Surgical navigation reference offset warning method and system
The method and system address the limitations of current surgical navigation by using a navigation device to monitor reference coordinates and generate warnings based on calculated thresholds, enhancing real-time detection and stability judgment for improved surgical precision.
Patent Information
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- REMEX MEDICAL CORP
- Filing Date
- 2026-01-09
- Publication Date
- 2026-07-23
AI Technical Summary
Current surgical navigation systems lack real-time monitoring and effective distinction between aperiodic and periodic displacements of reference members, lack objective stability judgment criteria, and fail to ensure optimal imaging timing and system performance.
A method and system that uses a navigation device to monitor reference coordinates, calculate distance values and amplitudes or standard deviations, and generate warnings based on predetermined thresholds to distinguish between aperiodic and periodic displacements, ensuring optimal imaging timing and system stability.
Enables real-time detection of reference member offsets, effectively distinguishes between displacement types, provides objective judgment criteria, and ensures optimal imaging timing, improving surgical accuracy and safety.
Smart Images
Figure 2026121301000001_ABST
Abstract
Description
Technical Field
[0001] The present invention relates to a reference offset warning method and its system, and particularly to a reference offset warning method and its system for surgical navigation.
Background Art
[0002] Generally, a reference member (Reference) is used for the marker and positioning of a patient or a surgical instrument, and plays an important role in a navigation surgery system. However, during the surgical process, positioning deviation may occur due to the following main factors. The main factors include: first, artificial interference such as a medical staff adjusting or accidentally touching the operating table, which causes a displacement of the reference member; and second, physiological interference such as the chest and abdomen undulating due to the patient's breathing, which causes a periodic displacement of the reference member.
[0003] For the marker and positioning of a patient, minute displacements are often difficult to detect, among which non-periodic accidental displacements are difficult to discover, and it is necessary to distinguish and process the periodic displacements caused by breathing. Moreover, the above two types of displacement types require different processing strategies. In the current prior art, real-time monitoring cannot be realized, and non-periodic accidental displacements and periodic displacements caused by breathing cannot be effectively distinguished.
[0004] For the marker and positioning of a surgical instrument, during the surgical process, it is necessary to adjust the position and angle of the surgical instrument, and wait until it becomes stable and does not move after the adjustment is completed, and then perform imaging and positioning. In the current prior art, there is a lack of an objective stability judgment criterion during the adjustment process of the surgical instrument, and it is easy for the user to have to judge whether the surgical instrument is stable only based on experience, and it is impossible to accurately grasp the optimal imaging timing, and imaging too early or too late may affect the positioning accuracy.
[0005] Furthermore, the optical tracker of the navigation device has distance-related accuracy characteristics, including an optimal positioning range (e.g., the highest accuracy can be achieved within a specific distance), accuracy attenuation characteristics (e.g., positioning accuracy gradually decreases beyond the boundary distance), and distance sensitivity (e.g., positioning accuracy and operating distance are inversely proportional). Current conventional technology faces challenges such as the inability to grasp the current operating distance in real time during the operation of the navigation device, the lack of objective distance judgment criteria, and the difficulty in ensuring that the positioning system is in an optimal operating state.
[0006] In light of this, the current market does not offer a surgical navigation reference offset warning method or system that enables real-time detection, effectively distinguishes between aperiodic and periodic displacements, warns of abnormal displacements to eliminate deviations, has objective judgment criteria, suggests optimal imaging timing, provides objective distance conditions, and ensures that the positioning system is in optimal working order. Therefore, the relevant industry is seeking a solution. [Overview of the Initiative] [Problems that the invention aims to solve]
[0007] Therefore, the object of the present invention is to provide a surgical navigation reference offset warning method and system that uses a navigation device to determine whether shaking (or instability) is occurring in an object to which a reference member and / or dynamic reference member is attached, and performs analysis based on the changes in the spatial coordinates during the tracking period of the object. Whether through the amplitude of the distance value amplitude or the standard deviation of the distance value, it can effectively realize real-time detection, effectively distinguish between aperiodic and periodic displacements, warn of abnormal displacements and enable the elimination of deviations, have objective judgment criteria, suggest the optimal imaging timing, provide an objective distance state, and ensure that the positioning system is in an optimal operating state, solving problems that could not be achieved with conventional technology, such as real-time monitoring, effective distinction between aperiodic and periodic displacements, lack of objective stability judgment criteria, accurate grasp of the optimal imaging timing, real-time grasp of the current operating distance, lack of objective distance judgment criteria, and difficulty in ensuring that the positioning system is in an optimal operating state. [Means for solving the problem]
[0008] According to one embodiment of the method of the present invention, a surgical navigation reference offset warning method is provided, comprising the steps of: monitoring a plurality of reference coordinates of a reference member by a navigation device; calculating a plurality of first distance values between the reference member and the navigation device based on the reference coordinates by the navigation device, where each first distance value is the distance between each reference coordinate and the navigation device; extracting a portion of the first distance values based on a first time interval by the navigation device, calculating a first amplitude of the portion of the first distance values within the first time interval, wherein the portion of the first distance values includes a plurality of second distance values, and the first amplitude is equal to the difference between the maximum distance value and the minimum distance value among the second distance values; extracting a plurality of first amplitudes corresponding to a plurality of time points based on a second time interval corresponding to a time point by the navigation device, calculating a second amplitude of the plurality of first amplitudes within the second time interval, wherein the plurality of first amplitudes includes a plurality of amplitude values, and the second amplitude is equal to the difference between the maximum amplitude value and the minimum amplitude value among the plurality of amplitude values; and determining by the navigation device whether the second amplitude of the plurality of first amplitudes is greater than a predetermined threshold.
