Improved imaging system and method

Abstract

The present invention relates to x-ray and fluoroscopic image capture, and more particularly to a general purpose x-ray emitter operative to capture targeted images configured to track and position x-ray radiation relative to an image sensor that uses x-ray radiation to generate an x-ray image. The system is configured to prompt a user or operator of the x-ray system with various informational data to improve x-ray results and reduce the frequency of x-ray radiation required to obtain a desired x-ray image.

Description

[Technical field]

[0001] The present invention relates to an improved method and system for X-ray and fluoroscopic image capture. In particular, the present invention relates to a general purpose X-ray emitter operative to capture an image of a target, configured to track and position the X-ray radiation relative to an imaging sensor that uses the X-ray radiation to generate the X-ray image. The system also prompts a user or operator of the X-ray system with various informational data to improve the X-ray results and reduce the frequency of required X-ray exposures to obtain a desired X-ray image. [Background technology]

[0002] The availability of small, lightweight x-ray systems that allow the x-ray operator or surgeon to manipulate the x-ray emitter while the system tracks the position of the emitter relative to the imaging sensor or workspace not only reduces the need to acquire multiple x-ray images due to improper positioning of the x-ray emitter relative to the detector, but also improves safety for the operator as well as humans, since the resulting positioning data prevents inadvertent x-ray exposure. Such systems may also use a positioning system to display a dynamic view of the x-ray detector, or the workspace that contains the x-ray detector. This real-time, dynamic view may provide the operator with an image of the tissue structures imaged prior to x-ray generation, and may also provide a system that can guide the operator to a particular x-ray view by overlaying directly on the camera view a view of the subject's tissue structures corrected for the active area of ​​the detector. Summary of the Invention [Means for solving the problem]

[0003] The present invention relates to an improved, versatile, multi-modal radiography system and method that allows a surgeon to operate without patient interference and to capture still and dynamic x-ray images, as well as other still and dynamic images, without repositioning the equipment, the subject, or the surgeon.

[0004] Described herein is an X-ray system that can safely obtain X-ray images and assists an operator of the system in obtaining one or more standard X-ray images of a human or body part that is subsequently examined by medical personnel. It is noted that in addition to improving the care of human patients, the systems and methods described herein can be used for X-ray imaging of subjects and other animals as well.

[0005] In some clinical scenarios, such as when the operator is inexperienced or a non-physician, the X-ray system may utilize a reference library or database to provide information to assist the user in capturing the optimal view. In some embodiments, the system displays reference X-rays (e.g., ideal X-ray images), orthogonal reference photographs, and patient alignment photographs. For example, in a shoulder X-ray examination, AP view, normal Y view, and normal axial view are standard views. For an untrained operator, capturing such views can sometimes be difficult. By providing information images and data from the reference library, the improved X-ray system can guide the user through these series of views and the positioning of the patient, body part, and / or emitter. In addition, as the views are recorded, the artificial intelligence can determine whether the captured X-ray matches the requested X-ray for each view. If the captured X-ray image does not meet the similarity score of the reference X-ray image, and if the view does not meet the similarity score of the criteria, the device system can alert the operator to retake to reduce physician intervention.

[0006] In some embodiments, the present disclosure includes a method for an operator to obtain a radiological image of a human or body part. The method includes positioning a radiation device at a predetermined distance from a work surface, the work surface including an imaging sensor, the radiation device including a camera system and an opening configured to pass radiant energy, orienting the radiation device so that the opening and the camera system face the work surface, transmitting a signal from the camera system to a display and displaying an image of the work surface on the display, providing at least one informational image on the display for viewing by the operator, the at least one informational image including a recommended positioning of the human or body part, and emitting radiant energy to the imaging sensor to generate a radiological image of the human or body part and displaying the radiological image on the display. Aspects of the method and system include a display mounted on the radiation device and / or a display mounted on a separate monitor.

