Ultrasonic evaluation device for antenatal sternum development of fetus
By measuring the ratio of fetal head circumference to sternal length using an ultrasound assessment device, and predicting sternal length using Spearman correlation analysis and constant coefficients, the diagnostic error caused by gestational age dependence in existing technologies is resolved, enabling accurate assessment of fetal sternal development, and is applicable to the Chinese population.
Patent Information
- Application Number
- CN202511822874.X
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2025-12-05
- Publication Date
- 2026-02-06
AI Technical Summary
Current technology relies on gestational age information to assess fetal sternal development, which leads to large diagnostic errors when gestational age is unknown or inaccurately estimated, and lacks data support based on the Chinese population.
An ultrasound assessment device was used to measure the ratio of fetal head circumference to sternal length (SL/HC). Spearman correlation analysis was used to screen out predictive parameters that are independent of gestational age. The sternal length was then predicted using constant coefficients, and comparisons and error analyses were performed in the assessment module.
In cases where gestational age is unknown, this method improves the accuracy and precision of fetal sternal development assessment, eliminates gestational age estimation errors, and is applicable to the characteristics of the Chinese population.
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Figure CN121465639A_ABST
Abstract
Description
TECHNICAL FIELD
[0001] The present application belongs to the technical field of ultrasonic diagnosis, and relates to an ultrasonic evaluation device for prenatal fetal sternal development. BACKGROUND
[0002] The sternum, as the core bony structure of the anterior wall of the thoracic cage, plays a key role in maintaining the stability of the thoracic volume, protecting the mediastinum and internal organs, etc. Abnormalities of the sternum are closely related to many genetic syndromes, such as sternal cleft, 18-trisomy syndrome, etc. Therefore, accurate prenatal evaluation of fetal sternal development is of great significance for early detection of congenital abnormalities.
[0003] At present, most of the research data on prenatal fetal sternum at home and abroad depends on the known gestational age of the fetus. However, in clinical practice, there are often cases where the gestational age of the fetus is unknown or the gestational age is not accurately calculated (for example, the pregnant woman forgets the last menstrual period). In the absence of accurate gestational age information, the existing evaluation method relying on the "gestational age-sternal length" standard curve will fail, or the diagnosis error will be caused due to forced estimation of gestational age. In addition, the existing research lacks sternal development data based on a large sample of Chinese fetuses, and does not fully consider racial and regional differences. Therefore, there is an urgent need for a new index and device for evaluating fetal sternal development that is independent of gestational age and based on Chinese population data. SUMMARY
[0004] The present application provides an ultrasonic evaluation device for prenatal fetal sternal development, aiming to solve the problems of dependence on gestational age information and lack of localized data support in the prior art.
[0005] The technical solution of the present application is as follows: An ultrasonic evaluation device for prenatal fetal sternal development, the device comprising: a data acquisition module for acquiring ultrasonic data of a fetus to be tested using an ultrasonic diagnostic instrument, the ultrasonic data including a measured value of the fetal sternal length (SL) and a measured value of the head circumference (HC); a prediction module including a storage unit; the storage unit is used to store pre-established fetal sternal development prediction parameters, the prediction parameters are established based on the statistical relationship of the sternal length to head circumference ratio (SL / HC) of normal population fetuses, and the prediction parameters represent the sternal development rule independent of gestational age; the prediction module is used to call the prediction parameters in the storage unit according to the measured value of the head circumference of the fetus to be tested, and calculate the predicted value of the sternal length of the fetus to be tested; an evaluation module for comparing the measured value of the sternal length of the fetus to be tested with the predicted value of the sternal length, outputting the comparison data or deviation rate of the measured value and the predicted value, and generating reference information for sternal development evaluation.
[0006] In some embodiments, the data acquisition module comprises: an image acquisition module configured to acquire an ultrasound image of a fetal sternum maximum length section in an obstetric examination mode by using a two-dimensional abdominal convex array probe with a probe frequency of 2-5 MHz; a positioning module configured to identify ossification centers of the sternum in the ultrasound image, position a head end of a first ossification center as a first end, and position a tail end of a last ossification center as a second end; a measurement module configured to measure a straight-line distance between the first end and the second end as a measurement value of the fetal sternum length.
