WO2018051265A1 - Mesure et affichage de précharge élastographique ultrasonore - Google Patents

Mesure et affichage de précharge élastographique ultrasonore Download PDF

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WO2018051265A1
WO2018051265A1 PCT/IB2017/055561 IB2017055561W WO2018051265A1 WO 2018051265 A1 WO2018051265 A1 WO 2018051265A1 IB 2017055561 W IB2017055561 W IB 2017055561W WO 2018051265 A1 WO2018051265 A1 WO 2018051265A1
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Prior art keywords
displacement
probe
subject
values
processor
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PCT/IB2017/055561
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English (en)
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Hua Xie
Man Nguyen
Vijay Thakur SHAMDASANI
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Koninklijke Philips N.V.
Massachusetts Institute Of Technology
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Publication of WO2018051265A1 publication Critical patent/WO2018051265A1/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/08—Detecting organic movements or changes, e.g. tumours, cysts, swellings
    • A61B8/0825—Detecting organic movements or changes, e.g. tumours, cysts, swellings for diagnosis of the breast, e.g. mammography
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/08—Detecting organic movements or changes, e.g. tumours, cysts, swellings
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/46—Ultrasonic, sonic or infrasonic diagnostic devices with special arrangements for interfacing with the operator or the patient
    • A61B8/461—Displaying means of special interest
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/46—Ultrasonic, sonic or infrasonic diagnostic devices with special arrangements for interfacing with the operator or the patient
    • A61B8/461—Displaying means of special interest
    • A61B8/465—Displaying means of special interest adapted to display user selection data, e.g. icons or menus
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/46—Ultrasonic, sonic or infrasonic diagnostic devices with special arrangements for interfacing with the operator or the patient
    • A61B8/467—Ultrasonic, sonic or infrasonic diagnostic devices with special arrangements for interfacing with the operator or the patient characterised by special input means
    • A61B8/469—Ultrasonic, sonic or infrasonic diagnostic devices with special arrangements for interfacing with the operator or the patient characterised by special input means for selection of a region of interest
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/48—Diagnostic techniques
    • A61B8/485—Diagnostic techniques involving measuring strain or elastic properties
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/52—Devices using data or image processing specially adapted for diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/5207—Devices using data or image processing specially adapted for diagnosis using ultrasonic, sonic or infrasonic waves involving processing of raw data to produce diagnostic data, e.g. for generating an image
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/52—Devices using data or image processing specially adapted for diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/5215—Devices using data or image processing specially adapted for diagnosis using ultrasonic, sonic or infrasonic waves involving processing of medical diagnostic data
    • A61B8/5223—Devices using data or image processing specially adapted for diagnosis using ultrasonic, sonic or infrasonic waves involving processing of medical diagnostic data for extracting a diagnostic or physiological parameter from medical diagnostic data
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01S—RADIO DIRECTION-FINDING; RADIO NAVIGATION; DETERMINING DISTANCE OR VELOCITY BY USE OF RADIO WAVES; LOCATING OR PRESENCE-DETECTING BY USE OF THE REFLECTION OR RERADIATION OF RADIO WAVES; ANALOGOUS ARRANGEMENTS USING OTHER WAVES
    • G01S7/00—Details of systems according to groups G01S13/00, G01S15/00, G01S17/00
    • G01S7/52—Details of systems according to groups G01S13/00, G01S15/00, G01S17/00 of systems according to group G01S15/00
    • G01S7/52017—Details of systems according to groups G01S13/00, G01S15/00, G01S17/00 of systems according to group G01S15/00 particularly adapted to short-range imaging
    • G01S7/52023—Details of receivers
    • G01S7/52036—Details of receivers using analysis of echo signal for target characterisation
    • G01S7/52042—Details of receivers using analysis of echo signal for target characterisation determining elastic properties of the propagation medium or of the reflective target
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01S—RADIO DIRECTION-FINDING; RADIO NAVIGATION; DETERMINING DISTANCE OR VELOCITY BY USE OF RADIO WAVES; LOCATING OR PRESENCE-DETECTING BY USE OF THE REFLECTION OR RERADIATION OF RADIO WAVES; ANALOGOUS ARRANGEMENTS USING OTHER WAVES
    • G01S7/00—Details of systems according to groups G01S13/00, G01S15/00, G01S17/00
    • G01S7/52—Details of systems according to groups G01S13/00, G01S15/00, G01S17/00 of systems according to group G01S15/00
    • G01S7/52017—Details of systems according to groups G01S13/00, G01S15/00, G01S17/00 of systems according to group G01S15/00 particularly adapted to short-range imaging
    • G01S7/52053—Display arrangements
    • G01S7/52057—Cathode ray tube displays
    • G01S7/52071—Multicolour displays; using colour coding; Optimising colour or information content in displays, e.g. parametric imaging
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01S—RADIO DIRECTION-FINDING; RADIO NAVIGATION; DETERMINING DISTANCE OR VELOCITY BY USE OF RADIO WAVES; LOCATING OR PRESENCE-DETECTING BY USE OF THE REFLECTION OR RERADIATION OF RADIO WAVES; ANALOGOUS ARRANGEMENTS USING OTHER WAVES
    • G01S7/00—Details of systems according to groups G01S13/00, G01S15/00, G01S17/00
    • G01S7/52—Details of systems according to groups G01S13/00, G01S15/00, G01S17/00 of systems according to group G01S15/00
    • G01S7/52017—Details of systems according to groups G01S13/00, G01S15/00, G01S17/00 of systems according to group G01S15/00 particularly adapted to short-range imaging
    • G01S7/52053—Display arrangements
    • G01S7/52057—Cathode ray tube displays
    • G01S7/52073—Production of cursor lines, markers or indicia by electronic means
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H50/00—ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics
    • G16H50/30—ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for calculating health indices; for individual health risk assessment
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/58—Testing, adjusting or calibrating the diagnostic device
    • A61B8/585—Automatic set-up of the device

Definitions

  • This invention relates to medical diagnostic ultrasound systems with elastography capabilities.
