Color Doppler ultrasound probe assembly

Abstract

In the field of medical device technology, we provide a probe assembly for a color Doppler ultrasound diagnostic device. [Solution] The device comprises a grip, a probe housing, and an acoustic transducer assembly 3. A support frame is fixed inside the probe housing, a transducer base 5 is connected to the support frame via a pivot axis, and the acoustic transducer assembly 3 is fixed to its top. An angle adjustment mechanism including a transmission shaft 7, a driven slider 8, and a connecting link rod is provided inside the probe housing. Rotation of the transmission shaft 7 causes the driven slider 8 to move axially, displacing the transducer base 5 within a range of ±30° via the connecting link rod. This improves the consistency of standard cross-sectional acquisition and the durability of the device. Existing transducer assemblies have the problem of low consistency in capturing cross-sectional areas of fetal ultrasound soft markers due to the fixed structure, and this device solves that problem.

Description

Technical Field

[0001] The present invention belongs to the technical field of medical devices, and specifically relates to a probe assembly for a color Doppler ultrasound diagnostic apparatus.

Background Art

[0002] Color Doppler ultrasound diagnostic technology is an important means used in prenatal examination of fetuses in the field of clinical medical imaging. By utilizing the Doppler effect and ultrasonic imaging principle, the anatomical structure and blood flow dynamic state of the fetus can be observed in real time. In prenatal screening, ultrasound diagnostic apparatuses are widely applied to the detection of various fetal growth indicators. In particular, by identifying ultrasonic soft markers such as the thickness of the fetal NT (nuchal translucency), the development status of the nasal bone, and the width of the lateral ventricle, important reference bases for clinically evaluating whether there are chromosomal abnormalities in the fetus are provided.

[0003] Ultrasonic examination has advantages such as non-invasiveness, real-time nature, reproducibility, and relatively simple operation, and plays an important role in ensuring the safety of pregnant women and fetuses. In an ultrasonic diagnostic system, as a core component for acquiring original acoustic signals, the probe assembly directly affects the sharpness of the image and the accuracy of diagnostic data. By combining with corresponding signal processing algorithms, the ultrasonic probe performs multi-section scanning on different organs of the fetus, acquires ultrasonic soft marker data reflecting its growth and development status, and further can assist doctors in evaluating the potential risk of chromosomal abnormalities such as fetal aneuploidy.

[0004] Chromosomal abnormalities are one of the leading causes of intellectual disability, developmental delay, and congenital structural abnormalities. While chromosomal karyotyping is the gold standard for prenatal diagnosis and can effectively detect numerical abnormalities and structural abnormalities of large fragments, it has limitations, including the need to obtain specimens through invasive means such as amniocentesis, the complexity of the procedure, the high cost, and the potential risks to the mother and fetus. Some fetuses with chromosomal abnormalities are identified by showing obvious structural malformations on ultrasound; however, some cases still show normal ultrasound findings or only slight structural abnormalities, i.e., only ultrasound soft markers are observed. Although these markers are mostly benign, they have a certain association with an increased risk of chromosomal abnormalities, serving as "warning signals." Studies have already shown that the predictive value of a single ultrasound soft marker is limited and highly heterogeneous. For example, when screening for chromosomal abnormalities using nuchal translucency (NT) alone, the detection rate is approximately 77% to 82% when the false positive rate is set at 5%. Similarly, when screening for chromosomal abnormalities using fetal nuchal fold thickness alone, the detection rate is only 4% to 35%. In clinical practice, it is necessary to improve the accuracy of risk assessment by comprehensively evaluating multiple soft markers, the clinical characteristics of pregnant women, Down syndrome prenatal screening, and non-invasive prenatal DNA testing (NIPT) indicators in combination.

