WO2024001142A1 - 用于评估肝脏病变状况的计算装置、肝脏弹性测量装置、远程工作站和介质 - Google Patents

用于评估肝脏病变状况的计算装置、肝脏弹性测量装置、远程工作站和介质 Download PDF

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WO2024001142A1
WO2024001142A1 PCT/CN2022/143958 CN2022143958W WO2024001142A1 WO 2024001142 A1 WO2024001142 A1 WO 2024001142A1 CN 2022143958 W CN2022143958 W CN 2022143958W WO 2024001142 A1 WO2024001142 A1 WO 2024001142A1
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liver
parameters
score
subject
computing device
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PCT/CN2022/143958
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English (en)
French (fr)
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何琼
邵金华
孙锦
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无锡海斯凯尔医学技术有限公司
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/08—Detecting organic movements or changes, e.g. tumours, cysts, swellings
    • A61B8/0833—Detecting organic movements or changes, e.g. tumours, cysts, swellings involving detecting or locating foreign bodies or organic structures
    • A61B8/085—Detecting organic movements or changes, e.g. tumours, cysts, swellings involving detecting or locating foreign bodies or organic structures for locating body or organic structures, e.g. tumours, calculi, blood vessels, nodules
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/44—Constructional features of the ultrasonic, sonic or infrasonic diagnostic device
    • A61B8/4483—Constructional features of the ultrasonic, sonic or infrasonic diagnostic device characterised by features of the ultrasound transducer
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/48—Diagnostic techniques
    • A61B8/485—Diagnostic techniques involving measuring strain or elastic properties
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/56—Details of data transmission or power supply
    • A61B8/565—Details of data transmission or power supply involving data transmission via a network
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H50/00—ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics
    • G16H50/20—ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for computer-aided diagnosis, e.g. based on medical expert systems
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H50/00—ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics
    • G16H50/30—ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for calculating health indices; for individual health risk assessment

Definitions

  • the present application relates to medical diagnostic and detection devices, and more specifically to computing devices, liver elasticity measurement devices, remote workstations and media for assessing liver disease conditions.
  • liver disease has become an important cause affecting human health worldwide.
  • the development of various liver diseases will be accompanied by liver fibrosis, and liver fibrosis will also be accompanied by changes in the elasticity of the liver.
  • transient elastography has been extensively studied in the diagnosis of liver fibrosis.
  • Transient elastography technology is usually used to measure liver stiffness (Liver Stiffness Measurement, English abbreviation LSM) and diagnose the degree of liver fibrosis based on this.
  • liver biopsy has many limitations. Its invasiveness, the risk of complications, and the risk of ongoing follow-up liver verification are not feasible. In addition, liver biopsy is also affected by sampling error. Therefore, there is still room for improvement in noninvasive liver lesion assessment methods.
  • this application provides a computing device, a liver elasticity measurement device, a remote workstation and a medium for assessing liver disease status, which can quickly and accurately determine liver disease based on ultrasound data in a non-invasive manner.
  • Fibrosis parameters, liver steatosis parameters and liver inflammation parameters and enables users to view three parameters, namely liver fibrosis parameters, liver steatosis parameters and liver inflammation parameters. Users can refer to this Three-dimensional parameters can more sensitively and accurately diagnose the varied and complex pathological conditions of the liver.
  • a computing device for assessing liver disease conditions includes a first processor configured to: determine liver fibrosis parameters including liver elasticity measurement values, including ultrasound attenuation measurement values based on ultrasound data collected by the liver elasticity measurement device from the subject The liver steatosis parameter and the liver inflammation parameter including the liver inflammation index; and displaying one or more of the liver fibrosis parameter, the liver steatosis parameter and the liver inflammation parameter on the display so that the user can view The liver fibrosis parameter, the liver steatosis parameter, and/or the liver inflammation parameter.
  • a liver elasticity measuring device includes: an ultrasonic transducer configured to transmit and receive ultrasonic waves to a subject under the condition that vibration excitation generates shear waves; a transmit/receive control circuit configured to transmit to the ultrasonic transducer A transmitting and receiving sequence is output to control the transmitting and receiving of ultrasound waves; a computing device adapted to be configured in a liver elasticity measuring device according to various embodiments of the present application.
  • a remote workstation communicably connected to a computing device and comprising: an interface configured to receive liver fibrosis including liver elastance measurements determined by the computing device Parameters, liver steatosis parameters including ultrasound attenuation measurements and liver inflammation parameters including liver inflammation index; receiving biological parameters or biochemical parameters of the subject; and a second processor configured to: according to the received The liver fibrosis parameters, liver steatosis parameters and liver inflammation parameters of the subject are supplemented by taking into account the biological parameters or biochemical parameters to calculate the comprehensive liver disease of the subject. Score, the liver lesion comprehensive score is a continuous value or a discrete grade; the subject's liver lesion comprehensive score is displayed.
  • a non-volatile computer storage medium on which computer instructions are stored.
  • the evaluation method includes: determining liver fibrosis parameters including liver elasticity measurement values, liver steatosis parameters including ultrasound attenuation measurement values, and liver inflammation including liver inflammation index based on ultrasound data collected from the subject by a liver elasticity measurement device. parameters; and displaying one or more of the liver fibrosis parameters, the liver steatosis parameters, and the liver inflammation parameters on the display so that the user can view the liver fibrosis parameters, the liver steatosis parameters. , and/or the liver inflammation parameters.
  • the evaluation method further includes: calculating a liver fibrosis score based on the liver fibrosis parameters; calculating a liver steatosis score based on the liver steatosis parameters; calculating a liver steatosis score based on the liver inflammation parameters. Inflammation score; one or more of the liver fibrosis score, the liver steatosis score, and the liver inflammation score are displayed on the display.
  • the liver fibrosis score, the liver steatosis score, and the liver inflammation score are continuous values, or discrete levels.
  • the evaluation method further includes: receiving a user's operation of selecting to view parameters or scoring; in the case where the user selects to view parameters, displaying the liver fibrosis parameter and the liver steatosis parameter on the display and one or more of the liver inflammation parameters, and if the user chooses to view the score, one of the liver fibrosis score, the liver steatosis score, and the liver inflammation score is displayed on the display, or Multiple.
  • the assessment method further includes: obtaining biological parameters of the subject, the biological parameters including weight, height, waist circumference, hip circumference, chest circumference, age, gender of the subject , at least one of BMI, subcutaneous tissue thickness and subcutaneous fat thickness; based on the liver fibrosis parameter, the liver steatosis parameter and the liver inflammation parameter, supplemented by taking into account the biological parameters, the calculated A comprehensive score of liver lesions of the subject is provided, and the comprehensive score of liver lesions is a continuous numerical value or a discrete grade.
  • the assessment method further includes: obtaining the biochemical parameters of the subject, the biochemical parameters including the subject's AST, ALT, transaminase, GGT, PAL, iron serum, ferritin, Transferrin saturation, fatty acid oxidizing hormone, cytokinin, cholesterol HDL, blood glucose, insulinemia, bilirubin, a2 macroglobulin, hematochromoglobulin, apolipoprotein A1, CK-18, triglycerides, Levels of at least one of high-density lipoprotein, low-density lipoprotein, very low-density lipoprotein, adiponectin, urea, polymorphic genes, CRP, leptin, and metabolic biochemical parameters; based on the liver fibrosis parameter , the liver steatosis parameters and the liver inflammation parameters, supplemented by taking the biochemical parameters into consideration, to calculate the subject's comprehensive score of liver lesions, and the comprehensive score of liver lesions is a
  • the liver fibrosis parameters further include liver viscosity parameters.
  • liver elasticity measurement device Utilizing the computing device, liver elasticity measurement device, remote workstation and medium for assessing liver disease status according to various embodiments of the present application, it is possible to quickly and accurately determine liver fibers in a non-invasive manner based on ultrasound data (even ultrasound data of the same batch) ification parameter, the liver steatosis parameter and the liver inflammation parameter, and enables the user to view three parameters at the same time, namely the liver fibrosis parameter, the liver steatosis parameter and the liver inflammation parameter, by comparing the reference With these three parameters, users can more sensitively and accurately diagnose the varied and complex pathological conditions of the liver.
  • Figure 1 shows a schematic diagram of a computing device for evaluating liver disease status according to an embodiment of the present application, which is built into a liver elasticity measuring device according to an embodiment of the present application.
  • FIG. 2 shows an interface diagram of a first example of displaying liver fibrosis parameters, the liver steatosis parameters, and the liver inflammation parameters on a display according to an embodiment of the present application.
