Instrument Calibration

Abstract

The present invention provides surgical instrument calibration methods, systems and devices that allow a virtual representation of a surgical instrument to be modified to adjust for any changes in the distal tip of the surgical instrument. For example, an instrument calibration system is provided that may have a surgical instrument, a calibration instrument and a monitoring system. The surgical instrument may have a distal tip and an orientation element located on the surgical instrument, and the calibration instrument may have a pivot point located thereon and a calibration reference element attached to the calibration instrument. The monitoring system may be configured to record the movement of the surgical instrument relative to the calibration instrument when the tip of the surgical instrument is inserted into the pivot point of the calibration instrument, and to calculate the deviation of the tip of the surgical instrument from a predefined ideal tip based on the recorded movement.

Description

Technical Field

[0001] Surgical devices, systems, and methods for performing instrument calibration on surgical instruments are provided. Background Art

[0002] Computer and / or robotic assisted surgery achieves more successful surgical outcomes by providing surgeons with a variety of benefits, such as improved visualization, guidance, better instrument control during surgery, etc. For computer and / or robotic systems that provide assistance, navigation systems are used to track the movement of surgical instruments during the procedure and provide a virtual representation of the instrument relative to the patient scan. Accurately tracking the movement of the instrument and accurately representing the instrument in various virtual representations is critical to patient safety. As such, each instrument must be calibrated prior to use to ensure accurate measurements and accurate virtual representations. However, current approaches present challenges, such as accurately modeling the instrument.

[0003] Therefore, there is a need for improved instrument calibration techniques. Summary of the invention

[0004] The methods, devices and systems provided herein allow for calibration of an instrument so that a virtual representation of the instrument can be updated to accommodate any warping or bending that may occur at the distal tip over time, such as in an instrument having a curved distal tip. In one aspect, a surgical instrument having an elongated shaft with a proximal end and a distal end is provided for an instrument calibration system. The distal end has a distal-most tip, and the proximal end has an orientation element fixed in an initial position. The system also has a calibration instrument having a point configured to receive the distal-most tip of the surgical instrument so as to pivot around it. The calibration instrument also has a predefined geometric structure and a calibration reference element attached to the calibration instrument. The system also has a monitoring system configured to record the movement of the surgical instrument by recording the position of the orientation element relative to the calibration reference element when the distal-most tip of the surgical instrument is positioned at the pivot point of the calibration instrument. The monitoring system is configured to calculate a deviation of the distalmost tip of the surgical instrument from a predefined ideal distalmost tip based on recorded movement of an orientation element of the surgical instrument, a predefined ideal instrument axis of the surgical instrument, and a predefined ideal distalmost tip of the surgical instrument, and the monitoring system is configured to modify a virtual representation of the surgical instrument on a display based on the calculated deviation.

[0005] The system may have a variety of variations. For example, the distal end of the surgical instrument may be a curved tip. In another example, the distal end of the surgical instrument may have a cavity formed therein. In one example, the monitoring system may be configured to determine an initial orientation of an orientation element relative to the surgical instrument while the orientation element remains in a fixed position relative to the surgical instrument. In another example, the monitoring system may be configured to determine the actual orientation of the surgical instrument in use while the orientation element on the proximal end of the surgical instrument moves to one of a plurality of second positions different from the initial position on the surgical instrument, without requiring re-recording the movement of the surgical instrument relative to the calibration instrument.

[0006] In yet another example, the pivot point on the calibration instrument can include a plurality of removable and replaceable pivot points, and each of the plurality of removable and replaceable pivot points can be configured to correspond to one of a plurality of different distal-most tips of a plurality of different surgical instruments. The monitoring system can also be configured to be updated based on which of the plurality of removable and replaceable pivot points is used.

[0007] In some embodiments, each of the orientation element and the calibration reference element may include an array having a plurality of trackable targets thereon, one of an electromagnetic sensor and a gyroscope. The monitoring system may also include at least one camera, at least one sensor, at least one processor, and at least one display. In some embodiments, the monitoring system may be part of a robotic surgical system, and the surgical instrument may be configured to be controlled by the robotic surgical system. Exemplary surgical instruments include, for example, screwdrivers and discectomy devices. In another embodiment, the orientation element may be configured to rotate around the surgical instrument at a plurality of known orientations, and the monitoring system may be configured to update the virtual representation of the surgical instrument on the display based on each of the plurality of known orientations of the orientation element, without re-recording the position of the orientation element relative to the calibration reference element at each of the plurality of known orientations.

[0008] In another aspect, a method for calibrating a surgical instrument used during surgical navigation is provided, the method comprising inserting a distal-most tip on a distal end of a surgical instrument into a pivot point on a calibration instrument, the calibration instrument having a predefined geometry and a calibration reference element attached to the calibration instrument. The method also comprises pivoting the surgical instrument about the pivot point so that the proximal end of the surgical instrument moves along a generally circular path above the calibration instrument, while a monitoring system records reference coordinate points of an orientation element fixed at a first position on the surgical instrument relative to reference coordinate points of a calibration reference element on the calibration instrument. The method also comprises comparing, by the monitoring system, the recorded reference coordinate points with at least one stored reference coordinate point of an orientation element on a predefined ideal surgical instrument to calculate a deviation of the distal-most tip of the surgical instrument from the predefined ideal distal-most tip based on the comparison. After determining the deviation of the distal-most tip, the monitoring system modifies a virtual representation of the surgical instrument on a display based on the calculated deviation.

[0009] The method may have many variations. For example, the method may include determining, by a monitoring system, an initial orientation of the orientation element relative to the surgical instrument while the orientation element remains in a fixed position relative to the surgical instrument.

[0010] In another embodiment, the pivot point may be formed on a removable portion of the calibration instrument, and the method may include replacing the removable portion of the calibration instrument with a second removable portion having a second pivot point, the second pivot point having a different shape configured to match the distal-most tip of the surgical instrument. In some embodiments, the method may include updating the monitoring system based on the second pivot point.

[0011] In other aspects, the method may include rotating an orientation element of the surgical instrument to a different known orientation after modifying the virtual representation of the surgical instrument based on the calculated deviation, and modifying, by the monitoring system, the virtual representation of the surgical instrument on the display based on the different known orientation of the orientation element.

[0012] In another aspect, a method for calibrating a surgical instrument having a distal-most tip is provided, the method comprising recording, by a monitoring system, movement of an orientation element at an initial position on the surgical instrument relative to a calibration reference element on the calibration instrument. The method also comprises calculating, by a processor operatively connected to the monitoring system, a deviation of the distal-most tip of the surgical instrument from a predefined virtual representation of the distal-most tip of the surgical instrument by comparing the recorded movement of the orientation element of the surgical instrument with the expected movement of the orientation element. The predefined virtual representation of the distal-most tip of the surgical instrument comprises a plurality of data points stored in a memory accessible by the processor, the data points defining a representation of the surgical instrument. The method also comprises updating, by the processor, one or more first data points of the plurality of data points of the predefined virtual representation of the distal-most tip of the surgical instrument stored in the memory based on the calculated deviation of the distal-most tip.

