Ultrasound-on-chip platform for medical imaging, analysis, and collective intelligence.

Over the past half-century, ultrasound imaging has become a key technology for assessing an ever-widening range of medical conditions at all stages of life. Despite ultrasound's proven value, expensive systems that require domain expertise in image acquisition and interpretation have limited its broad adoption. The proliferation of portable and low-cost ultrasound imaging can improve global health and also enable broad clinical and academic studies with great impact on the fields of medicine. Here, we describe the design of a complete ultrasound-on-chip, the first to be cleared by the Food and Drug Administration for 13 indications, comprising a two-dimensional array of silicon-based microelectromechanical systems (MEMS) ultrasonic sensors directly integrated into complementary metal-oxide-semiconductor-based control and processing electronics to enable an inexpensive whole-body imaging probe. The fabrication and design of the transducer array with on-chip analog and digital circuits, having an operating power consumption of 3 W or less, are described, in which approximately 9,000 seven-level feedback-based pulsers are individually addressable to each MEMS element and more than 11,000 amplifiers, more than 1,100 analog-to-digital converters, and more than 1 trillion operations per second are implemented. We quantify the measured performance and the ability to image areas of the body that traditionally takes three separate probes. Additionally, two applications of this platform are described-augmented reality assistance that guides the user in the acquisition of diagnostic-quality images of the heart and algorithms that automate the measurement of cardiac ejection fraction, an indicator of heart health.

Importance of Distending Stomach With Fluid for Ultrasound Detection of Focal Lesion in the Elongated Left Lobe of the Liver.

OBJECTIVES: The purpose of this study was to evaluate distending the stomach with water for ultrasound detection of focal lesions in the elongated left lobe of the liver. METHODS: A total of 13,277 patients undergoing liver ultrasound were evaluated for the presence of an elongated left lobe of the liver and a focal lesion. Patients with an elongated left lobe of the liver had their stomach distended with oral water for further evaluation of a focal lesion. A portion of the patients had computed tomography (CT) examinations, which were compared with the ultrasound studies. RESULTS: A total of 643 patients were found with elongated left lobe of the liver by ultrasound; of them, 451 underwent CT, 259 out of the 451 patients meeting the inclusion criteria underwent second ultrasound and final analysis, and 16 of these 259 patients had focal lesion in the elongated left lobe of the liver on CT study. The sonographic visualization of the liver and spleen at the same scan view before and after distending the stomach were 7% (7 of 100) and 100% (100 of 100), respectively (P < .001). The sonographic detection of the lesions before and after distending the stomach were zero and 87.5%, respectively (P < .001). CONCLUSIONS: Distending the stomach with water can greatly increase ultrasound detection of focal lesions in the elongated left lobe of the liver.

Integrating the incident angle of main vessel of breast nodule with BI-RADS can improve the efficacy of breast malignancy evaluation.

The aim of this study was to investigate the measurement of the incident angle of the main blood vessel, and the benefits of its integral with ultrasound malignant features of breast nodules for the assessment of breast malignancy based on BI-RADS. The incident angles of main blood vessels of 185 breast nodules in 185 patients who underwent breast nodule surgical excision or biopsy were quantitatively measured using color Doppler ultrasound from October 2022 to October 2023 in a tertiary hospital, and related data were collected and analyzed. Based on histopathology as the gold standard, the breast nodules were classified into benign and malignant groups. The incident angle values of both groups were compared, Receiver Operating Characteristic (ROC) curves were plotted, and the optimal cutoff value for distinguishing between benign and malignant breast nodules was determined. The malignancy risk of the breast nodules was assessed using the incident angle of the breast main vessel, BI-RADS classification, and a combination of ultrasound malignant features with the incident angle. The areas under the ROC curves (AUC) for each method were calculated and compared. The average incident angle of the main vessel of the breast nodule for the benign and malignant breast nodule groups was (41.47 ± 14.27)° and (22.65 ± 11.09)°, respectively, with a statistically significant difference (t = 10.027, P < 0.001). There was a significant negative correlation between the breast nodule vessel incident angle and histopathological malignancy (r = - 0.593, P < 0.001). The ROC curve and Youden index suggested that the optimal cutoff value for distinguishing between benign and malignant breast nodules using the vascular incident angle was 26.9°, with a sensitivity of 76.34%, specificity of 84.78%, positive predictive value of 83.53%, negative predictive value of 78.00%, and AUC of 0.853. The diagnostic performance of BI-RADS classification based on ultrasound malignant features of the breast nodules alone in assessing the malignancy risk of breast nodules showed a sensitivity of 78.50%, specificity of 92.39%, positive predictive value of 91.25%, negative predictive value of 79.95%, and AUC of 0.905. The integral of ultrasound malignant features and vascular incident angle for BI-RADS based assessment for breast nodule malignancy risk demonstrated a sensitivity of 90.32%, specificity of 89.13%, positive predictive value of 89.36%, negative predictive value of 90.11%, and AUC of 0.940. The differences in negative predictive value and AUC between ultrasound malignant features BI-RADS classification alone and the combination of ultrasound malignant features BI-RADS classification with the incident angle of the main vessel of the breast nodule were all statistically significant (x2 = 3.243, P = 0.042; Z = 2.955, P = 0.003). Measuring the incident angle of the main blood vessel of breast nodules and combining this measurement with ultrasound malignant features for BI-RADS classification can enhance the effectiveness of malignancy risk assessment of breast nodules, increase the negative predictive value, and potentially reduce unnecessary biopsies.

