Ultrasonic evaluation device for antenatal fetal scapula development

Abstract

The invention provides an ultrasonic evaluation device for antenatal fetal shoulder blade development, and the device comprises a data obtaining module which is used for obtaining ultrasonic data of an antenatal fetal through an ultrasonic diagnostic apparatus, and the ultrasonic data comprises a measured value of the shoulder blade length, a measured value of the shoulder blade width and a measured value of the femur length; the prediction module is used for obtaining a first prediction interval according to the measured value of the femur length of the to-be-predicted prenatal fetus and the first prediction parameter interval, and obtaining a second prediction interval according to the measured value of the femur length of the to-be-predicted prenatal fetus and the second prediction parameter interval; and the evaluation module is used for respectively judging whether the measured value of the shoulder blade length of the to-be-measured prenatal fetus is within the first prediction interval and whether the measured value of the shoulder blade width of the to-be-measured prenatal fetus is within the second prediction interval so as to evaluate the shoulder blade development condition of the fetus.

Description

TECHNICAL FIELD

[0001] The present disclosure belongs to the technical field of ultrasonic diagnosis, and relates to an ultrasonic evaluation device for prenatal fetal scapula development. BACKGROUND

[0002] Scapula and acromion are the main features of mammals, and play an important role in maintaining the active posture of upper limbs and shoulder joint movement. Abnormalities of scapula shape and height are related to many diseases, such as Sprengel deformity, scapular duplication deformity, Kosenow syndrome, etc., among which the most common one is Sprengel deformity, which is caused by the development stagnation and failure of scapula descent. Therefore, accurate prenatal evaluation of fetal scapula development is of great significance for early detection or diagnosis of congenital scapula deformity and diagnosis of related genetic syndromes.

[0003] At present, the research data on prenatal fetal scapula at home and abroad all depend on the known gestational age of the fetus. In addition, the fetal scapula measurement value may also be related to factors such as race and region. At present, the research on fetal scapula development in China lacks large-sample ultrasonic detection data of normal Chinese fetal scapula, and the gestational age of the fetus is often unknown in clinical practice, so a new index that does not depend on gestational age and can also evaluate scapula development is urgently needed. SUMMARY

[0004] The present disclosure provides an ultrasonic evaluation device for prenatal fetal scapula development, which can effectively solve the above problems.

[0005] The present disclosure is implemented in this way:

[0006] The present disclosure provides an ultrasonic evaluation device for prenatal fetal scapula development, which comprises:

[0007] A data acquisition module for acquiring ultrasonic data of a prenatal fetus by using an ultrasonic diagnostic instrument, wherein the ultrasonic data includes a measurement value of scapula length, a measurement value of scapula width, and a measurement value of femur length;

[0008] A prediction module for obtaining a first prediction interval according to the measurement value of femur length of a to-be-tested prenatal fetus and a first prediction parameter interval, and obtaining a second prediction interval according to the measurement value of femur length of the to-be-tested prenatal fetus and a second prediction parameter interval, wherein the first prediction parameter interval is calculated based on a first data set, the first data set is a data set of the ratio of scapula length to femur length of a normal prenatal fetus matched in gestational weeks, the second prediction parameter interval is calculated based on a second data set, the second data set is a data set of the ratio of scapula width to femur length of a normal prenatal fetus matched in gestational weeks, and the to-be-tested prenatal fetus is a prenatal fetus of 31-40 gestational weeks;

[0009] an evaluation module, configured to respectively judge whether the measured value of the scapula length of the to-be-tested prenatal fetus is located in the first prediction interval, and whether the measured value of the scapula width of the to-be-tested prenatal fetus is located in the second prediction interval, to evaluate the scapula development of the fetus.

[0010] The present disclosure has the following beneficial effects:

[0011] The present disclosure provides an ultrasonic evaluation device for prenatal fetal scapula development, which is based on an evaluation parameter for evaluating scapula development that is independent of the gestational age of the fetus, and by measuring the femur length FL of the late gestation fetus and simply calculating, the scapula length SL and width SW of the late gestation fetus can be obtained, which are used for the evaluation of scapula development.

