Computer-controlled surgical rotation tools

Abstract

A rotary tool includes a tool body and a powered rotary cutting tool tip that is oriented and positioned relative to the tool body by a plurality of processor-controlled actuators that provide degrees of freedom. The processor uses a surgical tracking system to identify the posture of the tool body and tool tip relative to the patient's anatomy and controls the actuator to maintain the tool tip in a predetermined cutting plane to compensate for deviations of the surgeon's hand or a robotic arm controlling the tool body during the cutting operation.

Description

[0001] Priority declaration

[0002] This application claims the benefit of priority to U.S. Provisional Application No. 62 / 863,039, filed on June 18, 2019, entitled “Computer Controlled Surgical Rotary Tool,” which is incorporated herein by reference in its entirety. Technical Field

[0003] The present disclosure generally relates to methods, systems and apparatus related to surgical rotation tools for bone resection in cooperation with a computer-assisted surgery system, the computer-assisted surgery system including various hardware and software components that work together to enhance surgical workflow and outcomes. More specifically, the present disclosure relates to a surgical rotation tool that is configured to be maintained relative to a virtual cutting plane under the control of a computer-assisted surgery system. The disclosed technology can be applied to shoulder, hip and knee surgical procedures, for example, as well as other surgical interventions such as arthroscopic surgery, spinal surgery, maxillofacial surgery, rotator cuff surgery, ligament repair and replacement surgery. Background Art

[0004] Conventional surgical procedures have recently been enhanced through the use of robotic assistance. Robotic assistance can enhance conventional surgical procedures to varying degrees. Robotic augmentation can fully automate the surgery or provide the surgeon with tracking and guidance that is not traditionally available. One type of system used for robotic augmented surgery is the NAVIO surgical system available from Smith and Nephewer. NAVIO is a registered trademark of Blue Belt Technologies, Inc., a wholly owned subsidiary of Smith & Nephew.

[0005] Bone resection for total knee replacement is typically accomplished using an oscillating saw and a cutting guide or jig. Postoperative function, pain, recovery, and satisfaction are all affected by implant placement. Robotic-assisted total knee arthroplasty (e.g., as can be performed using the NAVIO system) is designed to improve the accuracy and repeatability of implant placement. A disadvantage of some robotic surgical systems is that it takes slightly longer to remove the volume of bone required for total knee replacement using volumetric resection methods (e.g., a rotating circular saw).

[0006] To overcome the limitations of the resection rates achievable using small circular saws, some systems utilize a hybrid approach where a robotic handpiece is used to deburr features of limited size at specific / pre-planned locations. Thereafter, a special cutting fixture interfaces with the burred feature in the bone, placing the fixture in the correct position / orientation to resect the bone using a traditional oscillating saw, thereby allowing sections of bone to be cut away rather than ground away.

[0007] While this approach may be faster than removing the burr individually, it may have several limitations. For example, a feature of cutting guide deburring is a "post hole" that is cumbersome for the surgeon to create. Placing the cutting fixture into the burr feature may introduce additional errors. Cutting with a saw may introduce even more errors. Some robotic systems utilize a robotic arm to constrain the saw directly to the resection plane. This can overcome the limitations of systems that use burr post holes to mount the cutting guide. However, the complexity of the robotic arm may significantly increase the cost.

[0008] The exemplary NAVIO surgical system assists the surgeon by using optical tracking of tools in the operating room and tracking the patient's anatomy relative to the tools. Such tracking is typically performed by applying mechanical fiducial markers to the patient's anatomy (e.g., temporarily affixing fiducial markers to the patient's bone structure during arthroplasty and mounting fiducial markers to handpieces for tools). By using fiducial markers, objects in the operating room can be reliably and accurately optically tracked. Once objects in the operating room are spatially registered to one another by the optical tracking system, any future movement of these objects can be tracked, and their motion can be captured and calculated via image processing and geometric modeling.

[0009] For example, once the fiducial markers have been fixed to the patient's bone and have been registered in the system and the tool / handpiece has also been registered in the system, the surgeon can use the tool / handpiece to impact the bone and register the positioning of the prominent features of the patient's bone structure via the impact. For example, during knee replacement or correction surgery, the fiducial markers can be fixed to the femur and tibia. Using a probe with a tip at a predetermined location and orientation relative to the fiducial markers fixed to the probe, the surgeon can contact the tip of the probe with specific features on the tibial plateau and the femoral condyle or contact other important features for the surgical procedure. By tracking the positioning and orientation of the tibia and femur, by optically tracking the fiducial markers, and by tracking the position and positioning of the probe (when impacting the bone, to register these features of the tibia and femur), a three-dimensional model of the operating room can be created via a robot optical tracking system. Once the positioning of the important features of the patient's bone structure has been identified and the positioning has been registered relative to the fiducial markers, all future interactions with those bone features can be determined based on the positioning and orientation of the tool relative to the fiducial markers on the bone. Summary of the invention

[0010] This Summary is provided to comply with 37 CFR §1.73. It is to be understood that this Summary is not presented to interpret or limit the scope or meaning of the present disclosure.

[0011] A system for resecting a patient's bone is provided. The system includes: a rotary tool having: a tool body; a tracking array fixed to the tool body, the tracking array including three or more fiducial markers; a powered rotary cutting tip including a longitudinal axis, wherein the rotary cutting tip is fixed to the tool body and can be rotated by a motor about the longitudinal axis to resect the bone; a first linear actuator and a second linear actuator, the first linear actuator and the second linear actuator being configured to adjust one or more of a vertical position and a pitch position of the rotary cutting tip relative to the tool body; and a tool holder extending from the tool body, the tool holder being configured to maintain contact with the bone as the tool body is moved to resect the bone; a surgical tracking device; a surgical tracking device configured to identify a position of each of the one or more reference markers relative to the bone; and a processor configured to: receive a surgical plan, the surgical plan including at least one virtual cutting plane on the bone, receive the position of the tracking array from the surgical tracking device, determine a real-time posture of the cutting tip relative to the at least one virtual cutting plane based on the position of the tracking array, and control the first linear actuator and the second linear actuator based on the real-time posture to adjust one or more of a vertical position and a pitch position of the rotating cutting tip relative to the tool body so as to keep the rotating cutting tip on the at least one virtual cutting plane.

[0012] According to some embodiments, the rotating cutting tip has a fixed horizontal position and a fixed axial position relative to the tool body.

[0013] According to some embodiments, the rotating cutting tip has a fixed yaw position relative to the tool body.

[0014] According to some embodiments, the processor is configured to prevent the rotating cutting tip from cutting through the at least one virtual cutting plane.

[0015] According to some embodiments, the at least one virtual cutting plane includes a vertical cutting plane and a horizontal cutting plane. According to additional embodiments, the processor is further configured to maintain the longitudinal axis of the rotating cutting tip on the vertical cutting plane when the movement axes of the first linear actuator and the second linear actuator are substantially orthogonal to the vertical cutting plane; and to maintain the longitudinal axis of the rotating cutting tip on the horizontal cutting plane when the movement axes of the first linear actuator and the second linear actuator are substantially orthogonal to the horizontal cutting plane. According to additional embodiments, the tool holder is further configured to pivot around a fixed point on the contact surface with the bone during movement of the rotating cutting tip along the vertical cutting plane; and to move along the contact surface of the bone during movement of the rotating cutting tip along the horizontal cutting plane.

[0016] According to some embodiments, the processor is further configured to control the rotation speed of the rotating cutting tip about the longitudinal axis to resect the bone. According to additional embodiments, the processor is further configured to stop the rotation of the rotating cutting tip when the rotating cutting tip intersects the at least one virtual cutting plane. According to additional embodiments, the processor is further configured to stop the rotation of the rotating cutting tip when the rotating cutting tip moves outside of a designated cutting area.

[0017] According to some embodiments, each of the first linear actuator and the second linear actuator includes one or more of a linear motor, a piezoelectric motor, a pneumatic motor, a hydraulic motor, and a gear motor.

[0018] According to some embodiments, the tool holder is rotatable relative to the tool body.

[0019] According to some embodiments, the processor is further configured to control a position of a robotic arm to which the rotary tool is secured.

[0020] A rotary tool for resecting a patient's bone is provided. The rotary cutting tool comprises: a tool body; a tracking array fixed to the tool body, the tracking array comprising one or more reference markers configured to be tracked by a surgical tracking system; a powered rotary cutting tip comprising a longitudinal axis, wherein the rotary cutting tip is fixed to the tool body and can be rotated by a motor about the longitudinal axis to resect the patient's bone, a first linear actuator and a second linear actuator, the first linear actuator and the second linear actuator being configured to be controlled by a processor to adjust one or more of the vertical position and the pitch position of the rotary cutting tip relative to the tool body to maintain the rotary cutting tip on at least one virtual cutting plane; and a tool holder extending from the tool body, the tool holder being configured to maintain contact with the bone when the tool body is moved to resect the bone.

[0021] According to some embodiments, the rotating cutting tip has a fixed horizontal position and a fixed axial position relative to the tool body.

[0022] According to some embodiments, the rotating cutting tip has a fixed yaw position relative to the tool body.

[0023] According to some embodiments, each of the first linear actuator and the second linear actuator includes one or more of a linear motor, a piezoelectric motor, a pneumatic motor, a hydraulic motor, and a gear motor.

[0024] According to some embodiments, the tool holder is rotatable relative to the tool body.

[0025] According to some embodiments, the rotary tool is configured to be secured to a robotic arm, wherein the processor is further configured to control a position of the robotic arm.

[0026] According to some embodiments, the tool holder is further configured to pivot about a fixed point on the contact surface with the bone during movement of the rotating cutting tip along the vertical cutting plane, and to move along the contact surface with the bone during movement of the rotating cutting tip along the horizontal cutting plane. BRIEF DESCRIPTION OF THE DRAWINGS

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

[0028] Figure 1 An operating room including an exemplary computer assisted surgery system (CASS) is shown in accordance with an embodiment.

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

[0030] Figure 3A An alternative example of an electromagnetic sensor device having three perpendicular coils in accordance with some embodiments is shown.

[0031] Figure 3B An alternative example of an electromagnetic sensor device having two non-parallel fixed coils according to some embodiments is shown.

[0032] Figure 3C An alternative example of an electromagnetic sensor device having two non-parallel separate coils according to some embodiments is shown.

[0033] Figure 4 An example of an electromagnetic sensor device and a patient's bone is shown in accordance with some embodiments.

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

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

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

[0037] Figure 6 A surgical patient care system and illustrative data sources are shown in accordance with an embodiment.

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

[0039] Figure 7B An exemplary flow chart for determining a care period, including pre-operative, intra-operative, and post-operative actions, according to an embodiment is shown.

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

[0041] Figure 8 is a side view of a cutting tool resecting a portion of a patient's tibia according to some embodiments;

[0042] Fig. 9 is a pair of transverse cross-sectional views of a cutting tool compensating for tool body movement during a cutting operation on a patient's bone according to some embodiments;

[0043] Fig.10is a pair of side views of a cutting tool performing a vertical cutting operation on a patient's bone according to some embodiments;

[0044] Fig.11 is a pair of side views of a cutting tool performing a horizontal cutting operation on a patient's bone according to some embodiments;

[0045] Fig.12 is a system diagram of a surgical system utilizing a cutting tool according to some embodiments;

[0046] Fig.13 is a flow chart of exemplary operation of a surgical system utilizing a cutting tool according to some embodiments; and

[0047] Fig.14 A block diagram of an example environment for an operating system for navigating and controlling a computer-assisted surgical navigation system is depicted in accordance with an illustrative embodiment. DETAILED DESCRIPTION

[0048] The present disclosure is not limited to the specific systems, devices, and methods described, as these may vary. The terminology used in the description is for the purpose of describing the particular versions or embodiments only and is not intended to limit the scope.

[0049] 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 antedate the date of this disclosure due to prior invention. As used in this document, the term "including" means "including but not limited to."

[0050] definition

[0051] 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 total hip replacement surgery, a prosthetic acetabular cup (implant) is used to replace or enhance a patient's worn or damaged 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 a biological tissue or material that is transplanted to replace or enhance a biological structure.

[0052] For purposes of this disclosure, the term "real time" is used to refer to computations or operations that are performed immediately when an event occurs or an input is received by an operating 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.

[0053] Although much of the disclosure refers to surgeons or other medical professionals by specific positions or titles, nothing in the disclosure is intended to be limited to specific positions or titles. A surgeon or medical professional may include any doctor, nurse, medical professional, or technician. Any of these terms or titles may be used interchangeably with users of the system disclosed herein unless otherwise expressly provided. For example, in some embodiments, references to surgeons may also apply to technicians or nurses.

[0054] CASS Ecosystem Overview

[0055] Figure 1 An illustration of an example computer-assisted surgery system (CASS) 100 is provided in accordance with 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 a patient's anatomy, guiding surgical instruments, and implanting medical devices with high precision. Surgical navigation systems such as CASS 100 often employ various forms of computing technology to perform a wide variety of standard and minimally invasive surgical procedures and techniques. Moreover, these systems allow surgeons to more accurately plan, track, and navigate the position of instruments and implants relative to the patient's body, as well as perform preoperative and intraoperative body imaging.

[0056] 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 (e.g., hand piece 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. Figure 1One robotic arm 105A is shown in the figure, but in some embodiments, there may be multiple devices. For example, there may be one robotic arm 105A on each side of the operating table T, or there may be two devices on one side of the operating table T. The robotic arm 105A can be mounted directly to the operating table T, located on a floor platform (not shown) next to the operating table T, mounted on a floor pole, or mounted on the wall or ceiling of the operating room. The floor platform can be fixed or movable. In a specific embodiment, the robotic arm 105A is mounted on a floor pole located between the patient's legs or feet. In some embodiments, the end effector 105B may include a suture holder or stapler to help close the wound. In addition, in the case of two robotic arms 105A, the surgical computer 150 can drive the robotic arms 105A to work together to suture the wound when closed. Alternatively, the surgical computer 150 can drive one or more robotic arms 105A to suture the wound when closed.

[0057] 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, may be operated based on instructions received from a surgical computer 150 (described below) to change the position of the limb. Figure 1 One limb positioner 105C is shown, but in some embodiments there may be multiple devices. As an example, there may be one limb positioner 105C on each side of the operating table T, or there may be two devices on one side of the operating table T. The limb positioner 105C may be mounted directly to the operating table T, located on a floor platform (not shown) next to the operating table T, mounted on a pole, or mounted on a wall or ceiling of the operating room. In some embodiments, the limb positioner 105C may be used in an unconventional manner, such as a retractor or a specific bone holder. As an example, the limb positioner 105C may include an ankle boot, a soft tissue clamp, a bone clamp, or a soft tissue retractor spoon, such as a hooked, curved, or angled blade. In some embodiments, the limb positioner 105C may include a suture holder to assist in closing a wound.

[0058] The actuator platform 105 may include tools such as a screwdriver, a light or laser to indicate an axis or plane, a level, a pin driver, a pin puller, a flatness checker, an indicator, a finger, or some combination thereof.

[0059] Resection device 110 ( Figure 1The resection device 110 is a device that is used to perform bone or tissue resection using, for example, mechanical, ultrasonic, or laser techniques (not shown). Examples of the resection device 110 include drilling devices, deburring devices, oscillating sawing devices, vibrating impact devices, reamers, ultrasonic bone cutting devices, radiofrequency ablation devices, reciprocating motion devices (such as files or broaches), 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.

[0060] The actuator 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 actuator platform 105 or the robotic arm 105A, or the cutting guide may be an independent structure that may be cooperatively and / or removably attached to the actuator platform 105 or the robotic arm 105A. The actuator platform 105 or the robotic arm 105A may be controlled by CASS100 to position the cutting guide or fixture 105D near the patient's anatomical structure according to a surgical plan developed preoperatively or intraoperatively, so that the cutting guide or fixture will produce precise bone cutting according to the surgical plan.

