Imaging device and method for optimizing image acquisition

The imaging device addresses the limitations of current pulmonary diagnostics by acquiring time-series in vivo images during natural breathing, reducing radiation exposure and improving diagnostic accuracy for lung diseases across various age groups.

JP7735332B2Active Publication Date: 2025-09-08AUSTRALIAN LUNG HEALTH INITIATIVE PTY LTD
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Patent Information

Application Number
JP2022580415
Authority / Receiving Office
JP · JP
Patent Type
Patents
Current Assignee / Owner
Priority Date
2020-06-25
Filing Date
2021-06-25
Publication Date
2025-09-08
Estimated Expiration
2041-06-25

AI Technical Summary

Technical Problem

Current pulmonary diagnostics fail to provide accurate and early detection of lung diseases due to inadequate imaging technologies, especially for infants and young children, and existing X-ray methods expose vulnerable populations to excessive radiation.

Method used

An imaging device that acquires time-series in vivo images using sensors to monitor physiological parameters and bodily movements, allowing image acquisition during natural breathing without controlling the subject's position, and includes sensors near the mouth for airflow and temperature monitoring.

Benefits of technology

Enables frequent, radiation-reduced imaging of lung function over time, detecting subtle changes and improving diagnostic accuracy for a wide range of patient populations, including infants and young children.

✦ Generated by Eureka AI based on patent content.

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Abstract

An imaging device for acquiring time-series in-vivo images of a predetermined region of a subject's body is provided, the imaging device including at least one energy source, at least one detector positioned between the energy source and the detector for detecting energy from the at least one energy source passing through the region of the subject's body, a controller configured to operate the at least one energy source and the at least one detector to acquire time-series in-vivo images of the region of the subject's body, at least one sensor that monitors physiological parameters associated with the region of the subject's body being imaged, and at least one processor configured to determine timing of image acquisition based at least on the monitored physiological parameters. A method for acquiring time-series in-vivo images of a predetermined region of a subject's body using the imaging device is also provided.
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Description

[Technical Field]

[0001] (CROSS-REFERENCE TO RELATED APPLICATIONS) This application claims priority to U.S. Provisional Patent Application No. 63 / 044090, filed June 25, 2020, and U.S. Provisional Patent Application No. 63 / 043994, filed June 25, 2020, the contents of both of which are incorporated herein by reference.

[0002] The present invention relates to an imaging device and method for acquiring time-series in vivo images of a predetermined region of the body of a human or animal subject, and optimizing the acquisition of the images, and particularly, but not exclusively, relates to dynamic in vivo imaging of organs such as the lungs or heart of the subject. [Background technology]

[0003] Lung conditions and diseases, such as chronic obstructive pulmonary disease (COPD), asthma, bronchiectasis, cystic fibrosis (CF), and lung cancer, are associated with significant societal and economic costs. An estimated 1 billion people worldwide are affected, with approximately one death every two seconds attributable to lung disease. More than US$1.4 trillion is spent annually on lung health worldwide. In Australia, 7 million people (approximately one in three) live with lung disease, making it the second leading cause of death in Australia and accounting for more than 10 percent of the total health burden. Lung disease significantly impacts people's ability to enjoy life and be active and productive. It places a significant health and economic burden on people living with these diseases, their families, the healthcare system, and the wider community.

[0004] Current pulmonary diagnostics are inadequate and fail to provide an accurate assessment of lung health or early detection or diagnosis of lung disease. Early and reliable detection and localization of lung disease or disorders is critical to positive health outcomes. Because nearly all lung pathologies are essentially associated with localized changes in airflow throughout the lung, it is necessary to detect these localized changes at all lung locations and throughout the respiratory cycle. Without accurate and detailed lung health assessments, particularly for infants and young children who cannot access current lung testing, healthcare gaps are critical.

[0005] Existing pulmonary function testing methods, such as spirometry, are based on older technologies that only provide global average measurements of exhaled volume, which can vary widely due to factors unrelated to disease. Global measurements average out local changes across the lung, resulting in a lack of sensitivity to capture disease-related losses in lung function until the associated disease has progressed significantly. Furthermore, a significant problem with standard pulmonary function testing is that infants and young children are often completely excluded from early and ongoing lung health assessments due to their inability to understand and follow breathing instructions.

[0006] Current imaging modalities, such as X-ray computed tomography (CT) imaging and magnetic resonance imaging (MRI), provide methods for examining the structure and function of a patient's organs, such as the lungs, heart, and brain. However, structural changes in the lungs often occur after the onset of disease, precluding the possibility of disease prevention treatment (e.g., in early-stage cystic fibrosis). High-resolution CT imaging provides excellent structural detail but is costly and involves relatively high levels of radiation exposure (a high-resolution CT is often equivalent to 70 chest X-rays). Due to ionizing radiation doses, technologies based on the use of X-rays (especially CT) for the detection and treatment of various diseases, including acute respiratory diseases, are severely limited in vulnerable patients, such as infants and young children, who are more susceptible to radiation-induced tissue damage. Furthermore, inherent measurement limitations severely limit evidence-based detection and treatment of acute respiratory diseases across all age groups.

[0007] XV technology, developed by 4DMedical, represents a breakthrough in clinical lung function assessment. XV technology is disclosed in patent applications published as U.S. Patent Nos. 6,277,994 and 6,277,994. Current XV technology uniquely combines X-ray imaging with proprietary flow velocity measurement algorithms to measure motion at every location in the lung in fine spatial and temporal detail, enabling regional lung function measurements at each location within the lung throughout the respiratory cycle. This approach allows for the detection of even minor loss of function long before lung structure is irreversibly affected by disease, meaning that treatment can be applied early, when it has the greatest effect and the best chance of success.

[0008] Current XV technology is used in clinical applications via a Software as a Service (SaaS) model, whereby scans of a patient's lungs are acquired using existing X-ray fluoroscopy equipment. The scans are then processed using software algorithms that provide functional imaging analyses of the patient's lungs over time via a cloud-based server. However, the accuracy and quality of XV analyses are limited by the images obtainable using existing medical scanners, which require patients to remain motionless and breathe in a controlled manner during the scan. This limits their use in many patient populations, including young children, the elderly, and patients with speech, hearing, or cognitive impairments, who cannot be easily scanned due to positioning issues within the scanner and / or an inability to follow instructions for completing the scan.

[0009] Therefore, there is a need to provide a medical scanner for obtaining in vivo images of a patient's body that reduces X-ray radiation exposure while improving scan quality and allows for use with a wide range of patients of different ages and health conditions. Reducing radiation burden has important health consequences, especially for young people, because their easily dividing cells are more susceptible to radiation exposure and its consequences are more severe than those for adults. There is also a need to enable more frequent scanning of patients, including infants and young children, and to provide the ability to regularly monitor regional lung function over long periods of time for many patient populations. Even very subtle changes can be detected and closely followed over weeks, months, or years to assess their contribution to disease, the effectiveness of treatment, and the infant's development. The availability of regular regional lung ventilation data would greatly improve pulmonary disease diagnosis and treatment.

[0010] Therefore, it would ideally be desirable to provide an imaging device and method for obtaining in vivo images of a patient's body that are suitable for analysis by XV techniques, reducing the use of X-rays and allowing patients to be scanned more frequently, across a wide range of patient populations, including those who are not easily scannable. It would also be desirable to provide an imaging device and method that improves upon and / or overcomes one or more problems or disadvantages of the prior art.

[0011] Reference herein to a patent document or any other material identified as prior art should not be construed as an admission that the document or other material was publicly known or that the information it contains was part of the common general knowledge at the priority date of any of the claims. [Prior art documents] [Patent documents]

[0012] [Patent Document 1] International Publication No. 2011 / 032210 [Patent Document 2] International Publication No. 2015 / 157799 Summary of the Invention

[0013] In one aspect, the present invention provides an imaging device for acquiring time-series in vivo images of a predetermined region of a subject's body. The imaging device includes at least one energy source, at least one detector for detecting energy from the at least one energy source passing through a predetermined region of the subject's body located between the energy source and the detector, and a controller configured to operate the at least one energy source and the at least one detector to acquire time-series in vivo images of the region of the subject's body. The imaging device also includes at least one sensor for monitoring a physiological parameter associated with the region of the subject's body being imaged, and at least one processor configured to determine timing of image acquisition based at least on the monitored physiological parameter.

[0014] In some embodiments, the at least one sensor for monitoring a physiological parameter is configured to detect a physiological parameter related to respiration of the subject.

[0015] The processor may be further configured to analyze data from the at least one sensor for monitoring a physiological parameter to detect a breathing pattern of the subject and / or a duration of the subject's breathing, and monitor the detected breathing pattern and / or the duration of the subject's breathing to determine whether a repetitive breathing pattern is detected. If a repetitive breathing pattern is detected, the processor may be further configured to analyze the repetitive breathing pattern to identify one or more characteristics of the subject's breathing cycle, and determine a trigger signal to initiate image acquisition, including at least a start time and / or an end time, based on the identified one or more characteristics of the breathing cycle.

[0016] In some embodiments, the at least one sensor for monitoring physiological parameters is positionable near and / or within the mouth of the subject and includes one or more of a flow meter for monitoring changes in airflow near and / or within the mouth of the subject, a thermal sensor for monitoring changes in temperature of air near and / or within the mouth of the subject, and a gas sensor for monitoring changes in air content of gas near and / or within the mouth of the subject.

[0017] The imaging device may further include at least one sensor for monitoring bodily movement of the subject located between the energy source and the detector, and the processor may be further configured to determine the timing of image acquisition also based on the monitored bodily movement of the subject.

[0018] In some embodiments, the processor is further configured to process data from the at least one sensor for monitoring motion to detect bodily motion of a subject positioned between the energy source and the detector, monitor the detected motion to determine whether the subject is in a substantially stationary position, and, when the subject is in a substantially stationary position, determine a trigger signal, including at least a start time, to initiate image acquisition.

[0019] The at least one sensor for monitoring movement may include one or more of a motion sensor, a resistive sensor, a weight sensor, a force sensor, and a pressure sensor. The motion sensor may be a camera. The motion sensor may include an accelerometer, a gyroscope, and / or a magnetometer for measuring movement of the subject's body. The resistive sensor may include, for example, a strain gauge capable of measuring displacement of the subject's body.

[0020] Preferably, the detected and monitored motion is non-breath related motion of the subject's body between the energy source and the detector. Ideally, the subject's breathing is not restricted or controlled during image acquisition. The imaging device may be configured to acquire images while the subject is breathing, preferably of a single breath of the subject.

[0021] In some embodiments, the imaging device further includes at least one sensor for detecting a position and / or orientation of the subject's body located between the energy source and the detector, and the processor is further configured to determine the timing of image acquisition based also on the detected position and / or orientation of the subject's body.

[0022] The processor may further be configured to determine adjustments to the position and / or orientation of the subject's body to a desired position between the energy source and the detector to obtain an image of the region of the subject's body.

[0023] In some embodiments, the processor is further configured to estimate a position of the region of the subject's body to be imaged using the pre-acquired data and determine a desired position for acquiring the image based on the estimated position. The processor may be further configured to receive pre-acquired data including at least one of one or more pre-acquired images of the region of the subject's body, one or more body characteristics of the subject selected from the group including: anatomical dimensions of the region and / or the subject's body, height, and / or weight, and one or more attributes of the subject selected from the group including: age, sex, mobility, ethnicity, medical condition and / or medical history.

[0024] The imaging device may further include a support member for supporting the subject's body in a position between the energy source and the detector, and an actuator operable to adjust the position and / or orientation of the support member. The controller may be further configured to control the actuator to adjust the position and / or orientation of the support member to support the subject's body in a desired position for acquisition of the image.

[0025] In some embodiments, the imaging apparatus further includes an output device. The processor may be further configured to output, using the output device, instructions to an operator and / or subject for adjusting a position and / or orientation of the subject to a desired position for acquiring the image. The processor may be further configured to output, using the output device, instructions to an operator and / or subject regarding timing of image acquisition, the instructions including at least a trigger signal to initiate image acquisition.

[0026] The at least one sensor for detecting the position and / or orientation may include one or more of a camera, an optical sensor, a motion-based sensor, and a laser sensor.

[0027] The region of interest to be imaged may include at least a portion of the subject's lungs. The imaging device may image the entire lungs of the subject. The imaging device may also image both lungs of the subject. Alternatively, the region of interest to be imaged may include part or all of the subject's heart or brain.

[0028] The imaging device may be configured for use in one or more of X-ray imaging, ultrasound imaging, and magnetic resonance imaging (MRI). X-ray imaging may include fluoroscopic imaging, computed tomographic X-ray velocity (CTXV) imaging, and / or four-dimensional computed tomography (4DCT) imaging.

[0029] The imaging device may include at least three energy sources and at least three detectors for acquiring three time-series in-vivo images of the region of the subject's body. The processor may be further configured to construct a three-dimensional motion field based on the acquired three time-series images. In some embodiments, the imaging device may include at least four energy sources and at least four detectors for acquiring four time-series in-vivo images of the region of the subject's body.

[0030] In another aspect, the present invention provides a method for acquiring time-series in-vivo images of a region of a subject's body. The method includes providing an imaging device including at least one energy source, at least one detector positioned between the energy source and the detector to detect energy from the at least one energy source passing through the region of the subject's body, and a controller configured to operate the at least one energy source and the at least one detector to acquire time-series in-vivo images of the region of the subject's body. The method also includes monitoring, with at least one sensor, physiological parameters associated with the region of the subject's body being imaged, determining, with at least one processor, timing of image acquisition based at least on the monitored physiological parameters, and operating the controller to acquire time-series in-vivo images of the region of the subject's body.

[0031] In some embodiments, the method further comprises detecting a physiological parameter related to the subject's respiration with at least one sensor for monitoring the physiological parameter.

[0032] The method may further include: analyzing data from at least one sensor for monitoring a physiological parameter to detect a breathing pattern of the subject and / or a duration of the subject's breathing; and monitoring the detected breathing pattern and / or the duration of the subject's breathing to determine whether a repetitive breathing pattern is detected. If a repetitive breathing pattern is detected, the method may further include analyzing the repetitive breathing pattern to identify one or more characteristics of a breathing cycle of the subject; and determining a trigger signal to initiate image acquisition, including at least a start time and / or an end time, based on the identified one or more characteristics of the breathing cycle.

