Fixing device

Abstract

This application relates to a fixation device, particularly a fixation device for fixing a navigation array to a bone structure for use in robot-assisted surgery, comprising: a trocar; a cortical pin configured to be inserted into the trocar; a dowel pin configured to be attached to the cortical pin, wherein the dowel pin is configured to prevent the cortical pin from rotating in the bone structure; and a navigation array configured to be removably attached to the cortical pin.

Description

[0001] Cross - Reference to Related Applications

[0002] This application is a continuation-in-part of U.S. application Ser. No. 16 / 841,927, filed Apr. 7, 2020, which is a continuation-in-part of U.S. application Ser. No. 16 / 737,054, filed Jan. 8, 2020, which is a continuation-in-part of U.S. application Ser. No. 16 / 587,203, filed Sep. 30, 2019. U.S. application Ser. No. 16 / 737,054 also claims the benefit of U.S. Provisional Application No. 62 / 906,831, filed Sep. 27, 2019. The content of each of these applications is incorporated herein by reference in its entirety for all purposes. Technical Field

[0003] This disclosure relates to medical devices and systems, and more particularly, to robotic systems and associated end effectors for controlling the cutting of a patient's anatomy, as well as related methods and devices. Background Art

[0004] Total Knee Arthroplasty (TKA) involves placing implants on the resected surfaces of the distal femur and proximal tibia. The position and orientation of the resection planning define the position and orientation of the implant, which in turn affects the patient's prognosis. Surgeons need to use navigation techniques to place the implant, which enables them to more precisely plan and place the implant based on the patient's existing anatomy.

[0005] In the case of using navigation, a certain degree of reference to the human anatomy is required to allow the robotic system to correctly orient, align, and perform surgical actions. Although various methods can be employed, one method involves rigidly placing optical reference / tracking arrays (further referred to as "arrays") on the anatomy and referencing them to a global coordinate system. To ensure a rigid connection, especially in the case of orthopedic surgery, cortical pins can be placed into the bone and the arrays can be connected to the cortical pins.

[0006] Some requirements for the placement and function of the pins may be: (1) a rigid connection between the anatomy (bone) and the array; (2) no unwanted rotation of the array relative to the referenced anatomy; (3) no unwanted translation / bending of the array relative to the referenced anatomy; (4) minimal soft tissue damage; (5) minimal bone damage; (6) minimizing the risk of nerve / vascular injury; (7) being as minimally invasive as possible; and (8) being manually placed by one person without navigation.

[0007] However, placing navigation arrays on the femur and tibia using cortical pins may have some disadvantages. For example, two incisions may be required to place the pins, increasing the risk of infection and surgical time. Accidentally piercing the bone may cause bone instability at the end of the surgery and increase the spots where the patient's body heals. Placing the pins in the correct orientation and pattern / distance can only be done using a jig or (after multiple surgeries) by experience, so it is difficult for inexperienced surgeons. The penetration depth, angular orientation, and position can be arbitrary and thus depend on experience. The risk of fracture increases with the number of pins and holes implanted in the cortical wall.

[0008] Accordingly, a device and / or method that meets the above eight requirements is needed to rigidly attach an optical navigation array to a human anatomical structure, particularly a bone, such as the tibia and femur. Other application areas may also be included, such as using it with other bone structures, using it in animals, for rigidly attaching broken bones, or for fixing structures other than optical tracking arrays. Summary of the Invention

[0009] Some embodiments of the present invention are directed to a fixation device for fixing a navigation array to a bone structure for use in robot-assisted surgery. The fixation device includes a trocar, a cortical pin configured to be inserted into the trocar, and a dowel configured to be attached to the cortical pin. The dowel is configured to prevent the cortical pin from rotating in the bone structure. The fixation device includes a navigation array configured to be removably attached to the cortical pin.

[0010] Some embodiments of the present invention are directed to a method for performing knee arthroplasty surgery using a fixation device for fixing a navigation array to a bone structure for use in robot-assisted surgery. The method includes inserting a trocar through an incision in the patient's soft tissue, inserting a cortical pin through the trocar into the patient's bone, and deploying a dowel into the bone. The dowel is disposed at the tip of the cortical pin and is configured to be disposed in the bone in a manner that prevents the fixation device from rotating. The method includes attaching a navigation array to the cortical pin and registering the patient with a navigation system. Brief Description of the Drawings

[0011] The drawings illustrate certain non-limiting embodiments of the inventive concept, which are included to provide a further understanding of the present disclosure and are incorporated in and form a part of this application. In the drawings:

[0012] Figure 1 An embodiment of a surgical system according to some embodiments of the present disclosure is shown;

[0013] Figure 2 Shown according to some embodiments of the present disclosure Figure 1The surgical robot component of a surgical system;

[0014] Figure 3 Shows, according to some embodiments of the present disclosure, Figure 1 The camera tracking system component of a surgical system;

[0015] Figure 4 Shows an embodiment of a passive end effector that can be connected to a robotic arm and configured according to some embodiments of the present disclosure;

[0016] Figure 5 Shows a medical procedure in which a surgical robot and a camera system are positioned around a patient;

[0017] Figure 6 Shows an embodiment of an end effector coupler of a robotic arm configured to be connected to a passive end effector according to some embodiments of the present disclosure;

[0018] Figure 7 Shows Figure 6 An embodiment of a cross-sectional view of an end effector coupler;

[0019] Figure 8 Shows a block diagram of components of a surgical system according to some embodiments of the present disclosure;

[0020] Figure 9 Shows a block diagram of a surgical system computer platform according to some embodiments of the present disclosure, the surgical system computer platform including a surgical planning computer, the surgical planning computer being separable from and operatively connected to, or at least partially integrated with, the surgical robot herein;

[0021] Figure 10 Shows an embodiment of a C-arm imaging device that can be used in combination with a surgical robot and a passive end effector according to some embodiments of the present disclosure;

[0022] Figure 11 Shows an embodiment of an O-arm imaging device that can be used in combination with a surgical robot and a passive end effector according to some embodiments of the present disclosure; and

[0023] Figures 12 - 19 Shows an alternative embodiment of a passive end effector configured according to some embodiments of the present disclosure.

[0024] Figure 20 Is a screenshot showing the progress of bone cutting during surgery.

[0025] Figure 21Shows an exemplary embodiment of a direct blade guidance system consistent with the principles of the present disclosure.

[0026] Figure 22 Shows an exemplary embodiment of a direct blade guidance system consistent with the principles of the present disclosure.

[0027] Figures 23 - 24 Shows an exemplary embodiment of a part of a direct blade guidance system consistent with the principles of the present disclosure.

[0028] Figure 25 Shows an exemplary embodiment of a direct blade guidance system consistent with the principles of the present disclosure.

[0029] Figure 26 Shows an exemplary embodiment of a direct blade guidance system consistent with the principles of the present disclosure.

[0030] Figure 27 Shows an exemplary embodiment of a direct blade guidance system consistent with the principles of the present disclosure.

[0031] Figure 28 Shows an exemplary embodiment of a part of a direct blade guidance system consistent with the principles of the present disclosure.

[0032] Figures 29 - 30 Shows an exemplary embodiment of a direct blade guidance system consistent with the principles of the present disclosure.

[0033] Figure 31 Shows an exemplary embodiment of a blade adapter consistent with the principles of the present disclosure.

[0034] Figure 32 Shows an exemplary embodiment of a direct blade guidance system consistent with the principles of the present disclosure.

[0035] Figure 33 Shows a flowchart of a method for performing a knee surgery consistent with the principles of the present disclosure.

[0036] Figures 34 - 37 Shows a navigation pin guide drive system consistent with the principles of the present disclosure.

[0037] Figure 38 Shows a cutting block pin inserted using a navigation pin guide drive system consistent with the principles of the present disclosure.

[0038] Figures 39 - 40 Shows a cutting block inserted using a navigation pin guide drive system consistent with the principles of the present disclosure.

[0039] Figure 41 Shows a navigation pin guide drive system consistent with the principles of the present disclosure.

[0040] Figure 42 Shows a cutting block inserted using a navigation pin to guide the drive system, consistent with the principles of the present disclosure.

[0041] Figure 43 Shows a knee joint resected using a navigation pin to guide the drive system, consistent with the principles of the present disclosure.

[0042] Figure 44 Shows a navigation pin-guided drive system consistent with the principles of the present disclosure.

[0043] Figure 45 Shows a cutting block inserted using a navigation pin to guide the drive system, consistent with the principles of the present disclosure.

[0044] Figure 46 Shows a fixing device for a navigation array consistent with the principles of the present disclosure.

[0045] Figure 47 Shows a fixing device for a navigation array consistent with the principles of the present disclosure.

[0046] Figure 48 Shows a fixing device for a navigation array consistent with the principles of the present disclosure.

[0047] Figure 49 Shows a fixing device for a navigation array consistent with the principles of the present disclosure.

[0048] Figures 50A - 51C Shows an exemplary anti-rotation pin consistent with the principles of the present disclosure.

[0049] Figure 52 Shows a fixing device for a navigation array consistent with the principles of the present disclosure. Detailed Description

[0050] The inventive concept will now be described more fully hereinafter with reference to the accompanying drawings, in which examples of embodiments of the inventive concept are shown. However, the inventive concept may be embodied in many different forms and should not be construed as limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of each inventive concept to those skilled in the art. It should also be noted that these embodiments are not mutually exclusive. Components in one embodiment may be assumed to be present in or used in another embodiment.

[0051] Each embodiment disclosed herein relates to an improvement in the operation of a surgical system during a surgical intervention that requires osteotomy. A passive end effector connectable to a robotic arm positioned by a surgical robot is disclosed. The passive end effector has a pair of mechanisms that limit the movement of a tool attachment mechanism within a certain range of movement. The tool attachment can be connected to a surgical saw for cutting, such as a sagittal saw having an oscillating blade. The mechanism can be configured to limit the cutting plane of the saw blade to be parallel to the working plane. The surgical robot can determine the pose of the target plane based on a surgical plan that defines the location of the anatomical structure to be cut and based on the pose of the anatomical structure, and can generate manipulation information based on a comparison of the pose of the target plane with the pose of the surgical saw. The manipulation information indicates where the passive end effector needs to move so that the cutting plane of the saw blade becomes aligned with the target plane, and the saw blade is positioned at a certain distance from the anatomical structure to be cut, the distance being within the range of movement of the tool attachment mechanism of the passive end effector.

[0052] Compared to other robotic and manual (e.g., clamp) solutions for surgery, these and other related embodiments can operate to improve the accuracy of saw blade guidance. The mechanisms of the passive end effector can allow a surgeon to focus on interpreting direct force feedback when cutting bone using a surgical saw guided by the passive end effector. The mechanism can be a planar mechanism, such as an end joint having 1 to 3 appropriately selected degrees of freedom (e.g., one translation or rotation, two rotations, three rotations, or other combinations, etc.), which is configured to limit the cutting plane to be aligned with the target plane. The surgeon can also more precisely detect and control the speed of bone removal based on audio and / or visual notification feedback provided by the surgical robot.

[0053] These embodiments can provide guidance during arthroscopic surgery with high precision, high rigidity, sufficient workspace, and direct force feedback, and particularly during knee surgery. As will be explained in detail below, a tracking system can be used to precisely align the cutting plane with the target plane to cut bone. When the surgeon moves the saw blade along the cutting plane and directly senses the force feedback of the saw blade cutting bone, high-precision cutting can be achieved by a planar mechanism that restricts the cutting plane to remain aligned with the target plane. In addition, these embodiments can be quickly adopted into surgical practice through defined changes in existing recognized surgical workflows.

[0054] Figure 1 An embodiment of a surgical system 2 according to some embodiments of the present disclosure is shown. Before performing an orthopedic surgery, for example, Figure 10 a C-arm imaging device 104 orFigure 11 An O-arm imaging device 106, or another medical imaging device such as a computed tomography (CT) image or an MRI, performs a three-dimensional (“3D”) image scan of a planned surgical area of a patient. This scan can be performed preoperatively (e.g., several weeks before surgery, most commonly) or intraoperatively. However, any known 3D or 2D image scan can be used according to various embodiments of the surgical system 2. The image scan is sent to a computer platform in communication with the surgical system 2, such as Figure 9 the surgical system computer platform 900, which includes a surgical robot 800 (e.g., Figure 1 the robot 2 in Figure 9 ) and a surgical planning computer 910. The surgeon views one or more image scans on a display device of the surgical planning computer 910 ( Figure 9 ) and generates a surgical plan that defines a target plane in which to cut the patient's anatomy. This plane is a function of the patient's anatomical constraints, the selected implant, and its size. In some embodiments, the surgical plan that defines the target plane is projected onto the 3D image scan displayed on the display device.

[0055] Figure 1 The surgical system 2 of can assist the surgeon during a medical procedure by, for example, holding tools, aligning tools, using tools, guiding tools, and / or positioning tools for use. In some embodiments, the surgical system 2 includes a surgical robot 4 and a camera tracking system 6. The two systems can be mechanically coupled together by any of a variety of mechanisms. Suitable mechanisms can include, but are not limited to, mechanical latches, tethers, clamps, or supports, or magnetic surfaces or magnetized surfaces. The ability to mechanically couple the surgical robot 4 and the camera tracking system 6 can allow the surgical system 2 to be manipulated and moved as a single unit, and can allow the surgical system 2 to have a small footprint in the area, allowing for easier movement through narrow passageways and around turns, and allowing for storage within a smaller area.

[0056] An orthopedic surgery can begin with the surgical system 2 being moved from a medical storage room to a medical procedure room. The surgical system 2 can be maneuvered through doorways, hallways, and elevators to reach the medical procedure room. Inside the medical procedure room, the surgical system 2 can be physically separated into two separate and distinct systems (the surgical robot 4 and the camera tracking system 6). The surgical robot 4 can be positioned in any suitable location adjacent to the patient to appropriately assist the medical staff. The camera tracking system 6 can be positioned at the foot of the patient, at the patient's shoulder, or at any other location suitable for tracking the current pose and pose movements of the surgical robot 4 and the portion of the patient's trajectory. The surgical robot 4 and the camera tracking system 6 can be powered by an on-board power supply and / or plugged into an exterior wall outlet.

[0057] Surgical robot 4 can be used to assist a surgeon by holding and / or using tools during a medical procedure. To properly utilize and hold the tools, surgical robot 4 can rely on multiple motors, computers, and / or actuators to function properly. As Figure 1 shown, robot body 8 can serve as a structure within which multiple motors, computers, and / or actuators can be secured within surgical robot 4. Robot body 8 can also provide support for robot telescoping support arm 16. In some embodiments, robot body 8 can be made of any suitable material. Suitable materials can be, but are not limited to, metals such as titanium, aluminum, or stainless steel, carbon fiber, fiberglass, or heavy plastics. The size of robot body 8 can provide a stable platform for supporting the attachment assembly and can house, conceal, and protect the multiple motors, computers, and / or actuators that can operate the attachment assembly.

[0058] Robot base 10 can serve as the lower support of surgical robot 4. In some embodiments, robot base 10 can support robot body 8 and can attach robot body 8 to multiple powered wheels 12. This attachment to the wheels can allow robot body 8 to move effectively in space. Robot base 10 can run along the length and width of robot body 8. Robot base 10 can be from about two inches to about 10 inches high. Robot base 10 can be made of any suitable material. Suitable materials can be, but are not limited to, metals such as titanium, aluminum, or stainless steel, carbon fiber, fiberglass, or heavy plastics or resins. Robot base 10 can cover, protect, and support the driven wheels 12.