[0009] Other embodiments of the above-described embodiment are as follows: The navigation device described above determines whether the second amplitude is greater than a predetermined threshold and generates a determination result, and based on the determination result, generates a warning message to notify the user of the occurrence of an offset of the reference member.
[0010] Other embodiments of the aforementioned embodiment are as follows: The first time interval described above is longer than the second time interval.
[0011] Other embodiments of the above-described embodiment are as follows: The first time interval described above is the interval of the previous first time value with respect to the time point, and the second time interval is the interval of the previous second time value with respect to the time point.
[0012] Other embodiments of the above-described embodiment are as follows: The surgical navigation reference offset warning method further includes a navigation device determining one of the first distance values based on a predetermined set of distance intervals to generate a distance determination result, and generating an optical signal based on the distance determination result, wherein the predetermined set of distance intervals includes a first predetermined distance threshold and a second predetermined distance threshold, the first predetermined distance threshold being smaller than the second predetermined distance threshold, and the optical signal having a color which is one of green, yellow, and orange.
[0013] Other embodiments of the above-described embodiment are as follows: If, as a result of the distance determination, one of the first distance values is smaller than a first predetermined distance threshold, the color of the light signal is green; if, as a result of the distance determination, one of the first distance values is greater than or equal to the first predetermined distance threshold and smaller than a second predetermined distance threshold, the color of the light signal is yellow; and if, as a result of the distance determination, one of the first distance values is greater than a second predetermined distance threshold, the color of the light signal is orange.
[0014] Other embodiments of the above-described embodiment are as follows: The surgical navigation reference offset warning method further includes the steps of: monitoring a plurality of dynamic reference coordinates of a dynamic reference member by a navigation device; calculating a plurality of dynamic distance values between the dynamic reference member and the navigation device based on the dynamic reference coordinates by the navigation device, where each dynamic distance value is the distance between each dynamic reference coordinate and the navigation device; extracting a portion of the dynamic distance values based on a corresponding time interval by the navigation device and calculating the standard deviation of the portion of the dynamic distance values within the time interval; and determining whether the standard deviation of the portion of the dynamic distance values is greater than another predetermined threshold by the navigation device.
[0015] Other embodiments of the above-described embodiment are as follows: The reference member described above is provided on the first object, and the dynamic reference member is provided on a second object different from the first object.
[0016] According to another embodiment of the method of the present invention, a surgical navigation reference offset warning method is provided, comprising the steps of: monitoring a plurality of reference coordinates of a reference member by a navigation device; calculating a plurality of distance values between the reference member and the navigation device based on the reference coordinates by the navigation device, where each distance value is the distance between each reference coordinate and the navigation device; extracting a portion of the distance values based on a time interval by the navigation device and calculating the standard deviation of the portion of the distance values within the time interval; and determining whether the standard deviation of the portion of the distance values is greater than a predetermined standard deviation threshold by the navigation device.
[0017] Other embodiments of the above-described embodiment are as follows: The navigation device described above determines whether the standard deviation is greater than a predetermined standard deviation threshold and generates a determination result. Based on the determination result, a warning message is generated to notify the user of the occurrence of an offset in the reference member.
[0018] Other embodiments of the above-mentioned embodiment are as follows: The time interval described above is the interval of the previous time value with respect to the time point.
[0019] As one embodiment of the structural aspects of the present invention, a reference member and a navigation device provided toward the reference member, the device monitors a plurality of reference coordinates of the reference member, calculates a plurality of first distance values between the reference member and the navigation device based on the reference coordinates, each first distance value being the distance between each reference coordinate and the navigation device, extracts a portion of the first distance values based on a first time interval, calculates a first amplitude of the portion of the first distance values within the first time interval, the portion of the first distance values includes a plurality of second distance values, and the first amplitude is the distance between the maximum and minimum distance values among the second distance values. A surgical navigation reference offset warning system is provided, which includes a navigation device arranged to perform the following operations: extracting a portion of a plurality of first amplitudes corresponding to a plurality of time points based on a second time interval corresponding to a time point, calculating a second amplitude of the plurality of first amplitude portions within the second time interval, determining that the plurality of first amplitude portions include a plurality of amplitude values and the second amplitude is equal to the difference between the maximum amplitude value and the minimum amplitude value among the plurality of amplitude values, and determining whether the second amplitude of the plurality of first amplitude portions is greater than a predetermined threshold.
[0020] Other embodiments of the above-described embodiment are as follows: The surgical navigation reference offset warning system described above is connected to a navigation device and further includes a display device for displaying a warning message, the navigation device determines whether the second amplitude is greater than a predetermined threshold and generates a determination result, and based on the determination result generates a warning message and notifies the user of the offset of the reference member.
[0021] Other embodiments of the aforementioned embodiment are as follows: The first time interval described above is longer than the second time interval.
[0022] Other embodiments of the above-described embodiment are as follows: The first time interval described above is the interval of the previous first time value with respect to the time point, and the second time interval is the interval of the previous second time value with respect to the time point.
[0023] Other embodiments of the above-described embodiments are as follows. The above-described navigation device is arranged to perform an operation further including: judging one of the first distance values based on a set of predetermined distance intervals by the navigation device to generate a distance judgment result, and generating an optical signal based on the distance judgment result; the set of predetermined distance intervals includes a first predetermined distance threshold and a second predetermined distance threshold, the first predetermined distance threshold is smaller than the second predetermined distance threshold, and the optical signal has a color that is one of green, yellow, and orange.