  • FIG. 3 shows an interface diagram of a second example of displaying liver fibrosis parameters, liver steatosis parameters, and liver inflammation parameters on a display according to an embodiment of the present application.
  • Figure 4 shows a working schematic diagram of a remote workstation according to an embodiment of the present application.
  • Figure 5 shows a structural block diagram of a remote workstation according to an embodiment of the present application.
  • Figure 6 shows a flow chart of a method for evaluating liver disease status according to an embodiment of the present application.
  • FIG. 1 shows a schematic diagram of a computing device 100a for assessing liver disease status according to an embodiment of the present application.
  • the computing device 100a can be built into the liver elasticity measuring device 100 according to an embodiment of the present application, as illustrated in FIG. 1 , but can also be disposed in other locations, such as but not limited to remote workstations, cloud servers, etc. .
  • the computing device 100a can also be communicatively connected to the liver elasticity measuring device 100, as long as it can obtain the ultrasound collected by the liver elasticity measuring device 100 on the subject. Just data.
  • the following description takes the calculation device 100a built in the liver elasticity measuring device 100 as an example.
  • the computing device 100a may include a first processor 103 configured to: based on the ultrasound data collected by the liver elasticity measuring device 100 on the subject, determine whether the liver elasticity measurement includes Liver fibrosis parameters including ultrasound attenuation measurements, liver steatosis parameters including ultrasound attenuation measurements, and liver inflammation parameters including liver inflammation index.
  • the liver elasticity measurement value can use various parameters that characterize liver elasticity, such as but not limited to liver stiffness measurement value (English abbreviation is usually LSM).
  • liver fibrosis parameters may also include liver viscosity parameters, and collaborative analysis of liver elastic parameters and viscosity parameters can more comprehensively assess the degree of liver fibrosis.
  • Hepatic steatosis the accumulation of fat in the liver, can be quantified using measurements of the attenuation of ultrasound propagation (ultrasound attenuation measurement, often abbreviated as UAP).
  • Liver inflammation parameters include various parameters that characterize inflammatory activity.
  • information related to liver inflammation activity or tissue inflammation activity can be obtained as the liver inflammation index based on the preset liver hardness or the corresponding relationship between parameters reflecting liver hardness and liver inflammation activity.
  • the liver inflammation index is usually abbreviated as LID or RFIn, etc.
  • the corresponding relationship may include: when the liver stiffness LSM is 6.1-8.7kpa, the corresponding tissue inflammatory activity is mild inflammatory necrosis; when the LSM is 8.7-13.2kpa, the corresponding tissue inflammatory activity is moderate tissue inflammatory necrosis. ; When the LSM value is above 13.2kpa, the corresponding tissue inflammation activity is severe tissue inflammation and necrosis.
  • the corresponding relationship also includes: tissue hardness corresponding to different causes or parameters reflecting tissue hardness and tissue inflammation activity, for viral hepatitis, autoimmune hepatitis, primary biliary cholangitis, For non-alcoholic fatty liver disease, drug-induced liver disease and liver disease of unknown etiology, the corresponding relationship between LSM and liver inflammation activity is preset respectively.
  • the first processor 103 may be further configured to display one or more of the liver fibrosis parameter, the liver steatosis parameter, and the liver inflammation parameter on the display 105 so that the user can view the Liver fibrosis parameters, said liver steatosis parameters together with said liver inflammation parameters.
  • these three parameters do not necessarily have to be presented on the display 105 at the same time. They can be presented one after another, or they can be presented in response to the user's operation. The user can view any of the parameters, especially liver inflammation, if needed. parameter. In this way, the user can compare and refer to these three parameters (or compare and refer to some of the parameters) to more sensitively and accurately diagnose the varied and complex pathological conditions of the liver.
  • liver fibrosis parameters are high but liver inflammation parameters are low, doctors can accurately determine that the liver disease is in a stable phase and will not develop rapidly, and the dosage of medication can be controlled as appropriate.
  • the doctor can assess that although the liver is still in the compensatory stage, it may undergo rapid fibrosis. If the liver steatosis parameters are also seen at the same time, If it is not good, then it is necessary to arouse sufficient vigilance and conduct timely medical intervention, and the subject needs to conduct regular examinations at short intervals to monitor the effect of medical intervention, adjust medication, etc.
  • the ultrasound data can be obtained by the liver elasticity measurement device 100 collecting the subject at the same time. That is to say, the first processor 103 can quickly analyze the ultrasound data of the subject in the same period to obtain the liver fibrosis parameters, the liver steatosis parameters and the liver steatosis parameters of the subject in the same period. Inflammatory parameters. For example, even after the liver elasticity test is performed on the subject, the liver fibrosis parameters, liver steatosis parameters, and liver inflammation parameters of the period can be presented immediately, allowing doctors to pay attention to these parameters more conveniently and timely. The correlation and synergy of the three parameters can more accurately assess the disease status of the liver.
  • the first processor 103 may be further configured to: calculate a liver fibrosis score according to the liver fibrosis parameter; calculate a liver steatosis score according to the liver steatosis parameter; Liver inflammation parameters are used to calculate a liver inflammation score; the liver fibrosis score, the liver steatosis score, and the liver inflammation score are displayed together on the display 105, as shown in Figure 3.
  • the corresponding relationship between each parameter and the score can be established based on pre-measured ground truth values including each parameter and the score manually annotated by doctors as training data.
  • the corresponding relationship can be established as a mathematical model or implemented using a learning network.
  • the score prediction model takes into account the interaction between the three parameters and can more accurately predict scores at all levels.
  • the liver fibrosis score, the liver steatosis score, and the liver inflammation score are continuous values or discrete levels.
  • liver fibrosis score By displaying the liver fibrosis score, the liver steatosis score, and the liver inflammation score, it can help doctors (especially doctors with average professional skills) more intuitively understand the three components of fibrosis, steatosis, and inflammatory activity of liver lesions. development status at various levels, thereby more accurately assessing the disease status of the liver.
  • the first processor 103 may be further configured to receive a user's operation of selecting to view parameters or ratings. If the user chooses to view parameters, the first processor 103 may display the liver fibrosis parameter, the liver steatosis parameter, and the liver inflammation parameter together on the display 105, as shown in FIG. 2 . When the user chooses to view the score (check "Show Score" as shown in Figure 3), the first processor 103 can display the liver fibrosis score 40 and the liver steatosis score 60 on the display 105. and the liver inflammation score of 70.
  • the three-level scores shown in Figure 3 represent a situation where the degree of fibrosis is not high but the level of inflammatory activity is high, and rapid fibrosis and lesions will occur.
  • the computing device 100a can be configured in the liver elasticity measuring device 100, or can be configured as a remote workstation.
  • the liver elasticity measuring device 100 may include an ultrasonic transducer 101 configured to transmit and receive ultrasonic waves to the subject under the condition that vibration excitation generates shear waves; a transmit/receive control circuit 102 configured to transmit and receive ultrasonic waves to the subject; The ultrasonic transducer outputs a transmitting and receiving sequence to control it to transmit and receive ultrasonic waves; and the computing device 100a according to various embodiments of the present application is implemented via the first processor 103. That is to say, the computing device 100a multiplexes the first processor 103 of the liver elasticity measuring device itself.
  • the liver elasticity measuring device 100 may include a memory 104 and a display 105, wherein the memory 104 may be configured to store ultrasound data, may also store or load the evaluation method for liver disease status according to various embodiments of the present application, or may be stored when implementing the method. Intermediate data generated when evaluating methods, etc.
  • the first processor 103 may be a processing device including one or more general-purpose processing devices, such as a microprocessor, a central processing unit (CPU), a graphics processing unit (GPU), or the like.
  • Memory 104 may be a non-transitory computer-readable medium, such as read-only memory (ROM), random access memory (RAM), phase change random access memory (PRAM), static random access memory (SRAM), dynamic random access memory.
  • DRAM dynamic random access memory
  • EEPROM electrically erasable programmable read-only memory
  • RAM random access memory
  • flash disks or other forms of flash memory cache, registers, static memory, optical disk read-only memory (CD-ROM), digital versatile disk (DVD) or other optical storage, cassette tape or other magnetic storage device, or any other possible non-transitory medium used to store information or instructions that can be accessed by a computer device, etc. .
  • the display 105 may include a liquid crystal display (LCD), a light emitting diode display (LED), a plasma display, or any other type of display and provide a graphical user interface (GUI) presented on the display, as shown in Figures 2 and 2 3 shown.
