System for robotically assisted insertion of medical fasteners

Abstract

Methods and systems for placing medical fasteners at a predetermined depth within bone are described. The surgical tool may include: an attachment assembly configured to interchangeably engage a medical fastener and a cutting element or bone removal tool; and a drive assembly coupled to the attachment assembly. The attachment assembly may be configured to automatically release the medical fastener in response to the drive assembly reaching its distal or distal position, thereby placing the medical fastener at a predetermined depth within the bone.

Description

[0001] Cross-reference to related applications

[0002] This application claims priority to U.S. Provisional Patent Application No. 62 / 975,893, filed February 13, 2020, entitled “METHODS AND SYSTEMS FOR ROBOTIC-ASSISTED INSERTION OF MEDICALFASTENERS”, which is incorporated herein by reference in its entirety. Technical Field

[0003] This disclosure generally relates to methods, systems, and apparatus related to computer-assisted surgical systems, which include various hardware and software components that work together to enhance surgical procedures. The disclosed techniques can be applied to, for example, shoulder, hip, and knee replacement surgeries, as well as other surgical procedures such as arthroscopic surgery, spinal surgery, maxillofacial surgery, rotator cuff surgery, ligament repair and replacement surgery. Background Technology

[0004] The entire healthcare system is generally looking to reduce costs, ensure patient safety, and improve clinical outcomes. One way to achieve these goals is by improving surgical instruments to provide more consistent and reproducible results. For example, as indicated by the specific type of surgical procedure being performed and the type of surgical navigation system being used, orthopedic surgeons often have to use Kirschner needles, pins, and other medical fasteners during surgical procedures. One use of these medical fasteners is to attach markers to the bone. The surgical navigation system then identifies the markers to track bone movement throughout the procedure. Another use of these medical fasteners is to attach cutting guides or clamps to the bone to guide a saw or drill. Surgeons using conventional surgical navigation systems typically need to position the guide according to the navigation system's instructions and then drill through the guide to place the fastener. Some surgical systems may use robot-assisted placement of drilling guides, while others may be entirely surgeon-navigated. Regardless of whether the surgical system uses robot assistance and regardless of the end use of the fasteners, the surgeon must use multiple different tools and perform multiple different steps to place the fasteners, which can be an inefficient process.

[0005] Another approach to achieving the goals of cost reduction, ensuring patient safety, and improving clinical outcomes is to automate one or more steps of the surgical procedure. Human error remains a key driver of variability in surgical procedures, regardless of the rigor of the surgical workflow followed or the surgeon's experience. In particular, the selection and implantation of internal prostheses is complex and challenging even for the most experienced surgeons. Successful clinical outcomes are highly dependent on the surgeon's skill, and, as in any field, skill levels vary significantly from person to person. Therefore, automated robotic surgical systems that can eliminate or reduce human variability in procedural execution can provide patients with more consistent and safer clinical outcomes.

[0006] Therefore, there is a need in the art for systems and devices that allow for more efficient placement of medical fasteners in order to reduce the number of potential points of error in each surgical procedure and the number of different devices that need to be deployed by the surgeon. Summary of the Invention

[0007] Surgical instruments, methods, and systems are provided for placing medical fasteners and driving bone removal tools. Surgical instruments, methods, and systems for automatically placing medical fasteners at the desired depth are also provided. Additionally, robotic surgical systems suitable for automatically placing medical fasteners are provided.

[0008] In some embodiments, a surgical tool is provided, comprising: an attachment assembly including: a collet configured to interchangeably receive a medical fastener or a bone removal tool therein; a sleeve slidable relative to the collet between the first and second configurations; the sleeve including a sleeve recess; a biasing member configured to bias the sleeve toward the first configuration; and a pawl located within the sleeve recess, wherein the medical fastener or the bone removal tool is inserted into the collet such that the pawl moves into and at least partially occupies the corresponding recess of the medical fastener or the bone removal tool, wherein in the first configuration, the sleeve abuts against the pawl from... The attachment assembly includes: a pawl that holds the pawl in its position within a corresponding recess of the medical fastener or the bone removal tool and restricts axial movement of the medical fastener or the bone removal tool; a rotary actuator configured to rotatably drive the attachment assembly; a stop; and an axial actuator configured to axially drive the attachment assembly between a first position and a second position, wherein when the attachment assembly is driven by the axial actuator to approach the second position, the sleeve contacts the stop, causing the sleeve to slide relative to the collet into the second configuration, thereby causing the pawl to move radially into the sleeve recess and vacating a corresponding recess of the medical fastener, thereby releasing the medical fastener at a predetermined depth corresponding to the second position.

[0009] In some embodiments, a surgical system is provided, comprising: a surgical navigation system; and a surgical tool including: a tracking array configured to be detected by the surgical navigation system; an attachment assembly including: a collet configured to interchangeably receive a medical fastener or a bone removal tool; a sleeve slidable relative to the collet between the first and second configurations; the sleeve including a sleeve recess; a biasing member configured to bias the sleeve toward the first configuration; and a pawl located within the sleeve recess, wherein the medical fastener or the bone removal tool is inserted into the collet such that the pawl moves into and at least partially occupies the corresponding recess of the medical fastener or the bone removal tool. In the first configuration, the sleeve abuts against the pawl, thereby holding the pawl in its position within a corresponding recess of the medical fastener or the bone removal tool and restricting axial movement of the medical fastener or the bone removal tool; a rotary actuator configured to rotatably drive the attachment assembly; a stop; and an axial actuator configured to axially drive the attachment assembly between a first position and a second position, wherein when the attachment assembly is driven by the axial actuator to approach the second position, the sleeve contacts the stop, thereby causing the sleeve to slide relative to the collet into the second configuration, thereby moving the pawl radially into the sleeve recess and vacating a corresponding recess of the medical fastener, thereby releasing the medical fastener at a predetermined depth corresponding to the second position.

[0010] In some embodiments, the pawl includes a ball bearing.

[0011] In some embodiments, the surgical tool further includes a cylinder and a chamber configured to engage with a medical fastener box, the medical fastener box being configured to reload one of a plurality of medical fasteners into the cylinder when the attachment assembly is in the second configuration and the medical fastener is released from the surgical tool.

[0012] In some embodiments, the bone removal tool includes a sharpening blade.

[0013] In some embodiments, the actuator is selected from electric motors, hydraulic actuators, screw actuators, rack and pinion assemblies, and piezoelectric actuators.

[0014] In some embodiments, the surgical system further includes a medical fastener box comprising a plurality of medical fasteners and one or more trackers configured to be detected by the surgical navigation system.

[0015] In some embodiments, the surgical system further includes a robotic arm configured to manipulate the surgical instruments, wherein the robotic arm is configured to be controlled to selectively engage the surgical instruments with one of a plurality of medical fasteners in the medical fastener housing.

[0016] In some embodiments, a method is provided for positioning and placing a medical fastener in bone. The method includes: (i) tracking a surgical tool using a surgical navigation system, the surgical tool including an attachment component configured to interchangeably engage a medical fastener and a bone removal tool; (ii) positioning the surgical tool in an orientation relative to the bone using the surgical navigation system; (iii) implanting the medical fastener at a predetermined depth using the surgical tool in an orientation relative to the bone; and (iv) automatically disengaging the medical fastener from the surgical tool at the predetermined depth. Attached Figure Description

[0017] The accompanying drawings, which are incorporated in and form a part of this specification, illustrate embodiments of the present disclosure and, together with the written description, serve to explain the principles, features, and characteristics of the invention. In the drawings:

[0018] Figure 1 An operating room including an exemplary computer-assisted surgical system (CASS) is shown according to an embodiment.

[0019] Figure 2 An example of an electromagnetic sensor device according to some embodiments is shown.

[0020] Figure 3A Alternative examples of electromagnetic sensor devices with three vertical coils according to some embodiments are shown.

[0021] Figure 3B Alternative examples of electromagnetic sensor devices with two non-parallel fixed coils according to some embodiments are shown.

[0022] Figure 3C Alternative examples of electromagnetic sensor devices with two non-parallel, separate coils according to some embodiments are shown.

[0023] Figure 4 Examples of an electromagnetic sensor device and a patient's bone according to some embodiments are shown.

[0024] Figure 5A Illustrative control instructions provided by the surgical computer to other components of CASS according to an embodiment are shown.

[0025] Figure 5B Illustrative control instructions provided by components of a CASS according to an embodiment to a surgical computer are shown.

[0026] Figure 5C An illustrative embodiment is shown in which a surgical computer, according to an embodiment, is connected to a surgical data server via a network.

[0027] Figure 6 A surgical patient care system and illustrative data source according to an embodiment are shown.

[0028] Figure 7A An exemplary flowchart for determining a preoperative surgical plan is shown according to an embodiment.

[0029] Figure 7B An exemplary flowchart is shown for determining the care period, including preoperative, intraoperative, and postoperative actions, according to an embodiment.

[0030] Figure 7C (including the "in the attached diagram") Figure 7C "and the two paintings that followed" Figure 7C continued The diagram illustrates an illustrative graphical user interface according to an embodiment, including images depicting implant placement.

[0031] Figure 8 This is a perspective view of a handheld cutting device with a cutting guard according to certain embodiments of the present disclosure.

[0032] Figure 9 This is a cross-sectional view of a surgical tool in a retracted configuration according to certain embodiments of the present disclosure.

[0033] Figure 10 It is an extended configuration according to certain embodiments of this disclosure. Figure 9 A cross-sectional view of the surgical instruments.

[0034] Figure 11 According to certain embodiments of this disclosure Figure 9 Detailed cross-sectional view of the attachment components of the surgical instrument, wherein the attachment components are in an engagement configuration.

[0035] Figure 12 According to certain embodiments of this disclosure Figure 9 A detailed cross-sectional view of the attachment components of the surgical instrument, wherein the attachment components are in a disengaged configuration.

[0036] Figure 13 According to certain embodiments of this disclosure Figure 9 A detailed cross-sectional view of the attachment assembly of the surgical instrument, wherein the attachment assembly is in an unsealed state.

[0037] Figure 14 According to certain embodiments of this disclosure Figure 9 A detailed cross-sectional view of the attachment assembly of the surgical instrument, wherein the attachment assembly is in a sealed state.

[0038] Figure 15 This is a perspective view of a surgical instrument including a medical fastener box according to certain embodiments of the present disclosure.

[0039] Figure 16 It is an embodiment of the present disclosure having internal components shown in a blurred form. Figure 15 A detailed view of the distal end of the surgical instrument, where medical fasteners are loaded for placement.

[0040] Figure 17 It is an embodiment of the present disclosure having internal components shown in a blurred form. Figure 15 A detailed view of the distal end of the surgical instrument, where the medical fastener has been ejected from the surgical instrument.

[0041] Figure 18 According to certain embodiments of this disclosure Figure 15 Exploded view of the medical fastener box assembly of surgical instruments.

[0042] Figure 19 It is according to certain embodiments of this disclosure that internal components are shown in a blurred form. Figure 15 Exploded view of the medical fastener box assembly of surgical instruments.

[0043] Figure 20 This is a perspective view of a robotic surgical system including a medical fastener box according to certain embodiments of the present disclosure.

[0044] Figure 21 According to certain embodiments of this disclosure Figure 20 Another perspective view of the robotic surgical system.

[0045] Figure 22 According to certain embodiments of this disclosure Figure 20 A perspective view of the medical fastener box of a robotic surgical system.

[0046] Figure 23 According to certain embodiments of this disclosure Figure 20 A perspective view of the robotic surgical system selecting medical fasteners from a medical fastener box.

[0047] Figure 24 According to certain embodiments of this disclosure Figure 23 The image shows a detailed view of the medical fastener selection.

[0048] Figure 25 According to certain embodiments of this disclosure Figure 20 The robotic surgical system is being used to repair tibial fractures. (Image)

[0049] Figure 26According to certain embodiments of this disclosure Figure 20 The robotic surgical system drills a diagram of a guide hole through the tibial plate for medical fasteners.

[0050] Figure 27 According to certain embodiments of this disclosure Figure 20 The diagram shows the selection of appropriate medical fasteners for the tibial plate in the robotic surgical system. Detailed Implementation

[0051] For the purposes of this disclosure, the term "implant" is used to refer to a prosthetic device or structure manufactured to replace or enhance a biological structure. For example, in a total hip replacement procedure, a prosthetic acetabular cup (implant) is used to replace or enhance a patient's worn or damaged acetabulum. While the term "implant" is generally considered to refer to an artificial structure (in contrast to a transplant), for the purposes of this specification, an implant may include biological tissue or material transplanted to replace or enhance a biological structure.

[0052] For the purposes of this disclosure, the term "real-time" is used to refer to computations or operations performed immediately upon the occurrence of an event or the receipt of input by an operating system. However, the use of the term "real-time" is not intended to exclude operations that introduce some delay between input and response, provided that the delay is an unintended consequence of the machine's performance characteristics.

[0053] While much of this disclosure refers to surgeons or other medical professionals by specific titles or roles, nothing in this disclosure is intended to be limited to any particular title or function. A surgeon or medical professional can include any physician, nurse, medical professional, or technician. Any of these terms or titles may be used interchangeably with the systems disclosed herein, unless otherwise expressly stated. For example, in some embodiments, references to surgeons may also apply to technicians or nurses.

[0054] The systems, methods, and apparatus disclosed herein are particularly well-suited for surgical procedures utilizing surgical navigation systems, such as the NAVIO® Surgical Navigation System. NAVIO is a registered trademark of BLUE BELT TECHNOLOGIES, Inc., Pittsburgh, Pennsylvania, a subsidiary of SMITH & NEPHEW, Inc., Memphis, Tennessee.

[0055] CASS Ecosystem Overview

[0056] Figure 1Illustrations of an example computer-assisted surgical system (CASS) 100 according to some embodiments are provided. As described in further detail in the following sections, CASS uses computers, robotics, and imaging technologies to assist surgeons in performing orthopedic surgical procedures such as total knee replacement (TKA) or total hip replacement (THA). For example, surgical navigation systems can help surgeons locate the patient's anatomy, guide surgical instruments, and implant medical devices with high precision. Surgical navigation systems such as CASS 100 often employ various forms of computing technology to perform a wide range of standard and minimally invasive surgical procedures and techniques. Moreover, these systems allow surgeons to more accurately plan, track, and navigate the position of instruments and implants relative to the patient's body, as well as to perform preoperative and intraoperative body imaging.

[0057] The actuator platform 105 positions surgical instruments relative to the patient during surgery. The exact components of the actuator platform 105 will vary depending on the embodiment employed. For example, for knee surgery, the actuator platform 105 may include an end effector 105B that holds the surgical instruments or apparatus during its use. The end effector 105B may be a handheld device or instrument used by the surgeon (such as a NAVIO® handheld device, cutting guide, or clamp), or alternatively, the end effector 105B may include a device or instrument held or positioned by a robotic arm 105A. Although in Figure 1 A single robotic arm 105A is shown, but in some embodiments, multiple devices may be present. For example, there may be one robotic arm 105A on each side of the operating table T, or two devices on one side of the operating table T. The robotic arm 105A may be mounted directly to the operating table T, located on a floor platform (not shown) adjacent to the operating table T, mounted on a floor bar, or mounted on a wall or ceiling of the operating room. The floor platform may be fixed or movable. In one particular embodiment, the robotic arm 105A is mounted on a floor bar located between the patient's legs or feet. In some embodiments, the end effector 105B may include a suture retainer or stapler to aid in wound closure. Furthermore, in the case of two robotic arms 105A, the surgical computer 150 may drive the robotic arms 105A to work together to suture the wound upon closure. Alternatively, the surgical computer 150 may drive one or more robotic arms 105A to suture the wound upon closure.

[0058] The actuator platform 105 may include a limb locator 105C for positioning a patient's limb during surgery. An example of the limb locator 105C is the Smith and Nephew Spider2 system. The limb locator 105C can be manually operated by the surgeon, or alternatively, the limb position can be changed based on instructions received from the surgical computer 150 (described below). Figure 1A limb locator 105C is shown, but in some embodiments, multiple devices may be present. As an example, there may be one limb locator 105C on each side of the operating table T, or two devices on one side of the operating table T. The limb locator 105C may be directly mounted to the operating table T, located on a floor platform (not shown) next to the operating table T, mounted on a pole, or mounted on the wall or ceiling of the operating room. In some embodiments, the limb locator 105C may be used in unconventional ways, such as as a retractor or a specific bone retainer. As an example, the limb locator 105C may include an ankle boot, soft tissue clip, bone clip, or soft tissue retractor key, such as a hook-shaped, curved, or angled blade. In some embodiments, the limb locator 105C may include a suture retainer to assist in wound closure.

[0059] The actuator platform 105 may include tools such as screwdrivers, light or lasers indicating axes or planes, levels, pin drivers, pin pullers, plane checkers, indicators, fingers, or some combination thereof.

[0060] Resection device 110 ( Figure 1 (Not shown) Bone or tissue resection is performed using techniques such as mechanical, ultrasonic, or laser methods. Examples of resection devices 110 include drilling devices, deburring devices, vibratory sawing devices, vibratory impact devices, reamers, ultrasonic bone cutting devices, radiofrequency ablation devices, reciprocating motion devices (e.g., files or broaches), and laser ablation systems. In some embodiments, the resection device 110 is held and operated by a surgeon during surgery. In other embodiments, an actuator platform 105 may be used to hold the resection device 110 during use.

[0061] The actuator platform 105 may also include a cutting guide or clamp 105D for guiding a saw or drill used to remove tissue during surgery. Such a cutting guide 105D may be integrally formed as part of the actuator platform 105 or the robotic arm 105A, or the cutting guide may be a separate structure that can be mateably and / or removably attached to the actuator platform 105 or the robotic arm 105A. The actuator platform 105 or the robotic arm 105A may be controlled by the CASS 100 to position the cutting guide or clamp 105D near the patient's anatomy according to a preoperative or intraoperative surgical plan, such that the cutting guide or clamp will produce precise bone cuts according to the surgical plan.