[0024] Other embodiments of the above-described embodiments are as follows. When the one of the plurality of first distance values as the above-described distance judgment result is smaller than the first predetermined distance threshold, the color of the optical signal is green; when the one of the first distance values as the distance judgment result is greater than or equal to the first predetermined distance threshold and smaller than the second predetermined distance threshold, the color of the optical signal is yellow; when the one of the first distance values as the distance judgment result is greater than the second predetermined distance threshold, the color of the optical signal is orange.
[0025] Other embodiments of the above-described embodiments are as follows. In the reference offset warning system for surgical navigation in which the above-described reference member is provided on a first object, it further includes a dynamic reference member provided on a second object different from the first object; the navigation device monitors a plurality of dynamic reference coordinates of the dynamic reference member, calculates a plurality of dynamic distance values between the dynamic reference member and the navigation device based on the dynamic reference coordinates, each dynamic distance value is the distance between each dynamic reference coordinate and the navigation device, extracts a part of the dynamic distance values based on a corresponding time interval, calculates the standard deviation of the part of the dynamic distance values within the time interval, and determines whether the standard deviation of the part of the dynamic distance values is greater than another predetermined threshold.
Brief Description of the Drawings
[0026] [Figure 1] It is a schematic diagram showing a reference offset warning system for surgical navigation according to the first embodiment of the present invention. [Figure 2] It is a flowchart showing a reference offset warning method for surgical navigation according to a second embodiment of the present invention. [Figure 3] It is a flowchart showing a reference offset warning method for surgical navigation according to a third embodiment of the present invention. [Figure 4] It is a waveform schematic diagram showing the detection of the shake of the reference member of the present invention. [Figure 5] It is a flowchart showing a reference offset warning method for surgical navigation according to a fourth embodiment of the present invention. [Figure 6] It is a flowchart showing a reference offset warning method for surgical navigation according to a fifth embodiment of the present invention. [Figure 7] It is a waveform schematic diagram showing the detection of the shake of the dynamic reference member of the present invention. [Figure 8] It is a flowchart showing a reference offset warning method for surgical navigation according to a sixth embodiment of the present invention.
Embodiments for Carrying Out the Invention
[0027] Hereinafter, a plurality of embodiments of the present invention will be described with reference to the drawings. For the sake of clear explanation, many practical details are described in the following narrative. However, it should be understood that the above practical details are not for limiting the present invention. That is, in some embodiments of the present invention, the above practical details are not essential. Also, for the purpose of simplifying the drawings, some well-known structures and elements are shown in a simple schematic form in the drawings, and duplicate elements may be denoted by the same numbers.
[0028] Furthermore, in this specification, "connection" of one element (or unit or module, etc.) to another element may mean that the element is directly connected to the other element, or that the element is indirectly connected to the other element, i.e., that another element is interposed between the element and the other element. Only when it is explicitly stated that an element is "directly connected" to another element does it mean that no other element is interposed between the element and the other element. The terms first, second, third, etc., are used merely to describe different elements and do not limit the elements themselves, so the first element may also be called the second element. Also, the combinations of elements / units / circuits in this specification are not generally known, common, or practiced combinations in the art, and whether the elements / units / circuits themselves are practiced does not determine whether the combination relationship can be easily completed by a person skilled in the art.
[0029] Please refer to Figure 1, a schematic diagram showing a surgical navigation reference offset warning system 100 according to a first embodiment of the present invention. The surgical navigation reference offset warning system 100 includes a reference member 200 and a navigation device 300. The navigation device 300 is provided facing the reference member 200 and is positioned to perform the following operations: monitor a plurality of reference coordinates of the reference member 200; calculate a plurality of first distance values between the reference member 200 and the navigation device 300 based on the reference coordinates, each first distance value being the distance between each reference coordinate and the navigation device 300; extract a portion of the first distance values based on a first time interval, calculate a first amplitude of the portion of the first distance values within the first time interval, the portion of the first distance values including a plurality of second distance values, and the first amplitude being equal to the difference between the maximum and minimum distance values among the second distance values. Based on a second time interval corresponding to a time point, a portion of multiple first amplitudes corresponding to multiple time points is extracted, and the second amplitude of the portion of the multiple first amplitudes within the second time interval is calculated. The portion of the multiple first amplitudes includes multiple amplitude values, and the second amplitude is equal to the difference between the maximum and minimum amplitude values among the multiple amplitude values. It is also determined whether the second amplitude of the portion of the multiple first amplitudes is greater than a predetermined threshold.
[0030] Please refer to Figures 1 and 2 together. Figure 2 is a flowchart of the surgical navigation reference offset warning method S0 according to a second embodiment of the present invention. The surgical navigation reference offset warning method S0 is applied to a surgical navigation reference offset warning system 100 and includes performing steps S01, S02, S03, S04, and S05. Step S01 includes monitoring a plurality of reference coordinates of a reference member 200 by the navigation device 300. Step S02 includes calculating a plurality of first distance values between the reference member 200 and the navigation device 300 based on the reference coordinates by the navigation device 300, where each first distance value is the distance between each reference coordinate and the navigation device 300. Step S03 includes extracting a portion of the first distance values based on a first time interval by the navigation device 300 and calculating a first amplitude of the portion of the first distance values within the first time interval. Here, a portion of the first distance value includes a plurality of second distance values, and the first amplitude is equal to the difference between the maximum distance value and the minimum distance value among the second distance values. Step S04 includes the navigation device 300 extracting a portion of a plurality of first amplitudes corresponding to a plurality of time points based on a second time interval corresponding to a time point, and calculating the second amplitude of the plurality of first amplitudes within the second time interval. Here, a portion of the plurality of first amplitudes includes a plurality of amplitude values, and the second amplitude is equal to the difference between the maximum amplitude value and the minimum amplitude value among the plurality of amplitude values. Step S05 includes the navigation device 300 determining whether the second amplitude of the plurality of first amplitudes is greater than a predetermined threshold.