[0033] In some embodiments, the method further includes positioning at least one sensor near and / or in the mouth of the subject for monitoring physiological parameters, and the method further includes one or more of the following steps: monitoring airflow changes near and / or in the mouth of the subject using a flow meter; monitoring temperature changes of the air near and / or in the mouth of the subject using a thermal sensor; and monitoring changes in air content of the gas near and / or in the mouth of the subject using a gas sensor.

[0034] The method may further include monitoring, using at least one sensor, bodily movement of a subject positioned between the energy source and the detector, and the method may further include the processor determining timing of image acquisition also based on the monitored bodily movement of the subject.

[0035] In some embodiments, the method further includes the steps of: a processor processing data from at least one sensor for monitoring motion to detect bodily motion of a subject positioned between the energy source and the detector; a processor monitoring the detected motion to determine whether the subject is in a substantially stationary position; and a processor determining a trigger signal, including at least a start time, to initiate image acquisition when the subject is in a substantially stationary position.

[0036] The at least one sensor for monitoring movement may include one or more of a motion sensor, a resistive sensor, a weight sensor, a force sensor, and a pressure sensor. The motion sensor may be a camera. The motion sensor may include an accelerometer, a gyroscope, and / or a magnetometer for measuring movement of the subject's body. The resistive sensor may include, for example, a strain gauge capable of measuring displacement of the subject's body.

[0037] Preferably, the detected and monitored motion is non-breath related motion of the subject's body between the energy source and the detector. Ideally, the subject's breathing is not restricted or controlled during image acquisition. The imaging device may be configured to acquire images while the subject is breathing, preferably of a single breath of the subject.

[0038] In some embodiments, the method further includes detecting, using at least one sensor, a position and / or orientation of a body of the subject located between the energy source and the detector, and the method further includes a processor determining timing of image acquisition also based on the detected position and / or orientation of the body of the subject.

[0039] In some embodiments, the method further includes a step in which the processor determines adjustments to the position and / or orientation of the subject's body to a desired position between the energy source and the detector to obtain an image of the region of the subject's body.

[0040] In some embodiments, the method further includes the steps of: a processor estimating a position of the region of the subject's body to be imaged using the pre-acquired data; and determining a desired position for acquiring the image based on the estimated position. The method may further include the processor receiving the pre-acquired data including at least one of one or more pre-acquired images of the region of the subject's body, one or more body characteristics of the subject selected from the group including: anatomical dimensions of the region and / or the subject's body, height, and / or weight, and one or more attributes of the subject selected from the group including: age, sex, mobility, ethnicity, medical condition and / or medical history.

[0041] In some embodiments, the imaging device further includes a support member for supporting the subject's body in a position between the energy source and the detector, and an actuator operable to adjust the position and / or orientation of the support member. The method may further include supporting the subject's body on the support member of the imaging device and operating the actuator to adjust the position and / or orientation of the support member so as to support the subject's body in a desired position for image acquisition. In some embodiments, the method may further include operating the controller to control the actuator to adjust the position and / or orientation of the support member so as to support the subject's body in a desired position for image acquisition.

[0042] In some embodiments, the method further includes the processor outputting instructions, using an output device of the imaging device, to an operator and / or subject for adjusting a position and / or orientation of the subject to a desired position for acquiring the image. The method may further include the processor outputting instructions, using an output device of the imaging device, to an operator and / or subject regarding timing of image acquisition, the instructions including at least a trigger signal to initiate image acquisition.

[0043] The at least one sensor for detecting the position and / or orientation may include one or more of an optical sensor, a motion-based sensor, and a laser sensor.

[0044] In some embodiments, the region to be imaged may include at least a portion of the subject's lungs. The method may include operating the controller to acquire images of some or all of the subject's lungs. The method may also include operating the controller to acquire images of both lungs of the subject. Alternatively, the region to be imaged may include some or all of the subject's heart or brain.

[0045] The imaging device may be configured for use in one or more of X-ray imaging, ultrasound imaging, and magnetic resonance imaging (MRI). X-ray imaging may include fluoroscopic imaging, computed tomographic X-ray velocity (CTXV) imaging, and / or four-dimensional computed tomography (4DCT) imaging.

[0046] The imaging device may further include at least three energy sources and at least three detectors for acquiring three time-series in-vivo images of the region of the subject's body. The method may further include using a processor to reconstruct a three-dimensional motion field based on the acquired three time-series images.

[0047] In another aspect, the present invention provides an imaging device for acquiring time-series in-vivo images of a predetermined region of a subject's body. The imaging device includes at least one energy source, at least one detector located between the energy source and the detector for detecting energy from the at least one energy source passing through the region of the subject's body, and a controller configured to operate the at least one energy source and the at least one detector to acquire time-series in-vivo images of the region of the subject's body. The imaging device also includes at least one sensor located between the energy source and the detector for detecting a position and / or orientation of the subject's body, and at least one processor configured to determine timing of image acquisition based at least on the detected position and / or orientation of the subject's body.

[0048] In some embodiments, the processor is further configured to determine adjustments to the position and / or orientation of the subject's body to a desired position between the energy source and the detector to obtain an image of the region of the subject's body.

[0049] In some embodiments, the processor is further configured to estimate a position of the region of the subject's body to be imaged using the pre-acquired data and determine a desired position for acquiring the image based on the estimated position. The processor may be further configured to receive pre-acquired data including at least one of one or more pre-acquired images of the region of the subject's body, one or more body characteristics of the subject selected from the group including: anatomical dimensions of the region and / or the subject's body, height, and / or weight, and one or more attributes of the subject selected from the group including: age, sex, mobility, ethnicity, medical condition and / or medical history.

[0050] The imaging device may further include a support member for supporting the subject's body in a position between the energy source and the detector, and an actuator operable to adjust the position and / or orientation of the support member. The controller may be further configured to control the actuator to adjust the position and / or orientation of the support member to support the subject's body in a desired position for acquiring the image.

[0051] In some embodiments, the imaging apparatus further includes an output device. The processor may be further configured to output, using the output device, instructions to an operator and / or subject for adjusting a position and / or orientation of the subject to a desired position for acquiring the image. The processor may be further configured to output, using the output device, instructions to an operator and / or subject regarding timing of image acquisition, the instructions including at least a trigger signal to initiate image acquisition.

[0052] The at least one sensor for detecting the position and / or orientation may include one or more of a camera, an optical sensor, a motion-based sensor, and a laser sensor.

[0053] The imaging device may further include at least one sensor for monitoring bodily movement of the subject located between the energy source and the detector, and the processor may be further configured to determine timing of image acquisition also based on the monitored bodily movement of the subject.

[0054] The processor may further be configured to process data from at least one sensor for monitoring motion to detect bodily motion of a subject positioned between the energy source and the detector, monitor the detected motion to determine whether the subject is in a substantially stationary position, and, when the subject is in a substantially stationary position, determine a trigger signal, including at least a start time, to initiate image acquisition.

[0055] The at least one sensor for monitoring movement may include one or more of a motion sensor, a resistive sensor, a weight sensor, a force sensor, and a pressure sensor. The motion sensor may be a camera. The motion sensor may include an accelerometer, a gyroscope, and / or a magnetometer for measuring movement of the subject's body. The resistive sensor may include, for example, a strain gauge capable of measuring displacement of the subject's body.

[0056] Preferably, the detected and monitored motion is non-breath related motion of the subject's body between the energy source and the detector. Ideally, the subject's breathing is not restricted or controlled during image acquisition. The imaging device may be configured to acquire images while the subject is breathing, preferably of a single breath of the subject.

[0057] In some embodiments, the imaging device further includes at least one sensor for monitoring a physiological parameter associated with the region of the subject's body being imaged, and the processor may be further configured to determine the timing of image acquisition also based on the monitored physiological parameter.

[0058] The at least one sensor for monitoring a physiological parameter may be configured to detect a physiological parameter related to the subject's respiration.

[0059] The processor may be further configured to analyze data from the at least one sensor for monitoring a physiological parameter to detect a breathing pattern of the subject and / or a duration of the subject's breathing, and monitor the detected breathing pattern and / or the duration of the subject's breathing to determine whether a repetitive breathing pattern is detected. If a repetitive breathing pattern is detected, the processor is further configured to analyze the repetitive breathing pattern to identify one or more characteristics of the subject's breathing cycle, and determine a trigger signal to initiate image acquisition, including at least a start time and / or an end time, based on the identified one or more characteristics of the breathing cycle.

[0060] In some embodiments, the at least one sensor for monitoring physiological parameters is positionable near and / or within the mouth of the subject and includes one or more of a flow meter for monitoring changes in airflow near and / or within the mouth of the subject, a thermal sensor for monitoring changes in temperature of air near and / or within the mouth of the subject, and a gas sensor for monitoring changes in air content of gas near and / or within the mouth of the subject.

[0061] The region of interest to be imaged may include at least a portion of the subject's lungs. The imaging device may image the entire lungs of the subject. The imaging device may also image both lungs of the subject. Alternatively, the region of interest to be imaged may include part or all of the subject's heart or brain.

[0062] The imaging device may be configured for one or more of X-ray imaging, ultrasound imaging, and magnetic resonance imaging (MRI). X-ray imaging may include fluoroscopic imaging, computed tomographic X-ray velocity (CTXV) imaging, and / or four-dimensional computed tomography (4DCT) imaging.

[0063] The imaging device may include at least three energy sources and at least three detectors for acquiring three time-series in-vivo images of the region of the subject's body. The processor may be further configured to construct a three-dimensional motion field based on the acquired three time-series images. In some embodiments, the imaging device may include at least four energy sources and at least four detectors for acquiring four time-series in-vivo images of the region of the subject's body.

[0064] In another aspect, the present invention provides a method for acquiring time-series in-vivo images of a region of a subject's body. The method includes providing an imaging device including at least one energy source, at least one detector located between the energy source and the detector for detecting energy from the at least one energy source passing through the region of the subject's body, and a controller configured to operate the at least one energy source and the at least one detector to acquire time-series in-vivo images of the region of the subject's body. The method also includes detecting, with at least one sensor, a position and / or orientation of the subject's body located between the energy source and the detector, determining, with at least one processor, timing of image acquisition based at least on the detected position and / or orientation of the subject's body, and operating the controller to acquire time-series in-vivo images of the region of the subject's body.

[0065] In some embodiments, the method further includes a step in which the processor determines adjustments to the position and / or orientation of the subject's body to a desired position between the energy source and the detector to obtain an image of the region of the subject's body.

[0066] In some embodiments, the method further includes, by the processor, estimating a position of the region of the subject's body to be imaged using the pre-acquired data, and determining a desired position for acquiring the image based on the estimated position. The method may further include receiving pre-acquired data including at least one of one or more pre-acquired images of the region of the subject's body, one or more body characteristics of the subject selected from the group including: anatomical dimensions of the region and / or the subject's body, height, and / or weight, and one or more attributes of the subject selected from the group including: age, sex, mobility, ethnicity, medical condition and / or medical history.

[0067] In some embodiments, the imaging device further includes a support member for supporting the subject's body in a position between the energy source and the detector, and an actuator operable to adjust the position and / or orientation of the support member. The method may further include supporting the subject's body on the support member of the imaging device, and operating the actuator to adjust the position and / or orientation of the support member so as to support the subject's body in a desired position for acquiring the image. In some embodiments, the method may further include operating the controller to control the actuator to adjust the position and / or orientation of the support member so as to support the subject's body in a desired position for acquiring the image.

[0068] In some embodiments, the method further includes the processor outputting instructions, using an output device of the imaging device, to an operator and / or subject for adjusting a position and / or orientation of the subject to a desired position for acquiring the image. The method may further include the processor outputting instructions, using an output device of the imaging device, to an operator and / or subject regarding timing of image acquisition, the instructions including at least a trigger signal to initiate image acquisition.

[0069] The at least one sensor for detecting the position and / or orientation may include one or more of a camera, an optical sensor, a motion-based sensor, and a laser sensor.

[0070] The method may further include a step of monitoring, using at least one sensor, the movement of a body of a subject positioned between the energy source and the detector, and further includes a step in which the processor determines the timing of image acquisition also based on the monitored movement of the body of the subject.

[0071] In some embodiments, the method further includes the steps of: a processor processing data from at least one sensor for monitoring motion to detect bodily motion of a subject positioned between the energy source and the detector; a processor monitoring the detected motion to determine whether the subject is in a substantially stationary position; and a processor determining a trigger signal, including at least a start time, to initiate image acquisition when the subject is in a substantially stationary position.

[0072] The at least one sensor for monitoring movement may include one or more of a motion sensor, a resistive sensor, a weight sensor, a force sensor, and a pressure sensor. The motion sensor may include a camera. The motion sensor may include an accelerometer, a gyroscope, and / or a magnetometer for measuring movement of the subject's body. The resistive sensor may include, for example, a strain gauge capable of measuring displacement of the subject's body.

[0073] Preferably, the detected and monitored motion is non-breath related motion of the subject's body between the energy source and the detector. Ideally, the subject's breathing is not restricted or controlled during image acquisition. The imaging device may be configured to acquire images while the subject is breathing, preferably of a single breath of the subject.

[0074] In some embodiments, the method further includes monitoring, using at least one sensor, physiological parameters associated with the region of the subject's body being imaged, and determining, using at least one processor, the timing of image acquisition also based on the monitored physiological parameters.

[0075] The method may further include detecting a physiological parameter related to the subject's respiration using at least one sensor for monitoring the physiological parameter. The method may further include analyzing data from the at least one sensor for monitoring the physiological parameter to detect a breathing pattern of the subject and / or a duration of the subject's respiration, and monitoring the detected breathing pattern and / or the duration of the subject's respiration to determine whether a repetitive breathing pattern has been detected. If a repetitive breathing pattern is detected, the method may further include analyzing the repetitive breathing pattern to identify one or more characteristics of the subject's breathing cycle, and determining a trigger signal to initiate image acquisition, including at least a start time and / or an end time, based on the identified one or more characteristics of the breathing cycle.

[0076] The method may further include positioning at least one sensor near and / or in the subject's mouth for monitoring a physiological parameter. In some embodiments, the method further includes one or more of the following steps: monitoring airflow changes near and / or in the subject's mouth with a flow meter, monitoring temperature changes of the air near and / or in the subject's mouth with a thermal sensor, and monitoring changes in air content of the gas near and / or in the subject's mouth with a gas sensor.

[0077] In some embodiments, the region to be imaged may include at least a portion of the subject's lungs. The method may include operating the controller to acquire images of some or all of the subject's lungs. The method may also include operating the controller to acquire images of both lungs of the subject. Alternatively, the region to be imaged may include some or all of the subject's heart or brain.