[0062] Tracking system 115 uses one or more sensors to collect real-time position data for locating patient anatomy and surgical instruments. For example, for TKA procedures, the tracking system can provide the position and orientation of end effector 105B during the procedure. In addition to position data, data from tracking system 115 can also be used to infer the velocity / acceleration of the anatomy / instrument, which can be used for tool control. In some embodiments, tracking system 115 can use an array of trackers attached to end effector 105B to determine the position and orientation of end effector 105B. The position of end effector 105B can be inferred based on the position and orientation of tracking system 115 and a known relationship in three-dimensional space between tracking system 115 and end effector 105B. Various types of tracking systems can be used in various embodiments of the invention, including but not limited to infrared (IR) tracking systems, electromagnetic (EM) tracking systems, video or image-based tracking systems, and ultrasound registration and tracking systems. Using the data provided by tracking system 115, surgical computer 150 can detect objects and prevent collisions. For example, surgical computer 150 can prevent robotic arm 105A and / or end effector 105B from colliding with soft tissue.

[0063] 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, such as infrared LED light sources, can illuminate the scene, enabling three-dimensional imaging. In some embodiments, this can include stereo, three-view, four-view, etc., imaging. In addition to camera arrays fixed to a trolley in some embodiments, additional cameras can be placed throughout the operating room. For example, handheld tools or headgear worn by the operator / surgeon can include imaging capabilities that transmit images back to a central processor to correlate those images with those acquired by the camera array. This can provide more robust images for environments modeled using multiple perspectives. Furthermore, some imaging devices can have appropriate resolution or perspective on the scene to pick up information stored in quick response (QR) codes or barcodes. This helps identify specific objects that have not been manually registered with the system. In some embodiments, the cameras can be mounted on a robotic arm 105A.

[0064] As discussed in this paper, while most tracking and / or navigation technologies utilize image-based tracking systems (e.g., IR tracking systems, video or image-based tracking systems, etc.), electromagnetic (EM)-based tracking systems are becoming increasingly common for various reasons. For example, implantation of standard optical trackers requires tissue resection (e.g., down to the cortex) and subsequent drilling and driving of cortical pins. Additionally, because optical trackers require a direct line of sight to the tracking system, placement of such trackers may need to be away from the surgical site to ensure they do not restrict the movement of surgeons or medical professionals.

[0065] Typically, EM-based tracking devices include one or more coils and a reference field generator. The one or more coils can be energized (e.g., via a wired or wireless power source). Once energized, the coils generate an electromagnetic field that can be detected and measured (e.g., by the reference field generator or additional devices) in a manner that allows the position and orientation of the one or more coils to be determined. As will be understood by one of ordinary skill in the art, for example... Figure 2 The single coil shown is limited to detecting five (5) total degrees of freedom (DOF). For example, sensor 200 is able to track / determine movement in the X, Y, or Z directions, as well as rotation about the Y-axis 202 or the Z-axis 201. However, due to the electromagnetic properties of the coil, it is not possible to accurately track rotational motion about the X-axis.

[0066] Therefore, in most electromagnetic tracking applications, such as Figure 3A The three-coil system shown is used to achieve tracking in all six degrees of freedom (i.e., forward / backward 310°, up / down 320°, left / right 330°, roll 340°, pitch 350°, and yaw 360°) that allow a rigid body to move in three-dimensional space. However, including two additional coils and their 90° offset angle of positioning may require a much larger tracking device. Alternatively, as those skilled in the art will know, fewer than three complete coils can be used to track all 6DOF. In some EM-based tracking devices, two coils can be fixed to each other, for example... Figure 3B As shown in the diagram. Since the two coils 301B and 302B are rigidly fixed to each other, not perfectly parallel, and have known positions relative to each other, this arrangement can be used to determine the sixth degree of freedom 303B.

[0067] While using two fixed coils (e.g., 301B, 302B) allows for EM-based tracking at 6DOF, the sensor device has a significantly larger diameter than a single coil due to the additional coils. Therefore, practical application of an EM-based tracking system in a surgical setting may require tissue removal and drilling into a portion of the patient's bone to allow insertion of the EM tracker. Alternatively, in some embodiments, a single coil or 5DOF EM tracking device can be implanted / inserted into the patient's bone using only a pin (e.g., without drilling or extensive bone removal).

[0068] Therefore, as described herein, there is a need for a solution that limits the use of the EM tracking system to devices small enough to be inserted / embedded using small-diameter needles or pins (i.e., without requiring new incisions or large-diameter openings in the bone). Thus, in some embodiments, a second 5DOF sensor, not attached to the first sensor and therefore having a small diameter, can be used to track all 6DOF. Now refer to... Figure 3C In some embodiments, two 5DOF EM sensors (e.g., 301C and 302C) may be inserted into the patient (e.g., in the patient's bone) at different locations with different angular orientations (e.g., angle 303C is non-zero).

[0069] Now for reference Figure 4 This illustrates an example embodiment of inserting a first 5DOF EM sensor 401 and a second 5DOF EM sensor 402 into the patient's bone 403 using a standard hollow needle 405 typical in most orthopedic procedures. In another embodiment, the first sensor 401 and the second sensor 402 may have an angular offset of "α" 404. In some embodiments, the offset angle "α" 404 may need to be greater than a predetermined value (e.g., a minimum angle of 0.50°, 0.75°, etc.). In some embodiments, this minimum value may be determined by the CASS during surgical planning and provided to the surgeon or medical professional. In some embodiments, the minimum value may be based on one or more factors, such as the orientation accuracy of the tracking system, the distance between the first and second EM sensors, the location of the field generator, the location of the field detector, the type of EM sensor, the quality of the EM sensor, the patient's anatomy, etc.

[0070] Therefore, as discussed herein, in some embodiments, pins / needles (e.g., sleeve mounting pins, etc.) can be used to insert one or more EM sensors. Typically, the pins / needles will be disposable components, while the sensor itself can be reusable. However, it should be understood that this is only one possible system, and various other systems can be used where the pins / needles and / or EM sensors are either single-use or reusable. In another embodiment, the EM sensor can be secured to a mounting pin / needle (e.g., using Luer lock fittings, etc.), which allows for quick assembly and disassembly. In yet another embodiment, the EM sensor can utilize alternative sleeves and / or anchoring systems that allow for minimal intrusion into the sensor's placement.

[0071] In another embodiment, the system described above can allow for a multi-sensor navigation system that can detect and correct field distortions that plague electromagnetic tracking systems. It should be understood that field distortions can be caused by movement of any ferromagnetic material within the reference field. Therefore, as is known to those skilled in the art, a typical operating system (OR) has numerous devices that can cause interference (e.g., operating tables, LCD displays, lighting equipment, imaging systems, surgical instruments, etc.). Furthermore, field distortions are known to be difficult to detect. Using multiple EM sensors enables the system to accurately detect field distortions and / or alert the user that measurements of the current position may be inaccurate. Because the sensors (e.g., via pins / needles) are securely attached to the bone anatomy, relative measurements of the sensor positions (X, Y, Z) can be used to detect field distortions. As a non-limiting example, in some embodiments, after the EM sensors are attached to the bone, the relative distance between two sensors is known and should be kept constant. Therefore, any change in this distance can indicate the presence of field distortion.

[0072] In some embodiments, surgeons can manually register specific objects using the system before or during surgery. For example, by interacting with a user interface, a surgeon can identify the starting position of a tool or bone structure. By tracking reference markers associated with the tool or bone structure, or by using other conventional image tracking methods, the processor can track the tool or bone as it moves through the environment in a 3D model.

[0073] In some embodiments, certain markers, such as reference markers for identifying individuals, vital instruments, or bones in an operating room, may include passive or active identifiers that can be picked up by a camera or camera array associated with a tracking system. For example, an infrared LED may flash a pattern that conveys a unique identifier to the source of the pattern, thus providing dynamic identification markings. Similarly, one-dimensional or two-dimensional optical codes (barcodes, QR codes, etc.) may be affixed to objects in the operating room to provide passive identification that can occur based on image analysis. If these codes are placed asymmetrically on the object, they can also be used to determine the orientation of the object by comparing the location of the identifier to the extent of the object in an image. For example, a QR code may be placed in the corner of a tool tray, allowing tracking of the tray's orientation and identifier. Other tracking methods will be described throughout the text. For example, in some embodiments, surgeons and other personnel may wear augmented reality headsets to provide additional camera angles and tracking capabilities.

[0074] Besides optical tracking, certain features of an object can also be tracked by registering its physical properties and associating them with a trackable object (e.g., a reference marker fixed to a tool or bone). For example, a surgeon can perform a manual registration process, whereby the tracked tool and the tracked bone can be manipulated relative to each other. By striking the surface of the bone with the tip of the tool, a three-dimensional surface can be mapped onto the bone, which is associated with its position and orientation relative to a reference frame of reference. By optically tracking the position and orientation (pose) of the reference marker associated with the bone, a model of the surface can be tracked in the environment via extrapolation.

[0075] The registration process of CASS 100 to a patient's relevant anatomical structures can also involve the use of anatomical landmarks, such as those on bone or cartilage. For example, CASS 100 can include a 3D model of the relevant bone or joint, and the surgeon can use probes attached to CASS to collect data intraoperatively on the location of bone landmarks on the patient's actual bones. Bone landmarks can include, for example, the medial and lateral malleoli, the ends of the proximal femur and distal tibia, and the center of the hip joint. CASS 100 can compare and register the location data of the bone landmarks collected by the surgeon with the probes with the location data of the same landmarks in the 3D model. Alternatively, CASS 100 can construct a 3D model of a bone or joint without preoperative image data by using location data of bone landmarks and bone surfaces collected by the surgeon using CASS probes or other means. The registration process can also include determining the individual axes of the joint. For example, for TKA, the surgeon can use CASS 100 to determine the anatomical and mechanical axes of the femur and tibia. Surgeons and CASS 100 can identify the center of the hip joint by moving the patient's legs in a spiral direction (i.e., circumferentially) so that CASS can determine the location of the hip joint center.

[0076] Organizational Navigation System 120 ( Figure 1 (Not shown in the image) provides surgeons with real-time intraoperative visualization of the patient's bone, cartilage, muscle, nerves, and / or blood vessels surrounding the surgical area. Examples of systems that can be used for tissue navigation include fluorescence imaging systems and ultrasound systems.

[0077] Display 125 provides a graphical user interface (GUI) that displays images collected by the tissue navigation system 120, as well as other information relevant to the surgery. For example, in one embodiment, display 125 overlays image information collected preoperatively or intraoperatively from various modalities (e.g., CT, MRI, X-ray, fluorescence, ultrasound, etc.) to provide the surgeon with various views of the patient's anatomy and real-time status. Display 125 may include, for example, one or more computer monitors. As an alternative to or supplement to display 125, one or more surgical personnel may wear an augmented reality (AR) head-mounted device (HMD). For example, in Figure 1 In this case, the surgeon 111 wears an AR HMD 155, which can, for example, overlay preoperative image data onto the patient or provide surgical planning advice. Various exemplary uses of the AR HMD 155 in surgical procedures are described in detail in the following sections.

[0078] The surgical computer 150 provides control instructions to various components of the CASS 100, collects data from those components, and provides general processing for various data required during surgery. In some embodiments, the surgical computer 150 is a general-purpose computer. In other embodiments, the surgical computer 150 may be a parallel computing platform that uses multiple central processing units (CPUs) or graphics processing units (GPUs) to perform processing. In some embodiments, the surgical computer 150 is connected to a remote server via one or more computer networks (e.g., the Internet). The remote server may be used for, for example, data storage or the execution of computationally intensive processing tasks.

[0079] Various techniques known in the art can be used to connect the surgical computer 150 to other components of the CASS 100. Furthermore, the computer can be connected to the surgical computer 150 using a variety of technologies. For example, the end effector 105B can be connected to the surgical computer 150 via a wired (i.e., serial) connection. The tracking system 115, tissue navigation system 120, and display 125 can similarly be connected to the surgical computer 150 using wired connections. Alternatively, the tracking system 115, tissue navigation system 120, and display 125 can be connected to the surgical computer 150 using wireless technologies such as, but not limited to, Wi-Fi, Bluetooth, near field communication (NFC), or ZigBee.

[0080] Dynamic impact and acetabular reamer device

[0081] The above is about Figure 1 Part of the flexibility of the described CASS design lies in the ability to add additional or alternative devices to the CASS 100 as needed to support specific surgical procedures. For example, in the case of hip surgery, the CASS 100 may include a powered impact device. The impact device is designed to repeatedly apply impact forces that a surgeon can use to perform activities such as implant alignment. For instance, in total hip replacement (THA), surgeons typically use an impact device to insert a prosthetic acetabular cup into the acetabulum of the implant host. While impact devices can be inherently manual (e.g., operated by a surgeon striking the impactor with a hammer), powered impact devices are generally easier and faster to use in the surgical setting. The powered impact device may be powered, for example, by a battery attached to it. Various attachments can be connected to the powered impact device to allow the impact forces to be directed in various ways as needed during surgery. Similarly, in the case of hip surgery, the CASS 100 may include a powered, robot-controlled end effector to dilate the acetabulum to accommodate the acetabular cup implant.

[0082] In robot-assisted THA, the patient's anatomy can be registered to the CASS 100 using CT or other image data, identification of anatomical landmarks, a tracker array attached to the patient's bones, and one or more cameras. The tracker array can be mounted on the iliac crest using clamps and / or bone pins, and can be mounted externally through the skin or internally (posterolaterally or anterolaterally) through an incision made for performing the THA. For THA, the CASS 100 can utilize one or more femoral cortical screws inserted into the proximal femur as checkpoints to aid the registration process. The CASS 100 can also utilize one or more checkpoint screws inserted into the pelvis as additional checkpoints to aid the registration process. The femoral tracker array can be fixed or mounted in the femoral cortical screws. The CASS 100 can employ the following steps, where verification is performed using probes precisely placed on the monitor 125 by the surgeon on key areas of the proximal femur and pelvis identified by the surgeon. The tracker can be located on the robotic arm 105A or end effector 105B to register the arm and / or end effector to the CASS 100. The verification process can also utilize proximal and distal femoral checkpoints. The CASS 100 can use color cues or other cues to inform the surgeon that the registration process between the bone and the robotic arm 105A or end effector 105B has been verified with a certain level of accuracy (e.g., within 1 mm).

[0083] For THA, the CASS 100 may include a puller tracking option using a femoral array, allowing the surgeon to obtain the puller's position and orientation intraoperatively and calculate the patient's hip length and offset values. Based on the information provided about the patient's hip joint and the planned implant position and orientation after puller tracking is completed, the surgeon can modify or adjust the surgical plan.

[0084] For robot-assisted THA, CASS 100 may include one or more powered reamers connected to or attached to a robotic arm 105A or an end effector 105B, which prepare the pelvic bone according to the surgical plan to receive the acetabular implant. The robotic arm 105A and / or the end effector 105B may notify the surgeon and / or control the power of the reamers to ensure that the acetabulum is removed (reamed) according to the surgical plan. For example, if the surgeon attempts to remove bone outside the boundaries of the bone to be removed according to the surgical plan, CASS 100 may disconnect the power to the reamers or instruct the surgeon to disconnect the power to the reamers. CASS 100 may provide the surgeon with the option to turn off or disengage the robotic control of the reamers. The display 125 may show the progress of the bone being removed (reamed) compared to using a surgical plan in different colors. The surgeon can view the display of the bone being removed (reamed) to guide the reamers to complete the reaming according to the surgical plan. CASS 100 may provide the surgeon with visual or auditory cues to warn the surgeon that a resection not in accordance with the surgical plan is being performed.

[0085] After reaming, the CASS 100 can use a manual or powered impactor attached to or connected to the robotic arm 105A or end effector 105B to impact the test and final implants into the acetabulum. The robotic arm 105A and / or end effector 105B can be used to guide the impactor to impact the test and final implants into the acetabulum according to the surgical plan. The CASS 100 can display the position and orientation of the test and final implants relative to the bone to inform the surgeon how to compare the orientation and position of the test and final implants with the surgical plan. The display 125 can display the position and orientation of the implants as the surgeon manipulates the leg and hip. If the surgeon is not satisfied with the initial implant position and orientation, the CASS 100 can provide the surgeon with the option to replan and redo the reaming and implant impact by preparing a new surgical plan.

[0086] Preoperatively, the CASS 100 can develop a proposed surgical plan based on a 3D model of the hip joint and other patient-specific information, such as the mechanical and anatomical axes of the leg bones, the epicondyle axis, the femoral neck axis, the dimensions (e.g., length) of the femur and hip, the midline axis of the hip joint, the ASIS axis of the hip joint, and the location of anatomical landmarks such as the lesser trochanter landmark, the distal landmark, and the center of rotation of the hip joint. The surgical plan developed by CASS can provide recommended optimal implant size, as well as implant location and orientation, based on the 3D model of the hip joint and other patient-specific information. The surgical plan developed by CASS can include recommended details regarding offset values, tilt and anteversion values, center of rotation, cup size, mid-range value, superior-inferior fit, femoral stem size, and length.

[0087] For THA, the surgical plan developed by CASS can be viewed preoperatively and intraoperatively, and the surgeon can modify the CASS-developed surgical plan preoperatively or intraoperatively. The CASS-developed surgical plan can display the planned hip resection and, based on the planned resection, the planned implant is superimposed onto the hip joint. CASS 100 can provide the surgeon with a choice of different surgical procedures, which will be displayed to the surgeon according to their preferences. For example, the surgeon can choose from different workflows based on the number and type of anatomical landmarks examined and acquired and / or the location and number of tracker arrays used during registration.