[0031] As a result, the surgical navigation reference offset warning system 100 and surgical navigation reference offset warning method S0 of the present invention can determine the second amplitude of the first amplitude of the distance value (i.e., the amplitude of the amplitude of the distance value), thereby confirming whether the reference member 200 is offset under conditions where the navigation device 300 is not offset, and can effectively achieve real-time detection. Furthermore, it can effectively distinguish between aperiodic and periodic displacements and achieve the effect of offset warning.
[0032] In Figure 1, the surgical navigation reference offset warning system 100 may further include a display device 400 and a dynamic reference member 500. The display device 400 is connected to the navigation device 300 and is used to display warning messages. The reference member 200 is provided on a first object T1, and the dynamic reference member 500 is provided on a second object T2 that is different from the first object T1. Either the reference member 200 or the dynamic reference member 500 includes a plurality of reflective spheres which may be considered markers. The navigation device 300 may include an optical tracker and a processor, the optical tracker being electrically connected to the processor. The optical tracker is used to detect the reference member 200 and / or the dynamic reference member 500 and generate reference coordinates and / or dynamic reference coordinates. In one embodiment, the first object T1 may be a patient (a part of the patient's body), and the second object T2 may be a C-arm (mobile X-ray device). The processor receives coordinate data from the optical tracker and performs subsequent calculations and decisions. The processor may be an artificial intelligence (AI) chip, a central processing unit (CPU), a graphics processing unit (GPU), or other high-speed processor, but the present invention is not limited to these.
[0033] When the navigation device 300 detects a dynamic reference member 500, it is configured to perform the following operations: monitor multiple dynamic reference coordinates of the dynamic reference member 500; calculate multiple dynamic distance values between the dynamic reference member 500 and the navigation device 300 based on the dynamic reference coordinates, each of which is the distance between each dynamic reference coordinate and the navigation device 300; extract a portion of the dynamic distance values based on a time interval and calculate the standard deviation of the portion of the dynamic distance values within that time interval; and determine whether the standard deviation of the portion of the dynamic distance values is greater than another predetermined threshold.
[0034] Please refer to Figures 1, 3, and 4 together. Figure 3 is a flowchart of the surgical navigation reference offset warning method S2 according to a third embodiment of the present invention. Figure 4 is a schematic waveform diagram showing the detection of vibration of the reference member 200 according to the present invention. The surgical navigation reference offset warning method S2 of Figure 3 is applied to the surgical navigation reference offset warning system 100 and includes performing steps S21, S22, S23, S24, S25, S262, and S264. In Figure 4, the horizontal axis represents time (seconds) and the vertical axis represents distance value (mm).
[0035] Step S21 includes monitoring and recording multiple reference coordinates of the reference member 200 in real time using the navigation device 300. Step S22 includes calculating and recording multiple first distance values DV1 between the reference member 200 and the navigation device 300 based on the reference coordinates using the navigation device 300, where each first distance value DV1 is the distance between each reference coordinate and the navigation device 300. Step S23 includes extracting a portion of the first distance values DV1 based on a first time interval TW1 corresponding to a time point TP using the navigation device 300, and calculating a first amplitude AM1 of the portion of the first distance values DV1 within the first time interval TW1, where the portion of the first distance values DV1 includes a plurality of second distance values DV2, and the first amplitude AM1 is equal to the difference between the maximum and minimum distance values in the second distance values DV2. Step S24 includes the navigation device 300 extracting a portion of a plurality of first amplitudes AM1 corresponding to a plurality of time points TP based on a second time interval TW2 corresponding to a time point TP, and calculating a second amplitude AM2 of the plurality of first amplitudes AM1 within the second time interval TW2, wherein the plurality of first amplitudes AM1 comprises a plurality of amplitude values, and the second amplitude AM2 is equal to the difference between the maximum amplitude value and the minimum amplitude value among the plurality of amplitude values. Step S25 includes the navigation device 300 determining whether the second amplitude AM2 of the plurality of first amplitudes AM1 is greater than a predetermined threshold and generating a determination result, and based on the determination result, generating a warning message to notify the user of the occurrence of an offset of the reference member 200. If the determination result is "YES", step S262 is executed. If the determination result is "NO", step S264 is executed. Step S262 includes the display device 400 displaying a red warning message (indicating that the reference member 200 is unstable; Unstable). Step S264 includes displaying a green warning message (Stable) on the display device 400, indicating that the reference member 200 is stable.
