Systems for computer-assisted navigation during surgery

Abstract

The present application relates to a system for computer-assisted navigation during surgery. A navigable instrument that can be navigated by a surgeon using a surgical robotic system allows for navigational movement of an instrument or other surgical device. For example, the instrument may be suitable for use in procedures involving navigation and / or robotic total knee arthroplasty.

Description

Technical Field

[0001] The present disclosure relates to medical devices and systems, and more particularly, to navigated surgical instruments used during surgical procedures. Background Art

[0002] There are many surgical interventions that require osteotomy, i.e. cutting of an anatomical structure such as bone along a target plane. A total knee arthroplasty (TKA) may include cutting of the femoral and tibial epiphysis to remove damaged bone and cartilage and allow for installation of a knee prosthesis.

[0003] Currently in TKA surgery, patient satisfaction may only be around 80%. This is low compared to some other types of orthopedic surgery, such as hip arthroplasty, where patient satisfaction is typically around 95%. These satisfaction rates have remained largely unchanged for decades despite innovations in new implant designs, custom cutting template solutions, custom implants, etc. This suggests that TKA and other orthopedic surgeries may have some issues that previous medical procedures and related innovations have not yet solved.

[0004] Computer-assisted surgery (CAS), including navigation and / or robotic surgery systems, may utilize position recognition systems that can determine the location of a particular object and track it in 3 dimensions (3D). In navigation and / or robotic-assisted surgery, certain objects, such as surgical instruments, need to be tracked with a high degree of accuracy, for example, as the physician and / or robot positions and moves the instrument. There is also a need to provide improved instruments for navigation and / or robotic-assisted surgery. Summary of the invention

[0005] To meet this and other needs, and in view of its purpose, the present application provides devices, systems, instruments and methods for performing orthopedic surgery such as total knee arthroplasty (TKA). A surgical robotic system and / or navigation system can be provided that navigates one or more instruments and / or assists a user in performing one or more surgeries. Navigable instruments (including instruments that can be navigated) and navigation software allow instruments or other surgical devices to be navigated. The system allows locating anatomical structures in open or minimally invasive (MIS) procedures and navigating surgical instruments and other devices throughout the surgical procedure.

[0006] According to one embodiment, a system for computer-assisted navigation during surgery includes a robotic navigation system, first and second dynamic reference datums, and a navigable stylus. The robotic navigation system may include a computer, a display, and a camera configured to detect one or more tracking markers. The first dynamic reference datum may include a first reference array having a first plurality of tracking markers, and the first dynamic reference datum may be configured to attach to and track a first bone. The second dynamic reference datum may include a second reference array having a second plurality of tracking markers, and the second dynamic reference datum may be configured to attach to and track a second bone. The navigable stylus may include a third reference array having a third plurality of tracking markers and a universal quick-connect attachment tip configured to quickly attach the stylus to one or more instruments and return the position to the robotic navigation system. When used in total knee arthroplasty, the first bone may be a femur and the second bone may be a tibia, or vice versa. The femur and tibia may be in a flexed or extended position during surgery.

[0007] For example, the instrument can be a posterior tibial wall hook or a plane checker. The posterior tibial wall hook can include a loop and a hook. The loop can include a longitudinal opening configured to receive a universal tip, and the hook can be configured to locate the tibial wall during a total knee arthroplasty. The plane checker can include a loop and a foot. The loop can include a longitudinal opening configured to receive a universal tip, and the foot can include a U-shaped plate with a flat bottom surface that is configured to be placed on the resection plane to return angulation and / or cutting depth to a robotic navigation system. The instrument can be freely rotated relative to the longitudinal axis of the stylus, thereby allowing rapid reorientation of a third reference array, for example, to facilitate the line of sight of a camera.

[0008] According to another embodiment, a system for performing computer-assisted navigation during surgery includes a robotic navigation system, a first and a second dynamic reference datum, and one or more monitoring markers. For example, a first monitoring marker can be configured to be attached to a first bone (one of the femur or tibia), and a second monitoring marker can be configured to be attached to a second bone (the other of the femur or tibia). The monitoring marker can include a body including a fastener (e.g., a bone pin) terminating at a distal tip and a single tracking marker on the monitoring marker. The monitoring marker can include a verification divot integrated into the body of the monitoring marker. The verification divot can be configured to verify the navigation integrity of the system by placing the tip of a separate instrument (e.g., a stylus) into the verification divot of the monitoring marker.

[0009] According to another embodiment, a system for performing computer-assisted navigation during surgery includes a robotic navigation system, a first and a second dynamic reference datum, and one or more virtual landmarks. For example, the first virtual landmark can be configured to be attached to a first bone and the second virtual landmark can be configured to be attached to a second bone. For example, the virtual landmark can include a cortical bone screw with a verification indentation. The virtual landmark can be configured to verify the navigation integrity of the system by placing the tip of a separate instrument (e.g., a stylus) into the virtual landmark of the monitoring mark.

[0010] According to yet another embodiment, a system for computer-assisted navigation during surgery includes a robotic navigation system and one or more dynamic reference datums configured to attach to and track a bone. The dynamic reference datum may include a single monitoring marker. The distance between a reference array of the dynamic reference datum and the monitoring marker is stored by the system. If the dynamic reference datum and / or the monitoring marker are inadvertently moved, the system identifies the change in distance and / or movement, thereby changing the user to an interrupt.

[0011] According to yet another embodiment, a system for computer-assisted navigation during surgery includes a robotic navigation system, first and second dynamic reference datums, and a navigable plane checker. The plane checker may include a body having a reference array, the reference array including a plurality of tracking markers, an axis extending from the body, and a foot at the distal end of the axis. When used during knee surgery, the plane checker can be placed against a resection to ensure that the angle and / or position of the resection is correct.

