Method and device for protecting the recurrent laryngeal nerve from thermal injury based on a flexible temperature sensing patch

Abstract

The embodiment of the present application relates to a kind of based on flexible temperature sensing patch to the processing method and device of recurrent laryngeal nerve heat damage protection, the method includes: the mean value of three sampling temperature of patch is calculated, and the relative temperature of mean value, benchmark temperature is calculated, and based on the median temperature y of recent multiple relative temperatures t And its corresponding y t‑1 Change rate is calculated;And based on change rate whether rapid temperature rise occurs;If yes, then estimate compensation temperature, calculate correction temperature, calculate CEM43 equivalent minute number, set early warning level, and when level is switched from normal to one / two level, open high temperature early warning and carry out energy appliance linkage control, and when level is not normal, whether early warning can be closed is judged by continuously observing correction temperature and equivalent minute number, and when confirming that it can be closed, normal level is reset and early warning is closed.The present application can improve the accuracy of early warning, early warning timeliness, improve the intraoperative heat damage protection ability to recurrent laryngeal nerve.

Description

Technical Field

[0001] This invention relates to the field of data processing technology, and in particular to a method and apparatus for protecting the recurrent laryngeal nerve from thermal damage based on a flexible temperature sensing patch. Background Technology

[0002] Thyroidectomy is a routine surgical procedure for treating thyroid nodules and other diseases. The recurrent laryngeal nerve (RLN) runs behind the thyroid gland in the tracheoesophageal groove and is closely related to the inferior thyroid artery. It is highly susceptible to damage during surgery due to heat diffusion from energy instruments such as electrocautery and ultrasonic scalpels. Damage to the recurrent laryngeal nerve can lead to postoperative hoarseness, choking when drinking, and even difficulty breathing, and is one of the most serious complications of thyroid surgery.

[0003] Currently, there are two main types of techniques used clinically to protect the recurrent laryngeal nerve from thermal injury during thyroidectomy. 1) The first type is physical isolation devices, such as nerve protectors and isolation shields. These devices block heat conduction by covering the nerve surface with a thermal barrier, a passive protection method. Their obvious drawback is the inability to provide real-time temperature feedback. 2) The second type is Intraoperative Neurophysiological Monitoring (IONM). This technique records electromyography (EMG) signals of the vocal cord muscles while electrically stimulating the recurrent laryngeal nerve, and analyzes the EMG signals to assess the integrity of the recurrent laryngeal nerve function. However, IONM is essentially a "post-verification" of nerve function; abnormal EMG signals indicate that nerve damage has already occurred. In other words, IONM cannot provide early warning before damage occurs.

[0004] In light of this, we propose a novel technical solution: 1) Introduce a flexible temperature sensing patch with three built-in temperature sensing elements, and attach it to the recurrent laryngeal nerve during surgery; 2) In the patch's encapsulation structure, a "thermal insulated microcavity + exposure window" design is used to provide each temperature sensing element with an independent temperature acquisition space that is isolated from the surrounding tissue / fluid environment of the nerve, thereby improving acquisition accuracy; 3) During surgery, the flexible temperature sensing patch is used to acquire the real-time temperature of the nerve; 4) Based on the acquired data, real-time judgment is made on whether the flexible temperature sensing patch has experienced positional displacement, signal abnormalities, or rapid temperature rise, and customized early warning methods are provided for various abnormalities; 5) When a rapid temperature rise event is confirmed, the accuracy and real-time performance of the corrected temperature are improved through a temperature supplementation mechanism based on a first-order heat conduction model, and the cumulative equivalent minutes at 43°C are used. The auxiliary factor, namely the CEM43 equivalent minutes, is calculated using the cumulative heating dose increment function of 43℃ (CEM43). A comprehensive judgment mechanism integrating the corrected temperature and the CEM43 equivalent minutes is used to determine the high-temperature warning level. 6) When the high-temperature warning level is set to Level 1 or Level 2, the system simultaneously issues a high-temperature warning and uses the device linkage interface to promptly control the local tissue thermal diffusion effect caused by the thermal operation of the energy device. It also promptly prompts the surgeon to pause the thermal operation of the energy device and to flush and cool the area. Based on this new scheme, not only can the problems of no real-time feedback during surgery and the inability to provide timely warnings before injury occur be solved, but the accuracy of temperature data acquisition, the ability and accuracy of abnormal event identification, and the accuracy of setting high-temperature warning levels can also be improved, thereby achieving the goal of improving the protection against thermal injury to the recurrent laryngeal nerve. Summary of the Invention

[0005] The purpose of this invention is to address the shortcomings of existing technologies by providing a method and apparatus for protecting the recurrent laryngeal nerve from thermal injury using a flexible temperature-sensing patch. During surgery, this invention periodically uses the relative temperature of the average of three sampled temperatures obtained from the flexible temperature-sensing patch and the current reference temperature as temperature x. t And when it is confirmed that no patch position offset has occurred, it is added to sequence X, and the median temperature of the most recent multiple temperatures x is taken as temperature y. t Add to sequence Y, and based on temperature y t-1 y t Calculate the rate of change z t Add to sequence Z; and periodically calibrate the current reference temperature; and based on the latest rate of change z. tThe system checks for abnormal patch signals. If an abnormal patch signal is detected, the early warning module is invoked to issue an early warning. If no abnormal patch signal is detected, the system further determines whether rapid temperature rise has occurred based on the current rate of change. If rapid temperature rise is confirmed, a compensation temperature calculation is performed based on the first-order heat conduction model and sequence Y. A correction temperature calculation is then performed based on the compensation temperature calculation result, and a CEM43 equivalent minute count is calculated based on the correction temperature and CEM43 equivalent minute count. A high-temperature warning level is set based on the correction temperature and CEM43 equivalent minute count. When the high-temperature warning level switches from normal to level one or two, the early warning module is invoked to activate the high-temperature warning, and the device linkage interface is invoked for device linkage control. If the high-temperature warning level is not normal, the correction temperature sequence X is continuously monitored. real The invention uses a CEM43 equivalent minute sequence M to determine whether the high-temperature warning can be turned off. If it confirms that it can be turned off, the high-temperature warning level is reset to normal, and the warning module is invoked to disable the high-temperature warning. Based on this invention, not only can the problems of lack of real-time feedback during surgery and inability to provide timely warnings before injury occurs be solved, but the accuracy of temperature data acquisition, the ability and accuracy of abnormal event identification, and the accuracy of high-temperature warning level setting can also be improved, thereby enhancing the ability to prevent thermal injury to the recurrent laryngeal nerve during surgery.

[0006] To achieve the above objectives, a first aspect of the present invention provides a method for protecting the recurrent laryngeal nerve from thermal damage based on a flexible temperature-sensing patch, the method comprising: Before surgery, the protective module establishes a data communication connection with the flexible temperature sensing patch attached to the recurrent laryngeal nerve; it also connects with the early warning module and the instrument linkage interface; and initializes the current reference temperature x. base The temperature was set to 37℃; the high-temperature warning level was initialized to normal; and six empty sequences were initialized as the corresponding sequences X, Y, Z, X... base X real M; the flexible temperature sensing patch has three built-in temperature sensing elements; the instrument linkage interface is also connected to the energy device used in surgery; the energy device includes at least an electrosurgical unit and an ultrasonic scalpel; the high temperature warning level includes normal, level one, and level two; During surgery, the protective module periodically obtains three sampled temperatures from the flexible temperature sensing patch at a preset signal sampling frequency; and compares the average of the three sampled temperatures with the current reference temperature x. base The temperature difference is taken as the corresponding temperature x t And based on the pairwise absolute temperature difference of the three sampled temperatures, determine whether a patch position shift has occurred; if so, then x is the current temperature. t After setting the temperature to zero, add it to sequence X and call the warning module to issue a position offset warning; otherwise, directly set the temperature x. tAdd to the sequence X; The protection module, each time the sequence X completes a temperature addition, will update the most recent N... win The temperature x t The median temperature is taken as the corresponding temperature y. t Add to sequence Y; and based on the current temperature y t and its corresponding temperature y t-1 Calculate the corresponding rate of change z t Add to sequence Z; and set the current reference temperature x base As the corresponding reference temperature x base,t Add to sequence X base Preset sliding window width N win z is an odd number greater than 3; t =(y t -y t-1 ) / △t, where △t is the sampling interval, △t=1 / signal sampling frequency; The protection module periodically adjusts the current reference temperature x according to the current sequence Y at a preset reference calibration frequency. base Perform a calibration and update the sequence X based on the calibration result. base ; The protection module, each time the sequence Z completes an addition of a change rate, will update the added change rate z. t The current rate of change is used as the current rate of change; and based on the current rate of change, it is determined whether there is a patch signal anomaly; if a patch signal anomaly occurs, the early warning module is invoked to issue a signal anomaly warning, and the temperature y corresponding to the current rate of change in the sequence Y is set. t Reset to the corresponding temperature y t-1 And based on the reset sequence Y, the corresponding rate of change z in the sequence Z. t and the sequence X base The corresponding reference temperature x base,t Perform a reset; if no patch signal abnormality occurs, further determine whether rapid temperature rise has occurred based on the current rate of change; When the protection module confirms a rapid temperature rise, it performs a compensation temperature calculation based on the first-order heat conduction model according to the sequence Y, and then calculates the compensation temperature based on the result of the compensation temperature calculation and the sequence X. base Perform corrected temperature calculations and update sequence X based on the corrected temperature calculation results. real Based on the CEM43 cumulative heating dose increment function, the equivalent minutes are calculated according to the corrected temperature calculation results, and sequence M is updated based on the equivalent minutes calculation results; and based on sequence X... real M sets the high temperature warning level; When the high temperature warning level switches from normal to level one or level two, the protection module calls the warning module to activate the high temperature warning and calls the instrument linkage interface to perform instrument linkage control. When the high temperature warning level is not at the normal level, the protection module continuously observes sequence X. real The system uses M to determine whether the high-temperature warning can be turned off; and when it is confirmed that it can be turned off, the high-temperature warning level is reset to normal, and the warning module is invoked to turn off the high-temperature warning.

[0007] Preferably, the total thickness of the flexible temperature sensing patch does not exceed 0.5 mm, and the bending radius is not less than 5 mm; The flexible substrate of the flexible temperature sensing patch is I-shaped; The two sides of the I-shaped base are wing fixation areas, each with at least two positioning holes for fixing the patch and attaching it to the recurrent laryngeal nerve; a PTFE sleeve is installed on one of the wing fixation areas; the signal cable passing through the PTFE sleeve is connected to the three temperature sensing elements in the central sensing area and to the protection module. The width of both of the aforementioned winglet fixing areas is W1 and the length is L1, with the width W1 being between 4-6 mm and the length L1 being between 7-9 mm; The rectangular area between the two wing fixation areas is the central sensing area, with a width of W2 and a length of L2, where the width W2 is between 1.5-2.5 mm and the length L2 is between 12-18 mm. In the flexible substrate of the central sensing area, three temperature sensing elements are embedded at equal intervals along the centerline from one wing fixation area to the other. These three temperature sensing elements are designated as the proximal, mid-segment, and distal elements according to the direction of the recurrent laryngeal nerve. The temperature sensing element is a fiber Bragg grating sensor or a T-type thermocouple sensor; the thermal response time constant of the temperature sensing element does not exceed 0.2 seconds. When the sensor type is a fiber Bragg grating sensor, the center wavelengths of the gratings of the proximal, mid-section, and distal elements are 1530nm, 1545nm, and 1560nm, respectively. The output signal of each of the proximal, mid-section, and distal elements is a corresponding Bragg wavelength signal. The proximal, mid-section, and distal elements are connected in series on the same optical fiber, and wavelength division multiplexing technology is used to achieve multi-point temperature measurement over a single cable. The signal cable passing through the PTFE sheath at this time is a single optical fiber. When the sensor type is a T-type thermocouple sensor, the proximal, middle, and distal elements are three T-type thermocouple sensors. The output signal of each of the proximal, middle, and distal elements is a corresponding analog voltage signal. Each of the proximal, middle, and distal elements requires two cables to transmit the analog voltage signal. The signal cables passing through the PTFE sleeve at this time are six mutually isolated signal lines. With the base bottom plane as the top and the plane contacting the recurrent laryngeal nerve as the bottom, the cross-sectional structure of the element area AA corresponding to each temperature sensing element in the central sensing area from top to bottom is as follows: a flexible substrate with the temperature sensing element embedded, a thermal insulation microcavity, an insulating and moisture-proof layer, a biocompatible encapsulation layer, and a hydrophilic lubricating coating; the flexible substrate is a polyimide film with a thickness between 20-30 μm; the thermal insulation microcavity is made of foamed silicone rubber with a porosity of 20%-40% and a thickness between 50-150 μm; the thermal conductivity of the thermal insulation microcavity is less than 0.1 W / (m·K), ensuring that the attenuation ratio of heat conduction from surrounding tissue to the temperature sensing element is not less than 10:1; the insulating and moisture-proof layer is Parylene chemically vapor-deposited. The C film has a thickness between 8-12 μm; the biocompatible encapsulation layer is made of medical-grade silicone rubber with a thickness between 20-50 μm; the hydrophilic lubricating coating is a polyvinylpyrrolidone coating with a thickness between 5-15 μm; each temperature sensing element has a vertical slot with a diameter of 1 mm at its center as a corresponding exposure window, which penetrates the heat insulation microcavity, the insulating moisture-proof layer, the biocompatible encapsulation layer, and the hydrophilic lubricating coating.

