Method and system for retrospective m-mode and bpps

Abstract

A method for performing a biophysical assessment (BPP) or a modified biophysical assessment (mBPP) using recorded ultrasound data acquired by a non-skilled user, comprising: a) recording a video stream of ultrasound images, wherein the video stream includes images taken according to instructions given to the non-skilled user, the instructions being given by a remote healthcare professional or by pre-recorded or written instructions; and b) performing a BPP or mBPP analysis using three or more parameters selected from heart rate measurements, fetal respiration, movement, tone, and amniotic fluid volume, wherein values ​​of at least some of the parameters are obtained by analyzing the pre-recorded ultrasound image stream.

Description

Technical Field

[0001] This invention relates to a method for performing a 5-step or 4-step biophysical assessment (BPP and mBPP, respectively), including measuring fetal heart rate using pre-recorded data (particularly data recorded by an unskilled user). Background Technology

[0002] The Biophysical Proportioning (BPP) test measures the health of the fetus during pregnancy. A BPP test typically involves a non-stress test using electronic fetal heart rate monitoring (CTG) and fetal ultrasound imaging.

[0003] Fetal heart rate monitoring tracks the fetal heart rate during pregnancy. This helps healthcare professionals (HCPs) assess the fetus's condition and detect early signs of distress. It involves monitoring the fetal heart rate and the mother's uterine contractions to see how the fetus responds. Two types of monitoring can be used—external or internal. External monitoring involves placing an instrument to detect the fetal heartbeat around the pregnant woman's abdomen. An example is a band with ultrasonic piezoelectric or similar transducers or ECG electrodes. For internal monitoring, electrodes measuring the fetal heartbeat are attached to the fetal scalp.

[0004] Using ultrasound imaging, the BPP assesses the fetal heart rate, muscle tone, movement, respiration, and amniotic fluid levels. For high-risk pregnancies, or if there are concerns about fetal health, reduced fetal movement, fetal growth problems, or if the pregnancy is beyond 40 weeks, healthcare professionals may perform this test in the third trimester or earlier.

[0005] Until this invention, performing any kind of BPP test required the physical presence of a healthcare professional near the fetus, which limited the frequency of such tests and required pregnant women to visit a healthcare facility for each test, resulting in inconvenience and expense.

[0006] BPP score

[0007] The biophysical score combines two tests to check the overall health of the fetus: a non-stress test and ultrasound.

[0008] The non-stress test examines the fetal heart rate and uterine contractions. The device is used to monitor fetal movement and heart rate. This test assesses fetal health and determines if the fetus is at risk of complications. The presence of fetal heart rate acceleration or deceleration is crucial, and the test follows a systematic interpretation approach. It has no predictive value and only indicates fetal hypoxemia at the time of testing. Guideline examples for this test can be found in "Maternity - Fetal heart rate monitoring, GL2018_025, Ministry of Health, Public Health System, NSW, Australia" or from the US ACOG (American College of Obstetricians and Gynecologists) guidelines.

[0009] The Biophysical Scale (BCS) test [National Library of Medicine, National Center for Biotechnology Information, Ultrasound Biophysical Scale, January 2022] assesses fetal breathing, movement, tone, and amniotic fluid volume. Each zone is given a score of 0 or 2, with a total score ranging from 0 to 10. Scores of 8 to 10 are reassuring, 4 to 6 may require further testing or delivery, and scores of 0 or 2 almost always result in immediate delivery. This test can help healthcare professionals (HCPs) determine whether preterm delivery or medication is necessary.

[0010] Modified Biophysical Scale - mBPP

[0011] The modified biophysical score is a prenatal test that combines non-stress testing with imaging ultrasound to measure amniotic fluid volume. It can be just as valuable as the complete biophysical plethysmography (mBPP). Low levels of amniotic fluid may indicate placental problems. Several methods of mBPP exist, including rBPP, which has shown a high correlation with classic BPP in clinical trials [Nasrin Soufizadeh et al., 2019].

[0012] ACOG recommends that mBPP or BPP may also be used for prenatal fetal surveillance in pregnancies with an increased risk of adverse perinatal outcomes, including but not limited to pregnancies with the following conditions: hypertension, preeclampsia, pre-gestational diabetes mellitus, poorly controlled or pharmacologically treated gestational diabetes mellitus, poorly controlled hyperthyroidism, chronic kidney disease, systemic lupus erythematosus, antiphospholipid syndrome, hemoglobinopathies (sickle cell disease), maternal cyanotic heart disease, moderate or severe asthma during pregnancy, alloimmunization, oligohydramnios, unexplained or recurrent stillbirth risk, fetal growth restriction, and late pregnancy at 41 0 / 7 weeks or beyond, as described in several professional publications [2-5].

[0013] The Society of Obstetricians and Gynaecologists of Canada (SOGC) recommends that prenatal fetal monitoring may also be beneficial in pregnancies with the following conditions [Liston R et al.]: premature rupture of membranes, chronic (stable) abruption, vaginal bleeding, abnormal maternal serum screening in cases where no fetal abnormalities have been confirmed, motor vehicle accidents during pregnancy, morbid obesity, advanced maternal age, assisted reproductive technology, multiple pregnancies, polyhydramnios, and preterm birth.

[0014] Amniotic fluid volume is measured as a vertical measurement of the single deepest amniotic fluid pocket, in centimeters, and a lateral measurement of 1 cm or wider, excluding the small portion of the fetus or the umbilical cord [Chamberlain PF, etc.].

[0015] The measurement is defined as “reactive” if two or more fetal heart rate accelerations are observed during a 20-minute observation period that are at least 15 beats per minute above (but not necessarily maintained) the baseline and last for at least 15 seconds from baseline to baseline, and the measurement is defined as “non-reactive” if fewer than two fetal heart rate accelerations as described above are observed after a 40-minute observation period [Practice Bulletin No. 145].

[0016] A score of 10 out of 10, or 8 out of 10 with normal amniotic fluid, is considered normal. A score of 6 is considered ambiguous, and a score of 4 or less is abnormal. A score of less than 8 indicates that the fetus may not be receiving enough oxygen. However, as described in several publications [9-11], a transient decrease in biophysical activity may also be seen in preterm fetuses after administration of betamethasone ether or dexamethasone to enhance fetal lung maturation.

[0017] Other non-exclusive methods for calculating FHR without tapes

[0018] In addition to the classic DOPETONE (i.e., non-imaging Doppler signal for measuring heartbeat), new methods have been introduced to measure fetal heart rate (FHR) without the use of a band. These methods include 2D speckle tracking, which uses pattern matching methods to automatically calculate FHR. This technique uses myocardial deformity imaging to assess cardiac function and has been validated in several trials. Advanced ultrasound systems, such as Hitachi's AutoFHR, Toshiba's Artida system, and GE's Voluson E10 BT19 ultrasound system, provide these tools, but they are expensive and typically used in specialized healthcare settings.

[0019] It should be emphasized that all of the above methods must be performed by qualified healthcare professionals, typically in a clinical setting and using expensive equipment. Prior to this invention, no method has been provided that allows for the determination of fetal heart rate or estimation of BPP or mBPP based on data provided by the patient themselves (obtained outside of such a specialized professional setting).

