Imaging of the skull, bones, and lungs using multi-opening ultrasound imaging.

Abstract

A diagnostic ultrasound imaging method is provided, which includes: transmitting an omnidirectional, unfocused ultrasound waveform to a target region through the transmitting aperture of a multi-aperture ultrasound imaging probe; receiving echoes from the target region through multiple receiving apertures of the multi-aperture ultrasound imaging probe; optimizing the contrast between voxels or pixels in a target region within the target region by adjusting at least one of the frequency, voltage level, and acoustic impedance of the received echoes using a processor of the multi-aperture ultrasound imaging probe; beamforming the voxels or pixels in the target region using the adjusted frequency, voltage level, and / or acoustic impedance to generate a diagnostic 2D or 3D medical image; and presenting the diagnostic 2D or 3D medical image on a display device.

Description

TECHNICAL FIELD

[0001] (Priority Claim) This patent application claims priority to U.S. Provisional Patent Application No. 63 / 583,103, filed on September 15, 2023, entitled "IMAGING SKULL, BONE, AND LUNG IMAGING USING MULTIPLE APERTURE ULTRASOUND IMAGING", which is hereby incorporated by reference in its entirety into the present specification.

[0002] (Incorporation by Reference) Unless otherwise expressly stated herein, all patents, publications, and patent applications mentioned in this specification are hereby incorporated by reference into this specification to the same extent as if each individual publication and patent application was specifically and individually indicated to be incorporated by reference herein.

[0003] (Related Patents and Applications) This application also relates to the following U.S. Patent Applications: U.S. Patent No. 8,007,439 (title: "Method and Apparatus to Produce Ultrasonic Images Using Multiple Apertures"); U.S. Patent No. 9,247,926 (title: "Multiple Aperture Medical Ultrasound Transducers"); U.S. Patent No. 9,146,313 (title: "Point Source Transmission and Speed-of-Sound Correction Using Multi-Aperture Ultrasound Imaging"); U.S. Patent No. 9,668,714 (title: "Systems and Methods for Improving Ultrasound Image Quality by Applying Weighting Factors"); U.S. Patent No. 9,883,848 (title: "Ultrasound Imaging Using Apparent Point-Source Transducers") Transmit Transducer); U.S. Patent No. 10,401,493 (Title: "Network-Based Ultrasound Imaging System"); U.S. Patent No. 11,253,233 (Title: "Calibration of Multiple Aperture Probes"); U.S. Patent Application Publication No. 2017 / 0209121 (Title: "Ultrasound Imaging with Sparse Arrays"); U.S. Patent Application Publication No. 2023 / 024833 (Title: "Multiple Aperture Imaging Systems and Methods");This relates to International Patent Application No. PCT / US2020 / 05662 (title: "Systems and Methods for Tissue Characterization Using Multiple Aperture Ultrasound"), International Patent Application No. PCT / US2021 / 57725 (title: "Systems and Methods for Improving Ultrasound Image Quality"), and International Patent Application No. PCT / US2023 / 062069 (title: "Synthetic Aperture Unfocused Transmission for Multiple Aperture Ultrasound Systems"). The entire content of each of these patents and patent applications is incorporated herein by reference. These related applications may also refer herein to the prior patents and patent applications of the "Applicant".

[0004] (Field) This invention generally relates to medical diagnosis, and more particularly to diagnostic data collected through the use of ultrasound. [Background technology]

[0005] (background) Medical ultrasound imaging has numerous important diagnostic imaging applications. This modality is known to have barriers such as bone and gas, and users need to possess skilled abilities to circumvent them. Often, the desired target to be imaged is behind an obstacle whose influence can be neutralized by precise aiming of the transducer. For example, the liver can be imaged from below the ribs by placing the transducer under the ribs and aiming "up" toward the liver, or from between the ribs by placing the transducer between the ribs and imaging from the intercostal space. The same level of expertise is required to position the instrument directly below and on the same plane as the ultrasound transducer and to perform interventional procedures that require treatment under image guidance. Ribs and other obstacles often limit the field of view. For example, even if only a field of view matching the intercostal space is physically available, the desired access to the lesion may require an alternative route that does not match the intercostal space. Similarly, it may not always be possible to directly image the inside of the skull to access lesions for treatment, and access ports (holes) are often made in the skull to allow insertion of conventional ultrasound probes for direct access to the brain. It is highly desirable that bone does not need to be removed or bypassed in order to perform imaging guidance.