[0088] According to some embodiments, the powered impact device used with the CASS 100 can operate in a variety of different settings. In some embodiments, the surgeon adjusts the settings via a manual switch or other physical mechanism on the powered impact device. In other embodiments, a digital interface can be used, allowing setting input, for example, via a touchscreen on the powered impact device. Such a digital interface can allow available settings to vary based on, for example, the type of attachment connected to an electrical attachment device. In some embodiments, the settings can be changed by communicating with a robot or other computer system within the CASS 100, rather than adjusting the settings on the powered impact device itself. Such a connection can be established using, for example, a Bluetooth or Wi-Fi networking module on the powered impact device. In another embodiment, the impact device and end components can include features that allow the impact device to know which end components (cup impactor, puller handle, etc.) are attached without requiring any action from the surgeon, and adjust the settings accordingly. This can be achieved, for example, via QR codes, barcodes, RFID tags, or other methods.

[0089] Examples of possible settings include cup impact settings (e.g., unidirectional, specified frequency range, specified force and / or energy range); puller impact settings (e.g., bidirectional / oscillating within a specified frequency range, specified force and / or energy range); femoral head impact settings (e.g., unidirectional / single-shot impact with specified force or energy); and dry impact settings (e.g., unidirectional impact with specified force or energy at a specified frequency). Additionally, in some embodiments, the dynamic impact device includes settings related to acetabular liner impact (e.g., unidirectional / single-shot impact with specified force or energy). Multiple settings may be available for each type of liner (e.g., polymer, ceramic, oxinium, or other materials). Furthermore, the dynamic impact device can provide settings for different bone qualities based on preoperative testing / imaging / knowledge and / or intraoperative assessment by the surgeon. In some embodiments, the dynamic impact device can have dual functionality. For example, the dynamic impact device can not only provide reciprocating motion to deliver impact force but also provide reciprocating motion for a puller or file.

[0090] In some embodiments, the dynamic impact device includes a feedback sensor that collects data during instrument use and transmits the data to a computing device, such as a controller or surgical computer 150 within the device. The computing device can then record the data for later analysis and use. Examples of data that can be collected include, but are not limited to, sound waves, predetermined resonant frequencies of each instrument, reaction forces or rebound energy from the patient's bone, the position of the device relative to an image (e.g., fluorescence, CT, ultrasound, MRI, etc.) of a registered bone anatomy, and / or external strain gauges on the bone.

[0091] Once the data is collected, the computing device can execute one or more algorithms in real time or near real time to assist the surgeon in performing surgical procedures. For example, in some embodiments, the computing device uses the collected data to derive information such as the correct final retractor size (femur); when the shaft is fully in place (femoral side); or when the cup is in place relative to the THA (depth and / or orientation). Once this information is known, it can be displayed for the surgeon to view, or it can be used to activate haptic or other feedback mechanisms to guide the surgical procedure.

[0092] Furthermore, the data derived from the aforementioned algorithm can be used to operate the drive device. For example, during insertion of the prosthetic acetabular cup using a powered impact device, the device can automatically extend the impact head (e.g., an end effector) to move the implant into place, or shut off the device's power once the implant is fully in place. In one embodiment, the derived information can be used to automatically adjust bone quality settings, where the powered impact device should use less power to mitigate femoral / acetabular / pelvic fractures or damage to surrounding tissues.

[0093] robotic arm

[0094] In some embodiments, the CASS 100 includes a robotic arm 105A, which serves as an interface for stabilizing and holding various instruments used during surgical procedures. For example, in the case of hip surgery, these instruments may include, but are not limited to, retractors, sagittal or reciprocating saws, reamer handles, cup impactors, puller handles, and dry inserters. The robotic arm 105A may have multiple degrees of freedom (similar to a spider device) and the ability to lock into place (e.g., by pressing a button, voice activation, the surgeon removing their hand from the robotic arm, or other methods).

[0095] In some embodiments, movement of the robotic arm 105A can be achieved using a control panel built into the robotic arm system. For example, the display screen may include one or more input sources, such as physical buttons that guide the movement of the robotic arm 105A or a user interface with one or more icons. Surgeons or other healthcare professionals can engage with one or more input sources to position the robotic arm 105A during surgical procedures.

[0096] Tools or end effectors 105B attached to or integrated into the robotic arm 105A may include, but are not limited to, deburring devices, scalpels, cutting devices, retractors, joint tensioners, etc. In embodiments using the end effector 105B, the end effector may be positioned at the end of the robotic arm 105A, enabling any motor-controlled operation to be performed within the robotic arm system. In embodiments using the tool, the tool may be fixed at the distal end of the robotic arm 105A, but the motor-controlled operation may be located within the tool itself.

[0097] The robotic arm 105A can be internally motorized to stabilize it, preventing it from falling and impacting patients, operating tables, surgical personnel, etc., and allowing the surgeon to move the robotic arm without having to fully support its weight. While the surgeon moves the robotic arm 105A, it provides some resistance to prevent it from moving too quickly or activating too many degrees of freedom at once. The position and locked state of the robotic arm 105A can be tracked, for example, by a controller or surgical computer 150.

[0098] In some embodiments, the robotic arm 105A can be moved to its ideal position and orientation by hand (e.g., by a surgeon) or by internal motors to perform the task at hand. In some embodiments, the robotic arm 105A may be able to operate in a “free” mode, allowing the surgeon to position the arm in a desired location without restriction. In free mode, as described above, the position and orientation of the robotic arm 105A can still be tracked. In one embodiment, during a designated portion of the surgical plan tracked by the surgical computer 150, certain degrees of freedom can be selectively released upon input from a user (e.g., a surgeon). A design in which the robotic arm 105A is internally powered by hydraulics or motors, or provides resistance to external manual movement by similar means, can be described as a powered robotic arm, while an arm that is manually manipulated without power feedback but can be manually or automatically locked in place can be described as a passive robotic arm.

[0099] The robotic arm 105A or end effector 105B may include triggers or other devices to control the power of the saw or drill. Engagement of the trigger or other device by the surgeon can transition the robotic arm 105A or end effector 105B from a motorized alignment mode to a mode where the saw or drill is engaged and energized. Additionally, the CASS 100 may include a foot pedal (not shown) that, when activated, causes the system to perform certain functions. For example, the surgeon may activate the foot pedal to instruct the CASS 100 to place the robotic arm 105A or end effector 105B in an automatic mode, which positions the robotic arm or end effector relative to the patient's anatomy to perform necessary resections. The CASS 100 may also place the robotic arm 105A or end effector 105B in a cooperative mode, which allows the surgeon to manually manipulate the robotic arm or end effector and position it in a specific location. The cooperative mode can be configured to allow the surgeon to move the robotic arm 105A or end effector 105B medially or laterally while restricting movement in other directions. As discussed, the robotic arm 105A or end effector 105B may include a cutting device (saw, drill, and sharpener) or a cutting guide or clamp 105D that guides the cutting device. In other embodiments, the movement of the robotic arm 105A or the robot-controlled end effector 105B may be entirely controlled by the CASS 100 without any assistance or input from a surgeon or other medical professional, or with very little assistance or input. In still other embodiments, a surgeon or other medical professional may remotely control the movement of the robotic arm 105A or the robot-controlled end effector 105B using a control mechanism separate from the robotic arm or robot-controlled end effector device, such as a joystick or interactive monitor or display control device.

[0100] The following examples describe the use of robotic devices in hip surgery; however, it should be understood that robotic arms may have other applications in surgical procedures involving the knee, shoulder, etc. An example of the use of a robotic arm in creating anterior cruciate ligament (ACL) graft tunnels is described in WIPO Publication No. WO 2020 / 047051, filed August 28, 2019, entitled "Robotic Assisted Ligament Graft Placement and Tensioning," the entire contents of which are incorporated herein by reference.

[0101] The robotic arm 105A can be used to hold a retractor. For example, in one embodiment, the surgeon can move the robotic arm 105A to a desired position. At this point, the robotic arm 105A can lock into place. In some embodiments, the robotic arm 105A is provided with data about the patient's position so that if the patient moves, the robotic arm can adjust the retractor position accordingly. In some embodiments, multiple robotic arms can be used, thereby allowing multiple retractors to be held or more than one action to be performed simultaneously (e.g., retractor holding and dilation).

[0102] The robotic arm 105A can also be used to help stabilize the surgeon's hand when making a femoral neck incision. In this application, certain limitations can be imposed on the control of the robotic arm 105A to prevent soft tissue injury. For example, in one embodiment, the surgical computer 150 tracks the position of the robotic arm 105A as it operates. If the tracked position approaches an area where tissue damage is predicted, a command can be sent to the robotic arm 105A to stop it. Alternatively, in the case where the robotic arm 105A is automatically controlled by the surgical computer 150, the surgical computer can ensure that it does not provide any instructions to the robotic arm that would cause it to enter an area where soft tissue injury may occur. The surgical computer 150 can impose certain limitations on the surgeon to prevent the surgeon from digging too deep into the medial wall of the acetabulum or digging at an incorrect angle or orientation.

[0103] In some embodiments, the robotic arm 105A can be used to hold the cup impactor at a desired angle or orientation during cup impact. Once the final position has been reached, the robotic arm 105A can prevent any further positioning to avoid damage to the pelvis.

[0104] The surgeon can use the robotic arm 105A to position the retractor handle in the desired location, allowing the surgeon to impact the retractor into the femoral canal in the desired orientation. In some embodiments, once the surgical computer 150 receives feedback that the retractor is fully in place, the robotic arm 105A can restrict the handle to prevent further advance of the retractor.

[0105] The robotic arm 105A can also be used in surface resurfacing applications. For example, the robotic arm 105A can stabilize the surgeon while using conventional instruments and provide certain constraints or limitations to allow for the proper placement of implanted components (e.g., guidewire placement, chamfering cutter, sleeve cutter, planar cutter, etc.). When using only a scalpel, the robotic arm 105A can stabilize the surgeon's handpiece and impose limitations on it to prevent the surgeon from deviating from the surgical plan and removing unwanted bone.

[0106] Robotic arm 105A may be a passive arm. As an example, robotic arm 105A may be a CIRQ robotic arm available from Brainlab AG. CIRQ is a registered trademark of Brainlab AG, Olof-Palme-Str. 9 81829, Munich, Germany. In a particular embodiment, robotic arm 105A is an intelligent gripping arm, as disclosed in U.S. Patent Application No. 15 / 525,585 to Krinninger et al., U.S. Patent Application No. 15 / 561,042 to Nowatschin et al., U.S. Patent No. 15 / 561,048 to Nowatschin et al., and U.S. Patent No. 10,342,636 to Nowatschin et al., the entire contents of which are incorporated herein by reference.

[0107] Generation and collection of surgical procedure data

[0108] The various services provided by healthcare professionals to treat a clinical condition are collectively referred to as the "care period." For a specific surgical procedure, the care period may include three phases: preoperative, intraoperative, and postoperative. During each phase, data is collected or generated that can be used to analyze the care period in order to understand the various characteristics of the procedure and identify patterns that can be used, for example, to make decisions with minimal human intervention in a training model. The data collected during the care period may be stored as a complete dataset at the surgical computer 150 or the surgical data server 180. Thus, for each care period, there exists a dataset that includes all data collected collectively about the patient preoperatively, all data collected or stored intraoperatively by CASS 100, and any postoperative data provided by the patient or by the healthcare professionals monitoring the patient.

[0109] As explained in further detail, data collected during the care period can be used to enhance the execution of surgical procedures or provide a holistic understanding of surgical procedures and patient outcomes. For example, in some embodiments, data collected during the care period can be used to generate surgical plans. In one embodiment, advanced preoperative planning is refined intraoperatively while data is collected during surgery. In this way, the surgical plan can be viewed as dynamically changing in real-time or near real-time as new data is collected through components of CASS 100. In other embodiments, preoperative images or other input data can be used to develop a robust plan that is easy to execute during surgery. In this case, data collected by CASS 100 during surgery can be used to make recommendations to ensure the surgeon stays within the preoperative surgical plan. For example, if the surgeon is unsure how to achieve certain prescribed cuts or implant alignments, they can consult the surgical computer 150 for recommendations. In still other embodiments, preoperative and intraoperative planning schemes can be combined so that the refined preoperative plan can be dynamically modified as needed or desired during the surgical procedure. In some embodiments, biomechanical models of the patient's anatomy contribute simulation data to be considered by CASS 100 in developing preoperative, intraoperative, and postoperative / rehabilitation procedures to optimize the patient's implant performance outcomes.

[0110] Besides altering the surgical procedure itself, data collected during the care period can also be used as input for other surgical aids. For example, in some embodiments, care period data can be used to design implants. Example data-driven techniques for designing, sizing, and fitting implants are described in U.S. Patent Application No. 13 / 814,531, filed August 15, 2011, entitled "Systems and Methods for Optimizing Parameters for Orthopaedic Procedures"; U.S. Patent Application No. 14 / 232,958, filed July 20, 2012, entitled "Systems and Methods for Optimizing Fit of an Implant to Anatomy"; and U.S. Patent Application No. 12 / 234,444, filed September 19, 2008, entitled "Operatively Tuning Implants for Increased Performance". The entire contents of each of these patent applications are incorporated herein by reference.

[0111] Furthermore, the data can be used for educational, training, or research purposes. For example, using the following... Figure 5C The web-based approach described herein allows other doctors or students to remotely view surgeries through an interface that allows them to selectively view data collected from the various components of the CASS 100. After the surgical procedure, a similar interface can be used to “replay” the surgery for training or other educational purposes, or to identify the root cause of any problems or complications that occurred during the procedure.

[0112] Data acquired during the preoperative phase typically includes all information collected or generated prior to surgery. Thus, information about the patient may be obtained, for example, from a patient entry form or electronic medical record (EMR). Examples of patient information that may be collected include, but are not limited to, patient demographics, diagnosis, medical history, medical records, vital signs, medical history information, allergies, and laboratory test results. Preoperative data may also include images relating to the anatomical region of interest. These images may be acquired, for example, using magnetic resonance imaging (MRI), computed tomography (CT), X-ray, ultrasound, or any other means known in the art. Preoperative data may also include quality-of-life data obtained from the patient. For example, in one embodiment, the preoperative patient uses 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, anthropometry, culture, or other specific characteristics of the patient that may be correlated with activity levels and specific patient activities to tailor surgical plans for the patient. For example, people of certain cultures or demographics may prefer to use a squat toilet daily.

[0113] Figure 5A and 5B Examples of data that can be obtained during the intraoperative phase of the nursing period are provided. These examples are based on the above references. Figure 1 The various components of the CASS 100 are described; however, it should be understood that other types of data may be used based on the type of equipment used during the operation and its usage.

[0114] Figure 5A Examples of some control instructions provided by the surgical computer 150 to other components of the CASS 100 according to some embodiments are shown. Note that... Figure 5A The example assumes that all components of the actuator platform 105 are directly controlled by the surgical computer 150. In embodiments where components are manually controlled by the surgeon 111, instructions can be provided on the display 125 or AR HMD 155 to instruct the surgeon 111 on how to move the components.

[0115] Various components included in the actuator platform 105 are controlled by a surgical computer 150, which provides position commands indicating the location of the component within a coordinate system. In some embodiments, the surgical computer 150 provides commands to the actuator platform 105 defining how to react when a component of the actuator platform 105 deviates from the surgical plan. These commands are in... Figure 5A The term "tactile" is used as a reference. For example, the end effector 105B can provide force to resist movement outside the planned area to be removed. Other commands that the actuator platform 105 can use include vibration and audio cues.

[0116] In some embodiments, the end effector 105B of the robotic arm 105A is operatively coupled to the cutting guide 105D. In response to an anatomical model of the surgical scenario, the robotic arm 105A can move the end effector 105B and the cutting guide 105D to the appropriate position to match the location of the femoral or tibial cut to be performed according to the surgical plan. This reduces the possibility of errors, allowing the vision system and the processor utilizing that vision system to implement the surgical plan, positioning the cutting guide 105D in a precise location and orientation relative to the tibia or femur to align the cutting groove of the cutting guide with the cut to be performed according to the surgical plan. The surgeon can then use any suitable tool, such as a vibratory or rotary saw or drill, to perform the cut (or drill) with perfect placement and orientation, as the tool is mechanically limited by the characteristics of the cutting guide 105D. In some embodiments, the cutting guide 105D may include one or more pin holes used by the surgeon to drill and tighten or pin the cutting guide into the appropriate position before performing the resection of patient tissue using the cutting guide. This allows the robotic arm 105A to be released or ensures that the cutting guide 105D is fully fixed without moving relative to the bone to be removed. For example, this procedure can be used to create a first distal incision in the femur during total knee arthroplasty. In some embodiments, where the joint replacement is a hip replacement, the cutting guide 105D can be fixed to the femoral head or acetabulum for the corresponding hip replacement resection. It should be understood that any joint replacement utilizing a precise incision can employ the robotic arm 105A and / or the cutting guide 105D in this manner.

[0117] The resection device 110 provides a variety of commands to perform bone or tissue manipulations. Similar to the actuator platform 105, position information can be provided to the resection device 110 to specify where it should be positioned during resection. Other commands provided to the resection device 110 may vary depending on the type of resection device. For example, for mechanical or ultrasonic resection tools, commands may specify the tool's speed and frequency. For radiofrequency ablation (RFA) and other laser ablation tools, these commands may specify intensity and pulse duration.

[0118] Some components of the CASS 100 do not require direct control by the surgical computer 150; instead, the surgical computer 150 only needs to activate the components, which then execute software locally to specify how data is collected and provided to the surgical computer 150. Figure 5A In the example, two components operate in this manner: the tracking system 115 and the organization navigation system 120.

[0119] The surgical computer 150 provides the display 125 with any visualizations required by the surgeon 111 during surgery. For the monitor, the surgical computer 150 can use techniques known in the art to provide instructions for displaying images, a GUI, etc. The display 125 can include various parts of the surgical planning workflow. For example, during the registration process, the display 125 can display a preoperatively constructed 3D bone model and show the location of probes as the surgeon uses probes to collect anatomical landmarks on the patient. The display 125 can include information about the target surgical area. For example, in conjunction with TKA, the display 125 can show the mechanical and anatomical axes of the femur and tibia. The display 125 can show the varus and valgus angles of the knee joint based on the surgical plan, and the CASS 100 can show how such angles would be affected if anticipated modifications to the surgical plan were made. Therefore, the display 125 is an interactive interface that can dynamically update and display how changes to the surgical plan will affect the procedure and the final position and orientation of the implant mounted on the bone.

