Three-dimensional wearable imaging systems and methods thereof

Abstract

At least some embodiments of the present disclosure describe a wearable apparatus for medical imaging which includes: a supporting device; a plurality of x-ray signal emitters arranged in a first closed shape on the supporting device and configured to emit x-ray signals to an object; a plurality of detectors disposed on the supporting device and configured to detect the x-ray signals; and one or more processors coupled to the plurality of x-ray signal emitters and the plurality of detectors. In some embodiments, the one or more processors are configured to: receive data from the plurality of detectors; and generate a cross-sectional image based on the data received from the plurality of detectors. In certain embodiments, the plurality of x-ray signal emitters, the plurality of detectors, and the object remain physically stationary when the wearable apparatus is in use.

Description

535788.000001THREE-DIMENSIONAL WEARABLE IMAGING SYSTEMS AND METHODS THEREOFCROSS REFERENCE TO RELATED APPLICATION

[0001] This application claims the benefit of U.S. Provisional Application No. 63 / 722,024, filed November 18, 2024, the disclosure of which is incorporated herein by reference for all purposes.TECHNICAL FIELD

[0002] Certain embodiments of the present disclosure relate to wearable imaging systems. More particularly, certain embodiments of the present disclosure relate to three-dimensional wearable imaging system.BACKGROUND

[0003] Stroke is one of the leading causes of death and long-term disability in the U.S. and globally. The best outcomes for stroke treatment are achieved when care is provided within the first hour of stroke onset, a critical period known as the “Golden Hour.” Allowing the computed tomography (CT) imaging to be performed and stroke diagnosed at the point of care, such as in the patient’s home or ambulance (outside of hospital), could significantly improve early intervention and patient outcomes.

[0004] Hemorrhagic stroke and ischemic stroke present with similar emergency symptoms, but require very different treatments. Brain imaging is essential to distinguish between the two. Ischemic stroke, caused by a blockage of blood vessels, is best treated with clot-dissolving drugs within the first hour of symptom onset, for example. However, such treatments could be fatal for patients with hemorrhagic stroke, which is caused by bleeding in the brain.

[0005] CT has been the preferred imaging tool for emergency stroke assessment. In hemorrhagic strokes, the findings are immediately visible, with bleeding and hematoma present in the brain. In contrast, ischemic stroke findings are initially subtle and may include a hyperdense vessel, decreased gray -white matter differentiation, and sulcal effacement. Diffusion-weighted imaging is highly accurate and can detect strokes as early as 15 minutes after onset. By rapidly diagnosing whether a stroke is a hemorrhagic stroke or ischemic stroke, appropriate535788.000001treatment can be administered much faster than is currently possible, potentially improving patient outcomes and saving lives.

[0006] Hence, it is desirable to improve techniques for performing CT imaging and monitoring for stroke risks in a patient.SUMMARY

[0007] The present disclosure relates to medical imaging systems, and in some embodiments, more particularly to wearable or portable x-ray and computed tomography (CT) devices employing carbon nanotube x-ray sources and multi-dimensional detector arrays for real-time diagnostic imaging and monitoring. Certain embodiments of the present disclosure relate to wearable imaging systems. More particularly, certain embodiments of the present disclosure relate to three-dimensional wearable imaging system.

[0008] According to certain embodiments, a wearable apparatus for medical imaging includes: a supporting device; a plurality of x-ray signal emitters arranged in a first closed shape on the supporting device and configured to emit x-ray signals to an object; a plurality of detectors disposed on the supporting device and configured to detect the x-ray signals; and one or more processors coupled to the plurality of x-ray signal emitters and the plurality of detectors. The one or more processors are configured to: receive data from the plurality of detectors; and generate a cross-sectional image based on the data received from the plurality of detectors. The plurality of x-ray signal emitters, the plurality of detectors, and the object remain physically stationary when the wearable apparatus is in use.

[0009] According to some embodiments, the cross-sectional image is based on a plane in an angled or top-to-down configuration. According to certain embodiments, the plurality of x-ray signal emitters and the plurality of detectors are arranged to form a three-dimensional (3D) shape. According to some embodiments, the 3D shape is dome-shaped, ring-shaped, or boxshaped.

[0010] According to certain embodiments, the supporting device includes an inflatable component disposed between the object and the plurality of detectors. At least a part of the plurality of x-ray signal emitters is disposed on the inflatable component. According to some embodiments, the one or more processors are further configured to activate one or more x-ray535788.000001signal emitters of the plurality of x-ray signal emitters. The one or more x-ray signal emitters belong in a subset of the plurality of x-ray signal emitters.

[0011] According to certain embodiments, the one or more processors are further configured to activate one or more x-ray signal emitters of the plurality of x-ray signal emitters in a predetermined sequence. According to some embodiments, activating the one or more x-ray signal emitters of the plurality of x-ray signal emitters in the predetermined sequence causes the plurality of x-ray signal emitters to be electronically rotatable in a radial direction with respect to an orientation of the wearable apparatus.

[0012] According to certain embodiments, the plurality of x-ray signal emitters include a set of high-energy emitters and a set of low-energy emitters. In some examples, a first high-energy emitter in the set of high-energy emitters is configured to generate a first x-ray signal. In some examples, a second low-energy emitter in the set of low-energy emitters is configured to generate a second x-ray signal. In some embodiments, the first x-ray signal has higher energy than the second x-ray signal.

[0013] According to some embodiments, the supporting device is a 3D-shaped helmet. In certain embodiments, the plurality of detectors include a plurality of triangular detector modules forming a 3D-shaped detector.

[0014] According to certain embodiments, a size and a number of the plurality of triangular detector modules forming the 3D-shaped detector defines an image resolution of the cross-sectional image generated based on the received data. According to some embodiments, the plurality of x-ray signal emitters are arranged in a circular manner to form a source array ring, wherein the first closed shape is a circle, wherein the source array ring is positioned at an opening of the 3D-shaped helmet. According to certain embodiments, the source array ring includes a plurality of modules. In some embodiments, each module defines a 90-degree arc and is separately operable from other modules of the plurality of modules.

[0015] According to some embodiments, the cross-sectional image is generated for at least one selected from a group consisting of cranial imaging, dental imaging, cervical imaging, chest imaging, abdomen imaging, and limb imaging. According to certain embodiments, the wearable apparatus includes an x-ray shielding component configured to shield the x-ray signals emitted by the plurality of x-ray signal emitters. According to some embodiments, the wearable apparatus is a vest-type wearable apparatus or a limb-type wearable apparatus. According to535788.000001certain embodiments, the wearable apparatus includes at least one sensor selected from a group consisting of radio frequency (RF) sensor, electroencephalography (EEG) sensor, and electrocardiography (ECG) sensor.

[0016] According to some embodiments, a method of medical imaging includes: receiving data from a plurality of detectors configured to detect x-ray signals emitted by a plurality of x-ray signal emitters arranged in a first closed shape on a supporting device, the plurality of detectors disposed on the supporting device; generating one or more cross-sectional images of an object based on the received data; and processing the one or more cross-sectional images to generate one or more of two-dimensional (2D) representation or three-dimensional (3D) volumetric reconstruction of the object. The plurality of x-ray signal emitters, the plurality of detectors, and the object remain physically stationary.

[0017] According to certain embodiments, the method includes performing real-time monitoring or alert based on the processing the one or more cross-sectional images. According to some embodiments, the method includes performing artificial intelligence-assisted diagnosis of one or more medical conditions. According to certain embodiments, the artificial intelligence-assisted diagnosis includes at least one selected from a group consisting of medical triage, stroke classification, and hemorrhage detection. According to some embodiments, the stroke classification includes classifying a stroke into one of an ischemic stroke and an hemorrhagic stroke.

[0018] According to certain embodiments, the method includes activating one or more x-ray signal emitters of the plurality of x-ray signal emitters in a predetermined sequence to emit the x-ray signals and to cause the plurality of x-ray signal emitters to be electronically activated in a radial direction. According to some embodiments, the processing the one or more cross-sectional images includes connecting together a plurality of edges of the one or more cross-sectional images to reconstruct a 360-degree 3D digital image data of the object.

[0019] According to certain embodiments, a non-transitory computer-readable storage medium has instructions for medical imaging that, when executed by one or more processors, cause the one or more processors to perform a set of operations including: receiving data from a plurality of detectors configured to detect signals emitted by a plurality of x-ray signal emitters arranged in a first closed shape on a supporting device, the plurality of detectors disposed on the supporting device; generating one or more cross-sectional images of an object based on the535788.000001received data; and processing the one or more cross-sectional images to generate one or more of two-dimensional (2D) representation or three-dimensional (3D) volumetric reconstruction of the object. The plurality of x-ray signal emitters, the plurality of detectors, and the object remain physically stationary.

[0020] Depending upon embodiment, one or more benefits may be achieved. These benefits and various additional objects, features and advantages of the present disclosure can be fully appreciated with reference to the detailed description and accompanying drawings that follow.BRIEF DESCRIPTION OF THE DRAWINGS

[0021] FIG. l is a schematic diagram of a medical imaging system according to certain embodiments of the present disclosure.

[0022] FIG. 2A is a side view of components forming a wearable imaging device according to certain embodiments of the present disclosure.

[0023] FIG. 2B is an angled view of a patient wearing a helmet-type wearable imaging device according to certain embodiments of the present disclosure.

[0024] FIG. 2C is a side view of a patient wearing a helmet-type wearable imaging device according to certain embodiments of the present disclosure.

