Device, system, and method for guiding repeated ultrasonic examinations for continuous monitoring

Abstract

Systems, devices, and methods for continuous patient monitoring are provided. An ultrasound system is provided that includes subdividing a portion of a patient's anatomy into zones. Imaging data is received by an imaging device. The imaging data is used to generate a severity score for each zone based on imaging parameters within the imaging data. Changes in the severity score for each zone are displayed over time, so that a medical professional continuously monitors each zone.

Description

Technical Field

[0001]

[0001] This disclosure relates to performing continuous medical monitoring of a patient, and more particularly to guiding repeated ultrasound examinations of a patient for one or more specific anatomical zones. This monitoring includes receiving imaging data representing the anatomical zone from one or more external ultrasound transducers, generating a severity score associated with the imaging data, and comparing this severity score with other severity scores associated with the anatomical zone.

Background Art

[0002]

[0002] Non-invasive point-of-care ultrasound imaging devices are used to diagnose various diseases including cardiovascular diseases and diseases in the lungs. The device needs to scan at several locations within the patient's anatomical structure. For example, to evaluate a cardiovascular disorder or pneumonia, an ultrasound transducer is used to scan several locations within the patient's heart or lungs. In the case of heart failure, pulmonary edema occurs, resulting in reverberation features called B-lines. Since the locations of these B-lines in the chest vary, a general examination includes imaging several locations on both the right and left sides of the patient's chest.

[0003]

[0003] Another example is the evaluation of consolidation in the lungs in the case of pneumonia. This requires ultrasound imaging at various locations within the lungs. In a medical setting such as an intensive care unit (ICU), patients need to be continuously monitored to evaluate whether the condition of the heart or lungs is improving. This needs to be done in response to medication or intervention.

Summary of the Invention

Problems to be Solved by the Invention

[0004]

[0004] Repeating all monitoring procedures at all locations is particularly time-consuming in life-saving and emergency environments such as the ICU. For example, when several patients need to be monitored with limited equipment, the time allocated to each patient is limited. Existing methods for tracking and analyzing ultrasonic imaging data are often manual and not effective in enabling physicians to comprehensively evaluate and assess a patient's complete health status over time.

Means for Solving the Problem

[0005]

[0005] A system, device, and method for performing ultrasonic imaging are provided. The ultrasonic imaging system includes an ultrasonic probe having an ultrasonic transducer array used to collect imaging data from an area of a patient's anatomical structure. In some embodiments, the area of the anatomical structure is divided into several sections or zones. The imaging data for each zone is analyzed, and a severity level at a specific time is assigned to the section based on one or more parameters of the imaging data for the section. The system is used to monitor the severity level of each zone over time. For example, a medical professional can select a specific zone and access the temporal history of the zone over time. This helps the medical professional continuously monitor the patient over time and is particularly useful for patients with two or more physicians. The system is also used to evaluate the severity of the medical condition within various zones and highlight areas of severity for further observation by medical professionals. This enables medical professionals to focus on important areas of the anatomical structure and particularly reduces the evaluation burden in life-saving and emergency situations.

[0006] An ultrasonic transducer array configured to acquire imaging data related to a patient's anatomical structure, wherein the patient's anatomical structure is spatially arranged in a plurality of zones, and a processor circuit in communication with the ultrasonic transducer array, the processor circuit being configured to receive a first set of imaging data acquired by the ultrasonic transducer array, the first set of imaging data representing at least one of the plurality of zones, the processor circuit being configured to determine a first severity score related to anatomical parameters based on the first set of imaging data for at least one of the plurality of zones, the processor circuit being configured to receive a second set of imaging data acquired by the ultrasonic transducer array, the second set of imaging data representing at least one of the plurality of zones, the processor circuit being configured to determine a second severity score related to anatomical parameters based on the second set of imaging data for at least one of the plurality of zones, and the processor circuit being configured to output a visual representation of the plurality of zones including an indication of the first severity score and an indication of the second severity score to a display device in communication with the processor, an ultrasonic imaging system is provided that includes the processor circuit.

[0007]

[0007] In one embodiment, the first set of imaging data represents a first zone at a first time, and the second set of imaging data represents a second zone at the first time. In other embodiments, the first set of imaging data represents a first zone at a first time, and the second set of imaging data represents the first zone at a different second time. The visual representation shows the change in severity score over time based on the first severity score and the second severity score. The visual representation includes a plot of the change in severity score over time. The visual representation includes a time series representation of at least one of the first set of imaging data, the second set of imaging data, the first severity score, or the second severity score. The processor circuit is further configured to spatially relate the first and second sets of imaging data to each other in a plurality of zones.

[0008]

[0008] In some embodiments, the visual representation of the plurality of zones includes a selectable representation of the plurality of zones such that, upon selection of a zone by a user, the first and second sets of imaging data related to each other in the selected zone are displayed. The ultrasonic array is configured to acquire imaging data related to the patient's lungs. The parameter includes at least one of the degree of sclerosis, a measurement of the fluid in the lungs, the degree of lung collapse, the number of B-lines, a measurement of bronchial aerograms, or a measurement of a plurality of infiltrates. The ultrasonic array is configured to acquire imaging data related to the patient's heart. The parameter is one or more of the physical dimensions of the cardiac chambers, the degree of occlusion of the ejection fraction vessels, or a volume measurement.

[0009]

[0009] A method of performing ultrasonic imaging is further provided. The method includes steps of receiving, by a processor circuit, a first set of imaging data representing at least one of a plurality of zones, wherein the processor circuit communicates with an ultrasonic transducer array configured to obtain imaging data related to an anatomical structure of a patient spatially arranged in the plurality of zones; determining, by the processor circuit, a first severity score related to anatomical parameters based on the first set of imaging data, wherein the first severity score is related to at least one of the plurality of zones; receiving, by the processor circuit, a second set of imaging data displaying at least one of the plurality of zones; determining, by the processor circuit, a second severity score related to anatomical parameters based on the second set of imaging data, wherein the second severity score is associated with at least one of the plurality of zones; and outputting, to a display device in communication with the processor circuit, a visual representation of the plurality of zones including an indication of the first severity score and an indication of the second severity score.