  • Display 105 may be comprised of many different types of materials, such as plastic or glass, and may be touch-sensitive to receive commands from the user.
  • display 105 may include a substantially rigid touch-sensitive material (such as Gorilla GlassTM) or a substantially flexible touch-sensitive material (such as Willow GlassTM).
  • the liver elasticity measuring device 100 may include a shear wave generating device 106 to collect ultrasound data under external vibration excitation or acoustic radiation force excitation.
  • the frequency range of the external vibration excitation is 10-1000Hz
  • the vibration amplitude range is 0.001-10mm
  • the number of vibration cycles is 0.5-1000.
  • the frequency range of the acoustic radiation force excitation is 0.5-50Mhz
  • the excitation pulse length is greater than 10 ⁇ s, and there is more than one excitation position.
  • the liver elasticity measuring device 100 may not rely on a dedicated shear wave generating device 106 to generate shear waves, but may collect ultrasound data under endogenous vibration excitation.
  • Sexual vibration stimulation includes the subject's heartbeat or the subject's vocalizations. In this way, the structure of the liver elasticity measuring device 100 can be made more compact.
  • the ultrasound signal of the liver elasticity measurement device 100 has a frame rate greater than 100 Hz, thereby capturing shear waves with sufficient resolution.
  • the first processor 103 or the liver elasticity measurement device 100 can be further configured to: filter the collected ultrasound data, the filtering range is 20-2000Hz, and then filter The subsequent ultrasound data is subjected to principal component analysis with a rank greater than 3, and the data obtained after principal component analysis is then used to determine the liver fibrosis parameters, the liver steatosis parameters, and the liver inflammation parameters.
  • the background noise of endogenous vibration excitation can be fully filtered out, and the amount of data processing can be reduced, while the liver fibrosis parameters, the liver steatosis parameters, and the liver inflammation parameters can be accurately determined.
  • the first processor 103 can obtain richer information about the subject via the network 401.
  • the first processor 103 can obtain the biological parameters of the subject, the biological parameters include the subject's weight, height, waist circumference, hip circumference, chest circumference, age, gender, BMI, subcutaneous tissue At least one of thickness and subcutaneous fat thickness. These biological parameters can be inquired by a doctor when interviewing the subject or obtained during a basic physical examination, and can be transmitted to the remote workstation 400 via the network 401 .
  • the first processor 103 may additionally take the biological parameters into consideration to calculate the subject's Comprehensive score of liver lesions, which is a continuous numerical value or a discrete grade.
  • the biological parameters will also affect the comprehensive score of liver lesions to a certain extent, and the fluctuations in the short term are small, but the specificity is not enough when considered independently.
  • the subject can be calculated more accurately Comprehensive score of liver lesions.
  • biochemical parameters from the laboratory can be transmitted to the remote workstation 400 through the network 401. Further, detection data from various departments related to liver disease conditions can be transmitted to the remote workstation 400 for summary analysis.
  • the first processor 103 may be further configured to: obtain the subject's biochemical parameters, the biochemical parameters include the subject's AST, ALT, transaminase, GGT, PAL, iron serum, Ferritin, transferrin saturation, lipoic acid oxidizing hormone, cytokinin, cholesterol HDL, blood glucose, insulinemia, bilirubin, a2 macroglobulin, hemophilic chromoglobulin, apolipoprotein A1, CK-18, glycerol Levels of at least one of triesters, high-density lipoprotein, low-density lipoprotein, very low-density lipoprotein, adiponectin, urea, polymorphic genes, CRP, leptin, and metabolic biochemical parameters; based on the
  • ALT and AST are mainly distributed in liver cells. Increases in ALT and AST indicate damage to liver cells. ALT is the most sensitive. A 1-fold increase in ALT in serum indicates 1% hepatocyte necrosis. Normally, the elevation of ALT and AST is consistent with the degree of liver cell damage. ALT is mainly distributed in the liver cytoplasm. ALT elevation reflects damage to the liver cell membrane. AST is mainly distributed in the liver cytoplasm and liver cell mitochondria.
  • ALT and AST are different in different liver inflammations, and the ratios of ALT and AST are also different.
  • ALT The normal value of ALT is affected by many factors such as age and gender. At the same time, the baseline level of ALT varies greatly among different individuals. In practical applications, ALT cannot completely accurately reflect the "infiltration of inflammatory cells" in the liver. A considerable number of patients have moderate or even severe "infiltration of inflammatory cells" in the liver through liver biopsy, but their ALT is still normal. level, that is, less than or equal to 40U/L. Therefore, just normal ALT does not dispel the vigilance for liver disease, but needs to be combined with other parameters. When ALT is abnormal and the liver inflammation parameters are within the borderline between normal and abnormal, the presence of liver inflammation can be determined, and a more accurate assessment can be made in conjunction with liver fibrosis parameters and liver steatosis parameters.
  • Figure 5 shows a structural block diagram of a remote workstation according to an embodiment of the present application.
  • the remote workstation 400 includes an interface 501, a second processor 502 and a display 503, and is communicatively connected to a computing device according to various embodiments of the present application.
  • Interface 501 may include network adapters, cable connectors, serial connectors, USB connectors, parallel connectors, high-speed data transmission adapters (such as optical fiber, USB 3.0, Thunderbolt interface, etc.), wireless network adapters (such as WiFi adapters), telecommunications (3G, 4G/LTE, 5G, etc.) adapters, etc.
  • the second processor 502 and the display 503 may adopt similar hardware configurations to those of the first processor 103 and the display 105 shown in FIG. 1 , which will not be described again here.
  • the interface 501 may be configured to: receive liver fibrosis parameters including liver elasticity measurements, liver steatosis parameters including ultrasound attenuation measurements, and liver inflammation parameters including liver inflammation index determined by the computing device; receive the Describe the biological parameters or biochemical parameters of the subject.
  • the second processor 502 may be configured to: based on the received liver fibrosis parameter, the liver steatosis parameter, and the liver inflammation parameter of the subject, supplemented by taking into account the biological parameters or Biochemical parameters are used to calculate the subject's comprehensive score of liver lesions, and the comprehensive score of liver lesions is a continuous value or a discrete level; so that the display 503 displays the comprehensive score of liver lesions of the subject.
  • the biological parameters of the subject include at least one of the subject's weight, height, waist circumference, hip circumference, chest circumference, age, gender, BMI, subcutaneous tissue thickness and subcutaneous fat thickness. kind.
  • the subject's biochemical parameters include the subject's AST, ALT, transaminase, GGT, PAL, iron serum, ferritin, transferrin saturation, fatty acid oxidizing hormone, cell division Cholesterol, HDL, blood glucose, insulinemia, bilirubin, a2 macroglobulin, hematophilic chromoglobulin, apolipoprotein A1, CK-18, triglycerides, high-density lipoprotein, low-density lipoprotein, very low density Levels of at least one of lipoproteins, adiponectin, urea, polymorphic genes, CRP, leptin, and metabolic biochemical parameters.
  • These biological parameters and biochemical parameters can carry the measurement time when transmitted to the remote workstation 400, so that the measurement time of the subject's biological parameters and biochemical parameters and the acquisition time of the ultrasound data do not exceed the time threshold. .
  • these biological parameters, biochemical parameters and ultrasound data (as well as the liver fibrosis parameters, the liver steatosis parameters and the liver inflammation parameters and even scores calculated therefrom) can characterize the subjects examined in the same period.
  • Medical information reflecting the status of liver lesions at all levels of the patient can help doctors more accurately assess the status of liver lesions.
  • the present application also provides a non-volatile computer storage medium on which computer instructions are stored.
  • a third processor When the computer instructions are executed by a third processor, a method for evaluating liver disease conditions is implemented.
  • Figure 6 shows a flow chart of a method for evaluating liver disease status according to an embodiment of the present application.
  • the evaluation method may include step 601: based on the ultrasound data collected by the liver elasticity measuring device from the subject, determine liver fibrosis parameters including liver elasticity measurement values (which may also include liver viscosity parameters), Hepatic steatosis parameters including ultrasound attenuation measurements and liver inflammation parameters including hepatic inflammation index.
  • the evaluation method may include step 602: displaying one or more of the liver fibrosis parameters, the liver steatosis parameters, and the liver inflammation parameters on a display, so that the user can view the liver fibrosis parameters, the liver fibrosis parameters, and the liver inflammation parameters.