[0006] Similarly, users of medical ultrasound imaging need to avoid gas-filled obstructions. For example, when imaging the entire length of the pancreas, it is often "obstructed" by a gas-filled portion of the stomach. Imaging the abdominal aorta can also be obstructed by intestinal gas, so operators often push the transducer into the intestine to get closer to the aorta in the hope of being able to make a diagnosis.

[0007] These limitations regarding ultrasound are well known to those skilled in the art.

[0008] However, as disclosed in many of the patents and applications cited herein, it is possible to image tissues and lesions inside bone and gas-filled cavities using Ping-based multiple aperture imaging (PMA) systems. While the primary methods of computed tomography techniques incorporated into PMA systems have already been disclosed, further methods and apparatus enable advanced imaging of the inside of bone, lungs, and other forms of dense or gas-filled tissues.

[0009] This initiative concerns devices and methods for imaging the inside of bone, dense tissue, lungs, and other gas-filled tissues using PMA systems. Furthermore, it touches upon utilizing the raw data for qualitative and quantitative analysis, and using algorithms to train and evaluate that data. [Overview of the project]

[0010] (Summary of Disclosure) A diagnostic ultrasound imaging method comprising the steps of: transmitting an omnidirectional, unfocused ultrasound waveform to a target region through the transmitting aperture of a multi-aperture ultrasound imaging probe; receiving echoes from the target region through multiple receiving apertures of the multi-aperture ultrasound imaging probe; optimizing the contrast between voxels or pixels in a target region within the target region by adjusting at least one of the frequency, voltage level, and acoustic impedance of the received echoes using a processor of the multi-aperture ultrasound imaging probe; beamforming the voxels or pixels in the target region using the adjusted frequency, voltage level, and / or acoustic impedance to generate a diagnostic 2D or 3D medical image; and presenting the diagnostic 2D or 3D medical image on a display device.

[0011] In some embodiments, the method includes repeating the optimization step and the beamforming step for further target regions within the target region.

[0012] In one embodiment, the diagnostic 2D or 3D medical image includes a plurality of target regions in which the frequency, voltage level, and acoustic impedance vary, based on optimization for each target region.

[0013] In some embodiments, the processor implements a trained machine learning model and performs the optimization step.

[0014] A diagnostic ultrasound imaging method is provided. The method includes the steps of: transmitting an omnidirectional, unfocused ultrasound waveform to a target region through the transmitting aperture of a multi-aperture ultrasound imaging probe; receiving echoes from the target region through multiple receiving apertures of the multi-aperture ultrasound imaging probe; optimizing the contrast between voxels or pixels in a target region within the target region by adjusting at least one of the frequency, voltage level, and acoustic impedance of the received echoes using a trained machine learning model of the multi-aperture ultrasound imaging probe; beamforming the voxels or pixels in the target region using the adjusted frequency, voltage level, and / or acoustic impedance from the trained machine learning model using a processor to generate a diagnostic 2D or 3D medical image; and presenting the diagnostic 2D or 3D medical image on a display device.

[0015] In some embodiments, the target region is received as user input.

[0016] A diagnostic ultrasound imaging method is provided. The method includes the steps of: transmitting an omnidirectional, unfocused ultrasound waveform to a target region at the transmitting aperture of a multi-aperture ultrasound imaging probe; receiving echoes from the target region at multiple receiving apertures of the multi-aperture ultrasound imaging probe; receiving input from a user indicating a target region within the target region; optimizing the contrast between voxels or pixels in the target region within the target region by adjusting at least one of the frequency, voltage level, and acoustic impedance of the received echoes using a trained machine learning model of the multi-aperture ultrasound imaging probe; beamforming the voxels or pixels in the target region using the adjusted frequency, voltage level, and / or acoustic impedance from the trained machine learning model using a processor to generate a diagnostic 2D or 3D medical image; and presenting the diagnostic 2D or 3D medical image on a display device.

[0017] In some embodiments, the trained machine learning model is configured to identify one or more patterns in the echo data.

[0018] In one embodiment, the trained machine learning model is configured to compare the one or more patterns with previously collected ultrasound echo data stored in a database.

[0019] An ultrasound imaging system is provided. The system comprises at least one transmit transducer element configured to transmit an omnidirectional, unfocused ultrasound waveform to a target region; a plurality of receive transducer elements configured to receive ultrasound echoes from the target region; and a processor configured to optimize contrast between voxels or pixels in a region of interest within the target region by adjusting at least one of the frequency, voltage level, and acoustic impedance of the received echoes, wherein the processor is further configured to beamform the voxels or pixels in the region of interest using the adjusted frequency, voltage level, and / or acoustic impedance to generate a diagnostic 2D or 3D medical image.