[0010]

[0010] In one embodiment, the first set of imaging data represents a first zone at a first time, and the second set of imaging data represents a second zone at the first time. In other embodiments, the first set of imaging data represents a first zone at a first time, and the second set of imaging data represents the first zone at a different second time. The visual representation shows the change in severity score over time based on the first severity score and the second severity score. The visual representation includes a plot of the change in severity score over time. The visual representation includes a time-series representation of at least one of the first set of imaging data, the second set of imaging data, the first severity score, or the second severity score. In some embodiments, the method further comprises spatially relating the first and second sets of imaging data to each other in a plurality of zones by a processor circuit. The visual representation of the plurality of zones includes a selectable representation of the plurality of zones such that upon selection of a zone by a user, the first and second sets of imaging data related to each other in the selected zone are displayed.

[0011]

[0011] Additional aspects, features, and advantages of the present disclosure will become apparent from the following detailed description.

[0012]

[0012] Exemplary embodiments of the present disclosure are described with reference to the accompanying drawings.

Brief Description of the Drawings

[0013]

Figure 1

[0013] It is a schematic diagram of an ultrasonic imaging system according to an embodiment of the present disclosure.

Figure 2

[0014] It is a schematic diagram of a processor circuit according to an embodiment of the present disclosure.

Figure 3

[0015] It is an exemplary diagram of a screen display according to an aspect of the present disclosure.

Figure 4

[0016] It is an exemplary diagram of another screen display according to an aspect of the present disclosure.

Figure 5

[0017] An exemplary diagram of another screen display according to an aspect of the present disclosure.

Figure 6

[0018] A flowchart of a method of ultrasonic imaging according to an aspect of the present disclosure.

DETAILED DESCRIPTION OF THE INVENTION

[0014]

[0019] To facilitate understanding of the principles of the present disclosure, reference will now be made to the embodiments shown in the drawings and used to describe the embodiments. However, it should be understood that it is not intended to limit the scope of the present disclosure. Any modifications and further changes to the devices, systems, and methods described, as well as further applications of the principles of the present disclosure, are fully intended and included within the scope of the present disclosure as would be ordinarily conceived by one of ordinary skill in the art to which the present disclosure pertains. In particular, features, components, and / or steps described with respect to one embodiment may be combined with features, components, and / or steps described with respect to other embodiments of the present disclosure. However, for the sake of brevity, many of these combinations are not described separately.

[0015]

[0020] FIG. 1 is a schematic diagram of an ultrasonic imaging system 100 according to an aspect of the present disclosure. The ultrasonic imaging system 100 includes an imaging device 102, a processing system 106, and a display 108. The ultrasonic imaging system 100 is used to perform non-invasive imaging of human anatomical structures. This imaging includes 2D or 3D B-mode ultrasound examination and color flow mapping. For example, the imaging device 102 is an ultrasonic probe configured to visualize the anatomical structures inside a patient's body while the probe is positioned outside the patient's body. In some embodiments, the ultrasonic imaging system 100 is a Doppler ultrasonic imaging system. In some situations, the system 100 includes additional elements and / or is implemented without one or more of the elements shown in FIG. 1.

[0016]

[0021] The ultrasonic imaging system 100 is used in the context of blunt chest trauma, pulmonary edema, heart failure, lung failure, and other medical conditions. The system 100 is used in the pre-hospital environment, initial evaluation in the emergency room, and follow-up treatment. The system 100 is applicable to all ultrasonic systems including point-of-care applications including mobile platforms. The system 100 is also used at home by patients under remote guidance who have been discharged from the hospital, such as after lung treatment or heart failure treatment.

[0017]

[0022] In some embodiments, the imaging device 102 is sized, shaped, structurally arranged, and / or otherwise configured to be positioned on or near the anatomical structure of a subject to perform an ultrasonic imaging procedure. The imaging device 102 is positioned outside the patient's body. In some embodiments, the device 102 is positioned adjacent to and / or in contact with the patient's body. For example, the imaging device 102 is placed directly on the subject's body and / or adjacent to the body. For example, the imaging device 102 is in direct contact with the subject's body while acquiring imaging data. In certain embodiments, the device 102 includes one or more imaging elements that are placed directly on the subject's body or adjacent to the subject's body. In other embodiments, the housing of the imaging device is placed in direct contact with the subject's body such that the imaging elements are adjacent to the subject's body. The operator of the imaging device 102 contacts the distal portion of the imaging device with the patient's body such that the anatomical structure is elastically pressed. The view of the anatomical structure shown in the ultrasonic image depends on the position and orientation of the imaging device 102. To acquire imaging data of the anatomical structure, the imaging device 102 is manually and / or automatically positioned appropriately by a clinician such that the transducer 124 emits ultrasonic waves and receives ultrasonic echoes from an appropriate portion of the anatomical structure. The subject is a human patient or an animal. The imaging device 102 is portable and suitable for use by a user in a medical setting. For example, the imaging device 102 is a Doppler ultrasound imaging probe.