[0078] The imaging device may be configured for use in one or more of X-ray imaging, ultrasound imaging, and magnetic resonance imaging (MRI). X-ray imaging may include fluoroscopic imaging, computed tomographic X-ray velocity (CTXV) imaging, and / or four-dimensional computed tomography (4DCT) imaging.

[0079] The imaging device may further include at least three energy sources and at least three detectors for acquiring three time-series in-vivo images of the region of the subject's body. The method may further include using a processor to reconstruct a three-dimensional motion field based on the acquired three time-series images.

[0080] Also disclosed herein is an imaging device for acquiring time-series images of a predetermined region of a subject's body. The imaging device includes at least one energy source, at least one detector positioned between the energy source and the detector for detecting energy from the at least one energy source passing through the region of the subject's body, and a controller configured to operate the at least one energy source and the at least one detector to acquire time-series images of the region of the subject's body. The imaging device also includes at least one sensor for monitoring physiological parameters associated with the region of the subject's body being imaged, and at least one processor configured to determine timing of image acquisition based at least on the monitored physiological parameters. The imaging device may provide in vivo imaging of the region of the subject's body and provide time-series in vivo images. The region being imaged may include at least a portion of the subject's lungs.

[0081] Also disclosed herein is a method for acquiring time-series images of a region of a subject's body. The method includes providing an imaging device including at least one energy source, at least one detector positioned between the energy source and the detector for detecting energy from the at least one energy source passing through the region of the subject's body, and a controller configured to operate the at least one energy source and the at least one detector to acquire time-series images of the region of the subject's body. The method also includes monitoring, with at least one sensor, physiological parameters associated with the region of the subject's body to be imaged, determining, with at least one processor, timing of image acquisition based at least on the monitored physiological parameters, and operating the controller to acquire time-series images of the region of the subject's body. The method may provide in vivo imaging of the region of the subject's body and acquire time-series in vivo images. The region to be imaged may include at least a portion of the subject's lungs.

[0082] Also disclosed herein is an imaging device for acquiring time-series images of a predetermined region of a subject's body. The imaging device includes at least one energy source, at least one detector positioned between the energy source and the detector for detecting energy from the at least one energy source passing through the region of the subject's body, and a controller configured to operate the at least one energy source and the at least one detector to acquire time-series images of the region of the subject's body. The imaging device also includes at least one sensor positioned between the energy source and the detector for detecting a position and / or orientation of the subject's body, and at least one processor configured to determine timing of image acquisition based at least on the detected position and / or orientation of the subject's body. The imaging device provides in vivo imaging of the region of the subject's body and may provide time-series in vivo images. The region to be imaged may include at least a portion of the subject's lungs.

[0083] Also disclosed herein is a method for acquiring time-series images of a region of a subject's body. The method includes providing an imaging device including at least one energy source, at least one detector positioned between the energy source and the detector for detecting energy from the at least one energy source passing through the region of the subject's body, and a controller configured to operate the at least one energy source and the at least one detector to acquire time-series images of the region of the subject's body. The method also includes detecting, using at least one sensor, a position and / or orientation of the subject's body positioned between the energy source and the detector, determining, using at least one processor, timing of image acquisition based at least on the detected position and / or orientation of the subject's body, and operating the controller to acquire time-series images of the region of the subject's body. The method may provide in vivo imaging of the region of the subject's body and acquire time-series in vivo images. The region to be imaged may include at least a portion of the subject's lungs. [Brief explanation of the drawings]

[0084] [Figure 1] 1 is a perspective view of an imaging apparatus looking towards an energy source unit, showing a subject seated for a scan, according to some embodiments of the present invention; FIG. [Figure 2] 2 is a perspective view of the imaging apparatus of FIG. 1 looking towards the detector unit, showing a subject seated for a scan, according to some embodiments of the present invention. [Figure 3] 3 is a perspective view of the imaging device of FIG. 2 illustrating the internal positioning of a detector and an energy source for imaging a predetermined region of a subject's body, according to some embodiments of the present invention. [Figure 4] 4 is a perspective view of the imaging device of FIG. 3 with exemplary detector units and energy source units removed for clarity. [Figure 5] 4 is a plan view of the imaging device of FIG. 3 with exemplary detector units and energy source units removed for clarity. [Figure 6A]FIG. 4 is a front view of the detector unit of FIGS. 1 to 3, showing a support member for supporting a subject in a seated position for scanning, according to some embodiments of the present invention. [Figure 6B] 6B illustrates the detector unit of FIG. 6A showing internal components of the support member assembly, according to some embodiments of the present invention. [Figure 7] FIG. 4 shows a schematic diagram of components of a detector unit and an energy source unit of the imaging device of FIGS. 1 to 3, according to some embodiments of the present invention. [Figure 8] 10 is a flowchart illustrating steps in an imaging method according to some embodiments of the present invention, wherein timing of image acquisition is based at least on monitored physiological parameters; [Figure 9] 10 is a flowchart illustrating steps in an imaging method according to some embodiments of the present invention, in which the timing of image acquisition is based at least on a detected position and / or orientation of a subject's body; [Figure 10A] 10 is a flowchart illustrating steps in the method of FIG. 9 for positioning a subject's body at a desired position for scanning, according to some embodiments of the present invention. [Figure 10B] 10 is a flowchart illustrating steps in the method of FIG. 9 for positioning a subject's body at a desired position for scanning, according to some embodiments of the present invention. [Figure 11] 9 is a flowchart illustrating steps in the method of FIG. 8 for defining a trigger signal for acquisition based on the subject's respiration, as well as steps in both the methods of FIGS. 8 and 9 for acquiring images and uploading image data for XV processing, according to some embodiments of the present invention. DETAILED DESCRIPTION OF THE INVENTION

[0085] The present invention will now be described in more detail with reference to the accompanying drawings, in which like structures are designated by like numerals, and in which it should be understood that the illustrated embodiments are examples only and should not be construed as limiting the scope of the invention as defined in the claims that follow.

[0086] Embodiments of the present invention are described herein with reference to the drawings. The drawings are not to scale and are merely intended to aid in the explanation of the present invention. Reference herein to a subject may include a human or animal test subject, or a human or animal patient undergoing a medical procedure and / or being screened, monitored, and / or diagnosed for a disease or disorder. With respect to an animal patient, embodiments of the present invention may also be suitable for veterinary applications. The terms subject and patient, and the terms imaging device and scanner, respectively, are used interchangeably throughout the description and should be understood to refer to the same configuration of embodiments of the present invention. Reference is also made herein to anatomical planes of a subject's body, including transverse or horizontal, sagittal or vertical, and coronal or frontal planes through the subject's body.

[0087] Embodiments of the present invention are directed to imaging devices and methods for acquiring in vivo images of a predetermined region of a subject's body and optimizing the acquisition of those images, ideally reducing the use of X-rays in the scanning process. Preferably, the region to be imaged includes at least a portion of the subject's lungs, and may include the entirety of one or both of the subject's lungs. Alternatively, the region to be imaged may include part or all of the subject's heart or brain. As will be appreciated by those skilled in the art, other organs or regions of a subject's body may also be suitable for functional imaging, such as those in which dynamic in vivo changes, including changes in movement, position, and / or size of the subject's body during respiration or other physiological processes, can be detected.

[0088] The acquired images are ideally of a type suitable for XV processing using techniques described in International Application No. PCT / AU2010 / 001199, filed September 16, 2010, and International Publication No. WO 2011 / 032210, published March 24, 2011, by applicant Monash University, and International Application No. PCT / AU2015 / 000219, filed April 14, 2015, and International Publication No. WO 2015 / 157799, published October 22, 2015, by applicant 4Dx Pty Ltd, the entire disclosures of which are incorporated herein by reference. The acquired images can therefore be processed using the XV techniques described therein to provide a three-dimensional motion field of the imaged region, preferably showing all three spatial dimensions of the imaged region over time. This allows lung motion to be measured throughout the respiratory cycle in the context of lung imaging, enabling assessment of lung function in each region within the lung in fine spatial and temporal detail. Similar images may be acquired of other regions of the subject's body, including the heart or brain, or other organs or regions in which dynamic biotransformations are detectable.

[0089] 1 to 3 illustrate perspective views of an imaging device 100 showing a subject 200 seated for a scan, according to some embodiments of the present invention. The imaging device 100 is configured to acquire time-series in-vivo images of a region 230 (see FIG. 3) of the subject's body 210. The imaging device 100 includes at least one energy source 110 and at least one detector 120 for detecting energy from the at least one energy source 110 passing through the region 230 of the subject's body 210, the detector 120 being positioned between the energy source 110 and the detector 120 (see FIG. 3). The imaging device 100 also includes a controller 140 (see FIG. 7) configured to operate the at least one energy source 110 and the at least one detector 120 to acquire time-series in-vivo images of the region 230 of the subject's body 210. The imaging device 100 also includes at least one processor 150 (see FIG. 7) configured to determine the timing of image acquisition.

[0090] According to a first aspect of the invention, the imaging device 100 includes at least one sensor for monitoring a physiological parameter associated with a region 230 of the subject's body 210 to be imaged. The imaging device 100 also includes at least one processor 150 configured to determine timing of image acquisition based at least on the monitored physiological parameter. The timing of image acquisition may be based solely on the monitored physiological parameter. Configurations related to this first aspect of the invention and its advantageous effects are further described herein below.

[0091] According to a second aspect of the invention, the imaging device 100 includes at least one sensor for detecting a position and / or orientation of the subject's body 210 located between the energy source 110 and the detector 120. The imaging device 100 also includes at least one processor 150 configured to determine timing of image acquisition based at least on the detected position and / or orientation of the subject's body 210. The timing of image acquisition may be based solely on the detected position and / or orientation of the subject's body. Configurations related to this second aspect of the invention and its advantageous effects will now be further described.

[0092] Notably, in some preferred embodiments, the first and second aspects of the invention are such that the imaging device 100 includes at least one sensor for monitoring a physiological parameter associated with the region 230 of the subject's body 210 to be imaged, and at least one sensor for detecting the position and / or orientation of the subject's body 210. Alternatively, the imaging device 100 may include one sensor for monitoring a physiological parameter and detecting the position and / or orientation of the subject's body 210. Thus, the timing of image acquisition determined by the processor 150 may be based on both the monitored physiological parameter and the detected position and / or orientation of the subject's body 210. Additionally / alternatively, the first and second aspects of the invention may be separately combined with one or more other aspects that optimize the timing of image acquisition. As described herein, the imaging device 100 may also include at least one sensor for monitoring the motion of the subject's body 210 and determining the timing of image acquisition based on the detected motion of the subject's body 210. Thus, the timing of image acquisition may be based on either the monitored physiological parameter or the detected position and / or orientation of the subject's body 210, in addition to the detected motion of the subject's body 210. In some alternative embodiments, a single sensor may be used to monitor one or more of the physiological parameter, the position and / or orientation of the subject's body 210, and the motion of the subject's body 210. Optimization of the timing of image acquisition is described throughout this description.

[0093] 1-3, imaging device 100 may include a detector unit 122 having one or more detectors 120 positioned therein, and an energy source unit 112 having one or more energy sources 110 positioned therein. This is shown in more detail in FIG. 3, which provides a perspective view of imaging device 100 and shows the internal locations of energy source 110 and detector 120, along with energy in the form of imaging beam 116 generated by energy source 110, according to some embodiments of the present invention, through a projection image acquired by detector 120 through a region 230 of a subject's body 210 being imaged.

[0094] The imaging device 100 may be suitable for X-ray imaging techniques, as well as other imaging methods that do not involve the use of X-rays. In particular, the imaging device 100 and associated method 300 may be configured for one or more of X-ray imaging, ultrasound imaging, and magnetic resonance imaging (MRI). The imaging device 100 and associated method 300 may be configured for use with static or dynamic X-ray imaging techniques. Dynamic X-ray imaging techniques may include fluoroscopic imaging, computed tomographic X-ray velocity (CTXV) imaging, and / or four-dimensional computed tomography (4DCT) imaging. The imaging device 100 and method 300 are preferably configured for fluoroscopic imaging. CTXV imaging techniques using fluoroscopy are described in more detail in the aforementioned WO 2011 / 032210 and WO 2015 / 157799.

[0095] The imaging device 100 includes at least one energy source 110 and at least one detector 120. Preferably, however, the imaging device 100 includes at least three detectors 120 and at least three energy sources 110, such that the controller 140 is configured to operate the detectors 120 and energy sources 110 to acquire three time-series in-vivo images of a region 230 of the subject's body 210. To provide images suitable for XV processing, at least three time-series images are desirably provided as input. The processor 150 may then be configured to reconstruct a three-dimensional motion field based on the acquired three time-series images. This information is then processed by the processor 150 to generate three-dimensional (i.e., three spatial dimensions) movement measurements (e.g., displacement or velocity measurements) over time of the imaged region 230 (four-dimensional measurements, i.e., three spatial dimensions plus time). Furthermore, the three-dimensional movement measurements may have either one component of velocity (3D1C), two components of velocity (3D2C), or preferably three components of velocity (3D3C). The processor 150 may employ XV processing techniques described and incorporated herein by reference in the aforementioned International Publication Nos. 2011 / 032210 and 2015 / 157799. As shown in FIG. 3, the imaging device 100 may include four energy sources 110 and four detectors 120. Advantageously, the use of four detectors 120 and four energy sources 110 as shown in FIG. 3 may provide greater accuracy in generating a three-dimensional motion field indicative of three spatial dimensions of the region 230 of the imaged subject over time.

[0096] The imaging device 100 is configured to acquire time-series in-vivo images of a region 230 of a subject's body 210. Desirably, the inventive device 100 allows the patient (subject) 200 to relax and breathe normally while the imaging process is completed. This contrasts with existing imaging techniques that require the patient to understand or follow breathing instructions, which can be difficult for, for example, young children, elderly patients, or patients with speech, hearing, or cognitive impairments. By providing multiple energy sources 110 and detectors 120—ideally at least three pairs of detectors / energy sources, and in some embodiments, four pairs of detectors / energy sources as shown in FIGS. 3-5—time-series images of the subject 200 can be acquired simultaneously or substantially simultaneously at multiple angles through the patient's body 210. Timing may be limited to a specific duration based on physiological processes occurring in the subject's body 210. The region 230 to be imaged includes at least a portion of the subject's 200 lungs, and the duration of imaging may be based on a single breath of the subject. Desirably, the imaging device 100 allows multiple time series of images to be acquired of a portion or a single breath of the subject 200. This may include inspiration, expiration, or both inspiration and expiration for a complete breath. Preferably, the imaging device 100 allows multiple time series of a complete breath of the subject 200 to be acquired.