[0025] FIG. 2D is an angled view of a dome detector of the helmet-type wearable imaging device according to certain embodiments of the present disclosure.

[0026] FIG. 2E is a side view of the helmet-type wearable imaging device according to certain embodiments of the present disclosure.

[0027] FIG. 3A is a cross-sectional front view of the helmet-type wearable imaging device according to certain embodiments of the present disclosure.

[0028] FIG. 3B is a cross-sectional side view of the helmet-type wearable imaging device according to certain embodiments of the present disclosure.

[0029] FIG. 3C is a collection of cross-sectional front views of the helmet-type wearable imaging device according to certain embodiments of the present disclosure.

[0030] FIG. 3D is a cross-sectional side view of a box-shaped wearable imaging device according to certain embodiments of the present disclosure.535788.000001

[0031] FIG. 4 is a schematic diagram with a flow diagram showing the components and steps associated with a medical imaging system according to certain embodiments of the present disclosure.

[0032] FIG. 5A is a schematic diagram showing the components of a control box system according to certain embodiments of the present disclosure.

[0033] FIG. 5B is a flow diagram showing the data flow associated with the control box system according to certain embodiments of the present disclosure.

[0034] FIG. 6 is an angled view of a patient wearing a vest-type wearable imaging device according to certain embodiments of the present disclosure.

[0035] FIG. 7 is an angled view of a patient wearing a limb-type wearable imaging device according to certain embodiments of the present disclosure.

[0036] FIG. 8 is a schematic diagram of a source array ring implemented in a wearable imaging device according to certain embodiments of the present disclosure.

[0037] FIG. 9 is a flow diagram of a method of medical imaging according to certain embodiments of the present disclosure.

[0038] FIG. 10 is a simplified diagram showing a medical imaging system in accordance with at least one example set forth in the disclosure.DETAILED DESCRIPTION

[0039] Unless otherwise indicated, all numbers expressing feature sizes, amounts, and physical properties used in the specification and claims are to be understood as being modified in all instances by the term “about.” Accordingly, unless indicated to the contrary, the numerical parameters set forth in the foregoing specification and attached claims are approximations that can vary depending upon the desired properties sought to be obtained by those skilled in the art utilizing the teachings disclosed herein. The use of numerical ranges by endpoints includes all numbers within that range (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5) and any range within that range.

[0040] Although illustrative methods may be represented by one or more drawings (e.g., flow diagrams, communication flows, etc.), the drawings should not be interpreted as implying any requirement of, or particular order among or between, various steps disclosed herein.However, some embodiments may require certain steps and / or certain orders between certain535788.000001steps, as may be explicitly described herein and / or as may be understood from the nature of the steps themselves (e.g., the performance of some steps may depend on the outcome of a previous step). Additionally, a “set,” “subset,” or “group” of items (e.g., inputs, algorithms, data values, etc.) may include one or more items and, similarly, a subset or subgroup of items may include one or more items. A “plurality” means more than one.

[0041] As used herein, the term “based on” is not meant to be restrictive, but rather indicates that a determination, identification, prediction, calculation, and / or the like, is performed by using, at least, the term following “based on” as an input. For example, predicting an outcome based on a particular piece of information may additionally, or alternatively, base the same determination on another piece of information. As used herein, the term “receive” or “receiving” means obtaining from a data repository (e.g., database), from another system or service, from another software, or from another software component in a same software. In certain embodiments, the term “access” or “accessing” means retrieving data or information, and / or generating data or information.

[0042] Computed tomography (CT) imaging is a noninvasive diagnostic tool with numerous clinical applications and has continually evolved since its introduction over half a century ago. However, the large size and weight of CT devices limit their use outside of hospital in emergency situations and real-time monitoring. In some examples, a wearable CT device has immense potential for clinical applications, particularly in stroke emergencies and real-time monitoring during interventional treatments.

[0043] Conventional computed tomography systems are typically large, stationary devices that require a patient to be transported to a fixed gantry. Such systems are unsuitable for emergency, bedside, or in-field diagnosis. The existing CT scanners often rely on rotating mechanical components that increase system complexity and radiation exposure. There is a continuing need for compact, stationary, and wearable imaging systems capable of high-speed and low-dose three-dimensional (3D) imaging for head, neck, dental, and soft-tissue applications.

[0044] Systems, devices, and methods disclosed herein are able to accomplish such a determination in a free-form manner. In some aspects, a single x-ray image or a plurality of x-ray images alone may be used. In some embodiments, a phantom or other marker is placed on the535788.000001object, and two images per position may be captured, one for calibration and another for the image set.

[0045] In conventional 3D x-ray tomography imaging devices, systems, apparatuses, assemblies, and / or setups, a position of an x-ray detector relative to one or more x-ray source is always known due to prior calibrations and the one or more fixed positions thereof, such that geometry of the detector relative to the one or more sources or emitters does not need to be determined for each data acquisition. By contrast, in a free-form setup for a tomography imaging device, system, apparatus, assembly, and / or setups, one or more detectors can be in any one or more positions relative to the one or more sources or emitters and be moved from image to image, where relative positions of the one or more sources with respect to the one or more detectors need to be determined for each projection image.

[0046] FIG. 1 is a schematic diagram of a medical imaging system 100 providing an intelligent control, synchronization, and / or data-reconstruction architecture to achieve real-time volumetric imaging in a contact and wearable form factor, according to embodiments disclosed herein. FIG. 1 is merely an example. One of ordinary skill in the art would recognize many variations, alternatives, and modifications. The medical imaging system 100 includes at least one wearable imaging device 110 or a wearable apparatus. The wearable imaging devices 110 may also be referred to as peripheral imaging devices, where each peripheral imaging device is operatively coupled with at least one central imaging unit 121 and / or at least one remote imaging unit 122 of a monitoring system 120 for data transmission. In some embodiments, the medical imaging system 100 may include a plurality of wearable imaging devices 110 that are worn on different parts of a patient’s body (object) for monitoring the health (imaging changes) of the patient. The different parts of the body may include, for example, the head, the torso (thorax and / or abdomen), and / or at least one limb (arm and / or leg) of the patient.

[0047] In certain embodiments, the wearable imaging device 110 includes a supporting device 111, which may also be referred to as a wearable housing (e.g., a helmet for the head, a vest for the torso, a limb attachment for the limb, etc.) as well as a plurality of emitters 112 and / or a plurality of detectors 113 disposed thereon. The emitters 112 include x-ray signal emitters arranged in a first closed shape (e.g., a circle, rectangle, polygon, oval, etc.) on the supporting device 111 (which, in some examples, may be the detector itself). The emitters 112 may be capable of emitting pulsed x-ray signals at independently controlled energy levels. The535788.000001detectors 113 are arranged in a second shape on the supporting device 111. Tn some embodiments, the second shape may be similar to the first closed shape in configuration. In some examples, the second shape may be a closed shape different from the first closed shape. In some embodiments, the second shape may be an open shape, such as a semicircle, an arch, an open polygon, and / or the like. In certain embodiments, the wearable imaging device 110 includes one or more processors 114 coupled to the x-ray signal emitters 112 and the detectors 113. The one or more processors 114 are configured to receive data from the detectors 113 and generate a cross-sectional image based on the data received from the detectors 113 (e.g., 3D detectors, such as 3D-shaped detectors formed using a plurality of 2D flat panel detectors, which may be used to generate 3D images).

[0048] In some embodiments, the wearable imaging device 110 may be coupled with a control device 130 for controlling operation of the wearable imaging device 110, such as a user device or electronics (e.g., smartphone, computer, tablet, etc.) operatively coupled the wearable imaging device 110 and providing user interface allowing the user to control the operation of the wearable imaging device 110, and one or more data acquisition devices 140 for acquiring data from the wearable imaging device 110, such as data acquisition electronics for performing data readout from the detectors 113 and pre-processing of the data for immediate visualization before the captured data can be transmitted to an external processing device (e.g., one or more remote imaging units 122) for more advanced computations, such as a comprehensive 3D reconstruction process and / or artificial intelligence-assisted medical triage (e.g., stroke classification and / or hemorrhage detection). The one or more data acquisition devices 140 may wirelessly acquire data via wireless data transfer.

[0049] In certain embodiments, the medical imaging system 100 further includes a monitoring system 120 that is operatively coupled with at least one wearable imaging device 110. The monitoring system 120 may include at least one central imaging unit 121, at least one remote imaging unit 122, and / or at least one display 123. The central imaging unit 121 may include, for example, a portable or cloud-based central unit that performs image data reconstruction, algorithmic computation, and visualization. In some examples, the display 123 may be separately provided to allow the central imaging unit 121 to perform the visualization, such as to a radiologist or a physician. In some examples, the remote imaging unit 122 may be a cloud-based unit, such as a cloud server, that performs at least a portion of (or an entirety of) the535788.000001image data reconstruction and / or algorithmic computation, such that the computational workload (e.g., for the use of artificial intelligence) for the central imaging unit 121 may be reduced. In some examples, the central imaging unit 121 and / or the remote imaging unit 122 may execute advanced tomographic reconstruction algorithms such as interior reconstruction, compressed sensing, or iterative algebraic reconstruction, enabling high-speed, low-dose 3D imaging with minimal motion artifact.