[0020] B-mode and M-mode scanning

[0021] Ultrasound equipment uses B-mode imaging to create two-dimensional images of organs and tissues. M-mode operation, available in sophisticated ultrasound equipment, provides a high temporal resolution view of the fetal heart. Doppler measurements are not used except in specific cases due to ALARA rules, AIUM (American Society of Ultrasound in Medicine) guidelines, and guidelines from other national associations. Doppler ultrasound imaging is a technique that uses reflected sound waves to measure motions such as blood flow and heartbeat. The use of Doppler technology is often associated with high-risk pregnancies. In some cases, Doppler imaging can predict fetal distress earlier than BPP [FarzadAfzali-12]. Doppler ultrasound scans can be used to determine blood flow velocity and its direction. This information helps determine whether fetal growth is normal, whether tissues are receiving adequate blood and nutrient supply, and whether fetal distress is detected. Again, scans must be performed by qualified healthcare professionals, typically in a clinical setting and with expensive equipment.

[0022] Currently, home-use devices exist for self-scanning at home to generate ultrasound images, such as the Pulsenmore ES device (https: / / pulsenmore.com / prenatal) manufactured by the applicant. When patients scan themselves in non-clinical settings, such as using an ultrasound system at home, it should be understood that lay users are unfamiliar with all the terminology related to BPP, Doppler, and scanning. Therefore, it would be highly advantageous if the system allowed HCPs to obtain this information remotely or offline.

[0023] It is clear from the above that allowing for a more convenient and easier way to determine, for example, fetal heart rate through the actions of an unskilled operator (such as the patient themselves) is crucial for maintaining fetal health and avoiding adverse events that could be prevented if BPP or mBPP could be easily obtained.

[0024] One object of the present invention is to provide a method and system for performing a basic part of a fetal biophysical assessment using an ultrasound scanning device operated by a pregnant woman or other unskilled individual in the absence of the physical presence of a medical professional during the scan.

[0025] Another object of the present invention is to provide a method and system for performing offline fetal heart rate measurement using pre-recorded ultrasound images (regardless of the skill of the person recording them).

[0026] Another object of the present invention is to perform heart rate and other measurements by allowing M-mode measurements to be performed on previously acquired ultrasound images.

[0027] Another object of the present invention is to allow the use of pre-recorded Doppler data to measure fetal heartbeat.

[0028] Another object of the present invention is to allow the use of pre-recorded ultrasound data to perform additional measurements, such as amniotic fluid content and fetal movement.

[0029] Another object of the present invention is to allow healthcare professionals to derive the fetal heart rate from previously acquired ultrasound images, particularly if the organ being measured is moving or the scanner is moving during the scan, which typically occurs when a patient is performing a self-scan or when a non-skilled user is performing a scan.

[0030] Another object of the present invention is to provide a method and system in which the determination of fetal heart rate can be obtained from ultrasound images obtained by an unskilled user outside a medical setting (such as a self-scan obtained privately by a pregnant woman in her home).

[0031] Another object of the present invention is to allow the administration of BPP or mBPP performed at home to be guided by healthcare professionals using remotely activated Doppler measurements.

[0032] Another object of the present invention is to provide a method and system for generating BPP or mBPP scores offline or online, including but not limited to combining M-mode or Doppler measurements during remote scanning (telemedicine) when the patient is not in a clinical setting.

[0033] As the description proceeds, other objects and advantages of the invention will become clear. Summary of the Invention

[0034] In one aspect, the present invention relates to a method for performing BPP or mBPP using recorded ultrasound data acquired by a non-skilled user, comprising: a) A video stream recording ultrasound images, wherein the video stream includes images captured according to instructions given to the unskilled user, either by a telehealth professional or by pre-recorded or written instructions; and b) Perform BPP or mBPP analysis using three or more parameters selected from heart rate measurement, fetal respiration, movement, tension, and amniotic fluid volume, wherein values ​​of at least some of the parameters are obtained by analyzing a pre-recorded stream of ultrasound images.

[0035] The pre-recorded ultrasound image data stream can be stored at a location remote from the recording device, and the data stream can be stored at the remote location during or after the scanning operation. In one embodiment of the invention, the data stream is first stored in a memory provided in the scanning device or in a device communicating with the scanning device, and then transmitted to a remote location for analysis. In some embodiments, the device communicating with the scanning device communicates via Bluetooth or WiFi.

[0036] The present invention also relates to a method for measuring fetal heartbeat, comprising: i. Using a scanning device suitable for operation by an unskilled user, the user records the data stream of ultrasound image measurements; ii. Store the recorded data stream; and iii. At a location separate from the scanning device, analyze the stored stream to obtain measurements of the fetal heartbeat.

[0037] In some embodiments, the method includes: a) Displaying a video stream of the acquired ultrasound images on a display associated with the image processing device; b) Locate the fetal heart on the video stream; c) Selecting a beam from multiple beams that generate an ultrasound image on the display, the selected beam passing through the fetal heart; d) Create a periodic view of the fetal heartbeat by generating a magnified, time-lapse view of data captured from a selected portion of a beam passing through the heart; and e) Determine the heart rate by selecting at least two locations spatially separated by one cycle of a sinusoidal heartbeat signal on the time-delay view, determining the time difference between the at least two locations, and normalizing over a predetermined time period.

[0038] In embodiments of the invention, at least two positions spatially separated by one sinusoidal heartbeat signal cycle are two adjacent maximum or minimum values, and in other embodiments, the time difference between at least two adjacent maximum values ​​in the heartbeat is normalized to a time period of at least one minute.

[0039] Specific embodiments of the invention include using tracking processing to compensate for movement of the region of interest in the image and repositioning the analyzed beam to a new location. In some cases, data collected before repositioning the analyzed beam is used together with data collected on the repositioned beam.

[0040] In a further embodiment, the present invention relates to a method for obtaining a measurement result of a fetal heartbeat, comprising: a) Displaying a video stream of the acquired ultrasound images on a display associated with the image processing device; b) Locate the fetal heart on the video stream; c) Selecting a beam from a plurality of beams generating an ultrasound image on the display, the selected beam passing through the fetal heart; and Locate the beam that triggers the Doppler signal and extract the heart rate measurement results from it.

[0041] The Doppler device can be, for example, a pulse-wave Doppler device. In embodiments of the invention, the Doppler frequency shift is calculated using FOI, BOI, and POI by reconstructing the stored scan RBI, and in a particular embodiment, cloud computing is used to perform the reconstruction of the Doppler image in the cloud.

[0042] The present invention also includes a device for obtaining measurements of fetal heartbeat from ultrasound images, comprising: I) A display mechanism adapted to display a video stream of acquired ultrasound images; II) Selection component, which is adapted to select a single beam from multiple beams that make up an ultrasound image; III) An image generating apparatus adapted to generate an enlarged time-lapse view of data captured by a portion of the beam; and IV) A measuring element suitable for measuring the time difference between locations spatially separated by one cycle of a sine wave representing a heartbeat.