[0061] 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 position data, the data from the tracking system 115 can also be used to infer the speed / 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 the 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 and tracking systems. Using the data provided by the tracking system 115, the surgical computer 150 can detect objects and prevent collisions. For example, the surgical computer 150 can prevent the robot arm 105A from colliding with soft tissue.

[0062] Any suitable tracking system can be used to track surgical objects and patient anatomy in the operating room. For example, a combination of infrared and visible light cameras can be used in an array. Various illumination sources (e.g., infrared LED light sources) can illuminate the scene so that three-dimensional imaging can be performed. In some embodiments, this can include stereoscopic, three-view, four-view, etc. imaging. In addition to the camera array fixed to the cart in some embodiments, additional cameras can be placed throughout the operating room. For example, a handheld tool or headgear worn by the operator / surgeon can include an imaging function that transmits images back to a central processor to correlate those images with images acquired by the camera array. This can provide more robust images for environments modeled using multiple perspectives. In addition, some imaging devices can have a suitable resolution on the scene or have a suitable perspective to pick up information stored in a quick response (QR) code or barcode. This helps to identify specific objects that are not manually registered with the system. In some embodiments, the camera can be mounted on the robot arm 105A.

[0063] As discussed herein, although most tracking and / or navigation techniques utilize image-based tracking systems (e.g., IR tracking systems, video- or image-based tracking systems, etc.). However, electromagnetic (EM)-based tracking systems are becoming more and more common for a variety of reasons. For example, implantation of standard optical trackers requires tissue excision (e.g., down to the cortex) and subsequent drilling and driving of cortical pins. In addition, since optical trackers require a direct line of sight between the site and the tracking system, the placement of such trackers may need to be away from the surgical site to ensure that they do not restrict the movement of the surgeon or medical professional.

[0064] Typically, an EM-based tracking device includes one or more coils and a reference field generator. The one or more coils can be powered (e.g., via a wired or wireless power source). Once powered, the coils generate an electromagnetic field that can be detected and measured (e.g., by a reference field generator or an additional device) in a manner that allows the position and orientation of the one or more coils to be determined. As will be appreciated by one of ordinary skill in the art, for example, Figure 2 The single coil shown in is limited to detecting five (5) total degrees of freedom (DOF). For example, the sensor 200 is able to track / determine movement in the X, Y, or Z directions, as well as rotation about the Y axis 202 or the Z axis 201. However, due to the electromagnetic properties of the coil, it is not possible to properly track rotational motion about the X axis.

[0065] Therefore, in most electromagnetic tracking applications, such as Figure 3AThe three-coil system shown in is used to achieve tracking in all six degrees of freedom (i.e., front / back 310, up / down 320, left / right 330, roll 340, pitch 350, and yaw 360) that enables a rigid body to move in three-dimensional space. However, the inclusion of two additional coils and their positioning at a 90° offset angle may require the tracking device to be much larger. Alternatively, as known to those skilled in the art, less than three complete coils may be used to track all 6DOF. In some EM-based tracking devices, the two coils may be fixed to each other, such as Figure 3B Since the two coils 301B, 302B are rigidly fixed to each other, are not completely parallel, and have known positions relative to each other, the sixth degree of freedom 303B can be determined using this arrangement.

[0066] Although the use of two fixed coils (e.g., 301B, 302B) allows for the use of EM-based tracking in 6DOF, the diameter of the sensor device is much larger than a single coil due to the additional coils. Therefore, practical applications of using an EM-based tracking system in a surgical setting may require tissue removal and drilling of a portion of the patient's bone to allow for the insertion of the EM tracker. Alternatively, in some embodiments, a single coil or 5DOF EM tracking device may be implanted / inserted into the patient's bone using only pins (e.g., without the need for drilling or removal of a large amount of bone).

[0067] Therefore, as described herein, a solution is needed that can limit the use of EM tracking systems to devices that are small enough to be inserted / embedded using a small diameter needle or pin (i.e., without the need to make a new incision or a large diameter opening in the bone). Therefore, in some embodiments, a second 5DOF sensor that is not attached to the first sensor and therefore has a small diameter can be used to track all 6DOF. Now referring to Figure 3C In some embodiments, two 5DOF EM sensors (eg, 301C, 302C) may be inserted into a patient (eg, a patient's bone) at different locations and with different angular orientations (eg, angle 303C is non-zero).

[0068] Reference now Figure 4, shows an example embodiment of inserting a first 5DOF EM sensor 401 and a second 5DOF EM sensor 402 into a patient's bone 403 using a standard hollow needle 405 typical in most ORs. In another embodiment, the first sensor 401 and the second sensor 402 may have an angular offset 404 of "?". In some embodiments, the offset angle "?" 404 may need to be greater than a predetermined value (e.g., a minimum angle of 0.50°, 0.75°, etc.). In some embodiments, this minimum value may be determined by CASS during surgical planning and provided to the surgeon or medical professional. In some embodiments, the minimum value may be based on one or more factors, such as the directional accuracy of the tracking system, the distance between the first EM sensor and the second EM sensor. The location of the field generator, the location of the field detector, the type of EM sensor, the quality of the EM sensor, the patient's anatomy, and the like.

[0069] Thus, as discussed herein, in some embodiments, a pin / needle (e.g., a cannula mounting needle, etc.) may be used to insert one or more EM sensors. Typically, the pin / needle will be a disposable component, while the sensor itself may be reusable. However, it should be understood that this is only one possible system, and various other systems may be used where the pin / needle and / or EM sensor are independently disposable or reusable. In another embodiment, the EM sensor may be secured to the mounting needle / pin (e.g., using a Luer lock fitting, etc.), which may allow for rapid assembly and disassembly. In further embodiments, the EM sensor may utilize an alternative sleeve and / or anchoring system that allows for minimally invasive placement of the sensor.

[0070] In another embodiment, the above system can allow for a multi-sensor navigation system that can detect and correct field distortions that plague electromagnetic tracking systems. It should be understood that field distortions can be caused by the movement of any ferromagnetic material within the reference field. Therefore, as is known to those of ordinary skill in the art, a typical OR has a large number of devices that can cause interference (e.g., operating tables, LCD displays, lighting equipment, imaging systems, surgical instruments, etc.). In addition, it is well known that field distortions are difficult to detect. The use of multiple EM sensors enables the system to accurately detect field distortions, and / or alert the user that the current position measurement may be inaccurate. Because the sensors are firmly fixed to the bone anatomy (e.g., via pins / needles), relative measurements of the sensor positions (X, Y, Z) can be used to detect field distortions. As a non-limiting example, in some embodiments, after the EM sensors are fixed to the bone, the relative distance between the two sensors is known and should remain constant. Therefore, any change in this distance can indicate the presence of field distortion.

[0071] In some embodiments, the surgeon can manually register specific objects with the system before or during surgery. For example, by interacting with the 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 methods, the processor can track the tool or bone as it moves through the environment in the three-dimensional model.

[0072] In some embodiments, certain markers, such as fiducial markers that identify individuals, important tools, or bones in the operating room, may include passive or active identification that can be picked up by a camera or camera array associated with a tracking system. For example, an infrared LED may flash a pattern that conveys a unique identification to the source of the pattern, thereby providing a dynamic identification marker. Similarly, one-dimensional or two-dimensional optical codes (barcodes, QR codes, etc.) may be fixed 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 identification with the range of the object in the image. For example, a QR code may be placed in the corner of a tool tray, allowing the orientation and identification of the tray to be tracked. Other tracking methods will be described throughout the text. For example, in some embodiments, surgeons and other personnel may wear augmented reality headsets to provide additional camera angles and tracking capabilities.

[0073] In addition to optical tracking, certain features of an object can be tracked by aligning the physical properties of the object and associating them with an object that can be tracked (e.g., a fiducial marker fixed to a tool or bone). For example, a surgeon can perform a manual alignment 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 plotted for the bone, the three-dimensional surface being associated with the position and orientation of a reference system relative to the fiducial marker. By optically tracking the position and orientation (pose) of the fiducial marker associated with the bone, a model of the surface can be tracked in the environment by extrapolation.

[0074] The registration process of registering CASS 100 to the relevant anatomical structure of the patient may also involve the use of anatomical landmarks, such as landmarks on bones or cartilage. For example, CASS 100 may include a 3D model of the relevant bone or joint, and the surgeon may use a probe connected to CASS to collect data about the position of the bone landmarks on the patient's actual bone during surgery. Bone landmarks may include, for example, the medial and lateral malleolus, the ends of the proximal femur and the distal tibia, and the center of the hip joint. CASS 100 may 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 construct a 3D model of a bone or joint without preoperative image data by using the position data of the bone landmarks and bone surfaces collected by the surgeon using the CASS probe or other means. The registration process may also include determining the various axes of the joint. For example, for TKA, the surgeon may use CASS 100 to determine the anatomical and mechanical axes 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, circumduction) so that CASS can determine the location of the hip joint center.

[0075] Organizational Navigation System 120 ( Figure 1 (not shown) 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.

[0076] 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 overlays image information collected from various modalities (e.g., CT, MRI, X-ray, fluorescence, ultrasound, etc.) collected preoperatively or intraoperatively to provide the surgeon with various views of the patient's anatomical structure and real-time status. The display 125 may include, for example, one or more computer monitors. As an alternative or in addition to the display 125, one or more of the surgical staff may wear an augmented reality (AR) head mounted device (HMD). For example, in Figure 1 In the present invention, surgeon 111 wears AR HMD 155, which can, for example, overlay preoperative image data on the patient or provide surgical planning suggestions. Various exemplary uses of AR HMD 155 in surgical procedures are described in detail in the following sections.

[0077] 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). The remote server can be used, for example, for the storage of data or the execution of computationally intensive processing tasks.

[0078] The surgical computer 150 may be connected to the other components of the CASS 100 using various techniques known in the art. Moreover, the computer may be connected to the surgical computer 150 using a variety 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, the tissue navigation system 120, and the display 125 may similarly be connected to the surgical computer 150 using wired connections. Alternatively, the tracking system 115, the tissue navigation system 120, and the 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.

[0079] Power impact and acetabular reamer device

[0080] The above about Figure 1 Part of the flexibility of the described CASS design is that additional or alternative devices can be added to CASS 100 as needed to support specific surgical procedures. For example, in the case of hip surgery, CASS 100 may include a powered impact device. The impact device is designed to repeatedly apply impact forces that surgeons can use to perform activities such as implant alignment. For example, in total hip arthroplasty (THA), surgeons typically use an impact device to insert a prosthetic acetabular cup into the acetabulum of the implanted host. Although the impact device can be manual in nature (e.g., operated by the surgeon striking the impactor with a hammer), the powered impact device is typically easier and faster to use in a surgical environment. The powered impact device can be powered, for example, using a battery attached to the device. Various attachments can be connected to the powered impact device to allow the impact force to be directed in various ways as needed during surgery. Also in the case of hip surgery, CASS 100 may include a powered, robotically controlled end effector to ream the acetabulum to accommodate the acetabular cup implant.

[0081] In robot-assisted THA, the patient's anatomical structure 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 crest using a clamp and / or bone pins, and such a tracker array can be installed externally through the skin or internally (posterolateral or anterolateral) through an incision made to perform THA. For THA, CASS 100 can use one or more femoral cortical screws inserted into the proximal femur as checkpoints to help the registration process. CASS 100 can also use one or more checkpoint screws inserted into the pelvis as additional checkpoints to help the registration process. The femoral tracker array can be fixed or mounted in the femoral cortical screw. CASS 100 can adopt the following steps, in which verification is performed using a probe that the surgeon accurately places on the key areas of the proximal femur and pelvis identified by the surgeon on the display 125. The tracker can be located on the robotic arm 105A or the 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 bone and robotic arm 105A or end effector 105B has been verified to a certain degree of accuracy (e.g., within 1 mm).

[0082] For THA, CASS 100 can include a broach tracking option using a femoral array to allow the surgeon to intraoperatively capture the broach position and orientation and calculate the patient's hip length and offset values. Based on the information provided about the patient's hip joint and the planned implant position and orientation after broach tracking is completed, the surgeon can modify or adjust the surgical plan.

[0083] For robot-assisted THA, CASS 100 may include one or more power reamers connected or attached to a robot arm 105A or an end effector 105B, which prepare the pelvic bone to receive the acetabular implant according to the surgical plan. The robot 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 resected (reamed) according to the surgical plan. For example, if the surgeon attempts to resect the bone outside the boundary of the bone to be resected according to the surgical plan, CASS 100 may cut off the power supply of the reamer or instruct the surgeon to cut off the power supply of the reamer. CASS 100 may provide the surgeon with the option to turn off or disengage the robotic control of the reamer. Compared to the surgical plan using different colors, the display 125 may show the progress of the bone being resected (reamed). 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 may provide the surgeon with visual or auditory prompts to warn the surgeon that a resection that does not conform to the surgical plan is being performed.

[0084] After reaming, CASS 100 can use a manual or powered 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 implant and the final implant 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 how to compare the orientation and position of the trial implant and the final implant with the surgical plan, and the display 125 can display the position and orientation of the implant while the surgeon manipulates the leg and hip. If the surgeon is not satisfied with the initial implant position and orientation, CASS 100 can provide the surgeon with the option of replanning and redoing the reaming and implant impact by preparing a new surgical plan.

[0085] Preoperatively, CASS 100 can develop a proposed surgical plan based on a three-dimensional model of the hip joint and other patient-specific information (such as the mechanical and anatomical axes of the leg bones, the epicondylar axis, the femoral neck axis, the dimensions of the femur and hip (e.g., length), the midline axis of the hip joint, the ASIS axis of the hip joint, and the location of anatomical landmarks such as the lesser trochanter landmark, the distal landmark, and the center of rotation of the hip joint). The surgical plan developed by CASS can provide recommended optimal implant size and implant location 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 recommended details regarding offset values, inclination and anteversion values, center of rotation, cup size, midline value, superior-inferior fit, and femoral stem size and length.

[0086] 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 display the planned hip resection and superimpose the planned implant on the hip joint based on the planned resection. CASS 100 can provide the surgeon with a choice of different surgical processes, which will be displayed 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 acquired and / or the location and number of tracker arrays used in the alignment process.

[0087] According to some embodiments, the power impact device used with CASS 100 can be operated with a variety of different settings. In some embodiments, the surgeon adjusts the settings by a manual switch or other physical mechanism on the power impact device. In other embodiments, a digital interface can be used, which allows, for example, setting input via a touch screen on the power impact device. Such a digital interface can allow the available settings to change based on, for example, the type of attachment connected to the power attachment device. In some embodiments, the settings can be changed by communicating with a robot or other computer system within CASS 100, rather than adjusting the settings on the power impact device itself. Such a connection can be established using, for example, a Bluetooth or Wi-Fi networking module on the power impact device. In another embodiment, the impact device and the end piece can include features that allow the impact device to know what end piece (cup impactor, broach handle, etc.) is attached without the surgeon having to take any action, and adjust the settings accordingly. This can be achieved, for example, by a QR code, a barcode, an RFID tag, or other methods.

[0088] Examples of settings that can be used include cup impact settings (e.g., unidirectional, specified frequency range, specified force and / or energy range); broach impact settings (e.g., bidirectional / oscillating within a specified frequency range, specified force and / or energy range); femoral head impact settings (e.g., unidirectional / single blow at a specified force or energy); and dry impact settings (e.g., unidirectional at a specified force or energy at a specified frequency). In addition, in some embodiments, the power impact device includes settings related to acetabular liner impact (e.g., unidirectional / single blow at a specified force or energy). There may be multiple settings for each type of liner (e.g., polymer, ceramic, oxinium, or other material). In addition, the power impact device can provide settings for different bone qualities based on preoperative testing / imaging / knowledge and / or the surgeon's intraoperative assessment. In some embodiments, the power impact device can have dual functions. For example, the power impact device can not only provide reciprocating motion to provide impact force, but also provide reciprocating motion for the broach or rasp.