[0050] The imaging unit 121 and / or 122 may include at least one reconstruction module that employs graphical processing unit- or field-programmable gate array-based processing to generate high-resolution, real-time 3D volumetric images based on the data acquired by the detectors 113 and / or the data acquisition device 140 coupled with the wearable imaging device 110. The processed data may be displayed on a local or remote display interface (e.g., a wearable display interface in some embodiments), such as one or more displays 123 (e.g., for an operator or a physician). In certain embodiments, the monitoring system 120 may be provided with one or more diagnostic tools that are assisted by artificial intelligence for automated interpretation, motion correction, and / or dose optimization.

[0051] According to certain embodiments, the medical imaging system 100 is adaptable to include multiple form factors, including helmet-type, vest-type, and / or limb-type configurations in various embodiments of the wearable imaging device 110, allowing flexible use across various medical and industrial applications. For example, the helmet-type embodiment is shown in FIGs.2A through 2E, the vest-type embodiment is shown in FIG. 6, and the limb-type embodiment is shown in FIG. 7, as further described herein. The medical imaging system 100 facilitates x-ray and CT imaging procedures using the wearable imaging device 110. The wearable imaging device 110 is a stationary device capable of performing tomographic imaging without the use of any mechanical rotation of the emitters 112, the detectors 113, and the object to be scanned, such as a part of the patient’s body.

[0052] According to some embodiments, the medical imaging system 100 as disclosed herein offers several advantages over conventional CT imaging: (1) compact and wearable design for on-site diagnosis; (2) stationary 3D imaging without moving parts; (3) reduced radiation dose; (4) rapid real-time 3D imaging; and (5) versatile applications including emergency stroke assessment, intraoperative imaging, dental diagnostics, veterinary and industrial non-destructive testing, and / or continuous physiological monitoring. By combining wearable ergonomics,535788.000001stationary electronic tomography, and Al-enabled reconstruction, in certain embodiments, the medical imaging system 100 is capable of enabling high-speed, low-dose, real-time 3D imaging monitoring for interventional procedures or treatment at the point of care or in mobile environments, such as in ambulances.

[0053] FIGs. 2A through 2E show the wearable imaging device 110 in a head-mounted configuration according to some embodiments. A helmet 220 may be provided as the supporting device 111 for the other components of the wearable imaging device 110. The head-mounted configuration includes the detectors 113 (e.g., 3D-shaped detectors) in the form of a dome detector 200 that includes a plurality of triangular detector modules 201 and / or a plurality of tiled detector modules. In some examples, at least a part or all of the tiled detector modules each has a polygon shape. In certain examples, at least a part or all of the tiled detector modules each has a closed shape. In some examples, a tiled detector module is adjacent to two or more other tiled detector modules. In certain examples, the tiled detector modules are flat-panel detector modules. In some examples, the triangular detector modules 201 are flat-panel detector modules arranged hemi spherically around the imaging target, and the triangular detector modules 201 may include one or more sensors 203 with energy-integrating and / or photon-counting capabilities. In some examples, one or more of the triangular detector modules 201 may have an equilateral-triangular configuration or an isosceles-triangular configuration, as suitable. The dome detector 200 is coupled with one or more inflatable components 202, such as the inflatable component 202A which is positioned around the head of the patient, and the inflatable component 202B which is positioned at the top portion of the head of the patient. In some embodiments, the geometry of dome detector 200 employs a partial or full ring / geodesic dome design in order to minimize weight (e.g., limited to 2-5 kg) and enable modular expansion. In such examples, the second shape is a dome. Motion compensation is achieved via artificial intelligence-based correction algorithms and an innovative inflatable airbag method for secure head fixation. In some examples, sensors such as electroencephalogram sensors, or EEG sensors, may be included. Dose optimization utilizes ultra-short pulses (e.g., 50-500 ps), adaptive exposure, and dualenergy CT technology in which the emitters 112 alternate between two energy levels, such as an array of carbon nanotube x-ray emitters.

[0054] In certain embodiments, the 3D-shaped detectors may be box-shaped instead of dome-shaped, as shown in FIG. 3D. A box-shaped detector 300 may be disposed around the535788.000001object such as the head, torso, and / or limb. The box-shaped detector 300 may include the detectors 113 being disposed at the opening or rim at which the object may be positioned for imaging. In some embodiments, a box-shaped detector has an opening on one side. In certain embodiments, a box-shaped detector 300 has a cavity of various shapes (e.g., polyhedron shapes, ovoid shapes, etc.). The box-shaped detector 300 may include a plurality of triangular detector modules 201 and / or a plurality of polygonal (e.g., rectangular, square, etc.) detector modules, such as flat-panel detector modules arranged in the shape of a box around the imaging target, and the triangular detector modules 201 may include one or more sensors 203 with energyintegrating and / or photon-counting capabilities. The box-shaped detector 300 may be coupled with one or more inflatable components for safety. In some examples, sensors such as electrocardiogram sensors, or ECG sensors, may be included. It is to be understood that, although only dome-shaped and box-shaped configurations are explained, other suitable types of 3D-shaped detectors can also be employed, including suitable 3D-polygonal shapes.

[0055] Referring back to FIG. 2A, at least one inflatable component 202 may be provided as support for one or more of the emitters 112, such that at least a part of the plurality of emitters 112 are disposed (e.g., on the edge of one or more detectors) on the inflatable component 202. The one or more inflatable components 202 may allow secure fitting of the wearable imaging device 110 to patients with different head sizes, while the embedded sensors (e.g., electroencephalogram, electrocardiogram, or radio frequency sensors) facilitate physiological monitoring during imaging or interventional procedures. The helmet 220 may further include internal radiation shielding and localized beam collimation to reduce (e.g., minimize) dose to non-target regions.

[0056] In certain embodiments, the plurality of emitters 112 may include a plurality of carbon nanotube x-ray emitters. As shown in FIG. 2D, the emitters 112 may include at least one source array ring 206, such as a 3D carbon nanotube x-ray source array, that is arranged in the form of one or more modules or rings around the head of the patient (or, in other embodiments, around the chest or limb of the patient). The source array ring 206 may be positioned at or proximal to an opening of the helmet 220 or the dome detector 200. In such examples, the first closed shape is a circle. In some embodiments, the emitters 112 are vertically-aligned multiwalled carbon nanotubes (e.g., 10-50 nm diameter, 10-100 pm length) positioned on silicon substrates, with 8-12 focal spots in a 20-25 cm ring, 80-120 kV anode, 1-10 mA emission, and535788.00000150-200 W consumption. The emitters 112 may facilitate passive cooling and output data that is compatible with Digital Imaging and Communications in Medicine (DICOM) standards.

[0057] Surrounding the source array ring 206 is the dome detector 200 formed as a 3D geodesic dome. Each of the triangular detector modules 201 is equipped with a plurality of sensors 203, such as energy-integrating sensors, photon-counting sensors, and / or hybrid sensors with energy-integrating and photon-counting capabilities. The triangular detector module 201 and / or a polygon detector module may also be equipped with a scintillator coupled to one or more photodiodes and / or CMOS readout arrays. In some examples, the triangular detector modules 201 may be mounted on one or more lightweight and thermally stabilized frames (e.g., supporting device 111) with one or more embedded temperature and / or dose sensors. In some embodiments, each triangular detector module 201 may communicate via optical and / or wireless interfaces to reduce electromagnetic interference and improve wearability. The hemispherical geometry of the dome detector 200 may enhance photon collection efficiency, e.g., achieving at least 70% geometric detection efficiency and 0.4-0.5 mm spatial resolution.

[0058] According to some embodiments, the emitters 112 may be disposed on at least two separate locations such that the emitters 112 on each location are directed toward a different section of an object to be scanned, such as a portion of the body. In certain embodiments, the emitters 112 and the detectors 113 remain at stationary positions with respect to each other, such that the emitters 112 and the detectors 113 do not move against each other. The object to be scanned, in some embodiments, as well as the emitters 112 and the detectors 113, remains in a stationary position (e.g., remains physically stationary, remains physically relatively stationary, etc.) during the imaging process. In some embodiments, the emitters 112 do not move (e.g., remain stationary, etc.) relative to the object being scanned. In some embodiments, the detectors 113 do not move relative to the object being scanned. Therefore, in some embodiments, the object to be scanned, the emitters 112, and the detectors 113, remain at the same relative positions with respect to each other. In some embodiments, the size of the individual triangular detector module 201 may be adjusted according to the preferred resolution of the final image. For example, for higher-resolution imaging, it is preferrable to have smaller triangular detector modules 201 (with an increased number of triangular detector modules in total) forming the dome detector 200. Alternatively, if lower-resolution imaging is permitted or preferred (e.g., for535788.000001cost reduction or time reduction), larger triangular detector modules 201 (with fewer number of triangular detector modules in total) are encouraged.

[0059] According to certain embodiments, using the plurality of triangular detector modules 201, 3D reconstruction is facilitated by using either image jigsaw reconstruction method or image overlap reconstruction method. In the image jigsaw reconstruction method, in some embodiments, edges of the images are connected together like a jigsaw puzzle to reconstruct the final image that is the 360-degree 3D digital image data of the scanned object. In the image overlap reconstruction method, in certain embodiments, images obtained from the various triangular detector modules 201 are reconstructed by overlapping high-energy images and low-energy images with each other. In some embodiments, the resolution of the image may also be increased by adding more emitters 112 to the wearable imaging device 110 as well as increasing the exposures, thereby providing additional image data points. Although the above example refers to dome-shaped wearable detectors, it is to be understood that the same principle of operation also applies to other 3D-shaped wearable detectors, including but not limited to the box-shaped wearable detector 300 as shown in FIG. 3D.

