WO2014156370A1 - 血液状態評価装置、血液状態評価システム、血液状態評価方法及びプログラム - Google Patents
血液状態評価装置、血液状態評価システム、血液状態評価方法及びプログラム Download PDFInfo
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
- G01N33/86—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving blood coagulating time or factors, or their receptors
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N27/00—Investigating or analysing materials by the use of electric, electrochemical, or magnetic means
- G01N27/02—Investigating or analysing materials by the use of electric, electrochemical, or magnetic means by investigating impedance
- G01N27/026—Dielectric impedance spectroscopy
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/483—Physical analysis of biological material
- G01N33/487—Physical analysis of biological material of liquid biological material
- G01N33/49—Blood
- G01N33/4905—Determining clotting time of blood
Definitions
- the present technology relates to a blood state evaluation apparatus, a blood state evaluation system, a blood state evaluation method, and a program. More specifically, the present invention relates to a technique for evaluating a blood state from a change in electrical characteristics over time.
- Anti-platelet agglutinating drugs or anticoagulants are prophylactically administered to patients and healthy individuals who are at risk for thrombosis.
- Patients having a risk of thrombosis include, for example, patients with diabetes, arteriosclerosis, cancer, heart disease and respiratory disease, perioperative patients, patients taking immunosuppressants, and the like.
- healthy people having a risk of blood clot include pregnant women and elderly people.
- Acetylsalicylic acid or the like is used as an antiplatelet agglutinating agent, and warfarin or heparin, an activated blood coagulation factor X (Factor Xa) inhibitor, a thrombin direct inhibitor, or the like is used as an anticoagulant.
- Factor Xa activated blood coagulation factor X
- Prophylactic administration of antiplatelet aggregating drugs or anticoagulants against thrombosis has the side effect of increasing the risk of bleeding when the dosage is excessive. In order to obtain a sufficient preventive effect while preventing this side effect, it is important to administer medication in which the blood coagulation ability of the subject is evaluated in a timely manner, and the drug and dosage are appropriately selected and set.
- Blood coagulation ability tests for medication management include methods such as International Standardized Prothrombin Time (Prothrombin Time-International Normalized Ratio: PT-INR) and Activated Partial Thromboplastin Time (APTT).
- PT-INR Prothrombin Time-International Normalized Ratio
- APTT Activated Partial Thromboplastin Time
- PRP Platelet Rich Plasma
- VTE venous thromboembolism
- DVT deep vein thrombosis
- CT computed tomography
- PE pulmonary thromboembolism
- Etc. a study has been reported that attempts to predict venous thromboembolism (VTE) that occurs as a side effect of knee replacement by measuring a biomarker.
- image diagnosis by ultrasonography, computed tomography, etc. has high accuracy and certainty, so definitive diagnosis is possible, but inspection takes time.
- these image diagnoses basically detect a thrombus that has been formed, it is not possible to evaluate the “risk” of whether a thrombus will occur in the future before the thrombus is formed.
- the method using a biomarker has a sensitivity of 75% and a specificity of 63% in a study using D-dimer, and a sensitivity of 75% and a specificity of 59% in a study using e-XDP. And specificity is not enough.
- the main object of the present disclosure is to provide a blood state evaluation device, a blood state evaluation system, a blood state evaluation method, and a program that can easily and accurately evaluate the risk of thrombosis.
- the present inventors have proposed a method for performing dielectric measurement of the blood coagulation process as a method capable of easily and accurately evaluating the degree of blood coagulation (JP 2010-181400 A, JP 2012-2012). No. 194087).
- blood is filled in a capacitor-shaped sample portion composed of a pair of electrodes and the like, and an alternating electric field is applied thereto to measure a change in dielectric constant accompanying the blood coagulation process.
- a blood sample collected from a vein using citrate as an anticoagulant is added, and the anticoagulant action of citric acid is canceled by adding an aqueous calcium chloride solution immediately before the start of measurement to cause a blood coagulation reaction. Make it progress. Then, by analyzing the complex permittivity spectrum obtained by the measurement according to a predetermined algorithm, it is possible to evaluate the increase or decrease in blood coagulation ability such as blood coagulation time.
- VTE venous thromboembolism
- the blood state evaluation apparatus includes at least an evaluation unit that evaluates the blood state based on temporal change data of electrical characteristics of blood at two or more frequencies or frequency bands.
- the evaluation unit can extract one or more feature points from the temporal change data of electrical characteristics.
- the evaluation unit can also digitize the temporal change data of electrical characteristics.
- the evaluation unit may evaluate the blood state by comparing, for example, a determination value calculated from the temporal change data of electrical characteristics and a preset threshold value.
- the evaluation unit may be based on the temporal change data of the electrical characteristic, also evaluate the state of the blood by increasing and / or decreasing the electric characteristic value E at any frequency f x.
- the electrical characteristic can be at least one value selected from impedance, conductance, admittance, capacitance, dielectric constant, conductivity, phase angle, and an amount obtained by converting the quantity of electricity.
- the evaluation unit can also evaluate the coagulation state of the blood.
- a measurement unit that measures electrical characteristics over time at a specific frequency or frequency band for blood to be evaluated may be provided.
- a blood condition evaluation system is measured by an electrical property measurement device including a measurement unit that measures electrical properties over time at a specific frequency or frequency band for blood to be evaluated, and the electrical property measurement device.
- a blood condition evaluation apparatus including an evaluation unit that evaluates the blood condition based on temporal change data in two or more frequencies or frequency bands.