[0020] In some embodiments, the system includes a display device configured to present the diagnostic 2D or 3D medical image on the display device. [Brief Description of the Drawings]

[0021] (Brief Description of the Drawings) The novel features of the present invention are particularly set forth in the appended claims. The features and advantages of the present invention will be better understood with reference to the following detailed description, which describes exemplary embodiments in which the principles of the present invention are employed, and the accompanying drawings described below.

[0022] [Figure 1] Figure 1 is a schematic diagram of a multi-aperture imaging probe having a plurality of arrays.

[0023] [Figure 1A] Figure 1A is a schematic diagram of an array of a multi-aperture imaging probe that conforms to the contoured portion of the tissue to be imaged. This array is sufficiently flexible to conform to the shape, and can be moved or fixed to maintain a specific shape.

[0024] [Figure 2]Figure 2 is a schematic diagram of one embodiment of a concave curvilinear matrix having curvatures in two orthogonal directions, also referred to as a three-dimensional (3D) array. Each element in the 3D array is displaced relative to adjacent elements in all of the x, y, and z axes. In this figure, the element(s) of the transmit aperture are designated for emitting ultrasound waves into a medium. A plurality of targets within the medium are shown to illustrate how volumetric data may be acquired. A plurality of receive apertures are shown to illustrate how timing and adjustment of the speed of sound in tissue may be involved in simultaneous data acquisition. The array itself may be stationary or flexible. That is, like a mat or patch, it may conform to the region to be imaged.

[0025] [Figure 3A] Figure 3A is an example of a transducer enclosure that enables ease of use for field operators.

[0026] [Figure 3B] Figure 3B shows an enclosure that houses an adjustable or conformable 1D or 1.5D array.

[0027] [Figure 3C] Figure 3C shows an enclosure that houses an adjustable or conformable 2D or 3D array.

[0028] [Figure 3D] Figure 3D shows an enclosure that houses an adjustable or conformable 2D or 3D array using pMUT or cMUT transducers.

[0029] [Figure 4] Figure 4 shows both the side and end faces of a typical medical imaging piezoelectric array, including several matching layers and a lens. Typical speeds of sound associated with these layers are also listed.

[0030] [Figure 5] Figure 5 shows both the side and end faces of an ultrasonic transducer with a piezoelectric, pMUT, or cMUT array, including a single matching layer and lens. Typical sound velocities associated with these layers are also listed. This probe was specifically designed for imaging through and within bone.

[0031] [Figure 6] Figure 6 shows both the side and end faces of an ultrasonic transducer with a piezoelectric, pMUT, or cMUT array, including a single matching layer and lens. Typical sound velocities associated with these layers are also listed. This probe was specifically designed for imaging through and within bone.

[0032] [Figure 7] Figure 7 shows the outer layers of the skull and scalp, and their corresponding average thickness in adults.

[0033] [Figure 8] Figure 8 shows the materials and structure of the 3-array multi-aperture probe.

[0034] [Figure 9] Figure 9 shows the location of the faster matching layer in the desired probe for imaging through bone.

[0035] [Figure 10] Figure 10 shows the location of the faster matching layer in the desired probe for imaging through bone.

[0036] [Figure 11] Figure 11 is a flowchart illustrating the method for imaging through bone.

[0037] [Figure 12] Figure 12 shows a dataset consisting of pixels or voxels, which are shown here as 2D slices of pixels. [Modes for carrying out the invention]

[0038] (Detailed explanation) Various embodiments will be described in detail with reference to the accompanying drawings. References to specific examples and embodiments are illustrative and not intended to limit the scope of the invention or the claims.

[0039] This disclosure provides a system and method that utilizes artificial intelligence to analyze raw data generated by a ping-based multiple aperture imaging ("PMA") imaging system. The obtained data can be used to improve image quality and to perform quantitative or qualitative analysis of both visual and non-visual diagnostic conditions.

[0040] As described below and in further detail in the applicant's prior patents and patent applications, PMA imaging involves transmitting an ultrasound "ping," the echo of which can be received by a receiving element located some distance from the transmitter. Each received echo signal lies along an ellipse defined by the positions of the transmitter and receiver, and the time interval between ping transmission and echo reception. Data elements can be created almost anywhere in a 2D grid or a 3D volume. Typically, intersecting ellipses in a 2D grid are known as pixels. Intersecting ellipses in a 3D volume are known as voxels. Images can be formed by combining such pixels or voxels (i.e., data elements) such that their intersections are highlighted. Each intersection may be an image point in a two-dimensional or three-dimensional image. Simultaneously and separately, groupings of data elements, known as datasets, can be evaluated for quantitative and / or qualitative indicators of diagnostic conditions.