[0012] Further, the device uses two-dimensional ultrasonic observation to simultaneously obtain the scapula length SL and width SW of the fetus, which more comprehensively observes and evaluates the growth and development of the scapula of the fetus. Not only can it provide clues for early diagnosis of scapula dysplasia congenital deformity, but also is conducive to the diagnosis and classification of skeletal dysplasia. BRIEF DESCRIPTION OF DRAWINGS

[0013] In order to more clearly illustrate the technical solutions of the embodiments of the present disclosure, the following will briefly introduce the drawings needed to be used in the embodiments. It should be understood that the following drawings only show some embodiments of the present disclosure, and therefore should not be considered as a limitation to the scope. For those skilled in the art, other related drawings can also be obtained without creative labor.

[0014] Figure 1 FIG. 1 is a structural schematic diagram of an ultrasonic evaluation device for prenatal fetal scapula development 1000 provided by an embodiment of the present disclosure.

[0015] Figure 2 FIG. 2 is a structural schematic diagram of a data acquisition module 1001 of the device provided by an embodiment of the present disclosure.

[0016] Figure 3 (A) is an example of a two-dimensional ultrasonic image of the maximum length section of the scapula of the prenatal fetus provided by an embodiment of the present disclosure; Figure 3 (B) is an example of a two-dimensional ultrasonic image of the maximum width section.

[0017] Figure 4 (A) is a schematic diagram of the scapula length of the prenatal fetus provided by an embodiment of the present disclosure; Figure 4 (B) is a schematic diagram of the scapula width, and Figure 4 (C) is Figure 3 (A) is a schematic diagram of the scapula length; Figure 4 (D) is Figure 3(B) Schematic diagram of scapula width.

[0018] Figure 5 (A) is an example of a two-dimensional ultrasound image of the fetal femur length before birth provided by an embodiment of the present disclosure, and, Figure 5 (B) Yes Figure 5 (A) Schematic diagram of femur length. DETAILED DESCRIPTION

[0019] In order to make the purpose, technical solutions and advantages of the embodiments of the present disclosure clearer, the technical solutions in the embodiments of the present disclosure will be clearly and completely described below in conjunction with the drawings in the embodiments of the present disclosure. Obviously, the described embodiments are part of the embodiments of the present disclosure, rather than all of the embodiments. Based on the embodiments in the present disclosure, all other embodiments obtained by ordinary technicians in this field without making creative work are within the scope of protection of the present disclosure. Therefore, the following detailed description of the embodiments of the present disclosure provided in the drawings is not intended to limit the scope of the present disclosure for protection, but merely represents the selected embodiments of the present disclosure. Based on the embodiments in the present disclosure, all other embodiments obtained by ordinary technicians in this field without making creative work are within the scope of protection of the present disclosure.

[0020] The embodiment of the present disclosure provides an ultrasound assessment device 1000 for prenatal fetal scapula development.

[0021] Specifically, such as Figure 1 As shown, the device 1000 includes:

[0022] The data acquisition module 1002 is configured to acquire ultrasound data of the fetus before birth using an ultrasound diagnostic apparatus, wherein the ultrasound data includes a measurement value of the scapula length SL, a measurement value of the scapula width SW, and a measurement value of the femur length FL;

[0023] Prediction module 1004 is configured to obtain a first prediction interval based on the measured value FL of the femur length of the prenatal fetus to be measured and a first prediction parameter interval SL / FL, and to obtain a second prediction interval based on the measured value FL of the femur length of the prenatal fetus to be measured and a second prediction parameter interval SW / FL, wherein the first prediction parameter interval is calculated based on a first data set, which is a data set of ratios of scapula length to femur length of normal prenatal fetuses with matched gestational ages, and the second prediction parameter interval is calculated based on a second data set, which is a data set of ratios of scapula width to femur length of normal prenatal fetuses with matched gestational ages, and the prenatal fetus to be measured is a prenatal fetus of 31-40 weeks of gestation;

[0024] The evaluation module 1006 is configured to determine whether the measured scapula length SL of the to-be-tested prenatal fetus is within the first prediction interval and whether the measured scapula width SW of the to-be-tested prenatal fetus is within the second prediction interval, respectively, to evaluate the scapula development of the fetus.