- the evaluation system further includes a server including an information storage unit that stores a measurement result in the dielectric constant measurement device and / or an evaluation result in the blood state evaluation device, and the server is connected via a network.
- the dielectric constant measuring device and / or the blood state evaluating device may be connected.
- the blood state evaluation method includes an electrical property measurement step of measuring electrical characteristics over time at a specific frequency or frequency band for blood to be evaluated, and electrical characteristics measured in the electrical property measurement step.
- a blood state evaluation step is performed for evaluating the blood state based on time-dependent data in two or more frequencies or frequency bands.
- the program according to the present disclosure causes a computer to realize an evaluation function for evaluating the blood state based on temporal change data of blood electrical characteristics at two or more frequencies or frequency bands.
- the risk of thrombosis can be evaluated easily and accurately.
- FIG. 6 is a time-dependent change data of blood permittivity (change amount ⁇ of a real part of complex permittivity) of a diabetic patient measured in Example 4.
- FIG. FIG. 9 is a time-dependent change data of a dielectric constant (a variation ⁇ of a real part of a complex dielectric constant) of a blood sample within a normal value measured in Example 5.
- FIG. 9 is a time-dependent change data of a dielectric constant (a variation ⁇ of a real part of a complex dielectric constant) of a blood sample within a normal value measured in Example 5.
- FIG. FIG. 10 is a time-dependent change data of the dielectric constant (change amount ⁇ of the real part of the complex dielectric constant) of an abnormal blood sample measured in Example 5.
- FIG. FIG. 10 is a time-dependent change data of the dielectric constant (change amount ⁇ of the real part of the complex dielectric constant) of an abnormal blood sample measured in Example 5.
- FIG. 10 is a time-dependent change data of the dielectric constant
- VTE venous thromboembolism
- vascular endothelial disorder vascular endothelial disorder
- enhanced blood coagulation ability is known. "is called.
- thrombosis General risk factors for thrombosis include aging, obesity, long-term bedrock, maintenance of the same posture, and dehydration. Risk factors associated with the disease include congenital hypercoagulable states, malignant tumors, inflammatory bowel disease, and nephrotic syndrome. In addition, there are various risk factors such as those related to drugs such as steroids and hormone drugs, and those related to treatment such as surgery and catheterization. Among these risk factors, it is known that treatments such as artificial knee joint replacement have a high risk of thrombosis.
- VTE venous thromboembolism
- FIG. 1 is a block diagram showing a configuration example of a blood state evaluation apparatus according to this embodiment.
- the blood state evaluation apparatus 1 according to this embodiment includes a measurement unit 2, an evaluation unit 3, a storage unit 4, a display unit 5, and the like.
- the measurement unit 2 measures electrical characteristics over time at a specific frequency or frequency band for blood to be evaluated. Examples of the electrical characteristics measured by the measurement unit 2 include impedance, conductance, admittance, capacitance, dielectric constant, conductivity, phase angle, and the amount obtained by converting these quantities of electricity. In addition, although the blood state evaluation apparatus 1 of this embodiment can be evaluated with one of these electrical characteristics, two or more electrical characteristics can also be used.
- the configuration of the measurement unit 2 is not particularly limited, and can be set as appropriate according to the electrical characteristics to be measured.
- an impedance analyzer or a network analyzer can be used as the measurement unit 2 when an AC voltage is applied between a pair of electrodes provided in a sample container to measure the impedance or dielectric constant of blood.
- the measurement unit 2 may measure only the frequency or frequency band used in the evaluation unit 3 to be described later. However, the measurement unit 2 measures electrical characteristics in a wide band by changing the frequency, and uses the obtained spectrum for evaluation. A frequency or frequency band can also be extracted.
- the evaluation unit 3 evaluates the blood state based on the temporal change data in two or more frequencies or two or more frequency bands among the electrical characteristics measured by the measurement unit 2 described above.
- examples of the blood state to be evaluated include a blood coagulation state, an aggregation state, a sedimentation state, and a clot degeneracy state.
- the evaluation in the evaluation unit 3 includes a method of extracting feature points from the temporal change data of the electrical characteristics, a method of digitizing the temporal change data of the electrical characteristics, a determination value calculated from the temporal change data of the electrical characteristics and a preset value. It is possible to apply a method of comparing the threshold value. Further, the evaluation unit 3, for example, be based on the temporal change data of the electrical characteristic, also evaluate the condition of the blood by increasing and / or decreasing the electric characteristic value E at any frequency f x. Note that the evaluation method in the evaluation unit 3 is not limited to the method described above, and various methods can be applied.
- the storage unit 4 stores temporal change data of electrical characteristics of blood measured by the measurement unit 2, evaluation results by the evaluation unit 3, and the like, and includes a hard disk or the like.
- Display unit 5 The display unit 5 displays temporal change data of electrical characteristics of blood measured by the measurement unit 2, results evaluated by the evaluation unit 3, and the like, as long as these can be browsed.
- the measurement unit 2 measures the electrical characteristics of the blood to be evaluated over time at a specific frequency or frequency band.
- the measurement conditions of the electrical characteristics are not particularly limited, and can be set as appropriate according to the type of electrical characteristics and the like as long as the blood to be evaluated is not altered.
- the measurement may be performed only for the frequency or frequency band used in the evaluation process, but it is also possible to measure the electrical characteristics in a wide band including all of the used frequency and frequency band.
