiments may utilize a magnetic system (e.g., magnets 802-807) for coupler/target attachment. In some embodiments, the positioning and polarity of the magnets allow for consistency when attaching tracking frames of different shapes. As a specific example, the magnets in the dual coupler assembly 801 can be positioned so that their polarities are opposite (e.g., magnet 804 can have the north pole of the magnet facing outward to engage the tracking device 808, while magnet 805 can have the south pole of the magnet facing outward to engage the tracking device). Therefore, in some embodiments, the tracking device 808 will need to be in the proper orientation (e.g., so that the pole of magnet 802 attracts the pole of magnet 804 and the pole of magnet 803 attracts the pole of magnet 805) for establishing a secure connection with the coupler 801.

In another embodiment, and as shown in FIG. 9 , a mark or dimple 901 may be placed on the surface of each coupler. The marks/dimples may be placed such that a first dimple 901A (i.e., the dimple at the first coupler location) has a different orientation relative to its surface than a second dimple 901B (i.e., the dimple at the second coupler location). As shown in FIG. 9 , the tracker coordinate system “A” is known because the position of _D1 relative to the “A” coordinate system is known (i.e., when the tracker is in position 1, will be different than the relative position of _D2 relative to the “A” coordinate system (i.e., when the tracker is in position 2).

In another embodiment, and as shown in FIG. 10 , the tracking probe 1004 may be placed at any of the recesses (e.g., D ₁ , D ₂ , etc.) at any time during use to collect additional positioning data. Thus, in some embodiments, identifying the position of the tracker probe 1004 on the dual coupler assembly 1001 may involve placing the probe tip 1003 into one of the recesses, thereby allowing the image capture device to position the tracking frame 1002 on the probe and calculate the position of the probe tip relative to the coupler assembly. In another embodiment, the user may signal the system (e.g., via user input, such as a GUI input, tactile input (e.g., on a hand tool or foot pedal), voice command, gesture, etc.) to record the location of the tracker, and therefore the location of the recess. Additionally or alternatively, the system may automatically detect that the probe tracker 1001 is in use and automatically begin calibration/calculations as needed.

In some embodiments, if the system records the position and determines a match with a known pit (e.g., D1, _D2 , etc.), it can be assumed that the tracker is in a particular position (e.g., position ₁ , 2, etc.). As a specific example, if the system determines that the probe tracker is placed at _D1 while also recording that the tracker is attached to the coupler, the system can determine that the tracker is in position 2 because _D1 would not be accessible if the tracker was in position 1.

In another embodiment, the system can detect that, for example, the tracking probe 1004 is in the second pit by determining the probe to bone tracker distance. Thus, in some embodiments, the exact dimensions of the tracking probe 1004 may be known, and therefore, when the tracking probe moves (e.g., pivots within a pit), the tracking system will be able to discern which pit the probe tip 1003 is in based on the relative distance from the tracking frame 1002 to the fixed probe tip. As discussed, this would mean that the tracker is in the first position on the coupler. Similarly, contacting the first pit would indicate that the second coupler is being used. Thus, in some embodiments, the pits may be designed so that when the tracker is engaged with the coupler, the coupler interface physically prevents the probe tracker from contacting a particular pit.

In an additional or alternative embodiment, a redundant marker may be permanently attached to the dual coupler assembly. Thus, the marker may be visible in one of two positions and will be in a known relationship with the tracker. Thus, when that relationship is observed, it will indicate which position the tracker is in.

Thus, a system is disclosed herein that allows for more direct visibility of a skeletal tracker to one or more cameras, regardless of the patient's position. This ensures easier access to the user and therefore provides overall improvement and further assurance for joint replacement surgery.

As discussed herein, in some embodiments, a user may provide input data that informs the system that a tracker has moved from one coupler to another coupler on a dual coupler assembly. As a specific example, some embodiments may require a user to press a button (e.g., a button located on a hand tool such as a drill). Additionally or alternatively, a user may provide input data via a foot pedal or even hand gestures (e.g., a series of predefined hand movements in a space detectable by a tracking system or motion detection system).

11 is a block diagram depicting an exemplary system 1100 for providing navigation and control to an implant positioning device 1130 according to an exemplary embodiment. In an embodiment, the system 1100 may include a control system 1110, a tracking system 1120, and an implant positioning device 1130. Optionally, the system 1100 may also include a display device 1140 and a database 1150. In one example, these components may be combined to provide navigation and control of an implant positioning device 1130 during an orthopedic (or similar) prosthetic implantation procedure.