[0036] Specifically, the first time interval TW1 is greater than the second time interval TW2. The first time interval TW1 is the interval of the previous first time value with respect to time point TP, where the first time value is several seconds to several tens of seconds, preferably greater than 5 seconds and less than 11 seconds. The second time interval TW2 is the interval of the previous second time value with respect to time point TP, where the second time value is several hundred milliseconds to several seconds, preferably greater than 0 seconds and less than 2 seconds. The predetermined threshold may be greater than 0.10 mm and less than 0.20 mm. In one embodiment, the first time value may be 8 seconds, the second time value may be 1 second, and the predetermined threshold may be 0.15 mm, but the present invention is not limited to these. In another embodiment, the warning message is a sound emitted by the navigation device 300 or display device 400 to notify the user of the occurrence of an offset of the reference member 200.
[0037] As a result, the surgical navigation reference offset warning method S2 of the present invention determines the second amplitude AM2 of the first amplitude AM1 of the distance value (i.e., the amplitude of the amplitude of the distance value), thereby confirming whether the reference member 200 is offset under conditions where the navigation device 300 is not offset, effectively achieving real-time detection, and effectively distinguishing between aperiodic and periodic displacements. Furthermore, the present invention can use warning messages of specific colors to notify the user of abnormal displacement (aperiodic displacement) in real time, further achieving the elimination of deviations, and improving surgical accuracy and safety.
[0038] Please refer to Figures 1 and 5 together. Figure 5 is a flowchart of a surgical navigation reference offset warning method S4 according to a fourth embodiment of the present invention. The surgical navigation reference offset warning method S4 is applied to a surgical navigation reference offset warning system 100 and includes performing steps S41, S42, S43, and S44. Step S41 includes monitoring a plurality of reference coordinates of a reference member by the navigation device 300. Here, the reference member (reference module) may be a reference member 200 provided on a first object T1 (e.g., a patient) or a dynamic reference member 500 provided on a second object T2 (e.g., a C-arm), but the present invention is not limited to these. Step S42 includes the navigation device 300 calculating a plurality of distance values between the reference member and the navigation device 300 based on the reference coordinates, where each distance value is the distance between each reference coordinate and the navigation device 300. Step S43 includes the navigation device 300 extracting a portion of the distance values based on a time interval and calculating the standard deviation of the portion of the distance values within the time interval. Step S44 includes the navigation device 300 determining whether the standard deviation of the portion of the distance values is greater than a predetermined standard deviation threshold.
[0039] As a result, the surgical navigation reference offset warning method S4 of the present invention can determine whether the reference module is offset under conditions where the navigation device 300 is not offset by determining the standard deviation of the distance value, display the stability of the reference module in real time, have objective judgment criteria, suggest the optimal imaging timing, further improve the accuracy of image positioning, optimize the efficiency of the surgical process, reduce the uncertainty of the operator's subjective judgment, and improve the reliability of the entire system. In addition, the present invention provides more accurate and objective equipment stability monitoring for surgical navigation and ensures that image acquisition and positioning are performed under optimal conditions.
[0040] Please also refer to Figures 1, 6, and 7. Figure 6 is a flowchart of the surgical navigation reference offset warning method S6 according to a fifth embodiment of the present invention. Figure 7 is a schematic waveform diagram showing the detection of oscillation of the dynamic reference member 500 of the present invention. The surgical navigation reference offset warning method S6 of Figure 6 is applied to the surgical navigation reference offset warning system 100 and includes performing steps S61, S62, S63, S64, S652, and S654. In Figure 7, the horizontal axis represents time (seconds) and the vertical axis represents distance (mm).
[0041] Step S61 includes monitoring and recording multiple reference coordinates of a reference member in real time using the navigation device 300. In this embodiment, the reference member (reference module) may be a dynamic reference member 500 provided on a second object T2 (e.g., a C-arm). Step S62 includes calculating and recording multiple distance values DV between the reference member and the navigation device 300 based on the reference coordinates using the navigation device 300, where each distance value DV is the distance between each reference coordinate and the navigation device 300. Step S63 includes extracting a portion of the distance values DV based on a time interval corresponding to a time point using the navigation device 300, and calculating the standard deviation SD of the portion of the distance values DV within the time interval. Step S64 includes determining whether the standard deviation SD of the portion of the distance values DV is greater than a predetermined standard deviation threshold using the navigation device 300, generating a determination result, and generating a warning message based on the determination result to notify the user that the reference member is offset. If the determination result is "YES", step S652 is executed. If the judgment result is "NO", step S654 is executed. Step S652 includes displaying a red warning message (indicating that the dynamic reference member 500 is unstable; Unstable) on the display device 400. Step S654 includes displaying a green warning message (indicating that the dynamic reference member 500 is stable; Stable) on the display device 400.
[0042] Specifically, the time interval is the interval of the previous time value relative to the time point, and the time value is greater than 2 seconds and less than 4 seconds. The predetermined standard deviation threshold is greater than 0.01 mm and less than 0.05 mm. In one embodiment, the time value may be 3 seconds and the predetermined standard deviation threshold may be 0.03 mm, but the present invention is not limited to these.
[0043] As a result, the surgical navigation reference offset warning method S6 of the present invention determines the standard deviation SD of the distance value, confirms whether the reference module is offset under conditions where the navigation device 300 is not offset, displays the stability of the reference module in real time, has objective judgment criteria, and can suggest the optimal imaging timing. Furthermore, the present invention can use warning messages of specific colors to notify the user of abnormal displacement (non-periodic displacement) in real time, further achieve the elimination of deviations, and improve surgical accuracy and safety.