[0007] In some embodiments, the device further comprises a parameter acquisition module configured to establish or update the prediction parameter in the storage unit; the parameter acquisition module is configured to: acquire sample ultrasound data of a plurality of normal prenatal fetuses, the sample ultrasound data including sample sternum lengths and sample head circumferences; calculate a ratio (SL / HC) of the sternum length to the head circumference of each sample; perform a Spearman correlation analysis test on the ratio and the gestational age to screen out a ratio interval having no statistical correlation with the gestational age; and determine the prediction parameter according to statistical data of the screened ratio interval.
[0008] In some embodiments, the prediction parameter includes constant coefficients set for different development stages; the prediction module is configured to: determine a development stage of the fetus to be measured according to a measurement value of the head circumference of the fetus to be measured, select a corresponding constant coefficient as the prediction parameter, and multiply the measurement value of the head circumference by the constant coefficient to obtain the prediction value of the sternum length.
[0009] In some embodiments, the constant coefficients include: determining a development stage according to a head circumference measurement value range; the constant coefficient is 0.107 corresponding to a first development stage (equivalent to a gestational age of 23-27 weeks); the constant coefficient is 0.118 corresponding to a second development stage (equivalent to a gestational age of 29-32 weeks); and the constant coefficient is 0.126 corresponding to a third development stage (equivalent to a gestational age of 33-40 weeks).
[0010] In some embodiments, the evaluation module is configured to: calculate a relative error of the measurement value of the sternum length relative to the prediction value of the sternum length; or determine whether the measurement value of the sternum length falls within a normal reference value range determined based on the prediction parameter; if the relative error is within a preset threshold range or the measurement value falls within the normal reference value range, the sternum development of the fetus is evaluated as normal.
[0011] In some embodiments, end point values of the normal reference value range are determined based on the 5th percentile and the 95th percentile of the SL / HC ratio of the normal population of fetuses.
[0012] In some embodiments, the device further comprises a parameter correction module configured to: when the evaluation module determines that the sternum development of a fetus to be tested is normal, generate the ultrasound data of the fetus to be tested as new reference data; and incorporate the new reference data into the database of the storage unit and trigger the recalculation and correction of the prediction parameters.
[0013] In some embodiments, the fetus is a prenatal fetus of 19-40 gestational weeks, and the device does not require the gestational week information of the fetus when performing evaluation.
[0014] In some embodiments, the device further comprises a generation module configured to generate an evaluation report showing the measured value, the predicted value and the comparison result of the sternum length, and providing a visual reference curve based on Chinese population data.
[0015] The present application has the following advantages: Elimination of gestational week dependence: the device of the present application uses the relatively constant physiological parameter of SL / HC ratio to predict the sternum length by measuring the head circumference only, without knowing the gestational week of the fetus, thus eliminating misdiagnosis caused by estimation error of gestational week.
[0016] High data reliability: the device of the present application is based on large sample data (e.g. 611 cases) from multiple medical centers in China, covering 19-40 gestational weeks, and can better reflect the ethnic and regional characteristics of Chinese population.
[0017] Accurate diagnosis: the device of the present application uses specific ratio coefficients (e.g. 0.107, 0.118, 0.126) for segmented prediction, thus improving the accuracy of evaluation. BRIEF DESCRIPTION OF DRAWINGS
[0018] 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 limiting the scope. For those skilled in the art, other related drawings can also be obtained without creative labor.
[0019] Figure 1 The structure schematic diagram of the ultrasound evaluation device for prenatal fetal sternum development provided by the embodiments of the present application.
[0020] Figure 2 The structure schematic diagram of the data acquisition module.
[0021] Figure 3 The two-dimensional ultrasound image example of the fetal sternum length measurement section.
[0022] Figure 4Schematic diagram for fetal sternum length measurement and ultrasound schematic diagram.
[0023] Figure 5 Structural schematic diagram of the parameter acquisition module. DETAILED DESCRIPTION
[0024] For the purposes of the present disclosure, the technical solutions and advantages of the embodiments will be more apparent, the technical solutions of the embodiments of the present disclosure will be described clearly and completely 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 the embodiments. Based on the embodiments in the present disclosure, all other embodiments obtained by those of ordinary skill in the art without making creative efforts fall 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 claimed present disclosure, but only represents selected embodiments of the present disclosure. Based on the embodiments in the present disclosure, all other embodiments obtained by those of ordinary skill in the art without making creative efforts fall within the scope of protection of the present disclosure.
[0025] The embodiments of the present application will be described in detail below in conjunction with the drawings.