[0007] An additional method described for an operator to obtain a radiation image of a human includes providing a display, a camera system, and a radiation device having an aperture configured to pass radiant energy; displaying a tissue representation on the display, the tissue representation including one or more tissue sites, the display configured to allow the operator to identify a selected tissue site from the one or more tissue sites; providing at least one informational image on the display for viewing by the operator, the at least one informational image corresponding to the selected tissue site, the at least one informational image including a recommended positioning of the body site corresponding to the selected tissue site; positioning the radiation device at a predetermined distance from a work surface, the work surface including an imaging sensor; orienting the radiation device so that the aperture opening and the camera system face towards the work surface; transmitting a signal from the camera system to the display to generate and display an image of the work surface on the display; and emitting radiant energy to the imaging sensor to generate a radiation image of the body site and displaying the radiation image on the display.

[0008] The method can include providing a virtual tissue representation of the body part on the image, the virtual tissue representation being overlaid on a work surface on the image. The method can also include positioning the body part on the work surface using the virtual tissue representation.

[0009] In system aspects, the imaging sensor includes a sensing perimeter, and system and method aspects include displaying a virtual sensing perimeter on the display, the virtual sensing perimeter overlaid on the work surface and corresponding to the sensing perimeter. The systems and methods can also display a virtual radial perimeter on the display, the virtual radial perimeter overlaid on the work surface and corresponding to the radial perimeter of the radiant energy from the aperture opening.

[0010] The informational image may further include providing instructional messages on the display. For example, the instructional messages may include text instructions or video instructions.

[0011] Additionally, the systems and methods may include displaying a video image of the workspace and / or the tissue structures of the subject being examined. Alternatively, or in combination, the systems and methods may include at least one non-video image of the subject / object.

[0012] The systems and methods disclosed herein can further include providing informational data on the display, the informational data including data associated with the human.

[0013] The system and method can display multiple subset displays, where an image of the work surface is displayed on a first subset display and a radiological image is displayed on a second subset display, and in some embodiments, at least one informational image is displayed on a third subset display.

[0014] In the methods and systems of the present disclosure, providing at least one informational image may include selecting one or more images from a first database containing a plurality of radiological image information.

[0015] In some aspects, the methods described herein may further include displaying a tissue representation on a display prior to positioning the radiation device, the tissue representation having one or more tissue sites, the display configured to allow an operator to select one or more of the tissue sites to pre-select at least one informational image to be provided on the display for viewing by the operator.

[0016] The methods and systems described herein may further include performing a comparison of the radiological image with a reference radiological image and providing feedback to an operator based on the comparison.

[0017] The present disclosure includes a system for obtaining a radiographic image of a body part on a work surface having an x-ray image sensor. For example, one such system includes a camera system and a radiation device including an aperture configured to pass radiant energy, the radiation device including a display configured to display an image of the work surface generated by the camera system. The radiation device is configured to communicate with a database including a plurality of radiographic imaging information data to display at least one information image for viewing by an operator, the at least one information image including a recommended positioning of the body part, and the display is configured to display a virtual tissue representation of the body part on the image of the work surface, the display configured to provide a radiographic image after the radiant energy is emitted onto the body part and the x-ray image sensor.

[0018] In some aspects, the present disclosure includes a system in which the radiation device is in communication with a first database including a plurality of radiation image information, and the at least one information image includes one or more images from the first database including the plurality of radiation image information.

[0019] This application is related to U.S. Patent No. 10,076,302, issued on September 18, 2018, U.S. Patent No. 11,207,047, issued on December 28, 2021, and U.S. Patent No. 11,382,582, issued on July 12, 2022, and U.S. Patent Application Publication No. 2020 / 0289207, published on September 17, 2020, all of which are incorporated herein by reference in their entireties. [Brief description of the drawings]

