A personalized customized wearable brain oximetry device and method

Abstract

The application discloses a kind of individualized wearable brain blood oxygen detection devices, belong to brain blood oxygen monitoring technical field.The device includes individualized forehead positioning block and the brain blood oxygen detection module being set on it, the positioning block is obtained based on patient head CT data by frontal bone three-dimensional reconstruction and Boolean operation, its inner surface is consistent with patient frontal bone form;Detection module is arranged according to the projection position of frontal lobe functional area on positioning block.The application ensures the spatial position between detection module and frontal lobe functional area fixed by individualized customization, solves the technical problems that signal is unstable and longitudinal comparison cannot be carried out due to inconsistent wearing position of existing general brain blood oxygen detection equipment, improves the repeatability and reliability of detection signal, and is suitable for brain function monitoring and cognitive state assessment.

Description

Technical Field

[0001] This invention belongs to the field of brain blood oxygenation monitoring technology, and particularly relates to a personalized wearable brain blood oxygenation detection device and method. Background Technology

[0002] Functional near-infrared spectroscopy (fNIRS) is a commonly used method for detecting cerebral oxygenation. This technique emits near-infrared light of a specific wavelength that penetrates the scalp and skull. A detector receives the light signal scattered by the brain tissue and uses a modified Lambert-Beer law to calculate the changes in the concentration of oxyhemoglobin and deoxyhemoglobin in the tissue, thereby obtaining cerebral oxygenation parameters.

[0003] Current cerebral oxygenation monitoring devices typically use a common fixation method, such as an elastic cap or headband, to attach the light source and detector module to the patient's head. However, this standardized wearing method has the following technical drawbacks:

[0004] 1. Poor head circumference adaptability leads to detection failure. The elastic cap has inconsistent adaptability to patients with different head circumferences: when the head circumference is too large, the module is difficult to fit the forehead skin, and the near-infrared light cannot effectively penetrate the skull; when the head circumference is too small, the module position deviates from the preset detection area, resulting in severe light signal attenuation and unreliable data quality.

[0005] 2. Poor repeatability of wearing position leads to signal instability. Even for the same patient, the module position deviates each time it is worn, making it impossible to accurately locate the same brain region. This makes the monitoring data at different time points incomparable, and it is impossible to effectively use historical data for longitudinal analysis and disease progression tracking.

[0006] 3. The spatial registration problem remains unresolved. While multi-wavelength light source solutions have solved the time synchronization problem of different wavelength light signals in cerebral oxygenation detection, they have not solved the spatial asynchrony problem caused by the non-fixed wearing position—that is, the relative position between the detection module and the prefrontal cortex is inconsistent each time, resulting in uncertainty about the brain region from which the signal originates.

[0007] Existing patents, such as "A Multi-Point Intracranial Blood Oxygen Detection and Closed-Loop Ultrasonic Stimulation Device" (ZL202210461374.8), involve intracranial blood oxygen detection through fiber optic bundles and ceramic ferrules. However, their solutions require fixing the ferrule to the skull, which is an invasive procedure, and do not involve personalized customization of wearable detection devices based on individual anatomical characteristics. Summary of the Invention

[0008] This invention aims to solve the technical problems of inaccurate detection position and poor spatial registration consistency between different measurements caused by the use of a universal fixing method in existing brain oxygenation detection devices and methods. It provides a wearable brain oxygenation detection device and method that is personalized based on the patient's head CT images, can accurately locate the prefrontal cortex functional area, and has good wear repeatability.

[0009] To address the aforementioned technical problems, the specific technical solution of the present invention, a personalized wearable brain oxygenation detection device and method, is as follows:

[0010] A personalized wearable brain oxygenation detection device includes: a personalized forehead positioning block, which is obtained based on the patient's head CT data through three-dimensional reconstruction of the frontal bone and Boolean operations, and whose inner surface shape matches the outer surface morphology of the patient's frontal bone; a brain oxygenation detection module, disposed on the personalized forehead positioning block, the arrangement of the detection module on the positioning block being determined according to the projection position of the patient's prefrontal functional area on the surface of the positioning block; and a signal acquisition and processing unit, electrically connected to the detection module, for acquiring and processing brain oxygenation signals; the positioning block is provided with positioning structures corresponding to the anatomical landmarks of the patient's forehead to ensure that the relative position of the positioning block and the frontal bone is consistent each time it is worn.