  • the liver steatosis parameters and the liver inflammation parameters may include step 601: based on the ultrasound data collected by the liver elasticity measuring device from the subject, determine liver fibrosis parameters including liver elasticity measurement values (which may also include liver viscosity parameters), Hepatic steato
  • the evaluation method may further include: calculating a liver fibrosis score based on the liver fibrosis parameters; calculating a liver steatosis score based on the liver steatosis parameters; calculating a liver steatosis score based on the liver inflammation parameters. Liver inflammation score; the liver fibrosis score, the liver steatosis score, and the liver inflammation score are displayed together on the display.
  • the liver fibrosis score, the liver steatosis score, and the liver inflammation score are continuous values or discrete levels.
  • the evaluation method further includes: receiving a user's operation of selecting to view parameters or scores; when the user selects to view parameters, displaying the liver fibrosis parameters and the liver fat together on the display. degeneration parameters and liver inflammation parameters, and when the user chooses to view the scores, the liver fibrosis score, the liver steatosis score, and the liver inflammation score are displayed together on the display.
  • the evaluation method may further include: obtaining the biological parameters of the subject, the biological parameters including the subject's weight, height, waist circumference, hip circumference, chest circumference, age, At least one of gender, BMI, subcutaneous tissue thickness and subcutaneous fat thickness; calculated based on the liver fibrosis parameter, the liver steatosis parameter and the liver inflammation parameter, supplemented by taking into account the biological parameters.
  • the subject's comprehensive liver lesion score is a continuous numerical value or a discrete grade.
  • the assessment method may further include: obtaining biochemical parameters of the subject, the biochemical parameters including AST, ALT, transaminase, GGT, PAL, iron serum, ferritin of the subject , transferrin saturation, fatty acid oxidizing hormone, cytokinin, cholesterol HDL, blood glucose, insulinemia, bilirubin, a2 macroglobulin, hemochromoglobulin, apolipoprotein A1, CK-18, triglycerides , the level of at least one of high-density lipoprotein, low-density lipoprotein, very low-density lipoprotein, adiponectin, urea, polymorphic genes, CRP, leptin and metabolic biochemical parameters; based on the liver fibrosis parameters, the liver steatosis parameters and the liver inflammation parameters, supplemented by taking the biochemical parameters into consideration, to calculate the subject's comprehensive score of liver lesions, and the comprehensive score of liver lesions is a continuous value or

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Abstract

本申请涉及一种用于评估肝脏病变状况的计算装置、肝脏弹性测量装置、远程工作站和介质。该计算装置包括第一处理器，所述第一处理器配置为：基于肝脏弹性测量装置对受检者所采集的超声数据，确定包括肝脏弹性测量值的肝脏纤维化参数、包括超声衰减测量值的肝脏脂肪变性参数以及包括肝脏炎症指数的肝脏炎症参数；以及在显示器上显示所述肝脏纤维化参数、所述肝脏脂肪变性参数以及所述肝脏炎症参数中的一个或者多个，使得用户能够查看所述肝脏纤维化参数、所述肝脏脂肪变性参数连同所述肝脏炎症参数。如此，用户对照参考所述肝脏纤维化参数、所述肝脏脂肪变性参数和所述肝脏炎症参数能够更灵敏且准确地诊断出肝脏的多变复杂的病变状况。

Description

用于评估肝脏病变状况的计算装置、肝脏弹性测量装置、远程工作站和介质
相关申请的交叉引用
本申请要求在2022年06月30日提交中国专利局、申请号为202210769486.X、发明名称为“用于评估肝脏病变状况的计算装置、肝脏弹性测量装置、远程工作站和介质”的中国专利申请的优先权，其全部内容通过引用结合在本申请中。
技术领域
本申请涉及医疗诊断及检测装置，更具体地，涉及用于评估肝脏病变状况的计算装置、肝脏弹性测量装置、远程工作站和介质。
背景技术