[0018]

[0023] Imaging device 102 is configured to acquire ultrasonic imaging data related to the appropriate anatomical structures of a patient. For example, device 102 can be used to examine any number of anatomical locations and tissue types, including but not limited to organs such as the liver, heart, kidneys, gallbladder, pancreas, and lungs; ducts; intestines; nervous system structures including the brain, dural sac, spinal cord, and peripheral nerves; the urinary tract; and anatomical structures including valves within blood vessels, blood, chambers of the heart or other parts, and / or other systems of the body. The anatomical structures are blood vessels such as arteries or veins of the patient's vascular system, including the cardiovascular system, peripheral vascular system, neurovascular system, renal vascular system, and / or other appropriate lumens within the body. In addition to natural structures, imaging device 102 may be used to examine artificial structures such as but not limited to heart valves, stents, shunts, filters, and other devices.

[0019]

[0024] Imaging device 102 includes a housing or handle 110 that is sized, shaped, and / or otherwise configured to be structurally arranged for a portable device that a user can grasp. Handle 110 is configured to surround and protect the various components of imaging device 102, such as electronic circuit 121 and transducer array 124. Handle 110 includes an internal structure such as a space frame for securing the various components. For example, transducer array 124 is positioned at the distal portion of handle 110.

[0020]

[0025] The transducer elements of the array 124 are configured to emit ultrasonic signals and receive ultrasonic echo signals corresponding to the emitted ultrasonic signals. The ultrasonic echo signals are processed by the electronic circuit 121 of the imaging device 102 and / or the processing system 106. The transducer array 124 is part of an imaging assembly that includes an acoustic lens and matching material on the transmitting side of the transducer array 124 and an acoustic backing material on the back side of the transducer array 124. The transducer array 124 includes any number of transducer elements. For example, the array can include values such as two acoustic elements, four acoustic elements, a plurality of acoustic elements, 64 acoustic elements, 128 acoustic elements, 500 acoustic elements, 812 acoustic elements, 3000 acoustic elements, 9000 acoustic elements, etc., and / or other values such as larger and smaller values, including values between one acoustic element and 10,000 acoustic elements. In some cases, the transducer elements of the array are arranged in any suitable configuration, i.e., a linear array, a planar array, a curved array, a curved array, a circular array, an annular array, a phased array, a matrix array, a one-dimensional (ID) array, a 1.x-dimensional array (e.g., a 1.5D array), or a two-dimensional (2D) array, etc. The array of transducer elements (e.g., one or more rows, one or more columns, and / or one or more orientations) is controlled and operated uniformly or independently. The array is configured to acquire one-dimensional, two-dimensional, and / or three-dimensional images of the patient's anatomical structure. The ultrasonic transducer elements include piezoelectric / piezoresistive elements, piezoelectric micromachined ultrasonic transducer (PMUT) elements, capacitive micromachined ultrasonic transducer (CMUT) elements, and / or other suitable types of ultrasonic transducer elements.

[0021]

[0026] The ultrasonic transducer elements of the transducer array 124 communicate (e.g., are electrically coupled) with the electronic circuit 121. The electronic circuit 121 is any suitable passive or active electronic component including an integrated circuit (IC) for controlling the transducer array 124 to acquire ultrasonic imaging data. For example, the electronic circuit includes one or more transducer control logic dies. The electronic circuit includes one or more application specific integrated circuits (ASICs) or field programmable gate arrays (FPGAs). In some embodiments, one or more of the ICs include a microbeamformer (pBF). In other embodiments, one or more of the ICs include a multiplexer circuit (MUX). In some cases, the electronic circuit 121 includes a processor, memory, gyroscope, and / or accelerometer.

[0022]

[0027] In some embodiments, the imaging device 102 includes an endoluminal device sized, shaped, structurally arranged, and / or otherwise configured to be positioned within a patient's body cavity. For example, the imaging device 102 is a guide wire, catheter, or guide catheter. In some cases, the imaging device 102 includes a gastric camera. The imaging device 102 includes a flexible elongate member having a distal portion positioned within the body cavity and a proximal portion positioned outside the patient's body. The transducer array 124 is coupled to the distal portion of the flexible elongate member to acquire ultrasonic data while positioned inside the body cavity. For example, the imaging device 102 is an intravascular ultrasound (IVUS) catheter, an intracardiac echocardiogram (ICE) catheter, and / or a transesophageal echocardiogram (TEE) probe.

[0023]

[0028] The processing system 106 is configured to perform one or more processing steps to generate an ultrasonic image and output the ultrasonic image for display by the display 108. The one or more image processing steps are performed by the processor of the processing system 106 and / or the imaging device 102. The processing system 106 and / or the imaging device 102 includes one or more processor circuits that are arranged, operable, and / or otherwise configured to perform the operations described herein.

[0024]

[0029] FIG. 2 is a block diagram showing an exemplary processor 200 according to an embodiment of the present disclosure. The processor 200 is used to implement one or more processors described herein, for example, the electronic circuit 121 of the imaging device 102 and / or the electronic circuit of the processing system 106 shown in FIG. 1. The processor 200 is used to perform all or some of the processor steps described herein with respect to FIGS. 3-6. The processor 200 includes, without limitation, a microprocessor, a microcontroller, a digital signal processor (DSP), a field programmable gate array (FPGA) programmed to form a processor, a graphics processing unit (GPU), an application specific integrated circuit (ASIC) designed to form a processor, or a part of a custom integrated circuit, or any suitable processor type including a combination thereof. One or more functions of the processors described herein including the processor 200 are incorporated into a smaller number or a single processing unit (e.g., a CPU) programmed in response to executable instructions to perform the functions described herein. In particular, the functions of one or more processors are provided by a non-transitory computer-readable medium including executable instructions that, when executed, cause the processor circuits of the ultrasonic imaging system to perform the methods described herein.

[0025]

[0030] Processor 200 includes one or more cores 202 (one is shown). Core 202 includes one or more arithmetic logic units (ALUs) 204 (one is shown). In some embodiments, core 202 includes one or more floating point logic units (FPLUs) 206 (one is shown) and / or one or more digital signal processing units (DSPUs) 208 (one is shown) in addition to or instead of one or more ALUs 204.

