Methods and systems for customized ultrasound guidance

Abstract

A method (100) for locating a specific internal anatomy of a subject using an ultrasound system, comprising: receiving (120) ultrasound input from one or more blind sweeps of a first region of the subject; analyzing (130) the received ultrasound input to generate an anatomy map of the first region; providing (140) a guidance instruction to a user of the ultrasound system; receiving (150), after the user moves the ultrasound probe to a new first location based on the provided instruction, ultrasound input obtained from the new first location; comparing (160) the ultrasound input obtained from the new first location to the generated anatomy map; determining (180) that the ultrasound input comprises the specific internal anatomy of the subject; and providing (190) an instruction to the user of the ultrasound system that the specific internal anatomy of the subject has been located.

Description

2024PF00293METHODS AND SYSTEMS FOR CUSTOMIZED ULTRASOUND GUIDANCEField of the Disclosure

[0001] The present disclosure is directed generally to methods and systems for locating a specific internal anatomy of a subject using an ultrasound system.Background

[0002] Ultrasound technology has become a ubiquitous and indispensable tool in modern medicine. Its widespread adoption is due to its non-invasive nature, real-time imaging capabilities, and versatility in diagnosing and monitoring a variety of medical conditions. Ultrasound exams are routinely performed to assess fetal development, guide interventions, and provide critical information that aids in ensuring the health and well-being of both mother and child. Beyond obstetrics, ultrasound is used in cardiology, emergency medicine, and many other specialties, making it an essential component of contemporary healthcare practices. Its ability to deliver immediate, clear images without the risks associated with ionizing radiation further underscores its utility and widespread use in clinical settings worldwide.

[0003] One important use of prenatal ultrasound technology is the determination of fetal heart rate, which is a vital indicator of fetal well-being. Accurate measurement of the fetal heart rate can help detect abnormalities early, guiding appropriate medical interventions.

[0004] Despite its ubiquity and importance, performing a fetal heart sweep during an ultrasound exam presents several challenges. One of the main difficulties is that the probe users, often sonographers or obstetricians, must navigate without always being able to interpret the ultrasound images in real time. This task is further complicated if the exact position of the fetus is not known. Without this knowledge, locating the fetal heart and capturing relevant images becomes significantly more difficult. These challenges are heightened if the sonographer is inexperienced.Summary of the Disclosure

[0005] There is thus a continued need for methods and systems that efficiently and accurately enable the location of specific internal anatomy of a subject using an ultrasound system even for inexperienced users.2024PF00293

[0006] Various embodiments and implementations are directed to a method and system for locating internal anatomy of a subject using ultrasound. One or more blind sweeps are obtained of a region of a subject, such as the abdomen. A mapping algorithm analyzes the ultrasound input obtained from the blind sweeps and generates an anatomy map of the region. The map is then utilized by the system to provide guidance instructions to the user, which comprises at least an instruction to move the ultrasound probe to a location within the first region. After the user moves the ultrasound probe, additional ultrasound input is obtained. The system compares the ultrasound input obtained from the new location to the generated anatomy map, and determines that the ultrasound input comprises the specific target internal anatomy of the subject. Alternatively, the system may determine that the target internal anatomy has not been found, and provides additional guidance instructions. Once the target internal anatomy has been found, the system provides an instruction to the user of the ultrasound system that the specific internal anatomy of the subject has been located.

[0007] According to an aspect, a method for locating a specific internal anatomy of a subject using an ultrasound system is provided. The method includes: receiving ultrasound input from one or more blind sweeps of a first region of the subject; analyzing, with a mapping algorithm, the received ultrasound input to generate an anatomy map of the first region of the patient; providing, based on the generated anatomy map, a guidance instruction to a user of the ultrasound system, comprising an instruction to move an ultrasound probe of the ultrasound system; receiving, after the user moves the ultrasound probe to a new first location based on the provided instruction, ultrasound input obtained from the new first location; comparing the ultrasound input obtained from the new first location to the generated anatomy map; determining, based on the comparison, that the ultrasound input comprises the specific internal anatomy of the subject; and providing, based on the determination, an instruction to the user of the ultrasound system that the specific internal anatomy of the subject has been located.

[0008] According to an embodiment, the method further includes: determining, based on the comparison, that the ultrasound input obtained from the new first location does not comprise the specific internal anatomy of the subject; providing, based on the generated anatomy map, a second guidance instruction to the user of the ultrasound system, comprising an instruction to move an ultrasound probe of the ultrasound system; and receiving, after the user moves the ultrasound probe2024PF00293 to a new second location based on the provided instruction, ultrasound input obtained from the new second location.

[0009] According to an embodiment, the mapping algorithm is a machine learning algorithm.

[0010] According to an embodiment, the guidance instruction is a visual instruction provided via a user interface.

[0011] According to an embodiment, the guidance instruction is an audible instruction.

[0012] According to an embodiment, the guidance instruction further comprises a starting point for the ultrasound probe.

[0013] According to an embodiment, the guidance instruction further comprises an instructed angle of the ultrasound probe.

[0014] According to an embodiment, the subject is pregnant, and the specific internal anatomy is a region of a fetus.

[0015] According to an embodiment, the generated anatomy map is a map of a fetus.

[0016] According to an embodiment, the generated anatomy map comprises an estimated location of at least the heart of the fetus.