[0008] Preferably, the step of periodically obtaining three sampling temperatures from the flexible temperature sensing patch at a preset signal sampling frequency specifically includes: The protection module periodically identifies the sensor type of the flexible temperature sensing patch according to the signal sampling frequency; If the sensor type is a fiber Bragg grating sensor, then the three Bragg wavelengths of the proximal, middle and distal elements on the flexible temperature sensing patch are acquired in real time through optical fiber, and the corresponding temperature values ​​are converted for each acquired Bragg wavelength based on the conversion relationship between the Bragg wavelength and temperature of the fiber Bragg grating sensor. If the sensor type is a T-type thermocouple sensor, then the three analog voltage signals of the proximal, middle and distal elements on the flexible temperature sensing patch are acquired in real time through optical fiber. Each analog voltage signal is then subjected to signal isolation amplification, low-pass filtering with a cutoff frequency of 10Hz and analog-to-digital signal conversion to obtain the corresponding conversion value. Based on the conversion relationship between the T-type thermocouple sensor value and temperature, each conversion value is converted to the corresponding temperature value to obtain the corresponding conversion temperature. The three conversion temperatures obtained in this study are used as the corresponding three sampling temperatures.

[0009] Preferably, the step of determining whether patch position shift has occurred based on the pairwise absolute temperature difference of the three sampled temperatures specifically includes: The protection module calculates the pairwise absolute temperature difference of the three sampled temperatures to obtain three corresponding first temperature difference values; and identifies whether all three first temperature difference values ​​are less than a preset first temperature difference threshold; if yes, the judgment result of patch position offset is set to no; if no, the judgment result of patch position offset is set to yes.

[0010] Preferably, the step of periodically adjusting the current reference temperature x according to the current sequence Y at a preset reference calibration frequency is... base Perform a calibration and update the sequence X based on the calibration result. base Specifically, it includes: The protection module periodically adjusts the temperature y in the current sequence Y that is within the most recent first time period according to the reference calibration frequency. t Extract the data to form the current sequence; and set the current reference temperature x. base As the corresponding reference temperature x base,pre The system identifies the maximum and minimum temperatures within the current sequence; calculates the temperature difference between the maximum and minimum temperatures to obtain a second temperature difference; and checks whether the second temperature difference is less than a preset second temperature difference threshold. If so, the system compares the average temperature of the current sequence with the previous reference temperature x. base,pre The sum is taken as the latest current reference temperature x. base and the sequence X base In the context of the aforementioned reference temperature x base,pre The corresponding reference temperature x base,t Reset to the latest current reference temperature x base .

[0011] Preferably, the step of confirming whether there is an abnormal patch signal based on the current rate of change specifically includes: The protection module identifies whether the current rate of change exceeds a preset first rate of change threshold; if yes, the judgment result of the patch signal abnormality is set to yes; if no, the judgment result of the patch signal abnormality is set to no.

[0012] Preferably, determining whether a rapid temperature rise has occurred based on the current rate of change specifically includes: The protection module identifies whether the current rate of change is greater than a preset second rate of change threshold; if yes, the judgment result of rapid heating is set to yes; if no, the judgment result of rapid heating is set to no.

[0013] Preferably, the compensation temperature calculation based on the first-order heat conduction model according to the sequence Y, and the compensation temperature calculation result and the sequence X are used to calculate the compensation temperature. base Perform corrected temperature calculations and update sequence X based on the corrected temperature calculation results. real Based on the CEM43 cumulative heating dose increment function, the equivalent minutes are calculated according to the corrected temperature calculation results, and the sequence M is updated based on the equivalent minutes calculation results. Specifically, this includes: Step 81, the protection module selects the temperature y in the sequence Y that is within the most recent second time interval. t Extracted to form the sampling sequence Y samp ; Wherein, the temperature y of each of the current sub-sequences t Let y be the corresponding temperature. i 1 ≤ index i ≤ total number of samples N samp N samp =(Second duration / △t)+1; Step 82: Calculate each temperature y based on the first-order heat conduction model and the sequence Y. i The corresponding compensation temperature Δy i ; Specifically: [The text abruptly ends here, likely due to an incomplete sentence or a missing section.] i As the final temperature y end ; and the ending temperature y end The corresponding sampling time is recorded as the end time, and the corresponding start time is calculated as end time - second duration; the temperature y corresponding to the start time in the sequence Y is then recorded. t As the starting temperature y start ; and the initial temperature y start The ending temperature y end The second duration and the preset future duration are substituted into the first-order heat conduction model to calculate the corresponding compensation temperature Δy. i ; The first-order heat conduction model is as follows: ; Step 83, the sequence X base In and each of the aforementioned temperatures y i The corresponding reference temperature x base,t Let it be x base,i ; and based on each of the stated temperatures y i and its corresponding reference temperature x base,i and the compensation temperature Δy i Calculate the corresponding corrected temperature x real,i ; Wherein, the corrected temperature x real,i The calculation method is as follows: ; Step 84, and then use the various corrected temperatures x obtained this time. real,i The current corrected temperature is used as the current time; and the sampling time corresponding to the current corrected temperature is used as the current time; and the sequence X is... real Is there a corrected temperature x corresponding to the current time? real,t Perform identification; if so, then adjust the corresponding correction temperature x based on the current correction temperature. real,t Perform a reset; if not, use the current corrected temperature as the new corrected temperature x. real,t Add to the sequence X real middle; Step 85, based on the CEM43 cumulative heating dose increment function, according to the sampling interval Δt and the N obtained this time... samp The corrected temperature x real,i Estimate the corresponding equivalent number of minutes, m; The cumulative heating dose increment function of CEM43 is as follows: , ; R i For temperature coefficient, the equivalent minutes m is in minutes, and the sampling interval Δt is in seconds; Step 86: Take the equivalent minutes m obtained this time as the corresponding equivalent minutes m t Add to the sequence M.

[0014] Preferably, the sequence X-based real M sets the aforementioned high-temperature warning level, specifically including: The protection module will store the sequence X. real and the corrected temperature x in the sequence M corresponding to the current time. real,t Equivalent minutes (m) t Extract it as the corresponding current temperature Current number of minutes ; And the current temperature and the current number of minutes Perform identification; If the current temperature The current number of minutes is less than a preset first temperature threshold. If the number of minutes is less than the preset first minute threshold, the corresponding high temperature warning level is set to normal; the first temperature threshold is greater than 37°C. If the current temperature Greater than or equal to the first temperature threshold and less than the preset second temperature threshold, or the current number of minutes. If the temperature is greater than or equal to the preset second minute threshold, the corresponding high temperature warning level is set to Level 1; if the first temperature threshold is less than the second temperature threshold; or if the first minute threshold is less than the second minute threshold. If the current temperature If the temperature is greater than or equal to a preset third temperature threshold, then for the sequence X... real All corrected temperatures x within the most recent third time period real,t The system identifies whether all temperatures are greater than or equal to the third temperature threshold. If so, the corresponding high-temperature duration marker is set to "continuous"; otherwise, the corresponding high-temperature duration marker is set to "non-continuous". If the high-temperature duration marker is set to "continuous", or if the current number of minutes is... If the temperature is greater than or equal to the preset third minute threshold, the corresponding high temperature warning level is set to Level II; if the second temperature threshold is less than the third temperature threshold; if the second minute threshold is less than the third minute threshold.

[0015] Preferably, the step of continuously observing sequence X real The system uses M to determine whether the high-temperature warning can be turned off, specifically including: The protection module adds an equivalent minute m to the sequence M. t At that time, the equivalent number of minutes m will be... t As the current equivalent minutes; and the previous equivalent minutes m of the current equivalent minutes. t-1 As the corresponding previous equivalent minutes; and calculate the equivalent fraction difference = current equivalent minutes - previous equivalent minutes; and then set the sequence X real The corrected temperature x corresponding to the current equivalent number of minutes real,tThe current corrected temperature is used as the reference temperature; the equivalent fraction difference and the current corrected temperature are identified; if the equivalent fraction difference is less than or equal to 0 and the current corrected temperature is less than a preset fourth temperature threshold, it is confirmed that the high temperature warning can be turned off; if the equivalent fraction difference is greater than 0 or the current corrected temperature is greater than or equal to the fourth temperature threshold, it is confirmed that the high temperature warning cannot be turned off.

[0016] Preferably, the step of calling the instrument linkage interface for instrument linkage control specifically includes: The protection module sends a linkage control command to the device linkage interface; When the device linkage interface receives the linkage control command, it controls the local tissue heat diffusion effect caused by the thermal operation of the energy device by sending a stop heating command to the energy device; and prompts the surgeon to pause the thermal operation and rinse and cool down through text or voice prompts.

[0017] Preferably, the step of calling the early warning module to perform a position offset early warning specifically includes: the protection module setting the early warning type to position offset and setting the early warning parameters to empty; and sending a corresponding early warning command composed of the early warning type and the early warning parameters to the early warning module.

[0018] Preferably, the step of calling the early warning module to issue a signal anomaly warning specifically includes: the protection module setting the warning type to signal anomaly and setting the warning parameters to empty; and sending the corresponding warning command composed of the warning type and the warning parameters to the early warning module.

[0019] Preferably, the step of calling the warning module to activate the high temperature warning specifically includes: the protection module setting the warning type to high temperature warning activated and setting the warning parameters to the corresponding high temperature warning level; and sending the warning command composed of the warning type and the warning parameters to the warning module.

[0020] Preferably, the step of calling the warning module to turn off the high temperature warning specifically includes: the protection module setting the warning type to high temperature warning off and setting the warning parameters to empty; and sending the warning command composed of the warning type and the warning parameters to the warning module.

[0021] Preferably, the warning instruction includes the warning type and the warning parameters; the warning type includes position offset, signal abnormality, high temperature warning enabled, and high temperature warning disabled; when the warning type is position offset, signal abnormality, or high temperature warning disabled, the warning parameters are empty; when the warning type is high temperature warning enabled, the warning parameters are level one or level two; when the warning type is position offset, it corresponds to the position offset warning unit of the warning module; when the warning type is signal abnormality, it corresponds to the signal abnormality warning unit of the warning module; and when the high temperature warning is enabled or high temperature warning is disabled, it corresponds to the high temperature warning unit of the warning module.

[0022] Preferably, the early warning module includes at least an instruction forwarding unit, a position offset early warning unit, a signal anomaly early warning unit, and a high temperature early warning unit; The instruction forwarding unit is used to receive the warning instruction sent by the protection module; and based on the correspondence between the warning type and the three warning units, forward the current warning instruction to its corresponding position offset warning unit, signal abnormality warning unit or high temperature warning unit. Upon receiving the warning instruction of the type of position offset, the position offset warning unit provides the surgical operator with a text or voice prompt indicating the position offset of the patch. Upon receiving the warning instruction of the warning type being signal abnormality, the signal abnormality warning unit will provide the surgical operator with a text or voice prompt indicating an abnormality in the signal acquisition of the patch sensor element. Upon receiving the warning command indicating a high-temperature warning, the high-temperature warning unit identifies the warning parameters. If the warning parameter is Level 1, it activates the built-in buzzer based on a preset first buzzer frequency and first buzzer volume for a Level 1 buzzer warning. It then sets the illumination color and flashing frequency of the built-in warning light based on a preset first color and first flashing frequency, and then provides a Level 1 light warning by flashing the warning light. If the warning parameter is Level 2, it activates the buzzer based on a preset second buzzer frequency and second buzzer volume for a Level 2 buzzer warning. It then sets the illumination color and flashing frequency of the warning light based on a preset second color and second flashing frequency, and then provides a Level 2 light warning by flashing the warning light. The first buzzer frequency < the second buzzer frequency, the first buzzer volume < the second buzzer volume, the first color is set to yellow by default, the second color is set to red by default, and the first flashing frequency < the second flashing frequency. Upon receiving the warning instruction indicating that the warning type is "high temperature warning off", the high temperature warning unit shuts down the currently executing level one or level two buzzer warning and the corresponding level one or level two light warning.

[0023] A second aspect of the present invention provides an apparatus for implementing the treatment method for thermal damage protection of the recurrent laryngeal nerve based on a flexible temperature sensing patch as described in the first aspect above. The apparatus includes: a protection module, an early warning module, and an instrument linkage interface. The protective module is used to establish a data communication connection with the flexible temperature sensing patch attached to the recurrent laryngeal nerve before surgery; and to connect with the early warning module and the instrument linkage interface; and to initialize the current reference temperature x. base The temperature was set to 37℃; the high-temperature warning level was initialized to normal; and six empty sequences were initialized as the corresponding sequences X, Y, Z, X... base X real M; the flexible temperature sensing patch has three built-in temperature sensing elements; the instrument linkage interface is also connected to the energy device used in surgery; the energy device includes at least an electrosurgical unit and an ultrasonic scalpel; the high temperature warning level includes normal, level one, and level two; The protection module is also used to periodically obtain three sampled temperatures from the flexible temperature sensing patch at a preset signal sampling frequency during surgery; and to compare the average temperature of the three sampled temperatures with the current reference temperature x. base The temperature difference is taken as the corresponding temperature x t And based on the pairwise absolute temperature difference of the three sampled temperatures, determine whether a patch position shift has occurred; if so, then x is the current temperature. t After setting the temperature to zero, add it to sequence X and call the warning module to issue a position offset warning; otherwise, directly set the temperature x. t Add to the sequence X; The protection module is also used to, each time the sequence X completes a temperature addition, update the most recent N... win The temperature x t The median temperature is taken as the corresponding temperature y. t Add to sequence Y; and based on the current temperature y t and its corresponding temperature y t-1 Calculate the corresponding rate of change z t Add to sequence Z; and set the current reference temperature x base As the corresponding reference temperature x base,t Add to sequence X base Preset sliding window width N win z is an odd number greater than 3; t =(y t -y t-1 ) / △t, where △t is the sampling interval, △t=1 / signal sampling frequency; The protection module is also used to periodically adjust the current reference temperature x according to the current sequence Y at a preset reference calibration frequency. basePerform a calibration and update the sequence X based on the calibration result. base ; The protection module is also used to, each time the rate of change of sequence Z is added, to update the rate of change z added in that iteration. t The current rate of change is used as the current rate of change; and based on the current rate of change, it is determined whether there is a patch signal anomaly; if a patch signal anomaly occurs, the early warning module is invoked to issue a signal anomaly warning, and the temperature y corresponding to the current rate of change in the sequence Y is set. t Reset to the corresponding temperature y t-1 And based on the reset sequence Y, the corresponding rate of change z in the sequence Z. t and the sequence X base The corresponding reference temperature x base,t Perform a reset; if no patch signal abnormality occurs, further determine whether rapid temperature rise has occurred based on the current rate of change; The protection module is also used to, upon confirmation of a rapid temperature rise, perform a compensation temperature calculation based on the first-order heat conduction model according to the sequence Y, and calculate the compensation temperature based on the result of the compensation temperature calculation and the sequence X. base Perform corrected temperature calculations and update sequence X based on the corrected temperature calculation results. real Based on the CEM43 cumulative heating dose increment function, the equivalent minutes are calculated according to the corrected temperature calculation results, and sequence M is updated based on the equivalent minutes calculation results; and based on sequence X... real M sets the high temperature warning level; The protection module is also used to activate the high temperature warning by calling the warning module and to call the instrument linkage interface for instrument linkage control when the high temperature warning level switches from normal to level one or level two. The protection module is also used to continuously observe sequence X when the high temperature warning level is not a normal level. real The system uses M to determine whether the high-temperature warning can be turned off; and when it is confirmed that it can be turned off, the high-temperature warning level is reset to normal, and the warning module is invoked to turn off the high-temperature warning.

