Systems and methods for visualizing trajectories with surgical instruments

Abstract

A surgical system for performing a procedure on a patient's bone is described. The surgical system includes a reference device including one or more radiopaque markers, a first sensor configured to generate a first signal related to orientation data of the reference device relative to a first coordinate system, a surgical instrument for coupling to an end effector, a second sensor configured to generate a second signal related to orientation data of at least one of the end effector and the surgical instrument relative to a second coordinate system, and a navigation system. The navigation system is configured to determine an orientation of at least one of the end effector and the surgical instrument and to overlay a virtual representation of at least one of the end effector and the surgical instrument on the image based on the determined orientation and a user input.

Description

[0001] Cross-references to related applications

[0002] This application claims the benefit and priority of U.S. Provisional Patent Application No. 63 / 060726, filed August 4, 2020, which is incorporated herein by reference in its entirety. Background Technology

[0003] Traditional medical and surgical procedures typically involve the use of surgical tools and instruments that allow surgeons to access and manipulate the surgical site. As a non-limiting example, rotating instruments (such as handheld drills) are often used in conjunction with orthopedic surgery to address a variety of musculoskeletal conditions, such as trauma, sports injuries, degenerative diseases, joint reconstruction, and more.

[0004] In surgeries using handheld drills or similar surgical instruments, rotational torque selectively generated by an actuator (e.g., an electric motor) is used to rotate a releasably attached end effector (e.g., a drill) or other surgical accessory at varying speeds. The surgical head assembly drills holes in the bone against which the end effector rests.

[0005] One type of orthopedic surgery is open reduction and internal fixation (ORIF). During ORIF, the surgeon realigns the broken bone and secures it in place using one or more surgical implants. These implants may include bone plates and screws. The screws hold the bone plate in place relative to the bone. After a period of time, when bone healing is confirmed, the bone plate and screws can be removed. Summary of the Invention

[0006] A surgical system for performing surgery on a patient's bone is disclosed. The surgical system includes a reference device defining at least one reference axis and including one or more radiopaque markers. The reference device is configured to have a fixed orientation relative to a surgical implant. The surgical system also includes a first sensor configured to have a fixed orientation relative to the reference device when positioned on it, and configured to generate a first signal associated with orientation data of the reference device relative to a first coordinate system. The surgical system also includes a surgical instrument for coupling to an end effector. The surgical system also includes a second sensor configured to have a fixed orientation relative to the surgical instrument, and configured to generate a second signal associated with orientation data of at least one of the end effector and the surgical instrument relative to a second coordinate system. The surgical system also includes a navigation system configured to receive (i) the first signal, (ii) the second signal, and (iii) images of the reference device and the patient's bone; and to display images of the reference device and the patient's bone. The navigation system is also configured to receive at least one user input associated with a desired position of at least one of the end effector and the surgical instrument relative to the bone. The navigation system is further configured to: (i) register a first coordinate system to a second coordinate system when the axis of at least one of the surgical instruments and the end effector is aligned with at least one reference axis; (ii) register the orientation of at least one reference axis relative to bone in the image coordinate system; and (iii) register at least one position of at least one of the end effector and the surgical instrument relative to bone based on user input. The navigation system is also configured to determine the orientation of at least one of the end effector and the surgical instrument relative to bone based on a first signal and a second signal. The navigation system is further configured to overlay a virtual representation of at least one of the end effector and the surgical instrument onto the image based on the registered position and the determined orientation.

[0007] A method for performing surgery on a patient's bone using a surgical system is disclosed. The surgical system includes a navigation system, surgical instruments, a reference device defining at least one reference axis and including one or more radiopaque markers, and a first sensor having a first coordinate system and a fixed orientation relative to the reference device, the reference device being configured to have a fixed orientation relative to a surgical implant. The surgical instruments include a second sensor having a second coordinate system and a fixed orientation relative to the surgical instruments. The surgical instruments are configured to be coupled to an end effector. The method includes receiving (i) a first signal from the first sensor relating to orientation data of the reference device, (ii) a second signal from the second sensor relating to orientation data of at least one of the end effector and the surgical instruments, and (iii) images of the reference device and the patient's bone. The method also includes displaying images of the reference device and the patient's bone. The method further includes receiving user input on a display relating to a desired position of at least one of the end effector and the surgical instruments relative to the bone. The method further includes: (i) registering a first coordinate system to a second coordinate system when the axis of at least one of the surgical instruments and the end effector is aligned with at least one reference axis; and (iii) registering the position of at least one of the end effector and the surgical instrument relative to bone based on user input. The method further includes determining the orientation of at least one of the end effector and the surgical instrument relative to bone based on a first signal and a second signal. The method further includes overlaying a virtual representation of at least one of the end effector and the surgical instrument onto the image based on the registered position and the determined orientation of at least one of the end effector and the surgical instrument.

[0008] A surgical system for performing surgery on a patient's bone. The surgical system includes a reference device defining at least one reference axis and including one or more radiopaque markers. The reference device is configured to be placed on a patient. The surgical system also includes surgical instruments including sensors for coupling to an end effector, the sensors being configured to generate a first signal relating to orientation data of the surgical instruments relative to a first coordinate system. The surgical system also includes a surgical navigation system configured to receive images of the reference device and the patient's bone. The surgical navigation system is further configured to display images of the reference device and the patient's bone. The surgical navigation system is further configured to (i) register the orientation of at least one reference axis relative to the bone in an image coordinate system, and (ii) register the first coordinate system to the image coordinate system. The surgical navigation system is further configured to determine the orientation of the surgical instruments relative to the bone based on the first signal. The surgical navigation system is further configured to superimpose a virtual representation of the surgical instruments relative to the bone based on the determined orientation and position of the surgical instruments.

[0009] The further scope of this disclosure will become apparent from the detailed description, claims, and drawings. The detailed description and specific examples are for illustrative purposes only and are not intended to limit the scope of this disclosure. Attached Figure Description

[0010] This disclosure will be more fully understood through detailed description and accompanying drawings.

[0011] Figure 1 This is a perspective view of an exemplary layout of an operating room including a surgical system, in accordance with the teachings of this disclosure.

[0012] Figure 2 This is a functional block diagram of a surgical system based on the teachings of this disclosure.

[0013] Figure 3 This is a perspective view of the detector of an imaging system including a FluoroDisc, in accordance with the teachings of this disclosure.

[0014] Figure 4 It is a virtual representation of multiple reference markers applied to a medical image in accordance with the teachings of this disclosure.

[0015] Figure 5 This is a perspective view of a surgical head assembly according to the teachings of this disclosure, the surgical head assembly including a surgical instrument with a depth measuring attachment for drilling holes in bone.

[0016] Figure 6 yes Figure 5 Cross-section and partial perspective view of the surgical head assembly.

[0017] Figure 7 This is a schematic diagram of a surgical handpiece assembly based on the teachings of this disclosure.

[0018] Figure 8 This is a partial exploded view of the depth measurement appendix based on the teachings of this disclosure.

[0019] Figure 9 This is a perspective view of a surgical head assembly according to the teachings of this disclosure, wherein the depth measuring accessory is separated from the surgical instruments.

[0020] Figure 10 This is a perspective view of a surgical head assembly according to the teachings of this disclosure, wherein the depth measuring accessory is separated from the surgical instruments.

