Inspection system and inspection method

Abstract

An inspection system includes a pressurizing apparatus, a laser imaging apparatus, and a computing apparatus. The pressurizing apparatus is used to apply and relieve pressure to pressure areas of an individual in need thereof. The laser imaging apparatus is used to obtain image data from an inspection area of the individual. The computing apparatus is used to monitor and record pressure time series change data of the pressure apparatus applying and releasing pressure, monitor and convert the image data into blood flow perfusion time series change data of a region of interest in the inspection area, and generate blood perfusion evaluation results of the region of interest based on the pressure time series change data, the image data and the blood flow perfusion time series change data. An inspection method is implemented by the inspection system.

Description

TITLEInspection system and inspection methodBACKGROUND OF THE INVENTION

[0001] 1. FIELD OF THE INVENTION

[0002] The present invention relates to medical diagnostic technology, and more particularly to an inspection system and an inspection method.

[0003] 2. DESCRIPTION OF THE PRIOR ART

[0004] Blood circulation status is a significant indicator for the risk of chronic ulcers and wound necrosis. By monitoring blood circulation, patients can anticipate and prevent the occurrence of chronic ulcers and / or wound necrosis at an early stage. Conventional inspection methods, such as laser Doppler flowmetry (LDF), suffer from limitations including cumbersome operation, observation limited to only a specific point or a small area, and a requirement for direct skin contact, which increases the risk of additional infection for the patient.

[0005] For example, in the case of patients with diabetic foot, such patients are required to undergo regular blood circulation monitoring. Under frequent use of conventional inspection methods, the risks of chronic ulcers and wound necrosis are not reduced but rather increased. Furthermore, due to the limited inspection range of conventional methods, misdiagnosis or missed diagnosis of chronic ulcers and wound necrosis is likely to occur.

[0006] Accordingly, there is an urgent need in the art for an inspection system and inspection method to address the foregoing problems.SUMMARY OF THE INVENTION

[0007] An inspection system may comprise a pressurizing device, a laser imaging device, and a computing device. The pressurizing device may be configured to apply pressure to and release pressure from a pressurizing site of an individual in need thereof. The laser imaging device may be configured to acquire image data of an inspection site of the individual. The computing device may be coupled to the pressurizing device and the laser imaging device, and may be configured to monitor and record pressure variation sequence data corresponding to the application and release of pressure by the pressurizing device; to monitor and convert the image data into blood perfusion variation sequence data of regions of interest within the inspection site; and to generate a blood circulation distribution image of the inspection site and a blood perfusion evaluation result of the regions of interest based on the pressure variation sequence data, the image data, and the blood perfusion variation sequence data.

[0008] An inspection method may comprise applying pressure to and releasing pressure from a pressurizing site of an individual in need thereof by a pressurizing device; acquiring image data of an inspection site of the individual by a laser imaging device; monitoring and recording pressure variation sequence data corresponding to the application and release of pressure by the pressurizing device by a computing device; monitoring and converting the image data into blood perfusion variation sequence data of regions of interest within the inspection site by the computing device; and generating a blood circulation distribution image of the inspection site and a blood perfusion evaluation result of the regions of interest based on the pressure variation sequence data, the image data, and the blood perfusion variation sequence data by the computing device.BRIEF DESCRIPTION OF THE DRAWINGS

[0009] The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawings will be provided by the Office upon request and payment of the necessary fee.

[0010] FIG. 1 is a component architecture diagram of an inspection system according to at least one embodiment of the present invention.

[0011] FIG. 2 is a flowchart illustrating steps of an inspection method according to at least one embodiment of the present invention.

[0012] FIG. 3 is image data of an inspection site of an individual according to at least one embodiment of the present invention.

[0013] FIG. 4 is a dual-axis graph showing pressure variation sequence data and blood perfusion variation sequence data of a region of interest according to at least one embodiment of the present invention.

[0014] FIG. 5 is a blood circulation distribution image of an inspection site of an individual and a blood perfusion evaluation result of regions of interest of the inspection site according to at least one embodiment of the present invention.

[0015] FIG. 6 is a blood perfusion evaluation result of an inspection site of an individual according to at least one embodiment of the present invention.

[0016] FIG. 7 illustrates an embodiment of evaluating blood circulation of an inspection site of an individual through a plurality of regions of interest according to at least one embodiment of the present invention.

[0017] FIG. 8 is a human-machine interface displayed on a display device according to at least one embodiment of the present invention.DETAILED DESCRIPTION

[0018] The following embodiments are provided to illustrate the present invention. A person having ordinary skill in the art, upon reading the disclosure of the present invention, will readily understand the advantages and effects of the invention, and may also implement or apply the invention in other different embodiments. Therefore, any element or method within the scope of this disclosure may be combined with any other element or method disclosed in any embodiment of the present invention.

[0019] The order shown in the drawings of the present invention is provided only for illustrating the embodiments described herein so that a person having ordinary skill in the art may read and understand the disclosure of the present invention, and is not intended to limit the scope of the invention. Any changes, modifications, or adjustments to the described features, so long as they do not affect the spirit, purpose, and effect of the present invention, shall be deemed within the scope of the technical content of the present invention.

[0020] As used herein, when an object is described as “comprising,” “including,” or “having” a technical feature, unless otherwise specified, such object may further comprise additional elements, structures, regions, components, equipment, devices, systems, steps, connections, modules, or units, and other features are not excluded.

[0021] As used herein, sequential terms such as “first” or “second” are merely employed for the convenience of description or for distinguishing technical features such as elements, structures, regions, components, equipment, devices, systems, steps, connections, modules, or units, and are not intended to limit the scope of the invention or to impose a spatial sequence between such features. In addition, unless otherwise specified, singular forms such as “a,” “an,” and “the” also include plural forms, and terms such as “or” and “and / or” may be used interchangeably.

[0022] As used herein, the terms “subject in need,” “individual,” and “patient” may be used interchangeably.