[0024] This invention provides a method and apparatus for protecting the recurrent laryngeal nerve from thermal injury using a flexible temperature-sensing patch. As described above, this invention periodically uses the relative temperature of the average of three sampled temperatures obtained from the flexible temperature-sensing patch and the current reference temperature as temperature x during surgery. t And when it is confirmed that no patch position offset has occurred, it is added to sequence X, and the median temperature of the most recent multiple temperatures x is taken as temperature y. t Add to sequence Y, and based on temperature y t-1 y t Calculate the rate of change zt Add to sequence Z; and periodically calibrate the current reference temperature; and based on the latest rate of change z. t The system checks for abnormal patch signals. If an abnormal patch signal is detected, the early warning module is invoked to issue an early warning. If no abnormal patch signal is detected, the system further determines whether rapid temperature rise has occurred based on the current rate of change. If rapid temperature rise is confirmed, a compensation temperature calculation is performed based on the first-order heat conduction model and sequence Y. A correction temperature calculation is then performed based on the compensation temperature calculation result, and a CEM43 equivalent minute count is calculated based on the correction temperature and CEM43 equivalent minute count. A high-temperature warning level is set based on the correction temperature and CEM43 equivalent minute count. When the high-temperature warning level switches from normal to level one or two, the early warning module is invoked to activate the high-temperature warning, and the device linkage interface is invoked for device linkage control. If the high-temperature warning level is not normal, the correction temperature sequence X is continuously monitored. real The CEM43 equivalent minute sequence M is used to determine whether the high-temperature warning can be turned off. If it is confirmed that it can be turned off, the high-temperature warning level is reset to normal, and the warning module is invoked to turn off the high-temperature warning. This invention not only solves the problems of no real-time feedback during surgery and inability to provide timely warnings before damage occurs; it also improves the accuracy of temperature acquisition, the ability and accuracy of abnormal event identification, the accuracy of high-temperature warning level setting, the accuracy and timeliness of warnings, and the ability to protect against intraoperative thermal damage to the recurrent laryngeal nerve. Attached Figure Description

[0025] Figure 1 This is a schematic diagram of a method for protecting the recurrent laryngeal nerve from thermal damage based on a flexible temperature sensing patch, provided in Embodiment 1 of the present invention. Figure 2 This is a top view of the flexible temperature sensing patch provided in Embodiment 1 of the present invention. Figure 3 This is a schematic cross-sectional view of the temperature sensing element region AA provided in Embodiment 1 of the present invention; Figure 4 This is a schematic diagram showing the attachment position of the flexible temperature sensing patch provided in Embodiment 1 of the present invention; Figure 5 This is a module structure diagram of a treatment device for protecting the recurrent laryngeal nerve from thermal damage based on a flexible temperature sensing patch, as provided in Embodiment 2 of the present invention. Detailed Implementation

[0026] To make the objectives, technical solutions, and advantages of this invention clearer, the invention will be further described in detail below with reference to the accompanying drawings. Obviously, the described embodiments are merely some embodiments of this invention, and not all embodiments. Based on the embodiments of this invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of this invention.

[0027] Embodiment 1 of the present invention provides a method for protecting the recurrent laryngeal nerve from thermal damage based on a flexible temperature-sensing patch, such as... Figure 1 The schematic diagram shows a method for protecting the recurrent laryngeal nerve from thermal damage based on a flexible temperature-sensing patch, as provided in Embodiment 1 of the present invention. This method mainly includes the following steps: Step 1: Before surgery, the protective module establishes a data communication connection with the flexible temperature sensing patch attached to the recurrent laryngeal nerve; it also connects with the early warning module and the instrument linkage interface; and initializes the current reference temperature x. base The temperature was set to 37℃; the high-temperature warning level was initialized to normal; and six empty sequences were initialized as the corresponding sequences X, Y, Z, X... base X real M.

[0028] Here, the surgical procedure described in this embodiment of the invention is a thyroidectomy.

[0029] The flexible temperature sensing patch of this invention incorporates three temperature sensing elements. The total thickness of the flexible temperature sensing patch does not exceed 0.5 mm, and the bending radius is not less than 5 mm.

[0030] like Figure 2 The diagram shows a top view of the flexible temperature sensing patch provided in Embodiment 1 of the present invention. The flexible substrate of the flexible temperature sensing patch is I-shaped. Both sides of the I-shaped substrate are wing fixing areas, each with at least two positioning holes for fixing the patch and attaching it to the recurrent laryngeal nerve. A polytetrafluoroethylene (PTFE) sheath is installed on one of the wing fixing areas; a signal cable passing through the PTFE sheath is connected to three temperature sensing elements in the central sensing area and to a protective module.

[0031] Both wing fixation areas have a width of W1 and a length of L1, with W1 ranging from 4 to 6 mm and L1 ranging from 7 to 9 mm. The rectangular area between the two wing fixation areas is the central sensing area, with a width of W2 and a length of L2, ranging from 1.5 to 2.5 mm and L2 ranging from 12 to 18 mm. In the flexible substrate of the central sensing area, three temperature sensing elements are embedded at equal intervals along the centerline from one wing fixation area to the other. The three temperature sensing elements are labeled as the proximal, mid, and distal elements according to the direction of the recurrent laryngeal nerve.

[0032] The temperature sensing element in this embodiment of the invention uses either a fiber Bragg grating (FBG) sensor or a type T thermocouple (TC) sensor. The thermal response time constant of the temperature sensing element does not exceed 0.2 seconds. The fiber Bragg grating sensor is the preferred option, while the type T thermocouple sensor is an alternative.

[0033] When the sensor type is a fiber Bragg grating sensor, the center wavelengths of the gratings of the proximal, mid-section, and distal elements are 1530nm, 1545nm, and 1560nm, respectively. The output signal of each of the proximal, mid-section, and distal elements is a corresponding Bragg wavelength signal. The proximal, mid-section, and distal elements are connected in series on the same optical fiber and achieve multi-point temperature measurement over a single cable using wavelength division multiplexing technology. The signal cable passing through the PTFE sleeve at this time is a single optical fiber.

[0034] When the sensor type is a T-type thermocouple sensor, there are three T-type thermocouple sensors: the proximal end, the middle section, and the distal end. The output signal of each of the proximal end, the middle section, and the distal end is a corresponding analog voltage signal. Each of the proximal end, the middle section, and the distal end requires two cables to transmit the analog voltage signal. The signal cables passing through the PTFE sleeve at this time are six mutually isolated signal lines.

[0035] It should be noted that while these three T-type thermocouple sensors may have different parameters in principle, they must strictly meet a series of consistency requirements, such as consistency in type and graduation number, cold junction temperature, accuracy class, and circuit independence. In practice, to simplify operation, three T-type thermocouple sensors with identical parameters are usually selected, which will inevitably meet the consistency requirements.

[0036] With the base plane as the top and the plane contacting the recurrent laryngeal nerve as the bottom, the cross-sectional structure of the element area AA corresponding to each temperature sensing element in the central sensing area, from top to bottom, is as follows: a flexible substrate with embedded temperature sensing elements, a thermally insulating microcavity, an insulating and moisture-proof layer, a biocompatible encapsulation layer, and a hydrophilic lubricating coating, such as... Figure 3 The diagram shows a cross-sectional view of the temperature sensing element region AA provided in Embodiment 1 of the present invention.

[0037] The flexible substrate is a polyimide (PI) film with a thickness of 20-30 μm. The thermal insulation microcavity is made of foamed silicone rubber with a porosity of 20%-40% and a thickness of 50-150 μm. The thermal conductivity of the thermal insulation microcavity is less than 0.1 W / (m·K), ensuring that the attenuation ratio of heat conduction from surrounding tissue to the temperature sensing element is not less than 10:1. The insulating and moisture-proof layer is a chemically vapor-deposited poly(chloro-para-xylylene) (Parylene C) film with a thickness of 8-12 μm. The biocompatible encapsulation layer is made of medical-grade silicone rubber with a thickness of 20-50 μm. The hydrophilic lubricating coating is a polyvinylpyrrolidone (PVP) coating with a thickness of 5-15 μm. Additionally, such as... Figure 3 As shown, each of the temperature sensing elements has a vertical slot with a diameter of 1 mm at its center as a corresponding exposure window, which penetrates the thermal insulation microcavity, the insulating moisture-proof layer, the biocompatible encapsulation layer, and the hydrophilic lubricating coating.

[0038] The flexible temperature sensing patch of this invention can effectively attenuate heat conduction from the tissue surrounding the recurrent laryngeal nerve to the temperature sensing element through the "thermal insulation microcavity", thereby reducing the temperature of the tissue / liquid environment surrounding the nerve. Through the design of "thermal insulation microcavity + exposure window", an independent temperature sampling space can be provided for the temperature sensing element, which is isolated from the tissue / liquid environment surrounding the nerve and is only sensitive to the temperature of the recurrent laryngeal nerve tissue.

[0039] It should also be noted that when the flexible temperature sensing patch of this invention is attached to the recurrent laryngeal nerve, it must be attached in the direction of the recurrent laryngeal nerve. This ensures that the three temperature sensing elements are sequentially distributed along the recurrent laryngeal nerve at the proximal, middle, and distal ends. For details, please refer to... Figure 4 The attached position diagram of the flexible temperature sensing patch provided in Embodiment 1 of the present invention is provided for intuitive understanding.

[0040] The early warning module of this invention includes at least an instruction forwarding unit, a position offset early warning unit, a signal anomaly early warning unit, and a high temperature early warning unit.

[0041] The instruction forwarding unit in this embodiment of the invention is used to receive the warning instruction sent by the protection module; and based on the correspondence between the warning type and the three warning units, forward the current warning instruction to its corresponding position offset warning unit, signal abnormality warning unit or high temperature warning unit.

[0042] Here, the warning instruction in this embodiment of the invention includes warning type and warning parameters.

[0043] The warning types include location deviation, signal abnormality, high temperature warning activated, and high temperature warning deactivated.

[0044] When the warning type is location deviation, signal abnormality, or high temperature warning is off, the warning parameters are empty; when the warning type is high temperature warning is on, the warning parameters are level one or level two.

[0045] When the warning type is "position offset," it corresponds to the position offset warning unit of the warning module; that is, the position offset warning unit handles the position offset warning. When the warning type is "signal abnormality," it corresponds to the signal abnormality warning unit of the warning module; that is, the signal abnormality warning unit handles the signal abnormality warning. When the warning type is "high temperature warning on" or "high temperature warning off," it corresponds to the high temperature warning unit of the warning module; that is, the high temperature warning unit handles the on / off operation of the high temperature warning.

[0046] The position offset warning unit in this embodiment of the invention is used to provide text or voice prompts to the surgical operator regarding patch placement position offset upon receiving a warning command of the position offset type. Specifically, when providing text prompts, the position offset warning unit displays text information indicating patch placement position offset to the surgical operator or inspector through a built-in or external text display device. When providing voice prompts, the position offset warning unit plays audio information indicating patch placement position offset to the surgical operator or inspector through a built-in or external microphone.

[0047] The signal anomaly early warning unit of this invention is used to provide a text or voice prompt to the surgical operator regarding signal acquisition abnormalities of the patch sensing element after receiving an early warning command of "signal anomaly" type. Specifically, when providing a text prompt, the unit displays text information indicating the patch signal reception abnormality to the surgical operator or the inspector via a built-in or external text display device. When providing a voice prompt, the unit plays audio information indicating the patch signal reception abnormality to the surgical operator or the inspector via a built-in or external microphone.

[0048] The high-temperature warning unit of this invention is used to identify warning parameters after receiving a warning command indicating that the warning type is high-temperature warning activation. If the warning parameter is level one, the unit's built-in buzzer is invoked based on a preset first buzzer frequency and first buzzer volume to provide a level one buzzer warning. The unit's built-in warning light's illumination color and flashing frequency are first set based on a preset first color and first flashing frequency, and then the warning light flashes to provide a level one light warning. If the warning parameter is level two, the buzzer is invoked based on a preset second buzzer frequency and second buzzer volume to provide a level two buzzer warning. The warning light's illumination color and flashing frequency are first set based on a preset second color and second flashing frequency, and then the warning light flashes to provide a level two light warning.

[0049] Here, in this embodiment of the invention, the first and second buzzer frequencies are two preset buzzer frequency parameters, and the first and second flashing frequencies are two preset warning light flashing frequency parameters, with the first buzzer frequency < the second buzzer frequency and the first flashing frequency < the second flashing frequency. In this embodiment of the invention, the first and second buzzer volumes are two preset buzzer volume parameters, with the first buzzer volume < the second buzzer volume. In this embodiment of the invention, the first and second colors are two preset warning light colors, with the first color defaulting to yellow and the second color defaulting to red.

