Surgical system

The surgical system addresses inefficiencies in traditional navigation by using a reference device and tracking system to enhance precision and efficiency in orthopedic procedures, ensuring accurate and time-effective implant placement.

JP2025183284APending Publication Date: 2025-12-16STRYKER CORP
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Patent Information

Application Number
JP2025146973
Authority / Receiving Office
JP · JP
Patent Type
Applications
Current Assignee / Owner
Priority Date
2020-08-04
Filing Date
2025-09-04
Publication Date
2025-12-16

AI Technical Summary

Technical Problem

Traditional surgical navigation systems for orthopedic procedures, such as ORIF, rely heavily on procedural skill and anatomical knowledge, leading to inefficiencies and potential damage due to improper screw placement and the need for time-consuming manual alignment processes.

Method used

A surgical system incorporating a surgical navigation system with a reference device, sensors, and a tracking system that aligns surgical instruments relative to a patient's bone using a coordinate system, enabling precise alignment and real-time orientation tracking, thereby reducing the need for manual adjustments and improving accuracy.

Benefits of technology

Enhances the precision and efficiency of surgical procedures by providing real-time guidance for instrument positioning, reducing the risk of damage and rework, and minimizing the time required for accurate implant placement.

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Abstract

To disclose a surgical system for operating on a bone of a patient.SOLUTION: A surgical system includes: a reference device including one or more radiopaque markers; a first sensor configured to generate a first signal pertaining 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 pertaining 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 superimpose a virtual representation of at least one of the end effector and the surgical instrument over the image based on the determined orientation and user input.SELECTED DRAWING: Figure 15
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Description

[Technical Field]

[0001] [CROSS-REFERENCE TO RELATED APPLICATIONS] This application is a continuation of U.S. Provisional Patent Application No. 63 / 060,726, filed August 4, 2020. No. 6,399,499, filed on Dec. 1, 2003, which claims the benefit of and priority to the same and which is incorporated herein by reference in its entirety. This shall be done. [Background technology]

[0002] Traditional medical and surgical procedures involve the use of instruments that allow the surgeon to access and manipulate the surgical site. Non-limiting examples include handheld surgical instruments and surgical tools. Rotary instruments such as Rill are used in a variety of musculoskeletal conditions, including trauma, sports injuries, degenerative diseases, and joint reconstruction. It is commonly used in conjunction with orthopedic procedures to address musculoskeletal conditions. can be.

[0003] In procedures where a handheld drill or similar surgical instrument is employed, the actuator ( a rotary torque selectively generated by a motor (e.g., an electric motor) to rotate the drill bit or other surgical attachments at different speeds. The surgical handpiece assembly drills into the bone to which the end effector is applied.

[0004] One type of orthopedic procedure is open reduction internal fixation (ORIF). During an ORIF procedure, the surgeon realigns the broken bones and creates one The bone is fixed in place using one or more surgical implants. The implant may include a bone plate and screws. The screws may hold the bone plate in place relative to the bone. After a period of time, when the bone is determined to be healed, the bone plate and The screw threads can be removed. Summary of the Invention

[0005] A surgical system for performing surgery on a patient's bone is disclosed. The surgical system includes at least one The reference device defines a reference axis and includes one or more radiopaque markers. The surgical implant is configured to have a fixed orientation relative to the surgical implant. The operating system has a fixed orientation relative to the reference device when placed on the reference device. and generating a first signal relating to orientation data of the reference device relative to the first coordinate system. The surgical system also includes a first sensor configured to The surgical system also includes a surgical instrument coupled to the actuator. and a second coordinate system for the end effector and the surgical instrument. and configured to generate a second signal related to orientation data of at least one of the The surgical system also has a second sensor that receives (i) the first signal, (ii) the second signal, and (iii) receiving an image of the reference device and the patient's bones and The present invention also includes a navigation system configured to display an image of the navigation system. The system includes a desired positioning of at least one of an end effector and a surgical instrument relative to the bone. The device is further configured to receive at least one user input related to the location of the device. The navigation system includes: (i) at least one of a surgical instrument and an end effector; Positioning a first coordinate system in a second coordinate system when one axis is aligned with at least one reference axis (ii) aligning the orientation of at least one reference axis relative to the bone in the image coordinate system; (iii) adjusting the end effector and surgical instrument relative to the bone based on user input. and further configured to align at least one position of at least one of the tools. The navigation system determines a location of the bone based on the first signal and the second signal. The surgical instrument may further be configured to determine an orientation of at least one of the end effector and the surgical instrument. The navigation system is designed to locate the end effector and some of the surgical instruments. Based on the at least one aligned position and the determined orientation, and a virtual representation of at least one of the surgical instrument and the surgical instrument is further configured to overlay the virtual representation on the image. It has been completed.

[0006] A method for performing surgery on a patient's bones using a surgical system is disclosed. a gating system, a surgical instrument, and a surgical instrument defining at least one reference axis and one or more radiation beams; a reference device including a radiopaque marker; and a first coordinate system fixed relative to the reference device. and a first sensor having a determined orientation, the reference device being relative to the surgical implant. The surgical instrument is configured to have a fixed orientation. The surgical instrument has a second coordinate system and is externally The surgical instrument includes a second sensor having a fixed orientation relative to the endoscope. The method includes: (i) receiving a reference signal from a first sensor; (ii) a first signal relating to orientation data of the device; (iii) an end effector and and a second signal relating to orientation data of at least one of the surgical instrument and the surgical instrument; and (iii) ) receiving an image of the reference device and the patient's bone. The method further includes displaying an image of the end effector and the surgical instrument relative to the bone. receiving a user input on the display relating to a desired position of at least one of the tools; The method further includes (i) removing at least one of a surgical instrument and an end effector. A first coordinate system is converted to a second coordinate system when at least one axis is aligned with at least one reference axis. (ii) aligning the end effector and surgical instrument relative to the bone based on user input. The method includes aligning the position of at least one of the instruments. and moving at least one of the end effector and the surgical instrument relative to the bone based on the second signal. The method further includes determining an orientation of the end effector and the surgical instrument. Based on the aligned position and the determined orientation of at least one of superimposing a virtual representation of at least one of the effector and the surgical instrument on the image; and

[0007] A surgical system for performing surgery on a bone of a patient, the surgical system comprising at least one the one or more radiopaque markers, and the fiducial device. The datum is configured to be placed on the patient. a surgical instrument including a sensor coupled to a first coordinate system; a first signal related to instrument orientation data; The surgical system is configured to receive an image of the reference device and the patient's bone. The surgical navigation system further includes a reference device and a surgical navigation system. The surgical navigation system is further configured to display an image of the patient's bones. i) aligning the orientation of at least one reference axis relative to the bone in the image coordinate system; i) further configured to register the first coordinate system with the image coordinate system. The orientation system is adapted to determine an orientation of the surgical instrument relative to the bone based on the first signal. The surgical navigation system is further configured to: and further configured to superimpose a virtual representation of the surgical instrument on the bone based on the position. It is being done.

[0008] Further areas of applicability of the present disclosure will become apparent from the detailed description, claims, and drawings. The detailed description and specific examples are for purposes of illustration only and are not to be construed as limiting the scope of the present invention. It is not intended to limit the scope of the disclosure.