[0060] Referring back to FIG. 2C, a first set of emitters is positioned around the head of the patient, such as near the forehead and the temple, so as to be directed inwardly toward a center portion within the head, and a second set of emitters is positioned near the chin of the patient so as to be directed upwardly with respect to the head. Therefore, the different sets of emitters 112 may be used to provide signals, such as x-ray signals, to be detected by the detectors 113 to generate cross-sectional images associated with different planes, such as an angled cross-sectional image associated with a first plane that is in an angular orientation with respect to the target, or a top-to-down cross-sectional image associated with a second plane different from the first plane. In some examples, the detectors 113 can support and / or provide real-time (e.g., less than ten (10) milliseconds, less than fifty (50) milliseconds, etc.) wireless image data transmission and spectral imaging for low-dose applications (e.g., less than 1 mSv). Scanning may occur in less than 30 seconds, enabling differential diagnosis of ischemic stroke versus hemorrhagic stroke, or interventional monitoring in non-hospital settings.

[0061] In some embodiments, the emitters 112 may be x-ray sources located underneath the helmet 220 of the wearable imaging device 110, or alternatively located in any other suitable position relative to the helmet 220. For example, the helmet 220 may provide a dome-shaped535788.000001shell housing in which the source array ring 206 may be positioned around the head of the patient, and the dome detector 200 is positioned within the helmet 220 so as to line the inner curvature of the helmet 220. In some examples, the helmet 220 may provide a different 3D-shaped shell housing, for example, such as a box-shaped housing or other polygonal housing as suitable.

[0062] According to some embodiments, the emitters 112 are powered by a power source such as a battery. In some embodiments, the battery may be located in a control box 204 which also stores at least one processor 114 and at least one memory 115 associated with the wearable imaging device 110. In some embodiments, power is supplied via lightweight rechargeable batteries or tethered sources with capacitor banks for high-voltage pulses (e.g., 30-80 kV, 10-200 Hz repetition). In some embodiments, the memory 115 may operate as an image storage that employs one or more high-definition digital systems (e g., solid state drives) and have wireless transmission compatibility with electronic health records as well as one or more picture archiving and communication system. Additionally, the emitters 112 can be controlled remotely through wire and / or wireless signals from an operator terminal (e.g., a remote controller). The wearable imaging device 110 may be positioned on top and / or on one side of an object to be scanned, such as the head of the patient, while the one or more detectors 113 may be arranged in a position at least substantially diametrically opposite (e.g., around the object to be scanned) from the one or more emitters 112. The detectors 113 in the head-mounted arrangement may be formed as a 3D geodesic dome detector 200, but any other suitable detector type and shape may be utilized.

[0063] In some embodiments, the detectors 113 include one or more photon-activated, scintillating, energy -integrating detectors. In some embodiments, the detectors 113 include one or more photon-counting detectors. In some embodiments, the detectors 113 include one or more hybrid detectors with capabilities of both of the aforementioned detectors, or a combination of the aforementioned detectors. The detectors 113 may be in electronic communication with a wireless communication module, or the detectors 113 may themselves be capable of transmitting the x-ray images captured during activation of the emitters 112 to an operator terminal, such as control device 130 and / or data acquisition device 140, via any suitable wireless communication protocol (e.g., Wi-Fi®, Bluetooth®, radio frequency, etc.).535788.000001

[0064] In certain embodiments, the wearable imaging device 110 may include a control box 204 attached to or operatively coupled with the wearable imaging device 110. The control box may include, for example, a control and processing box or device (such as a control and processing unit). In some embodiments, the control box 204 is attached at a fixed and predetermined position relative to one or more emitters 112 such that the known geometric relationship between the emitters 112 and the processor 114 can be used during image reconstruction to manage / operate the x-ray images captured by the detectors 113. In certain embodiments, the control box 204 can be mounted, either directly or indirectly (e.g., via a linkage box or bar), to one or more emitters 112. In certain embodiments, the control box 204 may be a fixed or mobile device that is integral to the wearable imaging device 110.

[0065] In certain embodiments (e.g., referring to FIG. 8), the one or more source array rings 206 may be arranged in concentric or arc-shaped geometric configurations, where the emitters 112 of the source array rings 206 may be configured for both high-energy and low-energy operations (e.g., having at least two different sets of emitters 112 where one set is for high-energy operation and another set is for low-energy operation). For example, the emitters 112 may include a set of high-energy emitters 112A and a set of low-energy emitters 112B. In some examples, a first high-energy emitter in the set of high-energy emitters 112A is configured to generate a first x-ray signal with a first energy level, and a second low-energy emitter in the set of low-energy emitters 112B is configured to generate a second x-ray signal with a second energy level that is less than the first energy level, such that the first x-ray signal has higher energy than the second x-ray signal.

[0066] Such example of supporting both single-energy imaging and dual-energy imaging may be beneficial in spectral or material decomposition analysis. The dual-energy imaging implementation may facilitate material differentiation and enable effective atomic number and density computation for distinguishing ischemic stroke versus hemorrhagic stroke, or other tissue characterization tasks. In some embodiments, the system may perform backscatter imaging in which the x-ray detector 113 is configured to capture scattered radiation reflected from the object. Collimated pencil-beam geometry may be employed to enhance contrast for surface or shallow-depth imaging.

[0067] Referring to FIG. 2E, in certain embodiments, the source array ring 206 is shown to be affixed radially on the edge of the detectors 113 (e.g., on the edge of the dome detector 200)535788.000001over a predefined angular range (e.g., 90 degrees, 180 degrees, 270 degrees, and / or 360 degrees) such that the emitters 112 of the source array ring 206 are maintained within an internal space of the wearable imaging device 110, for example within the internal space defined by the dome detector 200. In some embodiments, the source array ring 206, or more specifically the plurality of emitters 112 associated with the source array ring 206, may be electronically rotatable in a radial direction with respect to an orientation of the wearable imaging device 110.

[0068] In some embodiments, the angular position at which the position of the source array ring 206 is angled with respect to that of the detectors 113 is known or predetermined relative to the wearable imaging device 110 and / or the detectors 113 such that the relative angular position may be used for geometric image correction of the x-ray projection images as captured by the wearable imaging device 110 and / or the detectors 113. In certain embodiments, the source array rings 206 for cross-sectional imaging (x-ray imaging and CT imaging) of different parts of the body may be positioned at different angular configurations with respect to each other. For example, the source array ring 206 for cross-sectional imaging of the head (also referred to as cranial imaging, labeled as “Head XCT” where “XCT” is the abbreviation for “x-ray and CT imaging”) may be positioned more angularly on the wearable imaging device 110 as compared to the source array ring 206 for cross-sectional imaging of the teeth (also referred to as dental imaging, labeled as “Dental XCT”) or the neck of the patient (also referred to as cervical imaging, labeled as “Neck XCT”). In some examples, the source array ring 206 has two sides (e.g., upper and lower) such that the cross-sectional imaging may be performed on one or both sides (e.g., one image looking down from the top and another image looking up from the bottom) with respect to the source array ring 206. In some examples, there may be a plurality of array rings 206 that are implemented, thereby forming a multi-ring source.

[0069] In some embodiments, the one or more processors 114 may be capable of controlling operation of one or more subsets of the emitters 112. For example, the one or more processors 114 may activate one or more emitters 112 of the plurality of emitters 112, such as those on a source array ring 206. The one or more emitters 112 belong in a subset of the plurality of emitters 112, and the subset may include a single individual emitter or multiple emitters. The one or more processors 114 may activate each subset individually and separately from other subsets. The one or more processors 114 may activate the subsets sequentially, for example in a predetermined sequence. The sequence may be in a circular motion rotating around the source535788.000001array ring 206 For example, the one or more processors 114 may electronically steer or sequentially activate multiple emitters 112 in order for the medical imaging system 100 to achieve stationary electronic rotation around the object to be scanned (e.g., a portion of the body of the patient), thereby emulating a 360-degree rotation with respect to the object, which enables tomographic acquisition comparable to conventional CT systems, without requiring any mechanical movement, such as the mechanical movement of the emitters 112, detectors 113, and / or a portion of the body of the patient, in order to perform the tomographic acquisition. This configuration results in faster imaging, lower radiation dose, reduced system complexity, and enhanced operator safety due to the lack of any moving parts with respect to the emitters 112, detectors 113, and / or the object to be scanned.

[0070] FIGs. 3A and 3B show examples of emitters 112 and the general directions in which the emitters 112 may be directed with respect to the object to be scanned, which in the illustrations is the head of a patient. FIGs. 3A and 3B are merely examples. One of ordinary skill in the art would recognize many variations, alternatives, and modifications. Referring to FIG. 3 A, in a helmet-type configuration, the wearable imaging device 110 may include an x-ray shield 210 disposed on an outermost portion of the wearable imaging device 110, with at least one radio frequency sensor 212 disposed underneath the x-ray shield 210, and further, the inflatable component 202 disposed underneath, thereby defining the multilayered configuration of the helmet-type wearable imaging device 110. In some examples, the helmet 220 may operate as the x-ray shield 210, or a separate component may be disposed on the helmet 220 to provide the x-ray shielding capability. Shielding may also integrate collimated beams, localized protection, and heat-cooling management to safeguard patients and operators. In some examples, the shielding may also protect operator and physician in various procedures involving x-ray and CT imaging.

[0071] The wearable imaging device 110 may include one or more electroencephalogram (EEG) sensors 214 disposed and / or positioned at different locations with respect to the object to be scanned, which in this case is the patient’s brain. The emitters 112 may be disposed in a substantially ring-shaped or circular configuration as defined by the source array ring 206 along a plane that intersects with the patient’s head in such a way to allow the emitters 112 to direct the emitted x-ray signals toward various locations of the brain, as shown by the plurality of arrows extending from the individual emitters 112. The emitters 112 may emit the signals in a535788.000001substantially converging manner such that one or more of the signals emitted by the emitters 112 may converge at one or more points within the object to be scanned.

[0072] Referring to FIG. 3B, the emitters 112 are positioned further from the object to be scanned than the emitters 112 of FIG. 3A. For example, the emitters 112 may be positioned at the chin of the patient such that the x-ray signals emitted by the emitters 112 radiate away from each other and are directed toward different locations of the object to be scanned (and also toward the detectors 113) in a substantially diverging manner such that a signal from one of the emitters 112 would not intersect with signals from other emitters 112, as represented by the arrows. In some embodiments, a phantom or other marker may be placed on the object to be scanned, such as on the head of the patient, and two images per position may be captured, one for calibration and another for the image set.

[0073] FIG. 3C illustrates the various examples in which the x-ray signals may be emitted in a three-dimensional manner from the emitters 112. FIG. 3C is merely an example. One of ordinary skill in the art would recognize many variations, alternatives, and modifications. In certain embodiments, the emitters 112 may be positioned near the chin in a curved configuration with respect to each other, as illustrated in the leftmost figure showing a front view of the brain, such that the emitters 112 may direct the x-ray signals to the left, right, and center portions of the brain. In some embodiments, the emitters 112 may be positioned near the chin of the user in a radial configuration with respect to each other, as illustrated in the second figure from the left showing a side view of the brain, such that the emitters 112 may direct the x-ray signals to the front, back, and center portions of the brain. In certain embodiments, the emitters 112 may be positioned near the temple of the patient, as illustrated in the second figure from the right showing a front view of the brain, such that the emitters 112 may direct the x-ray signals to the left and right portions of the brain. In some embodiments, the emitters 112 may be positioned near the temple of the patient, as illustrated in the rightmost figure showing a side view of the brain, such that the emitters 112 may direct the x-ray signals to the front and back portions of the brain. Any one or more of the emitters 112 may emit the x-ray signals in the form of a cone beam.

[0074] FIG. 4 illustrates a workflow schematic diagram of the medical imaging system 100 showing the hardware and software aspects of controlling and operating the individual components of the medical imaging system 100 according to certain embodiments. FIG. 4 is535788.000001merely an example. One of ordinary skill in the art would recognize many variations, alternatives, and modifications. Initially, a peripheral unit, or a wearable imaging device 110, is worn or mounted to a patient or object to be scanned. In some examples, one or more of the inflatable components 202 associated with the emitters 112 or the detectors 113 may be inflated, such as by air. Then, the control device 130 may activate the emitters 112 in a high-voltage power configuration 404, the high-voltage high-speed switches 403 may sequentially activate the emitters 112, or carbon nanotube arrays, on the source array ring 206. In some embodiments, a filler switch may be activated to facilitate high-energy and low-energy x-ray signals to be emitted around the object. The high-energy and low-energy emissions cause the formation of dual-energy sources 401. The emitters 112 of the source array ring 206 are sequentially and electronically activated in a radially rotating manner around the object to be scanned (e.g., the head of the patient) in forming an array of emitters 402, which may emit cone-beam x-rays. In certain embodiments, the emitters 112 include a plurality of high-energy emitters 112A and a plurality of low-energy emitters 112B, which may be positioned in an alternating pattern.

[0075] The detectors 113, which may be configured as any suitable 3D-shaped detector including but not limited to a dome detector 200 or a box-shaped detector 300, may be positioned to surround the side(s) of the object to capture the x-ray signals in order to generate one or more cross-sectional images associated with the object. The scanning is facilitated by using the detectors 113 to capture the entire digital image data of the object. Next, the digital image data information is sent or transmitted to the appropriate control device or system. For example, the data information may be stored on the memory 115 that is on board the wearable imaging device 110, the data information may be transmitted to the control device 130 or the data acquisition device 140 via one or more digital image acquisition and transmission systems 405 operatively coupled with the wearable imaging device 110, or the data information may be transmitted to the monitoring system 120, such as the central imaging unit 121 of the monitoring system 120. In some embodiments, one or more wireless communication devices and / or teleradiology system may be provided to transmit the data information to a portable or cloudbased central unit, such as the remote imaging unit 122, that performs image data reconstruction, algorithmic computation, and / or visualization.

[0076] In some embodiments, the one or more processors 114 may acquire digital image data and stores the digital image data in the memory 115. In certain embodiments, the digital image535788.000001data may be transmitted (e.g., when the patient is at home, in the ambulance, or in the hospital) to the one or more central imaging units 121 via teleradiology in order to transmit the data to a cloud system, such as a hospital cloud system (e.g., one or more remote imaging units 122), after which the cloud system may perform image data analysis such as to generate 2D representation and / or 3D volumetric reconstruction 407. Thereafter, the generated reconstruction or representation may be displayed for physicians such as radiologists to perform differential diagnosis 408. In some embodiments, real-time alert may be provided to the patient and the physician as well. Subsequently, real-time monitoring 409 for interventional treatment of stroke may be continued for the patient. In certain embodiments, the operation and control systems 406 associated with the wearable imaging devices 110 may also control the x-ray dosage for the imaging process, such as by controlling or limiting the intensity or time of the x-ray dosage to reduce the risk of causing harm to the patient.

[0077] A reconstruction module may be provided in any one or more of the aforementioned devices or systems capable of receiving the data information from the detectors 113. The module may employ graphical processing unit-based or field-programmable gate array-based processing to generate high -resolution, real-time 3D volumetric images using the data information provided by the detectors 113. The processed data may be displayed on a local or remote display interface, such as on the one or more displays 123, which may include diagnostic tools for automated interpretation, motion correction, and dose optimization. The diagnostic tools may be assisted by the use of artificial intelligence.

[0078] FIG. 5A shows the hardware components of a control box system 500, and FIG. 5B shows a flowchart 550 in the software embodiment associated with the control box system 500, according to embodiments disclosed herein. FIGs. 5A and 5B are merely examples. One of ordinary skill in the art would recognize many variations, alternatives, and modifications. The control box system 500 may include the components associated with the control box 204 in FIG.2C, also labeled as control box 526 in FIG. 5A.

[0079] The control box system 500 includes a primary energy source 502, which may include, for example, tethered mains with an isolated AC / DC (e.g., 48 VDC bus) and / or at least one battery pack (e.g., 48-52 V lithium-ion battery pack). The system 500 also includes one or more low-voltage rails 504 for DC-DC connection, as well as one or more DC-DC converters 506 associated therewith. The rails 504 and converters 506 may be associated with one or more535788.000001voltage levels such as 12 V, 5 V, 3.3 V, and / or 1.2 V for one or more of: application-specific integrated circuits, field-programmable gate arrays 514, and / or central processing units. In some embodiments, the system 500 may implement one or more voltage regulators 508, such as for 1.2 V, 3.3 V, and / or 12 V. In a helmet implementation, peak power usage may span from 200 W to 500 W depending on whether high-voltage or low-voltage emitters 112 are being activated and the type of one or more graphical processing units 516 that are implemented. In some embodiments, average power consumption may be lower with pulsed operation. In certain embodiments, one or more thermal control devices 510 may be implemented, including one or more fans and / or one or more thermal pumps, for example, for cooling and temperature regulation.

[0080] The control box system 500 includes a plurality of emitters 512 which may include, for example, a plurality of carbon nanotube x-ray sources. In the example as shown, the emitters 512 may operate in 3.3 V or 12 V setting, according to the regulated voltage from the regulators 508. In a high-voltage pulsar implementation, the system 500 may implement high-voltage pulser modules 524 may have an output voltage of 30-80 kV DC with fast pulsing capability (e.g., having a pulse width of 50-500 ps at a rate of 10-200 Hz). Carbon nanotube sources may allow lower instantaneous current with high-speed and high-voltage switching. In some embodiments, safety devices for current limiting and fast shutoff (<10 ps) may be provided for safety. In some embodiments, solid-state high-voltage module(s) may be used with optically isolated control lines. In certain embodiments, one or more local high-voltage capacitive energy storages may be implemented as the energy source 502.

[0081] In some embodiments, each carbon nanotube emitter node may be coupled with a local gate drive and a device for emission control. Emission sense resistor or current monitor may be provided per each source or emitter for per-node monitoring and shutoff. In some embodiments, the system 500 includes one or more detector devices (or detectors 113) such as a plurality of tiled detector modules 520 configured to detect signals from x-ray emitters 522 (or emitters 112). In some examples, a geodesic dome detector 200 may include a plurality of triangular detector modules 201 (e.g., at least 20, 40, 180, or 320 triangular detector modules), which may include one or more flat-panel energy-integrating detector tiles, photon-counting detector tiles, and / or hybrid tiles. In certain embodiments, each tile may include: at least one bias rail (e.g., 30-60 V depending on the type of detector); one or more low-noise low-voltage supply535788.000001(e g., 1.2V / 2.5V / 3.3V), one or more detector readout chains 518 for high-speed serial links (for low-voltage differential signaling or field-programmable gate array 514), and one or more local temperature sensors and thermal control devices 510.

