Non-invasive imaging methods for objects

Abstract

The system calculates the necessary techniques before the patient is exposed to radiation energy, generates superior captures of radiation images, and reduces the radiation dose. [Solution] The device comprises an energy source, a discharge passage, and a plurality of blades positioned within the discharge passage with a discharge window formed therein, filtering the energy passing through the discharge passage, and a motor assembly comprising a first motor coupled to the proximal swivel bearing and a second motor coupled to the distal swivel bearing, wherein the proximal and distal swivel bearings move in opposite directions due to the opposite rotation of the first and second motors, thereby increasing or decreasing the size of the discharge window.

Description

[Technical Field]

[0001] The present invention generally relates to improved methods and systems for X-ray and fluoroscopic imaging, particularly to versatile multimode imaging systems incorporating an operable handheld X-ray emitter for capturing digital or thermal images of an object, an operable stage for capturing static X-ray and dynamic fluoroscopic images of an object, a system for tracking and positioning X-ray emissions, a device for automatically limiting the field of X-ray emissions, and a method of use. The present invention also includes an automated system for automatically pre-determining the correct technical factors for fluoroscopy and radiography. By utilizing a sensor-driven, iterative, and networked, continuously improving computational approach, images can be captured more quickly and accurately without operator input, while simultaneously reducing exposure to patients, operators, and staff. [Background technology]

[0002] Current orthopedic surgical fluoroscopy systems use a large "C-arm" with the radiation source fixed to an image intensifier. Operating these large, unportable machines is difficult and time-consuming. The subject's position needs to be frequently changed to match the achievable field of view, which can be problematic during sensitive stages of the procedure. Thus, while the C-arm is ergonomically suitable for surgical treatment of the spine and larger joints, for surgical procedures on the hand / wrist / arm and foot / ankle / lower limbs, existing units are heavy and cumbersome, even when the relevant anatomical tissues are smaller and the surgeon is more mobile. Existing fluoroscopy machines are also expensive and emit large amounts of radiation. Often, these higher radiation doses are unnecessary for more delicate procedures, such as those involving limbs, unnecessarily exposing patients and surgeons to these higher doses.

[0003] In today's surgical environment, digital photographs and videos are often needed to document relevant surgical anatomy and pathology. Thermal imaging can also be a useful tool, especially for limb surgeons. Thermal imaging may be used to help determine whether blood supply to a limb or finger is threatened and whether reperfusion is necessary. Adding thermal imaging provides a quick and simple tool to guide intraoperative decision-making. However, existing fluoroscopy systems only take X-ray images, requiring a switch to a digital and / or thermal imaging system, which can delay the completion of surgery. Furthermore, in many situations, digital or thermal cameras are not sterile devices, forcing surgeons to intrude on the surgical area, take a picture, scrub, and return, or have an assistant take the picture, which can lead to confusion regarding image correlation.

[0004] Historically, X-ray images have been acquired using image intensifier devices. Due to their design and construction, the active area of ​​these devices has traditionally been circular. Due to manufacturing processes, the active area of ​​modern X-ray detectors, which utilize digital components, is typically rectangular. To provide a safe operating environment for both the user and the subject, it is necessary to ensure that X-ray emissions illuminate only the active area of ​​the X-ray detector. To achieve this safety requirement, a device that limits the size and shape of the X-ray beam is placed directly along the beam's path. This device is called a collimator.

[0005] Most fixed-position X-ray systems, where the orientation and distance between the X-ray source and X-ray detector are fixed, are equipped with a static collimator, which is typically sized and positioned during the calibration process. This calibration process is infrequent, usually performed only once a year.

[0006] In most dynamic position X-ray systems, where the orientation of the X-ray source is fixed but the distance between the X-ray detector and the X-ray source is variable, a collimator would be provided that can adjust the size of its aperture as the distance between the detector and the X-ray source changes.

[0007] The new, freely configurable X-ray system uses an array of sensors to allow the operator to position the radiation source and detector in any direction. From a collimation perspective, this presents new challenges that could not be addressed with conventional collimator designs.

[0008] To illuminate a complete rectangular field of view of the X-ray detector while allowing the operator to orient the radiation source at any desired position, a dynamic rolling collimator is necessary. Using a sensor array, the device can adjust the projection of the square onto the detector regardless of the alignment position by adjusting the size and angle of the collimator within the radiation source.

[0009] Therefore, there is a need for a small, lightweight system and method that allows surgeons to take X-ray images without having to rearrange the equipment.

[0010] Furthermore, there is a need to improve the quality of X-ray or fluoroscopic imaging, and this quality is related to many physical attributes of the subject. These factors define a set of technical factors (e.g., power, current, time) that control the radiation characteristics of the radiation source. It is the responsibility of the equipment operator to combine and set these factors so that the interpreter can see the necessary visual elements without exposing the subject to excessive radiation.

[0011] Setting these technical factors can be complex. Conventional fluoroscopy systems have automated processes to reduce the burden on operators who manually set these technologies. A typical approach involves using software or hardware dose detectors on the plate and gradually filling it while applying radiation. This approach has several challenges.

[0012] A major problem with existing approaches is motion. Because radiation is being applied to the subject over a long period of time, any movement—from the subject, the operator, the equipment, or even the blood vessels inside the subject—generates motion artifacts that severely degrade the image.

[0013] Furthermore, in conventional systems, the transmittance requirements are unknown before exposure, so the radiation source emits radiation at a predetermined power level (kV), often resulting in insufficient transmittance to create an image. Because images cannot be displayed in this way, patients, operators, and staff are exposed to excessive radiation without a clinical purpose.

[0014] The need remains to apply the capabilities of a new generation of systems with complex sensor arrays that can directly measure the number of physical elements necessary for radiation exposure calculations, and to use these improved systems to apply learning algorithms that assist medical professionals in obtaining optimal radiation images. [Overview of the Initiative] [Problems that the invention aims to solve]

[0015] By utilizing improved systems, sensors covering the full spectrum of the subject, and robust machine learning techniques, it is possible to compute the necessary techniques before the patient is exposed to radiation energy. This allows for the elimination of motion artifacts, the generation of superior radiation image captures, and the reduction of all exposure doses. [Means for solving the problem]

[0016] The present invention relates to an improved, versatile multimode radiography system and method that allows surgeons to perform surgery on patients without interference and to acquire static and dynamic X-rays and other still and video images without repositioning the equipment, patient, or surgeon.

[0017] Both X-ray emitters and detectors are described. One novel modification of the emitter allows for portable control of the emitter. Such emitters can be lightweight and highly maneuverable. Modifications include a portable emitter, which is a handheld unit. Alternatively, the portable emitter can be automated / controllable or fixed to a mounting structure that simply bears the weight of the emitter, to prevent the user from constantly holding the emitter. In further modifications, the emitter can be configured to be detachably coupled to a mounting structure, allowing for improved portability as needed and allowing it to be coupled to a mounting structure as desired. The emitter may include both X-ray emitters and at least one additional imaging modality, such as a digital camera, for generating visual, thermal, and infrared images of a patient, for the purpose of assisting in diagnosis, surgical interventions, and non-surgical interventions. Clearly, the systems and methods described herein can be used in non-medical applications where non-invasive imaging is desirable.

[0018] Ergonomically designed controls make image acquisition easier and faster, and an integrated display facilitates user-friendly control functions. The device detects the distance from the subject and will shut off radiation activation and emission if the X-ray tube is not at a safe distance, i.e., too close to the patient. The shortest distance can be defined in software and adjusted based on application and other factors. With the implementation and use of an inertial measurement unit (IMU) and various timing elements, the system automatically and intelligently manages its power state.

[0019] The X-ray emitter can be used in combination with any available X-ray detector. One option is to mount the emitter to a fixture including a properly positioned detector plate, which is similar to a conventional C-arm but much smaller and has greater capacity. Alternative modifications are described herein and disclosed in detail, including the use of an emitter having a clear X-ray capture stage, which automatically pivots with the emitter, orientations, and aligns itself to maximize exposure, quality, and safety.

[0020] The X-ray stage of the present invention comprises a statically fixed platform positioned at the start of surgery, having an open cavity that includes an X-ray sensor, an X-ray sensor positioning system, an emitter tracking system, a shielding system, and a control unit. Optionally, the system may utilize an external display monitor or any other method for reviewing captured images.

[0021] Modifications of the improved system described may include non-invasive imaging systems for examining objects for medical and non-medical examinations. Such a non-invasive imaging system comprises an emission device configured to emit energy; an imaging sensor configured to generate an imaging signal upon receiving energy, provided that the emission device and the imaging sensor are in operationally aligned positions; a platform having an outer surface for positioning an object and comprising at least one positioning mechanism positioned adjacent to the outer surface; at least one positioning mechanism coupled to the imaging sensor adjacent to the outer surface to allow movement of the imaging sensor; at least one position tracking element fixed to the platform; and a control system. The emission device is movable relative to the outer surface of the platform, the control system is configured to determine a first coordinate measurement between at least one position tracking element and the imaging sensor, the control system is configured to determine a second coordinate measurement between the emission device and at least one position tracking element, and the control system uses the first and second coordinate measurements to control the operation of the positioning mechanism to move the imaging sensor to an aligned position during or after movement of the emission device.

[0022] Modifications of the improvements described herein also include improved methods for non-invasively imaging an object. For example, such a method may include the steps of: moving an emitter to a position relative to an object; determining the position of the emitter with respect to at least one position tracking element; relaying the position of the emitter to a motor system that adjusts an imaging sensor to an operable alignment with the emitter; releasing energy from the emitter when the imaging sensor is in an operable alignment with the emitter; and transmitting an image signal from the imaging sensor to a display.

[0023] In another aspect of the method, a step of non-invasively imaging an object by moving an emitting device to a relative position with respect to the object, a step of emitting energy from the emitting device to the object such that the energy is received by an imaging sensor configured to generate image data, a step of determining the position and orientation of the emitting device with respect to at least one position tracking element disposed at a fixed position relative to the imaging sensor, a step of adjusting the image data using the position and orientation of the emitting device, and a step of transmitting the image data to a display may be included.

[0024] A modification of the system may include a platform having a plane that enables positioning of the object. Alternatively, the platform may include a support frame that enables fixing the object over free space such that a portion of the object located in free space can be viewed or inspected either in the whole or substantially the whole of the surroundings of the object.