- the evaluation unit 3 may extract the frequency or frequency band used for evaluation from the obtained spectrum.
- the evaluation unit 3 evaluates the state of the target blood. For example, when the electrical characteristic is a dielectric constant, data with time change as shown in FIGS. 2A to 2C is obtained.
- the time-dependent change data shown in FIGS. 2A to 2C are the changes in the real part of the complex dielectric constant of thrombotic blood (FIG. 2A), healthy blood (FIG. 2B) and hypersedated blood (FIG. 2C).
- These data are values obtained by performing impedance measurement for 60 minutes at a measurement interval of 1 minute under a temperature condition of 37 ° C. in a frequency range of 100 Hz to 40 MHz.
- FIG. 2A in thrombotic blood, the dielectric constant near 10 MHz is clearly increased by blood coagulation.
- FIG. 2B in the blood of a healthy person, in addition to such an increase, an increase in dielectric constant due to erythrocyte aggregation and a subsequent decrease in dielectric constant are observed in the vicinity of 1 MHz.
- FIG. 2C in the blood with increased blood sedimentation, an increase in dielectric constant showing blood sedimentation is observed at around 2.5 kHz. And by using these features, it becomes possible to predict the risk of blood clots.
- the risk of thrombosis can be predicted using this characteristic. Specifically, it is possible on the basis of the temporal change data of the electrical characteristic, to assess the state of the blood by increasing and / or decreasing the electric characteristic value E at any frequency f x.
- the electrical characteristic is a change in dielectric constant accompanying blood coagulation
- the overall tendency is that blood with a positive thrombosis has a dielectric constant accompanying blood coagulation in a high frequency band (3 to 30 MHz) near 10 MHz.
- the increase in rate becomes significant.
- blood that is positive for thrombosis is due to the formation of red blood cells in the intermediate frequency band near 1 MHz (from 100 kHz to less than 3 MHz) between about 12 minutes after adding the calcium aqueous solution for coagulating the blood.
- An increase in dielectric constant may be seen.
- blood that is positive for thrombosis has a small increase in dielectric constant due to blood coagulation in the intermediate frequency band near 1 MHz, compared to the high frequency band near 10 MHz, and greatly decreases immediately after this small increase. It tends to be a certain low value.
- blood that is positive for thrombosis has a tendency that the dielectric constant significantly decreases with blood coagulation in a low frequency band of 1 kHz or more and less than 100 kHz.
- blood with negative thrombosis has the following two characteristic patterns.
- the first pattern is a case where an increase in dielectric constant is seen in the low frequency band, contrary to positive blood.
- the second pattern in the intermediate frequency band, in addition to the increase in the dielectric constant due to the formation of red blood cells, which occurs between about 12 minutes after the addition of the calcium aqueous solution described above, the increase in the dielectric constant due to blood coagulation. And a subsequent decrease is observed.
- the 2nd pattern characterized by this intermediate frequency band is a characteristic change like the blood of a healthy person.
- the blood state evaluation apparatus 1 of the present embodiment uses this feature to evaluate the risk of thrombosis.
- the dielectric constant increases remarkably in the high frequency band (3 to 30 MHz) and changes little or greatly decreases in the intermediate frequency band (100 kHz to less than 3 MHz) and the low frequency band (1 kHz to less than 100 kHz). If you evaluate the risk of thrombosis is high.
- the dielectric constant increase is clearly observed in the intermediate frequency band (100 kHz or more and less than 3 MHz), or even when blood coagulation occurs, the dielectric constant in the low frequency band (1 kHz or more and less than 100 kHz) is high. Assess the low risk of thrombosis.
- the evaluation of the blood state can also be performed by a method of extracting one or more feature points from the temporal change data of electrical characteristics.
- the temporal change data of electrical characteristics can be digitized and evaluated.
- the electrical characteristic is a change in dielectric constant accompanying blood coagulation
- it can be evaluated using a judgment value p 1 calculated by the following mathematical formula 1.
- the determination value p 1 is the dielectric constant variation ⁇ (f 1 , t 1 ) at the first frequency f 1 and the first time t 1, the dielectric at the second frequency f 2 and the second time t 2 . It is calculated from the change amount ⁇ (f 2 , t 2 ) of the rate, the change amount ⁇ (f 3 , t 3 ) of the dielectric constant at the third frequency f 3 and the third time t 3 .
- a is an arbitrary constant.
- the following formula 2 is a formula derived from an empirical rule. The present inventor has found that the determination value p 2 calculated from the mathematical formula 2 is more effective in evaluating pulmonary thrombosis (PE) more severe than venous thromboembolism (VTE).
- the determination value is calculated using the three-point frequency data.
- evaluation is performed using the determination value p 3 calculated from the two-point frequency data according to the following Formula 3.
- the blood state can be easily evaluated.
- the blood state evaluation step described above can be implemented in a personal computer or the like by creating a computer program for realizing each function of the information processing apparatus.
- a computer program may be stored in a recording medium such as a magnetic disk, an optical disk, a magneto-optical disk, or a flash memory, and can be distributed via a network.
- the electrical characteristic data measured by the measurement unit 2 may be stored in the storage unit 4 in addition to being sent to the evaluation unit 3 for evaluation, and may be displayed on the display unit 5 as necessary. it can. Evaluation results obtained in the evaluation unit 3 may also be stored in the storage unit 4 and displayed on the display unit 5 as necessary.