[0011] Furthermore, the personalized forehead positioning block is prepared through the following Boolean operation steps: Step 1: Obtain the patient's head CT data, reconstruct a three-dimensional model of the skull, and extract the frontal bone model; Step 2: Create a copy of the frontal bone model and offset the frontal bone copy forward by a preset distance along the normal direction to obtain an expanded frontal bone model; Step 3: Create the first and second embryos; Step 4: Perform Boolean subtraction with the first embryo as the subtrahend and the frontal bone model as the subtractor to obtain the first Boolean model; Step 5: Perform a Boolean subtraction operation using the second embryo as the subtrahend and the expanded frontal bone model as the subtractor to obtain the second Boolean model; Step 6: Perform a Boolean subtraction operation using the first Boolean model as the subtrahend and the second Boolean model as the subtractor to obtain the personalized forehead positioning block.

[0012] Furthermore, the number of brain oxygenation detection modules is five, arranged as one central detection module and four surrounding detection modules, with the four surrounding detection modules distributed at the upper left, upper right, lower left, and lower right positions of the central detection module.

[0013] Furthermore, each of the detection modules includes at least one near-infrared light source and a near-infrared photodetector. The light source is a dual-wavelength near-infrared light-emitting device with emission wavelengths of 650~750 nm and 800~900 nm. The detector is used to receive the light signal scattered by brain tissue and convert it into an electrical signal.

[0014] Furthermore, the forehead anatomical landmarks include the brow ridge and / or the root of the nose.

[0015] Furthermore, the personalized forehead positioning block is made of medical-grade photocurable resin or nylon material through 3D printing.

[0016] This invention also discloses a personalized wearable method for detecting brain oxygenation, comprising the following steps: Step 1: Obtain the patient's head CT image data, perform three-dimensional reconstruction of the skull, and extract the frontal bone model; Step 2: Based on the frontal bone model, a personalized frontal positioning block is generated through Boolean operations, so that the inner surface of the positioning block fits the shape of the outer surface of the patient's frontal bone. Step 3: Delineate the functional areas of the prefrontal cortex on the CT image, map the position of the functional areas onto the surface of the personalized prefrontal positioning block, determine several functional area marker points within the obtained projection contour, and determine the arrangement position of the detection module on the positioning block based on the functional area marker points. Step 4: Install the cerebral oxygenation detection module onto the personalized forehead positioning block according to the determined layout; Step 5: Wear the positioning block on the patient's forehead, ensuring that the wearing position is unique and consistent through the anatomical positioning marks on the positioning block; Step 6: Activate the detection module to collect cerebral blood oxygenation signals, and output cerebral blood oxygenation parameters after processing by the signal acquisition and processing unit.

[0017] Furthermore, the extraction of the frontal bone model is based on the following anatomical landmarks to delineate the frontal bone boundaries: the coronal suture, the supraorbital margin and the superior orbital wall, the temporal line, and the frontal crest.

[0018] Furthermore, the functional area markers are determined as follows:

[0019] Under CT soft tissue window conditions, the anatomical regions of the prefrontal lobe are delineated in transverse, coronal, sagittal, and 3D reconstructed images. Regions meeting the following imaging characteristics are manually marked as target detection areas:

[0020] The gray and white matter are clearly demarcated;

[0021] The brain parenchyma has a uniform and moderate density;

[0022] There were no low-density ischemic foci, no high-density calcifications, and no mixed abnormal density shadows.

[0023] The above characteristics reflect that the area has good neural excitability and active function, belonging to the prefrontal cortex functional area suitable for cerebral blood oxygenation detection, and are marked as the labeled area.

[0024] The marked area is mapped from the CT image space to the surface of the personalized forehead positioning block to obtain the projection contour of the frontal lobe functional area on the positioning block. Multiple points are uniformly selected within the projection contour as functional area marking points.

[0025] Furthermore, the arrangement of the detection modules is determined as follows: A circular area with a diameter of 30 mm is drawn, centered on the marked points of each functional area within the projection outline of the prefrontal cortex on the surface of the positioning block; a large circle is drawn that encompasses all of the circular areas, with the center of the large circle serving as the center point of the first detection module; a circle with a radius of 30 mm is drawn, centered on the center of the first detection module; the intersections of the 30 mm diameter circles within the 30 mm radius circle are excluded; among the remaining intersections, the intersections located at the four corners (upper left, lower left, upper right, and lower right) are selected, and the centers of the four detection modules are placed at the selected intersections, with the hexagonal corners of the four detection modules coinciding with the 30 mm radius circle.