[0026] The algorithm of the embodiments of the present application is based on the previous research of the present application. In the previous research, each growth parameter of the normal prenatal fetus was measured, including sternum length (SL), biparietal diameter (BPD), head circumference (HC), abdominal circumference (AC), femoral length (FL), and estimated fetal weight (EFW), and then the ratios between these growth parameters were calculated, and then Spearman correlation analysis was used to test whether these ratios were statistically correlated with gestational age, and the prediction parameters that can evaluate sternum development regardless of gestational age were screened out. It is found that the SL / HC ratio of the normal fetus is not dependent on the gestational age of the fetus and can evaluate sternum development. Based on this, the ultrasonic evaluation device for prenatal fetal sternum development of the embodiments of the present application is constructed.
[0027] As shown in Figure 1 The ultrasonic evaluation device for prenatal fetal sternum development 1000 provided by the present application includes a data acquisition module 1001, a prediction module 1002, an evaluation module 1003, a parameter acquisition module 1004, a generation module 1005, and a parameter correction module 1006.
[0028] Data acquisition and measurement: The data acquisition module 1001 acquires fetal data by using an ultrasonic diagnostic apparatus. The ultrasonic diagnostic apparatus is configured to use an abdominal two-dimensional convex array probe, with a frequency of 2-5 MHz, and set obstetric conditions.
[0029] The data acquisition module 1001 includes: An image acquisition module 10011, configured to acquire an ultrasound image of a maximum length section of a fetal sternum by using an ultrasonic diagnostic apparatus; A measurement module 10012, configured to measure a length of the sternum in the ultrasound image as a measured value of the fetal sternum length; A positioning module 10013, configured to position a head end of a first ossification center in the ultrasound image as a first end, and position a tail end of a last ossification center in the ultrasound image as a second end.
[0030] Sternum length (SL) measurement: as shown in Figure 3 and Figure 4 , the fetal chest area is scanned in a coronal or sagittal plane until the full length of the sternum is displayed (as a "bead-like" arrangement of ossification centers). The head end of the first ossification center (first end) and the tail end of the last ossification center (second end) are positioned by the positioning module 10013, and the linear distance between the two ends is measured by the measurement module 10012, which is the SL.
[0031] Specifically, the fetal chest area is scanned in a coronal or sagittal plane by using an ultrasonic diagnostic apparatus, and the probe is adjusted constantly until the full length of the fetal sternum is displayed, as shown in Figure 4 A and B, the electronic vernier is placed at the head end of the first ossification center and the tail end of the last ossification center, respectively, to measure the maximum length of the sternum. The direction and position of the probe are adjusted constantly during continuous scanning to ensure that the fetal sternum presents the maximum length, and the freeze and save buttons are pressed. The endpoints for measurement are positioned by placing the electronic caliper at the positions in the ultrasound image, respectively.
[0032] Head circumference (HC) measurement: the fetal head circumference is measured according to the obstetric standard section.
[0033] Establishment of prediction parameters (core algorithm): The parameter acquisition module 1004 is based on 611 cases of normal prenatal fetal data of 19-40 gestational weeks from multiple medical centers in China.
[0034] The ultrasound data of the normal prenatal fetus is acquired by the data acquisition module 1001, and a database as shown in Table 1 is established.
[0035] The data in the database is further classified according to gestational weeks, and the values of the 5th percentile, 50th percentile and 95th percentile are counted to determine the reference value range.
[0036] Table 1 Reference range of normal fetal sternum length at different gestational weeks (5th, 50th, 95th percentile) (total number of cases = 611)
[0037] As shown in FIG. 10, the parameter acquisition module 1004 includes a calculation module 10041 and a parameter selection module 10042. Figure 5
[0038] The calculation module 10041 calculates the SL / HC ratio of each sample and performs correlation analysis.
[0039] Correlation analysis: the correlation between SL / HC and gestational weeks was tested by Spearman correlation analysis. As shown in Table 2, within a certain interval (such as 23-28 weeks, 29-32 weeks, 33-40 weeks), the SL / HC ratio had no significant statistical correlation with gestational weeks (r value close to 0, P value not significant), proving that the ratio was stable.
[0040] Table 2
[0041] The parameter selection module 10042 selects the 5th percentile and the 95th percentile of the ratio as the endpoint values of the prediction parameter. Among them, the values between the 5th percentile and the 95th percentile of all ratios SL / HC obtained according to the above 611 cases are averaged, that is, a constant interval parameter k can be obtained. For example: The system obtains the actual development time of the fetus according to the ultrasonic measurement of the fetal head circumference (HC): If it is determined to be the first development stage (corresponding to the head circumference of 21.3-27.6 cm), the constant parameter k = 0.107 is called; If it is determined to be the second development stage (corresponding to the head circumference of 27.7-30.1 cm), the constant parameter k = 0.118 is called; If it is determined to be the third development stage (corresponding to the head circumference of 30.2-34.7 cm), the constant parameter k = 0.126 is called.