[0023] As used herein, numerical ranges are inclusive and combinable. Any value falling within a disclosed range may serve as an upper limit or lower limit to derive sub-ranges. For example, the numerical range “10 to 20 mmHg” shall be understood to include any sub-range between the lower limit of 10 mmHg and the upper limit of 20 mmHg, such as 10 mmHg to 12.5 mmHg, 12.5 mmHg to 15 mmHg, or 15 mmHg to 17.5 mmHg. Furthermore, multiple numerical values disclosed herein may serve as both upper and lower limits to derive additional ranges. For example, the ranges of 10 mmHg to 30 mmHg, 10 mmHg to 60 mmHg, and 30 mmHg to 60 mmHg may be derived from the disclosed values of 10 mmHg, 30 mmHg, and 60 mmHg.

[0024] FIG. 1 illustrates a component architecture diagram of the detection system 1, which isused to perform blood circulation monitoring for an individual in need thereof. The detection system 1 may include a pressurization device 100, a laser imaging device 200, a computing device 300, and a display device 400. The components of the detection system 1 may be coupled to each other via any wired or wireless means. In some embodiments, the individual may be a patient suffering from diabetic foot, and the objective of the blood circulation monitoring performed by the detection system 1 may be set to detect the peripheral circulation condition of the foot and to determine the risk of chronic ulcer or wound necrosis in specific regions of interest on the foot. In other embodiments, the individual may be a patient requiring assessment of wound healing (e.g., a hand laceration), and the objective of the blood circulation monitoring performed by the detection system 1 may be set to detect the blood circulation condition at the wound site of the individual and to determine the risk of chronic ulcer or wound necrosis.

[0025] The pressurizing device 100 may comprise a pressurizer 110 and a cuff 120. The cuff 120 may be configured to be mounted on a pressurizing portion (PP) of a subject. The pressurizing portion (PP) may be, for example, an ankle of the subject. The pressurizer 110 may apply and release a predetermined pressure value to the pressurizing portion PP via the cuff 120, thereby enabling the detection system 1 to observe a blood circulation condition of a detection portion (EP) of the subject in response to the application and release of pressure.

[0026] In some embodiments, the pressurizer 110 may apply and release pressure by inflating and deflating the cuff 120 to apply and release pressure to the pressurizing portion PP. In certain embodiments, the pressure applied via the cuff 120 by the pressurizer 110 may be set greater than or equal to a systolic blood pressure of the subject, with a difference between the applied pressure value and the systolic blood pressure being less than or equal to 20 mmHg. For example, when the subject’s systolic blood pressure is 120 mmHg, the applied pressure value output by the pressurizer 110 may be any pressure between 120 mmHg and 140 mmHg.

[0027] In other embodiments, the pressurizer 110 may be configured to rapidly increase the applied pressure value via the cuff 120 to a desired pressure within a first predetermined time (for example, rapidly increasing from 0 mmHg to 140 mmHg, and maintaining 140 mmHg until the end of the first predetermined time), and then gradually release the applied pressure to an initial value (for example, from 140 mmHg to 0 mmHg) within a second predetermined time. The first predetermined time and the second predetermined time may be the same duration, for example, any time between 30 seconds and 120 seconds. Alternatively, the first predetermined time and the second predetermined time may be different durations, for example, the second predetermined time for releasing the pressure may be longer than the first predetermined time for applying the pressure.

[0028] The laser imaging device 200 may comprise a laser emitter 210 and a camera 220. Thelaser emitter 210 may irradiate a laser onto a detection portion EP of the subject. The detection portion EP may be, for example, a foot of the subject. The camera 220 may capture the detection portion EP irradiated by the laser, thereby acquiring image data of the detection portion EP.

[0029] In some embodiments, the laser imaging device 200 may be a laser speckle contrast imaging (LSCI) apparatus, and the image data obtained by the laser imaging device 200 may be laser speckle contrast image data. The laser speckle contrast image data may be used to record speckle changes corresponding to blood flow movement within the detection portion EP, and therefore may be used to represent the blood circulation condition of the detection portion EP.

[0030] The computing device 300 may be coupled to the pressurizing device 100 and the laser imaging device 200, and may be implemented by one or more of a mainframe computer, personal computer, tablet computer, mobile device, cloud computing device, server, or virtual machine, or any combination thereof. The computing device 300 may serve as a control and operation hub of the detection system 1, and may be configured to monitor and record pressure sequence variation data corresponding to the application and release of pressure by the pressurizing device 100, monitor and convert image data from the laser imaging device 200 into blood perfusion sequence variation data of a region of interest (ROI) in the detection portion EP, and generate a blood circulation distribution image of the detection portion EP and a blood perfusion evaluation result of the ROI in the detection portion EP based on the pressure sequence variation data, the image data, and the blood perfusion sequence variation data. The computing device 300 may further transmit the blood circulation distribution image and the blood perfusion evaluation result to a display device 400 for visualization, or store the blood circulation distribution image and the blood perfusion evaluation result for subsequent review by medical professionals.

[0031] The display device 400 may be coupled to the computing device 300 and may be configured to display a human-machine interface. In some embodiments, the display device 400 may visually present the blood circulation distribution image and the blood perfusion evaluation result from the computing device 300 via the human-machine interface, thereby assisting medical professionals in examining the blood circulation condition of the detection portion EP of the subject and determining the risk of chronic ulceration or wound necrosis. In other embodiments, during the execution of blood circulation monitoring for a subject, the medical professional may input operation settings of the detection system 1 via the human-machine interface displayed on the display device 400. Such settings may include, for example, adjustment settings for the pressurizer 110 of the pressurizing device 100 according to the subject’s physical condition; adjustment settings for the laser emitter 210 and / or the camera 220 of the laser imaging device 200 according to the environment in which blood circulationmonitoring is being conducted; or display settings for the human-machine interface of the display device 400 according to viewing requirements. The computing device 300 may then control the pressurizing device 100, the laser imaging device 200, and / or the display device 400 to adjust their operation in accordance with the adjustment settings.