[0025] In some embodiments, the data acquisition module 1001 is configured to acquire ultrasound data of the to-be-tested prenatal fetus by using an ultrasonic diagnostic instrument.

[0026] The normal prenatal fetus is a prenatal fetus with normal femur and scapula development.

[0027] The gestational age matching of the normal prenatal fetus is that the normal prenatal fetus is a fetus with a gestational age of 31-40 weeks.

[0028] In some embodiments, the first data set is a ratio data set of the measured scapula length SL and the measured femur length FL of the normal prenatal fetus, and the second data set is a ratio data set of the measured scapula width SW and the measured femur length FL of the normal prenatal fetus.

[0029] In some embodiments, the method for acquiring ultrasound data of the prenatal fetus by using an ultrasonic diagnostic instrument comprises:

[0030] The ultrasonic diagnostic instrument is configured to use an abdominal two-dimensional convex array probe with a probe frequency of 2-5 MHz and an obstetric condition set as an examination mode.

[0031] In some embodiments, as shown in Figure 2 The data acquisition module 1001 comprises:

[0032] The image acquisition module 10011 is configured to acquire, by using an ultrasonic diagnostic instrument, a first ultrasound image of a maximum length section of the scapula of the prenatal fetus and a second ultrasound image of a maximum width section of the scapula.

[0033] The measurement module 10012 is configured to measure the scapula length in the first ultrasound image as the measured scapula length SL of the fetus and measure the scapula width in the second ultrasound image as the measured scapula width SW.

[0034] As shown in Figure 3 The probe is scanned on the abdomen of the pregnant woman. The longitudinal section shows the fetal spine moving outward, and the probe can present the fetal scapula, as shown in Figure 3 The normal fetal scapula at the 12th week measures the SL section as a "Y" type similar to "lying down", as shown in Figure 3 The SW section measures a "V" type similar to "lying down", as shown in B.

[0035] With the increase of gestational age, the shape of the scapula did not change significantly.

[0036] The direction and position of the probe were adjusted constantly during the continuous scanning to ensure that the fetal scapula showed the maximum length and width, respectively, and the freeze and save buttons were pressed.

[0037] Specifically, using an ultrasonic diagnostic instrument, the longitudinal section of the fetal spine was displayed, and then the probe was moved outward parallel to the plane, as shown in Figure 4 The electronic cursors were placed at the acromion and the inferior angle of the scapula, respectively, to measure the maximum length of the scapula.

[0038] On this basis, the probe was rotated around the acromion until the spinoglenoid ridge was completely displayed, as shown in Figure 4 The longest distance between the acromion and the medial margin of the spinoglenoid ridge was the maximum width of the scapula.

[0039] Femur length measurement

[0040] Femur length is a routine test data, the measurement description and measurement image are written in the routine examination guide, and the ultrasonic instrument has normal data values.

[0041] As shown in Figure 5 A and B, the normally ossified femur appears as a straight high echo in the ultrasonic image, accompanied by a significant acoustic shadow behind. The proximal femur has a low echo femoral head and greater trochanter, while the distal femur has epiphyseal cartilage. The full length of the femur should be displayed during measurement, the beam is perpendicular to the long axis of the femur, and the angle between the long axis of the femur and the beam should be 45°-90°. The image of the region of interest is magnified to more than 50% of the ultrasonic image area. The measurement points should be located at the midpoint of the two ends of the corresponding bone, excluding the epiphyseal end.

[0042] The measurements of the ultrasonic data should be taken three times and averaged.

[0043] In some embodiments, as shown in Figure 2 The data acquisition module 1001 further includes:

[0044] The first positioning module 10013 is configured to position the acromion of the scapula in the first ultrasonic image as a first end, and position the inferior angle of the scapula in the first ultrasonic image as a second end.

[0045] The second positioning module 10014 is configured to position the acromion of the scapula in the second ultrasonic image as a third end, and position the medial margin of the spinoglenoid ridge of the scapula in the second ultrasonic image as a fourth end.