[0059] In some embodiments, as Figure 1As shown, at least one drive wheel 12 can be attached to the robotic base 10. The drive wheel 12 can be attached to the robotic base 10 at any location. Each individual drive wheel 12 can rotate about a vertical axis in any direction. A motor can be positioned above, within, or adjacent to the drive wheel 12. Such a motor can allow the surgical system 2 to be maneuvered to any position and stabilize and / or level the surgical system 2. A rod located within or adjacent to the drive wheel 12 can be pressed into a surface by the motor. The rod (not shown) can be made of any suitable metal to lift the surgical system 2. Suitable metals can be, but are not limited to, stainless steel, aluminum, or titanium. Additionally, the rod can include a buffer (not shown) at the surface contact side end, which can prevent the rod from slipping and / or create a suitable contact surface. The material can be any suitable material that acts as a buffer. Suitable materials can be, but are not limited to, plastic, neoprene, rubber, or textured metal. The rod can lift the drive wheel 10, which can lift the surgical system 2 to any height required to level or otherwise fix the orientation of the surgical system 2 relative to the patient. The weight of the surgical system 2 is supported by the small contact areas of the rods on each wheel, preventing the surgical system 2 from moving during a medical procedure. This rigid positioning can prevent an object and / or person from accidentally moving the surgical system 2.

[0060] The movement of the mobile surgical system 2 can be facilitated using a robotic track 14. The robotic track 14 provides the ability to move the surgical system 2 without grasping the robotic body 8. As Figure 1 shown, the length of the robotic track 14 can be as long as, shorter than, and / or longer than the robotic body 8. The robotic track 14 can be made of any suitable material. Suitable materials can be, but are not limited to, metals such as titanium, aluminum, or stainless steel, carbon fiber, fiberglass, or heavy-duty plastic. The robotic track 14 can further provide protection to the robotic body 8, thereby preventing an object and / or medical staff from contacting, hitting, or bumping into the robotic body 8.

[0061] The robotic body 8 can provide support for a Selective Compliance Articulated Robot Arm, hereinafter referred to as "SCARA". Due to the repeatability and compactness of the robotic arm, it may be advantageous to use a SCARA 24 within the surgical system 2. The compactness of the SCARA can provide additional space within a medical procedure, which can allow medical professionals to perform medical procedures without excessive clutter and restricted areas. The SCARA 24 can include a robotic telescoping support 16, a robotic support arm 18, and / or a robotic arm 20. The robotic telescoping support 16 can be positioned along the robotic body 8. As Figure 1As shown, the robotic telescoping support 16 can provide support for the SCARA 24 and the display 34. In some embodiments, the robotic telescoping support 16 can extend and contract in the vertical direction. The robotic telescoping support 16 can be made of any suitable material. Suitable materials can be, but are not limited to, metals such as titanium or stainless steel, carbon fiber, fiberglass, or heavy-duty plastics. The body of the robotic telescoping support 16 can be any width and / or height to support the stress and weight placed thereon.

[0062] In some embodiments, a medical staff member can move the SCARA 24 via a command submitted by the medical staff member. The command can originate from an input received on the display 34 and / or a tablet computer. The command can come from a press of a switch and / or a press of multiple switches. As Figure 4 and 5 best shown, the activation assembly 60 can include a switch and / or multiple switches. The activation assembly 60 can be operable to transmit a movement command to the SCARA 24, thereby allowing an operator to manually manipulate the SCARA 24. When the switch or multiple switches are pressed, the medical staff member has the ability to easily move the SCARA 24. Additionally, when the SCARA 24 does not receive a command to move, the SCARA 24 can be locked in place to prevent accidental movement by the medical staff member and / or other objects. By locking in place, the SCARA 24 provides a stable platform on which, as Figure 4 and 5 shown, the passive end effector 1100 and the connected surgical saw 1140 are ready for a medical procedure.

[0063] The robotic support arm 18 can be positioned on the robotic telescoping support 16 via various mechanisms. In some embodiments, best seen in Figure 1 and 2 , the robotic support arm 18 rotates in any direction relative to the robotic telescoping support 16. The robotic support arm 18 can rotate three hundred and sixty degrees around the robotic telescoping support 16. The robotic arm 20 can be connected to the robotic support arm 18 at any suitable location. The robotic arm 20 can be attached to the robotic support arm 16 via various mechanisms. Suitable mechanisms can be, but are not limited to, nuts and bolts, ball-and-socket joints, press fits, weldments, adhesives, screws, rivets, clamps, latches, and / or any combination thereof. The robotic arm 20 can rotate in any direction relative to the robotic support arm 18. In an embodiment, the robotic arm 20 can rotate three hundred and sixty degrees relative to the robotic support arm 18. This free rotation can allow an operator to position the robotic arm 20 as planned.

[0064] Figure 4 and 5The passive end effector 1100 therein can be attached to the robotic arm 20 at any suitable location. As will be further explained in detail below, the passive end effector 1100 includes a base, a first mechanism, and a second mechanism. The base is configured to be attached to the end effector coupler 22 of the robotic arm 20 positioned by the surgical robot 4. The various mechanisms can include, but are not limited to, latches, clamps, nuts and bolts, ball and socket joints, press fits, welds, adhesives, screws, rivets, and / or any combination thereof, and the base can be attached to the end effector coupler 22 through the various mechanisms. The first mechanism extends between a rotatable connection to the base and a rotatable connection to the tool attachment mechanism. The second mechanism extends between a rotatable connection to the base and a rotatable connection to the tool attachment mechanism. The first mechanism and the second mechanism pivot about the rotatable connection and can be configured to limit the movement of the tool attachment mechanism to a range of movement within the working plane. The rotatable connection can be a pivot joint allowing 1 degree of freedom (DOF) of movement, a universal joint allowing 2 DOFs of movement, or a spherical joint allowing 3 DOFs of movement. The tool attachment mechanism is configured to be connected to a surgical saw 1140 having a saw blade or directly to the saw blade. The surgical saw 1140 can be configured to oscillate the saw blade for cutting. The first mechanism and the second mechanism can be configured to limit the cutting plane of the saw blade to be parallel to the working plane. When the passive end effector is to be configured to limit the movement of the saw blade to the cutting plane, a pivot joint can preferably be used to connect the planar mechanism.

[0065] The tool attachment mechanism can be connected to the surgical saw 1140 or the saw blade through various mechanisms, which can include, but are not limited to, screws, nuts and bolts, clamps, latches, tethers, press fits, or magnets. In some embodiments, the dynamic reference array 52 is attached to the passive end effector 1100, such as attached to the tool attachment mechanism, and / or attached to the surgical saw 1140. The dynamic reference array (also referred to herein as "DRA") is a rigid body that can be positioned on the patient, the surgical robot, the passive end effector, and / or the surgical saw during a navigated surgical procedure. The camera tracking system 6 or other 3D positioning system is configured to track the pose (e.g., position and rotational orientation) of the tracking markers of the DRA in real time. The tracking markers can include the arrangement of balls or other optical markers shown. This tracking of the 3D coordinates of the tracking markers can allow the surgical system 2 to determine the pose of the DRA 52 in any space relative to Figure 5 the target anatomical structure of the patient 50 therein.

[0066] As Figure 1As shown, the light indicator 28 can be positioned at the top of the SCARA 24. The light indicator 28 can be lit in any type of light to indicate the "status" of the current operation of the surgical system 2 therein. For example, green illumination can indicate that all systems are normal. A red light can indicate that the surgical system 2 is not operating properly. A pulsating light can mean that the surgical system 2 is performing a function. Combinations of lights and pulsations can produce an almost infinite number of combinations in which the current operating conditions, status, or other operating instructions are conveyed. In some embodiments, the light can be produced by an LED bulb, which can form a ring around the light indicator 28. The light indicator 28 can include a fully permeable material that can allow the light to pass through the entirety of the light indicator 28.

[0067] The light indicator 28 can be attached to the lower display support 30. As Figure 2 shown, the lower display support 30 can allow the operator to manipulate the display 34 to any suitable position. The lower display support 30 can be attached to the light indicator 28 by any suitable mechanism. In an embodiment, the lower display support 30 can rotate around the light indicator 28. In an embodiment, the lower display support 30 can be rigidly attached to the light indicator 28. Then, the light indicator 28 can rotate 360 degrees around the robotic support arm 18. The lower display support 30 can be of any suitable length, and a suitable length can be from about eight inches to about thirty-four inches. The lower display support 30 can act as a base for the upper display support 32.

[0068] The upper display support 32 can be attached to the lower display support 30 by any suitable mechanism. The upper display support 32 can be of any suitable length, and a suitable length can be from about eight inches to about thirty-four inches. In an embodiment, as Figure 1 shown, the upper display support 32 can allow the display 34 to rotate 360 degrees relative to the upper display support 32. Similarly, the upper display support 32 can rotate 360 degrees relative to the lower display support 30.

[0069] The display 34 can be any device supported by the upper display support 32. In an embodiment, as Figure 2 shown, the display 34 can produce color and / or black and white images. The width of the display 34 can be from about eight inches to about thirty inches wide. The height of the display 34 can be from about six inches to about twenty-two inches high. The depth of the display 34 can be from about half an inch to about four inches.

[0070] In an embodiment, the tablet computer can be used in combination with and / or without the display 34. In an embodiment, the table can be placed on the upper display support 32, replacing the display 34, and can be removed from the upper display support 32 during a medical operation. Additionally, the tablet computer can communicate with the display 34. The tablet computer can be connected to the surgical robot 4 via any suitable wireless and / or wired connection. In some embodiments, the tablet computer can program and / or control the surgical system 2 during a medical operation. When the surgical system 2 is controlled by the tablet computer, all input and output commands can be replicated on the display 34. Using the tablet computer can allow the operator to manipulate the surgical robot 4 without having to move around the patient 50 and / or the surgical robot 4.

[0071] As Figure 5 shown, the camera tracking system 6 works in cooperation with the surgical robot 4 via a wired or wireless communication network. Referring Figure 1 to 5 and, the camera tracking system 6 can include some components similar to those of the surgical robot 4. For example, the camera body 36 can provide functions found in the robot body 8. The robot body 8 can provide a structure on which the camera 46 is mounted. The structure within the robot body 8 can also provide support for the electronic devices, communication means, and power supply for operating the camera tracking system 6. The camera body 36 can be made of the same material as the robot body 8. The camera tracking system 6 can communicate directly with the tablet computer and / or the display 34 via a wireless and / or wired network so that the tablet computer and / or the display 34 can control the functions of the camera tracking system 6.

[0072] The camera body 36 is supported by the camera base 38. The camera base 38 can serve as the robot base 10. In Figure 1 an embodiment, the camera base 38 can be wider than the robot base 10. The width of the camera base 38 can allow the camera tracking system 6 to be connected to the surgical robot 4. As Figure 1 shown, the width of the camera base 38 can be large enough to fit over the outside of the robot base 10. When the camera tracking system 6 is connected to the surgical robot 4, the additional width of the camera base 38 can allow the surgical system 2 to provide additional maneuverability and support for the surgical system 2.

[0073] Similar to the robot base 10, a plurality of drive wheels 12 can be attached to the camera base 38. Similar to the operation of the robot base 10 and the driven wheels 12, the driven wheels 12 can allow the camera tracking system 6 to be stabilized and leveled or set to a fixed orientation relative to the patient 50. This stabilization can prevent the camera tracking system 6 from moving during a medical procedure and can prevent the camera 46 from losing sight of Figure 5Tracking of one or more DRAs 52 within the designated region 56 shown that are connected to the anatomical structure 54 and / or the tool 58. This stability and maintenance of the tracking enhances the ability of the surgical robot 4 to operate effectively with the camera tracking system 6. Additionally, the wide camera base 38 can provide additional support for the camera tracking system 6. Specifically, as Figure 5 shown, when the camera 46 is positioned on the patient, the wide camera base 38 can prevent the camera tracking system 6 from tipping over. In the absence of the wide camera base 38, the protruding camera 46 may unbalance the camera tracking system 6, which could cause the camera tracking system 6 to topple over.

[0074] The camera telescoping support 40 can support the camera 46. In an embodiment, the telescoping support 40 can move the camera 46 higher or lower in the vertical direction. The telescoping support 40 can be made of any suitable material that supports the camera 46. Suitable materials can be, but are not limited to, metals such as titanium, aluminum, or stainless steel, carbon fiber, fiberglass, or heavy-duty plastics. The camera handle 48 can be attached to the camera telescoping support 40 at any suitable location. The camera handle 48 can be any suitable handle configuration. Suitable configurations can be, but are not limited to, bar-shaped, round, triangular, square, and / or any combination thereof. As Figure 1 shown, the camera handle 48 can be triangular, allowing the operator to move the camera tracking system 6 to a planned position prior to a medical procedure. In an embodiment, the camera handle 48 can be used to lower and raise the camera telescoping support 40. The camera handle 48 can perform the raising and lowering of the camera telescoping support 40 by pressing buttons, switches, levers, and / or any combination thereof.

[0075] The lower camera support arm 42 can be attached to the camera telescoping support 40 at any suitable location. In an embodiment, as Figure 1As shown, the lower camera support arm 42 can rotate 360 degrees around the telescopic support 40. This free rotation can allow the operator to position the camera 46 in any suitable position. The lower camera support arm 42 can be made of any suitable material that supports the camera 46. Suitable materials can include, but are not limited to, metals such as titanium, aluminum, or stainless steel, carbon fiber, fiberglass, or heavy-duty plastics. The cross-section of the lower camera support arm 42 can be any suitable shape. Suitable cross-sectional shapes can include, but are not limited to, circular, square, rectangular, hexagonal, octagonal, or I-beam. The length and width of the cross-section can be approximately one to ten inches. The length of the lower camera support arm can be approximately four inches to approximately thirty-six inches. The lower camera support arm 42 can be connected to the telescopic support 40 by any suitable mechanism. Suitable mechanisms can include, but are not limited to, nuts and bolts, ball-and-socket joints, press fits, weldments, adhesives, screws, rivets, clamps, latches, and / or any combination thereof. The lower camera support arm 42 can be used to provide support for the camera 46. The camera 46 can be attached to the lower camera support arm 42 by any suitable mechanism. Suitable mechanisms can include, but are not limited to, nuts and bolts, ball-and-socket joints, press fits, weldments, adhesives, screws, rivets, and / or any combination thereof. The camera 46 can pivot in any direction at the attachment area between the camera 46 and the lower camera support arm 42. In an embodiment, the curved track 44 can be disposed on the lower camera support arm 42.

[0076] The curved track 44 can be disposed at any suitable position on the lower camera support arm 42. As Figure 3 shown, the curved track 44 can be attached to the lower camera support arm 42 by any suitable mechanism. Suitable mechanisms can include, but are not limited to, nuts and bolts, ball-and-socket joints, press fits, weldments, adhesives, screws, rivets, clamps, latches, and / or any combination thereof. The curved track 44 can be any suitable shape, and suitable shapes can include crescent, circular, flat, oval, and / or any combination thereof. In an embodiment, the curved track 44 can be any appropriate length. The appropriate length can be approximately one foot to approximately six feet. The camera 46 can be movably disposed along the curved track 44. The camera 46 can be attached to the curved track 44 by any suitable mechanism. Suitable mechanisms can include, but are not limited to, rollers, brackets, braces, motors, and / or any combination thereof. Motors and rollers (not shown) can be used to move the camera 46 along the curved track 44. As Figure 3As shown, during a medical procedure, if an object blocks the camera 46 from viewing one or more DRAs 52, the motor can move the camera 46 along the curved track 44 using the rollers. This maneuverable movement can allow the camera 46 to move to a new position where it is no longer blocked by the object, without moving the camera tracking system 6. When there is an obstruction to the camera 46 viewing the DRA 52, the camera tracking system 6 can send a stop signal to the surgical robot 4, the display 34, and / or the tablet computer. The stop signal can prevent the SCARA 24 from moving until the camera 46 reacquires the DRA 52. This stop can prevent the SCARA 24 and / or the end effector coupler 22 from moving and / or using the medical tool without being tracked by the surgical system 2.