[0025] In the systems, devices, and methods described herein, emitters and sensors are placed in alignment or operable alignment, where the degree of alignment can include any industry specifications that define the alignment. For example, for medical applications, the alignment of the systems and methods described herein can include the degree of alignment required to comply with the federal regulations of the U.S.C.F.R. (e.g., 21 C.F.R. part 1020, incorporated herein by reference) applied by the Food and Drug Administration Department of Health and Human Services for health and human services. Neither the length nor the width of the x-ray field within the plane of the receiver (sensor) shall exceed 3 percent of the source-to-image distance (SID), the sum of the excess length and excess width shall not exceed 4 percent of the SID, and the alignment error shall be determined along the length and width dimensions of the x-ray field passing through the center of the visible area of the receiver. In other applications, or alternative jurisdictions, the alignments discussed herein may vary to meet their respective requirements. Alternatively, variations of the systems, devices, and methods can include measurements to obtain a substantially orthogonal positional relationship between the emitter and the receptor.

[0026] Similar to alignment, the minimum or maximum distance between the emitter and the receptor can be established by industry standards. In one example, the above FDA regulations are used to provide a maximum source-image receptor distance of less than 45 cm and means for limiting the source-skin distance to less than 19 cm.

[0027] In use, the stage accurately tracks the position and angle of the x-ray emission, accurately positions and tilts the embedded sensors to capture accurate and high-quality x-ray images. This stage requires less power to operate, corrects for emission skew and perspective, can keep the subject in place, and can continue without interrupting the surgeon's workflow.

[0028] In the "clinical" embodiment, the X-ray capture stage is statically positioned, and the emitter uses positioning to ensure that it is only fired when the emission can be positively captured by the active area of ​​the capture stage. If this positive capture is no longer obtained, firing is immediately terminated.

[0029] Another modified version of the improved system for taking radiographic images of an object is an emitter configured to emit energy under multiple output parameters when the emitter is activated, An imaging sensor configured to generate a radiation imaging signal when exposed to energy, A position tracking system comprising a plurality of sensors coupled to an emission device or an imaging sensor, wherein the position tracking system is configured to track the orientation between the emission device and the imaging sensor, A camera configured to capture an image of an object, It comprises a control unit, and the control unit is When tracking the orientation of the emission device relative to the image sensor, determine at least one sensor parameter of the position tracking system and verify that at least one sensor parameter of the emission device relative to the image sensor satisfies at least one operational safety parameter. The image of the object is analyzed, and a computer vision classifier database consisting of previously obtained images is used to assign a classification to the object. At least one inferred operating parameter is estimated using an estimator database of previously obtained data, including at least one sensor parameter, object classification, and sensor parameters. Set at least one of the multiple output parameters to at least one inferred operating parameter, and start releasing energy from the emitter. The radiation image is processed using the radiation imaging signal generated by the imaging sensor from the energy exposure. It is configured to transmit radiographic images to a display.

[0030] The control unit may be further configured to record at least one user interaction with the system for adjusting radiographic images.

[0031] In one embodiment, at least one user interaction includes adjustments to the radiographic image selected from the group consisting of brightness, sharpness, contrast, position, zoom, rotation, and any combination thereof. User interaction with the system may include manipulation of the radiographic image.

[0032] A modified version of the system includes a control unit configured to record the duration of user interaction with the system in order to adjust radiographic images.

[0033] At least one operational safety parameter may include a parameter selected from the group consisting of the distance from the source to the object, the distance from the source to the detector, the angle of incidence, the alignment from the source to the sensor, and the temperature of the emission device.

[0034] The control unit may be further configured to estimate at least one inferred operating parameter using at least one or more operating safety parameters.

[0035] In another embodiment, the control unit uses a position tracking system to further determine the alignment between the imaging device and the imaging sensor.

[0036] Modifications of the system are available in which the object includes a part of a patient's body, and the control unit is further configured to determine at least one inferred operating parameter using a CPT code.

[0037] In another aspect of the system, the control unit is further configured to use biometric data to determine at least one additional inferred operating parameter.

[0038] The systems described herein may further include one or more data storage devices. Such data storage devices may include a database of reference images, and the control unit is configured to analyze images of an object using the database of reference images. In yet another embodiment, the data storage device includes at least one statistical model that correlates radiation parameters with a plurality of historical sensor data and a plurality of historical classification data, and the control unit is configured to additionally determine at least one inferred operating parameter using the statistical model.

[0039] This disclosure also includes a method for radiographic imaging of an object, such method including the step of providing a radiographic imaging system comprising an emitter, an imaging sensor, a position tracking system comprising at least one sensor, and a camera. The emitter is configured to emit energy under a plurality of output parameters when the emitter is activated. The imaging sensor is configured to generate a radiation imaging signal when exposed to energy. The position tracking system and at least one sensor are configured to track the orientation between the emitter and the imaging sensor. The camera is configured to capture an image of the object. The method is, The process involves determining at least one sensor parameter when tracking the orientation of the emission device relative to the imaging sensor, A step of confirming that at least one sensor parameter satisfies at least one or more operational safety parameters, A process of assigning a classification to an object by analyzing the image of the object using a computer vision classifier database consisting of previously acquired images, The process involves estimating at least one inferred operating parameter using at least one sensor parameter, object classification, and an estimator database of previously acquired data including the sensor parameter, A step of setting at least one output parameter from among multiple output parameters to at least one inferred operating parameter, The process of starting the release of energy from the release device, A process of processing a radiation image using a radiation imaging signal generated by an imaging sensor from energy exposure, The process of transmitting a radiographic image to a display, Includes.

[0040] In another embodiment, the method of the present disclosure includes a method for determining an automatic exposure setting for one of a plurality of radiation imaging systems, each radiation imaging system including a camera, an emitter, an imaging sensor, one or more sensors, and a control unit configured to use one or more sensors to track the orientation between the emitter and the imaging sensor. A step of compiling a global measurement database that includes data selected from a group consisting of sensor data, interaction data, surgical data, and any combination thereof, wherein the data is collected over time from any of multiple radiographic imaging systems, the sensor data includes direct measurements from one or more sensors, the interaction data includes the interaction of an operator interacting with any of the multiple radiographic imaging systems to adjust radiographic images, and the surgical data includes details of surgery performed on any patient examined by any of the multiple radiographic imaging systems. The process involves compiling an imaging storage database containing raw imaging data from one of several radiographic imaging systems, A step of analyzing the statistical relationship between sensor data, interaction data, surgical data from global measurement data and previous estimator data, wherein the previous estimator data includes previously captured sensor data, previously captured interaction data, and previously captured surgical data, and the analysis of the statistical relationship generates modified estimator data. The process involves analyzing raw capture data, surgical data, and current computer vision classifier data to generate revised computer vision classifier data. The process involves transmitting the revised estimator data and revised computer vision classifier data to an active radiography imaging system. This includes, and as a result, the active radiography system, i) Using the revised computer vision classifier data, analyze images of the subject taken from the camera of the active radiography system and assign classifications to the images; ii) Using the sensor data, the classification and the revised estimator data, it is enabled to estimate at least one inferred operating parameter of the active radiation imaging system.

[0041] In one variation of the method, the step of compiling the imaging storage database further includes information about the specific radiographic imaging system that generates the raw imaging data.

[0042] In another variation of the method, interaction data includes adjustments to the radiographic image selected from a group consisting of brightness, sharpness, contrast, position, zoom, rotation, and any combination thereof. Interaction data may include the duration of interaction between the user and any of multiple radiographic imaging systems to adjust the radiographic image. Surgical data consists of one or more CPT codes.

[0043] In another variation of the method, the step of transmitting the revised estimator data and revised computer vision classification data to an active radioimaging system includes the step of storing the revised estimator data and revised computer vision classification data on a storage device that communicates with the active radioimaging system.

[0044] This application relates to U.S. Patent Application No. 15 / 716,099, filed on September 26, 2017, claiming the benefit of U.S. Patent Application No. 15 / 706,018, filed on September 15, 2017, claiming priority to U.S. Provisional Patent Application No. 62 / 394,909, filed on September 15, 2016; U.S. Provisional Patent Application No. 62 / 394,956, filed on September 15, 2016; U.S. Provisional Patent Application No. 62 / 471,191, filed on March 14, 2017; and U.S. Provisional Patent Application No. 62 / 504,876, filed on May 11, 2017, the entire contents of each application incorporated herein by reference. This application also incorporates by reference PCT Application PCT / US2017 / 051774, filed on September 15, 2017. [Brief explanation of the drawing]