[0041] Figure 1 shows a ping-based multiple aperture probe 830 comprising arrays 504, 506, 508, 510, and 512, and one or more processors 801, 802, and 803 configured to control the probe's operation, including the transmission of ultrasonic wavefronts from the arrays and the reception, processing, and storage of echo data. Subarrays, or often individual elements, exist within each array. However, subarrays may be located across physical gaps between arrays and should not be limited to individual elements on individual arrays. As disclosed in other inventions cited herein, the PMA system does not require the arrays to be continuous, flat, or even aligned. This is because the PMA system uses unfocused transmission and each receiver collects data independently. As discussed in U.S. Patent No. 11,253,233, the PMA system operates at optimal performance when calibrated, or ideally dynamically calibrated in real time.

[0042] The transducers may be sequential in some embodiments, or they may be configured using multiple arrays in other embodiments. Regardless of the type of array, the transducer elements operate independently and can be used to form any number of transmit or receive apertures within the structure. When used in the embodiments of Figure 1, the terms “transducer array” or “array” generally refer to a collection of transducer elements mounted on a common backing plate. Such arrays may have one dimension (1D), two dimensions (2D), 1.5 dimensions (1.5D), or three dimensions (3D). Other dimensions of arrays may also be used, as will be understood by those skilled in the art. A transducer array may be a collection of pMUT or cMUT transducer elements. The elements of a transducer array may be the smallest independently functioning component of the array. For example, in the case of an array of piezoelectric transducer elements, each element may be a single piezoelectric crystal or a single machined section of a piezoelectric crystal.

[0043] Next, Figure 1A shows that arrays 504–512 and emission surfaces 812–820 are positioned relative to a tissue or object, conforming to its shape. Electrical connections or wires 822 are shown coupled to each array. This is an ideal characteristic when the user needs to contact a uniquely shaped structure whose shape changes as the transducer is moved across it. This also applies to the skull, fracture sites, or limbs such as arms and legs. The probe's ability to conform particularly to concave shapes is beneficial in maintaining skin contact, which is very much needed throughout the examination. Furthermore, the convex shape properties allow the transducer element to be held closer to the desired target to be imaged.

[0044] Next, Figure 2 shows a 3D array. The shown 3D array 300 is concave around two different axes, thereby positioning the individual elements in three-dimensional space relative to each other. As shown in Figure 2, multiple transmit apertures T1-TN are shown to illustrate transmit pulses received at one or more receive apertures R2 and / or R3. A single target 321 or reflector 321 is shown within the 3D volume 310 to illustrate how data can be collected. The 3D array can be fixed to a desired concave shape for a particular type of anatomical structure, or it can be flexible. That is, the array can be made of flexible MEMS material and placed in the housing of a transducer as shown in Figures 3A-3D. Alternatively, the 3D array can be made of mesh material and placed on the patient with an adhesive such as a bandage applicator. Finally, the probe used to collect the 3D volume dataset does not have to be from the 3D array; instead, a 2D array with elements arranged in a straight rectangle or square, but not curved around an axis, can also be used to provide a 3D volume in a PMA system.

[0045] U.S. Patent No. 9,220,478 (title: "Concave Ultrasound Transducers and 3D Arrays") describes several versions of array configurations for generating volumetric datasets and their associated voxels. The diagram in Figure 2 is presented herein for the purpose of illustrating a 3D array used with a PMA system to create a 3D volumetric dataset. Figure 2 depicts a snapshot of multiple aperture data acquisition as a process of constructing an image of the entire volume 310. Here, one or more elements of the transmitting aperture T1 transmit pulses into the volume containing scatterers such as 321 and 322. The elements constituting the receiving aperture R2 can be assembled in various shapes. Here, a square of elements constitutes the receiving apertures R2 and R3. As described above, the speed of sound along the path from the transmitting aperture T1 to the reflector 321 or 322 is irrelevant to the coherent summation of the received signal as long as a single aperture is used for reception. However, if multiple receiving apertures R1 and R2 are used, the speed of sound can be modified to improve image quality.

[0046] In some embodiments, the size of the receiving aperture R2 may be similar to that of a conventional phased array (e.g., about 2 cm). However, unlike conventional arrays, the total aperture 340, which determines the lateral and transverse resolution of the system, is much larger because it includes the distance from the transmitter T1 to the group R2 of the receiving elements, and can be the same width as the entire array 300, or even wider, if the transmitter is located on a separate array within the probe (or in a separate probe communicating electronically). Each element located at the receiving aperture R2 collects volume data from the T1 transmit pulse. The size and sequence of the transmitter and receiver apertures can be varied across the array, as in the sequence described in Figure 2C, but the transmitter and receiver can be located anywhere in the array and on any axis.

[0047] Collecting data through various tissue types naturally requires adaptation to different acoustic impedances due to varying sound velocities in each tissue. Pixel and voxel calculations can only be accurate if these adaptations are made. U.S. Patent No. 9,146,313 (titled "Point Source Transmission and Speed-of-Sound Correction Using Multi-Aperture Ultrasound Imaging") details these methods.

[0048] Imaging through bone, dense tissue (breast), lungs, or gas-filled areas (pneumothorax) also presents challenges in probe handling. Placing an ultrasound probe to image the inside of bones and lungs on a patient should be as easy as placing your palm on a child's forehead. This is the case shown in Figure 3A. Those skilled in the art will recognize that any plastic housing and practical form can be designed. This particular housing was chosen to demonstrate its potential for easy use in trauma situations, for example, by relatively untrained individuals who need to image the inside of the skull. Whether 2D, as shown in Figure 3C, or 1.5D, as shown in Figure 3B, the internal motion or array used in the probe is not their concern.

[0049] Transmitting ultrasonic energy to a tissue medium and receiving ultrasonic energy reflected from the tissue medium requires careful consideration of the acoustic properties and impedances of various tissue types being imaged or scanned for non-imaged data. The mechanical design of the transducer and its associated matching layers, lenses, backing blocks, and housings is known to be crucial for obtaining the best signal. However, conventional ultrasound systems are primarily interested in imaging "soft tissues" such as the liver, kidneys, heart, and fetus. The sound velocity in these soft tissues is approximately 1540 m / s. Therefore, conventional imaging systems have utilized various mechanical inputs within the transducer to "match" these velocities both during transmission and reception.

[0050] Next, Figure 4 shows a conventional ultrasound array designed for imaging the inside of the human body, which may include a backing block 401, a piezoelectric array 403, a first matching layer 405, a second matching layer 407, and an acoustic lens 409. The backing block is located at the rear of the transducer head, and the lens actually makes contact with the patient. Beneath the lens are typically two metal, resin, or RTV layers used to match the transmitted pulses from the piezoelectric array to the human body. Similarly, upon reception, the matching layers speed up the received echoes for recording as reflections on the elements of the piezoelectric array. These pulses are then converted into digital signals through an analog-to-digital converter, and these signals are transformed into ultrasound data and images. The backing block is used as a backstop for the piezoelectric array. That is, upon transmission, the backing block acts as a "deaden" to reduce backward transmissions, preventing the transmitted energy from reflecting back into the array. Much of this energy is not in phase with the transmitted energy, resulting in degradation and / or deformation of outward transmissions away from the surface of the array. During reception, the backing block keeps the array noise level low, both to enable higher discriminative power between receive and transmit signals and to reduce crosstalk between elements sharing the same ground.

[0051] Figure 4 shows several samples of sound velocity associated with different layers. These figures are intended to illustrate those consistent with conventional ultrasonic imaging arrays. The matching layer, backing block, and lens will all vary depending on the type of material used by different manufacturers, and therefore the sound velocity will also differ. However, in this example, the sound velocity of the backing block is 1900 m / s, the sound velocity of the piezoelectric array is 5200 m / s, the sound velocity of the first matching layer is 2280 m / s, the sound velocity of the second matching layer is 2050 m / s, and the sound velocity of the acoustic lens is 960 m / s.

[0052] Imaging and data acquisition of bone and high-density tissues

[0053] This disclosure relates primarily to the construction of transducers for imaging from or collecting data from bone, dense tissue, lungs, or gas-filled cavities, and for collecting and utilizing that data for both visual and non-visual diagnostic applications.