[0042] This constant interval parameter is particularly valuable in evaluating SL in the late gestational period, especially in the case where the pregnant woman cannot accurately recall the last menstrual period (LMP). Comparing the calculated value with the actual measured value can provide valuable diagnostic information for the development of the fetal sternum, and has good clinical application value.
[0043] Prediction and evaluation process: The prediction module 1002 receives the measured HC value HC measured , combined with the predicted constant parameter k, to calculate the SL predicted value SL pred = HC measured x k.
[0044] The evaluation module 1003 compares the measured SL with the predicted value SL pred . If the deviation between the two is within the preset normal reference range (such as the threshold value determined based on the 5th-95th percentile), it is determined that the sternum development is normal.
[0045] In some embodiments, the device further comprises a generation module 1005 for generating a reference data based on the ultrasound data of the fetus if the sternum development of the fetus is normal. The reference data is added to the established original database to form a reference database of fetal sternum development for the evaluation of subsequent detected fetuses. The data in the original database is also used as reference data, and the integrated reference database is formed. The data in the database can be classified according to the gestational age estimated based on the head circumference. The reference database can be further classified according to the Chinese population or region to provide research data.
[0046] In some embodiments, as shown in Figure 1 , the device further comprises a parameter correction module 1006 for correcting the prediction parameters based on a plurality of reference data. By increasing the sample size in the reference database, the percentile value of the ultrasound measurement data of the normal prenatal fetal sternum in China can be more accurately displayed, the accuracy of the reference value range is improved, and the evaluation accuracy of the device is provided.
[0047] In some embodiments, the device further comprises a report generation module for generating a report of the evaluation result of the evaluation module 1003 and providing suggestions and opinions for the pregnant woman.
[0048] In some embodiments, the device further comprises a visualization module for providing query and visualization functions of the data in the reference database.
[0049] Comparative Example (Prior Art - Gestational Age Dependent): Scenario: Single fetus, actual gestational age 34 weeks ± 1 day, but the clinical scenario is set as "unknown gestational age". The measured HC = 31.1 cm, SL = 3.84 cm. The actual SL / HC of this fetus is 0.123, which is within the normal range.
[0050] Prior art operation: Without gestational age input, the traditional assessment system fails to invoke the "GA-SL" curve and fails the assessment. If the physician measures the biparietal diameter, head circumference, abdominal circumference and femur length of the fetus, the instrument will automatically derive a predicted gestational age of 34±2 weeks and manually look up the table: if the 32-week reference value (SL mean 3.67 cm) is taken, the measured value 3.84 cm may be judged as "too long"; if the 36-week reference value (SL mean 3.99 cm) is taken, the measured value may be judged as "too short".
[0051] Result: The diagnosis conclusion is uncertain or even wrong due to the error in gestational age estimation.
[0052] Example (not dependent on gestational age type): Scenario: As above, gestational age "hidden".
[0053] Steps: Data acquisition: Read HC=31.1 cm, SL=3.84 cm.
[0054] Prediction calculation: The prediction module invokes the constant parameter k=0.126 (corresponding to the large head circumference group) to calculate the expected value SL pred =31.1x0.126=3.91.
[0055] Evaluation: Calculate the relative error d=(3.84-3.91) / 3.91≈-1.7%. The absolute value of the error is lower than the system preset threshold (such as ±2.5% or within the reference interval).
[0056] Result: Output "normal sternal development".
[0057] Conclusion: This device eliminates the dependence on the accuracy of gestational age, avoids misdiagnosis due to time calculation error, and significantly improves clinical applicability.
[0058] Abnormal sternal development case: Scenario: Singleton, actual gestational age 35 weeks±1 day, but the clinical scenario is set as "unknown gestational age". After measurement, HC=27.6 cm, SL=2.91 cm.
[0059] Steps: Data acquisition: Read HC=27.6 cm, SL=2.91 cm.
[0060] Prediction calculation: The prediction module invokes the constant parameter k=0.126 (corresponding to the large head circumference group) to calculate the expected value SL pred =27.6x0.126=3.48.
[0061] Evaluation: Calculate the relative error d = (2.91-3.48) / 3.48 ≈ -16.3%. The absolute value of the error is higher than the system preset threshold (out of the ±2.5% set reference interval).