[0013] The method may have many variations. For example, the method may include controlling, by a processor, a surgical display so as to display one or more updated first data points of a predefined virtual representation of the distal-most tip of the surgical instrument. In another example, the method may include, after updating the one or more first data points, when an orientation element on the surgical instrument moves to a second position different from an initial position on the surgical instrument, determining, by the processor, the orientation of the surgical instrument during use without re-recording the movement of the surgical instrument relative to the calibration instrument. In one such example, the method may also include updating, by the processor, one or more second data points of a plurality of data points of a predefined virtual representation of the distal-most tip of the surgical instrument stored in a memory based on the second position of the orientation element. BRIEF DESCRIPTION OF THE DRAWINGS

[0014] The above embodiments will be more fully understood through the following detailed description in conjunction with the accompanying drawings. The accompanying drawings are not intended to be drawn to scale. For the sake of clarity, not every element in every drawing is labeled. In the drawings:

[0015] Figure 1 is a perspective view of one embodiment of a calibration apparatus;

[0016] Figure 2A for Figure 1 A cross-sectional side view of a pivot point in a calibration apparatus;

[0017] Figure 2B For similar Figure 1 A cross-sectional side view of a pivot point in another embodiment of a calibration apparatus of the calibration apparatus;

[0018] Figure 3 is a perspective view of one embodiment of a surgical instrument;

[0019] Figure 4 for Figure 3 A perspective view of a surgical instrument;

[0020] Figure 5 A top view of a patient and an embodiment of a monitoring system;

[0021] Figure 6 is a diagram illustrating one embodiment of a control system architecture;

[0022] Figure 7 Shows Figure 3 Surgical instruments relative to Figure 1 A flow chart of one embodiment of a calibration process for rotating and / or pivoting a calibration apparatus;

[0023] Figure 8 Shows Figure 3 Another flow chart of a calibration process for an instrument;

[0024] Fig. 9 for Figure 3 Surgical instruments and Figure 1 A perspective view of the interaction of calibration instruments;

[0025] Fig.10 for Figure 7 and Figure 8 perspective of the calibration process, where Figure 3 Surgical instruments relative to Figure 1 The calibration instrument rotates;

[0026] Fig.11 for Fig.10 A perspective view of the continuous rotation of surgical instruments and calibration instruments in FIG.

[0027] Fig.12 for Fig.11 A perspective view of the continuous rotation of surgical instruments and calibration instruments in FIG.

[0028] Fig.13A is an image of a graphical interface showing Figure 3 Virtual sphere fitting of a predefined or ideal form of the instrument;

[0029] Fig. 13B An image of a graphical interface showing the Figures 10 to 12 The virtual tracking point created by the rotation of

[0030] Fig. 13C An image of a graphical interface showing the Fig. 13B Tracking point Figure 3 A virtual instrument axis of an instrument;

[0031] Fig.13D is an image of a graphical interface showing Fig. 13BVirtual sphere fitting of the tracking points;

[0032] Fig.13E An image of a graphical interface showing the mapping or transposition to Fig.13A On the virtual sphere Fig.13D A virtual sphere;

[0033] Fig.14 is a perspective view of another embodiment of a surgical instrument;

[0034] Fig.15 for Fig.14 A perspective view of an orientation arm of a surgical instrument;

[0035] Fig.16 for Fig.14 A perspective view of a ring coupling of a surgical instrument;

[0036] Fig.17A for Fig.14 A perspective view of a surgical instrument in use;

[0037] Fig. 17B for Fig.14 A perspective view of a surgical instrument in use;

[0038] Fig.18 is a side view of another embodiment of a surgical instrument;

[0039] Fig.19 for Fig.18 a side view of a distal end of a surgical instrument with another embodiment of a calibration instrument; and

[0040] Fig. 20 for Fig.18 A side view of the distal end of a surgical instrument with Fig.19 Calibration equipment. DETAILED DESCRIPTION

[0041] Certain exemplary embodiments will now be described to provide a comprehensive understanding of the principles of the structure, function, manufacture and use of the apparatus and methods disclosed herein. One or more examples of these embodiments are shown in the accompanying drawings. Those skilled in the art will appreciate that the apparatus and methods specifically described herein and shown in the accompanying drawings are non-restrictive exemplary embodiments, and the scope of the present disclosure is limited only by the claims. The features shown or described in conjunction with an exemplary embodiment may be combined with the features of other embodiments. Such modifications and variations are intended to be included within the scope of the present invention.

[0042] In addition, in the present disclosure, components with similar names in various embodiments generally have similar features, so in a specific embodiment, each feature of each component with similar names may not necessarily be fully set forth. In addition, to the extent that linear or circular dimensions are used in the description of the disclosed systems, devices, and methods, such dimensions are not intended to limit the types of shapes that can be used in conjunction with such systems, devices, and methods. Those skilled in the art will recognize that equivalent dimensions of such linear and circular dimensions can be easily determined for any geometric shape. The size and shape of the systems and devices and their components may depend at least on the anatomy of the subject in which the systems and devices will be used, the size and shape of the components with which the systems and devices will be used, and the methods and surgeries in which the systems and devices will be used.

[0043] Various exemplary methods, devices and systems for performing instrument calibration on surgical instruments with curved distal tips are provided. During computer and / or robot-assisted surgery, in order for the computer or robot system to correctly assess the current position of the instrument and correctly provide assistance, guidance, etc. to the surgeon, an accurate virtual representation of any instrument used during surgery is required. Since the actual distal tip on the corresponding surgical instrument bends or warps over time, the virtual representation of the instrument with a curved distal tip may become inaccurate, and updating the virtual representation of the instrument with a curved distal tip so that it accurately reflects the current distal tip geometry of the instrument can achieve better surgical results. For example, the virtual representation used by the computer or robot system can accurately reflect the instrument used in the surgery, rather than the system having to assume that the distal tip is in an ideal state. In addition, it can reduce waste by not having to discard any surgical instrument that simply cannot be calibrated because the curved distal tip is not in a perfect or near-perfect state, where the instrument would have been surgically acceptable. Thus, the methods, devices, and systems provided herein can be used to accurately calibrate instruments having curved tips such that a computer or robotic system can determine the accurate distal tip geometry and measurements of the instrument, even after repeated use, and accurately update a virtual representation of the instrument.

[0044] Instrument calibration can be performed on a surgical instrument having a curved distal tip using a navigation array fixed to the surgical instrument in a first orientation. In certain embodiments, the navigation array can be rotated and / or moved to one or more different orientations on the surgical instrument during use to ensure that the surgical instrument can be continuously tracked by a computer or robotic system without the need to recalibrate the surgical instrument each time the orientation of the navigation array is changed. This movement allows the surgeon to more flexibly rotate or manipulate the surgical instrument during use while saving time and still ensuring that the instrument is tracked by the system.

[0045] An exemplary instrument calibration system may include a surgical instrument having an elongated shaft having a curved distal tip and an orientation array located thereon. A calibration instrument having a predefined geometry and a calibration reference array attached thereto may also be provided. A pivot point may be formed in a calibration instrument configured to receive the curved distal tip of the calibration instrument. A monitoring system may also be provided, the monitoring system being configured to record the coordinates of the surgical instrument when the curved distal tip of the surgical instrument is inserted into the pivot point of the calibration instrument and the instrument rotates around the pivot point. Based on the recorded coordinates, the monitoring system may be configured to calculate the deviation of the curved distal tip of the surgical instrument from the predefined ideal curved tip and modify the virtual representation of the surgical instrument on the display based on the calculated deviation, so that the virtual representation accurately mirrors the actual curved distal tip of the instrument, wherein any bend or deviation is reflected. The virtual representation may include various different information and / or data representing the parts of the instruments and systems described herein. For example, the virtual representation may include a plurality of data points defining and / or representing the shape, orientation, position, etc. of various components of the system described herein.

[0046] Figure 1 An exemplary embodiment of a calibration instrument 100 is shown, which has a pivot point 110 formed therein and has a calibration reference array 120 attached thereto. The calibration instrument 100 is configured to allow a surgical instrument 200 having a curved distal tip 210 to be calibrated by a monitoring system 300, as will be described in detail below. The calibration instrument 100 has a predefined side and shape known to the monitoring system 300, and the pivot point 110 is formed in one side 102 thereof.