[0097] By capturing images of a single breath simultaneously or substantially simultaneously, the inventive device 100 reduces radiation dose and scan duration because fewer separate images need to be captured, with all images acquired within one breath, typically taking approximately four seconds. In comparison, older hardware, such as fluoroscopes, requires repositioning the system and scanning four separate breaths for each image, resulting in scans that require longer times and contain inaccuracies due to measurements taken across four different breaths. Capturing a complete breath simultaneously or substantially simultaneously, rather than four separate breaths, reduces radiation dose, shortens scan time, and advantageously enables use of the imaging device 100 by younger patients, such as children over the age of three, as well as older patients, by eliminating the requirement that the patient 200 maintain consistent breathing across multiple breaths.

[0098] In the embodiment of FIG. 3, the imaging device 100 includes four energy sources 110 positioned in an exemplary energy source unit 112 and four detectors 120 positioned in an exemplary detector unit 122. Each of the four energy sources 110 and four detectors 120 are spatially positioned around a subject's body 210 in a generally diamond-shaped configuration. The subject's body 210 is oriented in an upright, seated position within the scanner (imaging device) 100. The energy sources 110 and detectors 120 remain stationary during the scan and assume fixed positions within the imaging device 100. While the embodiment of FIGS. 3-5 shows the use of four energy sources 110 and four detectors 120, embodiments of the invention may include only a single energy source 110 and detector 120. Still further, other embodiments may include two energy sources 110 and two detectors 120, or preferably three energy sources 110 and three detectors 120, so that sufficient imaging angles can be obtained for imaging dynamic events.

[0099] 4 is a perspective view of the imaging apparatus of FIG. 3 , with exemplary detector and energy source units removed for clarity. The imaging apparatus 100 includes four energy sources 110 (shown as 100A and 110B) and four detectors 120 (shown as 120A and 120B) for detecting energy from the four energy sources 110 passing through a region 230 of a subject's body 210 located between the energy sources 110 and the detectors 120. The two pairs of energy sources and detectors 110A and 120A are spatially positioned around the subject's body 210 in a first plane, which is a transverse or horizontal plane through the subject's body 210. The two pairs of energy sources and detectors 110B and 120B are spatially positioned around the subject's body 210 in a second plane, which is a sagittal or vertical plane through the subject's body 210. The first and second planes intersect through a region 230 of the subject's body 210 being imaged.

[0100] 4 shows that energy source 110A may be spaced circumferentially about 40 degrees to the left and right of the intersection of first arc 102 with second arc 104. Still further, energy source 110B may be spaced circumferentially about 30 degrees above and below the intersection of second arc 104 with first arc 102. Similar circumferential spacing may be provided for detectors 120A, 120B at their respective common arcs in the first and second planes (see, e.g., common arc 103 for detector 120A in FIG. 5).

[0101] While FIG. 4 illustrates approximately 60 and 80 degrees between the imaging angles or viewpoints provided by each pair of energy source and detector, embodiments of the present invention are not limited to these angles, nor are they limited to providing circumferential separation in an arc within a plane. The imaging angles may be further spaced circumferentially around the subject's body 210 by up to 180 degrees. However, to provide a more compact scanner 100, it is preferable that the energy sources 110A, 110B be positioned closely together. Furthermore, the configuration of the energy sources 110A, 110B is reflected in the corresponding placement of the detectors 120A, 120B, as shown by the imaging beam 116 through region 230. Thus, the detectors 120A, 120B are ideally positioned closely together to provide a more compact scanner 100.

[0102] In some embodiments, the imaging angle provided by the pair of energy source and detector 110A, 120A in the first plane may range from about 45 to 90 degrees, preferably spaced 80 degrees apart, in a diamond-shaped configuration as shown in Figure 4. Although not shown, various other configurations of energy sources and detectors may be provided, such as rectangular configurations or elliptical or oval configurations in which additional energy sources and detectors are provided. Furthermore, irregularly shaped configurations may also be provided.

[0103] In the diamond-shaped configuration of Figure 4, the two imaging angles provided by each pair of energy source and detector 110A, 120A can be spaced apart in the first plane by about 45-70 degrees, about 70-90 degrees, about 45-60 degrees, about 60-70 degrees, about 70-80 degrees, or about 80-90 degrees. The spacing can be about 45 degrees, about 50 degrees, about 55 degrees, about 60 degrees, about 65 degrees, about 70 degrees, about 75 degrees, about 80 degrees, about 85 degrees, or about 90 degrees. Preferably, however, the spacing is about 80 degrees for the diamond-shaped configuration as shown in Figure 4.

[0104] Still further, the two imaging angles provided by the energy source and detector 110B, 120B pair can be spaced apart in the second plane by a distance in the range of about 45-70 degrees. Preferably, the distance is in the range of about 45-60 degrees or about 60-70 degrees. The distance can be about 45 degrees, about 50 degrees, about 55 degrees, about 60 degrees, about 65 degrees, or about 70 degrees. Preferably, the distance is about 60 degrees for a diamond-shaped configuration, as shown in FIG. 4.

[0105] In some embodiments, the controller 140 is configured to acquire images using at least four imaging angles through the region 230 of the subject's body 210. At least two imaging angles may be provided in a first plane through the subject's body 210, and at least two imaging angles may be provided in a second plane through the subject's body 210. The spatial arrangement and positioning of each pair of energy source and detector provides four imaging angles through the region 230 of the subject's body 210, as illustrated by the imaging beams 116 generated by the energy sources 110A, 110B shown in FIGS.

[0106] Embodiments of the present invention advantageously acquire time-series in-vivo images of a region 230 of a subject's body 210. Embodiments of the present invention include at least one pair of energy source 110 and detector 120, preferably three pairs of energy source 110 and detector 120, or four pairs of energy source 110 and detector 120 (see FIGS. 3-5). In the embodiment of FIGS. 3-5, controller 140 is configured to operate four energy sources 110A, 110B and four detectors 120A, 120B to acquire time-series in-vivo images of a region 230 of the subject's body 210. This allows at least four time-series in-vivo images to be acquired during a scan. Acquiring time-series images from multiple angles can provide dynamic imaging of the subject's body 210. In particular, embodiments of the present invention may be suitable for functional imaging, such as those capable of detecting dynamic biological changes, including changes in the movement, position, and / or size of an organ or body region, during respiration or other physiological processes of the subject's body 210, as will be appreciated by those skilled in the art. This is described in more detail below in connection with the inventive method 300 using XV technology and the processing of acquired images.

[0107] The scanning process using the imaging device 100 of Figures 3-5 will now be described. As best shown in Figure 4, each energy source 110A, 110B generates an imaging beam 116 that passes through a region 230 to be imaged, and a projection image is acquired by a corresponding detector 120A, 120B. Each energy source 110A, 110B is tilted toward the region 230 to be imaged such that the imaging beam 116 is received through the same volume, which is the region of interest being imaged by all energy sources 110A, 110B, but from a different angle or perspective.

[0108] 4 and 5, the energy sources 110A, 110B are tilted toward the region 230 to be imaged, and the corresponding detectors 120A, 120B are tilted toward the respective energy sources 110A, 110B to acquire the image. Each of the detectors 120A, 120B is substantially aligned with, and in fact directly opposite, the respective energy source 110A, 110B. The detectors 120A, 120B are substantially aligned with the respective energy source such that the imaging beam 116 generated by the respective energy source 110A, 110B is approximately perpendicular to the detectors 120A, 120B.

[0109] FIG. 5 illustrates the imaging device 100 of FIG. 3 in a plan view with the energy source unit 112 and the detector unit 122 removed for clarity. FIG. 5 illustrates that the imaging beams 116 generated by the energy sources 110A, 110B intersect through an intersection region 142, which may include a single intersection point P. The intersection region 142 of the imaging device 100 will correspond to a region 230 of the subject's body 210 being imaged. The intersection point P is not equidistant from each of the energy sources 110A, 110B and the detectors 120A, 120B. In the embodiment of FIG. 5, the intersection point P is located closer to the detectors 120A, 120B than to the energy sources 110A, 110B, such that the region 230 of the subject's body 210 being imaged is closer to the detectors 120A, 120B than to the energy sources 110A, 110B (see also FIGS. 1-4). R from the intersection point P to the common arc 103 on which the pair of detectors 120A are located D The radius of curvature indicated by R is approximately 400 mm, and more specifically, may be approximately 410 mm. S The radius of curvature indicated by can be approximately 1200 mm.

[0110] An advantageous effect of having the intersection region 142, and more specifically, the intersection point P, closer to the detectors 120A, 120B than the energy sources 110A, 110B, is that it reduces exaggeration in the images acquired by the imaging device 100. Exaggeration occurs when the energy sources 110A, 110B are positioned too close to the region being imaged, e.g., region 230 of the subject 200, and the captured image exaggerates the size and dimensions of the structure. In embodiments of the present invention, it may be desirable to reduce exaggeration to provide a more accurate representation of the region 230 being imaged. Positioning region 230 closer to the detectors 120A, 120B makes it less exaggerated, and therefore the anterior-posterior (PA) projection beam view allows for a more accurate representation of the region 230 being imaged, particularly the heart or lungs of the subject 200. Those skilled in the art will appreciate that the radius of curvature R S and R D is the radius R S is the radius R D It should be understood that although it is still preferable that the value be larger than 1 / 2, this can be varied appropriately depending on the size of the imaging device 100.

[0111] As shown in FIGS. 1-3 , the detector unit 122 may include a support member in the form of a seat 124 for supporting the subject's body 210 in a seated position during image acquisition. A healthy subject 200 may walk into the scanner 100 and position themselves in the seat 124 to begin the imaging process. Alternatively, a subject 200 who fits into a wheelchair or has limited mobility may be transferred to the seat 124 of the imaging device 100 by an operator or technician before beginning the scanning process. In other embodiments, the subject 200 may be placed in a wheelchair, which is then positioned in the scanner 100 between the energy source 110 and the detector 120 without the use of the seat 124 (not shown). The wheelchair or other seating device may include a radiolucent backrest to allow transmission of x-rays from the energy source 110 to the detector 120 for use in x-ray imaging. Alternatively, as will be appreciated by those skilled in the art, the backrest may be made of any suitable material that allows the transmission of various forms of energy, including but not limited to ultrasound and magnetic fields, for medical imaging.

[0112] 6A and 6B show exemplary support members in the form of a sheet 124 and a support member assembly 128 for supporting a subject's body 210 at a position between an energy source 110 and a detector 120, according to an embodiment of the present invention. FIG. 6A shows the sheet 124 attached to a panel 126 that forms part of the detector unit 122. The internal components of the exemplary support member assembly 128 are shown in FIG. 6B. The sheet 124 may be movable by an actuator for adjusting the position and / or orientation of the sheet 124. A controller 140 (see FIG. 7) may be configured to control the actuators to adjust the position and / or orientation of the sheet 124 to support the subject's body 210 in a desired position for acquiring images.

[0113] The actuator may include a motor 130 supported by a nut 134 as shown in FIG. 6B . The motor 130 may be operable to vertically move a mount plate 138, which supports the seat 124 on a screw 132, to raise and lower the seat 124 relative to a bearing support 136. Vertical seat position adjustment may be achieved by this exemplary rotary screw mechanism, which converts rotation to linear motion and is powered by the motor 130. Although not shown, the motor 130 may also be operable to move the mount plate 138 horizontally and / or tiltedly to change the position and / or orientation of the seat 124, thereby changing the position and axis of the subject's body 210. Embodiments of the present invention are not limited to this particular arrangement of support members, and those skilled in the art will recognize that many other arrangements are possible that do not include a motor 130 as an actuator and operate on different principles to change the position and / or orientation of the seat 124 to change the position and axis of the subject's body 210. For example, the rotary screw mechanism may omit the motor 130 and instead include a manually operable rotary handle as the actuator.

[0114] In other embodiments, a manually operated or powered hydraulic or pneumatic system may be used to move the seat 124 (not shown). In this arrangement, a cylinder may be provided to move the seat vertically and raise and lower the seat, and the cylinder is driven by controlling a compressed fluid, such as air, within the cylinder. In some embodiments, the imaging device 100 may include a subject support system 175 having a subject control system 176 (see FIG. 7 ) for controlling the compressed fluid in addition to a fluid or air compressor (not shown). Additionally / alternatively, the seat 124 may be manually adjusted by an operator or technician. For example, a manually repositionable seat may be provided that can be positioned and secured in a predefined position by an operator (not shown). Alternatively, a manually operated spring or compressible gas strut seat may be provided (not shown).

[0115] In embodiments that do not include a seat 124, the imaging device 100 positions the subject 200 in an upright orientation or in a wheelchair or other chair (not shown) with a radiolucent back, and may alternatively include a support member in the form of a platform. The platform may be vertically and horizontally movable to raise and / or lower the subject 200 to a desired position for image acquisition and may include a tilting function to change the orientation and / or body axis of the subject's body 210. The platform on which the imaging device 100 is positioned so that the subject 200 enters the scanner 100 may initially be placed on the ground or floor and then moved vertically, horizontally, and / or tilted to move the subject's body 210 to a desired position for image acquisition. Similar mechanisms for raising, lowering, and / or tilting the platform may be employed as described above in connection with the seat 124. For embodiments including a movable platform, additional safety features may be required to immobilize the patient 200 and / or minimize potential tripping hazards for the patient 200 and / or the operator. For example, the platform may include a surface material with a high coefficient of friction and / or texturing that provides grip for the patient's footwear and / or wheelchair. The platform may also include safety panels around the edges to prevent falls from the platform when elevated relative to the ground or floor.

[0116] Advantageously, the imaging device 100 may allow a healthy patient 200 to walk into the scanner, or may allow a patient 200 with limited mobility to be positioned within the scanner in a seat 124 or wheelchair. This is fundamentally different from prior art scanners, such as CT scanners, which require the patient 200 to lie down for the scan to be completed. Typical CT scanner configurations employ a ring or C-arm to which an energy source and / or detector is attached for rotation around the patient's body. The patient must be positioned within the scanner in the position required to scan a given area of ​​their body and must remain motionless to capture the image. When imaging the lungs with a CT scanner, patients are required to hold their breath and remain motionless to capture still images of their lung structure. Furthermore, because they lie supine on the bed, their lungs are oriented against gravity, which is different from the usual upright position assumed when the patient 200 is standing or seated. The patient 200 can be more easily positioned within the inventive scanner 100 and held still during the scan. The inventive scanner 100 allows the patient 200 to be positioned in the scanner 100 in an upright seated or standing position, and their position and / or orientation can be adjusted to a desired position prior to the scan. Furthermore, because the inventive scanner 100 acquires dynamic information (enabling the extraction of functional information), the patient does not need to hold their breath. Thus, the inventive imaging device 100 provides a more accessible scanning method, regardless of the patient's mobility and / or age.