[0077] As Figure 6 shown, the end effector coupler 22 is configured to attach various types of passive end effectors to the surgical robot 4. The end effector coupler 22 can include a saddle joint 62, an activation assembly 60, a force sensor 64 ( Figure 7 ), and a connector 66. The saddle joint 62 can attach the end effector coupler 22 to the SCARA 24. The saddle joint 62 can be made of any suitable material. Suitable materials can be, but are not limited to, metals such as titanium, aluminum, or stainless steel, carbon fiber, fiberglass, or heavy plastics. The saddle joint 62 can be made of a single piece of metal, which can provide additional strength and durability to the end effector. The saddle joint 62 can be attached to the SCARA 24 through attachment points 68. There can be multiple attachment points 68 disposed around the saddle joint 62. The attachment points 68 can be recessed, flush, and / or disposed on the saddle joint 62. In some instances, screws, nuts, and bolts and / or any combination thereof can pass through the attachment points 68 and secure the saddle joint 62 to the SCARA 24. The nuts and bolts can connect the saddle joint 62 to a motor (not shown) within the SCARA 24. The motor can move the saddle joint 62 in any direction. The motor can further prevent the saddle joint 62 from moving due to accidental collisions and / or accidental contacts by actively servoing in the current position or passively by applying a spring-actuated brake.

[0078] The end effector coupler 22 can include a force sensor 64 inserted between the saddle joint 62 and the attached passive end effector. As Figure 7 shown, the force sensor 64 can be attached to the saddle joint 62 by any suitable mechanism. Suitable mechanisms can be, but are not limited to, screws, nuts, and bolts, threading, press fitting, and / or any combination thereof.

[0079] Figure 8 A block diagram of components of a surgical system 800 in accordance with some embodiments of the present disclosure is shown. Referring to Figure 7 and8 , the force sensor 64 can be any suitable instrument for detecting and measuring force. In some instances, the force sensor 64 can be a six-axis force sensor, a three-axis force sensor, or a single-axis force sensor. The force sensor 64 can be used to track the force applied to the end effector coupler 22. In some embodiments, the force sensor 64 can communicate with a plurality of motors 850, 851, 852, 853, and / or 854. When the force sensor 64 senses a force, information about the amount of the applied force can be distributed from the switch array and / or the plurality of switch arrays to the controller 846. The controller 846 can obtain the force information from the force sensor 64 and process it with a switching algorithm. The controller 846 uses the switching algorithm to control the motor driver 842. The motor driver 842 controls the operation of one or more motors. The motor driver 842 can direct a particular motor to generate, for example, an equal amount of force measured by the force sensor 64 through the motor. In some embodiments, as indicated by the controller 846, the generated force can come from a plurality of motors, such as 850 - 854. Additionally, the motor driver 842 can receive an input from the controller 846. The controller 846 can receive information about the direction of the force sensed by the force sensor 64 from the force sensor 64. The controller 846 can process this information using a motion controller algorithm. The algorithm can be used to provide information to a particular motor driver 842. To replicate the direction of the force, the controller 846 can activate and / or deactivate certain motor drivers 842. The controller 846 can control one or more motors, such as one or more of 850 - 854, to induce movement of the passive end effector 1100 in the direction of the force sensed by the force sensor 64. This force-controlled movement can allow an operator to move the SCARA 24 and the passive end effector 1100 effortlessly and / or with very little resistance. The movement of the passive end effector 1100 can be performed to position the passive end effector 1100 in any suitable orientation (i.e., position and angular orientation relative to a defined three-dimensional (3D) orthogonal reference axis) for use by medical personnel.

[0080] The connector 66 is configured to be connectable to the base of the passive end effector 1100 and connected to the force sensor 64. The connector 66 can include attachment points 68, sensing buttons 70, tool guides 72, and / or tool connectors 74. As Figure 6 and 8As best shown, there can be multiple attachment points 68. The attachment points 68 can connect the connector 66 to the force sensor 64. The attachment points 68 can be recessed, flush, and / or seated on the connector 66. The attachment points 68 and 76 can be used to attach the connector 66 to the force sensor 64 and / or the passive end effector 1100. In some instances, the attachment points 68 and 76 can include screws, nuts, and bolts, press fits, magnetic attachments, and / or any combination thereof.

[0081] As Figure 6 shown, the sensing button 70 can be disposed around the center of the connector 66. When the passive end effector 1100 is connected to the SCARA 24, the sensing button 70 can be depressed. Depressing the sensing button 70 can alert the surgical robot 4 and, in turn, alert the medical staff that the passive end effector 1100 has been attached to the SCARA 24. As Figure 6 shown, the guide 72 can be used to facilitate proper attachment of the passive end effector 1100 to the SCARA 24. The guide 72 can be recessed, flush, and / or seated on the connector 66. In some instances, there can be multiple guides 72, and they can have any suitable pattern and be oriented in any suitable direction. The guide 72 can be any suitable shape to facilitate attaching the passive end effector 1100 to the SCARA 24. Suitable shapes can be, but are not limited to, circular, flat, square, polyhedral, and / or any combination thereof. Additionally, the guide 72 can be cut with chamfers, straight lines, and / or any combination thereof.

[0082] The connector 66 can have an attachment point 74. As Figure 6 shown, the attachment point 74 can form a protrusion and / or multiple protrusions. The attachment point 74 can provide a surface on which the passive end effector 1100 can clamp. In some embodiments, the attachment point 74 is disposed around any surface of the connector 66 and is oriented in any suitable manner relative to the connector 66.

[0083] As Figure 6 and 7As best shown, the activation assembly 60 can surround the connector 66. In some embodiments, the activation assembly 60 can take the form of a bracelet that wraps around the connector 66. In some embodiments, the activation assembly 60 can be located in any suitable area within the surgical system 2. In some instances, the activation assembly 60 can be located on any part of the SCARA 24, any part of the end effector coupler 22, can be worn (and wirelessly communicate) by a medical staff member, and / or any combination thereof. The activation assembly 60 can be made of any suitable material. Suitable materials can include, but are not limited to, neoprene, plastic, rubber, gel, carbon fiber, fabric, and / or any combination thereof. The activation assembly 60 can include a main button 78 and a secondary button 80. The main button 78 and the secondary button 80 can surround the entirety of the connector 66.

[0084] The main button 78 can be a single ridge, as Figure 6 shown, which can surround the connector 66. In some instances, the main button 78 can be positioned on the activation assembly 60 at the end furthest from the saddle joint 62. The main button 78 can be positioned on the main activation switch 82, as Figure 7 best shown. The main activation switch 82 can be positioned between the connector 66 and the activation assembly 60. In some instances, there can be multiple main activation switches 82, and the multiple main activation switches can be positioned adjacent to and beneath the main button 78 along the entire length of the main button 78. Pressing the main button 78 on the main activation switch 82 can allow an operator to move the SCARA 24 and the end effector coupler 22. As described above, once positioned in place, the SCARA 24 and the end effector coupler 22 can not move until the operator programs the surgical robot 4 to move the SCARA 24 and the end effector coupler 22, or uses the main button 78 and the main activation switch 82 to move. In some instances, it may be necessary to press at least two non-adjacent main activation switches 82 before the SCARA 24 and the end effector coupler 22 will respond to an operator command. Pressing at least two main activation switches 82 can prevent accidental movement of the SCARA 24 and the end effector coupler 22 during a medical procedure.

[0085] Activated by the main button 78 and the main activation switch 82, the force sensor 64 can measure the magnitude and / or direction of the force applied by the operator, i.e., the medical staff, on the end effector coupler 22. This information can be transferred to the motors within the SCARA 24, which can be used to move the SCARA 24 and the end effector coupler 22. Information regarding the magnitude and direction of the force measured by the force sensor 64 can cause the motors to move the SCARA 24 and the end effector coupler 22 in the same direction as sensed by the force sensor 64. This force-controlled movement can allow the operator to easily move the SCARA 24 and the end effector coupler 22, and since the motors move the SCARA 24 and the end effector coupler 22 while the operator is moving them, a large amount of effort is not required.

[0086] As Figure 6 shown, the secondary button 80 can be positioned at the end of the activation assembly 60 closest to the saddle joint 62. In some instances, the secondary button 80 can include multiple ridges. The multiple ridges can be positioned adjacent to each other and can surround the connector 66. Additionally, the secondary button 80 can be positioned on the secondary activation switch 84. As Figure 7 shown, the secondary activation switch 84 can be positioned between the secondary button 80 and the connector 66. In some instances, the operator can use the secondary button 80 as a "select" device. During a medical procedure, the surgical robot 4 can notify the medical staff of certain situations via the display 34 and / or the light indicator 28. The surgical robot 4 can prompt the medical staff to select functions, modes, and / or evaluate the situation of the surgical system 2. Pressing the secondary button 80 once on the secondary activation switch 84 can activate certain functions, modes, and / or confirm the information transmitted to the medical staff via the display 34 and / or the light indicator 28. Additionally, pressing the secondary button 80 multiple times in quick succession on the secondary activation switch 84 can initiate additional functions, modes, and / or select the information transmitted to the medical staff via the display 34 and / or the light indicator 28. In some instances, at least two non-adjacent secondary activation switches 84 can be pressed before the secondary button 80 can function properly. This requirement can prevent the accidental collision of the medical staff during the activation of the assembly 60 from resulting in the unintended use of the secondary button 80. The main button 78 and the secondary button 80 can use the software architecture 86 to transmit the commands of the medical staff to the surgical system 2.

[0087] Figure 8FIG. 0 shows a block diagram of components of a surgical system 800 configured according to some embodiments of the present disclosure, and it may correspond to the above surgical system 2. The surgical system 800 includes a platform subsystem 802, a computer subsystem 820, a motion control subsystem 840, and a tracking subsystem 830. The platform subsystem 802 includes a battery 806, a power distribution module 804, a connector panel 808, and a charging station 810. The computer subsystem 820 includes a computer 822, a display 824, and a speaker 826. The motion control subsystem 840 includes drive circuits 842, motors 850, 851, 852, 853, 854, stabilizers 855, 856, 857, 858, an end effector connector 844, and a controller 846. The tracking subsystem 830 includes a position sensor 832 and a camera converter 834. The surgical system 800 may also include a removable foot pedal 880 and a removable tablet computer 890.

[0088] Input power is supplied to the surgical system 800 through a power source, and the power source may be supplied to the power distribution module 804. The power distribution module 804 receives the input power and is configured to generate different power supply voltages and provide the power supply voltages to other modules, components, and subsystems of the surgical system 800. The power distribution module 804 may be configured to provide different voltage supplies to the connector panel 808, and the voltage supplies may be provided to other components such as the computer 822, the display 824, the speaker 826, the driver 842 to power, for example, the motors 850-854 and the end effector coupler 844, and to the camera converter 834 and other components for the surgical system 800. The power distribution module 804 may also be connected to the battery 806, and the battery acts as a temporary power source when the power distribution module 804 does not receive power from the input power source. At other times, the power distribution module 804 may be used to charge the battery 806.

[0089] The connector panel 808 may be used to connect different devices and components to the surgical system 800 and / or related components and modules. The connector panel 808 may include one or more ports that receive lines or connectors from different components. For example, the connector panel 808 may have a ground terminal port for grounding the surgical system 800 to other devices, a port for connecting the foot pedal 880, a port for connecting the tracking subsystem 830, and the tracking subsystem may include a position sensor 832, a camera converter 834, and a marker tracking camera 870. The connector panel 808 may also include other ports to allow USB, Ethernet, and HDMI communication with other components such as the computer 822.

[0090] The control panel 816 can provide various buttons or indicators for controlling the operation of the surgical system 800 and / or providing information from the surgical system 800 for the operator to observe. For example, the control panel 816 can include buttons for turning the surgical system 800 on or off, raising or lowering the vertical column 16, and raising or lowering the stabilizers 855 - 858, which can be designed to engage the casters 12 to lock the surgical system 800 without physically moving it. Other buttons can stop the surgical system 800 in the event of an emergency, which can remove all motor power and apply mechanical brakes to stop all movement from occurring. The control panel 816 can also have indicators for notifying the operator of certain system conditions, such as the line power indicator or the charge status of the battery 806.

[0091] The computer 822 of the computer subsystem 820 includes an operating system and software for operating the designated functions of the surgical system 800. The computer 822 can receive and process information from other components (e.g., the tracking subsystem 830, the platform subsystem 802, and / or the motion control subsystem 840) in order to display information to the operator. Further, the computer subsystem 820 can provide output for the operator via the speaker 826. The speaker can be part of the surgical robot, part of the head - mounted display assembly, or within another component of the surgical system 2. The display 824 can correspond to Figure 1 and 2 the display 34 shown in, or can be a head - mounted display that projects an image onto a fluoroscopic display screen, which forms an augmented reality (AR) image overlaid on real - world objects visible through the fluoroscopic display screen.

[0092] The tracking subsystem 830 can include a position sensor 832 and a camera converter 834. The tracking subsystem 830 can correspond to Figure 3 the camera tracking system 6 of. The marker - tracking camera 870 operates together with the position sensor 832 to determine the pose of the DRA 52. This tracking can be performed in a manner consistent with the present disclosure, which includes using infrared or visible light techniques that separately track the positions of active or passive elements of the DRA 52, such as LEDs or reflective markers. The position, orientation, and positioning of structures such as the DRA 52 with these types of markers are provided to the computer 822 and can be shown to the operator on the display 824. For example, as Figure 4 and 5 shown, the surgical saw 1240 having the DRA 52 or connected to the end - effector coupler 22 can be shown to the operator relative to a three - dimensional image of the patient's anatomy, and the end - effector coupler has the DRA 52 tracked in this way (which can be referred to as the navigation space).

[0093] The motion control subsystem 840 can be configured to physically move the vertical column 16, the upper arm 18, the lower arm 20, or rotate the end effector coupler 22. The physical movement can be performed by using one or more motors 850 - 854. For example, the motor 850 can be configured to vertically lift or lower the vertical column 16. As Figure 2 shown, the motor 851 can be configured to laterally move the upper arm 18 about the joint point with the vertical column 16. As Figure 2 shown, the motor 852 can be configured to laterally move the lower arm 20 about the joint point with the upper arm 18. The motors 853 and 854 can be configured to move the end effector coupler 22 to provide translational movement along three-dimensional axes and rotation about them. Figure 9 The surgical planning computer 910 shown can provide control inputs to the controller 846, which guides the movement of the end effector coupler 22 to position the passive end effector connected thereto in a planned attitude (i.e., position and angular orientation relative to a defined 3D orthogonal reference axis) relative to the anatomical structure to be cut during a surgical procedure. The motion control subsystem 840 can be configured to use integrated position sensors (such as encoders) to measure the position of the passive end effector structure. In one embodiment of the embodiments, the position sensor is directly connected to at least one joint of the passive end effector structure, but can also be positioned at another location in the structure and remotely measure the joint position through an interconnect such as a timing belt, wire, or any other synchronous transmission interconnect.

[0094] Figure 9 A block diagram of a surgical system computer platform 900 according to some embodiments of the present disclosure is shown, the surgical system computer platform including a surgical planning computer 910, which can be separated from and operatively connected to the surgical robot 800 herein, or at least partially integrated therewith. Alternatively, at least a portion of the operations for the surgical planning computer 910 disclosed herein can be performed by components of the surgical robot 800 (such as by the computer subsystem 820).