[0020] [Figure 1A] FIG. 1A illustrates an example of an operating room layout for use with an X-ray imaging system in a standard surgical case of an extremity. [Figure 1B]1B and 1C show alternative examples of operating room layouts for using an imaging system with a dedicated operating table that provides improved access to the patient's area. [Figure 1C] 1B and 1C show alternative examples of operating room layouts for using an imaging system with a dedicated operating table that provides improved access to the patient's area. [Diagram 2] FIG. 2 is a simplified schematic diagram illustrating an X-ray emitter according to the present invention. [Diagram 3] FIG. 3 is a diagram illustrating a control panel for use with an emitter according to one embodiment. [Figure 4] FIG. 4 illustrates the X-ray emitter safety lockout procedure. [Diagram 5] FIG. 5 is a diagram showing a typical sequence for emitter power management. [Figure 6] FIG. 6 is a diagram illustrating the process by which the device captures simultaneous images upon request from a user. [Figure 7] FIG. 7 is a diagram illustrating the overall components of the capture stage according to one embodiment. [Figure 8A] FIG. 8A is a perspective view showing a sensor positioning system. [Figure 8B] FIG. 8B is a diagram illustrating an infrared (IR) positioning tile. [Figure 9] Figure 9 shows the x, y movement of the sensor tray as viewed from above. [Figure 10A] FIG. 10A is a perspective view showing a band-actuated imaging stage. [Figure 10B] FIG. 10B is a schematic diagram showing the band operation stage with key components identified. [Figure 11A] FIG. 11A is a side view showing tilt actuation of the sensor. [Figure 11B] FIG. 11B is a side view showing the panning operation of the sensor. [Figure 12A]FIG. 12A illustrates an arrangement in which the emitter does not need to be located on the imaging stage platform. [Figure 12B] FIG. 12B illustrates an additional arrangement of the imaging system in which the sensor may be configured to capture a lateral view by moving above the plane of the operating table. [Figure 13] FIG. 13 shows an infrared emitting device emitting infrared light from five points allowing relative positions in three-dimensional space to be calculated. [Figure 14] Figure 14 illustrates safety lockout of the capture stage based on emitter placement. [Figure 15] FIG. 15 is a diagram illustrating the capture of a perspective image. [Figure 16] FIG. 16 shows an X-ray emitting device having an aperture that forms the widest cone. [Figure 17] FIG. 17 shows an X-ray emitting device having an aperture that forms a narrow cone. [Figure 18] FIG. 18 shows the controls that are manipulated to adjust the aperture and cone. [Figure 19] FIG. 19 is a label diagram illustrating relative distances. [Figure 20] FIG. 20 is a diagram illustrating a situation where an emitting device projects an energy profile that exceeds the profile of the imaging sensor. [Figure 21A] FIG. 21A is a diagram illustrating a situation in which the emission profile extends beyond the sensor such that the emitter is not in operable relationship with the sensor. [Figure 21B] FIG. 21B is a diagram illustrating the situation where the emission profile is scaled to remain within the perimeter of the imaging sensor and operatively aligned with the sensor. [Figure 22A] 22A and 22B show an example of the effect of an adjustable collimator to generate a tailored radiation profile that is scaled and / or rotated to stay within the perimeter of an imaging sensor. [Figure 22B] 22A and 22B show an example of the effect of an adjustable collimator to produce a tailored radiation profile that is scaled and / or rotated to stay within the perimeter of an imaging sensor. [Figure 23] FIG. 23 illustrates an adjustable collimator according to one embodiment that can be used in or with a radiation device. [Figure 24] FIG. 24 is a diagram illustrating an example of a conventional automatic