[0005] However, existing color Doppler ultrasound transducer assemblies are often limited by the fixed structure of the transducer when acquiring fine soft marker data of specific fetal organs. Furthermore, when performing precise scans on fetuses at different gestational ages or in different fetal positions, the process of acquiring high-quality cross-sections is highly dependent on the operating angle, making it somewhat difficult to capture specific soft markers. In particular, when acquiring coronal or sagittal sections of the nasal bone, if the incident angle of the acoustic beam does not match the fetal position, or if the operator's wrist adjustment range is excessive, resulting in loss of the cross-section, it is extremely easy for the nasal bone to become unclear or for the measurement of nuchal translucency (NT) thickness to become distorted due to cross-sectional displacement or tilt of the image plane. Moreover, the reliability of subsequent comprehensive evaluations of chromosomal abnormalities based on this soft marker data is reduced. At the same time, existing devices still have room for improvement in data acquisition efficiency in simultaneously acquiring and integrating data from multiple soft markers, and further optimization is needed in terms of sensitivity to specific microstructural abnormalities. This, to some extent, affects the convenience of comprehensively predicting the risk of fetal chromosomal abnormalities, and therefore there is still room for improvement in accuracy. [Overview of the project] [Problems that the invention aims to solve]

[0006] In view of the shortcomings of the prior art described above, the present invention provides a probe assembly for a color Doppler ultrasound diagnostic device. [Means for solving the problem]

[0007] The technical means employed in this invention are as follows:

[0008] A probe assembly for a color Doppler ultrasound diagnostic apparatus, comprising a grip, a probe housing, and an acoustic transducer assembly installed within the probe housing, wherein the top end of the probe housing is provided with an acoustic window corresponding to the position of the acoustic transducer assembly.

[0009] A support frame is installed inside the aforementioned probe housing, and the support frame is fixedly connected to the inner wall of the probe housing.

[0010] A transducer base is connected to the inner wall of the support frame via a pivot axis, and the top of the transducer base is fixedly connected to the acoustic transducer assembly.

[0011] The probe housing is further equipped with an angle adjustment mechanism, which includes a transmission shaft, a driven slider, and a connecting link rod.

[0012] The transmission shaft is provided inside the probe housing, its bottom end extends outside the probe housing and is connected to an adjustment knob, and male threads are engraved on the outer surface of the transmission shaft.

[0013] The driven slider is fitted onto the transmission shaft, and has a female screw hole through its center that aligns with the male screw, so that the driven slider and the transmission shaft form a screw transmission pair.

[0014] One end of the connecting link rod is hinged to the driven slider via a pin shaft, and the other end is hinged to the side wall of the transducer base via a pin shaft.

[0015] The top outer surface of the aforementioned probe housing is covered with a flexible coupling capsule, and the internal space of the flexible coupling capsule is filled with an acoustic coupling medium.

[0016] The grip and the probe housing are fixedly connected to each other. [Effects of the Invention]

[0017] Compared to conventional technology, this invention has the following beneficial effects.

[0018] This invention achieves autonomous displacement of the acoustic transducer assembly within the housing by providing an angle adjustment mechanism consisting of a transmission shaft, a driven slider, and a connecting link rod inside the probe housing. When performing examinations on fetuses with abnormal fetal presentation or those with limited scanning angles, the physician does not need to twist their wrist significantly, only needing to fine-tune the incident angle of the acoustic beam via the adjustment knob. This improves the tracking and acquisition efficiency and reproducibility stability of fine ultrasound soft markers such as the thickness of the nuchal translucency (NT) and nasal bone relative to the target cross-section while maintaining a fixed wrist position, thereby increasing the success rate of obtaining high-quality standardized images. The standardized cross-section obtained by mechanical fine-tuning effectively reduces artificial measurement errors introduced by the operator's physiological tremor and angle control deviations. This provides a primitive ultrasound image data source that is less operator-dependent and has better reproducibility for constructing chromosomal abnormality risk assessment models based on ultrasound soft markers and the clinical characteristics of pregnant women.

[0019] In this invention, the flexible bonding capsule and the acoustic bonding medium filled inside it establish a good acoustic contact path between the probe head and the skin, and by utilizing its own flexible deformation ability, it adaptively adheres to body surfaces of different curvatures. As a result, the probe can maintain a stable sound transmission effect even under different pressing forces, and image artifacts caused by poor contact are reduced.