[0044] Please also refer to Figures 1, 2, 4, and 8. Figure 8 is a flowchart of a surgical navigation reference offset warning method S8 according to a sixth embodiment of the present invention. The surgical navigation reference offset warning method S8 is applied to a surgical navigation reference offset warning system 100 and includes performing steps S81, S82, S83, S84, S85, and S86. Step S81 includes monitoring a plurality of reference coordinates of a reference member 200 by the navigation device 300. Step S82 includes calculating a plurality of first distance values DV1 between the reference member 200 and the navigation device 300 based on the reference coordinates by the navigation device 300, where each first distance value DV1 is the distance between each reference coordinate and the navigation device 300. Step S83 includes the navigation device 300 extracting a portion of the first distance value DV1 based on a first time interval TW1 and calculating a first amplitude AM1 of the portion of the first distance value DV1 within the first time interval TW1, wherein the portion of the first distance value DV1 includes a plurality of second distance values DV2, and the first amplitude AM1 is equal to the difference between the maximum distance value and the minimum distance value in the second distance values DV2. Step S84 includes the navigation device 300 extracting a plurality of portions of the first amplitude AM1 corresponding to a plurality of time points TP based on a second time interval TW2 corresponding to a time point TP, and calculating a second amplitude AM2 of the plurality of portions of the first amplitude AM1 within the second time interval TW2, wherein the plurality of portions of the first amplitude AM1 include a plurality of amplitude values, and the second amplitude AM2 is equal to the difference between the maximum amplitude value and the minimum amplitude value in the plurality of amplitude values. Step S85 includes the navigation device 300 determining whether the second amplitude AM2 of the plurality of portions of the first amplitude AM1 is greater than a predetermined threshold.
[0045] Furthermore, step S86 is performed after step S82 and includes the step of the navigation device 300 determining one of the first distance values DV1 based on a predetermined distance interval set to generate a distance determination result, and generating an optical signal based on the distance determination result. The predetermined distance interval set includes a first predetermined distance threshold and a second predetermined distance threshold, where the first predetermined distance threshold is smaller than the second predetermined distance threshold. The optical signal has a color that is one of green, yellow, and orange. If, as a distance determination result, one of the first distance values DV1 is smaller than the first predetermined distance threshold, the color of the optical signal is green. If, as a distance determination result, one of the first distance values DV1 is greater than or equal to the first predetermined distance threshold and smaller than the second predetermined distance threshold, the color of the optical signal is yellow. If, as a distance determination result, one of the first distance values DV1 is greater than the second predetermined distance threshold, the color of the optical signal is orange. In one embodiment, the first predetermined distance threshold is 1.6m, the second predetermined distance threshold is 1.8m, and the predetermined distance interval set is (1.6m, 1.8m), but the present invention is not limited to these.
[0046] As a result, the surgical navigation reference offset warning method S8 of the present invention can determine the second amplitude AM2 of the first amplitude AM1 of the distance value (i.e., the amplitude of the amplitude of the distance value), thereby confirming whether the reference member 200 is offset under conditions where the navigation device 300 is not offset, and can effectively achieve real-time detection. Furthermore, it can effectively distinguish between aperiodic and periodic displacements and achieve the effect of offset warning. In addition, the present invention provides an objective distance state using a light signal of a specific color, helping the user maintain optimal system performance (by maintaining a green light signal in the system), and ensuring that the positioning system is in an optimal operating state.
[0047] It should also be explained that the surgical navigation reference offset warning system 100 and surgical navigation reference offset warning methods S0, S2, S4, S6, S8 of the present invention can also verify whether the navigation device 300 is offset under conditions where the reference member 200 is not offset. This is because, if the optical tracker and display device 400 of the navigation device 300 are mounted on the same stand and the display device 400 is a touchscreen, the optical tracker may shake or become offset if the force applied when the user touches the touchscreen with their finger is too strong. Therefore, the system and methods of the present invention can similarly detect the offset status of the navigation device 300.
[0048] In addition to the shaking of the patient and surgical instruments (e.g., C-arm), other factors that can cause offset include (1) the surgical instrument and the reference member 200 on the patient being positioned at the boundary of the effective detection range of the optical tracker, and (2) contamination of the surgical instrument and the reference member 200 on the patient, such as scratches or bloodstains. These factors can also cause situations in which the amplitude of the distance value (Reference) or the standard deviation of the distance value (C-arm) is greater than a threshold, and the present invention can effectively detect such situations.
[0049] Referring together to Figures 3 and 6, as can be seen from the drawings, the method (i.e., software) of the present invention executes a loop to continuously monitor the positional changes of the reference member 200 or the dynamic reference member 500. In Figure 3, the surgical navigation reference offset warning method S2 continuously repeats steps S21, S22, S23, S24, S25 and one of steps S262, S264. In Figure 6, the surgical navigation reference offset warning method S6 continuously repeats steps S61, S62, S63, S64 and one of steps S652, S654.
[0050] In other embodiments, in addition to determining the stability of an object by the amplitude of the distance value of the navigation device corresponding to the time interval or by the standard deviation of the distance value, the present invention can further determine stability by combining other dynamic features, such as velocity information, acceleration information, or a multi-parameter comprehensive judgment. For velocity information, the tracking system can calculate the amount of positional change of the object at consecutive time points and further derive instantaneous velocity or average velocity. Significant velocity fluctuations, for example, frequent changes in velocity over a short period, may indicate that the object is swaying. For acceleration information, acceleration reflects the rate of velocity change and therefore has high sensitivity to detecting sudden or intermittent swaying. Severe changes in acceleration indicate that the object is being affected by instantaneous external forces or vibrations. For multi-parameter comprehensive judgment, the sensitivity and accuracy of sway detection can be improved by comprehensively evaluating indicators such as the amplitude of the distance value, the standard deviation of the distance value, velocity information, and acceleration information.