[0017] According to another aspect is a system for locating a specific internal anatomy of a subject using an ultrasound system. The system includes an ultrasound probe configured to obtain ultrasound imagery from the subject; a user interface configured to provide output to a user; a mapping algorithm configured to generate an anatomy map of a region of the patient; and a processor configured to: (i) receive, from the ultrasound probe, ultrasound input from one or more blind sweeps of a first region of the subject; (ii) analyze, with the mapping algorithm, the received ultrasound input to generate an anatomy map of the first region of the patient; (iii) provide, based on the generated anatomy map, a guidance instruction to a user of the ultrasound system via the user interface, comprising an instruction to move an ultrasound probe of the ultrasound system; (iv) receive, after the user moves the ultrasound probe to a new first location based on the provided instruction, ultrasound input obtained from the new first location using the ultrasound probe; (v) compare the ultrasound input obtained from the new first location to the generated anatomy map; (vi) determine, based on the comparison, that the ultrasound input comprises the specific internal anatomy of the subject; and (vii) provide, based on the determination, an instruction to the user of the ultrasound system via the user interface that the specific internal anatomy of the subject has been located.2024PF00293

[0018] It should be appreciated that all combinations of the foregoing concepts and additional concepts discussed in greater detail below (provided such concepts are not mutually inconsistent) are contemplated as being part of the inventive subject matter disclosed herein. In particular, all combinations of claimed subject matter appearing at the end of this disclosure are contemplated as being part of the inventive subject matter disclosed herein. It should also be appreciated that terminology explicitly employed herein that also may appear in any disclosure incorporated by reference should be accorded a meaning most consistent with the particular concepts disclosed herein.

[0019] These and other aspects of the various embodiments will be apparent from and elucidated with reference to the embodiment(s) described hereinafter.Brief Description of the Drawings

[0020] In the drawings, like reference characters generally refer to the same parts throughout the different views. The figures showing features and ways of implementing various embodiments and are not to be construed as being limiting to other possible embodiments falling within the scope of the attached claims. Also, the drawings are not necessarily to scale, emphasis instead generally being placed upon illustrating the principles of the various embodiments.

[0021] FIG. 1 is a flowchart of a method for locating internal anatomy of a subject using an ultrasound system, in accordance with an embodiment.

[0022] FIG. 2 is a schematic representation of an ultrasound system, in accordance with an embodiment.

[0023] FIG. 3 is a flowchart of a method for training an anatomy mapping algorithm model, in accordance with an embodiment.

[0024] FIG. 4 is a schematic representation of a generated anatomy map, in accordance with an embodiment.2024PF00293Detailed Description of Embodiments

[0025] The present disclosure describes various embodiments of a system and method configured to locate internal anatomy of a subject using an ultrasound system. More generally, Applicant has recognized and appreciated that it would be beneficial to more efficiently and accurately enable the location of specific internal anatomy of a subject using an ultrasound system even for inexperienced users. Thus, one or more blind sweeps are obtained of a region of a subject, such as the abdomen. A mapping algorithm analyzes the ultrasound input obtained from the blind sweeps and generates an anatomy map of the region. The map is then utilized by the system to provide guidance instructions to the user, which comprises at least an instruction to move the ultrasound probe to a location within the first region. After the user moves the ultrasound probe, additional ultrasound input is obtained. The system compares the ultrasound input obtained from the new location to the generated anatomy map, and determines that the ultrasound input comprises the specific target internal anatomy of the subject. Alternatively, the system may determine that the target internal anatomy has not been found, and provides additional guidance instructions. Once the target internal anatomy has been found, the system provides an instruction to the user of the ultrasound system that the specific internal anatomy of the subject has been located.

[0026] The embodiments and implementations disclosed or otherwise envisioned herein can be utilized with any system or process that may utilize or benefit from locating patient anatomy. The embodiments and implementations disclosed or otherwise envisioned herein can be utilized with any system that generates the imaging data comprising patient-specific anatomical data, including but not limited to Philips® imaging modalities and devices (manufactured by Koninklijke Philips, N. V.), among other products. However, the disclosure is not limited to these devices or systems, and thus disclosure and embodiments disclosed herein can encompass any system that may utilize or benefit from improved location of patient anatomy.

[0027] Referring to FIG. 1 , in one embodiment, is a flowchart of a method 100 for locating a specific internal anatomy of a subject using an ultrasound system. The methods described in connection with the figures are provided as examples only, and shall be understood not to limit the scope of the disclosure. The ultrasound system can be any of the systems described or otherwise envisioned herein. The ultrasound analysis system can be a single system or multiple different systems.2024PF00293

[0028] At step 110 of the method, an ultrasound system 200 is provided. Referring to an embodiment of an ultrasound system 200 as depicted in FIG. 2, for example, the system comprises one or more of a processor 220, memory 230, user interface 240, communications interface 250, and storage 260, interconnected via one or more system buses 212. It will be understood that FIG. 2 constitutes, in some respects, an abstraction and that the actual organization of the components of the system 200 may be different and more complex than illustrated. Additionally, ultrasound system 200 can be any of the systems described or otherwise envisioned herein. Other elements and components of the ultrasound system 200 are disclosed and / or envisioned elsewhere herein.