[0050] The high temperature warning unit in this embodiment of the invention is also used to shut down the currently executing first-level or second-level buzzer warning and the corresponding first-level or second-level light warning after receiving a warning command of the warning type being high temperature warning shutdown.

[0051] The instrument linkage interface of this invention connects to surgical energy instruments and exchanges signals through relay dry contacts or wireless serial communication. It is compatible with the energy control protocols of electrosurgical units and ultrasonic scalpels, and the interface response delay is ≤50ms.

[0052] The energy device in this embodiment of the invention includes at least an electrosurgical unit and an ultrasonic scalpel.

[0053] The high temperature warning levels in this invention include normal, level one, and level two.

[0054] Step 2: During surgery, the protection module periodically obtains three sampled temperatures from the flexible temperature sensing patch at a preset signal sampling frequency; and compares the average of the three sampled temperatures with the current reference temperature x. base The temperature difference is taken as the corresponding temperature x t It also determines whether patch position shift has occurred based on the pairwise temperature differences between the three sampled temperatures; if so, it sets the current temperature x t After zeroing, add it to sequence X and call the early warning module to issue a position offset warning; otherwise, directly set the temperature x. t Add to sequence X.

[0055] Here, the signal sampling frequency in this embodiment of the invention is a pre-set time-frequency parameter, which can be customized based on application requirements; it is typically set to 10Hz. The sequence X in this embodiment of the invention is used to store temperature x. t Each temperature x t Both are relative to the current reference temperature x base The relative temperature, in principle, can have positive or negative values. It should be noted that, in this embodiment of the invention, sequence X is automatically reordered based on its chronological order after each update to ensure the correct temporal sequence.

[0056] The current step 2 specifically includes: Step 21: Periodically obtain three sampling temperatures from the flexible temperature sensing patch according to the preset signal sampling frequency.

[0057] Specifically, it includes: Step 211: Periodically identify the sensor type of the flexible temperature sensing patch according to the signal sampling frequency.

[0058] Step 212: If the sensor type is a fiber Bragg grating sensor, then the three Bragg wavelengths of the proximal, middle and distal elements on the flexible temperature sensing patch are acquired in real time through optical fiber, and the corresponding temperature values ​​are converted for each acquired Bragg wavelength based on the conversion relationship between the Bragg wavelength and temperature of the fiber Bragg grating sensor to obtain the corresponding converted temperature.

[0059] Here, the conversion relationship between the Bragg wavelength and temperature of the fiber Bragg grating sensor in this embodiment of the invention can be simply described as follows: first, the wavelength drift is calculated from the Bragg wavelength; then, the temperature drift is calculated based on the wavelength drift; and finally, the current temperature, i.e., the conversion temperature, is calculated based on the temperature drift and the initial temperature. This is a publicly available conversion mechanism, which can be further refined based on the user manuals of different FBG sensor manufacturers, and will not be elaborated further here.

[0060] Step 213: If the sensor type is a T-type thermocouple sensor, the three analog voltage signals of the proximal, middle and distal ends of the flexible temperature sensing patch are acquired in real time through optical fiber. Each analog voltage signal is then subjected to signal isolation amplification, low-pass filtering with a cutoff frequency of 10Hz and analog-to-digital signal conversion to obtain the corresponding conversion value. Based on the conversion relationship between the T-type thermocouple sensor value and temperature, each conversion value is converted to the corresponding temperature value to obtain the corresponding conversion temperature.

[0061] Here, the conversion relationship between the numerical value of the T-type thermocouple sensor and temperature in this embodiment of the invention is a publicly available conversion method based on a T-type thermocouple calibration table. The corresponding temperature can be obtained by looking up the table. This is a public conversion mechanism, which can be refined based on the user manuals of different thermocouple sensor manufacturers, and will not be elaborated further here.

[0062] Step 214, and use the three conversion temperatures obtained this time as the corresponding three sampling temperatures.

[0063] Step 22: Compare the average temperature of the three sampled temperatures with the current reference temperature x. base The temperature difference is taken as the corresponding temperature x t .

[0064] Step 23, and determine whether patch position shift has occurred based on the pairwise absolute temperature difference of the three sampled temperatures; if so, then x is set to the current temperature. t After zeroing, add it to sequence X and call the early warning module to issue a position offset warning; otherwise, directly set the temperature x. t Add to sequence X.

[0065] In the current step 23, determining whether patch position shift has occurred based on the pairwise absolute temperature difference of the three sampling temperatures specifically includes: calculating the pairwise absolute temperature difference of the three sampling temperatures to obtain the corresponding three first temperature difference values; and identifying whether all three first temperature difference values ​​are less than the preset first temperature difference threshold; if yes, then setting the determination result of patch position shift to no; if no, then setting the determination result of patch position shift to yes.

[0066] Here, the first temperature difference threshold in this embodiment of the invention is a pre-set temperature difference threshold parameter, which can be customized based on application requirements. Under normal circumstances, it is set to 2℃.

[0067] In the current step 23, the early warning module is invoked to issue a position offset warning. Specifically, the protection module sets the warning type to position offset and sets the warning parameters to empty; and sends the corresponding warning command composed of the warning type and warning parameters to the early warning module.

[0068] Step 3: The protection module, each time sequence X completes a temperature addition, will update the most recent N... win Temperature x t The median temperature is taken as the corresponding temperature y. t Add to sequence Y; and based on the current temperature y t and its corresponding temperature y t-1 Calculate the corresponding rate of change z t Add to sequence Z; and set the current reference temperature x base As the corresponding reference temperature x base,t Add to sequence X base.

[0069] Here, the sliding window width N is preset in the embodiment of the present invention. win It is an odd number greater than 3, which can be customized based on application requirements, but is usually set to 5.

[0070] The rate of change z in the embodiments of the present invention t The calculation method is as follows: z t =(y t -y t-1 ) / △t. Where △t is the sampling interval, △t = 1 / signal sampling frequency, and the unit of △t is milliseconds. When the signal sampling frequency is 10Hz, the corresponding sampling interval △t is 0.1 seconds, approximately equal to 0.0016667 minutes.

[0071] Sequence Y in this embodiment of the invention is used to store temperature y t Each temperature y t This is a median filtered temperature, which is also a relative temperature relative to a reference temperature. In this embodiment of the invention, the sequence Z is used to store the rate of change z. t Each rate of change z t This represents a median filtered rate of temperature change. The sequence X in this embodiment of the invention... base Used to store reference temperature x base,t Each reference temperature x base,t Its corresponding current reference temperature x at time t base .

[0072] It should be noted that the sequences Y, Z, and X in the embodiments of the present invention base After each update, the sequence is automatically reordered based on the chronological order to ensure the correct temporal order.

[0073] Step 4: The protection module periodically adjusts the current reference temperature x according to the current sequence Y at a preset reference calibration frequency. base Perform a calibration and update sequence X based on the calibration results. base .

[0074] Specifically, this includes: periodically adjusting the temperatures y in the current sequence Y that are within the most recent first time interval according to the baseline calibration frequency. t Extract the data to form the current sequence; and set the current reference temperature x. base As the corresponding reference temperature x base,pre The system identifies the maximum and minimum temperatures within the current sequence; calculates the temperature difference between the maximum and minimum temperatures to obtain a second temperature difference; and checks whether the second temperature difference is less than a preset second temperature difference threshold. If so, it compares the average temperature of the current sequence with the previous reference temperature x. base,pre The sum is taken as the latest current reference temperature x baseand sequence X base Middle and previous reference temperature x base,pre Corresponding reference temperature x base,t Reset to the latest current reference temperature x base .

[0075] Here, the reference calibration frequency in this embodiment of the invention is a preset time frequency parameter, which can be customized based on application requirements. Normally, it is set to 0.2Hz, i.e., once every 5 seconds. The first duration in this embodiment of the invention is a preset time length parameter, which can be customized based on application requirements. Normally, it is set to 1 second. The second temperature difference threshold in this embodiment of the invention is a preset temperature difference threshold parameter, which can be customized based on application requirements. Normally, it is set to 2℃.

[0076] Step 5: Each time the rate of change in sequence Z is added, the protection module will update the rate of change z added in that iteration. t The current rate of change is used as the current rate of change; based on the current rate of change, it is determined whether there is a patch signal anomaly; if a patch signal anomaly occurs, the early warning module is invoked to issue a signal anomaly warning, and the temperature y corresponding to the current rate of change in sequence Y is set. t Reset to the corresponding temperature y t-1 And based on the reset sequence Y, the corresponding rate of change z in sequence Z. t and sequence X base The corresponding reference temperature x base,t Perform a reset; if no abnormal patch signal occurs, further determine whether rapid temperature rise has occurred based on the current rate of change.

[0077] Specifically, it includes: Step 51: Each time the rate of change of sequence Z is added, the rate of change z added in that step is recorded. t As the current rate of change.

[0078] Step 52, and confirm whether there is an abnormal patch signal based on the current rate of change.

[0079] Specifically, this includes: identifying whether the current rate of change exceeds a preset first rate of change threshold; if yes, setting the judgment result of an abnormal patch signal to yes; if no, setting the judgment result of an abnormal patch signal to no.

[0080] Here, the first rate of change threshold in this embodiment of the invention is a pre-set rate of change parameter, which can be customized based on application requirements. Under normal circumstances, it is set to 20°C / second.

[0081] Step 53: If a patch signal abnormality occurs, the early warning module is invoked to issue a signal abnormality warning, and the temperature y corresponding to the current rate of change in sequence Y is set. t Reset to the corresponding temperature yt-1 And based on the reset sequence Y, the corresponding rate of change z in sequence Z. t and sequence X base The corresponding reference temperature x base,t Reset.

[0082] Specifically, the alarm module is invoked to issue an alarm for signal anomalies. This includes the protection module setting the alarm type to signal anomaly and the alarm parameters to empty; and sending the corresponding alarm command, composed of the alarm type and alarm parameters, to the alarm module.

[0083] Step 54: If no abnormality occurs in the patch signal, further determine whether rapid heating has occurred based on the current rate of change.

[0084] Specifically, this includes: identifying whether the current rate of change is greater than a preset second rate of change threshold; if yes, then setting the judgment result of rapid heating to yes; if no, then setting the judgment result of rapid heating to no.

[0085] Here, the second rate of change threshold in this embodiment of the invention is a pre-set rate of change parameter. The second rate of change threshold is less than the first rate of change threshold. Its specific value can be customized based on application requirements. Under normal circumstances, it is set to 2℃ / second.

[0086] Step 6: Upon confirming a rapid temperature rise, the protection module calculates the compensation temperature based on the first-order heat conduction model and sequence Y, and then calculates the compensation temperature based on the results of the compensation temperature calculation and sequence X. base Perform corrected temperature calculations and update sequence X based on the corrected temperature calculation results. real Based on the CEM43 cumulative heating dose increment function, the equivalent minutes are calculated according to the corrected temperature calculation results, and sequence M is updated based on the equivalent minutes calculation results; and based on sequence X... real M sets a high temperature warning level.

[0087] Here, sequence X of the present invention embodiment real Used to store correction temperature x real,t Each corrected temperature x real,t All corrections are based on compensated temperature, and their temperature values ​​are absolute temperatures, not relative temperatures. In this embodiment of the invention, sequence M is used to store the equivalent number of minutes m. t Each equivalent minute m t All are equivalent to one CEM43 minute. It should be noted that sequence X in this embodiment of the invention... real After each update, M will automatically reorder the sequences based on their chronological order to ensure the correct temporal sequence.

[0088] The current step 6 specifically includes: Step 61: Upon confirmation of a rapid temperature rise, calculate the compensation temperature based on the first-order heat conduction model according to sequence Y, and then calculate the compensation temperature based on the results of the compensation temperature calculation and sequence X. base Perform corrected temperature calculations and update sequence X based on the corrected temperature calculation results. real Based on the CEM43 cumulative heating dose increment function, the equivalent minutes are calculated according to the corrected temperature calculation results, and the sequence M is updated based on the equivalent minutes calculation results.

[0089] Specifically, it includes: Step 611, select the temperature y in sequence Y that is within the second most recent time period. t Extracted to form the sampling sequence Y samp .

[0090] Here, the second duration in this embodiment of the invention is a pre-set time length parameter, which can be customized based on application requirements, and is normally set to 1 second. The temperatures y of the current subsequence in this embodiment of the invention... t Let y be the corresponding temperature. i 1 ≤ index i ≤ total number of samples N samp N samp =(Second duration / △t)+1.

[0091] Step 612: Calculate the temperatures y based on the sequence Y using a first-order heat conduction model. i The corresponding compensation temperature Δy i .

[0092] Specifically: [The text abruptly ends here, likely due to an incomplete sentence or a formatting error.] i As the final temperature y end ; and will end at temperature y end The corresponding sampling time is recorded as the end time, and the corresponding start time is calculated as end time - second duration; the temperature y corresponding to the start time in sequence Y is then recorded. t As the starting temperature y start ; and the initial temperature y start End temperature y end The second duration and the preset future duration are substituted into the first-order heat conduction model to calculate the corresponding compensation temperature Δy. i .

[0093] Here, the first-order heat conduction model of this invention is: .

[0094] The future duration in this embodiment of the invention is a pre-set time length parameter, which can be customized based on application requirements. Under normal circumstances, it is set to 0.05 seconds.

[0095] Step 613, sequence X baseIn and at various temperatures y i Corresponding reference temperature x base,t Let it be x base,i ; and based on each temperature y i and its corresponding reference temperature x base,i and compensation temperature △y i Calculate the corresponding corrected temperature x real,i .

[0096] Here, the embodiment of the present invention corrects the temperature x. real,i The calculation method is as follows: ; Step 614, and then use the various corrected temperatures x obtained this time. real,i The current corrected temperature is used as the current time; and the sampling time corresponding to the current corrected temperature is used as the current time; and the sequence X is... real Is there a corrected temperature x corresponding to the current moment? real,t Perform identification; if any exist, then adjust the corresponding correction temperature x based on the current correction temperature. real,t Perform a reset; if not, use the current corrected temperature as the new corrected temperature x. real,t Add to sequence X real middle.