[0021] Figure 11 This is a schematic diagram of an exemplary surgical head assembly including surgical instruments and various accessories, based on the teachings of this disclosure.

[0022] Figure 12This is an example of a perspective view of a reference device according to the teachings of this disclosure, wherein a reference sensor is coupled to the reference device.

[0023] Figure 13A -C is a perspective view of a first embodiment and a second embodiment of a reference device according to the teachings of this disclosure.

[0024] Figure 14 This is a schematic diagram of an exemplary bone plate according to the teachings of this disclosure.

[0025] Figure 15 This is a front view of the surgical head assembly in reference orientation, in accordance with the teachings of this disclosure.

[0026] Figure 16 This is a front view of a surgical head assembly in borehole orientation, in accordance with the teachings of this disclosure.

[0027] Figure 17-20 A navigation display based on the teachings of this disclosure is shown, which depicts a virtual representation of bone, reference device, bone plate, and surgical head assembly.

[0028] In the accompanying drawings, reference numerals may be used multiple times to identify similar and / or identical elements. Detailed Implementation

[0029] refer to Figure 1 and Figure 2 This illustration shows an exemplary configuration of an operating room or surgical suite for performing medical procedures on a patient 20 using a surgical system 10 according to the teachings of this disclosure. The surgical system 10 can be used to perform various orthopedic surgeries (e.g., ORIF) to realign a broken bone 81 and fix it in place using one or more surgical implants. These one or more surgical implants may include bone plates 80 and screws inserted into the bone 81 until it heals. The surgical system 10 includes a surgical navigation system 50, which includes a trolley assembly 72 housing a navigation computer 70. The navigation computer 70 may also be referred to as a navigation controller.

[0030] The first navigation display 74-1 and the second navigation display 74-2 communicate operationally with the navigation computer 70. The first navigation display 74-1 and the second navigation display 74-2 may be collectively referred to as navigation display 74. The navigation computer 70 may be connected to one or more input devices 77 for inputting information into the navigation computer 70 or otherwise selecting / controlling certain aspects of the navigation computer 70. The one or more input devices 77 may include a keyboard, mouse, microphone (voice-activated), gesture control, or may be integrated with the navigation display 74 (e.g., which includes an interactive touchscreen display / menu, etc.). The functionality of the navigation computer 70 discussed in this paragraph may also be implemented on a tablet computer or other suitable mobile device.

[0031] The surgical system 10 may also include an imaging system 54 (e.g., a C-arm X-ray imaging device) or another suitable imaging system (e.g., a CT or MRI imaging device). The imaging system 54 may include a detector 56, a source 58, an imaging computer 60, an imaging display 62, and one or more user input devices 68. The detector 56 and source 58 are configured to generate one or more medical images. The detector 56 and source 58 may be arranged at opposite ends of the C-arm 64. The source 58 may include any source that emits or generates X-rays used in diagnostic medical imaging, such as a solid-state X-ray emission source, a rotating anode X-ray source, a stationary or fixed anode X-ray source, a standard X-ray source, a solid-state X-ray emission source, and / or a fluorescence fluoroscopy X-ray source, as well as a stationary or fixed anode X-ray source. The detector 56 may include an image intensifier or any other energy receiver for diagnostic medical imaging.

[0032] A C-arm 64, including detector 56 and source 58, may be configured to rotate around patient 20 to generate images of surgical site 30. Imaging computer 60 may be connected to one or more user input devices 68 (including keyboard, mouse, and other suitable devices) that enable a user to provide input to imaging computer 60. Imaging computer 60 and / or navigation computer 70 may include software known to those skilled in the art capable of acquiring images captured by imaging system 54 and generating one or more 2-D images and / or one or more 3-D models of surgical site 30. Imaging display 62 may be configured to display the resulting 2-D images and / or 3-D models.

[0033] Images from imaging system 54 (e.g., a C-arm X-ray imaging device) are typically distorted (i.e., de-distorted), so that all objects in the image may not be resized to the same degree. This is because the X-ray beam is not perfectly linear. Generally, objects closer to source 58 appear larger (and contain more pixels). Objects farther from source 58 may appear smaller (and contain fewer pixels). For accurate measurements, the image needs to be de-distorted.

[0034] refer to Figure 3 and Figure 4 Surgical system 10 may also include a fluorescence disk 57 to provide detorsion functionality. Fluorescence disk 57 is discussed in the FluoroMap™ Adaptive Positioning Technology for Gamma3™ Systems—User Manual, the entire contents of which are incorporated herein by reference. Fluorescence disk 57 is also discussed in U.S. Patent Publication No. 2018 / 0140309A1, filed November 18, 2016, entitled “Method and Apparatus For Treating A Joint, Including The Treatment Of Cam-Type Femoroacetabular Impingement In A Hip Joint And Pincer-Type Femoroacetabular Impingement In A Hip Joint,” the entire contents of which are incorporated herein by reference. In addition to the functions discussed herein, imaging computer 60 and / or navigation computer 70 may implement one or more systems, methods, and / or algorithms discussed in the foregoing references.

[0035] The fluorescent disk 57 may include a transparent lens 59, a plurality of reference marks 61 disposed on the transparent lens 59, and an attachment member 63 configured to attach the fluorescent disk 57 to a detector 56 of an imaging system 54. The fluorescent disk 57 (more specifically, the transparent lens 59) may have any suitable size, such as a 9-inch diameter, a 12-inch diameter, etc. The attachment member 63 may include a combination of a strap, one or more hooks, and one or more rings. The plurality of reference marks 61 have known dimensions. The fluorescent disk 57 may be configured to provide distortion correction by projecting a pattern of the plurality of reference marks 61 onto the image. Figure 4The image shows a virtual representation 65 of multiple reference marks 61 projected onto bone 81. While an example of an imaging system 54 including a fluorescence disk 57 is provided, in some embodiments, such as when the imaging system 54 includes a flat panel detector, the imaging system 54 can automatically provide a dedistorted image and therefore the fluorescence disk 57 can be omitted. Based on the pattern projected onto the image, the imaging computer 60 and / or navigation computer 70 can calibrate appropriate pixel sizes based on the dedistorted image.

[0036] In some embodiments, the imaging computer 60 and / or navigation computer 70 may perform various other calculations using the known dimensions of a plurality of reference markers 61. For example, the distance between the patient 20 and the source 58 may vary between images, and therefore the scaling factor or magnification factor may differ between different images. Thus, the imaging computer 60 and / or navigation computer 70 may use the known dimensions of the plurality of reference markers 61 and / or transmissive markers on the reference device to determine the scaling factor or magnification factor for each image. The imaging computer 60 and / or navigation computer 70 may also use the known dimensions of the plurality of reference markers 61 to determine the orientation of the C-arm 64 relative to the plurality of reference markers 61.

[0037] Imaging computer 60 can communicate with navigation computer 70. Imaging computer 60 can be configured to communicate with surgical navigation system 50 via a wired and / or wireless connection. For example, imaging system 54 can be configured to provide images, such as 2-D images and / or 3-D models of the obtained surgical site 30, to navigation computer 70. Navigation computer 70 can then be configured to provide the obtained 2-D images and / or 3-D models to navigation display 74, wherein a surgeon 79 or other medical professional can interact with the images to identify and / or define corresponding areas and / or zones around bone 81.