[0026]

[0031] Processor 200 includes one or more registers 212 communicatively coupled to core 202. Registers 212 are implemented using dedicated logic gate circuits (e.g., flip - flops) and / or any suitable memory technology. In some embodiments, registers 212 are implemented using static memory. The registers provide data, instructions, and addresses to core 202.

[0027]

[0032] In some embodiments, processor 200 includes one or more levels of cache memory 210 communicatively coupled to core 202. Cache memory 210 provides computer - readable instructions to core 202 for execution. Cache memory 210 provides data for processing by core 202. In some embodiments, the computer - readable instructions are provided to cache memory 210 by local memory, e.g., local memory attached to external bus 216. Cache memory 210 is implemented by any suitable cache memory type, such as static random access memory (SRAM), dynamic random access memory (DRAM), a metal - oxide - semiconductor (MOS) memory such as DRAM, and / or other suitable memory technologies.

[0028]

[0033] Processor 200 includes a controller 214, and the controller 214 controls inputs to the processor 200 from other processors and / or components included in the system 100 (FIG. 1) and / or outputs from the processor 200 to other processors and / or components included in the system 100. The controller 214 controls the data paths of the ALU 204, the FPLU 206, and / or the DSPU 208. The controller 214 is implemented as one or more state machines, data paths, and / or dedicated control logic. The gates of the controller 214 are implemented as stand-alone gates, FPGAs, ASICs, or other suitable technologies.

[0029]

[0034] Registers 212 and cache 210 communicate with the controller 214 and the core 202 via internal connections 220A, 220B, 220C, and 220D. The internal connections are implemented as buses, multiplexers, crossbar switches, and / or other suitable connection technologies.

[0030]

[0035] Inputs and outputs to the processor 200 are provided via a bus 216 that includes one or more conductive lines. The bus 216 is communicatively coupled to one or more components of the processor 200, such as the controller 214, the cache 210, and / or the registers 212. The bus 216 is coupled to one or more components of the system, such as the electronic circuit 121, the device 102, the processing system 106, and / or the display 108. The bus 216 is implemented as a bus, multiplexer, crossbar switch, and / or other suitable connection technology.

[0031]

[0036] Bus 216 is coupled to one or more external memories. The external memories include a read-only memory (ROM) 232. The ROM 232 is a mask ROM, an electronically programmable read-only memory (EPROM) 235, or other suitable technology. The external memories include a random access memory (RAM) 233. The RAM 233 is a static RAM, a battery-backed static RAM, a DRAM, an SRAM, or other suitable technology. The external memories include an electrically erasable programmable read-only memory (EEPROM (registered trademark)) 235. The external memories include a flash memory 234. The external memories include a magnetic storage device such as a disk 236. In some embodiments, the external memories are included in a system such as the system 100 and / or the processing system 106 shown in FIG. 1.

[0032]

[0037] Referring again to FIG. 1, the system 100 is deployed at a medical site such as a treatment room, a catheter examination room, an operating room, an emergency treatment room, etc. The device 102 is deployed adjacent to or in contact with the patient. The processing system 106 is installed near the patient, for example, in the same room as the patient. The processing system 106 may be located far from the patient, for example, in a different room or a different building. In some embodiments, the imaging data from the device 102 may be uploaded to the cloud and downloaded and processed at a remote location. The medical site is used to perform any number of medical imaging procedures, such as Doppler ultrasound imaging, angiography, fluoroscopy, computed tomography (CT), magnetic resonance imaging (MRI), intravascular ultrasound (IVUS), virtual histology (VH), forward-looking IVUS (FL-IVUS), intravascular photoacoustic (IVPA) imaging, fractional flow reserve (FFR) determination, coronary flow reserve (CFR) determination, optical coherence tomography (OCT), intracardiac echocardiography (ICE), forward-looking ICE (FLICE), intravascular palpography, transesophageal echocardiography (TEE), and other medical imaging modalities, or combinations thereof.

[0033]

[0038] Imaging device 102 and display 108 are communicatively coupled to processing system 106 either directly or indirectly. For example, imaging device 102 is connected to processing system 106 via connection 132, and display 108 is connected to the processing system via connection 107. Connections 107 and 132 may be of the same type of connection or different types of connections. Connections 107 and 132 include wired connections such as standard copper links or fiber optic links. For example, appropriate communication lines such as conductors and / or fiber optic enable data transmission between processing system 106 and imaging device 102 and / or display 108. In some embodiments, connections 107 and 132 are cables. In such embodiments, connector 130 at the distal portion of connection cable 132 is coupled to the proximal portion of handle 110 of imaging device 102. Connections 107 and 132 include appropriate communication standards such as Ethernet, Universal Serial Bus (USB), and / or proprietary communication protocols. In some embodiments, connections 107 and 132 are wireless connections using the IEEE802.11 Wi-Fi standard, Ultra-Wideband (UWB) standard, wireless FireWire, wireless USB, or another high-speed wireless network standard. In such embodiments, imaging device 102, processing system 106, and / or display 108 include one or more wireless transmission devices such as antennas. Processing system 106 is communicatively coupled to one or more data networks, for example, a TCP / IP-based local area network (LAN). In other embodiments, different protocols such as Synchronous Optical Network (SONET) are utilized. In some cases, processing system 106 is communicatively coupled to a wide area network (WAN). Processing system 106 utilizes network connections to access various resources. For example, processing system 106 communicates with a Digital Imaging and Communications in Medicine (DICOM) system, a Picture Archiving and Communication System (PACS), and / or a Hospital Information System via a network connection.It should be understood that connectors such as connector 130 can enable a processing system 106 to use one or more different imaging devices 102, such as different ultrasonic transducer arrays, when separate imaging procedures are performed over time. For example, the second imaging procedure is performed with the same or a different ultrasonic transducer array than that used in the first imaging procedure.