  • Elastography is the assessment of the elastic properties of tissue in the body.
  • ultrasound-based elastography stands out because of the advantages of realtime imaging, relatively low cost and absence of ionizing radiation.
  • tissue elastic properties have become more relevant in establishing the existence of and quantifying the severity of diseases such as cancer and systemic sclerosis.
  • the stiffness of tissue in the body can give an indication of whether the tissue may be malignant or benign.
  • the female breast for instance, can contain a variety of different lumps, cysts, and other growths, some of which may be malignant and some of which may be benign.
  • ultrasound elastography is frequently used to assess tissue characteristics to determine whether the tissue is a candidate for biopsy. Elastography can be performed to determine whether the breast contains softer or harder (stiffer) regions. Since stiffer tissue along with irregular boundaries correlates more greatly with malignant masses for some disease states, the identification of such regions can indicate a need to make a further diagnosis confirmation by biopsy.
  • Poisson's ratio is the ratio, when a sample is stretched or compressed in a given direction, of the expansion or contraction (strain) normal to the stretching or compressing force, to the expansion or contraction axially in the direction of the force.
  • Young's modulus is a measure of stiffness, and is defined as the ratio of the uniaxial stress (pressure) applied to a sample over the resulting uniaxial strain
  • strain a number of researchers have concentrated on assessing the strain or deformation exhibited by tissue at different applied pressures. While strain has been shown to be a useful parameter, its shortcoming is that it varies with the applied pressure, referred to as pre-load pressure. It is thus technique-dependent, with different results obtained by researchers who apply different pressures to the tissue or use different techniques for applying pressure. A consequence is that strain measurements from patient to patient or from exam to exam are not comparable. A patient subjected to one type of pressure will exhibit different strain
  • Pre-load pressure the compression force between the transducer and the skin surface
  • stiffness values due to tissue nonlinear elasticity, especially in organs that are compressible by a transducer (e.g., breast, thyroid, prostate, MSK, and the liver through subcostal scan).
  • tissue nonlinear elasticity especially in organs that are compressible by a transducer (e.g., breast, thyroid, prostate, MSK, and the liver through subcostal scan).
  • the user variations in measurements caused by pre-load variation can lead to difficulty in monitoring, and longitudinal studies of diseases can result in false positive outputs, where tissue appears to be stiffer in its compressed state than its neutral state.
  • the present invention generally relates to systems and methods that monitor and account for the above-described inter-user and intra-user variations in measurements caused by pre-load.
  • Systems and methods of the invention solve this problem by providing a pre-load indicator to users based on displacement values measured in target tissues under pre-load, and allowing informed initiation of an elasticity (shearwave) exam based on those displacement values.
  • Displacement values relate to compression or expansion of a subject or target in response to contact with a probe, and may be positive, negative or zero.
  • a preload indicator provides displacement values relative to an identified reference, which provides a frame of reference for an initial scan and any subsequent scans (during a single elastography procedure or several elastography procedures over time).
  • the system or users can select whether to begin an initial or subsequent elasticity scan based on the pre-load indicator, knowing that similarities or differences in elasticity may be due to the displacement value relative to the reference, as provided by the preload indicator, at the time of the scan(s).
  • the initial and subsequent scans are ideally initiated when the preload indicator indicates that a current displacement value is at or near an identified reference in order to reduce elasticity variations due to preload variations caused by user variation.
  • the initial and subsequent scans may be initiated when the preload indicator indicates that a current displacement value is different from the identified reference in order to investigate changes in the elasticity of tissue under different strains.
  • systems and methods include a probe in communication with a processor.
  • the probe may be configured to perform one or more elasticity scans and includes a distal portion configured to interface a subject.
  • the probe is configured to send ultrasound signals to a target of the subject and receive ultrasound signals from the target.
  • the processor in communication with the probe is configured to identify a reference corresponding to the interface between the probe and the subject.
  • One or more displacements values are then determined, relative to the reference, between the probe and the subject.