肝脏疾病在世界范围内已经成为影响人类健康的重要原因。各种肝病的发展过程会伴随肝脏的纤维化，而肝脏的纤维化也会伴随肝脏的弹性变化。近期对瞬时弹性成像技术在肝脏纤维化的诊断上进行了大量研究。通常利用瞬时弹性成像技术来测量肝脏硬度值(Liver Stiffness Measurement，英文缩写为LSM)，并据此诊断肝脏的纤维化程度。
但是，对于各种肝病，如果仅仅获知肝脏硬度值，并不能让医生及时且准确地诊断肝脏的当前病变状况及潜在发展的可能。有时候，偏高的纤维化程度也无需过度用药，患者的病程发展是稳定甚至停滞的；反而一些纤维化程度不高的肝脏，如果不引起重视而没有及时复查，会迅速发展恶化。目前医生还是经常依赖于临床病理检测进行肝脏活检来诊断肝脏病变状况。但是，肝脏活检具有许多限制因素，其侵入性的缺点、并发症风险使得无法持续进行俩跟踪肝脏验证，此外，肝脏活检还受到抽样误差的影响。因此，无创肝脏病变评估方式依然存在改进空间。
发明内容
提出本申请以解决以上技术问题。
针对现有技术中存在的上述技术问题，本申请提供了用于评估肝脏病变状况的计算装置、肝脏弹性测量装置、远程工作站和介质，其能够基于超声数据以无创的方式迅速且准确地确定肝脏纤维化参数、所述肝脏脂肪变性参数以及 所述肝脏炎症参数，并使得用户能够查看到三种参数，即肝脏纤维化参数、所述肝脏脂肪变性参数以及所述肝脏炎症参数，用户对照参考这三位参数能够更灵敏且准确地诊断出肝脏的多变复杂的病变状况。
根据本申请的第一方面，提供了一种用于评估肝脏病变状况的计算装置。该计算装置包括第一处理器，所述第一处理器配置为：基于肝脏弹性测量装置对受检者所采集的超声数据，确定包括肝脏弹性测量值的肝脏纤维化参数、包括超声衰减测量值的肝脏脂肪变性参数以及包括肝脏炎症指数的肝脏炎症参数；以及在显示器上显示所述肝脏纤维化参数、所述肝脏脂肪变性参数以及所述肝脏炎症参数中的一个或者多个，使得用户能够查看所述肝脏纤维化参数、所述肝脏脂肪变性参数，和/或所述肝脏炎症参数。
根据本申请的第二方面，提供了一种肝脏弹性测量装置。该肝脏弹性测量装置包括：超声换能器，其配置为在振动激励产生剪切波的情况下向受检者发射和接收超声波；发射/接收控制电路，其配置为向所述超声换能器输出发射和接收序列，以控制其发射和接收超声波；根据本申请各个实施例的适于配置在肝脏弹性测量装置中的计算装置。
根据本申请的第三方面，提供了一种远程工作站，以可通信方式连接到计算装置，且包括：接口，其配置为：接收所述计算装置所确定的包括肝脏弹性测量值的肝脏纤维化参数、包括超声衰减测量值的肝脏脂肪变性参数以及包括肝脏炎症指数的肝脏炎症参数；接收所述受检者的生物学参数或生化参数；以及第二处理器，其配置为：根据所接收的所述受检者的所述肝脏纤维化参数、所述肝脏脂肪变性参数以及所述肝脏炎症参数，辅以考虑到所述生物学参数或生化参数，来计算所述受检者的肝脏病变综合得分，所述肝脏病变综合得分为连续的数值或者离散的等级；显示所述受检者的肝脏病变综合得分。
根据本申请的第四方面，提供了一种非易失性计算机存储介质，其上存储有计算机指令，所述计算机指令由第三处理器执行时，实现肝脏病变状况的评估方法。该评估方法包括：基于肝脏弹性测量装置对受检者所采集的超声数据，确定包括肝脏弹性测量值的肝脏纤维化参数、包括超声衰减测量值的肝脏脂肪变性参数以及包括肝脏炎症指数的肝脏炎症参数；以及在显示器上显示所述肝脏纤维化参数、所述肝脏脂肪变性参数以及所述肝脏炎症参数中的一个或者多个，使得用户能够查看所述肝脏纤维化参数、所述肝脏脂肪变性参数，和/或所述肝脏炎症参数。
在一些实施例中，所述评估方法还包括：根据所述肝脏纤维化参数，计算肝脏纤维化评分；根据所述肝脏脂肪变性参数，计算肝脏脂肪变性评分；根据 所述肝脏炎症参数，计算肝脏炎症评分；在显示器上显示所述肝脏纤维化评分、所述肝脏脂肪变性评分以及所述肝脏炎症评分中的一个或者多个。
在一些实施例中，所述肝脏纤维化评分、所述肝脏脂肪变性评分以及所述肝脏炎症评分为连续的数值，或者离散的等级。
在一些实施例中，所述评估方法进一步包括：接收用户的选择查看参数或评分的操作；在用户选择查看参数的情况下，在显示器上显示所述肝脏纤维化参数、所述肝脏脂肪变性参数以及所述肝脏炎症参数中的一个或者多个，而在用户选择查看评分的情况下，在显示器上显示所述肝脏纤维化评分、所述肝脏脂肪变性评分以及所述肝脏炎症评分中的一个或者多个。
在一些实施例中，所述评估方法还包括：获取所述受检者的生物学参数，所述生物学参数包括所述受检者的体重、身高、腰围、臀围、胸围、年龄、性别、BMI、皮下组织厚度和皮下脂肪厚度中的至少一种；基于所述肝脏纤维化参数、所述肝脏脂肪变性参数以及所述肝脏炎症参数，辅以考虑到所述生物学参数，来计算所述受检者的肝脏病变综合得分，所述肝脏病变综合得分为连续的数值或者离散的等级。
在一些实施例中，所述评估方法还包括：获取所述受检者的生化参数，所述生化参数包括所述受检者的AST、ALT、转氨酶、GGT、PAL、铁血清、铁蛋白、输铁蛋白饱和度、脂酸氧化激素、细胞***素、胆固醇HDL、血糖、胰岛素血、胆红素、a2巨球蛋白、亲血色球蛋白、载脂蛋白A1、CK-18、甘油三酯、高密度脂蛋白、低密度脂蛋白、极低密度脂蛋白、脂联素、尿素、多态性基因、CRP、瘦体素和代谢生化参数的至少一种的水平；基于所述肝脏纤维化参数、所述肝脏脂肪变性参数以及所述肝脏炎症参数，辅以考虑到所述生化参数，来计算所述受检者的肝脏病变综合得分，所述肝脏病变综合得分为连续的数值或者离散的等级。
在一些实施例中，所述肝脏纤维化参数还包括肝脏粘性参数。
利用根据本申请各个实施例的评估肝脏病变状况的计算装置、肝脏弹性测量装置、远程工作站和介质，其能够基于超声数据(甚至是同一批的超声数据)以无创方式迅速且准确地确定肝脏纤维化参数、所述肝脏脂肪变性参数以及所述肝脏炎症参数，并使得用户能够一并查看到三种参数，即肝脏纤维化参数、所述肝脏脂肪变性参数以及所述肝脏炎症参数，通过对照参考这三位参数，用户能够更灵敏且准确地诊断出肝脏的多变复杂的病变状况。
附图说明
在不一定按比例绘制的附图中，相同的附图标记可以在不同的视图中描述相似的部件。具有字母后缀或不同字母后缀的相同附图标记可以表示相似部件 的不同实例。附图大体上通过举例而不是限制的方式示出各种实施例，并且与说明书以及权利要求书一起用于对所公开的实施例进行说明。这样的实施例是例证性的，而并非旨在作为本装置或方法的穷尽或排他实施例。
图1示出了根据本申请实施例的用于评估肝脏病变状况的计算装置的示意图，其内置于根据本申请实施例的肝脏弹性测量装置中。
图2示出了根据本申请实施例的在显示器上显示肝脏纤维化参数、所述肝脏脂肪变性参数以及所述肝脏炎症参数的第一示例的界面图示。
图3示出了根据本申请实施例的在显示器上显示肝脏纤维化参数、所述肝脏脂肪变性参数以及所述肝脏炎症参数的第二示例的界面图示。
图4示出了根据本申请实施例的远程工作站的工作示意图。
图5示出了根据本申请实施例的远程工作站的构造框图。
图6示出了根据本申请实施例的肝脏病变状况的评估方法的流程图。
具体实施方式
为使本领域技术人员更好的理解本申请的技术方案，下面结合附图和具体实施方式对本申请作详细说明。下面结合附图和具体实施例对本申请的实施例作进一步详细描述，但不作为对本申请的限定。
本申请中使用的“第一”、“第二”以及类似的词语并不表示任何顺序、数量或者重要性，而只是用来区分不同的部分。“包括”或者“包含”等类似的词语意指在该词前的要素涵盖在该词后列举的要素，并不排除也涵盖其他要素的可能。“上”、“下”、“左”、“右”等仅用于表示相对位置关系，当被描述对象的绝对位置改变后，则该相对位置关系也可能相应地改变。
图1示出了根据本申请实施例的用于评估肝脏病变状况的计算装置100a的示意图。请注意，该计算装置100a可以内置于根据本申请实施例的肝脏弹性测量装置100中，如图1中所例示的，但也可以设置于其他位置，例如但不限于远程工作站、云端服务器等中。所述计算装置100a除了可以配置在所述肝脏弹性测量装置100中，也可以与所述肝脏弹性测量装置100可通信地连接，只要能够获取到肝脏弹性测量装置100对受检者所采集的超声数据就可以。
下面以内置于肝脏弹性测量装置100的计算装置100a为例进行说明。