[0032] FIG. 2 is a flowchart illustrating the steps of a detection method implemented through the detection system 1. Steps S101 to S112 of the detection method and their embodiments may be understood with reference to FIGS. 3 to 8. The steps S101 to S112 may be divided into three phases — pre-pressurization, pressurization, and post-pressurization — according to the process during which the pressurization device 100 applies pressure to the pressurization site PP of the individual during blood circulation monitoring. For ease of explanation, the following steps are described with the detection site EP being the foot of the individual, and the pressurization site PP being the ankle of the individual. However, depending on the individual’s condition and monitoring needs, the detection method may also be applied to other detection sites EP and pressurization sites PP of the individual. For example, the detection site EP may be set to the hand, and the pressurization site PP may be set to the wrist.

[0033] The pre-pressurization stage of the detection method may include steps S101 to S103.

[0034] At step S101, the pressurizing device 100 and the laser imaging device 200 may be activated by the computing device 300 under operation of a medical professional via the display device 400. At this time, the cuff 120 may be mounted on the pressurizing portion PP of the subject, while the irradiation range of the laser emitter 210 and the imaging range of the camera 220 may be aligned with the detection portion EP of the subject.

[0035] At step S102, the laser imaging device 200 may acquire pre-pressurization image data of the detection portion EP prior to application of pressure by the pressurizing device 100 (e.g., within a 60-second period before pressure application). The pre-pressurization image data may correspond to the left image of FIG. 3, in which the reflected laser speckles from the detection portion EP irradiated by the laser may be captured by the camera 220 as laser speckle contrast image data comprising bright regions (displayed in red) and dark regions (displayed in blue). These visualizations represent blood flow conditions beneath the epidermis of the detection portion EP before the flow is obstructed by pressure. For example, areas closer to red indicate higher blood supply and thus higher blood perfusion pressure, while areas closer to blue indicate lower blood supply and thus lower blood perfusion pressure.

[0036] At step S103, the computing device 300 may convert the pre-pressurization image data into pre-pressurization blood perfusion temporal variation data of a region of interest (ROI) in the detection portion EP. The ROI may correspond to, for example, the distal end of the subject’s big toe as illustrated in FIG. 3. The pre-pressurization blood perfusion temporal variation datamay correspond to the red curve showing LSCI values from 0 to 60 seconds in FIG. 4, which is a quantified value curve of laser speckle variation within the ROI (e.g., big toe tip) generated by the computing device 300. For instance, the computing device 300 may quantify the contrast between red laser speckles (indicative of high blood perfusion pressure) and blue speckles (indicative of low perfusion pressure) such that each color level between red and blue corresponds to a numeric LSCI value. This quantification allows the computing device 300 to convert the color variations in the pre-pressurization image data — corresponding to blood perfusion pressure variations in the ROI — into a time-dependent LSCI value curve serving as the pre-pressurization blood perfusion temporal variation data. In some embodiments, the color quantification process may employ any suitable color quantization algorithm, such as RGB-based 3D clustering algorithms, Lab color space, or median-cut algorithms. Moreover, since the pre-pressurization blood perfusion temporal variation data represents the blood perfusion condition in the ROI of the detection portion EP before blood flow is blocked (as shown in the blue pressure curve in FIG. 4 from 0 to 60 seconds where the applied pressure remains at 0 mmHg), it may serve as a baseline reference for assessing blood circulation changes during the pressurization and pressure-release periods.

[0037] The pressurization stage of the detection method may include steps S104 through S107.

[0038] At step S104, the pressurizing device 100 may begin applying a predetermined pressure to the pressurizing portion PP. For example, the first predetermined time for applying pressure via the pressurizer 110 through the cuff 120 may be set to 75 seconds, during which the applied pressure may be ramped from 0 mmHg to 200 mmHg within 30 seconds to block blood flow into the detection portion EP.

[0039] At step S105, the computing device 300 may monitor the pressurization phase pressure temporal variation data corresponding to the pressure applied by the pressurizing device 100. This data may correspond to the blue curve from the 61st to the 135th second in FIG. 4, showing that the pressure output from the pressurizer 110 increases to 200 mmHg between the 61st and 90th seconds and is maintained at 200 mmHg from the 91st to the 135th second.

[0040] At step S106, the laser imaging device 200 may acquire pressurization -phase image data of the detection portion EP during pressure application by the pressurizing device 100. This pressurization-phase image data may correspond to the center image in FIG. 3, wherein the laser speckles reflected from the irradiated detection portion EP are captured by the camera 220 as laser speckle contrast image data comprising bright regions (displayed in red) and dark regions (displayed in blue). These images illustrate the blood flow condition beneath the epidermis of the detection portion EP during flow obstruction by the applied pressure. It may be observed that asblood flow is progressively obstructed, the captured image of the detection portion EP becomes predominantly blue, indicating overall reduced blood supply and decreased blood perfusion pressure during the pressurization period.

[0041] At step S107, the computing device 300 may convert the pressurization-phase image data into pressurization-phase blood perfusion temporal variation data of a region of interest (ROI) within the detection portion EP. The ROI may correspond to, for example, the distal end of the subject’s big toe as shown in FIG. 3. The pressurization-phase blood perfusion temporal variation data may correspond to the red LSCI value curve between the 61st and 135th seconds in FIG. 4. This curve may be a quantified numeric curve generated by the computing device 300 based on laser speckle variations within the ROI (e.g., big toe tip). The red laser speckles (representing higher blood perfusion pressure) and blue laser speckles (representing lower blood perfusion pressure) may each be mapped to respective color values (i.e., LSCI values). It can be seen that the LSCI value curve shows a decreasing trend during the pressurization phase, corresponding to the observation in the pressurization-phase image data that the detection portion EP appears increasingly blue as blood flow is obstructed.