[0009] The present disclosure will become more fully understood from the detailed description and the accompanying drawings, wherein: [Brief explanation of the drawings]

[0010] [Figure 1] FIG. 1 is a perspective view of an exemplary layout of an operating room including a surgical system according to the teachings of the present disclosure. [Figure 2] FIG. 1 is a functional block diagram of a surgical system according to the teachings of the present disclosure. [Figure 3] FIG. 1 is a perspective view of a detector of an imaging system including a FluoroDisc™ according to the teachings of the present disclosure. [Figure 4] 1 is a virtual representation of a plurality of fiducial markers applied on a medical image in accordance with the teachings of the present disclosure. [Figure 5] FIG. 1 is a perspective view of a surgical handpiece assembly including a surgical instrument with a depth measurement attachment for drilling into bone in accordance with the teachings of the present disclosure; [Figure 6] FIG. 6 is a cross-sectional and partial perspective view of the surgical handpiece assembly of FIG. 5. [Figure 7]1 is a schematic diagram of a surgical handpiece assembly in accordance with the teachings of the present disclosure; [Figure 8] FIG. 1 is a partially exploded view of a depth measurement attachment in accordance with the teachings of the present disclosure. [Figure 9] FIG. 1 is a perspective view of a surgical handpiece assembly with a depth measurement attachment separated from a surgical instrument in accordance with the teachings of the present disclosure; [Figure 10] FIG. 1 is a perspective view of a surgical handpiece assembly with a depth measurement attachment separated from a surgical instrument in accordance with the teachings of the present disclosure; [Figure 11] FIG. 1 is a schematic diagram of an exemplary surgical handpiece assembly including a surgical instrument and various attachments in accordance with the teachings of the present disclosure. [Figure 12] 1 is an example perspective view of a datum having a reference sensor coupled to the datum, in accordance with the teachings of the present disclosure. [Figure 13A] 1A-1C are perspective views of a first embodiment of a datum device and a second embodiment of a datum device in accordance with the teachings of the present disclosure. [Figure 13B] 1A-1C are perspective views of a first embodiment of a datum device and a second embodiment of a datum device in accordance with the teachings of the present disclosure. [Figure 13C] 1A-1C are perspective views of a first embodiment of a datum device and a second embodiment of a datum device in accordance with the teachings of the present disclosure. [Figure 14] 1 is a schematic diagram of an exemplary bone plate in accordance with the teachings of the present disclosure; [Figure 15] FIG. 1 is an elevational view of a surgical handpiece assembly in a reference orientation, in accordance with the teachings of the present disclosure. [Figure 16] FIG. 1 is an elevational view of a surgical handpiece assembly in a drilling orientation, in accordance with the teachings of the present disclosure; [Figure 17] FIG. 1 illustrates a navigation display depicting a virtual representation of a bone, a datum, a bone plate, and a surgical handpiece assembly in accordance with the teachings of the present disclosure. [Figure 18] FIG. 1 illustrates a navigation display depicting a virtual representation of a bone, a datum, a bone plate, and a surgical handpiece assembly in accordance with the teachings of the present disclosure. [Figure 19] FIG. 1 illustrates a navigation display depicting a virtual representation of a bone, a datum, a bone plate, and a surgical handpiece assembly in accordance with the teachings of the present disclosure. [Figure 20] FIG. 1 illustrates a navigation display depicting a virtual representation of a bone, a datum, a bone plate, and a surgical handpiece assembly in accordance with the teachings of the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0011] In the drawings, reference numbers are used to identify similar and / or identical elements. can be reused for

[0012] 1 and 2, a surgical system 10 according to the teachings of the present disclosure is used to perform a surgical procedure on a patient. An exemplary configuration of an operating room or surgical suite for performing a medical procedure is shown at 20 . The surgical system 10 realigns the fractured bone 81 and repairs the fractured bone 81 with one or more surgical implants. to fix bones 81 in place, and to perform various orthopedic procedures, such as ORIF procedures. One or more surgical implants may be used, such as a bone plate 80 and a bone 81. and a screw that is inserted into the bone 81 until healing. A surgical navigation system including a cart assembly 72 housing a navigation computer 70. The navigation computer 70 includes a navigation control system 50. It can also be called La.

[0013] First navigation display 74-1 and second navigation display 7 4-2 is in operative communication with a navigation computer 70. The first navigation display 74-1 and the second navigation display 74-2 are collectively referred to as navigation displays. This can be referred to as a navigation display 74. Navigation computer 70 may be used to input information into the navigation computer 70 or otherwise navigate. One or more inputs used to select or control certain aspects of the computer 70. One or more input devices 77 may be connected to the computer. It may include a microphone (voice activation), gesture control, or e.g. Interactive touchscreen display / menu, navigation display, etc. The navigation computer 7 discussed in this paragraph can be integrated with the display 74. The functionality of this invention may also be implemented on a tablet computer or another suitable mobile device. Cut.

[0014] The surgical system 10 includes an imaging system 54, such as a C-arm X-ray imager, or a CT or The imaging system 54 may also include another suitable imaging system, such as an MRI imaging device. , a detector 56, a radiation source 58, an imaging computer 60, an imaging display 62, and one or more The detector 56 and the source 58 may be provided with one or more medical The detector 56 and the source 58 are mounted on opposing sides of a C-arm 64. The source 58 may be a rotating anode X-ray source, a stationary or fixed anode X-ray source, or X-ray sources include standard X-ray sources, solid-state X-ray emission sources, fluorescent X-ray sources, and stationary or fixed anode X-ray sources. This includes any source or combination thereof used in diagnostic medical imaging that emits or generates radiation. The detector 56 may be an image intensifier or any other detector used in diagnostic medical imaging. The energy acceptor may include any other energy acceptor.

[0015] A C-arm 64 containing the detector 56 and the radiation source 58 rotates around the patient 20 to position the surgical site 3 The imaging computer 60 can be configured to generate an image of the A keyboard, mouse, and other devices that allow input to be provided to the image computer 60 It may be connected to one or more user input devices 68, including any suitable device. imaging computer 60 and / or navigation computer 70 (imaging computer 60 or navigation 70, or both), as known to those skilled in the art, The images taken by the imaging system 54 are captured to form one or more 2D images of the surgical site 30. image and / or one or more 3D models (2D images and / or 3D models) The imaging display 62 may include software that can generate the results. The device may be configured to display the resulting 2D image and / or 3D model.

[0016] Images from an imaging system 54, such as a C-arm X-ray imager, can often be distorted (e.g., Since the image may be distorted (i.e., distorted), all objects in the image are scaled identically. This is because the X-ray beam is not perfectly linear. Objects closer to the source 58 appear larger (and contain more pixels). Objects further from the source 58 appear smaller (and contain fewer pixels) To make accurate measurements, the image must be undistorted.

[0017] 3 and 4, the surgical system 10 includes a F FluoroDisc57 may also be included. For FluoroDisc57, FluoroMap™ Adaptive Positioning Technology User Manual for the amma3™ System and the like, the contents of which are incorporated herein by reference in their entirety. (https: / / www.strykermeded.com / media / 2325 / gamma3-adapt-fluoromap FluoroDisc57 is a method for producing a fluororesin-based polymeric material, which is disclosed in the patent application "Method A" filed on November 18, 2016. nd Apparatus For Treating A Joint, Including The Treatment Of Cam-Type Femoroace tabular Impingement In A Hip Joint and Pincer-Type Femoroacetabular Impingement In U.S. Patent Application Publication No. 2018 / 0140309 entitled "In A Hip Joint" and the contents of which are incorporated herein by reference in their entirety. In addition to the functionality described herein, the imaging computer 60 and / or navigation The computer 70 may implement one or more of the systems, methods, and / or The algorithm can be implemented.

[0018] The FluoroDisc 57 is made up of a transparent lens 59 and a plurality of lenses arranged on the transparent lens 59. The fiducial marker 61 and the FluoroDisc 57 are attached to the detector 56 of the imaging system 54. and a mounting member 63 configured to mount the FluoroDisc. 57 may be of any suitable size (more specifically, a transparent lens 59), for example, 9 inches (2 2.86 cm) diameter, 12 inch (30.48 cm) diameter, etc. The attachment member 63 may include a belt, one or more hooks, and one or more The plurality of fiducial markers 61 may include a combination of loops having known dimensions. FluoroDisc57 projects multiple fiducial61 patterns onto the image. 4 shows a projection of the image on the bone 81. A virtual representation 65 of a plurality of fiducials 61 is shown. Although an example including an isc 57 is provided, it is also possible to use an imaging system 54 that includes a flat panel detector. In some embodiments, such as when the imaging system 54 automatically generates the dewarped image. Therefore, FluoroDisc57 can be omitted. Based on the pattern projected onto the image, the imaging computer 60 and / or the navigation computer The application computer 70 calibrates the appropriate pixel size based on the undistorted image. It is possible.

[0019] In some embodiments, the imaging computer 60 and / or the navigation computer The computer 70 uses the known dimensions of the plurality of fiducial markers 61 for various other calculations. For example, the distance between the patient 20 and the radiation source 58 may change between images, and Therefore, the magnification or enlargement factor may vary from image to image. The navigation computer 60 and / or the navigation computer 70 may use a plurality of reference markers on the reference device. 61 and / or using the known dimensions of the radiopaque markers, for each of the images The imaging computer 60 and / or the navigation computer 62 can determine the magnification or enlargement factor of the image. The motion computer 70 uses the known dimensions of the plurality of fiducials 61 to calculate the position of the plurality of fiducial markers. The orientation of the C-arm 64 relative to 61 may be determined.

