Positioning deviation warning method for surgical navigation and system thereof

Abstract

This invention provides a reference offset warning method and system for surgical navigation. The method includes monitoring the reference coordinates of a reference component using a navigation device; calculating a first distance value between the reference component and the navigation device based on the reference coordinates; extracting a portion of the first distance value based on a first time interval and calculating a first amplitude of the portion of the first distance value within the first time interval; extracting a portion of the first amplitude corresponding to a second time point based on a second time interval and calculating a second amplitude of the portion of the first amplitude within the second time interval; and determining whether the second amplitude of the portion of the first amplitude is greater than a predetermined threshold. This effectively detects abnormal offsets of the reference component, providing warnings and improving safety.

Description

Technical Field

[0001] This invention relates to a reference offset warning method and system, and more particularly to a reference offset warning method and system for surgical navigation. Prior Technology

[0002] Reference elements typically play a crucial role in navigation surgical systems, serving as markers and positioning aids for patients or surgical instruments. However, positioning deviations can occur during surgery due to the following main factors: First, human interference: adjustments made by medical personnel or accidental contact with the operating table can cause reference element displacement. Second, physiological interference: the chest and abdominal movements caused by the patient's breathing can lead to periodic displacement of the reference element.

[0003] When it comes to patient identification and positioning, minute displacements are often difficult to detect. Non-periodic accidental displacements are particularly hard to spot, while periodic displacements caused by respiration require different treatment approaches. Furthermore, these two types of displacements necessitate different management strategies. Current technologies cannot provide real-time monitoring and cannot effectively distinguish between non-periodic accidental displacements and periodic displacements caused by respiration.

[0004] Regarding the marking and positioning of surgical instruments, the position and angle of the instruments are adjusted during the operation. After adjustment, it is necessary to wait until they are stable before taking pictures and positioning. Current conventional technology lacks objective stability judgment standards during the adjustment of surgical instruments, which easily leads users to judge whether the surgical instruments are stable based on experience, and they cannot accurately grasp the optimal time for imaging, and the positioning accuracy may be affected by imaging too early or too late.

[0005] Furthermore, optical trackers for navigation devices possess distance-dependent accuracy characteristics, including optimal positioning range (e.g., maximum accuracy achievable within a specific distance), accuracy decay characteristics (e.g., positioning accuracy gradually decreases beyond a certain boundary distance), and distance sensitivity (e.g., positioning accuracy is inversely proportional to operating distance). Current conventional technologies face difficulties in operating navigation devices, including the inability to instantly determine the current operating distance, the lack of objective distance judgment standards, and the difficulty in ensuring the positioning system is in optimal working condition.

[0006] In view of this, there is a lack of a reference offset warning method and system for surgical navigation that can instantly detect, effectively distinguish between acyclic and periodic displacements, alert abnormal displacements for deviation elimination, objective judgment criteria, prompt optimal imaging timing, provide objective distance status and ensure the positioning system is in optimal working condition. Invention content

[0007] Therefore, the purpose of the present invention is to provide a reference offset warning method for surgical navigation and its system, which uses the navigation device to determine whether the object attached to the reference piece or / and the dynamic reference piece produces shaking (or instability), the principle of which is based on the spatial coordinate change of the object during tracking. Whether through the amplitude of the amplitude of the distance value or the standard deviation of the distance value, it can effectively achieve real-time detection, effectively distinguish between non-periodic and periodic displacements, alert abnormal displacements for deviation elimination, have objective judgment standards, prompt optimal imaging timing, provide objective distance status and ensure that the positioning system is in optimal working condition. To solve the problems of inability to achieve real-time monitoring, inability to effectively distinguish between non-periodic and periodic displacements, lack of objective stability judgment criteria, inability to precisely grasp the optimal imaging timing, inability to grasp the current operating distance in real time, lack of objective distance judgment criteria and difficulty in ensuring that the positioning system is in optimal working condition.

[0008] An embodiment of a methodology according to the present invention provides a reference offset warning method for surgical navigation comprising monitoring the plural reference coordinates of a reference piece by means of a navigation device; The first distance value is the distance between each reference coordinate and the navigation device; two distance values, and the first magnitude is equal to the difference between a maximum distance value and a minimum distance value of these second distance values;by the navigation device extracts a part of the complex first magnitude corresponding to a complex time point based on a second time interval corresponding to a time point, and computes these firsts in the second time interval a second magnitude of one of the parts of the magnitude, wherein the portion of these first magnitudes contains plural magnitude values ​​and the second magnitude is equal to the difference between one maximum and one minimum magnitude value of these magnitude values;

[0009] Other embodiments of the aforementioned implementation are as follows: The aforementioned navigation device determines whether the second amplitude is greater than a predetermined threshold and generates a determination result, and generates a warning message based on the determination result to inform a user that the reference has shifted.

[0010] Other embodiments of the aforementioned implementation are as follows: the aforementioned first time interval is greater than the second time interval.