[0089] In some embodiments, the powered impact device includes a feedback sensor that collects data during use of the device and sends the data to a computing device, such as a controller within the device or a surgical computer 150. The computing device can then record the data for later analysis and use. Examples of data that can be collected include, but are not limited to, sound waves, predetermined resonant frequencies of each device, reaction forces or rebound energies from the patient's bones, the position of the device relative to the imaging (e.g., fluorescence, CT, ultrasound, MRI, etc.) of the registered bone anatomy, and / or external strain gauges on the bone.

[0090] 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 correct final broach size (femoral); when the stem is fully seated (femoral side); or when the cup is in place for the THA (depth and / or orientation). Once this information is known, it can be displayed for the surgeon to see, or it can be used to activate a haptic or other feedback mechanism to guide the surgical procedure.

[0091] 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 a powered impact device, the device can automatically extend the impact head (e.g., end effector), move the implant to the appropriate position, or shut off the power of the device once the implant is fully in place. In one embodiment, the derived information can be used to automatically adjust the setting of bone quality, where the powered impact device should use less power to reduce femoral / acetabulum / pelvic fractures or damage to surrounding tissues.

[0092] Robotic Arm

[0093] In some embodiments, CASS 100 includes a robotic arm 105A that serves as an interface for stabilizing and holding various instruments used during the surgical procedure. For example, in the case of hip surgery, these instruments may include, but are not limited to, retractors, sagittal or reciprocating saws, reamer handles, cup impactors, broach handles, and stem inserters. The robotic arm 105A may have multiple degrees of freedom (similar to a Spider device) and the ability to lock into place (e.g., by pressing a button, voice activation, the surgeon removing his hand from the robotic arm, or other methods).

[0094] In some embodiments, movement of the robotic arm 105A can be accomplished using a control panel built into the robotic arm system. For example, a display screen can include one or more input sources, such as physical buttons or a user interface with one or more icons that direct the movement of the robotic arm 105A. A surgeon or other healthcare professional can engage with one or more input sources to position the robotic arm 105A during the performance of a surgical procedure.

[0095] 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 be located within the tool itself.

[0096] The robotic arm 105A may be motorized internally to stabilize the robotic arm, thereby preventing it from falling and striking the patient, operating table, surgical staff, etc., and allowing the surgeon to move the robotic arm without having to fully support its weight. While the surgeon is moving the robotic arm 105A, the robotic arm may provide some resistance to prevent the robotic arm from moving too fast or activating too many degrees of freedom at once. The position and locking state of the robotic arm 105A may be tracked, for example, by a controller or surgical computer 150.

[0097] In some embodiments, the robotic arm 105A can be moved by hand (e.g., by a surgeon) or with an internal motor to its ideal position and orientation for the task being performed. In some embodiments, the robotic arm 105A may be able to operate in a "free" mode, allowing the surgeon to position the arm in a desired position without restriction. In free mode, the position and orientation of the robotic arm 105A may still be tracked as described above. In one embodiment, certain degrees of freedom may be selectively released upon input from a user (e.g., a surgeon) during a specified portion of a surgical plan tracked by the surgical computer 150. Designs in which the robotic arm 105A is powered internally by hydraulics or a motor or provides resistance to external manual movement by similar means may be described as powered robotic arms, while arms that are manually manipulated without power feedback but can be manually or automatically locked in place may be described as passive robotic arms.

[0098] The robotic arm 105A or the end effector 105B may include a trigger or other device to control the power of the saw or drill. The surgeon's engagement of the trigger or other device can cause the robotic arm 105A or the end effector 105B to transition from the motorized 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 causes the system to perform certain functions when activated. For example, the surgeon can 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 the necessary resection. CASS100 can 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 can be configured to allow the surgeon to move the robotic arm 105A or the end effector 105B medially or laterally while limiting movement in other directions. As discussed, the robotic arm 105A or end effector 105B may include a cutting device (saw, drill, and grinder) 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 professional, or with only minimal assistance or input. In still other embodiments, the surgeon or other medical professional may remotely control the movement of the robotic arm 105A or the robotically controlled end effector 105B using a control mechanism separate from the robotic arm or the robotically controlled end effector device, such as using a joystick or an interactive monitor or display control device.

[0099] 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 in surgical procedures involving the knee, shoulder, etc. An 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.

[0100] The robotic arm 105A can be used to hold a retractor. For example, in one embodiment, the surgeon can move the robotic arm 105A to a desired position. At this point, the robotic arm 105A can lock into place. In some embodiments, the robotic arm 105A is provided with data about the patient's position so that if the patient moves, the robotic arm can adjust the retractor position accordingly. In some embodiments, multiple robotic arms can be used, thereby allowing multiple retractors to be held or more than one action to be performed simultaneously (e.g., retractor holding and reaming).

[0101] The robotic arm 105A can also be used to help stabilize the surgeon's hand when making a femoral neck incision. 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 deep into the medial wall of the acetabulum or reaming at an incorrect angle or orientation.

[0102] 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 positioning to prevent damage to the pelvis.

[0103] The surgeon can use the robotic arm 105A to position the broach handle in a desired position and allow the surgeon to impact the broach into the femoral canal in a desired orientation. In some embodiments, once the surgical computer 150 receives feedback that the broach is fully in place, the robotic arm 105A can limit the handle to prevent further advancement of the broach.

[0104] The robotic arm 105A can also be used for resurfacing applications. For example, the robotic arm 105A can stabilize the surgeon while using traditional instruments and provide certain constraints or restrictions to allow for proper placement of implant components (e.g., guidewire placement, chamfer cutters, sleeve cutters, planar cutters, etc.). In the case of using only a bone drill, the robotic arm 105A can stabilize the surgeon's handpiece and can impose restrictions on the handpiece to prevent the surgeon from violating the surgical plan and removing undesirable bone.

[0105] The robotic arm 105A may be a passive arm. As an example, the robotic arm 105A may be a CIRQ robotic arm available from Brainlab AG. CIRQ is a registered trademark of Brainlab AG, Olof-Palme-Str. 981829, Munich, Germany. In a particular embodiment, the robotic arm 105A is an intelligent gripping arm, as disclosed in U.S. Patent Application No. 15 / 525,585 to Krinninger et al., U.S. Patent Application No. 15 / 561,042 to Nowatschin et al., U.S. Patent No. 15 / 561,048 to Nowatschin et al., and U.S. Patent No. 10,342,636 to Nowatschin et al., each of which is incorporated herein by reference in its entirety.

[0106] Generation and collection of surgical procedure data

[0107] The various services provided by a medical professional to treat a clinical condition are collectively referred to as a "care episode." For a particular surgical procedure, the 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 procedure and identify patterns that can be used, for example, in training models to make decisions with minimal human intervention. The data collected during a care episode may be stored as a complete data set at the surgical computer 150 or surgical data server 180. Thus, for each care episode, there is a data set that includes all of the data collectively collected about the patient preoperatively, all of the data collected or stored by CASS 100 intraoperatively, and any postoperative data provided by the patient or by the medical professional monitoring the patient.

[0108] As further explained in detail, the data collected during the care period can be used to enhance the execution of the surgical procedure or provide an overall understanding of the surgical procedure and patient results. For example, in some embodiments, the data collected during the care period can be used to generate a surgical plan. In one embodiment, when data is collected during surgery, the advanced preoperative plan is improved during surgery. In this way, when new data is collected by the components of CASS 100, the surgical plan can be regarded as a real-time or near-real-time dynamic change. In other embodiments, preoperative images or other input data can be used to preoperatively formulate a robust plan that is simply executed during surgery. In this case, the data collected by CASS 100 during surgery can be used to make suggestions to ensure that the surgeon is within the preoperative surgical plan. For example, if the surgeon is not sure how to achieve certain prescribed cutting or implant alignment, the surgical computer 150 can be queried to get suggestions. In other embodiments, preoperative and intraoperative planning schemes can be combined so that the perfect 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 contributes simulation data to be considered by CASS 100 in formulating preoperative, intraoperative, and postoperative / rehabilitation procedures to optimize implant performance outcomes for the patient.

[0109] In addition to changing the surgical procedure itself, the data collected during the nursing session can also be used as input for other surgical assistance procedures. For example, in some embodiments, the nursing session data can be used to design an implant. Example data-driven techniques for designing, sizing, and fitting implants are described in U.S. patent application Ser. No. 13 / 814,531, filed on Aug. 15, 2011, entitled “Systems and Methods for Optimizing Parameters for Orthopaedic Procedures”; U.S. patent application Ser. No. 14 / 232,958, filed on Jul. 20, 2012, entitled “Systems and Methods for Optimizing Fit of an Implant to Anatomy”; and U.S. patent application Ser. No. 12 / 234,444, filed on Sep. 19, 2008, entitled “Operatively Tuning Implants for Increased Performance,” the entire contents of each of the above patents are hereby incorporated by reference into this patent application.

[0110] In addition, the data may be used for educational, training or research purposes. For example, using Figure 5C Using the web-based solution described in , other physicians or students can view the surgery remotely in an interface that allows them to selectively view data collected from various components of the CASS 100. After the surgical procedure, a similar interface can be used to "replay" the surgery for training or other educational purposes, or to identify the source of any problems or complications during the surgery.

[0111] The data acquired during the preoperative phase typically includes all information collected or generated before the operation. Thus, for example, information about the patient can be obtained from a patient entry form 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, medical records, vital signs, medical history information, allergies, and laboratory test results. Preoperative data may also include images related to the anatomical region of interest. These images may be acquired, for example, using magnetic resonance imaging (MRI), computed tomography (CT), X-rays, ultrasound, or any other means known in the art. Preoperative data may also include quality of life data acquired from the patient. For example, in one embodiment, preoperative patients use a mobile application ("app") to answer a questionnaire about their current quality of life. In some embodiments, the preoperative data used by CASS 100 includes demographics, anthropometrics, culture, or other specific features about the patient, which may be consistent with activity levels and specific patient activities to customize the surgical plan for the patient. For example, people of certain cultures or demographics may prefer to use a toilet that squats every day.

[0112] Figure 5A and 5B Examples of data that can be acquired during the intraoperative phase of a care episode are provided. These examples are based on the above reference Figure 1 Various components of CASS 100 are described; however, it should be understood that other types of data may be used based on the type of equipment used during the procedure and its use.

[0113] Figure 5A 1 shows some examples of control instructions provided by the surgical computer 150 to other components of the CASS 100 according to some embodiments. Note that Figure 5A The example assumes that the components of the effector platform 105 are all 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 to instruct the surgeon 111 how to move the components.

[0114] The various components included in the effector platform 105 are controlled by the surgical computer 150, which provides position instructions that indicate where the components are to move within the coordinate system. In some embodiments, the surgical computer 150 provides instructions to the effector platform 105 that define how to react when components of the effector platform 105 deviate from the surgical plan. These commands are Figure 5A 105B. For example, the end effector 105B may provide a force to resist motion outside of the planned resection area. Other commands that may be used by the effector platform 105 include vibration and audio cues.

[0115] In some embodiments, the end effector 105B of the robotic arm 105A is operably coupled to the cutting guide 105D. In response to the anatomical model of the surgical scene, the robotic 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 to be 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 in a precise position and orientation relative to the tibia or femur to align the cutting groove of the cutting guide with the cut to be performed according to the surgical plan. The surgeon can then use any suitable tool, such as a vibrating or rotating saw or drill, to perform the cutting (or drilling) 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, which the surgeon uses to drill and tighten or pin the cutting guide to the appropriate position before using the cutting guide to perform the resection of the patient's tissue. This can free up 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 procedure can be used to make a first distal incision of the femur during a total knee replacement. In some embodiments, where the joint replacement is a hip replacement, the cutting guide 105D can be fixed to the femoral head or acetabulum for the corresponding hip replacement resection. It should be understood that any joint replacement that utilizes a precision incision can use the robotic arm 105A and / or cutting guide 105D in this manner.

[0116] The ablation device 110 is provided with a variety of commands to perform bone or tissue operations. As with the actuator platform 105, position information can be provided to the ablation device 110 to specify where it should be positioned 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, these commands may specify the intensity and pulse duration.

[0117] Some components of CASS 100 need not be directly controlled by the surgical computer 150; rather, the surgical computer 150 need only activate the component, which then executes software locally to specify the manner in which data is collected and provided to the surgical computer 150. Figure 5A In the example of , there are two components that operate in this manner: tracking system 115 and tissue navigation system 120.

[0118] 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 use techniques known in the art to provide instructions for displaying images, GUIs, etc. The display 125 can 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 the operation, and show 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 can include information about the surgical target area. For example, in conjunction with TKA, the display 125 can show the mechanical and anatomical axes of the femur and tibia. The display 125 can show the varus and valgus angles of the knee joint based on the surgical plan, and CASS 100 can show how such angles will be affected if the expected corrections to the surgical plan are made. Therefore, the display 125 is an interactive interface that can dynamically update and display how changes in the surgical plan will affect the final position and orientation of the implant installed on the bone.

[0119] As the workflow proceeds to preparation for bone cutting or resection, the display 125 can show the planned or recommended bone cutting before performing any cutting. 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 revising the planned bone cutting based on the patient's intraoperative assessment. The display 125 can show 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 show how the revised bone cutting will change the position and orientation of the implant when installed on the bone.

[0120] The display 125 can provide the surgeon 111 with various data and information about the patient, the planned surgical procedure, and the implant. Various patient-specific information can be displayed, including real-time data 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 landmarks, 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 cuts), and the future state of the anatomical structure as the surgical plan progresses. The display 125 can also provide or show additional information about the surgical target area. For TKA, the display 125 can provide information about the gap between the femur and the tibia (e.g., gap balance) and how such a gap will be changed if the planned surgical plan is performed. For TKA, the display 125 can provide additional relevant information about the knee joint, such as data about the tension of the joint (e.g., ligament laxity) and information about the rotation and alignment of the joint. The display 125 can show how the positioning and position of the planned implant will affect the patient when the knee joint is flexed. The display 125 can show how the use of different implants or the use of the same implant of different sizes will affect the surgical plan, and preview how such implants will be positioned on the bone. CASS 100 can provide such information for each planned osteotomy in TKA or THA. In TKA, CASS 100 can provide robotic control for one or more planned osteotomies. For example, CASS 100 can only provide robotic control for the initial distal femur cutting, and the surgeon 111 can manually perform other cuttings (front, back and chamfer cutting) using conventional means (e.g., 4-in-1 cutting guide or fixture 105D).

[0121] 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 bones in the display 125, and the implant colors may change or correspond to different types or sizes of implants.

[0122] The information and options shown on the display 125 can vary according to the type of surgical procedure performed. In addition, the surgeon 111 can request or select a specific surgical procedure display that matches or is consistent with his or her surgical plan preferences. For example, for the surgeon 111 who usually performs tibial cutting before femoral cutting in TKA, the display 125 and the associated workflow can be adapted to take into account this preference. The surgeon 111 can also pre-select to include or delete certain steps from the standard surgical procedure display. For example, if the surgeon 111 uses resection measurement to finalize the implantation plan, but does not analyze the ligament gap balance when finalizing the implantation plan, the surgical procedure display can be organized into modules, and the surgeon can select the modules to be displayed and the order of providing the modules according to the surgeon's preferences or the situation of a specific operation. For example, a module involving ligament and gap balance can include ligament / gap balance before and after resection, and the surgeon 111 can select which modules to include in its default surgical plan workflow according to whether such ligament and gap balance is performed before or after (or before and after) bone resection.

[0123] For more specialized display devices, such as an AR HMD, the surgical computer 150 can provide images, text, etc. using data formats supported by the device. For example, if the display 125 is a Microsoft HoloLens TM or Magic Leap One TM If the surgeon 111 is using a holographic device, the surgical computer 150 can use the HoloLens application programming interface (API) to send commands that specify the location and content of the hologram displayed in the surgeon's 111 field of view.