  • the displacement values may include values of zero displacement, positive displacement, negative displacement and undefined displacement.
  • the processor is then configured to generate a preload indicator for the elasticity scans using at least one determined displacement value.
  • the processor may further be in communication with a display, and configured to display the preload indicator and measurements/data from an elasticity scan alone or concurrently with an ultrasound image.
  • the reference and/or displacement values may be obtained from ultrasound data or from a force sensor.
  • the probe may include a force sensor, and the reference and/or displacement values are force measurements obtained by the force sensor.
  • the force measurements obtained by the force sensor may include the force of the subject against the probe as the probe interfaces the subject for ultrasound data collection (e.g. imaging and elastography scanning).
  • the reference and/or displacement values are obtained using the ultrasound signals received by the probe.
  • the reference and/or displacement values may comprise the displacement of a target being imaged (e.g. due to compression or expansion) over a plurality of image frames in response to pressure of the probe on the subject.
  • the displacement may be tracked across frames via a pixel-based comparison, phase shift estimation, ld/2d cross-correlation methods.
  • the displacement values may comprise the strain associated with the displacement of the target being imaged over a plurality of image frames in response to the probe pressure.
  • the strain is typically calculated as a spatial derivative of the displacements.
  • the displacement value relates to the average strain inside of the imaged target.
  • the reference may be identified automatically be the system or manually by the user.
  • the reference comprises an initial displacement value of at or about zero between the probe and the subject (e.g. at or about zero applied force between the probe or subject).
  • Acceptable ranges of force for the reference may be, for example, 1 N to -1 N, 1.5 N to -1.5 N, and 2 N to -2 N.
  • the reference comprises an initial displacement value between the probe and the subject sufficient to generate an image from received ultrasound signals of the probe. For example, the force of the probe on the subject is sufficient to establish acoustic coupling for image generation.
  • one or more displacement values are determined that relate to the reference.
  • Displacements values may include a measure of the actual linear and/or axial displacement of the tissue in response to force, or strain calculated from the actual displacement.
  • the determined displacement values may comprise one or more of a zero displacement, negative displacement, positive displacement, and undefined displacement. A zero displacement indicates no or little change from the reference (e.g.
  • an undefined displacement indicates that displacement between the subject and probe cannot be determined due to loss of contact between the probe and the subject.
  • an undefined displacement indicates that the displacement between the subject and the probe cannot be determined due to the displacement of the probe exceeding a predetermined threshold or complete changes in the probe position - e.g., as the users still look for the region of interest.
  • the predetermined threshold may correspond to a predetermined force or strain.
  • the system may be configured to issue an alert to the user when a displacement value is determined to be undefined.
  • systems and methods of invention adaptively change the reference to a new reference based on the determined displacement values. For example, the system may replace the reference with a new reference when the determined displacement is positive. This means that the previously determined reference frame is not captured when the tissue is still compressed relative to the updated reference frame.
  • the preload indicator for the elasticity scan is generated based on at least one of the determined displacement values.
  • the preload indicator is a display of at least one of the determined displacement values with respect to the reference.
  • the preload indicator may comprise a numerical display of a current displacement value of the probe in terms of force or strain.
  • the preload indicator includes a bar scale indicating a range of displacement values relative to the reference. The bar scale may be, for example, color coded or line gauged to show different values. The current displacement value may be highlighted within the range of the bar scale using one or more graphical features, including e.g., an arrow, a line, a color, etc.
  • the preload indicator provides indication for when to perform or initiate an elasticity scan at at least one of the determined displacement values.
  • the probe performs an elasticity scan by generating mechanical waves (i.e shear waves) in the subject and tracking the waves by sending and receiving ultrasound signals.
  • the processor may be configured to generate elasticity measurements based on the received tracking ultrasound signals.
  • pre-load pressures are monitored by an ultrasound system during an elastography procedure and displayed to a user.
  • the pre-load can be expressed in terms of strain percentage, or can be measured in terms of the force applied to the body by the ultrasound probe.
  • the system can guide the user in acquiring a baseline reference image used to measure pre-load in terms of strain percentage.
  • the system acquires and displays a measurement of pre-load force applied by a transducer probe.
  • An implementation of the present invention provides metrics for measuring, visualizing and reporting pre-loads, which allows users to account for and/or control the applied pre-load in conjunction with stiffness and/or viscosity measurements or any tissue mechanical properties. Tissue nonlinear behavior can thus be investigated with simultaneously recorded pre-load information and elasticity measurements through on-cart display and statistical analysis.
  • FIGURE 1A illustrates the principles of strain Elastography.
  • FIGURE IB illustrates the principles of shearwave elastography.
  • FIGURE 2 illustrates a method for acquiring a reference image to be used as a baseline during strain elastography, using the reference image to determine strain pre-load for display, and the reacquisition of a reference image when the user's actions require it.
  • FIGURE 3 illustrates an ultrasound display showing a dynamic indication of strain preload in accordance with the principles of the present invention.