[0047] The pivot point 110 is configured to receive a curved distal tip 210 of the surgical instrument 200 therein. The size and shape of the pivot point 110 can be set to complement the curved distal tip 210 and provide a relatively secure hold on the distal-most end 212 of the curved distal tip 210 to prevent the distal tip 210 from sliding in the pivot point 110. At the same time, the pivot point 110 provides a fixed point about which the surgical instrument 200 can be smoothly rotated or pivoted, as described in detail below. Therefore, the pivot point 110 can be specifically configured to receive the distal tips of certain instruments or groups of instruments, and the dimensions of the pivot point 110 (such as the depth of the cavity, the diameter of the circular opening on one side 102, the angle of the side wall of the cavity, etc.) can vary. For example, the pivot point 110 can be such as Figure 2AThe cavity shown is in the shape of an inverted cone for receiving a tapered or more rounded tip. However, different embodiments may have pivot points of different shapes, depending on the type of distal end to be received therein, such as cavities in the shape of an inverted cylinder, a sphere, a pyramid, a prism, etc. Although the pivot point 110 is formed in one side 102 of the calibration instrument 100, in other embodiments it may be formed in various other locations on the calibration instrument 100. Additionally, in some embodiments, the pivot point 110 may be removable and replaceable to allow different pivot points to be configured to receive different types of distal tips to be inserted and used during calibration of different types of instruments. For example, Figure 2B A removable pivot point mechanism 152 is shown that is insertable into and removable from a calibration instrument 150 similar to calibration instrument 100, and may be secured in place in a variety of different ways, such as by clamping, engagement, friction, and the like.

[0048] The calibration instrument 100 also has a calibration reference array 120 attached thereto that is configured to be tracked by the monitoring system 300. The calibration reference array 120 has a predefined arrangement known to the monitoring system 300 so that it can provide the monitoring system 300 with a predefined 3-dimensional calibration coordinate system 130 during calibration. For example, as the surgical instrument 200 is calibrated by pivoting the surgical instrument 200 relative to the pivot point 110, the calibration reference array 120 is configured to allow the monitoring system 300 to capture an image containing the calibration reference array 120. Because the dimensional arrangement and orientation of the calibration reference array 120 relative to itself and the calibration instrument 100 are predefined and known to the monitoring system 300, the calibration reference array 120 allows the monitoring system 300 to use the calibration reference array 120 as a reference scale in each image to determine various orientations and measurements of other objects in the image based on the position and visibility of the calibration reference array 120 in each image. This allows the monitoring system 300 to effectively place other objects in the image to scale within the context of the calibration coordinate system 130.

[0049] The illustrated calibration reference array 120 has three targets 122a, 122b, 122c thereon which can be imaged and tracked by the monitoring system 300 to provide a calibration coordinate system 130 to the monitoring system 300 and / or the control system 400. The targets 122a, 122b, 122c are arranged in a generally triangular configuration in a single plane parallel to and extending above the upper surface 104 of the calibration instrument 100. The targets 122a, 122b are arranged on wings 124, 126 which extend laterally away from each other on the upper surface 104 of the calibration instrument 100. The calibration instrument 100 can be tilted to one side to rest on the wings 126 and hold the calibration instrument 100 at a defined and consistent angle. Thus, during calibration, the pivot point 110 is accessible so that the distal tip of the instrument 200 can be inserted therein, as shown. Figures 10 to 12 However, in other embodiments, the orientation and placement of one or more targets 122a, 122b, 122c may vary, such as being arranged in a flat square, rectangle, etc. or a 3-dimensional cube, pyramid, etc., and the wings 124, 126 may be placed elsewhere on the calibration instrument 100 or removed from the calibration instrument entirely. The calibration instrument 100 itself may also have various targets thereon, such as providing reference planes on one or more sides of the instrument 100, along its edges, etc. Although the calibration instrument 100 has Figure 1 Although the particular rectangular wing structure shown in FIG. 1 is shown in FIG. 5 , in other embodiments, the calibration instrument can be any three-dimensional structure having one or more calibration reference elements and one or more pivot points thereon.

[0050] While various tracking methods may be used, the targets 122a, 122b, 122c are configured to provide orientation, position, and scale information when captured in an image and based on their relative positions to each other in the image. For example, if the image captures the targets 122a, 122b, 122c all in a triangular orientation and visible by looking down at the calibration apparatus 100, the calibration apparatus 100 is oriented such that the calibration reference array 120 is directly facing the monitoring system 300. If the targets 122a, 122b, 122c are captured such that all three targets are positioned along a common line, the calibration apparatus 100 is positioned such that the calibration reference array 120 is perpendicular to the monitoring system 300. Thus, as the calibration apparatus 100 is moved in three dimensions while the calibration reference array 120 is within the field of view of the monitoring system 300, the targets 122a, 122b, 122c allow the position, orientation, and scale of the calibration apparatus 100 within the image to be determined by mapping the known and predetermined coordinates of the targets 122a, 122b, 122c relative to each other to the actual coordinates of the targets 122a, 122b, 122c in the captured image. Thus, the virtual representation of the calibration apparatus 100 can be rotated and oriented so that the known and predefined orientation of the targets 122a, 122b, 122c on the virtual representation matches the actual imaged targets 122a, 122b, 122c. The virtual representation of the calibration apparatus can be a plurality of coordinates that define the shape of the calibration apparatus 100 and are stored in a memory, as described below. Because the calibration reference array 120 is attached to the calibration apparatus 100 in a known orientation and because the shape and size of the calibration apparatus 100 are known, the position and posture of the calibration apparatus can be accurately determined. Once the orientation of the calibration reference array 120 is determined, the relative distances between the objects 122a, 122b, 122c in the actual image can be used for scaling since the actual distances between the objects are known and predefined.

[0051] Although Figure 1Three targets 122a, 122b, 122c are shown in the form of spheres, but any number of targets may be used, and the targets may take a variety of different forms, such as flat images, grids, geometric shapes, patterns, various emitting elements, lights, etc. The targets 122a, 122b, 122c are constructed as passive targets, however, active targets may be used in some embodiments requiring one or more power sources such as light emitting diodes (LEDs), or a combination of active tracking and passive tracking may be used. In other embodiments, one or more different sensors may be used as reference elements to replace or assist one or more of the targets 122a, 122b, 122c or completely replace the calibration reference array 120, such as electromagnetic sensors, gyroscopes, various radio frequency identification (RFID) tags, or various transmission tags, etc. The calibration reference array 120 and the calibration device 100 may be made of a variety of different materials, such as medical grade metals, plastics, polymers, ceramics, etc.

[0052] As described above, pivot point 110 of calibration instrument 100 is configured to receive a tip on a surgical instrument to allow calibration of the surgical instrument. Figure 3 and Figure 4 One embodiment of a surgical instrument 200 is shown having an elongated shaft 204 extending from a handle 202 having a curved distal tip 210 on its distal end. The surgical instrument 200 may be calibrated so that an accurate virtual representation of at least the axis of the elongated shaft 204 and the curved distal tip 210 may be generated by the monitoring system 300. The virtual representation of the surgical instrument 200 may be a plurality of data points, such as coordinates, that help define the shape of the surgical instrument 200. The data points may be stored in a memory and updated in the memory based on the calculations described herein, as described in detail below.

[0053] The instrument 200 is configured to be calibrated by interaction with the calibration instrument 100 and the monitoring system 300. Calibration can be achieved by comparing the measured data with predetermined data based on a predefined or ideal instrument axis 250 and a predefined or ideal instrument tip 252. The predefined instrument axis 250 and the predefined instrument tip 252 may not necessarily reflect the current configuration of the elongated shaft 204 and the most distal end 212 of the instrument 200. Instead, they can be calculated based on the design and / or manufacturing parameters of the instrument. For example, the predetermined data can be in the form of one or more coordinates representing the ideal position of one or more reference arrays on an ideal instrument. The coordinate representation, referred to as the predetermined instrument coordinates, can be provided to the monitoring system 300 to generate initial or expected data for an initial or expected virtual representation of the instrument 200. The initial or expected virtual representation can be used to calibrate newly manufactured instruments and / or used instruments. The predefined instrument axis 250 and the predefined instrument tip 252 can be specific to the type of instrument, and the values ​​can be different when different instruments are used in other embodiments. While data representing the predefined instrument axis 250 and the predefined instrument tip 252 is provided to the monitoring system, various other data may also be provided in some embodiments, such as instrument type, number of uses, etc.