[0046] The measurement module 10012 is configured to measure the linear distance between the first end and the second end as the scapula length, and measure the linear distance between the third end and the fourth end as the scapula width.

[0047] The end points for measurement are located by placing electronic calipers at the positions in the ultrasound image, respectively.

[0048] The present disclosure first establishes the reference value range of the SL and SW of the normal prenatal fetus by collecting 647 cases of ultrasound measurement data of the scapula of the Chinese prenatal fetus of 12-40 gestational weeks.

[0049] The sample size collected by the present disclosure is large, the results are reliable, and the reference value range of the data related to the specialities of the Chinese ethnic group and region can be reflected.

[0050] Compared with previous domestic and foreign researches, the present disclosure not only measures the scapula length of the fetus, but also first applies two-dimensional ultrasound to observe the scapula width, comprehensively evaluates the shape and position of the scapula of the fetus in the prenatal stage, and thus more comprehensively evaluates the growth and development of the scapula of the fetus. Not only can it provide clues for early diagnosis of scapula dysplasia congenital deformity, but also is conducive to the diagnosis of skeletal dysplasia and classification.

[0051] Specifically, the SL and SW of the prenatal fetus are obtained by the data acquisition module 1001.

[0052] The present disclosure detects the scapula of the Chinese prenatal fetus, obtains the ultrasound image of the normal prenatal fetus scapula, establishes the reference value range of the scapula length and width of the normal prenatal fetus at different gestational weeks (12-40 gestational weeks), and is shown in Table 1 and Table 2, respectively.

[0053] Table 1 Normal reference value of scapula length of normal fetus at each gestational week (total number = 647)

[0054]

[0055] Table 2 Reference value of scapula width of normal fetus at each gestational week (total number = 647)

[0056]

[0057] The measured actual data of the scapula is compared with the reference value range, the value within the reference value range is determined as a normal value, and the value outside the reference value range is determined as an abnormal value.

[0058] In some embodiments, the reference value range of the scapula length of the prenatal fetus is an interval between the 5th percentile and the 95th percentile in the first data set; and the reference value range of the scapula width of the prenatal fetus is an interval between the 5th percentile and the 95th percentile in the second data set.

[0059] The end point values of the reference value range are the numerical value of the 5th percentile and the numerical value of the 95th percentile, respectively.

[0060] In other embodiments, other percentile values can be selected as the end point values of the reference value range.

[0061] On this basis, through screening calculation, a prediction parameter for evaluating the scapula development independent of the gestational age of the fetus is obtained.

[0062] The growth parameters of the normal prenatal fetus are measured respectively, including the biparietal diameter (BPD), the head circumference (HC), the abdominal circumference (AC), the estimated fetal weight (EFW) and the FL, and then the ratios of these growth parameters to the SL and the ratios of these growth parameters to the SW are calculated respectively, and then the Pearson coefficient is used to test whether these ratios have statistical correlation with the gestational age, and a prediction parameter for evaluating the scapula development independent of the gestational age of the fetus is screened out.

[0063] The Pearson coefficient is used to test whether the ratio of the SL to the FL of the prenatal fetus has statistical correlation with the gestational age (if P>0.05, the two have no significant correlation), and the data results show that the Pearson test P value of the ratio of the SL to the FL of the fetus of 31-40 gestational weeks to the gestational age is 0.069, so the ratio of the SL to the FL is not affected by the change of the gestational age, and the average value ± standard deviation of the ratio of the SL to the FL is 0.513 ± 0.002 (range: 0.511-0.515).

[0064] The Pearson coefficient is used to test whether the ratio of the SW to the FL of the prenatal fetus has statistical correlation with the gestational age, and the data results show that the Pearson test P value of the ratio of the SW to the FL of the fetus of 31-40 gestational weeks to the gestational age is 0.429, so the ratio of the SW to the FL is not affected by the change of the gestational age, and the average value ± standard deviation of the ratio of the SW to the FL is 0.447 ± 0.020 (range: 0.427-0.467).