  • FIGURE 4 illustrates an ultrasound display showing a dynamic indication of probe force pre-load in accordance with the principles of the present invention.
  • FIGURE 5 is a block diagram of an ultrasound system constructed in accordance with the principles of the present invention.
  • the present invention finds application in both qualitative and quantitative elastography to provide the user with information needed to monitor the pre-load during concurrent stiffness measurement.
  • the qualitative elastography is preferably strain elastography
  • the quantitative elastography is preferably shearwave elastography.
  • a force sensor is employed and its measurements can be combined with the qualitative and/or quantitative elastography used to provide a direct measurement of pre-load.
  • FIGURE la illustrates the acquisition of ultrasound images for strain analysis.
  • An ultrasound probe 10 is pressed into acoustic contact with a body 52 as indicated by force arrow F until ultrasound images of the target anatomy appear on the system display screen.
  • the target anatomy includes four masses to be analyzed, 60, 62, 64 and 66.
  • a strain image is reconstructed by 1) tracking the tissue displacement caused by the probe compression and then 2) calculating the strain as a spatial derivative of the tissue displacements.
  • Strain elasticity analysis can only measure the relative stiffness of the tissue because a number of tissue characteristics such as density and viscosity are not quantitatively known. Very often the strain ratio between the target anatomy and surrounding tissue is provided to users as the surrogate of stiffness measurement.
  • the second type of elastography can provide absolute stiffness values, as it quantifies the shearwave speed through the tissue.
  • the principle of shearwave generation is illustrated in FIGURE lb.
  • An ultrasound probe 10 is held in acoustic contact with a body 52 by application of a downward force F'.
  • One or more relatively high energy focused pulses known as push pulses or ARFI pulses PP are transmitted to the target anatomy. These push pulses cause a downward compression of tissue at the target anatomy which, when ended, allows the target anatomy to recoil and move up and down, producing a laterally traveling, relatively low frequency shearwave 54 which emanates outward from the push pulse focal point.
  • shearwave velocity through tissue can be measured from these tracking pulse echoes as described in US pat. pub. no. 2013/0131511 (Peterson et al.)
  • the principle of shearwave elastography is that shearwave speed is proportional to the stiffness of the tissue, i.e., the shearwave travels faster in stiff tissue than in soft tissue.
  • Outputs of shearwave elastography can be either 1) values related to tissue elasticity for a particular small area of interest, or 2) ultrasound images where pixels are color coded according to the tissue elasticity related parameters.
  • the values displayed to the user or color coded on the images can be shearwave speed, Young's modulus, shear modulus or any combination of these.
  • probe pre-load in terms of displacement can be continuously calculated and displayed to the user in real time with respect to a reference.
  • the pre-load is shown as a pre-load indicator, and can be displayed to a user alone or concurrently with an ultrasound image and/or elastography image Displacement values relate to compression or expansion of a subject or target in response to contact with a probe, and may be positive, negative or zero.
  • a preload indicator provides displacement values relative to an identified reference, which provides a frame of reference for an initial scan and any subsequent scans (during a single elastography procedure or several elastography procedures over time).
  • the system or users can select whether to begin an initial or subsequent elasticity scan based on the pre-load indicator, knowing that similarities or differences in elasticity may be due to the displacement value relative to the reference, as provided by the preload indicator, at the time of the scan(s).
  • the initial and subsequent scans are ideally initiated when the preload indicator indicates that a current displacement value is at or near an identified reference in order to reduce elasticity variations due to preload variations caused by user variation.
  • the initial and subsequent scans may be initiated when the preload indicator indicates that a current displacement value is different from the identified reference in order to investigate changes in the elasticity of tissue under different strains.
  • the pre-load By displaying these pre-load measures on the system display screen, the pre-load will automatically be captured and preserved when the clinician saves the screen images for a diagnostic report. Thus, the pre-load values are preserved in the report and available for use by the same or another clinician doing a follow-up exam in the course of longitudinal studies of a patient.
  • the reference may be an initial or selected displacement or strain in response to the imaging probe being in contact with the target or object being imaged.
  • the reference may be identified automatically be the system or manually by the user.
  • the reference comprises an initial displacement value of at or about zero between the probe and the subject (e.g. at or about zero applied force between the probe or subject).
  • the ranges of force of the reference may depend on the application of the desired elastography scan. In some instance, acceptable ranges of force for the reference may be, for example, 1 N to -1 N, 1.5 N to -1.5 N, and 2 N to -2 N.
  • the reference comprises an initial displacement value between the probe and the subject sufficient to generate an image from received ultrasound signals of the probe. For example, the force of the probe on the subject is sufficient to establish acoustic coupling for image generation.
  • one or more displacement values are determined relative to the reference.
  • Displacements values may include measure of the actual linear and/or axial displacement of the tissue in response to force with respect to the reference, or strain calculated from the actual displacement with respect to the reference.
  • the determined displacement values may comprise one or more of a zero displacement, negative displacement, positive displacement, and undefined displacement.