[0062] Result: Output "abnormal sternum development".
[0063] Conclusion: The device eliminates the dependence on the accuracy of gestational age, avoids misdiagnosis caused by time calculation errors, and significantly improves clinical applicability.
[0064] The above only describes the preferred embodiments of the present disclosure and is not intended to limit the present disclosure. Those skilled in the art can make various modifications and changes to the present disclosure. Any modification, equivalent replacement, improvement, etc. within the spirit and principles of the present disclosure shall be included in the protection scope of the present disclosure.
Claims
1. An ultrasound assessment device for prenatal fetal sternal development, characterized in that, The device includes: The data acquisition module is used to acquire ultrasound data of the fetus under test using an ultrasound diagnostic instrument. The ultrasound data includes the measurement values of the fetal sternal length (SL) and head circumference (HC). The prediction module includes a storage unit; the storage unit is used to store pre-established fetal sternal development prediction parameters, which are established based on the statistical relationship of the ratio of sternal length to head circumference (SL / HC) of normal fetuses, and the prediction parameters characterize the sternal development pattern independent of gestational age; the prediction module is used to calculate the predicted value of the sternal length of the fetus by calling the prediction parameters in the storage unit according to the measured value of the head circumference of the fetus to be tested; The assessment module is used to compare the measured value of the sternal length of the fetus under test with the predicted value of the sternal length, and output the comparison data or deviation rate of the measured value and the predicted value to generate reference information for sternal development assessment.
2. The apparatus according to claim 1, characterized in that, The data acquisition module includes: The image acquisition module is configured to acquire ultrasound images of the fetal sternum at its maximum length using an abdominal two-dimensional convex array probe with a probe frequency of 2-5MHz in obstetric examination mode. The positioning module is used to identify the ossification centers of the sternum in the ultrasound image, positioning the head end of the first ossification center as the first end and the tail end of the last ossification center as the second end. The measurement module is used to measure the straight-line distance between the first end and the second end, as a measurement value of the fetal sternum length.
3. The apparatus according to claim 1, characterized in that, The device further includes a parameter acquisition module for establishing or updating prediction parameters in the storage unit; the parameter acquisition module is configured to: acquire sample ultrasound data of multiple normal prenatal fetuses, the sample ultrasound data including sample sternal length and sample head circumference; calculate the ratio of sternal length to head circumference (SL / HC) for each sample; use Spearman correlation analysis to test the correlation between the ratio and gestational age, and screen out the ratio intervals that have no statistical correlation with gestational age; determine the prediction parameters based on the statistical data of the screened ratio intervals.
4. The apparatus according to claim 3, characterized in that, The prediction parameters include constant coefficients set for different developmental stages; the prediction module is configured to: determine the developmental stage of the fetus based on the measured head circumference, select the corresponding constant coefficient as the prediction parameter, and multiply the measured head circumference by the constant coefficient to obtain the predicted value of the sternal length.
5. The apparatus according to claim 4, characterized in that, The constant coefficient is determined based on the range of head circumference measurements to identify the developmental stage; for the first developmental stage, the constant coefficient is 0.107; for the second developmental stage, the constant coefficient is 0.118; and for the third developmental stage, the constant coefficient is 0.
126.
6. The apparatus according to claim 1, characterized in that, The assessment module is configured to: calculate the relative error of the measured value of the sternal length relative to the predicted value of the sternal length; or, determine whether the measured value of the sternal length falls within the normal reference range determined based on the predicted parameters; if the relative error is within a preset threshold range, or the measured value falls within the normal reference range, then the fetal sternal development is assessed as normal.
7. The apparatus according to claim 6, characterized in that, The endpoints of the normal reference range are determined based on the 5th and 95th percentiles of the SL / HC ratio in the normal fetal population.
8. The apparatus according to claim 1, characterized in that, The device further includes a parameter correction module, used to: when the evaluation module determines that the sternal development of a fetus to be tested is normal, generate new reference data from the ultrasound data of the fetus to be tested; import the new reference data into the database of the storage unit, and trigger the recalculation and correction of the prediction parameters.
9. The apparatus according to claim 1, characterized in that, The fetus is a prenatal fetus at 19-40 weeks of gestation, and the device does not require inputting the fetus's gestational age information when performing the assessment.
10. The apparatus according to claim 1, characterized in that, The device also includes a generation module for generating an assessment report that displays the measured value, predicted value and comparison of the sternal length, and provides a visual reference curve based on Chinese population data.