[0026] The personalized wearable brain oxygenation detection device and method of the present invention have the following advantages:

[0027] 1. Precise and consistent detection location: By using a personalized positioning block based on individual frontal bone anatomy, the relative position between the detection module and the patient's frontal lobe functional area is ensured to be fixed. The same detection spatial position can be reproduced every time it is worn, which solves the problem of inconsistent spatial registration in traditional devices and methods.

[0028] 2. Good individual adaptability: Based on the patient's own CT data, the inner surface of the positioning block is completely consistent with the shape of the frontal bone, which is suitable for patients with different head circumferences and frontal shapes, avoiding the detection failure caused by differences in head circumference of universal devices.

[0029] 3. Improved detection signal quality: The detection module is arranged in a targeted manner based on the projection position of the patient's prefrontal cortex functional area, and the distance between the light source and the detector is optimized according to the depth of the target brain region. Compared with a regular grid arrangement, it can obtain a stronger functional activation signal response.

[0030] 4. Supports longitudinal tracking and assessment: Due to the high repeatability of the wearing position, the monitoring data at different time points are comparable, and historical data can be effectively used to analyze the trend of changes in cerebral blood oxygenation and assess the rehabilitation effect. Attached Figure Description

[0031] Figure 1 A schematic diagram of a personalized wearable brain oxygenation detection method; Figure 2A schematic diagram of a 3D model of the skull generated using CT 3D reconstruction software; Figure 3 A schematic diagram of the process for generating a personalized forehead positioning block using Boolean operations; Figure 4 A schematic diagram of a replica of the frontal bone model; Figure 5 This is a schematic diagram of an expanded frontal bone model; Figure 6 A schematic diagram of the created embryo; Figure 7 This is a schematic diagram of one face of Boolean model 1; Figure 8 This is a schematic diagram of another face of Boolean model 1; Figure 9 A diagram showing the subtraction of the eye socket position from Boolean model 1; Figure 10 This is a schematic diagram of Boolean Model 2; Figure 11 A schematic diagram of a personalized forehead positioning block; Figure 12 To illustrate how to draw a circle with a diameter of 30mm on the personalized forehead fixation block, with each functional area marker as the center; Figure 13 A schematic diagram of a large circle that can include all circles with a diameter of 30mm; Figure 14 In order to be in Figure 13 A schematic diagram showing the placement of the first detection module at the center of the large circle; Figure 15 For Figure 14 Draw a circle with a radius of 30mm, with the center of the first detection block as the center. Figure 16 This is a schematic diagram showing the placement of the four detection modules; Figure 17 This diagram illustrates the corresponding arrangement of each detection module when it is fixedly installed on the personalized forehead positioning block. Figure 18 A diagram illustrating a personalized cerebral oxygenation monitoring device worn on a patient's forehead. Figure 19 A schematic diagram of signal data transmitted by the upper left module and received by the middle module of the control device and the personalized customization device of the present invention, which are composed of a regular hexagonal grid. Figure 20 A schematic diagram of signal data transmitted by the upper right module and received by the middle module of the comparison device and the personalized customization device of the present invention, which are composed of a regular hexagonal grid. Figure 21A schematic diagram of signal data transmitted by the lower left module and received by the middle module of the control device and the personalized customization device of the present invention, which are composed of a regular hexagonal grid. Figure 22 This is a schematic diagram of the signal data transmitted by the upper right module and received by the middle module of the control device and the personalized customization device of the present invention, which are composed of a regular hexagonal grid. Detailed Implementation

[0032] To better understand the purpose, structure, and function of this invention, the following detailed description of a personalized wearable brain oxygenation detection device and method, in conjunction with the accompanying drawings, is provided.

[0033] The present invention provides a personalized wearable brain oxygenation detection device, comprising: a personalized forehead positioning block, a brain oxygenation detection module, a signal acquisition and processing unit, and a data output and display terminal.

[0034] The personalized forehead positioning block is created from the patient's head CT data through 3D reconstruction of the frontal bone and Boolean operations, with its inner surface shape matching the morphology of the patient's frontal bone outer surface. The positioning block features anatomical landmarks corresponding to the patient's brow ridge and / or nasal root to ensure unique and consistent positioning each time it is worn. The positioning block is made of medical-grade photocurable resin or nylon material using 3D printing.

