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TOY-1 FIG. 5 is a perspective cut-away view of a surgical field and an intraoperative angle measurement apparatus according to one embodiment. FIG. 5 illustrates one example of a surgical device 200c and how the surgical device 200c can be used intraoperatively within a surgical field 602. 127 Added by DJM 1 2022 1/19/22, 12:00 AM
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TOY-1 In certain embodiments, the calibration circuit 340 determines a reference axis 130. The calibration circuit 340 may include one or more sensors 530 to facilitate determining the reference axis 130. The sensor 530 may be a level sensor, tilt sensor, or another type of sensor. The sensor 530 can determine a horizontal plane and the calibration circuit 340 may determine a reference axis 130 based on that determined horizontal plane. The In certain embodiments, the calibration circuit 340 and/or measurement circuit 330 may utilize the same sensors (e.g., a common accelerometer). In another embodiment, the calibration circuit 340 and measurement circuit 330 may each use separate sensors 510, 530. 126 Added by DJM 1 2022 1/19/22, 12:00 AM
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TOY-1 In certain embodiments, the electronic circuit 400 may be configured to enter a distance measuring mode. For example, in response to activation of a distance mode switch 260. In this mode, the measurement circuit 330 may serve to measure a linear distance. In certain embodiments, the measurement circuit 330 may include one or more transceivers 520. The one or more transceivers 520 of one surgical device 200 may send an electromagnetic wave pulse, magnetic wave pulse, or a light pulse to corresponding one or more transceivers of a second surgical device 200. The second surgical device 200 may be positioned at a point of origin and the surgical device 200 may be positioned at a destination point and the measurement circuit 330 may measure a linear distance between the two surgical devices based on characteristics of signals exchanged between the two surgical devices. The resulting linear measurement may be provided by the control circuit 350 to the output circuit 320 for communication to a user. 125 Added by DJM 1 2022 1/19/22, 12:00 AM
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TOY-1 In one embodiment, the opening 266 may be sized to accept one or more of a K-wire, a bone bore, an awl, a pedicle probe, a pedicle implant, and/or a pedicle inserter. A surgeon may pass one or more of these example instruments through the opening 266 as part of a pedicle screw placement procedure or step. The surgeon may use the surgical device 200b to determine, or confirm, a desired orientation (e.g., desired orientation angle) for the location of the pedicle and use one or more of these example instruments to mark, identify, or implement an insertion trajectory for one or more pedicle screws into the pedicle of the vertebra 100. 91 Added by DJM 1 2022 1/19/22, 12:00 AM
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TOY-1 In certain embodiments, the measurement circuit 330 uses an orientation sensor 510. The orientation sensor 510 may determine a horizontal plane parallel to the ground and/or an orientation of the orientation sensor 510 relative to the horizontal plane. Such an orientation sensor 510 can be used by the measurement circuit 330 to determine the reference axis and/or one or more orientation sensors 510 may be used to determine an orientation of the surgical device 200 relative to the reference axis. One example of an orientation sensor 510 may be a mercury switch, such as a mercury tilt switch. 123 Added by DJM 1 2022 1/19/22, 12:00 AM
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TOY-1 In certain embodiments, the measurement circuit 330 may use feedback from a first sensor 510 to determine a reference axis. For example, a first sensor 510 such as an accelerometer or gyroscope or other electronic, magnetic, and/or electromechanical sensor may determine a horizontal plane relative to an orientation of the surgical device 200. Based on the horizontal plane, the measurement circuit 330 may determine that the reference axis is perpendicular to the horizontal plane. The measurement circuit 330 may determine a horizontal plane determine the reference axis relative to the horizontal plane. For example, the horizontal plane may be a plane parallel to the ground or surface of an operating table and the reference axis may be perpendicular to the horizontal plane. 122 Added by DJM 1 2022 1/19/22, 12:00 AM
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TOY-1 The measurement circuit 330 may include one or more sensors 510 and one or more transceivers 520. In one embodiment, the measurement circuit 330 uses signals from one or more sensors 510 to detect a change in orientation of a shaft 210. As the orientation of the shaft 210, the sensor 510 can detect this change and the measurement circuit 330 provides a measurement of the amount of change (in units of degrees) from the reference axis. In certain embodiments, the sensor 510 can be an accelerometer. 121 Added by DJM 1 2022 1/19/22, 12:00 AM