[0054] Upon first examining hard tissue, imaging the inside of the skull is a crucial application. In the case of the skull, the speed of sound within the skull is 2050 m / s, considerably higher than in other tissues within the body. Furthermore, other bones have even higher speeds of sound, ranging from 2800 to 4080 m / s. Therefore, providing matching up to 960 m / s, as with conventional probes in Figure 4, is undesirable. Rather, providing matching up to 2050 m / s is desirable. This matching maximizes the energy entering and passing through the skull. It is truly desirable to deliver energy to the soft tissues of the brain. PMA systems beamform the energy returning only at the receiving end, providing adaptation to different acoustic densities in the process. Therefore, delivering acoustic energy to and from the inside and outside of the skull is the most important element. Both Figures 5 and 6 illustrate how the design of the matching layer, lens, and backing block for the piezoelectric array can be carried out. Figure 6 utilizes two matching layers 415 and 417, while Figure 5 utilizes only one matching layer 413. Furthermore, in the case of pMUT or cMUT arrays, matching layers are not required. In those cases, transmission can be controlled by ping-based transmission of the PMA system, which does not require matching layers and still results in transmission at a parameter of 2050 m / s.

[0055] Figure 7 shows a sample of bone thickness related to the skull. Larger bones such as the femur, ilium, and lumbar vertebrae may be even thicker and have even higher sound velocities, but are not shown here. When attempting to image the interior of these bones, receiving data through the cortical bone is key. The arrays shown in Figures 5 and 6 were designed for a “bone imaging probe” to provide clear images of the central structure of the bone.

[0056] Other embodiments of this device can be devised for other types of dense tissue (such as dense breast tissue, cancerous lesions, and hardened plaques), particularly when physically smaller, multiple-opening transducers (e.g., for IVUS, pediatric, transesophageal, or intracavitary guidance) are positioned directly against these tissue types. Alternatively, they can even be devised to assist in tracking mechanical instruments or catheters to hard tissue targets.

[0057] Figure 8 shows the material and structure of a 3-array multiple aperture probe. This may include faster or denser lens materials that are closer to the sound velocity of the skull. The probe may include an injection-molded nosepiece and an RTV array buffer region to reduce crosstalk within the array.

[0058] Figure 9 shows the location of the faster matching layer in a desired probe for imaging through bone. Similar to the embodiment in Figure 9, the probe may include a faster or denser lens material closer to the speed of sound within the skull, an injection-molded nosepiece, and an RTV array buffer region to reduce crosstalk within the array. The illustrated implementation may include two matching layers and a single array.

[0059] Figure 10 shows the location of a faster matching layer in a desired probe for imaging through bone. This implementation may include two matching layers and a single array having an injection-molded nosepiece with integrated lenses. The nosepiece with integrated lenses may have a faster or denser material that is closer to the speed of sound within the skull.

[0060] Imaging and data collection of the lungs and gas-filled areas.

[0061] The adaptive beamforming characteristics of PMA systems also work with tissues that have lower acoustic impedance and associated sound velocities. For example, lung parenchyma typically has a sound velocity of 25–70 m / s.

[0062] In the case of lung base trauma, transducers can be constructed to have a matching layer of 75 m / s at the skin surface. Different matching layer materials can be used to further reduce the speed of sound using the techniques described in Figures 5 and 6. Furthermore, in the case of pMUT or cMUT arrays, a matching layer is not required. In those cases, transmission can be controlled by ping-based transmission of the PMA system, resulting in transmission at a parameter of 75 m / s without the need for a matching layer.

[0063] Adaptive beamforming of high-density and gas-filled tissues using a Ping-based multiple aperture system.

[0064] The physical apparatus and use of PMA transducers and instruments provide the ability to collect channel data from different aspect angles around a target region, with all received data collected from the same unfocused transmission. This process is further described in U.S. Patent Application Publication 2023 / 024833 (title: "Multiple Aperture Imaging System and Method") and U.S. Patent Application 65 / 582,683 (title: "System and Method for Performing Visual and Non-Visual Diagnoses by Artificial Intelligence Using Multiple Aperture Ultrasound"). However, beamforming can be further modified to adapt to different tissue densities. For example, the optimal frequency used to beamform the bones of the skull may differ from the optimal frequency for beamforming the brain or vascular tissue inside the skull. Similarly, strong reflectors (e.g., the skull) that provide higher voltage values ​​can be associated, weighted, and reduced, thereby weighting weaker reflectors (e.g., brain and vascular tissue) beyond that strong reflector, and increasing their values ​​to enhance clarity.

[0065] In the case of brain imaging through the skull, a preferred embodiment involves transmitting at one frequency and receiving at another. For example, if only soft tissue is the desired target area, it may be preferable to transmit at a lower frequency and receive at a higher fundamental frequency to visualize it. The use of encoded transmissions can also help to allow lower frequency transmissions to reach deeper parts of the skull.