[0117] FIG. 7 shows a schematic diagram of components of the energy source unit 112 and the detector unit 122 of the imaging device 100 according to some embodiments of the present invention. The detector unit 122 and the energy source unit 112 are shown with dashed lines to indicate an exemplary arrangement of the components and systems of the imaging device 100, which may vary as would be understood by one skilled in the art. For example, the XV processing unit (processing unit) 186 (optionally provided in the detector unit 122) and the analyte sensor system 172 may be located in the energy source unit 112. Alternatively, the XV processing unit 186 may not be included in the imaging device 100, but may instead be provided via a cloud-based server having an XV processing application for off-board processing of image data. Furthermore, in some embodiments, the control system 152, safety system 182, output device 117, and communication system 188 of the energy source unit 112 may be located in the detector unit 122.

[0118] The processor 150 and processing units 158, 174, and 186 of FIG. 7 used to implement certain steps of the method 300 (see FIGS. 8-11 ) of an embodiment of the present invention and executed in the function of the imaging device 100 may include a microprocessor or the like configured to receive data from components of the device 100 or a computing server, such as via a wireless or wired connection (not shown). The controller 140 may include a programmable logic controller (PLC) and / or an embedded PCB (not shown). The controller 140 may include or store multiple predefined protocols or steps in non-volatile memory, such as a hard drive. The protocols may be programmable or predefined by an operator to implement multiple steps for the method 300 (shown as methods 300A and 300B in FIGS. 8 and 9 and as method 300 in FIGS. 10 and 11 ) executed by the processor 150 and processing units 158, 174, and 186. Additionally or alternatively, controller 140 and processor 150, processing units 158, 174, and 186 may comprise any other suitable processor or controller device known to those skilled in the art. The steps performed by processor 150, processing units 158, 174, and 186 may be implemented in various manners through controller 140 and further in software, firmware, and / or hardware, as will be appreciated by those skilled in the art.

[0119] FIG. 7 also omits, for simplicity, some additional components and systems that would otherwise be part of imaging device 100. For example, imaging device 100 may include one or more memory devices (not shown) for storing various types of data, including sensor data, image data, and previously acquired patient data, as well as software instructions for executing the image acquisition and processing workflow and XV processing and inventive algorithms executed by processor 150 of embodiments of the present invention, as described in more detail below. The schematic diagram of FIG. 7 also omits, for simplicity, some of the internal bus lines between various components and systems. The omitted aspects will be understood by those skilled in the art who can readily provide the omitted software, firmware, and / or hardware.

[0120] The energy source unit 112 may include one or more energy sources 110 powered by one or more power generators 114 that form part of a power supply 184 for the imaging device 100. A control system 152 having a controller 140 and a processor 150 may be configured to operate the energy sources 110 and the detectors 120 of the detector unit 122 to scan a region 230 of the subject's body 210. The energy source unit 112 may also include a safety system 182 in communication with the control system 152. The safety system 182 may include an emergency stop 180 in the form of a software or hardware component of the imaging device 100.

[0121] 1 illustrates an embodiment of an emergency stop 180 on the surface of the energy source unit 112 adjacent to the subject 200. The emergency stop 180 may include an actuator, such as a push-button or switch, for powering off the imaging device 100 in an emergency. The push-button or switch may remain depressed for the duration of the scan, independent of device-generated start-scan and stop-scan trigger signals. When the emergency stop 180 is activated, the controller 140 of the control system 152 may be operable to stop image acquisition via the energy source 110 and, optionally, directly power off the imaging device 100 via a power supply 184 (not shown) to prevent inadvertent radiation generation.

[0122] According to a second aspect of the invention, the imaging device 100 may include at least one sensor for detecting a position and / or orientation of the subject's body 210 located between the energy source 110 and the detector 120. The imaging device 100 may also include at least one processor 150 configured to determine timing of image acquisition based at least on the detected position and / or orientation of the subject's body 210.

[0123] The sensors for detecting the position and / or orientation may include one or more of a camera, an optical sensor, a motion-based sensor, and a laser sensor, to name a few. As shown in FIG. 7 , the sensors for detecting the position and / or orientation may include one or more motion sensors in the form of a camera 160, along with a processing unit 158 ​​for processing the sensor data, which together comprise a motion system 154 according to an embodiment of the present invention. The sensor data from the motion system 154 may be processed and subsequently used by the control system 152 to determine the timing of image acquisition based at least on the detected position and / or orientation of the subject's body 210. Thus, the imaging device 100 may include one sensor for detecting the position and / or orientation of the subject's body 210 and another sensor for monitoring physiological parameters, both of which may be used to determine the timing of image acquisition once the subject 200 is in a desired position for a scan and a trigger signal for acquisition is identified from the monitored physiological parameters.

[0124] As shown in FIG. 1 , a camera 160 is illustrated on the surface of the energy source unit 112 adjacent to the subject 200. The camera 160 may operate to visually detect the position and / or orientation of the subject's body 210 between the energy source 110 and the detector 120 by visible or infrared light. Preferably, the camera 160 is a depth-aware video camera system (e.g., a video camera combined with LIDAR, a Microsoft Kinect-type system, a stereoscopic camera setup, etc.), which allows visualization of the position and / or orientation of the subject 200 and the movement of the subject 200. The camera 160 may form part of a real-time motion-based vision system (motion system) 154 (not shown) that may locate the top of the subject's 200's head using fiducial reference markers positioned behind the subject 200 and find the boundary around the subject 200. Still further, in other embodiments, a laser sensor may additionally be included (not shown) to provide a laser curtain for visually detecting the position of the subject 200 for imaging, such as using Light Detection and Ranging (Lidar) techniques. Additionally / alternatively, an ultrasonic sensor may be provided to detect the position of the subject 200 for imaging through non-contact distance sensing via ultrasonic energy.

[0125] In an exemplary embodiment, the motion system 154 is a real-time vision system including a camera 160 and optionally additional sensors, such as a laser sensor, to position the subject 200 at a desired position for scanning within the field of view (FOV) of the detector 120 of the imaging device 100. The vision system may acquire 2D or 3D image data using the camera 160 and / or additional sensors, ideally processing the data in real time to locate and measure important reference points on the patient. The real-time image processing may employ known techniques such as edge detection, pose estimation, and face detection, to name a few, to locate important features of the patient. As the subject 200 sits or optionally stands between the energy source 110 and the detector 120, the processing unit 158 ​​may process the sensor data to create a trace of the subject's 200 boundary and calibrate this trace to fiducial reference markers located behind where the subject 200 sits or stands, such as in the detector unit 122 (not shown). To estimate the location of the region 230 for imaging, the processing unit 158 ​​may receive pre-acquired data, such as lung position reference data for the patient 200, obtained from previous scans, if available, or from published anthropometric body dimension and lung size data for various patient ages and sizes, as described in more detail below. The patient's key feature locations and lung position reference data are input to the processing unit 158 ​​and / or processor 150, along with fixed reference data, to identify the direction and / or magnitude of movement required to position the subject 200 in the desired position for the scan. Based on this data, an estimated current location of the region 230 of the subject's body 210 to be imaged, such as the location of the lungs to be imaged, can be calculated, and the position of the seat 124 or platform can be adjusted to the desired position for the scan, either autonomously by the scanner 100 or under operator control.

[0126] Advantageously, sensors for detecting the position and / or orientation of the subject's body 210 use energy sources and / or techniques that do not require the use of X-rays. Prior art techniques require performing live (i.e., constant) X-ray imaging of the subject's body 210 to determine whether the region to be imaged 230 is within the scanner's field of view (FOV). The inventive scanner 100 does not require performing this live X-ray imaging, thereby reducing the use of X-rays in the scanning process. This reduces the radiation burden on the subject 200 and allows more scans to be completed with less overall radiation burden. In particular, this is highly beneficial for younger patients, for whom radiation is more damaging to their bodies.

[0127] In an alternative embodiment, the imaging device 100 may be configured to perform a pre-scan of the subject's body 210 to determine whether the region 230 to be imaged is within the field of view (FOV). The controller 140 may be configured to acquire a pre-scan of the subject 200, e.g., a single X-ray image from a single projection acquired from an energy source / detector pair. The processor 150 may then be configured to process the image data to identify the region 230 to be imaged, such as based on image brightness, position, or bounding box techniques, to name a few, and determine the alignment of the subject's body 210 to a desired position for acquiring the time series of images. Beneficially, the controller 140 automatically moves the subject 200 to a desired position for the scan by adjusting the position and / or orientation of the seat 124 or platform, rather than an operator manually moving the subject 200 or the subject 200 being instructed. The controller 140 may further be configured to acquire a second preliminary scan of the subject 200 once the subject 200 has been moved to a desired position for the scanner to determine whether the region 230 to be imaged is currently within the field of view (FOV).

[0128] The energy source unit 112 may also include an output device 117, such as an audiovisual device, which may include a display 118 and a speaker 119. FIG. 1 shows the display 118 located below the camera 160 in the subject's line of sight when positioned within the scanner 100. Although not shown, the imaging apparatus 100 may also include a speaker 119 positioned in the energy source unit 112 and / or the detector unit 122. The output device 117 is provided so that communications can be transmitted between the subject 200 and / or operator and the imaging apparatus 100 via the communication system 188. For example, the control system 152, via the processor 150, may output instructions to the subject 200 and / or operator via the output device 117. The instructions may be provided to the display 118 and / or the speaker 119. The provided commands may include adjustments to be made to the subject's position and / or orientation within the scanner 100 to provide the subject's body 210 with a desired position for image acquisition within the scanner 100. For example, the output device 117 may provide body positioning commands to the subject 200, including commands to straighten their body, e.g., to correct the tilt or angle of their body side to side or forward or backward relative to their seated or standing position within the scanner 100. Commands may also relate to the timing of image acquisition, such as a trigger signal to initiate image acquisition. For example, the output device 117 may provide breathing commands to the subject 200, including commands to inhale and exhale, and to breathe at a particular rate, preferably to provide a regular breathing pattern.

[0129] It would be advantageous for the scanner 100, in some embodiments of the present invention, to provide fully automated positioning of the subject's body 210 for image acquisition. For example, the subject 200 would be seated in a seat 124 that would then automatically adjust the subject's 200 position, orientation (e.g., tilt / angle), and / or body axis for optimal scanning of the region 230. However, if the scanner 100 cannot be fully automated, it would be desirable to provide a communication system 188 useful for assisting the patient 200, particularly younger patients and / or those with reduced mental capacity, by providing visual instructions on the display 118 in addition to verbal instructions via a speaker 119. Prior art techniques simply require the technician or operator to explain to the patient how to change their position to optimize image acquisition. For younger patients and / or those with reduced mental capacity, simple explanations can be a difficult task, as they are more likely to respond positively to visual instructions and / or animations. Furthermore, the graphical display 118 and / or speaker 119 also provide an opportunity to make the patient 200 more comfortable during the procedure by explaining the steps as the scan progresses.

[0130] Although not shown, the imaging apparatus 100 may also include an input device for providing data input from the subject 200 and / or an operator. The data input may include pre-acquired data, which may include data related to the subject 200 and / or data related to a general or general population having characteristics representative of the subject 200. For example, the pre-acquired data may include one or more pre-acquired images of the region 230 of the subject's body 210 to be imaged. The pre-acquired images may include CT images or previous XV scans that provide the precise anatomical location and associated metadata of the subject's body 210. Additionally / alternatively, the pre-acquired data may include one or more body features of the subject 200, such as anatomical dimensions of the region 230 and / or the subject's body 210, the subject's 200's height and / or weight, etc. The anatomical dimensions may include dimensions of an organ of the subject 200, such as the lungs or the particular portion of the lungs being imaged. Furthermore, the pre-acquired data may also include one or more attributes of the subject 200, including age, sex, mobility, ethnicity, medical condition and / or medical history. The body characteristics and attributes of the subject 200 may be derived from data related to the general or general population. The pre-acquired data may be used in the process of optimizing the acquisition of images, which is described in more detail below.

[0131] 7, the detector unit 122 includes one or more detectors 120 operable by the controller 140 of the control system 152 to acquire a time series of in-vivo images of a region 230 of the subject's body 210. The acquired images may be used as input to the XV processing unit 186, as previously described, to generate an XV three-dimensional motion field of the region 230 of the subject's body 210, such as the lungs or heart. The XV processing unit 186 may alternatively be provided off-board via a server or cloud-based system in some embodiments.

[0132] The detector unit 122 may also include a subject support system 175 having a subject control system 176 (shown in FIG. 7) for controlling the positioning of a support member (e.g., the seat 124 or platform in FIGS. 1-3), such as by means of the support member assembly 128 and actuators including the motors 130 described above and shown in FIG. 6B. Accordingly, the controller 140 of the control system 152 of the energy source unit 112 may be operable to control the actuators to adjust, optionally automatically, the position and / or orientation (e.g., tilt / angle) or alignment of the seat 124 via the subject support system 175 and control system 176. Still further, the subject support system 175 may include a weight sensor 178 located on the seat 124 or platform. The weight sensor 178 may be a force or pressure sensor or transducer for detecting the weight of the subject when the subject's body 210 is positioned on the seat 124 or platform. Sensor data from weight sensor 178 may be provided as input to control system 152 of energy source unit 112 for use in optimizing image acquisition, as further described below.

[0133] According to a first aspect of the invention, the imaging device 100 may include at least one sensor for monitoring a physiological parameter associated with a region 230 of the subject's body 210 being imaged. The imaging device 100 may also include at least one processor 150 configured to determine timing of image acquisition based at least on the monitored physiological parameter.