[0038] For example, via one or more input devices 77, the surgeon 79 can select multiple views of the bone 81 to be displayed, define the expected trajectory for the end effector of the surgical head assembly 76, and / or select an applicable user interface for the navigation display 74. Although the source 58 and detector 56 are shown as being connected to the imaging computer 60, in some configurations, the X-ray imaging apparatus including detector 56 and source 58 can be directly connected to the navigation computer 70, thus eliminating the need for the imaging computer 60, imaging display 62, and user input device 68. The navigation computer 70 can be configured to perform all the same functions as the imaging computer 60.

[0039] Surgical system 10 may include a surgical head assembly 76. Surgeon 79 may use the surgical head assembly 76 to perform surgery on patient 20, including drilling holes in bone 81 of patient 20 and / or inserting screws through one or more openings 82 in bone plate 80 into the drilled holes in bone 81. Conventional surgical navigation systems typically use optical tracking systems or electromagnetic tracking systems, or combinations thereof, to track the position of the end effector of surgical head assembly 76 relative to bone 81 of patient 20. Each of these systems has its drawbacks, and both are time-consuming and costly to set up. A specific disadvantage of optical tracking systems is that they require a line of sight between the optical tracker and the position tracking unit (i.e., a camera), which can be difficult to maintain in an operating room. A specific disadvantage of electromagnetic tracking systems is that they are less accurate than optical tracking systems and are susceptible to distortion caused by surrounding metallic objects. Both systems also require surgeon 79 to perform a manual registration process, which can be time-consuming.

[0040] During ORIF procedures and other traumatic surgeries, due to the aforementioned limitations, surgeon 79 may not use a traditional navigation-guided tracking system. Instead, surgeon 79 may rely on his / her surgical skills and anatomical knowledge to align the trajectory of the end effector of the surgical head assembly 76 to create a guide hole for one or more screws (or other surgical implants). Similarly, during screw placement, surgeon 79 inserts the screw manually. Surgeon 79 then typically uses fluorescein microscopy to verify screw placement. If surgeon 79 is not satisfied with the screw placement, the surgeon may replace the screw. This causes additional damage to bone 81 because surgeon 79 must drill additional holes in bone 81. Improper screw placement also results in additional costs and wasted time, as the screw may be damaged and re-drilling and re-verification are time-consuming.

[0041] According to the teachings of this disclosure, the surgical system 10 may include a trajectory tracking system configured to track the real-time orientation (i.e., rotational position of three degrees of freedom) of the surgical head assembly 76 (more specifically, the end effector) without specifically tracking the position (i.e., translational position of three degrees of freedom) of the surgical head assembly 76 as conventional tracking systems (e.g., optical tracking systems and / or electromagnetic tracking systems). The surgical system 10 may optionally be configured to track a non-conventional fourth degree of freedom of translational position associated with the displacement of the end effector of the surgical head assembly 76.

[0042] For further reference Figure 5-10An exemplary surgical head assembly 76 is shown. The surgical head assembly 76 eliminates the need for a second device (e.g., a depth gauge) for determining the drilling depth. The surgical head assembly 76 includes a surgical instrument 104, a depth measuring accessory 116A, and an end effector 108, such as a drill bit. The surgical handpiece assembly 76 was discussed in International Patent Publication No. WO2017 / 0407172, filed September 1, 2016, entitled “Powered Surgical Drill With Integral Depth Gauge That Includes A Probe That Slides Over A Drill Bit,” and in International Patent Publication No. WO2019 / 035096A1, filed August 17, 2017, entitled “Surgical Handpiece For Measuring Depth Of Bore Holes And Relates Accessories,” the entire contents of which are incorporated herein by reference.

[0043] Surgical instrument 104 may include a housing 112, a motor 114, a surgical head controller 162, one or more user input devices 164, a battery, and other components, as described in more detail below. The user input device 164 may have a trigger-type configuration. The user input device 164 is responsive to actuation by a user (e.g., surgeon 79) and communicates with the surgical head controller 162, for example, via electrical signals generated by a magnet and a Hall effect sensor. Thus, when surgeon 79 actuates the user input device 164 to operate the surgical head assembly 76, the surgical head controller 162 directs power from the battery to the motor 114, which in turn generates rotational torque for rotating the end effector 108 or other surgical end effectors, as described in more detail below.

[0044] Figure 6 and Figure 7 A motor 114 positioned along a proximal / distal axis AX within the housing 112 is shown, but other motor positions are contemplated. The motor 114 can be electric, pneumatic, or hydraulic. The motor 114 is configured to selectively generate rotational torque in response to commands, signals, etc., received from a surgical head controller. The motor 114 includes a rotor sleeve 115 supported by a pair of bearings 117 for rotation about the axis AX. A drive gear, arranged adjacent to a gear set, is coupled to the rotor sleeve 115 and rotates simultaneously with it, serving to transmit rotational torque to the gear set.

[0045] In the example shown, the depth measuring accessory 116A is detachably coupled to the housing 112. However, the depth measuring accessory may be integrally formed with the housing 112. The depth measuring accessory 116A may include different housings, such as the modular housing 120. The depth measuring accessory 116A may be constructed in a manner that minimizes visual obstruction at the surgical site for the surgeon 79. The depth measuring accessory 114A may also include a displacement sensor 124 and a depth measuring extension 128. The displacement sensor 124 is operatively connected to the depth measuring extension 128. As shown, the depth measuring extension 128 is a cannula.

[0046] A depth measuring extension 128 is disposed within a guide bushing 132 and supported for translational movement along the measuring axis MX. When the depth measuring accessory 116A is attached to the surgical head assembly 76, the measuring axis MX is arranged coaxially with axis AX. An elongated recessed incision 143 is optionally formed laterally into the depth measuring extension 128 and extends longitudinally. The depth measuring extension 128 also includes a plurality of rack teeth 140 linearly arranged along at least a portion of the length of the depth measuring extension 128, the plurality of rack teeth 140 being configured to engage with a gear 146 disposed distally adjacent to the guide bushing 132. Figure 6 As shown, the window of the guide bushing 132 is arranged adjacent to the gear 146 to facilitate meshing between the rack teeth 140 and the gear 146, such that the rotation of the gear 146 is proportional to the movement of the depth measuring extension 128. The displacement sensor 124 responds to the rotation of the gear 146 caused by the axial movement of the depth measuring extension 128 and can be implemented using a potentiometer, rotary encoder, etc., to generate an electrical signal representing the change in position of the depth measuring extension 128 along the measurement axis MX.

[0047] For example, in some configurations, displacement sensor 124 may be configured to communicate with surgical head controller 162 or depth measurement accessory controller 144, which may be configured to interrupt or adjust the drive mode of the movement interrupt motor 114 of depth measurement extension 128 to slow the rotation of end effector 108 to a specific drilling depth in the tissue.

[0048] refer to Figure 8To ensure proper functioning of the depth measuring extension 128 and the displacement sensor 124, the depth measuring extension 128 can be biased toward the extension position. This bias ensures that the distal end of the depth measuring extension 128 remains in contact with the proximal surface of the bone 81 to be drilled or with the bone plate 80 adjacent to the bone 81 to be drilled. This bias is achieved by using a spring 160 that biases a rotatable gear 146 such that the gear 146 rotates in the direction that extends the depth measuring extension 128 distally out of the module housing 120. However, other methods of biasing the depth measuring extension 128 relative to the surgical instrument 104 are also conceivable.