[0054] As a non-limiting example, the illustrated surgical instrument 200 is a DePuy Synthes Concorde Clear minimally invasive discectomy device, however various instruments configured for both minimally invasive surgical procedures or more traditional surgical procedures may be used. The surgical instrument 200 may be made of a variety of different materials, such as medical grade metals, plastics, polymers, ceramics, etc. Although the illustrated instrument 200 has a curved distal tip 210, instruments with straight distal tips may be used in other embodiments, such as instruments with sharp or pointed distal tips, screwdrivers, etc.

[0055] Similar to the calibration instrument 100, the surgical instrument 200 also has an orientation array 220 attached thereto, which can be tracked by the monitoring system 300 and has a predefined arrangement known to the monitoring system 300 so that it can provide predefined instrument coordinates within a predefined 3-dimensional instrument coordinate system 230 to the monitoring system 300 during calibration.

[0056] As the instrument 200 is calibrated by pivoting in the pivot point 110, the orientation array 220 allows the monitoring system 300 to capture images containing the orientation array 220. Because the dimensional arrangement and orientation of the orientation array 220 are predefined and known to the monitoring system 300, the orientation array 220 allows the monitoring system 300 to use the orientation array 220 as a reference scale in each image to determine various orientations and measurements of other objects in the image, such as the surgical instrument 200, based on the position and visibility of the orientation array 220 in each image. Thus, the monitoring system 300 can effectively place other objects in the image to scale within the context of the instrument coordinate system 230.

[0057] Similar to the calibration reference array 120, in the illustrated embodiment, the orientation array 220 has three targets 222a, 222b, 222c thereon that can be imaged and tracked by the monitoring system 300 to provide an instrument coordinate system 230 in a manner similar to the targets 122a, 122b, 122c of the calibration instrument 100 described above. The targets 222a, 222b, 222c are arranged in a generally triangular arrangement with respect to one another in a single plane extending parallel to and offset from the longitudinal axis of the surgical instrument 200. The orientation array 220 is coupled to the surgical instrument 200 in a known and predefined orientation via an orientation arm 224 having a predefined length and an orientation ring 226, however the orientation array 220 can be coupled to the instrument 200 in a variety of different ways.

[0058] Using the same imaging method as the calibration reference array 120, the surgical instrument 200 is moved in three dimensions while the orientation array 220 is within the line of sight of the monitoring system 300. Thus, by mapping the actual imaging coordinates of the targets 222a, 222b, 222c in the captured image, the targets 222a, 222b, 222c allow the position, orientation, and scale of the surgical instrument 200 to be determined within the image. The mapped coordinates of the targets 222a, 222b, 222c on the instrument 200 are referred to herein as measured instrument coordinates, which can be compared to the predetermined instrument coordinates calculated based on the ideal instrument. The monitoring system 300 can use these coordinates to generate a virtual representation of the surgical instrument 200, so that the measured instrument coordinates of the targets 222a, 222b, 222c on the virtual representation are superimposed on the predetermined instrument coordinates of the actual imaging targets 222a, 222b, 222c. Because the orientation array 220 is attached to the surgical instrument 200 in a known orientation and because the shape and size of the surgical instrument 200 are known, the position and pose of the surgical instrument 200 having the curved distal tip 210 can then be determined. Once the orientation of the orientation array 220 is determined, the distance between the objects 222a, 222b, 222c in the actual image can be used for scaling because the actual distance between the objects is known and predefined.

[0059] Figure 3 and Figure 4 Three targets 222a, 222b, 222c are shown in FIG, and the targets 222a, 222b, 222c are in the form of spheres. However, any number of targets may be used, and the targets may take a variety of different forms, such as flat images, grids, geometric shapes, patterns, various emitting elements, lights, etc. The targets 222a, 222b, 222c may be passive targets, however, active targets may be used in some embodiments requiring one or more power sources such as light emitting diodes (LEDs), or a combination of active tracking and passive tracking may be used. In other embodiments, one or more different sensors may be used as orientation elements to replace or assist one or more of the targets 222a, 222b, 222c or completely replace the orientation array 220, such as electromagnetic sensors, gyroscopes, various radio frequency identification (RFID) tags, or various transmission tags, etc. The orientation array 220 may be made of a variety of different materials, such as medical grade metals, plastics, polymers, ceramics, etc.

[0060] As described above, the calibration instrument 100 and / or the surgical instrument 200 may be monitored by a monitoring system such as Figure 5 , and the monitoring system 300 shown in . Specifically, the monitoring system 300 is configured to track the orientation and position of the configuration reference array 120 and the orientation array 220 relative to the monitoring system 300 during calibration of the surgical instrument 200, and the monitoring system can be configured to track the surgical instrument 200 during use. For example, the monitoring system is configured to track the targets 122a, 122b, 122c of the calibration instrument 100 and the targets 222a, 222b, 222c of the surgical instrument 200, as described in detail above, and the monitoring system can be configured to record the movement of the surgical instrument 200 when the curved distal tip 210 of the surgical instrument 200 is inserted into and rotated about the pivot point 110 of the calibration instrument 100, as described in detail below. Based on the recorded movement, such as the recorded coordinates, the monitoring system 300 can be configured to calculate the deviation of the curved distal tip 210 of the surgical instrument 200 from the predefined instrument tip 252. Thus, the monitoring system 300 may modify the virtual representation of the surgical instrument 200 on the surgical display based on the calculated deviation, such as in Figure 5 10 is a surgical instrument 200 to be used during a surgical procedure on a patient 10 in the embodiment of the present invention, such that the virtual representation accurately mirrors the actual curved distal tip 210 of the instrument 200, with any bends or deviations being reflected. As described in detail below, this can be achieved in part by translating the measured instrument coordinates and the predetermined instrument coordinates in the coordinate system 230 to the coordinate system 130.

[0061] The monitoring system 300 can have various configurations and can include various components, such as navigation cameras for surgical procedures. Depending on the type of target used, the monitoring system 300 can be configured to directly visualize the surgical space through one or more cameras, and the monitoring system 300 can use active tracking, passive tracking, or some combination. The monitoring system can also be part of a robotic surgical system, part of a computer-assisted surgical system, or a stand-alone device.

[0062] The control system 400 or processor is configured to assist in calculating the orientation and position of the arrays 120, 220 relative to the monitoring system 300 based on the data collected by the monitoring system 300. The control system 400 can be configured to calculate the results in two ways, periodically at a single point in time or continuously over a period of time. The control system 400 can be part of the monitoring system 300, can be part of the robotic surgical system, can be a separate component, or can be some combination of the foregoing. In some embodiments, the control system can also communicate directly or indirectly with at least one of the monitoring system 300, the calibration instrument 100 and / or the array 120, the surgical instrument 200 and / or the array 220, or some combination of the foregoing and be connected wirelessly or by wire. Figure 6 A diagrammatic view of an exemplary device architecture for a control system 400 is shown.

[0063] like Figure 6 As shown, the control system 400 may include multiple components, including but not limited to an internal processor (e.g., a central processing unit (CPU) 410), a memory 420, a wired or wireless communication unit 430, one or more input units 440, and one or more output units 450. It should be noted that Figure 6 The architecture depicted in is simplified and is for demonstration purposes only. The architecture of the control system 400 may be modified in any suitable manner, as one of ordinary skill in the art would understand based on the claims. In addition, the components of the control system 400 themselves may be modified in any suitable manner, as one of ordinary skill in the art would understand based on the claims. Therefore, Figure 6 The device architecture depicted in the should be considered as exemplary only and should not be considered as limiting the scope of the present disclosure.