[0065] Specifically, the FL of the prenatal fetus is obtained by the data acquisition module 1001.

[0066] In some embodiments, the selected first prediction parameter interval is the average value ± standard deviation of the first data set, and the selected second prediction parameter interval is the average value ± standard deviation of the second data set.

[0067] In some other embodiments, the constant interval calculated based on the first data set / the second data set can be selected as the first prediction parameter interval / second prediction parameter interval.

[0068] For example, the mean value ± k x standard deviation of the data set can be selected, where k is a normal number.

[0069] In some embodiments, as shown in Figure 1 The device further comprises:

[0070] The parameter acquisition module 1004 is configured to obtain the first prediction parameter interval SL / FL and the second prediction parameter interval SW / FL based on the ultrasound data of the plurality of normal antenatal fetuses.

[0071] In some embodiments, as described above, specifically, the ultrasound data of the normal antenatal fetuses is acquired by the data acquisition module 1001, and the database shown in Tables 1 and 2 is established. The parameter acquisition module 1004 establishes the original database of the scapula of the normal antenatal fetuses based on the ultrasound data of the normal antenatal fetuses, and then calculates the first data set and the second data set, and further calculates the first prediction parameter interval SL / FL and the second prediction parameter interval SW / FL.

[0072] The data in the database is further classified according to the gestational weeks, and the values of the 5th percentile, 50th percentile and 95th percentile are counted to determine the reference value range.

[0073] The first prediction parameter interval SL / FL and the second prediction parameter interval SW / FL obtained by the parameter acquisition module 1004 are used for the calculation of the prediction interval in the prediction module 1002.

[0074] Specifically, all the values in the first data set obtained based on the above-mentioned 647 cases are averaged, and the average value is 0.513 and the standard deviation is 0.002. All the values in the second data set obtained based on the above-mentioned 647 cases are averaged, and the average value is 0.447 and the standard deviation is 0.020. That is, the obtained prediction parameter intervals are constant intervals.

[0075] The two constant parameter intervals are particularly valuable when evaluating the SL and SW of the antenatal fetus in the late gestational period, especially when the pregnant woman cannot accurately recall the last menstrual period (LMP), such as lactation period pregnancy, irregular menstruation, and the like. The prediction interval of the scapula length / width can be calculated by multiplying the FL by the constant interval, and the calculation result can be compared with the actual measurement value to provide valuable diagnostic information for the development of the scapula of the fetus, and has good clinical application value.

[0076] Further, the prediction parameter interval is selected as the mean value ± standard deviation, which can more objectively evaluate the scapula development of the fetus before birth.

[0077] The present disclosure first provides an evaluation parameter SL / FL and SW / FL which is independent of the gestational age of the fetus before birth. In the clinical work, when the gestational age of the fetus after birth is unknown, the length SL and width SW of the scapula of the fetus can be predicted by measuring the FL and simply calculating, thereby evaluating the development of the scapula.

[0078] In some embodiments, as shown in Figure 1 The device further comprises:

[0079] The generating module is configured to generate a reference data according to the ultrasound data of the fetus to be tested if the evaluation module evaluates that the scapula development of the fetus to be tested is normal.

[0080] The reference data is added to the established original database to form a reference database of the scapula development of the fetus, which is used for the evaluation of the fetus in subsequent detection.

[0081] The data in the original database is also used as the reference data, and the reference database is formed after integration.

[0082] The reference database can be further classified according to the Chinese population or region to provide research data.

[0083] In some embodiments, as shown in Figure 1 Figure 1 The device further comprises:

[0084] The parameter correction module 1006 is configured to correct the first prediction parameter interval SL / FL and the second prediction parameter interval SW / FL respectively according to at least one reference data.

[0085] The reference data is added to the reference database, and by increasing the sample size in the reference database, the standard error (SE) of the first data set / the second data set calculated by the reference database can be gradually reduced, thereby improving the estimation accuracy of the mean value and the standard deviation, and the evaluation accuracy of the device is correspondingly improved.