[0020] The imaging computer 60 can be in communication with a navigation computer 70 . The imaging computer 60 may be connected via wired and / or wireless connections (either wired or wireless connections or both). The surgical navigation system 50 may be configured to communicate with the surgical navigation system 50 via a For example, the imaging system 54 may capture the resulting 2D images of the surgical site 30 and / or Alternatively, the system may be configured to provide images such as 3D models to the navigation computer 70. The navigation computer 70 can then display the resulting 2D images and and / or 3D models may be configured to provide the navigation display 74. where a surgeon 79 or other medical professional can interact with the images and Corresponding regions and / or zones around the bone 81 may be identified and / or defined.

[0021] For example, the surgeon 79 may input multiple views of the bone 81 to be displayed via one or more input devices 77. for the end effector of the surgical handpiece assembly 76 A desired trajectory may be defined and / or an appropriate navigation display 74 may be generated. The source 58 and detector 56 may be connected to an imaging computer. Although shown connected to detector 60, in some configurations detector 56 and The X-ray imaging device including the radiation source 58 can be directly connected to the navigation computer 70. and eliminates the need for an imaging computer 60, imaging display 62, and user input device 68. The navigation computer 70 has the same functions as the imaging computer 60. It can be configured to perform a function.

[0022] The surgical system 10 may include a surgical handpiece assembly 76. The surgeon 79 uses the surgical handpiece assembly 76 to drill a hole in the bone 81 of the patient 20. and / or through one or more openings 82 in the bone plate 80 into a borehole in the bone 81. Surgery can be performed on the patient 20, including inserting screws. The navigation system generally comprises a surgical handpiece assembly for connecting the surgical handpiece assembly to the bone 81 of the patient 20. An optical tracking system or electromagnetic tracking system may be used to track the position of the end effector of the bridge 76. Such systems may use their own Both systems have their drawbacks and are time-consuming and expensive to set up. A particular drawback of optical tracking systems is the The main drawback is that the operating room requires a line of sight between the operating room and the camera. A particular drawback of electromagnetic tracking systems is that they can be more difficult to maintain than optical tracking systems. The drawbacks of both systems are that they are less accurate and more susceptible to distortion from surrounding metal objects. The system also requires the surgeon to perform a manual alignment process, which is time-consuming. Can be borrowed.

[0023] During ORIF and other trauma procedures, surgeons 79 rely on traditional navigation due to the above-mentioned shortcomings. Instead, the surgeon 79 cannot use his own Relying on procedural skill and anatomical knowledge, the end effector of the surgical handpiece assembly 76 Align the trajectory of the actuator to create a pilot for one or more screws (or other surgical implants). Similarly, during screw placement, the surgeon 79 inserts the screw freehand. The surgeon 79 then typically uses fluoroscopy to confirm the placement of the screws. If the surgeon 79 is not satisfied with the placement of the screws, the surgeon 79 may reposition the screws. The surgeon 79 must drill additional holes in the bone 81, causing additional damage to the bone 81. Improper screw placement can result in damage to the screw and the need for re-drilling and re-insertion. The verification process takes time, resulting in additional costs and wasted time.

[0024] In accordance with the teachings of the present disclosure, the surgical system 10 may include an optical tracking system and / or an electromagnetic tracking system. A surgical handpiece assembly 7 as is common in conventional tracking systems such as the without specifically tracking the position of the surgical hand (i.e., the translational position in 3 degrees of freedom). Real-time orientation (such as a trajectory tracking system configured to track the rotational position of the target object (i.e., three degrees of freedom) The surgical system 10 optionally includes a surgical handpiece assembly 76. A non-traditional fourth degree of freedom for translational position of the end effector is tracked relative to its displacement. It may be configured as follows.

[0025] With further reference to FIGS. 5-10, one exemplary surgical handpiece assembly 76 includes: The surgical handpiece assembly 76 includes a Eliminates the need for a secondary device such as a depth gauge. The surgical instrument 104, the depth measurement attachment 116A, and the end effector such as a drill bit are The surgical handpiece assembly 76 is manufactured by The patent application "Powered Surgical Drill With Integral Depth Gauge That Includes A Pro International Publication No. 2017 / 040783 entitled "Be That Slides Over A Drill Bit"; and "Surgical Handpiece For Measuring Depth Of International Publication No. 2019 / 035096 entitled "Bore Holes and Related Accessories" and the like, which are incorporated herein by reference in their entireties. This shall be done.

[0026] The surgical instrument 104 includes a housing 112, a motor 114, and a surgical handpiece component. a controller 162, one or more user input devices 164, a battery, and The user input device 164 may include a trigger, The user input device 164 can be a user (e.g., a surgeon 79) via a magnet and an electrical signal generated by a Hall effect sensor in response to actuation by the , communicate with the surgical handpiece controller 162. Thus, the surgeon 79 can Actuation of the user input device 164 to operate the handpiece assembly 76 The surgical handpiece controller 162 directs power from the battery to the motor 114, The motor 114 then drives the end effector 108 or generates a rotational torque that is employed to rotate another surgical end effector.

[0027] 6 and 7 show a motor positioned within housing 112 along a proximal / distal axis AX. Although motor 114 is shown, other motor positions are contemplated. Motor 114 may be electric, pneumatic, The motor 114 receives power from the surgical handpiece controller. The motor is configured to selectively generate rotational torque in response to a command, signal, or the like. 14 is a rotor supported by a pair of bearings 117 so as to rotate about an axis AX. A drive gear located adjacent to the gear set is connected to the rotor cannula 115. 115, which rotates simultaneously with the rotor cannula 115 and transmits rotational torque to the gear set. It is employed to communicate.

[0028] In the illustrated example, the depth measurement attachment 116A is attached to the housing 112. However, the depth measurement attachment is removably connected to the housing 11. The depth measurement attachment 116A may be integrally formed with the module housing 2. The depth measurement attachment 116 may have a separate housing such as a housing 120. A may be constructed to minimize obstruction of the view of the surgical site for the surgeon 79 The depth measurement attachment 116A further includes a displacement sensor 124 and a depth measurement extension 128. The displacement sensor 124 is operably connected to the depth measurement extension 128. As shown, the depth measurement extension 128 is a cannula.

[0029] The depth measurement extension 128 is disposed within a guide bushing 132 and extends along a measurement axis MX. The depth measurement attachment 116A is supported for translational movement. When mounted in assembly 76, measurement axis MX is aligned coaxially with axis AX. An elongated concave slot 143 is optionally formed laterally within the depth measurement extension 128. The depth measurement extension 128 is formed by a pair of extensions 128a and 128b extending in the longitudinal direction. The rack further comprises a plurality of rack teeth 140 arranged linearly along the partial length thereof, The gear teeth mesh with a gear 146 located adjacent the distal end of the guide bushing 132. As shown in FIG. 6, the window in the guide bushing 132 is positioned so that the gear 146 The rack teeth 140 and gear 146 are aligned such that rotation and movement of the depth measuring extension 128 are directly proportional. The displacement sensor is disposed adjacent to the gear 146 to facilitate meshing engagement therebetween. 124 responds to rotation of gear 146 resulting from axial movement of depth measurement extension 128, to generate an electrical signal representative of a change in position of the depth measuring extension 128 along a fixed axis MX; This may be achieved by a potentiometer, rotary encoder, etc.

[0030] By way of example, in some configurations, the displacement sensor 124 may be a surgical handpiece control. and arranged to communicate with the roller 162 or the depth measurement attachment controller 144. This may slow the rotation of the end effector 108 at a particular penetration depth into the tissue. How the motor 114 is driven based on the movement of the depth measurement extension 128, such as to increase the The system may be configured to interrupt or adjust the amount of data that is transmitted.

[0031] Referring to FIG. 8, proper functioning of the depth measurement extension 128 and displacement sensor 124 is confirmed. To ensure this, the depth measurement extension 128 may be biased towards the extended position. This bias causes the distal end of the depth measurement extension 128 to contact the proximal surface of the bone 81 being drilled, The force constantly maintains contact with the bone plate 80 abutting the bone 81 being drilled. Gear 146 is rotated in a direction that extends degree measuring extension 128 distally from module housing 120. This is achieved by using a spring 160 which biases the rotatable gear 146 to rotate. However, in addition to biasing the depth measurement extension 128 against the surgical instrument 104, The following method is contemplated.