[0042] In some embodiments, steps S106 and S107 may be executed concurrently with steps S104 and S105.

[0043] The pressure-release phase of the detection method may include steps S108 through S112.

[0044] At step S108, the pressurizing device 100 may begin releasing the applied pressure on the pressurizing portion PP. For example, the second predetermined time for releasing pressure by the pressurizer 110 via the cuff 120 may be set to 105 seconds, during which the pressure may be released gradually from the applied value to a baseline value (e.g., from 200 mmHg down to 0 mmHg).

[0045] At step S109, the computing device 300 may monitor the pressure-release phase pressure temporal variation data corresponding to the pressure released by the pressurizing device 100. This data may correspond to the blue pressure value curve from the 136th to the 240th second in FIG. 4, which shows a gradual decrease in the pressure released by the pressurizer 110 from 200 mmHg.

[0046] At step S110, the laser imaging device 200 may acquire pressure-release phase image data of the detection portion EP during the pressure release by the pressurizing device 100. The pressure-release phase image data may correspond to the right image in FIG. 3. The reflected laser speckles from the detection portion EP irradiated by the laser may be captured by the camera 220 as laser speckle contrast image data comprising bright regions (displayed in red) and dark regions (displayed in blue), thereby visualizing blood flow re-perfusion beneath theepidermis of the detection portion EP after pressure release. When the subject exhibits normal circulatory function in the detection portion EP, the image data during the pressure-release phase may show a progressive redistribution of red regions similar to that of the pre-pressurization image data, indicating that blood supply to the detection portion EP is gradually recovering toward its pre-pressurization state during pressure-release.

[0047] Furthermore, the mode of blood flow reperfusion into the detection portion EP after flow occlusion, the variation of laser speckles in the image data, and the differences relative to the pre-pressurization image data all carry clinical significance. Accordingly, the pressure-release phase image data may serve as a basis for determining the subject's blood circulation condition and assessing the risk of chronic ulcers or tissue necrosis. For example, if the blue (ischemic) regions in the pressure-release image data appear more widespread or more numerous than in the pre-pressurization image data, medical professionals may determine that the detection portion EP exhibits poorer blood circulation in the pressure-release phase.

[0048] At step S111, the computing device 300 may convert the pressure-release phase image data into blood perfusion temporal variation data of a region of interest within the detection portion EP. The region of interest may be the distal end of the big toe, as depicted in FIG. 3. The pressure-release phase blood perfusion temporal variation data may correspond to the red LSCI value curve between the 136th and 240th seconds in FIG. 4. This curve represents quantified data derived by the computing device 300 based on laser speckle variations in the region of interest (e.g., toe tip), wherein each color gradation — from red (high blood perfusion pressure) to blue (low blood perfusion pressure) — is mapped to a corresponding numeric LSCI value. In a case where the subject has no abnormalities in blood circulation at the detection portion EP, the LSCI value curve rises and then returns to a state similar to that observed during the 0 to 60 seconds of the pre-pressurization phase, consistent with the reperfusion of blood flow in the pressure-release phase image data.

[0049] Moreover, parameters such as the speed of reperfusion, volume of blood perfusion, perfusion pressure, and deviations from the pre-pressurization blood perfusion temporal variation data all carry clinical importance. Accordingly, the pressure-release phase blood perfusion temporal variation data may serve as an indicator for evaluating the subject's blood circulation status and determining the likelihood of developing chronic ulcers or tissue necrosis. For example, if the LSCI value curve of the pressure-release phase data for the region of interest fails to rise or does not return to a state comparable to that of the pre-pressurization phase, medical professionals may infer that the blood circulation in the region of interest is relatively poor.

[0050] At step S112, the computing device 300 may generate a blood circulation distribution image of the detection portion EP based on the acquired image data (including thepre-pressurization, pressurization, and pressure-release image data). Additionally, the computing device 300 may compute a blood perfusion evaluation result of the subject based on the pressure temporal variation data (including both the pressurization and pressure-release phase data) and the blood perfusion temporal variation data of the region of interest (including pre-pressurization, pressurization, and pressure-release phase data). The resulting blood circulation distribution image and blood perfusion evaluation result may then be presented in a visualized format via the human-machine interface of the display device 400.

[0051] In some embodiments, the computing device 300 may generate the blood perfusion evaluation result of the region of interest by calculating the skin perfusion pressure (SPP), which represents the pressure at which subdermal blood flow in the region of interest resumes following release of the occlusive pressure during the pressure-release phase. As illustrated in FIG. 4, the computing device 300 may obtain the SPP by comparing the pressure-release phase pressure temporal variation data with the corresponding blood perfusion temporal variation data. Specifically, the computing device 300 may first identify the time point in the blood perfusion temporal variation data where the LSCI value first rises from the lowest value recorded during the pressurization phase, and then determine the corresponding pressure value at that time point from the pressure temporal variation data. This pressure value is then designated as the SPP of the region of interest. The SPP may be used to assess the blood circulation status of the region of interest. For example, if the SPP is greater than or equal to a first threshold value (e.g., 70 mmHg), the region of interest is considered to have a healthy blood circulation status. If the SPP is less than the first threshold value (e.g., 70 mmHg), the region of interest may be identified as having impaired circulation and at higher risk for chronic ulceration and tissue necrosis. In certain embodiments, the first threshold value may range between 70 mmHg and 150 mmHg, including but not limited to: 70 mmHg, 75 mmHg, 80 mmHg, 85 mmHg, 90 mmHg, 95 mmHg, 100 mmHg, 105 mmHg, 110 mmHg, 115 mmHg, 120 mmHg, 125 mmHg, 130 mmHg, 135 mmHg, 140 mmHg, 145 mmHg, or 150 mmHg.