The utility of quantifying the orientation of breast masses in ultrasound imaging.

The aim of this study was to quantify the orientation of breast masses and determine whether it can enhance the utility of a not parallel orientation in predicting breast mass malignancy. A total of 15,746 subjects who underwent breast ultrasound examinations were initially enrolled in the study. Further evaluation was performed on subjects with solid breast masses (≤ 5 cm) intended for surgical resection and/or biopsy. The orientation angle, defined as the acute angle between the align of the maximal longitudinal diameter of the breast mass and the surface of the breast skin, was measured. Receiver operating characteristic (ROC) curve analysis was conducted, and various performance measures including sensitivity, specificity, positive and negative predictive values, accuracy, odds ratio, and the area under the ROC curve (AUC) were calculated. Multivariate analysis was performed to determine if the orientation angle was an independent predictor of breast malignancy. Decision curve analysis (DCA) was also conducted to assess the net benefit of adopting the orientation angle for predicting breast mass malignancy. The final analysis included 83 subjects with breast cancer and 135 subjects with benign masses. The intra-group correlation coefficient for the measurement of the orientation angle of breast masses was 0.986 (P = 0.001), indicating high reproducibility. The orientation angles of malignant and benign breast masses were 36.51 ± 14.90 (range: 10.7-88.6) degrees and 15.28 ± 8.40 (range: 0.0-58.7) degrees, respectively, and there was a significant difference between them (P < 0.001). The cutoff value for the orientation angle was determined to be 22.9°. The sensitivity, specificity, positive and negative predictive values, accuracy, odds ratio, and AUC for the prediction of breast malignancy using the orientation angle were 88.0%, 87.4%, 81.1%, 92.2%, 87.6%, 50.67%, and 0.925%, respectively. Multivariate analysis revealed that the orientation angle (> 22.9°), not circumscribed margin, and calcifications of the breast mass were independent factors predicting breast malignancy. The net benefit of adopting the orientation angle for predicting breast malignancy was 0.303. Based on these findings, it can be concluded that quantifying the orientation angle of breast masses is useful in predicting breast malignancy, as it demonstrates high sensitivity, specificity, AUC, and standardized net benefit. It optimizes the utility of the not parallel orientation in assessing breast mass malignancy.

Ultrasonic characteristics and influencing factors of atherosclerosis in diabetic patients.