[0049] refer to Figure 9 and Figure 10 The depth measurement accessory 116A may include a housing connector 150 configured to operatively connect with the instrument connector 152 of the surgical instrument 104. In one example, the surgical instrument 104 may provide power to the depth measurement accessory 116A solely via the connection between the instrument connector 152 and the housing connector 150. In another example, the depth measurement accessory 116A and the surgical instrument 104 may also exchange data via the instrument connector 152 and the housing connector 150. The depth measurement accessory controller 144 and the surgical head controller 162 may communicate with the navigation computer 70 or other devices via a wired connection (i.e., via the housing connector 150 and the instrument connector 152) or a wireless connection. For example, the surgical head controller 162 may transmit data to a remote device, such as a tablet computer or an external server.

[0050] The depth measurement accessory 116A may also include a display 156 (e.g., a screen), one or more light-emitting diodes (LEDs), etc., to provide the surgeon 79 with information related to the movement of the depth measurement accessory 116A, thereby displaying real-time borehole depth, recorded historical maximum borehole depth, screw length, penetration indication, visual information (e.g., graphical representation) related to the current trajectory relative to a planned trajectory used to guide the surgeon 79 to the intended position. The same information may also be transmitted to the user using a speaker to provide audio indications of real-time borehole depth, recorded historical maximum borehole depth, penetration indication, etc.

[0051] The depth measurement accessory controller 144 can also be configured to determine penetration events based on displacement signals. The depth measurement accessory controller 144 and the surgical instrument head controller 162 are shown as separate controllers respectively disposed within the depth measurement accessory 116A and the surgical instrument 104. The depth measurement accessory controller 144 and the surgical instrument head controller 162 can be housed in a remote device. Alternatively, the depth measurement accessory controller 144 and the surgical instrument head controller 162 can be integrated into a single controller.

[0052] Return to reference Figure 7 and Figure 8 The surgical head assembly 76 may also include a head orientation sensor 172. In one exemplary configuration, the head positioning sensor 172 may be included as part of a depth measurement accessory 116A. A depth measurement accessory controller 144 may be operatively connected to the head orientation sensor 172.

[0053] The head-mounted orientation sensor 170 generates head-mounted orientation signals, which the navigation computer 70 can use to deduce the orientation of the surgical head assembly 76, and more specifically, the orientation of the depth measurement accessory 116A and axis AX. The head-mounted orientation signals can represent the angular velocity of the head-mounted orientation sensor 172 relative to the head-mounted coordinate system.

[0054] In an exemplary configuration, the nose-orientation sensor 172 includes three single-axis gyroscopes arranged to sense the angular velocities of three orthogonal axes (e.g., the x-axis of the depth measurement accessory 116A or surgical instrument 104, the y-axis of the depth measurement accessory 116A or surgical instrument 104, and the z-axis of the depth measurement accessory 116A or surgical instrument 104). The x, y, and z axes of the nose-orientation sensor 172 may be referred to as a nose coordinate system, and the angular velocities of the x, y, and z axes are collectively referred to throughout this disclosure as a nose-orientation signal. For example, a first gyroscope may be configured to sense the angular velocity of the x-axis (i.e., roll axis) of the nose-orientation sensor 172, a second gyroscope may be configured to sense the angular velocity of the y-axis (i.e., pitch axis) of the nose-orientation sensor 172, and a third gyroscope may be configured to sense the angular velocity of the z-axis (i.e., yaw axis) of the nose-orientation sensor 172.

[0055] Although the sensor of the head-mounted orientation sensor 172 is conceived as a gyroscope, it could also be an inertial measurement unit (IMU) comprising an accelerometer and / or a magnetometer and capable of sensing in six degrees of freedom. While the head-mounted orientation sensor 172 is described as including three gyroscopes, it could include any number of gyroscopes. In another exemplary configuration, the first, second, and third gyroscopes could be replaced with a three-axis gyroscope. The head-mounted orientation sensor 172 could also include a controller configured to transmit head-mounted orientation signals directly to the navigation computer 70 and / or indirectly to the navigation computer 70, for example, via a depth measurement accessory controller 144 or a surgical head controller 162.

[0056] The head-mounted orientation sensor 172 is configured to have a fixed attitude (i.e., position and orientation) relative to the surgical head assembly 76. In some examples, the head-mounted orientation sensor 172 is disposed within the depth measurement accessory 116A, such as... Figure 8As shown, it may be located within the housing 112 of the surgical head assembly 76. The head orientation sensor 172 may also be located in another accessory (e.g., regarding...). Figure 11 (One of the attachments described)

[0057] In other examples, the head alignment sensor 172 is configured to be releasably attached to any part of the surgical head assembly 76, such as the depth measurement accessory 116A or the surgical instrument 104. Therefore, the depth measurement accessory 116A may include any suitable connector for coupling with the head alignment sensor 172. This connector may be a clamp, paperclip, or other suitable connector. For example, the head alignment sensor 172 may be coupled to the housing 112 of the surgical instrument 104 or the outer surface of the depth measurement accessory 116A.

[0058] The depth measurement accessory controller 144 can communicate with the head-mounted orientation sensor 172 to control its operation based on user input. For example, user input can be received via one or more input devices 148 of the depth measurement accessory 116A (e.g., a first button 148a and a second button 148b). The first button 148a can turn the power supply to the head-mounted orientation sensor 172 on / off, and the second button 148b can return the head-mounted orientation sensor 172 to zero. When positioned within the depth measurement accessory 116A, the head-mounted orientation sensor 172 can receive power from the surgical instrument 104 without requiring a separate power supply. Although in Figure 2 Although not shown in the illustration, the nose-alignment sensor 172 may have a dedicated controller that controls its operation based on user input entered into the first button 148a or the second button 148b. In other embodiments, another controller, such as a depth measurement accessory controller 144, may control the operation of the nose-alignment sensor 172.

[0059] In a configuration where the nose-alignment sensor 172 is not located inside the depth measurement accessory 116A, the nose-alignment sensor 172 may also include a housing, one or more input devices, and a power source (e.g., a battery). These one or more input devices may include a first button and a second button configured to function in a manner similar to the first button 148a and the second button 148b of the depth measurement accessory 116A.

[0060] refer to Figure 11In some cases, the depth measuring accessory 116A may not be used. In this case, the surgical instrument 104 may be coupled to a drill chuck 116B, a tap 116C for forming threads on the inner surface of a hole or cavity, or a drive 116D for driving a screw or inserting a screw into a drilled hole or cavity in the bone 81. A head orientation sensor 172 may be housed within the housing of the drill chuck 116B, tap 116C, or drive 116D. The drill chuck 116B, tap 116C, and drive 116D may include a first button 148a and a second button 148b for controlling the operation of the head orientation sensor 172. Alternatively, the head orientation sensor 172 may be coupled to the outer surface of the drill chuck 116B, tap 116C, or drive 116D. Thus, the drill chuck 116B, tap 116C, and drive 116D may include any suitable connector for attaching the head orientation sensor 172 to the outer surface of the drill chuck 116B, tap 116C, or drive 116D.