exposure process. [Diagram 25] FIG. 25 illustrates an improved system that relies on one or more databases to provide machine learning for determining exposure settings for radiological images. [Figure 26] FIG. 26 is a diagram illustrating a process for improving the auto-exposure process and database using feedback from the systems described herein. [Figure 27] FIG. 27 illustrates an X-ray system according to an additional embodiment using non-eye tracking elements, such as electromagnetic tracking sensors. [Figure 28] FIG. 28 illustrates an imaging system according to another embodiment described herein that uses a portable X-ray emitter and monitor to display one or more virtual images to assist in acquiring X-ray images. [Figure 29] 29 and 30 are diagrams illustrating the initial stages of an attempt to capture an x-ray image of an individual patient adjacent an image sensor in an obscured image sensing housing. [Diagram 30] 29 and 30 are diagrams illustrating the initial stages of an attempt to capture an x-ray image of an individual patient adjacent an image sensor in an obscured image sensing housing. [Diagram 31] FIG. 31 is a diagram illustrating a display of a first virtual representation of a boundary of an imaging sensor on a display. [Diagram 32] 32 and 33 show additional examples of images superimposed with a virtual image of the boundaries of the imaging sensor. [Diagram 33]32 and 33 show additional examples of images superimposed with a virtual image of the boundaries of the imaging sensor. [Figure 34A] 34A-34C show another embodiment of an emitter having a screen that allows for two configurations of emitter operation and monitor viewing. [Figure 34B] 34A-34C show another embodiment of an emitter having a screen that allows for two configurations of emitter operation and monitor viewing. [Figure 34C] 34A-34C show another embodiment of an emitter having a screen that allows for two configurations of emitter operation and monitor viewing. [Diagram 35] FIG. 35 is a diagram illustrating a tablet-type emitter for improving an operator's X-ray imaging capabilities. [Figure 36A] 36A to 36C are diagrams illustrating an example of the system shown in FIG. 35 with various information displayed on the display of a tablet-type emitter. [Figure 36B] 36A to 36C are diagrams illustrating an example of the system shown in FIG. 35 with various information displayed on the display of a tablet-type emitter. [Figure 36C] 36A to 36C are diagrams illustrating an example of the system shown in FIG. 35 with various information displayed on the display of a tablet-type emitter. [Figure 37A] 37A-37C are diagrams illustrating examples of database information that can be provided to various x-ray systems to enhance a person's ability to obtain one or more x-ray images. [Figure 37B] 37A-37C are diagrams illustrating examples of database information that can be provided to various x-ray systems to enhance a person's ability to obtain one or more x-ray images. [Figure 37C] 37A-37C are diagrams illustrating examples of database information that can be provided to various x-ray systems to enhance a person's ability to obtain one or more x-ray images. [Figure 38] FIG. 38 illustrates a display according to an additional embodiment configured to assist an operator in obtaining fluoroscopic images during initial screening of a person. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0021] 1A shows an example of an operating room layout for using an imaging system in a standard extremity surgery case. In this example, a surgeon 102 is operating on a patient's left hand. The patient 104 lies supine with the left upper extremity prepped and draped in an abducted position on a hand table 105. The surgeon sits adjacent to the side of the patient, and a surgical assistant 106 sits adjacent to the patient's head across the hand table. Surgical tools and equipment are arranged on a table 108 directly behind the surgical assistant.