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TOY-1 As with the input circuit 310 and output circuit 320, those of skill in the art appreciate that the measurement circuit 330 and/or calibration circuit 340 can have different configurations in different embodiments. The measurement circuit 330 measures a change in orientation angle of a shaft 210 in relation to a reference axis. In certain embodiments, the measurement circuit 330 measures the orientation angle of the shaft 210 relative to the reference axis in response to input data from a user (e.g., pressing or activating a button or switch). Alternatively, or in addition, the measurement circuit 330 measures the orientation angle of the shaft 210 relative to the reference axis in real time (e.g., as a user tilts the shaft 210 toa desired orientation) and coordinates with the control circuit 350 to update the orientation angle communicated to a user (e.g., displayed on a display), almost instantaneously. 120 Added by DJM 1 2022 1/19/22, 12:00 AM
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TOY-1 Those of skill in the art will appreciate that the output circuit 320 can communicate the orientation angle to a user using a variety of methods, including a visual display of an angle value in degrees, a distinct audible signal(s) when the surgical device 200 is at an orientation angle, visual indicators, and/or a haptic feedback signal and/or pattern. 119 Added by DJM 1 2022 1/19/22, 12:00 AM
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TOY-1 The one or more haptic feedback devices 490 can be used by the electronic circuit 400 to provide haptic output data and/or haptic feedback. The one or more haptic feedback devices 490 may be used for a variety of haptic feedback and/or output. For example, in one embodiment, the one or more haptic feedback devices 490 may activate at a single or a plurality of levels or rates and/or patterns to indicate when an electronic circuit 400 has been zeroed out. Alternatively, or in addition, the one or more haptic feedback devices 490 can activate with or without a distinctive pattern to indicate when a current orientation angle of the surgical device 200 gets closer to, further away from, and/or reaches a desired/target orientation. 118 Added by DJM 1 2022 1/19/22, 12:00 AM
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TOY-1 The one or more lights 480 can be used by the electronic circuit 400 to provide visual output data. The one or more lights 480 may be used for a variety of visual feedback and/or output. For example, in one embodiment, the one or more lights 480 may illuminate, flash, or blink with or without a distinctive pattern to indicate when an electronic circuit 400 has been zeroed out. Alternatively, or in addition, the one or more lights 480 can be used to illuminate, flash, or blink with or without a distinctive pattern to indicate when a current orientation angle of the surgical device 200 gets closer to, further away from, and/or reaches a desired/target orientation. 117 Added by DJM 1 2022 1/19/22, 12:00 AM
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TOY-1 The one or more speakers 470 can be used by the electronic circuit 400 to provide audible output data. The one or more speakers 470 may be used for a variety of audio feedback and/or output. For example, in one embodiment, the one or more speakers 470 may provide a distinctive beep or sound when an electronic circuit 400 has been zeroed out. Alternatively, or in addition, the one or more speakers 470 can be used to provide an audible sound or set of sounds or audio signals with distinctive changes in tone and/or frequency to indicate when a current orientation angle of the surgical device 200 gets closer to, further away from, and/or reaches a desired/target orientation. 116 Added by DJM 1 2022 1/19/22, 12:00 AM
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TOY-1 The output circuit 320 may include one or more displays 460. One display 460 may show the current orientation angle of the surgical device 200. Another display 460 may show a desired/target orientation. Another display 460 may accept touch input and may therefore display graphical input devices, such as switches, buttons, arrows, and the like. The output circuit 320 may have one or more displays 460 and/or a single display 460 may show different information on different parts of the display 460. In certain embodiments, the display 460 include numbers, letters, or symbols and a level of contrast that facilitates quick and clear reading by a surgeon during a procedure. 115 Added by DJM 1 2022 1/19/22, 12:00 AM
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TOY-1 A keypad 440 may also be included and can be used for input data. For example, the keypad 440 could be a numeric keypad and a user may enter a number representing a desired/target orientation. Alternatively, or in addition, the input circuit 310 may include a keyboard 450 and the user may use the keyboard 450 to enter a number representing a desired/target orientation. In certain embodiments, an electronic circuit 400 can be configured to store a desired/target orientation for a plurality of vertebrae and a label for the associated vertebrae. 114 Added by DJM 1 2022 1/19/22, 12:00 AM