[0120] As the workflow progresses to preparation for bone cutting or resection, the display 125 can show the planned or recommended bone cut before any cut is performed. The surgeon 111 can manipulate the image display to provide different anatomical views of the target area and may have the option to change or modify the planned bone cut based on the patient's intraoperative assessment. The display 125 can show how the selected implant will be placed on the bone if the planned bone cut is performed. If the surgeon 111 chooses to change the previously planned bone cut, the display 125 can show how the modified bone cut will change the position and orientation of the implant when placed on the bone.

[0121] The display 125 can provide the surgeon 111 with various data and information about the patient, the planned surgical procedure, and the implant. Various patient-specific information can be displayed, including real-time data on the patient's health, such as heart rate, blood pressure, etc. The display 125 can also include information about the anatomy of the surgical target area (including the location of landmarks), the current state of the anatomy (e.g., whether any resections have been performed, the depth and angle of the planned and performed bone cuts), and the future state of the anatomy as the surgical plan progresses. The display 125 can also provide or show additional information about the surgical target area. For TKA, the display 125 can provide information about the gap between the femur and tibia (e.g., gap balance) and how such a gap will change if the planned surgical procedure is performed. For TKA, the display 125 can provide additional relevant information about the knee joint, such as data on joint tension (e.g., ligament laxity) and information about joint rotation and alignment. The display 125 can show how the planned implant placement and location will affect the patient when the knee is flexed. The display 125 can show how the use of different implants or the use of the same implant of different sizes will affect the surgical plan and preview how such implants will be positioned on the bone. The CASS 100 can provide such information for each planned osteotomy in either a TKA or THA. In a TKA, the CASS 100 can provide robotic control for one or more planned osteotomies. For example, the CASS 100 can only provide robotic control for the initial distal femoral resection, and the surgeon 111 can manually perform other resections (anterior, posterior, and chamfered cuts) using conventional means such as a 4-in-1 cutting guide or clamp 105D.

[0122] The display 125 can use different colors to inform the surgeon of the status of the surgical plan. For example, unremoved bone can be displayed in a first color, removed bone in a second color, and planned removal in a third color. Implants can be superimposed on the bone in the display 125, and the implant color can be changed or correspond to different types or sizes of implants.

[0123] The information and options displayed on monitor 125 can vary depending on the type of surgical procedure being performed. Furthermore, surgeon 111 can request or select a specific surgical workflow display that matches or is consistent with his or her surgical planning preferences. For example, for surgeon 111 who typically performs a tibialis resection before a femoral resection in TKA, monitor 125 and the associated workflow can be adapted to take that preference into account. Surgeon 111 can also pre-select to include or remove certain steps from the standard surgical workflow display. For example, if surgeon 111 uses resection measurements to finalize the implantation plan but does not analyze ligament-space balance when finalizing the implantation plan, the surgical workflow display can be organized into modules, and the surgeon can select which modules to display and the order in which the modules are presented based on the surgeon's preferences or the specific surgical circumstances. For example, modules involving ligament and space balance can include pre- and post-resection ligament / space balance, and surgeon 111 can select which modules to include in their default surgical planning workflow depending on whether such ligament and space balance is performed before or after (or before and after) the osteotomy.

[0124] For more specialized display devices, such as AR HMDs, the surgical computer 150 can use data formats supported by the device to provide images, text, etc. For example, if the display 125 is a holographic device such as a Microsoft HoloLens™ or Magic LeapOne™, the surgical computer 150 can use the HoloLens application programming interface (API) to send commands specifying the location and content of the hologram displayed in the surgeon 111's field of vision.

[0125] In some embodiments, one or more surgical planning models may be incorporated into CASS 100 and used in the development of surgical plans provided to surgeon 111. The term "surgical planning model" refers to software that simulates the biomechanical properties of anatomical structures under various conditions to determine the optimal manner for performing incisions 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 incision locations on the knee to optimize implant placement. An example of a surgical planning model is the LIFEMOD™ simulation software from Smith and Nephew. In some embodiments, surgical computer 150 includes a computational architecture (e.g., a GPU-based parallel processing environment) that allows the surgical planning model to be fully executed during surgery. In other embodiments, surgical computer 150 may be network-connected to a remote computer that allows such execution, such as surgical data server 180 (see [link to surgical planning model]). Figure 5CAs an alternative to a full execution of the surgical planning model, in some embodiments, a set of transfer functions is derived that simplifies the mathematical operations acquired by the model into one or more predictive equations. These predictive equations are then used instead of performing a full simulation during surgery. Further details regarding the use of transfer functions are described in WIPO Publication No. 2020 / 037308, filed August 19, 2019, entitled “Patient Specific Surgical Method and System,” the entire contents of which are incorporated herein by reference.

[0126] Figure 5B Examples of some types of data that can be provided from the various components of CASS 100 to the surgical computer 150 are shown. In some embodiments, components may stream data to the surgical computer 150 in real time or near real time during surgery. In other embodiments, components may queue data and send it to the surgical computer 150 at set intervals (e.g., per second). Data can be transmitted using any format known in the art. Thus, in some embodiments, all components transmit data to the surgical computer 150 in a common format. In other embodiments, each component may use a different data format, and the surgical computer 150 may be configured with one or more software applications capable of converting data.

[0127] Typically, the surgical computer 150 can be used as a central point for collecting CASS data. The exact content of the data will depend on the source. For example, each component of the actuator platform 105 provides a measurement location to the surgical computer 150. Therefore, by comparing the measurement locations with the locations initially specified by the surgical computer 150 (see...), the data is collected and analyzed. Figure 5B By comparing these parameters, the surgical computer can identify deviations that occur during the procedure.

[0128] The resection device 110 can send various types of data to the surgical computer 150 depending on the type of device used. Exemplary data types that can be sent include measured torque, audio signatures, and measured displacement values. Similarly, the tracking technology 115 can provide different types of data depending on the tracking method employed. Exemplary tracking data types include tracked items (e.g., anatomical structures, tools, etc.), ultrasound images, and position values ​​of surface or marker collection points or axes. When the system is operating, the tissue navigation system 120 provides the surgical computer 150 with anatomical locations, shapes, etc.

[0129] While the display 125 is typically used to output data for presentation to a user, it can also provide data to the surgical computer 150. For example, in an embodiment where a monitor is used as part of the display 125, the surgeon 111 can interact with a GUI to provide input, which is then sent to the surgical computer 150 for further processing. For AR applications, the measured position and displacement of the HMD can be sent to the surgical computer 150, allowing it to update the presented view as needed.

[0130] During the postoperative phase of the care period, various types of data can be collected to quantify the overall improvement or deterioration of the patient's condition as a result of the surgery. Data can take the form of, for example, self-reported information from patients through questionnaires. For instance, in the case of knee replacement surgery, the Oxford Knee Score can be used to measure functional status, and the EQ5D-5L questionnaire can be used to measure postoperative quality of life. Other examples in the case of hip replacement surgery may include the Oxford Hip Score, the Harris Hip Score, and the WOMAC (Western University and McMaster University Osteoarthritis Index). Such questionnaires can be administered, for example, by healthcare professionals directly in a clinical setting, or using mobile applications that allow patients to answer questions directly. In some embodiments, patients may be equipped with one or more wearable devices to collect data related to the surgery. For example, after knee surgery, patients may be equipped with a knee brace that includes sensors for monitoring knee position, flexibility, etc. This information can be collected and transmitted to the patient's mobile device for the surgeon to review in order to assess the surgical outcome and address any issues. In some embodiments, one or more cameras may acquire and record the movement of the patient's body parts during designated postoperative activities. This motion can be compared with biomechanical models to better understand the function of the patient's joints, and to better predict rehabilitation progress and identify any necessary corrections.

[0131] The postoperative phase of the care period can continue throughout the patient's lifespan. For example, in some embodiments, the surgical computer 150 or other components including CASS 100 can continue to receive and collect data related to the surgical procedure after it has been performed. This data may include, for example, images, question answers, “normal” patient data (e.g., blood type, blood pressure, condition, medications, etc.), biometric data (e.g., gait, etc.), and objective and subjective data on specific issues (e.g., knee or hip pain). This data may be explicitly provided to the surgical computer 150 or other CASS components by the patient or the patient's physician. Alternatively or additionally, the surgical computer 150 or other CASS components may monitor the patient's EMR and retrieve relevant information when available. This longitudinal view of patient recovery allows the surgical computer 150 or other CASS components to provide a more objective analysis of patient outcomes to measure and track the success or failure of a given procedure. For example, regression analysis of various data items collected during the care period can link the patient's condition long after the surgical procedure to the surgery. This analysis can be further enhanced by analyzing patient groups with similar procedures and / or similar anatomy.

[0132] In some embodiments, data is collected at a central location to provide easier analysis and use. In some cases, data can be collected manually from various CASS components. For example, a portable storage device (e.g., a USB stick) can be attached to the surgical computer 150 to retrieve data collected during surgery. The data can then be transferred, for example, via a desktop computer to a centralized storage device. Alternatively, in some embodiments, the surgical computer 150 is directly connected to a centralized storage device via a network 175, such as... Figure 5C As shown in the image.

[0133] Figure 5C A cloud-based implementation is illustrated, in which surgical computer 150 is connected to surgical data server 180 via network 175. This network 175 can be, for example, a private intranet or the Internet. In addition to data from surgical computer 150, relevant data can also be transferred to surgical data server 180 from other sources. Figure 5CThe example illustrates three additional data sources: patient 160, healthcare professionals 165, and an EMR database 170. Therefore, patient 160 can, for example, use a mobile application to send pre- and post-operative data to surgical data server 180. Healthcare professionals 165 include the surgeon and his or her staff, as well as any other professionals working with patient 160 (e.g., private physicians, rehabilitation specialists, etc.). It should also be noted that the EMR database 170 can be used for pre- and post-operative data. For example, assuming patient 160 has given sufficient permission, surgical data server 180 can collect the patient's pre-operative EMR. Surgical data server 180 can then continue to monitor the EMR for any post-operative updates.

[0134] At surgical data server 180, a nursing period database 185 is used to store various data collected during a patient's nursing period. The nursing period database 185 can be implemented using any technology known in the art. For example, in some embodiments, an SQL-based database can be used, where all various data items are structured in a way that allows them to be easily incorporated into two sets of SQL rows and columns. However, in other embodiments, a No-SQL database can be employed to allow unstructured data while providing the ability to process and respond to queries quickly. As understood in the art, the term "No-SQL" is used to define a class of databases that are not related in their design. Various types of No-SQL databases can generally be grouped according to their underlying data model. These groupings can include databases using column-based data models (e.g., Cassandra), document-based data models (e.g., MongoDB), key-value-based data models (e.g., Redis), and / or graph-based data models (e.g., Allego). The various embodiments described herein can be implemented using any type of No-SQL database, and in some embodiments, different types of databases can support the nursing period database 185.

[0135] Data can be transferred between various data sources and surgical data server 180 using any data format and transmission technology known in the art. It should be noted that... Figure 5C The architecture shown allows for the transfer of data from a data source to the surgical data server 180, as well as the retrieval of data from the surgical data server 180 by the data source. For example, as explained in detail below, in some embodiments, the surgical computer 150 can use data from past surgeries, machine learning models, etc., to help guide the surgical procedure.

[0136] In some embodiments, the surgical computer 150 or surgical data server 180 may perform a deidentification process to ensure that data stored in the care period database 185 meets Health Insurance Portability and Accountability Act (HIPAA) standards or other legal requirements. HIPAA provides a list of certain identifiers that must be removed from the data during the deidentification process. The aforementioned deidentification process may scan for these identifiers in the data transferred to the care period database 185 for storage. For example, in one embodiment, the surgical computer 150 performs the deidentification process before initially transferring a specific data item or set of data items to the surgical data server 180. In some embodiments, unique identifiers are assigned to data from a specific care period for reidentification if necessary.

[0137] although Figure 5A –5C discusses data collection in the context of a single care period; however, it should be understood that the general concept can be extended to data collection across multiple care periods. For example, surgical data can be collected throughout the care period each time a surgery is performed using the CASS 100 and stored at the surgical computer 150 or surgical data server 180. As explained in further detail below, a robust database of care period data allows for the generation of optimized values, measurements, distances or other parameters, and other recommendations related to the surgical procedure. In some embodiments, various datasets are indexed in a database or other storage medium in a manner that allows for rapid retrieval of relevant information during the surgical procedure. For example, in one embodiment, a patient-centric set of indexes can be used so that data can be easily extracted from a specific patient or a group of patients similar to a specific patient. This concept can be similarly applied to surgeons, implant characteristics, CASS component types, etc.

[0138] Further details regarding the management of care period data are described in International Patent Application No. PCT / US19 / 67845, filed on December 20, 2019, entitled “METHODS AND SYSTEMS FOR PROVIDING AN EPISODE OF CARE,” the entire contents of which are incorporated herein by reference.

[0139] Open and Closed Digital Ecosystems

[0140] In some embodiments, the CASS 100 is designed to function as a standalone or “closed” digital ecosystem. Each component of the CASS 100 is specifically designed for use within a closed ecosystem, and devices outside the digital ecosystem typically cannot access the data. For example, in some embodiments, each component includes software or firmware implementing proprietary protocols for activities such as communication, storage, and security. The concept of a closed digital ecosystem may be ideal for companies that want to control all components of the CASS 100 to ensure compliance with certain compatibility, security, and reliability standards. For example, the CASS 100 may be designed such that new components cannot be used with the CASS without the company’s certification.

[0141] In other embodiments, CASS 100 is designed as an “open” digital ecosystem. In these embodiments, components can be manufactured by various different companies according to standards for activities such as communication, storage, and security. Therefore, by using these standards, any company is free to build independent, compliant components of the CASS platform. Data can be transferred between components using publicly available application programming interfaces (APIs) and open, shareable data formats.

[0142] To illustrate one type of recommendation that can be performed using CASS 100, a technique for optimizing surgical parameters is disclosed below. In this document, the term "optimization" refers to selecting the optimal parameters based on certain specified criteria. In extreme cases, optimization can refer to selecting the optimal parameters based on data from the entire period of care, including any preoperative data, the state of CASS data at a given time point, and postoperative goals. Furthermore, historical data can be used to perform optimization, such as data generated during past surgeries involving, for example, the same surgeon, past patients with similar physical characteristics to the current patient, etc.

[0143] Optimized parameters can be dependent on specific parts of the patient's anatomy to be operated on. For example, for knee surgery, surgical parameters may include positioning information for the femoral and tibial components, including but not limited to rotational alignment (e.g., varus / valgus rotation, external rotation, flexion rotation of the femoral component, posterior tilt angle of the tibial component), resection depth (e.g., varus knee, valgus knee), and the type, size, and location of the implant. Positioning information may also include surgical parameters for combining implants, such as overall limb alignment, combined tibiofemoral hyperextension, and combined tibiofemoral resection. Other examples of parameters that CASS 100 can optimize for a given TKA femoral implant include the following:

[0144]

[0145] Other examples of parameters that CASS 100 can optimize for a given TKA tibial implant include the following:

[0146] parameter refer to Exemplary suggestions size rear Implants that do not protrude beyond the maximum size of the medial, lateral, anterior, and posterior tibial margins Implant location Medial / lateral and anterior / posterior cortical bone margins The implant should be evenly centered between the medial / lateral and anterior / posterior cortical bone edges. Resection depth – varus knee outer / inner side 4mm bone Resection depth – valgus knee outer / inner side 5mm bone Rotation - Inversion / Outversion mechanical axis 1° eversion Rotation - External Tibial anterior-posterior axis 1° outside the anterior-posterior axis of the tibia Lean angle mechanical axis 3° lean angle

[0147] For hip surgery, surgical parameters may include femoral neck resection location and angle, cup tilt angle, cup anteversion angle, cup depth, femoral stem design, femoral stem size, femoral stem fit within the canal, femoral offset, leg length, and femoral type of implant.

[0148] Shoulder parameters may include, but are not limited to, humeral resection depth / angle, humeral shaft type, humeral deviation, glenoid type and tilt, as well as reverse shoulder parameters, such as humeral resection depth / angle, humeral shaft type, glenoid tilt / type, glenoid ball orientation, glenoid ball deviation and deviation direction.

[0149] Various routine techniques exist for optimizing surgical parameters. However, these techniques typically require extensive computation, thus necessitating preoperative parameter determination. Consequently, surgeons' ability to modify optimized parameters based on potential problems during surgery is limited. Moreover, routine optimization techniques often operate in a "black box" manner, with little or no explanation of the recommended parameter values. Therefore, if a surgeon decides to deviate from the recommended parameter values, they often do so without fully understanding the impact of that deviation on the remainder of the surgical procedure or on the patient's postoperative quality of life.

[0150] Surgical patient care system

[0151] Using the surgical patient care system 620, the general concept of optimization can be extended to the entire period of care. This system uses surgical data, along with other data from the patient 605 and healthcare professionals 630, to optimize outcomes and patient satisfaction, such as... Figure 6 As shown in the image.

[0152] Conventionally, preoperative diagnosis, preoperative surgical planning, intraoperative execution of the established plan, and postoperative management of total joint replacement surgery are all based on individual experience, published literature, and the surgeon's training knowledge base (ultimately, the tribal knowledge of individual surgeons and their peer "networks" and journal publications), as well as their instinct for accurate intraoperative tactile discrimination of "balance" using guidance and visual cues, and accurate manual execution of plane resections. This existing knowledge base and mode of execution are limited in their ability to optimize outcomes for patients requiring care. For example, limitations exist in: accurately diagnosing patients for appropriate, minimally invasive established care; aligning dynamic patient, medical economic, and surgeon preferences with the patient's desired outcome; executing the surgical plan to ensure proper bone alignment and balance, etc.; and receiving data from disconnected sources with varying deviations that are difficult to reconcile into the overall patient framework. Therefore, data-driven tools that more accurately simulate anatomical responses and guide surgical planning can improve existing methods.