[0051] The above embodiment can be implemented by a computer program product and may include a computer-readable storage medium storing multiple instructions, which can be programmed to execute the steps of the above embodiment. In other words, the computer-readable storage medium has multiple instructions, and when these instructions are executed on a processor, the processor is caused to execute the surgical navigation reference offset warning methods S0, S2, S4, S6, S8. The computer-readable storage medium may be, but is not limited to, a floppy disk, an optical disk, a read-only optical disk, a magneto-optical disk, a read-only memory, a random-access memory, an erasable programmable read-only memory (EPROM), an electrically erasable programmable read-only memory (EEPROM), an optical card or magnetic card, flash memory, or any computer-readable storage medium suitable for storing electronic instructions.
[0052] As can be seen from the embodiments described above, the present invention has the following advantages. Firstly, by determining the second amplitude of the first amplitude of the distance value (i.e., the amplitude of the amplitude of the distance value), it is possible to confirm whether the reference member is offset and effectively realize real-time detection, as well as effectively distinguish between aperiodic and periodic displacements and achieve the effect of offset warning. Secondly, by using warning messages of a specific color, abnormal displacements (aperiodic displacements) can be notified to the user in real time, further achieving the elimination of deviations and improving surgical accuracy and safety. Thirdly, by determining the standard deviation of the distance value, it is possible to confirm whether the reference module is offset, display the stability of the reference module in real time, have objective judgment criteria and present the optimal imaging timing, thereby improving the accuracy of image positioning, optimizing the efficiency of the surgical process, reducing the uncertainty of the operator's subjective judgment, and increasing the reliability of the entire system. Fourthly, by using light signals of a specific color to provide an objective distance state, it is possible to help the user maintain the optimal performance of the system (by maintaining a green light signal in the system) and ensure that the positioning system is in an optimal operating state.
[0053] Although the present invention has been disclosed in embodiments as described above, these embodiments are not intended to limit the present invention, and any person skilled in the art can make various changes and modifications without departing from the spirit and scope of the invention, and the scope of protection of the present invention should be based on the claims appended thereto. [Explanation of Symbols]
[0054] 100: Surgical Navigation Reference Offset Warning System 200: Reference member 300: Navigation device 400:Display device 500: Dynamic reference member AM1: 1st amplitude AM2: 2nd amplitude DV: Distance value DV1: First distance value DV2: Second distance value S0, S2, S4, S6, S8: Surgical navigation reference offset warning method S01, S02, S03, S04, S05, S21, S22, S23, S24, S25, S262, S264, S41, S42, S43, S44, S61, S62, S63, S64, S652, S654, S81, S82, S83, S84, S85, S86: Step SD: standard deviation T1: First object T2: Second object TP: Time point TW1: First hour section TW2: Second hour section
Claims
1. The steps include monitoring multiple reference coordinates of a reference member using a navigation device, The navigation device calculates a plurality of first distance values between the reference member and the navigation device based on the plurality of reference coordinates, and each of the first distance values is the distance between each of the reference coordinates and the navigation device, in steps: The navigation device extracts a portion of the plurality of first distance values based on a first time interval, calculates a first amplitude of the portion of the plurality of first distance values within the first time interval, the portion of the plurality of first distance values includes a plurality of second distance values, and the first amplitude is equal to the difference between the maximum distance value and the minimum distance value among the plurality of second distance values in steps, The navigation device extracts a portion of the plurality of first amplitudes corresponding to a plurality of time points based on a second time interval corresponding to a time point, calculates a second amplitude of the portion of the plurality of first amplitudes within the second time interval, the portion of the plurality of first amplitudes includes a plurality of amplitude values, and the plurality of second amplitudes is equal to the difference between the maximum amplitude value and the minimum amplitude value among the plurality of amplitude values in steps, The navigation device determines whether the second amplitude of a portion of the plurality of first amplitudes is greater than a predetermined threshold. A method for issuing reference offset warnings in surgical navigation, including those related to the offset.
2. The surgical navigation reference offset warning method according to claim 1, wherein the navigation device determines whether the second amplitude is greater than a predetermined threshold and generates a determination result, generates a warning message based on the determination result, and notifies the user of the occurrence of an offset of the reference member.
3. The surgical navigation reference offset warning method according to claim 1, wherein the first time interval is greater than the second time interval.
4. The aforementioned first time interval is the interval of the previous first time value with respect to the aforementioned time point. The surgical navigation reference offset warning method according to claim 3, wherein the second time interval is the interval of the previous second time value with respect to the time point.
5. The navigation device further includes the steps of determining one of the plurality of first distance values based on a predetermined distance interval set to generate a distance determination result, and generating an optical signal based on the distance determination result, The surgical navigation reference offset warning method according to claim 1, wherein the predetermined distance interval set includes a first predetermined distance threshold and a second predetermined distance threshold, the first predetermined distance threshold is smaller than the second predetermined distance threshold, and the optical signal has a color which is one of green, yellow, and orange.
6. If, as a result of the distance determination, one of the plurality of first distance values is smaller than the first predetermined distance threshold, the color of the light signal is green. If, as a result of the distance determination, one of the plurality of first distance values is greater than or equal to the first predetermined distance threshold and less than the second predetermined distance threshold, then the color of the light signal is yellow. The surgical navigation reference offset warning method according to claim 5, wherein if, as a result of the distance determination, one of the plurality of first distance values is greater than the second predetermined distance threshold, the color of the optical signal is orange.