[0097] Step 615, based on the CEM43 cumulative heating dose increment function, according to the sampling interval Δt and the N obtained this time... samp Corrected temperature x real,i Estimate the corresponding equivalent number of minutes, m.

[0098] Here, the cumulative heating dose increment function of CEM43 in this embodiment of the invention is: , ; R i The unit is temperature coefficient, the unit of equivalent minutes m is minutes, and the unit of sampling interval Δt is seconds.

[0099] Since the units of m and Δt are minutes and seconds respectively, the function needs to convert the units by Δt / 60.

[0100] It should also be noted that the lower limit of summation for the CEM43 cumulative heating dose increment function is i=2, not i=1. This is because each term in the CEM43 cumulative heating dose increment function... Both represent the increase in heat dose within the complete sampling interval from the previous sampling time to the current sampling time. Since the starting sampling point (i=1) does not have a corresponding previous sampling time, it cannot form a complete increment calculation interval; therefore, in this embodiment of the invention, the accumulation starts from i=2 to ensure that each term in the summation corresponds to an effective sampling period Δt, thereby ensuring the physical rationality and mathematical rigor of the heat dose accumulation calculation.

[0101] Step 616: Take the equivalent minutes m obtained this time as the corresponding equivalent minutes m t Add to sequence M.

[0102] It should be noted that the equivalent minutes m in this embodiment of the invention can be seen from the calculation method of the CEM43 cumulative heating dose increment function in step 615. t This is the result of local heat dose accumulation within a sliding time window, not the result of global continuous heat dose accumulation. The width of the sliding time window is the second duration. This design is made so that sequence X... real The changing trends of M are positively correlated, making synchronous observation convenient; on the other hand, the difference between two consecutive measurements of m can be used to measure the changes. t -m t-1 The trend of heat dose accumulation decreasing, remaining flat, or increasing at time t is observed, and this will be used as a branch for determining whether the high temperature warning can be turned off in subsequent step 81.

[0103] Step 62, based on sequence X real M sets a high temperature warning level.

[0104] Specifically, it includes: Step 621, sequence X real The corrected temperature x in sequence M corresponding to the current time. real,t Equivalent minutes (m) t Extract it as the corresponding current temperature Current number of minutes .

[0105] Step 622, and the current temperature and current minutes Perform identification.

[0106] Step 623, if the current temperature The temperature is less than the preset first temperature threshold and the current number of minutes If the number of minutes is less than the preset threshold, the corresponding high temperature warning level is set to normal.

[0107] Here, the first temperature threshold in this embodiment of the invention is a pre-set temperature parameter, which is >37°C; its specific value can be customized based on application requirements, and is typically set to 40°C. The first minute threshold in this embodiment of the invention is a pre-set CEM43 equivalent minute threshold, and its specific value can be customized based on application requirements, and is typically set to 0.01 minutes.

[0108] Step 624, if the current temperature Greater than or equal to the first temperature threshold and less than the preset second temperature threshold, or the current number of minutes. If the number of minutes is greater than or equal to the preset second minute threshold, then the corresponding high temperature warning level is set to Level 1.

[0109] Here, the second temperature threshold in this embodiment of the invention is a pre-set temperature parameter, where the first temperature threshold is less than the second temperature threshold; its specific value can be customized based on application requirements, and is typically set to 43°C. The second minute threshold in this embodiment of the invention is a pre-set CEM43 equivalent minute threshold, where the first minute threshold is less than the second minute threshold; its specific value can be customized based on application requirements, and is typically set to 0.05 minutes.

[0110] Step 625, if the current temperature If the temperature is greater than or equal to a preset third temperature threshold, then for sequence X... real All corrected temperatures x within the most recent third time period real,t The system identifies whether all temperatures are greater than or equal to the third temperature threshold. If so, the corresponding high-temperature duration is marked as continuous; otherwise, it is marked as non-continuous. If the high-temperature duration is marked as continuous, or if the current number of minutes is... If the number of minutes is greater than or equal to the preset threshold for the third minute, then the corresponding high temperature warning level is set to Level II.

[0111] Here, the third duration in this embodiment of the invention is a pre-set time length parameter, the specific value of which can be customized based on application requirements, and is typically set to 0.5 seconds. The third temperature threshold in this embodiment of the invention is a pre-set temperature parameter, where the second temperature threshold is less than the third temperature threshold; its specific value can be customized based on application requirements, and is typically set to 45°C. The third minute threshold in this embodiment of the invention is a pre-set CEM43 equivalent minute threshold, where the second minute threshold is less than the third minute threshold; its specific value can be customized based on application requirements, and is typically set to 0.1 minutes.

[0112] Step 7: When the high temperature warning level switches from normal to level 1 or level 2, the protection module calls the warning module to activate the high temperature warning and calls the device linkage interface to perform device linkage control.

[0113] In the current step 7, the warning module is invoked to activate the high temperature warning. Specifically, the protection module sets the warning type to high temperature warning activated and sets the warning parameters to the corresponding high temperature warning level; and sends the corresponding warning command composed of the warning type and warning parameters to the warning module.

[0114] In step 7, the device linkage interface is invoked for device linkage control. Specifically, this includes the protection module sending a linkage control command to the device linkage interface. Upon receiving the linkage control command, the device linkage interface controls the local tissue heat diffusion effect caused by the thermal operation of the energy device by sending a stop heating command to the energy device; and provides text or voice prompts to the surgical operator to pause the thermal operation and provide flushing and cooling reminders.

[0115] Step 8: When the high temperature warning level is not at the normal level, the protection module continuously monitors sequence X. real The system uses M to determine whether the high-temperature warning can be turned off; and if it is confirmed that it can be turned off, the high-temperature warning level is reset to normal, and the warning module is invoked to turn off the high-temperature warning.

[0116] Specifically, it includes: Step 81: When the high temperature warning level is not at the normal level, continuously observe sequence X. real The system uses M to determine whether the high-temperature warning can be turned off.

[0117] Specifically, this includes: adding an equivalent minute m to sequence M. t At that time, the current equivalent number of minutes m will be used. t As the current equivalent minutes; and the previous equivalent minutes m of the current equivalent minutes. t-1 As the corresponding previous equivalent minutes; and calculate the equivalent fraction difference = current equivalent minutes - previous equivalent minutes; and then set sequence X real Corrected temperature x corresponding to the current equivalent number of minutes real,t The current correction temperature is used as the reference temperature; the equivalent fraction difference and the current correction temperature are identified; if the equivalent fraction difference is less than or equal to 0 and the current correction temperature is less than the preset fourth temperature threshold, it is confirmed that the high temperature warning can be turned off; if the equivalent fraction difference is greater than 0 or the current correction temperature is greater than or equal to the fourth temperature threshold, it is confirmed that the high temperature warning cannot be turned off.

[0118] Here, the fourth temperature threshold in this embodiment of the invention is a pre-set temperature parameter, 37℃ < fourth temperature threshold < first temperature threshold; its specific value can be customized based on application requirements, and is typically set to 38℃. If the equivalent fraction difference is less than or equal to 0, it indicates that the thermal energy of the environment surrounding the nerve has not increased; if the current corrected temperature is less than the fourth temperature threshold, it indicates that the temperature of the recurrent laryngeal nerve has dropped below 38℃; if the equivalent fraction difference is less than or equal to 0 and the current corrected temperature is less than the fourth temperature threshold, it indicates that the thermal energy of the environment surrounding the recurrent laryngeal nerve has not increased or has even decreased, and since the temperature of the recurrent laryngeal nerve has dropped below 38℃, there is no risk of thermal damage to the recurrent laryngeal nerve, and the high-temperature warning can be turned off. Conversely, if the equivalent fraction difference is greater than 0, it indicates that the thermal energy of the environment surrounding the nerve has increased; if the current corrected temperature is greater than or equal to the fourth temperature threshold, it indicates that the temperature of the recurrent laryngeal nerve has not yet dropped below 38℃; if the equivalent fraction difference is greater than 0 or the current corrected temperature is greater than or equal to the fourth temperature threshold, it indicates that there is still a risk of increased thermal energy around the recurrent laryngeal nerve, and there is a risk of thermal damage to the recurrent laryngeal nerve, so the high-temperature warning cannot be turned off.

[0119] Step 82, and when it is confirmed that it can be turned off, reset the high temperature warning level to normal and call the warning module to turn off the high temperature warning.

[0120] Specifically, calling the early warning module to disable the high temperature warning includes: the protection module setting the warning type to high temperature warning disabled and setting the warning parameters to empty; and sending the corresponding warning command composed of the warning type and warning parameters to the early warning module.

[0121] It should be noted that the protection module in this embodiment of the invention can also be connected to a surgical monitoring terminal to transmit the six sequences X, Y, Z, X... base X real Part or all of the sequences in M ​​are synchronized with the surgical monitoring terminal as real-time monitoring curves. The surgical monitoring terminal uses the corresponding curve of sequence X or X+X... base The summation curve can be used to observe the mean sampling temperature of the recurrent laryngeal nerve in real time; through the corresponding curve of sequence Y or Y+X base The summation curve allows for real-time observation of the filtered sampled temperature after median filtering; the corresponding curve for sequence Z allows for real-time observation of the temperature change rate of the recurrent laryngeal nerve; and the curve for sequence X... base The corresponding curve allows for real-time observation of the drift state of the reference temperature; through sequence X... real The corresponding curve allows for real-time monitoring of the temperature of the recurrent laryngeal nerve after temperature compensation; the CEM43 equivalent minutes of the recurrent laryngeal nerve can be monitored in real-time using the corresponding curve of sequence M. The surgical monitoring terminal can also perform monitoring and early warning based on the real-time curve, using mechanisms similar to those in the protection module, such as positional deviation, signal anomalies, and high-temperature warnings.

[0122] It should also be noted that the protection module in this embodiment of the invention can further construct a component acquisition sequence corresponding one-to-one with the three temperature sensing elements, and store the raw acquisition data of the temperature sensing elements through the component acquisition sequence. The protection module can also synchronize the three component acquisition sequences as real-time monitoring curves with the surgical monitoring terminal. The surgical monitoring terminal can also observe the temperature acquisition status of the elements in real time through the corresponding curves of the three component acquisition sequences.

[0123] It should also be noted that the flexible temperature sensing patch of this invention can be industrially manufactured through contract manufacturing or prepared in a laboratory setting. The preparation process can be customized based on industrial or laboratory preparation methods. This invention provides one preparation process for a patch using a fiber Bragg grating sensor as the temperature sensing element, as shown below.

[0124] Step A1, sensor preprocessing, specifically: clean the grating area of ​​the three fiber Bragg grating sensors connected in series on the same optical fiber with anhydrous ethanol, and apply UV-curing acrylate adhesive 1 mm away from the sensor edge on both sides of the grating area of ​​each sensor to form a stress isolation zone.

[0125] Step A2, substrate preparation, specifically: a 25μm polyimide film is laser-cut into an I-shape to serve as a flexible substrate. Three sensor embedding slots are equally spaced on the central sensing area of ​​the substrate, and two positioning holes with a diameter of 0.8mm are drilled on the fixing areas of the two end flaps.

[0126] Step A3, sensor fixation, specifically: embed the three fiber Bragg grating sensors into their respective embedding slots, and fix the sensors with refractive index matching UV curing adhesive.

[0127] Here, the refractive index-matching UV-curable adhesive is an adhesive that undergoes a cross-linking reaction and changes from a liquid to a solid state under irradiation with UV light of a specific wavelength. In this embodiment of the invention, the specific wavelength of UV light corresponding to the refractive index-matching UV-curable adhesive is 365nm UV light, and the curing time is 30 seconds.

[0128] Step A4, fabrication of the thermal insulation microcavity, specifically: setting up three corresponding exposure window spaces for the three fiber Bragg grating sensors, and depositing and dispersing foamed silicone rubber with a thickness of 100μm and a porosity of 30% around the three exposure window spaces on the substrate using a micro-injection process to generate a thermal insulation microcavity structure, and curing it at room temperature for 2 hours.

[0129] Step A5, fabrication of the insulating and moisture-proof layer, specifically: a 10μm thick Parylene C film is generated as an insulating and moisture-proof layer on all patch surface areas except for the three exposed window spaces by chemical vapor deposition.

[0130] Step A6, biocompatible encapsulation, specifically involves: first, immersing the entire patch in medical-grade silicone rubber Nusil MED-6015 with a coating thickness of 30μm, and then removing the silicone from the three exposed window spaces using laser ablation to re-expose the grating.

[0131] Step A7, hydrophilic lubricating coating preparation, specifically: applying PVP solution to the outer surface of the patch and the window edges of the three exposed windows, and forming a hydrophilic lubricating coating after drying.

[0132] Step A8, fiber optic connector connection, specifically: fix a PTFE sleeve on one side wing fixing area, and lead the optical fiber of the three fiber Bragg grating sensors in series out from the PTFE sleeve, and install an FC / APC connector on the other end of the optical fiber leading out of the PTFE sleeve so that it can communicate with the protection module based on the connector.

[0133] Step A9, sterilization and packaging treatment, specifically: First, sterilize the encapsulated flexible temperature sensing patch with ethylene oxide at a temperature of 55℃ and a humidity of 50% for 12 hours; then, desorb the sterilized flexible temperature sensing patch for 48 hours to ensure that the residual ethylene oxide on the patch surface reaches a safe level; finally, package the desorbed flexible temperature sensing patch using aseptic packaging.

[0134] It should also be noted that the flexible temperature sensing patch of this invention requires quality inspection after fabrication. The inspection rules can be customized based on industrial or laboratory fabrication inspection rules. One set of inspection rules is provided in this invention embodiment, as shown below: 1) Insulation withstand voltage test: The flexible temperature sensing patch is completely immersed in physiological saline, and a 500V DC high voltage is applied between the internal wires of the patch sensor and the saline. The leakage current generated under this high voltage is measured simultaneously. If the leakage current is <5μA, it is considered qualified; otherwise, it is considered unqualified.

