# US 10,441,365 B2 · Patient reference device > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 10,441,365 B2 - Document ID: US10441365B2 - Status: Granted - Kind: B2 - Application number: 15/403,629 - Filed: 2017-01-11 - Published: 2018-07-12 - Granted: 2019-10-15 - Earliest claimed: 2017-01-11 - Assignees: Synaptive Medical (Barbados) Inc. - Applicants: Stewart David McLachlin; Gal Sela; Kamyar Abhari; Kai Michael Hynna; Jared Rowland Shoup; Aidan Alan Thompson - Inventors: Stewart David McLachlin; Gal Sela; Kamyar Abhari; Kai Michael Hynna; Jared Rowland Shoup; Aidan Alan Thompson - Web page: https://patentgrep.com/patent/US10441365B2 ## CPC - A61B 34/20: Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis - A61B 2017/00119: {alarm; indicating an abnormal situation} - A61B 2017/00221: {with wireless transmission of data, e.g. by infrared radiation or radiowaves} - A61B 2017/00477: {Coupling (A61B2017/0046 takes precedence)} - A61B 2017/00734: {battery operated} - A61B 2017/00876: {magnetic} - A61B 2034/2048: {using an accelerometer or inertia sensor} - A61B 2034/2055: {Optical tracking systems} - A61B 2090/037: {with a frangible part, e.g. by reduced diameter} - A61B 2090/3937: {Visible markers} - A61B 2090/3983: {Reference marker arrangements for use with image guided surgery} - A61B 2090/3991: {having specific anchoring means to fixate the marker to the tissue, e.g. hooks} - A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D) ## Abstract Methods and devices to track patient anatomy during a surgical operation. A patient reference device is attached to an anatomical feature of a patient and it includes an attachment base and an optically-trackable array detectable by an optical navigation system and having a longitudinally-extending arm to space apart the fixed geometric pattern from the anatomical feature. The arm includes a connector to be detachably secured to the attachment base. An inertial measurement unit within the attachment base enables determining, based on comparing a threshold level to a motion signal, that the attachment base has changed position, wherein the motion signal represents the change in position and its magnitude. Based on determining that the attachment base has changed position an alarm signal is generated an and an output device in the attachment base outputs an alarm in response to the alarm signal. ## Claims ### Claim 1 A patient reference device for tracking anatomical location of a patient by an optical navigation system during a surgical procedure, the patient reference device comprising: an attachment base having an attachment mechanism to secure the attachment base to an anatomical feature of the patient; an optically-trackable array including a plurality of fiducials in a fixed geometric pattern to be detected by the optical navigation system and having a longitudinally-extending arm to space apart the fixed geometric pattern from the anatomical feature, the arm including a connector to be detachably secured to the attachment base; an inertial measurement unit in the attachment base to detect a change in position of the attachment base and to output a motion signal representing the change in position and its magnitude; a logic circuit to receive the motion signal and to compare it to a threshold level and, if the motion signal exceeds the threshold level, to generate an alarm signal; and an output device to output an alarm in response to the alarm signal. ### Claim 2 (depends on 1) The patient reference device claimed in claim 1, wherein the connector is a quick-break attachment mechanism. ### Claim 3 (depends on 2) The patient reference device claimed in claim 2, wherein the quick-break attachment mechanism includes at least one magnet of a first polarity, and wherein the attachment base includes at least one corresponding magnet of an opposite polarity. ### Claim 4 (depends on 1) The patient reference device claimed in claim 1, wherein the attachment base includes a housing containing a battery, the inertial measurement unit, the logic circuit and the output device. ### Claim 5 (depends on 1) The patient reference device claimed in claim 1, wherein the attachment base includes a sensor base containing the inertial measurement unit, the logic circuit and the output device and a detachable battery housing containing a battery to power the sensor base. ### Claim 6 (depends on 5) The patient reference device claimed in claim 5, wherein a top of the sensor base includes electrical contact pads, and wherein a bottom of the battery housing includes electrical contacts connected to respective terminals of the battery, and wherein the electrical contacts make electrical connections with respective contact pads when the battery housing is attached to the sensor base. ### Claim 7 (depends on 1) The patient reference device claimed in claim 1, wherein the attachment mechanism comprises a clamp to secure the attachment base to the anatomical feature. ### Claim 8 (depends on 1) The patient reference device claimed in claim 1, further comprising a reset mechanism for generating a signal to the logic circuit to reset an alarm condition. ### Claim 9 (depends on 1) The patient reference device claimed in claim 1, wherein the output device includes at least one of a light emitting diode or a speaker. ### Claim 10 (depends on 1) The patient reference device claimed in claim 1, wherein the attachment base, attachment mechanism, and optically trackable array are arranged along a common axis to project away from the anatomical feature. ### Claim 11 (depends on 1) The patient reference device claimed in claim 1, wherein the output device comprises a wireless communication system to connect to an external device, and wherein the alarm comprises a communication to the external device, and the external device, in response thereto, outputs a visual or auditory alarm event. ### Claim 12 (depends on 1) The patient reference device claimed in claim 1, further comprising an input device to generate a signal to cause the logic circuit to begin comparing the motion signal to the threshold level. ### Claim 13 (depends on 12) The patient reference device claimed in claim 12, wherein the input device comprises a button. ### Claim 14 (depends on 12) The patient reference device claimed in claim 12, wherein, if the patient reference device is in an alarm condition, then actuation of the input device is to cancel the alarm condition and if the device is not in the alarm condition, then actuation of the input device is to cause the logic circuit to begin comparing the motion signal to the threshold level. ### Claim 15 (depends on 1) The patient reference device claimed in claim 1, wherein the attachment base includes a battery, wherein the connector includes an electrical connection to supply battery power, and wherein the plurality of fiducials comprises at least one active fiducial to be powered by the battery power. ### Claim 16 A method of tracking patient anatomy during a surgical operation using an optical navigation system and a patient reference device, the patient reference device being attached to an anatomical feature of the patient, the patient reference device including an attachment base having an attachment mechanism to secure the attachment base to the anatomical feature and a optically-trackable array including a plurality of fiducials in a fixed geometric pattern to be detected by the optical navigation system and having a longitudinally-extending arm to space apart the fixed geometric pattern from the anatomical feature, the arm including a connector to be detachably secured to the attachment base, the method comprising: determining, based on comparing a threshold level to a motion signal from an inertial measurement unit within the attachment base, that the attachment base has changed position, wherein the motion signal represents the change in position and its magnitude; based on determining that the attachment base has changed position, generating an alarm signal; and outputting, via an output device in the attachment base, an alarm in response to the alarm signal. ### Claim 17 (depends on 16) The method claimed in claim 16, further comprising receiving a reset signal, in response to the reset signal cancelling the alarm and the alarm signal, and repeating the determining. ### Claim 18 (depends on 16) The method claimed in claim 16, wherein outputting comprises illuminating a light emitting diode in the attachment base. ### Claim 19 (depends on 16) The method claimed in claim 16, wherein outputting comprises transmitting a short-range communication signal to an external device that outputs a visual or auditory alarm. ### Claim 20 (depends on 16) The method claimed in claim 16, further comprising first attaching the attachment base to the anatomical feature, securing the optically-trackable array to the attachment base once attached, and activating the inertial measurement unit.