[0032] 9 and 10, the depth measurement attachment 116A is attached to the surgical instrument 104. the housing connector 15 configured to operably connect with the instrument connector 152 of the 0. In one example, the surgical instrument 104 includes an instrument connector 152 and The depth measurement attachment 116A is connected only through the connection between the housing connector 150. In another example, a power connection can be provided to the depth measurement attachment 116A. and the surgical instrument 104 is connected to the device via the instrument connector 152 and the housing connector 150. The depth measurement attachment controller 144 and the surgical hardware The handpiece controller 162 is connected via a wired connection (i.e., through the housing connector 1 50 and instrument connector 152), or via a wireless connection to the navigation computer. The device may communicate with a computer 70 or other device, such as a surgical handpiece controller. The controller 162 can transmit data to a remote device such as a tablet or an external server. .

[0033] The depth measurement attachment 116A may include a display screen or the like and one or more light emitting diodes. The depth measurement attachment 116A also includes a display 156 such as an LED. Information about the movement may be provided to the surgeon 79, such as real-time drilling depth, recording Historical maximum drill depth, thread length, penetration indication, and current trajectory relative to the desired trajectory. Visual information (e.g., a graphic representation) is displayed to assist the surgeon 79 in positioning the desired trajectory, etc. This same information is available for real-time drilling depth, recorded historical maximum A speaker is used to communicate to the user to provide audio instructions such as drilling depth, penetration instructions, etc. This may also be done.

[0034] The depth measurement attachment controller 144 determines a penetration event based on the displacement signal. The depth measurement attachment controller 144 and the external The dental handpiece controller 162 controls the depth measurement attachment 116A and and a separate controller located within the surgical instrument 104, and a depth measurement attachment. The surgical handpiece controller 144 and the surgical handpiece controller 162 are located in the remote device. The depth measurement attachment controller 144 and the surgical handpiece may be housed in the The controllers 162 may also be combined into a single controller.

[0035] Referring again to Figures 7 and 8, the surgical handpiece assembly 76 includes a handpiece It may further include an orientation sensor 172. In one exemplary configuration, the handpiece An orientation sensor 172 may be included as part of the depth measurement attachment 116A. The orientation measurement attachment controller 144 is operable to the handpiece orientation sensor 172. may be connected to

[0036] The handpiece orientation sensor 172 is used to determine whether the navigation computer 70 is The orientation of the base assembly 76, more specifically, the depth measurement attachment 116A and axis A Generates a handpiece orientation signal that can be used to derive the X orientation. The handpiece orientation signal is the angle of the handpiece orientation sensor 172 relative to the handpiece coordinate system. It can show the speed.

[0037] In an exemplary configuration, the handpiece orientation sensor 172 is connected to the depth measurement attachment 1 16A or the x-axis of the surgical instrument 104, the depth measurement attachment 116A or the x-axis of the surgical instrument 104 04, and the z-axis of the depth measurement attachment 116A or surgical instrument 104. The system includes three single-axis gyroscopes arranged to sense angular rate about orthogonal axes. The x-, y-, and z-axes of the handpiece orientation sensor 172 are referred to as the handpiece coordinate system. The angular velocity of the x-axis, the angular velocity of the y-axis, and the angular velocity of the z-axis are collectively referred to throughout this disclosure. For example, the first gyroscope may be referred to as a handpiece orientation signal. The handpiece orientation sensor 172 is configured to sense the angular velocity of the x-axis (i.e., roll axis). The second gyroscope may be configured to sense the y-axis ( The third gyro may be configured to sense the angular velocity of the third gyro. The handpiece orientation sensor 172 is configured to sense the angular velocity of the z-axis (i.e., yaw axis). It may be configured as follows.

[0038] The sensor of the handpiece orientation sensor 172 is intended as a gyroscope, but The sensor is an inertial measurement unit that includes an accelerometer and / or magnetometer and is capable of sensing in six degrees of freedom. The handpiece orientation sensor 172 includes three gyroscopes. Although described as including a gyroscope, any number of gyroscopes may be included. In an exemplary configuration, a first gyroscope, a second gyroscope, and a third gyroscope The gyroscope can be replaced with a 3-axis gyroscope. The sensor 172 communicates the handpiece orientation signal directly to the navigation computer 70. and / or configured to transmit a depth measurement attachment controller 144 or through the surgical handpiece controller 162, etc., the navigation computer 70 The controller may also include a controller configured to indirectly transmit to the

[0039] The handpiece orientation sensor 172 is fixed relative to the surgical handpiece assembly 76. In some examples, , the handpiece orientation sensor 172 is connected to the depth measurement attachment 116A as shown in FIG. or within the housing 112 of the surgical handpiece assembly 76. The headpiece orientation sensor 172 may be attached to a device such as one of the attachments described with respect to FIG. It may be placed in another attachment.

[0040] In another example, the handpiece orientation sensor 172 is connected to the depth measurement attachment 116A. or releasably to any portion of the surgical handpiece assembly 76, such as the surgical instrument 104. Therefore, the depth measurement attachment 116A is configured to be attached to Any suitable connector for connecting to the handpiece orientation sensor 172 may be included. The connector may be a clamp, clip, or another suitable connector. The handpiece orientation sensor 172 may be positioned on the outer surface of the depth measurement attachment 116A or on the surgical instrument. 104 can be coupled to a housing 112 .

[0041] The depth measurement attachment controller 144 communicates with the handpiece orientation sensor 172. and can control the operation of the handpiece orientation sensor 172 based on user input. For example, user input may include depth measurement buttons such as a first button 148a and a second button 148b. The information may be received via one or more input devices 148 of the attachment 116A. One button 148a can power on / off the handpiece orientation sensor 172. The second button 148b can zero the handpiece orientation sensor 172. The handpiece orientation sensor 172 can receive power from the surgical instrument 104. , may not require a separate power source when placed within the depth measurement attachment 116A. Although not shown in FIG. 2, the handpiece orientation sensor 172 is connected to the first button 148a or determines the operation of the handpiece orientation sensor 172 based on user input to the second button 148b. In another embodiment, the depth measurement apparatus may have a dedicated controller for controlling the depth measurement apparatus. Another controller, such as the touch controller 144, controls the handpiece orientation sensor 17. 2's operation can be controlled.

[0042] The handpiece orientation sensor 172 is located inside the depth measurement attachment 116A. In one configuration, the handpiece orientation sensor 172 is connected to a housing and one or more input devices. The one or more input devices may include a depth measurement adapter and a power source such as a battery. The first button 148a and the second button 148b of the control panel 116A are configured to function similarly to each other. The button may include a first button and a second button configured as follows:

[0043] Referring to FIG. 11, in some cases, the depth measurement attachment 116A may include: In this case, the surgical instrument 104 may not be used. or a tap 116C for forming a thread on the inner surface of the opening, or a borehole or Alternatively, it may be coupled to a driver 116D for driving or inserting a screw into the opening. The handpiece orientation sensor 172 detects whether the drill chuck 116B, the tap 116C, or the drill The drill chuck 116B may be disposed within the housing of the tap 116D. 16C, and driver 116D to control the operation of handpiece orientation sensor 172. The button may include a first button 148a and a second button 148b. The drill piece orientation sensor 172 is connected to the drill chuck 116B, the tap 116C, or the driver. 116D. Therefore, the drill chuck 116B, the tap 11 6C, and driver 116D connects handpiece orientation sensor 172 to drill chuck 116 B, any suitable connection for attachment to the exterior surface of tap 116C or driver 116D. It may contain ingredients.

[0044] Referring to Figures 12 and 13A-13C, the tracking system includes at least one reference The reference 182 may be fixed to the bone 81 and define an axis. and / or in some configurations, bone plate 80 is configured to be attached to bone 81. The datum 182 can be interposed between the first extension 186 and the datum 182. The extension 186 includes one or more extensions 186, such as a first extension 186a, a second extension 186b, and a third extension 186c. The datum 182 is shown with three extensions 186, but the datum The device 182 may include any number of extensions 186 or surfaces. 6a, the second extension 186b and the third extension 186c have different dimensions, e.g. The datums 182 may have different heights, lengths, and widths. The present invention is not limited to the illustrated embodiments described throughout, and any other suitable embodiment may be used to define at least one reference axis. The term "design" may include any design or configuration.