[0082] In certain embodiments, a field-programmable gate array 514 and / or other processing units (e.g., programmable processing units, etc.) may handle: detector readout aggregation (e.g., for a plurality of low-voltage differential signaling lanes), timestamping and synchronization of data, high-voltage trigger timing generation (e.g., either for precise timing or for jitters shorter than 100 ns), and / or lossless data packing to be transmitted to the graphical processing unit 516 or the central processing unit. In some embodiments, one or more jitter-locked phase-locked loops and / or one or more external pulse-per-second synchronization signals may be provided for deterministic timing.

[0083] In certain embodiments, the control box system 500 may include one or more of one or more graphical processing units and / or other computing units (e.g., SoCs (system-on-a-chip), TPUs (tensor processing unit), CPUs (central processing unit), etc.) 516 for data reconstruction. The processing unit may include one or more embedded graphical processing units. In some embodiments, one or more graphical processing units may be provided in the control box 526. The graphical processing units 516 may be responsible for: offset / dark subtraction, bad-pixel correction, geometry mapping (tiled detector stitching), and / or preliminary reconstruction (e.g., using cone beam fdtered back-projection or iterative engine algorithm) as well as artificial intelligence-assisted medical triage (e.g., stroke detection) and / or fracture diagnosis. In some embodiments, a local storage may be provided for buffering and patient anonymized store before transfer.

[0084] In certain embodiments, a user interface may be provided, such as a touchscreen, on the control box 526 or a user device such as a smartphone or tablet app used with wireless data transmission via Wi-Fi or Ethernet). In some embodiments, an application programming interface (e.g., representational state transfer application programming interface) may be provided for remote integration. In some examples, one or more local interlock status LEDs and emergency stop push-button and / or isolation switch 528 may be provided for safety.

[0085] FIG. 5B shows a flowchart 550 illustrating the signal and timing flow between a master device (e.g., field-programmable gate array) 514, and one or more slave devices, such as the high-voltage pulser module 524 and the plurality of tiled detector modules 520 such as the535788.000001triangular detector modules 201. As an example, the field-programmable gate array 514 may transmit configuration data such as the amount of voltage, pulse length, and current limit to the high-voltage pulser modules 524. When the pulser modules 524 are ready for emission, as an example, the pulser modules 524 transmit a ready signal back to the field-programmable gate array 514, in response to which a signal to start the emission sequence is transmitted back to the pulser modules 524. Upon detecting the emissions, in some examples, the detector modules 520 wirelessly transmit one or more readout frames associated with the detected emissions to the field-programmable gate array 514 as well as transmitting the frame part data via direct memory access.

[0086] As an illustrative example, initially, the system may power up such that the low-voltage rails 504 are activated and all detectors are biased to standby (low bias) mode, during which the field-programmable gate array 514 performs a built-in self-test and a handshake process with the detector modules 520. Subsequently, in an emitter pre-check process, health of the high-voltage pulser modules 524 is verified, the carbon nanotube heaters and gates are checked, and emission from the emitters 522 is disabled. In the next step, the detector modules 520 are activated in normal integration mode (ready state), with cooling performed at one or more setpoints. In the subsequent step, for example in an acquire sequence, the field-programmable gate array 514 selects one or more emitter node sequences and provides a high-voltage trigger schedule, in response to which the high-voltage pulser module 524 charges to a preset high-voltage level. When ready, the field-programmable gate array 514 activates the high-voltage pulse gate (and, optically, an isolated trigger), and one or more carbon nanotube emitters 512 are enabled before the high-voltage pulse (microseconds) in order to allow emission only during a high-voltage time window. The detector readout chains 518 are integrated for a predetermined frame time (e.g., 100-500 ps), then the readout is performed for digitization, as repeated for a next emitter node. The sequence continues according to a chosen angular sampling. In a reconstruction step, the field-programmable gate array 514 forwards one or more frames to the graphical processing unit 516 for incremental reconstruction. In some embodiments, a low-resolution result may be available within seconds, whereas a fully iterative reconstruction may be available within minutes, depending on the amount of computing power that is available. In a shutdown step, emissions are disabled for the x-ray emitters 512 and 522,535788.000001the high-voltage pulser modules 524 are discharged, and the detector modules 520 perform power-down bias after safely discharging.

[0087] One or more safety devices may be provided, for example, an emergency or E-stop button and / or isolation switch 528. The E-stop button may be hard-wired to the system 500 to instantly disable high-voltage emitters and gate drives. In some embodiments, a sensor is provide such that, if the helmet is removed or moved beyond threshold, the system 500 would immediate stop. In some embodiments, an operator key such as a two-step enable process may be implemented to prevent accidental emission. In some embodiments, a ground-fault detection and leakage current monitors may be provided. In certain embodiments, high-voltage current sensing per module may be provided to facilitate automatic shutdown upon detecting one or more overcurrent events. In some embodiments, one or more software interlocks may be provided, such as a watchdog timer and / or heartbeat detector. In certain embodiments, radiation warning and radiation shield are provided such that local operator-side shielding is facilitated in the control box 526, as well as defining one or more emission exclusion zone during the emission process. In some embodiments, thermal limits may be set for safety, as monitored by one or more temperature sensors on the carbon nanotube emitters 512 and / or detector modules 520 with automatic duty-cycle reduction.

[0088] In certain embodiments, optical fibers may be implemented for high-speed data transmission where feasible to isolate grounds and reduce electromagnetic interference. In some embodiments, to reduce electromagnetic interference, low-voltage power may be transmitted over shielded multi-pin rugged connectors that are waterproofed for field use, and high-voltage lines may be short, well-insulated, and routed with physical standoffs. In some embodiments, spark-gap protection and bleed resistors may be incorporated. In some embodiments, the control box 526 and the high-voltage pulser modules 524 may be shielded in an earthed metal enclosure.

[0089] For improved diagnostics and test points, in some embodiments, scaled high-voltage monitor outputs may be provided to analog-to-digital converter for logging. In certain embodiments, emitter current sense outputs per node (low-side sense amplifiers) may be detected and analyzed. In some embodiments, detector temperature and bias sensing may be provided to the analog-to-digital converter. In certain embodiments, a field-programmable gate array status may be provided for debugging as well as a joint test action group test header. In some535788.000001embodiments, built-in self-test sequences may be provided for detector modules 520 and emission from carton nanotube x-ray emitters 512.

[0090] In some embodiments, the peripheral units (e.g., wearable imaging devices 110) may implement a plurality of small isolated high-voltage pulser modules (e.g., one pulser module per helmet quadrant) to improve redundancy and reduce cable length. In some embodiments, a central high-voltage pulser module with short, well-insulated leads may be implemented for simplicity. In some embodiments, computation-heavy calculations may be performed off-helmet (e.g., not in the control box 204) in order to reduce helmet mass. The helmet 220 may mainly host sensors such as detectors 113, emitters 112, and minimal drive electronics. A short tether may be used for power and data transfer to the control box 204. Pulsed low-duty operation (e.g., short pulses, sparse angular sampling) may reduce average power and thermal load and may facilitate improved integration with artificial intelligence-based sparse-reconstruction for medical triage (e.g., comparing stroke conditions to normal conditions).

[0091] FIG. 6 shows an example of a vest-type implementation of the wearable imaging device 110 according to some embodiments. FIG. 6 is merely an example. One of ordinary skill in the art would recognize many variations, alternatives, and modifications. The vest 600 is worn around the torso of the patient, with a plurality of detectors 113 positioned in a circular matter surrounding a region of interest, such as the object to be scanned. In such examples, the second shape is a circle. A plurality of source array rings 206 may be provided to peripherally surround the detectors 113. The detectors 113 may include one or more electrocardiogram sensors 604 or ECG sensors, as well as any other suitable type of sensor 606 for simultaneous sensing of different features. For example, a plurality of source array rings 206 (e.g., multiple carbon nanotube X-ray ring arrays) and detectors 113 (e.g., detector panels) may be distributed around the torso such that each pair operates independently or simultaneously, enabling dual-region scanning (e.g., heart and lungs, or chest and abdomen). The electrocardiogram sensors 604 may be embedded to provide physiological correlation for cardiac or respiratory imaging. Radio frequency sensors 212 as well as other suitable sensors 606 may also be capable of assisting in the sensing of physiological properties associated with cardiac or respiratory imaging, for example a chest x-ray or CT scan for the chest and / or abdomen. In some embodiments, the x-ray ring sources such as the source array rings 206 electronically rotate around the different positions and / or locations (chest and / or abdomen) with respect to the object to be scanned (but not535788.000001physically rotating around the object) while adjusting the position of each detector 113 relative to the locations (chest and / or abdomen) of the object. As such, the vest 600 is able to ensure that detectors 113 and emitters 112 are electronically rotated around the object so as to be located on the chest and / or abdomen. Radio frequency sensors 212, electrocardiogram sensors 604, and / or other sensors 606 may be provided for monitoring interventional procedures.

[0092] FIG. 7 shows an example of a limb-type implementation of the wearable imaging device 110 according to some embodiments. FIG. 7 is merely an example. One of ordinary skill in the art would recognize many variations, alternatives, and modifications. The wearable imaging device 110 is positioned around the limb, such as around an arm of the patient, and has a plurality of emitters 112 such as the source array ring 206 at multi locations with respect to the wearable imaging device 110, which may comprise a limb x-ray and CT imaging device operated independently. The detectors 113 and emitters 112 are in the different locations of the wearable imaging device 110. The emitters 112 electronically rotate (e.g., by controlling which emitters to activate) around the different positions of the limb to perform the imaging. The limbtype configuration may be used for high-resolution imaging of arms, legs, or joints for orthopedic diagnostics, fracture assessment, or prosthetic fit evaluation.