  • a zero displacement indicates no or little change from the reference (e.g. probe/surface interface is at or about the position at which the reference was obtained).
  • a positive displacement indicates that the subject is in an expanded state compared to when the reference was identified.
  • a negative displacement indicates that the subject is in a compressed state compared to when the reference was identified.
  • an undefined displacement indicates that displacement between the subject and probe cannot be determined due to loss of contact between the probe and the subject. In other embodiments, an undefined displacement indicates that the displacement between the subject and the probe cannot be determined due to the displacement of the probe exceeding a predetermined threshold. For example, the displacement results in exceeding a predetermined threshold of force or strain.
  • the system may be configured to issue an alert to the user when a displacement value is determined to be undefined.
  • the reference and/or displacement values may be, for example, an amount of
  • the reference and/or displacement values may be representative of an average displacement or strain within a region.
  • the reference and/or displacement values may be obtained from ultrasound data or from a force sensor. Any suitable method may be used to determine the reference and/or displacement value from ultrasound data, including those described hereinafter.
  • the probe may include a force sensor, and the reference and/or displacement values are force measurements obtained by the force sensor.
  • the force measurements obtained by the force sensor may include the force of the subject against the probe as the probe interfaces the subject for ultrasound data collection (e.g. imaging and elastography scanning).
  • a pressure or force sensor to the face of the probe. As the clinician presses the probe against the skin, the sensor will sense the applied pressure and its measurement is displayed to the user.
  • a preferred variation of this approach is to integrate the pressure sensor into the lens adjacent to the imaging transducer array, and bring the pressure signal to the ultrasound system through the probe cable.
  • Another approach is to use a rigid plastic shell which fits over the handle of the ultrasound probe. Pressure sensors are positioned at one or more locations inside the shell where the shell fits over upward-facing surfaces of the probe, such as the shoulders 11 of the probe 10 shown in FIGURE la. As the clinician holds the shell and probe and bears down against the body of the patient, the downward force is transmitted to the probe through the pressure sensors, which thereby measure the applied compression force.
  • a handheld ultrasound probe control device which includes a frame adapted to receive a probe, a linear drive system that translates the frame along an actuation axis, a sensor such as a force sensor, a torque sensor, or some combination of these, and a controller. These may be adapted for uses in accordance with systems and methods of the present invention, and are incorporated by reference herein.
  • CMUTs capactive micro machined transducers
  • PZT piezoelectric material
  • CMUTs capactive micro machined transducers
  • Each cell comprises a membrane suspended above a cavity, with one electrode located on the membrane and another on the floor of the cavity.
  • the application of an a.c. signal at ultrasound frequencies to the two electrodes causes them to alternately move toward and away from each other by movement of the membrane at the frequency of the applied signal.
  • the movement of the membrane produces an ultrasound signal which is transmitted into a body.
  • ultrasonic echoes returning from the transmission cause the membrane to vibrate, varying the distance between and hence the capacitance presented by the spacing of the two electrodes.
  • This capacitance variation is sensed and measured by the ultrasound system to receive the ultrasound echo for display.
  • a CMUT cell's capacitance can also be changed by applying a pressure to the membrane to distend it closer to the electrode at the floor of the cell. The resulting increase in capacitance is thus a measure of the applied pressure.
  • An ultrasound probe using a CMUT transducer array with some CMUT cells operating as ultrasound signal transmitters and receivers, and other CMUT cells functioning as sensors of the pressure applied to the face of the array, can perform the ultrasound imaging needed for elastography and also measure the compression force applied to the skin by the face of the probe during the procedure.
  • the reference and/or displacement values are obtained using the ultrasound signals received by the probe.
  • the reference and/or displacement values are obtained using the ultrasound signals received by the probe.
  • displacement values may comprise the displacement of a target being imaged (e.g. due to compression or expansion) over a plurality of image frames in response to pressure of the probe on the subject.
  • the displacement may be tracked via a pixel-based comparison across frames.
  • the displacement values may comprise the strain associated with the displacement of the target being imaged over a plurality of image frames in response to the probe pressure.
  • the strain is typically calculated as a spatial derivative of the displacements.
  • the displacement value relates to the average strain inside of the imaged target.
  • the value Pi(x,y) for a position (x,y) in one image should correspond as closely as possible to the same tissue portion as the value P 2 (x,y) in the following (or preceding) image, which would be the case if there were no compression and no probe movement from the first to the second frame.
  • Any known registration algorithm may be used to register the pixels of the image frames.
  • the preferred image registration procedure was based on a minimum-sum-absolute-difference (MSAD) motion estimation method to calculate local tissue motion during the compression/decompression period.
  • MSAD minimum-sum-absolute-difference
  • the image frame data in each intensity frame P(x,y) is divided into windows, for example, of SxS elements (pixels) each, where S is determined by conventional experimental methods.
  • the windows could also be rectangular, or have some other shape.
  • the subsequent (or previous) frame n+1 is then searched for the SxS pixel window for which the sum-absolute-difference (or some other metric, such as least squares) in intensity values as compared with the current window is a minimum.