[0045] [Figure 1A] This figure shows an example of an operating room layout for the use of an X-ray imaging system in standard surgery for limb cases. [Figure 1B] This figure shows an alternative operating room layout for using an image processing system equipped with a special operating table that improves access to the patient's area. [Figure 1C] This figure shows an alternative operating room layout for using an image processing system equipped with a special operating table that improves access to the patient's area. [Figure 2] This is a simplified schematic diagram of the X-ray emitter according to the present invention. [Figure 3] This figure shows a control panel according to one embodiment for use in an emitter. [Figure 4] This diagram shows the procedure for safe lockout of the X-ray emitter. [Figure 5] A typical sequence diagram for emitter power management is shown. [Figure 6] This diagram illustrates the process by which a device takes images in parallel in response to a user's request. [Figure 7] This figure shows the overall components of a preferred embodiment of the capture stage. [Figure 8A] This is a perspective view showing the sensor positioning system. [Figure 8B] This diagram illustrates an infrared (IR) positioning tile. [Figure 9] This diagram shows the x and y coordinate movements of the sensor tray as viewed from above. [Figure 10A] This is a perspective view showing the capture stage using band operation. [Figure 10B] This is a schematic diagram showing the band manipulation stage, which involves the identification of key components. [Figure 11A] This is a side view showing the tilt movement of the sensor. [Figure 11B] This is a side view showing the panning operation of the sensor. [Figure 12A] This diagram shows an arrangement where the emitter does not need to be located on the image stage platform. [Figure 12B] This figure illustrates a further arrangement of an imaging system in which the sensor may be configured to move across the surface of a table to capture a lateral view. [Figure 13] This figure shows an infrared emitter that emits infrared rays from five points, enabling relative position calculations in three-dimensional space. [Figure 14] This diagram illustrates safe lockout of the capture stage based on the emitter placement. [Figure 15] This is a diagram illustrating the acquisition of a fluoroscopic image. [Figure 16] This figure shows an X-ray emission device with an opening that forms the widest cone. [Figure 17] This figure shows an X-ray emission device having an opening that forms a narrow cone. [Figure 18] This figure shows a control unit that can be operated to adjust the opening and cone. [Figure 19] This is a diagram with labels illustrating relative distances. [Figure 20] This illustrates a situation where the emission device casts an energy profile that exceeds the profile of the imaging sensor. [Figure 21A]This diagram shows a situation where the emission profile extends beyond the sensor, preventing the emitter from being operationally aligned with the sensor. [Figure 21B] This figure shows the emission profile being scaled to remain within the boundaries of the imaging sensor and being operationally aligned with the sensor. [Figure 22A] This figure shows an example of the effect of an adjustable collimator to generate a scaled and / or rotated adjusted emission profile that remains within the boundaries of the imaging sensor. [Figure 22B] This figure shows an example of the effect of an adjustable collimator to generate a scaled and / or rotated adjusted emission profile that remains within the boundaries of the imaging sensor. [Figure 23] This figure shows a modified example of an adjustable collimator that can be used in or in combination with a discharge device. [Figure 24A] This is an exploded view showing an example of an adjustable collimator. [Figure 24B] Figure 24A is a front view illustrating some of the components of the adjustable collimator. [Figure 24C] Figure 24A is a rear view illustrating some of the components of the adjustable collimator. [Figure 25A] This figure shows an example of an emitter with an adjustable collimator. [Figure 25B] This figure shows an example of an emitter with an adjustable collimator. [Figure 26A] This figure shows an example of a collimator validation method discussed herein. [Figure 26B] This figure shows an example of a collimator validation method discussed herein. [Figure 26C] This figure shows an example of a collimator validation method discussed herein. [Figure 26D] This figure shows an example of a collimator validation method discussed herein. [Figure 26E]This figure shows an example of a collimator validation method discussed herein. [Figure 26F] This figure shows an example of a collimator validation method discussed herein. [Figure 26G] This figure shows an example of a collimator validation method discussed herein. [Figure 26H] This figure shows an example of a collimator validation method discussed herein. [Figure 26I] This figure shows an example of a collimator validation method discussed herein. [Figure 26J] This figure shows an example of a collimator validation method discussed herein. [Figure 27] This figure shows an example of a conventional automated exposure process. [Figure 28A] This figure illustrates an improved system that relies on one or more databases to provide machine learning for determining exposure settings for radiographic images. [Figure 28B] This figure illustrates a process for improving the automated exposure process and database using feedback from the system described herein. [Modes for carrying out the invention]

[0046] Figure 1A shows an example of an operating room layout for the use of an imaging system in a standard surgery for limb cases. In this example, surgeon 102 is operating on the patient's left hand. Patient 104 is lying supine with the left upper limb abducted on a hand table 105, prepared and draped. The surgeon is seated adjacent to the patient's side, and the surgical assistant 106 is seated adjacent to the patient's head, with the hand table in between. Surgical instruments and equipment are laid out on a back table 108 directly behind the surgical assistant.

[0047] In one embodiment, the imaging system uses X-ray imaging. Thus, a sterilized X-ray emitter 110 according to the present invention is placed on a surgical hand table 105 for use. A monitor 112 is positioned on a stand immediately next to the hand table so that X-ray, fluoroscopic, thermal, and digital images can be wirelessly transmitted from the X-ray imaging system to a screen for the surgeon to view. The emitter 110 allows the surgeon to hold it with one hand and operate another instrument, such as a drill, with the other hand. A detector stage according to the present invention may be positioned on or within the table 105 to collect radiographic images for storage and / or viewing on an external monitor such as the device 112. As discussed herein, the emitter may be handheld, automatable / controllable, or simply fixed to a mounting structure that supports the weight of the emitter and prevents the user from constantly holding the emitter.

[0048] Figure 1B illustrates a further modification of the system, including a sensor 706 and an emitter 710, for use in a dedicated operating table 300. As shown, the operating table 300 includes a structure 302 that stabilizes the patient while increasing access to the area around the patient's organs, as some organs are suspended in free space. In this modification, a shell 707 containing the sensor 706 (described later) is coupled to a first boom or arm 716. The arm / boom 716 makes the sensor 706 movable. In an alternative modification, the boom 716 may be automated so that the sensor 706 is directly coupled to a controllable boom 716. Similarly, the emitter 710 is coupled to a second arm or boom 714 that can be fixed to a wall, ceiling, or portable frame structure. Figure 1C illustrates the arrangement of the sensor 706 and boom 716 adjacent to a portion of the patient 104's body so that the emitter 710 can be positioned in a desired location by an operator or medical professional. Modifications of the system allow the boom or arm to accommodate components of the device, such as a heat sink and power supply, and make the emitter smaller and easier to maneuver. In addition, either boom can be configured to include features to assist the physician in performing the procedure. For example, the boom may incorporate a locking system so that the physician can position at least one of the sensor 706 and emitter 710 and then lock the associated boom in place. In addition, or in combination, the boom may incorporate memory positioning so that, when performing a procedure, the boom can automatically retract to a predetermined position away from the operating space so that it does not interfere with the physician. In addition, the memory position may include a "last position" of the emitter or sensor so that the components can be automatically repositioned to their last position before the system moves away from the operating space.

[0049] Figure 2 is a simplified schematic diagram showing an X-ray emitter according to the present invention. Typical features of the device include ease of handling, light weight, and portability. Preferably, the device has a rounded handle that fits ergonomically into the surgeon's hand, allowing for better directing of fluoroscopic, digital, and thermal images to the limbs and surgical areas. Note that the drawing in Figure 2 is not intended to depict any particular decorative appearance.

[0050] The rear of the emitter 110 is provided with a control panel that allows activation of at least three different operating modes: fluoroscopy mode, digital imaging mode, or infrared thermal imaging mode. Once activated, each mode is controlled at the front of the device by a trigger 202. Pressing the trigger once activates the device and takes one image (i.e., one X-ray or digital image). Different operating modes may be activated. For example, pressing trigger 12 may activate live fluoroscopy, digital video, or infrared thermal imaging. Figure 2 also illustrates the emitter 110 as being coupled to a power supply 221. The power supply may be a battery 221 located away from or inside the emitter 110. Alternatively, or in combination, the power supply 221 can be coupled to the emitter 110 via wiring. In a further variation, the battery 221 may be located within the emitter 110 and used in addition to the remote power supply 221 to temporarily disconnect the emitter 110 from the external power supply while the internal battery 221 is being used to supply power.

[0051] Figure 3 illustrates a control panel according to one embodiment used in combination with an emitter. The control panel is located behind the discharge handle and controls various inputs and outputs of the system. The control panel is easily accessible to the user and is ergonomically designed to facilitate operation of the emitter. The control panel consists of a large, clear screen 204 (i.e., LCD or OLED), control buttons 302 located on the left side of the unit, control buttons 304 located on the right side of the unit, and a clickable toggle button 206 located in the center.

[0052] The display screen 204 shows the image, as well as a digital control panel for controlling fluoroscopy settings, digital camera settings, and infrared settings. The control panel may include a touchscreen. A toggle button 206 controls the power input in fluoroscopy and infrared modes, and controls the digital zoom in image mode. A preferred emitter structure houses a dynamic X-ray collimating cone 210, a digital camera lens 212, an infrared camera 214, and a distance sensor 216. The digital camera and infrared camera preferably use charge-coupled device (CCD) technology. The distance sensor may be infrared, acoustic, or other operating techniques well known to those skilled in the art of proximity and distance measurement. The sensor 216 continuously detects the distance from the patient and blocks the activation and emission of radiation if the X-ray tube is too close, for example, less than 19 cm directly from the patient. In addition, the system may include any number of auditory, visual, or tactile indicators to enable a physician or user of the system to determine that the sensor is within an acceptable distance or ready to emit. In further modifications, auditory, visual, and / or tactile indicators are positioned to allow the user to identify the system's operating state without taking their focus off the object being inspected. In one embodiment, a visible indicator (e.g., one or more LEDs) is positioned on the emitter, providing clearly distinguishable feedback regarding the system's distance, alignment, or other operating state.

[0053] The handle 200 tapers towards the tip, accommodating a high-voltage power supply 218, an external charging port 220, and a battery docking station 222. When the trigger 202 is activated in X-ray or fluoroscopy mode, a high voltage from the power supply 218 is supplied to the X-ray generation unit 230 via the high-voltage connector assembly 228. The power generated by the power supply 218 is converted into an appropriate input voltage usable by the X-ray generation unit 230. This power ranges from 1kV to 120kV, but is typically in the range of 30kV to 90kV in relation to clinical applications.

[0054] The X-ray generation unit 230 is custom-designed for the miniaturization required for instantaneous applications, but is based on an existing high-voltage emitter. Appropriate thickness of electrical insulating material surrounds the high-voltage power supply 218, connector assembly 228, and X-ray generation unit 230 to prevent radiation loss and maintain good beam quality. All three components 218, 228, and 230 are positioned immediately adjacent to each other to minimize potential interference with high-voltage leaks and low-voltage components within the system. In an alternative embodiment, components 218, 228, and 230 may be located in an external control unit (not shown).

[0055] A suitable layered combination of silicone rubber and epoxy encapsulates the X-ray generating unit 230 (except when X-rays are emitted to the collimator) to shield against radiation loss and dissipate the high temperatures generated by the operation of the X-ray tube. Radiation is generated by the X-ray tube and transmitted through the collimating cone 210 at the head of the device. Fluoroscopy settings such as peak kilovolts (kV), amperes (mA), and digital brightness are controlled by a digital control panel located on the back of the neck.

[0056] The digital camera lens 212 and the infrared thermal camera 214 are immediately adjacent to the collimating cone 210, and these components are also shielded by an insulator. The digital camera 214 is controlled by switching to digital mode using the control panel. Images are generated via a trigger 202 located on the device handle.

[0057] Similarly, the infrared thermal camera 214 is controlled by setting the device to infrared mode using a control panel. By holding down the trigger, a live infrared thermograph is generated. Digital X-rays, conventional digital visible images, and thermal images may be transferred to and displayed on an external screen 112 as shown in Figure 1. Depending on the level of cooperation between the emitter and detector as described below, X-ray images may be transferred directly to an external monitor for viewing. Memory 233 may be used to store any type of image collected, and such images may be encrypted at capture in accordance with the pending U.S. Patent Application No. 15 / 466,216, the entire contents of which are incorporated herein by reference. Audio pickup 235 may be provided for procedure memorialization or other purposes, and the recording may also be stored in memory 233, optionally in an encrypted form.

[0058] The device is powered by an external plug-in power supply equipped with an external charging port 220. The digital display, control interface, and trigger are controlled via a control system microprocessor electronic control unit 232 powered by a low-voltage power amplifier system 234. The low-voltage amplification system 234 and the microprocessor control system 232 are also conveniently located away from the high-voltage power supply to further minimize interference.

[0059] The following table lists the various control modes associated with the emitter using the multiple buttons and toggle switches on the control panel in Figure 3.

[0060] [Table 1] For various practical and certification reasons, it is important to maintain a minimum distance between the subject and the X-ray generator. This distance varies depending on many factors and can be set by the emitter software. Figure 4 shows the process by which the device manages the X-ray emitter safety lockout procedure. The safety lockout determination process is as follows:

[0061] Step 402 The user initiates the X-ray emission process by pressing the trigger during X-ray mode. This may be a fluoroscopic image or a still image.

[0062] Step 404: Retrieve the distance setting from the emitter's distance setting database.

[0063] Step 405 The distance measuring unit is activated and images the distance between the edge of the emitter and the subject directly in front of the emitter.

[0064] Step 406: Distance setting and distance measurement are relayed to the emitter's ECU calculation unit.

[0065] Step 408 In step 408, the ECU calculation unit uses distance measurement, distance setting, and internal generator offset to determine whether the emitter should fire.

[0066] Step 410: The determination of whether a launch or alarm has occurred is made by the ECU in step 410 and relayed to the hardware unit.

[0067] Step 412: If the ECU determines in Step 412 that the subject is too close to the emitter, the unit activates a warning procedure, displays a message on the LCD panel, and activates the lockout warning light.

[0068] Step 414: If the ECU determines in Step 414 that the subject is at a safe distance, the emitter signals all internal and external components to initiate the X-ray generation and emission process.

[0069] Since the device can move freely in three-dimensional space, the size of the projection cone from the X-ray emitter changes according to the distance to the target. Thus, according to the present invention, the cone size can be managed and controlled based on the distance of the X-ray emission device from a sensor placed on the stage.

[0070] Figure 16 is a simplified diagram illustrating an applicable X-ray source, including an anode 1602 and a cathode 1604. The anode typically contains a tungsten or molybdenum object 1606. A high voltage across the anode and cathode generates X-rays in the object, which form a cone 1608 that exits through an aperture 1610 in the housing 1612.

[0071] One aspect of the present invention includes a telescopic chamber positioned in the direction of the aperture and sensor. The distance from the X-ray source to the output aperture can be increased or decreased by rotating the external chamber along a screw-type internal mount. As shown in Figure 17, the angle widens when the aperture is closer to the source, and narrows when it is further away from the source.

[0072] Referring to Figure 18, the control unit 1802 in the handheld emitter controls the retractable aperture. Based on the following process, the control unit 1802 rotates the threaded shaft 1804 so that the threads engage with the groove 1806 in the retractable chamber 1614, causing the aperture 1610 to be directed toward and away from the X-ray source.

[0073] Referring to Figure 19, the control method is as follows. First, the distance between the X-ray origin of the device and the X-ray sensor is calculated. If the distance is outside the permissible range for X-ray emission, no X-rays are emitted. However, the distance between the X-ray origin and the sensor (d sIf the distance to [it] is within the allowable range, the aperture automatically moves to a predetermined position. Then, the distance from the X-ray origin to the aperture (da) is calculated, and the control unit rotates the aperture chamber to an appropriate distance.

[0074] R s Assuming that [it] represents the radius of X-ray emission when [it] contacts the sensor, the angle between the normalized vector of the sensor plate and the dispersion cone is θ = tan -1 (R s / d s ) and can be expressed as such. In order to accurately disperse and emit X-rays, the distance at which the aperture needs to be located from the emission source is d<00000​​​​​​​​​​​​​​​

[0077] The systems and methods described herein may also utilize multiple sensors to improve error correction and / or positioning. For example, if the emitter and detector / sensor are in place and the system loses tracking of one or more sensors on the platform, the loss of tracking can typically reduce the FPS of the output image. To address this situation, the emitter may include one or more inertial measurement units that can track the emitter's movement to adjust the intervening frame, especially when necessary. The IMU may then be used to adjust the intervening frame to increase the FPS of the output. In some modifications, with a sufficiently accurate IMU, an IMU may be used in place of, or in addition to, multiple sensors on the platform.

[0078] Figure 5 shows a typical sequence for power management.

[0079] Point 502 The user initiates the power sequence on the device by pressing a physical button on the emitter (i.e., 208 in Figure 2). This activates the device's electronics and puts the device into ON mode.

[0080] Point 504: The device's pickup is detected by the IMU in the emitter, and the power level is quickly raised to STANDBY. This STANDBY state initializes the entire power system and raises the power supply charge to a medium level.

[0081] Point 505 If the user does not shut down the device, move the emitter, or initiate it via the control panel or control computer, the device will automatically power down and enter the off phase after time t0.

[0082] Point 506: The user picks up and activates the device by changing the settings on the control panel itself or by bringing the device within range of an object detected by the built-in distance sensor. This further increases the device's power level by fully charging the power system and making the device radiant, thus putting the device into READY mode.

[0083] Point 507: After the duration of t1 has elapsed without the unit being actively activated, the emitter powers itself down to the STANDBY level.

[0084] Point 510: The user initiates X-ray imaging by pressing down trigger 202 on the emitter. Assuming all other safety checks are cleared, this further activates the power supply and emits a stream of X-ray photons toward the subject until state 511 is reached, at which point the emission is complete. However, once the device returns to READY mode, the user can continue emitting X-ray photons indefinitely at points 510', 511'.

[0085] After a duration t2 during which the emitter at point 511 is not firing, the device automatically powers itself down to the STANDBY level at point 520.

[0086] As shown in points 508, 522, and 524, the device follows the timing described above to transition from the ON phase to the OFF phase after a certain duration has elapsed without positive action to maintain or change the power state. By utilizing these steps, the device can conserve power while maintaining a READY state without user intervention.

[0087] Figure 6 illustrates the process by which the device acquires images in parallel, in response to user requests. By using settings on the emitter's control screen or by specifying simultaneous imaging in the control unit, the emitter initiates the process of acquiring any combination of X-rays, conventional digital images, and / or thermal images. The imaging process is as follows:

[0088] Step 602 The user initiates the capture sequence on the device by pulling the emitter trigger. This starts the capture process and parallel imaging process if sensor grouping is enabled.

[0089] Step 604: The emitter immediately enters X-ray standby mode and prepares to emit X-rays from the X-ray generator.

[0090] Step 604' Simultaneously, when enabled, the conventional camera component focuses on the desired subject. This preferably occurs as soon as the trigger is pressed.

[0091] Step 604: Simultaneously, when enabled, the thermal camera is powered on and the startup sequence begins. This also preferably occurs as soon as the trigger is pressed.

[0092] Step 606 As shown in Figure 4, the X-ray system begins its safety check.

[0093] Step 608 The digital imaging camera captures an image of the subject. Preferably, the image is automatically transferred to a control unit for display on an external monitor.

[0094] Step 610 The thermal camera captures a thermal image of the subject. Preferably, the image is automatically transferred to a control unit for display on an external monitor.

[0095] Step 620 In a preferred embodiment, after both steps 608 and 610 are completed and all safety checks from step 606 have been confirmed, the X-ray unit emits an X-ray, generating an X-ray image in the sensor. Preferably, the image is automatically transferred to a control unit for display on an external monitor. Thus, the X-ray system charges, checks for safety, and emits X-rays only after all other systems have been performed, in order to minimize operational interference.

[0096] Implementation of an X-ray detector The emitters described herein are intended for use in conjunction with an X-ray detector to acquire X-ray images. The emitters are not limited to the technology of the detector and can be used with any available flat-panel detector, even a film detector. However, given the complete portability of the emitters, procedures must be taken to ensure that the emitters are properly oriented relative to the detector and that clear images are acquired while avoiding false or unwanted X-ray emissions. One option is to mount the emitters in a fixture that includes a properly positioned detector plate, which is similar to a traditional C-arm but much smaller and has greater capacity. However, the preferred option is to use the emitters in conjunction with an X-ray capture stage, one of which includes an embedded sensor that automatically pivots, adjusts angles and aligns with the emitter to maximize exposure quality and safety.

[0097] A preferred X-ray capture stage includes a statically fixed platform that is positioned at the start of surgery, having an internal cavity containing an X-ray sensor, an X-ray sensor positioning system, an emitter tracking system, a shielding system, and a control unit. The X-ray capture stage is configured to receive X-ray emissions from individual emitter devices, including portable handheld units as described herein. Preferably, the X-ray capture stage also incorporates wireless (or wired) communication capabilities that allow for review of captured X-ray or fluoroscopic images on an external display monitor or on any other structure for the captured images, including external storage.

[0098] There are broadly two embodiments of the capture stage. In the clinical embodiment, the stage tracks the emission and simply locks out the X-ray emission if it is not in a straight line. The tracking stage embodiment also not only allows or locks out the emission according to the alignment, but also positions and tilts an embedded sensor to precisely track the position and angle of the X-ray emission in order to capture accurate and high-quality X-ray images. This configuration requires less power consumption, corrects for emission skew or perspective, and keeps the subject in place, so that the surgeon's workflow can continue without interruption and X-rays can be captured without repositioning the equipment, the subject, or the surgeon.