[0034]

[0039] Imaging system 100 is used to perform non-invasive imaging of anatomical structures such as a patient's heart or lungs. For example, imaging device 102 is configured to emit ultrasonic energy to create an image of a blood vessel or lumen and / or surrounding anatomical structures within a patient's body. The ultrasonic waves emitted by transducer array 124 of device 102 are reflected from tissue structures and other features within the anatomical structure. The echoes from the reflected waves are received by imaging device 102 and passed to processing system 106. Processing system 106 processes the received ultrasonic echoes to create an image of the patient's anatomical structure based on the acoustic impedance associated with the ultrasonic echoes. The image is a two-dimensional cross-sectional image or a three-dimensional image of the blood vessel. Imaging device 102 and / or processing system 106 include functions similar to or identical to those found in commercially available ultrasonic imaging elements, such as the L12-4U Lumify probe and system, EPIQ, Affmiti, and / or CX50 ultrasonic systems, each available from Koninklijke Philips N.V.

[0035]

[0040] Imaging device 102 is positioned outside the patient's body. In some embodiments, device 102 is positioned adjacent to and / or in contact with the patient's body near a blood vessel or lumen. The operator of imaging device 102 contacts the distal portion of the imaging device with the patient's body such that the anatomical structure is elastically pressed. The view of the anatomical structure shown in the ultrasound image depends on the position and orientation of imaging device 102, and imaging device 102 is manually positioned by the clinician and / or automatically positioned appropriately by the operator such that transducer 124 emits ultrasound and receives ultrasound echoes from the desired region of the anatomical structure.

[0036]

[0041] This imaging includes dividing the imaging area into specific zones within the anatomical structure, such as 8 - 28 zones, etc. The image of each zone is monitored over time to provide a temporal history. In some embodiments, imaging device 102 is used to measure one or more imaging parameters, such as the number of B - lines, the size and severity of lesions, the volume and diameter of blood vessels, cardiac output, heart rate, bright - dark zones of the lungs, the amount of collapse within the lungs, lung water content, and degree of sclerosis, etc. The imaging data related to these parameters is received by processing system 106 and output to display 108 to show a visual representation of the anatomical structure including B - mode ultrasound examination and color - flow map. The imaging procedure includes measuring the parameters multiple times, for example, once per respiratory cycle or once every two respiratory cycles, etc. In some embodiments, the parameters of each zone are displayed independently, and as a result, medical experts can monitor the changes in the parameters of each zone over time as shown in more detail with reference to FIG. 3. The imaging data including the parameters discussed above is transmitted to processing system 106 for analysis. In some embodiments, the imaging data and related measurements are transmitted to the cloud and accessed remotely.

[0037]

[0042] Figure 3 shows an exemplary display 300 created by the imaging system 100. The display is shown on the screen of the display 108 as shown in FIG. 1. The display 300 includes windows 308, 310 that show views of the patient's anatomical structure. These windows 308, 310 include a plurality of zones 302 that represent subdivisions of the anatomical structure. In the example of FIG. 3, eight zones 302 of approximately equal area are shown across the patient's chest. Any suitable number of zones are contemplated, such as 2, 4, 6, 10, 12, 16, 20, 28, and other greater and lesser numbers. The zones 302 may be of different sizes. For example, a zone 302 may correspond to a portion of the patient's anatomical structure, such as a lung. The zones 302 are based on physiology related to the anatomical structure (e.g., pulmonary edema in the lungs). The size, shape, quantity, and / or location of the zones are selected such that sufficient ultrasound data of different portions of the anatomical structure is acquired. The zones 302 are selectable, such that an operator can select a zone and access the imaging data related to the zone. In some embodiments, the operator selects one or more zones via an input device (such as by clicking on them with a mouse). Zones of unequal size are also contemplated and shown in alternative embodiments.

[0038]

[0043] In some cases, the number of zones corresponds to an ultrasound imaging protocol utilized by a medical professional to perform an ultrasound examination of a patient's anatomical structure. Exemplary ultrasound imaging protocols are described in Doerschug et al., Intensive Care Ultrasound: III. Lung and Pleural Ultrasound for the Intensivist (Annals of the American Thoracic Society, December 2013, Vol. 10, No. 6, pp. 708 - 712) and Volpicelli et al., International evidence - based recommendations for point - of - care lung ultrasound (Intensive Care Medicine, April 2012, Vol. 38, No. 4, pp. 577 - 591), the entireties of which are incorporated herein by reference. In some cases, a complete lung examination includes 12 zones, with 6 zones on each side of the patient's body. Each hemithorax is divided into an anterior zone, a lateral zone, and a posterior zone, which are distinguished by the anterior axillary line and the posterior axillary line. Each of the anterior zone, lateral zone, and posterior zone is further divided into an upper zone and a lower / base zone. In some cases, a lung examination includes 8 zones by omitting the two posterior zones on each side of the body as described above. In some cases, a lung examination includes 2 zones. Although these examples specifically describe ultrasound examinations of the lungs, it should be understood that the present disclosure contemplates any suitable anatomical structure of the patient.

[0039]

[0044] Zone 302 is colored to provide an indication of the severity of the patient's physiological state based on one or more imaging parameters. For example, zones 4, 5, 6, 7, and 8 are not colored and represent either not imaged or low severity, zones 1 and 2 are lightly colored and represent acceptable severity, and zone 3 304 is darkly colored and represents high severity. The color is accompanied by other visual or text hints such as an image, an alert, a measurement, or a message. Although the color is specifically described in the above explanation, it should be understood that the screen display 300 can include an appropriate visual representation of zone 302 that includes one or more shades, patterns, textures, or images. Zone 302 is shown in an anatomical structure reference window 302 (such as overlaid on a representation of the patient 306's anatomical structure), as well as in a stand-alone window 310 that shows an overview of zone 302 and accompanying information such as measurements of imaging parameters. Windows 308, 310 are simultaneously displayed on the display 108. Zone 302 is continuously updated throughout a medical treatment or over several treatments so that a medical professional can view changes in the zone over time. This is useful when the patient is being monitored by a number of medical professionals as it allows newly assigned professionals to easily access the medical history of each zone 302 through the received imaging data.