[0124] In some embodiments, one or more surgical planning models may be incorporated into CASS 100 and used in the development of a surgical plan provided to the surgeon 111. The term "surgical planning model" refers to software that simulates the biomechanical properties of anatomical structures in various situations to determine the best way to perform cutting and other surgical activities. For example, for knee replacement surgery, a surgical planning model may measure parameters of functional activities, such as deep knee flexion, gait, etc., and select cutting locations on the knee to optimize implant placement. An example of a surgical planning model is the LIFEMODTM simulation software from SMITH AND NEPHEW. In some embodiments, the surgical computer 150 includes a computing architecture (e.g., a GPU-based parallel processing environment) that allows the surgical planning model to be fully executed during surgery. In other embodiments, the surgical computer 150 may be connected via a network to a remote computer that allows such execution, such as a surgical data server 180 (see Figure 5C). As an alternative to full execution of the surgical planning model, in some embodiments, a set of transfer functions is derived that simplifies the mathematical operations obtained by the model into one or more prediction equations. Then, instead of performing a full simulation during surgery, the prediction equations are used. More details on 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.

[0125] Figure 5B Examples of some types of data that may be provided to the surgical computer 150 from the various components of the CASS 100 are shown. 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, all components transmit data to the surgical computer 150 in a common format. In other embodiments, each component may use a different data format, and the surgical computer 150 is configured with one or more software applications capable of converting the data.

[0126] In general, the surgical computer 150 can be used as a central point for collecting CASS data. The exact content of the data will depend on the source. For example, each component of the actuator platform 105 provides a measured position to the surgical computer 150. Thus, by comparing the measured position to the position originally specified by the surgical computer 150 (see Figure 5B ) for comparison, the surgical computer can identify deviations that occur during surgery.

[0127] The resection device 110 can send various types of data to the surgical computer 150 depending on the type of device used. Exemplary data types that can be sent include measured torque, audio signatures, and measured displacement values. Similarly, the tracking technology 115 can provide different types of data depending on the tracking method used. Exemplary tracking data types include position values ​​of tracked items (e.g., anatomical structures, tools, etc.), ultrasound images, and surface or landmark collection points or axes. When the system is operating, the tissue navigation system 120 provides anatomical positions, shapes, etc. to the surgical computer 150.

[0128] Although the display 125 is typically used to output data for presentation to a user, it 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, which 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.

[0129] During the postoperative phase of the nursing period, various types of data can be collected to quantify the overall improvement or deterioration of the patient's condition caused by the operation. The data can take the form of self-reported information reported by the patient through a questionnaire, for example. For example, in the case of a knee replacement surgery, the Oxford knee score questionnaire can be used to measure the functional status, and the postoperative quality of life can be measured by the EQ5D-5L questionnaire. Other examples in the case of hip replacement surgery can include the Oxford hip score, the Harris hip score, and the WOMAC (Western Ontario and McMaster University Osteoarthritis Index). Such a questionnaire can be managed, for example, by a medical professional directly in a clinical setting, or managed using a mobile application that allows the patient to answer questions directly. In some embodiments, one or more wearable devices that collect data related to the operation can be provided to the patient. For example, after performing a knee operation, a knee brace can be provided to the patient, and the knee brace includes a sensor for monitoring knee position, 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 obtain and record the movement of the patient's body parts during the activity specified after surgery. This motion acquisition can be compared to the biomechanical model to better understand the function of the patient's joint and better predict rehabilitation progress and determine any modifications that may be needed.

[0130] The postoperative phase of the care period can continue throughout the patient's life cycle. For example, in some embodiments, the surgical computer 150 or other components including CASS 100 can continue to receive and collect data related to the surgical procedure after the operation is performed. The data may include, for example, images, answers to questions, "normal" patient data (e.g., blood type, blood pressure, condition, medication, etc.), biometric data (e.g., gait, etc.), and objective and subjective data about specific problems (e.g., knee or hip pain). The data can be explicitly provided to the surgical computer 150 or other CASS components by the patient or the patient's physician. Alternatively or additionally, the surgical computer 150 or other CASS components can monitor the patient's EMR and retrieve relevant information when it 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 of a given procedure. For example, the conditions experienced by the patient long after the surgical procedure can be linked to the surgery by performing regression analysis on various data items collected during the care period. The analysis can be further enhanced by analyzing a group of patients with similar procedures and / or similar anatomical structures.

[0131] 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 surgical computer 150 to retrieve data collected during surgery. The data can then be transferred to a centralized storage device, such as via a desktop computer. Alternatively, in some embodiments, surgical computer 150 is directly connected to a centralized storage device via network 175, such as Figure 5C as shown in .

[0132] Figure 5C A "cloud-based" embodiment is shown, in which the surgical computer 150 is connected to a surgical data server 180 via a network 175. The network 175 can be, for example, a private intranet or the Internet. In addition to data from the surgical computer 150, other sources can also transmit relevant data to the surgical data server 180. Figure 5CThe example of shows three additional data sources: patient 160, healthcare professional 165, and EMR database 170. Thus, patient 160 can send pre-operative and post-operative data to surgical data server 180, for example using a mobile application. Healthcare professionals 165 include the surgeon and his or her staff, as well as any other professionals working with patient 160 (e.g., personal physician, rehabilitation specialist, etc.). It should also be noted that EMR database 170 can be used for pre-operative and post-operative data. For example, assuming that patient 160 has given sufficient permission, surgical data server 180 can collect the patient's pre-operative EMR. The surgical data server 180 can then continue to monitor the EMR for any updates after the surgery.

[0133] At the surgical data server 180, the nursing period database 185 is used to store various data collected during the patient's nursing period. The nursing period 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 structured in a way that allows them to be easily incorporated into two SQL sets of 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 databases that are not related in their design. Various types of No-SQL databases can generally be grouped according to their underlying data models. These groups can include databases using column-based data models (e.g., Cassandra), document-based data models (e.g., MongoDB), key-value-based data models (e.g., Redis), and / or graph-based data models (e.g., Allego). 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 nursing period database 185.

[0134] 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. Figure 5C The architecture shown in allows for the transmission of data from data sources to the surgical data server 180, and the retrieval of data by the data sources from the surgical data server 180. For example, as explained in detail below, in some embodiments, the surgical computer 150 may use data from past surgeries, machine learning models, etc. to help guide the surgical procedure.

[0135] 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 session database 185 meets 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 session database 185 for storage. For example, in one embodiment, the surgical computer 150 performs a de-identification process before initially transmitting a particular data item or group of data items to the surgical data server 180. In some embodiments, a unique identifier is assigned to the data from a particular care session to allow for re-identification of the data when necessary.

[0136] although Figures 5A-5C Data collection in the context of a single care session has been discussed, but it should be understood that the general concept can be extended to data collection for multiple care sessions. For example, surgical data can be collected throughout the care session each time a surgery is performed using CASS 100, and stored at the surgical computer 150 or surgical data server 180. As further explained in detail below, a robust database of care session data allows the generation of optimized values, measurements, distances or other parameters, and other suggestions 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 set of indexes can be used so that data for a group of patients similar to a specific patient or a specific patient can be easily extracted. This concept can be similarly applied to surgeons, implant characteristics, CASS component types, etc.

[0137] Further details for managing episode of care 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,” the entire contents of which are incorporated herein by reference.

[0138] Open vs. Closed Digital Ecosystems

[0139] In some embodiments, CASS 100 is designed to be used as a standalone or "closed" digital ecosystem. Each component of CASS 100 is specifically designed to be used in a closed ecosystem, and devices outside the digital ecosystem generally cannot access the data. For example, in some embodiments, each component includes software or firmware that implements a proprietary protocol for activities such as communication, storage, security, etc. The concept of a closed digital ecosystem may be ideal for companies that want 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.

[0140] In other embodiments, CASS 100 is designed to function as an "open" digital ecosystem. In these embodiments, components can be produced by a variety of different companies according to standards for activities such as communication, storage, and security. Thus, by using these standards, any company is free to build independent, compliant components of the CASS platform. Data can be transferred between components using publicly available application programming interfaces (APIs) and open, shareable data formats.

[0141] To illustrate one type of recommendation that can be performed with CASS 100, a technique for optimizing surgical parameters is disclosed below. The term "optimization" herein refers to selecting optimal parameters based on certain specified criteria. In the extreme case, optimization can refer to selecting optimal parameters based on data from the entire care period (including any preoperative data, the state of the CASS data at a given point in time, and the postoperative goals). Moreover, optimization can be performed using historical data, such as data generated during past surgeries involving, for example, the same surgeon, past patients with similar physical characteristics to the current patient, etc.

[0142] The optimized parameters can depend on the part of the patient's anatomical structure to be operated on. For example, for knee surgery, the surgical parameters can include the positioning information of the femur and tibial components, including but not limited to rotational alignment (for example, varus / valgus rotation, external rotation, flexion rotation of the femoral component, the posterior tilt angle of the tibial component), resection depth (for example varus knee, valgus knee), and the type, size and position of the implant. The positioning information can also include surgical parameters for combined implants, such as overall limb alignment, combined tibiofemoral hyperextension and combined tibiofemoral resection. Other examples of parameters that CASS 100 can optimize for a given TKA femoral implant include the following:

[0143]

[0144] Other examples of parameters that the CASS 100 can optimize for a given TKA tibial implant include the following:

[0145]

[0146] 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 in the canal, femoral offset, leg length, and femoral pattern of the implant.

[0147] Shoulder parameters may include, but are not limited to, humeral resection depth / angle, humeral shaft type, humeral offset, glenoid type and inclination, and reverse shoulder parameters such as humeral resection depth / angle, humeral shaft type, glenoid inclination / type, glenosphere orientation, glenosphere offset, and offset direction.

[0148] There are various conventional techniques for optimizing surgical parameters. However, these techniques are often computationally intensive and, therefore, often require that the parameters be determined preoperatively. As a result, the surgeon's ability to modify the optimization parameters based on problems that may arise during surgery is limited. Moreover, conventional optimization techniques often operate in a "black box" manner, with little or no explanation regarding 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 process or the impact of the deviation on the patient's quality of life after surgery.

[0149] Surgical Patient Care Systems

[0150] The general concept of optimization can be extended to the entire care episode using a surgical patient care system 620 that uses surgical data as well as other data from the patient 605 and healthcare professionals 630 to optimize outcomes and patient satisfaction, such as Figure 6 as shown in .

[0151] Conventionally, preoperative diagnosis, preoperative surgical planning, intraoperative execution of the established plan, and postoperative management of total joint replacements are based on personal experience, published literature, and the surgeon's training knowledge base (ultimately, the tribal knowledge of the individual surgeon and his or her peer "network" and journal publications) and their instinct for accurate intraoperative tactile discrimination of "balance" and accurate manual execution of planar resections using guidance and visual cues. This existing knowledge base and execution style is limited in terms of optimizing outcomes for patients who need care. For example, there are limitations in: accurately diagnosing patients for appropriate, minimally invasive established care; aligning dynamic patient, medical economic, and surgeon preferences with patient desired outcomes; executing surgical plans to properly align and balance bones, etc.; and receiving data from disconnected sources with different biases that are difficult to reconcile into a holistic patient framework. Therefore, data-driven tools that more accurately model anatomical responses and guide surgical planning can improve upon existing approaches.

[0152] The surgical patient care system 620 is designed to utilize patient-specific data, surgeon data, institutional data, and historical outcome data to develop algorithms that suggest or recommend the best overall treatment plan for the patient throughout the care period (pre-operative, intra-operative, and post-operative) based on the desired clinical outcomes. For example, in one embodiment, the surgical patient care system 620 tracks 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 surgical patient care system 620 records the collected data in a historical database. This database can be accessed by future patients and used to develop future treatment plans. In addition to utilizing statistical and mathematical models, simulation tools (e.g., ) simulates outcomes, alignment, kinematics, etc. based on a preliminary or proposed surgical plan, and reconfigures the preliminary or proposed plan to achieve a desired or optimal outcome based on the patient's profile or the surgeon's preferences. The surgical patient care system 620 ensures that each patient is receiving personalized surgical and rehabilitation care, thereby improving the chances of a successful clinical outcome and reducing the financial burden on the facility associated with near-term revisions.

[0153] In some embodiments, the surgical patient care system 620 employs a data collection and management approach to provide a detailed surgical case plan with different steps that are monitored and / or executed using CASS 100. The user's performance is calculated as each step is completed and used to suggest changes to subsequent steps of the case plan. The generation of the case plan relies on a series of input data stored in a local or cloud storage database. The input data can be related to the patient currently being treated or historical data from patients who have received similar treatments.

[0154] The patient 605 provides inputs such as current patient data 310 and historical patient data 615 to the surgical patient care system 620. Various methods generally known in the art can be used to collect such inputs from the patient 605. For example, in some embodiments, the patient 605 fills out a paper or digital survey that the surgical patient care system 620 parses to extract patient data. In other embodiments, the surgical patient care system 620 can extract patient data from existing information sources such as electronic medical records (EMRs), health history files, and payer / provider history files. In other embodiments, the surgical patient care system 620 can provide an application program interface (API) that allows external data sources to push data to the surgical patient care system. For example, the patient 605 can have a mobile phone, a wearable device, or other mobile device that collects data (e.g., heart rate, pain or discomfort level, movement or activity level, or a patient-submitted response to the patient's compliance with any number of preoperative planning standards or conditions) and provides the data to the surgical patient care system 620. Similarly, patient 605 may have a digital application on their mobile or wearable device that can collect data and transmit it to the surgical patient care system 620.

[0155] Current patient data 610 may include, but is not limited to: activity level, past conditions, comorbidities, pre-rehabilitation performance, health and fitness level, pre-operative expectation level (related to hospital, surgery, and rehabilitation), metropolitan statistical area (MSA) driver score, genetic background, previous injuries (sports, trauma, etc.), previous joint replacements, previous trauma surgeries, previous sports medicine surgeries, treatment of contralateral joints or limbs, gait or biomechanical information (dorsal and ankle tissue), pain or discomfort level, care infrastructure information (payer coverage type, home medical infrastructure level, etc.), and an indication of the expected ideal outcome of the surgery.

[0156] Historical patient data 615 may include, but is not limited to: activity level, previous conditions, comorbidities, pre-rehabilitation performance, health and fitness level, pre-operative expectation level (related to hospital, surgery, and rehabilitation), MSA driver score, genetic background, previous injuries (sports, trauma, etc.), previous joint replacements, previous trauma surgeries, previous sports medicine surgeries, treatment of contralateral joints or limbs, gait or biomechanical information (dorsal and ankle tissues), pain or discomfort level, care infrastructure information (payer coverage type, home medical infrastructure level, etc.), expected ideal outcome of the surgery, actual outcome of the surgery (patient reported outcomes [PRO], implant survival, pain level, activity level, etc.), size of implant used, position / orientation / alignment of implant used, soft tissue balance achieved, etc.

[0157] The healthcare professional 630 performing the surgery or treatment can provide various types of data 625 to the surgical patient care system 620. The healthcare professional data 625 can include, for example, a description of known or preferred surgical techniques (e.g., cruciate retention (CR) vs. posterior stabilization (PS), size increase vs. size reduction, with tourniquet vs. without tourniquet, femoral stem style, preferred scheme for THA, etc.), the training level of the healthcare professional 630 (e.g., years in practice, position trained, place of training, technique modeled), previous success level including historical data (outcomes, patient satisfaction), and expected ideal results with respect to range of motion, recovery days, and device survival. The healthcare professional data 625 can be obtained, for example, through a paper or digital survey provided to the healthcare professional 630, via the healthcare professional's input to a mobile application, or by extracting relevant data from an EMR. In addition, the CASS 100 can provide data such as profile data (e.g., patient-specific knee instrument profile) or a historical record describing the use of the CASS during surgery.