7. The steps include: monitoring multiple dynamic reference coordinates of a dynamic reference member using the navigation device; The navigation device calculates a plurality of dynamic distance values between the dynamic reference member and the navigation device based on the plurality of dynamic reference coordinates, and each of the dynamic distance values is the distance between each of the dynamic reference coordinates and the navigation device. The steps include: extracting a portion of the plurality of dynamic distance values based on the time intervals corresponding to the navigation device, and calculating the standard deviation of the portion of the plurality of dynamic distance values within the time interval; The navigation device determines whether the standard deviation of some of the plurality of dynamic distance values is greater than another predetermined threshold, A surgical navigation reference offset warning method according to claim 1, further comprising:
8. The surgical navigation reference offset warning method according to claim 7, wherein the reference member is provided on a first object, and the dynamic reference member is provided on a second object different from the first object.
9. The steps include monitoring multiple reference coordinates of a reference member using a navigation device, The navigation device calculates a plurality of distance values between the reference member and the navigation device based on the plurality of reference coordinates, and each distance value is the distance between each of the reference coordinates and the navigation device, The navigation device extracts a portion of the plurality of distance values based on a time interval, and calculates the standard deviation of the portion of the plurality of distance values within the time interval. The navigation device determines whether the standard deviation of a portion of the plurality of distance values is greater than a predetermined standard deviation threshold. A surgical navigation reference offset warning method that includes the following features.
10. The surgical navigation reference offset warning method according to claim 9, wherein the navigation device determines whether the standard deviation is greater than a predetermined standard deviation threshold and generates a determination result, and based on the determination result, generates a warning message and notifies the user of the occurrence of an offset of the reference member.
11. The surgical navigation reference offset warning method according to claim 9, wherein the time interval is an interval of previous time values with respect to the time point.
12. Reference member and, A navigation device provided toward the aforementioned reference member, Monitoring multiple reference coordinates of the aforementioned reference member, Based on the plurality of reference coordinates, a plurality of first distance values are calculated between the reference member and the navigation device, and each of the first distance values is the distance between each of the reference coordinates and the navigation device. Based on the first time interval, a portion of the plurality of first distance values is extracted, and the first amplitude of the portion of the first distance values within the first time interval is calculated, and the portion of the first distance values includes a plurality of second distance values, and the first amplitude is equal to the difference between the maximum distance value and the minimum distance value among the plurality of second distance values. Based on a second time interval corresponding to a time point, a portion of the multiple first amplitudes corresponding to multiple time points is extracted, and a second amplitude is calculated for the portion of the multiple first amplitudes within the second time interval, wherein the portion of the multiple first amplitudes includes multiple amplitude values, and the second amplitude is equal to the difference between the maximum amplitude value and the minimum amplitude value among the multiple amplitude values. A navigation device is arranged to perform an operation that includes determining whether a portion of the plurality of first amplitudes has a second amplitude greater than a predetermined threshold, A surgical navigation reference offset warning system, including the following:
13. A display device connected to the aforementioned navigation device for displaying warning messages, It further includes, The surgical navigation reference offset warning system according to claim 12, wherein the navigation device determines whether the second amplitude is greater than a predetermined threshold and generates a determination result, and based on the determination result generates the warning message to notify the user of the occurrence of an offset of the reference member.
14. The surgical navigation reference offset warning system according to claim 12, wherein the first time interval is greater than the second time interval.
15. The aforementioned first time interval is the interval of the previous first time value with respect to the aforementioned time point. The surgical navigation reference offset warning system according to claim 14, wherein the second time interval is the interval of the previous second time value with respect to the time point.
16. The aforementioned navigation device is The navigation device is configured to perform an operation that further includes determining one of the plurality of first distance values based on a predetermined distance interval set to generate a distance determination result, and generating an optical signal based on the distance determination result, The surgical navigation reference offset warning system according to claim 12, wherein the predetermined distance interval set includes a first predetermined distance threshold and a second predetermined distance threshold, the first predetermined distance threshold being smaller than the second predetermined distance threshold, and the optical signal having a color which is one of green, yellow, and orange.
17. If, as a result of the distance determination, one of the plurality of first distance values is smaller than the first predetermined distance threshold, the color of the light signal is green. If, as a result of the distance determination, one of the plurality of first distance values is greater than or equal to the first predetermined distance threshold and less than the second predetermined distance threshold, then the color of the light signal is yellow. The reference offset warning system for surgical navigation according to claim 16, wherein if, as a result of the distance determination, one of the plurality of first distance values is greater than the second predetermined distance threshold, the color of the light signal is orange.
18. In a surgical navigation reference offset warning system in which the aforementioned reference member is provided on a first object, The system further includes a dynamic reference member provided on a second object different from the first object, The aforementioned navigation device is The monitoring of multiple dynamic reference coordinates of the aforementioned dynamic reference member, Based on the plurality of dynamic reference coordinates, a plurality of dynamic distance values are calculated between the dynamic reference member and the navigation device, and each of the dynamic distance values is the distance between each of the dynamic reference coordinates and the navigation device. Based on the corresponding time interval, extract a portion of the multiple dynamic distance values and calculate the standard deviation of the portion of the multiple dynamic distance values within the time interval. Determining whether the standard deviation of some of the aforementioned multiple dynamic distance values is greater than another predetermined threshold, A surgical navigation reference offset warning system according to claim 12, which is arranged to perform an operation that further includes the following: