WO2020131517A1

WO2020131517A1 - 3d handheld ultrasound imaging device

Info

Publication number: WO2020131517A1
Application number: PCT/US2019/065687
Authority: WO
Inventors: Mu TIAN; Todd ZHOU
Original assignee: Ultrasee Corporation
Priority date: 2018-12-17
Filing date: 2019-12-11
Publication date: 2020-06-25

Abstract

A method and system for home use for performing ultrasound 3D scans is disclosed. The method uses a special designed 2D array transducer. During scan, the device transmits ultrasound waves, and captures a complete set of echo data in RF format. For 2D array, the device does a 3D scan by switching the elements of the 2D array. The collected RF data are first stored in the memory of the device. Then the data is uploaded through, for example using wireless data communications, e.g. Bluetooth, Wi-Fi, etc. or via direct connection, e.g., USB, SATA, eSATA, etc., or using a portable memory device, to a computing system, for example, a desktop, laptop, server, smartphone, wearable, or cloud-based system, or the like. The 3D image is then analyzed by artificial intelligence algorithms and compared to previous captures.

Description

INTERNATIONAL PATENT APPLICATION

TITLE

3D handheld ultrasound imaging device

CROSS-REEERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to U.S. Provisional Patent Application No.

62/780,896 entitled“A 3D handheld ultrasound imaging device,” filed Dec. 17, 2018, the contents of which are hereby incorporated by reference in their entirety.

BACKGROUND

[0002] This disclosure generally relates to ultrasound systems, and more specifically to a method and system for three-dimensional (3D) ultrasound imaging of body tissues.

[0003] Ultrasound systems have become widely-used diagnostic tools for various medical applications. Many ultrasound systems, compared to some other diagnostic tools or systems, are non-invasive and non-destructive. An ultrasound system generally includes a probe for approaching or placing directly on and moving over a subject, such as a patient. The ultrasound system may provide visualization of the subject’s internal structures, such as tissues, vessels, and/or organs. The ultrasound system works by electrically-exciting transducer elements inside the probe to generate ultrasound signals, which travel into the body, and by receiving the echo signals reflected from tissues, vessels, and/or organs. The reflected echo signals are then processed to produce a visualization of the subject’s internal structures.

[0004] One of the uses for ultrasound imaging is for the detection and treatment of cancer tumors. For example, a large body of research has been the developed on the use of ultrasound imaging for the detection and treatment of breast cancer. It is widely accepted in the medical community that early diagnosis of cancerous tumors is crucial for successful treatment. Conventionally, the best approach for detection of tumors in patients has been through magnetic resonance imaging (“MRI”). However, MRI imaging systems and procedures are very expensive. Another approach for tumor detection is through computed tomography (“CT”). CT scanning is a cheaper alternative, but it presents other potential health risks due to the use of X-ray radiation. Yet another imaging alternative is the traditional ultrasound imaging. Ultrasound imaging is even cheaper, but it requires experienced doctors and technicians to do a careful scan and read the results. While these approaches are viable, they all involve costly procedures and the involvement of medical personnel, requiring patients to attend a medical facility to undergo the imaging procedure. These drawbacks make these tumor diagnosis techniques less practical for regular use. For example, it is recommended to perform a monthly self-check for women at risk of breast cancer but making monthly appointments for an imaging procedure is not practical. Thus, women end up relying on their self-checks, which are not as accurate and may lead to missed diagnosis and detection of tumors later than it is desirable.

[0005] Thus, what is needed is an ultrasound-based too and method for self-diagnosis by patients that addresses the deficiencies of the prior art to provide a cost-effective and practical tool for patients to perform regular checks for early tumor detection.

BRIEF SUMMARY

[0006] According to various embodiments of the present invention, an ultrasound-based tool and method are provided that allow users to perform 3D imaging scans conveniently and in a cost-effective and easy to use approach.

[0007] In one embodiment, an apparatus is provided for real-time multi-beam ultrasound imaging. The apparatus includes a transducer container including a plurality of transducers providing a two-dimensional transducer array. A hand-held housing of the apparatus includes ultrasound beam processing and image processing circuits and a memory. The apparatus includes a data interface to transfer ultrasound data to an external computing system for further analysis.

[0008] According to one embodiment, a 3D ultrasound device includes a 2D transducer, a plurality of channels of Analog-to-digital conversion, a plurality of channels of ultrasound pulse generator, an FPGA that collects RF data, compresses RF data or beamforming a 2D image, and stores data into a memory. In embodiments, the memory may include an

SDRAM, USB drive, or the like. In embodiments, the transducer can be a convex transducer or a linear transducer.

[0009] In embodiments, the devices may further include a Wi-Fi module, a rechargeable battery, and a breast coupling cup.

[0010] According to embodiments, a 3D scan of breast tissue may be performed using water as coupling material. The user may lean forward to put a breast inside the breast coupling cup filled with water and perform the 3D scanning with the ultrasound device.

[0011] In embodiments, the breast coupling cup may be of different sizes and replaceable.

[0012] According to embodiments, the 3D ultrasound device can be used to do 3D scan on any other human body tissue, such as, thyroid, skin, eye, and abdominal areas.

[0013] According to embodiments, the device may be water proof. [0014] According to embodiment the 3d ultrasound device stores 3D scanned RF data.

[0015] According to embodiments, the transducer may be an NxN 2D array transducer. Each element of the 2D array includes two wires, a top wire and a bottom wire. In embodiments, the top wires of the same row are connected together resulting in N top wires. The bottom wires of the same column are connected together, resulting in N bottom wires. In embodiments, the N top wires and N bottom wires are coupled to a 2xN switch, where N top wires are sent for analog-to-digital sampling, and one out of N bottom wires is chosen to be the ground signal. In alternative embodiments, N bottom wires are sent to analog-to-digital sampling, and one out of N top wires is chosen to be the ground signal.

[0016] According to embodiments, a 3D ultrasound device has no real-time image viewing capabilities and operates as an offline data capture device.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

[0017] FIG. 1 is a diagram illustrating how to use a handheld ultrasound device on breast according to one embodiment.

[0018] FIG. 2 is a diagram illustrating how to use a handheld ultrasound device on an eye according to one embodiment.

[0019] FIGS. 3A-3B are block diagrams of handheld ultrasound imaging devices according to embodiments of the invention.

[0020] FIG. 4 is an illustrative flow chart of a method of ultrasound imaging according to one embodiment.

[0021] FIG. 5 is an illustrative flow chart of a method of ultrasound imaging and determining an anomaly according to one embodiment.

[0022] The figures depict various example embodiments of the present disclosure for purposes of illustration only. One of ordinary skill in the art will readily recognize form the following discussion that other example embodiments based on alternative structures and methods may be implemented without departing from the principles of this disclosure and which are encompassed within the scope of this disclosure.

DETAILED DESCRIPTION

[0023] A detailed description of one or more example embodiments of a system and method is provided below along with accompanying figures. While this system and method is described in conjunction with such embodiment(s), it should be understood that the system and method is not limited to any one embodiment. On the contrary, the scope of the system and method is limited by the claims and the system and method encompasses numerous alternatives, modifications, and equivalents. For the purpose of example, numerous specific details are set forth in the following description in order to provide a thorough understanding of the present system and method. These details are provided for the purpose of example, and the system and method may be practiced according to the claims without some or all of these specific details.

[0024] For the purpose of clarity, technical material that is known in the technical fields related to the system and method has not been described in detail so that the present system and method is not unnecessarily obscured.

[0025] A system is described for performing ultrasound imaging for detection and diagnosis of tumors. Various embodiments may be implemented in discrete hardware components or, alternatively, in programmed processing units such as digital signal processors using software which is compiled, linked and then loaded from disk-based storage for execution during run time. Various programs including the methods employed in these embodiments may also reside in firmware or other similar non-volatile storage means.

[0026] It should also be appreciated that the present system and method may be implemented in numerous ways, including as a process, an apparatus, a device, or a computer-readable medium such as a non-transitory computer-readable storage medium containing computer- readable instructions or computer program code, or as a computer program product, comprising a non-transitory computer-usable medium having a computer-readable program code embodied therein. In the context of this disclosure, a computer-usable medium or computer-readable medium may be any non-transitory medium that can contain or store the program for use by or in connection with the instruction execution system, apparatus or device. For example, the computer-readable storage medium or computer-usable medium may be, but is not limited to, a random access memory (RAM), read-only memory (ROM), or a persistent store, such as a mass storage device, hard drives, CDROM, DVDROM, tape, erasable programmable read-only memory (EPROM or flash memory), or any magnetic, electromagnetic, infrared, optical, or electrical means or system, apparatus or device for storing information. Alternatively, or additionally, the computer-readable storage medium or computer-usable medium may be any combination of these devices. Applications, software programs or computer-readable instructions may be referred to as components or modules. Applications may be hardwired or hard coded in hardware or take the form of software executing on a general-purpose computer or be hardwired or hard coded in hardware such that when the software is loaded into and/or executed by the computer, the computer becomes an apparatus for practicing the system and method. Applications may also be downloaded, in whole or in part, through the use of a software development kit or toolkit that enables the creation and implementation of the present system and method. In this specification, these implementations, or any other form that the system and method may take, may be referred to as techniques. In general, the order of the steps of disclosed processes may be altered within the scope of the system and method.

[0027] Only claims that use the word“means” in claim elements are intended to be construed under 35 U.S.C. §112(f). The inventors do not intend any other limitations that use words other than“means” to be construed under 35 U.S.C. § 112(f). The claims that do not include the word“means” recite words that provide specific structural elements that are known to those of ordinary skill in the art or otherwise have the structure described in this specification.

[0028] Referring now to FIG. 1 , a diagram illustrating how to use a handheld ultrasound device on breast according to one embodiment. As used herein, the terms“handheld ultrasound device,”“ultrasonic handheld device,”“ultrasound handheld device,” and “handheld device” are used interchangeably to mean a portable ultrasound device for home use, embodiments of which are illustrated in FIGS. 1-3B and described herein. An ultrasound handheld device 100 includes a wired 2D array of ultrasound transducer elements (e.g., 2D transducer array 102). In this embodiment, the 2D transducer array 104 is designed to perform a 3D scan of the user’s tissue of interest by transmitting ultrasound waves at a plurality of locations and receiving response radio frequency (RF) signals by a number of the transducer elements in the 2D transducer array 102. The response RF signals are captured, converted into digital data and stored in local memory. Once a complete 3D scan is done, the complete set of 3D scanned channel RF data is stored in memory. The memory may include an SDRAM or USB drive or the like. Ultrasound handheld device 100 also may include a coupling cup 102, a handheld housing 106 and a button 108. Coupling cup 102 may be configured to be removeably coupled to 2D tranducer array 104 and to hold a liquid (e.g., water, gel, or other coupling medium). Handheld housing 106 may comprise ultrasound beam processing and image processing circuits and memory. Button 108 may be configured to cause 2D tranducer array 102 to perform a 3D scan as described herein.

[0029] According to embodiments, the handheld device 100 may include wireless connectivity, such as Bluetooth, Wi-Fi, or the like. In one embodiment, the wireless connectivity is provided by a wireless module, which may be housed in handheld housing 106. The wireless module reads the RF data out of memory and transmits it to an external computing system, such as a desktop, laptop, server, smartphone, wearable, or the like. In one embodiment, the wireless module provides an Internet data connection to a cloud-based system. In other embodiments, the RF data may be first communicated to another external computing system and then via an Internet connection to a cloud-based system.

[0030] According to embodiments, the RF data is used to generate a 3D image. The 3D image can be displayed on any device comprising a display. For example, in one

embodiment, the ultrasound handheld device includes a display (not shown) for displaying the 3D image. In another embodiment, the external computing system includes software for displaying the 3D image in an attached display. According to embodiments, upon generation, the 3D image may be compared to previous 3D images to assist the user in identifying any change. The 3D image and RF data may be further analyzed using artificial intelligence (“AI”) algorithms to generate a report. The report may be automatically generated and sent to the user. In addition, in embodiments, the report may also be sent electronically to a pre designated doctor for evaluation.

[0031] According to embodiments, compression algorithms are applied to the RF data. In one embodiment, the handheld device includes a processor configured to apply data compression algorithms to the RF data as it is digitized and stored in the memory.

Alternatively, the external computing system may receive the uncompressed data from the handheld device and compress the data, for example before transmission to a cloud-base system. In other embodiments, the RF data may not be compressed.

[0032] According to embodiments, the RF data may be transmitted from handheld ultrasound device 100 to an external computing system using alternative modes. For example, the handheld device may be connected to a wired computer network, e.g., Ethernet, may be directly connected to the external computing system, e.g., via a USB connection. In yet other embodiments, the RF data is transferred to a portable memory system, such as a portable hard-drive, USB drive, or other computer readable media, that then is used to transfer the data to the external computing system.

[0033] According to another aspect of embodiments, the handheld ultrasound device 100 achieves fast ultrasound imaging while keeping lateral resolution the same along an x- direction and a z-direction. In one embodiment, this fast imaging is achieved by wiring the 2D matrix with NxN elements. According to embodiments, the 2D matrix may form a convex (i.e., curved) transducer or linear transducer. Each N element of the 2D transducer array 104 includes two, a top wire and a bottom wire. For each row in the NxN array, the top wires of each N transducer in the row are connected together, such that there are a total of N top wire nodes. The bottom wires of the N elements in the same column are connected together, such that there are a total of N bottom wires nodes. The N top wire nodes and N bottom wire nodes are connected to a 2xN switch, where N top wire nodes are sent for analog-to-digital sampling, and one out of N bottom wire nodes is chosen to be the ground signal. In another embodiment, the N bottom wire nodes are analog-to-digital sampled, while one out of N top wire nodes is chosen to be the ground signal.

[0034] According to one embodiment, the handheld ultrasound device 100 that comprises a 2D transducer array 104, a plurality of channels of Analog-to-digital conversion, a plurality of channels of ultrasound pulse generator, a FPGA that collects the RF data, compresses the RF data or beamforms a 2D image, and stores the resulting data into a memory, such as an SDRAM or a USB drive. In one embodiment, the device also includes a Wi-Fi module and a rechargeable battery. In some embodiments, a breast coupling cup (e.g., coupling cup 102) is also provided. Breast coupling cups may be provided in different sizes and be user replaceable.

[0035] Referring to FIG. 4, according to embodiments, a breast tumor detection method is provided. In one embodiment, a handheld ultrasound device 100 performs a 3D scan using water as ultrasound coupling material. As illustrated in FIG. 1, the handheld device 100 includes a coupling cup 102 attached at the proximal end of the of the device, contiguously to the 2D transducer array. At step 402, a coupling cup may be provided to which a predetermined amount of liquid may be added, the coupling cup configured to hold the predetermined amount of liquid on a surface of ultrasound handheld device 100 and to receive a breast. The surface against which the liquid is added or applied may be adjacent to the 2D transducer array. For example, a user adds a predetermined amount of liquid (e.g., water, gel or other coupling medium) to coupling cup 102. Given the size variability of breasts, the size of coupling cup 102 may be selectable to fit the breast the size. The predetermined amount of water will depend on the cup size and breast size and may be determined by the user through trial and error, or as recommended for a size of coupling cup. The desirable amount of water allows full contact between the water and the skin tissue of the breast to be scanned, leaving no air gaps between the skin tissue and the water. Once the breast has been inserted in the cup, the user pushes an activation interface on handheld ultrasound device 100, for example a button 108, a wireless controller, or the like, and thus ultrasound handheld device 100 receives an input from the activation interface at step 404. In response to the input received, the ultrasound handheld device 100 performs the ultrasound scanning at step 406. Upon completion of the scan, the device 100 provides a feedback signal at step 408, such as a sound, light, or vibration, to indicate to the user that the procedure has terminated and the scan is complete. In some examples, an image of the scan may be displayed on a display at step 410.

[0036] According to embodiments, the handheld ultrasound device 100 is waterproof to avoid any damage from the interaction with the water during the imaging procedure, or at least a surface or side of handheld ultrasound device 100 that is adjacent to the 2D transducer array and is in contact with liquid is waterproof. In one embodiment, the activation interface may communicate with software on a separate device, such as an app on a smartphone, watch, or other remote device in wireless communication with the handheld ultrasound device 100. In another embodiment, an activation interface may be provided by said separate device (e.g., in an app or other user interface) to control the handheld ultrasound device 100.

[0037] Referring now to FIG. 2, a diagram is shown illustrating how to use a handheld ultrasound device on an eye according to one embodiment. A handheld ultrasound device 200 may include the same or similar 2D transducer array 104, handheld housing 106, and button 108. In this embodiment, a coupling liquid (e.g., gel or other suitable coupling medium) is applied on the eye by the user. The user then places the eye on the transducer array side of the handheld ultrasound device 200. Once in a stable position, the user then activates the scanning function, via a button, wireless controller, or the like, and waits for completion. Upon completion, the device provides a feedback signal, such as a sound, light, or vibration, to indicate to the user that the procedure has terminated.

[0038] According to embodiments, the handheld ultrasound device 200 includes a display 210 for displaying the 3D image or other notifications (e.g., light or text to indicate aspects of device 200, such as battery level, status of a scan, scan completed or terminated, errors, and the like). Software on the handheld device may also be provided to perform image processing of the 3D image and prior 3D images taken by the user to highlight any significant differences that may have developed since the last scan.

[0039] Referring now to FIGS. 3A-3B, block diagrams show handheld ultrasound imaging devices according to embodiments of the invention. A handheld ultrasound device 300 includes a probe 310 with a wired 2D array of ultrasound transducer elements. In this embodiment, the 2D array is designed to perform a 3D scan of the user’s tissue of interest by transmitting ultrasound waves at a plurality of locations and receiving response ultrasound signals by a number of the transducer elements in the 2D array. The response ultrasound signals are captured by the transducers and transmitted via wiring 360 between the probe 310 and the controller 320. In the controller 320, the response signals are converted into digital data and stored in local memory. Once a complete 3D scan is done, the complete set of 3D scanned channel ultrasound data is stored in memory. The memory may include any type of storage device, including SDRAM, Flash (e.g., a USB drive), or the like.

[0040] According to embodiments, the handheld device 300 may include a connection 380, which may be a wired connection, such as USB, HDMI, or the like, and/or a wireless connection, such as Bluetooth, Wi-Fi, or the like, to connect the controller 320 with a display-capable device 340. In one embodiment, wireless connection 380 is provided by a wireless module, such as a Qualcomm®-based module including a Snapdragon™-based modem and a FastConnect Wi-Fi and Bluetooth subsystem. Other similar wireless modules, with one or more wireless communication capabilities, including one or more of cellular (e.g., 2G, 3G, LTE, 5G, or the like), Wi-Fi (e.g., 802.11-x), and/or Bluetooth capabilities, may be used in various embodiments. The wireless module reads the ultrasound data out of memory and transmits it to an external display, such as an LCD or OLED display, or a display-capable computing system, such as a desktop, laptop, server, smartphone, wearable, or the like.

[0041] While illustrated as a display or a display-capable device 340, this system element may be a remote computer system or a cloud-based system. For example, in other embodiments, instead of transmitting to a display or a display-capable device, the wireless module 380 provides an Internet data connection to a cloud-based system 340. In other embodiments, the ultrasound data may be first communicated to another external computing system 340 and then via an Internet connection to a cloud-based system.

[0042] According to embodiments, the ultrasound data is used to generate a 3D image. The 3D image can be displayed on any of the devices 340. For example, in one embodiment, the ultrasound handheld device includes an LCD display for displaying the 3D image. In embodiments, the 3D image and/or the ultrasound data may be transmitted through remote computing systems 340 for additional processing, storage, and/or communication. For example, in another embodiment, the external computing system includes software for displaying the 3D image in an attached display. According to embodiments, upon generation, the 3D image may be compared to previous 3D images to assist the user in identifying any change. The 3D image and ultrasound data may be further analyzed using artificial intelligence (“AI”) algorithms to generate a report. The report may be automatically generated and sent to the user. In addition, in embodiments, the report may also be sent electronically to a pre-designated doctor for evaluation.

[0043] According to embodiments, compression algorithms are applied to the ultrasound data. In one embodiment, the handheld device 300 includes a processor-based controller 320 configured to apply data compression algorithms to the ultrasound data as it is digitized and stored in the memory. Alternatively, the external computing system may receive the uncompressed data from the handheld device 300 and compress the data, for example before transmission to a cloud-base system. In other embodiments, the ultrasound data may not be compressed.

[0044] According to embodiments, the ultrasound data may be transmitted from the handheld device 100 to an external computing system using alternative modes. For example, the handheld device 300 may be connected to a wired computer network, e.g., Ethernet, may be directly connected to the external computing system, e.g., via a USB connection. In yet other embodiments, the ultrasound data is transferred to a portable memory system, such as a portable hard-drive, USB drive, or other computer readable media, that then is used to transfer the data to the external computing system.

[0045] According to other embodiments, the handheld ultrasound device has no real-time image display capabilities, is an offline data capture device. In these embodiments, the handheld device transfers the captured data to an external computing system. In one embodiment, the handheld ultrasound device is paired with a smartphone device running software for interfacing with the ultrasound device, for analyzing the scan data, and to provide a user interface to the handheld ultrasound device. For example, in one embodiment, an Android OS app, iOS app, or similar is provided. The app is used to establish a connection between the handheld device and a smartphone, for example, via Bluetooth, Wi Fi, or the like. Through this connection, the scan data is transferred from the ultrasound handheld device to the smartphone for processing. The data may be transferred as it is captured, at periodic intervals during the capturing process, or after completion of the scanning. The app on the smartphone may process the data or may transfer the data to a cloud-service for processing. The app may also provide analysis results to the user. For example, in one embodiment, a cloud service uses artificial intelligence (AI) or other machine learning techniques to analyze a user’s scan data and generate a report that is provided back to the user via the app. An AI system may track multiple instances of scan data from a user and detect changes that are significant to a user’s health (e.g., growth or development of kidney stones, growth or development of a fetus in-utero, growth or development of cancer tissue, development of liquid or abnormal tissue in various areas of the body). In embodiments, the app provides a user interface to control the operation of the handheld device.

[0046] In another embodiment, a ultrasound handheld device 350 includes an NxN 2D array transducer 312, high voltage switches 314 (e.g., 2xN high voltage switches), a pulser module 316, an FPGA 318, and memory 322. In some embodiments, pulser module 316 may be an ultrasound pulse generator with a plurality of channels (e.g., N channels), and may include an analog-to-digital converter (ADC). In some embodiments, the FPGA may function as described herein, configured to collect and compress RF data. Ultrasound handheld device 350 may store data into memory 322. In embodiments, memory 322 may include an SDRAM, USB drive, or the like. In some embodiments, device 350 also may include Wi-Fi 320, or other communications modules, for example to transmit scan data to display 340. In other embodiments, ultrasound handheld device 350 itself may include a display.

[0047] As those in the art will understand, a number of variations may be made in the disclosed embodiments, all without departing from the scope of the invention, which is defined solely by the appended claims. It should be noted that although the features and elements are described in particular combinations, each feature or element can be used alone without the other features and elements or in various combinations with or without other features and elements. The methods or flow charts provided may be implemented in a computer program, software, or firmware tangibly embodied in a computer-readable storage medium for execution by a general-purpose computer or a processor.

[0048] Suitable processors include, by way of example, a general-purpose processor, a special purpose processor, a conventional processor, a GPU, a digital signal processor (DSP), a plurality of microprocessors, one or more microprocessors in association with a DSP core, a controller, a microcontroller, Application Specific Integrated Circuits (ASICs), Field Programmable Gate Arrays (FPGAs) circuits, any other type of integrated circuit (IC), and/or a state machine.

[0049] According to other embodiments, any of the handheld devices described herein (e.g., devices 100, 200, 300 and 350) can be used to do 3D scan on any other human body tissues, such as the thyroid, kidney, uterus, and the like. Referring to FIG. 5, a method of ultrasound imaging and determining an anomaly, according to one embodiment, may begin with receiving an input from an activation interface on a handheld ultrasound device, a surface of which is being applied to a liquid configured to couple skin tissue to the surface at step 502.

In response to the input, an ultrasound scan may be performed at step 504. An ultrasound handheld device may provide a feedback signal indicating when the ultrasound scan is complete at step 506. An image of the ultrasound scan may be displayed at step 508, either on the handheld device itself or on a separate display, a described herein. In some embodiments, the image may be compared with a plurality of images of prior scans at step 510. The plurality of images may be a result of prior ultrasound scans using the same handheld device applied to the same area of skin tissue. In some embodiments, an anomaly may be determined based on said comparison of the image with the plurality of images of prior scans at step 512. In an example, an anomaly may be determined by an AI system configured to determine anomalies in scanned tissue (e.g., abnormalities in a fetus, growth of kidney stones, etc.) based on a series of ultrasound scans, as described above.

[0050] While several implementations have been provided in the present disclosure, it should be understood that the disclosed systems and methods may be implemented in many other specific forms without departing from the scope of the present disclosure. The present examples are to be considered as illustrative and not restrictive, and the intention is not to be limited to the details given herein. For example, the various elements or components may be combined or integrated in another system or certain features may be omitted, or not implemented. Method steps may be implemented in an order that differs from that presented herein.

[0051] Also, techniques, systems, subsystems and methods described and illustrated in the various implementations as discrete or separate may be combined or integrated with other systems, modules, techniques, or methods without departing from the scope of the present disclosure. Other items shown or discussed as coupled or directly coupled or communicating with each other may be indirectly coupled or communicating through some interface, device, or intermediate component, whether electrically, mechanically, or otherwise. Other examples of changes, substitutions, and alterations are ascertainable by one skilled in the art and could be made without departing from the spirit and scope disclosed herein.

[0052] While the above detailed description has shown, described, and pointed out the fundamental novel features of the disclosure as applied to various implementations, it will be understood that various omissions and substitutions and changes in the form and details of the system illustrated may be made by those skilled in the art, without departing from the intent of the disclosure.

[0053] Although this invention has been disclosed in the context of certain preferred embodiments and examples, it will be understood by those skilled in the art that the present invention extends beyond the specifically disclosed embodiments to other alternative embodiments and/or uses of the invention and obvious modifications and equivalents thereof. Thus, it is intended that the scope of the present invention herein disclosed should not be limited by the particular disclosed embodiments described above, but should be determined only by a fair reading of the claims that follow. In particular, materials and manufacturing techniques may be employed as within the level of those with skill in the relevant art.

Furthermore, reference to a singular item, includes the possibility that there are plural of the same items present. More specifically, as used herein and in the appended claims, the singular forms“a,”“and,”“said,” and“the” include plural referents unless the context clearly dictates otherwise. It is further noted that the claims may be drafted to exclude any optional element. As such, this statement is intended to serve as antecedent basis for use of such exclusive terminology as“solely,”“only” and the like in connection with the recitation of claim elements, or use of a“negative” limitation. Unless defined otherwise herein, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs.