[0052] In other embodiments, the computing device 300 may generate the blood circulation distribution image by rendering the variations of laser speckles corresponding to blood flow motion from the pre-pressurization, pressurization, and pressure-release phase image data into an animation. This animated representation allows medical professionals to intuitively observe the blood circulation condition across different regions of the detection portion EP. For example, regions with ischemia or irregular blood flow may exhibit time-varying blue laser speckle patterns in the animated circulation distribution image, whereas regions with healthy circulation may show time-varying red laser speckle patterns.

[0053] FIG. 5 illustrates the blood circulation distribution image and the blood perfusionevaluation result of a region of interest ROI E at a detection site EP for a healthy subject after undergoing a single blood circulation monitoring process, as generated by the computing device 300 based on pressure temporal variation data, image data, and blood perfusion temporal variation data. The upper portion of FIG. 5 displays an animated sequence of laser speckle variations at the detection site EP during the pre-pressurization phase (upper left image), the pressurization phase (upper middle image), and the pressure-release phase (upper right image). The lower portion of FIG. 5 shows a dual-axis plot presenting both the pressure temporal variation data output by the pressurization device 100 and the blood perfusion temporal variation data at the region of interest ROI E, located at the tip of the subject’s big toe. The time point at which the LSCI value first rises during the pressure-release phase from the low point during the pressurization phase is marked, and the corresponding pressure value is identified as the SPP Further, since the SPP of the subject’s region of interest ROI E exceeds the first threshold (here, 70 mmHg) with a value of 205.58 mmHg, the computing device 300 determines that the blood circulation status of the region of interest ROI E is favorable.

[0054] FIG. 6 illustrates the blood perfusion evaluation result of a region of interest ROI E at a detection site EP for a subject with diabetic foot following a single blood circulation monitoring process, as generated by the computing device 300 based on pressure temporal variation data, image data, and blood perfusion temporal variation data. The left side of FIG. 6 depicts the foot of the subject with diabetic foot, in which necrosis of the fourth toe is visibly identifiable through visual inspection. Accordingly, the fourth toe is selected as the region of interest ROI E for the blood circulation monitoring session. The center portion of FIG. 6 displays the blood circulation distribution image generated by the computing device 300, showing that the region of interest ROI E appears as a blue region indicative of low blood perfusion across the pre-pressurization, pressurization, and pressure-release phases due to necrosis of the fourth toe. The right portion of FIG. 6 shows a dual-axis plot combining the pressure temporal variation data output by the pressurization device 100 and the blood perfusion temporal variation data for the region of interest ROI E at the tip of the fourth toe. The time point at which the LSCI value first rises from the low point during the pressurization phase in the pressure-release phase is marked, and the corresponding pressure value is defined as the SPP Since the SPP of the subject’s region of interest ROI E is less than the first threshold (here, 70 mmHg), the computing device 300 determines that the blood circulation status of the region of interest ROI E is poor.

[0055] In steps S101 through S112, the temporal variation data of blood perfusion generated by the detection system 1 based on the image data may correspond to more than one region of interest (ROI). Accordingly, the blood perfusion evaluation result generated by the detectionsystem 1 may also be a comprehensive evaluation result of the temporal variation data of blood perfusion in multiple ROIs relative to the pressure temporal variation data.

[0056] FIG. 7 illustrates an embodiment in which the computing device 300 evaluates the blood circulation status of the detection site EP of a subject using multiple regions of interest: ROI El, ROI E2, ROI E3, ROI E4, ROI E5, and ROI G. In this case, the detection site EP may be assumed to be the subject’s foot. The regions of interest ROI El through ROI E5 correspond to the distal areas of the first through fifth toes, respectively, while ROI G corresponds to the plantar region of the foot. After a single session of blood circulation monitoring, the computing device 300 may have obtained the skin perfusion pressure (SPP) for all regions of interest ROI El through ROI E5 and ROI G. Since the plantar region serves as a non-distal area with relatively good blood circulation in the foot, ROI G (reference ROI) may be used as a reference standard to determine whether the blood circulation status of the distal regions ROI El through ROI E5 (first through fifth ROIs) is favorable or poor. The blood perfusion evaluation result for the detection site EP may be generated by evaluating the following aspects:

[0057] I. Relative SPP Difference: The SPP of each region of interest ROI El through ROI E5 is compared against the SPP of the reference ROI ROI G. The relative difference in SPP for the i-th toe’s distal region ROI Ei relative to the reference SPP of ROI G is calculated using the following equation:> i. ■ I Reference SPP-SPPROI Ei| / Relative DifferenceROI Ei= - - — x 100%,... Equation (1)Reference SPPReference SPP = Σ SPPROI Gj / number of reference ROInumber of refereGi-(Equation (2)nce ROI

[0058] At this point, the reference SPP is the first average SPP of the region of interest ROI G, SPP_(ROI_Gj) is the SPP of the j-th region of interest ROI G (when there is only one region of interest ROI G, the reference SPP is equivalent to the SPP of the j-th region of interest ROI G. That is, the number of reference ROIs = 1, and there is only SPP_(ROI_G1) of the (j=l)-th region of interest ROI G), SPP (ROI Ei) is the SPP of the region of interest ROI Ei of the i-th toe extremity (i-th, i is a positive integer between 1 and the number of ROIs), and when the relative difference_(ROI_Ei) is greater than a second threshold, the computing device 300 may determine that the blood circulation condition of the i-th toe extremity is poor. The second threshold may be set to a value between 3% and 20%, including but not limited to: 3%, 6%, 9%, 12%, 15%, 18%, or 20%.