- the electrical property measurement step and the blood state evaluation step described above do not need to be performed continuously, the data obtained by the measurement unit 2 is stored in the storage unit 4, and the evaluation unit 3 appropriately stores the storage unit. It is also possible to read out data from 4 and perform evaluation.
- the blood state evaluation apparatus 1 shown in FIG. 1 is provided with the measurement unit 2, the storage unit 4, and the display unit 5, it is sufficient that at least the evaluation unit 3 is provided.
- the electrical characteristic is a dielectric constant
- the present disclosure is not limited to the method using the dielectric constant, and other electrical characteristics such as impedance, admittance, and capacitance are used. Similar evaluation can be performed using characteristics.
- FIGS. 3A to 3D are time-dependent data of blood electrical conductivity ⁇ measured in the range of 100 Hz to 40 MHz.
- the frequency band of 5 kHz to 1 MHz in the case where the erythrocyte sedimentation rate shown in FIGS. 3A and 3B is in the normal value range, the electrical conductivity ⁇ is lowered on the long time side with blood coagulation.
- those with an erythrocyte sedimentation rate shown in FIG. 3C and FIG. 3D show abnormal values in the range of 5 kHz to 1 MHz, and the electric conductivity ⁇ is high on the long time side.
- the blood condition evaluation apparatus As described above in detail, in the blood condition evaluation apparatus according to the present embodiment, the blood condition is evaluated based on the temporal change data of electrical characteristics. Therefore, thrombus with high sensitivity and high specificity can be obtained by a simple blood test. The risk of disease can be assessed. Thereby, the burden on a medical field can be reduced.
- FIG. 4 is a diagram showing a schematic configuration of the blood state evaluation system of the present embodiment.
- the measurement of the electrical characteristics and the evaluation of the blood state are performed in the apparatus, but the evaluation of the blood state is performed by an information processing apparatus connected to the electrical characteristic measurement apparatus. It can also be done.
- the blood state evaluation system of this embodiment is provided with an electrical characteristic measurement device 11 and an information processing device 12.
- the blood state evaluation system of the present embodiment may be connected to the server 13 or the display device 14 as necessary.
- the electrical characteristic measuring device 11 applies a voltage between electrode pairs provided in a sample container filled with blood to be evaluated, and measures the electrical characteristics of blood over time at a specific frequency or frequency band. Department.
- the configuration of the electrical property measuring device 11 is not particularly limited, and can be set as appropriate according to the electrical property to be measured. For example, when an AC voltage is applied between the electrode pairs to measure blood impedance or dielectric constant, an impedance analyzer or network analyzer can be used.
- the information processing device 12 is connected to the electrical property measuring device 11 and evaluates the state of blood based on temporal change data in two or more frequencies or frequency bands among the electrical properties measured by the electrical property measuring device 11.
- An evaluation unit is provided. The specific configuration and operation of the evaluation unit are the same as those in the first embodiment described above.
- the server 13 is connected to the information processing device 12 and the display device 14 via the network 15, and is provided with an information storage unit and the like. And the server 13 manages the various data uploaded from the information processing apparatus 12, and outputs it to the display apparatus 14 or the information processing apparatus 12 according to a request
- the display device 14 displays time-dependent change data of blood electrical characteristics measured by the electrical property measuring apparatus 11, evaluation results obtained by the evaluation unit of the information processing apparatus 12, and the like.
- the display device 14 may be provided with an information input unit for selecting and inputting data to be displayed by the user. In this case, information input by the user is transmitted to the server 13 and the information processing apparatus 12 via the network 15.
- the risk of thrombosis can be evaluated with high accuracy by a simple blood test.
- a blood state evaluation apparatus comprising at least an evaluation unit that evaluates the blood state based on temporal change data of electrical characteristics of blood at two or more frequencies or frequency bands.
- the blood condition evaluation apparatus according to (1) wherein the evaluation unit extracts one or more feature points from the temporal change data of electrical characteristics.
- Characteristic points, the electrical characteristic changes of value E ⁇ E ( E (f x between the reference time t a at any frequency fx to any time t y, t y) / E (f x, t a
- E ⁇ E E (f x between the reference time t a at any frequency fx to any time t y, t y) / E (f x, t a
- the blood condition evaluation apparatus according to (2) wherein (4)
- the blood state evaluation apparatus evaluates the blood state by comparing a determination value calculated from the temporal change data of electrical characteristics and a preset threshold value.
- the evaluation unit on the basis of the temporal change data of the electric characteristics, the blood condition evaluation apparatus according to an increase and / or decrease in the electrical characteristic value E for evaluating the state of the blood (1) at any frequency f x.
- the electrical characteristic is at least one value selected from impedance, conductance, admittance, capacitance, dielectric constant, electrical conductivity, phase angle, and a quantity obtained by converting these quantities of electricity (1) to (6
- the blood state evaluation apparatus according to any one of the above.
- the blood state evaluation apparatus according to any one of (1) to (7), wherein the evaluation unit evaluates a coagulation state of the blood.
- the blood state evaluation apparatus according to any one of (1) to (8), further comprising a measurement unit that measures electrical characteristics over time at a specific frequency or frequency band for blood to be evaluated.
- An electrical property measuring device including a measuring unit that measures electrical properties over time at a specific frequency or frequency band for blood to be evaluated;
- a blood state evaluation apparatus comprising an evaluation unit that evaluates the state of the blood based on temporal change data in two or more frequencies or frequency bands among the electric characteristics measured by the electric characteristic measurement device;
- a blood state evaluation system A blood state evaluation system.