[0153] The Surgical Patient Care System 620 is designed to utilize patient-specific data, surgeon data, facility data, and historical outcome data to develop algorithms that suggest or recommend optimal overall treatment plans for patients throughout their entire care period (preoperative, intraoperative, and postoperative) based on desired clinical outcomes. For example, in one embodiment, the Surgical Patient Care System 620 tracks adherence to the suggested or recommended plan and adjusts the plan based on patient / care provider performance. Once the surgical treatment plan is finalized, the Surgical Patient Care System 620 records the collected data in a historical database. This database is accessible for future patients and for developing future treatment plans. In addition to utilizing statistical and mathematical models, simulation tools (such as LIFEMOD®) can be used to model outcomes, alignment, kinematics, etc., based on the initial or suggested surgical plan, and to reconfigure the initial or suggested plan to achieve the desired or optimal outcome according to the patient profile or surgeon's preferences. The Surgical Patient Care System 620 ensures that each patient is receiving personalized surgical and rehabilitation care, thereby increasing the chances of successful clinical outcomes and reducing the financial burden on facilities associated with recent modifications.

[0154] In some embodiments, the surgical patient care system 620 employs a data collection and management approach to provide a detailed surgical case plan, which has different steps monitored and / or performed using CASS 100. User execution is calculated upon completion of each step and used to suggest changes to subsequent steps in the case plan. The generation of the case plan relies on a series of input data stored in a local or cloud storage database. The input data may be related to the patient currently receiving treatment or to historical data from patients who have received similar treatment.

[0155] Patient 605 provides inputs such as current patient data 610 and historical patient data 615 to surgical patient care system 620. Various methods generally known in the art can be used to collect such inputs from patient 605. For example, in some embodiments, patient 605 completes a paper or digital survey parsed by surgical patient care system 620 to extract patient data. In other embodiments, surgical patient care system 620 may extract patient data from existing information sources such as electronic medical records (EMRs), health history files, and payer / provider history files. In still other embodiments, surgical patient care system 620 may provide an application programming interface (API) that allows external data sources to push data to the surgical patient care system. For example, patient 605 may have a mobile phone, wearable device, or other mobile device that collects data (e.g., heart rate, pain or discomfort level, exercise or activity level, or patient-submitted responses to any number of preoperative planning criteria or conditional compliance) and provides that data to surgical patient care system 620. Similarly, patient 605 may have a digital application on their mobile or wearable device that can collect data and transmit it to surgical patient care system 620.

[0156] Current patient data 610 may include, but is not limited to: activity level, past medical history, comorbidities, pre-rehabilitation performance, health and fitness level, preoperative expected level (related to hospital, surgery, and rehabilitation), Metropolitan Statistical Area (MSA) driven score, genetic background, previous injuries (sports, trauma, etc.), previous joint replacement surgery, previous trauma surgery, previous sports medicine surgery, treatment of contralateral joints or limbs, gait or biomechanical information (back and ankle tissues), level of pain or discomfort, nursing infrastructure information (payer coverage type, level of home medical infrastructure, etc.), and indications of the expected ideal surgical outcome.

[0157] Historical patient data 615 may include, but is not limited to: activity level, past medical history, comorbidities, pre-rehabilitation performance, health and fitness level, preoperative expected level (related to hospital, surgery, and rehabilitation), MSA-driven score, genetic background, previous injuries (sports, trauma, etc.), previous joint replacement surgery, previous trauma surgery, previous sports medicine surgery, treatment of contralateral joints or limbs, gait or biomechanical information (back and ankle tissues), pain or discomfort level, nursing infrastructure information (payer coverage type, level of home medical infrastructure, etc.), expected desired surgical outcome, actual surgical outcome (patient-reported outcome [PRO], implant survival, pain level, activity level, etc.), size of the implant used, position / orientation / alignment of the implant used, and soft tissue balance achieved, etc.

[0158] The healthcare professional 630 performing the surgery or treatment can provide various types of data 625 to the surgical patient care system 620. This healthcare professional data 625 may include, for example, descriptions of known or preferred surgical techniques (e.g., cruciate retention (CR) vs. posterior stabilization (PS), size increase vs. size decrease, with and without a tourniquet, femoral stem style, preferred THA options, etc.), the healthcare professional 630's training level (e.g., years of experience, position trained, place of training, techniques imitated), previous success levels including historical data (outcomes, patient satisfaction), and expected desired outcomes regarding range of motion, recovery days, and device survival. The healthcare professional data 625 can be obtained, for example, through paper or digital surveys provided to the healthcare professional 630, via input from the healthcare professional into a mobile application, or by extracting relevant data from the EMR. Additionally, the CASS 100 can provide data such as profile data (e.g., patient-specific knee device profile) or a historical record describing the use of the CASS during surgery.

[0159] Information related to the facility where the surgery or treatment will be performed can be included in the input data. This data may include, but is not limited to, the following: outpatient surgery center (ASC) versus hospital, facility trauma level, Joint Replacement Comprehensive Care Plan (CJR) or bundled candidate, MSA-driven score, community versus city, academic versus non-academic, postoperative network access (specialty care facilities only [SNF], home health, etc.), availability of medical professionals, implant availability, and availability of surgical hardware.

[0160] These facility inputs can be, for example, but not limited to, surveys (paper / digital), surgical planning tools (e.g., apps, websites, electronic medical records [EMR], etc.), hospital information databases (on the Internet), etc. Input data related to the associated healthcare economics can also be obtained, including but not limited to the patient's socioeconomic profile, the level of reimbursement the patient will receive, and whether the treatment is patient-specific.

[0161] These healthcare economic inputs can be obtained (e.g., but not limited to) through surveys (paper / digital), direct payer information, socioeconomic databases (providing postal codes online), etc. Finally, data derived from the simulation of the program is obtained. Simulation inputs include implant size, location, and orientation. Simulations can be performed using custom or commercially available anatomical modeling software programs such as LIFEMOD®, AnyBody, or OpenSIM. It should be noted that the above data inputs may not be available for every patient, and the available data will be used to generate a treatment plan.

[0162] Prior to surgery, patient data 610, 615 and healthcare professional data 625 can be acquired and stored in a cloud-based database or online database (e.g., Figure 5C The surgical data server 180 shown is used. Information related to the procedure is provided to the computing system via wireless data transmission or manually using portable media storage. The computing system is configured to generate case plans for the CASS 100. The generation of case plans will be described below. It should be noted that the system can access historical data of previously treated patients, including implant size, location, and orientation automatically generated by a computer-assisted patient-specific knee device (PSKI) selection system or by the CASS 100 itself. For this purpose, a surgical sales representative or case engineer uploads case log data to the historical database using an online portal. In some embodiments, data transmission to the online database is wireless and automated.

[0163] Historical datasets from online databases are used as input to machine learning models, such as recurrent neural networks (RNNs) or other forms of artificial neural networks. As is generally understood in the art, artificial neural networks function similarly to biological neural networks and consist of a series of nodes and connections. The machine learning model is trained to predict one or more values ​​based on the input data. For the following sections, it is assumed that the machine learning model is trained to generate predictive equations. These predictive equations can be optimized to determine the optimal size, location, and orientation of the implant for best results or satisfaction.

[0164] Once the procedure is complete, all patient data and available outcome data, including implant size, location, and orientation determined by CASS 100, are collected and stored in a historical database. Any subsequent calculations of the objective equation via RNN will, in this manner, incorporate data from previous patients, allowing for continuous improvement of the system.

[0165] In addition to or as an alternative to determining implant location, in some embodiments, the predictive equations and associated optimizations can be used to generate a resection plane for use with a PSKI system. When used with a PSKI system, the computation and optimization of the predictive equations are performed preoperatively. The patient's anatomy is estimated using medical imaging data (X-ray, CT, MRI). Global optimization of the predictive equations can provide the ideal size and location of the implant component. The Boolean intersection of the implant component and the patient's anatomy is defined as the resection volume. A PSKI can be generated to remove the optimized resection envelope. In this embodiment, the surgeon cannot change the surgical plan intraoperatively.

[0166] Surgeons can choose to change the surgical case plan at any time before or during surgery. If a surgeon chooses to deviate from the surgical case plan, the size, position, and / or orientation of the changed components are locked, and global optimization (using previously described techniques) is refreshed based on the new size, position, and / or orientation of the components to find new ideal positions for other components, as well as the corresponding resections required to achieve the new optimized size, position, and / or orientation of the components. For example, if the surgeon determines that the size, position, and / or orientation of the femoral implant in a TKA needs to be updated or modified intraoperatively, the position of the femoral implant will be locked relative to the anatomy, and a new optimal position for the tibia will be calculated (through global optimization) by taking into account the surgeon's changes to the size, position, and / or orientation of the femoral implant. Furthermore, if the surgical system used to implement the case plan is robot-assisted (e.g., using NAVIO® or MAKO Rio), bone removal and bone morphology can be monitored in real time during surgery. If resections performed during the procedure deviate from the surgical plan, the processor can take into account the actual resections performed to optimize the subsequent placement of additional components.

[0167] Figure 7AThis illustrates how a surgical patient care system 620 can be adapted to perform a case plan matching service. In this example, data related to the current patient 610 is acquired and compared, in whole or in part, with a historical database of patient data and related outcomes 615. For example, the surgeon may choose to compare the current patient's plan with a subset of the historical database. The data in the historical database can be filtered to include, for example, datasets with only good outcomes, datasets corresponding to historical surgeries of patients with profiles identical or similar to the current patient's profile, datasets corresponding to specific surgeons, datasets corresponding to specific elements of the surgical plan (e.g., surgery that preserves only specific ligaments), or any other criteria chosen by the surgeon or medical professional. For example, if the current patient data matches or correlates with data from a previous patient who experienced a good outcome, the previous patient's case plan can be accessed and adapted or adopted for the current patient. Predictive equations can be used in conjunction with intraoperative algorithms that identify or determine actions associated with the case plan. Based on relevant information from the historical database and / or pre-selected information, the intraoperative algorithm determines a set of recommended actions for the surgeon to perform. Each execution of the algorithm generates the next action in the case plan. If the surgeon performs the action, the outcome is evaluated. The results of the surgeon's actions are used to refine and update the inputs to the intraoperative algorithm, which generates the next step in the case plan. Once the case plan has been fully executed, all data related to it, including any deviations by the surgeon from the recommended actions, 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 the entire continuous care. In other words, caregivers can specify any arrangement or combination of treatment modules, including the use of a single module. These concepts are... Figure 7B As shown in the diagram, it can be applied to any type of surgery using CASS 100.

[0168] Surgical procedure showed

[0169] As mentioned above Figure 1 and Figures 5A-5CThe various components of the CASS 100 generate detailed data logs during surgery. The CASS 100 can track and record various actions and activities of the surgeon during each step of the surgery and compare the actual activities with the preoperative or intraoperative surgical plan. In some embodiments, software tools can be used to process this data into a format that allows for efficient “replay” of the surgery. For example, in one embodiment, one or more GUIs can be used, displaying all information presented on the display 125 during surgery. This can be supplemented with graphics and images showing data collected by different tools. For example, a GUI providing a visual illustration of the knee during tissue removal can provide measured torque and displacement of the resection equipment adjacent to the visual illustration to better provide an understanding of any deviations that occur from the planned resection area. The ability to review the replay of the surgical plan or switch between different stages of the actual surgery and the surgical plan can benefit surgeons and / or surgical personnel, allowing them to identify any deficiencies or challenging phases of the surgery that can be modified in future surgeries. Similarly, in an academic setting, the aforementioned GUI can be used as a teaching tool to train future surgeons and / or surgical personnel. In addition, because the dataset effectively records many elements of a surgeon's activities, it can also be used as evidence of whether a particular surgical procedure was performed correctly or incorrectly for other reasons, such as legal or compliance reasons.

[0170] Over time, as more surgical data is collected, a rich database may be acquired, describing surgical procedures performed by different surgeons on various types of anatomical structures (knee, shoulder, hip, etc.) for different patients. Furthermore, information such as implant type and size, patient demographics, etc., can be further used to augment the overall dataset. Once the dataset is established, it can be used to train machine learning models (e.g., RNNs) to predict how surgery will proceed based on the current state of CASS 100.

[0171] The training of the machine learning model can be performed as follows. During surgery, the overall state of the CASS 100 can be sampled over multiple time periods. The machine learning model can then be trained to transform the current state of the first time period into future states for different time periods. By analyzing the entire state of the CASS 100 rather than individual data items, any causal effects of interactions between the different components of the CASS 100 can be obtained. In some embodiments, multiple machine learning models can be used instead of a single model. In some embodiments, the machine learning model can be trained not only using the state of the CASS 100, but also using patient data (e.g., obtained from EMR) and the identity of the surgeon. This allows the model to make predictions with greater specificity. Moreover, if needed, it allows surgeons to make predictions selectively based solely on their own surgical experience.

[0172] In some embodiments, predictions or recommendations made by the aforementioned machine learning model can be directly integrated into the surgical procedure. For example, in some embodiments, the surgical computer 150 can execute a machine learning model in the background to make predictions or recommendations for upcoming actions or surgical conditions. Thus, multiple states can be predicted or recommended for each period. For example, the surgical computer 150 can predict or recommend states for the next 5 minutes in 30-second increments. Using this information, the surgeon can utilize a "process display" view of the surgery to allow visualization of future states. For example, Figure 7C A series of images illustrating the implant placement interface are shown and can be displayed to the surgeon. The surgeon can navigate these images, for example, by entering a specific time in the display 125 of the CASS 100 or instructing the system to advance or rewind the display in specific time increments using tactile, verbal, or other commands. In one embodiment, the process display may be presented at the top of the surgeon's field of vision in the AR HMD. In some embodiments, the process display can be updated in real time. For example, as the surgeon moves the resection tool around the planned resection area, the process display can be updated, allowing the surgeon to see how his or her movements affect other factors of the procedure.

[0173] In some embodiments, instead of simply using the current state of CASS 100 as input to the machine learning model, the model's input can include the planned future state. For example, a surgeon may instruct that he or she is planning to perform a specific bone resection of the knee joint. This instruction can be manually entered into the surgical computer 150, or the surgeon can provide the instruction verbally. The surgical computer 150 can then generate films showing the expected effects of the incision on the surgery. Such films can show, over specific time increments, how the surgery will be affected if the expected procedures are performed, including, for example, changes in patient anatomy, changes in implant position and orientation, and changes in surgical procedures and instruments. Surgeons or medical professionals can recall or request this type of film at any time during the surgery to preview how the expected procedures will affect the surgical plan if the expected procedures are performed.

[0174] It should be further noted that using a well-trained machine learning model and the CASS robot can automate various elements of the surgery, requiring minimal intervention from the surgeon, for example, by providing approval only for each step of the procedure. For instance, over time, robotic control using arms or other means can be gradually integrated into the surgical process, with less manual interaction between the surgeon and the robot's operation. In this case, the machine learning model can learn which robotic commands are needed to achieve certain states of the CASS implementation plan. Ultimately, the machine learning model can be used to generate films or similar views or displays that can predict and preview the entire surgery from its initial state. For example, an initial state including patient information, surgical plan, implant characteristics, and surgeon preferences can be defined. Based on this information, the surgeon can preview the entire surgery to confirm that the CASS-recommended plan meets the surgeon's expectations and / or requirements. Moreover, since the output of the machine learning model is the state of the CASS 100 itself, commands can be derived to control the components of the CASS to achieve each predicted state. Therefore, in extreme cases, the entire surgery can be automated based solely on initial state information.

[0175] High-resolution imaging of critical areas is obtained using a point probe during hip surgery.

[0176] The use of point probes is described in U.S. Patent Application No. 14 / 955,742, entitled "Systems and Methods for Planning and Performing Image-Free Implant Revision Surgery," the entire contents of which are incorporated herein by reference. In short, optically tracked point probes can be used to map the actual surface of the target bone where a new implant is needed. Mapping is performed after the removal of defective or worn implants, and after the removal of any diseased or otherwise unwanted bone. Multiple points can be collected on the bone surface by brushing or scraping the remaining bone with the tip of the point probe. This is called tracking or "mapping" the bone. The collected points are used to create a three-dimensional model or surface map of the bone surface in a computer planning system. The created 3D model of the remaining bone is then used as the basis for planning the surgery and determining the necessary implant dimensions. Alternative techniques for determining 3D models using X-rays are described in U.S. Patent Application No. 16 / 387,151, filed April 17, 2019, entitled "Three-Dimensional Selective Bone Matching," and U.S. Patent Application No. 16 / 789,930, filed February 13, 2020, entitled "Three-Dimensional Selective Bone Matching," the entire contents of each of which are incorporated herein by reference.

[0177] For hip applications, point probe mapping can be used to acquire high-resolution data of key areas such as the acetabular rim and acetabular fossa. This allows the surgeon to obtain a detailed view before initiating reaming. For example, in one embodiment, the point probe can be used to identify the floor (fossa) of the acetabulum. As is well known in the art, in hip surgery, it is important to ensure that the floor of the acetabulum is not damaged during reaming to avoid destroying the medial wall. If the medial wall is unintentionally damaged, the surgery will require additional bone grafting steps. With this in mind, information from the point probe can be used to provide operational guidance for the acetabular reamer during the surgical procedure. For example, the acetabular reamer can be configured to provide tactile feedback to the surgeon when the surgeon reaches the floor or otherwise deviates from the surgical plan. Alternatively, the CASS100 can automatically stop the reamer when the floor is reached or when the reamer is within a threshold distance.

[0178] As an additional safeguard, the thickness of the area between the acetabulum and the medial wall can be estimated. For example, once the acetabular rim and acetabular fossa are drawn and registered to the preoperative 3D model, the thickness can be easily estimated by comparing the position of the acetabular surface with that of the medial wall. Using this knowledge, the CASS100 can provide alerts or other responses in case any surgical activity during reaming is anticipated to protrude through the acetabular wall.