[0061] refer to Figure 12 and Figure 13A -C, The tracking system may include a reference device 182 defining at least one reference axis. The reference device 182 is configured to be fixed to bone 81 and / or, in some configurations, a bone plate 80 may be located between bone 81 and the reference device 182. The reference device 182 may include one or more extensions 186, such as a first extension 186a, a second extension 186b, and a third extension 186c. Although the reference device 182 is shown as having three extensions 186, the reference device 182 may include any number of extensions 186 or surfaces. The first extension 186a, the second extension 186b, and the third extension 186c may each have different dimensions, such as different heights, lengths, and widths. The reference device 182 is not limited to the embodiments shown throughout this disclosure and may include any design or configuration that defines at least one reference axis.

[0062] The reference device 182 may include one or more reference marks 188 arranged in a manner suitable for determining the orientation of the reference device 182 during imaging. The reference marks 188 may, for example, be radiopaque marks. For example, in an exemplary configuration, each of the first extension 186a, the second extension 186b, and the third extension 186c may include reference marks 188 imageable by the imaging system 54. The first extension 186a may have a first set of reference marks 188a, the second extension 186b may have a second set of reference marks 188b, and the third extension 186c may have a third set of reference marks 188c. The first set of reference marks 188a, the second set of reference marks 188b, and the third set of reference marks 188c may each have different reference marks 188. The size, shape, and / or spacing of the reference marks 188a of the first extension 186a may differ from the reference marks 188b of the second extension 186b and the reference marks 188c of the third extension 186c. One or more reference markers 188 allow the navigation computer 70 or imaging computer 60 to calculate the orientation (i.e., position and orientation) of the reference device 182 relative to the bone 81 in an image-based coordinate system. The image-based coordinate system can define the shape and / or orientation of the patient surface and / or bone plate 80 in the medical image. One or more reference markers 188 can also allow the navigation computer 70 to calculate rotation angles between images.

[0063] The reference device 182 may form a surface 194 defining at least one reference axis. In some examples, such as Figure 12 and Figure 13A As shown, surface 194 can be a protrusion extending from the second extension 186b, such as a notch or a stud. In this configuration, depth measuring accessory 116A can be attached to this protrusion. When depth measuring accessory 116A is attached to the protrusion, depth measuring accessory 116A and the protrusion are concentric, and this aligns the measuring axis MX of depth measuring accessory 116A with the axis of the protrusion, which in turn allows the two axes to be registered, as will be described in more detail below. In other examples, such as Figure 13B As shown, surface 194 is a tube or cylindrical bag into which end effector 108 is inserted to align axis AX with the axis of the tube or cylindrical bag. One or more extensions 186 may be connected to coupling portion 190. Coupling portion 190 may be configured to be releasably attached to bone plate 80 or bone 81 of patient 20 via fixation member 192 (e.g., Kirschner wires, pins or other suitable fixation member).

[0064] refer to Figure 14An exemplary bone plate 80 is shown. The bone plate 80 may be made of metal or other suitable material and is configured to fix a broken bone (e.g., bone 81). As shown, the bone plate 80 may include a plurality of larger openings 82 and a pair of smaller openings 83. The surgeon 79 may first fix the bone plate 80 to the bone 81 using a fixation member 192 such that the bone plate 80 does not move until a screw is inserted into the bone 81.

[0065] Return to reference Figure 12 and Figure 13A -C, the fixation member 192 can be driven through either of the pair of smaller openings 83 and into the bone 81. The other portion of the Kirschner wire (i.e., the side not driven into the bone 81) can be used as an anchor for the reference device 182. Once the fixation member 192 is fed through one of the pair of smaller openings 83 and driven into the bone 81, the reference device 182 can be coupled to the fixation member 192. The coupling portion 190 may include a finger support collar 208, a threaded portion 210, a clamp 212, and a locking knob 214. The finger support collar 208 may be mounted to or integrally formed with the bottom of the reference device 182. The threaded portion 210 may include male threads and may be mounted to or integrally formed with the finger support collar 208.

[0066] The collet 212 may be mounted on or integrally formed with the threaded portion 210. The collet 212 is configured to form a collar around the retaining member 192 to secure the reference device 182 to the retaining member 192. When the collet forms a collar around the retaining member 192, rotation and axial movement of the reference device 182 are prevented. While an example is provided of a connection including the collet 212 to secure the reference device 182 to the retaining member 192, any suitable component, element, or device may be used to secure the reference device 182 to the retaining member 192 such that the reference device 182 cannot move independently of the retaining member 192.

[0067] Locking knob 214 may be configured to engage with threaded portion 210. For example, locking knob 214 may be shaped to define a channel configured to receive threaded portion 210 and collet 212. Locking knob 214 may include internal threads on its inner surface. Threaded portion 210 and locking knob 214 may be mated. In some embodiments, the dimensions (e.g., height) of the combined threaded portion 210 and collet 212 may be substantially the same as the dimensions (e.g., height) of locking knob 214. Locking knob 214 may be used to cover collet 212, such that the connection between reference device 182 and fixation member 192 remains secure and is not accidentally disconnected throughout the procedure.

[0068] In other configurations, even when the bone plate 80 is used in surgery, the reference device 182 can still be directly attached to the bone 81 without the intervention of the bone plate 80. In this configuration, the fixation member 192 can be inserted into the bone 81 near the bone plate 80, but does not pass through either of the pair of openings 82, 83.

[0069] Once the bone plate 80 has been temporarily fixed to the bone 81, the surgeon 79 or other medical professional can use the imaging system 54 to image the patient 20. The imaging system 54 then generates images and any 3D models, and transmits the images and / or 3D models to the navigation computer 70.

[0070] Reference sensor 184 is configured to be detachably attached to reference device 182. While an example of reference sensor 184 being detachably attached to reference device 182 is provided, in some cases, reference sensor 184 may not be detachably attached to reference device 182, such as when reference sensor 184 is integrally formed with reference device 182. Reference sensor 184 generates a reference device orientation signal, which navigation computer 70 can use to deduce the orientation of reference device 182. The reference device orientation signal may represent the angular velocity of reference device 182 relative to time. The integral of the angular velocity relative to time is a measure of the angular motion (i.e., orientation) of reference device 182 (and the reference device coordinate system) since reference sensor 184 was last zeroed. For example, reference sensor 184 may be zeroed when reference device 182 and depth measuring extension 128 are aligned. Reference sensor 184 may include housing 191 having attachment members 183 integrally formed or mounted to housing 191. The attachment member 183 may be in the form of a clamp, a paperclip, or another suitable means for attaching the reference sensor 182 to the reference device 182. When releasably attached to the reference device 182, the attitude (i.e., position and orientation) of the reference sensor 184 is fixed relative to the reference device 182.

[0071] Reference sensor 184 may include reference controller 187, orientation sensor 189, one or more input devices 185, and a power source (e.g., a battery). In an exemplary configuration, orientation sensor 189 includes three single-axis gyroscopes. A first gyroscope may be configured to sense the angular velocity of reference sensor 184 along the x-axis, a second gyroscope may be configured to sense the angular velocity of reference sensor 184 along the y-axis, and a third gyroscope may be configured to sense the angular velocity of reference sensor 184 along the z-axis. The x-axis, y-axis, and z-axis of reference sensor 184 may be referred to as a reference device coordinate system, and throughout this disclosure, the angular velocities of the x-axis, y-axis, and z-axis may be collectively referred to as reference device orientation signals. While the sensor is contemplated as a gyroscope, it may also be an inertial measurement unit, including accelerometers and / or magnetometers, capable of sensing in six degrees of freedom. Although orientation sensor 189 is described as including three gyroscopes, it may include any number of gyroscopes. In another exemplary configuration, the first gyroscope, the second gyroscope, and the third gyroscope can be replaced with a three-axis gyroscope.