[0064] The internal processor 410 is capable of controlling the operation of the control system 400 and / or the monitoring system 300, depending on whether the control system 400 and the monitoring system 300 are combined or separate. More specifically, the processor 410 is operable to control and interact with a number of components associated with the control system 400, such as Figure 6As shown. For example, the memory 420 may store program instructions and data that can be executed by the internal processor 410. The process described herein may be stored in the memory 420 in the form of program instructions for execution by the internal processor 410. The communication unit 430 may allow the control system 400 to transmit data to one or more external devices via a communication network and receive data from one or more external devices. The input unit 440 may enable the control system 400 to receive various types of inputs, such as audio / visual input, user input, data input, etc. To this end, the input unit 440 may be composed of a plurality of input devices for accepting various types of inputs, including, for example, one or more cameras 442 (i.e., imaging devices), a touch panel 444, a microphone (not shown), a sensor 446, one or more buttons or switches (not shown), etc. The input device included in the input unit 440 may be manipulated by the user. It is worth noting that the term image acquisition unit as used herein may refer to the camera 442, but is not limited thereto. For example, the image acquisition unit may be the monitoring system 300 or a part thereof. The output unit 450 may display information on a display screen 452 for the user to view. The display screen 452 may also be configured to accept one or more inputs through various mechanisms known in the art, such as a user tapping or pressing the display screen 452, and the output unit 450 may also include a light source 454. In some embodiments, the output unit 450 may be configured to send any processing results to various systems, such as a robotic surgical system or a computer-assisted surgical system. The control system 400 and / or the monitoring system 300 may also be configured to calculate the orientation of the instrument, distance, translation of the coordinate system, etc. based on the information from the arrays 120, 220.

[0065] As described above, the interaction of the calibration instrument 100, the surgical instrument 200, the monitoring system 300, and the control system 400 may allow the monitoring system 300 and / or the control system 400 to calculate the deviation of the curved distal tip 210 of the surgical instrument 200 and modify the virtual representation of the surgical instrument 200 on the surgical display based on the calculated deviation. Figure 7 and Figure 8As shown in step 600 in , the monitoring system 300 and / or the control system 400 are initially provided with various known and predefined data as described above, such as: a virtual representation of the surgical instrument 200 having a predefined instrument axis 250, a predefined instrument tip 252, and information about the orientation and arrangement of the orientation array 220 on the surgical instrument 200, all of which can be represented by a plurality of data points (e.g., predetermined instrument coordinates) defining the shape and orientation of the surgical instrument having the predefined axis and tip; and a virtual representation of the calibration instrument 100 having a known shape and size and information about the orientation and arrangement of the calibration reference array 120 on the calibration instrument 100, which can be represented by a plurality of data points defining the shape and orientation of the calibration instrument. This information can be provided in various ways, such as manual input, automatic loading by, for example, scanning or imaging one or more of the instruments 100, 200 and / or arrays 120, 220, which can have identification information thereon, downloading to the system 300, etc. The monitoring system 300 is activated to begin tracking the calibration instrument 100 and the surgical instrument 200 at step 602, for example, each instrument 100, 200 and / or each array 120, 220 may be displayed to the monitoring system 300, or the monitoring system 300 may be manually instructed to initiate tracking.

[0066] For example, by Figures 10 to 12 The calibration instrument 100 is tilted at a limited angle as shown and the distal end 212 is inserted into the pivot point 110, and at steps 604 and Fig. 9 The curved distal tip 210 of the surgical instrument 200 is inserted into the pivot point 110 of the calibration instrument 100. The surgical instrument 200 is rotated in a generally circular motion over the calibration instrument, such as Figures 10 to 12 As shown, the monitoring system 300 records the movement of the orientation array 220 on the surgical instrument 200 relative to the fixed position of the calibration reference array 120 on the calibration instrument 100. As the surgical instrument 200 moves, the distal-most end 212 of the curved distal tip 210 remains in the cavity of the pivot point 110 because the size and shape of the pivot point 110 are set to fix the distal-most end 212 in the pivot point while allowing the surgical instrument 200 to rotate and pivot smoothly. Therefore, the pivot point 110 provides a fixed and known point about which the surgical instrument 200 can rotate. Therefore, when the surgical instrument 200 is in a plurality of different postures or positions at step 606, the monitoring system 300 captures images and records the coordinates of the orientation array 220. For example, Figures 10 to 12 An exemplary rotation of surgical instrument 200 is shown while monitoring system 300 captures various images of orientation array 220 relative to calibration reference array 120. As such, the rotation generally defines a circular shape 240 of movement over pivot point 110 corresponding to the path of motion of orientation array 220.

[0067] The monitoring system 300 and / or the control system 400 may use the captured movement (e.g., measured instrument coordinates) of the orientation array 220 relative to the fixed pivot point 110 and the calibration reference array 120 to update the virtual representation of the surgical instrument 200. The monitoring system 300 / control system 400 may do this by comparing the captured calibration movement (e.g., measured instrument coordinates) to the expected calibration movement (e.g., predetermined instrument coordinates) of a model of the surgical instrument 200 having a predefined instrument axis 250 and an ideal tip 252, as described in detail below.

[0068] Data representing a model of a surgical instrument 200 having a predefined instrument axis 250 and an ideal tip 252 may be initially provided to the monitoring system 300 and / or the control system 400. Expected calibration movement data (e.g., predetermined instrument coordinates) for the surgical instrument 200 having the predefined instrument axis 250 and the ideal tip 252 may also be provided to the monitoring system 300 / control system 400. However, in some embodiments, the monitoring system 300 / control system 400 may also use the predefined instrument axis 250 and ideal tip 252 data to model the expected behavior itself. For a new or ideal instrument, the calibration movement data is modeled based on a technical drawing of the instrument. Although in other embodiments, direct measurements and recordings may be made on an instrument that has never been used. The expected calibration movement data may be modeled by assuming that the ideal instrument is rotated in a manner similar to the instrument 200 about a fixed pivot point 256. Thus, as Fig.13A As shown, a moving circle 257 is defined above the fixed pivot point 256, which corresponds to the motion path of the orientation array if the orientation array is fixed to the ideal instrument. For example, multiple points 258 can represent multiple coordinates of the ideal orientation array during the calibration movement. The predefined instrument axis 250 defines the distance from the fixed pivot point 256 that the ideal orientation array will move, wherein each of the points 258 is positioned at a position at the same distance from the fixed pivot point 256. Therefore, the movement of the ideal surgical instrument around the fixed pivot point 256 in which the ideal tip 252 is inserted can define an ideal hemisphere 254, wherein the predefined instrument axis 250 serves as the radius of the ideal hemisphere 254, and the fixed pivot point 256 represents both the center of the ideal hemisphere 254 and the position of the distal-most tip of the ideal surgical instrument. Thus, ideal hemisphere 254 may represent calibration movement data (e.g., predetermined instrument coordinates) of an ideal surgical instrument having a predefined instrument axis 250 and an ideal tip 252, and the center of the ideal hemisphere may represent the location in 3-dimensional space of the distal-most end of ideal tip 252. While the steps for actually creating such a model are discussed above, in some embodiments, calibration movement data (e.g., predetermined instrument coordinates) may be initially provided such that extensive modeling of the ideal surgical instrument is not required.