[0095] Referring Figure 9 , the surgical planning computer 910 includes a display 912, at least one processor circuit 914 (also referred to as a processor for brevity), at least one memory circuit 916 containing computer-readable program code 918 (also referred to as a memory for brevity), and at least one network interface 920 (also referred to as a network interface for brevity). The network interface 920 can be configured to connect to Figure 10 the C-arm imaging device 104 in Figure 11the O-arm imaging device 106 therein, another medical imaging device, the image database 950 of medical images, components of the surgical robot 800, and / or other electronic devices.

[0096] When the surgical planning computer 910 is at least partially integrated within the surgical robot 800, the display 912 can correspond to Figure 2 the display 34 of Figure 8 the tablet computer 890 of Figure 8 and / or the head-mounted display, and the network interface 920 can correspond to Figure 8 the platform network interface 812 of

[0097] The processor 914 can include one or more data processing circuits, such as general and / or special-purpose processors, such as microprocessors and / or digital signal processors. The processor 914 is configured to execute the computer-readable program code 918 in the memory 916 to perform operations, which may include some or all of the operations described herein as being performed by the surgical planning computer.

[0098] The processor 914 is operable to display an image of a bone on the display device 912, receiving the image from one of the imaging devices 104 and 106 and / or from the image database 950 via the network interface 920. The processor 914 receives a definition by the operator of the location at which an anatomical structure (i.e., one or more bones) shown in one or more images is to be cut, such as by the operator touching a selected location on the display 912 for a planned surgical cut, or using a mouse-based cursor to define the location for a planned surgical cut.

[0099] The surgical planning computer 910 is capable of performing anatomical measurements useful for knee surgery, similar to measurements of various angles for determining the center of the hip, the center of the angle, natural landmarks (such as the transepicondylar line, the Whitesides line, the posterior condylar line, etc.). Some measurements can be automatic, while some others involve manual input or assistance. The surgical planning computer 910 allows the operator to select the correct implant for the patient, including the selection of size and alignment. The surgical planning computer 910 is capable of automatically or semi-automatically (involving manual input) segmenting (image processing) CT images or other medical images. The surgical plan for the patient can be stored in a cloud-based server for retrieval by the surgical robot 800. During the surgical procedure, the surgeon will use a computer screen (such as a touch screen) or augmented reality interaction, for example, via a head-mounted display, to select which cuts to make (such as the posterior femur, the proximal tibia, etc.). The surgical robot 4 can automatically move the surgical saw blade to the planned position such that the target plane of the planned cut is optimally placed within the workspace of the passive end effector that interconnects the surgical saw blade and the robotic arm 20. The user can give commands to effect the movement using various means (such as a foot pedal).

[0100] In some embodiments, the surgical system computer platform 900 can use two DRAs to track the patient's anatomical position: one on the patient's tibia and one on the patient's femur. The platform 900 can use standard navigation instruments for registration and inspection (e.g., a pointer similar to the pointer used in the Globus ExcelsiusGPS system for spinal surgery). Tracking markers that allow detection of DRA movement with reference to the tracked anatomical structures can also be used.

[0101] An important difficulty in knee surgery is how to plan the position of the implant in the knee, and many surgeons strive to complete this plan on a computer screen, which is a 2D representation of the 3D anatomy on the computer screen. The platform 900 can solve this problem by using an augmented reality (AR) head-mounted display to generate an implant overlay around the actual patient's knee. For example, the surgeon can operatively display virtual handles to grasp the implant and move it to the desired pose, and adjust the planned implant placement. Then, during the surgery, the platform 900 can provide navigation through the AR head-mounted display to show the surgeon what is not directly visible. Additionally, the progress of bone removal, such as depth or cut, can be displayed in real time. Other features that can be displayed through AR can include but are not limited to the gap or ligament balance along the range of joint motion, the contact line on the implant along the range of joint motion, the ligament tension and / or laxity through color or other graphical overlays, etc.

[0102] In some embodiments, the surgical planning computer 910 can allow the use of standard implants to be planned, such as posterior stabilized implants and cruciate ligament retaining implants, cemented and non-cemented implants, revision systems for surgeries related to, for example, total knee or partial knee and / or hip replacement and / or trauma.

[0103] The processor 912 can graphically display on the display 912 one or more cutting planes that intersect the displayed anatomy at positions selected by the operator for cutting the anatomy. The processor 912 also determines a set or sets of angular orientations and positions at which the end effector coupler 22 must be positioned such that the cutting plane of the surgical saw blade will align with the target plane to perform the cut defined by the operator, and stores the set of angular orientations and positions as data in the surgical planning data structure. The processor 912 uses the known range of motion of the tool attachment mechanism of the passive end effector to determine where the end effector coupler 22 attached to the robotic arm 20 needs to be positioned.

[0104] The computer subsystem 820 of the surgical robot 800 receives data from a surgical planning data structure and receives information from the camera tracking system 6 that indicates the current pose of the anatomical structure to be cut and indicates the current pose of the passive end effector and / or the surgical saw tracked by the DRA. The computer subsystem 820 determines the pose of the target plane based on a surgical plan that defines the location where the anatomical structure is to be cut and based on the pose of the anatomical structure. The computer subsystem 820 generates manipulation information based on a comparison of the pose of the target plane and the pose of the surgical saw. The manipulation information indicates where the passive end effector needs to move so that the cutting plane of the saw blade becomes aligned with the target plane and the saw blade is positioned at a distance from the anatomical structure to be cut, the distance being within the movement range of the tool attachment mechanism of the passive end effector.

[0105] As explained above, the surgical robot includes a robot base, a robot arm connected to the robot base, and at least one motor operatively connected to move the robot arm relative to the robot base. The surgical robot also includes at least one controller, such as the computer subsystem 820 and the motion control subsystem 840, which are connected to at least one motor and are configured to perform operations.

[0106] As will be explained in further detail below with respect to Figures 12 - 19 The passive end effector includes a base configured to be attached to the activation assembly of the robot arm, a first mechanism, and a second mechanism. The first mechanism extends between a rotatable connection to the base and a rotatable connection to the tool attachment mechanism. The second mechanism extends between a rotatable connection to the base and a rotatable connection to the tool attachment mechanism. The first mechanism and the second mechanism pivot about the rotatable connection, which can be configured to limit the movement of the tool attachment mechanism to a movement range within a working plane. The rotatable connection can be a pivot joint that allows 1 degree of freedom (DOF) of movement, a gimbal joint that allows 2 DOFs of movement, or a ball joint that allows 3 DOFs of movement. The tool attachment mechanism is configured to be connected to the surgical saw that includes a saw blade for cutting. The first mechanism and the second mechanism can be configured to limit the cutting plane of the saw blade to be parallel to the working plane.

[0107] In some embodiments, the operations performed by at least one controller of the surgical robot further include controlling the movement of the at least one motor based on the manipulation information to reposition the passive end effector such that the cutting plane of the saw blade becomes aligned with the target plane, and the saw blade is positioned at the distance from the anatomical structure to be cut, the distance being within the movement range of the tool attachment mechanism of the passive end effector. The manipulation information can be displayed to guide the operator to move the surgical saw and / or the at least one controller can use it to automatically move the surgical saw.

[0108] In one embodiment, the operations performed by the at least one controller of the surgical robot further include providing the manipulation information to a display device for display to guide the operator to move the passive end effector such that the cutting plane of the saw blade becomes aligned with the target plane, and the saw blade is positioned at the distance from the anatomical structure to be cut, the distance being within the movement range of the tool attachment mechanism of the passive end effector. The display device can correspond to the display 824( Figure 8 )、 Figure 1 the display 34 of and / or the head-mounted display.

[0109] For example, the manipulation information can be displayed on a head-mounted display that projects an image onto a see-through display screen, the see-through display screen forming an augmented reality image overlaid on real-world objects visible through the see-through display screen. The operation can display a graphical representation of the target plane, the graphical representation having an orientation overlaid on the bone, and the relative orientation therebetween corresponding to the surgical plan for how to cut the bone. The operation can alternatively or additionally display a graphical representation of the saw blade cutting plane such that the operator can more easily align the cutting plane with the planned target plane for cutting the bone. Thus, the operator can visually observe and perform the movement to align the cutting plane of the saw blade with the target plane such that the saw blade is positioned relative to the bone in the planned orientation and within the movement range of the tool attachment mechanism of the passive end effector.

[0110] The automatic imaging system can be used in combination with the surgical planning computer 910 and / or the surgical system 2 to acquire pre-operative, intra-operative, post-operative, and / or real-time image data of the patient. Figure 10 and 11 shows an example automatic imaging system. In some embodiments, the automatic imaging system is an imaging device of the C-arm 104( Figure 10 ) or 106( Figure 11)。(Medtronic Navigation, Inc., which has a place of business in Louisville, Colo., USA) owns the copyright) may desire to perform x-ray examinations of a patient from many different orientations without the need for frequent manual repositioning of the patient, which may be required in an x-ray system. The C-arm 104 x-ray diagnostic device can address the problem of frequent manual repositioning and is well known in the medical field of surgical and other interventional procedures. As Figure 10 shown, the C-arm includes an elongated C-shaped member terminating at opposite distal ends 112 of the "C". The C-shaped member is attached to an x-ray source 114 and an image receiver 116. The space within the C-arm 104 of the arm provides substantially unobstructed space for a doctor to attend to the patient without interference from the x-ray support structure.

[0111] The C-arm is mounted such that the arm can rotate and move in two degrees of freedom (i.e., in a spherical motion about two perpendicular axes). The C-arm is slidably mounted to the x-ray support structure, which allows the C-arm to orbitally rotate about its center of curvature, which can allow selective vertical and / or horizontal orientation of the x-ray source 114 and the image receiver 116. The C-arm can also be rotatable laterally (i.e., in a direction perpendicular to the orbital travel direction such that the positioning of the x-ray source 114 and the image receiver 116 can be selectively adjusted relative to the width and length of the patient). The spherical rotation aspect of the C-arm device allows a doctor to perform x-ray examinations of a patient at an optimal angle determined relative to a particular anatomical condition being imaged.

[0112] Figure 11 shown in 106 includes a gantry housing 124, which may enclose an image capture portion not shown. The image capture portion includes an x-ray source portion and / or an x-ray emitting portion and an x-ray receiving portion and / or an image receiving portion, which may be positioned approximately one hundred and eighty degrees apart from each other and are mounted on a rotor (not shown) relative to the orbit of the image capture portion. The image capture portion can be operatively rotated three hundred and sixty degrees during image acquisition. The image capture portion can rotate about a center point and / or an axis, thereby allowing image data of a patient to be acquired from multiple directions or in multiple planes.

[0113] With the gantry housing 124 106 has a central opening for positioning around an object to be imaged, a radiation source rotatable within the gantry housing 124, the radiation source being adapted to project radiation from a plurality of different projection angles. A detector system is adapted to detect the radiation at each projection angle, thereby acquiring an object image from a plurality of projection planes in a quasi-simultaneous manner. The gantry may be attached to the support structure in a cantilevered fashion a support structure such as a wheeled mobile cart with wheels. The positioning unit preferably translates and / or tilts the gantry to a planned position and orientation under the control of a computerized motion control system. The gantry may include a source and a detector disposed opposite each other on the gantry. The source and the detector may be fixed to a motorized rotor that can rotate the source and the detector around the interior of the gantry in combination with each other. The source may be pulsed at a plurality of positions and orientations in a partial and / or complete three-hundred-sixty-degree rotation to perform multi-planar imaging of a target object positioned within the gantry. The gantry may further include a track and bearing system for guiding the rotor during rotation of the rotor, the track and bearing system being capable of carrying the source and the detector. Both 106 and the C-arm 104 and / or one of them can be used as an automatic imaging system to scan a patient and send information to the surgical system 2.

[0114] The images captured by the automatic imaging system can be displayed on a display device of the surgical planning computer 910, the surgical robot 800, and / or another component of the surgical system 2.

[0115] Now described in the context of Figures 12 - 19 various embodiments of a passive end effector configured for a surgical system.

[0116] As will be further explained in detail below, Figures 12 - 19 each of the various passive end effectors shown includes a base, a first planar mechanism, and a second planar mechanism. The base is configured to be attached to an end effector coupler of a robotic arm (e.g., Figure 1 and 2 the robotic arm 18 in Figure 4 and 5The end effector coupler 22). A variety of clamping mechanisms can be used to firmly attach the base to the end effector coupler, thereby removing clearance and ensuring appropriate stiffness. Irreversible clamping mechanisms that can be used to attach the base to the end effector coupler can include, but are not limited to, toggle mechanisms or one or more irreversible locking screws. The user can use additional tools such as, but not limited to, a screwdriver, torque wrench, or wrench to activate or tighten the clamping mechanism. The first mechanism extends between a rotatable connection to the two bases and a rotatable connection to the tool attachment mechanism. The second mechanism extends between a rotatable connection to the base and a rotatable connection to the tool attachment mechanism. The first mechanism and the second mechanism pivot about the rotatable connection. The rotatable connection can be a pivot joint that allows 1 degree of freedom (DOF) of movement, a universal joint that allows 2 DOF of movement, or a ball joint that allows 3 DOF of movement. When using a pivot joint, the first mechanism and the second mechanism can be configured to limit the movement of the tool attachment mechanism to a range of movement within the working plane. The tool attachment mechanism is configured to connect to a surgical saw having a saw blade configured to oscillate for cutting. The first mechanism and the second mechanism can be configured to limit the cutting plane of the saw blade to be parallel to the working plane, for example, by a pivot joint having 1 DOF of movement. The tool attachment mechanism can be connected to the surgical saw or the saw blade by various mechanisms, which can include, but are not limited to, screws, nuts, and bolts, clamps, latches, tethers, press fits, or magnets. The DRA can be connected to the tool attachment mechanism or the surgical saw to enable tracking of the pose of the saw blade by the camera tracking system 6( Figure 3 ).

[0117] As explained above, a surgical system (e.g., Figure 1 and Figure 2 the surgical system 2) includes a surgical robot (e.g., Figure 1 and Figure 2 the surgical robot 4) and a tracking system (e.g., Figure 1 and Figure 3 the camera tracking system 6), the tracking system being configured to determine the pose of the anatomical structure to be cut by the saw blade and to determine the pose of the saw blade. The surgical robot includes a robot base, a robot arm rotatably connected to the robot base and configured to position a passive end effector. At least one motor is operatively connected to move the robot arm relative to the robot base. At least one controller is connected to the at least one motor and is configured to perform operations that include determining the pose of a target plane based on a surgical plan that defines the location where the anatomical structure is to be cut and based on the pose of the anatomical structure, where the surgical plan can be generated by Figure 9The surgical planning computer 910 is generated based on inputs from an operator (such as a surgeon or other surgical personnel). The operation further includes generating manipulation information based on a comparison of the pose of the target plane and the pose of the surgical saw. The manipulation information indicates where the passive end effector needs to be moved to position the working plane of the passive end effector such that the cutting plane of the saw blade is aligned with the target plane.

[0118] In some additional embodiments, the operation performed by the at least one controller further includes controlling the movement of the at least one motor based on the manipulation information to reposition the passive end effector such that the cutting plane of the saw blade becomes aligned with the target plane and the saw blade is positioned at a distance from the anatomical structure to be cut, the distance being within the movement range of the tool attachment mechanism of the passive end effector.

[0119] The operation may include providing the manipulation information to a display device for display to guide the operator to move the passive end effector such that the cutting plane of the saw blade becomes aligned with the target plane and the saw blade is positioned at a distance from the anatomical structure to be cut, the distance being within the movement range of the tool attachment mechanism of the passive end effector.