[0099] Figure 7 is a simplified diagram showing a preferred embodiment of an X-ray capture stage, including a platform 702 having a hollow cavity containing an embedded sensor 706. In one embodiment, the stage may have legs 703 and be used as a table. In another configuration, the stage may be enclosed in a bag and placed under the patient. Thus, the platform 702 is enclosed in a sterile drape, and surgical procedures can be performed on the platform, such as the table 105 in Figure 1.

[0100] The capture stage works in conjunction with a separate X-ray emitter 710. The X-ray emitter can have various configurations and embodiments, including wall-mounted, reinforced, and floor-standing types, in addition to the handheld unit described in detail above. Any embodiment is compatible with the operable X-ray stage, as long as the emitter's electronic system can communicate with the interface of the operable X-ray stage central control unit to provide pivoting, orientation, or alignment.

[0101] Platform 702 communicates electrically with the central control unit 704. A display monitor 712, electronically connected to the control unit 704, may be used for both displaying images and providing control of the entire system. Generally, the user interacts with the emitter 710, but in some cases, the user may interact directly with the central control unit 704 to manipulate images, set specific capture scenarios, control parameters, or adjust other settings. The system may also use a tablet, mobile phone, or other display device electronically connected to the central control unit for display purposes. The central control unit 704 and the display may be coupled to a single device such as a laptop computer or other mobile computing device. Optionally, the central control unit may be electronically connected to multiple display devices for educational or other purposes.

[0102] Figure 8A is a perspective view showing an X-ray capture stage according to the present invention. One particular configuration of the stage is a hollow, sealed shell, which measures approximately 20 inches x 30 inches (approximately 50.8 cm x approximately 76.2 cm), although the overall size of the present invention can be modified to suit other surgical applications. The shell forms a cavity 800 that houses an X-ray sensing sensor 706, which operates to capture X-ray emissions from an X-ray emitter. Suitable X-ray sensors are available from various commercial manufacturers. The sensor 706 is mounted on an electric moving system used to pan and tilt the sensor within the cavity. This electric system ensures that the sensor is precisely positioned to obtain the best image quality and capture view.

[0103] The X-ray sensor 706 is preferably mounted on a movable tray 802 that moves under controlled motion within the cavity 800. The tray and sensor can move in the XY direction and tilt along both axes, as described later. Figure 9 is a top view of the capture stage. The sensor 706 in the tray 802 is mounted to translate on a series of motorized rails 720, 722, so that the sensor can be positioned at any point along the X and Y axes within the shell. At least one of the X and Y tracks may be, for example, a screw rod, driven by a motor to precisely move the tray 802 laterally in the X and Y dimensions, respectively. As a further alternative, the XY movement of the tray may be controlled using bands 1002, 1004 in Figure 10A. Such bands are precisely controlled by rods 1006, 1008, causing tray supports 1110, 1112 to translate the tray 808. Although four tray supports 902 and 904 are shown in Figure 9, please note that single supports 1110 and 1112 may be used instead, as shown in Figure 10A.

[0104] Figure 10B is a schematic diagram showing a band operation stage with identification of key components. An X-ray detector 1030 is shown, and a detector carrier 1032 is depicted. In this particular embodiment, it is driven by an H-shaped belt 1040. Small offset bearings 1042 and large offset bearings 1044 are provided. The belt is driven by motors 1050, 1052. A stage housing 1060 is shown, and power is supplied via a cable 1062. Detector tilt motors 1070, 1072 are shown. An IR positioning tile 850 and an IR emitter 852, which were described with reference to Figure 8B, are shown. A typical IR emitter described herein is an active beacon, as it actively emits a signal or energy received by the emitter to help determine the position of the emitter. Alternatively, or in combination therewith, further variations of the methods, systems, and apparatus described herein may include passive markings or objects to help determine the orientation of the emitter. The system, apparatus, and method may include a camera or emitter that simply records a specific pattern (e.g., a QR symbol or a predetermined unique object within the surgical field such as a clock, table, or fixation device). The system may use these patterns in place of, or in combination with, an IR beacon and rely on a computer to determine the emitter's position. In the latter case, the emitter's position is calculated by a processing device such as a computer.

[0105] In all stage embodiments, the upper cover 1018 (Figure 10A) of the platform or shell is covered with a radioactive material. However, the lower base 1020 (Figure 10A) of the platform is preferably covered with an X-ray absorbing material such as lead. This covering prevents excess X-rays from penetrating the field and being absorbed by the emitter operator. This X-ray absorbing undercoating also prevents excess X-ray emissions from bouncing off the floor and scattering throughout the facility. The sides of the platform may also be made of a radiopaque material.

[0106] Figures 11A and 11B illustrate the pan-tilt mechanism. In Figure 11A, the sensor tray 802 is positioned within the cavity, and the sensor 706 is tilted about the Y-axis. In Figure 11B, the sensor tray 802 is tilted along both the X-axis and the Y-axis. This panning and tilting allows for precise sensor positioning and X-ray image acquisition while minimizing distortion caused by the offset angle of the emitter. In other words, the capture stage and X-ray emitter are adjusted to minimize skew and maximize the capture of both X-ray and fluoroscopic images. By moving the sensor within the stage, the user can obtain clear and usable X-ray and fluoroscopic images without changing the position of the subject.

[0107] In the case of handheld emitters where the emitter is physically separated from the stage, it is important for quality and safety reasons to position the sensors relative to the emitter. Various techniques can be used to achieve this goal. As shown in Figures 8 and 10, multiple position trackers 830 may be mounted on the edges or corners of the tray. These tools can be used at all four corners, but only one is needed for accurate triangulation. These embodiments may be based on the generation of ultrasonic sound or on the emission of infrared light. In these embodiments, the acoustic or infrared signal generated within the platform is detected by the emitter device, which causes the sensor to translate and tilt to maximize capture. In further embodiments, magnetic position and orientation sensors and detectors of the type used in surgical navigation may be used to orient the tray and X-ray sensor.

[0108] The emitter 830 is used to measure the distance from point 810 on the handheld unit 710 to three (or more) fixed points 830 mounted on the stage. These distances are depicted as D1, D2, and D3 in Figure 8A. Based on these distances, the system employs a tracking method to precisely determine the center point 801 on the sensor 706 and the angle (θ5) of emission from the source to the platform. An exemplary embodiment of this tracking system would include a combination of infrared sensors in the platform and the handheld unit, and gyroscopes in the stage and the handheld unit for detecting the angle θ5.

[0109] Multiple sensors are used in combination to position the detector. When the user picks up the handheld unit, the system becomes ready. Infrared beacons located at the corners of the table illuminate. The position-tracking camera mounted on the handheld unit immediately begins analyzing the infrared spectrum captured within a 140-degree field of view. The camera searches for infrared patterns. Each corner 830 has a specific pattern that determines which corner of the stage the handheld unit's infrared camera is looking at.

[0110] Referring to Figure 8B, the IR positioning emitter tiles 850 are seated at each corner of the operating table or clinical table. The figure shows examples of four unique tiles. The patterns differ when using mounted positioning beacons. These tiles contain a number of infrared emitters 852, typically five individual emitters, arranged in a specific pattern. Each tile contains a different pattern of five IR emitters. As the operator moves the X-ray emitters around the stage, the IR positioning camera captures and analyzes the infrared radiation from the tiles. Because each tile has a unique pattern, the camera can determine its exact position in relation to the table. In addition, because each tile has multiple lights arranged in a unique pattern, the exact position of the tile can be determined from within the XYZ space.

[0111] Optionally, or in addition to this unique IR layout, the IR emitters can flash in a syncopated manner. By modulating the flashing frequency, a unique signature can be added to each tile, and the pattern can be repeated in scenarios with a large number of tiles. Due to this unique arrangement, for the system to function fully, only a single corner of the unit, i.e., a single positioning beacon, must be visible to the emitter. That is, the arrangement of the pattern allows the camera to triangulate the position in space relative to each corner. Using the triangulation data and orientation data from the IMU unit on the emitter, the system can determine the center point of the emitter. The stage moves the center point to that area of ​​the stage and tilts the detector so that it is as orthogonal as possible to the emission. While the sensor is moving into place, a collimator on the emitter adjusts the beam output to ensure that only the detector panel is illuminated.

[0112] Positional information from the sensor 830 combination is routed via the control unit 704 (Figure 7) to interpolate the raw sensor data to the target point on the platform. Subsequently, the platform moves the sensor tray 802 to a predetermined position. The platform then tilts the sensor to the correct orientation (θ5) to remove as much skew as possible. In other words, assuming that the X-ray source in the emitter 710 emits radiation around axis 803, the goal is for axis 803 to be positioned as close as possible to the center point 801 of the sensor so that the sensor plane is as orthogonal as possible to axis 201 in order to minimize skew.

[0113] The X, Y, pan, and tilt positioning of the tray and sensors may be achieved without using a position emitter on the platform portion of the system. Figures 12A and 13 show alternative systems and methods for position calculation that eliminate the dependency on having a position emitter embedded in the table. Alternatively, the position of the X-ray emitter relative to the capture stage and X-ray sensing sensor may be calculated based on an external position emitter. As described above, the emitter may be held purely by hand so that a person skilled in the art can move the emitter in free space. Alternatively, the emitter may be movable with (or combinable with) a support structure that holds the emitter in place relative to the object without requiring a physician to continuously hold the emitter.

[0114] The process for determining the position of the X-ray emission apparatus according to this embodiment is as follows:

[0115] The external positional emitter(s) are installed in fixed positions and include a series of infrared emitters. These emitters emit infrared patterns from five faces of the cubic object 1202, resulting in infrared energy being emitted from slightly different sources.

[0116] The stage detects the infrared pattern and calculates the relative position from the stage to the center of each infrared emitter in three-dimensional space. This position is considered to be [xsi, ysi, zsi] = [-xei, -yei, -zei], where s is the stage, e is the infrared light-emitting element, and i is the index of the infrared light-emitting element (if multiple infrared light-emitting elements are used).

[0117] The X-ray emission device continuously detects infrared signal patterns and determines the relative position of the emission device with respect to the center of each infrared emitter in space. This relative position is relayed to the emission position control unit for each emitter. This position can also be considered as [xhi,yhi,zhi]=[-xei,-yei,-zei], where h is the index of the X-ray light-emitting element, e is the index of the infrared light-emitting element, and i is the index of the infrared light-emitting element.