  • the local motion vector in turn gives an estimate of the optimal shift of the elements in the subsequent frame that brings them into registration with the corresponding elements in the previous frame, and hence represents tissue displacement from one frame to another. If the local motion vector is within a desired range of values, the tissue is tracked from one image to another; if it is not, tracking has failed. Subsequent computations of displacement can then be performed window-by-window to continue to track the compressed tissue, frame-by-frame.
  • strain can be calculated for one or more pixels in the images as a spatial derivative of the tissue displacements.
  • systems and methods of invention adaptively change the reference to a new reference based on the determined displacement values. For example, the system may replace the reference with a new reference when the determined displacement is positive.
  • the preload indicator for the elasticity scan is generated based on at least one of the determined displacement values.
  • the preload indicator is a display of at least one of the determined displacement values with respect to the reference.
  • the preload indicator may comprise a numerical display of a current displacement value of the probe in terms of force or strain.
  • the preload indicator includes a bar scale indicating a range of displacement values relative to the reference. The bar scale may be, for example, color coded or line gauged to show different values. The current displacement value may be highlighted within the range of the bar scale using one or more graphical features, including e.g., an arrow, a line, a color, etc.
  • the preload indicator provides indication for when to perform or initiate an elasticity scan at at least one of the determined displacement values.
  • the probe performs an elasticity scan by generating acoustic waves in the subject and tracking the waves by sending and receiving ultrasound signals.
  • the processor may be configured to generate elasticity measurements based on the received tracking ultrasound signals.
  • FIGURE 2 is a flow chart of an embodiment of the invention for providing a preload indicator.
  • a clinician images the target anatomy of a subject and identifies a region of interest (ROI) for elastography in step 102.
  • ROI region of interest
  • the probe displacement or compression on subject surface is released in step 104, if any, until the ROI is imaged with a very low probe pressure/force. If the compression release results in the loss of acoustic contact with the skin, the compressive force (or displacement) is increased until acoustic coupling is re-established in step 106 and images of the ROI are again produced on the display screen.
  • the probe compression at this stage of the procedure should be the minimum needed to produce ultrasound images of the ROI.
  • a reference is selected. There reference may be selected by the user at an desired starting force between the probe and the skin. Alternatively, the reference may be selected with the displacement value is at or about zero. The displacement value may include measure of the actual linear and/or axial displacement of the tissue in response to force, or strain calculated from the actual displacement. In yet another embodiment, the reference may be selected when the pre-load is sufficient to generate an image of a specific quality. The reference can then be saved to the system. Additionally, the reference frame and related parameters such as force, strain, or displacement can be displayed to the user in any suitable means, e.g. numerically or graphically. After the reference frame is chosen, the system continues to track any displacement between the current image frame and the reference, as in step 110.
  • the displacements from frame to frame can be accumulated so that the total displacement from the reference frame to the current frame can be used for the displayed strain value.
  • the displacement value can be calculated as actual movement or compression of target with respect to probe.
  • the displacement value may be the strain calculated from the actual displacements, as in step 112. In either event, the displacement value may be negative, positive, zero or undefined in relation to the reference. If the displacement value is defined (negative, positive, or zero displacement or strain, as compared to reference), the displacement value is provided to the user as a preload indicator (as in Step 116).
  • the displacement value is undefined, the displacement (axial or lateral) or strain with respect to the reference cannot be identified. This may be due to loss of acoustic coupling or a displacement/strain exceeding a predetermined threshold amount (e.g. a displacement amount that is not trackable using imaging means).
  • a predetermined threshold amount e.g. a displacement amount that is not trackable using imaging means.
  • an alert can be sent to the user, as in step 118, and a new reference can be identified, e.g., starting at step 102 or 104.
  • the alert may be an audio, visual, and/or tactile alert.
  • the preload indicator to be displayed in step 116 can be displayed in an ultrasound image such as that illustrated in FIGURE 3. In this display a B mode ultrasound image 120 in grayscale is overlaid with an ROI box 122 inside of which strain is to be measured and displayed.
  • a strain display 126 of pre-load in accordance with the present invention.
  • the pre-load there are numerous ways to display the pre-load, such as a simple number.
  • the instantaneous strain average of step 116, Xx% is indicated along a color bar of a range of strain percentages, varying in this example from 0% (no strain) to 10% which, in this example, is the maximum strain occurring during the present procedure.
  • the resulting strain value is shown on the ultrasound display.
  • FIGURE 4 An ultrasound image display, a probe force colorbar 128, similar to that used for strain percentage display in FIGURE 3, is displayed alongside the ultrasound image 120 and its elasticity image ROI 122.
  • the colorbar 128 in this example extends over a range of zero to 20 Newtons, with the instantaneous measured pre-load force of Xx Newtons indicated in the middle of the bar.
  • Other indicators, such as the variation of force or elasticity or both with time may also be presented as shown in the lower corner of the display.
  • An ultrasound system constructed in accordance with the principles of the present invention is shown in block diagram form in FIGURE 5.