[0135] 2) Response Time Test: The flexible temperature sensing patch is first placed in a 37°C constant temperature water bath. After the temperature stabilizes, it is quickly transferred to another 45°C constant temperature water bath, and the entire temperature change process is recorded. Based on the recorded process, the time required for the patch temperature reading to change by 63.2% is calculated, and the calculation result is used as the response time indicator. If the response time indicator is <0.2 seconds, it is considered qualified; otherwise, it is considered unqualified.

[0136] 3) Bending durability test: The flexible temperature sensing patch is repeatedly bent around a cylinder with a diameter of 10 mm, and the number of bending times is 1000. The temperature error of the sensor before and after the bending test is measured. If the temperature error is between ±0.5°C, it is considered qualified; otherwise, it is considered unqualified.

[0137] 4) Biocompatibility test: The test is carried out based on a series of tests of ISO-10993, such as cytotoxicity test, sensitization test, irritation test, etc. If all series of tests of ISO-10993 are passed, it is considered qualified; otherwise, it is considered unqualified.

[0138] 5) Sterility test: Aseptic culture verification is performed on the flexible temperature sensing patch. If the Sterility Assurance Level (SAL) reaches 10 -6 it is considered qualified; otherwise, it is considered unqualified.

[0139] It should also be noted that since the flexible temperature sensing patch is used in surgical scenarios and needs to be implanted into the human internal environment, in order to ensure the safety of the patch during use, it is also necessary to standardize the preoperative, intraoperative and postoperative operation guidelines for the flexible temperature sensing patch. These guidelines can be customized in combination with the specific surgical guidelines of specific hospitals. A set of customized preoperative, intraoperative and postoperative operation guidelines is given in the embodiment of the present invention, as shown below.

[0140] The preoperative operation guidelines include at least the following operation requirements. 1) Aseptic packaging opening requirement: Before the start of the operation, the nurse opens the sterile packaging bag of the flexible temperature sensing patch, takes out the patch and places it in a sterile kidney basin. The whole operation follows the aseptic technical specification, and the patch must not contact non-sterile items after being taken out of the packaging. 2) Integrity inspection requirement: First visually inspect the integrity of the patch, and then inspect the following items one by one: the biocompatible encapsulation layer is free of damage and cracks; the exposure window is clean, transparent and free of obstructions; the PTFE sleeve is intact, and the optical fiber lead drawn out from the PTFE sleeve is not broken; the positioning hole in the flap fixing area is intact and free of deformation. 3) System self-inspection requirement: First connect the flexible temperature sensing patch and the protection module through an optical fiber connector, and then inspect the following items one by one: detect the light source power, grating reflection signal intensity and zero point calibration capability of the fiber Bragg grating sensor. 4) Skin contact temperature verification requirement: Gently touch the dorsal skin of the operator's hand or sterile warm saline gauze (temperature about 37°C) with the plane of the exposure window end of the fiber Bragg grating sensor, and observe whether the temperature reading obtained by the protection module is within the normal reading range, which is 36-38°C. 5) Auxiliary consumables preparation requirement: Prepare the following auxiliary consumables and place them in a position easily accessible to the operator: warm normal saline cotton sheets used for moistening the nerve surface during the operation and moistening the patch edge after the operation, and miniature fixing clips or medical silica gel adhesive for fixing the flap.

[0141] Intraoperative procedures include intraoperative patching guidelines and intraoperative coordination guidelines.

[0142] Intraoperative patching guidelines should include at least the following operational requirements: 1) Anatomical requirements: During thyroidectomy, the surgeon should dissect the tracheoesophageal groove to fully expose the recurrent laryngeal nerve. The exposure area should cover the segment of the nerve from its entry point into the larynx to its crossing with the inferior thyroid artery, typically 15-20 mm in length, to ensure that the central sensing area of ​​the patch completely covers the critical segment of the nerve. 2) Nerve moistening requirements: Gently wipe the nerve surface with a cotton swab soaked in warm saline to remove blood and tissue fluid, while simultaneously moistening the nerve surface to reduce the air gap between the patch and the nerve. Handle the operation gently to avoid traction or compression of the nerve. 3) Patch application requirements: Gently lift the connective tissue lateral to the nerve using toothless forceps (this must be connective tissue, not the nerve itself); and holding the patch wings, slowly lower the patch with the exposure window of the central sensing area aligned with the nerve surface. Ensure that the long axis of the patch is aligned with the course of the recurrent laryngeal nerve, so that the gratings of the three fiber Bragg grating sensors cover the proximal, mid-segment, and distal ends of the nerve, respectively. Ensure the exposure window directly contacts the nerve surface. Insulated microcavities are located around the window to block thermal interference from surrounding tissues. The wing fixation area is laid flat on the connective tissue sheaths on both sides of the nerve. 4) Wing Fixation Requirements: After confirming the patch is in place, use either mechanical or adhesive fixation. Mechanical fixation involves using a miniature fixation clip through the positioning hole on the wing to clamp and fix the fascia tissue surrounding the nerve. At least one fixation clip should be used for each wing. Adhesive fixation involves applying medical silicone adhesive to the lower surface of the wing and attaching it to the connective tissue adjacent to the nerve. The fixation principle is: apply force only to the wing fixation area; never apply any pressure to the central sensing area. The patch's dual fixation point design ensures the patch will not shift during intraoperative irrigation, suction, or other procedures. 5) Verification Requirements: After application, observe whether the temperature reading obtained by the protective module is within the normal range. If the reading is below 35℃, it indicates an air gap between the patch and the nerve, requiring reapplication. If the reading is above 39℃, it suggests potential local inflammation or damage during the procedure, necessitating a nerve examination before proceeding. 6) Lead fixing requirements: After confirming the temperature reading is normal, lead the fiber optic lead along the edge of the surgical field and secure it to the skin incision edge with sutures or tape to prevent patch displacement due to intraoperative traction. The lead path should avoid the operating area of ​​the energy device to prevent accidental damage to the fiber optic during the procedure.

[0143] The intraoperative coordination guidelines should include at least the following operational requirements: 1) Normal operation requirements: After the patch is applied and the readings are confirmed to be normal, the surgeon can begin using the energy device for procedures such as thyroidectomy and lymph node dissection. At this time, the protection module continuously collects temperature data at a frequency of 10Hz; the distance between the working end of the energy device and the recurrent laryngeal nerve is maintained at a safe distance of ≥2mm; the high temperature warning level of the protection module is normal and no warning is output. 2) Warning trigger operation requirements: After the working end of the energy device approaches the recurrent laryngeal nerve area and enters within a safe distance, heat diffusion causes the nerve surface temperature to gradually rise. The protection module activates the warning after the high temperature warning level rises to level one or two. The warning prompts the surgeon to suspend the heating operation and rinse with room temperature saline to cool down, and sends a stop heating command to the energy device to control the local tissue heat diffusion effect caused by the energy device. 3) Rinsing and cooling operation requirements: After temporarily suspending the energy device operation, the surgeon rinses the nerve surface with room temperature saline to cool down. When the protection module releases the warning, the energy device is restored to standby mode, and the surgeon continues the surgical operation.

[0144] Postoperative procedures should include at least the following requirements: 1) Initiation of patch removal: After thyroidectomy, if all energy device procedures have been completed and there is no active bleeding in the surgical field, patch removal can be initiated. 2) Edge moistening: Thoroughly moisten the edges and wing of the patch with warm saline-soaked cotton pads for approximately 10-15 seconds; use miniature fixation clips or medical silicone adhesive to reduce adhesion between the patch and the tissue. 3) Parallel removal: Hold the wing fixation area with toothless forceps and gently and evenly remove the patch parallel to the course of the recurrent laryngeal nerve. During removal, maintain an angle of no more than 30° between the patch and the nerve surface, gradually lifting rather than tearing it off in one go. 4) Nerve Surface Examination Requirements: After patch removal, carefully examine the nerve surface using a surgical magnifying glass or head-mounted magnifying glass. The examination includes: checking for indentations (no indentations indicate no prolonged pressure on the nerve during patch fixation); checking for adhesions (no adhesions indicate no abnormal adhesion between the patch encapsulation layer and the nerve sheath); and checking for bleeding (no bleeding indicates intact blood vessels on the nerve surface and no iatrogenic bleeding). 5) Patch Integrity Inspection Requirements: Check that all three fiber Bragg grating sensors are intact; check that the biocompatible encapsulation layer is free of tears and perforations; check that the PTFE sheath is intact and that the fiber optic leads from the PTFE sheath are not broken. 6) Disposal and Report Generation Requirements: After confirming that the patch has been completely removed and the nerve is in good condition, dispose of the patch as disposable medical waste according to regulations, placing it in a yellow medical waste bag.

[0145] Figure 5This is a module structure diagram of a processing device for protecting the recurrent laryngeal nerve from thermal damage based on a flexible temperature-sensing patch, provided in Embodiment 2 of the present invention. This device can be a terminal device or server implementing the aforementioned method embodiment, or it can be a device that enables the aforementioned terminal device or server to implement the aforementioned method embodiment. For example, the device can be a device or chip system of the aforementioned terminal device or server. Figure 5 As shown, the device 200 includes: a protection module 2001, an early warning module 2002, and a device linkage interface 2003.

[0146] The protection module 2001 is used to establish a data communication connection with the flexible temperature sensing patch 100 attached to the recurrent laryngeal nerve before surgery; and to connect with the early warning module 2002 and the instrument linkage interface 2003; and to initialize the current reference temperature x. base The temperature was set to 37℃; the high-temperature warning level was initialized to normal; and six empty sequences were initialized as the corresponding sequences X, Y, Z, X... base X real M; the flexible temperature sensing patch 100 has three built-in temperature sensing elements; the instrument linkage interface 2003 is also connected to the energy instrument 300 used in surgery; the energy instrument 300 includes at least an electrosurgical unit and an ultrasonic scalpel; the high temperature warning levels include normal, level one, and level two.

[0147] The protection module 2001 is also used to periodically obtain three sampled temperatures from the flexible temperature sensing patch 100 at a preset signal sampling frequency during surgery; and to compare the average temperature of the three sampled temperatures with the current reference temperature x. base The temperature difference is taken as the corresponding temperature x t It also determines whether patch position shift has occurred based on the pairwise absolute temperature difference between the three sampled temperatures; if so, it sets the current temperature x t After zeroing, add it to sequence X and call the early warning module 2002 to issue a position offset warning; otherwise, directly set the temperature x. t Add to sequence X.

[0148] The protection module 2001 is also used to, each time a temperature addition is completed in sequence X, update the most recent N... win Temperature x t The median temperature is taken as the corresponding temperature y. t Add to sequence Y; and based on the current temperature y t and its corresponding temperature y t-1 Calculate the corresponding rate of change z t Add to sequence Z; and set the current reference temperature x base As the corresponding reference temperature x base,t Add to sequence X base Preset sliding window width N win z is an odd number greater than 3;t =(y t -y t-1 ) / △t, where △t is the sampling interval, △t=1 / signal sampling frequency.

[0149] The protection module 2001 is also used to periodically adjust the current reference temperature x according to the current sequence Y at a preset reference calibration frequency. base Perform a calibration and update sequence X based on the calibration results. base .

[0150] The protection module 2001 is also used to, each time the rate of change of sequence Z is added, record the rate of change z added in that iteration. t The current rate of change is used as the current rate of change; based on the current rate of change, it is determined whether there is a patch signal abnormality; if a patch signal abnormality occurs, the early warning module 2002 is invoked to issue a signal abnormality early warning, and the temperature y corresponding to the current rate of change in sequence Y is set. t Reset to the corresponding temperature y t-1 And based on the reset sequence Y, the corresponding rate of change z in sequence Z. t and sequence X base The corresponding reference temperature x base,t Perform a reset; if no abnormal patch signal occurs, further determine whether rapid temperature rise has occurred based on the current rate of change.

[0151] The protection module 2001 is also used to calculate the compensation temperature based on the first-order heat conduction model according to sequence Y when a rapid temperature rise is confirmed, and to calculate the compensation temperature based on the result of the compensation temperature calculation and sequence X. base Perform corrected temperature calculations and update sequence X based on the corrected temperature calculation results. real Based on the CEM43 cumulative heating dose increment function, the equivalent minutes are calculated according to the corrected temperature calculation results, and sequence M is updated based on the equivalent minutes calculation results; and based on sequence X... real M sets a high temperature warning level.

[0152] The protection module 2001 is also used to call the warning module 2002 to activate the high temperature warning when the high temperature warning level switches from normal to level one or level two, and to call the instrument linkage interface 2003 to perform instrument linkage control.

[0153] The protection module 2001 is also used to continuously monitor sequence X when the high temperature warning level is not at the normal level. real The system uses M to determine whether the high-temperature warning can be turned off; and when it is confirmed that it can be turned off, the high-temperature warning level is reset to normal, and the warning module 2002 is called to turn off the high-temperature warning.

[0154] The present invention provides a treatment device for protecting the recurrent laryngeal nerve from thermal damage based on a flexible temperature sensing patch. It can perform the method steps in the above method embodiments, and its implementation principle and technical effect are similar, so they will not be described again here.

[0155] It should be noted that the division of the various modules in the above device is merely a logical functional division. In actual implementation, they can be fully or partially integrated into a single physical entity, or they can be physically separated. Furthermore, these modules can be implemented entirely in software via processing element calls; they can be fully implemented in hardware; or some modules can be implemented by processing element calls to software, while others are implemented in hardware. For example, the protection module can be a separate processing element, or it can be integrated into a chip in the above device. Alternatively, it can be stored as program code in the memory of the above device, and called and executed by a processing element of the device. The implementation of other modules is similar. Moreover, these modules can be fully or partially integrated together, or they can be implemented independently. The processing element described here can be an integrated circuit with signal processing capabilities. In the implementation process, each step of the above method or each of the above modules can be completed through integrated logic circuits in the hardware of the processor element or through software instructions.