[0134] At least one sensor for monitoring a physiological parameter may be located in the detector unit 122, as illustrated by the subject sensor 170 shown in FIG. 7 . The subject sensor 170 may be operated by a subject sensor system 172 that also has a processing unit 174 for providing sensor data for processing by the processor 150 of the control system 152 of the energy source unit 112. The subject sensor 170 may be configured to monitor a physiological parameter associated with the region 230 of the subject's body 210 being imaged. The physiological parameter may include airflow or blood pressure. If the region 230 being imaged includes the lungs, the physiological parameter may include airflow at the mouth, lung volume, chest wall measurements using a laser-generated grid or image, or a band around the rib cage to fit a standard respiratory curve. If the region 230 being imaged includes the heart or blood vessels, the physiological parameter may include blood pressure or blood flow measurements. Additionally or alternatively, numerous other monitoring means for various physiological parameters may be used, such as using an ECG to image the heart and estimating temporal variations in blood volume, as will be appreciated by those skilled in the art.

[0135] The subject sensor 170 may be configured to detect physiological parameters related to the subject's breathing. In particular, the sensor data may be analyzed by the processor 150 to detect the subject's 200 breathing pattern and / or the duration of the subject's breathing. The timing of image acquisition may then be determined based on the detected breathing pattern and / or the duration of the subject's breathing. More specifically, image acquisition may be based on monitoring the detected breathing pattern and / or the typical duration of the subject's breathing to determine whether a repetitive breathing pattern is detected, and analyzing the repetitive breathing pattern therefrom to identify one or more features of a breathing cycle, such as the start of inspiration to begin a scan and the end of expiration to stop a scan. This data may be used to generate a breathing cycle trigger signal for image acquisition. The imaging device 100 and method 300 may acquire images over a portion of a breath (e.g., only the inspiration phase or only the expiration phase of the breathing cycle) or over the entire breath (i.e., both the inspiration and expiration phases of the breathing cycle). This process is described in more detail below in connection with an imaging method 300 according to an embodiment of the invention, as shown in FIGS.

[0136] FIG. 2 illustrates a connector 190 for a sensor 170 (not shown) for monitoring a physiological parameter provided by the imaging device 100. Thus, in some embodiments, the sensor 170 may be included as part of the imaging device 100 or, alternatively, may be connected to the device 100 via the connector 190. The connector 190 may enable electrical, mechanical, and / or pneumatic connection of the sensor 170 to the imaging device 100 for operation. The sensor 170 may be positionable near and / or within the subject's mouth to detect physiological parameters related to the subject's breathing. For example, the sensor 170 may be a flow meter for monitoring changes in airflow related to the subject's breathing. The flow meter may include a spirometer. Additionally / alternatively, the sensor 170 may include a gas sensor for monitoring changes in the air content of a gas related to the subject's breathing. The gas content sensor may be positioned near the subject's mouth to detect the concentration of carbon dioxide or oxygen entering and leaving the subject's mouth. This may enable the scanner 100 to detect the subject's breathing pattern.

[0137] In some embodiments, sensor 170 may include a thermal sensor, such as an infrared thermal camera, mounted to be aimed at the subject's mouth. As is known and understood, cooler air enters the mouth upon inhalation and warmer air exits the mouth upon exhalation, so the thermal sensor may monitor changes in air temperature associated with the subject's breathing. To improve the accuracy of the thermal camera measurements, a temperature sensor, such as a thermocouple, resistance temperature detector (RTD), or similar metal-based device, may be placed near the subject's mouth, which will respond to temperature changes caused by breathing. This may enable the thermal camera to more effectively measure the inhaled and / or exhaled air of subject 200.

[0138] 8-11, the steps performed by imaging device 100 and processor 150, processing units 158, 174 and / or 186 will now be described in more detail in connection with exemplary methods 300A and 300B for imaging shown in FIGS. 8 and 9, according to some preferred embodiments of the present invention.

[0139] 8 and 9 illustrate methods 300A and 300B, respectively, for acquiring in-vivo images of a region 230 of a subject's body 210, according to some preferred embodiments of the present invention. The methods 300A and 300B include an initial step 302 of providing an imaging device 100 including at least one energy source 110, at least one detector 120 for detecting energy from the at least one energy source 110 passing through the region 230 of the subject's body 210, the at least one detector 120 being positioned between the energy source 110 and the detector 120, and a controller 140 configured to operate the at least one energy source 110 and the at least one detector 120 to acquire time-series in-vivo images of the region 230 of the subject's body 210. The methods 300A and 300B also include a final step 330 of operating the controller 140 to acquire time-series in-vivo images of the region 230 of the subject's body 210.

[0140] 8 is directed to a first inventive aspect described in connection with the above-described inventive embodiment of imaging device 100. Method 300A includes, after step 302, step 303 of monitoring, using at least one sensor, a physiological parameter associated with region 230 of subject's body 210 to be imaged. The method further includes step 305 of determining, using at least one processor 150, timing of image acquisition based at least on the monitored physiological parameter. The timing of image acquisition may be based solely on the monitored physiological parameter.

[0141] FIG. 9 is directed to a second inventive aspect described in connection with the above-described inventive embodiment of the imaging device 100. After step 302, method 300B includes step 304 of detecting, using at least one sensor, the position and / or orientation of the subject's body 210 located between the energy source 110 and the detector 120. The method further includes step 306 of determining, using at least one processor 150, the timing of image acquisition based at least on the detected position and / or orientation of the subject's body 210. The timing of image acquisition may be based solely on the detected position and / or orientation. However, as described below, methods 300A and 300B may be combined to provide a method 300 (as shown in FIGS. 10 and 11 ) incorporating both the first and second inventive aspects. That is, the timing of image acquisition is based on both the monitored physiological parameters and the detected position and / or orientation of the subject's body 210.

[0142] 10A and 10B are flow charts illustrating steps in the method 300B of FIG. 9 for positioning a subject's body 210 in a desired position for a scan, according to some embodiments of the present invention.

[0143] 10A , in step 308, the method 300 includes identifying the subject 200 and acquiring prior data related to the subject 200. The subject 200 may be identified manually or through scanning a barcode or RFID tag on their patient tag or label. This step may include an operator providing the prior data as input to the processor 150 of the imaging device 100. The operator may enter the prior data based on their manual assessment of the subject 200 or from a prior report or data source. Additionally / alternatively, the prior data may be acquired automatically by the processor 150, via the imaging device 100, querying a server having a database storing patient data. The prior acquired data may include data related to the subject 200 and / or data related to a general or general population having characteristics representative of the subject 200.

[0144] The pre-acquired data may include one or more attributes of the subject 200, including age, sex, mobility, ethnicity, medical condition, and / or medical history. The pre-acquired data may be based on characteristics of the subject's 200 physique, such as anatomical dimensions of the region to be imaged 230 and / or the subject's body 210, or the subject's height and / or weight. Additionally / alternatively, the pre-acquired data may include one or more pre-acquired images of the region to be imaged 230, such as a CT scan or a previous XV processing scan, if available. In particular, the pre-acquired image data is important for use in algorithms for optimizing the scan performed by the processor 150. It is assumed that the previous scan contains precise information regarding the location of the region to be scanned 230 and associated metadata of the subject 200.

[0145] Prior data entered into the imaging device 100 constitutes part of the scanner setup. For example, mobility status identifies whether a seat 124 is required and / or whether a wheelchair or other seat with a radiolucent back may be required. Furthermore, the age of the subject 200 is important for determining the level of communication provided by the communication system 188 to adjust the subject's position and / or body axis within the scanner 100 and explain the various steps of the scanning procedure. For example, younger subjects 200 may require simpler instructions or graphical displays on the display screen 118 about where and how they should adjust their body 210 for image acquisition. Older patients 200 may only require verbal instructions via the speaker 119. The communication system 188 may provide scanner-to-patient communication or two-way technician-to-patient communication. Advantageously, the imaging device 100 utilizes a communication system 188 to provide patient interaction and clear explanations of the scanning process, making it particularly useful and user-friendly for younger patients, such as those aged 3 and above.

[0146] The next step 310 in method 300 is to seat or position subject 200 in an upright or standing position within scanner 100. For able-bodied patients, they may simply walk into the space between energy source 110 and detector 120 and sit in seat or chair 124, or position themselves in an upright or standing position for image acquisition. For wheelchair-bound or limited mobility patients, an operator may assist with transfer into seat (chair) 124, or a wheelchair with a radiolucent back may be provided and positioned within scanner 100. After this step is completed, the operator or communication system 188 will advise subject 200 of the estimated duration of the scan.

[0147] Step 304 in method 300B includes detecting the position and / or orientation of the subject's body 210 using at least one sensor. This step includes acquiring data regarding the patient's initial position or location upon entry into the scanner 100. For example, the weight of a seated patient may be acquired using a weight sensor 178 of the subject support system 175. The current seat position height may also be acquired via the support control system 176. This initial data may be provided as an input to the processor 150 to execute an algorithm for optimizing the scan. As previously mentioned, the initial position and / or orientation of the subject's body 210 may be detected via a first sensor, such as the camera 160 and associated motion system 154 shown in FIG. 1 . Camera vision may enable the determination of the position and / or orientation of the subject's body 210. Advantageously, the camera 160 preferably operates based on visible or infrared light. This advantageously avoids the need for a preliminary scan of the subject's body using the imaging device 100. The pre-scan involves manually positioning the subject using low-dose x-rays from a scanner in existing imaging systems, such as fluoroscopes. Thus, the inventive imaging device 100 and method 300 avoids the use of x-rays to identify and adjust the position of the subject's body 210, and can limit the use of x-rays to scanning once the subject 200 is in the desired location or correctly positioned.

[0148] Once the initial position and / or orientation of the subject's body 210 has been detected, the next step 312 of method 300 is to estimate the position of the region 230 of the subject's body 210 to be imaged using pre-acquired data from the scanner setup. For example, if region 230 is the subject's 200 lung or a portion of the lung, the pre-acquired image data can be used to accurately estimate the position of the subject's lung. This estimated position can then be combined with first sensor data indicating the subject's initial position / orientation and used to determine the desired position for the scan in step 314 of method 300. In some embodiments, the position of the patient's lungs can be estimated from identifying the contours of the subject's body 210 via sensor (camera) 160 or from specific features such as the shoulders or head of the subject 200 using motion system 154.

[0149] 10B, method 300 continues at step 316 with determining, using processor 150, an adjustment to the initial position and / or orientation of subject's body 210 to a desired position between energy source 110 and detector 120 for acquiring an image of region 230 of subject's body 210. The adjustment is determined based on a comparison of the initial detected position and / or orientation of subject's body 210 to the desired position determined in step 314, which was derived from the estimated position of region 230 in step 312.

[0150] The next step in method 300 includes one or both of steps 318 and 320 (shown in dashed lines) for reaching the subject 200 positioned at a desired position for the scan in step 306 of FIG. 9 . In step 318, method 300 includes outputting instructions to an output device 117, such as a display device (display) 118 and / or speaker 119, for an operator and / or subject 200 to adjust the subject's position and / or orientation to a desired position for image acquisition. In an embodiment of this method 300, the subject 200 may be positioned in an upright or standing position or in a wheelchair positioned within the scanner 100. The operator and / or subject 200 may move the subject's body 210 to the desired position without automation by the imaging device 100. Additionally / alternatively, the subject 200 may be seated in a seat 124 or positioned on a platform, and the imaging device 100 may perform the vertical adjustment of the subject's position in step 320. The operator and / or subject 200 may then receive horizontal adjustment instructions and / or change the body axis to position the subject's body 210 in a desired position. Additionally / alternatively, the imaging device 100 may be configured to provide left / right or front / back adjustments to the horizontal or tilt of the subject's position to straighten the subject's posture within the scanner 100. These may be given to the operator and / or subject 200 as instructions to move the subject's body 210 to a desired position for the scan.

[0151] In other embodiments, only step 320 may be performed, and the adjustment steps may be fully automated by imaging device 100. Accordingly, controller 140 may be configured to automatically adjust the position and / or orientation of seat 124 or platform on which subject 200 is positioned, optionally using support member assembly 128 or actuators including motors 130, to support subject's body 210 in a desired position for image acquisition. In alternative embodiments in which seat 124 or platform is not provided, the position of an upright patient may be adjusted by adjusting settings on scanner 100. For example, processor 150 may output instructions to an operator to adjust scanner settings, e.g., to adjust collimation settings to change the scanner's field of view. In other embodiments, scanner 100 may automatically adjust scanner settings without input from an operator.

[0152] In some embodiments (not shown), the method 300 may include changing the magnification of the imaging device 100. This step is preferably performed once the patient 200 is in the desired position for the scan. The magnification may be adjusted to ensure that the region 230 of the subject 200 to be imaged (e.g., the lungs) is positioned within the field of view (FOV) of each of the detectors 120. The method 300 may include moving the subject 200 toward the detectors 120 (i.e., decreasing the magnification) or away from the detectors 120 (i.e., increasing the magnification). The subject 200 may be moved using the seat or chair 124 (e.g., manually by the operator or automatically by the imaging device 100 via the controller 140) or by moving the patient's body 210 (e.g., by the operator or imaging device 100 providing instructions to the patient 200 or by the operator moving the patient's body 210).

[0153] Positioning the patient 200 closer to the detector 120 than the energy source 110 reduces exaggeration in the images acquired by the imaging device 100. Exaggeration occurs when the energy source 110 is positioned too close to the region being imaged, e.g., region 230 of the subject 200, and the captured image exaggerates the size and dimensions of structures. In this example, it may be desirable to reduce the exaggeration to provide a more accurate representation of the region 230 being imaged. An anterior-posterior (PA) projection beam view allows for a more accurate representation of the region 230 being imaged, particularly the heart or lungs of the subject 200, because the region 230 is positioned closer to the detector 120 and therefore less exaggerated.

[0154] 11 , method 300 continues responsive to subject 200 being positioned to begin a scan. Method 300 may actually begin once subject 200 is positioned to begin a scan, as determined by, for example, an operator or technician, skipping each of the preceding steps. Steps in the flowchart of FIG. 11 may relate to method 300A of FIG. 8, i.e., optimizing timing of image acquisition based on physiological parameters of subject 200. Additionally, steps throughout the illustrated method 300 may include acquiring images and then optionally uploading the image data for XV processing, according to some embodiments of the present invention.

[0155] In step 322, the method 300 includes monitoring the subject's respiration using at least one sensor 170, e.g., a flow meter, as described above with reference to FIG. 2 . The first step of the method 300 may include connecting the sensor 170 to the imaging device 100 via the connector 190. Alternatively, a second sensor 170 may be integrated into the imaging device 100. The method 300 may include positioning the analyte sensor 170 near or within the subject's mouth to monitor the subject's respiration. If the analyte sensor 170 is a flow meter or a spirometer, the method 300 may include monitoring changes in airflow associated with the subject's respiration. If the analyte sensor 170 is a thermal sensor, the method 300 may include monitoring changes in air temperature associated with the subject's respiration. If the analyte sensor 170 is a gas sensor, the method 300 includes monitoring changes in the gaseous air content associated with the subject's respiration.