[0158] Information about the facility where the surgery or treatment is to be performed may be included in the input data. This data may include, but is not limited to, the following: ambulatory surgical center (ASC) vs. hospital, facility trauma level, comprehensive care plan (CJR) or bundle candidacy for joint replacement, MSA driver score, community vs. metropolitan, academic vs. non-academic, postoperative network access (skilled nursing facility [SNF] only, home health, etc.), availability of medical professionals, availability of implants, and availability of surgical equipment.

[0159] These facility inputs may be obtained, for example, but not limited to, via surveys (paper / digital), surgical planning tools (e.g., apps, websites, electronic medical records [EMR], etc.), hospital information databases (on the Internet), etc. Input data related to associated healthcare economics may also be obtained, including, but not limited to, the patient's socioeconomic profile, the expected level of reimbursement the patient will receive, and whether the treatment is patient-specific.

[0160] These healthcare economic inputs can be obtained, for example but not limited to, through surveys (paper / digital), direct payer information, socioeconomic status databases (zip codes available on the Internet), etc. Finally, data derived from simulations of the procedure are obtained. Simulation inputs include implant size, location, and orientation. Custom or commercially available anatomical modeling software programs (such as It should be noted that the above data inputs may not be available for every patient and the available data will be used to generate the treatment plan.

[0161] Prior to surgery, patient data 610, 615 and healthcare professional data 625 may be acquired and stored in a cloud-based or online database (e.g., Figure 5C The information related to the procedure is provided to the computing system by wireless data transmission or manually using portable media storage. The computing system is configured to generate a case plan for CASS 100. The generation of the case plan will be described below. It should be noted that the system can access historical data of previously treated patients, including implant sizes, positions and orientations automatically generated by a computer-aided patient-specific knee instrument (PSKI) selection system or CASS 100 itself. To this end, a surgical sales representative or case engineer uploads case log data to a historical database using an online portal. In some embodiments, data transmission to the online database is wireless and automated.

[0162] Historical data sets from online databases are used as input to machine learning models (e.g., recurrent neural networks (RNNs) or other forms of artificial neural networks). As is generally understood in the art, artificial neural networks function similarly to biological neural networks and consist of a series of nodes and connections. The machine learning model is trained to predict one or more values ​​based on the input data. For the following sections, it is assumed that the machine learning model is trained to generate prediction equations. These prediction equations can be optimized to determine the optimal size, position, and orientation of the implant to achieve the best results or satisfaction.

[0163] Once the procedure is complete, all patient data and available outcome data, including implant size, position, and orientation determined by the CASS 100, are collected and stored in a historical database. Any subsequent calculation of the objective equation by the RNN will in this way include data from previous patients, allowing for continual improvement of the system.

[0164] In addition to or as an alternative to determining implant positioning, in some embodiments, prediction equations and associated optimization can be used to generate resection planes for use with the PSKI system. When used with the PSKI system, the calculation and optimization of the prediction equations are completed before surgery. The patient's anatomical structure is estimated using medical image data (X-ray, CT, MRI). Global optimization of the prediction equations can provide the ideal size and position of the implant components. The Boolean intersection of the implant components and the patient's anatomical structure 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 intraoperatively.

[0165] 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, the sizes, positions, and / or orientations of the altered components are locked, and the global optimization (using the previously described techniques) is refreshed to find new ideal positions for the other components based on the new sizes, positions, and / or orientations of the components, and the corresponding resections that need to be performed to achieve the new optimized sizes, positions, and / or orientations of the components. For example, if the surgeon determines that the size, position, and / or orientation of the femoral implant in a TKA needs to be updated or modified intraoperatively, the position of the femoral implant will be locked relative to the anatomy, and a new optimal position for the tibia will be calculated (via global optimization) by taking into account the surgeon's changes to the size, position, and / or orientation of the femoral implant. Additionally, if the surgical system used to implement the case plan is robotically assisted (e.g., using a robotically assisted system), the surgeon may also be able to perform a global optimization to find new optimal positions for the other components and the corresponding resections that need to be performed to achieve the new optimized sizes, positions, and / or orientations of the components. If, for example, a 3D-printed surgical system such as the MAKO or MAKO Rio is used, bone removal and bone morphology during surgery can be monitored in real time. If the resection performed during the procedure deviates from the surgical plan, the processor can optimize the subsequent placement of additional components taking into account the actual resection that has been performed.

[0166] Fig. 7AHow a surgical patient care system 620 can be adapted to perform a case plan matching service is shown. In this example, data related to a current patient 610 is obtained and compared to all or part of a historical database of patient data and related results 615. For example, a surgeon may choose to compare the current patient's plan with a subset of the historical database. The data in the historical database may be filtered to include, for example, only data sets with good results, data sets corresponding to historical surgeries of patients with profiles that are the same or similar to the current patient's profile, data sets corresponding to specific surgeons, data sets corresponding to specific aspects of the surgical plan (e.g., surgery that preserves only specific ligaments), or any other criteria selected by the surgeon or medical professional. For example, if the current patient data matches or correlates with data from a previous patient who experienced good results, the case plan of the previous patient may be accessed and adapted or adopted for the current patient. The prediction equation may be used in conjunction with an intraoperative algorithm that identifies or determines actions associated with the case plan. Based on relevant information from the historical database and / or pre-selected information, the intraoperative algorithm determines a series of recommended actions for the surgeon to perform. Each execution of the algorithm results in the next action in the case plan. If the surgeon performs the action, the results are evaluated. The results of the actions performed by the surgeon are used to refine and update the inputs to the intraoperative algorithm, which is used to generate the next step in the case plan. Once the case plan has been fully executed, all data related to the case plan (including any deviations from the surgeon's execution of the suggested actions) are stored in a database of historical data. In some embodiments, the system uses preoperative, intraoperative, or postoperative modules in a segmented manner, rather than across the entire continuum of care. In other words, the caregiver can prescribe any permutation or combination of treatment modules, including the use of a single module. These concepts are described in detail in the literature. Figure 7B and can be applied to any type of surgery using CASS 100.

[0167] The surgical process is shown

[0168] As mentioned above about Figure 1 and Figures 5A-5CAs described, 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 surgery, and compare the actual activities with the preoperative or intraoperative surgical plan. In some embodiments, software tools can be used to process the data into a format that can effectively "play back" the surgery. For example, in one embodiment, one or more GUIs can be used, which show all the information presented on the display 125 during the operation. This can be supplemented with graphics and images showing data collected by different tools. For example, a GUI that provides a visual illustration of the knee during tissue resection can provide a measured torque and displacement of the resection device adjacent to the visual illustration to better provide an understanding of any deviation from the planned resection area that occurs. The ability to view the playback of the surgical plan or switch between different aspects of the actual surgery and the surgical plan can benefit surgeons and / or surgical personnel, so that such personnel can identify any deficiencies or challenging aspects of the surgery, so that they can be modified in future operations. 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 can also be used as evidence of whether a specific surgical procedure was performed correctly or incorrectly for other reasons, such as legal or compliance reasons.

[0169] Over time, as more and more surgical data is collected, a rich database may be acquired that describes surgical procedures performed by different surgeons for different patients for various types of anatomies (knee, shoulder, hip, etc.). Moreover, 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 CASS 100.

[0170] Training of the machine learning model can be performed as follows. During surgery, the overall state of CASS100 can be sampled over multiple time periods. The machine learning model can then be trained to transform the current state of the first time period into a future state for a different time period. By analyzing the entire state of CASS 100 rather than individual data items, any causal effects of interactions between different components of CASS 100 can be obtained. In some embodiments, multiple machine learning models can be used instead of a single model. In some embodiments, the machine learning model can be trained not only with the state of CASS 100, but also with patient data (e.g., obtained from EMR) and the identity of the surgical staff. This allows the model to make predictions with greater specificity. Moreover, if necessary, it allows surgeons to selectively make predictions based solely on their own surgical experience.

[0171] In some embodiments, the predictions or recommendations made by the aforementioned machine learning models can be integrated directly into the surgical process. For example, in some embodiments, the surgical computer 150 can execute a machine learning model in the background to make predictions or recommendations for upcoming actions or surgical conditions. Therefore, multiple states can be predicted or recommended for each period. For example, the surgical computer 150 can predict or recommend the state of the next 5 minutes in 30-second increments. Using this information, the surgeon can utilize a "process display" view of the surgery to allow visualization of future states. For example, Figure 7C A series of images that can be displayed to the surgeon are shown, which show the implant placement interface. The surgeon can, for example, traverse these images by entering a specific time in the display 125 of CASS 100 or instructing the system to use tactile, verbal or other instructions to advance or rewind 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 or her actions affect other aspects of the operation.

[0172] In some embodiments, rather than simply using the current state of CASS 100 as an input to a machine learning model, the input to the model may include a planned future state. For example, a surgeon may indicate that he or she is planning to perform a specific bone resection of the knee joint. This 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 showing the expected effect of the incision on the surgery. Such a film may show at a specific time increment how the surgery will be affected if the expected course of action is to be performed, including, for example, changes in the patient's anatomy, changes in implant position and orientation, and changes in related surgical procedures and instruments. A surgeon or medical professional may call or request this type of film at any time during the surgery to preview how the expected course of action will affect the surgical plan if the expected action is to be performed.

[0173] It should be further noted that, using a fully trained machine learning model and robotic CASS, various aspects of the surgery can be automated so that the surgeon only needs to be minimally involved, for example, only needing to provide approval for each step of the surgery. For example, over time, robotic control using arms or other means can be gradually integrated into the surgical process, and the manual interaction between the surgeon and the robotic operation gradually becomes less and less. In this case, the machine learning model can learn which robot commands are needed to achieve certain states of the CASS implementation plan. Ultimately, the machine learning model can be used to generate a film or similar view or display that can predict and preview the entire operation from an initial state. For example, an initial state including patient information, surgical plan, implant characteristics, and surgeon preferences can be defined. Based on this information, the surgeon can preview the entire operation to confirm that the plan recommended by CASS meets the surgeon's expectations and / or requirements. Moreover, since the output of the machine learning model is the state of CASS100 itself, commands can be derived to control the components of CASS to achieve each predicted state. Therefore, in extreme cases, the entire operation can be automated based only on the initial state information.

[0174] Using a point probe to obtain high resolution of critical areas during hip surgery

[0175] 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 map the actual surface of a target bone that requires a new implant. Mapping is performed after a defective or worn implant is removed, and after any diseased or otherwise unwanted bone is removed. By brushing or scraping the entire remaining bone with the tip of the point probe, multiple points can be collected on the bone surface. This is called tracking or "mapping" the bone. The collected points are used to create a three-dimensional model or surface map of the bone surface in a computer planning system. The created 3D model of the remaining bone is then used as the basis for planning surgery and the necessary implant size. An alternative technique for determining a 3D model using X-rays is described in U.S. Provisional Patent Application No. 62 / 658,988, filed on April 17, 2018, and entitled “Three Dimensional Guide with Selective Bone Matching,” the entire contents of which are incorporated herein by reference.

[0176] For hip applications, point probe mapping can be used to obtain high-resolution data of key areas such as the acetabular rim and acetabular fossa. This can enable the surgeon to obtain a detailed view before starting reaming. For example, in one embodiment, a point probe can be used to identify the bottom (fossa) of the acetabulum. As is well known in the art, in hip surgery, it is important to ensure that the bottom 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 additional bone transplantation steps. With this in mind, during the surgical procedure, information from the point probe can be used to provide operational guidance for the acetabular reamer. For example, the acetabular reamer can be configured to provide tactile feedback to the surgeon when the surgeon reaches the bottom or otherwise deviates from the surgical plan. Alternatively, when the bottom is reached or when the reamer is within a threshold distance, CASS 100 can automatically stop the reamer.

[0177] As an additional safeguard, the thickness of the area between the acetabulum and the medial wall can be estimated. For example, once the acetabular rim and acetabular socket are mapped 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, CASS100 can provide an alarm or other response in the event of any surgical activity predicted to protrude through the acetabular wall when reaming.

[0178] The point probe can also be used to collect high-resolution data of common reference points used when orienting the 3D model to the patient. For example, for pelvic plane landmarks like the ASIS and pubic symphysis, the surgeon can use a point probe to draw the bones to represent the true pelvic plane. Knowing a more complete view of these landmarks, the registration software will have more information to orient the 3D model.

[0179] Point probes can also be used to collect high-resolution data describing proximal femoral reference points that can be used to improve the accuracy of implant placement. For example, the relationship between the tip of the greater trochanter (GT) and the center of the femoral head is often used as a reference point for aligning femoral components during hip replacement. Alignment is highly dependent on the correct position of the GT; therefore, in some embodiments, a point probe is used to draw the GT to provide a high-resolution view of the area. Similarly, in some embodiments, a high-resolution view with the lesser trochanter (LT) may be useful. For example, during hip replacement, the Dorr classification helps to select a stem that will maximize the ability to achieve a press fit during surgery, thereby preventing micromotion of the femoral component after surgery and ensuring 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 draw the LT to provide a high-resolution view of the area.

[0180] In some embodiments, a point probe is used to map the femoral neck to provide high-resolution data, allowing the surgeon to better understand where to make the neck incision. The navigation system can then guide the surgeon as they make the neck cut. For example, as understood in the art, the femoral neck angle is measured by placing a line below the center of the femoral stem and a second line below the center of the femoral neck. Therefore, a high-resolution view of the femoral neck (and possibly the femoral stem) will provide a more accurate calculation of the femoral neck angle.

[0181] High-resolution femoral head and neck data can also be used to navigate resurfacing procedures, where software / hardware helps the surgeon prepare the proximal femur and place 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 covered with a smooth metal covering. In this case, it would be advantageous for the surgeon to draw the femur and cap so that an accurate assessment of their respective geometries can be understood and used to guide trimming and placement of the femoral component.

[0182] Use point probes to register preoperative data to patient anatomy

[0183] As described above, in some embodiments, a 3D model is developed based on a 2D or 3D image of an anatomical region of interest during the preoperative phase. In such embodiments, registration between the 3D model and the surgical site is performed prior to the surgical procedure. The registered 3D model can be used to track and measure the patient's anatomical structures and surgical tools during surgery.

[0184] 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, distal femoral axis, medial and lateral epicondyles, medial and lateral malleolus, proximal tibial mechanical axis, and tibial A / P orientation. For hip surgery, these points may include the anterior superior iliac spine (ASIS), pubic symphysis, points along the acetabular rim and within the hemisphere, greater trochanter (GT), and lesser trochanter (LT).

[0185] In revision surgery, the surgeon may draw certain areas containing anatomical defects in order to better visualize and navigate implant insertion. These defects can be identified based on analysis of preoperative images. For example, in one embodiment, each preoperative image is compared to an image library showing "healthy" anatomical structures (i.e., without defects). Any significant deviation between the patient image and the healthy image can be marked as a potential defect. Then, during surgery, the surgeon can be warned of possible defects by a visual alarm on the display 125 of CASS 100. The surgeon can then draw areas to provide more detailed information about potential defects to the surgical computer 150.

[0186] In some embodiments, the surgeon can use a non-contact method to align the incisions within the bone anatomy. For example, in one embodiment, laser scanning is used for alignment. A laser bar is projected onto the anatomical region of interest, and changes in height of the region are detected as changes in the line. Other non-contact optical methods, such as white light interferometry or ultrasound, may also be used alternatively for surface height measurement or alignment of anatomical structures. For example, where there is soft tissue between the alignment point and the bone being aligned (e.g., ASIS, pubic symphysis in hip surgery), ultrasound technology may be beneficial, providing a more precise definition of the anatomical plane.

[0187] As described herein, some embodiments of the present disclosure are particularly suitable for surgical procedures utilizing a surgical navigation system (e.g., the NAVIO surgical navigation system) that uses optical tracking of patient anatomy and tools in the operating room. Such procedures may include knee replacement and / or revision surgery as well as shoulder and hip surgery.