[0045] The reference device 182 is mounted in a manner suitable for determining the orientation of the reference device 182 when it is imaged. The reference markers 188 may include one or more fiducial markers 188 arranged in the following manner: For example, in one exemplary configuration, In this case, each of the first extension portion 186a, the second extension portion 186b, and the third extension portion 186c The first may include a fiducial marker 188 that can be imaged by the imaging system 54. The extension 186a can have a first set of fiducial markers 188a, and the second extension 1 86b can have a second set of fiducial markers 188b, and a third extension 186c , and a third set of fiducial markers 188c. The second set of fiducial markers 188b, and the third set of fiducial markers 188c are unique fiducial markers. For example, the first extension 188a may have a reference marker 188b. The size, shape, number, and / or spacing of the reference markers 188a of the second extension 186b may be adjusted to match the size, shape, number, and / or spacing of the reference markers 188a of the second extension 186b. The reference markers 188b and 188c of the third extension 186c may be different. The reference marker 188 is used by the navigation computer 70 or the imaging computer 60 to The orientation (i.e., position and orientation) of the reference device 182 relative to the bone 81 in the image-based coordinate system The image-based coordinate system allows the calculation of the patient surface and / or may define the shape and / or orientation of the bone plate 80. One or more fiducial markers 188 allows the navigation computer 70 to calculate the rotation angle between the images. You can also do this.

[0046] The datum 182 may be formed with a surface 194 that defines at least one reference axis. In some examples, as shown in FIGS. 12 and 13A, the surface 194 may be a second The extension 186b may be a protrusion such as a notch or a peg protruding from the extension 186b. In this configuration, the depth measurement attachment 116A may be coupled to the protrusion. When the attachment 116A is connected to the protrusion, the depth measurement attachment 116A and The protrusions are concentric, so that the measurement axis MX of the depth measurement attachment 116A is aligned with the protrusions. This allows the two axes to be aligned, and In another example, as shown in FIG. 13B, surface 19 4 is a part of the end effector 1 to align the axis AX with the axis of the tube or cylindrical pocket. 08 is inserted into the tube or cylindrical pocket. One or more extensions 186 are The connection portion 190 can be connected to a Kirschner wire (K-wire), a pin, or 1. The bone plate 80 or bone 8 of the patient 20 may be secured to the bone 8 via a fixation member 192, such as another suitable fixation member. The device may be configured to facilitate releasable attachment to the device.

[0047] Referring to Figure 14, an exemplary bone plate 80 is shown. The bone plate 80 is made of gold. The bone 81 may be made of metal or another suitable material and is configured to fixate a broken bone, such as bone 81. As shown, the bone plate 80 has a plurality of large openings 82 and a pair of small openings. The surgeon 79 may insert the screw into the bone 81. First, the bone plate 80 is fixed to the bone 81 by the fixing member 192 so that the bone plate 80 does not move. It can be fixed.

[0048] Referring again to Figures 12 and 13A to 13C, the fixing member 192 has a pair of small openings. The K-wire can be driven into the bone 81 through either opening in the mouth 83. The portion (i.e., the side not driven into the bone 81) serves as a fixture for the reference device 182. The fixing member 192 can be inserted through one of the pair of small openings 83. Once delivered and driven into bone 81, datum 182 may couple to fixation member 192. The connecting portion 190 includes a finger support collar 208, a threaded portion 210, and a collet 212. and a locking knob 214. The finger support collar 208 can be attached to the bottom of the datum 182. The threaded portion 210 may be attached to the bottom portion or may be integrally formed with the bottom portion. The finger support collar 208 may include a screw and may be attached to the finger support collar 208 may be formed integrally with the

[0049] Collet 212 may be attached to threaded portion 210 or may be integral with threaded portion 210. The collet 212 may be formed to secure the datum 182 to the fixed member 192. The fixing member 192 is configured to form a collar around the fixing member 192 for this purpose. Forming a collar around the fixed member 192 prevents rotational and axial movement of the datum 182. The coupling portion is provided with a collet 212 for fixing the datum device 182 to the fixed member 192. Although examples including the above are provided, any suitable member, element, or device may be used. The datum 182 is fixed to a fixed member 192 so that it cannot move independently of the datum 182. It may be used to determine

[0050] The locking knob 214 may be configured to couple to the threaded portion 210. For example, The knob 214 defines a passage configured to receive the threaded portion 210 and the collet 212. The locking knob 214 may include internal threads on its interior surface. The threaded portion 210 and the locking knob 214 may form a mating pair. In this case, the dimensions (for example, height) of the threaded portion 210 and the dimensions (for example, height) of the collet 212 The combined dimensions may be approximately the same as the dimensions (e.g., height) of the locking knob 214. The locking knob 214 ensures that the connection between the datum 182 and the fixed member 192 remains secure. , which serves to cover the collet 212 to prevent it from unintentionally disconnecting throughout the procedure. It is possible to do so.

[0051] In other configurations, even when bone plate 80 is used in a surgical procedure, the reference The device 182 still connects directly to the bone 81 without the intervening bone plate 80. In such a configuration, the fixation members 192 may be attached to the bone 8 adjacent the bone plate 80. 1, but does not penetrate either of the pair of openings 82, 83.

[0052] Once the bone plate 80 is temporarily secured to the bone 81, the surgeon 79 or other medical professional The patient 20 can be imaged using the imaging system 54. generates images and any 3D models, and uses the images and / or 3D models in a navigation control The data is transmitted to the computer 70.

[0053] The reference sensor 184 is configured to be removably attached to the reference device 182. An example is provided in which the reference sensor 184 is removably attached to the reference device 182. However, in some examples, the reference sensor 184 may be a reference device 1 182, or the like. The reference sensor 184 may be used by the navigation computer 70 to determine the orientation of the reference device 182. generating a reference device orientation signal that can be used to derive the reference device orientation signal can represent the angular velocity of the reference device 182 with respect to time. The product of angular velocity with respect to time The minutes are the time since the reference sensor 184 was last zeroed. The reference sensor 184 is a measure of the angular motion (i.e., orientation) of the object relative to the coordinate system of the device. The datum 182 and depth measurement extension 128 may be zeroed when aligned. The reference sensor 184 is mounted on a mounting element integrally formed or attached to the housing 191. The mounting member 183 may include a housing 191 having a clamping member 183. A lamp, clip, or other suitable means for attaching the reference sensor 184 to the reference device 182 may be used. When releasably attached to the datum device 182, the datum sensor The attitude (ie, position and orientation) of sensor 184 is fixed relative to reference device 182 .

[0054] The reference sensor 184 includes a reference controller 187, an orientation sensor 189, and one or more input devices. In an exemplary configuration, the orientation sensor 185 may include a power source such as a battery. The sensor 189 includes three single-axis gyroscopes. The first gyroscope is referenced to the x-axis. The second gyroscope may be configured to sense the angular velocity of the sensor 184. , the reference sensor 184 may be configured to sense the y-axis angular velocity, and the third gyroscope may be configured to sense the y-axis angular velocity of the reference sensor 184. The roscope can be configured to sense the z-axis angular velocity of the reference sensor 184. The x-, y-, and z-axes of the reference sensor 184 can be referred to as the reference device coordinate system, and x The angular velocity of the y-axis, the angular velocity of the y-axis, and the angular velocity of the z-axis are collectively referred to as the reference velocity throughout this disclosure. The sensor is intended as a gyroscope, but the sensor The sensor is an inertial measurement unit that includes an accelerometer and / or magnetometer and is capable of sensing in six degrees of freedom. The orientation sensor 189 is described as including three gyroscopes. However, any number of gyroscopes may be included. The first gyroscope, the second gyroscope, and the third gyroscope are It can be replaced with a gyroscope.

[0055] The reference controller 187 controls the output of the reference sensor 184 based on one or more input devices 185. Controls the operation and transmission of reference device orientation signals to the navigation computer 70 The reference controller 187 can communicate with the depth measurement adapter via a wired or wireless connection. Communicating with the touchment controller 144 or the surgical handpiece controller 162 One or more input devices 185 of the reference sensor 184 may be used to control the operation of the sensor. For example, one or more input devices 185 of the reference sensor 184 may be configured to The first button 185a powers the reference sensor 184 on / off and starts / stops sensing. A second button 185b of the one or more input devices 185 may be used to It may be used to zero the sensor 184. In some examples, the reference sensor The sensor 184 may include an output. The output may be an LED, a display, or any other The output may include a reference sensor 184 and / or one or more output devices of the system 10. It may also be configured to indicate the status of other components above.

[0056] Referring to FIG. 15, the navigation computer 70 Once the reference orientation 204 between the bridge 76 and the datum 182 is established, the handpiece coordinate system may be aligned to a reference device coordinate system. 16) between a reference orientation 204 and a drilling orientation 206 by the surgeon 79. It may be movable.