[0156] Then, in step 324, a trigger signal for image acquisition is defined by an algorithm executed by processor 150. Data from subject sensor 170 is preferably received by control system 152 and processed by processor 150 to detect the breathing pattern of subject 200 and / or the duration of the subject's breath. Processor 150 is configured to monitor the detected breathing pattern and / or the duration of the subject's breath to determine whether a repetitive breathing pattern is detected. For example, subject sensor 170 may be a flow meter that detects changes in airflow during the subject's breath. Processor 150 may receive airflow data from the flow meter over a predetermined period, e.g., one minute, of the patient breathing in a relaxed state. Processor 150 may process the airflow data using signal processing techniques to determine whether a repetitive breathing pattern unrelated to hiccups, sneezing, runny nose, coughing, or hyperventilation is detected in each sequence analyzed.

[0157] Once a repetitive breathing pattern is detected, processor 150 may be configured to further analyze the repetitive breathing pattern to identify one or more features of the subject's 200 respiratory cycle. For example, peaks and valleys are evident in the airflow data that indicate the start of inspiration and the end of expiration and can be detected using well-known signal processing techniques. Furthermore, the respiratory cycle features are also well known to those skilled in the art and may be input into the processor algorithm. Processor 150 may then be configured to determine a trigger signal to initiate image acquisition in step 324 based on the one or more features of the respiratory cycle. The trigger signal defined by processor 150 may include at least a start time for initiating the scan, typically related to the start of inspiration identified by data processing. The end of expiration is then estimated as the stop or end time for the scan using the average or typical duration of breathing.

[0158] In some embodiments, processor 150 may be configured to analyze repetitive breathing patterns to detect the amplitude (e.g., peaks and valleys) of the respiratory signal from the airflow data, particularly from the volume versus time data. Processor 150 may then be configured to determine a trigger signal to initiate image acquisition in step 324 based on the amplitude of the respiratory signal corresponding to a predefined threshold or range of values. For example, the predefined threshold or range of values ​​may correlate with the subject's peak inspiratory volume (or related flow rate) or peak expiratory volume (or related flow rate) as measured by a flow meter in imaging device 100. Thus, the start time at which the scan begins may be defined based on the signal amplitude rather than the phase and / or duration of the subject's breathing.

[0159] The imaging device 100 and method 300 may acquire images over a portion of a breath (e.g., only the inspiratory or expiratory phase of the respiratory cycle) or over the entire breath (i.e., both the inspiratory and expiratory phases of the respiratory cycle). To ensure optimal images are acquired, the processor 150 may be configured to determine start and end points for acquisition, which may be based on the frame rate of image acquisition of the scanner 100. For example, the scanner 100 may acquire images using the energy source 110 and detector 120 at a frame rate desirably greater than 7 frames / second, preferably greater than 10 frames / second, e.g., 15 frames / second. The frame rate may be a fixed frame rate or may be triggered based on the amplitude of the respiratory signal, e.g., a number of evenly spaced points (e.g., seven points) between the maximum peak inspiratory or expiratory volume (or associated flow rate) and the minimum peak inspiratory or expiratory volume (or associated flow rate).

[0160] For image acquisition spanning some or all of subject 200's breath, the start time for acquisition may be shifted earlier, for example, by one frame (or several frames), to ensure that the acquired images include the desired dynamic events. For example, if an entire breath is acquired, image acquisition may be shifted to begin one to two frames before the start of inspiration (to ensure that the entire inspiration is captured), and the end of acquisition may be shifted one to two frames after the end of expiration (to ensure that the entire expiration is captured). This may beneficially provide a time delay when controller 140 turns on energy source 110 and detector 120 to acquire images.

[0161] In some embodiments, processor 150 determines the subject's 200 expected breath length (e.g., the duration of one breath) for image acquisition by measuring the time between successive maxima or minima in a volume versus time curve from the airflow data, and / or by determining an average volume versus time curve and then measuring the time between successive maxima or minima, or through spectral analysis of the volume data. Processor 150 also determines the expected inspiration time by calculating the length of time between the time points of minimum and maximum volume, and determines the expiration time by calculating the length of time between the time points of maximum and minimum volume.

[0162] In some embodiments, the processor 150 then uses the breath length or inspiration time to calculate the number of phases and / or frames required and the required inter-frame time. The frame rate may be based on the expected breathing time, calculated as Nb / Tb, where Nb is the desired number of frames per breath and Tb is the measured breathing period for the subject 200. Nb may be a number between 5 and 15, optimized for successful CTXV scanning without excessive dose. The start time for image acquisition is determined based on the amplitude of the breathing signal (volume versus time curve) corresponding to the start of inspiration, with image acquisition timed to begin just before the start of inspiration (e.g., one or two frames before the start of inspiration). The end time for image acquisition may be determined based on the expected breath length or inspiration time. This results in a trigger signal for image acquisition.

[0163] When the imaging device 100 includes two or more energy sources 110 and detectors 120 (e.g., four energy sources 110 and detectors 120 as shown in FIGS. 3-5 ), multiple time series images are advantageously acquired by the imaging device 100 and method 300 simultaneously or substantially simultaneously over a portion or entire breath of the subject 200. Preferably, the time series images are acquired over one complete breath of the subject 200. Acquiring multiple time series of a single breath (from different angles) rather than acquiring a single time series of multiple breaths (from different angles) eliminates the requirement that the subject 200 maintain consistent breathing over the multiple breaths. The controller 140 operates each energy source 110 and corresponding detector 120 to acquire images at the same or substantially the same defined start and end points of the trigger signal. Rather than operating the energy sources 110 and corresponding detectors 120 simultaneously, it may be preferable to acquire images sequentially with a small timing offset for the operation of the energy source / detector pair. This may advantageously reduce x-ray backscatter and result in improved image quality. Processor 150 may be configured to correct for timing differences between acquired time-series images when processing the data.

[0164] In particular, the trigger signal for initiating image acquisition as in step 324 may be defined based on one or both of the first and second aspects of the invention, i.e., the trigger signal for initiating image acquisition may be based on the subject 200 being in a desired position for scanning (a detected position and / or orientation of the subject's body) and / or the detection of a repetitive breathing pattern (a monitored physiological parameter). Alternatively, the trigger signal for initiating image acquisition may be based on only one of the first or second aspects of the invention.

[0165] Still further, additional outputs for defining a trigger signal may include motion of the subject 200. In particular, the timing of image acquisition may be based on the detection of no motion of the subject 200 or the detection of any motion indicating that the subject 200 is in a relatively stationary position (compared to a threshold). Preferably, in embodiments for dynamic lung imaging, the detected and monitored motion is non-breathing-related motion of the subject's body 210 between the energy source 110 and the detector 120. Any breathing-related motion, such as that due to diaphragm expansion and contraction during expiration and inspiration, respectively, is preferably excluded from the analysis. Ideally, the subject's breathing is not restricted or controlled during image acquisition. Advantageously, the imaging device 100 may be configured to acquire images while the subject 200 is breathing, and preferably for a single breath.

[0166] This output may be achieved through the use of motion data of the subject 200 monitored using at least one sensor. The sensor may include one or more of a motion sensor (e.g., camera 160), a resistive sensor, a weight sensor (e.g., sensor 178), a force sensor, and a pressure sensor. The motion sensor may include an accelerometer, a gyroscope, and / or a magnetometer for measuring movement of the subject's body 210. The resistive sensor may include, for example, a strain gauge that can measure displacement of the subject's body 210. In some embodiments, the motion sensor includes camera 160, which may be used to monitor non-breathing-related motion or to determine if the subject 200 is in a desired position for the scan.

[0167] The sensor data may be processed by the processor 150 to monitor the motion of the subject's body 210, which is located between the energy source 110 and the detector 120. The motion is preferably non-breathing-related motion of the subject's body. For example, multiple sensor readings may be taken over a period of time to provide multiple data points on changes in the movement, resistance, weight, pressure, or force of the subject's body 210 within the scanner 100. The changes in movement may be monitored, for example, by the camera 160 and / or other weight sensors 178. If a change in movement, resistance, weight, pressure, or force is detected by the processor 150, an output may include that patient 200 motion has been detected and that a scan should not begin. In this case, instructions may be output to the subject 200 and / or operator via the output device 117 instructing the subject 200 to remain stationary and continue breathing normally to begin image acquisition. The processor 150 may then continue to monitor the subject's motion until successive comparisons of the sensor readings reveal no motion or only limited motion based on threshold requirements.

[0168] Motion of the subject 200 may be identified by detecting changes in the subject's weight through a weight sensor 178 located on a support member (e.g., the seat 124 or platform of the imaging device 100) for supporting the subject's body 210. The processor 150 may receive sensor data from the weight sensor 178 over a predetermined period of time to determine whether there is any motion from the subject 200 or only limited motion based on threshold requirements. The detected weight fluctuations may be indicative of motion of the subject 200 and may be used by the processor 150 to determine the timing of image acquisition and trigger signal generation in step 324.

[0169] Once the trigger signal is defined, step 326 of method 300 outputs the trigger signal to the operator and / or subject 200 via output device 117. Based on the trigger signal and data output from processor 150, the operator then determines that a scan can begin and arms scanner 100 for the scan. This places scanner 100 in a standby mode ready to begin scanning the subject's body 210. In step 328, scanner 100 begins the scanning process upon receiving a signal received as input from the operator. At the defined trigger start time, the scan begins and continues for the duration of the patient's breathing, as determined during the monitoring phase or controlled by the operator. Imaging device 100 is also configured to provide audible and / or visual alerts of scan progress and duration to the operator and / or subject 200 via output device 117. At the end of the scanning process, imaging device 100 performs a scan quality check and outputs the acquired image data in step 330. The data may be output for review and quality check by the operator.

[0170] In other embodiments, method 300 may omit step 326, and the scanner may automatically proceed to scan subject 200 once a trigger signal is defined and requirements are met. Optionally, the patient's respiration may be monitored during image acquisition using a flow meter in imaging device 100. Processor 150 processes the airflow data to determine the end time for image acquisition based on the amplitude of the respiratory signal (volume versus time curve) corresponding to the end of exhalation. In step 332, the operator may manually stop the scan once all required images have been acquired, or the scan may be automatically terminated by scanner 100.

[0171] Once the scan is complete, the image data may be uploaded to the XV processing unit 186 in step 334, which may be located on-board the imaging device 100 or accessed via a cloud-based server and XV processing application. This step may be initiated in response to an action taken by an operator, or the processor 150 may be configured to automatically upload the image data once the scan is complete. The final step 336 of method 300 is where a three-dimensional motion field is reconstructed by the processor 150 or by an off-board XV processing application of the region 230 of the subject's body 210 that was imaged, such as using the XV techniques described in the aforementioned WO 2011 / 032210 and WO 2015 / 157799 and incorporated herein by reference.

[0172] Embodiments of the present invention advantageously provide an imaging device 100 and imaging method 300 that can acquire images suitable for use with XV technology and reduce the use of X-rays in the scanning process, allowing the ability to scan patients, including young children, more frequently due to reduced radiation burden. Embodiments of the inventive device 100 and imaging method 300 can reduce radiation dose because fewer separate images need to be taken, and require shorter scan durations because scans can be performed with a single patient breath. This advantageously enables use of embodiments of the imaging device 100 and imaging method 300 with younger patients, such as those over the age of three, by reducing radiation dose, shortening scan time, and eliminating the requirement for patients to hold their breath. Embodiments of the inventive imaging device 100 and imaging method 300 can also facilitate use across a larger patient population, including young children and patients with mobility impairments, by providing a walk-in scanner that can scan patients in a seated or upright position.

[0173] Various modifications, additions and / or substitutions may be made to the parts described above without departing from the scope of the present invention as defined in the claims that follow.

[0174] Any or all of the terms "comprise", "comprises", "comprised" or "comprising", when used in this specification (including the claims), should be interpreted as specifying the presence of stated features, integers, steps or components and not as excluding the presence of one or more other features, integers, steps or components or groups thereof. [Example]

[0175] Examples illustrating the application of some embodiments of the present invention will now be described. The examples are provided to provide context and to explain features and advantages of embodiments of the present invention, but are not intended to limit the scope of the invention as defined by the claims.

[0176] A method of using an imaging device to acquire time-series in-vivo images of a region 230 of a patient's body 210 over a single breath of the patient 200 will now be described with reference to the imaging device 100 of FIGS.

[0177] The patient 200 enters the imaging device 100 between the energy source unit 112 and the detector unit 122 and is seated in a seat or chair 124 facing the energy source unit 112. The position and / or orientation of the patient's body 210 between the energy source 110 and the detector 120 is detected using a camera 160, preferably a depth-based video camera system. The depth-based video camera system (e.g., a video camera combined with LIDAR, a Microsoft Kinect-type system, a stereo camera setup, etc.) allows visualization of the position and / or orientation of the patient 200 and detection of the patient's 200 movement and / or breathing. The motion-based system 154 uses the image data from the camera 160 to locate and measure important patient reference points to detect the position and / or orientation of the patient's body 210.

[0178] The processor 150 determines adjustments to the detected position and / or orientation of the patient's body 210 to a desired position for acquiring an image of the scanned region 230. The adjustments may also be determined based on an estimated position of the imaged region 230 using historical matching data (e.g., a model of the lungs' location in the body based on other lung scans) or pre-acquired data of the patient 200 (such as previous scan data or physique characteristics / attributes of the patient 200).

[0179] The processor 150 also determines if the patient 200 is not sitting upright and is leaning to the side or forward or backward. This is accomplished by evaluating data from the camera 160. If the patient 200 is outside the desired position for image acquisition, the patient 200 is given patient positioning directions to make adjustments and move to the desired position for the scan. The directions are provided via the display 118 and / or speaker 119 via the communication system 188. If the region 230 of the patient's body 210 to be scanned is not within the field of view, the operator manually adjusts the seat 124 to the desired position for the scan, or this is done automatically by the controller 140 of the imaging device 100 operating the actuators of the seat 124.