[0179] Point probes can also be used to collect high-resolution data of common reference points used when orienting a 3D model to a patient. For example, for pelvic plane landmarks like the ASIS and pubic symphysis, surgeons can use point probes to map the bone to represent the actual pelvic plane. With a more complete view of these landmarks, the registration software will have more information to orient the 3D model.

[0180] Point probes can also be used to collect high-resolution data describing proximal femoral reference points that can be used to improve the accuracy of implant placement. For example, the relationship between the tip of the greater trochanter (GT) and the center of the femoral head is commonly used as a reference point for aligning the femoral components during hip replacement surgery. Alignment height depends on the correct location of the GT; therefore, in some embodiments, point probes are used to map the GT to provide a high-resolution view of the area. Similarly, in some embodiments, a high-resolution view of the lesser trochanter (LT) may be useful. For example, during hip replacement surgery, Dorr classification helps to select the trunk that will maximize the ability to achieve compression fit during surgery, thereby preventing micromovement of the femoral components postoperatively and ensuring optimal bone ingrowth. As understood in the art, Dorr classification measures the ratio between the canal width at the LT and the canal width 10 cm below the LT. The accuracy of classification is highly dependent on the correct location of the relevant anatomy. Therefore, mapping the LT to provide a high-resolution view of the area may be advantageous.

[0181] In some embodiments, a point probe is used to map the femoral neck to provide high-resolution data, allowing surgeons to better understand where to make the neck incision. A navigation system can then guide the surgeon as they make the neck incision. For example, as understood in the art, the femoral neck angle is measured by placing a line below the center of the femoral stem and a second line below the center of the femoral neck. Therefore, a high-resolution view of the femoral neck (and possibly the femoral stem) will provide a more accurate calculation of the femoral neck angle.

[0182] High-resolution femoral head and neck data can also be used to navigate resurfacing procedures, where software / hardware assists the surgeon in preparing the proximal femur and placing femoral components. As is generally understood in the art, during hip resurfacing, the femoral head and neck are not removed; instead, the head is trimmed and covered with a smooth metal cap. In this case, it is advantageous for the surgeon to map the femur and cap, allowing for a precise assessment of their respective geometries and its use to guide the trimming and placement of femoral components.

[0183] Preoperative data was registered to the patient's anatomical structures using a point probe.

[0184] As described above, in some embodiments, a 3D model is developed based on 2D or 3D images of the anatomical region of interest during the preoperative phase. In such embodiments, registration between the 3D model and the surgical site is performed prior to the surgical procedure. The registered 3D model can be used to track and measure the patient's anatomy and surgical instruments during surgery.

[0185] During the surgical procedure, landmarks are acquired to facilitate the registration of the preoperative 3D model to the patient's anatomy. For knee surgery, these points may include the femoral head center, distal femoral axis, medial and lateral epicondyles, medial and lateral malleoli, proximal tibial mechanical axis, and tibial A / P direction. For hip surgery, these points may include the anterior superior iliac spine (ASIS), pubic symphysis, points along the acetabular rim and within the hemisphere, greater trochanter (GT), and lesser trochanter (LT).

[0186] In revision surgery, the surgeon may map certain areas containing anatomical defects to better visualize and navigate implant insertion. These defects can be identified based on analysis of preoperative images. For example, in one embodiment, each preoperative image is compared to a library of images showing “healthy” anatomy (i.e., defect-free). Any significant deviation between the patient image and the healthy image can be flagged as a potential defect. During surgery, the surgeon can then be alerted to the potential defect via a visual alert on the CASS 100’s display 125. The surgeon can then map the area to provide the surgical computer 150 with more detailed information about the potential defect.

[0187] In some embodiments, surgeons may use non-contact methods to register incisions within the bone anatomy. For example, in one embodiment, laser scanning is used for registration. A laser strip is projected onto the anatomical region of interest, and changes in the height of that region are detected as changes in the line. Other non-contact optical methods, such as white light interferometry or ultrasound, may also be used alternatively for surface height measurement or registration of anatomical structures. For example, ultrasound may be beneficial where there is soft tissue between the registration point and the bone being registered (e.g., ASIS, pubic symphysis in hip surgery), providing a more precise definition of the anatomical plane.

[0188] Robot-assisted insertion of medical fasteners to a predetermined depth

[0189] Figure 8 A handheld cutting tool 228 is shown that can be used in conjunction with certain embodiments of this disclosure. As previously disclosed in U.S. Patent No. 6,757,582 to Brisson et al., the entire contents of which are incorporated herein by reference, the tool 228 can be controlled by a camera of an optical detection tracker 220 (e.g., Figure 1 The tracking system 115 (using a camera) tracks and transmits this information to a computer system (e.g., surgical computer 150), which is also tracking the bone within the surgical space and comparing the position of the tool 228 with a predetermined surgical plan. In some embodiments, the tool 228 opens when the cutting element 230 is at a position indicated by the surgical plan where the bone should be cut, and closes when the tool 228 approaches the bone to be preserved. In some other embodiments, the cutting element 230 extends and cuts where it should, and retracts behind the cutting guard 232 when bone should not be cut. In yet another embodiment, the cutting element 230 may extend a controlled distance away from the guard, such that it cuts only to a certain depth or at a distance from the distal end 234 of the guard, according to the surgical plan.

[0190] As described above, there is a need in the field for systems and devices that allow for more efficient placement of medical fasteners during orthopedic surgical procedures. One solution to this problem, and other problems with such systems, is to allow users to position medical fasteners under system navigation using a single surgical tool and to use robot assistance to place the medical fasteners. For example, a surgical tool configured for use with a cutting element can be additionally configured to place the medical fastener at a desired depth within a target location (e.g., bone). In particular, some surgical tools for removing bone or other tissue may include a clamp assembly configured to engage and release a cutting element, as position-controlled by an axial drive system. Such surgical tools can also be used in conjunction with compatible medical fasteners to automatically release the medical fastener at a predetermined implantation depth, as instructed by the surgical plan performed by the surgical system.

[0191] Figure 9-12 It is in a retracted configuration (such as) Figure 6 and Figure 8 (as shown) and extended configurations (such as) Figure 10 and Figure 12 Surgical tools 500 (as shown) may include Figure 8 The surgical tool 500 is shown as a cross-sectional view of tool 228. The surgical tool 500 may include a handheld component 560 and a guiding component 570 (which may include, for example, a cutting guard 232). In one embodiment, the surgical tool 500 may include an attachment component 502 configured to interchangeably receive cutting elements (e.g., Figure 8 The cutting element 230 (or a sharpening tool or other bone removal tool) or medical fastener 550 (e.g., a pin, Kirschner needle, or Schanz nail) shown is engaged with the cutting element or medical fastener, as described in more detail below. When the cutting element is attached to the surgical tool 500, the surgical tool can be used to remove, cut, or otherwise manipulate bone or other biological material or perform other surgical tasks. When the medical fastener is attached to the surgical tool 500, the surgical tool can be used to implant or place the medical fastener 550 by automatically releasing the medical fastener 550 at the desired implantation depth, as described in more detail below.

[0192] The surgical tool 500 can be configured to impart axial (longitudinal) movement to the medical fastener 550 or a cutting element coupled thereto via an electromechanical axial drive assembly 520, and rotational movement via an electromechanical rotary drive assembly 530. The rotational and axial movements can be driven simultaneously or separately. Specifically, the axial drive assembly 520 and the rotary drive assembly 530 can drive the attachment assembly 502 axially and rotationally, which in turn imparts corresponding movement to the medical fastener 550 or the cutting element coupled thereto. Furthermore, the axial drive assembly 520 and the rotary drive assembly 530 can be controlled synchronously according to the spacing of the medical fastener 550 (or another threaded component driven by the surgical tool 500), allowing the medical fastener to advance into the bone at a rate that prevents bone stripping. In various embodiments, the axial drive assembly 520 and / or the rotary drive assembly 530 may be controlled by the CASS 100 (e.g., via the surgical computer 150) or by a controller on the surgical tool 500, thereby controlling, for example, the rate of translation and rotation of the medical fastener 550, the cutting element, or another such component. Avoiding bone stripping during insertion of the medical fastener 550 improves the resulting stability of the medical fastener during insertion.

[0193] The axial drive assembly 520 may include an axial actuator 521 operatively coupled to the attachment assembly 502 via a link 522. The axial actuator 521 may include, for example, a linear motor, a hydraulic actuator, a screw actuator, a rack and pinion assembly, or a piezoelectric linear actuator. In the illustrated embodiment, the attachment assembly 502 is supported and / or nested within a bracket assembly 524, which is coupled to the axial actuator 521 via the link 522. The bracket assembly 524 is slidably movable through a hole in the surgical tool 500 such that axial movement of the bracket assembly 524 subsequently drives the attachment assembly 502 axially (i.e., proximal or distal, as indicated by the axial actuator 521). However, in other embodiments, the axial actuator 521 may otherwise be coupled to and drive the attachment assembly 502. Therefore, the axial actuator 521 can translate the medical fastener 550 or cutting element that engages with the attachment assembly 502 through the interior of the shaft 572 of the guide assembly 570 in order to selectively expose (i.e., extend from the shaft 572) or hide (i.e., retract into the shaft 572) the medical fastener 550 or cutting element.

[0194] The rotary drive assembly 530 may include a rotary actuator 531 operatively coupled to the attachment assembly 502 via a drive shaft 532. The rotary actuator 531 may include, for example, a brushless DC motor, such as a Bien-Air NANO micromotor or a Maxon ECX SPEED 19 motor. The rotary actuator 531 may be configured to rotaryly drive the attachment assembly 502, which in turn rotaryly drives a cutting element or medical fastener 550 connected thereto. When driven by the rotary actuator 531, a cutting element coupled to the surgical tool 500 may remove bone (or perform another surgical task), and a medical fastener coupled to the surgical tool 500 may be drilled into or otherwise implanted within the bone. In the illustrated embodiment, the rotary actuator 531 and drive shaft 532 are coaxial with the attachment assembly 502 (i.e., positioned along axis LA). However, in other embodiments, the rotary actuator 531 and / or drive shaft 532 may be offset from the attachment assembly 502. Furthermore, the rotary actuator 531 may be fixed or coupled to the axial drive assembly 520, such that it translates according to the attachment assembly 502. In embodiments where the rotary actuator 531 is fixed, the rotary actuator 531 may be coupled to the attachment assembly 502 via, for example, a slip ring assembly.

[0195] As described above, the attachment assembly 502 can be configured to interchangeably receive cutting elements, medical fasteners, and other compatible devices. In the illustrated embodiment, the attachment assembly 502 may include a collet 504 sized and shaped to receive and securely hold the corresponding end of the cutting element or medical fastener 550 therein. It should be noted that, although Figure 9and Figure 10 The attachment assembly 502 is shown engaging with the medical fastener 550, but this is for illustrative purposes only, and the attachment assembly 502 may alternatively engage with a cutting element or other device having a compatible attachment mechanism. In the illustrated embodiment, the attachment mechanism of the medical fastener 550 includes a recess 552 located at its proximal or drive end 554, the recess being sized or otherwise configured to engage with a pawl 510 of the attachment assembly 502 to securely hold the medical fastener 550 within the attachment assembly 502 when it is inserted therein. For example, the pawl 510 may include a ball bearing, a spring-biased member, or another mechanism configured to selectively engage with the medical fastener 550. For example, the recess 552 may include a groove extending around the medical fastener 550. When the medical fastener 550 is inserted into the collet 504, the pawl 510 can move into the recess 552 and at least partially occupy the recess, thereby restricting the movement of the medical fastener 550 along the longitudinal axis LA and preventing the medical fastener 550 from being withdrawn from the surgical tool 500. A cutting element designed for use with the surgical tool 500 may similarly include an attachment mechanism corresponding to the illustrated medical fastener attachment mechanism or otherwise compatible with the attachment assembly 502.

[0196] The attachment assembly 502 may also include a sleeve 506 and a spring 508 or another biasing member, the sleeve being slidably operable relative to the collet 504, the spring or other biasing member being configured to bias the sleeve 506 relative to the collet 504 toward a first position. In the first position (e.g., Figure 9 and Figure 11 In the position shown, the inner surface of the sleeve 506 abuts against the pawl 510 so that the pawl 510 maintains its position occupying the recess 552 of the medical fastener 550 (or cutting element, as applicable), which in turn maintains engagement of the medical fastener 550 with the attachment assembly 502. When the axial actuator 521 moves distally (i.e., from...), Figure 11 The position shown is to Figure 12When the attachment assembly 502 is driven (as shown in the position), the distal end of the sleeve 506 contacts the stop 512, which prevents the sleeve 506 from translating further distally. However, since the collet 504 can move independently relative to the sleeve 506, the collet 504 is not restricted in this way and can continue to translate distally. Therefore, further translation of the attachment assembly 502 by the axial actuator 521 compresses the spring 508, and thus moves the collet 504 relative to the sleeve 506. As the positions of the collet 504 and the sleeve 506 shift relative to each other, the sleeve 506 can be transformed to a second position relative to the collet 504, wherein the orifice 505 in the collet 504 can be aligned with the recess 507 in the sleeve 506. For example, the recess 507 may include a groove extending around the inner surface of the sleeve 506. Therefore, the pawl 510, which is at least partially located within the collet orifice 505, is allowed to translate radially into the recess 507 in the sleeve 506, which in turn empties the pawl 510 from the recess 552 in the medical fastener 550 (e.g., as shown in the image). Figure 10 and Figure 12 (As shown in the diagram). Because the pawl 510 retracts from the medical fastener recess 552 in this configuration of the attachment assembly 502, the medical fastener 550 disengages from the attachment assembly 502 and the surgical tool 500 as a whole. In summary, the axial drive assembly 520 can translate the attachment assembly 502 distally and disengage the attachment assembly 502 from the medical fastener 550 when the axial drive assembly 520 reaches its distal position. As described above, the rotary drive assembly 530 can rotaryly drive the medical fastener 550 while it is simultaneously axially driven by the axial drive assembly 520, thereby drilling or implanting the medical fastener 550 into the bone. Therefore, the distal position of the axial drive assembly 520 corresponds to the depth at which the medical fastener 550 is implanted into the bone. The surgical tool 500 can then be withdrawn from the medical fastener 550, thereby holding the medical fastener 550 within the bone at a specific implantation depth corresponding to the distal or distal position of the axial drive assembly 520.

[0197] In various embodiments, CASS 100 can be used to implant the medical fastener 550 to a predetermined depth in various ways. In some embodiments, CASS 100 can be configured to provide information or alerts to a user via display 125 or another output device. The information or alerts may instruct the surgeon on the time when the surgical tool 500 should be detached from the medical fastener 550, given the type of surgical tool 500 used in the surgical procedure, or that the surgeon should set specific values ​​for operational parameters (e.g., implantation depth, length of guide assembly 570, or starting position of axial drive assembly 520) for the surgical tool 500 to automatically implant the medical fastener 550 to a predetermined depth specified by the surgical plan. In other embodiments, CASS 100 can be configured to control the surgical tool 500 or other surgical instruments used in the surgical procedure to automatically implant the medical fastener 550 to a predetermined depth. As described above, the surgical tool 500 and other components of CASS 100 can be connected to and controlled by the surgical computer 150. Therefore, the surgical computer 150 can directly control the operating parameters of the surgical tool 500 (e.g., the length of the guide assembly 570 or the starting position of the axial drive assembly 520), as indicated by the intraoperative algorithm executed by the surgical computer 150.

[0198] In one embodiment, CASS 100 can be configured to automatically implant a medical fastener 550 to a predetermined depth by selecting a medical fastener 550 of appropriate length. Medical fasteners can be provided in many different sizes or lengths, which correspond to different implantation depths when driven by the surgical tool 500. The length of the medical fastener 550 corresponds to its intended implantation depth because the implantation depth indicates the amount of the medical fastener 550 exposed from the guide assembly 570 when driven by the axial drive assembly 520. In other words, a shorter medical fastener can be implanted at a shallower depth because a smaller amount of the shorter medical fastener is available for implantation into the bone compared to a longer medical fastener. Therefore, CASS 100 can be configured to recommend a medical fastener 550 of appropriate length for a given surgical plan, such that the medical fastener 550 is placed at the desired implantation depth. As described above, the surgical tool 500 is configured to automatically release the medical fastener 550 when the axial drive assembly 520 reaches its end position. Therefore, the surgical tool 500 specified by CASS 100 can automatically release the medical fastener 550 at a predetermined depth by controlling the length of the medical fastener 550.

[0199] In another embodiment, the length of the guide assembly 570 may be adjustable, and the CASS 100 may be configured to automatically implant the medical fastener 550 to a predetermined depth by adjusting the guide assembly 570 to an appropriate length. The ability to adjust the length of the guide assembly 570 allows the user to control the implantation depth of the medical fastener 550 because the length of the guide assembly 570 indicates the degree to which the medical fastener 550 is exposed. In other words, if the guide assembly 570 is longer, less of the medical fastener 550 will be exposed when the axial drive assembly 520 fully extends the medical fastener from the guide assembly 570. Since the degree to which the medical fastener 550 is exposed indicates the depth to which the medical fastener 550 can be implanted, controlling the length of the guide assembly 570 controls the implantation depth of the medical fastener 550.

[0200] In use, for example, the guide assembly 570 can be lengthened when a shallow implantation depth is desired, or shortened when a deeper implantation depth is desired. In one such embodiment, the shaft 572 may, for example, include a telescopic structure that thereby allows the length of the guide assembly 570 to be controlled by the user and / or the robotic surgical system. The length of the guide assembly 570 can be manually adjusted by the surgeon and / or the electromechanical control system of the surgical tool 500. Thus, the CASS 100 can be configured to recommend an appropriate length of the guide assembly 570 for a given surgical plan, such that the medical fastener 550 is placed at the desired implantation depth. Alternatively, the CASS 100 can be configured to directly control the surgical tool 500 to adjust the length of the guide assembly 570. As described above, the surgical tool 500 is configured to automatically release the medical fastener 550 when the axial drive assembly 520 reaches its end position. Thus, the surgical tool 500 specified by the CASS 100 can automatically release the medical fastener 550 at a predetermined depth by controlling the length of the guide assembly 570.