[0020] The overall structure of this invention, by combining purely mechanical adjustment with a flexible, close-fitting design, provides a more accurate and efficient hardware foundation for clinically evaluating the risk of fetal chromosomal abnormalities. This invention helps optimize non-invasive prenatal screening diagnostic strategies in clinical big data analysis and provides a reliable technical foundation to reduce the rate of unnecessary invasive prenatal diagnoses due to poor image quality, by improving the capture consistency of standard sections and reducing interoperator procedural variability. [Brief explanation of the drawing]

[0021] [Figure 1]FIG. 1 is a schematic diagram showing the overall structure of the present invention. [Figure 2] FIG. 2 is a schematic diagram showing the internal cross-sectional structure of the present invention. [Figure 3] FIG. 3 is a partially enlarged schematic diagram of the top of the detection housing of the present invention. [Figure 4] FIG. 4 is a schematic diagram showing the connection structure between the support frame and the transducer base of the present invention.

Embodiments for Carrying Out the Invention

[0022] Hereinafter, embodiments of the present invention will be described with reference to the drawings. The embodiments are for clearly and completely explaining the present invention and do not limit the scope of the present invention.

[0023] Referring to FIGS. 1 to 4, the present invention provides a probe assembly for a color Doppler ultrasonic diagnostic apparatus, which is applied in the field of medical ultrasonic imaging diagnosis. In particular, in the process of performing color Doppler blood flow imaging and morphological scanning on the fine structure of a fetus, through the mechanized displacement adjustment of the internal structure of the probe and the improvement of the external connection structure, precise compensation of the acoustic beam incident angle is realized.

[0024] The probe assembly includes a grip 1, a detection housing 2, and an acoustic transducer assembly 3. Among them, the grip 1 and the detection housing 2 are fixedly connected, and the two do not have relative movement as a whole during operation.

[0025] A support frame 4 is installed inside the detection housing 2. The support frame 4 is a frame structure made of a high-strength polycarbonate material and is fixed to the inner wall of the detection housing 2 by a plurality of screws.

[0026] A transducer base 5 is connected to the inner wall of the support frame 4 via a rotation fulcrum shaft. The rotation fulcrum shaft straddles the central axis of the support frame 4, and both ends thereof are fitted into bearing holes preset in the support frame 4.

[0027] The top of the transducer base 5 is fixedly connected to the acoustic transducer assembly 3. The acoustic transducer assembly 3 includes a convex array consisting of 128 piezoelectric ceramic elements, with acoustic isolation material filled between each piezoelectric ceramic element.

[0028] An acoustic window 6 corresponding to the position of the acoustic transducer assembly 3 is provided at the top of the probe housing 2.

[0029] An angle adjustment mechanism is provided inside the probe housing 2. The angle adjustment mechanism includes a transmission shaft 7, a driven slider 8, and a connecting link rod. The transmission shaft 7 is made of stainless steel and its surface is hardened. The bottom end of the transmission shaft 7 extends to the outside of the probe housing 2 and is connected to an adjustment knob. Male threads are engraved on the outer surface of the transmission shaft 7. The driven slider 8 is made of polytetrafluoroethylene material and has a female threaded hole through its center that matches the male threads. The driven slider 8 is fitted onto the transmission shaft 7 and together with the transmission shaft 7 forms a screw transmission pair. One end of the connecting link rod is hinged to the driven slider 8 via a pin shaft, and the other end is hinged to the side wall of the transducer base 5 via a pin shaft.