[0059] II. Mean Relative Difference Calculation: The computing device 300 may calculate themean relative difference of the skin perfusion pressure (SPP) for each of the toe distal regions (regions of interest ROI El, ROI E2, ROI E3, ROI E4, and ROI E5; i.e., the number of ROIs = 5), relative to a second average SPP value, denoted as ( SPPall), which is calculated over all regions of interest, including ROI G and ROI El through ROI E5, according to Equation (3) below:SPP_all = (Σ(j=1 to n_ref) SPP_ROI_Gj + Σ(i=1 to n_ROI) SPP_ROI_Ei) / (number of reference ROI + number of ROI), Equation (3)Mean Relative Difference = |SPPR0I Ei— SPPall|, Equation (4)

[0060] Here, the SPPallrepresents the average SPP of all regions of interest on the detection site EP, including ROI El through ROI E5 and ROI G (with number of ROIs = 5 and number of reference ROIs = 1). When the calculated mean relative difference exceeds a third threshold, the computing device 300 may determine that the overall blood circulation condition of the detection site EP is poor. The third threshold may be set to a value between 2 mmHg and 10 mmHg, including but not limited to: 2 mmHg, 3 mmHg, 4 mmHg, 5 mmHg, 6 mmHg, 7 mmHg, 8 mmHg, 9 mmHg, or 10 mmHg.

[0061] The standard deviation of the SPP of all regions of interest ROI El, ROI E2, ROI E3, ROI E4, ROI E5, and ROI G may be calculated ( σSPP_all) to evaluate the blood flow variability of the detection site EP, and to quantify the fluctuation of SPP among ROI El, ROI E2, ROI E3, ROI E4, ROI E5, and ROI G, and to determine whether the blood flow distribution of the detection site EP is uniform, as shown in the following equation:σSPPall=^ ^ ^ Equation (5)

[0062] And when the standard deviation of differences σSPPallis greater than a fourth threshold value, it indicates that the blood flow variability is high, and the computing device 300 may determine that the blood circulation condition of the detection site EP is poor. The fourth threshold value may be set to a value between 2 mmHg and 20 mmHg, including but not limited to: 2 mmHg, 4 mmHg, 6 mmHg, 8 mmHg, 10 mmHg, 12 mmHg, 14 mmHg, 16 mmHg, 18 mmHg, or 20 mmHg.

[0063] IV. Maximum-Minimum Difference: The maximum-minimum difference may be calculated between the highest and lowest skin perfusion pressure (SPP) values among the regions of interest ROI El, ROI E2, ROI E3, ROI E4, ROI E5, and ROI G. This calculation may be used to determine the maximum range of SPP variation (S) at the detection site EP, thereby reflecting the overall condition of blood reperfusion at the detection site EP after bloodflow has been occluded.S — SPPG1,... SPPGj...} U {SPPROI E1,... SPPROIEi,...}, Equation (6):Maximum-Minimum Difference = max(S) — min(S), Equation (7).

[0064] When the maximum-minimum difference exceeds a fifth threshold value, the computing device 300 may determine that the blood circulation condition of the detection site EP is poor. The fifth threshold value may be set to a value between 5 mmHg and 20 mmHg, including but not limited to: 5 mmHg, 10 mmHg, 15 mmHg, or 20 mmHg.

[0065] In some embodiments, the above-described implementation for evaluating blood circulation conditions using multiple regions of interest may also be applied to other parts of the subject. For example, when the detection site EP is set as the hand, the regions of interest ROI El, ROI E2, ROI E3, ROI E4, and ROI E5 may be set as the distal areas of the first to fifth fingers of the hand, and the region of interest ROI G may be set as the palm area. Additionally, the number of reference regions of interest and regions of interest may be configured based on operational needs. For example, the number of ROIs may be set to a positive integer greater than or less than 5; or the number of reference ROIs may be set to a positive integer greater than 1, such that the reference SPP is set as the average SPP of all reference regions of interest.

[0066] FIG. 8 illustrates a human-machine interface displayed on the display device 400 after a subject has undergone a blood circulation monitoring session, wherein the interface shows the blood perfusion distribution map and the evaluation results of the regions of interest output by the computing device 300. It can be seen that the human-machine interface may display the monitored detection site EP in window 401, display the blood perfusion distribution map corresponding to the detection site EP in window 402, and display in window 403 the blood perfusion evaluation results of the region of interest ROI E marked in window 402. In some embodiments, the blood perfusion evaluation results may be presented as a dual-axis graph combining pressure time variation data and the blood perfusion time variation data of the region of interest ROI E. In other embodiments, the blood perfusion evaluation results may be textual information generated by the computing device 300 based on the pressure time variation data, image data, and blood perfusion time variation data, including but not limited to: textual descriptions of laser speckle changes in the image data and differences in the laser speckle changes during the compression and / or decompression periods relative to before compression; textual descriptions of the SPP value, blood perfusion velocity, blood perfusion volume, blood perfusion pressure, and blood perfusion condition based on the pressure time variation data and blood perfusion time variation data during the compression and / or decompression periods relative to before compression; textual descriptions of the relative differences, mean differences,standard deviations of differences, and maximum-minimum differences of SPP calculated based on multiple regions of interest; and / or textual descriptions of the individual risk value and the blood circulation risks of different distal locations (e.g., all four fingers are healthy, only the second finger has blood circulation issues), thereby reflecting the risk that upstream blood vessels and nearby skin tissue of the affected finger are prone to difficult wound healing due to poor blood circulation. Therefore, medical professionals may intuitively understand the blood circulation status of the subject’s detection site through the human-machine interface, thereby making appropriate medical decisions and recommendations.

[0067] In summary, the detection system and detection method of the present invention may evaluate the blood circulation condition of a detection site of a subject and determine the risk of chronic ulcers and wound necrosis through a non-invasive approach, thereby reducing the risk of infection during blood circulation monitoring. Moreover, by performing synchronous cross-analysis of blood circulation conditions in multiple regions of interest, the automated detection becomes more accurate and easier to operate.

[0068] The foregoing description merely illustrates preferred embodiments of the present invention. Any equivalent modifications or alterations made according to the scope of the claims of the present invention shall fall within the scope of protection of the present invention.