[0120] As explained above, some surgical systems may include a head-mounted display device that can be worn by a surgeon, a nurse practitioner, and / or other people assisting with the surgery. The surgical system may display information that allows the wearer to more precisely position the passive end effector and / or confirm that it has been precisely positioned, where the saw blade is aligned with the target plane for cutting at a planned location on the anatomical structure. The operation of providing the manipulation information to the display device may include configuring the manipulation information for display on a head-mounted display device having a see-through display screen that displays the manipulation information as an overlay on the anatomical structure to be cut to guide the operator to move the passive end effector such that the cutting plane of the saw blade becomes aligned with the target plane and the saw blade is positioned at the distance from the anatomical structure within the movement range of the tool attachment mechanism of the passive end effector.

[0121] The operation of configuring the manipulation information for display on the head-mounted display device may include generating a graphical representation of the target plane that is displayed as an overlay anchored to and aligned with the anatomical structure to be cut, and generating another graphical representation of the cutting plane of the saw blade that is displayed as an overlay anchored to and aligned with the saw blade. The wearer can thereby move the surgical saw to provide a visually observed alignment between the graphically presented target plane and the graphically presented cutting plane.

[0122] The operation of configuring the manipulation information for display on the head-mounted display device may include generating a graphical representation of the cutting depth produced by the saw blade as a graphical representation of the anatomical structure being cut. Thus, the wearer can use the graphical representation of the cutting depth to better monitor how the saw blade penetrates the bone, even though direct observation of the cutting is obstructed by tissue or other structures.

[0123] The tracking system may be configured to determine the pose of the anatomical structure to be cut by the saw blade based on determining the pose of a tracking marker, such as a DRA, attached to the anatomical structure, and may be configured to determine the pose of the surgical saw based on determining the pose of a tracking marker connected to at least one of the surgical saw and the passive end effector. The tracking system may be configured to determine the pose of the surgical saw based on a rotational position sensor configured to measure the rotational positions of the first and second mechanisms during movement of the tool attachment mechanism within the working plane. As explained above, the position sensor may be directly connected to at least one joint of the passive end effector structure, but may also be located at another position within the structure and remotely measure the joint position through an interconnection such as a timing belt, wire, or any other synchronous transmission interconnection. Additionally, the pose of the saw blade may be determined based on tracking markers attached to the structure base, position sensors within the passive structure, and a kinematic model of the structure.

[0124] The various passive end effectors disclosed herein may be sterilizable or non-sterilizable (covered by a sterile drape) passive 3-DOF (degrees of freedom) mechanical structures that allow mechanical guidance of a surgical saw or saw blade, such as a sagittal saw, along two translations in a plane parallel to the saw blade (defining the cutting plane) and one rotation (instrument orientation) perpendicular to this cutting plane. During surgery, the surgical robot 4 automatically moves the end effector coupler 22 and the attached passive end effector and surgical saw to a position close to the knee or other anatomical structure such that all the bone to be cut is within the working space of the passive end effector. This position depends on the cut to be made and the surgical plan as well as the implant structure. The passive end effector may have 3 DOF to guide a sagittal saw or saw blade on the cutting plane, which provides Figure 12 the two translations (X and Y directions) and one rotation (about the Z axis) shown.

[0125] When the surgical robot 4 reaches the planned position, it holds that position (by brakes or active motor control) and does not move during a particular bone cut. The passive end effector allows the saw blade of the surgical saw to move along the planned target plane. Such planar cuts are particularly useful for traditional total knee arthroplasty where all bone cuts are planar. In partial knee arthroplasty, there are special types of implants, called "on-lay", which can be used in combination with the sawn bone surface. The various passive end effectors have a mechanical structure that can ensure guidance accuracy during cutting, with higher accuracy than traditional clamps, and provide a sufficient working space range to cut all planned bones, and at the same time provide sufficient lateral stiffness (corresponding to locked DOFs), even though there may be a significant amount of vibration from the surgical saw in addition to the forces applied by the surgeon and the bone reaction forces.

[0126] At the same time, it is preferable to measure the position of the passive end effector as it enables the surgical robot 4 to inform the surgeon how much bone has been removed (progression of the procedure). One method of providing real-time information about bone removal is to have the surgical robot 4 measure the position of the saw blade with respect to the passage of the bone, as the saw blade can only pass through the position where the bone has been cut. To measure the saw blade position, a DRA can be mounted to the surgical saw and / or the passive end effector. This enables the saw position to be measured directly or indirectly in 3D space. An alternative method of measuring the saw blade position is to integrate position (rotational or translational) sensors (such as encoders, resolvers) into the position information of the passive end effector in order to calculate the position of the saw blade using a mathematical model of the defined relationship between the position of the passive end effector geometry and the tip of the saw blade.

[0127] In one embodiment, a traditional sagittal saw mechanism can be used with the surgical system computer platform 900 with little or no modification. Potential changes would involve adjusting the outer guard to enable the surgical saw to be easily attached to the passive end effector, but would not necessarily involve changes to the internal structure. The passive end effector can be configured to connect to a traditional sagittal saw provided by, for example, the DeSoutter company. Additionally, the saw blade can be directly attached to the passive end effector without a saw head.

[0128] When the surgical robot 4 positions the passive end effector, to prevent the saw from being affected by unexpected movement of the passive end effector, e.g., to prevent the surgical saw from falling onto the patient due to gravity, the passive end effector can include a locking mechanism that moves between an engaged operation and a disengaged operation. When engaged, the locking mechanism prevents movement of the saw blade relative to the robot end effector coupler, either directly by locking the degrees of freedom (DOF) of the surgical saw, or indirectly by braking or locking specific joints of the passive end effector. When disengaged, the first and second mechanisms of the passive end effector can move relative to the base without interference from the locking mechanism. The locking mechanism can also be used when the surgeon holds the surgical saw and controls the movement of the surgical robot 4 by applying force and torque to the surgical saw. The surgical robot 4 uses force sensors 64 integrated in the distal end of the robot arm 22 Figure 6 and 7 to measure the applied force and torque, and generate responsive forces and torques on the robot arm 22, such that the surgeon can more easily move the passive end effector back and forth, left and right, and apply rotation about the respective axes.

[0129] Figure 12 A first embodiment of the passive end effector is shown. Referring to Figure 12 , the passive end effector 1200 includes a base 1202 configured to be attached to an end effector coupler of a robot arm (e.g., the robot arm 18 in Figure 1 and 2 ) positioned by the surgical robot, and an end effector coupler (e.g., the end effector coupler 22 in Figure 4 and 5 ). The passive end effector 1200 further includes a first mechanism and a second mechanism that extend between a rotatable connection to the base 1202 and a rotatable connection to a tool attachment mechanism. The rotatable connection can be a pivot joint that allows 1 degree of freedom (DOF) of movement, a universal joint that allows 2 DOFs of movement, or a spherical joint that allows 3 DOFs of movement. The first and second mechanisms form a parallel architecture that positions the surgical saw axis in the cutting plane.

[0130] The first link section and the second link section 1210a and 1220a form a first planar mechanism, and the third link section and the fourth link section 1210b and 1220b form a second planar mechanism. The first link section 1210a extends between a rotatable connection to a first position on the base 1202 and a rotatable connection to the end of the second link section 1220a. The third link section 1210b extends between a rotatable connection to a second position on the base 1202 and a rotatable connection to the end of the fourth link section 1220b. When rotated by the robotic arm, the first and second positions on the base 1202 are spaced on opposite sides of the axis of rotation of the base. The tool attachment mechanism is formed by a fifth link section that extends relative to the base 1202 between rotatable connections to the distal ends of the second link section 1220a and the fourth link section 1220b. The first and second mechanisms (the first and second link sections 1210a - 1220a and the third and fourth link sections 1210b - 1220b) pivot about their rotatable connections to limit the movement of the tool attachment mechanism 1230 to a range of movement within the working plane. The tool attachment mechanism 1230 is configured to connect to a surgical saw 1240 having a saw blade 1242 configured to oscillate for cutting. The first and second mechanisms (the first and second link sections 1210a - 1220a and the third and fourth link sections 1210b - 1220b) can be configured to limit the cutting plane of the saw blade 1242 to be parallel to the working plane, for example, by means of pivot joints having 1 DOF movement. The tool attachment mechanism 1230 can be connected to the surgical saw 1240 by various mechanisms that can include but are not limited to screws, nuts and bolts, clamps, latches, tethers, press fits, or magnets. The DRA 52 can be connected to the tool attachment mechanism 1230 or the surgical saw 1240 to enable tracking of the attitude of the saw blade 1242 by the camera tracking system 6( Figure 3 ).

[0131] The passive end effector 1200 provides passive guidance for the surgical saw 1240 to limit the saw blade 1242 to a defined cutting plane and reduce its mobility to three degrees of freedom (DOF): two translations Tx and Ty in a plane parallel to the cutting plane of the saw blade 1242; and one rotation Rz about an axis perpendicular to the cutting plane.

[0132] In some embodiments, the tracking system is configured to determine the pose of the saw blade 1242 based on the rotational position sensors of the rotary joints of at least some of the link segments connected to the passive end effector 1200. The rotational position sensors are configured to measure the rotational positions of the engaged link segments during movement of the tool attachment mechanism within the working plane. For example, a rotational position sensor may be configured to measure the rotation of the first link segment 1210a relative to the base 1202, another rotational position sensor may be configured to measure the rotation of the second link segment 1220a relative to the first link segment 1210a, and another rotational position sensor may be configured to measure the rotation of the tool attachment mechanism 1230 relative to the second link segment 1220a. The surgical saw 1240 may be connected to have a fixed orientation relative to the tool attachment mechanism 1230. The serial kinematic chain connecting the saw blade 1242 and the passive end effector 1200 of the robotic arm 22 has serial link segments and pivot joints that provide the required mobility for the surgical saw 1240. The position of the tip of the saw blade 1242 in the plane defined by the passive kinematic chain can be fully determined by the joint angles sensed by the rotational position sensors and the structural geometry of the interconnected link segments. Thus, by measuring the relative angles between each connected link segment, e.g., along one or more interconnected paths between the base 1202 and the surgical saw 1240, the proposed forward kinematic model can be used to calculate the position of the tip of the saw blade 1242 in the cutting space. When the position and orientation of the distal end of the robotic arm 22 relative to the position and orientation of the bone are known, the position and orientation of the saw blade 1242 relative to the bone can be calculated and displayed as feedback to the surgeon. For an exemplary embodiment in which the saw blade is directly attached to the passive end effector, the frequency of the measurements provided by the rotational position sensors may be at least twice higher than the saw blade oscillation frequency so that the saw blade position can be measured even during oscillation.

[0133] Example types of rotational position sensors that may be used with the passive end effector herein may include, but are not limited to: potentiometers; optical; capacitive; rotary variable differential transformers (RVDT); linear variable differential transformers (LVDT); Hall effect; and encoders.

[0134] Potentiometer-based sensors are passive electronic components. Potentiometers work by changing the position of a sliding contact on a uniform resistor. In a potentiometer, the entire input voltage is applied across the entire length of the resistor, and the output voltage is the voltage drop between the fixed contact and the sliding contact. To receive the absolute position, calibration of the position is required. The measurement range of a potentiometer may be less than 360°.

[0135] An optical encoder can include a rotating disk, a light source, and a light detector (photosensor). The disk mounted on the rotating shaft has a pattern of opaque and transparent sectors encoded on the disk. When the disk rotates, these patterns interrupt the light emitted onto the light detector, thereby generating a digital signal or a pulse signal output. Absolute measurement, relative measurement, and multi-turn measurement are all possible through the signals encoded on the disk.

[0136] A capacitive encoder detects capacitance changes using a high-frequency reference signal. This is achieved with three main parts: a fixed transmitter, a rotor, and a fixed receiver. A capacitive encoder can also be provided in a two-part configuration with a rotor and a combined transmitter / receiver. The rotor can be etched with a sine pattern, and when it rotates, this pattern modulates the high-frequency signal of the transmitter in a predictable manner. The encoder can be multi-turn, but it is difficult to achieve absolute measurement. Calibration is required at startup.

[0137] RVDT and LVDT sensors operate with the core of the transformer in the zero position, where the output voltage magnitudes of both the primary and secondary windings are equal, yet opposite in direction. The total output at the zero position is always zero. An angular displacement relative to the zero position induces a total differential output voltage. Therefore, the total angular displacement is proportional to the linear differential output voltage. The differential output voltage increases in the clockwise direction and decreases in the counterclockwise direction. This encoder functions in absolute measurement and may not be compatible with multi-turn measurement. Calibration is required during assembly.

[0138] In a Hall effect sensor, a current is applied along a thin metal strip. In the presence of a magnetic field, the electrons in the metal strip are deflected towards one edge, thereby generating a voltage gradient across the short side of the metal strip (i.e., perpendicular to the feed current). The sensor operates in its simplest form as an analog transducer, thus directly returning a voltage. In the case of a known magnetic field, its distance from the Hall plate can be determined. Using a group of sensors, the relative position of the magnet can be deduced. By combining multiple sensor elements with a patterned magnet plate, absolute and relative positions can be detected similar to an optical encoder.

[0139] An encoder sensor works in a similar manner to a rotary variable transformer sensor, a brushless resolver, or a synchro. The stator receives DC power and generates a low-power AC electromagnetic field between the stator and the rotor. This electromagnetic field is modified by the rotor according to its angle. The stator induces the generated electromagnetic field and outputs the rotation angle as an analog signal or a digital signal. Different from a resolver, the encoder uses a laminated circuit instead of a wound wire spool. This technology makes the encoder compact in shape, low in mass, low in inertia, and high in precision without the need for high-precision installation. A signal (Z) for counting a complete rotation is emitted. Multi-turn sensing and absolute sensing are possible.

[0140] Figure 13 shows a second embodiment of a passive end effector. Referring to Figure 13 , the passive end effector 1300 includes a base 1302 configured to be attached to an end effector coupler (e.g., Figure 1 and 2 the end effector coupler 22 in Figure 4 and 5 ) of a robotic arm (e.g., the robotic arm 18 in Figure 3 and ) positioned by a surgical robot. The passive end effector 1300 further includes a first mechanism and a second mechanism that extend between a rotatable connection to the base 1302 and a rotatable connection to a tool attachment mechanism. The rotatable connection can be a pivot joint allowing 1 DOF of movement, a universal joint allowing 2 DOF of movement, or a ball joint allowing 3 DOF of movement. The first link segment and the second link segment 1310a and 1320a form a first planar mechanism, and the third link segment and the fourth link segment 1310b and 1320b form a second planar mechanism. The first link segment 1310a extends between a rotatable connection to a first position on the base 1302 and a rotatable connection to the end of the second link segment 1320a. The third link segment 1310b extends between a rotatable connection to a second position on the base 1302 and a rotatable connection to the end of the fourth link segment 1320b. When rotated by the robotic arm, the first position and the second position on the base 1302 are spaced apart on opposite sides of the axis of rotation of the base. The distal ends of the second link segment 1320a and the fourth link segment 1320b remote from the base 1302 are rotatably connected to each other and connected to the tool attachment mechanism 1330. The first mechanism and the second mechanism (the first link segment and the second link segment 1310a - 1320a and the third link segment and the fourth link segment 1310b - 1320b) can be configured to rotate about their rotatable connections, for example, by a pivot joint having 1 DOF of movement, to limit the movement of the tool attachment mechanism 1330 within a range of movement in a working plane. The tool attachment mechanism 1330 is configured to be connected to a surgical saw 1240 having a saw blade 1242 configured to oscillate for cutting. The first mechanism and the second mechanism (the first link segment and the second link segment 1310a - 1320a and the third link segment and the fourth link segment 1310b - 1320b) limit the cutting plane of the saw blade 1242 to be parallel to the working plane. The tool attachment mechanism 1330 can be connected to the surgical saw 1240 by various mechanisms that can include but are not limited to screws, nuts and bolts, clamps, latches, tethers, press fits, or magnets. A DRA can be connected to the tool attachment mechanism 1330 or the surgical saw 1240 to enable tracking by a camera system 6 ()Track the attitude of the saw blade 1242.