[0035] Five brain oxygenation detection modules are mounted on a personalized forehead positioning block, arranged as one central module and four surrounding modules, with a spacing of 30 mm between adjacent modules. Each detection module includes at least one near-infrared light source and one near-infrared photodetector.

[0036] The light source is a dual-wavelength near-infrared light-emitting device with emission wavelengths of 650~750 nm and 800~900 nm;

[0037] The detector is a photodiode or an avalanche photodiode, used to receive light signals scattered by brain tissue and convert them into electrical signals.

[0038] The signal acquisition and processing unit is electrically connected to the detection module via a flexible circuit board or wires. It includes a signal amplification circuit, an analog-to-digital conversion circuit, and a microprocessor, which are used to amplify, filter, and digitize the electrical signals output by the detector, and calculate cerebral blood oxygenation parameters according to the modified Lambert-Beer law.

[0039] The data output and display terminal is connected to the signal acquisition and processing unit via wired or wireless means to display the cerebral blood oxygenation parameter curve and value in real time, and supports the storage and comparative analysis of historical data.

[0040] like Figure 1As shown, the present invention provides a personalized wearable brain oxygenation detection method, comprising the following steps:

[0041] Step 1: CT Data Acquisition and 3D Reconstruction

[0042] Acquire digital CT images (DICOM format) of the patient's head. In the CT images, different tissues are highlighted by adjusting the window width (WW) and window level (WL).

[0043] Bone window conditions: window level 300~500 HU, window width 1000~2000 HU. At this time, bone tissue is displayed in high-density white, soft tissue has small gray value differences and no obvious outline, which is convenient for extracting the skull outline.

[0044] Soft tissue window conditions: window level 40~60 HU, window width 350~400 HU. At this setting, the contrast of brain tissue is optimal, and bones will be overexposed and appear completely white, making it easier to identify the prefrontal lobe region.

[0045] Using CT 3D reconstruction software, a CT value threshold for bone tissue (>200 HU) was set to segment the bone tissue and generate a 3D model of the skull, such as... Figure 2 As shown. Simultaneously, a three-dimensional model of the brain was reconstructed under soft tissue window conditions for subsequent prefrontal lobe anatomical localization.

[0046] Step 2: Frontal bone feature modeling and personalized frontal localization block generation

[0047] In the three-dimensional model of the skull, the frontal bone boundary was defined and the frontal bone model was extracted separately based on the following anatomical landmarks:

[0048] Posterior boundary: Coronal suture – runs in a serrated pattern, traversing the front of the skull, and is the natural boundary between the frontal and parietal bones;

[0049] Inferior boundary: supraorbital margin and superior orbital wall, medially connected to the ethmoid bone, laterally connected to the greater wing of the sphenoid bone;

[0050] Lateral boundary: Temporal line – extending backward along the brow ridge, with the frontal bone on the anteromedial side of the temporal line, transitioning to the temporal bone on the posterior and inferior side;

[0051] Midline landmark: Frontal crest - runs longitudinally along the midline of the medial surface of the frontal bone, dividing the frontal bone into two symmetrical halves.

[0052] Based on the extracted frontal bone model, personalized frontal lobe localization blocks are generated through Boolean operations, such as... Figure 3 As shown, the specific steps are as follows:

[0053] 1. Import the frontal bone model into 3D modeling software and create a copy of the frontal bone model, such as... Figure 4 As shown;

[0054] 2. Offset the frontal bone copy forward along the normal direction by a preset distance (preferably 2-5 mm) to obtain an expanded frontal bone model, such as... Figure 5 As shown;

[0055] 3. Create an embryonic body (the bottom surface of the embryonic body is parallel to the horizontal plane, the bottom surface is 10 mm below the highest point of the supraorbital margin of the frontal bone, and the side surface of the embryonic body extends 20 mm into the orbit), and copy this embryonic body for later use, such as... Figure 6 As shown;

[0056] 4. Boolean operation ①: Using the first embryonic body as the subtrahend and the original frontal bone model as the subtrahend, perform a Boolean subtraction operation to remove the excess portion of the orbital region, obtaining Boolean model 1, such as... Figures 7-9 As shown;

[0057] 5. Boolean operation ②: Using the second embryonic body as the subtrahend and the expanded frontal bone model as the subtrahend, perform a Boolean subtraction operation to remove the excess portion of the orbital region, obtaining Boolean model 2, as shown below. Figure 10 As shown;

[0058] 6. Boolean operation ③: Perform a Boolean subtraction operation using Boolean model 1 as the subtrahend and Boolean model 2 as the subtrahend to obtain a personalized forehead localization block, such as... Figure 11 As shown.