如图1所示，该计算装置100a可以包括第一处理器103，所述第一处理器103被配置为：基于肝脏弹性测量装置100对受检者所采集的超声数据，确定包括肝脏弹性测量值的肝脏纤维化参数、包括超声衰减测量值的肝脏脂肪变性参数以及包括肝脏炎症指数的肝脏炎症参数。肝脏弹性测量值可以采用各种表征肝脏弹性的参数，例如但不限于肝脏硬度测量值(英文缩写通常为LSM)。在一些实施例中，肝脏纤维化参数也可以包括肝脏粘性参数，协同分析肝脏弹性 参数和粘性参数能够更全面地评估肝脏的纤维化程度。肝脏的脂肪变性是脂肪在肝脏中的积累，可以利用超声波传播衰减的测量结果(超声衰减测量值通常缩写为UAP)来量化脂肪变性。肝脏炎症参数包括各种表征炎症活动度的参数。在一些实施例中，可以根据预先设定的肝脏硬度或者反映肝脏硬度的参量及肝脏炎症活动度的对应关系，获得肝脏炎症活动度或组织炎症活动度相关信息，作为所述肝脏炎症指数。该肝脏炎症指数通常缩写为LID或者RFIn等。例如，所述对应关系可以包括：肝脏硬度LSM为6.1-8.7kpa时，对应组织炎症活动度为轻度组炎症坏死；LSM为8.7-13.2kpa时，对应组织炎症活动度为中度组织炎症坏死；LSM值为13.2kpa以上时，对应组织炎症活动度为重度组织炎症坏死。在一些实施例中，所述对应关系还包括：不同病因所对应的组织硬度或者反映组织硬度的参量及组织炎症活动度，针对病毒性肝炎、自身免疫性肝炎、原发性胆汁性胆管炎、非酒精脂肪肝以及药物性肝病及病因不明的肝病，分别预先设置LSM及肝脏炎症活动度的对应关系。
所述第一处理器103可以被进一步配置为：在显示器105上显示所述肝脏纤维化参数、所述肝脏脂肪变性参数以及所述肝脏炎症参数中的一个或者多个，使得用户能够查看所述肝脏纤维化参数、所述肝脏脂肪变性参数连同所述肝脏炎症参数。请注意，未必这三个参数都要同一时刻呈现在显示器105上，先后呈现也可以，响应于用户的操作而呈现也可以，用户只要需要，能够查看到其中的任何一个参数，尤其是肝脏炎症参数。如此，用户能够对照参考这三种参数(或者对照参考其中的部分参数)，更灵敏且准确地诊断出肝脏的多变复杂的病变状况。例如说来，在肝脏纤维化参数较高但肝脏炎症参数很低的情况下，医生就可以准确判定肝脏病变处于稳定期，不会迅速发展，用药量可以酌情控制。又例如，在肝脏纤维化参数不高，但是肝脏炎症参数显著高的情况下，医生可以评估肝脏虽然还属于可代偿阶段，但可能会发生快速纤维化，如果同时看到肝脏脂肪变性参数也不佳，那么就要引起足够警惕并及时进行医学干预，而且需要受检者以较短的间隔定期检查来监控医学干预的效果，并调整用药等等。
在一些实施例中，所述超声数据可以由肝脏弹性测量装置100对受检者同次采集而得到。也就是说，第一处理器103可以对受检者同个时段的超声数据进行迅速分析，来得出受检者同个时段的所述肝脏纤维化参数、所述肝脏脂肪变性参数以及所述肝脏炎症参数。例如，甚至可以在对受检者进行肝脏弹性检测之后，即时呈现该时段的所述肝脏纤维化参数、所述肝脏脂肪变性参数以及所述肝脏炎症参数，可以让医生更方便及时地关注到这三个参数的关联和协同作用，从而更准确地评估肝脏的病变状况。
在一些实施例中，所述第一处理器103可以被进一步配置为：根据所述肝脏纤维化参数，计算肝脏纤维化评分；根据所述肝脏脂肪变性参数，计算肝脏脂肪变性评分；根据所述肝脏炎症参数，计算肝脏炎症评分；在显示器105上一并显示所述肝脏纤维化评分、所述肝脏脂肪变性评分以及所述肝脏炎症评分，如图3所示。可以基于预先测量的包括各个参数与医生手动标注的评分的地面真值作为训练数据，来建立各个参数与评分之间的对应关系。该对应关系可以建立为数学模型，也可以利用学习网络来实现。在一些实施例中，可以基于预先测量的一组上述三类参数(肝脏纤维化参数、肝脏脂肪变性参数和肝脏炎症参数)与医生手动标注的三类评分(肝脏纤维化评分、肝脏脂肪变性评分和肝脏炎症评分)作为训练数据，来构建评分预测模型，如此，该评分预测模型考虑到了三种参数之间的交互影响，能够更准确地预测出各个层面的评分。具体说来，所述肝脏纤维化评分、所述肝脏脂肪变性评分以及所述肝脏炎症评分为连续的数值，或者离散的等级。通过显示所述肝脏纤维化评分、所述肝脏脂肪变性评分以及所述肝脏炎症评分，可以帮助医生(尤其是专业技能一般的医生)更直观地理解肝脏病变的纤维化、脂肪变性和炎症活性三个层面的发展状况，从而更准确地评估肝脏的病变状况。
可以让用户自由地选择查看参数还是评分，对于专业技能较高的医生，可能更希望获取原始的参数值以进行更精细的分析，而对于专业技能一般的医生，可能会依赖于评分来进行更可靠的分析。相应地，所述第一处理器103可以被进一步配置为：接收用户的选择查看参数或评分的操作。在用户选择查看参数的情况下，第一处理器103可以在显示器105上一并显示所述肝脏纤维化参数、所述肝脏脂肪变性参数以及所述肝脏炎症参数，如图2所示。而在用户选择查看评分(如图3勾选了“显示评分”)的情况下，第一处理器103可以在显示器105上一并显示所述肝脏纤维化评分40、所述肝脏脂肪变性评分60以及所述肝脏炎症评分70。图3所示的三个层面的评分就表征了纤维化程度不高但炎症活性水平很高，会发生快速纤维化而病变的状况。
如上所述，计算装置100a可以配置在肝脏弹性测量装置100，也可以配置为远程工作站。
回到图1，对肝脏弹性测量装置100进行例示性说明。该肝脏弹性测量装置100可以包括超声换能器101，其被配置为在振动激励产生剪切波的情况下向受检者发射和接收超声波；发射/接收控制电路102，其被配置为向所述超声换能器输出发射和接收序列，以控制其发射和接收超声波；以及根据本申请各个实施例的计算装置100a，其经由第一处理器103来实现。也就是说，计算装置100a复用了肝脏弹性测量装置自身的第一处理器103。肝脏弹性测量装置 100可以包括存储器104和显示器105,其中，存储器104可以被配置为存储超声数据，也可以存储或加载根据本申请各个实施例的肝脏病变状况的评估方法，也可以存储在实施该评估方法时产生的中间数据等等。
在一些实施例中，第一处理器103可以是包括一个以上通用处理设备的处理设备，诸如微处理器、中央处理单元(CPU)、图形处理单元(GPU)等。存储器104可以是非暂时性计算机可读的介质，诸如只读存储器(ROM)、随机存取存储器(RAM)、相变随机存取存储器(PRAM)、静态随机存取存储器(SRAM)、动态随机存取存储器(DRAM)、电可擦除可编程只读存储器(EEPROM)、其他类型的随机存取存储器(RAM)、闪存盘或其他形式的闪存、缓存、寄存器、静态存储器、光盘只读存储器(CD-ROM)、数字通用光盘(DVD)或其他光学存储器、盒式磁带或其他磁存储设备，或被用于储存能够被计算机设备访问的信息或指令的任何其他可能的非暂时性的介质等。
在一些实施例中，显示器105可以包括液晶显示器(LCD)、发光二极管显示器(LED)、等离子显示器或任何其他类型的显示器，并提供显示器上呈现的图形用户界面(GUI)，如图2和图3所示。显示器105可以包括许多不同类型的材料(诸如塑料或玻璃)，并且可以是触敏的以从用户接收命令。例如，显示器105可以包括基本上刚性的触敏材料(诸如Gorilla玻璃TM)或基本上柔韧的(诸如Willow玻璃TM)的触敏材料。
如图1所示，肝脏弹性测量装置100中可以包括剪切波发生装置106，从而在进行外部振动激励或声辐射力激励的情况下进行超声数据的采集。例如，所述外部振动激励的频率范围为10-1000Hz，振动幅度范围为0.001-10mm，振动周期数为0.5-1000个。又例如，所述声辐射力激励的频率范围为0.5-50Mhz，激励脉冲长度大于10μs，且激励位置有一个以上。
在一些实施例中，肝脏弹性测量装置100也可以不依赖于专门的剪切波发生装置106来引发剪切波，而是在进行内源性振动激励的情况下采集超声数据，所述内源性振动激励包括所述受检者的心跳或者所述受检者的发声。如此，可以使得肝脏弹性测量装置100的结构更紧凑。
在采用内源性振动激励的情况下，所述肝脏弹性测量装置100的超声信号具有大于100Hz的帧频，从而以充足的分辨率捕捉剪切波。
在采用内源性振动激励的情况下，所述第一处理器103或者所述肝脏弹性测量装置100可以进一步配置为：对所采集的超声数据进行滤波，滤波范围为20-2000Hz，再对滤波后的超声数据进行秩数大于3的主成分分析，主成分分析后所得的数据再用于确定所述肝脏纤维化参数、所述肝脏脂肪变性参数以及所述肝脏炎症参数。从而能够充分过滤掉内源性振动激励的背景噪声，并降低数 据处理量，同时准确地确定所述肝脏纤维化参数、所述肝脏脂肪变性参数以及所述肝脏炎症参数。