[0069] Returning to surgical instrument 200, circular shape 240 of movement of surgical instrument 200 over pivot point 110 represents motion similar to circle 257 of movement over fixed pivot point 256, which defines an ideal or predefined motion of the surgical instrument in an ideal form. Circular shape 240 of movement of surgical instrument 200 is defined by movement data points 260 of orientation array 220 (captured by monitoring system 300). Fig. 13B The points 260 shown in the figure represent the coordinates of the movement of the orientation array 220 (and therefore the surgical instrument 200) in 3-dimensional space relative to the pivot point 110 during calibration. Therefore, the data points 260 represent coordinates similar to the points 258 that define the ideal orientation array movement during calibration. In this way, the points 260 can be used to model a virtual representation 262 of the elongated shaft 204 of the surgical instrument 200 during actual pivoting, and the surgical instrument is in multiple postures corresponding to the multiple postures of the elongated shaft 204, such as Fig. 13C as shown. The virtual representations 262 can be determined because they extend from points 260 representing the movement of the orientation array 220 of the instrument 200 and terminate at a common virtual distal tip 264 that represents the bent distal tip 210 as the common virtual distal tip pivots in the pivot point 110. During pivoting, the recorded points 260 are all the same distance from the pivot point 110 because the overall length of the elongated shaft 204 of the instrument 200 does not change during calibration. This is similar to an ideal surgical instrument, where the predefined instrument axis 250 defines the distance from the fixed pivot point 256 at which the point 258 is positioned in the ideal instrument. The monitoring system 300 and / or the control system 400 can then mathematically match the hemisphere 266 to the recorded points 260, as shown. Fig.13D 260. The movement of the actual surgical instrument 200 and the recorded point 260 may not represent a perfect hemisphere because the measurements are made in an actual operating setting and the curved distal tip 210 may be warped or bent. Therefore, the hemisphere 266 may be the best fit sphere for the point 260, and if necessary, the predefined instrument axis 250 may be used as an initial sphere radius to help determine the sphere fit. The center 268 of the hemisphere 266 represents the location of the distal-most end 212 of the curved distal tip 210 because the curved distal tip is stationary in the pivot point 110 when the instrument 200 pivots about this point. This is similar to the fixed pivot point 256 representing both the center of the ideal hemisphere 254 and the location of the distal-most tip of the ideal surgical instrument. Therefore, the center 268 may correspond to the actual curved distal tip 210 with any warping or bending thereon.

[0070] The monitoring system 300 and / or the control system 400 may then map or transpose the hemisphere 266 of the actual curved distal tip 210 onto the ideal hemisphere 254 of the ideal tip 252, such as Fig.13E As shown. The monitoring system 300, the control system 400 can compare the ideal hemisphere 254 and the hemisphere 266 to each other, while placing the center of the ideal hemisphere 254 and the center 268 of the hemisphere 266 at the same or common coordinate point. The center of the ideal hemisphere 254 and the center 268 of the hemisphere 266 can be placed at the same coordinate point because these centers represent the pivot point 110 and the fixed pivot point 256, about which the surgical instrument 200 and the ideal surgical instrument pivot. If the ideal hemisphere 254 and the hemisphere 266 correspond perfectly to each other, the monitoring system 300, the control system 400 can determine that the distal tip 210 is not warped or bent from the ideal tip 252 because there is no deviation between the ideal hemisphere 254 and the hemisphere 266. If there is any deviation between the ideal hemisphere 254 and the hemisphere 266, the monitoring system 300 and / or the control system 400 can determine that there is bending or warping at the distal tip 210 because the calibration motion of the surgical instrument 200 does not exactly correspond to the calibration motion of the instrument having the ideal tip 252. In addition, the amount of deviation can be determined because the ideal hemisphere 254 and the hemisphere 266 are modeled in the same 3-dimensional coordinate system 130. As such, any deviation of the measured hemisphere 266 (representing the measured instrument coordinates) from the ideal hemisphere 254 (representing the predetermined instrument coordinates) is therefore correlated to any bending or warping of the actual curved distal tip 210 from the ideal distal tip 252. This correlated deviation can then be used to update the virtual model of the curved distal tip 210 to more accurately represent any bending or warping measured during calibration. As an illustrative example, the ideal hemisphere 254 has a smaller curvature than the ideal hemisphere 254. Fig.13E. Thus, the deviation indicates that the curved distal tip 210 has been bent toward the orientation array 220, thereby reducing the distance between the distal tip 210 and the orientation array 220 and thus causing the radius of the measurement hemisphere 266 to be shorter or smaller. Based on the amount of deviation between the radius of the ideal hemisphere 254 and the radius of the measurement hemisphere 266, the degree or amount to which the curved distal tip 210 has been bent toward the orientation array 220 can be determined. Once any deviation is calculated, the monitoring system 300, the control system 400 can update the virtual model of the curved distal tip 210 at step 608 so that the virtual model accurately represents the 3-dimensional position of the distal-most end 212 of the curved distal tip with any bend or warp. Updating the virtual model provides a more accurate representation of the surgical instrument 200, thereby providing the surgeon with better surgical results because the instrument 200 can be accurately represented while also not requiring surgically acceptable instruments to be discarded due to slight bends. The updated virtual model may also be created through a single-step process of rotating the surgical instrument 200 in the pivot point 110 rather than any multi-stage process involving multiple measuring and calibrating instruments.

[0071] The monitoring system 300 and / or the control system 400 may provide the surgeon and / or the surgical system with an updated virtual representation of any warping of the surgical instrument 200 with the curved distal tip 210 in step 610 in a variety of ways: for example, by displaying it to the surgeon on various displays; by modeling it in real time as a virtual 3-dimensional image; by providing it to a computer-assisted surgical system; by providing it to a robotic surgical system, etc. Figure 5 As shown, updating the virtual representation of the surgical instrument 200 with any warping of the curved distal tip 210 may thus include updating the virtual representation 275 of the surgical instrument 200 with multiple data points defining the shape and orientation of the surgical instrument 200 and the curved distal tip 210 by saving new values ​​of the multiple data points based on the calculated deviations to a memory, such as the memory 420 of the control system 400. As described above, in other embodiments, the monitoring system 300 and / or the control system 400 may be directly integrated into various computer-assisted surgical systems and / or robotic surgical systems. In some embodiments, the surgeon may then use the updated virtual representation 275 of the surgical instrument 200 to perform an operation on a patient, such as a minimally invasive surgical procedure. The calibration process described herein may be repeated as needed, and the predefined and / or ideal values ​​described herein may represent values ​​from an instrument that has not experienced any bending or warping or values ​​from a previously performed calibration process that represent some previous bending or warping but may need to be updated for continued accurate use.

[0072] Figures 14 to 17BAnother embodiment of a surgical instrument 700 is shown that is similar to surgical instrument 200 and has an elongated shaft 704 extending from a handle 702 and a curved distal tip 710 located on the distal end of the elongated shaft 704. As with surgical instrument 200, surgical instrument 700 can be calibrated so that an accurate virtual representation of at least the axis of the elongated shaft 704 and the actual curved distal tip 710 can be generated and provided to a computer or robotic surgical system, such as monitoring system 300, that accurately reflects the bend or warp of the curved distal tip 710. Instrument 700 can be calibrated through interaction with calibration instrument 100 and monitoring system 300.