[0072] The reference controller 187 can control the operation of the reference sensor 184 based on one or more input devices 185, and control the transmission of the reference device orientation signal to the navigation computer 70. The reference controller 187 can also communicate with the depth measurement accessory controller 144 or the surgical head controller 162 via a wired or wireless connection. One or more input devices 185 of the reference sensor 184 can be configured to control the operation of the sensor. For example, a first button 185a of one or more input devices 185 of the reference sensor 184 can be used to turn the power to the reference sensor 184 on / off to start / stop sensing, and a second button 185b of one or more input devices 184 can be used to zero the reference sensor 184. In some cases, the reference sensor 184 may include an output. This output may include an LED, a display, or any other output device. This output can be configured to indicate the status of the reference sensor 184 and / or one or more other components of the system 10.

[0073] refer to Figure 15 When a reference orientation 204 is established between the surgical head assembly 76 and the reference device 182, the navigation computer 70 can calibrate the head coordinate system to the reference device coordinate system. The surgical head assembly 76 can be operated by the surgeon 79 between the reference orientation 204 and the drilling orientation 206 (e.g., ...). Figure 16 Move between (as shown).

[0074] To align the corresponding coordinate system, the surgical head assembly 76 can be attached to surface 194 of the reference device 182. In the illustrated example, the depth measurement extension 128 can be positioned such that it is attached to surface 194 of the reference device 182 (i.e., a stud or cannula). The surgeon 79 can press a second button 148b on this accessory to zero the head coordinate system relative to the reference device coordinate system.

[0075] In an alternative configuration, navigation computer 70 may detect the proximity of surgical head assembly 76 to reference device 182 based on one or more sensors of reference device 182 or surgical head assembly 76. Based on the detected proximity of surgical head assembly 76 to reference device 182, navigation computer 70 may automatically register the reference device coordinate system to the head coordinate system. For example, reference device 182 may include a magnet, and surgical head assembly 76 may include a Hall effect sensor; alternatively, reference device 182 may include a Hall effect sensor, and surgical head assembly 76 may include a magnet. In another example, head controller 162 may detect a magnetic field and register itself to the reference device coordinate system, then send a signal to navigation computer 70 to begin integrating orientation information after registration.

[0076] The head-mounted orientation sensor 172 and the reference sensor 184 include gyroscopes, which are subject to bias instability, causing them to drift over time. Thus, the surgeon 79 can periodically align the head-mounted orientation sensor 172 with the reference device 182 during surgery to minimize tracking inaccuracies caused by gyroscope drift. This can be achieved by reconnecting the end effector 108 to the surface 194 of the reference device 182 and by pressing the second button 148b to zero the head-mounted orientation sensor 172.

[0077] In reference orientation 204, the axis AX of the surgical head assembly 76 is aligned with the reference axis RX defined by the reference device 182. In many configurations, the reference axis RX is perpendicular to one or both of the bone 81 and the bone plate 80; however, the reference axis RX need not be perpendicular to either the bone 81 or the bone plate 80. Figure 16 The surgical head assembly 76 is shown in drill orientation 206, with its axis AX at an angle relative to the reference axis RX. This angle is the drill angle at which a screw can be inserted later.

[0078] After the navigation computer 70 registers the head coordinate system relative to the reference device coordinate system, the navigation computer 70 can begin integrating the head orientation signal. Alternatively, this integration function can be handled by another controller (e.g., the depth measurement accessory controller 144, the controller of the head orientation sensor 172, the surgical head controller 162, or any other suitable controller). For example, the navigation computer can begin integrating the head orientation signal when the depth measurement extension 128 and the reference device 182 are aligned and the surgeon presses the second button 148b. During registration, the coordinate transformation matrix between the head coordinate system and the reference device coordinate system is determined. For example, when the surgeon 79 presses the second button 148b associated with zeroing the head orientation sensor 172, the navigation computer 70 can be prompted to register the head coordinate system to the reference device coordinate system. In other examples, the navigation computer 70 can prompt the surgeon 79 to initiate the registration process. The navigation computer 70 can be configured to determine the orientation of the surgical head assembly 76 by integrating the head orientation signal over a period of time. By integrating the head-mounted orientation signals, the navigation computer 70 can subsequently determine the orientation of the surgical head assembly 76 from the reference orientation 204 (e.g., ...). Figure 15 As shown) to borehole orientation 206 (as shown) Figure 16 The changes shown in the diagram indicate that the navigation computer 70 can determine the orientation of the surgical head assembly 76.

[0079] As previously described, since the reference sensor 184 is fixedly attached to the reference device 182, and the reference device 182 has a fixed orientation relative to the bone 81, the reference sensor 184 serves as a patient tracker. Each time an image is acquired, the current value of the angular orientation of the reference sensor 184 can be recorded and associated with the specific image being acquired. The navigation computer 70 can be configured to determine the orientation of the bone 81 by integrating the angular velocity values ​​of the reference device orientation signal over a period of time. By integrating the angular velocity values, the navigation computer 70 can subsequently determine changes in the orientation of the bone 81 during the surgical procedure.

[0080] refer to Figure 17The navigation computer 70 displays images and 3D models on the navigation display 74. For example, it may display one or more of a coronal view, a sagittal view, and a cross-sectional view of the tibia. Since the system does not rely on conventional tracking devices to track the position of the surgical head assembly 76, the actual position of the surgical head assembly 76 must be input by the surgeon 79. Thus, the navigation computer 70, via the navigation display 74, can be configured to prompt the surgeon 79 to indicate the actual position of the surgical head assembly 76 (more specifically, the end effector 108) relative to the bone plate 80 and / or bone 81. For example, when the surgical system 10 includes the bone plate 80, the navigation computer 70 may prompt the surgeon 79 to make a first and a second selection corresponding to the expected position of the end effector 108. The first selection may include selecting a shadow of a hole in a virtual bone plate corresponding to the expected position of the end effector 108 in the xy-plane. The second selection may include selecting the expected position in a plane including the z-axis. For example, in order to receive the expected position of the end effector in the xy plane, the navigation computer 70 can prompt the surgeon 79 to select the desired aperture on the image displayed on the surgical navigation display 74 via touch operation or via the input device 77.

[0081] In another example, the navigation computer 70 can prompt the surgeon 79 with a single user input regarding the expected position of the end effector 108 relative to a 3D model. When the system does not include the bone plate 80, the navigation computer 70 can prompt the user to indicate or select anatomical features of an image corresponding to the current position of the surgical head assembly 76. Whenever the head orientation sensor 172 is zeroed, the navigation computer 70 can prompt the surgeon 79 to confirm the position of the surgical head assembly 76.

[0082] refer to Figure 18 The navigation computer 70 can overlay a virtual representation based on the surgeon 79's position input and the determined orientation of the surgical head assembly 76 onto the image. This virtual representation may include a model of the surgical head assembly 76, such as a model of the depth measuring attachment 116A and / or the end effector 108. The virtual representation may also include a virtual trajectory projected onto the bone 81. The surgeon 79 can then change the angle of the surgical head assembly 76 until the surgeon 79 is satisfied with the virtual trajectory. For example, in the case where the surgical system 10 includes a bone plate 80, a model of the end effector 108 can be overlaid at a selected aperture. In another example, such as when the surgical system 10 does not include a bone plate 80, a model of the depth measuring attachment 116A or the end of the end effector 108 can be overlaid at selected anatomical features in the image.