The control system 1110 may include one or more computing devices configured to coordinate information received from the tracking system 1120 and provide control of the implant positioning device 1130. In one example, the control system 1110 may include a planning module 1112, a navigation module 1114, a control module 1116, and a communication interface 1118. The planning module 1112 may provide a preoperative planning service that enables a clinician to virtually plan a procedure before entering the operating room. Background technology discusses various preoperative planning procedures used in total hip replacement (total hip arthroplasty (THA)), which may be used in a surgical robot-assisted joint replacement procedure. In addition, U.S. Patent No. 6,205,411, entitled "Computer-Assisted Surgery Planner and Intra-Operative Guidance System", discusses another preoperative planning method, which is incorporated herein by reference in its entirety.

In an example of THA, for example, planning module 1112 can be used to manipulate the virtual model of the implant with reference to the virtual implant host model. The implant host model can be constructed according to the scan of the target patient. Such scans may include computed tomography (CT), magnetic resonance imaging (MRI), positron emission tomography (PET) or ultrasonic scanning of joints and surrounding structures. Alternatively, preoperative planning can be performed by selecting a predefined implant host model from a model group based on the input selected by the patient's measurements or other clinicians. In some instances, the preoperative planning is refined intraoperatively by measuring the actual anatomical structure of the patient's (target implant host). In an example, a point probe connected to tracking system 1120 can be used to measure the actual anatomical structure of the target implant host.

In one example, navigation module 1114 can coordinate the location and orientation of tracking implant, implant host and implant positioning device 1130. In some examples, navigation module 1114 can also coordinate the tracking of the virtual model used during the preoperative planning in planning module 1112. Tracking virtual model can include such operation, such as aligning virtual model with implant host by the data obtained via tracking system 1120. In these examples, navigation module 1114 receives input about the physical location and orientation of implant positioning device 1130 and implant host from tracking system 1120. Tracking of implant host can include tracking multiple individual bone structures. For example, during total knee replacement procedure, tracking system 1120 can use the tracking device anchored to individual bones to track femur and tibia separately.

In one example, the control module 1116 can process the information provided by the navigation module 1114 to generate a control signal for controlling the implant positioning device 1130. In some examples, the control module 1116 can also work with the navigation module 1114 to generate a visual animation to assist the surgeon during the surgical procedure. The visual animation can be displayed by a display device, such as a display device 1140. In one example, the visual animation can include a real-time 3-D representation of the implant, the implant host, and the implant positioning device 1130, etc. In some examples, the visual animation is color-coded to further help the surgeon locate and orient the implant.

In one example, the communication interface 1118 facilitates communication between the control system 1110 and external systems and devices. The communication interface 1118 may include wired and wireless communication interfaces, such as Ethernet, IEEE 802.11 wireless, or Bluetooth, etc. As shown in Figure 11, in this example, the main external systems connected via the communication interface 1118 include a tracking system 1120 and an implant positioning device 1130. Although not shown, a database 1150 and a display device 1140 and other devices may also be connected to the control system 1110 via the communication interface 1118. In one example, the communication interface 1118 communicates with other modules and hardware systems within the control system 1110 through an internal bus.

In one instance, the tracking system 1120 provides positioning and orientation information for the surgical device and portions of the anatomy of the implant host to assist in navigating and controlling the semi-active robotic surgical device. The tracking system 1120 may include a tracker that includes or otherwise provides tracking data based on at least three positions and at least three angles. The tracker may include one or more first tracking markers associated with the implant host and one or more second markers associated with the surgical device (e.g., implant positioning device 1130). The marker or some of the markers may be one or more of an infrared source, a radio frequency (RF) source, an ultrasonic source, and/or a transmitter. The tracking system 1120 may therefore be an infrared tracking system, an optical tracking system, an ultrasonic tracking system, an inertial tracking system, a wired system, and/or an RF tracking system. An illustrative tracking system may be the one described herein. 3-D motion and position measurement and tracking systems, but those skilled in the art will recognize that other tracking systems of other accuracy and/or resolution may be used.

U.S. Patent No. 6,757,582 to Brisson et al., entitled “Methods and Systems to Control a Shaping Tool,” provides additional details regarding the use of tracking systems such as tracking system 1120 within a surgical environment. U.S. Patent No. 6,757,582 (the '582 patent) is incorporated herein by reference in its entirety.