[0011] Other embodiments of the aforementioned implementation are as follows: The aforementioned first time interval is the interval preceding a first time value based on the current time point. The second time interval is the interval preceding a second time value based on the current time point.

[0012] Other embodiments of the aforementioned implementation are as follows: The aforementioned surgical navigation reference offset warning method further includes generating a distance judgment result by the navigation device judging one of these first distance values ​​based on a predetermined distance interval group, and generating a light signal based on the distance judgment result. The predetermined distance interval group includes a first predetermined distance threshold and a second predetermined distance threshold, wherein the first predetermined distance threshold is less than the second predetermined distance threshold. The light signal has a color, and the color is one of green, yellow, and orange.

[0013] Other embodiments of the aforementioned implementation are as follows: When the aforementioned distance judgment result is that one of these first distance values ​​is less than a first predetermined distance threshold, the color of the light signal is green. When the distance judgment result is that one of these first distance values ​​is greater than or equal to the first predetermined distance threshold and less than a second predetermined distance threshold, the color of the light signal is yellow. When the distance judgment result is that one of these first distance values ​​is greater than the second predetermined distance threshold, the color of the light signal is orange.

[0014] Other embodiments of the aforementioned implementation are as follows: The aforementioned surgical navigation reference offset warning method further includes monitoring a plurality of dynamic reference coordinates of a dynamic reference element by a navigation device; calculating a plurality of dynamic distance values ​​between the dynamic reference element and the navigation device based on these dynamic reference coordinates, wherein each dynamic distance value is the distance between each dynamic reference coordinate and the navigation device; extracting a portion of these dynamic distance values ​​based on a corresponding time interval by the navigation device, and calculating a standard deviation of a portion of these dynamic distance values ​​within the time interval; and determining whether the standard deviation of a portion of these dynamic distance values ​​is greater than another predetermined threshold by the navigation device.

[0015] Other embodiments of the aforementioned implementation are as follows: the aforementioned reference component is disposed on a first target object, and the dynamic reference component is disposed on a second target object, wherein the first target object and the second target object are different.

[0016] According to another embodiment of the method of the present invention, a reference offset warning method for surgical navigation is provided, comprising: monitoring a plurality of reference coordinates of a reference element by a navigation device; calculating a plurality of distance values ​​between the reference element and the navigation device based on the reference coordinates, wherein 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 a standard deviation of a 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 aforementioned implementation are as follows: The aforementioned navigation device determines whether the standard deviation is greater than a predetermined standard deviation threshold and generates a judgment result, and generates a warning message based on the judgment result to inform a user that the reference has shifted.

[0018] Other embodiments of the aforementioned implementation are as follows: The aforementioned time interval is an interval based on a point in time and preceding a previous time value.

[0019] According to one embodiment of the structural configuration of the present invention, a surgical navigation reference offset warning system is provided, which includes a reference element and a navigation device. The navigation device is oriented toward a reference element and configured to perform the following operations: monitoring a plurality of reference coordinates of the reference element; calculating a plurality of first distance values ​​between the reference element and the navigation device based on these reference coordinates, wherein each first distance value is the distance between each reference coordinate and the navigation device; extracting a portion of these first distance values ​​based on a first time interval, and calculating a first amplitude of a portion of these first distance values ​​within the first time interval, wherein the portion of these first distance values ​​includes a plurality of second distance values, and the first amplitude is equal to the difference between a maximum distance value and a minimum distance value among these second distance values; extracting a portion of a plurality of first amplitudes corresponding to a second time interval corresponding to a point in time, and calculating a second amplitude of a portion of these first amplitudes within the second time interval, wherein the portion of these first amplitudes includes a plurality of amplitude values, and the second amplitude is equal to the difference between a maximum amplitude value and a minimum amplitude value among these amplitude values; and determining whether the second amplitude of the portion of these first amplitudes is greater than a predetermined threshold.

[0020] Other embodiments of the aforementioned implementation are as follows: The aforementioned surgical navigation reference offset warning system further includes a display device connected to the navigation device and used to display a warning message. The navigation device determines whether the second amplitude is greater than a predetermined threshold and generates a judgment result, and generates a warning message based on the judgment result to inform a user that the reference has shifted.

[0021] Other embodiments of the aforementioned implementation are as follows: the aforementioned first time interval is greater than the second time interval.

[0022] Other embodiments of the aforementioned implementation are as follows: The aforementioned first time interval is the interval preceding a first time value based on the current time point. The second time interval is the interval preceding a second time value based on the current time point.

[0023] Other embodiments of the aforementioned implementation are as follows: The aforementioned navigation device is configured to perform operations further including: generating a distance determination result by determining one of these first distance values ​​based on a predetermined distance interval group, and generating a light signal based on the distance determination result. The predetermined distance interval group includes a first predetermined distance threshold and a second predetermined distance threshold, the first predetermined distance threshold being less than the second predetermined distance threshold, and the light signal having a color, which is one of green, yellow, and orange.