[0201] In another embodiment, CASS 100 can be configured to automatically insert the medical fastener 550 to a predetermined depth by controlling the amount or extent to which the axial drive assembly 520 is translated. In this embodiment, the geometry of the various components of the attachment assembly 502 and / or the corresponding components of the medical fastener 550 can be designed to indicate the amount of force required to remove the medical fastener 550 (or another device, such as a cutting element) from the attachment assembly 502. Specifically, the geometry of these components can be designed to allow the medical fastener 550 to be withdrawn from the attachment assembly 502 before the axial drive assembly 520 has reached its end position (i.e., before the collet 504 is fully open), given a sufficient force. For example, the recess 552 of the medical fastener 550 can be configured to be shallow enough and / or the pawl 510 can be configured to be small enough that the user and / or the robotic surgical system can overcome the nominal frictional forces generated between the engagement between the pawl 510 and the recess 552 to disengage the medical fastener 550 and the surgical instrument 500. Of course, the medical fastener 550 and the surgical tool 500 can also disengage from each other when the axial drive assembly 520 has reached its end position, as described above. Therefore, the CASS 100 can be configured to cause the axial drive assembly 520 to translate only by the amount necessary to place the medical fastener 550 at the desired implantation depth, as indicated by a given surgical plan. Alternatively, the CASS 100 can be configured to recommend a distance that the axial drive assembly 520 should be driven, or recommend a corresponding activation time, to allow the medical fastener 550 to reach the desired implantation depth. Once at the predetermined depth, the surgical tool 500 can be withdrawn from the medical fastener 550 (by a surgeon or robotic surgical system) even if the axial drive assembly 520 has not yet reached its end position. Thus, the surgical tool 500, as specified by the CASS 100, can automatically release the medical fastener 550 at a predetermined depth by controlling the amount or extent to which the axial drive assembly 520 is translated.

[0202] In another embodiment, CASS 100 can be configured to automatically implant the medical fastener 550 to a predetermined depth by controlling the position of the axial drive assembly 520, which initiates rotational drive of the medical fastener 550. As described above, the surgical tool 500 is configured to automatically release the medical fastener 550 coupled to its attachment assembly 502 when the axial drive assembly 520 reaches its end position. Therefore, controlling the position of the axial drive assembly 520, which initiates rotational drive of the medical fastener 550 by the rotational drive assembly 530, allows control over the amount of translation of the medical fastener 550 during implantation, which in turn allows control over the implantation depth of the medical fastener 550. Thus, CASS 100 can be configured to set the starting position of the axial drive assembly 520 to a position that causes the axial drive assembly 520 to reach its end position when the medical fastener 550 is installed at the desired implantation depth, as indicated by a given surgical plan. Alternatively, CASS 100 can be configured to recommend a starting position for the axial drive assembly 520 corresponding to the desired implantation depth of a given type of medical fastener 550, which can then be used by the surgeon to adjust the surgical tool 500 accordingly. As described above, the surgical tool 500 is configured to automatically release the medical fastener 550 when the axial drive assembly 520 reaches its end position. Thus, the surgical tool 500 specified by CASS 100 can automatically release the medical fastener 550 at a predetermined depth by controlling the starting position of the axial drive assembly 520.

[0203] During the procedure, the surgeon can use surgical tool 500 to place medical fastener 550 in the target bone, and when the medical fastener 550 has reached the predetermined implantation depth, use the following steps to automatically detach the medical fastener 550 from the surgical tool 500. In some embodiments, surgical computer 150 can determine the desired implantation depth of the medical fastener 550 for a given step of the surgical procedure, or receive a desired implantation depth as input by the surgeon. In some embodiments, the surgeon can select a medical fastener 550 of appropriate length, input various control parameter settings into surgical tool 500, or take other actions as instructed by surgical computer 150 to implant the medical fastener 550. In other embodiments, surgical computer 150 may alternatively directly control surgical tool 500 and / or other components of CASS 100. The tracking system 115 can then track the movement of surgical tool 500 while it is under the surgeon's control. The surgeon can then use the tracking system 115 to position surgical tool 500 in a posture relative to the bone specified by the surgical plan. In one embodiment, the display 125 can visualize the posture of the tracked surgical tool 500 and then instruct the surgeon when the surgical tool 500 is in the desired posture. Next, the surgeon can activate the surgical tool 500 to initiate the implantation of the medical fastener 550 into the target bone. Once the medical fastener 550 has reached the desired implantation depth, the surgical tool 500 can subsequently disengage from the medical fastener 550 to allow the medical fastener 550 to automatically implant at the desired depth. As described above, the CASS 100 can control the implantation depth by recommending an appropriately sized medical fastener 550, controlling the starting position of the axial drive assembly 520 before driving the medical fastener 550, stopping the axial drive assembly 520 once it has translated a set amount, etc.

[0204] Various embodiments of the surgical tool 500 described herein can be configured as a multi-purpose device or a disposable device. In embodiments where the surgical tool 500 is a disposable device, the support surface of the surgical tool 500 may include, for example, a self-lubricating polymer that is depleted after a single use. Various embodiments of the surgical tool 500 described herein can also be configured for use as a handheld device, in conjunction with a robotic surgical system (e.g., supported and / or driven by a robotic surgical arm), or both. Such robotic surgical systems can be incorporated into computer-based surgical systems (e.g., those described above in...). Figure 1 –7C describes CASS 100) or is controlled by it.

[0205] Those skilled in the art will understand that the hardware components of the CASS 100 can vary depending on the implementation. Other internal hardware or peripheral devices, such as flash memory, equivalent non-volatile memory, or optical disc drives, may be used in addition to or in place of the hardware described herein. Furthermore, the surgical computer 150 and other data processing components of the CASS 100 can take the form of any of many different data processing systems, including but not limited to client computing devices, server computing devices, tablet computers, laptops, telephones or other communication devices, personal digital assistants, etc. Essentially, the surgical computer 150 and other data processing components of the CASS 100 can be any known or subsequently developed data processing system, without architectural limitations.

[0206] Dynamic sealing components

[0207] At the end of the surgical procedure using this tool, for including Figure 8 Many surgical instruments of the surgical instrument 500 shown in –12 undergo reprocessing and sterilization. However, reprocessing and sterilization can cause significant damage to the electromechanical components of the surgical instrument 500 if they are not properly sealed. Therefore, it is desirable for the surgical instrument 500 to include a sealing mechanism that protects the electromechanical components from moisture. However, the high operating speed of the rotary drive assembly 530 presents technical challenges to sealing the surgical instrument 500. In particular, the common rotary seal material and construction can generate significant friction with the drive shaft of the rotary drive assembly 530. It should also be noted that the rotary seal material used for various types of surgical instruments is typically unlubricated to avoid biocompatibility issues with lubricants and compliance issues where the user is forced to reapply lubricant to the tool to make it function as intended. The excessive heat generated by drive shaft friction leads to wear of the drive shaft at high speeds and generates torque, which reduces the power from the rotary drive assembly 530 and generally negatively impacts the performance of the rotary drive assembly. Therefore, the operating speed of the drive shaft must be limited, accepting a shortened lifespan and adversely affected performance of the surgical tool 500, or the rotary seal must be replaced with a labyrinth seal (which has its own additional limitations). One solution to these problems is to utilize a sealing assembly that dynamically seals the surgical tool 500 based on whether the tool is in operation, such that the sealing assembly components selectively engage with the rotary drive component only when the tool is not in use.

[0208] As mentioned above, when in use, surgical instrument 500 can be used as follows: Figure 9 and Figure 11 The transition between the retracted and extended configurations is roughly shown in the diagram. Now refer to... Figure 13 and Figure 14Surgical instrument 500 may be configured accordingly to be in an unsealed state suitable for use (e.g., during a surgical procedure). Figure 13 ) and the sealed state after use for reprocessing and / or sterilization ( Figure 14 The surgical instrument 500 may be configured to switch between a sealed and unsealed state, at least partially, depending on whether the cutting element (e.g., a sharpening tool) or medical fastener 550 engages with the attachment assembly and / or whether the bracket assembly 524 is in a properly distal position. When sealed, the sealing assembly 580 may be configured to engage with the various parts of the surgical instrument 500 (e.g., parts of the bracket assembly 524 and / or attachment assembly 502) to prevent moisture from contacting the electromechanical components of the surgical instrument 500 during reprocessing and / or sterilization. When unsealed, the sealing assembly 580 may be configured to disengage from parts of the rotary drive assembly 530 and / or other movable parts of the surgical instrument 500, thereby preventing friction between the associated surgical instrument parts and the sealing assembly 580 when the rotary drive assembly 530 is operable.

[0209] In various embodiments, the sealing assembly 580 may include a plurality of different seals positioned at different locations within the surgical instrument 500. In the illustrated embodiment, the sealing assembly 580 includes a first seal 582 positioned distally relative to the surgical instrument 500 and a second seal 584 positioned proximally. The first seal 582 and / or the second seal 584 may be configured to selectively engage (i.e., seal) or disengage with the attachment assembly 502 and / or the bracket assembly 524 components depending on their position. Thus, the first seal 582 and / or the second seal 584 may be configured to control moisture entry into the surgical instrument 500 at different points and / or protect different components of the surgical instrument. In other embodiments, the sealing assembly 580 may include only one of the first seal 582 or the second seal 584. The sealing assembly 580 may also include an additional seal 586, which may or may not be configured to selectively engage or disengage with the surgical instrument components depending on their position. For example, seals 582, 584, and 586 may include O-rings.

[0210] In the illustrated embodiment, the surgical tool 500 is configured to transition between a sealed and unsealed state, at least in part, depending on whether the tool is engaged with a medical fastener or cutting element. When the surgical tool 500 is in its unsealed state (e.g., as...), Figure 13When (as shown in the diagram), the attachment assembly 502 and / or the bracket assembly 524 are at least partially retracted or otherwise not advanced to their most distal position. Therefore, a gap 587 is defined between the axial face 509 of the sleeve 506 and the first seal 582. In one embodiment, the attachment assembly 502 is configured such that the presence of a medical fastener 550 or cutting element within the attachment assembly 502 pushes the sleeve 506 (and therefore the axial face 509 of the sleeve 506) proximally relative to the first seal 582, thereby creating the gap 587. Therefore, when the medical fastener 550 or cutting element engages with the surgical tool 500, the surgical tool transitions to an unsealed state. Due to the gap 587, the first seal 582 does not contact or otherwise frictionally engage any surgical tool component rotated by the rotary drive assembly 530, and therefore, no heat or torque is generated between the surgical tool component and the first seal 582 when the medical fastener 550 or cutting element is driven by the surgical tool 500. Accordingly, removing the medical fastener 550 or cutting element from the attachment assembly 502 removes the proximal force on the sleeve 506, which in turn allows the sleeve 506 to advance distally (e.g., due to the distal biasing of the sleeve 506 by the spring 508), thereby bringing the axial surface 509 into contact with the first seal 582, thus preventing moisture ingress due to the engagement between the respective components. Therefore, the surgical tool 500 can be configured to switch between a sealed and unsealed state depending on whether the medical fastener 550 or cutting element is engaged with the surgical tool.

[0211] In the illustrated embodiment, the surgical tool 500 is configured to transition between a sealed and unsealed state, at least partially, due to the position of the bracket assembly 524. When the surgical tool 500 is in operation, a gap 588 is defined between the second seal 584 and the bracket assembly 524, such that the second seal 584 does not contact or otherwise frictionally engage any surgical tool component driven by the rotary drive assembly 530 and / or the axial drive assembly 520. When the bracket assembly 524 is in a distal position (e.g., when driven by the axial drive assembly 520), a portion 525 of the bracket assembly 524 with an increased diameter contacts the second seal 584, preventing moisture ingress due to the engagement between the respective components. Thus, when the bracket assembly 524 is in an extended position, the surgical tool 500 transitions to a sealed state. As described above, the axial drive assembly 520 can control the axial position of the bracket assembly 524, the attachment assembly 502, and other surgical tool components. Therefore, the surgical tool 500 can be configured to switch between an operating mode or configuration suitable for use during a surgical procedure and a sealed mode or configuration suitable for reprocessing / sterilization by controlling the position of the bracket assembly 524, the operating mode or configuration avoiding the generation of heat and / or torque through the action of the sealing assembly 580. In one embodiment, the surgical tool 500 may be in its sealed state when it is not engaged with the medical fastener 550 or the cutting element and the bracket assembly 524 is in its most distal position.

[0212] The surgical instrument 500 may also include a locking component 590 configured to, for example, lock the surgical instrument in a sealed state. This locking component 590 can be advantageous, for example, to prevent the surgical instrument 500 from becoming unsealed during reprocessing or sterilization. Figure 14 In the illustrated embodiment, locking assembly 590 may include pawl 592 (e.g., pawl ball) configured to selectively engage a recess 594 on bracket assembly 524 when the bracket assembly has been axially advanced to its distal or sealed position.

[0213] Automatic fastener placement

[0214] In some embodiments, the robotic surgical system can be configured to autonomously use surgical instruments (e.g., Figure 8-14The cutting tools shown and described above are used to cut bone (e.g., drill holes) and / or place medical fasteners. Automating one or more steps of a surgical procedure with such robotic surgical systems has several advantages, including (e.g., by enabling the robotic surgical system to execute a checklist of instructions) ensuring the correct execution of surgical procedures, (by reducing the impact of natural human variability on the execution of surgery) ensuring surgery is performed in a consistent manner, reducing the workload of human error or lack of skill, and applying (through sensing, software, actuators, and AI) skills that are more advanced than those handled by humans, and allowing surgeons to treat more patients during their practice by relieving them of performing routine, repetitive tasks (e.g., drilling, tightening screws, and molding or cutting bone). In some embodiments, these robotic surgical systems can be used to autonomously implant various types of internal prostheses for a wide range of surgical applications. For example, these robotic surgical systems can be used to place plates and screws for long bone trauma, craniofacial repair, spinal repair, or dental restoration. As another example, these robotic surgical systems can be used to implant reconstructive implants for joint replacement surgery for a variety of different joints, including the hip, knee, ankle, shoulder, or finger. As yet another example, these robotic surgical systems can be used for spinal alignment or related surgical procedures. One challenge in implementing these types of robotic surgical systems is how medical fasteners are supplied to and driven by the robotic arm. In particular, there are many different types of medical fasteners, and these fasteners are relatively small components; therefore, automated robotic surgical systems need to overcome a range of challenges, including identifying the correct medical fastener for use in any given scenario (which may include distinguishing between different types of medical fasteners), and correctly implanting or manipulating the medical fastener during the specific type of surgical procedure being performed.

[0215] In one embodiment, the robotic surgical system can be configured to use surgical instruments including a medical fastener delivery mechanism, such as... Figure 15-19 The surgical instrument 700 shown. In some embodiments, the surgical instrument 700 may be similar to... Figure 9-14The cutting tool 500 shown may share some or all of the same features as the cutting tool. The surgical instrument 700 may be configured to implant a medical fastener 550 (e.g., a screw) into bone or surgical hardware (e.g., a bone plate). In one embodiment, the surgical instrument 700 may include a chamber 704 configured to removably receive a cassette 706 for retaining the medical fastener 550. In one embodiment, the chamber 704 may be located at or near the distal end 702 of the surgical instrument 700. The cassette 706 may be configured to supply one or more medical fasteners 550 to the surgical instrument 700 such that the surgical instrument can drive the medical fastener into or through bone or surgical hardware (e.g., a bone plate). As generally described above, the medical fasteners 550 implanted by the surgical instrument 700 may be used to directly secure bone or bone fragments together, secure surgical hardware such as a bone plate to one or more bones or bone fragments, or serve as anchor points for other devices (e.g., tracking system markers or cutting guides). The box chamber 704 may be sized, shaped, or otherwise configured to removably receive the box 706 and hold the box in place (e.g., until it is removed by the user).

[0216] The surgical instrument 700 may also include one or more drive components for axially and / or rotationally driving the medical fastener 550. In some embodiments, the surgical instrument 700 may include at least one of the axial drive component 520 or the rotation drive component 530 described above. Figure 8-14 In the illustrated embodiment, the surgical instrument 700 includes a drive assembly 710, which includes a driver 712 configured to engage with the head of a medical fastener 550 (e.g., Figure 16 As shown in the diagram, the drive assembly 710 can axially and rotatably drive the medical fastener engaged therewith. For example, the drive 712 may include a hexagonal head. In use, the surgical instrument 700 can implant the medical fastener 550 into bone or surgical hardware. In some embodiments, the surgical instrument 700 may be configured to automatically disengage from the medical fastener 550 once it has been implanted to the desired depth, as described above regarding... Figure 8The embodiment shown in –14 illustrates this. Once the implanted medical fastener 550 has been ejected from the surgical instrument 700, the drive assembly 710 can be axially withdrawn (e.g., moved in a proximal direction) to clear space within the cylinder 708 of the surgical instrument to receive a new medical fastener. In one embodiment, the cartridge 706 may include one or more biasing elements 720 configured to bias the medical fastener 550 toward the cylinder 708 such that a replacement medical fastener is loaded into the cylinder after the loaded medical fastener has been ejected from the surgical instrument 700 (e.g., implanted in bone). In the illustrated embodiment, the biasing element 720 is a spring, but in other embodiments, the biasing element may include other mechanisms. Once the replacement medical fastener 550 has been loaded into the cylinder 708, the drive assembly 710 can engage the medical fastener 550, thereby preparing the surgical instrument 700 for implantation of the newly loaded medical fastener.

