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TOY-1 Next, a user/surgeon may tilt the shaft 210 /surgical device 200c to a desired orientation with the bone probe 216 remaining in stationary contact with cortical bone of the pedicle of the vertebrae. FIG. 6B is a perspective cut-away view after a surgeon has tilted the shaft 210 /surgical device 200c to a desired orientation. The display 262 shows the current orientation of angle. Suppose the right pedicle of the vertebra 608 is at 15.4 degrees. If this is the case, then the surgical device 200c shows the insertion trajectory needed to deploy fixation devices into the pedicle. 143 Added by DJM 1 2022 1/19/22, 12:00 AM
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TOY-1 FIG. 6A illustrates a vertebra 608. A surgeon has created an opening that may expose one or more of the spinous process 104, first transverse process 106 and/or second transverse process 108. These processes 104, 106, 108, may be used as landmarks to identify the vertebra 608 and/or locate a surface point for the pedicle. Advantageously, the bone probe 216 can be placed on the surface point for the pedicle and the bone probe 216 remains in contact with the surface of the bone as an orientation angle is measured. 142 Added by DJM 1 2022 1/19/22, 12:00 AM
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TOY-1 The surgical device 200c may be used with a method for intraoperatively confirming a pedicle screw insertion trajectory on a vertebra of a patient. The method may start by positioning a patient on a table for a spinal surgery procedure such that a coronal plane of the patient is parallel to a floor supporting the table. Next, the surgical device 200c may be calibrated by positioning the surgical device 200c superficial to skin of the patient and substantially centering the surgical device 200c above the patient’s spine. Next, the surgical device 200c may be calibrated to set a reference axis for the hand-held surgical device relative to the patient’s spine. Next, a distal end 214 (e.g., bone probe 216) of the shaft 210 and/or surgical device 200c is placed on a surface of a pedicle of a vertebra of the patient’s spine. 141 Added by DJM 1 2022 1/19/22, 12:00 AM
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TOY-1 FIG. 6A is a perspective cut-away view of an intraoperative angle measurement apparatus, surgical device 200c, in use to contact a vertebra of a patient in a prone position in accordance with one embodiment. Advantageously, the surgical device 200c can be a small handheld portable device that can accurately determine or confirm an orientation angle for using confirming a pedicle insertion trajectory on vertebrae of a patient. 140 Added by DJM 1 2022 1/19/22, 12:00 AM
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TOY-1 In one embodiment, the electronic circuit 300/400 may indicate that the surgical device 200c is calibrated by causing the display 262 to display 0 degrees, or flash 0 degrees, or provide another output signal indicating the calibration is completed. In certain embodiments, once the surgical device 200c is calibrated, the surgical device 200c may start measuring and reporting/displaying an orientation angle of the shaft 210 (surgical device 200c). Alternatively, or in addition, the surgical device 200c may not measure and report/display orientation angles until the user presses the angle mode switch 258 indicating that the user is prepared to use the surgical device 200c and obtain orientation angle readings. 139 Added by DJM 1 2022 1/19/22, 12:00 AM
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TOY-1 The user may position the surgical device 200c as shown in FIG. 5 before, after, or while pressing or activating the zero-out switch 256 which can send a zero-out input signal from the user. Of course, embodiments of the surgical device 200c can be configured to calibrate to identify the horizontal plane 614 and/or reference axis 130 using any one or more of the surfaces of the housing 220. 138 Added by DJM 1 2022 1/19/22, 12:00 AM
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TOY-1 In one embodiment, the user may re-orient and/or position the surgical device 200c for the calibration by resting the superior surface 226 of the housing 220 on the surface of the skin 606 of the patient in a position substantially centered above a patient’s spine (e.g., one or more vertebrae 608). In this manner, the superior surface 226 (with the surgical device 200c positioned as shown in FIG. 5) serves to define, or serves as a suitable proxy to define, the horizontal plane 614 during a calibration mode. As explained above, the reference axis 130 can be defined as an axis perpendicular to the horizontal plane 614. 137 Added by DJM 1 2022 1/19/22, 12:00 AM
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TOY-1 In the illustrated embodiment, the user may re-orient the surgical device 200c as part of the calibration process (calibration mode). After the zero-out switch 256 is activated or pressed a user may have some time (e.g., one to five seconds) to re-orient and/or position the surgical device 200c for the calibration circuit 340 to calibrate for orientation angle measurements. 136 Added by DJM 1 2022 1/19/22, 12:00 AM
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TOY-1 1. A surgical device for intraoperative angle measurements during surgery on a patient, the surgical device comprising: 171 Added by DJM 1 2022 1/19/22, 12:00 AM
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TOY-1 a power supply configured to provide power to the electronic circuit. 181 Added by DJM 1 2022 1/19/22, 12:00 AM
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TOY-1 an output device coupled to the control circuit and configured to communicate the orientation angle to the user; and 180 Added by DJM 1 2022 1/19/22, 12:00 AM
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TOY-1 a control circuit coupled to the input device and measurement circuit and configured to determine the orientation angle of the shaft relative to the reference axis; 179 Added by DJM 1 2022 1/19/22, 12:00 AM
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TOY-1 a measurement circuit configured to measure a change in orientation of the shaft in relation to a reference axis; 178 Added by DJM 1 2022 1/19/22, 12:00 AM
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TOY-1 an input device configured to receive user input data; 177 Added by DJM 1 2022 1/19/22, 12:00 AM
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TOY-1 an electronic circuit configured to measure an orientation angle, the electronic circuit comprising: 176 Added by DJM 1 2022 1/19/22, 12:00 AM
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TOY-1 a housing coupled to the shaft, the housing comprising: 175 Added by DJM 1 2022 1/19/22, 12:00 AM
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TOY-1 a distal end comprising a bone probe configured to engage and remain in contact with cortical bone of the patient while a user orients the shaft to a desired orientation; and 174 Added by DJM 1 2022 1/19/22, 12:00 AM
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TOY-1 a proximal end; and 173 Added by DJM 1 2022 1/19/22, 12:00 AM
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TOY-1 a shaft comprising: 172 Added by DJM 1 2022 1/19/22, 12:00 AM
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TOY-1 To calibrate the surgical device 200c, a user may press the zero-out switch 256 (for example, a button) (i.e., activate a zeroing switch). Pressing the zero-out switch 256 may send a zero-out input signal to a calibration circuit 340 of the electronic circuit 300/400. In response to the zero-out input signal, the calibration circuit 340 may determine a horizontal plane 614 and/or reference axis 130. In certain embodiments, re-orienting the surgical device 200c for the calibration mode may not be needed. 135 Added by DJM 1 2022 1/19/22, 12:00 AM

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