[0024] Other embodiments of the aforementioned implementation are as follows: When the distance determination result is that one of these first distance values ​​is less than a first predetermined distance threshold, the color of the light signal is green. When the distance determination result is that one of these first distance values ​​is greater than or equal to the first predetermined distance threshold and less than a second predetermined distance threshold, the color of the light signal is yellow. When the distance determination result is that one of these first distance values ​​is greater than the second predetermined distance threshold, the color of the light signal is orange.

[0025] Other embodiments of the aforementioned implementation are as follows: The aforementioned reference element is disposed on a first target object. The surgical navigation reference offset warning system further includes a dynamic reference element disposed on a second target object, the first target object being different from the second target object. The navigation device is configured to perform operations including: monitoring a plurality of dynamic reference coordinates of the dynamic reference element; calculating a plurality of dynamic distance values ​​between the dynamic reference element and the navigation device based on these dynamic reference coordinates, wherein each dynamic distance value is the distance between each dynamic reference coordinate and the navigation device; extracting a portion of these dynamic distance values ​​based on a corresponding time interval, and calculating a standard deviation of a portion of these dynamic distance values ​​within the time interval; and determining whether the standard deviation of the portion of these dynamic distance values ​​is greater than another predetermined threshold. Simple Explanation of the Diagram

[0026] Figure 1 is a schematic diagram illustrating a reference offset warning system for surgical navigation according to a first embodiment of the present invention; Figure 2 is a flowchart illustrating a reference offset warning method for surgical navigation according to a second embodiment of the present invention; Figure 3 is a flowchart illustrating a reference offset warning method for surgical navigation according to a third embodiment of the present invention; Figure 4 is a waveform diagram illustrating the shaking detection of the reference component of the present invention; Figure 5 is a flowchart illustrating a reference offset warning method for surgical navigation according to a fourth embodiment of the present invention; Figure 6 is a flowchart illustrating a reference offset warning method for surgical navigation according to a fifth embodiment of the present invention; Figure 7 illustrates a waveform diagram of the shaking detection of the dynamic reference element of the present invention; and Figure 8 is a flowchart illustrating a reference offset warning method for surgical navigation according to a sixth embodiment of the present invention. Implementation

[0027] Several embodiments of the present invention will now be described with reference to the drawings. For clarity, many practical details will be set forth in the following description. However, it should be understood that these practical details are not intended to limit the invention. That is, in some embodiments of the invention, these practical details are not essential. Furthermore, for the sake of simplicity, some conventional structures and elements will be depicted in a simple schematic manner in the drawings; and repeated elements may be denoted by the same number.

[0028] Furthermore, in this document, when a component (or unit or module, etc.) is "connected" to another component, it can mean that the component is directly connected to the other component, or that the component is indirectly connected to the other component, meaning that there is another component between the component and the other component. Only when it is explicitly stated that a component is "directly connected" to another component does it indicate that there is no other component between the component and the other component. The terms "first," "second," and "third" are only used to describe different components and do not limit the components themselves; therefore, "first component" can also be referred to as "second component." Moreover, the combinations of components / units / circuits in this document are not combinations generally known, conventional, or customary in this field. Whether the components / units / circuits themselves are customary cannot be used to determine whether their combination relationships are easily accomplished by someone with ordinary knowledge in the art.

[0029] Please refer to Figure 1, which is a schematic diagram illustrating 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 element 200 and a navigation device 300. The navigation device 300 is positioned toward the reference element 200 and configured to perform the following operations: monitoring a plurality of reference coordinates of the reference element 200; calculating a plurality of first distance values ​​between the reference element 200 and the navigation device 300 based on these reference coordinates, wherein each first distance value is the distance between each reference coordinate and the navigation device 300; extracting a portion of these first distance values ​​based on a first time interval, and calculating a first amplitude of a portion of these first distance values ​​within the first time interval, wherein the portion of these first distance values ​​includes a plurality of second distance values, and the first amplitude is equal to the difference between a maximum distance value and a minimum distance value among these second distance values; extracting a portion of a plurality of first amplitudes corresponding to a second time interval corresponding to a point in time, and calculating a second amplitude of a portion of these first amplitudes within the second time interval, wherein the portion of these first amplitudes includes a plurality of amplitude values, and the second amplitude is equal to the difference between a maximum amplitude value and a minimum amplitude value among these amplitude values; and determining whether the second amplitude of the portion of these first amplitudes is greater than a predetermined threshold.