[0188] Some embodiments of the present disclosure are well suited for use with handheld surgical tools that have a position and orientation (which may be referred to as a pose) that is tracked and modeled relative to sensors (e.g., optical sensors, cameras, position encoders, RF / microwave / laser ranging, etc.). In various embodiments, such tools may be suitable for being held by a surgeon's hand or by a robotic arm. In some embodiments that utilize a robotic arm to hold the tool, the position and orientation of the tool can be determined from a sensor (e.g., a position encoder) that detects the real-time geometry of the robotic arm. As used herein, the term tool or handpiece may refer to a tool that can be held by a surgeon or a tool that can be held or mounted to a robotic arm or integrated with a robotic arm. Although many embodiments may provide the greatest benefit to handheld tools, unless otherwise mentioned, the embodiments are not intended to be limited to handheld tools.

[0189] Embodiments of the present invention utilize tools with at least two degrees of freedom to manipulate the tool tip relative to the tool body, wherein these degrees of freedom are controlled by the processor of the surgical system. In some embodiments, the tool is a handheld (or robot-held) device with fiducial markers to allow optical tracking of the position and orientation of the tool body relative to the patient's anatomy. In some embodiments, other conventional sensor devices can be used to track position and orientation. By tracking the position of the tool body relative to the patient's anatomy, the processor can control the position of the tool tip relative to the tool body, and by extending relative to the patient's anatomy, processor control of the tool tip is provided. This can allow smoother, finer cutting with the tool tip, even if the tool body is used in a freehand manner or by a robot arm that lacks precise control. The processor can track the tool body and adjust the degrees of freedom based on the position and orientation of the handheld device to adjust the position of the cutting tip relative to the patient's anatomy.

[0190] By utilizing the processor control of the tool tip relative to the tool body, the processor can define the cutting plane. This plane can be identified in the surgical plan based on preoperative imaging or intraoperative measurement. This plane can be selected based on the implant geometry of partial or total arthroplasty of the knee or hip joint. In the embodiment utilizing two degrees of freedom, the axis of the tool tip can be defined in one dimension with offset position and orientation. If the tool body remains on approximately the same vertical or horizontal orientation (with a slow drift of up to several degrees, for example, + / -40 degrees in some embodiments) during cutting, two degrees of freedom are sufficient to roughly keep the tool tip in the cutting plane. This allows the surgeon or robot arm to hold the tool and move it generally in the direction of the cutting plane, while the processor provides real-time control to accurately keep the tool tip in the desired cutting plane, thereby providing a smoother, straighter / flatter and more consistent cutting than can be achieved by freehand cutting. This plane cutting will usually be sufficient to directly connect with the implant with minimal cutting rear surface preparation.

[0191] In addition to using two degrees of freedom to keep the cutting tip consistent with the predetermined cutting plane, processor control of the rotational speed of the cutting tip can also be used to allow the processor to control the extent of the cut in the cutting plane. For example, when the operator (according to the surgical plan) moves the cutting tip along the cutting plane near the edge of the prescribed cut, the processor can slow down the tip rotation speed to provide finer control when the operator approaches the edge of the cut. Similarly, when the operator moves to the predetermined end of the cut, the processor can stop the rotation of the tip. The terminal edge of the cut in the cutting plane can be considered to be the intersection of two substantially orthogonal planes.

[0192] An exemplary tool used with the embodiment is a rotary cutting tool that cuts perpendicular to the axis of the tip of the elongated cutting tool. The rotary cutting tool can be a surgical drill or a linear, sharpened slotted cutting drill, such as a spiral cutting grinding drill. This allows a cutting length of several millimeters or more along the axis of the cutting / deburring tool tip. When the cutting drill is kept in a predetermined cutting plane, the slotted cutting drill can provide a smooth cut. The entire cutting surface can be regarded as a cutting tip, and the processor seeks to control the position of this cutting surface to ensure that it remains in a predetermined cutting plane. Two or more degrees of freedom can be used to adjust the position of the axis of the cutting tool relative to the axis of the tool body and the angle between the two axes. More than two degrees of freedom can allow control of other position offsets (e.g., in the lateral or transverse direction) and the angle between the axis of the tool tip and other axes of the tool body (e.g., lateral or transverse axis). It should be understood that the number of degrees of freedom can be selected to balance complexity and cost with the accuracy and control of the position and orientation of the tool tip relative to the tool body.

[0193] In the example using two degrees of freedom, these degrees can be presented as linear extension or contraction devices (actuators) extending parallel to the axis of the tool body and roughly perpendicular to the axis of the tool tip. These actuators can be connected between points in the tool body and the angle of the tool tip and the motor bracket / housing that provides the rotational force. By extending or contracting these devices along the tool body axis, the position of the axis of the tool tip along the axis of the tool body and the angle between the two axes can be manipulated under processor control. This allows the axis of the tool tip to be manipulated to always be placed along the plane whenever the axis of the tool body is roughly aligned (within several degrees) with the normal axis of the virtual cutting plane. The operator can deviate from this normal axis by several degrees in any direction, and the manipulation of the degrees of freedom can offset the difference between the tool body axis and the normal axis of the plane. When only two degrees of freedom are used, it should be noted that the tool tip axis may not always remain in the same orientation in the plane, but the tool tip can be maintained in a direction parallel to the two-dimensional plane. For planar cutting, except for approaching the boundary, the tool orientation in the plane is generally not important for maintaining a smooth flat cut with a rotating tool. Thus, real-time control of the offset and orientation of the tool tip relative to the axis of the tool body can compensate for any deviation in the position and orientation of the tool body relative to the virtual cutting plane within a number of degrees of deviation. This can allow for abnormal movement of the surgeon's hand or robotic arm without compromising the ability of the tool tip to cut along the virtual cutting plane with a smooth and straight cut, provided that any abnormal movement of the tool body is not faster than the processor and actuator can compensate for the deviation. The processor can use any suitable control method, such as a proportional integral derivative controller (PID), or a machine learning algorithm to predict the motion and compensate for the motion to manipulate the tool tip to provide a suitably smooth and accurate cut.

[0194] Figure 8 An exemplary cutting tool 800 is shown for resecting a portion 7 of a patient's bone 6. After a vertical cut, the tool 800 resects the bone 6 along a plane in a cutting direction 8. The tool 800 includes a reference marker array 802 fixed to a tool body 804 that facilitates optical tracking of the position and location of the tool body. A rotating cutting tool tip 806 cuts perpendicularly to its axis as it moves along the cutting direction 8. An internal actuator provides freedom to move the position and vertical orientation of the cutting tool tip 806 relative to the tool body 804.

[0195] In some embodiments, the tool tip 806 extends from the tool body 804 at a depth less than the total depth of the patient's bone 6. In such embodiments, after the cut in the cutting direction 8 is completed, further removal of the resected portion 7 is required, but the resected surface will be flat and smooth. Other surgical tools, such as a rasp or osteotome, can be used to complete the resection and flatten any portion of the patient's bone 6 that was not cut by the tool tip 806.

[0196] In some embodiments, the diameter of the tool tip 806 varies along the length of the tool tip. For example, the tool tip 806 can be tapered distally so that the distal portion of the tool tip 806 has a smaller diameter than the proximal portion of the tool tip 806. The diameters at various portions of the tool tip 806 can be selected to control the stiffness and / or required motor torque for cutting and removing bones. For example, a larger diameter at various portions of the tool tip 806 can provide greater stiffness for the tool tip 806, and a smaller diameter at various portions of the tool tip 806 can reduce the motor torque required to rotate the tool tip 806 and / or the force required to cut through the bone applied by the surgeon. Therefore, in some embodiments, the diameter at each portion of the tool tip 806 and / or the slope of the tapered portion of the tool tip 806 can be selected to provide the best balance of the stiffness of the tool tip 806 and the required motor torque. In other embodiments, the diameter of the tool tip 806 is constant along the length of the tool tip 806, and the diameter can be selected to provide the best balance of the stiffness of the tool tip 806 and the motor torque.

[0197] In some embodiments, a tool holder or cutting guide 808 is provided as part of the tool body 804. This cutting guide 808 allows the tool body 804 to mechanically contact the surface of the patient's bone 6 during the cutting operation. Therefore, the cutting guide 808 can be used to reduce vibration and deviation from the cutting plane. In addition, when the tool moves in the cutting direction 8, the processor can determine a rough model of the path that the tool tip 806 will follow relative to the tool body 804, because the geometry of the cutting plane relative to the surface of the patient's bone 6 and any angular deviation caused by the robot arm or the surgeon's hand largely determine the necessary distance between the tool tip 806 and the cutting guide 808. The offset distance between the tool tip 806 and the cutting guide 808 can be predetermined and / or input to the processor. Therefore, the processor can predict the path of the tool tip 806 and plan to actuate the tool tip to keep the tool tip at the cutting plane. For example, a model of the patient's bone 6 can be used to identify height changes (e.g., peaks or valleys) along the upper surface of the patient's bone 6. As the cutting guide 808 slides along the upper surface of the patient's bone 6, the processor can use this information to predict the corresponding change in the vertical position of the tool 800 and begin to adjust the position of the tool tip 806 in a predictive manner. For example, the processor can begin adjusting the position of the tool tip 806 before the tracking system detects movement of the tool body 804. The processor can also use the speed and / or vector of movement of the tool 800 along the cutting plane to predict the timing of the position adjustment of the tool tip 806. Predictive control of the tool tip 806 as described herein can additionally compensate for delays or gaps in the position detection of the tool 800.

[0198] In some embodiments, the cutting guide 808 includes an arm having a proximal end coupled to the tool body 804 and a distal contact end (eg, Fig. 9 In some embodiments, the cutting guide 808 extends from the tool body 804 in substantially the same direction as the tool tip 806 so that the cutting guide 808 can contact the surface of the patient's bone 6 during bone resection.

[0199] In some embodiments, the cutting guide 808 is configured to contact the upper surface of the patient's bone 6 during resection. Figure 8 As shown in , the cutting guide 808 can be located above the tool tip 806 to contact the upper surface of the patient's bone 6. The proximal portion of the arm can extend substantially parallel to the tool tip 806, and the distal portion of the arm can bend downward in the direction of the tool tip. However, in some embodiments, the cutting guide 808 can be substantially straight along its entire length.

[0200] Additional shapes and orientations for the cutting guide 808 are contemplated herein. In some embodiments, the proximal end of the cutting guide 808 can be coupled to another portion of the tool body 804, e.g., a portion to the left of the tool tip 806, a portion to the right of the tool tip, or a portion below the tool tip. For example, the proximal end of the cutting guide 808 can be coupled to a portion of the tool body 804 that houses the internal actuator, i.e., a portion below the tool tip 806. Thus, the size of the cutting guide 808 can be appropriately set to position the distal contact end above the tool tip 806 to contact the upper surface of the patient's bone 6 during resection. The cutting guide 808 can include one or more curved portions extending around and / or above the remainder of the tool body 804 so as to position the distal contact end of the cutting guide 808 above the tool tip 806.

[0201] The overall shape and position of the arms of the cutting guide 808 can be configured to provide sufficient clearance between the cutting guide and the tool tip 806 to prevent interference with the positioning of the tool 800 during resection. In some embodiments, the arms of the cutting guide 808 are sufficiently spaced apart from the tool tip 806 along the entire length of the cutting guide to prevent interference with the positioning of the tool 800, such as due to accidental contact of the cutting guide 808 with the patient's bone 6.

[0202] In some embodiments, the distal contact end of the cutting guide 808 is configured to slide along the surface of the patient's bone 6. In some embodiments, the distal contact end of the cutting guide 808 can be shaped to reduce resistance to sliding movement along the surface of the patient's bone 6. For example, the distal contact end can include a sphere or ball (e.g., Figure 8-9 ), so that the distal contact end can slide along the surface of the patient's bone. In some embodiments, the distal contact end may include a portion of a hemisphere or a sphere. The spherical shape can be particularly advantageous because rotation of the tool 800 (e.g., rotation around the pitch, yaw and / or roll axis) does not substantially affect contact with the patient's bone 6. Therefore, the distal contact end can continue to slide along the surface of the patient's bone 6 in substantially the same manner. In another embodiment, the distal contact end may include a substantially cylindrical shape. Additional or alternative smooth and / or rounded shapes can be implemented at the distal contact end, as will be apparent to those of ordinary skill in the art.

[0203] Fig. 9 The tool 800 is shown operating with the degrees of freedom of movement as the forward pitch of the tool body 804 changes. Fig. 9As shown in , the tool tip 806 can be rotated to cut in a direction coming out of the page. The surgeon places the cutting guide 808 in contact with the surface of the patient's condyle or tibial plateau at a position that allows the tool tip 806 to be manipulated in a predetermined cutting plane. The contact positioning between the cutting guide 808 and the patient's bone 6 also allows the surgeon to control the depth of the tool tip 806 so that the depth of the cut made in the cutting plane allows the tool tip to cut the majority of the depth of the patient's bone, but leaves enough bone past the tip to allow the surface of the bone 6 along which the cutting guide 808 travels to remain intact throughout the cutting process.

[0204] In the tool body 804, linear actuators (e.g., 810 and 812) can provide, for example, but not limited to, two degrees of freedom to manipulate the position and pitch of the tool tip 806 relative to the tool body. The sliding pin and slot 814 limit the movement of the cutting tool tip 806 in the axial direction. The linear actuator devices 810, 812 are described as linear actuators, but may include any suitable device that provides contraction and extension along the axis. In some embodiments, the linear actuator device may include any combination of a linear motor, a piezoelectric motor, a pneumatic or hydraulic actuator, and a gear motor with a ball screw attached to the output shaft. The actuator device (e.g., 810, 812) can be pinned to the motor housing 816 to allow the actuator device to push or pull the motor housing without a rigid connection. The axis of the motor housing 816 can be parallel to the axis of the cutting tool tip 806. The motor in the motor housing 816 rotates the tool tip 806 at an angular velocity suitable for providing a cutting action in a direction transverse to the axis.

[0205] In one example, the surgeon's hand holds a portion of the tool body 804 below the motor housing 816 and deviates the hand position toward the patient's bone 6, thereby moving the tool body in a first direction 817. The processor controlling the linear actuators 810, 812 can adjust the extension of the actuators to move the tool body 804, thereby compensating for the motion and moving the direction 817 of the tool 800. In another example, the surgeon's hand moves away from the patient's bone 6 with a slight deviation. Such movement can move the tool body 804 in a second direction 818. The processor controlling the linear actuators 810, 812 can adjust the extension of the actuators to compensate for this movement by aligning the axis of the motor housing 816 and the tool tip 806 with the cutting plane. For example, the actuator 812 can be retracted more than the actuator 810 (which may need to be extended) to compensate.

[0206] Fig.10 and Fig.11It is shown that a tool 800 with only two degrees of freedom can effectively achieve orthogonal cuts. This can be achieved using rotational movement of the tool body 804 during the first vertical cut and then maintaining the tool body in a vertical position during the horizontal cut. In this example, a partial resection of the tibial plateau is performed using two orthogonal cuts. The workflow uses the vertical cut as the initial cut and then cuts in the horizontal cutting plane. Because the tool has only two degrees of freedom, in this example (allowing the processor to Fig. 9 In order to adjust the tool body in a vertical plane defined by the sheet of material in the cut (e.g., to make adjustments in the vertical plane defined by the sheet of material in the cut), the tool should be rotated so that the axis of the actuator is slightly horizontal (e.g., within 40 degrees of horizontal). Because the cutting plane is perpendicular to the axis of the cutting tip, these degrees of freedom allow the vertical cutting plane to be substantially perpendicular to the plane of the tool defining the degrees of freedom. When the cutting plane is substantially perpendicular to the axis of the actuator, the degrees of freedom give the processor the greatest control over the cutting tip. However, because the orientation of the cutting tip within this cutting plane is generally unimportant (except when approaching a boundary), the processor can still exercise control of the cutting tip to keep it within the cutting plane even when rotating the tool body so that the actuator deviates substantially from the direction of travel perpendicular to the cutting tip (e.g., in Fig. 9 In the embodiment of the invention, the bottom of the tool body can be rotated in or out of the page substantially up to 40+ degrees and still allow the actuator to keep the cutting tip in the cutting plane. Fig.10 Shown in.