[0093] FIG. 8 shows an example of a source array ring 206 formed using a plurality of modules 800, with each module including a plurality of emitters 112, such as a set of high-energy emitters 112A and a set of low-energy emitters 112B. FIG. 8 is merely an example. One of ordinary skill in the art would recognize many variations, alternatives, and modifications. In some embodiments, the high-energy emitters 112A and the low-energy emitters 112B are disposed in an alternating configuration on the inflatable component 202 provided as support for the emitters. In certain embodiments, each module 800 extends 90 degrees or forms a 90-degree arc with respect to a full circle (which is 360 degrees requiring a total of four modules combined together), and each module 800 may be separately and independently operable. In some embodiments, it may not be necessary to prepare a source array ring 206 that extends the entirety of the circle (e.g., a full 360-degree configuration), in which case a single module (90 degrees), two modules (180 degrees) or three modules (270 degrees) may be implemented. An example of an implementation that does not require a full 360-degree configuration is for dental imaging, which only requires sufficient coverage along the front portion of the head (e.g., only along the face of the patient) that would span 180 degrees, or employing two modules 800. In comparison,535788.000001a full 360-degree configuration may be required for cranial and cervical imaging and reconstruction.

[0094] FIG. 9 is a simplified diagram showing a method 900 for medical imaging according to certain embodiments of the present disclosure. This diagram is merely an example. One of ordinary skill in the art would recognize many variations, alternatives, and modifications.Although the method 900 has been shown using a selected group of processes (e.g., steps), there can be many alternatives, modifications, and variations. For example, some of the processes may be expanded and / or combined. Other processes may be inserted into those noted above.Depending upon the embodiments, the sequence of processes may be interchanged with others replaced. Further details of these processes are found throughout the present disclosure.

[0095] According to some embodiments, the method 900 includes step 902 in which data from the plurality of detectors that detect signals emitted by the plurality of emitters are received. The emitters may be x-ray signal emitters arranged in a first closed shape on the supporting device of a wearable imaging device. In some embodiments, to enhance safety of the patient, an emergency stop feature may be implemented in the wearable imaging device so as to instantly disable the high-voltage emitters upon detecting one or more predetermined conditions, thereby preventing accidental overdose of x-ray signals by the body of the patient. The conditions may include, but are not limited to, upon a sensor detecting that the helmet is removed or moved beyond threshold, upon ground-fault detection, upon current leakage detection or over-current event detection, and / or upon reaching a predetermined thermal limit.

[0096] In some embodiments, in step 904, a cross-sectional image of an object is generated based on the received data, such as the data received from the plurality of detectors. The plurality of detectors may be arranged in a second shape on the supporting device. The first and second shapes may be similar to or different from each other.

[0097] According to certain embodiments, in step 906, the cross-sectional image is processed to generate 2D representation and / or 3D volumetric reconstruction of the object. In some examples, a plurality of cross-sectional images may be generated and processed in order to generate the 2D representation and / or the 3D volumetric reconstruction. In some embodiments, 2D representation may be a projection image of the object that superimposes all the structures onto a single image, such as in an x-ray image. In some embodiments, 2D representation may be a cross-sectional image of the object, such as an image generated via CT scan. In some535788.000001embodiments, 3D volumetric reconstruction may be a digital 3D model of the object to be accessed and viewed by the a radiologist or physician.

[0098] According to some embodiments, in step 908, one or more of real-time monitoring and / or alert may be performed. In some examples, artificial intelligence-assisted diagnosis of one or more medical conditions may also be facilitated in step 908. According to certain embodiments, the artificial intelligence-assisted diagnosis may include medical triage, which may include but is not limited to stroke classification and / or hemorrhage detection. In some examples, the stroke classification involves classifying the type of stroke such as ischemic stroke and hemorrhagic stroke.

[0099] Although the above has been shown using a selected group of processes for the method 900, there can be many alternatives, modifications, and variations. For example, some of the processes may be expanded and / or combined. Other processes may be inserted into those noted above. Depending upon the embodiments, the sequence of processes may be interchanged with others replaced. Further details of these processes are found throughout the present disclosure.

[0100] In some embodiments, some or all processes (e.g., steps) of the method 900 are performed by a system (e.g., the medical imaging system 1000). In certain examples, some or all processes (e.g., steps) of the method 900 are performed by a computer and / or a processor directed by a code. For example, a computer includes a server computer and / or a client computer (e.g., a personal computer). In some examples, some or all processes (e.g., steps) of the method 900 are performed according to instructions included by a non-transitory computer-readable medium (e.g., in a computer program product, such as a computer-readable flash drive).

[0101] FIG. 10 is a simplified diagram showing the components of a medical imaging system 1000 in accordance with at least one example set forth in the disclosure. This diagram is merely an example, which should not unduly limit the scope of the claims. One of ordinary skill in the art would recognize many variations, alternatives, and modifications.

[0102] The medical imaging system 1000 includes a bus 1002 or other communication mechanism for communicating information, a processor 114, an input device 1010 (e.g., one or more detectors 113), memory 115, and a network interface 1018. In certain embodiments, the memory 115 includes one or more of a main memory 115A, a read only memory (ROM) 115B, and / or a storage unit 115C. In some embodiments, some or all processes (e.g., steps) of the535788.000001methods and / or processes (e.g., the method 900, etc.) disclosed herein are performed by the medical imaging system 1000. In some embodiments, the bus 1002 is coupled to the processor 114, the input device 1010, the memory 115, and / or the network interface 1018. In certain embodiments, the network interface is coupled to a network 1020. For example, the processor 114 includes one or more general purpose microprocessors. In some embodiments, the main memory 115A (e.g., random access memory (RAM), cache and / or other dynamic storage devices) is configured to store information and instructions to be executed by the processor 114. In certain embodiments, the main memory 115A is configured to store temporary variables or other intermediate information during execution of instructions to be executed by processor 114. For example, the instructions, when stored in the storage unit 115C accessible to processor 114, render the medical imaging system 1000 into a special-purpose machine that is customized to perform the operations specified in the instructions. In some embodiments, the ROM 115B is configured to store static information and instructions for the processor 114. In certain embodiments, the storage unit 115C (e.g., a magnetic disk, optical disk, or flash drive) is configured to store information and instructions.

[0103] In certain embodiments, a wearable x-ray and computed tomography system includes a triple three-dimensional (3D) stationary wearable imaging device architecture. The architecture may include: a central or cloud-based network system and a wearable peripheral imaging device operatively coupled with the central or cloud-based network system. The wearable peripheral imaging device is configured to operate in a stationary configuration without mechanical rotation and includes: (a) a 3D carbon nanotube x-ray source array arranged in one or more concentric rings or arcs and configured for high-energy emission and low-energy emission of x-ray beams; (b) a 3D-shaped detector comprising a plurality of flat panel detector modules, the plurality of flat panel detector modules including one or more detector elements selected from a group consisting of energy-integrating detector elements, photon-counting detector elements, and hybrid detector elements having energy-integrating and photon-counting capabilities; and (c) a control module configured to synchronize emission timing of the 3D carbon nanotube x-ray source array and a readout of the 3D-shaped detector.

[0104] In some embodiments, the wearable peripheral imaging device includes: a portable power unit; a digital image data storage; and a wireless communication interface.535788.000001

[0105] In certain embodiments, the 3D carbon nanotube x-ray source array is disposed on or integrated with an edge of the 3D-shaped detector in a stationary arrangement with respect to the 3D-shaped detector such that the x-ray beams are electronically steered or sequentially activated to simulate rotational scanning around a 3D object, and the 3D-shaped detector receives the x-ray beams emitted from the 3D carbon nanotube x-ray source array.

[0106] In some embodiments, the central or cloud-based network system includes: (a) a digital image data receiver; (b) a reconstruction unit including a graphical processing unit (GPU)-based real-time image processor configured to reconstruct volumetric images from detector data provided by the 3D-shaped detector; and (c) an image display interface with one or more real-time monitoring and artificial intelligence (Al)-assisted diagnostic tools.

[0107] In certain embodiments, the 3D-shaped detector is positioned between the 3D object and the 3D carbon nanotube x-ray source array.

[0108] In some embodiments, the system includes a plurality of 3D carbon nanotube x-ray source arrays configured for dual-energy emission of both the high-energy emission and the low-energy emission of the x-ray beams.

[0109] In certain embodiments, each 3D carbon nanotube x-ray source array of the plurality of 3D carbon nanotube x-ray source arrays is configured to emit a plurality of individually addressable x-ray beams.

[0110] In some embodiments, the 3D carbon nanotube x-ray source array is disposed in an arc-shaped configuration, a ring-shaped configuration, a multi-ring-shaped configuration, or a box-shaped configuration.[OHl] In certain embodiments, the 3D carbon nanotube x-ray source array comprises a plurality of carbon nanotube x-ray emitters, and each carbon nanotube x-ray emitter of the plurality of carbon nanotube x-ray emitters is electronically programmable for pulsed or continuous operation.

[0112] In some embodiments, the wearable peripheral imaging device is arranged in a helmet-type configuration, a vest-type configuration, or a limb-type configuration.

[0113] In certain embodiments, the 3D carbon nanotube x-ray source array is disposed circumferentially around or opposite of the 3D-shaped detector.