如图4所示，如果所述计算装置100a被配置在远程工作站400，所述第一处理器103可以经由网络401获取更丰富的受检者的信息。例如，第一处理器103可以获取所述受检者的生物学参数，所述生物学参数包括所述受检者的体重、身高、腰围、臀围、胸围、年龄、性别、BMI、皮下组织厚度和皮下脂肪厚度中的至少一种。这些生物学参数可以通过医生面诊受检者时询问或者在进行基础的体检时获取，并经由网络401传输给远程工作站400。如此，在基于所述肝脏纤维化参数、所述肝脏脂肪变性参数以及所述肝脏炎症参数的同时，第一处理器103可以辅以考虑到所述生物学参数，来计算所述受检者的肝脏病变综合得分，所述肝脏病变综合得分为连续的数值或者离散的等级。所述生物学参数在一定程度上也会影响所述肝脏病变综合得分，且短期内波动性较小，但独立考虑则特异性不够，作为辅助因素考虑，能够更准确地计算所述受检者的肝脏病变综合得分。
在一些实施例中，来自检验科的生化参数可以通过网络401传输给远程工作站400。进一步地，各种与肝脏病变状况相关的各种科室的检测数据都可以传输给远程工作站400以进行汇总分析。相应地，所述第一处理器103可以被进一步配置为：获取所述受检者的生化参数，所述生化参数包括所述受检者的AST、ALT、转氨酶、GGT、PAL、铁血清、铁蛋白、输铁蛋白饱和度、脂酸氧化激素、细胞***素、胆固醇HDL、血糖、胰岛素血、胆红素、a2巨球蛋白、亲血色球蛋白、载脂蛋白A1、CK-18、甘油三酯、高密度脂蛋白、低密度脂蛋白、极低密度脂蛋白、脂联素、尿素、多态性基因、CRP、瘦体素和代谢生化参数的至少一种的水平；基于所述肝脏纤维化参数、所述肝脏脂肪变性参数以及所述肝脏炎症参数，辅以考虑到所述生化参数，来计算所述受检者的肝脏病变综合得分，所述肝脏病变综合得分为连续的数值或者离散的等级。这些生化参数可能会随着受检者的食物结构和检测时间而波动，导致特异性不足，但作为辅助因素考虑，能够更准确地计算所述受检者的肝脏病变综合得分。例如，ALT与AST主要分布在肝细胞内，ALT和AST升高，说明肝细胞受损。ALT最为敏感。血清中的ALT增加1倍表明1％肝细胞坏死。通常情况下ALT和AST升高程度与肝细胞受损程度相一致。ALT主要分布在肝细胞浆，ALT升高反映了肝细胞膜的损伤，AST主要分布在肝细胞浆和肝细胞线粒体。因此不同的肝脏炎症所出现的ALT、AST升高情况是不同的，ALT与AST的比值也是不同的。以ALT为例。ALT正常值受年龄，性别等多种因素的影响，同时不同个体间，ALT的基线水平相差较大。在实际应用中，ALT并不能够完全准 确的反映肝脏的“炎症细胞的浸润”，有相当一部分患者通过肝活检发现有中度乃至重度的肝脏“炎症细胞的浸润”，但其ALT仍处于正常水平，即小于等于40U/L。因此，仅仅ALT正常并不能打消对于肝脏病变的警惕，而需要结合其他参数。而当ALT异常时，在肝脏炎症参数在正常与不正常的交界范围时，就可以确定肝脏炎症存在，可以配合肝脏纤维化参数和肝脏脂肪变性参数来进行更准确的评估。
图5示出了根据本申请实施例的远程工作站的构造框图。如图5所示，该远程工作站400包括接口501、第二处理器502以及显示器503，且以可通信方式连接到根据本申请各个实施例的计算装置。接口501可以包括网络适配器、电缆连接器、串行连接器，USB连接器、并行连接器、高速数据传输适配器(诸如光纤、USB 3.0、雷电接口等)、无线网络适配器(诸如WiFi适配器)、电信(3G、4G/LTE、5G等)适配器等。第二处理器502和显示器503可以采用与图1中所示的第一处理器103和显示器105分别相似的硬件配置，在此不赘述。
所述接口501可以被配置为：接收所述计算装置所确定的包括肝脏弹性测量值的肝脏纤维化参数、包括超声衰减测量值的肝脏脂肪变性参数以及包括肝脏炎症指数的肝脏炎症参数；接收所述受检者的生物学参数或生化参数。第二处理器502可以被配置为：根据所接收的所述受检者的所述肝脏纤维化参数、所述肝脏脂肪变性参数以及所述肝脏炎症参数，辅以考虑到所述生物学参数或生化参数，来计算所述受检者的肝脏病变综合得分，所述肝脏病变综合得分为连续的数值或者离散的等级；使得显示器503显示所述受检者的肝脏病变综合得分。
在一些实施例中，所述受检者的生物学参数包括所述受检者的体重、身高、腰围、臀围、胸围、年龄、性别、BMI、皮下组织厚度和皮下脂肪厚度中的至少一种。在一些实施例中，所述受检者的生化参数包括所述受检者的AST、ALT、转氨酶、GGT、PAL、铁血清、铁蛋白、输铁蛋白饱和度、脂酸氧化激素、细胞***素、胆固醇HDL、血糖、胰岛素血、胆红素、a2巨球蛋白、亲血色球蛋白、载脂蛋白A1、CK-18、甘油三酯、高密度脂蛋白、低密度脂蛋白、极低密度脂蛋白、脂联素、尿素、多态性基因、CRP、瘦体素和代谢生化参数的至少一种的水平。
这些生物学参数和生化参数在传输给远程工作站400的时候可以携带测量时间，可以使得所述受检者的生物学参数和生化参数的测量时间与所述超声数据的采集时间相距不超过时间阈值。如此，可以确保这些生物学参数、生化参数和超声数据(以及由其计算的肝脏纤维化参数、所述肝脏脂肪变性参数以及所 述肝脏炎症参数乃至得分)，可以表征在同个时段的受检者的各个层面的反映肝脏病变状况的医学信息，由此可以有助于医生更准确地评估肝脏病变的状况。
在一些实施例中，本申请还提供一种非易失性计算机存储介质，其上存储有计算机指令，所述计算机指令由第三处理器执行时，实现肝脏病变状况的评估方法。
图6示出了根据本申请实施例的肝脏病变状况的评估方法的流程图。如图6所示，该评估方法可以包括步骤601：基于肝脏弹性测量装置对受检者所采集的超声数据，确定包括肝脏弹性测量值(也可以还包括肝脏粘性参数)的肝脏纤维化参数、包括超声衰减测量值的肝脏脂肪变性参数以及包括肝脏炎症指数的肝脏炎症参数。该评估方法可以包括步骤602：在显示器上显示所述肝脏纤维化参数、所述肝脏脂肪变性参数以及所述肝脏炎症参数中的一个或者多个，使得用户能够查看所述肝脏纤维化参数、所述肝脏脂肪变性参数以及所述肝脏炎症参数。
在一些实施例中，所述评估方法还可以包括：根据所述肝脏纤维化参数，计算肝脏纤维化评分；根据所述肝脏脂肪变性参数，计算肝脏脂肪变性评分；根据所述肝脏炎症参数，计算肝脏炎症评分；在显示器上一并显示所述肝脏纤维化评分、所述肝脏脂肪变性评分以及所述肝脏炎症评分。
例如，所述肝脏纤维化评分、所述肝脏脂肪变性评分以及所述肝脏炎症评分为连续的数值，或者离散的等级。
在一些实施例中，所述评估方法进一步包括：接收用户的选择查看参数或评分的操作；在用户选择查看参数的情况下，在显示器上一并显示所述肝脏纤维化参数、所述肝脏脂肪变性参数以及所述肝脏炎症参数，而在用户选择查看评分的情况下，在显示器上一并显示所述肝脏纤维化评分、所述肝脏脂肪变性评分以及所述肝脏炎症评分。
在一些实施例中，所述评估方法还可以包括：获取所述受检者的生物学参数，所述生物学参数包括所述受检者的体重、身高、腰围、臀围、胸围、年龄、性别、BMI、皮下组织厚度和皮下脂肪厚度中的至少一种；基于所述肝脏纤维化参数、所述肝脏脂肪变性参数以及所述肝脏炎症参数，辅以考虑到所述生物学参数，来计算所述受检者的肝脏病变综合得分，所述肝脏病变综合得分为连续的数值或者离散的等级。
在一些实施例中，所述评估方法还可以包括：获取所述受检者的生化参数，所述生化参数包括所述受检者的AST、ALT、转氨酶、GGT、PAL、铁血清、铁蛋白、输铁蛋白饱和度、脂酸氧化激素、细胞***素、胆固醇HDL、血糖、胰岛素血、胆红素、a2巨球蛋白、亲血色球蛋白、载脂蛋白A1、CK-18、 甘油三酯、高密度脂蛋白、低密度脂蛋白、极低密度脂蛋白、脂联素、尿素、多态性基因、CRP、瘦体素和代谢生化参数的至少一种的水平；基于所述肝脏纤维化参数、所述肝脏脂肪变性参数以及所述肝脏炎症参数，辅以考虑到所述生化参数，来计算所述受检者的肝脏病变综合得分，所述肝脏病变综合得分为连续的数值或者离散的等级。
在本申请中的各个步骤的顺序仅仅是示例性的，而非限制性的。在不影响本申请的实现的情况下(不破坏所需的步骤之间的逻辑关系的情况下)，可以对步骤的执行顺序进行调整，调整后得到的各种实施例依然落在本申请的范围内。