FIG. 12 is a diagram showing an exemplary environment for operating a system 1200 for navigating and controlling an implant positioning device 1130 according to an exemplary embodiment. In one example, the system 1200 may include components similar to those discussed above with reference to the system 1100. For example, the system 1200 may include a control system 1110, a tracking system 1120, an implant positioning device 1130, and one or more display devices, such as display devices 1140A, 1140B. The system 1200 also shows an implant host 1101, tracking markers 1160, 1162, and 1164, and a foot controller 1170.

In one example, tracking markers 1160, 1162, and 1164 can be used by tracking system 1120 to track the position and orientation of implant host 1101, implant positioning device 1130, and a reference, such as an operating table (tracking marker 1164). In this example, tracking system 1120 uses optical tracking to monitor the position and orientation of tracking markers 1160, 1162, and 1164. Each of tracking markers 1160, 1162, and 1164 includes three or more tracking balls that provide easy-to-handle targets to determine position and orientation in up to six degrees of freedom. Tracking system 1120 can be calibrated to provide a local 3-D coordinate system within which implant host 1101 and implant positioning device 1130 (via a reference implant) can be spatially tracked. For example, as long as the tracking system 1120 can image three tracking balls on a tracking marker (e.g., tracking marker 1160), the tracking system 1120 can generate points in a 3-D coordinate system using an image processing algorithm. Subsequently, the tracking system 1120 (or the navigation module 1114 (FIG. 11) within the control system 1110) can use the three points to triangulate the exact 3-D position and orientation associated with the device to which the tracking marker is attached (e.g., implant host 1101 or implant positioning device 1130). Once the precise position and orientation of the implant positioning device 1130 are known, the system 1200 can use the known characteristics of the implant positioning device 1130 to accurately calculate the position and orientation associated with the implant (in the case where the tracking system 1120 cannot visualize the implant, the implant may be within the implant host 1101 and invisible to the surgeon or the tracking system 1120).

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

The present disclosure is not limited to the specific embodiments described in this application, which are intended to be illustrations of various aspects. Without departing from the spirit and scope that are clearly understood by those skilled in the art, many modifications and changes can be made. According to the foregoing description, functionally equivalent methods and devices (except those listed herein) within the scope of the present disclosure will be apparent to those skilled in the art. Such modifications and changes are intended to fall within the scope of the appended claims. The present disclosure will only be limited by the wording of the appended claims and the full range of equivalents to which these claims are entitled. It should be understood that the present disclosure is not limited to specific methods, reagents, compounds, compositions or biological systems, which can certainly vary. It should also be understood that the terms used herein are only used for the purpose of describing specific embodiments, and are not intended to be restrictive.

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

Those skilled in the art will understand that, in general, the terms used herein and particularly in the appended claims (e.g., the bodies of the appended claims) are generally intended to be "open" terms (e.g., the term "including" should be interpreted as "including but not limited to", the term "having" should be interpreted as "having at least", the term "comprising" should be interpreted as "including but not limited to", etc.). Although various compositions, methods, and apparatus are described in terms of "comprising" various components or steps (interpreted to mean "including but not limited to"), the compositions, methods, and apparatus may also "consist essentially of" or "consist of" the various components and steps, and such terms should be interpreted as defining substantially closed groups of components. Those skilled in the art will also understand that if a specific number of an introduced claim recitation is intended, such intent will be explicitly detailed in the claims, and in the absence of such detail, no such intent is present.

For example, to aid understanding, the following appended claims may contain the use of the introductory phrases "at least one" and "one or more" to introduce claim recitations. However, the use of such phrases should not be interpreted as implying that a claim recitation introduced by the indefinite article "a/an" limits any particular claim containing such introduced claim recitation to embodiments containing only such recitation, even when the same claim includes the introductory phrases "one or more" or "at least one" and an indefinite article such as "a" (e.g., "a" should be interpreted to mean "at least one" or "one or more"); the same applies to the use of definite articles to introduce claim recitations.

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

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

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

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

Claims (23)

1. A computer-assisted surgery navigation system, comprising:

A computer program adapted to generate navigational reference information regarding the position and orientation of a body part of a patient;

A tracking device mounted to the patient, the tracking device comprising a tracking frame and a coupler base having a plurality of surfaces, wherein the tracking frame is configured to removably engage coupler features on each of the plurality of surfaces, and wherein the positions of the coupler features are known relative to each other such that when the tracking frame is attached to any coupler feature, the position of the tracking frame is known, whereby a marker on a bone or skeletal structure registered relative to the tracking frame position can be converted using a coordinate transformation algorithm;

A sensor configured to identify a location of the tracking frame; and

A computer configured to store the navigational reference information and to receive the position of the tracking frame from the sensor for tracking the position and orientation of at least one surgical reference relative to the body part.