[0040]

[0045] As shown in FIG. 1, FIG. 4 shows an exemplary display 400 of the imaging system 100, which is also shown on the display 108. The display 400 includes an anatomical structure reference window 308 and a zone detail window 410 that shows imaging information related to the selected window. In some embodiments, the patient ID 413 is associated with all medical treatments of a particular patient. This patient ID 413 is displayed on the display 400 and is used to examine all medical data related to the patient. In some embodiments, when the patient associated with the patient ID 413 is scanned by the ultrasonic imaging system 100, the system 100 automatically displays the location of the zone 302 (e.g., zone 3 304) that had the highest ultrasonic feature score or severity score in the previous examination.

[0041]

[0046] In the example of FIG. 4, the zone detail window 410 shows the severity score over time, and the severity score is calculated by the processing system 106 based on the ultrasonic imaging data received from the imaging device 102. The severity score of a particular zone over time (e.g., zone 3 in the example of FIG. 4 as indicated by label 412) is represented by a plot, chart, or graph 314. In some embodiments, the plot 314 of the severity score over time is based on one or more of the imaging parameters of the received imaging data that indicate the severity of the patient's physiological condition. Generally, the severity score is a numerical quantification of the imaging parameters. The evaluation of the severity score over time provides an indication of whether the patient's condition is improving, worsening, or remaining the same. For example, the imaging parameters include the number of B-lines, the size and severity of the lesion, the volume and diameter of the blood vessels, the cardiac output, the heart rate, the bright and dark zones of the lungs, the amount of collapse in the lungs, the lung water content, and the degree of sclerosis. The plot 414 of the severity score includes one or more reference positions 416 that identify the timing of previous treatments. The reference positions 416 represent medical treatments, medication management, or interventions and are represented by symbols, shapes, points, lines, colors, or other visual representations. In the example of FIG. 4, the plot 414 of the severity score shows the degree of sclerosis over time in a patient with pneumonia. The disease is shown to have been increasing in the patient's condition up to the reference time point 416 (represented by the dotted line) at which the medication was administered to the patient. After this point, it can be seen that the degree of sclerosis (and the associated severity score in graph 414) is steadily decreasing over time. Medical experts can similarly access the zone detail window 410 corresponding to each of zone 302 having a severity score measured over time.

[0042]

[0047] In some embodiments, the numerical value of the severity score at a specific time is provided to the screen display 300. In some embodiments, numerical values of a number of severity scores at different times are provided. For example, a number of severity scores are output in a table. The coloring (e.g., visual representation of severity) of zone 3 304 of the anatomical structure reference window 308 is based on the severity score at the latest point in time, the selected point in time, or the average over the entire time period.

[0043]

[0048] In some embodiments, a medical expert can select imaging parameters on the display 400. In this case, zone 302 displays the severity score associated with that parameter (e.g., the spatial distribution of the parameter across the various zones 302). In one embodiment, the medical expert manually adds a reference time point 416 for each medical procedure. In other embodiments, the reference time point 416 is automatically added each time a patient ID 413 (in the current example, the patient ID has the value 402) is received by the processing system for a medical procedure. In some embodiments, the ultrasonic imaging system 100 automatically tags the zone 302 (e.g., zone 3 304 in FIG. 4) with the highest severity score so that zone 302 is automatically shown on the display 108 at the time of the next procedure. This assists the medical expert in monitoring the area in question. The medical expert can also manually select one or more zones 302 for observation using, for example, a mouse or a touch screen. The display 400 is also used to monitor some of the zones 302 within the patient's anatomical structure. In this case, the temporal history for each zone 302 is automatically stored by the processing system 106 and is readily available for the next procedure. In one embodiment, the ultrasonic feature score for each zone is based on at least one common imaging parameter. In other embodiments, the ultrasonic feature scores for two different zones are based on different imaging parameters.

[0044]

[0049] In some embodiments, system 100 generates a recommended location for further imaging treatment based on the results of the imaging analysis. For example, processing system 106 determines that zone 3 has the highest severity score or a severity score above a selected threshold. The threshold is selected by an operator or set according to a healthcare provider policy. Next, display 108 includes a prompt for placing the probe of imaging device 102 in zone 3 to perform further imaging treatment.

[0045]

[0050] As shown in FIG. 1, FIG. 5 shows an exemplary display 500 of the imaging system 100, which is also shown on the display 108. The display 500 shows various temporal representations of one or more zones 302. In particular, the display is used to highlight scanning locations that had high severity scores in past scans. For example, a medical professional selects zone 3 304 of the anatomical structure reference window 308, whereby a temporal history window 510 related to zone 3 is displayed on the display 108. The temporal history window 510 includes one or more visual representations of severity scores over time, such as a timeline 520. In the example of FIG. 5, the timeline 520 includes severity scores represented in various colors at time 1 (severe), time 2 (moderate), time 3 (severe), and time 4 (minimal). As discussed above, the severity score is represented by other visual cues such as shading, pattern, texture, image, text, or animation features. For example, a movie is displayed along with imaging data and color-coding to show the change in imaging data over time for a particular zone. The severity score is accompanied by corresponding imaging data. For example, the severity ultrasound scores at times 1 and 3 (reference numerals 522, 523) include ultrasound data corresponding to those zones. The date and time of these severity scores are further displayed along with treatment information and notes from previous medical professionals. In some embodiments, imaging data related to high (i.e., "severe") severity scores is automatically displayed in the temporal history window 510, while low severity scores are not automatically displayed. This allows medical professionals to focus on important areas of the anatomical structure, especially reducing the evaluation burden in life-saving emergency situations. In other embodiments, the imaging data for each severity score is manually selected by the medical professional.