[0030] Please refer to Figures 1 and 2 together, where Figure 2 is a flowchart illustrating the reference offset warning method S0 for surgical navigation according to a first embodiment of the present invention. The reference offset warning method S0 for surgical navigation is applied to a reference offset warning system 100 for surgical navigation and includes execution steps S01, S02, S03, S04, and S05. Step S01 includes monitoring a plurality of reference coordinates of a reference element 200 by a navigation device 300. Step S02 includes calculating a plurality of first distance values ​​between the reference element 200 and the navigation device 300 based on these reference coordinates by the navigation device 300. Each first distance value is the distance between each reference coordinate and the navigation device 300. Step S03 includes extracting a portion of these first distance values ​​by the navigation device 300 based on a first time interval, and calculating a first amplitude of a portion of these first distance values ​​within the first time interval. The portion of these first distance values ​​includes a plurality of second distance values, and the first amplitude is equal to the difference between a maximum distance value and a minimum distance value among these second distance values. Step S04 includes using the navigation device 300 to extract a portion of a plurality of first amplitudes corresponding to a plurality of time points based on a second time interval corresponding to a given time point, and calculating a second amplitude of a portion of these first amplitudes within the second time interval. These portions of the first amplitudes include a plurality of amplitude values, and the second amplitude is equal to the difference between a maximum amplitude value and a minimum amplitude value among these amplitude values. Step S05 includes using the navigation device 300 to determine whether the second amplitude of these portions of the first amplitudes is greater than a predetermined threshold.

[0031] Therefore, the surgical navigation reference offset warning system 100 and surgical navigation reference offset warning method S0 of the present invention determine whether the reference member 200 has shifted under the condition that the navigation device 300 will not shift. This not only effectively achieves real-time detection, but also effectively distinguishes between non-periodic and periodic displacements, thereby achieving 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 element 500. The display device 400 is connected to the navigation device 300 and is used to display a warning message. The reference element 200 is disposed on a first target object T1, and the dynamic reference element 500 is disposed on a second target object T2, the first target object T1 and the second target object T2 being different. Either the reference element 200 and the dynamic reference element 500 includes a plurality of reflective spheres, which can be considered as 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 element 200 and / or the dynamic reference element 500 to generate reference coordinates and / or dynamic reference coordinates. In one embodiment, the first target object T1 may be a patient (a part of the patient's body), and the second target object T2 may be a C-arm (mobile X-ray machine). The processor receives coordinate data from the optical tracker and performs subsequent calculations and judgments. 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 thereto.

[0033] When the navigation device 300 detects the dynamic reference element 500, the navigation device 300 is configured to perform the following operations: monitor a plurality of dynamic reference coordinates of the dynamic reference element 500; calculate a plurality of dynamic distance values ​​between the dynamic reference element 500 and the navigation device 300 based on these dynamic reference coordinates, wherein each dynamic distance value is the distance between each dynamic reference coordinate and the navigation device 300; extract a portion of these dynamic distance values ​​based on a corresponding time interval, and calculate a standard deviation of a portion of these dynamic distance values ​​within the time interval; and determine whether the standard deviation of the portion of these dynamic distance values ​​is greater than another predetermined threshold.

[0034] Please refer to Figures 1, 3, and 4 together. Figure 3 is a flowchart illustrating the reference offset warning method S2 for surgical navigation according to the third embodiment of the present invention; and Figure 4 is a waveform diagram illustrating the shaking detection of the reference member 200 of the present invention. The reference offset warning method S2 for surgical navigation in Figure 3 is applied to the reference offset warning system 100 for surgical navigation and includes execution steps S21, S22, S23, S24, S25, S262, and S264. In Figure 4, the horizontal axis represents time (seconds), and the vertical axis represents distance (mm).

[0035] Step S21 includes real-time monitoring and recording of a plurality of reference coordinates of a reference element 200 by a navigation device 300. Step S22 includes calculating and recording a plurality of first distance values ​​DV1 between the reference element 200 and the navigation device 300 based on these reference coordinates by the navigation device 300, wherein each first distance value DV1 is the distance between each reference coordinate and the navigation device 300. Step S23 includes extracting a portion of these first distance values ​​DV1 by the navigation device 300 based on a first time interval TW1 corresponding to a time point TP, and calculating a first amplitude AM1 of one portion of these first distance values ​​DV1 within the first time interval TW1, wherein the portion of these first distance values ​​DV1 includes a plurality of second distance values ​​DV2, and the first amplitude AM1 is equal to the difference between a maximum distance value and a minimum distance value among these second distance values ​​DV2. Step S24 includes using the navigation device 300 to extract a portion of the complex first amplitude AM1 of the corresponding complex time points TP according to a second time interval TW2 of the corresponding time point TP, and calculating a second amplitude AM2 of the portion of these first amplitude AM1 within the second time interval TW2, wherein the portion of these first amplitude AM1 includes complex amplitude values, and the second amplitude AM2 is equal to the difference between a maximum amplitude value and a minimum amplitude value among these amplitude values. Step S25 includes using the navigation device 300 to determine whether the second amplitude AM2 of the portion of these first amplitude AM1 is greater than a predetermined threshold to generate a determination result, and generating a warning message based on the determination result to inform a user that the reference 200 has deviated. When the determination result is yes, step S262 is executed; when the determination result is no, step S264 is executed. Step S262 includes using a display device 400 to display a red warning message (indicating that the reference 200 is unstable). Step S264 includes displaying a green warning message (indicating that reference 200 is stable) via display device 400.