[0118] The emission position control unit will receive the relative positions ([xhi, yhi, zhi]) of the X-ray emitter. Using these relative positions, the emission position control unit calculates the relative position of the X-ray emitter to the stage (Figure 13), which is [xhi-xsi, yhi-ysi, zhi-zsi]. This operation is performed for each infrared light-emitting element (i), and the range of error can be inferred using this.

[0119] The stage, after applying the position along with other data as shown in the original application, moves and rotates the X-ray sensor plate to the correct position to capture an X-ray image.

[0120] Figure 12B shows a modification in which the emitter 710 can apply energy to a sensor / detector 706, which is configured to move as discussed herein but can also move to enable lateral imaging. In the illustrated modification, the sensor / detector 706 moves outside the central X-axis of the table 105 to capture a lateral view of the patient 104. However, variations of the sensor 706 may include a structure in which the table is non-planar and the sensor 706 is configured to receive the sensor on the plane in which the patient is positioned. Figure 12B also shows an additional concept in which multiple detectors 706 are used as described herein. In such modifications, the sensors 706 are moved as described herein, but the sensor with the best operational alignment would be used to generate the signal.

[0121] Safety Lockout Procedure Just as it is important to limit emission from the emitter to a specific target distance, for various reasons, both practical and certification, it is crucial that the X-ray emitter only emits when the emitter is properly oriented on the capture stage. Preventing the X-ray emitter from emitting photons when it is not oriented on the stage improves system safety and enhances emitter performance. Figure 14 illustrates the process by which the device manages emitter safety lockout and captures X-ray images, with corresponding numerals used in Figure 14.

[0122] Step 1 The user initiates the capture process by sending a signal via the emitter 110, typically by pressing a trigger. The emitter sends a data packet (D) to the control unit containing the capture request, distance measurements (d1, d2, ...), and the emitter angle.

[0123] Step 2a The control unit verifies that the emitter is in a safe orientation.

[0124] Step 2b If the control unit detects that the emitter is not in a safe and valid orientation, the control unit sends an error message to the emitter. This prevents the emitter from firing and also informs the user that there is a problem.

[0125] Step 3: The stage positions the sensor according to the emitter's position. The stage tilts the sensor to achieve the correct orientation for capturing a clear image. The orientation should be as close as possible to the complementary angle of emission.

[0126] Step 4: The stage then sends a confirmation message to the control unit after its position has been established.

[0127] Step 5 The control unit forwards a start message to the emitter. The emitter will then perform any additional safety or preparation tasks as necessary. If the emitter determines that the environment is safe to emit, it will then emit X-rays.

[0128] Step 6a: The emitter emits pulses of X-ray photons at the stage for the requested duration.

[0129] Step 6b: During the emission of the X-ray photon stream, the emitter continuously streams updates of its position and angle to the central control unit.

[0130] Step 6c The control unit records these position updates and relays them to the stage.

[0131] Step 6d: In this stage, the sensor position and angle will be rapidly and continuously updated to optically stabilize the X-ray image.

[0132] Step 7: The sensor captures the emission of X-ray photons from the emitter and constructs an image.

[0133] Step 8: Once X-ray emission is complete, the sensor relays the data to the control unit.

[0134] Step 9 The control unit then sharpens the image from the sensor using various well-known optical enhancement techniques. Where applicable, the control unit further enhances the output by utilizing the accumulated motion data from the emitter.

[0135] The above process ensures that the emitter can reliably emit light directed towards the sensor and stage, as opposed to any other target. By moving the sensor beneath the emission target, the user can generate high-resolution, flexible images of the exact desired portion of the subject without changing the subject's position.

[0136] Figure 15 illustrates the process by which the apparatus acquires fluoroscopic images. The process for acquiring fluoroscopic images is very similar to acquiring still X-ray images, but the fluoroscopic process will involve repeating multiple emissions and image acquisitions to generate a moving image. In Figure 15, a corresponding code is used to perform a process to ensure safe emissions, similar to the process for acquiring fluoroscopic images.

[0137] Step 1 The user initiates the capture process by sending a signal via the emitter handle, typically by pressing the trigger. The emitter sends a data packet (D) containing the capture request, distance measurements (d1, d2, ...), and the emitter angle to the control unit.

[0138] Step 2a The control unit verifies that the emitter is in a safe orientation.

[0139] Step 2b If the control unit detects that the emitter is not in a safe and valid orientation, the control unit sends an error message to the emitter. This prevents the emitter from firing and also informs the user that there is a problem.

[0140] Step 3: The stage positions the sensor according to the emitter's position. The stage tilts the sensor to achieve the correct orientation for capturing a clear image. The orientation should be as close as possible to the complementary angle of emission.

[0141] Step 4: Next, after positioning, the stage sends a confirmation message to the control unit.

[0142] Step 5 The control unit forwards a start message to the emitter. The emitter will then perform any additional safety or preparatory tasks.

[0143] In fluoroscopic mode, the emitter will repeat the following steps while the emitter device continues to request additional fluoroscopic frames.

[0144] Step 6a: The emitter emits pulses of X-ray photons at the stage for the requested duration.

[0145] Step 6b: During the emission of the X-ray photon stream, the emitter continuously streams position and angle updates to the central control unit. If, at any point during the fluoroscopy process, the surgical stage detects that the emission is not oriented towards the stage, the surgical stage sends a termination signal to the emitter and skips directly to step 9.

[0146] Step 6c The control unit records these position updates and relays them to the stage.

[0147] Step 6d: The stage rapidly and continuously updates the sensor position and angle to optically stabilize the X-ray image.

[0148] Step 7: The sensor captures the emission of X-ray photons from the emitter and constructs an image.

[0149] Step 8: The sensor immediately transmits the image to the control unit. At this time, a simple sharpening process is performed, and the image is displayed on an external viewing device. This perspective frame is stored in memory.

[0150] By continuously repeating this process, a moving image is generated on the external display. This process will continue until the user releases the trigger on the emitter.

[0151] Step 9 When the user releases the emitter trigger, the control unit "clears" the frames stored from the sensor using various known enhancement techniques. Where applicable, the control unit further enhances the output using the accumulated motion data from the emitter. The control unit will then combine the view frames into a single video and play it repeatedly.

[0152] Through the above process, the user can view a POV image of the subject in real time. After the image capture is complete, the image is saved and reprocessed to generate a single high-quality POV image that can be viewed and reviewed later.

[0153] Self-adaptive collimator As described above, the system of this disclosure moves the emitter to a position relative to an object, at least one position tracking element measures the distance between the emitter and the object and prevents energy emission until the distance becomes less than a predetermined distance, and the system allows determining the relative position of the emitter to at least one position tracking element. Modifications of the system described herein can use a self-adjusting collimator to optimize the emission profile or boundary on the working plane of the sensor. As with other modifications described herein, these systems can relay the position of the emitter to a motor system that adjusts the imaging sensor to an operable alignment with the emitter, wherein relaying the position of the emitter includes using the emitter for both providing orientation data of the emitter and determining the distance from each of a plurality of tracking elements. However, by using a self-adjusting collimator, the emission profile on the imaging sensor can be automatically maximized.

[0154] Figure 20 shows a representation of an X-ray emitter 110 directed towards a table 114 containing an imaging sensor (not shown) to illustrate the advantages of an adjustable collimator. The boundary of the imaging sensor's working area 116 is shown to illustrate the area that generates an image during exposure of the X-ray emission. As shown, the profile of the X-ray emission 120 from the X-ray emitter 110 extends beyond the boundary of the imaging sensor's working area 116, causing the X-ray emitter to deviate from the operational alignment with the sensor. In such a case, a system like the one described herein would not allow the X-ray emitter 110 to emit or initialize. The explanatory diagram in Figure 20 is for illustrative purposes to illustrate the concept of the system being deviated from the operational alignment. As described herein, the imaging sensor can be coupled to a motor system to move the sensor to align with the emission profile 120. Alternatively, the table (or operating surface) 114 may include a number of position tracking elements (not shown in Figure 20) that enable measurement of the position and distance of the emitter 110 relative to a non-movable sensor or the sensor's working area 116.

[0155] Figure 21A illustrates a situation where the emission profile 120 extends beyond the sensor 116 so that the emitter is not operationally aligned with the sensor 116. For illustrative purposes, the sensor 116 shown in Figures 21A and 21B is stationary, and the tracking element 118 allows the system to measure the relative position, alignment, and distance of the emitter (not shown) to the sensor 116. The emission profile 120 is also illustrated as representing the boundary of the emission provided by the emission device. For illustrative purposes, the illustrated profile 120 is the profile that would occur if the emitter axis were perpendicular to the sensor 116.

[0156] If the system cannot establish an operable alignment as described herein, in the state shown in Figure 21A, the operator is prompted to adjust the emitter position. In some modifications, the system may provide feedback such as an audible or visual indicator of misalignment. Figure 21B shows the situation after the emitter has been repositioned such that the emission profile 120 is within the boundaries of the sensor 116. However, as shown, this emission profile 120 is not maximized relative to the dimensions of the sensor 116. Due to the failure to maximize the emission profile 120 relative to the sensor, the operator may be required to take additional radiographic images of the subject to adjust to a smaller profile.

[0157] Figure 22A is a diagram illustrating the effect of an adjustable collimator. Again, for illustrative purposes, the illustrated emission profile represents illumination by an emitter orthogonal to the sensor. Figure 22A shows an unadjusted emission profile 120, which would normally be considered out of operational compatibility with the imaging sensor 116 if a portion of the emission region constrained by profile 120 falls outside the sensor 116. However, in one embodiment of the system described herein, in addition to components fixed to the emitter (as described above), position tracking elements 118 also depend on determining the orientation of the emitter and positional information such as the distance between the emitter and the sensor 116. The system would use the positional information to rotate the collimator on the emitter and / or adjust it to scale the emission by the emitter in order to generate an adjusted emission profile 122. In this modified example, as shown in the figure, the adjusted emission profile 122 is reduced in size (indicated by arrow 126) and further rotated (indicated by arrow 124) to scale the emission profile 120 to the adjusted emission profile 122 that maximizes exposure to the image sensor. Note that the adjusted emission profile can be enlarged, reduced in size, and rotated as needed. Furthermore, system variations will generate adjusted profiles during the real-time movement of the emitter relative to the sensor 118.