[0156] For example, these modules can be one or more integrated circuits configured to implement the above methods, such as one or more Application Specific Integrated Circuits (ASICs), one or more Digital Signal Processors (DSPs), or one or more Field Programmable Gate Arrays (FPGAs). As another example, when a module is implemented using processing element scheduler code, the processing element can be a general-purpose processor, such as a Central Processing Unit (CPU) or other processor capable of calling program code. Furthermore, these modules can be integrated together as a System-on-a-Chip (SOC).

[0157] In the above embodiments, implementation can be achieved, in whole or in part, through software, hardware, firmware, or any combination thereof. When implemented in software, it can be implemented, in whole or in part, as a computer program product. This computer program product includes one or more computer instructions. When these computer program instructions are loaded and executed on a computer, all or part of the processes or functions described in the foregoing method embodiments are generated. The computer described above can be a general-purpose computer, a special-purpose computer, a computer network, or other programmable device. The aforementioned computer instructions can be stored in a computer-readable storage medium or transmitted from one computer-readable storage medium to another. For example, the aforementioned computer instructions can be transmitted from one website, computer, server, or data center to another via wired (e.g., coaxial cable, fiber optic, Digital Subscriber Line (DSL)) or wireless (e.g., infrared, wireless, Bluetooth, microwave, etc.) means. The aforementioned computer-readable storage medium can be any available medium that a computer can access or a data storage device such as a server or data center that integrates one or more available media. The aforementioned available media can be magnetic media (e.g., floppy disks, hard disks, magnetic tapes), optical media (e.g., DVDs), or semiconductor media (e.g., solid-state disks (SSDs)).

[0158] This invention provides a method, apparatus, electronic device, and computer-readable storage medium for protecting the recurrent laryngeal nerve from thermal injury using a flexible temperature-sensing patch. As described above, this invention periodically uses the relative temperature of the average of three sampled temperatures obtained from the flexible temperature-sensing patch and the current reference temperature as temperature x during surgery. t And when it is confirmed that no patch position offset has occurred, it is added to sequence X, and the median temperature of the most recent multiple temperatures x is taken as temperature y. t Add to sequence Y, and based on temperature y t-1 y t Calculate the rate of change z t Add to sequence Z; and periodically calibrate the current reference temperature; and based on the latest rate of change z. tThe system checks for abnormal patch signals. If an abnormal patch signal is detected, the early warning module is invoked to issue an early warning. If no abnormal patch signal is detected, the system further determines whether rapid temperature rise has occurred based on the current rate of change. If rapid temperature rise is confirmed, a compensation temperature calculation is performed based on the first-order heat conduction model and sequence Y. A correction temperature calculation is then performed based on the compensation temperature calculation result, and a CEM43 equivalent minute count is calculated based on the correction temperature and CEM43 equivalent minute count. A high-temperature warning level is set based on the correction temperature and CEM43 equivalent minute count. When the high-temperature warning level switches from normal to level one or two, the early warning module is invoked to activate the high-temperature warning, and the device linkage interface is invoked for device linkage control. If the high-temperature warning level is not normal, the correction temperature sequence X is continuously monitored. real The CEM43 equivalent minute sequence M is used to determine whether the high-temperature warning can be turned off. If it is confirmed that it can be turned off, the high-temperature warning level is reset to normal, and the warning module is invoked to turn off the high-temperature warning. This invention not only solves the problems of no real-time feedback during surgery and inability to provide timely warnings before damage occurs; it also improves the accuracy of temperature acquisition, the ability and accuracy of abnormal event identification, the accuracy of high-temperature warning level setting, the accuracy and timeliness of warnings, and the ability to protect against intraoperative thermal damage to the recurrent laryngeal nerve.

[0159] The steps of the methods or algorithms described in conjunction with the embodiments disclosed herein can be implemented in hardware, a software module executed by a processor, or a combination of both. The software module can be located in random access memory (RAM), main memory, read-only memory (ROM), electrically programmable ROM, electrically erasable programmable ROM, registers, hard disk, removable disk, CD-ROM, or any other form of storage medium known in the art.

[0160] The specific embodiments described above further illustrate the purpose, technical solution, and beneficial effects of the present invention. It should be understood that the above description is only a specific embodiment of the present invention and is not intended to limit the scope of protection of the present invention. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the scope of protection of the present invention.

Claims

1. A method for protecting the recurrent laryngeal nerve from thermal damage based on a flexible temperature-sensing patch, characterized in that, The method includes: Before surgery, the protective module establishes a data communication connection with the flexible temperature sensing patch attached to the recurrent laryngeal nerve; it also connects with the early warning module and the instrument linkage interface; and initializes the current reference temperature x. base The temperature was set to 37℃; the high-temperature warning level was initialized to normal; and six empty sequences were initialized as the corresponding sequences X, Y, Z, X... base X real M; the flexible temperature sensing patch has three built-in temperature sensing elements; the instrument linkage interface is also connected to the energy device used in surgery; the energy device includes at least an electrosurgical unit and an ultrasonic scalpel; the high temperature warning level includes normal, level one, and level two; During surgery, the protective module periodically obtains three sampled temperatures from the flexible temperature sensing patch at a preset signal sampling frequency; and compares the average of the three sampled temperatures with the current reference temperature x. base The temperature difference is taken as the corresponding temperature x t And based on the pairwise absolute temperature difference of the three sampled temperatures, determine whether a patch position shift has occurred; if so, then x is the current temperature. t After setting the temperature to zero, add it to sequence X and call the warning module to issue a position offset warning; otherwise, directly set the temperature x. t Add to the sequence X; The protection module, each time the sequence X completes a temperature addition, will update the most recent N... win The temperature x t The median temperature is taken as the corresponding temperature y. t Add to sequence Y; and based on the current temperature y t and its corresponding temperature y t-1 Calculate the corresponding rate of change z t Add to sequence Z; and set the current reference temperature x base As the corresponding reference temperature x base,t Add to sequence X base Preset sliding window width N win z is an odd number greater than 3; t =(y t -y t-1 ) / △t, where △t is the sampling interval, △t=1 / signal sampling frequency; The protection module periodically adjusts the current reference temperature x according to the current sequence Y at a preset reference calibration frequency. base Perform a calibration and update the sequence X based on the calibration result. base ; The protection module, each time the sequence Z completes an addition of a change rate, will update the added change rate z. t The current rate of change is used as the current rate of change; and based on the current rate of change, it is determined whether there is a patch signal anomaly; if a patch signal anomaly occurs, the early warning module is invoked to issue a signal anomaly warning, and the temperature y corresponding to the current rate of change in the sequence Y is set. t Reset to the corresponding temperature y t-1 And based on the reset sequence Y, the corresponding rate of change z in the sequence Z. t and the sequence X base The corresponding reference temperature x base,t Perform a reset; if no patch signal abnormality occurs, further determine whether rapid temperature rise has occurred based on the current rate of change; When the protection module confirms a rapid temperature rise, it performs a compensation temperature calculation based on the first-order heat conduction model according to the sequence Y, and then calculates the compensation temperature based on the result of the compensation temperature calculation and the sequence X. base Perform corrected temperature calculations and update sequence X based on the corrected temperature calculation results. real Based on the CEM43 cumulative heating dose increment function, the equivalent minutes are calculated according to the corrected temperature calculation results, and sequence M is updated based on the equivalent minutes calculation results; and based on sequence X... real M sets the high temperature warning level; When the high temperature warning level switches from normal to level one or level two, the protection module calls the warning module to activate the high temperature warning and calls the instrument linkage interface to perform instrument linkage control. When the high temperature warning level is not at the normal level, the protection module continuously observes sequence X. real The system uses M to determine whether the high-temperature warning can be turned off; and when it is confirmed that it can be turned off, the high-temperature warning level is reset to normal, and the warning module is invoked to turn off the high-temperature warning.

2. The method for protecting the recurrent laryngeal nerve from thermal damage based on a flexible temperature-sensing patch according to claim 1, characterized in that, The total thickness of the flexible temperature sensing patch shall not exceed 0.5 mm, and the bending radius shall not be less than 5 mm. The flexible substrate of the flexible temperature sensing patch is I-shaped; The two sides of the I-shaped base are wing fixation areas, each with at least two positioning holes for fixing the patch and attaching it to the recurrent laryngeal nerve; a PTFE sleeve is installed on one of the wing fixation areas; the signal cable passing through the PTFE sleeve is connected to the three temperature sensing elements in the central sensing area and to the protection module. The width of both of the aforementioned winglet fixing areas is W1 and the length is L1, with the width W1 being between 4-6 mm and the length L1 being between 7-9 mm; The rectangular area between the two wing fixation areas is the central sensing area, with a width of W2 and a length of L2, where the width W2 is between 1.5-2.5 mm and the length L2 is between 12-18 mm. In the flexible substrate of the central sensing area, three temperature sensing elements are embedded at equal intervals along the centerline from one wing fixation area to the other. These three temperature sensing elements are designated as the proximal, mid-segment, and distal elements according to the direction of the recurrent laryngeal nerve. The temperature sensing element is a fiber Bragg grating sensor or a T-type thermocouple sensor; the thermal response time constant of the temperature sensing element does not exceed 0.2 seconds. When the sensor type is a fiber Bragg grating sensor, the center wavelengths of the gratings of the proximal, mid-section, and distal elements are 1530nm, 1545nm, and 1560nm, respectively. The output signal of each of the proximal, mid-section, and distal elements is a corresponding Bragg wavelength signal. The proximal, mid-section, and distal elements are connected in series on the same optical fiber, and wavelength division multiplexing technology is used to achieve multi-point temperature measurement over a single cable. The signal cable passing through the PTFE sheath at this time is a single optical fiber. When the sensor type is a T-type thermocouple sensor, the proximal, middle, and distal elements are three T-type thermocouple sensors. The output signal of each of the proximal, middle, and distal elements is a corresponding analog voltage signal. Each of the proximal, middle, and distal elements requires two cables to transmit the analog voltage signal. The signal cables passing through the PTFE sleeve at this time are six mutually isolated signal lines. With the base bottom plane as the top and the plane contacting the recurrent laryngeal nerve as the bottom, the cross-sectional structure of the element area AA corresponding to each temperature sensing element in the central sensing area from top to bottom is as follows: a flexible substrate with the temperature sensing element embedded, a thermal insulation microcavity, an insulating and moisture-proof layer, a biocompatible encapsulation layer, and a hydrophilic lubricating coating; the flexible substrate is a polyimide film with a thickness between 20-30 μm; the thermal insulation microcavity is made of foamed silicone rubber with a porosity of 20%-40% and a thickness between 50-150 μm; the thermal conductivity of the thermal insulation microcavity is less than 0.1 W / (m·K), ensuring that the attenuation ratio of heat conduction from surrounding tissue to the temperature sensing element is not less than 10:1; the insulating and moisture-proof layer is Parylene chemically vapor-deposited. The C film has a thickness between 8-12 μm; the biocompatible encapsulation layer is made of medical-grade silicone rubber with a thickness between 20-50 μm; the hydrophilic lubricating coating is a polyvinylpyrrolidone coating with a thickness between 5-15 μm; each temperature sensing element has a vertical slot with a diameter of 1 mm at its center as a corresponding exposure window, which penetrates the heat insulation microcavity, the insulating moisture-proof layer, the biocompatible encapsulation layer, and the hydrophilic lubricating coating.

3. The method for protecting the recurrent laryngeal nerve from thermal damage based on a flexible temperature-sensing patch according to claim 1, characterized in that, The process of periodically obtaining three sampling temperatures from the flexible temperature sensing patch at a preset signal sampling frequency specifically includes: The protection module periodically identifies the sensor type of the flexible temperature sensing patch according to the signal sampling frequency; If the sensor type is a fiber Bragg grating sensor, then the three Bragg wavelengths of the proximal, middle and distal elements on the flexible temperature sensing patch are acquired in real time through optical fiber, and the corresponding temperature values ​​are converted for each acquired Bragg wavelength based on the conversion relationship between the Bragg wavelength and temperature of the fiber Bragg grating sensor. If the sensor type is a T-type thermocouple sensor, then the three analog voltage signals of the proximal, middle and distal elements on the flexible temperature sensing patch are acquired in real time through optical fiber. Each analog voltage signal is then subjected to signal isolation amplification, low-pass filtering with a cutoff frequency of 10Hz and analog-to-digital signal conversion to obtain the corresponding conversion value. Based on the conversion relationship between the T-type thermocouple sensor value and temperature, each conversion value is converted to the corresponding temperature value to obtain the corresponding conversion temperature. The three conversion temperatures obtained in this study are used as the corresponding three sampling temperatures.

4. The method for protecting the recurrent laryngeal nerve from thermal damage based on a flexible temperature-sensing patch according to claim 1, characterized in that, The determination of whether patch position shift has occurred based on the pairwise absolute temperature difference of the three sampled temperatures specifically includes: The protection module calculates the pairwise absolute temperature difference of the three sampled temperatures to obtain three corresponding first temperature difference values; and identifies whether all three first temperature difference values ​​are less than a preset first temperature difference threshold; if yes, the judgment result of patch position offset is set to no; if no, the judgment result of patch position offset is set to yes.

5. The method for protecting the recurrent laryngeal nerve from thermal damage based on a flexible temperature-sensing patch according to claim 1, characterized in that, The current reference temperature x is periodically adjusted according to the current sequence Y at a preset reference calibration frequency. base Perform a calibration and update the sequence X based on the calibration result. base Specifically, it includes: The protection module periodically adjusts the temperature y in the current sequence Y that is within the most recent first time period according to the reference calibration frequency. t Extract the data to form the current sequence; and set the current reference temperature x. base As the corresponding reference temperature x base,pre The system identifies the maximum and minimum temperatures within the current sequence; calculates the temperature difference between the maximum and minimum temperatures to obtain a second temperature difference; and checks whether the second temperature difference is less than a preset second temperature difference threshold. If so, the system compares the average temperature of the current sequence with the previous reference temperature x. base,pre The sum is taken as the latest current reference temperature x. base and the sequence X base In the context of the aforementioned reference temperature x base,pre The corresponding reference temperature x base,t Reset to the latest current reference temperature x base .