[0073] Surgical instrument 700 has an orientation array 720 attached thereto that is similar to array 220 and can be tracked by monitoring system 300 similar to arrays 120, 220 described in detail above and has a predefined arrangement known to monitoring system 300 such that it can provide a predefined 3-dimensional instrument coordinate system similar to coordinate system 230. However, while orientation array 220 is configured to remain in one fixed orientation after calibration, orientation array 720 can be rotated to a predefined plurality of different known orientations during use without requiring recalibration by monitoring system 300 and calibration instrument 100. Because a plurality of different known orientations are provided to monitoring system 300 during initial calibration, monitoring system 300 and / or control system 400 can be configured to determine the orientation and update the virtual representation of surgical instrument 700 during use when orientation array 720 is moved to a known orientation of the plurality of known orientations that is different from a known orientation used during initial calibration. Thus, surgical instrument 700 can be configured for use in a plurality of different orientations, with curved distal tip 710 being rotated as needed during a surgical procedure while being able to rotate orientation array 720 to one of a plurality of different known orientations to ensure that orientation array 720 remains visible to monitoring system 300 without obstructing the view and without having to recalibrate instrument 700, such as Fig.17A and Fig. 17B For example, the orientation array 720 has three targets 722a, 722b, 722c thereon, which can be imaged in a manner similar to targets 122a, 122b, 122c and targets 222a, 222b, 222c. The orientation array 720 is coupled to the surgical instrument 700 in one of four known and predefined orientations by engaging an array interface 725 at one end of an orientation arm 724 having a predefined length, the orientation arm being provided with an orientation ring 726 at the opposite end, as shown in FIG. Fig.15 The orientation ring 726 is coupled to the instrument 700 by engaging with a ring coupling 728 disposed at the proximal end of the handle 702, and as shown in FIG. Fig.16As shown, the ring coupling 728 has a generally circular engagement surface 730 that is configured to interact with the ring coupling 728 of the orientation array 720 and has four notches 732a, 732b, 732c, 732d formed therein. The orientation ring 726 interacts with the four notches 732a, 732b, 732c, 732d so that the orientation ring 726 can sequentially engage with each notch and remain in a temporarily fixed orientation relative to the surgical instrument 700 relative to one of the notches 732a, 732b, 732c, 732d. For example, the orientation ring 726 can have four corresponding protuberances (not shown) on its inner surface that are configured to engage the four notches 732a, 732b, 732c, 732d. The ring 726 can also be opened by the engagement mechanism 726a and the hinge 726b so that the orientation ring 726 can be opened, rotated, and reengaged with the notches as needed. In use, the orientation ring 726, and therefore the orientation array 720 extending therefrom, may engage with the notch 732a during calibration and initial use, such that the orientation array 720 is visible to the monitoring system 300, as shown in FIG. Fig.17A However, during use, the orientation ring 726 can be disengaged from the notch 732a and rotated 180 degrees about the elongated shaft 704 of the surgical instrument 700 and reengage the ring coupling 728 at the notch 732c, thereby rotating the orientation array 720 coupled to the surgical instrument 700 to the opposite side of the surgical instrument during use, as shown in FIG. Fig. 17B As a result of this rotation, the curved distal tip 710 of the surgical instrument 700 can be applied to different bone structures of the patient while the orientation array 720 can remain visible to the monitoring system 300 to allow continued tracking. Although four notches 732a, 732b, 732c, 732d are shown herein, any number and type of engagement points may be present to allow the orientation array to be rotated to a predefined plurality of different known orientations.

[0074] Calibration of the instrument 700 is performed by the same process as the instrument 200 described above, which involves rotation in the pivot point 110 of the calibration instrument 100 and tracking by the monitoring system 300 to generate an accurate virtual representation of the surgical instrument 700 and the curved distal tip 710. However, a predefined plurality of different known orientations of the orientation array 720, such as four different known orientations in the illustrated embodiment, are provided to the monitoring system 300 and / or the control system 400, and each orientation (such as the orientations in the notches 732a, 732b, 732c, 732d) is uniquely identified. As the orientation changes during use, such as Fig.17A and Fig. 17BAs shown, when the instrument 700 is applied to the vertebrae of the patient 10, the monitoring system 300 and / or the control system 400 are provided with a unique identifier of the new orientation so that the monitoring system 300 and / or the control system 400 can determine the new position and posture of the surgical instrument 700 and its curved distal tip 710 based on the newly specified orientation, such as when the orientation array 720 is changed from Fig.17A The orientation of the notch 732a in the Fig. 17B Because the monitoring system 300 and / or the control system 400 know the fixed orientation at the notches 732a, 732b, the monitoring system 300 and / or the control system 400 can update the virtual representation of the overall orientation or posture of the surgical instrument 700 without having to recalibrate the instrument 700, for example, by updating multiple data points that define the virtual representation of the surgical instrument 700. After changing the orientation of the orientation array 720, the identification of the newly specified orientation can be provided to the monitoring system 300 and / or the control system 400 in a variety of ways during use. For example, the instrument 700 can have various markings, indicia, sensors, engagements, patterns, etc. on the handle 702, the shaft 704, the orientation ring 726, the ring coupling 728, etc., which can indicate the change to the monitoring system 300 and / or the control system 400 electronically or visually. Information can also be manually input to the monitoring system 300 and / or the control system 400, such as by a surgeon or an assistant.

[0075] While instruments having protruding distal-most tips have been shown, in other embodiments, instruments having cavities or voids at their distal ends may also be calibrated with calibration instruments having ridges, cones, spheres, etc., using the same methods described above. Figures 18 to 20 A surgical instrument 800 similar to instruments 200, 700 is shown. The surgical instrument 800 has an elongated shaft 804 extending from a handle 802 and a straight distal tip 810 located at the distal end of the elongated shaft 804, the straight distal tip having a cavity 810a defined therein. The cavity 810a is in the shape of an inverted cone, however, a variety of different instruments having different cavities may be used, such as elliptical, hemispherical, cylindrical, curved, etc. Surgical instrument 800 has an orientation array 820 attached thereto, similar to arrays 220, 720, which can be tracked by the monitoring system 300. Thus, the surgical instrument 800 can be calibrated similar to surgical instruments 200, 700 so that an accurate virtual representation of at least the axis of the elongated shaft 804 and the actual distal tip 810 can be generated, which accurately reflects any bending or warping of the distal tip 810 and can be provided to a computer or robotic surgical system, such as the monitoring system 300.

[0076] Additionally, the instrument 800 may be calibrated by interacting with a calibration instrument 900 that is similar to the calibration instrument 100. The calibration instrument 900 has a calibration reference array 920 thereon that is similar to the array 110 and that can be tracked by the monitoring system 300. The instrument 900 also has a pivot point 910 similar to the pivot point 110 about which the instrument 800 can be pivoted and rotated for calibration, similar to the calibration process described above. The pivot point 910 protrudes from the upper surface of the calibration instrument 900 and is in the shape of a cone that is inserted into the cavity 810a of the distal tip 810 on the instrument 800, as indicated by Fig.19 However, any protrusion shape may be used to correspond to a particular cavity on the surgical instrument to be calibrated, such as a hemisphere, a cylinder, a prism, etc. Once the distal tip 810 of the surgical instrument 800 is engaged with the calibration instrument 900, the instrument 800 is rotated about it for calibration, as shown in FIG. Fig. 20 As shown by the arrows in and is similar to the process described above.

[0077] All devices disclosed herein can be designed to be discarded after one use, or can be designed for multiple uses. However, in either case, the device can be reconditioned and reused after at least one use. Reconditioning can include any combination of disassembling the device, cleaning or replacing specific parts, and subsequent reassembly steps. Specifically, the device is removable, and any number of specific parts or components of the device can be selectively replaced or removed in any combination. After cleaning and / or replacing specific components, the device can be reassembled for subsequent use at a repair facility or by a surgical team just before a surgical operation. Those skilled in the art will appreciate that the finishing device can be disassembled, cleaned / replaced, and reassembled using a variety of techniques. The use of such techniques and the resulting repair device are within the scope of this application.

[0078] Preferably, the devices disclosed herein are sterilized prior to use. This can be accomplished by any number of means known to those skilled in the art, including beta or gamma radiation, ethylene oxide, steam, and liquid baths (e.g., cold soaks). Exemplary embodiments of sterilizing devices including internal circuitry are described in more detail in U.S. Patent Publication No. 2009 / 0202387, filed February 8, 2008, and entitled "System And Method Of Sterilizing An Implantable Medical Device." Preferably, if implanted, the device is hermetically sealed. This can be accomplished by any number of means known to those skilled in the art.