本申请使用的所有术语(包括技术术语或者科学术语)与本申请所属领域的普通技术人员理解的含义相同，除非另外特别定义。还应当理解，在诸如通用字典中定义的术语应当被解释为具有与它们在相关技术的上下文中的含义相一致的含义，而不应用理想化或极度形式化的意义来解释，除非这里明确地这样定义。
对于相关领域普通技术人员已知的技术、方法和设备可能不作详细讨论，但在适当情况下，这些技术、方法和设备应当被视为说明书的一部分。
以上描述旨在是说明性的而不是限制性的。例如，上述示例(或其一个或更多方案)可以彼此组合使用。例如本领域普通技术人员在阅读上述描述时可以使用其它实施例。另外，在上述具体实施方式中，各种特征可以被分组在一起以简单化本申请。这不应解释为一种不要求保护的公开的特征对于任一权利要求是必要的意图。相反，本申请的主题可以少于特定的公开的实施例的全部特征。从而，以下权利要求书作为示例或实施例在此并入具体实施方式中，其中每个权利要求独立地作为单独的实施例，并且考虑这些实施例可以以各种组合或排列彼此组合。本申请的范围应参照所附权利要求以及这些权利要求赋权的等同形式的全部范围来确定。

Claims (21)

  1. 一种用于评估肝脏病变状况的计算装置，其特征在于，包括第一处理器，所述第一处理器配置为：
    基于肝脏弹性测量装置对受检者所采集的超声数据，确定包括肝脏弹性测量值的肝脏纤维化参数、包括超声衰减测量值的肝脏脂肪变性参数以及包括肝脏炎症指数的肝脏炎症参数；以及
    在显示器上显示所述肝脏纤维化参数、所述肝脏脂肪变性参数以及所述肝脏炎症参数中的一个或者多个，使得用户能够查看所述肝脏纤维化参数、所述肝脏脂肪变性参数，和/或所述肝脏炎症参数。
  2. 根据权利要求1所述的计算装置，其特征在于，所述超声数据是由肝脏弹性测量装置对受检者同次采集的。
  3. 根据权利要求1或2所述的计算装置，其特征在于，所述计算装置配置在所述肝脏弹性测量装置中，或者与所述肝脏弹性测量装置可通信地连接。
  4. 根据权利要求1所述的计算装置，其特征在于，所述超声数据在进行内源性振动激励的情况下由所述肝脏弹性测量装置采集，所述内源性振动激励包括所述受检者的心跳或者所述受检者的发声。
  5. 根据权利要求4所述的计算装置，其特征在于，所述肝脏弹性测量装置的超声信号具有大于100Hz的帧频。
  6. 根据权利要求4或5所述的计算装置，其特征在于，所述第一处理器或者所述肝脏弹性测量装置进一步配置为：对所采集的超声数据进行滤波，滤波范围为20-2000Hz，再对滤波后的超声数据进行秩数大于3的主成分分析，主成分分析后所得的数据再用于确定所述肝脏纤维化参数、所述肝脏脂肪变性参数以及所述肝脏炎症参数。
  7. 根据权利要求1所述的计算装置，其特征在于，所述超声数据在进行外部振动激励或声辐射力激励的情况下由所述肝脏弹性测量装置采集。
  8. 根据权利要求7所述的计算装置，其特征在于，所述外部振动激励的频率范围为10-1000Hz，振动幅度范围为0.001-10mm，振动周期数为0.5-1000个。
  9. 根据权利要求7所述的计算装置，其特征在于，所述声辐射力激励的频率范围为0.5-50Mhz，激励脉冲长度大于10μs，且激励位置有一个以上。
  10. 根据权利要求1或2所述的计算装置，其特征在于，所述第一处理器进一步配置为：根据所述肝脏纤维化参数，计算肝脏纤维化评分；根据所述肝脏脂肪变性参数，计算肝脏脂肪变性评分；根据所述肝脏炎症参数，计算肝脏炎 症评分；在显示器上显示所述肝脏纤维化评分、所述肝脏脂肪变性评分以及所述肝脏炎症评分中一个或者多个。
  11. 根据权利要求10所述的计算装置，其特征在于，所述肝脏纤维化评分、所述肝脏脂肪变性评分以及所述肝脏炎症评分为连续的数值，或者离散的等级。
  12. 根据权利要求10所述的计算装置，其特征在于，所述第一处理器进一步配置为：接收用户的选择查看参数或评分的操作；在用户选择查看参数的情况下，在显示器上显示所述肝脏纤维化参数、所述肝脏脂肪变性参数以及所述肝脏炎症参数中的一个或者多个，而在用户选择查看评分的情况下，在显示器上显示所述肝脏纤维化评分、所述肝脏脂肪变性评分以及所述肝脏炎症评分中的一个或者多个。
  13. 根据权利要求1或2所述的计算装置，其特征在于，所述计算装置配置在远程工作站，所述第一处理器进一步配置为：获取所述受检者的生物学参数，所述生物学参数包括所述受检者的体重、身高、腰围、臀围、胸围、年龄、性别、BMI、皮下组织厚度和皮下脂肪厚度中的至少一种；基于所述肝脏纤维化参数、所述肝脏脂肪变性参数以及所述肝脏炎症参数，辅以考虑到所述生物学参数，来计算所述受检者的肝脏病变综合得分，所述肝脏病变综合得分为连续的数值或者离散的等级。
  14. 根据权利要求1或2所述的计算装置，其特征在于，所述计算装置配置在远程工作站，所述第一处理器进一步配置为：获取所述受检者的生化参数，所述生化参数包括所述受检者的AST、ALT、转氨酶、GGT、PAL、铁血清、铁蛋白、输铁蛋白饱和度、脂酸氧化激素、细胞***素、胆固醇HDL、血糖、胰岛素血、胆红素、a2巨球蛋白、亲血色球蛋白、载脂蛋白A1、CK-18、甘油三酯、高密度脂蛋白、低密度脂蛋白、极低密度脂蛋白、脂联素、尿素、多态性基因、CRP、瘦体素和代谢生化参数的至少一种的水平；基于所述肝脏纤维化参数、所述肝脏脂肪变性参数以及所述肝脏炎症参数，辅以考虑到所述生化参数，来计算所述受检者的肝脏病变综合得分，所述肝脏病变综合得分为连续的数值或者离散的等级。
  15. 根据权利要求1或2所述的计算装置，其特征在于，所述肝脏纤维化参数还包括肝脏粘性参数。
  16. 一种肝脏弹性测量装置，其特征在于，包括：
    超声换能器，其配置为在振动激励产生剪切波的情况下向受检者发射和接收超声波；
    发射/接收控制电路，其配置为向所述超声换能器输出发射和接收序列，以控制其发射和接收超声波；
    根据权利要求1-12中任何一项所述的计算装置。
  17. 一种远程工作站，其特征在于，以可通信方式连接到根据权利要求1-12中任何一项所述的计算装置，且包括：
    接口，其配置为：接收所述计算装置所确定的包括肝脏弹性测量值的肝脏纤维化参数、包括超声衰减测量值的肝脏脂肪变性参数以及包括肝脏炎症指数的肝脏炎症参数；接收所述受检者的生物学参数或生化参数；以及
    第二处理器，其配置为：根据所接收的所述受检者的所述肝脏纤维化参数、所述肝脏脂肪变性参数以及所述肝脏炎症参数，辅以考虑到所述生物学参数或生化参数，来计算所述受检者的肝脏病变综合得分，所述肝脏病变综合得分为连续的数值或者离散的等级；显示所述受检者的肝脏病变综合得分。
  18. 根据权利要求17所述的远程工作站，其特征在于，所述受检者的生物学参数包括所述受检者的体重、身高、腰围、臀围、胸围、年龄、性别、BMI、皮下组织厚度和皮下脂肪厚度中的至少一种。
  19. 根据权利要求17所述的远程工作站，其特征在于，所述受检者的生化参数包括所述受检者的AST、ALT、转氨酶、GGT、PAL、铁血清、铁蛋白、输铁蛋白饱和度、脂酸氧化激素、细胞***素、胆固醇HDL、血糖、胰岛素血、胆红素、a2巨球蛋白、亲血色球蛋白、载脂蛋白A1、CK-18、甘油三酯、高密度脂蛋白、低密度脂蛋白、极低密度脂蛋白、脂联素、尿素、多态性基因、CRP、瘦体素和代谢生化参数的至少一种的水平。
  20. 根据权利要求18或19所述的远程工作站，其特征在于，所述受检者的生物学参数和生化参数的测量时间与所述超声数据的采集时间相距不超过时间阈值。
  21. 一种非易失性计算机存储介质，其上存储有计算机指令，所述计算机指令由第三处理器执行时，实现肝脏病变状况的评估方法：
    基于肝脏弹性测量装置对受检者所采集的超声数据，确定包括肝脏弹性测量值的肝脏纤维化参数、包括超声衰减测量值的肝脏脂肪变性参数以及包括肝脏炎症指数的肝脏炎症参数；以及
    在显示器上显示所述肝脏纤维化参数、所述肝脏脂肪变性参数以及所述肝脏炎症参数中的一个或者多个，使得用户能够查看所述肝脏纤维化参数、所述肝脏脂肪变性参数，和/或所述肝脏炎症参数。
PCT/CN2022/143958 2022-06-30 2022-12-30 用于评估肝脏病变状况的计算装置、肝脏弹性测量装置、远程工作站和介质 WO2024001142A1 (zh)

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