[0043] The apparatus of the present invention can be used both for real-time generation of ultrasound image streams and for in-situ generation of ultrasound image streams. As will be understood, the apparatus can operate in conjunction with a pre-recorded ultrasound image stream. Furthermore, the apparatus may also include an image processing unit, which can also be adapted to perform image tracking.

[0044] The present invention also relates to a system for obtaining measurement results of fetal heartbeat, comprising: A. A device suitable for recording a data stream of ultrasound images or Doppler measurements by a user using a scanning device suitable for operation by a non-skilled user; B. A remote storage device suitable for storing recorded data streams; and C. Cloud computing equipment suitable for collaborative analysis of acquired streams to derive fetal heart rate values.

[0045] In some embodiments, the system of the present invention includes a communication channel for transmitting a data stream from the scanning device to a location remote from the recording device.

[0046] In some embodiments, the cloud computing device communicates with a display for displaying a video stream of acquired ultrasound images and with an image processing device adapted to perform the following operations: a) Locate the fetal heart on the video stream; b) Select a beam from multiple beams that generate an ultrasound image on the display, the selected beam passing through the fetal heart; c) Create a periodic view of the fetal heartbeat by generating a magnified, time-lapse view of data captured from a selected portion of a beam passing through the heart; and d) The heart rate is determined by selecting at least two locations spatially separated by one cycle of a sinusoidal heartbeat signal on the time-delay view, determining the time difference between the at least two locations, and normalizing over a predetermined time period.

[0047] Specific embodiments of the present invention relate to a system for obtaining blood flow velocity measurement results using Doppler imaging, comprising: i. A device suitable for recording a data stream of ultrasound images or Doppler measurements by a user using a scanning device suitable for operation by a non-skilled user; ii. A remote storage device for storing the recorded data stream; and iii. A cloud computing device or HCP interpreter device suitable for analyzing stored flows to derive estimates of blood flow velocity.

[0048] The system can also be used to color blood vessels with different colors to distinguish between blood flow moving toward the transducer and blood flow moving away from the transducer.

[0049] Another embodiment of the present invention relates to a means for assisting the execution of mBPP, comprising: a) A housing adapted to hold the scanning assembly, the housing being provided with an opening that allows the ultrasound transducer to contact the patient's skin; b) A fastening component adapted to maintain the housing securely positioned on the patient's skin; and c) A positioning component adapted to position the transducer and change its orientation relative to the patient's body.

[0050] The fastening component may include a strap, and in some embodiments, the fastening component further includes a resilient segment. In some embodiments, the positioning component is a ball joint adapted for fitting into a socket provided in the housing.

[0051] In some cases, a system for performing mBPP may include the means for assisting in performing mBPP as described above and a device provided with an ultrasonic transducer suitable for acquiring ultrasonic data.

[0052] In some cases, the method of the present invention for performing BPP or mBPP using recorded ultrasound data acquired by a non-skilled user determines fetal breathing, fetal movement, and fetal tone by comparing two or more subsequent images in a video stream of ultrasound images.

[0053] In other cases, the method of the present invention for performing BPP or mBPP using recorded ultrasound data acquired by a non-skilled user determines the amount of amniotic fluid by locating the amniotic fluid bag on a frame in the video stream of the ultrasound image and measuring its height.

[0054] As will be apparent to those skilled in the art, the present invention allows for retrospective M-mode analysis to measure fetal heartbeats during ultrasound scans, even when the scanner is moving relative to an organ or tissue, or when the scanner is stationary but the organ is moving. The invention can also be implemented during remote, real-time measurements over a smartphone, Wi-Fi, or cellular network.

[0055] M-mode ultrasound is a common ultrasound imaging technique designed to extract motion signals from a series of ultrasound frames. One application of M-mode is to analyze heart rate by tracking the cardiac cycle of systole and diastole. In a hospital setting, M-mode is performed by intersecting the heart with a line plotted on the screen corresponding to one of the ultrasound beams. The M-mode image shows the change in signal along this line over time during the ultrasound scan, generating a cardiac cycle image that can be evaluated by medical professionals.

[0056] When a patient (a lay user) performs a scan at home using a home ultrasound device (such as that described in, for example, U.S. Patent No. 10,610,194), the signal across each ultrasound beam is stored and then transmitted to the cloud. As will be explained further below, this makes it possible to generate M-mode images afterward, and clinicians can retrospectively evaluate cardiac activity on a pre-recorded scan, even though it was acquired by an unskilled patient or assistant. The same applies, with necessary modifications, to Doppler.

[0057] A key aspect of this invention is the ability to handle movement of the heart's position within a frame. Such movement is typically caused by the patient moving the probe during the scan, which usually does not occur in clinical settings when professional healthcare professionals perform scans using standard clinic equipment. To address this issue, a retrospective M-mode algorithm tracks the heart's position on the B-mode image, and when the heart no longer intersects with the beam, a new intersecting beam is selected, and the signal along that beam is plotted in the M-mode image. With necessary modifications, this also applies when using Doppler mode.

[0058] All the above and other features and advantages of the present invention will be further described in the following illustrative description of its embodiments. Attached Figure Description

[0059] In the attached diagram: Figure 1 A dashboard for healthcare professionals is shown, displaying five different ultrasound scan streams that healthcare professionals can choose from; Figure 2 The frames of interest (FOIs) that have been selected for further operations are shown. Figure 3 The illustration shows the selection of a single beam of interest (BOI) from which data is to be extracted; Figure 4 The selection of points of interest (POIs) along the BOI is shown; Figures 5-8 Various manipulations are shown on the bottom screen window that displays the cardiac cycle derived from M mode: Figure 5 : This shows the M-mode cardiac cycle; Figure 6 Controls the contrast of the M-mode image; Figure 7 Controlling the time window of the M-mode image; and Figure 8 Controls the depth window of the M-mode image.

[0060] Figure 9 The diagram illustrates how cardiac cycles can be marked during the analysis; Figure 10 The diagram illustrates motion compensation in M ​​mode; Figure 11 The diagram illustrates the operation of a Doppler probe, where one element of the probe acts as a transmitter and the other element acts as a receiver. Figure 12 This is a schematic illustration of CW, PW, and multi-range gated PW Doppler technologies; Figure 13 The standard Doppler realization is illustrated schematically; Figure 14 This is an illustrative view of the heart rate measurement results using Doppler; Figure 15 The image shown is obtained using a pulse wave Doppler device; Figure 16 (AB) illustrates the determination of amniotic fluid status; Figure 17 (AC) illustrates three different situations regarding amniotic fluid in the fetus; Figure 18 (AB) shows the determination of fetal movement (head); Figure 19 (AB) shows the determination of fetal movements (limbs); Figure 20 (AB) shows the head circumference measurement; Figure 21 The measurement of the biapex diameter (BPD) plane is shown; Figure 22 (AB) shows the detection of fetal breathing; Figure 23 (AB) is a further illustration of fetal breathing detection; Figure 24 This is a perspective view of an embodiment of a novel apparatus suitable for carrying out the present invention; Figure 25 From Figure 24 A perspective view of the device from below; Figure 26 These are exploded views of specific embodiments of the device of the present invention; and Figure 27 What the patient saw Figure 24 Front view of the device. Detailed Implementation

[0061] The system of the present invention includes a storage device for the entire stream of ultrasound images acquired by an ultrasound scanner or Doppler device, which will be discussed later. Although ultrasound devices currently available on the market employ M-mode imaging, this is only a real-time function, and they do not retrospectively support this function after a scan has been completed.