[0066] In the case of brain imaging through the skull, another embodiment involves combining a series of low-frequency transmissions with a series of slightly higher-frequency transmissions. This may help to better identify interfaces near the skull, such as the subdural space.

[0067] Related but inverse terms, the tissues beyond the pleura and inside the lung have even lower sound velocities than the pleura and skin above them. The optimal frequency used to beamform the pleura covering the outside of the lung may differ from the optimal frequency for beamforming the lung parenchyma inside the lung. Similarly, stronger reflectors (e.g., pleura) that provide higher voltage echo values ​​can be associated, weighted, and reduced, thereby weighting and increasing the values ​​of weaker reflectors (e.g., lung parenchyma) beyond those strong reflectors to enhance clarity.

[0068] This adaptive beamforming can be implemented in PMA systems and is available in conjunction with the transducers described herein for clearer imaging of bone, dense tissue, lung, and gas-filled tissue.

[0069] Figure 11 shows a flowchart 1100 illustrating the process of adaptive beamforming of tissue that may be extremely dense or gas-filled to improve contrast that may be relevant to the diagnosis. Using a PMA system with multiple aperture probes, the probes are positioned over the area of ​​interest. The system may provide imaging data at that point according to step 1101, or it may be used without providing imaging data according to step 1102. The data can be collected in real time and stored in system memory, or even transmitted to and stored in the cloud during step 1104 (see U.S. Patent No. 10,401,493, “Network-Based Ultrasound Imaging System”).

[0070] Next, step 1105 offers the user the option to manually control the subsequent steps or to choose an automated process to optimize each contributing dataset. A “region” is a subset of pixels or voxels, also controlled by the user.

[0071] User controls are used to define the size of a pixel or voxel region. That is, the number of pixels to be analyzed together for pattern recognition is selectable by the user. This selectable pattern of pixels or voxels is called a region. Region 1200 in Figure 12 shows a dataset composed of pixels or voxels, in this case shown as a 2D slice of pixels. The smallest possible region or group is a single pixel, and the largest corresponds to the system's resolution (e.g., 1260 x 1260 pixels). 1202, 1204, and 1206 represent three pixel regions in Figure 12. Each of 1202, 1204, and 1206 uses 6 x 3 pixels to define their region. However, a typical choice might be around 8 x 8 pixels. In a 3D system, the desired cube could be 8 x 8 x 8 voxels.

[0072] The initial values ​​presented in steps 1106 and 1108 are naturally generated as a function of beamforming in step 1104. Then, in steps 1107 and 1109, the frequency and voltage levels can be adjusted independently and separately for each pixel or voxel pattern, region by region. In other words, the user can adjust the data frequency and data voltage controls for each region to achieve optimal identification and contrast between regions. This step can also be performed automatically by involving artificial intelligence or machine learning to optimize these parameters, either by learning from existing datasets or by learning from datasets that have been collected and validated in the past for that type of organization.

[0073] The values ​​used in steps 1107, 1109, and 1111 are crucial steps in the process because they eliminate the need to select a single frequency or voltage threshold for the entire dataset. Optimized frequencies, voltage levels, or tissue densities can be mapped onto different regions of the dataset, respectively, to generate images with optimal contrast, and similarly, to generate the optimal dataset for subvisual use.

[0074] In one embodiment, beamforming in step 1112 is typically performed using only frequency data or voltage data from steps 1107 and 1109.

[0075] In another embodiment, the beamforming in step 1112 is further enhanced by using the frequency, voltage, and acoustic impedance from steps 1107, 1109, and 1111.

[0076] The enhanced dataset generated by the adaptive beamforming process can now be used to preset the image data in step 1118.

[0077] The dataset generated by this enhanced adaptive beamforming process in step 1122 may provide greater clarity to the data used in the subvisual range.

[0078] Step 1126 indicates that the process is repeated in order to continue imaging and providing the dataset using this process.

[0079] While the present invention is disclosed in the context of certain preferred embodiments and examples, those skilled in the art will understand that the invention extends not only to the specifically disclosed embodiments but also to other alternative embodiments and / or to the use of the invention and its obvious modifications or equivalents. Various modifications of the above embodiments will be readily apparent to those skilled in the art, and the general principles defined herein can be applied to other embodiments without departing from the spirit or scope of the invention. Accordingly, the scope of the invention disclosed herein should not be limited by the specific disclosed embodiments described above, but should be determined solely by the correct interpretation of the claims below.