[0141] Figure 14 A third embodiment of a passive end effector is shown. Referring Figure 14 , the passive end effector 1400 includes a base 1402 configured to be attached to an end effector coupler (e.g., Figure 1 and 2 the end effector coupler 22 in Figure 4 and 5 ) of a robotic arm positioned by a surgical robot (e.g., the robotic arm 18 in

[0142] ). The base 1402 includes a first elongated base section and a second elongated base section 1404a and 1404b that extend from spaced positions on opposite sides of the axis of rotation of the base 1402 when rotated by the robotic arm. The first elongated base section and the second elongated base section 1404a and 1404b extend in a direction away from the end effector coupler of the robotic arm when attached to the passive end effector 1400. The passive end effector 1400 further includes a first mechanism and a second mechanism that extend between rotatable connections to the elongated base sections 1404a and 1404b and rotatable connections to a tool attachment mechanism. One or more of the rotatable connections disclosed for this embodiment may be a pivot joint that allows 1 DOF of movement, a universal joint that allows 2 DOF of movement, or a ball joint that allows 3 DOF of movement.

[0142] The first mechanism includes a first link section 1411a, a second link section 1410a, a third link section 1420a, and a fourth link section 1430a. The first link section and the second link section 1411a and 1410a extend parallel to each other between rotatable connections to spaced positions on the first elongated base section 1404a and spaced positions on the third link section 1420a. The end of the third link section 1420a is rotatably connected to the end of the fourth link section 1430a.

[0143] The second mechanism includes a fifth link section 1411b, a sixth link section 1410b, and a seventh link section 1420b. The fifth link section and the sixth link section 1411b and 1410b extend parallel to each other between rotatable connectors at spaced positions on the second elongated base section 1404b and at spaced positions on the seventh link section 1420b. The tool attachment mechanism includes an eighth link section 1440 that extends between a fourth link section and a rotatable connector at the distal end of the seventh link section 1430a and 1420b remote from the base 1402. In another embodiment, the eighth link section 1440 of the tool attachment mechanism includes an attachment member 1442 that extends in a direction away from the base 1402 to a rotatable connector that is configured to connect to a surgical saw 1240. The attachment member 1442 extends from a position on the eighth link section 1440 that is closer to the fourth link section 1430a than the seventh link section 1420b.

[0144] The first mechanism and the second mechanism (the group of link sections 1411a, 1410a, 1420a, 1430a and the group of link sections 1411b, 1410b, 1420b) can be configured to pivot about their rotatable connectors to limit the movement of the tool attachment mechanism 1440 to a range of movement within the working plane. The tool attachment mechanism 1440 is configured to connect to a surgical saw 1240 that has a saw blade 1242 configured to oscillate for cutting. The first mechanism and the second mechanism can be configured to limit the cutting plane of the saw blade 1242 to be parallel to the working plane, for example, by a pivot joint having 1 DOF movement. The tool attachment mechanism 1440 can be connected to the surgical saw 1240 by various mechanisms that can include, but are not limited to, screws, nuts and bolts, clamps, latches, tethers, press fits, or magnets. The DRA can be connected to the tool attachment mechanism 1440, such as to the attachment member 1442 or the surgical saw 1240 to enable tracking of the attitude of the saw blade 1242 by a camera tracking system 6( Figure 3 )

[0145] Figure 14 The passive end effector 1400 has a parallel architecture that enables the surgical saw to be positioned about a rotation axis in the cutting plane. The synchronous movement and / or different movements of the lateral parallelograms allow the surgical saw rotation axis to be positioned in the cutting plane.

[0146] Figure 15 A fourth embodiment of the passive end effector is shown. The passive end effector 1500 includes a base 1502 that is configured to be attached to a robotic arm positioned by a surgical robot (e.g., Figure 1 and 2the end - effector coupler of the robotic arm 18) (e.g., Figure 4 and 5 the end - effector coupler 22) in. The base 1502 can include a first elongated base section and a second elongated base section that extend from spaced - apart positions on opposite sides of the axis of rotation of the base 1502 when rotated by the robotic arm. The first elongated base section and the second elongated base section extend away from each other. The passive end - effector 1500 further includes a first mechanism and a second mechanism that extend between a rotatable connection to the base 1502 and a rotatable connection to the tool - attachment mechanism. One or more of the rotatable connections disclosed for this embodiment can be a pivot joint that allows 1 DOF of movement, a universal joint that allows 2 DOFs of movement, or a ball joint that allows 3 DOFs of movement.

[0147] The first mechanism includes a first link section 1510a. The second mechanism includes a second section 1510b. The tool - attachment mechanism includes a third link section 1520, a fourth link section 1530, a fifth link section 1540a, a sixth link section 1540b, and a seventh link section 1550. The first link section and the second link section 1510a and 1510b extend between rotatable connections to a first and a second position on the base 1502, e.g., rotatable connections to the first elongated base section and the second elongated base section that extend away from the base 1502, and a rotatable connection to the opposite end of the third link section 1520. When rotated by the robotic arm, the first position and the second position on the base 1502 are spaced apart on opposite sides of the axis of rotation of the base. The fourth link section 1530 extends from the third link section 1520 in a direction toward the base 1502. The fifth link section and the sixth link section 1540a and 1540b extend parallel to each other between rotatable connections to spaced - apart positions on the fourth link section 1530 and spaced - apart positions on the seventh link section 1550. The seventh link section 1550 is configured to have a rotatable connector that is configured to connect to the surgical saw 1240.

[0148] The first through sixth link segments 1510a-b, 1520, 1530, and 1540a-b can be configured to pivot about their rotatable connections to limit movement of the seventh link segment 1550 to a range of movement within the working plane. The seventh link segment 1550 is configured to be coupled to a surgical saw 1240 having a saw blade 1242 configured to oscillate for cutting. The first through sixth link segments 1510a-b, 1520, 1530, and 1540a-b can be configured to limit the cutting plane of the saw blade 1242 to be parallel to the working plane, such as by a pivot joint having 1 DOF of motion. The seventh link segment 1550 can be coupled to the surgical saw 1240 by various mechanisms that can include, but are not limited to, screws, nuts and bolts, clamps, latches, tethers, press fits, or magnets. A DRA can be coupled to the seventh link segment 1550 or the surgical saw 1240 to enable tracking of the pose of the saw blade 1242 by a camera tracking system 6( Figure 3 )

[0149] Figure 16 A fifth embodiment of a passive end effector is shown. The passive end effector 1600 includes a base 1602 configured to be attached to an end effector coupler (e.g., Figure 1 and 2 the end effector coupler 22 in Figure 4 and 5 ) of a robotic arm (e.g., the robotic arm 18 in

[0150] ) positioned by a surgical robot. The passive end effector 1600 further includes a first mechanism and a second mechanism that extend between a rotatable connection to the base 1502 and a rotatable connection to a tool attachment mechanism. The first mechanism includes a first link segment 1610a. The second mechanism includes a second segment 1610b. The tool attachment mechanism includes a third link segment 1620, a fourth link segment 1630, a fifth link segment 1640a, a sixth link segment 1640b, and a seventh link segment 1650. One or more of the rotatable connections disclosed for this embodiment can be a pivot joint that allows 1 DOF of motion, a universal joint that allows 2 DOF of motion, or a ball joint that allows 3 DOF of motion.The first link section and the second link sections 1610a and 1610b extend between rotatable connectors at a first position and a second position, respectively, on the base 1602 to a rotatable connector at an opposite end of the third link section 1620. When rotated by the robotic arm, the first position and the second position on the base 1602 are spaced apart on opposite sides of the axis of rotation of the base 1602. The fourth link section 1630 extends from the third link section 1620 in a direction away from the base 1602. The fifth link section and the sixth link sections 1640a and 1640b extend parallel to each other between rotatable connectors at spaced-apart positions on the fourth link section 1630 and at spaced-apart positions on the seventh link section 1650. The seventh link section 1650 is configured to have a rotatable connector that is configured to connect to the surgical saw 1240.

[0151] The first through sixth link sections 1610a-b, 1620, 1630, and 1640a-b can be configured to pivot about their rotatable connectors to limit movement of the seventh link section 1650 to a range of movement within the working plane. The seventh link section 1650 is configured to connect to the surgical saw 1240, which has a saw blade 1242 configured to oscillate for cutting. The first through sixth link sections 1610a-b, 1620, 1630, and 1640a-b can be configured to pivot while restricting the cutting plane of the saw blade 1242 to be parallel to the working plane. The seventh link section 1650 can be connected to the surgical saw 1240 by various mechanisms, which can include but are not limited to screws, nuts and bolts, clamps, latches, tethers, press fits, or magnets. The DRA can be connected to the seventh link section 1650 or the surgical saw 1240 to enable tracking of the attitude of the saw blade 1242 by the camera tracking system 6( Figure 3 )

[0152] The passive end effector 1600 provides two translational movements perpendicular to each other for positioning the axis of rotation of the surgical saw in the cutting plane, and two of the translations are implemented by a parallelogram.

[0153] Figure 17 A sixth embodiment of the passive end effector is shown. The passive end effector 1700 includes a base 1702 that is configured to be attached to an end effector coupler (e.g., Figure 1 and 2 of the robotic arm 18) of the robotic arm positioned by the surgical robot (e.g., Figure 4 and 5the end - effector coupler 22). The passive end - effector 1700 further includes a first mechanism and a second mechanism that extend between a rotatable connection to the base 1702 and a rotatable connection to the tool - attachment mechanism. One or more of the rotatable connections disclosed for this embodiment can be a pivot joint that allows 1 - DOF movement, a universal joint that allows 2 - DOF movement, or a ball joint that allows 3 - DOF movement. The first and second mechanisms are connected to provide translation along the parallelogram radius. The first mechanism includes a first link segment and a second link segment 1710 and 1720b. The first link segment 1710 extends between a rotatable connection to the base 1702 and a rotatable connection to the end of the second link segment 1720b. The second mechanism includes a third link segment 1720a. The tool - attachment mechanism includes a fourth link segment 1730. The second and third link segments 1720b and 1720a extend away from the base 1702 and extend parallel to each other between rotatable connections to spaced - apart positions on the first link segment 1710 and spaced - apart positions on the fourth link segment 1730. The fourth link segment 1730 includes an attachment member 1732 that extends in a direction away from the base to a rotatable connector that is configured to connect to a surgical saw 1240. The attachment member 1732 extends from a position on the fourth link segment 1730 that is closer to the third link segment 1720a than the second link segment 1720b.

[0154] The first through third link segments 1710, 1720b, 1720a can be configured to pivot about their rotatable connections to limit the movement of the fourth link segment 1730 to a range of movement within the working plane. The fourth link segment 1730 is configured to connect to a surgical saw 1240 that has a saw blade 1242 configured to oscillate for cutting. The first through third link segments 1710, 1720b, 1720a can be configured to limit the cutting plane of the saw blade 1242 to be parallel to the working plane. The fourth link segment 1730, for example its attachment member 1732, can be connected to the surgical saw 1240 by various mechanisms that can include, but are not limited to, screws, nuts and bolts, clamps, latches, tethers, press - fits, or magnets. The DRA can be connected to the fourth link segment 1730, for example to the attachment member 1732 or the surgical saw 1240 to enable tracking of the pose of the saw blade 1242 by a camera tracking system 6( Figure 3 )

[0155] Figure 18 A seventh embodiment of the passive end - effector is shown. The passive end - effector 1800 includes a base 1802 that is configured to be attached to a robotic arm positioned by a surgical robot (e.g.,Figure 1 and 2 the end - effector coupler of the robotic arm 18) (e.g., Figure 4 and 5 the end - effector coupler 22). The passive end - effector 1800 further includes a first mechanism and a second mechanism that extend between a rotatable connection to the base 1802 and a rotatable connection to the tool - attachment mechanism. One or more of the rotatable connections disclosed for this embodiment can be a pivot joint that allows 1 DOF of motion, a universal joint that allows 2 DOFs of motion, or a ball joint that allows 3 DOFs of motion. The first mechanism includes a first link segment 1810a. The second mechanism includes a second link segment 1810b. The tool - attachment mechanism includes a third link segment 1820. The first link segment and the second link segment 1810a and 1810b extend to rotatable connections at opposite ends of the third link segment between rotatable connections to a first position and a second position on the base 1802, respectively. When rotated by the robotic arm, the first position and the second position on the base 1802 are spaced on opposite sides of the axis of rotation of the base 1802. The third link segment 1820 includes an attachment member 1822 that extends in a direction away from the base 1802 to a rotatable connector that is configured to connect to a surgical saw 1240. The attachment member 1822 extends from a position on the third link segment 1820 that is closer to the first link segment 1810a than to the second link segment 1810b. One or more of the rotatable connections disclosed for this embodiment can be a pivot joint that allows 1 DOF of motion, a universal joint that allows 2 DOFs of motion, or a ball joint that allows 3 DOFs of motion.

[0156] The first link segment and the second link segments 1810a and 1810b can be configured to pivot about their rotatable connection between the base 1802 and the third link segment 1820 to limit the movement of the attachment member 1822 to a range of movement within the working plane. In some other embodiments, one or more rotatable connections can be a universal joint that allows 2 DOF movement or a ball joint that allows 3 DOF movement such that the movement is not restricted to the working plane. The tool attachment mechanism 1822 is configured to connect to a surgical saw 1240 having a saw blade 1242 configured to oscillate for cutting. The first link segment and the second link segments 1810a and 1810b pivot while restricting the cutting plane of the saw blade 1242 to be parallel to the working plane. The attachment member 1822 can be connected to the surgical saw 1240 by various mechanisms that can include but are not limited to screws, nuts and bolts, clamps, latches, tethers, press fits, or magnets. The DRA can be connected to the third link segment 1820, such as to the attachment member 1822 or the surgical saw 1240 to enable tracking of the attitude of the saw blade 1242 by a camera tracking system 6( Figure 3 ) to track the attitude of the saw blade 1242.

[0157] Figure 19 An eighth embodiment of a passive end effector is shown. The passive end effector 1900 includes a base 1902 configured to be attached to an end effector coupler (e.g., Figure 1 and 2 ) of a robotic arm (e.g., Figure 4 and 5 ) of the robotic arm 18 positioned by a surgical robot. The passive end effector 1900 further includes a first link segment 1910 and a second link segment 1920. The first link segment 1910 extends between a rotatable connection to the base 1902 and a rotatable connection to one end of the second link segment 1920. The other end of the second link segment 1920 is rotatably connected to a tool attachment mechanism. The axes of rotation q1, q2, and q3 are parallel to each other to provide a planar cutting plane for the blade 1242. Thus, the 3 DOF movement of the saw 1240 includes a translational direction Tx in the x direction, a translational direction Ty in the y direction, and a rotational direction Rz about the z-axis. One or more of the rotatable connections disclosed for this embodiment can be a pivot joint that allows 1 DOF movement, a universal joint that allows 2 DOF movement, or a ball joint that allows 3 DOF movement.

[0158] Tracking markers 52 attached to the end effector base 1902 and the saw 1240, as well as tracking markers on the bone (e.g., tibia and femur), can be used to accurately and continuously monitor the real-time position of the blade 1242 and the blade tip relative to the patient's bone being cut. Although not explicitly shown in other figures, in all embodiments, tracking markers can be attached to the saw 1240 and all end effectors 1902 to track the position of the blade relative to the patient's bone being cut. Although not shown, alternatively or in addition to tracking markers, encoders can be positioned in each of the link sections 1910 and 1920 to always accurately determine where the saw blade tip is.