[0062] In contrast to existing technologies, this invention allows healthcare professionals to evaluate cardiac cycles from ultrasound images of previously completed scans performed by a patient or another individual (skilled or unskilled). In other words, according to the invention, selected beam signals acquired during a scan can be reconstructed to retrospectively generate M-mode images. This reconstruction is possible because this information is captured during the scan and stored in a special structure representing the raw beam information (“RBI”), which can then be used for offline analysis. Each RBI file comprises a series of Z vector arrays (Z depends on the device’s frame rate and the length of the scan record – for example, 1200 arrays for a 60-second scan at 20 frames per second). Each vector array comprises N vectors representing the ultrasound beam (N is typically 128 for commercial devices and is determined by the beamforming function, such as the Pulsenmore ES device (https: / / pulsenmore.com / prenatal / )).

[0063] Each vector (beam) comprises M elements (e.g., 1008 elements per vector, where element 0 represents the closest distance to the transducer and element 1008 represents the farthest distance to the transducer). Each element is represented by a numeric value (e.g., using a byte structure, where 0 represents no signal and 255 represents the highest possible signal received). A single element represents the signal strength on a specific beam at a specific time, and by depicting all elements as pixels varying over time for a specific beam, we obtain an M-mode image. This is a typical M-mode structure for a specific BOI N, where pixels (representing depth) are drawn from top to bottom (from P1 to P...). M ), and the frames (representing time) span from left to right across frames (from F1 to F). Z )draw, [F1 B N P1] [F2 B N P1] … [F Z B N P1] [F1 B N P2] [F2 B N P2] … [F Z B N P2] ... [F1 B N P M [F2 B] N P M … [F Z B N P M ] In contrast to existing technologies, it is also possible to retrospectively select the beam on which M-mode analysis has already been performed. This means that if the heart position changes over time, or if there is a need to assess other types of motion, the user can select a different BOI and generate time-series M-mode images along this newly selected beam.

[0064] According to the present invention, the system operator (usually, but not necessarily, a healthcare professional) can select the BOI and generate different M-mode images for different selected beams. Furthermore, since the analysis is performed retrospectively, the M-mode time series includes information collected for past and future frames relative to the current frame selected with respect to the BOI.

[0065] As will be apparent to those skilled in the art, this invention opens up numerous opportunities for system users to analyze different parts of ultrasound as if they were captured in M-mode, even if they are not. This allows users to freely run ultrasound image streams forward and backward and obtain the best possible information that can be extracted from the image stream.

[0066] The system according to the illustrative embodiment of the present invention has the following features: 1. App functionality: This app collects and stores the RBI structure during scanning and uploads it to the cloud upon completion of the scan; 2. User interface, used to view scan segments and play them back as a series of B-mode images; 3. A user interface for generating M-mode images by selecting the FOI, BOI, and POI of a given scan and fragment; and 4. Cloud functionality for generating M-mode images for a given scan, fragment, FOI, BOI, and POI.

[0067] According to an alternative embodiment of the invention, instead of performing steps 1-4 as described above, the RBI structure is directly sent to a reader device (also referred to as an "interpreter"), which may be, for example, a smart device or a computer, in which data interpretation is performed.

[0068] Example

[0069] The following abbreviations are used in the example below: MVP – Maximum Vertical Bag BPD – Biapervous Diameter AC – Waist circumference HC – Head Circumference FHR – Fetal Heart Rate MM – millimeter BPM - Heart rate per minute AF – Amniotic fluid The features and advantages of the invention will be further illustrated by the following examples provided with reference to the accompanying drawings. Referring to the use of the Pulsenmore system and the aforementioned Pulsenmore ES device, it should be understood that, with necessary modifications, the same applies to ultrasound image streams acquired through different devices.

[0070] Example 1

[0071] Fetal heart rate measurement

[0072] Figure 1 A clinician dashboard user interface is shown, in which a user logged into the Pulsenmore system can view multiple ultrasound scan video clips. The actual structure of the dashboard is not important to the present invention, and the dashboard shown in the figure is provided merely for illustrative purposes. Various methods and apparatuses for labeling ultrasound images and performing measurements thereon are known in the art and therefore will not be discussed herein for the sake of brevity. For illustration, the user selects clip 3 and performs an M-mode measurement. The user can generate a retrospective M-mode for each scan by clicking the FHR (fetal heart rate) button at the top of each clip.

[0073] Before starting FHR measurement, the user needs to locate the heart in the clip. Once the heart is visible, the user pauses the clip and uses... Figure 2 The arrow button shown moves back and forth between frames to find the frame of interest (FOI), which is the frame that shows a good image of the heart.

[0074] On FOI, users select the beam of interest (“BOI”) by intersecting the line with the heart's location. For example... Figure 3 As shown, this line is used to specify the beam index for generating an M-mode image by plotting the ultrasound signal over time along this line. Since the lines that can be plotted can only exist in overlap with the actual beams forming the image, the coordinates of the intersecting lines define the actual BOI.

[0075] On the BOI, when measuring fetal heart rate using M mode, the user clicks to mark a point of interest ("POI"), i.e., the location of the heart. For example... Figure 4 As shown, this location also defines the vertical center on the M-mode image, which is the POI depth in the image. This sets the FOI, BOI, and POI used to generate the M-mode image.

[0076] As will be apparent to those skilled in the art, the detection of FOI, BOI, and POI can be automated using image processing designed to detect the location of the heart in a scanned segment. The manual process is explained herein for the purpose of better illustrating the procedure, but any automated detection is also intended to be covered by this invention.

[0077] The Pulsenmore system generates an M-mode image using FOI, BOI, and POI by invoking a cloud function that reconstructs the image using raw beam information (RBI) stored in the cloud. This reconstruction process will be clear to those skilled in the art; therefore, for the sake of brevity, it will not be described in detail herein. Figure 5 As shown, once the image is ready, it is displayed below the B-mode image to demonstrate the cardiac cycle with objective heart rate measurement enabled.

[0078] like Figures 6-8 As shown, users can use various controls to enhance the visibility of the cardiac cycle, change image contrast, and zoom in / out along the depth and time axes. Figure 9 As shown, once the heartbeat cycle is clearly visible, the user marks two or three points (or more if desired, though not required) to enable automatic measurement of the fetal heart rate.

[0079] Mobility compensation

[0080] Motion compensation is crucial in home use scenarios. In a home setting, the patient (or someone assisting the patient) holds the ultrasound device. As the patient moves it to capture scan information, the heart's position changes across consecutive frames. For example... Figure 10 As shown, the motion compensation algorithm tracks the heart location in a series of B-mode images and allows for automatic relocation of the BOI and POI in consecutive frames. The tracking method is well-known in the art and therefore will not be described in detail here. A bounding box defining the region of interest (AOI) around the POI is used across consecutive frames using a pattern matching algorithm, and the center of the bounding box defines the calculated BOI and POI in different frames. The M-mode image constructed using motion compensation aggregates the signal along the calculated BOI instead of simply using the original BOI as a fixed index for this reconstruction, and enables the generation of M-mode images from scans performed comfortably by a lay user at home.