6. The method for protecting the recurrent laryngeal nerve from thermal damage based on a flexible temperature-sensing patch according to claim 1, characterized in that, The process of confirming whether there is an anomaly in the patch signal based on the current rate of change specifically includes: The protection module identifies whether the current rate of change exceeds a preset first rate of change threshold; if yes, the judgment result of the patch signal abnormality is set to yes; if no, the judgment result of the patch signal abnormality is set to no.

7. The method for protecting the recurrent laryngeal nerve from thermal damage based on a flexible temperature-sensing patch according to claim 1, characterized in that, The determination of whether a rapid temperature rise has occurred based on the current rate of change specifically includes: The protection module identifies whether the current rate of change is greater than a preset second rate of change threshold; if yes, the judgment result of rapid heating is set to yes; if no, the judgment result of rapid heating is set to no.

8. The method for protecting the recurrent laryngeal nerve from thermal damage based on a flexible temperature-sensing patch according to claim 1, characterized in that, The compensation temperature calculation is performed based on the first-order heat conduction model according to the sequence Y, and the compensation temperature calculation result is combined with the sequence X. base Perform corrected temperature calculations and update sequence X based on the corrected temperature calculation results. real Based on the CEM43 cumulative heating dose increment function, the equivalent minutes are calculated according to the corrected temperature calculation results, and the sequence M is updated based on the equivalent minutes calculation results. Specifically, this includes: Step 81, the protection module selects the temperature y in the sequence Y that is within the most recent second time interval. t Extracted to form the sampling sequence Y samp ; Wherein, the temperature y of each of the current sub-sequences t Let y be the corresponding temperature. i 1 ≤ index i ≤ total number of samples N samp N samp =(Second duration / △t)+1; Step 82: Calculate each temperature y based on the first-order heat conduction model and the sequence Y. i The corresponding compensation temperature Δy i ; Specifically: [The text abruptly ends here, likely due to an incomplete sentence or a missing section.] i As the final temperature y end ; and the ending temperature y end The corresponding sampling time is recorded as the end time, and the corresponding start time is calculated as end time - second duration; the temperature y corresponding to the start time in the sequence Y is then recorded. t As the starting temperature y start ; and the initial temperature y start The ending temperature y end The second duration and the preset future duration are substituted into the first-order heat conduction model to calculate the corresponding compensation temperature Δy. i ; The first-order heat conduction model is as follows: ； Step 83, the sequence X base In and each of the aforementioned temperatures y i The corresponding reference temperature x base,t Let it be x base,i ; and based on each of the stated temperatures y i and its corresponding reference temperature x base,i and the compensation temperature Δy i Calculate the corresponding corrected temperature x real,i ; Wherein, the corrected temperature x real,i The calculation method is as follows: ； Step 84, and then use the various corrected temperatures x obtained this time. real,i The current corrected temperature is used as the current time; and the sampling time corresponding to the current corrected temperature is used as the current time; and the sequence X is... real Is there a corrected temperature x corresponding to the current time? real,t Perform identification; if so, then adjust the corresponding correction temperature x based on the current correction temperature. real,t Perform a reset; if not, use the current corrected temperature as the new corrected temperature x. real,t Add to the sequence X real middle; Step 85, based on the CEM43 cumulative heating dose increment function, according to the sampling interval Δt and the N obtained this time... samp The corrected temperature x real,i Estimate the corresponding equivalent number of minutes, m; The cumulative heating dose increment function of CEM43 is as follows: ， ； R i For temperature coefficient, the equivalent minutes m is in minutes, and the sampling interval Δt is in seconds; Step 86: Take the equivalent minutes m obtained this time as the corresponding equivalent minutes m t Add to the sequence M.

9. The method for protecting the recurrent laryngeal nerve from thermal damage based on a flexible temperature-sensing patch according to claim 1, characterized in that, The sequence X real M sets the aforementioned high-temperature warning level, specifically including: The protection module will store the sequence X. real and the corrected temperature x in the sequence M corresponding to the current time. real,t Equivalent minutes (m) t Extract it as the corresponding current temperature Current number of minutes ; And the current temperature and the current number of minutes Perform identification; If the current temperature The current number of minutes is less than a preset first temperature threshold. If the number of minutes is less than the preset first minute threshold, the corresponding high temperature warning level is set to normal; the first temperature threshold is greater than 37°C. If the current temperature Greater than or equal to the first temperature threshold and less than the preset second temperature threshold, or the current number of minutes. If the temperature is greater than or equal to the preset second minute threshold, the corresponding high temperature warning level is set to Level 1; if the first temperature threshold is less than the second temperature threshold; or if the first minute threshold is less than the second minute threshold. If the current temperature If the temperature is greater than or equal to a preset third temperature threshold, then for the sequence X... real All corrected temperatures x within the most recent third time period real,t The system identifies whether all temperatures are greater than or equal to the third temperature threshold. If so, the corresponding high-temperature duration marker is set to "continuous"; otherwise, the corresponding high-temperature duration marker is set to "non-continuous". If the high-temperature duration marker is set to "continuous", or if the current number of minutes is... If the temperature is greater than or equal to the preset third minute threshold, the corresponding high temperature warning level is set to Level II; if the second temperature threshold is less than the third temperature threshold; if the second minute threshold is less than the third minute threshold.

10. The method for protecting the recurrent laryngeal nerve from thermal damage based on a flexible temperature-sensing patch according to claim 1, characterized in that, The continuous observation sequence X real The system uses M to determine whether the high-temperature warning can be turned off, specifically including: The protection module adds an equivalent minute m to the sequence M. t At that time, the equivalent number of minutes m will be... t As the current equivalent minutes; and the previous equivalent minutes m of the current equivalent minutes. t-1 As the corresponding previous equivalent minutes; and calculate the equivalent fraction difference = current equivalent minutes - previous equivalent minutes; and then set the sequence X real The corrected temperature x corresponding to the current equivalent number of minutes real,t The current corrected temperature is used as the reference temperature; the equivalent fraction difference and the current corrected temperature are identified; if the equivalent fraction difference is less than or equal to 0 and the current corrected temperature is less than a preset fourth temperature threshold, it is confirmed that the high temperature warning can be turned off; if the equivalent fraction difference is greater than 0 or the current corrected temperature is greater than or equal to the fourth temperature threshold, it is confirmed that the high temperature warning cannot be turned off.

11. The method for protecting the recurrent laryngeal nerve from thermal damage based on a flexible temperature-sensing patch according to claim 1, characterized in that, The process of calling the device linkage interface to perform device linkage control specifically includes: The protection module sends a linkage control command to the device linkage interface; When the device linkage interface receives the linkage control command, it controls the local tissue heat diffusion effect caused by the thermal operation of the energy device by sending a stop heating command to the energy device; and prompts the surgeon to pause the thermal operation and rinse and cool down through text or voice prompts.

12. The method for protecting the recurrent laryngeal nerve from thermal damage based on a flexible temperature-sensing patch according to claim 1, characterized in that, The step of calling the early warning module to issue a position offset warning specifically includes: the protection module setting the warning type to position offset and the warning parameters to empty; and sending a corresponding warning command composed of the warning type and the warning parameters to the early warning module. The step of calling the early warning module to issue a signal anomaly warning specifically includes: the protection module setting the warning type to signal anomaly and setting the warning parameters to empty; and sending the corresponding warning command composed of the warning type and the warning parameters to the early warning module. The step of invoking the early warning module to activate the high temperature warning specifically includes: the protection module setting the warning type to high temperature warning activated and setting the warning parameters to the corresponding high temperature warning level; and sending the corresponding warning command composed of the warning type and the warning parameters to the early warning module. The step of calling the warning module to turn off the high temperature warning specifically includes: the protection module setting the warning type to high temperature warning off and setting the warning parameters to empty; and sending the corresponding warning command composed of the warning type and the warning parameters to the warning module. The warning instruction includes the warning type and the warning parameters; the warning type includes position deviation, signal abnormality, high temperature warning enabled, and high temperature warning disabled; when the warning type is position deviation, signal abnormality, or high temperature warning disabled, the warning parameters are empty; when the warning type is high temperature warning enabled, the warning parameters are level one or level two; when the warning type is position deviation, it corresponds to the position deviation warning unit of the warning module; when the warning type is signal abnormality, it corresponds to the signal abnormality warning unit of the warning module; when the warning type is high temperature warning enabled or high temperature warning disabled, it corresponds to the high temperature warning unit of the warning module. The early warning module includes at least an instruction forwarding unit, a position offset early warning unit, a signal anomaly early warning unit, and a high temperature early warning unit; The instruction forwarding unit is used to receive the warning instruction sent by the protection module; and based on the correspondence between the warning type and the three warning units, forward the current warning instruction to its corresponding position offset warning unit, signal abnormality warning unit or high temperature warning unit. Upon receiving the warning instruction of the type of position offset, the position offset warning unit provides the surgical operator with a text or voice prompt indicating the position offset of the patch. Upon receiving the warning instruction of the warning type being signal abnormality, the signal abnormality warning unit will provide the surgical operator with a text or voice prompt indicating an abnormality in the signal acquisition of the patch sensor element. Upon receiving the warning command indicating a high-temperature warning, the high-temperature warning unit identifies the warning parameters. If the warning parameter is Level 1, it activates the built-in buzzer based on a preset first buzzer frequency and first buzzer volume for a Level 1 buzzer warning. It then sets the illumination color and flashing frequency of the built-in warning light based on a preset first color and first flashing frequency, and then provides a Level 1 light warning by flashing the warning light. If the warning parameter is Level 2, it activates the buzzer based on a preset second buzzer frequency and second buzzer volume for a Level 2 buzzer warning. It then sets the illumination color and flashing frequency of the warning light based on a preset second color and second flashing frequency, and then provides a Level 2 light warning by flashing the warning light. The first buzzer frequency < the second buzzer frequency, the first buzzer volume < the second buzzer volume, the first color is set to yellow by default, the second color is set to red by default, and the first flashing frequency < the second flashing frequency. Upon receiving the warning instruction indicating that the warning type is "high temperature warning off", the high temperature warning unit shuts down the currently executing level one or level two buzzer warning and the corresponding level one or level two light warning.

13. An apparatus for performing the treatment method for protecting the recurrent laryngeal nerve from thermal damage based on a flexible temperature-sensing patch according to any one of claims 1-12, characterized in that, The device includes: a protection module, an early warning module, and a device linkage interface; The protective module is used to establish a data communication connection with the flexible temperature sensing patch attached to the recurrent laryngeal nerve before surgery; and to connect with the early warning module and the instrument linkage interface; and to initialize the current reference temperature x. base The temperature was set to 37℃; the high-temperature warning level was initialized to normal; and six empty sequences were initialized as the corresponding sequences X, Y, Z, X... base X real M; the flexible temperature sensing patch has three built-in temperature sensing elements; the instrument linkage interface is also connected to the energy device used in surgery; the energy device includes at least an electrosurgical unit and an ultrasonic scalpel; the high temperature warning level includes normal, level one, and level two; The protection module is also used to periodically obtain three sampled temperatures from the flexible temperature sensing patch at a preset signal sampling frequency during surgery; and to compare the average temperature of the three sampled temperatures with the current reference temperature x. base The temperature difference is taken as the corresponding temperature x t And based on the pairwise absolute temperature difference of the three sampled temperatures, determine whether a patch position shift has occurred; if so, then x is the current temperature. t After setting the temperature to zero, add it to sequence X and call the warning module to issue a position offset warning; otherwise, directly set the temperature x. t Add to the sequence X; The protection module is also used to, each time the sequence X completes a temperature addition, update the most recent N... win The temperature x t The median temperature is taken as the corresponding temperature y. t Add to sequence Y; and based on the current temperature y t and its corresponding temperature y t-1 Calculate the corresponding rate of change z t Add to sequence Z; and set the current reference temperature x base As the corresponding reference temperature x base,t Add to sequence X base Preset sliding window width N win z is an odd number greater than 3; t =(y t -y t-1 ) / △t, where △t is the sampling interval, △t=1 / signal sampling frequency; The protection module is also used to periodically adjust the current reference temperature x according to the current sequence Y at a preset reference calibration frequency. base Perform a calibration and update the sequence X based on the calibration result. base ; The protection module is also used to, each time the rate of change of sequence Z is added, to update the rate of change z added in that iteration. t The current rate of change is used as the current rate of change; and based on the current rate of change, it is determined whether there is a patch signal anomaly; if a patch signal anomaly occurs, the early warning module is invoked to issue a signal anomaly warning, and the temperature y corresponding to the current rate of change in the sequence Y is set. t Reset to the corresponding temperature y t-1 And based on the reset sequence Y, the corresponding rate of change z in the sequence Z. t and the sequence X base The corresponding reference temperature x base,t Perform a reset; if no patch signal abnormality occurs, further determine whether rapid temperature rise has occurred based on the current rate of change; The protection module is also used to, upon confirmation of a rapid temperature rise, perform a compensation temperature calculation based on the first-order heat conduction model according to the sequence Y, and calculate the compensation temperature based on the result of the compensation temperature calculation and the sequence X. base Perform corrected temperature calculations and update sequence X based on the corrected temperature calculation results. real Based on the CEM43 cumulative heating dose increment function, the equivalent minutes are calculated according to the corrected temperature calculation results, and sequence M is updated based on the equivalent minutes calculation results; and based on sequence X... real M sets the high temperature warning level; The protection module is also used to activate the high temperature warning by calling the warning module and to call the instrument linkage interface for instrument linkage control when the high temperature warning level switches from normal to level one or level two. The protection module is also used to continuously observe sequence X when the high temperature warning level is not a normal level. real The system uses M to determine whether the high-temperature warning can be turned off; and when it is confirmed that it can be turned off, the high-temperature warning level is reset to normal, and the warning module is invoked to turn off the high-temperature warning.

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