[0030] In this embodiment, the installation of an angle adjustment mechanism enables autonomous displacement of the acoustic transducer assembly 3 within the probe housing 2. The rotational motion of the transmission shaft 7 is converted by screw transmission into a linear displacement of the driven slider 8 along the axial direction of the transmission shaft 7. The linear displacement of the driven slider 8 is converted by a connecting link rod into an angular displacement about the pivot axis of the transducer base 5. The displacement angle range of the transducer base 5 is set to between ±30°. This mechanical adjustment structure enables fine adjustment of the acoustic beam incidence angle, allowing the physician to change the acoustic cross-section by rotating the adjustment knob when scanning a fetus in a specific position, without requiring a significant change in wrist gripping posture, and enabling precise capture of the thickness of the nuchal translucency (NT) and fine structures such as the nasal bone.

[0031] In the above embodiment, the outer surface of the top end of the probe housing 2 is covered with a flexible bonding capsule 9. The flexible bonding capsule 9 is made of a medical-grade thermoplastic elastomer, and its internal space is filled with an acoustic bonding medium, which is either degassed water or acoustic bonding oil. The flexible bonding capsule 9 deforms upon contact with human skin, achieving seamless adhesion between the probe end face and the skin surface.

[0032] The operation process of this invention is as follows: First, the operator grasps the grip 1 and brings the flexible coupling capsule 9 at the top of the probe housing 2 into close contact with the skin surface of the person being examined. At this time, the acoustic coupling medium inside the flexible coupling capsule 9 achieves acoustic impedance matching. Due to its own flexible deformation, the flexible coupling capsule 9 can adaptively conform to the curvature of the skin at different locations, ensuring close contact between the probe end surface and the skin, so the operator does not need to adjust the handle position separately.

[0033] Next, when performing a color Doppler blood flow scan, if it is necessary to capture a specific fetal section, for example, to obtain a standard midline sagittal section to measure the thickness of the nuchal translucency (NT) at 11-13+6 weeks of gestation, or to obtain coronal and sagittal facial sections to assess nasal bone development at 18-24 weeks of gestation, the operator rotates the adjustment knob at the bottom of the transmission shaft 7. The rotation of the transmission shaft 7 drives the driven slider 8 to move along the axial direction, pulling the transducer base 5 via the connecting link rod and displacing it around the pivot axis. At this time, the incident angle of the acoustic beam emitted by the acoustic transducer assembly 3 changes, and the physician observes the image feedback on the display to efficiently acquire high-quality primitive ultrasound soft marker data necessary for clinical chromosomal abnormality risk assessment by optimizing the relative angle between the acoustic beam and the fetal facial region until the boundary between the hyperechoic and anechoic zones of the fetal nasal bone is clearly visible, or by exploring a better sound window by fine-tuning the adjustment.

[0034] Example: The standardized ultrasonic cross-sectional images and corresponding ultrasonic soft marker measurement data obtained using the present invention can be used in a retrospective study to construct a fetal chromosomal abnormality clinical prediction model. The design plan of the study is as follows.

[0035] Inclusion criteria for the study subjects: singleton pregnancy; complete clinical data including general information, clinical characteristics of the pregnant woman, and ultrasonic examination results; having a clear chromosomal diagnosis result. The exclusion criteria are as follows: the fetus has severe anatomical structural malformations; the pregnant woman has severe underlying diseases; the clinical data is incomplete.

[0036] The fetal ultrasonic soft marker data to be collected includes the following: NT thickening, absent or hypoplastic nasal bone, choroid plexus cyst, renal pelvis dilation, increased intestinal echogenicity, lateral ventricle enlargement, single umbilical artery. The clinical characteristics of the pregnant woman include age, pregnancy and delivery history, and the median multiples of Down syndrome prenatal screening and non-invasive prenatal DNA testing (NIPT).