[0081] Use B [Fx] To describe the calculated beam index in frame X, the M-mode image reconstructed using motion compensation is: [F1 B [F1] P1] [F2 B [F2] P1] … [F Z B [FZ] P1] [F1 B [F1] P2] [F2 B [F2] P2] … [F Z B [FZ] P2] … [F1 B [F1]P M [F2 B] [F2] P M … [F Z B [FZ] P M ] Compared to reconstructed B-mode images without motion compensation: [F1 B N P1] [F2 B N P1] … [F Z B N P1] [F1 B N P2] [F2 B N P2] … [F Z B N P2] … [F1 B N P M [F2 B] N P M … [F Z B N P M ] From the above description of this illustrative embodiment, it is now clear that, unlike the M-mode currently available to healthcare professionals, which does not allow for alteration of the selected beam during ultrasound image examination to obtain better and more accurate results, the present invention allows for the operation of a “retrospective M-mode” that is necessary to generate a fetal biophysical score with high accuracy and is based on all data acquired during the ultrasound scan. This novel method and system opens new avenues for better and easier determination of the fetal BPP, which was not available prior to this invention.

[0082] In one embodiment of the invention, Doppler measurements are applied remotely to a home device by a healthcare professional. The resulting response can be used by the healthcare professional to draw clinical conclusions during the procedure; however, according to another embodiment of the invention, the output of the results can also be saved for later analysis.

[0083] This alternative embodiment of the invention can be used when performing Doppler measurements. According to this embodiment, the entire ultrasound measurement stream performed by a non-skilled user (or, of course, if the user is skilled) is saved and subsequently analyzed. As will be apparent to those skilled in the art, the Doppler effect will only exist where the beam passes through the fetal heart. Therefore, the saved raw data can be analyzed to identify the location in the data stream where the maximum Doppler effect is observed, and then the fetal heartbeat can be extracted using methods known in the art.

[0084] When Doppler is involved, the Pulsenmore system calculates the Doppler frequency shift using FOI, BOI, and POI by invoking a cloud function that reconstructs the image using the scanned RBI stored in the cloud or a function of the device itself. This reconstruction process will be clear to those skilled in the art, and therefore, for the sake of brevity, it will not be described in detail herein. Examples of signal mixers implemented in hardware can be found in many AFE (Analog Front-End - Tx / Rx) chips used for ultrasound, such as the Texas Instruments 58XX series. However, according to the present invention, the information stored in the original beam is now used to generate IQ channels fed to a software mixer and used to extract the Doppler frequency shift from which heart rate or blood flow velocity is derived. Furthermore, typically in hardware AFE semiconductors (integrated circuits), the IQ mixer is used for several channels. This is due to the size of the chip and the cost of implementing the mixer. In one embodiment of the invention, the mixer is implemented in the cloud or in the reader's intelligent device or computer (i.e., the interpreter) using at least one mixer for each channel implemented in software. Therefore, for a 64-element ultrasound probe, 64 software mixers are provided, and for a 128-element ultrasound probe, 128 software mixers are provided accordingly. It is also possible to store transmitted signals with known frequencies, correlated reflected signals (received signals), extract Doppler frequency shifts in frequencies, and derive, for example, velocities. If a transducer with 128 or more elements is considered, the same applies to 128 or more elements, thereby generating 128 (or more, depending on the case) cloud mixers or mixers generated in a reader smart device or computer.

[0085] There are many options for estimating fetal heart rate. The standard options are listed below; please refer to the details. Figure 12 The illustration shows CW, PW, and multi-range gated PW Doppler techniques. These estimates are performed in the cloud or HCP reading device, all derived from the raw beam uploaded from the patient device.

[0086] CW Doppler employs two piezoelectric elements: one continuously emits ultrasound waves, while the other continuously detects ultrasound echoes from the tissue. The overlap field is the location where the Doppler signal can be detected, the "sampling volume" (SV). The sampling volume is smaller in PW Doppler, and the SV depth can be remotely selected or varied based on the original beam present in a file sent from the scanner to the cloud or an HCP device (i.e., the interpreter mentioned above). In multi-range gated PW Doppler, the SV is segmented, enabling the identification of various Doppler spectra through cross-sections of the blood vessel.

[0087] Figure 13The diagram schematically illustrates a standard implementation where the signal is multiplied by the Doppler measurement in the IQ scheme, the envelope is detected, and the fetal heart rate is estimated. Similar results can be achieved in a remote HCP device or in the cloud, where the method detects the amplitude (directional signal) of the positive and negative signals, rather than the envelope. Figure 14 The image shows an illustrative view of the heart rate measurement results using Doppler.

[0088] In pulsed-wave Doppler, the same elements are used for both transmission and reception, and a brief pulse of ultrasonic energy is emitted. Range gating is used to receive only echoes from a specific depth. Duplexing involves Doppler imaging superimposed on B-mode imaging. Figure 15 The image shown is obtained using a pulse-wave Doppler device. Figure 15 In the image, number 151 indicates negative flow, where blood flows away from the probe, and 152 indicates positive flow, where blood flows towards the probe. In actual Doppler images, different colors (e.g., blue and red) will indicate these two flows.

[0089] Three types of pulse-wave Doppler are used in ultrasound machines: Color, power, and spectrum. In color Doppler, a sampling volume is set, and the mean and variance of the velocity of the moving structure are calculated in a cloud or HCP remote device. Power Doppler images only map the amplitude of the Doppler signal and do not provide any indication of velocity. All movement, regardless of phase, contributes to the amplitude. This means that power Doppler emphasizes blood flow. Therefore, for example, blood flow in the umbilical cord can be visualized, and the presence of a problem can be determined when very low blood flow is present. Spectral Doppler shows the range of Doppler frequencies that return over time and are displayed in the spectrogram. Differences in vascular wall resistance produce different spectral trajectories.

[0090] In embodiments of the invention, a lay user (i.e., the patient) performs a scan when Doppler imaging is activated. Therefore, measurements of blood flow and heart rate are stored in a data file on the patient's device, which is uploaded to the cloud or to a reader (HCP) device and extracted from the image (raw beam). It can be concluded that if CW (continuous wave) is used, for example by an IQ (in-phase and quadrature) scheme known in the art, PW (pulse wave) can be used to utilize software and process the selected beam. Furthermore, if Doppler measurements are applied remotely, information about the raw beam is stored in a file to generate I and Q channels in the cloud, or sent for processing in a remote HCP device. A signal mixer can be used, thus allowing the extraction of frequency offset (Doppler) and calculation of heart rate, all in software, rather than in hardware in the cloud (i.e., instead of integrated circuits) or in the remote HCP device. Furthermore, to measure heart rate, HCP can remotely use one element from the probe to transmit and another element to receive for applying heart rate measurement, and Doppler calculations can be performed in the cloud or on the HCP interpreter device. Therefore, this invention enables HCP to view scan segments in which Doppler has been applied, as well as to view information that is not real-time but scanned by lay users in non-clinical settings.