[0046]

[0051] The medical information created by the imaging system 100 and displayed on the display device 108 is sent to a central location and accessed remotely. For example, a medical expert accesses the data via a cloud location that is away from the hospital. In this case, the medical data shown in FIGS. 3-5 is displayed at a remote location such as a computer monitor.

[0047]

[0052] FIG. 6 is a flowchart of a method 600 for ultrasonic imaging. In some embodiments, the steps of method 600 are performed by an ultrasonic imaging system 100 and associated components as shown in FIG. 1, such as the electronic circuit 121 of the imaging device 102, the electronic circuit of the processing system 106, and / or the display 108. For example, the processor 200 (FIG. 2) performs all or some of the steps of method 600. It should be understood that the steps of method 600 may be executed in an order different from that shown in FIG. 6, additional steps may be performed before, during, and after the steps, and / or some of the described steps may be replaced or deleted in other embodiments.

[0048]

[0053] In step 602, method 600 has the step of defining a plurality of zones within a patient's anatomical structure. These zones are regularly arranged across the patient's anatomical structure, such as across the lungs or heart. The zones may be regular or irregular in size and shape. The number of zones includes 2, 4, 6, 10, 12, 16, 20, 28, and other numbers of zones. In some embodiments, the coordinates of each zone are further defined and stored in memory such that the imaging data is automatically spatially related to that zone. For example, at the start, during, and / or end of an imaging procedure, the user manually indicates which zones are to be imaged. In some cases, the processor circuit automatically determines which zones are to be imaged based on image processing using the acquired ultrasonic data.

[0049]

[0054] In step 604, method 600 includes a step of performing a first imaging procedure on at least one zone of a plurality of zones. This imaging procedure is performed using an imaging device such as imaging device 102. The imaging procedure includes ultrasonic imaging, Doppler ultrasonic imaging, angiography, fluoroscopy, computed tomography (CT), magnetic resonance imaging (MRI), intravascular ultrasound (IVUS), virtual histology (VH), forward-looking IVUS (FL-IVUS), intravascular photoacoustic (IVPA) imaging, optical coherence tomography (OCT), intracardiac echocardiography (ICE), forward-looking ICE (FLICE), intravascular palpography, transesophageal echocardiography (TEE), and other medical imaging modalities, or combinations thereof. In some embodiments, the imaging procedure is performed on a patient's heart or lungs. Imaging data from the imaging procedure is transmitted to a processing system for analysis. The imaging data is received by a processor from a transducer array (such as during the first imaging procedure) or from memory (such as from a previously performed imaging procedure).

[0050]

[0055] In step 606, method 600 includes a step of determining a first severity score for at least one zone based on imaging data from the first imaging procedure. The first severity score is determined by a processor circuit based on one or more parameters of the imaging data. For example, one or more parameters are determined, identified, and / or quantified using image processing by the processor circuit on the acquired ultrasonic data. For example, in an imaging procedure of the heart, these parameters include the size and severity of lesions, the volume and diameter of blood vessels, cardiac output, and heart rate. In an imaging procedure of the lungs, the parameters include the number of B-lines, bright and dark zones of the lungs, the amount of collapse in the lungs, lung water content, and degree of sclerosis.

[0051]

[0056] In step 608, method 600 includes displaying a first severity score on a diagram of a patient having a plurality of zones. In some embodiments, the plurality of zones are superimposed over a diagram of an anatomical structure, such that a medical professional can readily understand the location and extent of each zone. The first severity score is visually represented for each zone, for example, by a color, pattern, shading, texture, or image displayed in the zone. For example, as in the example of FIG. 3, a high severity score is displayed in a dark color, while a low severity score is displayed in a light color. The zones are selected by a medical professional, for example, via a touch screen or a mouse. When a zone is selected, additional information about the zone, such as previous severity scores associated with the zone, is displayed. In some embodiments, when a zone is selected from the diagram, a timeline showing the temporal history of all medical data associated with the zone is displayed.

[0052]

[0057] In step 610, method 600 includes performing a second imaging procedure on at least one zone. The second imaging procedure is performed at a time later than the first imaging procedure and is any of the types of procedures discussed above. In some embodiments, the second imaging procedure is performed on a different zone than the first imaging procedure. For example, the first imaging procedure includes imaging zones 1-4, while the second imaging procedure includes imaging zones 5-8. In this case, the first and second imaging procedures may be performed at the same time or at different times. Imaging data from the second imaging procedure is transmitted to the processing system for analysis. It should be understood that the second imaging procedure may be performed with the same ultrasonic transducer array used in the first imaging procedure or with a different ultrasonic transducer array.

[0053]

[0058] In step 612, method 600 has a step of determining a second severity score for at least one zone based on imaging data from a second imaging procedure. The second severity score is based on any of the parameters discussed above.

[0054]

[0059] In step 614, method 600 has a step of updating the display using the second severity score. This step 614 has steps of updating the visual representation of the severity score, for example, darkening the color of the zone for a higher severity score, or lightening the color of the zone for a lower severity score.

[0055]

[0060] In step 616, method 600 optionally has a step of displaying a timeline including the first and second severity scores. The timeline includes ancillary information from the first and second imaging procedures such as time and position. The timeline further includes a graph, chart, or other visual representation showing the two severity scores and, if available, other severity scores. By the steps of method 600, a medical professional can view the progression of a patient over time in a particular zone of the patient's anatomical structure. This helps in adjusting the treatment among physicians and in providing special treatment to the diseased area of the patient's anatomical structure.