2. The system of claim 1, further comprising a monitor configured to receive and display one or more of the navigation reference information and the position and orientation of the at least one surgical reference.

3. The system of any of claims 1-2, wherein each of the plurality of surfaces comprises a dimple.

4. The system of claim 3, further comprising a tracking probe,

Wherein the sensor is further configured to identify the position of the tracking probe, and

Wherein the computer is further configured to receive the position of the tracking probe and determine whether the tracking probe is located in a pit of one of the plurality of surfaces.

5. The system of any one of claims 1-2, further comprising a robotic arm,

Wherein the computer is further configured to notify a user to reposition the tracking frame when the robotic arm blocks the view of the sensor to the tracking frame.

6. The system of any of claims 1-2, wherein the sensor is adapted to sense at least one of: electrical signals, magnetic fields, sound, radio frequency, or x-rays.

7. The system according to any one of claims 1-2, wherein the sensor is at least adapted to sense the body.

8. The system of any of claims 1-2, wherein the sensor comprises at least two optical tracking cameras for sensing at least one surgical reference associated with a body part of the patient.

9. The system of any one of claims 1-2, wherein the body part is at least a bone of the patient.

10. The system of any one of claims 1-2, wherein the body part is at least tissue of the patient.

11. The system of any one of claims 1-2, wherein the body part is at least the head of the patient.

12. The system of claim 1, wherein the navigational reference information relates to a bone of the patient.

13. The system of claim 12, wherein the tracking device is mounted to the bone.

14. The system of any of claims 1-2, wherein the navigational reference information is a mechanical axis of the body part.

15. The system of any one of claims 1-2, wherein the surgical reference is an anterior pelvic plane.

16. The system of any of claims 1-2, further comprising an imager for obtaining an image of the body part of the patient, and wherein the computer is adapted to store the image.

17. A repositionable surgical tracking assembly comprising:

A base, the base comprising:

A first surface comprising one or more first coupling features;

a second surface different from the first surface, the second surface comprising one or more second coupling features; and

One or more bone coupling features configured to secure the coupling device to a bone; and

A tracking framework, the tracking framework comprising:

one or more optical tracking marks; and

One or more complementary coupling features configured to mate with the one or more first coupling features to engage the tracking frame on the first surface and configured to mate with the one or more second coupling features to engage the tracking frame on the second surface,

Wherein each of the one or more first coupling features and the one or more second coupling features are configured to require an orientation of the tracking frame based on the one or more complementary coupling features, and wherein the positions of the first coupling features and the second coupling features are known relative to each other such that when the tracking frame is attached to either of the first coupling features and the second coupling features, the position of the tracking frame is known, whereby a marker on a bone or skeletal structure registered relative to the tracking frame position can be converted using a coordinate transformation algorithm.

18. The surgical tracking assembly of claim 17, wherein the one or more first coupling features comprise a first dimple, the one or more second coupling features comprise a second dimple, and the one or more complementary coupling features comprise a protrusion complementary to each of the first dimple and the second dimple.

19. The surgical tracking assembly of claim 18, wherein when the tracking frame is engaged with the first surface, the probe is receivable in a recess of the second surface, thereby indicating to a tracking system that the tracking frame is engaged with the first surface.

20. A coupling device for securing a tracking frame to a patient's bone during a surgical procedure, the coupling device comprising:

A plurality of surfaces, wherein each surface comprises one or more coupling features configured to engage the tracking frame thereto by mating with one or more complementary coupling features of the tracking frame; and

One or more bone coupling features configured to secure the coupling device to the bone,

Wherein the one or more coupling features are configured to require an orientation of the tracking frame based on the one or more complementary coupling features, and wherein the positions of the coupling features are known relative to each other such that when the tracking frame is attached to any coupling feature, the position of the tracking frame is known, whereby a marker on a bone or skeletal structure registered relative to the tracking frame position can be converted by using a coordinate transformation algorithm.

21. The coupling device of claim 20, wherein the one or more coupling features comprise one or more magnets.

22. The coupling device of any of claims 20-21, wherein the one or more complementary coupling features comprise one or more magnets.

23. The coupling device of any of claims 20-21, wherein the one or more coupling features comprise a dimple and the one or more complementary coupling features comprise a protrusion complementary to the dimple.