[0091] When applying Doppler, two mandatory parameters must be monitored: the mechanical index and the temperature index (Mi and Ti, respectively). Therefore, during remote BPP or via Doppler imaging scans, the HCP sets the system parameters, applies Doppler or M-mode, and measures the heartbeat (or, where appropriate, visualizes blood flow, such as from the umbilical cord). Mi and Ti can be presented along with the image. In the case of offline M-mode analysis, where the patient scans themselves and sends the scan fragments to the HCP for reading and interpretation, these parameters are extracted from the beam (raw data) that generated the image.

[0092] Example 2

[0093] A comparative BPP test was conducted at Belinson Hospital in Israel over a three-month period. The test was performed on 30 women. The comparison involved performing BPP tests using ultrasound scans collected remotely under the guidance of healthcare professionals using the aforementioned Pulsenmore ES device, followed by repeating the BPP analysis using a standard ultrasound setup.

[0094] Thirty participants were recruited. Data from all participants were analyzed; there were no withdrawals or exclusions, and no one refused to participate. The mean gestational age at participation was 33.0 ± 2.6 weeks. The mean maternal age of the participants was 31.4 ± 4.51 years, and the mean BMI was 27.4 ± 5.24 kg / m². 2It is worth noting that 30% of the participants had a body mass index (BMI) greater than 30 kg / m³. 2 BMI. 80% of participants were classified as having a high-risk pregnancy, attributed to a chronic pre-existing condition or maternal / fetal complications in their current pregnancy (Table 1).

[0095] The overall concordance between BPP scores obtained from physician-guided scans and in-hospital scans was 90%, including complete concordance for 25 participants with normal BPP scores and 2 participants with abnormal BPP scores. Both methods defined AFV (amniotic fluid volume) and fetal movement score as normal (2 / 2) for all participants, indicating 100% concordance. Fetal tone score was 2 / 2 for all participants via in-hospital scan, but not observed in one participant via Pulsenmore ES scan (0 / 2), indicating 96.7% concordance between scans for this biophysical parameter. Fetal respiratory movement concordance between the two scans was obtained for 28 participants (93.3% concordance); 26 participants had normal scores (2 / 2) and two participants had abnormal scores (0 / 2). Inconsistency was obtained for two participants: one received a score of 0 / 2 only on the Pulsenmore ES scan, and the other received a score of 0 / 2 only on the in-hospital scan.

[0096] Compared with in-hospital scanning, Pulsenmore ES scanning showed a sensitivity of 92.6% and a specificity of 66.7% (Table 2).

[0097] The comparison of the mean total BPP score between the two methods showed the smallest difference between remote Pulsenmore ES and in-hospital scanning, with a total score difference of 0.07 ± 0.64 (0.5 ± 9.01%).

[0098] The average duration required to achieve a full BPP score for remote scanning was 8.0 ± 3.94 minutes, while the average duration for in-hospital scanning was 4.6 ± 3.33 minutes. Considering only normal BPP (8 / 8 score for both methods, n = 25), the average duration for Pulsenmore ES and the in-hospital method decreased to 6.9 ± 3.05 minutes and 3.8 ± 2.08 minutes, respectively. Notably, the total time required to complete a remote BPP scan is still significantly shorter than the 20-minute test limit (Table 3).

[0099] Cardiac activity was detected in all participants using both methods, and fetal heart rate (FHR) could be measured. FHR values ​​measured in both methods were similar, with a mean difference of 1.7 ± 8.4 beats / minute (BPM) (1.5 ± 5.88%). Subjective assessments of AFV were identical in all participants under both procedures; 27 participants had normal AFV, and 3 had abnormalities, all due to oligohydramnios. MVP values ​​measured in both methods were also similar, with a mean difference of 0.19 ± 1.11 cm (6.5 ± 23.06%) (Table 4). Fetal presentation and placental location were successfully identified in all participants, with 100% concordance between the methods (Table 4).

[0100] Table 1: Demographic and medical information of participants

[0101] Table 2: Scores of BPP spectrogram parameters obtained by Pulsenmore ES and conventional clinical scanning

[0102] Table 3: Duration required to achieve each BPP parameter and total BPP score, comparison of Pulsenmore ES with conventional in-hospital scanning.

[0103] Table 3 (continued)

[0104] Table 4: Image quality, cardiac activity, AFV, fetal presentation, and placental position assessment during BPP, compared with routine in-hospital scanning.

[0105] Table 4 (continued)

[0106] Table 4 (continued)

[0107] Example 3

[0108] Measurement of amniotic fluid bag

[0109] Figure 16A The image shows a frame containing the amniotic fluid bag. To determine the amniotic fluid volume, the recorded video was stopped at that frame, and two points were marked using a measurement tool (known in itself), then the distance between those two points was measured. Figure 16B In the example shown, the measurement result is 5.5cm.

[0110] like Figure 17A , Figure 17B and Figure 17C As shown, three different conditions are clearly identified: normal amniotic fluid bag, abnormal amniotic fluid condition (low AF < 2 cm), and abnormal amniotic fluid condition (high AF > 8 cm).

[0111] Example 4

[0112] fetal head movements

[0113] Figure 18A The image shows the fetus's head at time 0:00 in the video, 180 degrees, before it moves in the direction indicated by the arrow. From Figure 18B It is clearly visible that the fetal head had already moved at time 0:01. Therefore, this important parameter for BPP analysis can be obtained by retrospectively analyzing a series of recorded ultrasound images.

[0114] Example 5

[0115] Fetal tone - fetal limb movements (flexion and extension)

[0116] Figure 19 (A and B) shows how to determine fetal tension—another important BPP factor. Figure 19A An ultrasound scan obtained from a series of consecutive scans is shown, in which the fetal legs are seen in a resting position at time 0:19. Figure 19B The same limb is shown in the extended position at time 0:20.

[0117] Example 6

[0118] Head circumference (HC) and body circumference (BPD) measurements

[0119] Instructions are given to the subject via written or recorded guidance or through remote assistance from a healthcare professional to guide her to align the ultrasound with the biparietal diameter (BPD) plane of the fetal head.

[0120] In the recorded images, the person performing BPP can see the entire fetal head on the desired plane (e.g.) Figure 20A The video was paused when 200 locations were observed, and then the HC tool was selected. The measurement involved the following steps: Identification marker: Locate the biparietal diameter (BPD) plane, which is the widest part of the head. This plane should include the thalamus and the cavum septum pellucidum.

[0121] Mark points: Use the mouse cursor to mark two points at the anterior-posterior (AP) ends of the outer edge of the skull. This will draw a circle based on the two marked points.

[0122] Track the circumference: Use the mouse wheel to widen or narrow the ellipse. Adjust the mouse width until the ellipse is positioned as close to the fetal skull as possible.

[0123] like Figure 21 As shown, BPD can also be measured on the same image. Figure 21 The BPD shown at the top is also an important factor in BPP.