[0207] In order to make a vertical cut, the operator places the cutting guide 808 in contact with the head of the tibial plateau and keeps the tool roughly perpendicular to the long axis of the bone 6. Once the operator activates the cutting tip and engages the patient's bone for vertical cutting, the tool is pushed down and rotated. Because the cutting guide 808 is just engaging the top of the tibial plateau, it is impossible to make a vertical cut without rotating in this example. However, since the goal of the processor is to keep the axis of the cutting tip in the vertical plane, and it is not necessary to keep the axis of the cutting tip completely horizontal, the cutting tip can also be kept in the vertical virtual cutting plane even through this rotation of two degrees of freedom. In addition, the processor can control the speed of the cutting tool to prevent the end or any part of the cutting tip from cutting beyond the second horizontal cutting plane. In addition, since the tool is rotated by the operator when cutting is carried out downward, once the cutting tip approaches the horizontal virtual cutting plane, the tool should be closer to vertical. This ensures that the degree of freedom can be used to prevent the cutting tip from crossing this virtual boundary.

[0208] In some embodiments, during a vertical cut, as the angle of the tool body is rotated toward a vertical position, the processor can intentionally deviate the cut from the vertical cutting plane into the resection area, requiring later cleanup near the boundary between the vertical and horizontal cutting planes. Such cleanup can be done manually using a rasp or osteotome, as is routinely done during surgery. This can be useful because as the tool becomes more vertical, the degrees of freedom become more limited in the ability to maintain the tool tip in the vertical cutting plane. In some embodiments, as the tool moves into a more vertical position during this vertical cut, the tool tip spin rate can be reduced by the processor to limit damage that can occur when the degrees of freedom have less impact on keeping the cut coincident with the vertical virtual cutting plane. In some embodiments, during this vertical cut, the operator intentionally does not rotate the cutting tool beyond a certain angle, such as 45 degrees, such as Fig.10 This may limit the depth of the vertical cut due to the cutting guide, but ensure that the degree of freedom has sufficient control over the cutting tip relative to the vertical cutting plane to avoid cutting outside the resection area, across either virtual cutting plane.

[0209] In some embodiments, the fiducial marker may be less effective when rotated away from the vertical position. Fig.10 As shown in , as the tool is rotated, the fiducial marker array 802 becomes less vertical, and beyond a certain angle, the fiducial markers with some camera systems may not be effective. Therefore, it may be undesirable to rotate the tool beyond a certain angle relative to any tracking camera used in the operating room. Fig.11 As shown in , in some embodiments, the fiducial marker array 802 can be manually rotated before starting a horizontal cut. An encoder or user input can inform the processor of the rotation angle of the array, and the tracking system can take into account the change in the position of the fiducial marker array 802 relative to the tool body and cutting tip due to the known tool geometry. In some embodiments, a multi-faceted fiducial marker array 802 can be used in three dimensions rather than a two-dimensional plane. This can allow the tool to operate in a variety of orientations without repositioning the fiducial marker array 802. In some embodiments, the cutting guide 808 can also be rotated or removed by the operator to provide greater flexibility in the possible types of cuts.

[0210] Furthermore, although the fiducial marker array 802 is described as being coupled to the tool body 804, the fiducial marker array 802 may be arranged on the tool 800 in a variety of ways. In some embodiments, the fiducial marker array 802 may be coupled to the motor housing 816 or a support thereon, such as Fig. 9800 and / or the position and location of the tool tip 806 can be facilitated based on the known geometry between the tool body 804, the tool tip 806, and / or the motor housing 816. Reducing the number of components in the kinematic chain between the fiducial marker array 802 and the tool tip 806 in this manner can reduce the amount of error in the calculated position of the tool tip. Additional arrangements and orientations of the tool 800 that will be apparent to one of ordinary skill in the art are contemplated herein.

[0211] exist Fig.11 In , the operator has completed the vertical cut and now rotates the tool body to a substantially vertical position. This allows the cutting guide to be substantially higher than the cutting tip and allows the cutting guide 808 to travel along the tibial plateau during the horizontal cut, thereby providing a stable base for the operator's hand or robotic arm. During this cut, the tool remains in a substantially vertical position, and ideally, within the operator's ability, the vertical orientation of the tool is not changed as the tool travels horizontally along the cutting plane. The degrees of freedom under processor control can be used to account for angle and vertical position changes due to deviations in the movement of the surgeon's hand or robotic arm. This ensures that when the operator moves the tool body, the cutting tip travels in a plane substantially the same as the virtual horizontal cutting plane. The degrees of freedom primarily compensate for the pitch and vertical position of the tool tip. Yaw is usually not compensated, but yaw does not affect the ability of the tool tip to remain in the horizontal cutting plane. It is not important that the cutting tip remain parallel to the surface of the vertical cut during the horizontal cut, except near the boundary of these two planes. Roll of the cutting tool may also be compensated to the extent that it affects the ability of the tool tip to remain in the cutting plane, but due to the rotating nature of the cutting tool, roll generally does not affect the ability of the rotating cutting tip to perform a cut.

[0212] Fig.121 is a top-level system diagram of a surgical system utilizing a multi-degree-of-freedom tool as described herein. System 1200 includes a processor 1202 that controls the degrees of freedom of the tool and the operation of the rotary motor. Processor 1202 controls the surgical tool according to a surgical plan that can be stored in a non-transitory memory device 1204. The surgical plan can be a preoperative plan created based on surgeon input and medical imaging (e.g., MRI, CAT scan, x-ray, ultrasound, etc.) before the start of the operation. In some embodiments, the surgical plan can be updated or modified or created during surgery based on surgeon input. For example, ultrasound or x-ray information obtained or generated during surgery can be used to create or modify the surgical plan. Similarly, the surgeon can modify the surgical plan based on what he sees during surgery. For example, once the patient's anatomical structure is registered with a robot tracking system, the surgeon can interact with the model of the patient's anatomical structure on a user interface to create or update the surgical plan based on the surgeon's expertise and information learned by interacting with the patient's anatomical structure. This can include moving the patient's joints, detecting resistance or stress, or by determining the extent of damage after the patient's soft tissue is exposed. This can be used for partial or total hip and knee arthroplasty and any other joint surgery. In some embodiments, the processor 1202 automatically updates the surgical plan based on observed / imaged / recorded anatomical features or geometries and a model of the geometry of the implanted prosthesis.

[0213] The processor 1202 also communicates with a tracking system that utilizes any suitable tracking device to register and track patient anatomy (e.g., bone or soft tissue) and any relevant surgical tools, such as cutting tools, robotic arms, or surgical personnel. In this example, an optical tracking system is used. The tracking system 1206 may include one or more optical or IR cameras that record images of the operating room, and the cameras may include fiducial markers that have been registered to prominent features of the tools or anatomy. The tracking system 1206 processes the images to create a three-dimensional model of relevant features of the environment. In the example of an optical tracking system, within the operating room, multiple fiducial markers 1208 may be fixed to tools and patient anatomy; known geometry or input from the surgical personnel can assist the image tracking system 1206 in determining the position and orientation of these markers or lead to relevant features, such as bone surfaces and the orientation or important geometry of the tools used by the personnel.

[0214] The processor 1202 controls the tool 800 using information collected from the tracking system 1206. The tool 800 may include an array or 3-dimensional group of fiducial markers 802 to allow the tracking system 1206 to model the orientation and position of the tool relative to the environment and communicate this information to the processor 1202. The processor 1202 communicates with the tool 800 via a communication interface 1214. The communication interface 1214 can communicate with the processor 1202 wirelessly or through a hard-wired connection. In some embodiments, the hard-wired connection provides a convenient and reliable means of sending control and sensor information between the processor 1202 and the tool 800, particularly in embodiments where the tool requires a power source. In some embodiments, the tool 800 may be a wireless battery-powered device, and communication may occur wirelessly, such as through Wi-Fi, Bluetooth, or any other suitable wireless communication protocol. The communication interface 1214 receives power from the power source 1212. The power source 1212 may include a battery or an AC or DC connection to a central power source of the system 1200. The communication interface 1214 can send control signals to a degree of freedom (DoF) controller 1216 that controls the linear actuators 810, 812 in response to the processor 1202. Communication between the fiducial marker array 802, the image tracking system 1206, the processor 1202, the communication interface 1214, and the DoF controller 1216 allows the processor to determine the position of the tool body 804 relative to the patient's anatomy and send control signals to actuators within the tool to compensate for deviations in position and orientation to ensure that the tool tip 806 travels along a virtual cutting plane during a cutting operation.

[0215] In some embodiments, the communication interface can be used to control the power supply 1212 and selectively send current to the motor that rotates the tool tip 806. In such embodiments, the speed of the rotating tool can be controlled by the processor 1202. In such embodiments, when the tool tip is at risk of intersecting another virtual cutting plane or leaving the designated cutting area, the processor 1202 can stop the rotation action of the tool tip 806. Similarly, in such embodiments, the processor 1202 can selectively initiate a cutting operation.

[0216] In some embodiments, one or more sensors 1218 can provide additional information about the state of the cutting tool 800 to the processor 1202. For example, one or more sensors 1218 can include a switch that allows the surgeon to selectively instruct the processor 1202 to start a cutting operation. The processor 1202 can control the DoF controller 1216 and selectively provide power to the cutting tool tip 806 to perform a cutting operation according to the surgical plan and the real-time positioning of the cutting tip. The one or more sensors 1218 can also include one or more encoders that provide information about the state of the actuators 810, 812 and the speed of the cutting tool tip 806 to the processor 1202.

[0217] Fig.13 13 is a flow chart of an exemplary method 1300 for using a surgical rotational tool according to some embodiments. At step 1302, a surgical plan is created. This may include a plan automatically generated using a machine learning algorithm or through human interaction based on 3D (MRI, CT scan, 3D ultrasound) or 2D (X-ray or ultrasound) medical imaging. The surgical plan may include a model of one or more implants and cutting planes used relative to the geometry of the bone tissue to ensure proper function of an arthroplasty implant (e.g., partial or total knee or hip replacement hardware).

[0218] At step 1304, during surgery, the position tracking system is calibrated and prepared. This may include mounting fiducial marker arrays to the patient's bones and registering the locations of these fiducial marker arrays relative to the bone joint surfaces, such as by "drawing" the joint surfaces using a stylus with the fiducial marker arrays while the fiducial marker arrays of the patient's bones are registered to the tracking system. This may also include using a robotic arm to interact with the patient's bone surfaces to register those surfaces relative to the robotic arm geometry, thereby creating a model of the patient's anatomy relative to the known locations of the features of the robotic arm.

[0219] Once the environment is ready for tracking, the rotary tool is placed in contact with the patient's bone tissue and resection can begin at step 1306. Resection begins by placing the tool cutting guide 808 in contact with some known surface of the patient's bone tissue and rotating the rotary cutting tool tip as it engages the patient's tissue.

[0220] At step 1308, the position of the tool body and tool tip relative to the patient's anatomy is tracked. This may include tracking the position of a robotic arm of known geometry that holds a tool body of known geometry, and identifying the location of the cutting tip based on the state of a linear actuator that controls the position and orientation of the cutting tip. This may also include optically tracking an array of fiducial markers affixed to the tool body, and using a model of the geometry of the fiducial marker array relative to the tool body and a model of the actuator, and by the extended location of the tool tip relative to the tool body. In some embodiments, the tracking system has a means for optically or directly tracking the orientation of the tool tip.

[0221] At step 1310, the processor controls the rotational speed and degrees of freedom of the tool in response to tracking the body and tool tip relative to the patient anatomy. This in turn controls the cutting positioning of the tool tip relative to the patient anatomy to compensate for the position and orientation of the tool body. The speed can be controlled to make a cut, stop a cut, slow down a cut, and the like. In some embodiments, more than two degrees of freedom can be used to add additional control to the tool tip (i.e., in addition to ensuring that the tool tip is in a plane substantially perpendicular to the main axis of the tool body). For example, the depth of the distal end of the tool tip can be controlled relative to the tool body to increase or decrease the depth of the cut, the lateral degrees of freedom can be used to adjust the relative angle of the tool tip in the cutting plane to assist the surgeon in precise movement in the cutting plane, and the like.

[0222] At step 1312, the processor determines whether the cut is complete or whether the tool tip deviates from the surgical plan so that it will cut into the tissue beyond the length of the planned cut (e.g., beyond the intersection of the vertical cutting plane and the horizontal cutting plane). If so, the processor can reduce the rotational speed of the shaft of the rotating tool and repeat step 1310. If not, the process can continue at step 1314 when the surgeon or robotic arm moves the tool along the cutting plane. This can make the bone tissue cut in the virtual cutting plane according to the surgical plan. Then, this cycle can return to step 1308, repeatedly tracking the tool tip position, and compensating for the position and angle of the tool body, and determining whether the cut is complete when the surgeon moves the tool.

[0223] The devices, systems and methods described herein are not intended to be limited to the aspects of the specific embodiments described, which are intended only as illustrations of various features. Many modifications and variations may be made to the devices, systems and methods without departing from the spirit and scope that will be apparent to those skilled in the art.

[0224] Although the device, system and method for performing tibial cutting are particularly described, the device, system and method can also be used for performing femoral cutting. For example, one or more distal femoral cutting, front cutting, rear cutting and / or chamfer cutting can be performed by the device, system and method described herein.

[0225] Although the tool body 804 is depicted as enclosing the linear actuators 810 / 812 and the motor housing 816, in some embodiments, one or more components may be external to the tool body 804. For example, the motor housing 816 may be external to the tool body 804. In some embodiments, the tool body 804 encloses the linear actuators 810 / 812 and is sealed beneath the motor housing 816. For example, a flexible material may be used to seal the tool body 804 around the linear actuators 810 / 812 at the junction with the motor housing 816. Additional configurations of the tool body 804 are contemplated that are apparent to one of ordinary skill in the art.

[0226] In some embodiments, the tool body 804 may also include a front guard to prevent the tool 800 from advancing toward the patient's bone 6 beyond a predetermined distance. For example, the front guard may be in contact with the tool tip 806 (e.g., Fig. 9 ) to maintain the tool 800 at least a predetermined distance from the patient's bone 6, thereby preventing the tool tip 806 from cutting beyond the planned depth and / or damaging other portions of the patient's anatomy.

[0227] In some embodiments, the cutting guide 808 is adjustable to change the offset distance between the cutting guide and the tool tip 806. For example, the offset distance can be adjusted to approximately match the distance of the virtual cutting plane from the surface of the patient's bone 6. In some cases, it may be necessary to adjust the cutting guide 808 to reach the virtual cutting plane with the tool tip 806 because the ability of the linear actuator 810 / 812 to vertically reposition the tool tip may be limited.

[0228] In some embodiments, a plurality of removable cutting guides 808 may be provided. In some embodiments, each removable cutting guide 808 is configured for a different offset distance from the tool tip 806, and the surgeon may select the cutting guide 808 based on the desired offset distance. In some embodiments, the proximal end of the cutting guide 808 may be threaded and configured to mate with an opening on the tool body 804, the opening having corresponding threads to secure the cutting guide to the tool body. In some embodiments, the cutting guide 808 may be configured to mate with the opening on the tool body 804 by friction or interference fit. Additional ways of mating the cutting guide 808 with the tool body 804 that will be apparent to those of ordinary skill in the art are contemplated herein. In some embodiments, the cutting guide 808 may include a marking associated with an offset distance that may be input to the processor. For example, the marking may indicate the offset distance as a measured value and / or index number or setting corresponding to a known offset distance of each removable cutting guide 808. The processor may determine the offset distance based on the marking and utilize the offset distance to control the tool tip 806 as further described herein.