[0079] In addition, in the present disclosure, components with similar names in various embodiments generally have similar features, so in a specific embodiment, each feature of each component with similar names may not necessarily be fully set forth. In addition, to the extent that linear or circular dimensions are used in the description of the disclosed systems, devices, and methods, such dimensions are not intended to limit the types of shapes that can be used in conjunction with such systems, devices, and methods. Those skilled in the art will recognize that equivalent dimensions of such linear and circular dimensions can be easily determined for any geometric shape. The size and shape of the systems and devices and their components may depend at least on the anatomy of the subject in which the systems and devices will be used, the size and shape of the components with which the systems and devices will be used, and the methods and surgeries in which the systems and devices will be used.

[0080] In addition, it should be understood that one or more of the systems and methods herein or aspects thereof may be performed by at least one processor. The processor may be implemented in various devices, as described herein. A memory configured to store program instructions may also be implemented in a device, in which case the processor may be specifically programmed to execute the stored program instructions to perform one or more processes further described herein. In addition, it should be understood that the method may be performed by a specially designed device including a processor, a mobile device, a computing device, etc., in combination with one or more additional components, as described in detail herein.

[0081] In addition, the systems and methods of the present disclosure or aspects thereof may be embodied as non-transitory computer-readable media on a computer-readable medium containing executable program instructions executed by a processor. Examples of computer-readable media include, but are not limited to, ROM, RAM, compact disk (CD)-ROM, magnetic tape, floppy disk, flash drive, smart card, and optical data storage device. The computer-readable recording medium may also be distributed in a network-connected computer system so that the computer-readable medium is stored and executed in a distributed manner, for example, by a cloud-based system, a telematics server, a controller area network (CAN), etc.

[0082] Those skilled in the art will know other features and advantages of the device and method based on the above embodiments. Therefore, except as indicated in the appended claims, the present invention should not be limited by the specific shown and described contents. All publications and references cited herein are expressly incorporated herein by reference in their entirety.

Claims

1. An instrument calibration system, comprising: a surgical instrument having an elongated shaft having a proximal end and a distal end, the distal end having a distal-most tip, the proximal end having an orientation element fixed thereon in an initial position; a calibration instrument having a pivot point thereon configured to receive the distal-most tip of the surgical instrument so that the distal-most tip pivots about the pivot point, the calibration instrument having a predefined geometry and a calibration reference element attached to the calibration instrument; as well as a monitoring system configured to map coordinates of the orientation element relative to the calibration reference element as the surgical instrument moves with the distal-most tip of the surgical instrument positioned at the pivot point of the calibration instrument, the monitoring system configured to calculate a deviation of the mapped coordinates of the orientation element from at least one predetermined reference coordinate of a predefined surgical instrument having a predefined ideal distal-most tip, and to modify a virtual representation of the surgical instrument on a display based on the calculated deviation, wherein the monitoring system is configured to determine an initial orientation of the orientation element relative to the surgical instrument while the orientation element is maintained in a fixed position relative to the surgical instrument, and The monitoring system is configured to determine the actual orientation of the surgical instrument while the orientation element on the proximal end of the surgical instrument moves to one of a plurality of second positions different from the initial position on the surgical instrument, without re-recording the movement of the surgical instrument relative to the calibration instrument.

2. The instrument calibration system of claim 1, wherein the distal end of the surgical instrument has a curved tip.

3. The instrument calibration system of claim 1, wherein the distal end of the surgical instrument has a cavity formed therein.

4. An instrument calibration system according to claim 1, wherein the pivot point on the calibration instrument includes a plurality of removable and replaceable pivot points, each of the plurality of removable and replaceable pivot points being configured to correspond to one of a plurality of different distal tips of a plurality of different surgical instruments.

5. The instrument calibration system of claim 4, wherein the monitoring system is configured to be updated based on which of the plurality of removable and replaceable pivot points is being used.

6. The instrument calibration system of claim 1, wherein each of the orientation element and the calibration reference element comprises at least one of an array having a plurality of trackable targets thereon, an electromagnetic sensor, and a gyroscope.

7. The instrument calibration system of claim 1, wherein the monitoring system comprises at least one camera, at least one sensor, at least one processor, and at least one display.

8. The instrument calibration system of claim 1, wherein the surgical instrument comprises at least one of a screwdriver and a discectomy device.

9. The instrument calibration system of claim 1, wherein the monitoring system is part of a robotic surgical system and the surgical instrument is configured to be controlled by the robotic surgical system.

10. The instrument calibration system of claim 1, wherein the orientation element is configured to rotate about the surgical instrument in a plurality of known orientations, and Wherein the monitoring system is configured to update the virtual representation of the surgical instrument on the display based on each of the plurality of known orientations of the orientation element without re-recording the relative position of the orientation element with respect to the calibration reference element at each of the plurality of known orientations.

11. A method of calibrating a surgical instrument used during surgical navigation, comprising: inserting a distal-most tip on a distal end of the surgical instrument onto a first pivot point on a calibration instrument, the first pivot point formed on a first removable portion of the calibration instrument, the calibration instrument having a predefined geometry and a calibration reference element attached to the calibration instrument; pivoting the surgical instrument about the first pivot point so that the proximal end of the surgical instrument moves along a generally circular path over the calibration instrument while a monitoring system records reference coordinate points of an orientation element affixed at a first position on the surgical instrument relative to reference coordinate points of the calibration reference element on the calibration instrument; comparing, by the monitoring system, the recorded reference coordinate point with at least one stored reference coordinate point of an orientation element on a predefined ideal surgical instrument to calculate, based on the comparison, a deviation of the distal-most tip of the surgical instrument from a predefined ideal distal-most tip; After determining the deviation of the distal-most tip, modifying, by the monitoring system, a virtual representation of the surgical instrument on a display based on the calculated deviation; replacing the first removable portion of the calibration instrument with a second removable portion having a second pivot point having a different shape configured to match the distal-most tip of the surgical instrument; as well as The monitoring system is updated based on the second pivot point.

12. The method of claim 11, further comprising determining, by the monitoring system, an initial orientation of the orientation element relative to the surgical instrument while the orientation element is maintained in a fixed position relative to the surgical instrument.

13. The method according to claim 11, further comprising: rotating the orientation element of the surgical instrument to a different known orientation after modifying the virtual representation of the surgical instrument based on the calculated deviation; as well as The virtual representation of the surgical instrument on the display is modified by the monitoring system based on the different known orientations of the orientation element.

14. A method of calibrating a surgical instrument having a distal-most tip, comprising: recording, by a monitoring system, movement of an orientation element at an initial position on the surgical instrument relative to a calibration reference element on a calibration instrument; calculating, by a processor operatively coupled to the monitoring system, a deviation of the distal-most tip of the surgical instrument from a predefined virtual representation of the distal-most tip of the surgical instrument by comparing the recorded movement of the orientation element of the surgical instrument with an expected movement of the orientation element, the predefined virtual representation of the distal-most tip of the surgical instrument comprising a plurality of data points stored in a memory accessible by the processor, the plurality of data points defining a representation of the surgical instrument; updating, by the processor, one or more first data points of the plurality of data points of the predefined virtual representation of the distal-most tip of the surgical instrument stored in the memory based on the calculated deviation of the distal-most tip; determining, by the processor, an orientation of the surgical instrument during use when the orientation element on the surgical instrument moves to a second position different from the initial position on the surgical instrument after updating the one or more first data points, without re-recording the movement of the surgical instrument relative to the calibration instrument; as well as One or more second data points of the plurality of data points of the predefined virtual representation of the distal-most tip of the surgical instrument stored in the memory are updated, by the processor, based on the second position of the orientation element.

15. The method of claim 14, further comprising controlling, by the processor, a surgical display to display the updated one or more first data points of the predefined virtual representation of the distal-most tip of the surgical instrument.

Images