[0124] Example 7

[0125] Breathing Practice Demonstration

[0126] After the 27th week of pregnancy, the fetus in the uterus can demonstrate respiratory movements by expanding its chest. These movements can be captured in ultrasound images.

[0127] Focusing on the fetal chest allows you to see the breathing exercises, but because the breathing in a fetus is very subtle, Figures 22A to 2 The 2D diagram will describe this feature in detail. In the drawing, 220 indicates the top of the chest. (As shown...) Figure 22A As seen in the image, the top of the chest is almost entirely outside the two dashed lines drawn on the map, but lies in... Figure 22A Shot one second later Figure 22B In the image, the top of the chest is almost entirely within the area defined by the dotted line. This indicates breathing, and while breathing may be difficult to see in a live scan, it can be more easily located using pre-recorded video.

[0128] Figure 23B Further, by showing at four different times (i.e., 458 seconds, 466 seconds, 477 seconds, and 511 seconds) Figure 23A The four images taken in the rectangular section 230 illustrate this point.

[0129] Illustrative embodiments of a device for facilitating self-acquisition of BPP data will now be described. For example, the device may use a 2D phased array transducer (e.g., a 32×16 element or other combination) or a 64×1 element phased array for mBPP ultrasound scanning. The phased array transducer is housed in a device that is fixed to the patient's abdomen. In the illustrative embodiments described below, a strap with an elastic portion is used for fixation, but it can be fixed by any other means known per se in the art.

[0130] The device is designed to allow the transducer to perform a two-dimensional scan (i.e., a rectangular coverage area of ​​the fetus) and collect its mBPP vital signs. As those skilled in the art will understand, the time required to collect significant vital signs is long, approximately 20 minutes, and it is impractical to require the patient to keep the transducer stationary for such a long period while data is being collected. The device according to the invention overcomes this problem and avoids related discomfort to the patient.

[0131] Now go to Figure 24 The numeral 260 generally indicates an apparatus according to an embodiment of the invention, which provides a structure 261 for holding a transducer, the structure 261 being incorporated into a device 264 which will be discussed further below, and is provided with a hook and loop belt 262, a portion of which includes a rubber cord 263, to be referenced. Figure 26 Discuss its functions. Figure 25 The bottom portion 270 of structure 261 is shown, in which the transducer contacts the patient's skin through opening 271.

[0132] Figure 26 yes Figure 24 An exploded view of the device. The base 280 of the device 261 has four cord rollers 282 at its corners, allowing for fine tightening or loosening of the straps 262. The base 280 has a socket 281 into which a ball-and-socket connector 283 is fitted. An opening 271 is provided at the bottom of the socket 281, through which the transducer can reach the patient's skin. The bottom of the socket 283 is also opened (not shown) to allow the transducer to pass through.

[0133] Device 264, including the transducer, is fitted into ball joint 283. For ease of assembly, this specific embodiment also provides a sponge housing 284 fitted into the upper opening of ball joint 283; however, as those skilled in the art will understand, it may be built into ball joint 283 and is not provided separately. Device 264 may be any suitable device adapted to scan and transmit ultrasound scan data to another device or location for further processing, and may be, for example, the Pulsenmore ES device manufactured by Pulsenmore Ltd (https: / / pulsenmore.com / prenatal / ) or a device as described in WO2021 / 220263.

[0134] Figure 27 yes Figure 24 The front view of component 260. Device 264 is adapted to accommodate a smartphone for operating the transducer, recording or transmitting scan data, and performing other activities. In this specific embodiment, a connector 290 is provided, which is adapted for, for example, an Android device, and an additional connector 291 may be provided for other types of smart devices, such as iOS smartphones. Device 264 may also communicate with smart devices via a wireless connection (e.g., Bluetooth or Wi-Fi).

[0135] As will be clear to those skilled in the art, Figures 24-27The device is a useful aid for patients who have difficulty performing the procedure themselves without it, but it is not essential for BPP or mBPP. Some patients can perform the procedure quickly while holding the transducer with one hand and do not require the device.

[0136] Although the invention is illustrated by the example of fetal heart rate measurement, the retrospective M-mode of the invention can be used to analyze any other real-time changes occurring anywhere in an ultrasound scan, such as visualization of routine lung movement.

[0137] All descriptions of the methods and systems of the present invention above are provided for illustrative purposes and are not intended to limit the invention in any way. As will be apparent to those skilled in the art, different implementations of the method can be designed using various image processing and data processing methods without departing from the scope of the invention.

[0138] List of references: 1. Diagnostic Value of Rapid Biophysical Profile in Comparison toBiophysical Profile in Pregnant Women with Insulin-Dependent Diabetes NasrinSoufizadeh, MD, Fariba Farhadifar, MD, Saghar Tamri, MD, SaraBehafarid, MD, Karim Sharifi, MD, Sima Aslani, MD, and MobinNaqshbandi, MD J Family Reprod Health. 2019 Dec; 13(4): 209–213. 2. Antepartum fetal surveillance. Practice Bulletin No. 145. American College of Obstetricians and Gynecologists. Obstet Gynecol 2014;124:182–92PMID:24945455. 3. Asthma in pregnancy. ACOG Practice Bulletin No. 90. 4. American College of Obstetricians and Gynecologists. ObstetGynecol 2008; 111:457–64.PMID: PMID:18238988. 5. Management of late-term and post-term pregnancies. PracticeBulletin No. 146. American College of Obstetricians and Gynecologists. ObstetGynecol 2014;124:390–6. PMID: PMID:25050770. 6. Liston R, Sawchuck D, Young D; Society of Obstetrics andGynaecologists of Canada; British Columbia Perinatal Health Program. J ObstetGynaecol Can. 2007 Sep;29(9 Suppl 4):S3-56. Erratum in: J Obstet GynaecolCan. 2007 Nov;29(11):909. PMID:17845745 Available at: http: / / sogc.org. 7. Chamberlain PF, Manning FA, Morrison I, Harman CR, Lange IR.Ultrasound evaluation of amniotic fluid volume. I. The relationship ofmarginal and decreased amniotic fluid volume to perinatal outcome. Am JObstet Gynecol 1984;150:245–9.PMID:6385713. 8. Antepartum fetal surveillance. Practice Bulletin No. 145. AmericanCollege of Obstetricians and Gynecologists. Obstet Gynecol 2014;124:182–92PMID:24945455. 9. Rotmensch S, et al., The effect of betamethasone and dexamethasoneon fetal heart rate patterns and biophysical activities, A prospectiverandomized trial. Acta Obstet Gynecol Scand. 1999 Jul;78(6):493-500. PMID:PMID:10376858. 10. Antepartum fetal surveillance. Practice Bulletin No. 145.American College of Obstetricians and Gynecologists. Obstet Gynecol 2014;124:182–92PMID:24945455. 11. Fetal health surveillance: antepartum and intrapartum consensusguideline. Liston R, Sawchuck D, Young D; Society of Obstetrics andGynaecologists of Canada; British Columbia Perinatal Health Program. J ObstetGynaecol Can. 2007 Sep;29(9 Suppl 4):S3-56. Erratum in: J Obstet GynaecolCan. 2007 Nov;29(11):909. PMID:17845745 Available at: http: / / sogc.org / wp-content / uploads / 2013 / 01 / gui197CPG0709r.pdf 12. Biophysical Profile & Color Doppler Ultrasound in the High-RiskPregnancy August 17, 2011, Farzad Afzali, MD.