[0059] The inner surface of the positioning block perfectly conforms to the surface morphology of the patient's frontal bone, ensuring that the relative position of the positioning block and the frontal bone is consistent each time it is worn, thus achieving repeatability of spatial registration.

[0060] Step 3: Arrangement of Prefrontal Functional Area Localization and Detection Module

[0061] Under CT soft tissue window conditions, the anatomical regions of the prefrontal lobe are delineated in transverse, coronal, sagittal, and 3D reconstructed images. Regions meeting the following imaging characteristics are manually marked as target detection areas:

[0062] The gray and white matter are clearly demarcated;

[0063] The brain parenchyma has a uniform and moderate density;

[0064] There were no low-density ischemic foci, no high-density calcifications, and no mixed abnormal density shadows.

[0065] The above characteristics reflect that the area has good neural excitability and active function, and belongs to the prefrontal cortex functional area suitable for cerebral blood oxygenation detection.

[0066] The marked area is mapped from the CT image space onto the surface of a personalized forehead localization block to obtain the projected contour of the prefrontal functional areas on the localization block. Multiple points are uniformly selected within the projected contour as functional area marker points. These functional area marker points are used to characterize the spatial distribution of the prefrontal functional areas on the surface of the localization block, serving as a localization reference for the subsequent arrangement of detection modules.

[0067] 1. For example Figure 12 As shown, draw a circular area with a diameter of 30 mm, centered on each functional area marker point. Figure 13 As shown, draw a large circle that can encompass all circles with a diameter of 30mm, such as... Figure 14 As shown, the center of the circle, serving as the center point of the first detection module, is placed vertically.

[0068] 2. For example Figure 15 As shown, draw a circle with a radius of 30 mm centered on the center of the first detection module. Exclude the intersection points of the circle with a diameter of 30 mm that are inside the circle with a radius of 30 mm. Among the remaining intersection points, as shown... Figure 16 As shown, the intersection points of the four corners (top left, bottom left, top right, and bottom right) are preferentially selected, and the centers of the four detection modules are placed at the selected intersection points. The edges of each detection module are placed tangent to / coincide with the circle with a radius of 30mm.

[0069] 3. The detection modules are arranged as follows: four detection modules are arranged around a central detection module, and the four surrounding detection modules are distributed in the upper left, upper right, lower left and lower right positions of the central detection module.

[0070] The detection module, arranged in the above manner, offers significant advantages in signal acquisition. In resting-state and standardized cognitive paradigm tasks, compared to the traditional regular hexagonal grid arrangement, the personalized arrangement of this invention allows each detection channel to simultaneously capture stronger neurovascular coupling signals. The physiological basis for this is that when the prefrontal cortex is activated, the increased firing frequency of local neurons leads to a rise in energy demand, triggering microvascular dilation and resulting in a significant increase in local cerebral blood flow (exceeding oxygen consumption). This manifests as a significant increase in oxyhemoglobin (HbO2) concentration and a relative decrease in deoxyhemoglobin (Hb) concentration in capillaries and veins. Therefore, each effective brain functional activity corresponds to a significant increase in HbO2 accompanied by a moderate decrease in Hb.

[0071] In the signals acquired using the arrangement method of this invention, the changes in HbO2 and Hb are larger and the waveform characteristics are more significant. In contrast, signals obtained from traditional regular arrangements are often close to the baseline level and are easily misjudged as instrument noise or environmental interference and thus rejected. Specifically: stronger signal amplitude means that the true physiological response is much greater than system noise and ambient light interference, resulting in a higher signal-to-noise ratio and more reliable statistical analysis results; the large physiological signal amplitude makes motion artifacts and physiological noise (such as heartbeat and respiratory fluctuations) easier to identify and remove in the time and frequency domains, simplifying the data cleaning process and resulting in more stable results; for subjects such as children, the elderly, and patients with cognitive impairment who have difficulty cooperating with fixed tasks for extended periods, fewer trials are needed to achieve statistical significance, effectively shortening the detection time; shorter activation / rest cycles can be used in block design to improve temporal resolution or complete more conditional tests per unit time, enriching experimental paradigms; in neurofeedback and brain-computer interface systems, strong signals can support faster and more accurate generation of control commands, improving system response speed and user experience. In summary, the arrangement method described in this invention maximizes the capture of effective neural activation signals by precisely matching the spatial distribution of individual prefrontal cortex functional areas, fundamentally improving the sensitivity and reliability of cerebral blood oxygenation detection, and providing a high-quality signal foundation for clinical assessment, cognitive research, and brain-computer interaction.