[0083] The navigation computer 70 can be configured to allow the surgeon 79 to freeze or store the trajectory as a desired trajectory when the surgeon 79 is satisfied with the virtual trajectory depicted in the image. When storing the desired trajectory, the navigation display 74 may also include a graphical representation to provide visual cues to the surgeon 79 when the current trajectory matches the stored desired trajectory. For example, a movement indicator may be displayed on the navigation display 74 that moves with the orientation of the surgical head assembly 76. This movement indicator may be shown on the navigation display 74 relative to a target (e.g., a representation of a crosshair or circle). This target represents the desired trajectory. Once the moving circle overlaps with the target, the current trajectory matches the desired trajectory. Furthermore, visual information (e.g., a graphical representation) may be displayed on the display 156 of the surgical head assembly 76, enabling the surgeon to align the current trajectory with the stored desired trajectory without consulting the navigation display 74.

[0084] The surgical navigation system 50 can be configured to generate auditory, visual, or tactile alerts when a desired trajectory has been achieved. While this disclosure envisions displaying images and virtual representations on the navigation display 74, the navigation computer 70 can send virtual representations to other computing devices and / or displays, including displays, tablets, laptops, or any other mobile devices attached to the surgical head assembly 76.

[0085] refer to Figure 20 As described above, displacement sensor 124 can be configured to generate a displacement signal to surgical head controller 162, which is then transmitted to navigation computer 70. The displacement signal is in response to the displacement of end effector 108 relative to depth measuring extension 128 during or before the drilling process. In some examples, navigation computer 70 can be configured to depict the drilling process as the end effector 108 drills through bone 81 in real time. As previously mentioned, since the scale / magnification factor can vary between different images, navigation computer 70 can use a scale / magnification factor to depict this real-time depth depiction. For example, navigation computer 70 can use a scale / magnification factor when determining the appropriate pixel-to-millimeter conversion for each image.

[0086] In other examples, such as when the second accessory is attached to the surgical instrument 104 (i.e., without the depth measurement accessory 116A), the navigation computer 70 can be configured to stop displaying a virtual representation of the attitude (i.e., position and orientation) and associated virtual trajectory of the surgical head assembly 76 once drilling has begun.

[0087] The foregoing description is illustrative in nature and is in no way intended to limit this disclosure, its application, or its use. The broad teachings of this disclosure can be implemented in various forms. Therefore, although this disclosure includes specific examples, its true scope should not be so limited, as other modifications will become apparent upon examination of the drawings, description, and appended claims. It should be understood that one or more steps in the method may be performed in a different order (or simultaneously) without altering the principles of this disclosure. Furthermore, although each example is described above as having certain features, any one or more of those features described in conjunction with any example of this disclosure may be implemented in and / or combined with features of any other example, even if such combination is not explicitly described. In other words, the described examples are not mutually exclusive, and the arrangement of one or more examples relative to each other remains within the scope of this disclosure.

[0088] Various terms are used to describe the spatial and functional relationships between elements (e.g., controllers, circuit elements, semiconductor layers, etc.), including "connection," "joint," "linkage," "adjacent," "side," "on top," "above," "below," and "arrangement." Unless explicitly described as "direct," when the relationship between the first and second elements is described in the foregoing disclosure, the relationship can be a direct relationship, where no other intervening element exists between the first and second elements, but it can also be an indirect relationship, where one or more intervening elements (spatially or functionally) exist between the first and second elements.

[0089] As used herein, the phrase "at least one of A, B, and C" should be interpreted as meaning the logic of using non-exclusive OR (A or B or C), and should not be interpreted as meaning "at least one of A, at least one of B, and at least one of C". The term subset does not necessarily require an appropriate subset. In other words, a first subset of the first set can be conextent to (equal to) the first set.

[0090] In the accompanying drawings, the direction of the arrows typically indicates the flow of information (e.g., data or instructions) of interest in the illustration. For example, when components A and B exchange various types of information, but the information sent from component A to component B is relevant to the illustration, the arrow can point from component A to component B. This unidirectional arrow does not imply that no other information is being sent from component B to component A. Furthermore, for information sent from component A to component B, component B can send a request for or confirmation of receipt of the information to component A.

[0091] In this application, which includes the following definitions, the term "controller" may be replaced by the term "circuit". The term "controller" may refer to or include some of the following: application-specific integrated circuit (ASIC); digital, analog, or mixed analog / digital discrete circuit; digital, analog, or mixed analog / digital integrated circuit; combinational logic circuit; field-programmable gate array (FPGA); processor circuitry (shared, dedicated, or grouped) that executes code; memory circuitry (shared, dedicated, or grouped) that stores code executed by the processor circuitry; other suitable hardware components that provide the functions described; or, for example, some or all of the above combinations in a system-on-a-chip.

[0092] The controller may include one or more interface circuits. In some examples, the interface circuits may implement wired or wireless interfaces for connecting to a local area network (LAN) or a wireless personal area network (WPAN). Examples of LANs are IEEE standards 802.11-2016 (also known as the Wi-Fi wireless network standard) and IEEE standard 802.3-2015 (also known as the Ethernet wired network standard). Examples of WPANs are the Bluetooth wireless network standard from the BLUETOOTH Special Interest Group and IEEE standard 802.15.4.

[0093] The controller can communicate with other controllers using interface circuitry. Although the controller may be depicted in this disclosure as communicating logically directly with other controllers, in many configurations, the controller may actually communicate via a communication system. Communication systems include physical and / or virtual network devices such as hubs, switches, routers, and gateways. In some configurations, the communication system is connected to or traverses a wide area network (WAN) such as the Internet. For example, the communication system may include multiple LANs interconnected via the Internet or peer-to-peer leased lines using technologies including Multiprotocol Label Switching (MPLS) and Virtual Private Networks (VPNs).

[0094] In various configurations, the functionality of a controller can be distributed among multiple controllers connected via a communication system. For example, multiple controllers can perform the same functionality distributed by a load balancing system. In another example, the functionality of the controller can be distributed between a server (also known as a remote or cloud) controller and a client (or user) controller.

[0095] Some or all of the controller's hardware characteristics can be defined using a hardware description language, such as IEEE Standard 1364-2005 (often referred to as "Verilog") and IEEE Standard 10182-2008 (often referred to as "VHDL"). Hardware description languages ​​can be used to fabricate and / or program hardware circuits. In some configurations, some or all of the controller's characteristics can be defined by a language such as IEEE 1666-2005 (often referred to as "SystemC"), which covers the code and hardware description as described below.

[0096] As described above, the term "code" can include software, firmware, and / or microcode, and can refer to programs, routines, functions, classes, data structures, and / or objects. The term "shared processor circuitry" covers a single processor circuitry that executes some or all of the code from multiple controllers. The term "group processor circuitry" covers a processor circuitry that, in conjunction with additional processor circuitry, executes some or all of the code from one or more controllers. The reference to "multiprocessor circuitry" covers multiprocessor circuitry on a discrete chip, multiprocessor circuitry on a single chip, multiple cores of a single processor circuitry, multiple threads of a single processor circuitry, or a combination of the above. The term "shared memory circuitry" covers a single memory circuitry that stores some or all of the code from multiple controllers. The term "group memory circuitry" covers a memory circuitry that, in conjunction with additional memory, stores some or all of the code from one or more controllers.