[0229] In some embodiments, the cutting guide 808 forms an adjustable joint with the tool body 804 for changing the offset distance. For example, the cutting guide 808 can be screwed into the tool body 804 or otherwise rotatable axially (i.e., about a rolling axis) relative to the tool body. Thus, in embodiments where the cutting guide 808 includes one or more turns or bends, rotation of the cutting guide can cause the offset distance between the distal contact end of the cutting guide and the tool tip 806 to change. In the case of multiple removable cutting guides 808 as described herein, the offset distance can be slightly adjusted (i.e., fine-tuned) using the adjustable joint.

[0230] In some embodiments, the cutting guide 808 includes an adjustable joint along the arm, which is used to change the offset distance. For example, the adjustable joint can be a Hess joint formed with the tool body 804 or formed at a point along the arm of the cutting guide 808. The mating portion of the Hess joint may include interlocking teeth that are fixed together by screws or other fasteners to lock the joint. In some embodiments, the offset distance can be changed by rotating the first mating portion relative to the second mating portion around the pitch axis, thereby changing the pitch of the arm of the cutting guide 808 and rotating the distal contact end toward or away from the tool tip 806. When the appropriate offset distance is reached, the mating portion can be locked together by a screw. In some embodiments, the adjustable joint may include a mark associated with the offset distance, which can be input to a processor as described herein. For example, the mark can indicate the offset distance as a measured value and / or index number or setting corresponding to a known offset distance based on the position of the adjustable joint. The processor can determine the offset distance based on the mark, and use the offset distance to control the tool tip 806, as further described herein.

[0231] In some embodiments, the cutting guide 808 can be formed of a semi-rigid material. For example, the cutting guide 808 can be formed of a stiff wire. The semi-rigid material can be flexible enough to reshape under relatively high forces (e.g., forceful bending by the surgeon's hand) and rigid enough to maintain shape against relatively low forces (e.g., conventional contact forces during resection).

[0232] In some embodiments, the distal contact end of the cutting guide 808 may include a low friction surface or a low friction coating thereon to reduce the resistance of the distal contact end to movement along the surface of the patient's bone 6.

[0233] The cutting guide 808 can be modified in various ways to increase the contact surface with the patient's bone, thereby improving the stability of the tool 800. In some embodiments, multiple distal contact ends can be included on the cutting guide 808. For example, two or more balls can extend from the cutting guide 808 (e.g., a forked cutting guide) to further stabilize the tool 800 and reduce rotation with additional degrees of freedom. In some embodiments, the distal contact end can be formed as a plate that can rotate freely relative to the tool body 804. For example, as shown in FIG. Fig. 9 The spherical body of the cutting guide 808 shown in the figure can be received in the socket of the plate element to form a ball joint. The plate element can be used as a distal contact end and rest on the surface of the patient's bone 6 to provide greater stability for the tool 800.

[0234] In some embodiments, the tool holder or cutting guide 808 is provided separately from the tool body 804. In some embodiments, the cutting guide 808 is configured to be fixed to the patient's bone 6 or another part of the patient's anatomical structure so that the tool body 804 and the tool tip 806 can contact the cutting guide 808 to rest thereon and stabilize the tool 800. For example, the cutting guide 808 can be a rigid element that can be fixed to the patient's anatomical structure and fixed relative to it. The cutting guide 808 can be fixed to the patient's anatomical structure by an adjustable strap (e.g., one or more straps fixed by hook and loop fasteners) or any other fixing device known to those of ordinary skill in the art. In some embodiments, the cutting guide 808 includes a flat or substantially planar surface for receiving a portion of the tool body 804 or the tool tip 806. In some embodiments, the tool 800 can rest on the cutting guide 808 and can move along the planar surface when the cutting is completed, thereby providing additional stability to the tool 800 and / or relieving stress on the surgeon's hand during resection. In some embodiments, the cutting guide 808 may include a low friction surface or a low friction coating thereon to reduce resistance to movement of the tool body 804 along the cutting guide.

[0235] In one example, the rigid element can be an L-shaped bracket or a U-shaped bracket, which forms a crossbar for placing and guiding the tool 800. The bracket can be tied to the tibia to perform tibia cutting and / or tied to the femur to perform femoral cutting. The bracket can have enough depth to receive the tool 800 and allow the tool 800 to move toward or away from the patient's bone 6. In some embodiments, the patient contact surface of the bracket includes a pad or foam to fit the shape of the patient's anatomical structure and reduce the discomfort caused to the patient. In some embodiments, the horizontal surface of the bracket can be used to guide the tool 800 through the horizontal incision on the tibia. Similarly, the vertical surface of the bracket can be used to guide the tool 800 through the vertical incision on the tibia. In some embodiments, the bracket can also be used to guide the tool 800 through the horizontal and / or vertical incision on the femur in a similar manner. In some embodiments, the bracket can include a guard or a stopper to prevent the tool 800 from advancing toward the patient's bone 6 beyond a predetermined distance. For example, a guard or stop can maintain the tool 800 at least a predetermined distance from the patient's bone 6, thereby preventing the tool tip 806 from cutting beyond a planned depth and / or damaging other portions of the patient's anatomy.

[0236] In some embodiments, a bracket can be used to guide the tool 800 through the chamfered cut on the femur. Because the chamfered cut can be angled (e.g., approximately 45°) relative to the longitudinal axis of the patient's bone, the bracket and / or the patient's bone can be repositioned to provide a suitable angled crosspiece for the tool 800. For example, the bracket can be tied to the tibia, and the knee joint can be flexed to position the femur at a suitable angle to the bracket. In another example, a bracket (e.g., an L-shaped bracket) can be rotated 45° and tied to the femur, thereby providing two surfaces at a 45° angle to the longitudinal axis of the femur for guiding the chamfered cut on the opposite side of the patient's bone. In some embodiments, separate cutting guides 808 can be provided for the tibia and femur. In some embodiments, the surgeon can choose to perform various cuttings of one or more bones to reduce the favorable order of repositioning of the cutting guide 808.

[0237] In some embodiments, the bracket may include an adjustable crossbar. The adjustable crossbar may allow the position of the crossbar relative to the cutting plane to be fine-tuned without separating the bracket from the patient's anatomy. In some embodiments, the U-shaped bracket may include a separate flat movable platform that is reversibly coupled to one or both of the vertical portions of the bracket. For example, the vertical portion may include a plurality of holes and / or extension slots that are used to receive the platform and are fixed to the U-shaped bracket at various heights by fasteners. In some embodiments, the movable platform may also be configured to be positioned at an angle, for example, to guide a chamfered incision on the femur. In some embodiments, the movable platform may be arranged on an L-shaped bracket with slight modifications.

[0238] Fig.14 1400 is a block diagram of an exemplary data processing system 1400 in which aspects of the illustrative embodiments are implemented. Data processing system 1400 is an example of a computer, such as a server or client, in which computer usable code or instructions implementing the processes of the illustrative embodiments of the present invention are located. In one embodiment, Fig.14 May represent a server computing device.

[0239] In the depicted example, data processing system 1400 may employ a hub architecture including north bridge and memory controller hub (NB / MCH) 1401 and south bridge and input / output (I / O) controller hub (SB / ICH) 1402. Processing unit 1403, main memory 1404, and graphics processor 1405 may be connected to NB / MCH 1401. Graphics processor 1405 may be connected to NB / MCH 1401 through, for example, an accelerated graphics port (AGP).

[0240] In the depicted example, a network adapter 1406 is connected to the SB / ICH 1402. An audio adapter 1407, a keyboard and mouse adapter 1408, a modem 1409, a read-only memory (ROM) 1410, a hard disk drive (HDD) 1411, an optical drive (e.g., CD or DVD) 1412, a universal serial bus (USB) port and other communication ports 1413, and a PCI / PCIe device 1414 can be connected to the SB / ICH 1402 via a bus system 1416. The PCI / PCIe device 1414 can include an Ethernet adapter, an add-on card, and a PC card for a laptop computer. The ROM 1410 can be, for example, a flash basic input / output system (BIOS). The HDD 1411 and the optical drive 1412 can use an integrated drive electronics (IDE) or a serial advanced technology attachment (SATA) interface. A super I / O (SIO) device 1415 can be connected to the SB / ICH 1402.

[0241] An operating system may run on processing unit 1403. The operating system may coordinate and provide control of various components within data processing system 1400. As a client, the operating system may be a commercially available operating system. An object-oriented programming system such as the Java™ programming system may run with the operating system and provide calls to the operating system from object-oriented programs or application programs executing on data processing system 1400. As a server, data processing system 1400 may be a server running the Advanced Interactive Executive operating system or the Linux operating system. eServerTMSystem Data processing system 1400 may be a symmetric multiprocessor (SMP) system, which may include a plurality of processors in processing unit 1403. Alternatively, a single processor system may be employed.

[0242] Instructions for the operating system, object-oriented programming system, and application programs or programs are located on a storage device such as HDD 1411 and are loaded into main memory 1404 for execution by processing unit 1403. The processes of the embodiments described herein may be performed by processing unit 1403 using computer usable program code, which may be located in a memory such as main memory 1404, ROM 1410, or in one or more peripheral devices.

[0243] The bus system 1416 may be composed of one or more buses. The bus system 1416 may be implemented using any type of communication structure or architecture that can provide data transmission between different components or devices attached to the structure or architecture. A communication unit such as a modem 1409 or a network adapter 1406 may include one or more devices that can be used to transmit and receive data.

[0244] Those of ordinary skill in the art will understand that Fig.14 The hardware depicted in the data processing system 1400 may vary depending on the implementation. Other internal hardware or peripherals, such as flash memory, equivalent non-volatile memory, or an optical drive, may be used in addition to or in place of the hardware shown. Furthermore, the data processing system 1400 may take the form of any of a number of different data processing systems, including but not limited to a client computing device, a server computing device, a tablet computer, a laptop computer, a telephone or other communication device, a personal digital assistant, and the like. Essentially, the data processing system 1400 may be any known or later developed data processing system that is not limited by architecture.

[0245] 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 parts 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 is readily understood that various aspects of the present disclosure (as generally described herein and shown in the accompanying drawings) may be arranged, substituted, combined, separated, and designed into a variety of different configurations, all of which are expressly contemplated herein.

[0246] 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.

[0247] 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.

[0248] 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.

[0249] 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.

[0250] 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, 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, 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".

[0251] 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 thereby described in terms of any individual member or subgroup of members of the Markush group.

[0252] 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.

[0253] 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

1. A system for resecting a bone in a patient, the system comprising: A rotating tool, the rotating tool having: Tool body, a tracking array secured to the tool body, the tracking array comprising one or more fiducial markers, a powered rotary cutting tip including a longitudinal axis, wherein the rotary cutting tip is fixed to the tool body and is rotatable by a motor about the longitudinal axis to resect the bone, a first linear actuator and a second linear actuator configured to adjust one or more of a vertical position and a pitch position of the rotating cutting tip relative to the tool body, and a tool holder extending from the tool body, the tool holder configured to maintain contact with the bone as the tool body is moved to resect the bone; a surgical tracking device configured to identify a position of each of the one or more fiducial markers relative to the bone; as well as A processor configured to: receiving a surgical plan, the surgical plan comprising at least one virtual cutting plane on the bone, receiving the position of the tracking array from the surgical tracking device, determining a real-time pose of the cutting tip relative to the at least one virtual cutting plane based on the position of the tracking array, and The first and second linear actuators are controlled based on the real-time posture to adjust one or more of the vertical position and the pitch position of the rotating cutting tip relative to the tool body so as to maintain the rotating cutting tip on the at least one virtual cutting plane.

2. The system of claim 1, wherein the rotating cutting tip has a fixed horizontal position and a fixed axial position relative to the tool body.

3. The system of any one of claims 1-2, wherein the rotating cutting tip has a fixed yaw position relative to the tool body.

4. The system of claim 1 or 2, wherein the processor is configured to prevent the rotating cutting tip from cutting through the at least one virtual cutting plane. 5 . The system according to claim 1 , wherein the at least one virtual cutting plane comprises a vertical cutting plane and a horizontal cutting plane.

6. The system of claim 5, wherein the processor is further configured to: maintaining a longitudinal axis of the rotary cutting tip in the vertical cutting plane when the axes of movement of the first and second linear actuators are substantially orthogonal to the vertical cutting plane; and When the axes of movement of the first and second linear actuators are substantially orthogonal to the horizontal cutting plane, the longitudinal axis of the rotating cutting tip is maintained in the horizontal cutting plane.

7. The system of claim 5, wherein the tool rack is further configured to: pivoting about a fixed point on a contact surface with the bone during movement of the rotary cutting tip along the vertical cutting plane; and During movement of the rotating cutting tip along the horizontal cutting plane, it moves along the contact surface of the bone.

8. The system of claim 1 or 2, wherein the processor is further configured to control a rotation speed of the rotating cutting tip about the longitudinal axis to resect the bone.

9. The system of claim 8, wherein the processor is further configured to stop the rotation of the rotating cutting tip when the rotating cutting tip intersects the at least one virtual cutting plane.

10. The system of claim 8, wherein the processor is further configured to stop the rotation of the rotating cutting tip when the rotating cutting tip moves outside of a designated cutting area.

11. The system of claim 1 or 2, wherein each of the first linear actuator and the second linear actuator comprises one or more of a linear motor, a piezoelectric motor, a pneumatic motor, a hydraulic motor, and a gear motor.

12. The system of claim 1 or 2, wherein the tool holder is rotatable relative to the tool body.

13. The system of claim 1 or 2, wherein the processor is further configured to control a position of a robotic arm to which the rotary tool is secured.

14. The system of claim 1 or 2, wherein the tracking array comprises three or more fiducial markers, and the surgical tracking device is configured to identify a position of each of the three or more fiducial markers relative to the bone.

15. A rotational tool for resecting a patient's bone, the rotational tool comprising: Tool body; a tracking array secured to the tool body, the tracking array comprising one or more fiducial markers configured to be tracked by a surgical tracking system; a powered rotary cutting tip including a longitudinal axis, wherein the rotary cutting tip is secured to the tool body and is rotatable by a motor about the longitudinal axis to resect the patient's bone; a first linear actuator and a second linear actuator, the first linear actuator and the second linear actuator configured to be controlled by a processor to adjust one or more of a vertical position and a pitch position of the rotating cutting tip relative to the tool body to maintain the rotating cutting tip in at least one virtual cutting plane; as well as A tool holder extends from the tool body, the tool holder being configured to remain in contact with the bone as the tool body is moved to resect the bone.

16. The rotary tool of claim 15, wherein the rotary cutting tip has a fixed horizontal position and a fixed axial position relative to the tool body.

17. A rotary tool according to claim 15 or 16, wherein the rotary cutting tip has a fixed yaw position relative to the tool body.

18. The rotary tool according to claim 15 or 16, wherein each of the first linear actuator and the second linear actuator comprises one or more of a linear motor, a piezoelectric motor, a pneumatic motor, a hydraulic motor, and a gear motor.

19. The rotary tool according to claim 15 or 16, wherein the tool holder is rotatable relative to the tool body.

20. The rotary tool of claim 15 or 16, wherein the rotary tool is configured to be secured to a robotic arm, wherein the processor is further configured to control the position of the robotic arm.

21. The rotary tool according to claim 15 or 16, wherein the tool holder is further configured as follows: pivoting about a fixed point on a contact surface with the bone during movement of the rotary cutting tip along a vertical cutting plane; and During movement of the rotating cutting tip along the horizontal cutting plane, it moves along the contact surface of the bone.

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