[0029] According to an embodiment, the ultrasound system 200 comprises or is in direct or indirect communication with an imaging modality 270. The imaging modality can be, for example, an ultrasound system such as EPIQ® system, Philips Lumify®, and Philips Affinity®, among many others. The images obtained using the imaging modality may be obtained from a clinical provider or other individual. For example, the user of the imaging modality may be an experienced sonographer, a first-time user of ultrasound, or any experience level in between.

[0030] According to an embodiment, the ultrasound system 200 comprises or is in direct or indirect communication with an image database 280. The image database may be any image database, and may comprise images or videos or reports or other data obtained using any imaging modality, such as imaging modality 270. The image database 280 may be local to the ultrasound system, and may optionally be a component of the system. The image database 280 may alternatively be remote to the ultrasound system, and thus is in direct or indirection communication with the ultrasound system.

[0031] According to an embodiment, the ultrasound system 200 comprises or is in direct or indirect communication with an electronic medical record system and / or an electronic medical records (EMR) database from which the information about patients, including demographic, diagnosis, and / or treatment information, may be obtained or received. For example, EMR database may comprise information about an imaging or treatment procedure for a patient, including the anatomy that will be imaged during the procedure. According to an embodiment, the electronic medical record system may be a local or remote database and is in direct and / or indirect communication with system 200. Thus, according to an embodiment, the system comprises an electronic medical record database or system.2024PF00293

[0032] At step 120 of the method, initial ultrasound imaging of the patient or subject is obtained using the imaging modality 270 of the ultrasound system 200. The patient or subject can be any subject that could potentially benefit from ultrasound. According to one embodiment, the subject is pregnant and the target of the ultrasound is the fetus. However, many other subjects and targets are possible. Thus, the ultrasound imaging may be obtained of any region of the subject’s body, such as the abdomen, chest, head, or limbs among other regions. The ultrasound imaging may be obtained using any method, system, or technique for obtaining ultrasound imaging.

[0033] According to an embodiment, the ultrasound imaging is obtained via one or more blind sweeps of a target region of the subject. Ultrasound blind sweeps, also known as blind scanning, is a technique used in ultrasound imaging where the ultrasound user systematically moves an ultrasound probe across the patient’s body without the immediate visual feedback of the ultrasound images. This method is often employed when the exact location of a target structure, such as the fetal heart, is unknown. The user may optionally rely on their knowledge of anatomy and the typical positions of structures to guide the probe. Typically, once the general area is identified via the blind sweep(s), detailed imaging can be performed to confirm the findings. This technique is particularly useful in scenarios where time is of the essence, or when the patient’s anatomy or the position of the fetus makes targeted scanning difficult.

[0034] Once obtained, the ultrasound imaging may be utilized immediately, and / or it may be temporarily or permanently stored in local and / or remote memory for future use, including in image database 280.

[0035] At step 130 of the method, the ultrasound system 200 analyzes the input from the initial ultrasound imaging to generate an anatomy map of the scanned region of the subject. The anatomy map can be generated using any method for creating a map using ultrasound. According to an embodiment, anatomy maps are created to show the estimated location of anatomy, such as fetal anatomies, detected in blind sweeps. The ultrasound system can analyze the input received during the blind sweeps of the subject’s body in a variety of different ways to generate the anatomy map of the region. For example, a processor of the ultrasound system may be configured or programmed to receive and analyze the input to generate the anatomy map. The generation of an anatomy map from ultrasound blind sweeps involves creating a comprehensive visual representation of anatomical structures based on the systematic scanning of the scanned area. During this process,2024PF00293 the user methodically moves the ultrasound probe across the region of interest, capturing multiple ultrasound images without real-time visualization. These images are then compiled and analyzed to construct a detailed map of the underlying anatomy. A mapping algorithm may be used to construct the map, and / or to enhance image quality and integrate the individual scans into a single depiction. Once generated, the anatomy map may be utilized immediately, and / or it may be temporarily or permanently stored in local and / or remote memory for future use.

[0036] According to an embodiment, the ultrasound system analyzes the ultrasound input received during the blind sweep(s) using a mapping algorithm, in order to analyze the input (such as through object detection) and to generate the anatomy map. The mapping algorithm can be any model or algorithm that can be trained to utilize the input to generate the output, as described or otherwise envisioned herein. According to one possible embodiment, the mapping algorithm can be a neural network or other trained machine learning model, for example a convolutional neural network (CNN) or a transformer network or other neural network. According to another embodiment, the mapping algorithm is a traditional algorithm, utilizing programming to analyze the input (a predefined set of rules or procedures to perform a specific task). Thus, according to an embodiment, the ultrasound system comprises a mapping algorithm that receives the input data and outputs at least a generated anatomy map.

[0037] If the mapping algorithm is a machine learning algorithm, it can be trained in a variety of different ways (however, as indicated herein, the mapping algorithm can be an algorithm other than a machine learning algorithm). According to one embodiment, the mapping algorithm is trained using a supervised or unsupervised training process. Referring to FIG. 3, in one embodiment, is a flowchart of a method 300 for training the mapping algorithm of the ultrasound system 200. This method may be performed by the ultrasound system, or may be performed by another system such as a specialized machine learning model training system.

[0038] At step 310 of the method, the training system receives training data which will be used to train the model. The training data can be any data sufficient to train the model to utilize the described input data to generate the described output. For example, the training data may comprise ultrasound imaging for each of a plurality of patients, together with object recognition information and / or an anatomy map for each of ultrasound imaging for the respective plurality of patients. This training data, which could be utilized in a supervised or unsupervised manner, can comprise2024PF00293 imaging for 100s or 1000s of patients and / or procedures, and can be updated with new imaging. The training data may also comprise other information, such as patient information. This training data may be curated by an expert such as a clinician, or it may be obtained and utilized without curation. The training data may be received from any source. For example, the training data may be received from an electronic medical record database or system, or any other component of the system or a training system. According to an embodiment, system 200 comprises or is in direct or indirect communication with an imaging database which comprises some or all of the training data set.

[0039] According to an embodiment, the training system may comprise a data pre-processor or similar component or algorithm configured to process the received training data. For example, the data pre-processor analyzes the training data to remove noise, bias, errors, and other potential issues. The data pre-processor may also analyze the input data to remove low quality data. Many other forms of data pre-processing or data point identification and / or extraction are possible.

[0040] At step 320 of the method, the training system trains the mapping algorithm, using the training data, to perform object recognition and to generate an anatomy map from input data. The mapping algorithm is trained using any method for training such a model. The trained mapping algorithm is a unique model based on the training data used to train the model. Following training, the system comprises a trained mapping algorithm.

[0041] Thus, following training, the mapping algorithm is a specialized model configured to receive the specialized input (namely, ultrasound imaging obtained during blind sweeps), perform object recognition, and generate the very specific output, namely an anatomy map for the subject.

[0042] At step 330 of the method, the trained mapping algorithm is stored for future use. According to an embodiment, the trained mapping algorithm may be stored in local or remote storage.

[0043] Referring to FIG. 4, in one embodiment, is an example of a generated anatomy map 400 in an example using a fetus as a target anatomy, and more specifically the fetal heart. The map comprises the location of the one or more blind sweeps (“Guided Sweep”) as well as anatomy generated based on the one or more blind sweeps (“Urinary bladder,” “heart,” and “head,” as examples).2024PF00293

[0044] Returning to method 100 in FIG. 1, at step 140 of the method, the ultrasound system provides, such as via a user interface, guidance instructions to the user of the ultrasound system. The ultrasound system generates the guidance instructions based on the anatomy map generated by the system. Thus, the system utilizes the generated anatomy map - which is specific to the subject since it is generated from the blind sweeps of the subject - to generate and then provide guidance instructions to a user.

[0045] According to an embodiment, the ultrasound system is configured, programmed, or otherwise directed to target a specific internal anatomy of the subject. Thus, the system can utilize the generated anatomy map to identify the location or likely location of that specific internal anatomy in the subject. For example, the specific internal anatomy which is being targeted can be an internal organ or a portion of an organ, a vessel, a fetus or a portion of a fetus, and any other structure or region of the subject. According to an embodiment, the ultrasound system may be a dedicated system that is programmed to always identify a specific anatomical structure or region. According to another embodiment, the ultrasound system may receive an input indicating the target anatomical structure. This input may be provided by the ultrasound user, or a clinician or other individual, via a user interface of the ultrasound system. The user may select a specific anatomical structure or region from a list, identify a specific anatomical structure or region on a display, or provide the target via any other mechanism for providing input to an ultrasound system.

[0046] According to an embodiment, the guidance instructions are any instruction that can guide the user to position the ultrasound probe at a target location, such as a specific anatomical structure or region. For example, the guidance instructions may comprise a starting position on the subject. This may be, for example, a starting anatomical landmark that would be recognizable, identifiable, or otherwise findable by the user (including, optionally, a novice ultrasound user). Thus, the guidance instructions may comprise an instructed position of the ultrasound probe relative to the starting anatomical landmark. As another example, the guidance instructions may comprise an angle of the ultrasound probe. For example, the guidance instructions may direct the user to adjust the angle of the ultrasound probe in addition to, or as an alternative to, adjusting the location of the ultrasound probe. As yet another example, the guidance instructions may comprise an instruction to move the ultrasound probe to a new location (optionally relative to the starting anatomical landmark). Thus, the guidance instructions may direct the user to move the ultrasound2024PF00293 probe a certain amount in a certain direction, and / or move the ultrasound probe in a certain direction and / or certain amount relative to the starting anatomical landmark.

[0047] According to an embodiment, the guidance instructions may be provided via any mechanism for providing instructions to a user of the ultrasound system. For example, the guidance instructions may be provided via a user interface that provides a text-based or diagrammatical output. The text-based output may be a word-based instruction such as “move the ultrasound probe 2 cm toward the umbilicus.” A diagrammatical output may optionally comprise a map, such as the generated anatomy map, along with the guidance instructions. Those guidance instructions may be overlaid on the map or other diagram, and may use words, arrows, or other indicators of where to move the ultrasound probe. As another example, the guidance instructions may be provided via a user interface that provides an audible instruction. Thus, the guidance instruction may be an audible announcement delivered via speaker to “move the ultrasound probe 2 cm toward the umbilicus.” Many other methods for providing guidance instructions are possible.

[0048] As yet another example, the ultrasound system 200 may comprise a projector or projecting device that projects the estimated location of one or more anatomies, and guidance, onto the subject for visualization. Accordingly, the guidance instructions may comprise a visual component of the display, such as a target location which is identified with any visual indicator (arrow, highlighting, etc.) optionally with instructions to move the ultrasound probe to the target location (arrow, etc.).

[0049] According to an embodiment, the user of the ultrasound system moves the ultrasound probe in response to receiving the guidance instructions. Notably, the user may move the ultrasound probe correction in response to the guidance instructions, or the user may move the ultrasound probe incorrectly in response to the guidance instructions. In any event, the user moves the ultrasound probe to a new location on the subject based on the provided guidance instructions.

[0050] At step 150 of the method, after the user moves the ultrasound probe to a new location based on the provided instruction, the ultrasound system obtains new ultrasound input - that is, new ultrasound imaging - from the new location. The new ultrasound input may be received in response to the movement of the probe, in response to an instruction provided by the system to the user that new ultrasound input should be obtained at the new location, and / or in response to the user knowing to obtain new ultrasound input at the new location.2024PF00293

[0051] At step 160 of the method, the ultrasound system compares the received ultrasound input from the new location to the generated anatomy map, and / or to the target specific internal anatomy of the subject, with the goal of determining whether the ultrasound input from the new location is imaging the target anatomy. Thus, based on the comparison, the ultrasound input from the new location either does or does not comprise the target anatomy. For example, at step 180 of the method, the ultrasound system determines, based on the comparison, that the ultrasound input from the new location comprises the specific internal anatomy of the subject.

[0052] However, at optional step 170 of the method, the ultrasound system compares the received ultrasound input from the new location to the generated anatomy map, and / or to the target specific internal anatomy of the subject, with the goal of determining whether the ultrasound input from the new location is imaging the target anatomy, and determines - based on the comparison - that the new location does not comprise or otherwise include the target anatomy.

[0053] Thus, at optional step 172 of the method, the ultrasound system provides second (or subsequent) guidance instructions to the user of the ultrasound system via the user interface, based on the anatomy map generated by the system. Thus, the system utilizes the generated anatomy map- which is specific to the subject since it is generated from the blind sweeps of the subject - to generate and then provide guidance instructions to a user. The second (or subsequent) guidance instructions can comprise any of the guidance instructions components described or otherwise envisioned herein, and can be provided via any of the mechanisms or methods described or otherwise envisioned herein.

[0054] At optional step 174 of the method, after the user moves the ultrasound probe to a new second (or subsequent) location based on the provided second (or subsequent) guidance instructions, the ultrasound system obtains new ultrasound input - that is, new ultrasound imaging- from the new location. The new ultrasound input may be received in response to the movement of the probe, in response to an instruction provided by the system to the user that new ultrasound input should be obtained at the new location, and / or in response to the user knowing to obtain new ultrasound input at the new location.

[0055] According to an embodiment, steps 160 through 174 of the method can be repeated as many times are necessary to identify or find the location of the target anatomy. Thus, the system may provide guidance instructions to the user once, twice, or many times.2024PF00293

[0056] From either step 160 of the method, or from step 174 of the method (either a first time or a subsequent time), the method progresses to step 180. At step 180 of the method, as described above, the system determines, based on the comparison, that the ultrasound input from the new location comprises the specific internal anatomy of the subject.

[0057] Accordingly, based on the determination that the ultrasound input from the new location comprises the specific internal anatomy of the subject, the ultrasound system provides an instruction to the user of the ultrasound system that the specific internal anatomy of the subject has been located. According to an embodiment, the instruction to the user of the ultrasound system that the specific internal anatomy of the subject has been located may be provided via any mechanism for providing instructions to a user of the ultrasound system. For example, the guidance instructions may be provided via a user interface that provides a text-based or diagrammatical output. The text-based output may be a word-based instruction such as “STOP” or “the target has been located.” A diagrammatical output may optionally comprise a visual indication that the target has been located. As another example, the guidance instructions may be provided via a user interface that provides an audible instruction. Thus, the indication may be an audible announcement delivered via speaker to “STOP” or that “the target has been located.” Many other methods for providing guidance instructions are possible.

[0058] Referring again to FIG. 2 is a schematic representation of an ultrasound system 200. System 200 may be any of the systems described or otherwise envisioned herein, and may comprise any of the components described or otherwise envisioned herein. It will be understood that FIG. 2 constitutes, in some respects, an abstraction and that the actual organization of the components of the system 200 may be different and more complex than illustrated.

[0059] According to an embodiment, system 200 comprises a processor 220 capable of executing instructions stored in memory 230 or storage 260 or otherwise processing data to, for example, perform one or more steps of the method. Processor 220 may be formed of one or multiple modules. Processor 220 may take any suitable form, including but not limited to a microprocessor, microcontroller, multiple microcontrollers, circuitry, field programmable gate array (FPGA), application-specific integrated circuit (ASIC), a single processor, or plural processors.2024PF00293

[0060] Memory 230 can take any suitable form, including a non-volatile memory and / or RAM. The memory 230 may include various memories such as, for example LI, L2, or L3 cache or system memory. As such, the memory 230 may include static random access memory (SRAM), dynamic RAM (DRAM), flash memory, read only memory (ROM), or other similar memory devices. The memory can store, among other things, an operating system. The RAM is used by the processor for the temporary storage of data. According to an embodiment, an operating system may contain code which, when executed by the processor, controls operation of one or more components of system 200. It will be apparent that, in embodiments where the processor implements one or more of the functions described herein in hardware, the software described as corresponding to such functionality in other embodiments may be omitted.

[0061] User interface 240 may include one or more devices for enabling communication with a user. The user interface can be any device or system that allows information to be conveyed and / or received, and may include a display, a mouse, and / or a keyboard for receiving user commands. In some embodiments, user interface 240 may include a command line interface or graphical user interface that may be presented to a remote terminal via communication interface 250. The user interface may be located with one or more other components of the system, or may located remote from the system and in communication via a wired and / or wireless communications network.

[0062] Communication interface 250 may include one or more devices for enabling communication with other hardware devices. For example, communication interface 250 may include a network interface card (NIC) configured to communicate according to the Ethernet protocol. Additionally, communication interface 250 may implement a TCP / IP stack for communication according to the TCP / IP protocols. Various alternative or additional hardware or configurations for communication interface 250 will be apparent.

[0063] Storage 260 may include one or more machine-readable storage media such as readonly memory (ROM), random-access memory (RAM), magnetic disk storage media, optical storage media, flash-memory devices, or similar storage media. In various embodiments, storage 260 may store instructions for execution by processor 220 or data upon which processor 220 may operate. For example, storage 260 may store an operating system 261 for controlling various operations of system 200.2024PF00293

[0064] It will be apparent that various information described as stored in storage 260 may be additionally or alternatively stored in memory 230. In this respect, memory 230 may also be considered to constitute a storage device and storage 260 may be considered a memory. Various other arrangements will be apparent. Further, memory 230 and storage 260 may both be considered to be non-transitory machine-readable media. As used herein, the term non-transitory will be understood to exclude transitory signals but to include all forms of storage, including both volatile and non-volatile memories.

[0065] While system 200 is shown as including one of each described component, the various components may be duplicated in various embodiments. For example, processor 220 may include multiple microprocessors that are configured to independently execute the methods described herein or are configured to perform steps or subroutines of the methods described herein such that the multiple processors cooperate to achieve the functionality described herein. Further, where one or more components of system 200 is implemented in a cloud computing system, the various hardware components may belong to separate physical systems. For example, processor 220 may include a first processor in a first server and a second processor in a second server. Many other variations and configurations are possible.

[0066] According to an embodiment, system 200 comprises or is in direct or indirect communication with an imaging modality 270. The imaging modality can be any modality sufficient to obtain imagery utilized by the ultrasound system 200 to obtain ultrasound imagery. The imaging modality can be, for example, an ultrasound system such as EPIQ® system, Philips Lumify®, and Philips Affinity®, among many others.

[0067] According to an embodiment, system 200 comprises or is in direct or indirect communication with an image database 280. The image database may be any image database, and may comprise images or videos or reports or other data obtained using any imaging modality, such as imaging modality 270. The image database 280 may be local to the ultrasound system, and may optionally be a component of the system. The image database 280 may alternatively be remote to the ultrasound system.

[0068] According to an embodiment, the system 200 may also comprise or be in direct or indirect communication with an electronic medical record system and / or an electronic medical records (EMR) database from which the information about patients, including demographic,2024PF00293 diagnosis, and / or treatment information, may be obtained or received. For example, EMR database may comprise information about an imaging or treatment procedure for a patient, including the anatomy that will be imaged during the procedure. According to an embodiment, the electronic medical record system may be a local or remote database and is in direct and / or indirect communication with system 200. Thus, according to an embodiment, the system comprises an electronic medical record database or system.

[0069] According to an embodiment, storage 260 of system 200 may store one or more algorithms, modules, and / or instructions to carry out one or more functions or steps of the methods described or otherwise envisioned herein. For example, storage 260 may comprise, among other instructions or data, a mapping algorithm 262, training instructions 263, guidance instructions or algorithm 264, and / or reporting instructions 265.

[0070] According to an embodiment, mapping algorithm 262 of the ultrasound system 200 is trained to analyze the received input, including but not limited to ultrasound imagery from one or more blind sweeps (as input to the model) to perform object recognition, and to generate an anatomy map (as output of the model). The mapping algorithm can be any model that can be trained to utilize the input to generate the output, as described or otherwise envisioned herein. According to one possible embodiment, the mapping algorithm can be a neural network or other trained machine learning model, for example a convolutional neural network (CNN) or a transformer network or other neural network. According to another embodiment, the mapping algorithm is a traditional algorithm, utilizing programming to analyze the input (a predefined set of rules or procedures to perform a specific task). Thus, according to an embodiment, the ultrasound system comprises a trained mapping algorithm that receives the input data and outputs an anatomy map.

[0071] According to an embodiment, training instructions 263 direct the system to train a mapping algorithm 262 of the ultrasound system 200. Thus, a trained mapping algorithm can be a neural network or other trained machine learning model, for example a convolutional neural network (CNN) or a transformer network or other neural network (however, as indicated herein, the mapping algorithm can be an algorithm other than a machine learning algorithm). The training instructions 263 direct the system to retrieve, obtain, or receive training data. The training data can be any data sufficient to train the model to utilize the described input data to generate the described2024PF00293 output. For example, the training data may comprise imaging for each of a plurality of patients and procedures along with objection recognition and anatomy maps for each of the imaging for the plurality of patients. The training data may also comprise other information, such as patient information. This training data may be curated by an expert such as a clinician, or it may be obtained and utilized without curation. The training data may be received from any source. For example, the training data may be received from an electronic medical record database or system, or any other component of the system or a training system. According to an embodiment, system 200 comprises or is in direct or indirect communication with an imaging database which comprises some or all of the training data set. The training instructions 263 further direct the system to train the mapping algorithm using the obtained training data. The mapping algorithm can be trained using a variety of different training methods. The training instructions 263 further direct the system to store the trained mapping algorithm for future use.

[0072] According to an embodiment, the ultrasound system 200 is configured to process many thousands or millions of datapoints in the input data used to train the mapping algorithm 262, such as via the training instructions 263. For example, generating a functional and skilled trained mapping algorithm from a corpus of training data requires processing of millions of datapoints from input data and generated features. This can require millions or billions of calculations to generate a novel trained mapping algorithm from those millions of datapoints and millions or billions of calculations. As a result, each trained mapping algorithm is novel and distinct based on the input data and parameters of the model, and thus improves the functioning of the system. Generating a functional and skilled trained mapping algorithm comprises a process with a volume of calculation and analysis that a human brain cannot accomplish in a lifetime, or multiple lifetimes.

[0073] According to an embodiment, guidance instructions or algorithm 264 direct the system to generate and provide guidance instructions to the user of the ultrasound system. The ultrasound system generates the guidance instructions based on the anatomy map generated by the system. Thus, the system utilizes the generated anatomy map - which is specific to the subject since it is generated from the blind sweeps of the subject - to generate and then provide guidance instructions to a user. According to an embodiment, the guidance instructions are any instruction that can guide the user to position the ultrasound probe at a target location, such as a specific anatomical structure or region. For example, the guidance instructions may comprise a starting position on the subject.2024PF00293This may be, for example, a starting anatomical landmark that would be recognizable, identifiable, or otherwise findable by the user (including, optionally, a novice ultrasound user). Thus, the guidance instructions may comprise an instructed position of the ultrasound probe relative to the starting anatomical landmark. As another example, the guidance instructions may comprise an angle of the ultrasound probe. For example, the guidance instructions may direct the user to adjust the angle of the ultrasound probe in addition to, or as an alternative to, adjusting the location of the ultrasound probe. As yet another example, the guidance instructions may comprise an instruction to move the ultrasound probe to a new location (optionally relative to the starting anatomical landmark). Thus, the guidance instructions may direct the user to move the ultrasound probe a certain amount in a certain direction, and / or move the ultrasound probe in a certain direction and / or certain amount relative to the starting anatomical landmark.

[0074] According to an embodiment, reporting instructions 265 direct the system to provide the output of the system to a user, such as a clinician, via a user interface. The provided output can be any of the information as described or otherwise envisioned herein, including but not limited to guidance instructions. The system may provide the information to a user via any mechanism, including but not limited to a visual display, an audible notification, a page, or any other method of notification. The information may be communicated by wired and / or wireless communication to another device. For example, the system may communicate the information to a mobile phone, computer, laptop, wearable device, and / or any other device configured to allow display and / or other communication of the information.

[0075] All definitions, as defined and used herein, should be understood to control over dictionary definitions, definitions in documents incorporated by reference, and / or ordinary meanings of the defined terms.

[0076] The indefinite articles “a” and “an,” as used herein in the specification and in the claims, unless clearly indicated to the contrary, should be understood to mean “at least one.”

[0077] The phrase “and / or,” as used herein in the specification and in the claims, should be understood to mean “either or both” of the elements so conjoined, i.e., elements that are conjunctively present in some cases and disjunctively present in other cases. Multiple elements listed with “and / or” should be construed in the same fashion, i.e., “one or more” of the elements so conjoined. Other elements may optionally be present other than the elements specifically2024PF00293 identified by the “and / or” clause, whether related or unrelated to those elements specifically identified.

[0078] As used herein in the specification and in the claims, “or” should be understood to have the same meaning as “and / or” as defined above. For example, when separating items in a list, “or” or “and / or” shall be interpreted as being inclusive, i.e., the inclusion of at least one, but also including more than one, of a number or list of elements, and, optionally, additional unlisted items. Only terms clearly indicated to the contrary, such as “only one of’ or “exactly one of,” or, when used in the claims, “consisting of,” will refer to the inclusion of exactly one element of a number or list of elements. In general, the term “or” as used herein shall only be interpreted as indicating exclusive alternatives (i.e. “one or the other but not both”) when preceded by terms of exclusivity, such as “either,” “one of,” “only one of,” or “exactly one of.”

[0079] As used herein in the specification and in the claims, the phrase “at least one,” in reference to a list of one or more elements, should be understood to mean at least one element selected from any one or more of the elements in the list of elements, but not necessarily including at least one of each and every element specifically listed within the list of elements and not excluding any combinations of elements in the list of elements. This definition also allows that elements may optionally be present other than the elements specifically identified within the list of elements to which the phrase “at least one” refers, whether related or unrelated to those elements specifically identified.

[0080] It should also be understood that, unless clearly indicated to the contrary, in any methods claimed herein that include more than one step or act, the order of the steps or acts of the method is not necessarily limited to the order in which the steps or acts of the method are recited.

[0081] In the claims, as well as in the specification above, all transitional phrases such as “comprising,” “including,” “carrying,” “having,” “containing,” “involving,” “holding,” “composed of,” and the like are to be understood to be open-ended, i.e., to mean including but not limited to. Only the transitional phrases “consisting of’ and “consisting essentially of’ shall be closed or semi-closed transitional phrases, respectively.

[0082] While several inventive embodiments have been described and illustrated herein, those of ordinary skill in the art will readily envision a variety of other means and / or structures for performing the function and / or obtaining the results and / or one or more of the advantages2024PF00293 described herein, and each of such variations and / or modifications is deemed to be within the scope of the inventive embodiments described herein. More generally, those skilled in the art will readily appreciate that all parameters, dimensions, materials, and configurations described herein are meant to be exemplary and that the actual parameters, dimensions, materials, and / or configurations will depend upon the specific application or applications for which the inventive teachings is / are used. Those skilled in the art will recognize, or be able to ascertain using no more than routine experimentation, many equivalents to the specific inventive embodiments described herein. It is, therefore, to be understood that the foregoing embodiments are presented by way of example only and that, within the scope of the appended claims and equivalents thereto, inventive embodiments may be practiced otherwise than as specifically described and claimed. Inventive embodiments of the present disclosure are directed to each individual feature, system, article, material, kit, and / or method described herein. In addition, any combination of two or more such features, systems, articles, materials, kits, and / or methods, if such features, systems, articles, materials, kits, and / or methods are not mutually inconsistent, is included within the inventive scope of the present disclosure.

Claims

2024PF00293ClaimsWhat is claimed is:

1. A method (100) for locating a specific internal anatomy of a subject using an ultrasound system, comprising: receiving (120) ultrasound input from one or more blind sweeps of a first region of the subject; analyzing (130), with a mapping algorithm, the received ultrasound input to generate an anatomy map of the first region of the patient; providing (140), based on the generated anatomy map, a guidance instruction to a user of the ultrasound system, comprising an instruction to move an ultrasound probe of the ultrasound system; receiving (150), after the user moves the ultrasound probe to a new first location based on the provided instruction, ultrasound input obtained from the new first location; comparing (160) the ultrasound input obtained from the new first location to the generated anatomy map; determining (180), based on the comparison, that the ultrasound input comprises the specific internal anatomy of the subject; and providing (190), based on the determination, an instruction to the user of the ultrasound system that the specific internal anatomy of the subject has been located.

2. The method of claim 1, further comprising: determining (170), based on the comparison, that the ultrasound input obtained from the new first location does not comprise the specific internal anatomy of the subject; providing (172), based on the generated anatomy map, a second guidance instruction to the user of the ultrasound system, comprising an instruction to move an ultrasound probe of the ultrasound system; and receiving (150), after the user moves the ultrasound probe to a new second location based on the provided instruction, ultrasound input obtained from the new second location.2024PF002933. The method of claim 1, wherein the mapping algorithm is a machine learning algorithm.

4. The method of claim 1, wherein the guidance instruction is a visual instruction provided via a user interface.

5. The method of claim 1, wherein the guidance instruction is an audible instruction.

6. The method of claim 1, wherein the guidance instruction further comprises one or more of a starting point for the ultrasound probe and a distance from the starting point.

7. The method of claim 1, wherein the guidance instruction further comprises an instructed angle of the ultrasound probe.

8. The method of claim 1, wherein the subject is pregnant, and wherein the specific internal anatomy is a region of a fetus.

9. The method of claim 1, wherein the generated anatomy map comprises one or more of a map of a fetus and a map of maternal anatomy.

10. The method of claim 9, wherein the generated anatomy map comprises an estimated location of at least the heart of the fetus.

11. A system (200) for locating a specific internal anatomy of a subject using an ultrasound system, comprising: an ultrasound probe configured to obtain ultrasound imagery from the subject; a user interface (240) configured to provide output to a user; a mapping algorithm (262) configured to generate an anatomy map of a region of the patient; a processor (220) configured to: (i) receive, from the ultrasound probe, ultrasound input from one or more blind sweeps of a first region of the subject; (ii) analyze, with the mapping2024PF00293 algorithm, the received ultrasound input to generate an anatomy map of the first region of the patient; (iii) provide, based on the generated anatomy map, a guidance instruction to a user of the ultrasound system via the user interface, comprising an instruction to move an ultrasound probe of the ultrasound system; (iv) receive, after the user moves the ultrasound probe to a new first location based on the provided instruction, ultrasound input obtained from the new first location using the ultrasound probe; (v) compare the ultrasound input obtained from the new first location to the generated anatomy map; (vi) determine, based on the comparison, that the ultrasound input comprises the specific internal anatomy of the subject; and (vii) provide, based on the determination, an instruction to the user of the ultrasound system via the user interface that the specific internal anatomy of the subject has been located.

12. The system of claim 11, wherein the mapping algorithm is a machine learning algorithm.

13. The system of claim 11, wherein the guidance instruction is a visual instruction provided via a user interface.

14. The system of claim 11, wherein the guidance instruction is an audible instruction.

15. The system of claim 11, wherein the guidance instruction further comprises one or more of a starting point for the ultrasound probe, an instructed angle of the ultrasound probe, and a distance from a starting point.

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