- a server comprising an information storage unit for storing the measurement result in the dielectric constant measurement device and / or the evaluation result in the blood state evaluation device,
- An electrical property measurement step for measuring electrical properties over time at a specific frequency or frequency band for blood to be evaluated; Of the electrical characteristics measured in the electrical characteristics measurement step, based on the temporal change data in two or more frequencies or frequency bands, the blood state evaluation step of evaluating the blood state, A blood state evaluation method.
- An evaluation function for evaluating the state of the blood based on temporal change data of electrical characteristics of blood in two or more frequencies or frequency bands; A program to be realized on a computer.
- Example 1 Blood collection was performed using a vacuum blood collection tube using sodium citrate as an anticoagulant on the morning after surgery (before the start of postoperative medication). The sample blood was kept warm at 37 ° C. in advance, and immediately before the start of measurement, a 0.25 M calcium chloride aqueous solution was added at a concentration of 85 ⁇ L per mL of blood to initiate the blood coagulation reaction.
- dielectric measurement (impedance measurement) was performed on the blood coagulation process of the sample blood using a dielectric core gromometry prototype machine manufactured by Sony Corporation.
- the measurement conditions were a temperature of 37 ° C., a frequency range of 100 Hz to 40 MHz, a measurement interval of 1 minute, and a measurement time of 60 minutes.
- a sample container 20 shown in FIG. 5 was used. Further, in order to reduce the influence of blood sedimentation, measurement was performed while rotating the sample container 20 180 degrees at a frequency of once per minute.
- VTE venous thromboembolism
- DVT deep vein thrombosis
- PE pulmonary thromboembolism
- VTE venous thromboembolism
- VTE venous thromboembolism
- VTE venous thromboembolism
- sensitivity and specificity are indices used in clinical tests. Specifically, “sensitivity” is a value defined as “probability to correctly determine what should be determined as positive”, and “specificity” is “probability to correctly determine negative as negative” It is. In addition, it is preferable that both values are high, and it can be said that a technique having both high values of “sensitivity” and “specificity” is an excellent inspection technique. However, when setting the threshold, these values have a relationship that the sensitivity decreases when priority is given to the sensitivity, and the sensitivity decreases when priority is given to the specificity. Is set.
- Example 2 the blood sample (sample number 27), was thrombus risk assessment using determination value p 2 in the above equation 2.
- f 1 2.5 kHz
- f 2 1 MHz
- f 3 10 MHz
- a 0.67
- the threshold is set to 0.11
- the determination value p 2 is the determined smaller than this value as "positive”.
- Table 2 The results are shown in Table 2 below.
- PE pulmonary thromboembolism
- Example 3 the blood sample (sample number 30), was thrombus risk assessment using determination value p 3 of the formula 3.
- f 1 2.5 kHz
- f 2 10 MHz
- t 1 t 2 ⁇ 6 min
- t 2 were dielectric blood coagulation times.
- the threshold is set to 0.765
- the determination value p 3 was determined if less than this value as "positive”. The results are shown in Table 3 below.
- Example 4 In Example 4, the measurement by venous blood of a diabetic patient and a patient who has both diabetes and collagen disease was performed. At that time, a vacuum blood collection tube using sodium citrate as an anticoagulant was used for blood collection. The sample blood was kept warm at 37 ° C. in advance, and immediately before the start of measurement, a 0.25 M calcium chloride aqueous solution was added at a concentration of 85 ⁇ L per mL of blood to initiate the blood coagulation reaction. The measurement conditions were a measurement temperature of 37 ° C., a frequency range of 40 Hz to 110 MHz, a measurement interval of 2 minutes, and a measurement time of 60 minutes.
- FIG. 6 shows time-dependent data of the blood dielectric constant of the diabetic patient (the amount of change ⁇ in the real part of the complex dielectric constant).
- the data surrounded by the thick line in FIG. 6 is the blood of a patient with collagen disease, but the pattern was clearly different from other data. Specifically, in patients with collagen disease, a rapid increase in dielectric constant and a subsequent decrease were observed in the frequency band of 1 to 100 kHz for about 20 minutes immediately after the start of measurement. Such characteristics are not seen in diabetic patients who do not have collagen disease or healthy subjects, and by using this method, it is possible to evaluate whether or not collagen disease is caused by blood tests. Was confirmed.
- Example 5 For patients scheduled for artificial knee joint replacement, measurement was performed using venous blood collected before surgery. At that time, a vacuum blood collection tube using sodium citrate as an anticoagulant was used for blood collection. The sample blood was kept warm at 37 ° C. in advance, and immediately before the start of measurement, a 0.25 M calcium chloride aqueous solution was added at a concentration of 85 ⁇ L per mL of blood to initiate the blood coagulation reaction. The measurement conditions were a temperature of 37 ° C., a frequency range of 100 Hz to 40 MHz, a measurement interval of 1 minute, and a measurement time of 60 minutes.
- ESR erythrocyte sedimentation rate
- the normal value of the erythrocyte sedimentation rate is 10 mm / 60 min for men and 15 mm / 60 min for women.
- FIG. 7 shows time-dependent data of the dielectric constant (the variation ⁇ of the real part of the complex dielectric constant) of blood (A, B) within normal values and blood (C, D) within abnormal values.
- the erythrocyte sedimentation rates of the blood samples of FIGS. 7A to D are shown in Table 4 below.