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TOY-1 It should be noted that with the patient in a prone position, the ML axis 122 may be parallel to, or extend within, the coronal plane of the patient. Generally, the coronal plane of a patient in the prone position is a horizonal plane also parallel to a floor of the operating room. Where angle A is the orientation angle used to determine an insertion trajectory for a pedicle screw and the AP axis 124 is the reference axis 130, the reference axis 130 may be perpendicular to the horizonal plane of the surgical field which may be parallel to the coronal plane of the patient. 58 Added by DJM 1 2022 1/19/22, 12:00 AM
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TOY-1 FIGS. 2A-2E, illustrate a perspective top front view, a perspective top rear view, a perspective side view, a top view, and a bottom view of an exemplary embodiment of an intraoperative angle measurement apparatus (surgical device 200a). Referring to FIGS. 2A-2E, in the illustrated embodiment, the housing 220 has six surfaces: an anterior surface 222, a posterior surface 224, a superior surface 226, an inferior surface 228, a first lateral surface 230, and a second lateral surface 232. The surfaces may meet at edges. In the illustrated embodiment, the first lateral surface 230 and second lateral surface 232 are positioned to be a pair of opposite lateral surfaces. The first lateral surface 230 and second lateral surface 232 may extend at an obtuse angle in relation to the inferior surface 228 and engage with the superior surface 226. The angles of the first lateral surface 230 and/or second lateral surface 232 may be configured to minimize the size of the housing 220 and/or mitigate blockage of a surgeon’s view into a wound the surgical device 200a is in. 69 Added by DJM 1 2022 1/19/22, 12:00 AM
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TOY-1 As used herein, a "housing" refers to a structure that serves to connect, interconnect, surround, enclose, and/or protect one or more other structural components. A housing may be made from a variety of materials including, but not limited to, metal, plastic, ceramic, wood, fiberglass, acrylic, carbon, biocompatible materials, biodegradable materials or the like. Often a housing is made from plastic due to its in expense, strength and durability. A housing may also be formed of any biocompatible materials (particularly when part of an implant), including but not limited to biocompatible metals such as Titanium, Titanium alloys, stainless steel alloys, cobalt-chromium steel alloys, nickel-titanium alloys, shape memory alloys such as Nitinol, biocompatible ceramics, and biocompatible polymers such as Polyether ether ketone (PEEK) or a polylactide polymer (e.g. PLLA) and/or others. A housing may include a frame or framework or function within a larger system, component, structure, or device. 68 Added by DJM 1 2022 1/19/22, 12:00 AM
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TOY-1 The housing 220 may serve to enclose the electronic circuit 300 and a power supply. The housing 220 may be of a variety of different shapes and sizes. In certain embodiments, the housing 220 can be as small as possible to facilitate use of the surgical device 200a. The housing 220 can be coupled to the shaft 210 near or at the proximal end 212. 67 Added by DJM 1 2022 1/19/22, 12:00 AM
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TOY-1 In certain embodiments, distal end 214 of the shaft 210 includes the bone probe 216. The bone probe 216 can be integrated with the shaft 210 or coupled to the shaft 210 by way of a connector. In certain embodiments, the connector may include a threaded end and a corresponding threaded opening each of these formed in one or the other of the shaft 210 and the bone probe 216. Of course, the bone probe 216 may couple to the shaft 210 by way of a variety of other connectors and/or fasteners. In certain embodiments, the bone probe 216 is engineered and constructed to engage and remain in contact with cortical bone of a patient while a user orients the shaft 210 to a desired orientation. 66 Added by DJM 1 2022 1/19/22, 12:00 AM
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TOY-1 The bone probe 216 can be structured to engage and remain in contact with cortical bone of a patient when the surgical device 200a is in use. In one embodiment, the bone probe 216 can be structured to engage and remain in stationary contact with cortical bone of a patient while a user orients the shaft 210 to a desired orientation. For example, in one embodiment, the bone probe 216 may include a point on one end that contacts and may press into cortical bone of a patient. "Stationary contact" refers to a form of contact between two structures in which during the contact the structures do not translate relative to each other. In certain embodiments, a surgeon may tap on the head 240 to ensure that the bone probe 216 engages and remains in stationary contact with cortical bone as the surgical device 200a is being used. 65 Added by DJM 1 2022 1/19/22, 12:00 AM

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