[0056]

[0061] Those skilled in the art will recognize that the devices, systems, and methods described above may be varied in various ways. As a result, those skilled in the art will understand that the embodiments encompassed by this disclosure are not limited to the specific exemplary embodiments described above. In that regard, although exemplary embodiments have been illustrated and described, a wide range of changes, modifications, and substitutions are intended in the foregoing disclosure. It will be understood that such modifications can be made to the foregoing without departing from the scope of this disclosure. As a result, the appended claims are appropriately construed broadly and in accordance with this disclosure.

Claims

**Claim 1** A processor circuit that communicates with one or more ultrasonic transducer arrays for acquiring imaging data related to a patient's anatomical structure, wherein an imaging region of the patient's anatomical structure is spatially divided into a plurality of zones, the anatomical structure is the patient's lung or heart, and the processor circuit receives a first set of imaging data acquired by one of the ultrasonic transducer arrays, an ultrasonic imaging system comprising: the first set of the imaging data represents at least one of the plurality of zones, and the processor circuit determines a first severity score related to an anatomical parameter based on the first set of the imaging data for the at least one of the plurality of zones; the processor circuit receives a second set of imaging data acquired by the one or another of the ultrasonic transducer arrays; the second set of the imaging data represents at least one of the plurality of zones; the processor circuit determines a second severity score related to the anatomical parameter based on the second set of the imaging data for the at least one of the plurality of zones; the processor circuit outputs a visual representation of the plurality of zones including an indication of the first severity score and an indication of the second severity score to a display device that communicates with the processor circuit. An ultrasonic imaging system. **Claim 2** The first set of the imaging data represents a first zone at a first time. The ultrasonic imaging system according to claim 1, wherein the second set of the imaging data represents a second zone at the first time. **Claim 3** The first set of the imaging data represents a first zone at a first time. The ultrasonic imaging system according to claim 1, wherein the second set of the imaging data represents the first zone at a different second time. **Claim 4** The ultrasonic imaging system according to claim 1, wherein the visual representation shows a change in the severity score over time based on the first severity score and the second severity score. **Claim 5** The ultrasonic imaging system according to claim 4, wherein the visual representation includes a plot of the change in the severity score over time. **Claim 6** The ultrasonic imaging system according to claim 1, wherein the visual representation includes a time-series representation of at least one of the first set of the imaging data, the second set of the imaging data, the first severity score, or the second severity score. **Claim 7** The ultrasonic imaging system according to claim 1, wherein the processor circuit further spatially correlates the first set and the second set of the imaging data with respect to each other in the plurality of zones. **Claim 8** The ultrasonic imaging system according to claim 1, wherein the visual representation of the plurality of zones includes a selectable representation of the plurality of zones such that, upon selection of a zone by a user, the first set and the second set of the imaging data correlated with respect to each other in the selected zone are displayed. **Claim 9** The ultrasonic imaging system according to claim 1, wherein the anatomical structure is the patient's lung, and the anatomical parameter includes at least one of a degree of sclerosis, a measurement of fluid in the lung, a degree of lung collapse, a number of B-lines, a measurement of bronchial aerograms, or a measurement of a plurality of exudates. **Claim 10** The ultrasonic imaging system according to claim 1, wherein the anatomical structure is the patient's heart, and the anatomical parameter is one or more of a physical dimension of a heart chamber, an ejection fraction, a degree of vascular occlusion, or a volume measurement. **Claim 11** A method for performing ultrasonic imaging of a patient's anatomical structure, the method comprising: Receiving, by a processor circuit, a first set of imaging data representing at least one of a plurality of zones, wherein the plurality of zones spatially divides an imaging region of the anatomical structure of the patient, the processor circuit communicates with an ultrasonic transducer array, and the ultrasonic transducer array acquires imaging data related to the imaging region of the anatomical structure of the patient spatially divided into the plurality of zones, and the anatomical structure is the patient's lung or heart. A step of determining, by the processor circuit, a first severity score related to anatomical parameters based on a first set of the imaging data, wherein the first severity score is related to at least one of the plurality of zones; A step of receiving, by the processor circuit, a second set of imaging data representing at least one of the plurality of zones; A step of determining, by the processor circuit, a second severity score related to the anatomical parameters based on the second set of the imaging data, wherein the second severity score is related to the at least one of the plurality of zones; A step of outputting, to a display device communicating with the processor circuit, a visual representation of the plurality of zones including an indication of the first severity score and an indication of the second severity score A method comprising the above steps.

12. The first set of the imaging data represents a first zone at a first time, The method according to claim 11, wherein the second set of the imaging data represents a second zone at the first time.

13. The first set of the imaging data represents a first zone at a first time, The method according to claim 11, wherein the second set of the imaging data represents the first zone at a different second time.

14. The method according to claim 11, wherein the visual representation shows a change in the severity score over time based on the first severity score and the second severity score.

15. The method according to claim 11, wherein the visual representation includes a plot of the change in the severity score over time.

16. The method according to claim 11, wherein the visual representation includes a time-series representation of at least one of the first set of the imaging data, the second set of the imaging data, the first severity score, or the second severity score.

17. The method according to claim 11, further comprising a step of spatially relating the first set and the second set of the imaging data to each other in the plurality of zones using the processor circuit.

18. The method according to claim 11, wherein the visual representation of the plurality of zones includes a selectable representation of the plurality of zones such that, upon selection of a zone by a user, the first set and the second set of the imaging data associated with each other in the selected zone are displayed.

19. A non-transitory computer-readable medium including executable instructions that, when executed, cause a processor circuit of an ultrasonic imaging system to execute the method according to claim 11.

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