[0180] Position verification is optionally performed by a low-dose pre-scan of the patient 200 using an X-ray image acquired from a single projection via the energy source / detector pair. The processor 150 is configured to process the image data, identify the region 230 to be imaged, and determine any necessary adjustments to the subject's body 210 to the desired position. Again, the patient 200 is instructed to move to the desired position, and / or the seat 124 is moved (as needed) manually or automatically to the desired position. Furthermore, once the patient 200 is correctly positioned, the magnification of the energy source 110 / detector 120 is optionally adjusted to ensure that the lungs are properly positioned in the field of view (FOV) of each of the detectors 120. This is accomplished by moving the patient 200 toward the detector 120 (i.e., to decrease the magnification) or further away from the detector 120 (i.e., to increase the magnification). The patient 200 may be moved using the seat 124 (e.g., manually by an imaging technician or operator or automatically by the imaging device 100) or by moving the patient's body 210 (e.g., by the operator or imaging device 100 giving instructions to the patient 200, or by the operator moving the patient's body 210).

[0181] The patient 200 is then optionally given breathing instructions before the scan begins. The instructions are provided by the operator or automatically to the display 118 and / or speaker 119 via the communication system 188. The patient 200 is instructed to relax and breathe normally. The patient's breathing is then monitored using a flow meter in the imaging device 100. The flow meter measures airflow during the patient's breathing. The processor 150 receives airflow data from the flow meter over a predetermined period, e.g., one minute of the patient breathing in a relaxed state. The processor 150 processes the airflow data to determine volume versus time and determines whether sufficient repetitive breathing patterns free of artifacts (e.g., hiccups, sneezing, runny nose, coughing, and hyperventilation) are detected in each analyzed sequence. If a repetitive breathing pattern is detected, the processor 150 analyzes the pattern to identify one or more characteristics of the subject's 200 breathing cycle.

[0182] Processor 150 determines the patient's 200 expected breath length for image acquisition by measuring the time between successive maxima or minima in the volume versus time curve, and / or by determining an average volume versus time curve and then measuring the time between successive maximums or minima, or through spectral analysis of the volume data. Processor 150 also determines the expected inspiration time by calculating the length of time between the time points of minimum and maximum volume, and determines the expiration time by calculating the length of time between the time points of maximum and minimum volume.

[0183] The processor 150 then calculates the required number of phases and / or frames, as well as the required time between frames, using the breath length or inspiration time. The frame rate based on the expected breath time is calculated as Nb / Tb, where Nb is the desired number of frames per breath and Tb is the patient's measured breathing period. Nb is a value between 5 and 15, optimized for successful CTXV scanning without excessive dose. The start time for image acquisition is determined based on the amplitude of the respiratory signal (volume vs. time curve) corresponding to the start of inspiration, and image acquisition is timed to begin just before the start of inspiration (e.g., one or two frames before the start of inspiration). The end time for image acquisition can be determined based on the expected breath length or expected inspiration time. This results in a trigger signal for image acquisition.

[0184] The trigger signal is also optionally determined based on the patient 200 being in a substantially stationary position within the scanner 100. Non-breathing-related motion of the patient's body 210 is monitored through data acquired using the camera 160, which is preferably a depth-aware video camera system. Sensor data from the camera 160 is processed by the processor 150 to monitor the motion of the patient's body 210 within the scanner 100. Multiple sensor readings are acquired over a predetermined period of time to provide multiple data points about changes in the subject's body movement within the scanner 100. If a change in movement is detected by the processor 150, the scanner 100 outputs to the patient 200 and / or operator via the display 118 and / or speaker 119 that motion has been detected and that a scan should not begin. Instructions are optionally output to the subject 200 and / or operator via the display 118 and / or speaker 119 instructing the subject 200 to remain stationary and continue breathing normally to begin image acquisition. The processor 150 then continues to monitor the subject's motion until successive comparisons of the sensor readings reveal no motion or only limited motion based on threshold requirements. The trigger signal that initiates image acquisition may include at least a start time when the patient 200 is in a substantially stationary position.

[0185] Imaging of region 230 is then performed by either the operator arming scanner 100 and initiating the scan process, or by processor 150 automatically activating imaging. Optionally, the patient's respiration can be monitored during image acquisition using a flow meter in imaging device 100. Processor 150 can process the airflow data to determine the end time of image acquisition based on the amplitude of the respiratory signal (volume versus time curve) corresponding to the end of exhalation. The scan is then terminated automatically by scanner 100 or manually by the operator. Time-series in-vivo images of region 230 of patient's body 210 are thus acquired over one breath of patient 200. Patient 200 then exits imaging device 100.

[0186] The image data is optionally uploaded to a computer (e.g., processor 150 in scanner 100 or a remote computing device) and subsequently uploaded to the cloud for XV processing via an XV processing unit 186 located off-board scanner 100. Finally, XV processing unit 186 optionally reconstructs a three-dimensional motion field of region 230 of patient's body 210.

[0187] It should be understood that the following claims are provided by way of example only and not as limiting the scope of what may be claimed in any future application. Features may be added to or omitted from the claims at a later date so as to further define or redefine the invention or inventions.

Claims

1. An imaging device for acquiring time-series in vivo images of at least a portion of a subject's lungs, comprising: At least three energy sources; at least three detectors for detecting energy from the at least three energy sources passing through the portion of the subject's lungs, the at least three detectors being positioned between the energy sources and the detectors; a controller configured to operate the at least three energy sources and the at least three detectors to acquire three time-series in-vivo images of the portion of the subject's lung; at least one sensor for monitoring a physiological parameter associated with the portion of the subject's lung being imaged; at least one processor configured to determine timing of acquisition of the images based at least on the monitored physiological parameters; Including, and at least one sensor for monitoring a physical movement of the subject, the sensor being positioned between the energy source and the detector, the processor further comprising: determining the timing of image acquisition based also on the monitored body movement of the subject; processing data from the at least one motion monitoring sensor to detect bodily motion of the subject positioned between the energy source and the detector; monitoring the detected motion to determine whether the subject is in a substantially stationary position; determining a trigger signal to initiate image acquisition when the subject is in the stationary position, the trigger signal including at least a start time; An imaging device configured to reconstruct a three-dimensional motion field of the lungs based on the three acquired time series images.

2. The imaging device of claim 1 , wherein the at least one sensor for monitoring the physiological parameter is configured to detect a physiological parameter related to respiration of the subject.

3. The processor further comprises: analyzing data from the at least one sensor for monitoring the physiological parameter to detect a breathing pattern of the subject and / or a duration of the subject's breathing; monitoring the detected breathing pattern and / or the duration of the subject's breathing to determine if a repetitive breathing pattern is detected; The imaging device according to claim 2 , configured as follows:

4. If the repetitive breathing pattern is detected, the processor further: analyzing the repetitive breathing pattern to identify one or more characteristics of the subject's breathing cycle; determining the trigger signal to initiate image acquisition, including at least the start time and / or end time, based on the one or more identified characteristics of the respiratory cycle; The imaging device according to claim 3 , configured as follows:

5. the at least one sensor for monitoring the physiological parameter is positionable near and / or in the subject's mouth; a flow meter for monitoring changes in airflow near and / or within the subject's mouth; a thermal sensor for monitoring changes in the temperature of the air near and / or within the subject's mouth; and a gas sensor for monitoring changes in the air content of the gas near and / or in the subject's mouth; The imaging device according to claim 1 , further comprising one or more of:

6. The imaging device of claim 1 , wherein the at least one sensor for monitoring movement includes one or more of a motion sensor, a resistive sensor, a weight sensor, a force sensor, and a pressure sensor.

7. and at least one sensor for detecting a position and / or orientation of the subject's body located between the energy source and the detector, wherein the processor further: The imaging device of claim 1 , configured to determine the timing of image acquisition based also on the detected position and / or orientation of the subject's body.

8. The processor further comprises:

8. The imaging device of claim 7, configured to determine adjustments to the position and / or orientation of the subject's body to a desired position between the energy source and the detector to acquire the image of the portion of the subject's lungs.

9. The processor further comprises: estimating a position of the portion of the subject's lung to be imaged using pre-acquired data; determining the desired location for acquiring the image based on the estimated location; The imaging device according to claim 8 , configured as follows:

10. The processor further comprises: one or more pre-acquired images of the portion of the subject's lung; one or more physical characteristics of the subject selected from the group comprising anatomical dimensions, height and / or weight of the part and / or body of the subject; and one or more attributes of the subject selected from the group including age, sex, mobility, ethnicity, medical condition, and medical history; The imaging device of claim 9 , configured to receive the pre-acquired data including at least one of:

11. a support member for supporting the subject's body in a position between the energy source and the detector; an actuator operable to adjust the position and / or orientation of the support member; The imaging device according to claim 8 , further comprising:

12. The controller further comprises:

12. The imaging device of claim 11, configured to control the actuator to adjust the position and / or orientation of the support member to support the subject's body in the desired position for acquiring the image.

13. further including an output device; The processor further comprises:

13. The imaging apparatus of claim 12, configured to use the output device to output instructions to an operator and / or the subject to adjust the position and / or orientation of the subject to the desired position for acquiring the image.

14. 14. The imaging device of claim 7, wherein the at least one sensor for detecting position and / or orientation comprises one or more of a camera, an optical sensor, a motion-based sensor, and a laser sensor.

15. The imaging device of claim 1 , wherein the portion of the imaging target includes an entire lung of the subject.

16. 16. The imaging device of any one of claims 1 to 15, configured for use in one or more of X-ray imaging, ultrasound imaging, and magnetic resonance imaging (MRI).

17. An imaging device described in any one of claims 1 to 16, wherein the controller is configured to acquire three time-series in vivo images of the portion of the subject's lungs while the energy source and the detector are stationary.

18. A method for obtaining time-series in vivo images of at least a portion of a lung of a subject, comprising: At least three energy sources; at least three detectors, at least one detector detecting energy from the at least three energy sources passing through the portion of the subject's lung located between the energy sources and the detector; a controller configured to operate the at least three energy sources and the at least three detectors to acquire three time-series in-vivo images of the portion of the subject's lung; providing an imaging device comprising: monitoring, with at least one sensor, a physiological parameter associated with the portion of the subject's lung being imaged; determining, with at least one processor, the timing of acquisition of the images based at least on the monitored physiological parameters; operating the controller to acquire three of the time-series in-vivo images of the portion of the subject's lung; and monitoring, with at least one sensor, bodily movement of the subject positioned between the energy source and the detector; The method further comprises the processor: determining the timing of image acquisition based also on monitored body movements of the subject; processing data from the at least one motion monitoring sensor to detect bodily motion of the subject positioned between the energy source and the detector; monitoring the detected motion to determine whether the subject is in a substantially stationary position; determining a trigger signal to initiate image acquisition when the subject is in the stationary position, the trigger signal including at least a start time; a step configured to reconstruct a three-dimensional motion field of the lungs based on the acquired three time-series images; A method comprising:

19. 20. The method of claim 18, further comprising detecting a physiological parameter related to the subject's respiration using the at least one sensor for monitoring the physiological parameter.

20. the processor analyzing data from the at least one sensor for monitoring the physiological parameter to detect a breathing pattern of the subject and / or a duration of the subject's breathing; the processor monitoring the detected breathing pattern and / or duration of the subject's breathing to determine if a repetitive breathing pattern is detected; 20. The method of claim 19 further comprising:

21. If the repetitive breathing pattern is detected, the processor analyzing the repetitive breathing pattern to identify one or more characteristics of the subject's breathing cycle; determining, by the processor, a trigger signal to initiate image acquisition based on the one or more identified characteristics of the respiratory cycle, the trigger signal including at least a start time and / or an end time; 21. The method of claim 20 further comprising:

22. positioning the at least one sensor for monitoring the physiological parameter near and / or in the subject's mouth; below, monitoring airflow changes near and / or within the subject's mouth using a flow meter; monitoring temperature changes of the air near and / or within the subject's mouth using a thermal sensor; and monitoring changes in the air content of the gas near and / or in the subject's mouth using a gas sensor; 22. The method of any one of claims 18 to 21, further comprising one or more of:

23. 23. The method of any one of claims 18 to 22, wherein the portion of the imaging target includes all of the subject's lungs.

24. 24. The method of any one of claims 18 to 23, wherein the imaging device is configured for use in one or more of X-ray imaging, ultrasound imaging, and magnetic resonance imaging (MRI).

25. A method described in any one of claims 18 to 24, comprising a step of configuring a controller to acquire three time-series in vivo images of the portion of the subject's lung while the energy source and the detector are stationary.

26. An imaging device for acquiring time-series in vivo images of at least a portion of a subject's lungs, comprising: At least three energy sources; at least three detectors for detecting energy from the at least three energy sources passing through the portion of the subject's lungs, the at least three detectors being positioned between the energy sources and the detectors; a controller configured to operate the at least three energy sources and the at least three detectors to acquire three time-series in-vivo images of the portion of the subject's lung; at least one sensor located between the energy source and the detector for detecting a position and / or orientation of the subject's body; at least one processor configured to determine timing of image acquisition based at least on the detected position and / or orientation of the subject's body; Including, and at least one sensor for monitoring a physical movement of the subject, the sensor being positioned between the energy source and the detector, the processor further comprising: determining the timing of image acquisition based also on the monitored body movement of the subject; processing data from the at least one motion monitoring sensor to detect bodily motion of the subject positioned between the energy source and the detector; monitoring the detected motion to determine whether the subject is in a substantially stationary position; determining a trigger signal to initiate image acquisition when the subject is in the stationary position, the trigger signal including at least a start time; An imaging device configured to reconstruct a three-dimensional motion field of the lungs based on the three acquired time series images.

27. A method for obtaining time-series in vivo images of at least a portion of a lung of a subject, comprising: At least three energy sources; at least three detectors for detecting energy from the at least three energy sources passing through the portion of the subject's lungs, the at least three detectors being positioned between the energy sources and the detectors; a controller configured to operate the at least three energy sources and the at least three detectors to acquire three time-series in-vivo images of the portion of the subject's lung; providing an imaging device comprising: detecting, using at least one sensor, a position and / or orientation of the subject's body located between the energy source and the detector; determining, with at least one processor, timing of image acquisition based at least on the detected position and / or orientation of the subject's body; operating the controller to acquire the time series of in-vivo images of the portion of the subject's lung; and monitoring, with at least one sensor, bodily movement of the subject positioned between the energy source and the detector; The method further comprises the processor: determining the timing of image acquisition based also on monitored body movements of the subject; processing data from the at least one motion monitoring sensor to detect bodily motion of the subject positioned between the energy source and the detector; monitoring the detected motion to determine whether the subject is in a substantially stationary position; determining a trigger signal to initiate image acquisition when the subject is in the stationary position, the trigger signal including at least a start time; a step configured to reconstruct a three-dimensional motion field of the lungs based on the acquired three time-series images; A method comprising:

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