[0036] Specifically, the first time interval TW1 is greater than the second time interval TW2. The first time interval TW1 is the interval preceding a first time value based on time point TP, and the first time value can be between several seconds and tens of seconds, preferably greater than 5 seconds and less than 11 seconds. The second time interval TW2 is the interval preceding a second time value based on time point TP, and the second time value can be between hundreds of milliseconds and several seconds, preferably greater than 0 seconds and less than 2 seconds. The predetermined threshold can be greater than 0.10 mm and less than 0.20 mm. In one embodiment, the first time value can be 8 seconds, the second time value can be 1 second, and the predetermined threshold can be 0.15 mm, but the present invention is not limited thereto. In other embodiments, the warning message can be an audio message, which can be emitted by the navigation device 300 or the display device 400 to inform the user that the reference element 200 has deviated.

[0037] Therefore, the surgical navigation reference deviation warning method S2 of the present invention determines whether the reference element 200 has deviated under the condition that the navigation device 300 does not deviate, by judging the second amplitude AM2 (i.e., the amplitude of the distance value's amplitude) of the first amplitude AM1 of the distance value. This effectively achieves real-time detection and distinguishes between non-periodic and periodic displacements. In addition, the present invention uses a specific color warning message to allow the user to be aware of abnormal displacement (non-periodic displacement) in real time, thereby eliminating deviations and improving surgical accuracy and safety.

[0038] Please refer to Figures 1 and 5 together, where Figure 5 is a flowchart illustrating the reference offset warning method S4 for surgical navigation according to the fourth embodiment of the present invention. The reference offset warning method S4 for surgical navigation is applied to the reference offset warning system 100 for surgical navigation and includes execution steps S41, S42, S43, and S44. Step S41 includes monitoring a plurality of reference coordinates of a reference element by a navigation device 300. The reference element (reference module) may be a reference element 200 disposed on a first target object T1 (e.g., a patient), or a dynamic reference element 500 disposed on a second target object T2 (e.g., a C-arm), but the present invention is not limited thereto. Step S42 includes calculating a plurality of distance values ​​between the reference element and the navigation device 300 based on these reference coordinates by the navigation device 300, wherein each distance value is the distance between each reference coordinate and the navigation device 300. Step S43 includes extracting a portion of these distance values ​​based on a time interval using the navigation device 300, and calculating a standard deviation of the portion of these distance values ​​within the time interval. Step S44 includes determining whether the standard deviation of the portion of these distance values ​​is greater than a predetermined standard deviation threshold using the navigation device 300.

[0039] Therefore, the surgical navigation reference offset warning method S4 of the present invention, by judging the standard deviation of the distance value, confirms whether the reference module has shifted under the condition that the navigation device 300 will not shift. It can display the stability of the reference module in real time, provide an objective judgment standard, and indicate the optimal image acquisition time, thereby improving the accuracy of image positioning, optimizing the efficiency of the surgical procedure, reducing the uncertainty of the operator's subjective judgment, and improving the overall reliability of the system. In addition, the present invention provides more accurate and objective equipment stability monitoring for surgical navigation, ensuring that image acquisition and positioning are performed under optimal conditions.

[0040] Please refer to Figures 1, 6, and 7 together. Figure 6 is a flowchart illustrating the reference offset warning method S6 for surgical navigation according to the fifth embodiment of the present invention; and Figure 7 is a waveform diagram illustrating the sway detection of the dynamic reference member 500 of the present invention. The reference offset warning method S6 for surgical navigation in Figure 6 is applied to the reference offset warning system 100 for surgical navigation and includes execution 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 real-time monitoring and recording of multiple reference coordinates of a reference element by a navigation device 300. In this embodiment, the reference element (reference module) may be a dynamic reference element 500 set on the second target object T2 (e.g., a C-arm). Step S62 includes calculating and recording multiple distance values ​​DV between the reference element and the navigation device 300 based on these reference coordinates by the navigation device 300, wherein each distance value DV is the distance between each reference coordinate and the navigation device 300. Step S63 includes extracting a portion of these distance values ​​DV based on a time interval corresponding to a time point by the navigation device 300, and calculating a standard deviation SD of the portion of these distance values ​​DV within the time interval. Step S64 includes determining whether the standard deviation SD of the portion of these distance values ​​DV is greater than a predetermined standard deviation threshold by the navigation device 300, generating a determination result, and generating a warning message based on the determination result to inform a user that the reference element has shifted. If the determination result is yes, proceed to step S652; if the determination result is no, proceed to step S654. Step S652 includes displaying a red warning message (indicating that the dynamic reference 500 is unstable) on a display device 400. Step S654 includes displaying a green warning message (indicating that the dynamic reference 500 is stable) on the display device 400.

[0042] Specifically, the time interval is the interval preceding a given time point, where 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 thereto.

[0043] Therefore, the surgical navigation reference deviation warning method S6 of the present invention uses the standard deviation SD of the distance value to confirm whether the reference module has deviated under the condition that the navigation device 300 does not deviate. It can display the stability of the reference module in real time, provide an objective judgment standard, and indicate the optimal imaging time. In addition, the present invention uses a specific color warning message to allow the user to know about abnormal displacement (non-periodic displacement) in real time, thereby achieving deviation elimination and improving surgical accuracy and safety.