[0159] Example surgical procedure

[0160] An example surgical procedure for using the surgical robot 4 in the operating room (OR) can include:

[0161] Optional step: Preoperatively plan the surgery based on medical images.

[0162] 1. The surgical robot 4 system is outside the operating room (OR). The nurse

[0163] Brings the system into the OR when the patient is ready for surgery.

[0164] 2. The nurse powers on the robot and deploys the robot arm. The nurse verifies the accuracy of the robot system and the tracking system.

[0165] 3. In the case of a sterilized passive end effector, the scrub nurse places a sterile drape on the robot arm and mounts the passive end effector with the sagittal saw on the robot arm. The scrub nurse locks the passive end effector with the locking mechanism. The scrub nurse attaches the DRA to the passive structure through the drape (if necessary). For an unsterilized passive end effector, the drape is placed after attaching the passive end effector to the robot arm, the DRA is attached to the passive end effector with the drape in between, and a sterilized saw or saw blade is attached to the passive end effector with the drape in between. To fix the position of the saw blade relative to the end effector coupler, the locking mechanism is engaged.

[0166] 4. The surgeon attaches navigation markers to one or more bones of the patient, such as the tibia and femur. The bones are registered to the camera tracking system 6 using, for example, the Horn point-to-point algorithm, surface matching, or other algorithms. Soft tissue balance assessment can be performed, whereby the system allows the surgeon to evaluate the balance of soft tissues in the operating room. For example, when the surgeon applies forces in different directions (such as varus / valgus stress), by tracking the relative movement of the femur and tibia. The soft tissue balance information can be used to change the surgical plan (such as moving implant components, changing implant types, etc.).

[0167] 5. When the surgeon is ready to cut the bone, the scrub nurse brings the surgical robot 4 to the operating table near the knee joint where the surgery is to be performed and stabilizes the surgical robot 4 on the floor. The system can be operated to guide the nurse to find the position of the robot 4 such that all cutting planes are within the workspace of the robot and the passive structure.

[0168] 6. The surgeon selects different parameters (such as the bone to be cut, the desired cutting plan, etc.) on the screen of the surgical robot 4 according to the surgical plan to make the first cut.

[0169] 7. The surgical robot 4 automatically moves the robotic arm 22 to reposition the passive end effector such that the cutting plane of the saw blade becomes aligned with the target plane, and the saw blade is positioned at a certain distance from the anatomical structure to be cut, the distance being within the movement range of the tool attachment mechanism of the passive end effector.

[0170] 8. The surgeon unlocks the passive end effector.

[0171] 9. The surgeon performs a cut restricted to the cutting plane provided by the passive end effector. The surgical robot 4 can provide a real-time display of the tracking position of the saw blade relative to the bone, such that the surgeon can monitor the progress of bone removal. In one way, the tracking subsystem processes the position of the saw relative to the bone in real time based on camera images and various tracking markers attached to the saw, robotic arm, end effector, femur, and tibia. Then, the surgeon can use the locking mechanism to lock the passive end effector when the cut is completed.

[0172] 10. The surgeon selects the next cut to be performed on the screen and proceeds as before.

[0173] 11. The surgeon can perform trial implant placement and intermediate soft tissue balance assessment and change the implant plan and related cuts based on this.

[0174] 12. After all the cutting is completed, the nurse removes the surgical robot 4 from the operating table and detaches the passive end effector from the robotic arm.

[0175] 13. The surgeon places the implant and completes the surgery.

[0176] In step 9 above, due to the tissue and ligaments around the bone, the debris generated by the cutting, and other surgical instruments near the bone, it may be difficult for the doctor to visually confirm the progress of the cutting. Even if visual confirmation is acceptable, there are certain areas of the bone that the doctor cannot see, such as the rear of the bone being cut.

[0177] Advantageously, an embodiment of the robotic system of the present invention provides a method for the doctor to confirm the progress of the bone being cut in multiple dimensions. The camera tracking system 6 and the tracking markers attached to the end effector bases (1100, 1202, 1302, 1402, 1502, 1602, 1702, 1802, 1902), the robotic arm 20, and the saws (1140, 1240) allow the tracking subsystem 830 and the computer subsystem 820 to calculate the exact position of the saw blade relative to the bone in real time, enabling the surgeon to monitor the progress of bone removal.

[0178] Figure 20 is a screenshot showing the progress of bone cutting during surgery. Figure 20 The subsystems 830 and 820 are shown displaying three images: a side view, an A-P view, and a top view. In each image, the real-time position of the saw blade 1242 relative to the bone (e.g., the tibia 2000) is displayed on the monitor 34. The side view and the top view are particularly useful for the doctor because they show the position of the saw blade, which is not easily visible. At the top of the monitor, the computer subsystems 830, 820 display the number of cutting programs and the program currently running. For example, as shown in the screenshot, the doctor may have programmed 6 planar cuts, and the current cutting program is the first. Additionally, because the subsystems 830 and 820 can track the position where the blade may have traveled with the tracking markers, they can determine how much of the bone cutting (the area being cut) for a particular cutting program has been completed, and the percentage of progress is displayed on the monitor 34. The bone image itself is preferably derived from the actual image of the patient's body to obtain an accurate representation. The bone image is enhanced by the subsystem 820 with contour lines showing the cortical bone 2004 and the cancellous bone 2002. This is important for the doctor because the resistance to cutting between the two types of bone varies greatly.

[0179] If an augmented reality (AR) head-mounted display is used, the computer subsystem 820 can generate the same contour lines showing cortical and cancellous bone and continuously superimpose them on the actual leg as the doctor moves his / her head. The areas that have been cut can be overlaid on the actual bone with a shadow. Additionally, the implant to be inserted into the cut area can also be overlaid on the bone to show the doctor that the cut is being made correctly along the plane of the implant. This is all possible because subsystems 830 and 820 can use tracking markers and the camera subsystem to track the position of the blade and its movement history relative to the bone.

[0180] Now referring Figures 21 - 32 , an exemplary embodiment of a direct blade guidance system in the context of orthopedic surgery is described. As Figure 21 , 22 , shown in 29 and 30, the direct blade guidance system 2100 can include a robotic system that holds an end effector arm (EEA) 2102. The EEA 2102 can include a base configured to be attached to the end effector coupler of the robotic arm. Other exemplary embodiments of the end effector arm consistent with the principles of the present disclosure are described with respect to Figures 12 - 19 . To achieve planar cutting, the saw blade 2104 should be guided in the plane in which it vibrates. The high vibration frequency of the saw blade (e.g., 200 - 300 Hz) makes it difficult to achieve mechanical guidance. The EEA 2102 can include a number of joints and linkages 2106, 2108 that can be used to achieve movement of the tip 2110 of the EEA 2102 in a plane. Similar to the Figures 12 - 18 embodiment, the tip 2110 of the EEA 2102 can have three (3) degrees of freedom: movement in two directions in the plane and rotation about an axis perpendicular to the plane. The EEA 2102 can allow planar cutting and access to the target bone from all angles. The system 2100 can also include a head 2112 and a blade adapter 2114 that are each connected to the EEA 2102 and the blade 2104.

[0181] The concept of directly guiding the saw blade 2104 involves aligning the axis of rotation of the distal end of the linkage 2110 (the distal rotary joint 2116 of the EEA 2102) with the axis of saw blade vibration. A sagittal saw is the mechanism in most embodiments that causes the saw blade to produce a small rotational movement (vibration / oscillation) about an axis near where the saw blade is attached. By aligning the axis of rotation with the distal rotary joint 2116 of the EEA 2102 (at the distal end of the linkage 2108), the joint 2116 can be configured to effect general saw head rotation and achieve saw blade vibration.

[0182] The saw blade 2104 can be configured to be connected to the distal joint rotating shaft of the EEA 2102 via a blade adapter 2114. The blade adapter 2114 can be configured to tighten the saw blade 2104. By adjusting the blade adapter 2114, different sagittal saws can be integrated into the system 2100. Exemplary configurations of the blade adapter 2114 consistent with the present disclosure are discussed below. In Figure 31 an exemplary blade adapter is shown.

[0183] Permanent Fixation

[0184] In a permanent fixation configuration, the blade 2104 can be permanently clamped to the blade adapter 2114. When the surgeon prepares the surgical area, a user (e.g., an operating room nurse) can assemble the blade 2104 to the blade adapter 2114. Exemplary permanent fixation configurations can include the following.

[0185] · Components such as screws or spring-loaded latches can be used to firmly clamp the blade 2104 to the blade adapter 2114, and the components are configured to provide a clamping force to the blade 2104.

[0186] · The blade 2104 can include an interface, such as a through hole, configured to fix the blade 2104 to the blade adapter 2114.

[0187] · The blade 2104 and the blade adapter 2114 can be manufactured as a single reusable device to be later set on the EEA 2102. Example embodiments relate to metal blades attached to PEEK or stainless steel blade adapters. The assembly of the blade to the blade adapter is performed by an operating room nurse.

[0188] · The blade 2104 and the blade adapter can also be manufactured as a sterile delivered disposable (single-use) device. Example embodiments relate to overmolded metal blades using plastic injection molding techniques.

[0189] Figure 22 A system 2200 is shown, which is an exemplary embodiment consistent with the principles of the present disclosure. In this embodiment, the blade adapter is permanently fixed to a saw blade in a base that can rotate about the saw blade rotation axis and a clamping assembly that clamps the blade to the blade adapter base via screws. Figure 23 A blade 2204, a blade adapter 2214, a distal rotary joint 2216, and a fixture 2218 consistent with this configuration are shown. These components can be the same as or similar to the components previously described with respect to Figure 21 description.

[0190] Detachable Fixation

[0191] In a detachable fixation configuration, the blade can be quickly attached to or detached from the blade adapter on-site. The blade adapter incorporates a clamping mechanism, which can be active (normally closed clamping mechanism opened by an electrical signal) or passive (quick coupling and / or quick release mechanism).

[0192] Moment of Inertia

[0193] The blade adapter 2114 can significantly increase the moment of inertia of the "blade / blade adapter" assembly rotating about the blade rotation axis. Once the blade adapter 2114 vibrates together with the saw blade 2104, the unbalanced inertia generates power and torque that are output to the mechanical structure and the surgeon's hand. To optimize the implementation, the inertia of the vibrating element about the vibration axis can be minimized. This means that the lighter the mass of the vibrating element and the closer it is to the vibration axis, the better. The moment of inertia of the saw blade element for the nose guidance concept about the vibration axis is:

[0194] ·I h =I d +MD 2

[0195] where D is the distance between the blade vibration axis and the distal joint rotation axis, M is the weight of the blade (weight of the saw blade element), and I d is the moment of inertia of the saw blade element about the blade vibration axis. Then, using the direct blade guidance concept, the moment of inertia is reduced by MD 2 , which is minimized when the distance between the vibration axis and the blade vibration axis is 0 (axis combination).

[0196] Figure 24 Shows a system using a standard clamp 2402. According to the principles discussed herein, direct blade guidance can provide more effective blade cutting length compared to the effective blade cutting length provided by a standard clamp (such as the clamp 2402 shown in Figure 24 ). L G represents the guidance length (the length guiding the saw blade), and L E represents the effective blade length. Since the guidance length can be made shorter using the direct blade guidance concept, the effective blade length is longer. This may be more comfortable for the surgeon, and the surgeon can cut through more bone.

[0197] The precision of cutting is given by the stiffness of the different elements from the floor to the saw blade tip that make up the robotic system, including the robotic system, EEA 2102, nose sagittal saw, saw blade swing mechanism (such as blade adapter 2114 or 2214), and saw blades 2104, 2204. With direct blade guidance, the clearance and inaccuracy of the nose can be significantly reduced or completely avoided because the saw blade is directly tightened through the blade adapter.

[0198] In addition, the direct blade guidance concept can be more easily integrated with various existing sagittal saws. Since the blade adapter is the element that only needs to tighten the saw blade with a simple shape, it may not be necessary to construct components specific to the shape of the sagittal saw (specific to the manufacturer). Additionally, the blade adapter is easy to sterilize. It is a small, lightweight, and relatively simple mechanical element that can be manufactured in such a way that it has no any narrow spaces and can be easily disassembled. As previously mentioned, the blade including the blade adapter can be delivered as a single reusable device.

[0199] Tracking

[0200] Figure 25 The direct blade guidance system 2100 is shown, which may include a navigation marker or marker array 2500 attached to the nose 2112 of the sagittal saw. The marker 2500 allows the sagittal saw to be tracked by a camera (such as the camera tracking system 6). Optical tracking enables the measurement of the saw position, but it may be difficult to measure the direct saw blade position during cutting (the high-frequency vibration of the blade). In addition, due to the poor stiffness of the blade / saw nose connection, the tracking will directly measure the deflection of the saw nose 2112 relative to the blade 2104.

[0201] To measure the direct saw blade position, Figure 26 The system 2100 is shown, where the encoders 2600, 2602, and 2604 are integrated into the joints of the EEA 2102. Compared with using optical tracking, encoder measurements can generally be performed at a higher frequency and rotational accuracy. For example, the measurement frequency can be at least twice higher than the saw blade oscillation. Using the blade position signal, additional useful information can be extracted, such as the saw vibration frequency, on / off state, and jamming of the saw blade in the bone (e.g., by interpreting the signal and its derived information).

[0202] In an exemplary embodiment consistent with the principles of the present disclosure, the vibration of the sagittal saw nose held by the surgeon can be reduced. By reducing the vibration of the nose, the haptic feedback can be improved and the cutting efficiency can be increased. As previously mentioned, the vibration output to the surgeon's hand is caused by the output power and torque, which are generated by the unbalanced inertia of the coupled blade / blade adapter around the blade rotation axis.

[0203] One method for reducing vibration can be achieved by filtering the vibration. In Figure 27 it, the damping element 2700 can be connected between the nose 2112 and the EEA 2102. This can be implemented using a rubber sheet, a pneumatic cylinder, or a hydraulic cylinder.

[0204] Another method for reducing vibration can be achieved by dynamically balancing the inertia of the coupled saw / saw adapter about the saw's axis of rotation. This can be implemented by using a compensating inertia to dynamically compensate for the output forces and torques generated by the vibrating saw blade, with the compensating inertia performing precise opposite movements in the same dynamics. Figure 28 and 32 shows an exemplary embodiment where the compensating inertia can be coupled to the main inertia for balancing using a mechanical reverser 2800.

[0205] Now referring Figures 33 - 45 , consistent with the principles of the present disclosure, a navigation pin guiding driver having a handle and an attached reference element can be used to avoid the need to use placement instruments and navigate placement instruments. For example, a surgeon can hold the handle, and the navigation system can track the reference element. The navigation system provides real-time feedback on the placement of the pin and a visual representation of the cut, or a visual representation of the cutting block relative to the patient's anatomy. The surgeon can use the navigation pin handle either manually or in combination with a passive end effector as previously described herein.

[0206] A proposed workflow consistent with the principles of the current embodiment is shown as method 3300 in Figure 33 . At step 3302, the patient can be registered with the navigation system. At step 3304, the navigation pin guiding driver system is aligned to the target area of the bone using the navigation system feedback. At step 3306, the cutting block pin is driven into the bone. At step 3308, the cutting block is attached to the bone over the cutting block pin, and at step 3310, the cut is performed via the cutting block.