- the characteristics of the blood sample within the normal value and the blood sample with the abnormal value were significantly different in the frequency band of 1 to 30 kHz.
- ⁇ became a low value on the long time side in the frequency range of 1 to 30 kHz with blood coagulation.
- ⁇ was a high value on the long time side in the frequency range of 1 to 30 kHz. And it was confirmed that abnormality of erythrocyte sedimentation rate can be evaluated by utilizing this method.
- 1 blood state evaluation device
- 2 measurement unit
- 3 evaluation unit
- 4 storage unit
- 5 display unit
- 11 electrical characteristic measurement device
- 12 information processing device
- 13 server
- 14 display device
- 15 Network
- 20 Sample container
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Abstract
Description
前記評価部は、電気特性の経時変化データから1又は2以上の特徴点を抽出することができる。
その場合、前記特徴点を、例えば任意の周波数fxにおける基準時間taから任意の時間tyまでの間の電気特性値Eの変化量δE(=E(fx,ty)/E(fx,ta))としてもよい。
前記評価部は、電気特性の経時変化データを数値化することもできる。
その場合、前記評価部は、例えば電気特性の経時変化データから算出された判定値と、予め設定された閾値とを比較することにより前記血液の状態を評価してもよい。
前記評価部は、電気特性の経時変化データに基づいて、任意の周波数fxにおける電気特性値Eの増加及び/又は減少により前記血液の状態を評価することもできる。
一方、前記電気特性は、インピーダンス、コンダクタンス、アドミッタンス、キャパシタンス、誘電率、導電率、位相角及びこれらを電気量変換することにより得られる量から選択される少なくとも1種の値とすることができる。
また、前記評価部は、前記血液の凝固状態を評価することもできる。
更に、評価対象の血液について、特定の周波数又は周波数帯域で、電気特性を経時的に測定する測定部を設けてもよい。
この評価システムでは、更に、前記誘電率測定装置での測定結果及び/又は前記血液状態評価装置での評価結果を記憶する情報記憶部を備えるサーバを有し、前記サーバは、ネットワークを介して、前記誘電率測定装置及び/又は前記血液状態評価装置と接続されていてもよい。
1.第1の実施の形態
(電気特性の経時変化から血栓症リスクを評価する血液状態評価装置の例)
2.第2の実施の形態
(血液状態評価システムの例)
先ず、本開示の第1の実施形態に係る血液状態評価装置について説明する。静脈血栓塞栓症(VTE)のリスクファクター(危険因子)としては、「血流の停滞」、「血管内皮障害」及び「血液凝固能の亢進」が知られており、これらは「Virchowの3徴」と呼ばれている。
測定部2は、評価対象の血液について、特定の周波数又は周波数帯域で、電気特性を経時的に測定する。測定部2で測定される電気特性は、例えばインピーダンス、コンダクタンス、アドミッタンス、キャパシタンス、誘電率、導電率、位相角及びこれらを電気量変換することにより得られる量が挙げられる。なお、本実施形態の血液状態評価装置1は、これらの電気的特性のうち1種で評価可能であるが、2種以上の電気特性を利用することもできる。
評価部3は、前述した測定部2により測定された電気特性のうち、2以上の周波数又は2以上の周波数帯域における経時変化データに基づいて血液の状態を評価する。ここで、評価対象とする血液の状態としては、例えば血液の凝固状態、凝集状態、沈降状態及び血餅縮退状態が挙げられる。
記憶部4は、測定部2で測定された血液の電気特性の経時変化データや、評価部3での評価結果などを記憶するものであり、ハードディスクなどで構成されている。
表示部5は、測定部2で測定された血液の電気特性の経時変化データや、評価部3で評価された結果などを表示するものであり、これらが閲覧可能なものであればよい。
次に、前述した血液状態評価装置1の動作、即ち、血液状態評価装置1を用いて血液の状態を評価し、血栓症リスクを予測する方法について説明する。
本実施形態の血液状態評価装置1では、先ず、測定部2において、評価対象の血液について、特定の周波数又は周波数帯域で、電気特性を経時的に測定する。その際、電気特性の測定条件は、特に限定されるものではなく、評価対象の血液を変質させない範囲で、電気特性の種類などに応じて適宜設定することができる。
次に、電気特性測定工程により得られた血液の電気特性を用いて、評価部3において、対象となる血液の状態を評価する。例えば、電気特性が誘電率である場合、図2A~図2Cに示すような経時変化データが得られる。ここで、図2A~図2Cに示す経時変化データは、血栓症の血液(図2A)、健常者の血液(図2B)及び血沈亢進の血液(図2C)の複素誘電率の実数部の変化量δε(=ε/εt=0)である。また、これらのデータは、100Hz~40MHzの周波数範囲おいて、37℃の温度条件下で、測定間隔を1分間として60分間インピーダンス測定を行って得た値である。