  • An ultrasound probe 10 has an array transducer 12 for transmitting ultrasound waves to and receiving echoes from a region of the body.
  • the array transducer can be a one-dimensional array of transducer elements or a two- dimensional array of transducer elements for scanning a two dimensional image field or a three dimensional image field in the body.
  • the elements of the array can be formed of a PZT material or as cells of a CMUT array, some of which function for ultrasound imaging and others of which function for pressure sensing as described above.
  • the elements of the array transducer are driven by a transmit beamformer 16 which controls the steering, focusing and penetration of transmit beams from the array.
  • a receive beamformer 18 receives echoes from the transducer elements for imaging and combines them to form image data of coherent echo signals from points in the image field.
  • the transmit and receive beamformers are coupled to the transducer array elements by transmit/receive switches 14 which protect sensitive receive circuitry during transmission.
  • a beamformer controller 20 synchronizes and controls the operation of the beamformers.
  • the received echo signals are demodulated into quadrature (I and Q) samples by a quadrature bandpass (QBP) filter 22.
  • the QBP filter can also provide band limiting and bandpass filtering of the received signals.
  • the received signals may then undergo further signal processing such as harmonic separation and frequency compounding by a signal processor 24.
  • the processed echo signals are applied to a detector 25 which performs amplitude detection of the echo signals by the equation (I 2 + Q 2 ) 112 for a B mode processor 26, and to a Doppler processor 28 for Doppler shift detection at points in the image field.
  • the baseband I and Q echo signals of each image frame are applied to a frame memory 30.
  • the outputs of the B mode processor 26 and the Doppler processor 28 are also coupled to the frame memory 30.
  • the frame memory stores consecutive samplings of the image field on a spatial basis for the calculation of strain by a strain estimator 32 from the frame-to-frame displacement of anatomy in the image field; strain is calculated as a spatial derivative of displacement. Strain may be calculated from
  • RF radiofrequency
  • B mode amplitude- detected
  • tissue Doppler data Any form of strain calculation such as strain, the ratio of lateral to axial strain, and strain velocity estimation may be employed.
  • strain the echoes received at a common point in consecutive frames may be correlated to estimate displacement at the point. If no motion is present at the point, the echoes from consecutive frames will be the same. If motion is present, the echoes will be different and the motion vector indicates the displacement.
  • US Pat. 6,558,324 (Von Behren et al.) describes both amplitude and phase sensitive techniques for estimating strain and employs speckle tracking for strain estimation through block matching and correlation. US Pat.
  • the strain estimator 32 produces an estimated strain value one or more points in the image field, and these values are stored as a strain image of the image field in strain image memory 34.
  • the strain image is applied to an elastographic image processor 36, where it may undergo further enhancement such as frame averaging or noise reduction.
  • the strain estimator is more generally configured as an elastographic metric estimator.
  • the signals returned from the sampling pulses following shearwave generation are stored as a function of space and time in frame memory 30 and strain estimator 32 is operated as a shearwave velocity estimator, using the data from the shearwave sampling pulses to estimate shearwave velocity at each measured point in the image field as discussed in the aforementioned Peterson et al. patent application. These estimates are then stored as a spatial representation of shearwave velocities in image memory 34. The shearwave velocities are then converted to values for an elastographic image by the elastographic image processor 36, such as an image expressed in terms of estimates of Young's modulus at each point in the ROI.
  • Young's modulus can be estimated as three times the shear modulus, and the shear modulus at a point in the ROI is estimated as the square of the shearwave velocity at the point times density, where density is taken to be 1000kg/m 3 for soft tissue.
  • the elastographic image is coupled to an image processor 42, as are outputs of the B mode processor 26 and the Doppler processor 28.
  • the image processor processes the image data from these sources, e.g., by scan conversion to a desired image format, image and graphic overlay, etc., and produces an elastographic image such as image 120 for display on a display 50.
  • one format for display of a elastographic image is with an ROI 122 of elastographic values overlaid on a B mode image for structural orientation.
  • values for pre-load indicators such as colorbars 126 and 128 in FIGURES 3 and 4 are calculated by a pre-load calculator 44.
  • the calculator 44 calculates the average strain value for the current strain image as explained above.
  • the pre-load calculator receives ROI select information from the user control panel 40, which delineates the region of the image field where strain is to be displayed.
  • the pre-load calculator also tracks and stores the maximum strain percentage when that metric is to be used for the pre-load display.
  • the average strain value is computed from the strain values in the delineated ROI.
  • These values are coupled to a graphics generator 38, which converts the values to colors for a colorbar by a color value lookup table.
  • the resultant pre-load colorbar graphics are coupled to the image processor 42, where they are overlaid with the ultrasound image and shown on the display 50 as illustrated in
  • the force signal from the ultrasound probe 10 is coupled to the pre-load calculator 44.
  • this force signal can be produced by a pressure sensor attached to or integrated into the face of the ultrasound probe, a pressure sensor inside a rigid shell enclosing the probe handle, or CMUT cells of a CMUT transducer array 12 which function as pressure sensors.