Claims

CLAIMSWhat is claimed is:

1. An inspection system comprising:a pressurizing apparatus configured to apply a pressure and release the pressure to a pressure area of an individual in need thereof;a laser imaging apparatus configured to acquire an image data of an inspection area of the individual; anda computing apparatus coupled to the pressurizing apparatus and the laser imaging apparatus, the computing apparatus configured to:monitor and record a pressure time series change data of the application and release of pressure by the pressurizing apparatus;convert the image data into a blood flow perfusion time series change data of a region of interest within the inspection area; andgenerate a blood perfusion evaluation result of the region of interest based on the pressure time series change data, the image data, and the blood flow perfusion time series change data.

2. The inspection system of claim 1, wherein:the pressurizing apparatus comprising:a cuff configured to be mounted on the pressure area; anda pressurizer configured to apply and release the pressure to the pressure area through the cuff;the laser imaging apparatus comprising:a laser emitter configured to irradiate the inspection area with a laser light; and a camera configured to capture the inspection area irradiated by the laser light, thereby acquiring the image data;the image data records a laser speckle variation corresponding to blood flow movement in the inspection area; andthe blood flow perfusion time series change data is a laser speckle contrast image value curve obtained by the computing apparatus through quantifying the laser speckle variation.

3. The inspection system of claim 1, wherein:the blood perfusion evaluation result comprising a skin perfusion pressure corresponding to a moment at which subepidermal blood flow in the region of interest beginsreperfusion after being blocked by the pressure and subsequently released; wherein when the skin perfusion pressure is less than a first threshold value, the computing apparatus determining that the blood circulation condition in the region of interest is poor; andwhen the skin perfusion pressure is greater than or equal to the first threshold value, the computing apparatus determining that the blood circulation condition in the region of interest is good.

4. The inspection system of claim 3, wherein:the inspection area is a foot of the individual;the inspection area further comprising a reference region of interest in a plantar region of the foot; andthe blood perfusion evaluation result further comprising:a relative difference in skin perfusion pressure between the region of interest (ROI) and the reference region of interest (reference ROI):TI i ■ [Reference SPP-SPPR0I Ei|, Relative DifferenceROI Ei= |Reference SPP−SPPROI Ei| / Reference SPP-x100%, where ^number of ref erence ROI „„„ReferenceSPP = -R°LGi, andnumber of reference ROIthe Reference SPP is a first average skin perfusion pressure of the reference region of interest, SPPROI GJ is the skin perfusion pressure of a / -th reference region of interest, and SPPROI Ei is the skin perfusion pressure of an z-th toe terminal region of interest;a mean relative difference between the skin perfusion pressure of the region of interest and a second average skin perfusion pressure of the reference regions of interest and the regions of interest:gpp _ SPPROI Gj+1-=1_ SPPROI Einumber of ROI+number ofreference ROI ’Mean Relative Difference = | SPPR0I Ei— SPPall|,a standard deviation of the difference in skin perfusion pressure between the region of interest and the reference region of interest:σspp_all=^ ^ ^ a maximum-minimum difference in the skin perfusion pressure between the region of interest and the reference region of interest:S = SPPG1,... SPPGj...} U {SPPROI E1,... SPPROIEI,...},Maximum-Minimum Difference = max(S) — min(S).

5. The inspection system of claim 4, wherein:when the relative difference exceeds a second threshold value, the computing apparatus determines that the blood circulation condition in the z-th toe terminal region of interest is poor;when the mean relative difference exceeds a third threshold value, the computing apparatus determines that the blood circulation condition in the inspection area is poor; when the standard deviation of the difference exceeds a fourth threshold value, the computing apparatus determines that the blood circulation condition in the inspection area is poor; and / orwhen the maximum-minimum difference exceeds a fifth threshold value, the computing apparatus determines that the blood circulation condition in the inspection area is poor.

6. The inspection system of claim 1, wherein:the pressure is greater than or equal to a systolic blood pressure of the individual, and a difference between the pressure and the systolic blood pressure is less than or equal to 20 mmHg.

7. The inspection system of claim 1, wherein:the blood flow perfusion time series change data comprises a pressure release phase blood flow perfusion time series change data and a pressurization phase blood flow perfusion time series change data;the pressure time series change data comprises a pressure release phase pressure time series change data;the blood perfusion evaluation result comprises a skin perfusion pressure corresponding to a moment at which subepidermal blood flow in the region of interest begins reperfusion after pressure release; andthe computing apparatus is further configured to:identify a time point in the blood flow perfusion time series change data corresponding to a first increase in laser speckle contrast image value from a lowest point in the pressurization phase blood flow perfusion time series change data;identify a pressure value in the pressure release phase pressure time series change data corresponding to the time point; andidentify the pressure value as the skin perfusion pressure.

8. The inspection system of claim 1, wherein:the computing apparatus is further configured to generate a blood circulation distribution image of the inspection area based on the pressure time series change data, the image data, and the blood flow perfusion time series change data.

9. The inspection system of claim 8, wherein:the image data comprises a pre-pressurization image data, a pressurization phase image data, and a pressure release phase image data; andthe blood circulation distribution image presents, in an animated format, a process of the laser speckle variation corresponding to blood flow movement in the pre-pressurization image data, the pressurization phase image data, and the pressure release phase image data.

10. The inspection system of claim 1, wherein:the blood perfusion evaluation result comprising:a laser speckle variation in the image data and / or differences in the laser speckle variation during the pressurization phase and / or pressure release phase relative to the pre-pressurization phase; and / ora skin perfusion pressure value, a blood perfusion velocity, a blood perfusion volume, a blood perfusion pressure, and / or a blood perfusion status representing blocked and reperfused blood flow in the region of interest, as shown in the pressure time series change data and the blood flow perfusion time series change data, and respective differences during the pressurization phase and / or pressure release phase relative to the pre-pressurization phase.

11. A method for inspection, comprising:a pressurizing apparatus applying a pressure and releasing the pressure to a pressure area of an individual in need thereof;a laser imaging apparatus acquiring an image data of an inspection area of the individual; a computing apparatus monitoring and recording a pressure time series change data of the application and release of pressure;the computing apparatus monitoring and converting the image data into a blood flow perfusion time series change data of a region of interest within the inspection area; and the computing apparatus generating a blood perfusion evaluation result of the region ofinterest based on the pressure time series change data, the image data, and the blood flow perfusion time series change data.