次に、本開示の第2の実施形態に係る血液状態評価システムについて説明する。図4は本実施形態の血液状態評価システムの概略構成を示す図である。前述した第1の実施形態の血液状態評価装置では、装置内で、電気特性の測定及び血液状態の評価を行っているが、血液状態の評価を電気特性測定装置に接続された情報処理装置で行うこともできる。
電気特性測定装置11は、評価対象の血液が充填されるサンプル容器に設けられた電極対間に電圧を印加して、特定の周波数又は周波数帯域で、血液の電気特性を経時的に測定する測定部を備えている。電気特性測定装置11の構成は、特に限定されるものではなく、測定する電気的特性に応じて、適宜設定することができる。例えば、電極対間に交流電圧を印加し、血液のインピーダンスや誘電率を測定する場合は、インピーダンスアナライザーやネットワークアナライザーを使用することもできる。
情報処理装置12は、電気特性測定装置11に接続されており、電気特性測定装置11で測定された電気特性のうち、2以上の周波数又は周波数帯域における経時変化データに基づいて血液の状態を評価する評価部を備えている。なお、評価部の具体的構成及び動作は、前述した第1の実施形態と同様である。
サーバ13は、ネットワーク15を介して情報処理装置12や表示装置14と接続されており、情報記憶部などが設けられている。そして、サーバ13は、情報処理装置12からアップロードされた各種データを管理し、要求に応じて表示装置14や情報処理装置12に出力する。
表示装置14は、電気特性測定装置11で測定された血液の電気特性の経時変化データや、情報処理装置12の評価部での評価結果などを表示するものである。表示装置14には、ユーザが表示するデータを選択し入力するための情報入力部が設けられていてもよい。この場合、ユーザにより入力された情報は、ネットワーク15を介してサーバ13や情報処理装置12に送信される。
(1)
2以上の周波数又は周波数帯域における血液の電気特性の経時変化データに基づいて前記血液の状態を評価する評価部
を少なくとも備える血液状態評価装置。
(2)
前記評価部は、電気特性の経時変化データから1又は2以上の特徴点を抽出する(1)に記載の血液状態評価装置。
(3)
前記特徴点は、任意の周波数fxにおける基準時間taから任意の時間tyまでの間の電気特性値Eの変化量δE(=E(fx,ty)/E(fx,ta))である(2)に記載の血液状態評価装置。
(4)
前記評価部は、電気特性の経時変化データを数値化する(1)に記載の血液状態評価装置。
(5)
前記評価部は、電気特性の経時変化データから算出された判定値と、予め設定された閾値とを比較することにより前記血液の状態を評価する(4)に記載の血液状態評価装置。
(6)
前記評価部は、電気特性の経時変化データに基づいて、任意の周波数fxにおける電気特性値Eの増加及び/又は減少により前記血液の状態を評価する(1)に記載の血液状態評価装置。
(7)
前記電気特性は、インピーダンス、コンダクタンス、アドミッタンス、キャパシタンス、誘電率、導電率、位相角及びこれらを電気量変換することにより得られる量から選択される少なくとも1種の値である(1)~(6)のいずれかに記載の血液状態評価装置。
(8)
前記評価部は、前記血液の凝固状態を評価する(1)~(7)のいずれかに記載の血液状態評価装置。
(9)
更に、評価対象の血液について、特定の周波数又は周波数帯域で、電気特性を経時的に測定する測定部を有する(1)~(8)のいずれかに記載の血液状態評価装置。
(10)
評価対象の血液について、特定の周波数又は周波数帯域で、電気特性を経時的に測定する測定部を備える電気特性測定装置と、
前記電気特性測定装置で測定された電気特性のうち、2以上の周波数又は周波数帯域における経時変化データに基づいて前記血液の状態を評価する評価部を備える血液状態評価装置と、
を有する血液状態評価システム。
(11)
更に、前記誘電率測定装置での測定結果及び/又は前記血液状態評価装置での評価結果を記憶する情報記憶部を備えるサーバを有し、
前記サーバは、ネットワークを介して、前記誘電率測定装置及び/又は前記血液状態評価装置と接続されている(10)に記載の血液状態評価システム。
(12)
評価対象の血液について、特定の周波数又は周波数帯域で、電気特性を経時的に測定する電気特性測定工程と、
前記電気特性測定工程で測定された電気特性のうち、2以上の周波数又は周波数帯域における経時変化データに基づいて、前記血液の状態を評価する血液状態評価工程と、
を行う血液状態評価方法。
(13)
2以上の周波数又は周波数帯域における血液の電気特性の経時変化データに基づいて前記血液の状態を評価する評価機能を、
コンピュータに実現させるためのプログラム。
<実験方法>
採血は、手術の翌朝(術後の投薬治療が始まる前)に、クエン酸ナトリウムを抗凝固剤として用いた真空採血管を使用して行った。検体血液は、予め37℃で保温し、測定開始直前に0.25M塩化カルシウム水溶液を血液1mL当たり85μLの濃度で加えて血液凝固反応を開始させた。
超音波検査及びコンピュータ断層撮影(CT)による画像診断の結果、30例の検討数中21例が、静脈血栓塞栓症(VTE)陽性であり、9例が静脈血栓塞栓症(VTE)陰性であった。
また、10MHzにおける誘電率の変化から誘電血液凝固時間を算出したところ、静脈血栓塞栓症(VTE)陽性の血液の誘電血液凝固時間は23±5分、陰性の血液の誘電血液凝固時間は20±4分であった。これらの値は、いずれも健常者の血液の数値40±6分よりも短く、血栓症リスクが高い血液凝固能亢進状態であることが確認された。しかしながら、誘電血液凝固時間のみによっては、実際に静脈血栓塞栓症(VTE)を発症するかどうかについて、高感度かつ高特異度で予測することは困難であることが分かった。
