This invention relates to medical diagnostic imaging systems and, in particular, to the combined use of ultrasound imaging and near infrared spectroscopy for stroke detection and diagnosis.
Stroke is one of the most debilitating disorders known to medicine. The blockage of the flow of blood to the brain, ischemic stroke, or the rupture of a cranial blood vessel, hemorrhagic stroke, can rapidly result in paralysis or death. Attempts to achieve recanalization of an occluded blood vessel through thrombolytic drug therapy such as treatment with tissue plasminogen activator (tPA) has been reported to cause symptomatic intracerebral hemorrhage in a number of cases. Advances in the diagnosis and treatment of this crippling affliction are the subject of continuing medical research.
U.S. Pat. No. 8,211,023 (Swan et al.) describes a diagnostic ultrasound system and method which enable a clinician to transcranially visualize a region of the cerebral vasculature where blood clots may be present. Either two dimensional or three-dimensional imaging may be employed. The imaging of the vasculature is preferably enhanced by the administration of microbubbles. If the flow conditions of the vasculature indicate the presence of a partial or complete occlusion from a blood clot, a focused or pencil beam is directed to the location of the blockage to break up the clot by the vibrations and/or rupturing of the microbubbles, a procedure known as sonothrombolysis. In some instances the ruptured microbubbles may also release an encapsulated thrombolytic drug. The patent also describes monitoring the cranial vasculature by ultrasonic imaging for changes which are indicative of the recurrence of an occlusion so that medical aid can be alerted to the recurrent condition.
Another imaging modality which is useful in stroke detection is near infrared spectroscopy, or NIRS. NIRS is based on the same physical principle as pulse oximetry, in which blood inside the body is illuminated at a near infrared wavelength of light which is sensitive to the coloration of oxygenated blood. The intensity of the returning light at a detection wavelength is a measure of the oxygenation of the blood which was illuminated. In a cranial NIRS system the patient is fitted with a headset carrying numerous emitter laser diodes and high-sensitivity photo-diodes which transmit light at infrared frequencies into the head of the patient and receive non-absorbed light reflected to the photo-diodes. At the wavelengths used, the infrared light is capable of penetrating the cerebral cortex for a few centimeters (e.g., 2-3 cm) and reflected light is received by light-sensitive detectors to sense the quantum of oxygenated or de-oxygenated blood at the locations of the illumination. The amount of oxygenated or de-oxygenated blood and their relative proportions at different locations in the cerebral cortex can then be assessed for possible perfusion or blood flow deficiencies.
In diagnosing and treating stroke it is important to be able to quickly determine that a stroke has occurred, its location in the brain, and the type of stroke so that the appropriate treatment can be rapidly commenced. As discussed above, applying the wrong treatment, such as tPA when the patient has suffered hemorrhagic stroke, can have grievous consequences. One way to increase the certainty of a diagnosis is to perform diagnoses with different diagnostic modalities, so that the results of one diagnosis can confirm or challenge the other. US Pat. Pub. No. 2019/0231316 (Sutton et al.) illustrates a multi-modality approach to diagnosing and treating myocardial infarction, in which the results of a digital ECG diagnosis are used to aid in locating a thrombus for ultrasonic imaging and subsequent sonothrombolytic treatment. It would correspondingly be desirable to combine two modalities, ultrasonic imaging and NIRS imaging, for stroke detection and follow-on treatment.
In accordance with the principles of the present invention, a combined ultrasonic cranial imaging system and near infrared spectroscopy system is described for diagnosing stroke. Both the ultrasound system and the NIRS system produce their cranial analytical data in a common spatial coordinate system. This enables the data to be merged together in a common analytical framework such as spatially corresponding images or fused into a single 2D or 3D cerebral image map. Pathology revealed by the image data of one modality should spatially correlate with pathology identified by the other modality, enabling a clinician to confidently proceed with the appropriate plan of treatment. For example the detection of a possibly occluded vessel in an ultrasound image can be confirmed by a lack of oxygenated blood in the cranial region downstream of the suspected occlusion. Such a system may employ a common transducer/sensor headset that can be quickly applied to a patient for the production of data of both modalities in a common coordinate system and resulting rapid diagnosis and treatment.
A multimodality imaging system which can diagnose abnormalities of the brain such as indicia of the occurrence of stroke comprises a NIRS system adapted to acquire NIRS signals from the brain and produce NIRS image data using the acquired NIRS signals; an ultrasound imaging system adapted to acquire ultrasound signals from the brain and produce ultrasound image data using the acquired ultrasound signals; an image processor adapted to register the NIRS image data and the ultrasound image data to a common system of spatial coordinates; and an image display adapted to display spatially related NIRS image data and ultrasound image data.