[0080] In particular, materials and manufacturing techniques are available to those skilled in the art. Furthermore, references to a singular item include the possibility of multiple identical items. More specifically, the singular forms “a,” “and,” “said,” and “the” as used herein and in the appended claims include multiple referents unless the context clearly indicates otherwise. Unless otherwise explicitly stated, the term “or” as used herein includes all alternatives presented and is essentially the same as the commonly used phrase “and / or.” It should be further noted that claims can be drafted to exclude any one of their components. This statement is therefore intended to serve as a preliminary basis for the use of exclusive words such as “solely” and “only,” or “negative” limitations, in relation to the description of the components of the claims. Unless otherwise stated herein, all technical and scientific terms used herein have the same meaning as commonly understood by those skilled in the art to which the invention pertains.

Claims

1. A diagnostic ultrasound imaging method, which includes: Transmitting omnidirectional, non-focused ultrasound waveforms to a target region through the transmitting apertures of a multi-aperture ultrasound imaging probe; Receiving ultrasound echoes from the target region at multiple receiving apertures of the multi-aperture ultrasound imaging probe; The processor of the multi-aperture ultrasound imaging probe optimizes the contrast between voxels or pixels in the target region within the target area by adjusting at least one of the frequency, voltage level, and acoustic impedance of the received echoes; The processor uses the adjusted frequency, voltage level, and / or acoustic impedance to beamform voxels or pixels in the target region to generate 2D or 3D medical images for diagnostics; and To display the diagnostic 2D or 3D medical image on a display device; The method comprising the step of

2. The method according to claim 1, further comprising repeating the optimization step and the beamforming step for further target regions within the target region.

3. The method according to claim 2, wherein the diagnostic 2D or 3D medical image includes a plurality of target regions having varying frequencies, voltage levels, and acoustic impedances, based on optimization for each target region.

4. The method according to claim 1, wherein the processor implements a trained machine learning model and performs the optimization step.

5. A diagnostic ultrasound imaging method, which includes: Transmitting omnidirectional, non-focused ultrasound waveforms to a target region through the transmitting apertures of a multi-aperture ultrasound imaging probe; Receiving ultrasound echoes from the target region at multiple receiving apertures of the multi-aperture ultrasound imaging probe; Optimizing the contrast between voxels or pixels in a target region within the target area by adjusting at least one of the frequency, voltage level, and acoustic impedance of the received echoes using a machine learning model trained on the multi-aperture ultrasound imaging probe; The processor beamforms voxels or pixels in the target region using the adjusted frequency, voltage level, and / or acoustic impedance from the trained machine learning model to generate 2D or 3D medical images for diagnosis; and To display the diagnostic 2D or 3D medical image on a display device; The method comprising the step of

6. The method according to claim 5, wherein the target area is received as user input.

7. A diagnostic ultrasound imaging method, which includes: Transmitting omnidirectional, non-focused ultrasound waveforms to a target region through the transmitting apertures of a multi-aperture ultrasound imaging probe; Receiving ultrasound echoes from the target region at multiple receiving apertures of the multi-aperture ultrasound imaging probe; Receiving input from the user indicating the target area within the target region; Optimizing the contrast between voxels or pixels in a target region within the target area by adjusting at least one of the frequency, voltage level, and acoustic impedance of the received echoes using a machine learning model trained on the multi-aperture ultrasound imaging probe; The processor beamforms voxels or pixels in the target region using the adjusted frequency, voltage level, and / or acoustic impedance from the trained machine learning model to generate 2D or 3D medical images for diagnosis; and To display the diagnostic 2D or 3D medical image on a display device; The method comprising the step of

8. The system according to claim 7, wherein the trained machine learning model is configured to identify one or more patterns in the echo data.

9. The method according to claim 7, wherein the trained machine learning model is configured to compare the one or more patterns with previously collected ultrasound echo data stored in a database.

10. An ultrasound imaging system: At least one transmitting transducer element configured to transmit an omnidirectional, non-focused ultrasonic waveform to a target region; Multiple receiving transducer elements configured to receive ultrasonic echoes from the target region; A processor configured to optimize the contrast between voxels or pixels in a target region within a target region by adjusting at least one of the frequency, voltage level, and acoustic impedance of a received echo, and further configured to beamform the voxels or pixels in the target region using the adjusted frequency, voltage level, and / or acoustic impedance to generate a 2D or 3D medical image for diagnosis, The system comprising the above.

11. The system according to claim 10, further comprising a display device configured to present the diagnostic 2D or 3D medical image on the display device.

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