OBJECTIVE: The purpose of this research was to observe the characteristics of atherosclerosis in diabetic patients by ultrasound and analyze the factors influencing the development of atherosclerosis in these patients. METHODS: Ninety diabetic patients treated in our hospital from January 2019 to December 2019 were enrolled in this retrospective analysis. The transcranial Doppler ultrasound (TCD) and carotid ultrasound were used to determine the presence of intracranial (stenosis) and extracranial (plaque) atherosclerosis. The differences in characteristics of different lesions and risk factors for the development of atherosclerosis were compared. RESULTS: Ultrasound examination of the 90 enrolled patients showed that 5 (5.56%) had only intracranial artery stenosis, 30 (33.33%) had only extracranial atherosclerosis, 20 (22.22%) had intracranial artery stenosis combined with extracranial atherosclerosis, and 35 (38.89%) had no lesions. The intracranial stenosis rate (27.78%) was significantly higher than that of extracranial carotid stenosis or occlusion (2.22%) (P < 0.001). Logistic regression analysis revealed that the duration of diabetes mellitus and concomitant hypertension were independent risk factors for intracranial and extracranial atherosclerosis (P < 0.05). Compared with the control group, the study group showed reduced carotid plaque, decreased inflammatory response, total cholesterol (TC) and low-density lipoprotein cholesterol (LDL-C) as well as elevated high-density lipoprotein cholesterol (HDL-C) (P < 0.05). CONCLUSION: Diabetic patients have a higher incidence of atherosclerosis, which is related to the duration of the diabetes mellitus and concomitant hypertension, so the monitoring of these patients needs to be strengthened. In addition, the administration of atorvastatin can better improve hyperlipidemia and slow down the development of atherosclerosis.

A Column-Row-Parallel Ultrasound Imaging Architecture for 3D Plane-wave Imaging and Tx 2nd-Order Harmonic Distortion (HD2) Reduction.

We propose a Column-Row-Parallel imaging frontend architecture for integrated and low-power 3D medical ultrasound imaging. The Column-Row-Parallel architecture offers linear-scaling interconnection, acquisition and programming time with row-by-row or column-by-column operations, while supporting volumetric imaging functionality and fault-tolerance against possible transducer element defects with per-element controls. The combination of column-parallel selection logic, row-parallel selection logic, and per-element selection logic reaches a balance between flexible imaging aperture definition and manageable imaging data / control interface to a 2D array. A 16×16 CMUT-ASIC Column-Row-Parallel prototype is fabricated and assembled with a flip-chip bonding process. It facilitates the 3D plane-wave coherent compounding algorithm for volumetric imaging with a fast frame rate of 62.5 Hz and 46% improved lateral resolution with 10-angle compounding and a field of view volume of 2.3mm in both azimuth and elevation, 8.5mm in depth. At a hypothetically scaled up 64x64 array size, the frame rate can still be kept at 31.2 Hz for a volume of 40mm in both azimuth and elevation, 150mm in depth. An interleaved checker board pattern with in-phase (I) and quadrature (Q) excitations is also demonstrated for reducing CMUT second harmonic distortion (HD2) emission by up to 25 dB at the loss of 3 dB fundamental energy reduction. The method reduces nonlinear effects from both transducers and circuits and is a wide band technique that is applicable to arbitrary pulse shapes.

A Column-Row-Parallel Ultrasound Imaging Architecture for 3-D Plane-Wave Imaging and Tx Second-Order Harmonic Distortion Reduction.

We propose a column-row-parallel imaging front-end architecture for integrated and low-power 3-D medical ultrasound imaging. The column-row-parallel architecture offers linear-scaling interconnection, acquisition, and programming time with row-by-row or column-by-column operations, while supporting volumetric imaging functionality and fault-tolerance against possible transducer element defects with per-element controls. The combination of column-parallel selection logic, row-parallel selection logic, and per-element selection logic reaches a balance between flexible imaging aperture definition and manageable imaging data/control interface to a 2-D array. A capacitive micromachined ultrasonic transducer (CMUT)-application-specific integrated circuit (ASIC) column-row-parallel prototype is fabricated and assembled with a flip-chip bonding process. It facilitates the 3-D plane-wave coherent compounding algorithm for volumetric imaging with a fast frame rate of 62.5 Hz and 46% improved lateral resolution with 10-angle compounding and a field of view volume of 2.3 mm in both azimuth and elevation, 8.5 mm in depth. At a hypothetically scaled up array size, the frame rate can still be kept at 31.2 Hz for a volume of 40 mm in both azimuth and elevation, 150 mm in depth. An interleaved checkerboard pattern with in-phase ( ) and quadrature ( ) excitations is also demonstrated for reducing CMUT second-harmonic distortion emission by up to 25 dB at the loss of 3-dB fundamental energy reduction. The method reduces nonlinear effects from both transducers and circuits and is a wide band technique that is applicable to arbitrary pulse shapes.