[0207] Referring Figure 34 , an exemplary schematic diagram of a navigation pin driver system 3400 is shown. The navigation pin guiding driver system 3400 can include a handle 3402 for the user to hold, a reference element 3404, a distal tip 3406 for docking onto the cortical bone, and two parallel pin guides (or guide tubes) 3408 separated by a bridge 3410. The bridge 3410 maintains the spacing to ensure that the pin spacing matches the spacing of the corresponding cutting block. Although Figure 34 is shown as having a single instrument with two parallel pin guides 3408, the system 3400 can be configured to have only one pin guide 3408. To optimize the user's perspective and ergonomics, the bridge 3410 and the reference element 3404 can rotate about an axis 3500, as shown in Figure 35 . The reference element can include markers configured to be tracked by the navigation system, such as optical markers detectable by an infrared camera.

[0208] When using the system 3400, the user may register the patient with the navigation system and perform an initial cut to expose the knee joint. Once exposed, the user may position the navigation pin driver system as indicated by the navigation system. The user may then insert a cutting block pin (which may be a pin of a conventional style) through the pin guide tube 3408, as Figure 36 shown.

[0209] An example of how the navigation pin guide driver system 3400 may be used clinically is as follows: (1) plan implant placement; (2) register the patient with the navigation system; (3) expose the knee; and (4) use the navigation pin driver system 3500 to insert a pin 3800 for a distal femoral cutting block, as Figures 37 - 38 shown.

[0210] After steps (1)-(4) mentioned above, at step (5), a distal cutting block 3900 may be attached over the pin 3800, as Figure 39 shown. As Figure 40 shown, at step (6), a distal resection may be performed. Figure 41 As shown in, at step (7), use the system 3400 to insert a pin, or form a hole for positioning a 4-in-1 cutting block 4200, which is attached to the resection section at step (8) and as Figure 42 shown.

[0211] After attaching the 4-in-1 cutting block 42, at step (9), use the 4-in-1 cutting block 4200 to perform an anterior femoral, femoral bevel, dorsal femoral, and bevel dorsal resection. At step (10), use the navigation pin guide driver system 3400 to place a pin for a proximal tibial cutting block 4500. At step (11), position the proximal tibial cutting block 4500 in place and perform the resection. At step (12), total knee arthroplasty may be completed by inserting the appropriate implant. Alternatively and without departing from the principles of the present disclosure, the resection may be performed on the tibia before the femur is resected.

[0212] Consistent with the principles of the present disclosure, the navigation pin driver system 3500 may include a compliant clamp instead of a serrated distal tip. The clamp may use particulate jamming and be activated by a vacuum already present in the operating room.

[0213] In an alternative, to allow the user to directly position the pin guide and simplify navigation pin guide placement, the software may assist the user, as explained in the following workflow.

[0214] (1) Display to the user, via the software, a target position of a pin guide (e.g., distal tip) on the bone, such as on a computer screen, an augmented reality (AR) headset, and a laser pointer.

[0215] (a) Only the position or entry point is displayed, i.e., correct instrument rotation is not required at this stage.

[0216] (b) The distal tip teeth / sharp edges assist the user in finding and maintaining the correct entry point.

[0217] (c) Once the position of the distal tip of the instrument is within a predefined safety limit (e.g., 1 mm) from the target position, the user is indicated (e.g., shown in green) via software and moved to the next step.

[0218] (2) The target rotation of the pin guide is displayed via software, allowing the user to find the correct trajectory of the first pin.

[0219] (3) The user places the first pin.

[0220] (4) The target rotation around the first pin is displayed via software to define the correct trajectory of the second pin.

[0221] (5) The user places the second pin and retracts the guide along the pins.

[0222] Now referring to Figures 46 - 52 , an exemplary fixation device and method for an optical navigation array attached to a bone structure will be described. Figure 46 An exemplary fixation device 4600 with bicortical pins 4602 having a connecting bridge 4604 is shown. Two standard round and automatically piercing cortical pins 4602 are drilled through the soft tissue and through both the bone cortex and the bone canal. The drilling distance between the pins 4602 is indicated by a drilling guide (not shown), and the depth and orientation can be determined by the surgeon based on personal preference. A rigid bridge 4604 is attached to the pins 4602 (e.g., by closing fixation screws 4606), thereby preventing the navigation array 4608 from rotating and serving as the primary connection point for the navigation array. The connection of the array 4608 to the bridge 4604 can be adjusted in two orthogonal rotations and one translational DOF. Removal of the pins is accomplished by turning and pulling the pins 4602 from the leg. The incision left due to piercing the skin is sutured.

[0223] Figure 47 An exemplary external foot fixation device 4700 is shown. The device 4700 is rigidly connected to a foot orthosis / guide. The foot and tibia are locked in the orthosis by attaching two ankle bones with adjustable screws 4702, pushing against two anatomical landmarks, and closing the kinematic chain. This ensures the correlation of tibial and foot rotation. The navigation array 4704 is connected to a rod 4706 and a foot orthosis 4708 whose length and angle (in two axes orthogonal to the central axis of the rod) can be adjusted. To enable the navigation array to track the femur, other fixation devices described herein can be used. For removal of the array, no surgical intervention is required. The soft tissue and bone are not damaged.

[0224] Figure 48 Shows an exemplary fixation device 4800 having a cortical pin 4802 with an anti-rotation clamp 4804. The outer rigid anti-rotation clamp 4804 is connected to the inside of the bone surface incision with two spikes 4806. A cortical pin 4802 is inserted through the incision into the bone using the anti-rotation clamp as a clamp 4804. Together they form a rigid anchoring / connection point to the bone. The clamp 4804 is connected to the cortical pin by an adjustment screw 4807 and a form fit, thereby blocking all remaining DOFs. The anti-rotation clamp 4804 does not puncture the bone cortex but rigidly clamps by means of a force fit. The navigation array 4808 is connected to a structure described, for example, in Figure 46 and has the possibility of adjustment in different planes. Removal is performed by opening the anti-rotation clamp and pulling the cortical pin from the leg.

[0225] Figure 49 Shows an exemplary fixation device 4900 having a cortical pin 4902, an anti-rotation dowel 4904, a trocar 4906, a navigation array 4908, and a screw 4910. Figure 50A -C and 51A-C show exemplary embodiments of anti-rotation dowels that can be used with the fixation device 4900. In an exemplary method, a hollow shaft (trocar) 4906 is inserted through an incision in soft tissue onto the bone. A pin 4902 is inserted through the trocar 4906 and penetrates the first bone cortex until a predefined end point on the pin 4902 indicates the correct depth. The tip of the pin 4902 is equipped with a "dry-wall-dowel" anchor structure that can open and close freely in the bone canal. The navigation array 4908 can be attached to the cortical pin 4902 via a screw 4910.

[0226] Examples of anti-rotation dowels are shown in Figures 50A - 51C and include Figure 50A the anchoring device 5002 shown in. The device 5002 includes at least two wings 5004 that pivot around a common axis at the tip of the pin 4902 and can be translated orthogonally to the central / longitudinal axis of the pin (e.g., by employing a linear guide fixation). The device 5002 can be opened / closed by elongating / shortening a central screw / central pin to change the pivot distance to the fixation.

[0227] Another example is Figure 50B the morning star device 5006 shown in. The morning star device 5006 can have at least two connected wings 5008 that can pivot about their respective centers when the distance between the end points (fixed to the central screw or rod and the pin 4902) is shortened. The morning star device 5006 can be opened / closed by elongating / shortening a central screw / central pin to change the pivot distance to the fixation.

[0228] Another example is Figure 50C the Morning Star device 5010 shown in Figure 50C . The Morning Star device 5010 may have at least two wings 5012 that are bent into a circular shape by shortening the distance between the end points (fixed to the central screw or rod and pin 4902). The device 5010 may be opened / closed by extending / shortening the central screw / central pin to change the fixed pivot distance.

[0229] Figure 51A An exemplary reverse clamp device 5102 is shown. The device 5102 may have at least two wires 5104 (e.g., Nitinol) and a central member forming a pin 4902. The central member terminates in the shape-constrained wires 5104 to be pushed away from the central (longitudinal) axis and thus form an anchor. The device 5102 may be opened / closed by extending / shortening the free wire length.

[0230] Figure 51B A device 5106 whose shape may be similar to Origami / Octopus - finger is shown. The device 5106 may have at least two Origami structures 5107 (a series of flexible hinge joints) forming a pin 4902. A wire / cable 5108 is guided through the structure and enables opening. The ends of the Origami structure consist of "cut" surfaces. In the deployed configuration, a double - hook - like structure is formed. This device may be opened / closed by pulling / releasing the cable 5108.

[0231] Figure 51C A unwinding spring device 5110 is shown. The device 5110 may include at least one torsion - spring - like structure 5112 that is connected to the end of the pin 4902 on one side and to an internal pin / screw 5114 on the other side, thus increasing the surface and locking the array by unwinding. This device may be opened / closed by rotating the internal pin / screw clockwise / counter - clockwise.

[0232] By opening any of the described dowel pins, all possible translations and rotations are locked. A rigid connector, which is an attachment point for the navigation array, is attached to the pin 4902 (e.g., by closing a fixing screw and shape - fitting). The connection of the array to the connector may be adjusted in two orthogonal rotations and one translational DOF. The removal of the pin 4902 is accomplished by reversing the installation steps.

[0233] Figure 52An exemplary tripod fixation device 5200 is shown. The external rigid anti-rotation clamp 5202 is connected to the bone surface incision by means of two spikes 5204. A cortical pin 5206 is placed in the incision to prevent rotation. The fixation strap 5208 is tightened around the leg to allow for increased stability and is connected to the anti-rotation clamp 5202 via a flexible / elastic 5210 arm. The flexible / elastic arm ensures that a controlled force is applied to the cortical pin 5206 when the leg moves (during leg movement, the skin can move up to 2 cm with reference to the bone). All DOFs are locked. The spikes 5204 do not puncture the bone cortex but rigidly grip by force fit. The navigation array is connected to the arm 5210, allowing for adjustment in different planes (two rotations and one translational DOF). Removal is performed by opening the anti-rotation clamp 5202 and the fixation strap 5208 and pulling the cortical pin 5206 from the leg. Suturing at the cortical pin location is not required as it is within the incision.

[0234] Additional definitions and embodiments:

[0235] In the foregoing description of the various embodiments of the present inventive concept, it should be understood that the terms used herein are for the purpose of describing particular embodiments only and are not intended to be limiting of the present inventive concept. Unless otherwise defined, all terms used herein (including technical and scientific terms) have the same meaning as commonly understood by one of ordinary skill in the art to which this inventive concept belongs. It should be further understood that terms defined in commonly used dictionaries should be interpreted as having a meaning consistent with their meaning in the context of the present specification and the relevant art, and will not be interpreted in an idealized or overly formal sense.

[0236] When an element is referred to as "connected to" or "coupled to" or "responsive to" another element or a variation thereof, it can be directly connected to, coupled to, or responsive to the other element, or there can be an intermediate element. In contrast, when an element is referred to as "directly connected" or "directly coupled" or "directly responsive to" another element or a variation thereof, there is no intermediate element. Like numerals refer to like elements throughout. Further, as used herein, "coupled", "connected", "responsive", or variations thereof can include wireless coupling, connection, or response. Unless the context clearly dictates otherwise, as used herein, the singular forms "a / an" and "the" are intended to include the plural forms. For brevity and / or clarity, well-known functions or constructions may not be described in detail. The term "and / or" includes any and all combinations of one or more of the associated listed items.

[0237] It should be understood that although the terms first, second, third, etc. may be used herein to describe various elements / operations, these elements / operations should not be limited by these terms. These terms are only used to distinguish one element / operation from another. Thus, a first element / operation in some embodiments may be referred to as a second element / operation in other embodiments without departing from the teachings of the inventive concept. Throughout this specification, the same reference numerals or the same reference indicators denote the same or similar elements.

[0238] As used herein, the terms "comprise / comprising / comprises", "include / including / includes", "have / has / having" or variations thereof are open-ended and include one or more stated features, integers, elements, steps, components or functions, but do not preclude the presence or addition of one or more other features, integers, elements, steps, components, functions or combinations thereof. Further, as used herein, the general abbreviation "e.g.", derived from the Latin phrase "exempli gratia", may be used to introduce or specify one or more general examples of the item(s) previously mentioned and is not intended to limit such item(s). The general abbreviation "i.e.", derived from the Latin phrase "id est", may be used to specify a particular item from a more general statement.

[0239] Example embodiments are described herein with reference to block diagrams and / or process illustrations of computer-implemented methods, apparatus (systems and / or devices) and / or computer program products. It should be understood that the blocks of the block diagrams and / or process illustrations, and combinations of blocks in the block diagrams and / or process illustrations, can be implemented by computer program instructions executed by one or more computer circuits. These computer program instructions may be provided to a processor circuit of a general purpose computer circuit, a special purpose computer circuit and / or other programmable data processing circuit to produce a machine such that the instructions executed by the processor of the computer and / or other programmable data processing device transform and control transistors, values stored in memory locations, and other hardware components within such circuitry to implement the functions / actions specified in the block diagram and / or one or more flowchart blocks, and thereby create means (functions) and / or structures for implementing the functions / actions specified in the block diagram and / or one or more flowchart blocks.

[0240] These tangible computer program instructions can also be stored in a computer-readable medium that can direct a computer or other programmable data processing apparatus to operate in a particular manner, such that the instructions stored in the computer-readable medium produce an article of manufacture including instructions implementing the function / act specified in the block diagrams and / or one or more flowchart blocks. Accordingly, embodiments of the inventive concept can be embodied in hardware and / or software (including firmware, resident software, microcode, etc.) that runs on a processor such as a digital signal processor, which may be collectively referred to as "circuitry", "module", or variants thereof.

[0241] It should also be noted that in some alternative implementations, the functions / acts noted in the blocks may not occur in the order noted in the flowchart. For example, two blocks shown in succession may in fact be executed substantially concurrently, or the blocks may sometimes be executed in the reverse order, depending upon the functionality / acts involved. Further, the functionality of a given block of the flowchart and / or block diagram may be split into multiple blocks, and / or the functionality of two or more blocks of the flowchart and / or block diagram may be at least partially integrated. Finally, other blocks / operations may be added / inserted between the blocks shown, and / or blocks / operations may be omitted, without departing from the scope of the inventive concept. Also, although some of the figures in the drawings include arrows on communication paths to show a primary direction of communication, it should be understood that communication may occur in the opposite direction to that depicted by the arrows.

[0242] Many variations and modifications can be made to the embodiments without materially departing from the principles of the inventive concept. All such variations and alterations are intended to be included within the scope of the inventive concept herein. Accordingly, the subject matter disclosed above is to be considered illustrative and not restrictive, and the examples of the appended embodiments are intended to cover all such modifications, enhancements, and other embodiments that fall within the spirit and scope of the inventive concept. Thus, to the maximum extent permitted by law, the scope of the inventive concept will be determined by the broadest permissible interpretation of the present disclosure, including the following examples of embodiments and their equivalents, and should not be limited or restricted to the foregoing specific detailed description.

Claims

1. A fixation system for use in robotic-assisted surgery, comprising: a fixation device, the fixation device comprising: a trocar; a cortical pin configured to be inserted into the trocar; and a dowel pin configured to be attached to the cortical pin, wherein the dowel pin is configured to prevent the cortical pin from rotating in a bone structure; and a navigation array configured to be removably attached to the cortical pin, wherein: the dowel pin is a spring device having a torsion spring structure configured to deploy at the tip of the cortical pin.

2. The system according to claim 1, wherein the dowel pin is configured to be inserted into cortical bone and a bone channel.

3. The system according to claim 1, wherein the navigation array is removably attached to the cortical pin via a screw.

4. The system according to claim 1, wherein the navigation array comprises optical markers visible to an infrared camera system.

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