[0097] The term memory circuit is a subset of the term computer-readable medium. As used herein, the term computer-readable medium does not cover transient electrical or electromagnetic signals propagating through a medium (e.g., on a carrier wave); the term computer-readable medium can therefore be considered tangible and non-transitory. Non-limiting examples of non-transitory computer-readable media are non-volatile memory circuits (e.g., flash memory circuits, erasable programmable read-only memory circuits, or mask read-only memory circuits), volatile memory circuits (e.g., static random access memory circuits or dynamic random access memory circuits), magnetic storage media (e.g., analog or digital magnetic tape or hard disk drives), and optical storage media (e.g., CDs, DVDs, or Blu-ray discs).

[0098] The apparatus and methods described in this application can be implemented, in part or in whole, by a special-purpose computer created by configuring a general-purpose computer to perform one or more specific functions embodied in a computer program. The aforementioned function blocks and flowchart elements serve as software specifications that can be converted into computer programs through the routine work of skilled technicians or programmers.

[0099] A computer program includes processor-executable instructions stored on at least one non-transitory computer-readable medium. A computer program may also include or depend on stored data. A computer program may encompass a basic input / output system (BIOS) that interacts with the hardware of a special-purpose computer, device drivers that interact with specific devices of the special-purpose computer, one or more operating systems, user applications, background services, background applications, etc.

[0100] Computer programs may include: (i) descriptive text to be parsed, such as HTML (Hypertext Markup Language), XML (Extensible Markup Language), or JSON (JavaScript Object Notation), (ii) assembly code, (iii) object code generated from source code by a compiler, (iv) source code executed by an interpreter, (v) source code compiled and executed by a real-time compiler, etc. As an example only, source code may be written using syntax from languages ​​including C, C++, C#, Objective-C, Swift, Haskell, Go, SQL, R, Lisp, Java®, Fortran, Perl, Pascal, Curl, OCaml, JavaScript®, HTML5 (Hypertext Markup Language 5th Edition), Ada, ASP (Dynamic Server Web Pages), PHP (PHP: Hypertext Preprocessor), Scala, Eiffel, Smalltalk, Erlang, Ruby, Flash®, Visual Basic®, Lua, MATLAB, SENSORLINK, and Python®.

Claims

1. A surgical system for performing surgery on a patient's bone, the surgical system comprising: A reference device that defines at least one reference axis and includes one or more radiopaque markers, the reference device being configured to have a fixed orientation relative to a surgical implant; A first sensor is configured to have a fixed attitude relative to the reference device when it is placed on the reference device, and is configured to generate a first signal related to orientation data of the reference device relative to a first coordinate system. Surgical instruments, the surgical instruments being coupled to a first end effector; The second sensor is configured to have a fixed posture relative to the surgical instrument and is configured to generate a second signal relating to orientation data of at least one of the first end effector and the surgical instrument relative to a second coordinate system. as well as Navigation system, the navigation system being configured to: Receive (i) a first signal, (ii) a second signal, and (iii) images of the reference device and the patient's bones; Images of the reference device and the patient's bones are displayed; Receive an input signal related to the expected position of at least one of the first end effector and the surgical instrument relative to the bone; (i) when the axis of at least one of the surgical instrument and the first end effector is aligned with the at least one reference axis, the first coordinate system is registered to the second coordinate system; (ii) the orientation of the at least one reference axis relative to the bone is registered in the image coordinate system; and (iii) the position of the first end effector and at least one of the surgical instrument relative to the bone is registered based on the input signal. The orientation of at least one of the first end effector and the surgical instrument relative to the bone is determined based on the first signal and the second signal; as well as Based on the registered position and determined orientation of at least one of the first end effector and the surgical instrument, a virtual representation of at least one of the first end effector and the surgical instrument is superimposed on the image.

2. The surgical system of claim 1, wherein, The second sensor is configured to be mounted on the surgical instrument.

3. The surgical system as described in any of the preceding claims, wherein: The image includes the shadows of the one or more transmissive markers; and The navigation system is configured to register the orientation of the first sensor relative to the bone in the image coordinate system based on the pose of the shadows of the one or more transmissive markers.

4. The surgical system of claim 1, wherein, The surgical system also includes the surgical implant, which is a bone plate comprising one or more pores.

5. The surgical system of claim 4, wherein, The surgical system also includes a fixation component, wherein: The reference device includes a coupling portion; and A first portion of the fixation member is configured to fix the surgical implant to the bone, and another portion of the fixation member is configured to be coupled to the coupling portion of the reference device.

6. The surgical system of claim 4 or 5, wherein: The image includes one or more shadows of the one or more apertures; and The input signal is a user input, which includes a first selection of the shadow of the one or more apertures corresponding to a desired location in the xy plane and a second selection of the desired location in a plane including the z-axis.

7. The surgical system of claim 1, wherein, The surgical system also includes a second end effector, wherein: The surgical instrument is configured to perform a first function when coupled to the first end effector; The surgical instrument is configured to be coupled to the second end effector to perform a second function; and The first function and the second function are different functions.

8. The surgical system of claim 1, wherein, The first sensor and the second sensor are inertial measurement units.

9. The surgical system of claim 1, wherein, The surgical system further includes the first end effector, and the reference device includes a surface defining the at least one reference axis, and the surface is configured to receive the first end effector.

10. The surgical system of claim 1, wherein, The first sensor and the second sensor are gyroscopes.

11. The surgical system of claim 9 or 10, wherein, The surgical system is configured to automatically register the reference device coordinate system of the reference device to the second coordinate system.

12. The surgical system of claim 9, wherein, The surgical system is configured to detect the proximity of the surgical head assembly to the reference device and automatically register the reference device coordinate system to the second coordinate system based on the detected proximity.

13. The surgical system of claim 9, wherein, One or more transmissive markings are set on the at least one reference axis.

14. The surgical system of claim 1, wherein: The first end effector is a drill bit; The surgical system also includes a depth measuring accessory configured to be attached to the surgical instrument. The depth measuring accessory includes a depth sensor configured to provide a third signal associated with the displacement of the first end effector during drilling. The navigation system is configured to receive the third signal, and the virtual representation is also based on the third signal.

15. The surgical system of claim 1, wherein, The surgical system further includes a depth measuring accessory configured to be attached to the surgical instrument, the depth measuring accessory including a depth sensor configured to provide a third signal associated with the displacement of the first end effector during drilling, the reference device including a post defining the at least one reference axis and configured to be inserted into the depth measuring accessory, and the second sensor being disposed within the depth measuring accessory.

16. The surgical system of claim 14, wherein, The surgical system also includes an attachment device configured to be attached to an imaging system, wherein: The navigation system is configured to determine the scale factor of the image based on at least one of the one or more transmissive markers of the reference device and the attachment device; and The navigation system is configured to receive the third signal, and the virtual representation is also based on the scaling factor.

17. The surgical system of claim 16, wherein, The attachment device is a fluorescent disk, which includes a transparent lens, a plurality of reference marks disposed on the transparent lens, and an attachment member configured to attach the fluorescent disk to the imaging system.

Images