  • the force signal is converted to a display metric such as Newtons by a lookup table calibrated to the particular sensor used.
  • the force display metric is coupled to the graphics generator 38 for generation of a colorbar graphic overlay 128 as shown in FIGURE 4 or other display format.
  • the choice of the format of the pre-load display, strain percentage, compression force, or other, is determined by a pre-load display select signal from the user control panel 40 that is set by the user.
  • the preload indicator includes displaying or providing a user with a report or table that concurrently provides the displacement value (displacement or strain) at the time of an elasticity reading at one or more acquisition times (i.e. time stamps). This would allow a clinician to directly assess how preload affects elasticity for a particular target or region of interest. Measurement no Elasticity Pre-load (strain) Acquisition time
  • an ultrasound system suitable for use in an implementation of the present invention may be implemented in hardware, software or a combination thereof.
  • the various embodiments and/or components of an ultrasound system for example, the strain or shearwave estimator 32, the elastographic image processor 36, the pre-load calculator 44, the Doppler processor 28, the B mode processor 26, and the image processor 42, or components and controllers therein, also may be implemented as part of one or more computers or
  • the computer or processor may include a computing device, an input device, a display unit and an interface.
  • the computer or processor may include a microprocessor.
  • the microprocessor may be connected to a communication bus, for example, to access a PACS system or the data network for importing training images.
  • the computer or processor may also include a memory.
  • the memory devices such as the frame memory 30 and the strain or shearwave image memory 34, may include Random Access Memory (RAM) and Read Only Memory (ROM).
  • the computer or processor further may include a storage device, which may be a hard disk drive or a removable storage drive such as a floppy disk drive, optical disk drive, solid-state thumb drive, and the like.
  • the storage device may also be other similar means for loading computer programs or other instructions into the computer or processor.
  • the term "computer” or “module” or “processor” or “workstation” may include any processor-based or microprocessor-based system including systems using microcontrollers, reduced instruction set computers (RISC), ASICs, logic circuits, and any other circuit or processor capable of executing the functions described herein.
  • RISC reduced instruction set computers
  • ASIC application specific integrated circuit
  • logic circuits logic circuits, and any other circuit or processor capable of executing the functions described herein.
  • the above examples are exemplary only, and are thus not intended to limit in any way the definition and/or meaning of these terms.
  • the computer or processor executes a set of instructions that are stored in one or more storage elements, in order to process input data.
  • the storage elements may also store data or other information as desired or needed.
  • the storage element may be in the form of an information source or a physical memory element within a processing machine.
  • the set of instructions of an ultrasound system including those controlling the acquisition, processing, and transmission of ultrasound images as described above may include various commands that instruct a computer or processor as a processing machine to perform specific operations such as the methods and processes of the various embodiments of the invention.
  • the set of instructions may be in the form of a software program.
  • the software may be in various forms such as system software or application software and which may be embodied as a tangible and non-transitory computer readable medium. Further, the software may be in the form of a collection of separate programs or modules such as an elastography module, an elastography program module within a larger program or a portion of a program module.
  • the software also may include modular programming in the form of object-oriented programming.
  • the processing of input data by the processing machine may be in response to operator commands, or in response to results of previous processing, or in response to a request made by another processing machine.

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Abstract

L'invention concerne de manière générale des systèmes et des procédés pour identifier une précharge avant d'informer une évaluation d'élasticité. Les systèmes et les procédés de l'invention permettent d'identifier une référence correspondant à l'interface entre la sonde et le sujet, de déterminer une ou plusieurs valeurs de déplacement entre la sonde et le sujet et par rapport à la référence, les valeurs de déplacement étant sélectionnées dans le groupe constitué par un déplacement nul, un déplacement négatif, un déplacement positif et un déplacement indéfini et de générer un indicateur de précharge pour le balayage d'élasticité à l'aide d'au moins une valeur de déplacement.
PCT/IB2017/055561 2016-09-15 2017-09-14 Mesure et affichage de précharge élastographique ultrasonore WO2018051265A1 (fr)

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FR3104736A1 (fr) * 2019-12-13 2021-06-18 Supersonic Imagine Procédé ultrasonore pour quantifier l’élasticité non linéaire par ondes de cisaillement d’un milieu, et dispositif pour mettre en œuvre ce procédé

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CN109145450A (zh) * 2018-08-23 2019-01-04 东汉新能源汽车技术有限公司 一种电池包碰撞安全分析方法和装置
FR3104736A1 (fr) * 2019-12-13 2021-06-18 Supersonic Imagine Procédé ultrasonore pour quantifier l’élasticité non linéaire par ondes de cisaillement d’un milieu, et dispositif pour mettre en œuvre ce procédé
WO2021116326A3 (fr) * 2019-12-13 2021-08-05 Supersonic Imagine Procédé ultrasonore pour quantifier l'élasticité non linéaire par ondes de cisaillement d'un milieu, et dispositif pour mettre en oeuvre ce procédé

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