[0072] Step 4: Installation of the cerebral blood oxygenation detection module and device completion

[0073] like Figure 17 As shown, each detection module is fixedly installed on the personalized forehead positioning block at its corresponding position. Each module is connected to the signal acquisition and processing unit via a flexible circuit board or wires. Positioning structures corresponding to the patient's anatomical landmarks on the forehead, such as the brow ridge and nasal root, are set on the positioning block to ensure unique orientation during wear. The positioning block is fabricated using 3D printing technology to complete the device assembly.

[0074] Step 5: Wearing and Detecting Brain Oxygen Signals

[0075] like Figure 18 As shown, the personalized cerebral oxygenation detection device prepared in step four is worn on the patient's forehead. The anatomical positioning marks on the positioning block (corresponding structures of the brow ridge and nasal root) ensure that the orientation of the device is unique and consistent each time it is worn.

[0076] Once the device is worn, the detection module is activated. The near-infrared light source emits dual-wavelength near-infrared light (650~750 nm and 800~900 nm). The light signal penetrates the patient's scalp and skull, reaching the prefrontal lobe brain tissue region. The detector receives the emitted light signal after it has been scattered and absorbed by the brain tissue, converts the light signal into an electrical signal, and transmits it to the signal acquisition and processing unit.

[0077] The signal acquisition and processing unit calculates the concentration changes of oxyhemoglobin and deoxyhemoglobin in the tissue based on the modified Lambert-Beer law and the change in dual-wavelength light intensity, thereby obtaining the blood oxygenation parameters of the prefrontal cortex, including but not limited to: tissue oxygenation index, change in oxyhemoglobin concentration (Δ[HbO2]), change in deoxyhemoglobin concentration (Δ[Hb]), and change in total hemoglobin concentration (Δ[tHb]).

[0078] Step Six: Data Output and Evaluation

[0079] The cerebral blood oxygenation parameters obtained in step five are transmitted to a data display and storage terminal, and output as real-time curves or numerical values ​​for clinicians or researchers to assess the patient's brain function status. Because the personalized positioning blocks ensure that the spatial position of the detection module and the prefrontal cortex is completely consistent with each test, data collected at different time points are spatially comparable, supporting longitudinal tracking of the patient's cerebral blood oxygenation trend and disease progression assessment.

[0080] Example 1

[0081] A healthy adult volunteer was selected, and their head CT image data (slice thickness ≤ 1.25 mm) was collected. The personalized cerebral oxygenation detection device was then prepared following steps one through four above. The detection module used a dual-wavelength near-infrared light source (760 nm and 850 nm) and a photodiode detector, with a light source-detector distance of 30 mm. Cerebral oxygenation signals were acquired as per step five, with a sampling frequency of 10 Hz and continuous acquisition for 10 minutes. The acquired cerebral oxygenation parameters were transmitted to a tablet computer for real-time display via Bluetooth.

[0082] Example 2

[0083] A patient with mild cognitive impairment was selected, and a personalized device was prepared according to the method in Example 1 to collect cerebral blood oxygenation data. The patient was tested once a week for four consecutive weeks. Due to the personalized design of the positioning block, the consistency of the testing position was ensured each time, and the Δ[HbO2] data from the four tests were highly comparable and could be used to assess the dynamic trend of changes in the patient's cognitive function.

[0084] Verification Experiment

[0085] Experimental Methods: The same subject was used with (1) a control device consisting of 5 detection modules arranged in a regular hexagonal grid, and (2) the personalized device of this invention. Under the condition of stable heart rate baseline, a standardized reading cognitive paradigm task was performed, and the light signal intensity of the receiver of the central detection module of both devices was collected simultaneously. Figures 19-22As shown, the blue curve represents the customized device of this invention, and the number after ch is the experimental channel serial number during testing; the red curve represents the regular arrangement (two on top and three on the bottom); HbO2 oxyhemoglobin, HHR deoxyhemoglobin.