[0012] According to yet another embodiment, a system for performing computer-assisted navigation during surgery includes a robotic navigation system, first and second dynamic reference datums, and a navigable stylus configured for landmark location and / or point acquisition. When the stylus is over a landmark or point of interest, the stylus can be rotated a threshold rotation (e.g., at least 30°). The threshold rotation can be captured by the robotic navigation system, thereby capturing the landmark or point of interest by the robotic navigation system. In another embodiment, a tracking marker associated with a reference array of the stylus can be physically moved relative to other tracking markers. When the stylus is over a landmark or point of interest, the robotic navigation system detects the movement of one tracking marker relative to another tracking marker and captures the landmark or point of interest.

[0013] According to yet another embodiment, a system for computer-assisted navigation during surgery includes a robotic navigation system, first and second dynamic reference datums, and a tensor, the tensor including a body having a pair of independent upper traction paddles, a lower traction paddle, an axis connected to a knob, the knob configured to move the upper traction paddle relative to the lower traction paddle, and a spring positioned about the axis between the body and the knob. The tensor can be configured to provide traction between the tibia and the femur. For example, rotation of the traction knob can translate the upper traction paddle outward and away from the lower traction paddle, thereby providing a gap between the upper traction paddle and the lower traction paddle. The tensor can include a pivotable ligament balance indicator positioned on the body of the tensor. The first upper traction paddle can be connected to a first end of the ligament balance indicator by a first rod, and the second upper traction paddle can be connected to an opposite end of the ligament balance indicator by a second rod. When traction is applied, for example, during knee surgery, the tensor is configured to apply a traction force F to the lower traction paddle. 牵引 , apply force F to the first upper traction paddle LCL (lateral collateral ligament), and exerts a force F against the second upper traction paddle MCL (Medial collateral ligament). When the ligament is at F LCL =F MCL The ligament balance indicator indicates balance, for example, by displaying the indicator in a horizontal position. LCL <F MCL or F LCL >F MCL When the ligament balance indicator is in an unbalanced state, it indicates the unbalance, for example, by displaying the indicator in a tilted, slanted, or askew position. The indicator can also indicate the amount of imbalance or degree of imbalance for each corresponding force.

[0014] According to yet another embodiment, a system for computer-assisted navigation during surgery includes a robotic navigation system and one or more modular dynamic reference datums. The modular dynamic reference datum may include a reference array with multiple tracking marks, an integrated bridge and pin guide, and one or more fasteners. Each of the multiple tracking marks may be positioned in a protective cover configured to prevent navigation loss. The bridge may include a first opening aligned with a first pin guide and a second opening aligned with a second pin guide. The first and second fasteners may be received by the bridge and the pin guide to fix the dynamic reference datum to the bone. The reference array may include a rectangular frame with a cross brace, and tracking marks placed at each corner of the rectangular frame in each corresponding cover. The reference array may be configured to rotate, for example, about two axes. The array may be able to rotate about the longitudinal axis of the bridge and / or an axis perpendicular to the bridge. After one or two adjustments along the axis, the reference array may be locked in place by one or more locking screws. If desired, an extension arm may be used to increase the positioning options of the reference array. The bridge may be temporarily connected to a removable handle for installation. The modular assembly of the dynamic reference datum can reduce the number of instruments used throughout the surgical procedure.

[0015] According to another embodiment, a method for installing a modular dynamic reference datum may include one or more of the following in any suitable order: (1) forming an incision in a patient's body; (2) connecting a handle to an integrated bridge and pin guide; (3) inserting a bridge into the incision until the bridge contacts cortical bone; (4) driving one or more bone pins through the bridge and pin guide; (5) locking the bridge on the pins, for example using locking screws; (6) removing the handle from the bridge; (7) attaching a reference array to the bridge; (8) optionally, attaching an extension between the reference array and the bridge to facilitate more positioning options for the reference array; (9) adjusting the orientation of the reference array, for example along one or two axes; and (10) locking the final position of the reference array relative to the bridge via one or more locking screws.

[0016] Also provided are kits that include navigable instruments and components of varying types and sizes, implants, fasteners or anchors, k-wires, insertion tools, and other components for performing the procedure. BRIEF DESCRIPTION OF THE DRAWINGS

[0017] A more complete understanding of the present invention and its attendant advantages and features will be more readily appreciated by reference to the following detailed description when considered in conjunction with the accompanying drawings, in which:

[0018] Figure 1 A femur and tibia are shown with a dynamic reference datum attached to each bone, and a stylus with a universal reference element, according to one embodiment;

[0019] Figure 2illustrates a surgical robot and / or navigation system according to one embodiment;

[0020] Figure 3 A medical operation is illustrated in which a surgical robot and a camera system are positioned around a patient;

[0021] Figures 4A-4C An embodiment of a stylus with a universal reference element, a planarity checking instrument attached to the stylus, and a posterior tibial wall hook attached to the stylus is shown;

[0022] Figure 5A-5B The use of a stylus with a tibial wall hook and a planimetry attachment are shown, respectively;

[0023] Figure 6 shows a resected femur and a resected tibia and a stylus according to one embodiment;

[0024] Figure 7A-7B An embodiment of one or more surveillance markers that may be used to maintain navigation integrity is shown;

[0025] Figure 8 It is an example of landmark inspection using monitoring markers and stylus;

[0026] Figures 9A-9B An embodiment of one or more virtual landmarks using a stylus is shown;

[0027] Fig.10 is an embodiment of a dynamic reference datum with an integrated monitoring mark;

[0028] Figures 11A-11B An embodiment of a plane checker is shown;

[0029] Figures 12A-12B An embodiment of a stylus that allows landmark and / or point capture without depressing a robot's foot pedal during operation is shown;

[0030] Fig.13 An embodiment of a tensioning device for use during femoral and tibial flexion is shown;