[0114] In some embodiments, the 3D-shaped detector has a dome-shaped structure or a boxshaped structure.535788.000001

[0115] In certain embodiments, a method of imaging a region of interest (ROT) of a 3D object includes: (a) irradiating a wearable region of interest (WROI) using a 3D stationary wearable imaging device architecture that includes: a stationary 3D carbon nanotube x-ray source array fixed in a ring configuration, an arc configuration, a curved surface configuration, or a box-shaped configuration, and a stationary 3D-shaped detector fixed relative to the source array; (b) electronically steering or activating the stationary 3D carbon nanotube x-ray source array to generate projection data around the 3D object; (c) receiving, with the stationary 30-shaped detector, x-ray signals emitted from the source array; and (d) reconstructing an image of the WROI using (i) an interior or external reconstruction or (ii) compressive-sensing algorithm.

[0116] In some embodiments, the x-ray signals include collimated x-ray beams to limit radiation dose and improve contrast.

[0117] In certain embodiments, the source array and the detector operate in a stationary mode to facilitate electronically controlled rotational imaging.

[0118] In some embodiments, the reconstruction is performed by a central or cloud-based graphical processing unit providing real-time 3D visualization.

[0119] In certain embodiments, a real-time multimodal imaging system includes: a first imaging modality and at least one second modality. The first imaging modality includes a 3D stationary wearable imaging device architecture that includes: (a) a 3D carbon nanotube x-ray source array fixed at a periphery of a 3D-shaped detector, and (b) a 3D geodesic dome or 3D box type detector fixed relative to a 3D object. The at least one second imaging modality is selected from a group consisting of radio frequency (RF) modality, electroencephalography (EEG) modality, and electrocardiography (ECG) modality. The first and second imaging modalities are configured for concurrent or synchronized acquisition and wearable region-of-interest (WROI) targeted reconstruction.

[0120] In certain embodiments, the RF modality includes a pair of RF sensors or detectors.

[0121] In some embodiments, the 3D carbon nanotube x-ray source array is on / off programmable and supports dual imaging using high-energy emission and low-energy emission.

[0122] In certain embodiments, the X-ray and secondary modalities are operably configured to perform simultaneous signal fusion for Al-assisted monitoring or diagnostic applications.

[0123] In some embodiments, an x-ray or computed tomography imaging apparatus includes: a 3D x-ray source array comprising a plurality of carbon nanotube x-ray emitters configured to535788.000001facilitate high-energy emission and low-energy emission; and a 3D-shaped detector fixed relative to the source array and arranged in a geodesic, ring-shaped, orbox geometry. The source array and the detector are stationary with respect to each other during operation and are electronically controlled to simulate mechanical rotation.

[0124] In certain embodiments, the source array is configured to sequentially emit x-rays along a 5-10 mm focal track to minimize thermal loading.

[0125] In some embodiments, the apparatus includes an inflatable interface layer between the detector and an imaging target, the inflatable interface layer comprising one or more sensors to facilitate electroencephalography (EEG), electrocardiography (ECG), or respiration monitoring.

[0126] In certain embodiments, the apparatus includes a radiation shielding component configured to prevent local overheating of the detector at an outer layer or a shell of the detector.

[0127] Although specific embodiments of the present disclosure have been described, it will be understood by those of skill in the art that there are other embodiments that are equivalent to the described embodiments. Accordingly, it is to be understood that the present disclosure is not to be limited by the specific illustrated embodiments. Various modifications and alterations of the disclosed embodiments will be apparent to those skilled in the art. The embodiments described herein are illustrative examples. The features of one disclosed example can also be applied to all other disclosed examples unless otherwise indicated. It should also be understood that all U.S. patents, patent application publications, and other patent and non-patent documents referred to herein are incorporated by reference, to the extent they do not contradict the foregoing disclosure.

Claims

535788.000001CLAIMSWhat is claimed is:

1. A wearable apparatus for medical imaging, the wearable apparatus comprising:a supporting device;a plurality of x-ray signal emitters arranged in a first closed shape on the supporting device and configured to emit x-ray signals to an object;a plurality of detectors disposed on the supporting device and configured to detect the x-ray signals; andone or more processors coupled to the plurality of x-ray signal emitters and the plurality of detectors and configured to:receive data from the plurality of detectors; andgenerate a cross-sectional image based on the data received from the plurality of detectors;wherein the plurality of x-ray signal emitters, the plurality of detectors, and the object remain physically stationary when the wearable apparatus is in use.

2. The wearable apparatus of claim 1, wherein the cross-sectional image is based on a plane in an angled or top-to-down configuration.

3. The wearable apparatus of claim 1, wherein the plurality of x-ray signal emitters and the plurality of detectors are arranged to form a three-dimensional (3D) shape.

4. The wearable apparatus of claim 3, wherein the 3D shape is dome-shaped, ring-shaped, or box-shaped.

5. The wearable apparatus of claim 1, wherein the supporting device includes an inflatable component disposed between the object and the plurality of detectors, wherein at least a part of the plurality of x-ray signal emitters is disposed on the inflatable component.535788.0000016. The wearable apparatus of claim 1 , wherein the one or more processors are further configured to activate one or more x-ray signal emitters of the plurality of x-ray signal emitters, wherein the one or more x-ray signal emitters belong in a subset of the plurality of x-ray signal emitters.

7. The wearable apparatus of claim 1, wherein the one or more processors are further configured to activate one or more x-ray signal emitters of the plurality of x-ray signal emitters in a predetermined sequence.

8. The wearable apparatus of claim 7, wherein activating the one or more x-ray signal emitters of the plurality of x-ray signal emitters in the predetermined sequence causes the plurality of x-ray signal emitters to be electronically rotatable in a radial direction with respect to an orientation of the wearable apparatus.

9. The wearable apparatus of claim 1, wherein the plurality of x-ray signal emitters include a set of high-energy emitters and a set of low-energy emitters, wherein a first high-energy emitter in the set of high-energy emitters is configured to generate a first x-ray signal, wherein a second low-energy emitter in the set of low-energy emitters is configured to generate a second x-ray signal, wherein the first x-ray signal has higher energy than the second x-ray signal.

10. The wearable apparatus of claim 1, wherein the supporting device is a 3D-shaped helmet, wherein the plurality of detectors include a plurality of triangular detector modules forming a 3D-shaped detector.

11. The wearable apparatus of claim 10, wherein a size and a number of the plurality of triangular detector modules forming the 3D-shaped detector defines an image resolution of the cross-sectional image generated based on the received data.

12. The wearable apparatus of claim 10, wherein the plurality of x-ray signal emitters are arranged in a circular manner to form a source array ring, wherein the first closed shape is a circle, wherein the source array ring is positioned at an opening of the 3D-shaped helmet.535788.00000113. The wearable apparatus of claim 12, wherein the source array ring comprises a plurality of modules, wherein each module defines a 90-degree arc and is separately operable from other modules of the plurality of modules.

14. The wearable apparatus of claim 1, wherein the cross-sectional image is generated for at least one selected from a group consisting of cranial imaging, dental imaging, cervical imaging, chest imaging, abdomen imaging, and limb imaging.

15. The wearable apparatus of claim 1, further comprising an x-ray shielding component configured to shield the x-ray signals emitted by the plurality of x-ray signal emitters.

16. The wearable apparatus of claim 1, wherein the wearable apparatus is a vest-type wearable apparatus or a limb-type wearable apparatus.

17. The wearable apparatus of claim 1, further comprising at least one sensor selected from a group consisting of radio frequency (RF) sensor, electroencephalography (EEG) sensor, and electrocardiography (ECG) sensor.

18. A method of medical imaging, the method comprising:receiving data from a plurality of detectors configured to detect x-ray signals emitted by a plurality of x-ray signal emitters arranged in a first closed shape on a supporting device, the plurality of detectors disposed on the supporting device;generating one or more cross-sectional images of an object based on the received data; andprocessing the one or more cross-sectional images to generate one or more of two-dimensional (2D) representation or three-dimensional (3D) volumetric reconstruction of the object;wherein the plurality of x-ray signal emitters, the plurality of detectors, and the object remain physically stationary.535788.00000119. The method of claim 18, further comprising performing real-time monitoring or alert based on the processing the one or more cross-sectional images.

20. The method of claim 18, further comprising performing artificial intelligence-assisted diagnosis of one or more medical conditions.

21. The method of claim 20, wherein the artificial intelligence-assisted diagnosis includes at least one selected from a group consisting of medical triage, stroke classification, and hemorrhage detection.

22. The method of claim 21, wherein the stroke classification comprises classifying a stroke into one of an ischemic stroke and an hemorrhagic stroke.

23. The method of claim 18, further comprising:activating one or more x-ray signal emitters of the plurality of x-ray signal emitters in a predetermined sequence to emit the x-ray signals and to cause the plurality of x-ray signal emitters to be electronically activated in a radial direction.

24. The method of claim 18, wherein the processing the one or more cross-sectional images comprises connecting together a plurality of edges of the one or more cross-sectional images to reconstruct a 360-degree 3D digital image data of the object.

25. A non-transitory computer-readable storage medium having instructions for medical imaging that, when executed by one or more processors, cause the one or more processors to perform a set of operations comprising:receiving data from a plurality of detectors configured to detect signals emitted by a plurality of x-ray signal emitters arranged in a first closed shape on a supporting device, the plurality of detectors disposed on the supporting device;generating one or more cross-sectional images of an object based on the received data; and535788.000001processing the one or more cross-sectional images to generate one or more of two-dimensional (2D) representation or three-dimensional (3D) volumetric reconstruction of the object;wherein the plurality of x-ray signal emitters, the plurality of detectors, and the object remain physically stationary.

Images