A multimodality method of the present invention for diagnosing abnormalities of the brain such as indicia of the occurrence of stroke comprises operating a NIRS system adapted to acquire NIRS signals from the brain and produce NIRS image data using the acquired NIRS signals; operating an ultrasound imaging system adapted to acquire ultrasound signals from the brain and produce ultrasound image data using the acquired ultrasound signals; operating an image processor adapted to register the NIRS image data and the ultrasound image data to a common system of spatial coordinates; and operating an image display adapted to display spatially related NIRS image data and ultrasound image data.
A method for diagnosing a suspect region of a body using multiple imaging modalities in accordance with the present invention comprises acquiring image data of a region of the body using a first imaging modality; acquiring image data of the region of the body using a second imaging modality, wherein the image data of both imaging modalities is related to a common coordinate system; producing images of the region of the body using the image data of each modality; detecting regions of suspect pathology in the images of both modalities; merging the image data of the detected regions into a 3D dataset; selecting a region of suspect pathology; displaying an image of one or both modalities of the selected region of suspect pathology; and displaying diagnostic data related to the suspect pathology.
In the drawings:
Referring first to
The partially beamformed signals produced by the microbeamformers 12a, 12b are coupled to a main beamformer 20 where partially beamformed signals from the individual patches of elements are combined into fully beamformed signals. For example, the main beamformer 20 may have 128 channels, each of which receives a partially beamformed signal from a patch of 12 transducer elements. In this way the signals received by over 1500 transducer elements of a two-dimensional array can contribute efficiently to a single beamformed signal.
The beamformed signals are coupled to a fundamental/harmonic signal separator 22. The separator 22 acts to separate linear and nonlinear signals so as to enable the identification of the strongly nonlinear echo signals returned from microbubbles. The separator 22 may operate in a variety of ways such as by bandpass filtering the received signals in fundamental frequency and harmonic frequency bands, or by a process known as pulse inversion harmonic separation. A suitable fundamental/harmonic signal separator is shown and described in international patent publication WO 2005/074805 (Bruce et al.) The separated signals are coupled to a signal processor 24 where they may undergo additional enhancement such as speckle removal, signal compounding, and noise elimination.
The processed signals are coupled to a B mode processor 26 and a Doppler processor 28. The B mode processor 26 employs amplitude detection for the imaging of structures in the body such as muscle, tissue, and blood vessels. B mode images of structures of the body may be formed in either the harmonic mode or the fundamental mode. Tissues in the body and microbubbles both return both types of signals and the harmonic returns of microbubbles enable microbubble-perfused tissue and blood flow to be clearly segmented in an image. The Doppler processor processes temporally distinct signals from moving tissue and blood flow for the detection of motion of substances in the image field including microbubbles. The structural and motion signals produced by these processors are coupled to a scan converter 32 and a volume renderer 34, which produce image data of tissue structure, flow, or a combined image of both characteristics. The scan converter will convert echo signals with polar coordinates into image signals of the desired image format such as a sector image in Cartesian coordinates. The volume renderer 34 will convert a 3D data set into a projected 3D image as viewed from a given reference point as described in U.S. Pat. No. 6,530,885 (Entrekin et al.) As described therein, when the reference point of the rendering is changed the 3D image can appear to rotate or be viewed from a different direction in what is known as kinetic parallax. This image manipulation is controlled by the user as indicated by the Display Control line between the user interface 38 and the volume renderer 34. Also described is the representation of a 3D volume by planar images of different image planes, a technique known as multiplanar reformatting. The volume renderer 34 can operate on image data in either rectilinear or polar coordinates as described in U.S. Pat. No. 6,723,050 (Dow et al.) The 2D or 3D images are coupled from the scan converter and volume renderer to an image processor 30 for further enhancement, buffering and temporary storage for display on an image display 40.