[0044] Please refer to Figures 1, 2, 4, and 8, where Figure 8 is a flowchart illustrating the reference offset warning method S8 for surgical navigation according to the sixth embodiment of the present invention. The reference offset warning method S8 for surgical navigation is applied to a reference offset warning system 100 for surgical navigation and includes execution steps S81, S82, S83, S84, S85, and S86. Step S81 includes monitoring a plurality of reference coordinates of a reference element 200 by a navigation device 300. Step S82 includes calculating a plurality of first distance values ​​DV1 between the reference element 200 and the navigation device 300 based on these reference coordinates, wherein each first distance value DV1 is the distance between each reference coordinate and the navigation device 300. Step S83 includes using the navigation device 300 to extract a portion of the first distance values ​​DV1 according to a first time interval TW1, and calculating a first amplitude AM1 of the portion of the first distance values ​​DV1 within the first time interval TW1, wherein 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 a maximum distance value and a minimum distance value among the second distance values ​​DV2. Step S84 includes using the navigation device 300 to extract a portion of a plurality of first amplitudes AM1 corresponding to a plurality of time points TP according to a second time interval TW2, and calculating a second amplitude AM2 of the portion of the first amplitudes AM1 within the second time interval TW2, wherein the portion of the first amplitudes AM1 includes a plurality of amplitude values, and the second amplitude AM2 is equal to the difference between a maximum amplitude value and a minimum amplitude value among the amplitude values. Step S85 includes using the navigation device 300 to determine whether the second amplitude AM2 of the portion of the first amplitudes AM1 is greater than a predetermined threshold.

[0045] Furthermore, step S86 is performed after step S82 and includes the navigation device 300 determining one of the first distance values ​​DV1 based on a predetermined distance interval group to generate a distance determination result, and generating a light signal based on the distance determination result. The predetermined distance interval group includes a first predetermined distance threshold and a second predetermined distance threshold, wherein the first predetermined distance threshold is less than the second predetermined distance threshold. The light signal has a color, which is one of green, yellow, and orange. When the distance determination result is that one of the first distance values ​​DV1 is less than the first predetermined distance threshold, the light signal is green. When the distance determination result is that one of the first distance values ​​DV1 is greater than or equal to the first predetermined distance threshold and less than the second predetermined distance threshold, the light signal is yellow. When the distance determination result is that one of the first distance values ​​DV1 is greater than the second predetermined distance threshold, the light 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 group is (1.6m, 1.8m), but the present invention is not limited thereto.

[0046] Therefore, the surgical navigation reference offset warning method S8 of the present invention determines whether the reference element 200 has shifted under the condition that the navigation device 300 does not shift, by judging the second amplitude AM2 of the first amplitude AM1 of the distance value (i.e., the amplitude of the distance value amplitude). This not only effectively achieves real-time detection but also effectively distinguishes between non-periodic and periodic displacements, thereby achieving the effect of offset warning. In addition, the present invention uses a specific color light signal to provide an objective distance status and assists the user in maintaining the optimal performance of the system (keeping the system in a green light signal) to ensure that the positioning system is in optimal working condition.

[0047] It is also worth mentioning that the surgical navigation reference offset warning system 100 and surgical navigation reference offset warning methods S0, S2, S4, S6, and S8 of the present invention can also confirm whether the navigation device 300 has shifted when the reference component 200 does not shift. This is because the optical tracker of the navigation device 300 and the display device 400 are mounted on the same frame. If the display device 400 is a touch screen, and the user touches the screen with too much force, it may cause the optical tracker to shake or shift. Therefore, the system and method of the present invention can also detect when the navigation device 300 has shifted.

[0048] Besides patient and surgical instrument (such as C-arm) movement, other factors causing deviation include: (1) the reference piece 200 on the surgical instrument and patient being positioned at the boundary of the effective detection range of the optical tracker; and (2) the reference piece 200 on the surgical instrument and patient being contaminated, such as scratched or stained with blood. These factors can also cause the amplitude of the distance value (Reference) or the standard deviation of the distance value (C-arm) to exceed a threshold, and the present invention can effectively detect these situations.

[0049] Please refer to Figures 3 and 6 together. As shown in the figures, the method (i.e., the software) of this invention executes a loop to continuously monitor the positional changes of the reference element 200 or the dynamic reference element 500. In Figure 3, the surgical navigation reference offset warning method S2 continuously repeats one of steps S21, S22, S23, S24, S25, and steps S262 and S264. In Figure 6, the surgical navigation reference offset warning method S6 continuously repeats one of steps S61, S62, S63, S64, and steps S652 and S654.