[0057] To align the respective coordinate systems, the surgical handpiece assembly 76 The depth measurement extension 194 may be coupled to the surface 194 of the sub-device 182. 128 is coupled to a surface 194 (i.e., a peg or cannula) of the datum 182 The surgeon 79 can position the attachment by pressing the second button 14 on the attachment. Press 8b to zero the handpiece coordinate system relative to the reference device coordinate system. do.

[0058] In an alternative configuration, the navigation computer 70 may be connected to the reference device 182 or the surgical based on one or more sensors in the handpiece assembly 76 relative to the reference device 182. The proximity of the surgical handpiece assembly 76 can be detected. The navigation system is configured to determine the proximity of the surgical handpiece assembly 76 to the target. The computer 70 automatically aligns the reference device coordinate system with the handpiece coordinate system. For example, the datum 182 may include a magnet, The assembly 76 may include a Hall effect sensor, or alternatively, the reference device 182 may be , a Hall effect sensor, and the surgical handpiece assembly 76 includes a magnet. In another example, the handpiece controller 162 may detect the magnetic field and automatically The body is aligned with the reference frame and the signal is sent to the navigation computer 70. After transmission and alignment, the integration of orientation information may begin.

[0059] The handpiece orientation sensor 172 and the reference sensor 184 include a gyroscope. Gyroscopes suffer from bias instability that causes the gyroscope to drift over time. Therefore, the surgeon 79 can avoid tracking caused by gyroscope drift. To minimize inaccuracies in the trace, periodically check the handpiece orientation sensor during the surgical procedure. The end effector 172 can be aligned with the datum 182. 08 to the surface 194 of the datum 182 and press the second button 148b. This can be done by zeroing the handpiece orientation sensor 172 with

[0060] In reference orientation 204, axis AX of surgical handpiece assembly 76 is aligned with reference device 1. 82. In many configurations, the reference axis RX is The reference axis RX is perpendicular to one or both of the bone 81 and the bone plate 80. It is not necessary that the surgical hand be perpendicular to the bone plate 80. Referring to FIG. The piece assembly 76 is shown in a drilling orientation 206 and is a surgical handpiece assembly. The axis AX of the screw 76 is at an oblique angle to the reference axis RX. This oblique angle allows the screw to be inserted later. The drilling angle is

[0061] The navigation computer 70 is After aligning the coordinate system with the reference device coordinate system, start integrating the handpiece orientation signal. Alternatively, the integration function can be implemented by the depth measurement attachment controller 144, Controller of handpiece orientation sensor 172, surgical handpiece controller 162 , or any other suitable controller. For example, the navigation computer may determine whether the depth measurement extension 128 and the reference device 182 are aligned. and when the surgeon presses the second button 148b, the integral of the handpiece orientation signal is During alignment, the distance between the handpiece coordinate system and the reference device coordinate system can be calculated. A coordinate transformation matrix is ​​determined. For example, the navigation computer 70 The surgeon 79 presses a second button 148b associated with zeroing the orientation sensor 172. Pressing may prompt the user to align the handpiece coordinate system with the reference device coordinate system. In another example, the navigation computer 70 may guide the surgeon 79 through the alignment process. The navigation computer 70 may be prompted to start By integrating the handpiece orientation signal over the The handpiece orientation signal may be integrated to determine the orientation of the handpiece 76. , the navigation computer 70 obtains the reference orientation 204 as shown in FIG. 16 to the drilling orientation 206 as shown in FIG. The navigation computer 70 may determine changes in the surgical The orientation of the handpiece assembly 76 may be determined.

[0062] As previously mentioned, the reference sensor 184 is fixed to the reference device 182 in a fixed manner. Since the reference device 182 has a fixed orientation relative to the bone 81, the reference sensor 184 Each time an image is taken, the angular orientation of the reference sensor 184 is The current value of the navigation time can be recorded and associated with the particular image being taken. The computer 70 integrates the angular velocity values ​​of the reference device orientation signal over a period of time. The orientation of the bone 81 may be determined by integrating the angular velocity values. By this, the navigation computer 70 can detect changes in the orientation of the bone 81 during the surgical procedure. can be determined.

[0063] Referring to FIG. 17, the navigation computer 70 displays the navigation display. Images and 3D models are displayed on the screen. For example, a coronal view of the tibia is displayed. one of the following: tibia, sagittal view, or tibia traverse view The system tracks the position of the surgical handpiece assembly 76. The surgical handpiece assembly 76 does not rely on traditional tracking means to The actual position must be entered by the surgeon 79. The application computer 70, via the navigation display 74, The endoscope assembly 76, more specifically, the bone plate 80 and / or the bone 81 The device may be configured to prompt the surgeon 79 to indicate the actual location of the tip of the effector 108. For example, if the surgical system 10 includes a bone plate 80, the navigation computer The controller 70 selects a first and a second position corresponding to the desired position of the tip of the end effector 108. The surgeon 79 can be prompted to make a selection of: This may include selecting a shadow for the opening in the virtual bone plate that corresponds to the desired position of the effector 108. The second selection can involve selecting a desired location in a plane containing the z axis. For example, x The navigation computer receives the desired position of the end effector in the y-plane. The computer 70 can be operated via touch or via an input device 77 to display the surgical navigation display. The surgeon 79 may be prompted to select the desired opening on the image shown on the screen 74. stomach.

[0064] In another example, the navigation computer 70 may perform end-effect analysis on the 3D model. The surgeon 79 may be prompted with a single user input regarding the desired position of the tip of the vector 108. If the system does not include a bone plate 80, the navigation computer 70 1. Point to or select the anatomical feature in the image that corresponds to the current position of the handpiece assembly 76. The navigation computer 70 may prompt the user to select the handpiece. Whenever the orientation sensor 172 is zeroed, the surgical handpiece assembly 7 The surgeon 79 may be prompted to confirm the position of 6.

[0065] Referring to FIG. 18, the navigation computer 70 receives input from the surgeon 79. and drawing a virtual representation based on the determined position and orientation of the surgical handpiece assembly 76. The virtual representation can be superimposed on the image. or a model of the surgical handpiece assembly 76, such as a model of the end effector 108. The virtual representation may also include a virtual trajectory projecting into the bone 81. The surgeon 79 then adjusts the surgical handpiece assembly until the surgeon 79 is satisfied with the virtual trajectory. For example, the model of the end effector 108 may be If the system 10 includes a bone plate 80, it may be superimposed on the selected opening. In other examples, such as when the surgical system 10 does not include a bone plate 80, a depth measurement attachment A model of the tip of the end effector 108 or the anatomical element 116A is displayed on the selected anatomical element in the image. It can be superimposed on biological characteristics.

[0066] The navigation computer 70 then determines whether the surgeon 79 is satisfied with the virtual trajectory depicted in the image. allows the surgeon 79 to freeze or memorize the trajectory as the desired trajectory when When the desired trajectory is stored, the navigation display The device 74 provides a visual cue to the surgeon 79 when the current trajectory matches the stored desired trajectory. For example, the movement instructions may include a graphical representation to provide a surgical hand The navigation display 74 moves with the orientation of the piece assembly 76. The movement instructions may be displayed as a navigation target (e.g., a crosshair or circle representation). The target may be shown on the display 74. The target represents the desired trajectory. When the current trajectory is adjusted, it matches the desired trajectory. The present system allows the surgeon to memorize the current trajectory without having to look at the navigation display 74. the surgical handpiece assembly so that it can be aligned to the desired trajectory 76 may be displayed on the display 156.

[0067] The surgical navigation system 50 provides an audible and visual notification when the desired trajectory is achieved. The present disclosure can be configured to generate visual and virtual alerts. It is intended that the representation be displayed on the navigation display 74, but The computer 70 projects the virtual representation onto a surgical handpiece assembly 76. a display, tablet, laptop computer, or any other mobile device The image may be transmitted to other computing devices and / or displays, including

[0068] Referring to FIG. 20, as described above, the displacement sensor 124 is The roller 162 may be configured to generate a displacement signal, which may be used for navigation. The displacement signal is transmitted to the application computer 70. The depth measuring extension 128 responds to the displacement of the end effector 108 relative to the depth measuring extension 128 until In some examples, the navigation computer 70 determines whether the end effector 108 is moving toward the bone 8. 1. The device may be configured to depict a live depth depiction of the drilling procedure as the drill is drilled through the As mentioned before, the magnification / expansion factor can vary from image to image, so the navigation The computer 70 may use a magnification / expansion factor to render the live depth representation. For example, the navigation computer 70 may perform a conversion to millimeters for each of the images. A magnification / expansion factor can be used when determining the appropriate pixel.

[0069] A second attachment 116B is attached to the surgical instrument 104 (i.e., In other instances, such as when the depth measurement attachment 116A is not present, the navigation controller The computer 70 determines the position of the surgical handpiece assembly 76 (i.e., configured to stop displaying the virtual representation of the object (i.e., position and orientation) and the associated virtual trajectory. That's fine.

[0070] The preceding description is merely exemplary in nature and is not intended to limit the disclosure, its application, or uses. It is not intended in any way to limit the scope of the present disclosure. The broad teachings of the present disclosure may be embodied in a variety of forms. Therefore, although this disclosure includes specific examples, the true scope of the disclosure should not be so limited. This should not be determined because, upon review of the drawings, the specification, and the accompanying claims, One or more steps in a method may be modified in accordance with the principles of the present disclosure. It should be understood that these steps may be performed in a different order (or simultaneously) without changing the principles. Furthermore, although each example is described above as having certain particular features, any of the examples of this disclosure may be used. Any one or more of the features described with respect to the examples may be used in combination as desired. may be implemented in any feature of other examples even if not specifically described; and and / or may be combined with any features of other examples. In other words, the examples described may be combined with each other. Non-exclusive substitution of one or more examples with one another remains within the scope of the present disclosure.

[0071] The spatial and functional relationships between elements (e.g., between controllers, circuit elements, semiconductor layers, etc.) Relationships can be defined as "connected," "engaged," or "coupled." upled," "adjacent," "next to," "on top of" ", "above," "below," and "disposed." Unless expressly described as "direct," Unless otherwise specified, if a relationship between a first element and a second element is described in the disclosure above, that The relationship is a direct relationship between the first element and the second element, with no other intervening elements present. However, there may be one or more intervening elements (spatial or functional) between the first and second elements. The relationship may be an indirect one existing between the parties.

[0072] As used herein, the phrase at least one of A, B, and C refers to non The use of exclusive logical OR should be interpreted to mean the logical (A OR B OR C). and "at least one of A, at least one of B, and at least one of C" The term subset should not be interpreted as meaning "at least one." In other words, the first subset of the first set is May refer to the same objects (be equal) as the first set.

[0073] In the figures, the direction of the arrows, as indicated by the arrowheads, generally points to the information being highlighted in the illustration. For example, element A and element B exchange various information. If the information transmitted from element A to element B is relevant to the diagram, the arrow points to element A. This one-way arrow indicates that other information is being sent from element B to element A. Furthermore, regarding the information sent from element A to element B, Thus, Element B can send Element A a request for information or an acknowledgment of receipt.

[0074] In this application, including the definitions below, the term "controller" is used interchangeably with the term "circuitry." The term "controller" refers to an application specific integrated circuit (AS ICs), digital, analog, or mixed analog / digital discrete circuits, digital analog or mixed analog / digital integrated circuits, combinational logic circuits, field Programmable gate arrays (FPGAs), processor circuits that execute code (shared, dedicated) (for example, a group of processors), a memory circuit (for example, a processor group) for storing code to be executed by the processor circuit. shared, dedicated, or group), or any other suitable hardware configuration that provides the described functionality. or a combination of some or all of the above in a single chip, or system on a chip, etc. It may be part of or include it.

[0075] The controller may include one or more interface circuits. The interface circuitry is connected to a local area network (LAN) or a wireless personal area network (WLAN). It may implement a wired or wireless interface to connect to a wireless personal area network (WPAN). An example of N is the Institute of Electrical and Electronics Engineers (IEEE) standard 802.11-2016 (Wi-Fi Wireless Networking Standard) and IEEE Standard 802.3-2015 (E (also known as the THERNET wired networking standard). An example of a WPAN is , Bluetooth Special Interest Group's BLUETOOTH wireless networking standard and and IEEE standard 802.15.4.

[0076] The controller can communicate with other controllers using an interface circuit. Controllers are depicted in this disclosure as logically communicating directly with other controllers. Although the controller may be depicted as a A communication system may include physical devices such as hubs, switches, routers, and gateways. and / or virtual networking appliances. In some configurations, the communication system , connect to a wide area network (WAN) such as the Internet, or For example, a communication system may use Multiprotocol Label Switching (MPLS) and and virtual private networks (VPNs) to access the Internet or It may include multiple LANs connected together via point-to-point leased lines.

[0077] In various configurations, the controller functions are performed by a number of devices connected via a communication system. For example, multiple controllers may be used in a load balancing system. In a further example, the functionality of the controller may be implemented in a distributed manner. The server (also known as remote or cloud) controller and the client (or user) The data can be split between the user and the controller.

[0078] Some or all of the hardware features of the controller comply with IEEE Standard 1364-20 05 (commonly referred to as "Verilog") and IEEE Standard 10182-2008 ( Define it using a hardware description language such as VHDL A hardware description language can be used to create and / or program hardware circuits. In some configurations, some or all of the controllers The features are IEEE 1666 including both code and hardware descriptions as described below. -2005 (commonly referred to as "SystemC").

[0079] As used above, the term code includes software, firmware, and / or It can contain microcode, programs, routines, functions, classes, data structures, and The term shared processor circuit may refer to multiple processors and / or objects. The system contains a single processor circuit that executes some or all of the code from the controller. The term group processor circuit refers to one or more processor circuits in combination with additional processor circuits. The controller includes a processor circuit that executes some or all of the code from the controller. References to multiple processor circuits include multiple processor circuits on separate dies, multiple processor circuits on a single die, Multiple processor circuits, multiple cores of a single processor circuit, The term shared memory circuit includes multiple threads, or a combination of the above. a single memory circuit that stores some or all of the code from the controller The term group memory circuit refers to a circuit that contains one or more controllers in combination with additional memory. The code includes a memory circuit that stores some or all of the codes from the controller.

[0080] The term memory circuit is a subset of the term computer-readable medium. The term computer-readable medium, as used herein, refers to a medium (such as a carrier wave) that transmits data. It does not encompass transient electrical or electromagnetic signals propagated by a computer. The term computer-readable medium may be considered tangible and non-transitory. Non-limiting examples of such memory circuits include non-volatile memory circuits (flash memory circuits, erasable programmable memory circuits, volatile memory circuits, (Static random access memory circuit or dynamic random access memory circuit magnetic storage media (analog or digital magnetic tape or hard disk drive) disks, and optical storage media (such as CDs, DVDs, or Blu-ray discs).

[0081] The apparatus and methods described in this application may include one or more computer programs embodied in the Dedicated software created by configuring a general-purpose computer to perform a specific function The above-described functional blocks and functions may be implemented in part or entirely by a computer. The flow chart elements act as software specifications and are designed to allow the skilled engineer or programmer to It can be converted into a computer program by a programming operation.

[0082] The computer program is stored on at least one non-transitory computer-readable medium. A computer program may also include stored data. A computer program may include or depend on a dedicated computer hardware. Basic Input / Output System (BIOS) that interacts with the hardware, specific device device drivers, one or more operating systems, and user applications that interact with the This includes applications, background services, background applications, etc. It is possible.

[0083] As a computer program, (i) HTML (HyperText Markup Language ), XML (Extensible Markup Language), or JSON (JavaScript Object Notation) (ii) assembly code; (iii) a compiler (iv) execution by an interpreter; (v) compilation and execution by a just-in-time compiler; By way of example only, the source code may be in C, C++, etc. , C#, Objective C, Swift, Haskell, Go, SQL, R, L isp, Java(TM), Fortran, Perl, Pascal, Curl, OC aml, JavaScript (trademark), HTML5 (Hypertext Markup Language) 5th revision), Ada, ASP (Active Server Pages), PHP (Hyp ertext Preprocessor), Scala, Eiffel, Smalltalk, Erlan g, Ruby, Flash (trademark), Visual Basic (trademark), Lua, MA Uses syntax from languages ​​including TLAB, SENSORLINK, and Python™ It can be described using

Claims

1. a reference device defining at least one reference axis and including one or more radiopaque markers; a reference configured to have a fixed orientation relative to the surgical implant; The device, When placed on the reference device, the device has a fixed orientation relative to the reference device. and generating a first signal relating to orientation data of the reference device relative to a first coordinate system. a first sensor configured to: a surgical instrument coupled to the end effector; a second coordinate system configured to have a fixed orientation relative to the surgical instrument; and at least one of the end effector and the surgical instrument. a second sensor configured to generate a second signal corresponding to the second sensor; (i) the first signal; (ii) the second signal; and (iii) the reference device and the patient's and receiving an image of the bone, displaying the image of the reference device and the bone of the patient, and a desired position of at least one of the end effector and the surgical instrument relative to the receiving associated user input; and (i) determining whether or not the surgical instrument and the end effector are the first coordinate system when at least one axis is aligned with the at least one reference axis; (ii) aligning the bone to the second coordinate system; and (iii) and (iii) aligning the orientation of at least one reference axis based on the user input. , the position of at least one of the end effector and the surgical instrument relative to the bone. and aligning the position of the bone based on the first signal and the second signal. determining an orientation of at least one of an end effector and the surgical instrument; The aligned position and position of at least one of the do-effector and the surgical instrument. and based on the determined orientation, determining at least one of the end effector and the surgical instrument. a navigation system configured to superimpose at least one virtual representation onto the image; system and 1. A surgical system for performing surgery on a patient's bone, comprising:

2. 10. The method of claim 1, wherein the second sensor is configured to be disposed on the surgical instrument. A surgical system as described in claim 1.

3. the image includes shadows of the one or more radiopaque markers; The navigation system detects the shadow pose of the one or more radiopaque markers. and aligning the orientation of the first sensor with respect to the bone in the image coordinate system based on the The surgical system of claim 1 or 2, configured to:

4. The surgical implant further comprises one or more openings. The surgical system according to any one of claims 1 to 3, wherein the surgical system is a bone plate including:

5. Further comprising a fixing member, the datum includes a linkage; The first portion of the fixation member is configured to fix the surgical implant to the bone. and another portion of the fixed member is configured to be coupled to the coupling portion of the datum device. The surgical system of claim 4 .

6. the image includes one or more shadows of the one or more openings; The user input is in front of the one or more openings corresponding to the desired location in the xy plane. a first selection of a desired position in a plane containing the z-axis; and a second selection of a desired position in a plane containing the z-axis.

6. A surgical system according to claim 4 or 5.

7. further comprising a first end effector and a second end effector; The end effector is further defined as the first end effector; When coupled to the first end effector, the surgical instrument performs a first function. It is configured to The surgical instrument is coupled to the second end effector to perform a second function. It is designed to be 7. The method according to claim 1, wherein the first function and the second function are different functions. Item 14. A surgical system as described in item 14.

8. The first sensor and the second sensor are gyroscopes. A surgical system according to any one of claims 1 to 4.

9. The end effector further includes a reference device that defines the at least one reference axis. The surgical system of any one of claims 1 to 8, comprising a surface defining a

10. The method of claim 9 , wherein the end effector is configured to be inserted into the surface. Surgical systems.

11. 10. The method of claim 9, wherein the end effector is coupled to the surgical instrument in a fixed orientation.

11. The surgical system according to claim 10.

12. The surgical system of claim 9 , wherein the surface is a cannula.

13. The one or more radiopaque markers are positioned on the at least one reference axis. The surgical system according to any one of claims 9 to 12, wherein

14. the end effector is a drill bit; The surgical instrument generates a third signal related to the displacement of the drill bit during the drilling process. a depth sensor configured to provide the navigation system is configured to receive the third signal, and the virtual The representation according to any one of claims 9 to 13, wherein the representation is further based on the third signal. surgical system.

15. a depth measurement attachment configured to be attached to the surgical instrument; The depth measurement attachment is related to the displacement of the end effector during the drilling process. a depth sensor configured to provide a third signal corresponding to the depth of said at least one reference device; a depth measuring attachment configured to define at least one reference axis and to be inserted into the depth measuring attachment; a post for receiving the second sensor, the second sensor being disposed within the depth measurement attachment; The surgical system according to any one of claims 1 to 13,

16. further comprising an apparatus configured to be attached to the imaging system; The navigation system is configured to: determining a magnification of the image based on at least one of the radiopaque markers; It is configured to the navigation system is configured to receive the third signal, and the virtual The surgical system of claim 15 , wherein the representation is further based on the magnification.

17. The device is a FluoroDisc, and includes a transparent lens and a and a plurality of fiducial markers for attaching the FluoroDisc to the imaging system. and a mounting member configured to:

18. 1. A method of performing surgery on a bone of a patient using a surgical system, the surgical system comprising: a navigation system, a surgical instrument, and a surgical instrument, the system defining at least one reference axis and one or more a reference device including a radiopaque marker; and a first coordinate system fixed relative to the reference device. a first sensor having a fixed orientation, the datum being relative to the surgical implant; The surgical instrument is configured to have a fixed orientation relative to a second coordinate system. a second sensor having a fixed orientation relative to the surgical instrument; The instrument is configured to be coupled to the end effector; (i) a first signal relating to orientation data of the reference device from the first sensor; i) detecting at least one of the end effector and the surgical instrument from the second sensor; (iii) a second signal relating to another orientation data of the reference device and the patient; receiving an image of the bone; displaying the image of the fiducial and the bone of the patient; Positioning of at least one of the end effector and the surgical instrument relative to the bone. receiving a user input on a display relating to a desired location; (i) the axis of at least one of the surgical instrument and the end effector is and aligning the first coordinate system with the second coordinate system when aligned with at least one reference axis. (ii) adjusting the end effector and the bone based on the user input. aligning the position of at least one of the surgical instruments; based on the first signal and the second signal, and determining an orientation of at least one of the surgical instruments; The aligned position of at least one of the end effector and the surgical instrument. and adjusting the end effector and the surgical instrument based on the determined position and the determined orientation. overlaying a virtual representation of at least one of the following on the image: The method comprising:

19. At least one of the end effector and the surgical instrument is positioned relative to the reference device. aligning with a surface; The at least one of the end effector and the surgical instrument is aligning the first coordinate system with the second coordinate system when aligned with the surface of Steps and 20. The method of claim 18, further comprising:

20. the image includes shadows of the one or more radiopaque markers; based on the position of the shadow of the one or more radiopaque markers, 10. The method of claim 1, further comprising the step of: aligning the orientation of the first sensor with respect to the bone. 8 or 19.

21. Claims 18-20, further comprising coupling the datum to the surgical implant.

10. The method according to any one of the preceding claims.

22. The surgical system further includes the surgical implant having one or more openings. 、 the image includes a shadow of the one or more openings; The user input is in front of the one or more openings corresponding to the desired location in the xy plane. a first selection of a desired position in a plane containing the z-axis; and a second selection of a desired position in a plane containing the z-axis. The method according to any one of claims 18 to 21.

23. The surgical system includes a second end effector, the second end effector Further defining a first end effector; coupling the first end effector to the surgical instrument to perform a first function; and coupling the second end effector to the surgical instrument to perform a second function; Steps and The method of any one of claims 18 to 22, further comprising:

24. The surgical system includes a depth measurement adapter configured to be attached to the surgical instrument. The endoscope further includes a depth measurement attachment for measuring the depth of the endoscope during the drilling process. a depth sensor configured to provide a third signal related to the displacement of the effector; The reference device includes a post defining the at least one reference axis, the post being attached to the By inserting the depth measurement attachment into the The method according to any one of claims 18 to 23, further comprising the step of connecting the How to do it.

25. a reference device defining at least one reference axis and including one or more radiopaque markers; a datum configured to be placed on a patient; A surgical instrument including a sensor coupled to an end effector, the sensor comprising: a first and configured to generate a first signal relating to orientation data of the surgical instrument relative to a coordinate system of a surgical instrument, receiving an image of the reference device and the patient's bone; displaying the image; and (i) determining the at least one reference relative to the bone in an image coordinate system. and (ii) aligning the first coordinate system with the image coordinate system. determining an orientation of the surgical instrument relative to the bone based on the first signal; and positioning the surgical instrument relative to the bone based on the determined orientation and position of the surgical instrument. A surgical navigation system that is configured to overlay imaginary expressions.

1. A surgical system for performing surgery on a patient's bone, comprising:

26. The position of the surgical instrument is determined based on user input to the surgical navigation system.

26. The surgical system of claim 25, wherein the distance is determined by:

27. The first coordinate system is a coordinate system of at least one of the surgical instrument and the end effector. When one axis is aligned with the at least one reference axis, the image coordinate system is aligned.

27. The surgical system of claim 25 or 26.

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