[0158] Figure 22B illustrates the unadjusted emission profile 120 along with the adjusted emission profile 122, in both cases the profiles resemble an isosceles trapezoid because the axis of the emission path is neither orthogonal to nor normal to the sensor 116. However, in this modification, the system uses positional information to generate an adjusted profile 122 that maximizes the exposure area on the image sensor 116.

[0159] The modifications disclosed herein also rely on sensors within the emission unit (as described herein) in addition to the tracking element 118. Modifications of the system for generating the adjusted emission profile can also be used in combination with positional data obtained from an external camera, sensor, or mechanical support to determine the relative motion between the emission device and the imaging sensor.

[0160] Figure 23 shows a modified adjustable collimator 130 that can be used in or in combination with an emission device (not shown in Figure 23). As shown, the adjustable collimator 130 can rotate and / or scale an aperture or emission window 132 to generate an adjusted emission profile on an imaging sensor (as discussed in Figures 20 to 22B). In this modified adjustable collimator 130, a number of movable and rotatable blades or leaves 134 are used to adjust the orientation of the aperture 132. The blades 134 prevent the passage of emitted energy so that energy is limited to passing through the aperture or emission window 132.

[0161] The movement and rotation of the blades can be driven by any number of motors or drive units. In the illustrated modification, the adjustable collimator 130 includes a motor assembly having a first drive unit 138 coupled to a proximal swivel bearing 152 and a second drive unit 136 coupled to a distal swivel bearing. The drive units 136, 138 adjust the rotation of the blades 134 as well as the size adjustment of the opening 132. For example, rotation of the motors 136, 138 in opposite directions causes the swivel bearings to rotate in opposite directions, resulting in the movement of the blades 134 to open and close the opening 132. In the illustrated example, if the first drive unit 138 moves clockwise and the second drive unit 136 moves counterclockwise, the blades 134 will move toward each other to reduce the size of the opening 132. Similarly, as the first drive unit 138 moves counterclockwise and the second drive unit 136 moves clockwise, the blades 134 will move apart from each other to increase the size of the opening 132. When the drive units 138 and 136 move in the same direction, this causes the proximal swivel bearing 150 and the distal swivel bearing 152 to rotate in the same direction, which in turn causes the blades to rotate, which in turn causes the opening 134 to rotate.

[0162] The adjustable collimator 130 maintains an aperture 132 with a nearly square shape, as all blades 134 move to adjust the size of the aperture. Additional modifications of the device may include any number of additional motors or actuators for further control of the angular direction of the blades. In this case, the aperture 134 is not limited to a square shape, but can be an isosceles trapezoid. Such features can help maintain a square emission profile (as shown in Figure 22A) regardless of the orientation of the axis of emission energy relative to the imaging sensor.

[0163] Furthermore, a variation of the adjustable collimator 230 shown in Figure 23 includes a housing or enclosure 140 that accommodates a drive mechanism (e.g., bearings, pulleys 144, belt 146, etc.) that converts the motion of gears 144 driven by motors 136, 138 into rotation and movement of the blades. In addition, the adjustable collimator 230 may include any number of position tracking systems that enable the system to maintain information regarding the size and direction of rotation of the aperture. For example, a first movable disk (or encoder wheel) 142 is shown as part of an optical encoder system that can use any conventional light source, sensor, mask, and photosensor (e.g., photodiode).

[0164] Figure 24A is an exploded view showing an example of an adjustable collimator 130 to illustrate a variation of the mechanism used to rotate and adjust the scaling of an opening 132 formed by a blade 134. As shown, a pulley 144 coupled to motors 136 and 138 rotates a belt 146 coupled to a cam / pin assembly 148. The blade 134 is housed within the cam / pin assembly 148, although for illustrative purposes the cam / pin assembly 148 is shown without the blade. The assembly 148 consists of a cam wheel 150 and a proximal slewing bearing 152, each coupled to the corresponding motors 136, 138 via the belt system 146. The blade 134 is coupled to one or more pins 154 within the slewing bearing 150, 152 assembly 148 such that the rotation of the slewing bearings 150, 152 causes scaling of the opening 132 as described above. This scaling occurs due to movement towards or away from the blade 142. The rotation of the opening 132 is caused by the rotation of the slewing bearings 150 and 152 in the same direction.

[0165] Figure 24B is a front view showing some components of the adjustable collimator 130 (some components have been removed for illustrative purposes). As shown, the opening 134 is defined by the region enclosed by the blades 134. Each blade is coupled at one end to a pin 154. The opposite end of the blade 134 contains a bearing 158 in a slot 156. The motor 138 moves the bearing 158 in the slot 156 while the blade 134 pivots around the pin 154, causing the blades to move either closer to each other (depending on the direction of rotation) or farther apart (depending on the direction of rotation) in the opening 132, resulting in scaling of the opening 132. Rotation of the opening 132 occurs when the motor 136 rotates the cam wheel 150 (shown in Figure 24A). As described above, rotation of the opening 132 requires the slewing bearings 150, 152 to rotate in the same direction.

[0166] Figure 24C is a rear view showing some of the components of the adjustable collimator 130 (some components have been removed for illustration purposes). As shown, the collimator 130 includes a second movable disk (or encoder wheel) 160, shown as part of an optical encoder system, which can use any conventional light source, sensor, mask, or photosensor (e.g., a photodiode) to track the movement of the blade 134.

[0167] Figures 25A and 25B show an example of an emitter 164 having an adjustable collimator 130 as described above. As shown, the adjustable collimator can rotate and scale the aperture 132 based on information regarding the emitter's distance and orientation from the system's position tracking element. The scaling and rotation of the aperture 132 may be performed automatically or on demand. Figures 25A and 25B show a modified emitter having a cable 166. In other modifications, the emitter and adjustable collimator can be used in a fully portable emitter as described herein.

[0168] The optical encoder 160 in Figure 24C ensures the precise positioning of the leaf or blade to ensure patient safety. The encoder 160 can also assist in determining any number of conditions that may cause a failure. For example, the encoder can detect, but is not limited to, conditions such as: the drive belt skipping teeth on the gear, the drive belt breaking or losing tension, motor failure, ring gear failure, leaf pin failure, etc. Detecting such failure conditions can prevent the emission source from being triggered, thus avoiding excessive radiation exposure to the patient or operator.

[0169] Figures 26A to 26J illustrate an example of a method by modification of the collimator discussed herein. The rotating collimator has two processes performed to verify the mechanical operation and alignment of the device. Due to the emission of ionizing radiation from the X-ray tube, it is essential to detect physical damage and verify the mechanical function of the device before use, before the operator is exposed to additional radiation. The freely movable, unconstrained design of this device presents an additional challenge for the collimator, namely, locating the wheel position to any alignment of the X-ray detector. The collimator performs a homing process to determine the minimum / maximum aperture position and the 0° position of the device. The homing process establishes the zero orientation reference necessary for the collimator's aperture control. The leaf detection process verifies the physical operation of the device by verifying the full range of aperture size adjustment.

[0170] Figure 26A shows the random positions of the leaves of the collimator device. These positions would represent the orientation of the device from a previous procedure or other scenario after a previous operation. The device cannot know the aperture or orientation until after the homing process. The device consists of (1)(2)(3) optical sensors for monitoring the leaf positions and (4)(5) motors for driving the distal swivel ring (12) and proximal swivel ring (13), which are connected by a pair of belts (10)(11). Four collimation leaves (6)(7)(8)(9) are connected in pairs to the swivel rings.

[0171] Optical sensors (1), (2), and (3) operate by detecting the presence or absence of leaf material directly in front of the sensor. If there is no leaf material in front of the sensor, the sensor is considered to be open. If the presence of leaf material is detected, the sensor is considered to be closed.

[0172] Homing procedure: Step 1: Open Position - The homing procedure is performed whenever the device is powered on, idle, or when the device detects drift. The device is initiated by rotating the proximal ring until the device detects movement in the distal ring via the link. Figure 26B shows the non-determined position in this scenario illustrated by the visibility of the home keyway (14). This alignment allows the optical sensor 1 to detect the open state when the keyway is directly in front of the sensor. This is the fully open position of the collimator.

[0173] Step 2: 0-degree position, maximum aperture - Figure 26C shows the 0-degree position, maximum aperture position. Once the fully open position is determined, the device will rotate the proximal and distal rings simultaneously, thereby rotating the leaf assembly. The system will monitor the state of the optical sensor 1 until the sensor register opens (15). This open signal indicates that the keyway has rotated to the position of the sensor in the fully open position. The system then registers this as the fully open 0-degree position.

[0174] Step 3: 0-degree position, minimum opening - The device will then rotate the distal through-ring until it detects movement within the proximal through-ring. Once this movement is detected, the system will then register a minimum opening position of 0 degrees, as shown in Figure 26D.

[0175] These positions are registered in the current operational session. With the motor positions recorded, the device can calculate the relative movement of the motor and through-ring to any other desired positions.

[0176] Damage detection procedure: As mentioned above, fully functional and undamaged collimators are essential for the safety and performance of the collimation system. Furthermore, it is crucial to detect any damage or drift before it is released through the device. To ensure performance, the device will continuously monitor the positioning status of each leaf.

[0177] At a minimum, each leaf must be checked once, but for safety reasons, the exemplary device uses checks at three locations. The optical sensor arrays (1)(2)(3) are used to verify the performance of individual leaves, but any number of sensors may be used to perform the process. The order of checks may vary. Once the three-stage processing of the first leaf (16) is complete, the process will proceed to verify leaf 2 (17), leaf 3 (18), and leaf 4 (19). This process applies regardless of the number of leaves.

[0178] Step 1: Verification of Maximum Aperture - After some time has passed since the homing process was completed, the device will rotate the leaf assembly to the closed position (20) of the optical sensor 1 shown in Figure 26E by moving both the proximal and distal rings as necessary to form a fully open aperture. The device will then immediately move to the open position of the optical sensor 1 by moving the rings to reduce the aperture, as shown in Figure 26F. If the calculated movement of the device matches the physical feedback of the optical sensor 1 (21), the device has verified the maximum aperture position of the leaf 1 (16).