[0050] In other embodiments, besides judging stability by the amplitude or standard deviation of the distance value of the object corresponding to the navigation device within a time interval, the present invention can further combine other dynamic characteristics for judgment, such as velocity information, acceleration information, or multi-parameter comprehensive judgment. Regarding velocity information, the tracking system can calculate the change in position of the object at consecutive time points, thereby deriving instantaneous velocity or average velocity. If the velocity fluctuates significantly, for example, if the velocity changes frequently in a short period of time, it may indicate that the object is in a swaying state. Regarding acceleration information, since acceleration reflects the rate of change of velocity, it is highly sensitive to detecting sudden or intermittent swaying. If the acceleration changes drastically, it indicates that the object has been subjected to instantaneous external force or vibration interference. Regarding multi-parameter comprehensive judgment, the amplitude of the distance value, the standard deviation of the distance value, velocity information, and acceleration information can be combined for evaluation, thereby improving the sensitivity and accuracy of sway detection.

[0051] The above embodiments can be implemented using computer program products, which may include a computer-readable storage medium storing a plurality of instructions that can program a computer to perform the steps in the above embodiments. In other words, the computer-readable storage medium has a plurality of instructions that, when executed by a processor, cause the processor to execute the surgical navigation reference offset warning method S0, S2, S4, S6, and S8. The computer-readable storage medium may be, but is not limited to, a floppy disk, optical disk, read-only optical disk, magneto-optical disk, read-only memory, random access memory, erasable programmable read-only memory (EPROM), electronically erasable programmable read-only memory (EEPROM), 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 above embodiments, the present invention has the following advantages: First, by judging the second amplitude of the first amplitude of the distance value (i.e., the amplitude of the distance value's amplitude), it is confirmed whether the reference component has shifted. This not only effectively achieves real-time detection but also effectively distinguishes between non-periodic and periodic displacements, thereby achieving the effect of offset warning. Second, by using a specific color warning message, the user can immediately know about abnormal displacement (non-periodic displacement), thereby eliminating deviations and improving surgical accuracy and safety. Third, by judging the standard deviation of the distance value, it is confirmed whether the reference module has shifted. This can instantly display the stability of the reference module, provide objective judgment standards, and indicate the optimal imaging time, thereby improving image positioning accuracy, optimizing surgical process efficiency, reducing the uncertainty of the operator's subjective judgment, and improving the overall reliability of the system. Fourth, by using a specific color light signal, it provides an objective distance status and helps the user maintain the system's optimal performance (keeping the system in a green light signal) to ensure that the positioning system is in optimal working condition.

[0053] Although the present invention has been disclosed above by way of embodiments, it is not intended to limit the present invention. Anyone skilled in the art can make various modifications and refinements without departing from the spirit and scope of the present invention. Therefore, the scope of protection of the invention shall be determined by the claims attached.

[0054] 100: Surgical Navigation Reference Deviation Warning System 200: Reference 300: Navigation device 400: Display device 500: Dynamic Reference Component AM1: First amplitude AM2: Second amplitude DV: Distance value DV1: First distance value DV2: Second distance value S0, S2, S4, S6, S8: Reference Deviation Warning Method for Surgical Navigation 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: Steps SD: Standard Deviation T1: First target object T2: Second target TP: Time Point TW1: First Time Interval TW2: Second Time Interval

Claims

1. A reference offset warning method for surgical navigation, comprising: monitoring a plurality of reference coordinates of a reference element by a navigation device; calculating a plurality of first distance values ​​between the reference element and the navigation device by the navigation device based on the reference coordinates, wherein each of the first distance values ​​is a distance between each of the reference coordinates and the navigation device; extracting a portion of the first distance values ​​by the navigation device based on a first time interval, and 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 a maximum distance value and a minimum distance value among the second distance values; The navigation device extracts a portion of a plurality of the first amplitudes corresponding to a given time point based on a second time interval, and calculates a second amplitude of a portion of the first amplitudes within the second time interval. The portion of the first amplitudes includes a plurality of amplitude values, and the second amplitude is equal to the difference between a maximum amplitude value and a minimum amplitude value among these amplitude values. The navigation device also determines whether the second amplitude of the portion of the first amplitudes is greater than a predetermined threshold. The predetermined threshold is determined based on the stability of the reference component.

2. The surgical navigation reference offset warning method as described in claim 1, wherein the navigation device determines whether the second amplitude is greater than the predetermined threshold and generates a judgment result, and generates a warning message based on the judgment result to inform a user that the reference has shifted.

3. The surgical navigation reference offset warning method as described in request item 1, wherein the first time interval is greater than the second time interval.

4. The surgical navigation reference offset warning method as described in claim 3, wherein, The first time interval is the interval preceding the first time value based on the current time point; and the second time interval is the interval preceding the second time value based on the current time point.

5. The surgical navigation reference offset warning method as described in claim 1 further comprises: generating a distance judgment result by the navigation device determining one of the first distance values ​​based on a predetermined set of distance intervals, and generating an optical signal based on the distance judgment result; wherein, The predetermined distance interval group includes a first predetermined distance threshold and a second predetermined distance threshold, the first predetermined distance threshold being less than the second predetermined distance threshold, and the optical signal having a color, which is one of green, yellow, and orange.