A graphics processor 36 is also coupled to the image processor 30 which generates graphic overlays for displaying with the ultrasound images. These graphic overlays can contain standard identifying information such as patient name, date and time of the image, imaging parameters such as depth and the like, and can also produce a graphic overlay of a beam vector steered by the user as shown in
In accordance with the principles of the present invention, a near infrared spectroscopy (NIRS) system 50 is coupled to the image processor, enabling NIRS image data to be coupled to the system for viewing and combining with the ultrasound information. The NIRS system 50 can comprise a commercially available system such as the NIRScout system available from NIRx Medizintechnik GmbH of Berlin, Germany, or the Hitachi ETG 4100 fNIRS system available from Philips Healthcare of Eindhoven, The Netherlands. NIRS is based upon the strong chromophoric or light-absorbing properties of the hemoglobin molecule. The NIRS system transmits near infrared light into the skull at wavelengths which are absorbed by hemoglobin, and signals in the form of non-absorbed light is reflected back to one or more photodiodes where it is detected for production of an estimate of the amount of hemoglobin at the illuminated location. Since oxyhemoglobin and de-oxyhemoglobin absorb light differently, it is preferable to use two different wavelengths of light, 695 nm-760 nm and 830 nm-900 nm, so that the ratio between oxy- and deoxy-hemoglobin and cerebral arterial-venous oxygen saturation levels can be calculated. The data produced by a NIRS system is generally calibrated in arbitrary units, since it is derived from optical density units and converted mathematically to dimensionless units. Thus, NIRS data values are usually used comparatively, such as to monitor trends in which data values at a certain location may decline over time, or to compare differences in NIRS data values measured at different locations in the cerebral cortex. In healthy patients, the oxygen saturation in the cerebral cortex is generally uniform over the entire surface of the brain. Thus, a decreased oxyhemoglobin measurement at a specific region of the cortex is an indication of a possible problem. Since the brain is a physically symmetrical organ, comparative NIRS measurements are often made in corresponding locations of the left and right lobes of the cerebrum. Thus, measurements may be made at mirrored locations of the left and right lobes of the cerebrum and compared. In a normal patient, these two measurements should be very comparable. But if they differ significantly, such as by 20% or more, or a particular location shows a reduction in blood oxygenation of 20% or more compared to the rest of the brain, a possible oxygenated blood deficiency caused by an occlusion of a vessel feeding that area of the brain may be indicated. Comparative measurements such as these may be used in an implementation of the present invention. Accordingly, blood oxygen measurements made at specific locations in the cerebral cortex are coupled to image processor 30 of the ultrasound system where they are processed in conjunction with ultrasound data to produce combined ultrasound/NIRS information for the clinician as described more fully below.
The transducer arrays 10a and 10b of the ultrasound system transmit ultrasonic waves into the cranium of a patient from opposite sides of the head, although other locations may also or alternately be employed such as the front of the head or the sub-occipital acoustic window at the back of the skull. The sides of the head of most patients advantageously provide suitable acoustic windows for transcranial ultrasound at the temporal bones around and above the ears on either side of the head. In order to transmit and receive echoes through these acoustic windows the transducer arrays must be in good acoustic contact at these locations which may be done by holding the transducer arrays against the head with a headset. For instance,
Also shown in
The use of a handheld ultrasound probe with the NIRS cap 70, such as the probe 66 in
Each volumetric ultrasound image field 102, 104 is seen to have an origin at a certain point on a matrix array 10a, 10b. Since each matrix array is positioned at a known location 74 of the NIRS cap, the result is that each point in the ultrasound image fields has 3D coordinates in the same spatial reference system as the NIRS emitters and sensors. Thus, the ultrasound image data and the NIRS image data can be spatially related to each other since they share a common spatial coordinate system for either 2D or 3D imaging.
Stroke regions and vascular structures in the NIRS and ultrasound data can be detected by advanced processing such as that performed by a neural network or deep learning software run on the image processor. The neural network is first trained with NIRS images and ultrasound images that contain clinically identified stroke regions and vascular structures. In the training images, regions to be detected have been annotated. Once properly trained with known images, the neural network or deep learning software can be used to segment diagnostically relevant regions in both types of images.
A method for multimodality diagnosis of a suspect region of the body using ultrasound imaging and NIRS imaging in accordance with the present invention is illustrated in
It should be noted that an ultrasound system and a NIRS system suitable for use in an implementation of the present invention, and in particular the component structure of the combined ultrasound/NIRS system of
As used herein, 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. 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 elements 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 display 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 registration algorithm mentioned above, as well as other methods and processes of the various embodiments of the invention. Software instructions could be used by the image processor to register the different types of image data, for instance. 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. Numerous ultrasound and NIRS system functions are typically calculated by or under the direction of software routines. Further, the software may be in the form of a collection of separate programs or modules, or a 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.
Furthermore, the limitations of the following claims are not written in means-plus-function format and are not intended to be interpreted based on 35 U.S.C. 112, sixth paragraph, unless and until such claim limitations expressly use the phrase “means for” followed by a statement of function devoid of further structure.
Filing Document | Filing Date | Country | Kind |
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PCT/EP2023/063412 | 5/18/2023 | WO |
Number | Date | Country | |
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63344150 | May 2022 | US |