12. The method of claim 11, wherein:the pressurizing apparatus applying a pressure and releasing the pressure to the pressure area of the individual in need thereof comprising:a cuff of the pressurizing apparatus mounting onto the pressure area; anda pressurizer of the pressurizing apparatus applying and releasing the pressure through the cuff;the laser imaging apparatus acquiring the image data of the inspection area of the individual comprising:a laser emitter of the laser imaging apparatus irradiating the inspection area with a laser light; anda camera of the laser imaging apparatus capturing the inspection area irradiated by the laser, thereby acquiring the image data;the image data records a laser speckle variation corresponding to blood flow movement in the inspection area; andthe computing apparatus monitoring and converting the image data into the blood flow perfusion time series change data of the region of interest within the inspection area comprising:the computing apparatus quantifying the laser speckle variation to obtain a laser speckle contrast image value curve as the blood flow perfusion time series change data.

13. The method of claim 11, wherein:the blood perfusion evaluation result comprising a skin perfusion pressure corresponding to a moment at which subepidermal blood flow in the region of interest begins reperfusion after being blocked by the pressure and subsequently released;when the skin perfusion pressure is less than a first threshold value, the computing apparatus determining that the blood circulation condition in the region of interest is poor; andwhen the skin perfusion pressure is greater than or equal to the first threshold value, the computing apparatus determines that the blood circulation condition in the region of interest is good.

14. The method of claim 13, wherein:the inspection area is a foot of the individual;the inspection area further comprising a reference region of interest in a plantar region of the foot; andthe computing apparatus generating the blood perfusion evaluation result further comprising:the computing apparatus evaluating a relative difference in skin perfusion pressure between the region of interest (ROI) and the reference region of interest (reference ROI):T-. >. I Reference SPP- SPPo oi pi I,Relative DifferenceRKOUi - EI=- Re 7f -erence SPP -x100%, wherei u der of reference ROIC DDReference SPP = - — — - ^212,number of reference ROIthe Reference SPP is a first average skin perfusion pressure of the reference region of interest, SPPROI GJ is the skin perfusion pressure of a / -th reference region of interest, and SPPROI Ei is the skin perfusion pressure of an z-th toe terminal region of interest; the computing apparatus evaluating a mean relative difference between the skin perfusion pressure of the region of interest and a second average skin perfusion pressure of the reference regions of interest and the regions of interest:Z number of reference ROI. ^number °f$ppj = lbrhROI_Gj ^rhROI_Eial1number of ROI + number of reference ROIMean Relative Difference = |SPPR0I Ei— SPPall|,the computing apparatus evaluating a standard deviation of the difference in skin perfusion pressure between the region of interest and the reference region of interest:_ _and / orthe computing apparatus evaluating a maximum-minimum difference in the skin perfusion pressure between the region of interest and the reference region of interest:S = SPPG1,... SPPGj...} U {SPPROI E1,... SPPROIEI,...},Maximum-Minimum Difference = maxes') — min(S15. The method of claim 14, whereinwhen the relative difference exceeds a second threshold value, the computing apparatus determining that the blood circulation condition in the z-th toe terminal region of interest is poor;when the mean relative difference exceeds a third threshold value, the computing apparatusdetermining that the blood circulation condition in the inspection area is poor; when the standard deviation of the difference exceeds a fourth threshold value, the computing apparatus determining that the blood circulation condition in the inspection area is poor; and / orwhen the maximum-minimum difference exceeds a fifth threshold value, the computing apparatus determining that the blood circulation condition in the inspection area is poor.

16. The method of claim 11, wherein:the pressure is greater than or equal to a systolic blood pressure of the individual, and a difference between the pressure and the systolic blood pressure is less than or equal to 20 mmHg.

17. The method of claim 11, wherein:the blood flow perfusion time series change data comprises a pressure release phase blood flow perfusion time series change data and a pressurization phase blood flow perfusion time series change data;the pressure time series change data comprises a pressure release phase pressure time series change data;the blood perfusion evaluation result comprises a skin perfusion pressure corresponding to a moment at which subepidermal blood flow in the region of interest begins reperfusion after pressure released; andgenerating the blood perfusion evaluation result of the region of interest comprising:the computing apparatus identifying a time point in the pressure release phase blood flow perfusion time series change data corresponding to a first increase in laser speckle contrast image value from a lowest point in the pressurization phase blood flow perfusion time series change data;the computing apparatus identifying a pressure value in the pressure release phase pressure time series change data corresponding to the time point; and the computing apparatus identifies the pressure value as the skin perfusion pressure.

18. The method of claim 11, further comprising:the computing apparatus generating a blood circulation distribution image of the inspection area based on the pressure time series change data, the image data, and the blood flow perfusion time series change data.

19. The method of claim 18, wherein:the image data comprises a pre-pressurization image data, a pressurization phase image data, and a pressure release phase image data; andthe computing apparatus generating the blood circulation distribution image further comprising:the blood circulation distribution image presenting, in an animated format, a process of the laser speckle variation corresponding to blood flow movement in the pre-pressurization image data, the pressurization phase image data, and the pressure release phase image data.

20. The method of claim 11, wherein:the blood perfusion evaluation result comprising:a laser speckle variation in the image data and / or a difference in the laser speckle variation during the pressurization phase and / or the pressure release phase relative to the pre-pressurization phase; and / ora skin perfusion pressure value, a blood perfusion velocity, a blood perfusion volume, a blood perfusion pressure, and / or a blood perfusion status representing blocked and reperfused blood flow in the region of interest as shown in the pressure time series change data and the blood flow perfusion time series change data, and respective differences during the pressurization phase and / or the pressure release phase relative to the pre-pressurization phase.

Images