6. The surgical navigation reference offset warning method as described in claim 5, wherein, When the distance determination result is that one of the first distance values ​​is less than the first predetermined distance threshold, the color of the light signal is green; when the distance determination result is that one of the first distance values ​​is greater than or equal to the first predetermined distance threshold and less than the second predetermined distance threshold, the color of the light signal is yellow; and when the distance determination result is that one of the first distance values ​​is greater than the second predetermined distance threshold, the color of the light signal is orange.

7. The surgical navigation reference offset warning method as described in claim 1 further comprises: monitoring a plurality of dynamic reference coordinates of a dynamic reference element by the navigation device; calculating a plurality of dynamic distance values ​​between the dynamic reference element and the navigation device based on the dynamic reference coordinates by the navigation device, wherein 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 a standard deviation of the portion of the dynamic distance values ​​within the time interval; and determining by the navigation device whether the standard deviation of the portion of the dynamic distance values ​​is greater than another predetermined threshold.

8. The surgical navigation reference offset warning method as described in claim 7, wherein the reference element is disposed on a first target object, the dynamic reference element is disposed on a second target object, and the first target object and the second target object are different.

9. A reference offset warning method for surgical navigation, comprising: monitoring a plurality of reference coordinates of a reference element using a navigation device; calculating a plurality of distance values ​​between the reference element and the navigation device based on the reference coordinates, wherein each distance value is a distance between each reference coordinate and the navigation device; extracting a portion of the distance values ​​based on a time interval using the navigation device, and calculating a 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 using the navigation device; wherein, The predetermined standard deviation threshold is determined based on the stability of the reference component.

10. The surgical navigation reference offset warning method as described in claim 9, wherein the navigation device determines whether the standard deviation is greater than the predetermined standard deviation threshold and generates a judgment result, and generates a warning message based on the judgment result to inform a user that the reference has shifted.

11. The surgical navigation reference offset warning method as described in claim 9, wherein the time interval is an interval of one time value prior to a given time point.

12. A surgical navigation reference offset warning system, comprising: a reference element; and a navigation device disposed toward the reference element and configured to perform operations including: monitoring a plurality of reference coordinates of the reference element; calculating a plurality of first distance values ​​between the reference element and the navigation device based on the reference coordinates, wherein each of the first distance values ​​is a distance between each reference coordinate and the navigation device; extracting a portion of the first distance values ​​based on a first time interval, and calculating a first amplitude of one 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 a maximum distance value and a minimum distance value among the second distance values; Based on a second time interval corresponding to a given time point, a portion of the complex first amplitude corresponding to that time point is extracted, and a second amplitude of that portion of the first amplitudes within the second time interval is calculated, wherein that portion of the first amplitudes contains complex amplitude values, and the second amplitude is equal to the difference between a maximum amplitude value and a minimum amplitude value among the amplitude values; and it is determined whether the second amplitude of that portion of the first amplitudes is greater than a predetermined threshold; wherein, The predetermined threshold is determined based on the stability of the reference component.

13. The surgical navigation reference offset warning system as described in claim 12 further comprises: a display device connected to the navigation device and used to display a warning message; wherein, The navigation device determines whether the second amplitude is greater than the predetermined threshold and generates a judgment result, and generates the warning message based on the judgment result to inform a user that the reference has shifted.

14. The surgical navigation reference offset warning system as described in claim 12, wherein the first time interval is greater than the second time interval.

15. The surgical navigation reference offset warning system as described in claim 14, wherein, The first time interval is the interval preceding the first time value based on the current time point; and the second time interval is the interval preceding the second time value based on the current time point.

16. The surgical navigation reference offset warning system as described in claim 12, wherein the navigation device is configured to perform operations further including: determining one of the first distance values ​​based on a predetermined set of distance intervals by the navigation device to generate a distance determination result, and generating an optical signal based on the distance determination result; wherein, The predetermined distance interval group includes a first predetermined distance threshold and a second predetermined distance threshold, the first predetermined distance threshold being less than the second predetermined distance threshold, and the optical signal having a color, which is one of green, yellow, and orange.

17. The surgical navigation reference offset warning system as described in claim 16, wherein, When the distance determination result is that one of the first distance values ​​is less than the first predetermined distance threshold, the color of the light signal is green; when the distance determination result is that one of the first distance values ​​is greater than or equal to the first predetermined distance threshold and less than the second predetermined distance threshold, the color of the light signal is yellow; and when the distance determination result is that one of the first distance values ​​is greater than the second predetermined distance threshold, the color of the light signal is orange.

18. The surgical navigation reference offset warning system as described in claim 12, wherein the reference element is disposed on a first target object, the surgical navigation reference offset warning system further comprising: a dynamic reference element disposed on a second target object, the first target object being different from the second target object; wherein, The navigation device is configured to perform operations including: monitoring a plurality of dynamic reference coordinates of the dynamic reference element; calculating a plurality of dynamic distance values ​​between the dynamic reference element and the navigation device based on the dynamic reference coordinates, wherein 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, and calculating a 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.

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