[0031] Fig.14 An embodiment of a tensioning apparatus is shown;

[0032] Fig.15 The tensioner used during femoral and tibial extension is shown;

[0033] Fig.16 is an example of a tensor with ligament balance;

[0034] Fig.17 is an illustration of a femur and tibia with a dynamic reference datum attached to each bone;

[0035] Figures 18A-18B An embodiment of a modular dynamic reference datum having a removable handle for mounting the dynamic reference datum is shown;

[0036] Figures 19A-19C depicts inserting an integrated bridge and pin guide into a dynamic reference datum with an attached handle, driving a pin through the bridge and pin guide, and locking the pin to the bridge with a locking element;

[0037] Figures 20A-20C A dynamic reference datum depicting removal of a handle, attachment of a reference array, adjustment of a position and / or orientation of the reference array, and locking of a final position of the reference array;

[0038] Fig.21 An embodiment of a dynamic reference datum having an extension arm between a bridge and a reference array is shown; and

[0039] Figures 22A-22B An embodiment of a bone pin that may be used to secure a dynamic reference datum to a bone is shown. DETAILED DESCRIPTION

[0040] During knee replacement, knee arthroplasty or total knee arthroplasty (TKA), one or more implants can be used to cover the ends of the femur and / or tibia that form the knee joint. The knee includes the femur or thigh bone of the thigh, the tibia or osteophyte of the calf, and the patella or kneecap. When osteoarthritis causes the cartilage and / or one or more bones of the knee to break, rheumatoid arthritis causes synovial inflammation, or trauma causes knee bone and / or cartilage damage, TKA may be needed. Although TKA is illustrated here, it should be understood that other orthopedic or other surgical procedures can use the devices and systems described herein. In order to improve the surgical results, surgical navigation and / or robotic systems can be used to navigate one or more instruments and / or assist the surgeon in performing one or more operations.

[0041] Reference now Figure 1 , a system or procedure for performing one or more steps in a knee arthroplasty is shown. The femur 4 and tibia 6 are shown with a patient tracking device or dynamic reference datum 26 attached to each bone. The dynamic reference datum 26 tracks the patient's anatomy throughout the procedure. The dynamic reference datum 26 can be configured by, for example Figure 2The surgical robot and / or navigation system 10 shown is tracked. The surgical robot and / or navigation system 10 may include, for example, a surgical robot 12, one or more robotic arms 14, a base 16 (including a computer platform), a display or monitor 20 (and / or an optional wireless tablet, headset, etc.), an end effector 22, and one or more tracking markers 18. The end effector 22 may be configured to secure a catheter, an access instrument, or other tool suitable for performing one or more steps in plastic surgery. Figure 2 In one embodiment shown, an access instrument 34 (e.g., a retractor) is attached to the end effector 22 via an articulated arm 24 and is positioned at a position adjacent to the end effector 22. Figure 3 In the illustrated alternative embodiment, an instrument holder for securing a surgical saw 36 (eg, a saw blade configured to swing for cutting bone) is coupled to the end effector 22. It should be appreciated that suitable instruments or devices may be coupled to the end effector 22 for control by the robot 12.

[0042] In navigation-type and / or robot-assisted surgery, one or more instruments may be tracked using reference elements, arrays, or dynamic reference arrays 28, 42, 94. Reference arrays 28, 42, 94 may include one or more tracking markers 18 that are attached or attachable to instruments and allow the tracking system 10 to detect and locate the position of the instruments in 3D space. The computer platform is configured to track the pose (e.g., position and rotational orientation) of the reference arrays 28, 42, 94 in real time in combination with a camera tracking system or other 3D positioning system. Tracking of the 3D coordinates of the reference arrays 28, 42, 94 may allow the surgical system 10 to determine the pose of the reference arrays 28, 42, 94 in any multidimensional space associated with the target anatomical structure of the patient 2.

[0043] The surgical robotic system 10 may include one or more patient tracking devices or dynamic reference datums 26, 130, which include one or more tracking markers 18, which are suitable for being directly fixed to the patient 2 (e.g., fixed to a bone of the patient 2). Figure 1 In the illustrated embodiment, a first patient tracking device or first dynamic reference datum 26 is secured to femur 4 and a second patient tracking device or second dynamic reference datum 26 is secured to tibia 6 of patient 2. In this manner, system 10 is able to track femur 4 and tibia 6 throughout the procedure.

[0044] The surgical robotic system 10 may also utilize a camera 30 positioned, for example, on a camera support 32. The camera support 32 may have any suitable configuration to move, orient, and support the camera 30 in a desired position. The camera 30 may include any suitable one or more cameras capable of identifying, for example, active and / or passive tracking markers 18 in a given measurement volume visible from the perspective of the camera 30, such as one or more infrared cameras (e.g., a dual-focus or stereophotogrammetry camera). The camera 30 may scan the given measurement volume and detect light from the markers 18 to identify and determine the position of the markers 18 in three dimensions. For example, active markers 18 may include infrared emitting markers activated by electrical signals (e.g., infrared light emitting diodes (LEDs)), and passive markers 18 may include retroreflective markers that reflect infrared light (e.g., they reflect incident IR radiation into the direction of the incident light), such as emitted by an illuminator or other suitable device on the camera 30.

[0045] The surgical robot 12 is capable of controlling the translation and orientation of the end effector 22. For example, the robot 10 may be capable of moving the end effector 22 along the x-axis, y-axis, and z-axis. The end effector 22 may be configured for selective rotation about one or more of the x-axis, y-axis, and z-axis, as well as the Z-frame axis (so that one or more Euler angles (e.g., roll, pitch, and / or yaw) associated with the end effector 22 may be selectively controlled). In some exemplary embodiments, selective control of the translation and orientation of the end effector 22 may allow medical procedures to be performed with significantly improved precision.

[0046] The robotic positioning system 12 includes one or more computer-controlled robotic arms 14 to assist the surgeon in planning the position of one or more instruments relative to preoperative and / or intraoperative patient images. The system 10 may include 2D and 3D imaging software that allows for preoperative planning, navigation, and guidance through dynamic reference arrays, navigation instruments, and cameras for placement of instruments, orthopedic devices, or other devices. Further details of surgical robots and / or navigation systems can be found, for example, in U.S. Patent 8,257,360, U.S. Patent Publication 2019 / 0021795, and U.S. Patent Publication 2017 / 0239007, all of which are incorporated herein by reference in their entirety for all purposes.

[0047] Now turn to Figures 4A-4C, an embodiment of a universal stylus instrument or stylus 40 is shown. In navigation and / or robotic-assisted surgery, it is often necessary to track multiple instruments. If a user wishes to track different instruments, several different reference elements or arrays can be used, each with a different configuration. These unique configurations communicate to the navigation system 10 that a new instrument is being used and redefine its position in 3D space. Therefore, in order to track many instruments, many corresponding reference elements are required, which increases cost and complexity as the user is constantly acquiring and configuring different reference elements.

[0048] According to one embodiment, the stylus 40 is used as a universal reference element. The stylus 40 can be inserted into several different instruments to make each navigable, thereby eliminating the need for many different reference elements. Figure 4A As shown, the stylus 40 may include an array 42 having a plurality of markers 18 at a proximal end 48, an elongated body 44, and a universal quick-connect attachment tip 46 at a distal end 50. The universal attachment tip 46 is configured to quickly attach the stylus 40 to one or more instruments and return their positions to the navigation system 10. For example, in TKA, the stylus 40 may be used to navigate itself, an attached planimetry 52, an attached posterior tibial wall hook 54, or any other suitable instrument. The tracking markers 18 on the array 42 of the stylus 40 may be viewed by the navigation system 10 and the positions of the stylus tip 46 and any attached instruments are returned.

[0049] The universal stylus 40 may be used alone or with an attached instrument (e.g., posterior tibial wall hook 54 or plane checker 52). The mechanical connection of the universal stylus 40 to the instruments 52, 54 may allow the functional length between the instrument's navigated tip 46 (e.g., the measurement surface of the hook 54 or plane checker 52) and the pattern of the stylus reference array 42 to be controlled with a high level of repeatability. The universal tip 46 may act as a quick connect mechanism for rapid attachment of the instrument by the user.

[0050] exist Figure 4BIn one embodiment shown, a plane checker 52 is attached to the stylus 40. The universal attachment tip 46 can be inserted and secured to the plane checker 52. The plane checker 52 can include a collar 56 and a foot 58. The collar 56 can include a longitudinal opening configured to receive the universal tip 46 of the stylus 40. The universal attachment tip 46 of the stylus 40 can be sized so that it forms a clearance fit with the opening in the collar 56. If desired, a spring preload mechanism can be positioned in the opening so that it preloads the connection component to the reference surface. The plane checker 52 can rotate freely relative to the stylus 40. The free rotation of the plane checker 52 about the longitudinal axis A of the stylus 40 can allow the user to quickly reorient the reference array 42, for example, to ensure a line of sight to the camera 30. Although a clearance fit is described, any suitable connection between the tip 46 and the plane checker 52 can be used to temporarily secure the assembly together. The foot 58 can include a U-shaped plate or other suitably shaped plate. The foot 58 may include a flat bottom surface or flat portion configured to contact a resection surface on a bone.When used during a TKA procedure, the plane checker 52 may be used to ensure that the angle and / or location of the resection plan matches the plane.

[0051] exist Figure 4C In another embodiment shown, a posterior tibial wall hook 54 is attached to the feeler pin 40. The universal attachment tip 46 can be inserted into and connected to the posterior tibial wall hook 54. The size of the universal attachment tip 46 of the feeler pin 40 can be designed so that it forms a positional fit with the opening in the collar 56. The static fit allows the posterior tibial wall hook 54 to be fixed in position and orientation relative to the feeler array 42. Although a static fit is described, any suitable connection between the tip 46 and the wall hook 54 can be used to temporarily fix the components together. The wall hook 54 may include a collar 56 having an enlarged tip or hook 60 at its distal end. When used during a TKA procedure, the posterior tibial wall hook 54 can be used to locate the tibial wall.

[0052] like Figure 1 As shown, the stylus 40 can be used alone. In this case, the dynamic reference datum 26 is tracking the patient anatomy of the femur 4 and tibia 6. The stylus 40 can be used for tasks such as landmark inspection or characteristic bone surface acquisition (including the condyle or tibial plateau). Figure 5A In FIG. 4 , the tibial wall hook 54 has been attached to the distal end 50 of the stylus 40 via the attachment tip 46. For example, when attached to the stylus 40, the hook 54 can be navigated through the stylus tracking array 42 and the user can perform acquisition of points to define the posterior tibial wall. Figure 5BIn the embodiment of the present invention, the user can use the attached plane checker 52 to check the angle and / or position of the resection plane. The plane checker 52 is attached to the universal tip 46 of the stylus 40, and the stylus 40 serves as a universal reference element for the plane checker 52. The resection plane determined by the plane checker 52 can be returned to the user by the navigation system 10.

[0053] Now turn to Figure 6 , shows the resected femur 4 and tibia 6 of the patient registered during TKA surgery. Figure 1 As shown, the patient has dynamic reference datums 26 inserted into the tibia 6 and femur 4, and after registration is complete, the stylus 40 can be used to perform landmark checks and establish confidence in the integrity of the navigation. Figure 6 However, since much of the unique bony anatomy has been resected, post-resection landmark checking is significantly more challenging. In robotic and navigated TKA, it is important for the surgeon to have confidence that the patient's anatomy has been accurately registered to the system 10 and that accuracy is maintained throughout the procedure. Navigation integrity can be used to describe this confidence. Specifically, in TKA, since major anatomical landmarks that the surgeon may use as reference points are resected during the procedure, it can be challenging to maintain navigation integrity throughout the procedure.

[0054] Thus, one or more embodiments described herein enable a user to perform physical landmark checks even after bone resection has removed natural landmarks. One or more embodiments described herein provide for monitoring of the dynamic reference datum 26 to ensure that any relative motion to the dynamic reference datum 26 is identified and / or recorded. These techniques help improve the user's ability to establish and maintain confidence in the integrity of the system navigation.

[0055] Focus on Figure 7A-7B According to one embodiment, one or more monitoring markers 62 may be used to maintain navigation integrity throughout the procedure. For example, patient registration may include adding a first monitoring marker 62 in the femur 4 and a second monitoring marker 62 in the tibia 6 in an area that will not be resected during surgery. Figure 7B As shown, the monitoring marker 62 may include a body 64 including a fastener 66 terminating in a distal tip 68, a verification indentation 70, and a tracking marker 18. The fastener 66 may include a bone pin, a screw, or an anchor that is inserted into the patient's bone anatomy. The distal tip 68 may be pointed, sharp, or otherwise configured to engage bone. The verification indentation 70 may be integrated into the body 64 of the monitoring marker 62. A single tracking marker 18 may be attached to the top of the marker 62, for example, near the verification indentation 70.

[0056] Once inserted into the patient, the position of the monitoring marker 62 can be registered relative to the dynamic reference datum 26. This registration stores a virtual distance between the monitoring marker 62 and the dynamic reference datum 26. If the dynamic reference datum 26 moves (e.g., if it is bumped by the user), the system 10 measures the distance and alerts the user if a threshold of movement, such as 2 mm, is exceeded. If the user wants to verify or reestablish navigation integrity, an additional landmark check can be performed using the verification indentation 66 in the monitoring marker 62, such as Figure 8 For example, the tip 46 of the stylus 40 may be inserted into the verification indentation 70 of the surveillance marker 62 to confirm navigation integrity.

[0057] exist Figures 9A-9B In the alternative embodiment shown, one or more virtual landmarks 72 may be used in place of the monitoring markers to maintain navigation integrity throughout the procedure. For example, a first virtual landmark 72 may be positioned in the femur 4 and a second virtual landmark 72 may be positioned in an area of ​​the tibia 6 that will not be resected. The virtual landmarks 72 may include a fastener 74, such as a cortical bone screw, having, for example, a verification indentation 76 nested in the drive feature of the screw. The fastener 74 may include a threaded shaft 78 and an enlarged head 80. As shown in FIG. Fig. 9A As shown, at the beginning of surgery, the virtual landmark 72 can be inserted into the patient's bony anatomy and the location returned to the system 10 using the stylus 40. If the user wants to perform an intraoperative landmark check at any time (including after resection), the user simply inserts the distal tip 46 of the stylus 40 into the indentation 76 of the virtual landmark 72.

[0058] exist Fig.10 In the illustrated alternative embodiment, a monitoring marker 82 may be integrated into the dynamic reference datum 26 to maintain navigation integrity throughout the process. The monitoring marker 82 may be secured to the dynamic reference datum 26 via a bridge 84 and one or more arms 86. For example, the monitoring marker 82 may be secured to the bridge 84. The distance between the reference element of the dynamic reference datum 26 and the monitoring marker 82 is stored by the system 10. If the dynamic reference datum 26 and / or the monitoring marker 82 collide and / or rotate about the indicated axis, the change in distance and / or movement will be recognized and recorded by the system 10, and the user is immediately alerted of the interruption.

[0059] exist Figures 11A-11BIn the illustrated alternative embodiment, the plan checker instrument 90 can be used to maintain navigation integrity even if traditional anatomical landmarks are removed during surgery. The plan checker 90 may include a body 92 having a reference element or array 94 including a plurality of tracking markers 18, a shaft 96 extending from the body 92, and a foot 98 at the distal end of the shaft 96. The array 94 is located at a known position relative to the foot 98. The foot 98 may include a U-shaped plate or other suitably shaped plate having a flat bottom surface 100. When used during a TKA procedure, the plan checker 90 can be used to ensure that the angle and / or location of the resection plan matches the plane. As shown in FIG. Fig.11A As shown, after the femur 4 and / or tibia 6 are resected, the foot 98 includes a flat surface 100 that can be placed on the resection plane and return the angle and cutting depth to the system 10. Using this information, the user can locate the position of traditional anatomical landmarks and maintain navigation integrity even after they have been resected.

[0060] Now turn to Figures 12A-12B , showing an embodiment of a stylus 40. In navigated and robotic TKA, the surgeon may need to capture anatomical landmarks or points in order to register the patient anatomy to the system 10, establish and maintain confidence in the integrity of the system navigation, and / or position trials and implants to compare the accuracy of planning and placement. Figure 1 A setup for navigation and / or robotic TKA is shown. A dynamic reference datum 26 is attached to the femur 4 and tibia 6, and after being registered, the system 10 is able to track the position of each bone in 3D space. A navigation stylus 40 can be used for landmark positioning and / or point acquisition. In one workflow, the stylus tip 46 is located at a point of interest, and a foot pedal on the robot 12 is pressed to capture a point on the system 10. In this embodiment, point capture depends on the surgeon stepping on a foot pedal connected to the system 10.

[0061] The foot pedal method of point capture may be problematic if the location of the foot pedal on the operating room (OR) floor is unknown. For example, the foot pedal may be inadvertently kicked out or moved out of the surgeon's reach. If this occurs, the surgeon may need to divert attention from the surgical area to search for the foot pedal. In addition, the cable connecting the foot pedal may be problematic, for example, because it may be a tripping hazard or block free passage of equipment in the OR. In addition, the software may need to handle disabling other functions, such as robotic control, which may also be linked to the foot pedal before enabling the point capture function, which increases the complexity of the software algorithm. Therefore, it may be desirable to include additional embodiments that can be used in place of a traditional foot pedal.

[0062] Fig. 12A Alternative setups for navigated and / or robotic TKA are shown. Fig. 12A Shown with Figure 1 A similar arrangement is provided, except that in this arrangement, once the point of interest has been located by the stylus tip 46, the surgeon can rotate the stylus 40 about the long vertical axis of the stylus by a threshold rotation. By rotating the stylus 40, the marker 18 moves from a first position (before rotation) to a second position (after rotation). The stylus 40 can be rotated about its axis by a threshold rotation, such as about 30°, about 60°, about 180°, or any suitable degree to indicate rotation. The rotation is captured by the system 10 and the point of interest is returned, thereby capturing the landmark by the system 10 without depressing a foot pedal or other button. To ensure that the system 10 operates as expected when the surgeon identifies a point rather than freely moving the tool, the system 10 can use algorithmic rules to filter out false positives. For example, when the tip 46 moves less than a given amount (e.g., less than 0.5 mm), the system can check that a threshold rotation (e.g., a rotation of at least 30°) occurs. For example, if a movement greater than 0.5 mm occurs at the tip 46 during a 30° rotation, point capture is ignored. If less than 0.5 mm of movement occurs at the tip 46 during the 30° rotation, the point / landmark is captured.

[0063] Fig. 12B Another embodiment of a navigated and / or robotic TKA is shown. Fig. 12B Shown with Fig. 12A In a similar arrangement, except in this embodiment, once the stylus 40 is over a point of interest or landmark, one of the tracking markers 18 associated with the array 42 can be physically moved. For example, one of the tracking markers 18 can be moved from a first tracking marker position 18a to a second tracking marker position 18b. The surgeon can manually move the marker 18 by pressing with a thumb or finger while holding the stylus tip 46 in place. The system 10 detects the movement of one array marker 18a, 18b relative to the other markers and captures the point of interest.

[0064] In yet further embodiments, the method may include point capture via voice input from a user; point capture by blocking or displaying tracking markers, or then preventing one or more markers from being displayed at a particular time (e.g., equivalent to a "double-click"); point capture via gestures of another hand, face, or elbow, captured and interpreted by visible light tracking; capturing points by synchronizing stylus positioning with a metronome so that a new point is captured at each beat, which may be valuable if the joints of a skeleton are being systematically digitized; or any other suitable point capture method or technique.

[0065] Now turn to Fig.13, a tensioning device or tensioner 102 is shown with the femur 4 and tibia 6 in flexion. The goal of total knee arthroplasty (TKA) can be to obtain a flexion and extension gap with symmetrical and balanced tension. One method to achieve this goal is to use a gap balancing technique, in which the femoral incision (posterior femur 4 flexion, distal femur 4 extension) is made parallel to the resected proximal tibia 6, and each collateral ligament is equally tensioned to obtain a rectangular flexion and extension gap. The implant can follow this parallel placement, thereby maintaining tension after implantation is completed.

[0066] In robotic and / or navigated TKA, the patient's anatomy is registered to the computing system 10. Once registered, the relative position of the patient's tibia 6 and femur 4 can be tracked to allow real-time updating of the patient's gap measurements on the computing system 10. With the help of the tensioner 102, the surgeon can view the quantified ligament balance on the navigation display 20. The tensioner 102 can facilitate gap balance by: (1) applying traction between the tibia 6 and femur 4; and / or (2) applying traction so that the difference in tension between the medial collateral ligament (MCL) and the lateral collateral ligament (LCL) is transparent to the user.

[0067] like Fig.13 As shown, the dynamic reference datum 26 is rigidly connected to the patient's tibia 6 and femur 4. During registration, the patient's anatomy is registered to the system 10 and tracked by the dynamic reference datum 26. Once the patient is registered, the surgeon can make the first resection. After the resection, the tensioner 102 can be used to assess the gap balance. Fig.13 In the embodiment shown, the proximal tibia 6 is resected and the tensioner 102 is placed against the resection while the bones are held in flexion. Fig.15 In the embodiment of the present invention, the proximal tibia 6 is resected and the tensioner 102 is placed against the resected portion while the bone is held in extension. It should be understood that the resection can be performed after a femur-first or tibia-first approach.

[0068] refer to Fig.14 , the tensioner 102 may extend from the proximal end 104 to the distal end 106. The tensioner 102 includes a body 108 having a pair of independent upper traction paddles 110 and lower traction paddles 112 at the distal end 106; a central shaft 120 extending along the length of the body 108, which is configured to move the upper traction paddle 110 relative to the lower traction paddle 112; a knob 116 at the proximal end 104, which is configured to move the upper traction paddle 110; and a traction balance spring 118 positioned between the body 108 and the knob 104 around the shaft 120.

[0069] The tensioner 102 is configured to provide traction between the tibia 6 and the femur 4. The tensioner 102 can allow any imbalance between the MCL and LCL tension to be displayed by a ligament balance indicator 114 positioned on the body 108 of the tensioner 102. The first upper traction paddle 110 can be connected to a first end of the ligament balance indicator 114 by a first rod 124, and the second upper traction paddle 110 can be connected to the opposite end of the ligament balance indicator by a second rod 126. The indicator 114 can be pivotally connected to the body 108 by a pivot pin 128. For example, traction can be provided by rotating the traction knob 116. Rotation of the traction knob 116 can translate the upper traction paddle 110 outward and away from the lower traction paddle 112, thereby providing a gap 122 between the upper traction paddle 110 and the lower traction paddle 112. As the tensioner 102 applies traction, the bone anatomy will move. The movement can be registered by the navigation system 10 and can be displayed for interpretation by the surgeon. Specifically, the motion of the femur and tibia is continuously captured by the camera 30 via the DRB 26 tracking markers on both the tibia and femur (e.g., as the tensioner 102 is adjusted) and the gap information is automatically determined by the computer 16 based on the 3-dimensional position of the tracking markers on the DRB 26 rather than by the surgeon manually viewing the tensioner. The changing gap information can be continuously displayed / updated in the display 20 for interpretation by the surgeon and can also be used by the computer 16 to automatically determine whether the planned cuts of the tibia and / or femur need to be adjusted. In some cases, the computer 16 can modify the planned cut based on the automatically determined gap information and display the modified cut plane on the display 20 (preferably in a format similar to the image above). Fig.15 3-D graphical representation relative to the skeleton, the surgeon can then use, for example, a finger or mouse to grab and rotate the displayed bones, their spacing and desired cutting planes in different directions or angles using all 6 degrees of freedom or at least pitch, yaw and roll) for inspection, approval or modification by the surgeon. The clearance data can include the angle and spatial spacing between the femur and tibia. The angle and spatial spacing data can be 3-dimensional data. In addition, the graphical user interface of the computer 16 is configured to graphically display the original cutting plane and the proposed modified cutting plane on the display 20, preferably in different colors such as red and blue, which are superimposed on each other to facilitate comparison by the surgeon.

[0070] refer to Fig.16 When the tensioner 102 is inserted and stretched between the femur 4 and the tibia 6, the traction paddles 110, 112 of the tensioner 102 are subjected to a force. For example, the traction force F 牵引 Pressing on the lower traction paddle 112, the force F LCL is applied to the first upper traction paddle 110, and the force F MCLis applied to the second upper traction paddle 110. If the ligament is in a balanced state (F LCL =F MCL ),like Fig.16 As shown, the ligament balance indicator 114 can indicate balance. For example, the ligament balance indicator 114 can be displayed as being generally horizontal. If the ligament is unbalanced (F LCL <F MCL 、F LCL >F MCL ), the ligament balance indicator 114 may indicate an imbalance. For example, the ligament balance indicator 114 may be displayed as being generally tilted. The lower side of the indicator 114 may indicate a greater force on the corresponding upper traction paddle 110. The indicator 114 may indicate the amount of imbalance or degree of imbalance for each corresponding force.

[0071] According to one embodiment, the workflow for using the tensioner 102 may include one or more of the following: (1) insert the dynamic reference datum 26 into the bone and register the patient; (2) make the first resection (proximal tibia 6 or distal femur 4); (3) check ligament balance with the tensioner 102 in extension; (4) adjust the implant plan accordingly; (5) make the remaining resection; (6) check flexion-extension balance; (7) adjust the incision as needed; (8) insert the femoral trial piece and check flexion-extension balance; (9) adjust the tibial plan as necessary; (10) complete the procedure according to standard practice. In this way, the tensioner 102 can promote gap balance. By applying traction between the tibia 6 and the femur 4, information can be displayed on the navigation screen 20 for user interpretation. In addition, the traction can be applied so that the different tensions in the MCL and LCL on the tensioner 102 are obvious to the user.

[0072] Now turn to Fig.17 , an embodiment of a modular dynamic reference datum 130 is described in more detail. In robotic and / or navigational TKA, the patient's anatomy is registered to the system 10. Registration is facilitated by attaching one or more dynamic reference datums 130 to the bones. For example, a first dynamic reference datum 130 can be rigidly attached to the femur 4 and a second dynamic reference datum 130 can be rigidly attached to the tibia 6. Once the registration is complete, the dynamic reference datum 130 is able to track the patient's anatomy in real time.

[0073] Now turn to Figures 18A-18B, the dynamic reference datum 130 can be modular, which can reduce the number of instruments used in the entire process. The modular dynamic reference datum 130 may include a reference element or array 132, which includes a plurality of tracking markers 18, a bridge 134 and one or more fasteners or bone pins 136 for fixing the dynamic reference datum 130 to the bone. The array 132 may include a rectangular frame with cross braces. However, it should be understood that the array 132 may include a suitable frame for supporting the tracking markers 18 in a desired configuration. In the illustrated embodiment, the tracking markers 18 are placed at each corner of the rectangular frame.

[0074] The tracking markers 18 can be protected from contamination by one or more physical barriers, protectors, or covers 138 configured to prevent loss of intraoperative navigation. For example, each of the four tracking markers 18 can be positioned within a corresponding cover 138. The cover 138 can provide protection for each individual tracking marker 18. The cover 138 can include a circular shallow plate with inclined sides. It should be understood that the cover 138 can have any suitable configuration for protecting the tracking markers 18. In particular, the tracking markers 18 can be protected from contamination by the cover 138.

[0075] The dynamic reference datum 130 may include an integrated bridge 134 and a pin guide 140. The bridge 134 may include one or more through holes 142 and one or more pin guides 140 configured to receive a bone pin 136. The pin guide 140 may include an elongated channel configured to guide the bone pin 136 into the bone. In the illustrated embodiment, the bridge 134 may include a first opening 142 aligned with and in fluid communication with the first pin guide 140 and a second opening 142 aligned with and in fluid communication with the second pin guide 140. For example, the openings 142 and the pin guides 140 may be aligned substantially parallel. It should be understood that any suitable number, position, and orientation of the openings 142 and the pin guides 140 may be selected to effectively attach the bridge 134 to the bone. The dynamic reference datum 130 may be attached to the patient via the bone pin 136. The bone pin 136 may include a self-drilling bone pin. The bridge 134 may be locked to the pin 136 with a first locking screw 144. The integrated bridge 134 and pin guide 140 may reduce the number of instruments required and simplify the surgical workflow.

[0076] The dynamic reference datum 130 can be attached to the patient via bone pins 136 and bridge 134. Subsequently, the array 132 can be attached to the bridge 134, for example, via one or more legs 143. The dynamic reference datum 130 can include multiple legs 143 that are provided in different lengths for internal and external incisions, which can increase workflow flexibility by facilitating external and internal incision placement of constructs. Legs 143 can be fixed to the frame of the array 132 and attached to the distal end of the bridge 134. For example, as Fig. 20AAs shown, the legs 143 may be positioned through the openings 141 in the bridge 134. Fig. 20B As best seen, the legs 143 and attached arrays 132 may be configured to rotate about one or more axes. For example, the legs 143 and attached arrays 132 may be able to rotate about a longitudinal axis A1 of the bridge 134 and / or an axis A2 perpendicular to the bridge 134. Thus, the bridge 134 may facilitate adjustment about both axes A1, A2. Fig. 20C As shown, after adjustment along one or more axes, the array 132 can be locked in place with one or more locking screws 146.

[0077] like Fig.21 As shown, an optional extension arm or extension 148 can be provided to increase the positioning options of the reference element 132. For example, a first end of the extension 148 can be connected to the leg 143 at an additional pivot point 150 and a second end of the extension 148 can be connected to the bridge 134. A locking screw 146 can secure the extension 148 in place. The extension 148 can increase the positioning options of the reference element 132, thereby increasing the flexibility of the workflow.

[0078] To install the modular dynamic reference datum 130, a handle 150 may be attached to the bridge 134. The handle 150 may be temporarily connected, for example, to the proximal end of the bridge 134. The handle 150 may include, for example, a thumb lock 152 to ensure a rigid fixation between the handle 150 and the bridge 134 during use. After the bridge 134 and bone pin 136 are installed, the handle 150 may be removed from the assembly.

[0079] The workflow for installing the modular dynamic reference datum 130 may include one or more of the following: (1) making a skin incision on the patient; (2) connecting the handle 150 to the bridge 134 (eg, Fig.19A (3) inserting the bridge 134 until it contacts the cortical bone; (4) driving the bone pin 136 through the bridge 134 (as shown in FIG. Fig.19B (5) Use locking screw 144 to lock bridge 134 to pin 136 (as shown); Fig.19C (6) removing the handle 150; (7) attaching the reference element 132 to the bridge 134 (as shown); Fig. 20A (8) adjusting the direction of the reference element 132 (as shown); Fig. 20B (9) Lock the adjustment by locking screw 146 (as shown); Fig. 20C and (10) optionally, attaching an extension 148 between the reference element 132 and the bridge 134 to facilitate more positioning options for the reference element 132 (eg Fig.21 shown).

[0080] Now turn to Figures 22A-22B, an embodiment of a bone pin 136 is shown. The bone pin 136 can be used to secure the dynamic reference datum 130 to the bone. The bone pin 136 may include a self-drilling tip 154, a chip extraction groove 156, and a bone thread 158. The bone thread 158 may extend along a portion of the pin 136 and may have any suitable properties, including handedness, thread angle, lead, pitch, etc. The pin 136 may include a pin driver interface 160. The pin driver interface 160 may include an engagement surface that is configured to interface with a driver instrument to install the pin 136. For example, the driver interface 160 may be configured to transmit axial insertion force and torque to the pin 136 to facilitate the pin 136 being driven into the patient's anatomy.

[0081] It will be further understood that those skilled in the art may make various changes to the details, materials and arrangements of the components described and illustrated for the purpose of explaining the essence of the present invention without departing from the scope of the present invention as expressed in the claims. Those skilled in the art will appreciate that the embodiments discussed above are non-limiting. It should also be understood that one or more features of an embodiment may be partially or completely incorporated into one or more other embodiments described herein.

Claims

1. A system for computer-assisted navigation during surgery, the system comprising: a robotic navigation system including a computer, a display, and a camera configured to detect a tracking marker; a first dynamic reference datum including a first reference array having a plurality of tracking markers, the first dynamic reference datum configured to attach to and track a first bone; a second dynamic reference datum including a second reference array having a plurality of tracking markers, the second dynamic reference datum being configured to attach to and track a second bone; and a navigable stylus comprising a third reference array having a plurality of tracking markers, and a universal quick connect attachment tip configured to quickly connect the stylus to a plurality of surgical instruments, wherein the robotic navigation system is adapted to determine the position of the surgical instruments attached to the stylus, Wherein the plurality of surgical instruments configured to be connected to the stylus include a plane finder, and wherein the plane finder includes a collar and a foot, wherein the collar includes a longitudinal opening configured to receive the universal quick connect attachment tip, and the foot includes a U-shaped plate having a flat bottom surface, the U-shaped plate being configured to be placed on a resection plane to report an angle and / or cutting depth to the robotic navigation system.

2. The system of claim 1, wherein the plane checker is freely rotatable relative to the longitudinal axis of the stylus, thereby allowing rapid reorientation of the third reference array.

3. The system of claim 1, wherein the stylus is configured for landmark location and point acquisition.

4. The system of claim 3, wherein once the stylus is located over a landmark or point of interest, the robotic navigation system captures a rotation of the stylus by a threshold rotation such that the landmark or point of interest is captured by the robotic navigation system.

5. The system of claim 4, wherein the threshold rotation is at least 30°.

6. The system of claim 3 wherein one tracking marker associated with the third reference array is physically movable relative to the other tracking markers, and once the stylus is positioned over a landmark or point of interest, the robotic navigation system detects movement of the one tracking marker relative to the other tracking markers and captures the landmark or point of interest.

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