[0217] Because the surgical instrument 700 is configured to automatically load the medical fastener 550 for actuation by the surgical instrument, a robotic surgical system including the surgical instrument can (e.g., by a surgical operator) load the correct type of medical fastener for a given surgical procedure or step of a procedure being performed. Furthermore, because the medical fastener 550 is automatically loaded and reloaded for implantation, the robotic surgical system can implant multiple medical fasteners quickly and efficiently without requiring excessive movement of the robotic arm or additional tracking and / or processing by the computer system associated with the robotic surgical system.

[0218] In another embodiment, a robotic surgical system (e.g., Figure 20-27 The robotic surgical system 800 shown can be configured to use a fastener housing 810 suitable for use with a robotic surgical system. As generally described above, the robotic surgical system 800 may include a robotic arm 802 configured to hold and / or manipulate surgical instruments 804 and a tracking system 806. In one embodiment, the surgical instrument 804 may be held by an end effector of the robotic arm 802. In another embodiment, the surgical instrument 804 may be integral with or a component of the end effector of the robotic arm 802. As described in more detail above, in one embodiment, the tracking system 806 may be configured to identify a tracker 220 (also referred to as a marker or reference) to determine the attitude (i.e., position and orientation) of the robotic arm 802 (or a component thereof) and the surgical instrument 804 in the operating room. In another embodiment, the tracking system 806 may include an electromagnetic tracking system, as described above in conjunction with... Figure 2-4 As described. In some embodiments, the surgical instrument 804 may be similar to Figure 9-14The cutting tool 500 shown may share some or all of the same features as the cutting tool. The surgical instrument 800 may be configured to cut (e.g., drill) bone or to implant medical fasteners 550 (e.g., screws) into bone or surgical hardware.

[0219] In the illustrated embodiment, the robotic surgical system also includes a fastener housing 810, which includes one or more markings 220 identifiable by the tracking system 806. The fastener housing 810 can hold one or more types of medical fasteners 550 for use with surgical instruments 804. In one embodiment, the fastener housing 810 can be configured to hold the medical fasteners 550 in an upright manner. For example, the fastener housing 810 can be configured to hold the medical fasteners 550 with the head of the fastener exposed. By exposing the head of the medical fastener 550, it can engage the surgical instrument 804 without having to remove the medical fastener from the fastener housing 810 or otherwise further manipulate it. Therefore, the robotic arm 802 can be controlled to engage the distal end of the surgical instrument 804 with the head of the medical fastener 550 during surgery. Thus, the robotic surgical system 800 (or a computer system coupled thereto) can be programmed or otherwise configured to recognize the markings 220 on the fastener housing 810 and thereby register the orientation of the fastener housing 810. In various embodiments, the orientation of the fastener box 810 may be registered relative to the robotic arm 802 or, for example, in a global reference frame. It should be noted that the robotic arm 802 and / or surgical instruments 804 may include one or more markers 220 (e.g., arranged in a tracker array 805), which similarly allow tracking of these components of the robotic surgical system 800. Since the orientation of the fastener box 810 and the surgical instruments 804 can be tracked by the tracking system 806, the robotic arm 802 can interact with the fastener box to remove one or more medical fasteners 550 from it as needed during surgical procedures, such as... Figure 23 and 24 As shown in the diagram. Specifically, the robotic surgical system 800 can move the robotic arm 802 such that the distal tip of the surgical instrument 804 engages with a medical fastener 550 selected from a set of medical fasteners arranged by a fastener housing 810. Thereafter, the robotic arm 802 can move away from the fastener housing 810 while the medical fastener 550 is engaged with the surgical instrument 804, and can activate the surgical instrument to implant or pass the medical fastener into or through bone or surgical hardware.

[0220] The markings 220 on the fastener box 810 can vary in number and be arranged in various different configurations. Figure 24An illustrative configuration is shown, which includes four marks 220 located at different positions on the face of the fastener box 810. However, this embodiment is for illustrative purposes only, and the marks 220 can be arranged on the fastener box 810 in any manner that allows the tracking system 806 to identify the orientation of the fastener box 810.

[0221] In one embodiment, the medical fastener 550 may further include markings (e.g., references) indicating the type of the medical fastener. In another embodiment, the fastener housing 810 may include markings indicating the type of medical fastener adjacent to the medical fastener 550. In these embodiments, the robotic surgical system 800 may be configured to distinguish the type of medical fastener 550 within the fastener housing 810 based on the associated markings. In still other embodiments, the robotic surgical system 800 may be programmed or otherwise configured to use image recognition technology to distinguish the type of medical fastener 550 within the fastener housing 810.

[0222] Any embodiment of the robotic surgical system and / or surgical instruments described above can be used in revision or non-revision surgical procedures. For example, Figure 25 –27 illustrates the use of [this method] in surgical procedures. Figure 20 The robotic surgical system 800 in section 24 is used to repair tibial fractures. In this embodiment, the robotic surgical system 800 can use surgical instruments 804 to position the robotic arm 802 to drill a guide hole through a hole 822 in the tibial plate 820, such as... Figure 26 As shown in the figure. In one embodiment, surgical instrument 804 may include... Figure 9-14 The surgical instrument 500 is shown. Once the guide hole has been drilled, the robotic surgical system 800 can identify the type of medical fastener 550 suitable for a given hole 822, position the robotic arm 802 to engage the surgical instrument 804 with the selected type of medical fastener in the fastener box 810, and remove the selected medical fastener, such as... Figure 27 As shown in the diagram, the robotic surgical system 800 can control the robotic arm 802 to position and orient the surgical instrument 804 in the appropriate location to insert the selected medical fastener 550 through the hole 822, and control the surgical instrument to insert the medical fastener. The robotic surgical system 800 can repeat these steps to secure the tibial plate 820 to the opposite segment of the tibia 824. The robotic surgical system 800 can also be implemented in a wide range of other surgical applications (e.g., spinal surgery) or revision surgeries.

[0223] In various embodiments, the robotic surgical system 800 can be configured to work with a variety of different medical fasteners and bone plate assemblies. For example, the bone plate may have variable locking holes, conventional holes, and slots. For example, the medical fastener may have a threaded shaft and a smooth head, a threaded shaft and a threaded head (wherein the threaded head is configured to engage with a corresponding thread in a corresponding bone plate hole), and a smooth shaft and a threaded head (i.e., a locking pin).

[0224] Fastener torque distribution

[0225] A common problem with bone plates with threaded holes is that the threads of fasteners inserted through the holes can cross-thread with the threads of the holes. When this happens, the fasteners are essentially cold-welded to the plate. Robotic surgical systems can address this problem in two ways. First, they can reduce the placement and orientation errors of the fasteners relative to the human user. Second, they can identify the torque distribution of the fasteners as they are inserted through the plate and quickly detect potential cross-threading or other problems based on the deviation between the measured torque distribution and the intended torque distribution. In routine practice, surgeons rely on tactile feedback from the screws as they are screwed into the plate to sense any cross-threading and determine when to stop turning the fastener. Specifically, surgeons are typically instructed to stop tightening the fastener after turning it a quarter turn from the moment resistance is first felt. However, sensing cross-threading and knowing when to stop turning the fastener still relies on the surgeon's "feel" and is therefore highly dependent on the surgeon's skill and experience, which in turn means a high degree of variability among surgeons. Robotic surgical systems can address these issues by being configured to precisely determine how far the fasteners need to be passed through the plate and how much torque is required to properly secure the fasteners to the plate.

[0226] In one embodiment, the robotic surgical system may include a database, or be communicatively connected to a database, that stores the precise amount of rotation a fastener should undergo based on the type of fastener, the patient's type, and the type of bone into which the fastener is being screwed. Thus, the robotic surgical system can retrieve values ​​defining how much the fastener should be tightened and control the surgical instruments accordingly. In another embodiment where the surgical instruments are used to drill a guide hole for the fastener, the robotic surgical system may be configured to determine the depth of the drilled guide hole and, therefore, select an appropriate screw length for the guide hole. In yet another embodiment, the fastener may include an index that can be tracked by the robotic surgical system to precisely determine how many times the fastener has been rotated. For example, the index may include a tracker identifiable by the tracking system, a rotary encoder, a Hall effect sensor configured to sense one or more magnetic elements on the fastener, or a reference or other visually identifiable element for tracking the number of rotations of the fastener as it is drilled into the bone. Thus, the robotic surgical system may be configured to control the surgical instruments to implant the fastener into the bone with a precise number of rotations as indicated by the surgical condition.

[0227] While various exemplary embodiments incorporating the principles of this teaching have been disclosed, this teaching is not limited to the disclosed embodiments. Rather, this application is intended to cover any variations, uses, or modifications of this teaching and its general principles. Furthermore, this application is intended to cover deviations from this disclosure that fall within the scope of known or customary practices in the field to which these teachings pertain.

[0228] In the above detailed description, reference is made to the accompanying drawings, which form a part thereof. In the drawings, like symbols generally identify like parts unless the context otherwise requires. The illustrative embodiments described in this disclosure are not intended to be limiting. Other embodiments may be used, and other changes may be made without departing from the spirit or scope of the subject matter presented herein. It will be readily understood that various features of this disclosure (as generally described herein and illustrated in the accompanying drawings) may be arranged, replaced, combined, separated, and designed into a wide variety of different configurations, all of which are expressly contemplated herein.

[0229] This disclosure is not limited to the specific embodiments described herein, which are intended as illustrations of various features. Many modifications and variations can be made without departing from the spirit and scope that will be apparent to those skilled in the art. Functionally equivalent methods and apparatuses within the scope of this disclosure (other than those listed herein) will be apparent to those skilled in the art based on the foregoing description. It should be understood that this disclosure is not limited to specific methods, reagents, compounds, compositions, or biological systems, which can certainly be varied. It should also be understood that the terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting.

[0230] Regarding the use of virtually any plural and / or singular terms in this document, those skilled in the art may, at their discretion, convert from plural to singular and / or from singular to plural depending on the context and / or application. For clarity, various singular / plural permutations are explicitly described herein.

[0231] Those skilled in the art will understand that, in general, the terms used herein are intended to be “open-ended” terms (e.g., the term “comprising” should be interpreted as “including but not limited to”, the term “having” should be interpreted as “having at least”, the term “including” should be interpreted as “including but not limited to”, etc.). While various compositions, methods, and apparatuses are described as “comprising” various components or steps (interpreted as meaning “including but not limited to”), compositions, methods, and apparatuses may also be “consistently composed of various components and steps” or “comprises various components and steps,” and such terms should be interpreted as defining a substantially closed group of components.

[0232] Furthermore, even when a specific number is explicitly stated, those skilled in the art will recognize that such a statement should be interpreted as referring to at least the stated number (e.g., stating "two narratives" without other modifiers means at least two narratives or two or more narratives). Additionally, in cases where terms like "at least one of A, B, and C" are used, this construction is generally intended for those skilled in the art to understand the meaning of the term (e.g., "a system having at least one of A, B, and C" includes, but is not limited to, systems having only A, only B, only C, A and B together, A and C together, B and C together, and / or A, B, and C together, etc.). In cases where terms like "at least one of A, B, or C" are used, this construction is generally intended for those skilled in the art to understand the meaning of the term (e.g., "a system having at least one of A, B, or C" includes, but is not limited to, systems having only A, only B, only C, A and B together, A and C together, B and C together, and / or A, B, and C together, etc.). Those skilled in the art will also understand that virtually any transition words and / or phrases presenting two or more alternative terms, whether in the specification, sample embodiments, or drawings, should be understood to account for the possibility of including one, any one, or both of the terms. For example, the phrase "A or B" will be understood to include the possibility of including "A" or "B" or "A and B".

[0233] Furthermore, in the context of the features of this disclosure being described in accordance with the Markush Group, those skilled in the art will recognize that this disclosure is also based on any individual member of the Markush Group or a subgroup of its members.

[0234] Those skilled in the art will understand that, for any and all purposes, such as for the purpose of providing a written description, all scopes disclosed herein also cover any possible subscopes and all possible combinations of subscopes and their subscopes. Any listed scope can be readily considered sufficiently descriptive and realized by decomposition into at least equal halves, thirds, quarters, fifths, tenths, etc., of the same scope. As a non-limiting example, each scope discussed herein can be readily decomposed into a lower third, a middle third, and an upper third, etc. Those skilled in the art will also understand that all language such as “reach,” “at least,” etc., includes the numbers stated and refers to a scope that can subsequently be decomposed into subscopes as described above. Finally, those skilled in the art will understand that a scope includes each individual member. Thus, for example, a group having 1-3 cells means a group having 1, 2, or 3 cells. Similarly, a group having 1-5 cells means a group having 1, 2, 3, 4, or 5 cells, and so on.

[0235] As used herein, the term "about" refers to a change in a numerical quantity that can occur, for example, through measurement or processing procedures in the real world, through unintentional errors in these procedures, through differences in the manufacture, origin, or purity of the composition or reagent, etc. Generally, the term "about" as used herein refers to a value or range of values ​​that is greater than or less than 1 / 10 (e.g., ±10%) of the stated value. The term "about" also refers to variations that will be understood by those skilled in the art as equivalents, provided that such variations do not contain values ​​known in prior art practice. Each value or range of values ​​following the term "about" is also intended to cover embodiments of the absolute value or range of values. Whether or not modified by the term "about," quantitative values ​​referenced in this disclosure include equivalents to the referenced values, such as possible numerical variations of such values, but those skilled in the art will recognize the equivalents.

[0236] The various features and functions disclosed above, as well as their alternatives, can be combined into many other different systems or applications. Those skilled in the art can then make various currently unforeseen or unintended alternatives, modifications, variations, or improvements, each of which is also intended to be covered by the disclosed embodiments.

[0237] The functions and procedures described herein can be executed automatically, wholly or partially, in response to user commands. Activities (including steps) are performed automatically in response to one or more executable instructions or device operations, without being directly initiated by the user.

Claims

1. A surgical instrument, comprising: Attachment component, the attachment component comprising: A collet, configured to interchangeably receive a medical fastener or a bone removal tool therein. A sleeve, slidable relative to the collet between a first configuration and a second configuration, the sleeve including a sleeve recess. A biasing member configured to bias the sleeve toward the first configuration, and A pawl, the pawl being located within the sleeve recess, wherein the medical fastener or the bone removal tool is inserted into the collet to move the pawl into a corresponding recess of the medical fastener or the bone removal tool and to at least partially occupy the corresponding recess of the medical fastener or the bone removal tool, wherein in the first configuration, the sleeve abuts against the pawl to maintain the pawl in its position within the corresponding recess of the medical fastener or the bone removal tool and to restrict axial movement of the medical fastener or the bone removal tool; A rotary actuator configured to rotatably drive the attachment assembly; Stops; and An axial actuator is configured to axially drive the attachment assembly between a first position and a second position, wherein when the attachment assembly is driven by the axial actuator to approach the second position, the sleeve contacts the stop, thereby causing the sleeve to slide relative to the collet into the second configuration, thereby causing the pawl to move radially into the sleeve recess and vacate the corresponding recess of the medical fastener, thereby releasing the medical fastener at a predetermined depth corresponding to the second position.

2. The surgical tool according to claim 1, wherein the pawl comprises a ball bearing.

3. The surgical instrument according to claim 1 or 2, further comprising: cylinder; as well as A chamber configured to engage with a medical fastener box, the medical fastener box being configured to reload one of a plurality of medical fasteners into the chamber when the attachment assembly is in the second configuration, upon release of the medical fastener from the surgical instrument.

4. The surgical tool according to claim 1 or 2, wherein the bone removal tool comprises a sharpening blade.

5. The surgical instrument according to claim 1 or 2, wherein the axial actuator is selected from electric motors, hydraulic actuators, screw actuators, rack and pinion assemblies, and piezoelectric actuators.

6. The surgical tool according to claim 1 or 2, wherein the biasing member comprises a spring.

7. A surgical system comprising: Surgical navigation system; as well as Surgical instruments, the surgical instruments including: A tracking array, configured to be detected by the surgical navigation system. Attachment component, the attachment component comprising: Clips configured to interchangeably engage medical fasteners or bone removal tools. A sleeve, slidable relative to the collet between a first configuration and a second configuration, the sleeve including a sleeve recess. A biasing member configured to bias the sleeve toward the first configuration, and A pawl, located within the sleeve recess, wherein the medical fastener or the bone removal tool is inserted into the collet, causing the pawl to move into and at least partially occupy the corresponding recess of the medical fastener or the bone removal tool, wherein in the first configuration, the sleeve abuts against the pawl, thereby maintaining the pawl in its position within the corresponding recess of the medical fastener or the bone removal tool and restricting axial movement of the medical fastener or the bone removal tool. A rotary actuator configured to rotatably drive the attachment assembly; Stops; and An axial actuator is configured to axially drive the attachment assembly between a first position and a second position, wherein when the attachment assembly is driven by the axial actuator to approach the second position, the sleeve contacts the stop, thereby causing the sleeve to slide relative to the collet into the second configuration, thereby causing the pawl to move radially into the sleeve recess and vacate the corresponding recess of the medical fastener, thereby releasing the medical fastener at a predetermined depth corresponding to the second position.

8. The surgical system of claim 7, wherein the pawl comprises a ball bearing.

9. The surgical system according to claim 7 or 8, wherein the surgical tool further comprises: cylinder; as well as A chamber configured to engage with a medical fastener box, the medical fastener box being configured to reload one of a plurality of medical fasteners into the chamber when the attachment assembly is in the second configuration, upon release of the medical fastener from the surgical instrument.

10. The surgical system of claim 7 or 8, wherein the bone removal tool comprises a sharpening blade.

11. The surgical system according to claim 7 or 8, wherein the axial actuator is selected from electric motors, hydraulic actuators, screw actuators, rack and pinion assemblies, and piezoelectric actuators.

12. The surgical system according to claim 7 or 8, further comprising: Medical fastener box, the medical fastener box comprising: Multiple medical fasteners, and One or more trackers, the one or more trackers being configured to be detected by the surgical navigation system.

13. The surgical system of claim 12, further comprising: A robotic arm configured to manipulate the surgical instrument, wherein the robotic arm is configured to be controlled to selectively engage the surgical instrument with one of a plurality of medical fasteners in the medical fastener housing.

Images