[0086] Experimental results:

[0087] like Figure 19 As shown, channels 1162 and 1164 transmit signal data from the upper left module and receive it from the middle module. The graph shows that the regularly arranged oxyhemoglobin signal has four distinct peaks and three distinct valleys; the individually arranged oxyhemoglobin signal has six distinct peaks and five distinct valleys. This indicates that the individually arranged signal is superior to the regularly arranged signal for oxyhemoglobin detection. The regularly arranged deoxyhemoglobin signal is very close to the zero position and is easily treated as noise. The individually arranged deoxyhemoglobin signal has similar fluctuations to the regularly arranged signal, but it is further away from the zero position and is not treated as noise. Therefore, the individually arranged signal is superior to the regularly arranged signal for deoxyhemoglobin detection.

[0088] like Figure 20 As shown, channels 1383 and 1381 transmit signal data from the upper right module and receive it from the middle module. As can be seen from the figure, the waveforms of oxyhemoglobin signals in the two arrangements are similar, but the personalized arrangement has greater fluctuations, which is beneficial for the identification and extraction of effective signals. For deoxyhemoglobin, both arrangements have a portion close to 0, and the difference is not significant. In summary, the personalized arrangement is superior to the regular arrangement.

[0089] like Figure 21 As shown, channels 393 and 391 transmit signal data from the lower left module and receive it from the middle module. The graph shows that the waveform of the regularly arranged oxyhemoglobin signal is similar to that of the personalized arrangement, but closer to the zero position, with some peaks being removed as noise. The personalized oxyhemoglobin signal has a larger amplitude and is farther from the zero position, making it a valid signal. Therefore, for oxyhemoglobin detection, the personalized arrangement is superior to the regular arrangement. For deoxyhemoglobin, the waveform of the regularly arranged signal is far from the zero position, while the personalized arrangement is treated as noise and removed. Therefore, for deoxyhemoglobin detection, the personalized arrangement is less effective than the regular arrangement.

[0090] like Figure 22 As shown in the figure, channels 400 and 399 are the signal data transmitted by the lower right module and received by the middle module. It can be seen from the figure that the waveform of the regularly arranged oxyhemoglobin signal is just as obvious as that of the personalized arrangement, but the personalized arrangement has a larger amplitude; the regularly arranged oxyhemoglobin signal is similar to that of the personalized arrangement; in summary, the personalized arrangement signal has a larger amplitude, which is beneficial for data analysis.

[0091] It is understood that the present invention has been described through some embodiments, and those skilled in the art will recognize that various changes or equivalent substitutions can be made to these features and embodiments without departing from the spirit and scope of the invention. Furthermore, under the teachings of the present invention, these features and embodiments can be modified to adapt to specific situations and materials without departing from the spirit and scope of the invention. Therefore, the present invention is not limited to the specific embodiments disclosed herein, and all embodiments falling within the scope of the claims of this application are within the protection scope of the present invention.

Claims

1. A personalized wearable brain oxygenation detection device, characterized in that, include: A personalized forehead positioning block, which is obtained based on the patient's head CT data through three-dimensional reconstruction of the frontal bone and Boolean operation, and whose inner surface shape matches the morphology of the patient's frontal bone outer surface. A brain oxygenation detection module is mounted on the personalized forehead positioning block. The arrangement of the detection module on the positioning block is determined according to the projection position of the patient's frontal lobe functional area on the surface of the positioning block. A signal acquisition and processing unit is electrically connected to the detection module and is used to acquire and process brain oxygenation signals. The positioning block is provided with a positioning structure corresponding to the anatomical landmarks of the patient's forehead to ensure that the relative position of the positioning block and the frontal bone is consistent each time it is worn.

2. The personalized wearable brain oxygenation detection device according to claim 1, characterized in that, The personalized forehead positioning block is prepared through the following Boolean operation steps: Step 1: Obtain the patient's head CT data, reconstruct a three-dimensional model of the skull, and extract the frontal bone model; Step 2: Create a copy of the frontal bone model and offset the frontal bone copy forward by a preset distance along the normal direction to obtain an expanded frontal bone model; Step 3: Create the first and second embryos; Step 4: Perform Boolean subtraction with the first embryo as the subtrahend and the frontal bone model as the subtractor to obtain the first Boolean model; Step 5: Perform a Boolean subtraction operation using the second embryo as the subtrahend and the expanded frontal bone model as the subtractor to obtain the second Boolean model; Step 6: Perform a Boolean subtraction operation using the first Boolean model as the subtrahend and the second Boolean model as the subtractor to obtain the personalized forehead positioning block.