[0054] For the sake of clarity, the processes and methods herein have been illustrated with a specific flow, but it should be understood that other sequences may be possible and that some may be performed in parallel, without departing from the spirit of the invention.

[0055] All references cited herein are intended to be incorporated by reference. Although the present invention has been described above in terms of specific embodiments, it is anticipated that alterations and modifications to this invention will no doubt become apparent to those skilled in the art and may be practiced within the scope and equivalents of the appended claims. More than one computer may be used, such as by using multiple computers in a parallel or load-sharing attribute or distributing tasks across multiple computers such that, as a whole, they perform the functions of the components identified herein; i.e. they take the place of a single computer. Various functions described above may be performed by a single process or groups of processes, on a single computer or distributed over several computers. Processes may invoke other processes to handle certain tasks. A single storage device may be used, or several may be used to take the place of a single storage device. The present embodiments are to be considered as illustrative and not restrictive, and the invention is not to be limited to the details given herein. It is therefore intended that the disclosure and following claims be interpreted as covering all such alterations and modifications as fall within the true spirit and scope of the invention.

Claims

CLAIMS What is claimed is:

1. A method for real-time multi-beam ultrasound imaging, the method comprising: providing a coupling cup to which a predetermined amount of liquid may be added, the coupling cup configured to receive a breast and removeably coupled to a handheld device; receiving an input by an activation interface;

performing an ultrasound scan by the handheld device in response to the input;

providing a feedback signal indicating the ultrasound scan has terminated; and displaying an image of the scan on a display.

2. The method of claim 1, wherein the coupling cup is further configured to hold the predetermined amount of liquid against a surface of the handheld device adjacent to a 2D array of ultrasound transducers.

3. The method of claim 2, wherein at least the surface of the handheld device is waterproof.

4. The method of claim 1, wherein the predetermined amount of liquid is sufficient to allow full contact with the area of breast tissue to be scanned by the handheld device.

5. The method of claim 1, wherein the activation interface comprises a button on the handheld device.

6. The method of claim 1, wherein the activation interface is provided by an application on another device in wireless communication with the handheld device.

7. The method of claim 1, wherein the feedback signal comprises a sound.

8. The method of claim 1, wherein the feedback signal comprises a light.

9. The method of claim 1, wherein the feedback signal comprises a vibration.

10. The method of claim 1, wherein the handheld device comprises the display.

11. The method of claim 1, wherein the display is provided on another device in wireless communication with the handheld device.

12. The method of claim 1, wherein the ultrasound scan comprises a 3D scan.

13. A method for real-time multi-beam ultrasound imaging, the method comprising: receiving an input from an activation interface on a handheld ultrasound device, a surface of the handheld ultrasound device being applied to a liquid configured to couple skin tissue to the surface;

perform an ultrasound scan on an area of the skin tissue being coupled by the liquid, in response to receiving the input; provide a feedback signal indicating the ultrasound scan is complete; displaying an image of the ultrasound scan;

comparing the image with a plurality of images from prior ultrasound scans; and determining an anomaly based on a comparison of the image with the plurality of images of prior ultrasound scans.

14. The method of claim 13, wherein the plurality of images resulted from prior scans performed by the same handheld ultrasound device applied to the same area of skin tissue.

15. The method of claim 13, wherein the determining the anomaly is by an AI system configured to to determine anomalies based on a series of ultrasound scans.

16. The method of claim 13, wherein the activation interface comprises a button on the handheld ultrasound device.

17. The method of claim 13, wherein the activation interface is provided by an application on another device in wireless communication with the handheld ultrasound device.

18. The method of claim 13, wherein the feedback signal comprises a sound.

19. The method of claim 13, wherein the feedback signal comprises a light.

20. The method of claim 13, wherein the feedback signal comprises a vibration.

21. The method of claim 13, wherein the handheld ultrasound device comprises the display.

22. The method of claim 13, wherein the display is provided on another device in wireless communication with the handheld ultrasound device.

23. The method of claim 13, wherein the ultrasound scan is a 3D scan.