Claims

1. A method for performing BPP or mBPP using recorded ultrasound data acquired by a non-skilled user, comprising: a) A video stream of recorded ultrasound images, wherein the video stream includes images captured in accordance with instructions given to the unskilled user, the instructions being given by a remote healthcare professional or by pre-recorded or written instructions; as well as b) Perform BPP or mBPP analysis using three or more parameters selected from heart rate measurement, fetal respiration, movement, tension, and amniotic fluid volume, wherein values ​​of at least some of the parameters are obtained by analyzing a pre-recorded stream of ultrasound images.

2. The method of claim 1, wherein, The data stream of pre-recorded ultrasound images is stored at a location far from the recording device.

3. The method of claim 2, wherein, During the scanning operation, the data stream is stored to a remote location.

4. The method of claim 2, wherein, The data stream is first stored in a memory provided in the scanning device or in a device communicating with the scanning device, and then transmitted to a remote location for analysis.

5. The method of claim 4, wherein, The device communicating with the scanning device communicates via Bluetooth or WiFi.

6. A method for measuring a fetal heartbeat, comprising: iv. Using a scanning device suitable for operation by an unskilled user, the user records the data stream of ultrasound image measurements; v. To store the recorded data stream; as well as vi. At a location separate from the scanning device, analyze the stored stream to obtain a measurement of the fetal heartbeat.

7. The method of claim 6, comprising: a) Displaying a video stream of the acquired ultrasound images on a display associated with the image processing device; b) Locate the fetal heart on the video stream; c) Selecting a beam from a plurality of beams that generate the ultrasound image on the display, the selected beam passing through the fetal heart; d) Create a periodic view of the fetal heartbeat by generating an enlarged, time-lapse view of data captured from a selected portion of the beam passing through the heart; as well as e) Determine the heart rate by selecting at least two locations on the delay view that are spatially separated by one cycle of a sinusoidal heartbeat signal, determining the time difference between the at least two locations, and normalizing over a predetermined time period.

8. The method of claim 7, wherein, The at least two positions spatially separated by one sinusoidal heartbeat signal cycle are two adjacent maximum or minimum values.

9. The method of claim 7, wherein, The time difference between at least two adjacent maximum values ​​in the heartbeat is normalized for a period of at least one minute.

10. The method of claim 7, further comprising using tracking processing to compensate for movement of the region of interest in the image and repositioning the analyzed beam to a new location.

11. The method of claim 10, wherein, The data collected before the analyzed beam was repositioned was used together with the data collected on the repositioned beam.

12. A method for obtaining a measurement result of a fetal heartbeat, comprising: a) Displaying a video stream of the acquired ultrasound images on a display associated with the image processing device; b) Locate the fetal heart on the video stream; c) Selecting a beam from a plurality of beams that generate the ultrasound image on the display, the selected beam passing through the fetal heart; as well as Locate the beam that triggers the Doppler signal and extract the heart rate measurement results from it.

13. The method of claim 12, wherein the Doppler device is a pulse wave Doppler device.

14. The method of claim 11, wherein the Doppler shift is calculated using FOI, BOI, and POI by reconstructing the stored scan RBI.

15. The method of claim 14, wherein cloud computing is used to perform the reconstruction of the Doppler image in the cloud.

16. An apparatus for obtaining a measurement result of a fetal heartbeat from an ultrasound image, comprising: I) A display mechanism adapted to display a video stream of acquired ultrasound images; II) A selection component adapted to select a single beam from a plurality of beams constituting the ultrasound image; III) An image generating apparatus adapted to generate an enlarged time-lapse view of data captured by a portion of the beam; as well as IV) A measuring element adapted to measure the time difference between locations spatially separated by one cycle of a sine wave representing a heartbeat.

17. The apparatus of claim 16, wherein an ultrasound image stream is generated in real time.

18. The apparatus of claim 16, wherein the ultrasound image stream is generated in situ.

19. The apparatus of claim 16, wherein an ultrasound image stream is pre-recorded.

20. The apparatus of claim 16, further comprising an image processing component.

21. The apparatus of claim 20, wherein the image processing unit is adapted to perform image tracking.

22. A system for obtaining measurements of a fetal heartbeat, comprising: D. A device suitable for recording a data stream of ultrasound images or Doppler measurements by a user using a scanning device suitable for operation by a non-skilled user; E. A remote storage device adapted to store a recorded data stream; as well as F. Cloud computing equipment, which is suitable for collaborative analysis of acquired streams to derive fetal heart rate values.

23. The system of claim 22, further comprising a communication channel for transmitting a data stream from the scanning device to a location remote from the recording device.

24. The system of claim 22, wherein the cloud computing device communicates with a display for displaying a video stream of acquired ultrasound images and with an image processing device adapted to perform the following operations: a) Locate the fetal heart on the video stream; b) Select a beam from a plurality of beams that generate the ultrasound image on the display, the selected beam passing through the fetal heart; c) Create a periodic view of the fetal heartbeat by generating an enlarged, time-lapse view of data captured from a selected portion of the beam passing through the heart; as well as d) The heart rate is determined by selecting at least two locations spatially separated by one cycle of a sinusoidal heartbeat signal on the time-delay view, determining the time difference between the at least two locations, and normalizing over a predetermined time period.

25. A system for obtaining blood flow velocity measurement results using Doppler imaging, comprising: iv. A device suitable for recording a data stream of ultrasound images or Doppler measurements by a user using a scanning device suitable for operation by a non-skilled user; v. A remote storage device for storing a recorded data stream; as well as vi. A cloud computing device or HCP interpreter device, which is adapted to analyze stored flows to derive an estimate of blood flow velocity.

26. The system of claim 25 is further adapted to color blood vessels with different colors to distinguish between blood flow moving toward the transducer and blood flow moving away from the transducer.

27. An apparatus for assisting the execution of mBPP, comprising: a) A housing adapted to hold the scanning assembly, the housing being provided with an opening that allows the ultrasound transducer to contact the patient's skin; b) A fastening component adapted to maintain the housing securely positioned on the patient's skin; and c) A positioning component adapted to position the transducer and change its orientation relative to the patient's body.

28. The device of claim 27, wherein the fastening component comprises a strap.

29. The device of claim 28, wherein the fastening member further comprises an elastic segment.

30. The apparatus of claim 27, wherein the positioning component is a ball joint adapted for fitting into a socket provided in the housing.

31. A system for performing mBPP, the system comprising the apparatus of claim 27 and a device provided with an ultrasonic transducer adapted to acquire ultrasonic data.

32. The method of claim 1, wherein fetal breathing, fetal movement, and fetal tone are determined by comparing two or more subsequent images in a video stream of ultrasound images.

33. The method of claim 1, wherein the amount of amniotic fluid is determined by locating the amniotic bag on a frame in the video stream of the ultrasound image and measuring its height.

Images