[0179] Step 2: Verification of the intermediate aperture - After some time has passed since the homing process was completed, the device will rotate the leaf assembly to the closed position (22) of the optical sensor 2 shown in Figure 26G by moving both the proximal and distal rings as necessary to form an aperture that is opened to the intermediate position. The device will then immediately move to the open position of the optical sensor 2 by moving the rings to reduce the aperture, as shown in Figure 26H. If the calculated movement of the device matches the physical feedback of the optical sensor 2 (23), the device has verified the maximum aperture position of leaf 1 (16).

[0180] Step 3: Verification of Minimum Aperture - After some time has passed since the homing process was completed, the device will rotate the leaf assembly to the closed position (24) of the optical sensor 3 shown in Figure 26I by moving both the proximal and distal rings as necessary to form the minimum aperture. The device will then immediately move to the open position of the optical sensor 3 by moving the rings to reduce the aperture, as shown in Figure 26J. If the calculated movement of the device matches the physical feedback from the optical sensor 3 (25), the device has verified the maximum aperture position of leaf 1 (16).

[0181] Once step 3 is completed for leaf 1, the device will repeat the procedure for each leaf to ensure that each leaf is in the expected position.

[0182] Figures 27, 28A, and 28B illustrate another embodiment in which a radiation system having a sensor configuration as described herein can improve the quality of X-ray or fluoroscopic imaging.

[0183] The quality of X-ray or fluoroscopic imaging is related to the number of physical attributes of the subject. These elements define a set of technical factors (e.g., power, current, time, etc.) that control the radiation characteristics of the radiation source / emitter. It is the responsibility of the equipment operator to set these factors in a combination that allows individuals viewing the radiographic images to identify the necessary visual elements without exposing the subject to excessive radiation.

[0184] Setting up these technical elements can be complex. Conventional fluoroscopy systems have implemented automated processes to reduce the burden on operators who are primarily responsible for setting up these technologies. A typical approach involves using software or hardware dose detectors on the plate and gradually filling it while applying radiation. This conventional approach has several challenges.

[0185] A major challenge with conventional approaches is motion. Because subjects are exposed to radiation over long periods, all kinds of movement occur in the subject, operator, machine, and even the subject's blood vessels, resulting in motion artifacts that significantly degrade the image.

[0186] Another challenge is that the transmission requirements are unknown before exposure, and therefore, when a radiation source emits radiation at a given power level (kV), insufficient transmission is often achieved to render an image. This inability to render an image means that patients, operators, and staff are exposed to radiation without obtaining useful radiographic images. In such cases, these individuals are exposed to excessive radiation that does not serve clinical purposes.

[0187] Innovations in the field of fluoroscopy equipment, including but not limited to the systems described herein, will create a new generation of machines with complex sensor arrays capable of directly measuring the number of physical elements required for exposure calculations.

[0188] By utilizing these sensors across the entire range of the device and subject, and leveraging robust machine learning techniques, it becomes possible to calculate the necessary techniques before exposure, eliminate motion artifacts, and create superior captures, while simultaneously reducing all doses.

[0189] The following description provides illustrative details of the invention so that the invention may be understood. Minor engineering modifications could be employed to carry out the invention without adopting these details. Although the invention is described in relation to applications in radiographic imaging for surgical purposes, it can be used in other medical applications, including but not limited to general medical imaging, veterinary imaging, and bone densitometry. The invention can also be used in non-medical applications such as industrial imaging, metal fatigue testing, welding inspection, and security inspection.

[0190] Figure 27 shows an example of a conventional automated X-ray exposure process. The physician or operator initiates exposure by requesting an X-ray (Step 1). The X-ray apparatus will then evaluate the detector while tracking the amount of radiation received on the imaging sensor plate (Step 2). Internal measurements of the X-ray apparatus will determine whether this energy is sufficient exposure to produce an image (Step 3). If the apparatus determines that an appropriate amount of radiation has been collected (Step 4a), it will determine that exposure is complete and display the X-rays. If the user cancels the X-rays or if the dose has been accumulating for too long, the machine will cancel the exposure (Step 4b). Alternatively (Step 4c), the apparatus will continue to emit radiation until an image is generated, time runs out, or the user cancels the exposure, and will return to the evaluation step.

[0191] Conventional processing has several drawbacks, but the two biggest are that exposure begins without a guarantee that an image will be displayed, and the time required to evaluate the exposure introduces motion artifacts into the final image, resulting in unusable X-rays. In either case, patients, operators, and staff are exposed to unnecessary radiation, which has a significant impact on safety.

[0192] Figures 28A and 27B illustrate an improved approach compared to the conventional method described in Figure 27. The improved approach can determine the optimal technical factors for reliably producing effective radiographic images without exposing operators, staff, and patients to unnecessary or excessive radiation. By utilizing a radiographic imaging device with a comprehensive sensor array and enterprise-scale applications of machine learning technology, System 20 can compute and refine the technology before any radiation is emitted. This allows operators to accurately position the device and understand whether the device can image anatomical tissue.

[0193] Figure 28B shows an example of how statistical data is compiled for use in the imaging process shown in Figure 28A. In practice, numerous statistical models are sent from a central server (shown in Figure 28B) to system 20. These models, called computer vision classifiers (1a) and estimator updates (1b), are stored locally in the machine so that they can be used before the operator requests exposure.

[0194] Turning to Figure 28A, the process can begin with the operator initiating the capture (2). The operator then uses the device's positioning system to align the emitter with the anatomical tissue (3), and after completing safety checks, performs automated technical detection (as described above). Depending on the precise terrain of the X-ray system, CPT code information (4a) and / or biometric information (4b) may be entered by the operator or extracted from other systems by automated means.

[0195] While the system is preparing to emit energy for X-ray or fluoroscopic imaging, two simultaneous measurement acquisitions are performed: on-device sensor acquisition (5a) and computer vision classification (5b).

[0196] Sensor acquisition uses an array on the device to collect several input parameters, including but not limited to the distance from the source to the skin (SSD), the distance from the source to the detector (SDD), the angle of incidence, the ambient environment, and the temperature of the X-ray tube and the device. All of these parameters are fed into the inference execution function (6).

[0197] The computer vision classifier uses an on-board imaging camera to capture images of the subject's anatomical tissues. These images, along with CV classifier data stored locally on the device, are passed to the CV analysis function. This process makes decisions about the captured subject and passes its recommendations to the inference execution engine.

[0198] Once inputs are collected from the instrument's various subsystems, these values ​​are processed against the instrument's inference execution engine, along with estimator updates provided by a central server (6a). The output of this family of functions is the determined X-ray technique, which is time, kV, and beam current (7).

[0199] The device output is set to the calculated value, radiation is emitted for a predetermined setting (8), an image is captured and processed (9), and the image is displayed to the user (10).

[0200] As soon as the X-ray is displayed to the operator, the system immediately begins monitoring the operator's interactions in the interaction monitoring system (11). This system records all interactions the operator makes with the image, including changes in brightness, sharpness, contrast, position, zoom, and rotation. The time the operator spends on the X-ray or fluoroscopic examination is also recorded.

[0201] In steps 12a through 12d, the system will submit the captured data to the central processing system. The submitted data will include four main elements of the capture, namely (12a) direct measurement information such as SSD and temperature, (12b) interaction heuristics such as changes in brightness and time spent examining the capture, (12c) surgical details such as biometric information, associated CPT codes, as well as computer vision captures and the resulting classification output, and (12d) raw captured data from the detector, as well as information associated with the capture such as machine details and software version.

[0202] This captured information is stored on the central processing system in corresponding databases 13a and 13b for future processing.

[0203] At the scheduled time, the central processing system will train the estimator labels using sophisticated regression analysis (14). By examining the statistical relationships between sensor data, capture data, and surgical data across universally captured large cross-sections, as well as the results of the previous estimator generation (14a), the system can fit the data to more accurate labels. The output of the training step is the new estimator (17).

[0204] Similar to the label training step (14), the X-ray and fluoroscopic imaging data, surgical detail data, and classifier data will be trained using a classifier refinement process (15). This process utilizes a large capture cross-section from a vast number of input X-rays to generate a more accurate classifier (16).

[0205] Depending on the terrain of the X-ray apparatus at the site, the central processing system will transmit new estimators (18) and classifiers (19) to the apparatus as quickly as possible. These updates will then be loaded into the apparatus's local storage (1a), (1b), and the new algorithms will be applied to further improve accuracy and reduce the dose for automated exposure.

[0206] The above description provides illustrative details of the invention to provide an understanding of the present invention, but routine engineering modifications may be employed to carry out the invention without departing from the spirit or scope of the invention. Furthermore, although the invention is described for use in radiographic imaging for surgical purposes, it can be used for other medical applications such as general medical imaging, veterinary measurements, and bone densitometry. The system and method can also be used for non-medical applications such as industrial imaging, metal fatigue testing, welding inspection, and security inspection.

Claims

1. A method for non-invasively imaging an object, One or more magnetic sensors are fixed to define a surrounding area, and the process involves moving a discharge device to the relative position of one or more of the magnetic sensors provided on the tray and the object, The process involves releasing energy through the emission window of the emission device, forming an exposure pattern on the object, and receiving the exposure pattern by an image sensor configured to generate image data. A step of continuously determining the position and orientation of the discharge device with respect to one or more magnetic sensors, In order to limit the exposure pattern to the image sensor, the process involves continuously adjusting the size of the emission window and the rotation of the emission window relative to the emission device in response to changes in the position and orientation of the emission device relative to one or more of the magnetic sensors, A method for non-invasively imaging an object, including [specific example].

2. The method according to claim 1, further comprising the step of adjusting the image data using the position and orientation of the emission device.

3. The method according to claim 1, wherein the step of determining the position of the discharge device includes the step of detecting one or more magnetic sensors using the magnetic detector of the discharge device.

4. The method according to claim 1, wherein the step of determining the orientation of the discharge device includes the step of detecting one or more magnetic sensors using a magnetic detector of the discharge device.

5. The method according to claim 1, wherein the step of continuously adjusting the size of the emission window and the rotation of the emission window relative to the emission device includes the steps of scaling the size of the emission window and adjusting the rotation of the emission window to maximize the area of ​​the exposure pattern on the image sensor.

6. The method according to claim 1, wherein the step of releasing energy includes a step of releasing X-ray energy.

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