3. The personalized wearable brain oxygenation detection device according to claim 1, characterized in that, The number of brain oxygenation detection modules is five, arranged as one central detection module and four surrounding detection modules. The four surrounding detection modules are distributed in the upper left, upper right, lower left and lower right positions of the central detection module.

4. The personalized wearable brain oxygenation detection device according to claim 1, characterized in that, Each of the detection modules includes at least one near-infrared light source and a near-infrared light detector. The light source is a dual-wavelength near-infrared light-emitting device with emission wavelengths of 650~750 nm and 800~900 nm. The detector is used to receive light signals scattered by brain tissue and convert them into electrical signals.

5. The personalized wearable brain oxygenation detection device according to claim 1, characterized in that, The anatomical landmarks of the forehead include the brow ridge and / or the root of the nose.

6. The personalized wearable brain oxygenation detection device according to claim 1, characterized in that, The personalized forehead positioning block is made of medical-grade photocurable resin or nylon material through 3D printing.

7. A personalized wearable method for detecting brain oxygenation, characterized in that, Includes the following steps: Step 1: Obtain the patient's head CT image data, perform three-dimensional reconstruction of the skull, and extract the frontal bone model; Step 2: Based on the frontal bone model, a personalized frontal positioning block is generated through Boolean operations, so that the inner surface of the positioning block fits the shape of the outer surface of the patient's frontal bone. Step 3: Delineate the functional areas of the prefrontal cortex on the CT image, map the position of the functional areas onto the surface of the personalized prefrontal positioning block, determine several functional area marker points within the obtained projection contour, and determine the arrangement position of the detection module on the positioning block based on the functional area marker points. Step 4: Install the cerebral oxygenation detection module onto the personalized forehead positioning block according to the determined layout; Step 5: Place the positioning block on the patient's forehead, ensuring that the placement is unique and consistent through the anatomical positioning marks on the positioning block; Step 6: Start the detection module to collect cerebral blood oxygenation signals, and output cerebral blood oxygenation parameters after processing by the signal acquisition and processing unit.

8. The personalized wearable brain oxygenation detection method according to claim 7, characterized in that, The extraction of the frontal bone model is based on the following anatomical landmarks to delineate the frontal bone boundaries: coronal suture, supraorbital margin and superior orbital wall, temporal line, and frontal crest.

9. The personalized wearable brain oxygenation detection method according to claim 7, characterized in that, The functional area markers are determined as follows: Under CT soft tissue window conditions, the anatomical regions of the prefrontal lobe are delineated in transverse, coronal, sagittal, and 3D reconstructed images. Regions meeting the following imaging characteristics are manually marked as target detection areas: The gray and white matter are clearly demarcated; The brain parenchyma has a uniform and moderate density; No low-density ischemic foci, no high-density calcifications, and no mixed abnormal density shadows; The above characteristics reflect that the area has good neural excitability and active function, and belongs to the prefrontal cortex functional area suitable for cerebral blood oxygenation detection, which is marked as the marked area; The marked area is mapped from the CT image space to the surface of the personalized forehead positioning block to obtain the projection contour of the frontal lobe functional area on the positioning block. Multiple points are uniformly selected within the projection contour as functional area marking points.

10. The personalized wearable brain oxygenation detection method according to claim 7, characterized in that, The arrangement of the detection modules is determined as follows: A circular area with a diameter of 30 mm is drawn, centered on the marked points of each functional area within the projection outline of the prefrontal cortex on the surface of the positioning block; a large circle is drawn that encompasses all of the circular areas, with the center of the large circle serving as the center point of the first detection module; a circle with a radius of 30 mm is drawn, centered on the center of the first detection module; the intersections of the 30 mm diameter circles within the 30 mm radius circle are excluded; among the remaining intersections, the intersections located at the four corners (upper left, lower left, upper right, and lower right) are selected, and the centers of the four detection modules are placed at the selected intersections, with the hexagonal corners of the four detection modules coinciding with the 30 mm radius circle.

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