[0037] The diagnostic criteria for ultrasonic soft markers are as follows: NT thickening means that the thickness of NT (nuchal translucency) measured in the mid-sagittal plane at 11 - 13+6 weeks of pregnancy (fetal crown-rump length 45 - 84 mm) is 2.5 mm or more; lateral ventricle enlargement means that the diameter of the atrium of the lateral ventricle is 10 mm or more at 15 - 40 weeks of pregnancy; renal pelvis separation is distinguished by gestational age (>4 mm within 20 weeks, >5 mm at 20 - 30 weeks, >7 mm at 30 weeks or more); absent or short nasal bone means that in the multi-sectional observation at 11 - 13+6 weeks or 18 - 24 weeks of pregnancy, the high echo of the nasal bone is absent or the length is less than the 2.5th percentile of fetuses of the same gestational age; choroid plexus cyst means that a circular / elliptical anechoic structure with a diameter of 3 mm or more appears in the choroid plexus during the second trimester; single umbilical artery means that only two blood vessels appear in a "吕" shape or an "8" shape in the cross-section; increased intestinal echogenicity means that the echo of the intestine is stronger than or similar to the echo of the skeleton.

[0038] Chromosome testing involves obtaining a specimen by amniocentesis or umbilical vein puncture under ultrasound guidance, and performing diagnosis using chromosomal karyotype analysis and / or low-depth whole-genome copy number variation sequencing (CNV-Seq) technology.

[0039] Based on the standardized ultrasound soft marker data and the clinical characteristics of pregnant women collected as described above, a binary logistic regression model and a CHAID decision tree model are constructed to predict the risk of fetal chromosomal abnormalities. The predictive performance of both models can be evaluated by creating ROC curves and calculating indices such as AUC value, sensitivity, and specificity. Simultaneously, a multinomial logistic regression model is employed to analyze the correlation between different types of chromosomal abnormalities, each ultrasound soft marker, and the clinical characteristics of pregnant women, and the strength of the association is expressed by the relative risk ratio (RR) and 95% confidence interval. Statistical analysis is completed using SPSS 26.0 and R 4.2.0 software, with a test level of α=0.05.

[0040] In summary, this invention, through the combination of an internal mechanical angle fine-adjustment structure and an adaptive flexible coupling design, can effectively reduce cross-sectional variations and measurement biases introduced due to differences in operator technique. This contributes to improving the consistency and stability of the input data for the prediction model described above, and provides a more reliable hardware foundation for prenatal chromosomal abnormality risk assessment. [Explanation of Symbols]

[0041] 1 Grip 2. Probe housing 3. Acoustic transducer assembly 4. Support frame 5. Transducer Base 6 Acoustic window 7. Transmission shaft 8. Driven slider 9 Flexible binding capsules

Claims

1. A probe assembly for a color Doppler ultrasound diagnostic apparatus, comprising a grip, a probe housing, and an acoustic transducer assembly installed within the probe housing, wherein a support frame is provided inside the probe housing, the support frame is fixedly connected to the inner wall of the probe housing, a transducer base is connected to the inner wall of the support frame via a pivot axis, the top of the transducer base is fixedly connected to the acoustic transducer assembly, and an angle adjustment mechanism is further provided inside the probe housing, the angle adjustment mechanism comprising a transmission shaft, a driven slider, and a connecting link rod A probe assembly for a color Doppler ultrasound diagnostic apparatus, comprising: a transmission shaft provided inside the probe housing, one end of which extends outside the probe housing and is connected to an adjustment knob; a male thread provided on the outer surface of the transmission shaft; a driven slider fitted onto the transmission shaft, with a female threaded hole at its center that aligns with the male thread; the driven slider together with the transmission shaft forming a screw transmission pair; one end of the connecting link rod hinged to the driven slider via a pin shaft; and the other end hinged to the side wall of the transducer base via a pin shaft.

2. The probe assembly for a color Doppler ultrasound diagnostic apparatus according to claim 1, characterized in that an acoustic window corresponding to the position of the acoustic transducer assembly is provided at the top end of the probe housing.

3. The probe assembly for a color Doppler ultrasound diagnostic apparatus according to claim 2, characterized in that a flexible coupling capsule is covered on the outer surface of the top end of the probe housing, and an acoustic coupling medium is filled in the internal space of the flexible coupling capsule.

4. The probe assembly for a color Doppler ultrasound diagnostic apparatus according to claim 3, characterized in that the grip and the probe housing are fixedly connected.

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