次に、上記数式1を用いて判別値p1を求めた。その際、f1=2.5kHz、f2=1MHz、f3=10MHz、t1=t3-5min、t2=18minとした。なお、t3は誘電血液凝固時間である。そして、閾値を0.765と設定し、判定値p1がこの値より小さい場合を「陽性」と判定とした。その結果を下記表1に示す。
次に、前述した実施例1と同様の方法で、検体血液(検体数27)について、上記数式2の判定値p2を用いた血栓リスク評価を行った。その際、f1=2.5kHz、f2=1MHz、f3=10MHz、a=0.67、t1=t2=t3は誘電血液凝固時間とした。そして、閾値を0.11と設定し、判定値p2がこの値より小さい場合を「陽性」と判定とした。その結果を下記表2に示す。
次に、前述した実施例1と同様の方法で、検体血液(検体数30)について、上記数式3の判定値p3を用いた血栓リスク評価を行った。その際、f1=2.5kHz、f2=10MHz、t1=t2-6min、t2は誘電血液凝固時間とした。そして、閾値を0.765と設定し、判定値p3がこの値より小さい場合を「陽性」と判定とした。その結果を下記表3に示す。
実施例4では、糖尿病患者、及び、糖尿病と膠原病を併発している患者の静脈血による測定を行った。その際、採血には、クエン酸ナトリウムを抗凝固剤として用いた真空採血管を使用した。検体血液は、予め37℃で保温し、測定開始直前に0.25M塩化カルシウム水溶液を血液1mL当たり85μLの濃度で加えて血液凝固反応を開始させた。測定条件は、測定温度37℃、周波数域40Hz~110MHz、測定間隔2分、測定時間60分間とした。
実施例5では、人工膝関節置換術が予定されている患者について、手術前に採血された静脈血による測定を行った。その際、採血には、クエン酸ナトリウムを抗凝固剤として用いた真空採血管を使用した。検体血液は、予め37℃で保温し、測定開始直前に0.25M塩化カルシウム水溶液を血液1mL当たり85μLの濃度で加えて血液凝固反応を開始させた。測定条件は、温度37℃、周波数域100Hz~40MHz、測定間隔1分、測定時間60分間とした。
Claims (13)
- 2以上の周波数又は周波数帯域における血液の電気特性の経時変化データに基づいて前記血液の状態を評価する評価部
を少なくとも備える血液状態評価装置。 - 前記評価部は、電気特性の経時変化データから1又は2以上の特徴点を抽出する請求項1に記載の血液状態評価装置。
- 前記特徴点は、任意の周波数fxにおける基準時間taから任意の時間tyまでの間の電気特性値Eの変化量δE(=E(fx,ty)/E(fx,ta))である請求項2に記載の血液状態評価装置。
- 前記評価部は、電気特性の経時変化データを数値化する請求項1に記載の血液状態評価装置。
- 前記評価部は、電気特性の経時変化データから算出された判定値と、予め設定された閾値とを比較することにより前記血液の状態を評価する請求項4に記載の血液状態評価装置。
- 前記評価部は、電気特性の経時変化データに基づいて、任意の周波数fxにおける電気特性値Eの増加及び/又は減少により前記血液の状態を評価する請求項1に記載の血液状態評価装置。
- 前記電気特性は、インピーダンス、コンダクタンス、アドミッタンス、キャパシタンス、誘電率、導電率、位相角及びこれらを電気量変換することにより得られる量から選択される少なくとも1種の値である請求項1に記載の血液状態評価装置。
- 前記評価部は、前記血液の凝固状態を評価する請求項1に記載の血液状態評価装置。
- 更に、評価対象の血液について、特定の周波数又は周波数帯域で、電気特性を経時的に測定する測定部を有する請求項1に記載の血液状態評価装置。
- 評価対象の血液について、特定の周波数又は周波数帯域で、電気特性を経時的に測定する測定部を備える電気特性測定装置と、
前記電気特性測定装置で測定された電気特性のうち、2以上の周波数又は周波数帯域における経時変化データに基づいて前記血液の状態を評価する評価部を備える血液状態評価装置と、
を有する血液状態評価システム。 - 更に、前記誘電率測定装置での測定結果及び/又は前記血液状態評価装置での評価結果を記憶する情報記憶部を備えるサーバを有し、
前記サーバは、ネットワークを介して、前記誘電率測定装置及び/又は前記血液状態評価装置と接続されている請求項10に記載の血液状態評価システム。 - 評価対象の血液について、特定の周波数又は周波数帯域で、電気特性を経時的に測定する電気特性測定工程と、
前記電気特性測定工程で測定された電気特性のうち、2以上の周波数又は周波数帯域における経時変化データに基づいて、前記血液の状態を評価する血液状態評価工程と、
を行う血液状態評価方法。 - 2以上の周波数又は周波数帯域における血液の電気特性の経時変化データに基づいて前記血液の状態を評価する評価機能を、
コンピュータに実現させるためのプログラム。
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CN111272820A (zh) | 2020-06-12 |
EP2980570B1 (en) | 2020-07-22 |
US20160282366A1 (en) | 2016-09-29 |
JP6883228B2 (ja) | 2021-06-09 |
CN105102969A (zh) | 2015-11-25 |
KR20150133716A (ko) | 2015-11-30 |
EP2980570A1 (en) | 2016-02-03 |
JP2020042042A (ja) | 2020-03-19 |
JPWO2014156370A1 (ja) | 2017-02-16 |
US20200174027A1 (en) | 2020-06-04 |
US10393761B2 (en) | 2019-08-27 |
EP2980570A4 (en) | 2016-10-26 |
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