[0086] In some embodiments, the device further comprises:

[0087] The report generating module is configured to generate a report of the evaluation result of the evaluation module 1003 and provide suggestions and opinions for the pregnant woman.

[0088] In some embodiments, the device further comprises:

[0089] a visualization module for providing query and visualization functions of data in the reference database.

[0090] The above only the preferred embodiments of the present disclosure, and not for limiting the present disclosure, for those skilled in the art, the present disclosure can have various changes and variations. Any modification, equivalent replacement, improvement, etc. made within the spirit and principles of the present disclosure shall be included in the protection scope of the present disclosure.

Claims

1. An apparatus for ultrasonic assessment of fetal shoulder blade development prenatally, characterized in that, The device comprises: a data acquisition module configured to acquire ultrasonic data of a prenatal fetus by using an ultrasonic diagnostic apparatus, wherein the ultrasonic data comprises a measurement of a scapula length, a measurement of a scapula width, and a measurement of a femur length; a prediction module configured to obtain a first prediction interval according to the measurement of the femur length of a prenatal fetus to be measured and a first prediction parameter interval, and obtain a second prediction interval according to the measurement of the femur length of the prenatal fetus to be measured and a second prediction parameter interval, wherein the first prediction parameter interval is calculated based on a first data set, the first data set is a data set of ratios of scapula lengths to femur lengths of normal prenatal fetuses matched in gestational weeks, the second prediction parameter interval is calculated based on a second data set, the second data set is a data set of ratios of scapula widths to femur lengths of normal prenatal fetuses matched in gestational weeks, and the prenatal fetus to be measured is a prenatal fetus of 31-40 gestational weeks; an evaluation module configured to determine whether the measurement of the scapula length of the prenatal fetus to be measured is within the first prediction interval, and determine whether the measurement of the scapula width of the prenatal fetus to be measured is within the second prediction interval, to evaluate a scapula development condition of the prenatal fetus.

2. The apparatus of claim 1, wherein, The device further comprises: a parameter acquisition module configured to obtain the first prediction parameter interval and the second prediction parameter interval according to ultrasonic data of a plurality of normal prenatal fetuses.

3. The apparatus of claim 2, wherein, The device further comprises: a generation module configured to generate a reference data according to the ultrasonic data of the prenatal fetus to be measured if the evaluation module evaluates that the scapula development condition of the prenatal fetus to be measured is normal.

4. The apparatus of claim 3, wherein, The device further comprises: a parameter correction module configured to correct the first prediction parameter interval and the second prediction parameter interval respectively according to at least one reference data.

5. The apparatus of claim 2, wherein, The data acquisition module is configured to acquire ultrasonic data of the prenatal fetus by using an ultrasonic diagnostic apparatus, comprising: The ultrasonic diagnostic apparatus is configured to use a two-dimensional abdominal convex array probe with a frequency of 2-5 MHz and set an examination mode as a obstetric condition.

6. The apparatus of claim 1, wherein, The data acquisition module comprises: an image acquisition module configured to acquire a first ultrasonic image of a maximum length section of a scapula and a second ultrasonic image of a maximum width section of the scapula of the prenatal fetus by using an ultrasonic diagnostic apparatus; a measurement module configured to measure a scapula length in the first ultrasonic image as a measurement of a scapula length of the prenatal fetus, and measure a scapula width in the second ultrasonic image as a measurement of a scapula width of the prenatal fetus.

7. The apparatus of claim 6, wherein, The data acquisition module further comprises: a first positioning module configured to position a first end of a scapula at a acromion in the first ultrasonic image, and position a second end of the scapula at a infraspinatus angle in the first ultrasonic image; a second positioning module configured to position a third end of a scapula at the acromion in the second ultrasonic image, and position a fourth end of the scapula at a medial border of the infraspinatus in the second ultrasonic image; The measurement module is configured to measure a straight-line distance between the first end and the second end as a scapular length, and to measure a straight-line distance between the third end and the fourth end as a scapular width.

8. The apparatus of claim 1, wherein, The first prediction parameter interval is the mean ± standard deviation of the first data set, and the second prediction parameter interval is the mean ± standard deviation of the second data set.

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