[0022] In one embodiment, the imaging system uses X-ray imaging. Thus, a sterile X-ray emitter 110 according to the present invention is placed on a surgical hand table 105 for use. A monitor 112 is placed on a stand immediately adjacent to the hand table, allowing wireless transfer of X-ray, fluoroscopic, thermal, and digital images from the X-ray imaging system to a screen for viewing by the surgeon. The emitter 110 allows the surgeon to hold it in one hand while using the other to operate another instrument, such as a drill. A detector stage according to the present invention can be placed on or within the table 105 to collect radiographic image information for storage and / or display on an external monitor, such as device 112. As discussed herein, the emitter can be held in one hand or can be secured to a mounting structure that can be automated / controllable or simply can withstand the weight of the emitter, preventing the user from constantly holding the emitter.

[0023] FIG. 1B illustrates a system according to an additional embodiment with a sensor 706 and an emitter 710 for use with a dedicated operating table 300. As shown, the operating table 300 includes a structure 302 that increases access to the surroundings of the patient's organs and stabilizes the patient as some of the patient's organs are suspended in free space. In this embodiment, a shell 707 containing the sensor 706 (described below) is coupled to a first boom or arm 716. The arm / boom 716 allows the sensor 706 to move. In another embodiment, the boom 716 can be automated such 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 secured to a wall, ceiling, or portable frame structure. FIG. 1C illustrates the positioning of the sensor 706 and the boom 716 adjacent to a body part of the patient 104 such that the emitter 710 can be positioned as desired by an operator or medical personnel. In this embodiment of the system, the boom or arm can also house components of the device, such as heat sinks and power supplies, allowing for a smaller, more maneuverable emitter. Additionally, either boom can be designed with features to assist the physician in performing the procedure. For example, a locking system can be incorporated into the boom so that the physician can position either the sensor 706 and / or emitter 710 and lock the associated boom in place. Additionally or in combination, the boom can incorporate memory positioning, such that the boom automatically retracts from the surgical space to a predefined position and automatically moves out of the way of the physician as he or she performs the procedure. Additionally, the memory positions can include a "last position" of the emitter or sensor so that the system can automatically reposition the component to its last position before it is moved away from the surgical space.

[0024] As described herein, the systems described herein can include one or more distance sensors 708 disposed on the image sensor and / or other areas of the surgical table or work area. The one or more distance sensors 708 allow for a measurement of any space between the body part or tissue structure disposed on the image sensor, the surgical table, and / or the work area. As described below, such additional measurements allow for an accurate measurement of the thickness of the body part when there is a gap or space between the image sensor, the surgical table, and / or the work area and the body part.

[0025] 2 is a simplified schematic diagram of an X-ray emitter according to the present invention. The general configuration of the device is one that can be held in one hand, is lightweight, and is very portable. The device preferably has a rounded contoured handle to ergonomically fit the surgeon's hand and to better direct fluoroscopic, digital, and thermal images to the limb and surgical field.

[0026] In one embodiment, the back of the emitter 110 can include a control panel that can activate at least three different modes of operation: fluoroscopy mode, digital image mode, or infrared thermal imaging mode. When activated, each mode is controlled on the front of the device by a trigger 202. Pressing the trigger once activates the device to take an image (i.e., an x-ray or digital image). The different modes of operation can be activated in different ways. As an example, pressing and holding the trigger 12 can activate live fluoroscopy, digital video, or infrared thermal imaging. Also shown in FIG. 2 is an embodiment in which the emitter 110 is coupled to a power source 221. The power source can be a battery 221 located remotely from the emitter 110 or within the emitter 110. Alternatively or in combination, the power source 221 can be coupled via wires between the emitter 110 and the power source 221. As an additional embodiment, in addition to the remote power source 221, a battery 221 can be placed within the emitter 110 and used to temporarily isolate the emitter 110 from an external power source and power it with the internal battery 221.

[0027] 3 illustrates a control panel for use with the emitter according to one embodiment. The control panel is located on the rear of the emitting handle and controls various inputs and outputs of the system. The control panel is easily accessible to the user and ergonomically designed to facilitate operation of the emitter. The control panel consists of a large, transparent screen 204 (i.e., LCD or OLED), a control button 302 located on the left side of the unit, a control button 304 located on the right side of the unit, and a clickable toggle button 206 located in the center.

[0028] A display screen 204 displays the image and displays a digital control panel that controls fluoroscopy, digital camera, and infrared settings. The control panel may include a touch screen. Toggle buttons 206 control power input in fluoroscopy and infrared modes, and digital zoom in image mode. One embodiment of the emitter configuration includes a dynamic x-ray collimation 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 technology known to those skilled in the art of proximity and distance measurement. The sensor 216 continuously senses the distance to the patient and prevents activation and emission of radiation if the x-ray tube is too close, e.g., less than 19 centimeters directly from the patient. In addition, the system may include any number of audible, visual, or tactile indicators to allow the physician or user of the system to determine when the sensor is within an acceptable distance or is ready to fire. In additional embodiments, the audible, visual, and / or tactile indicators are positioned to allow a user to identify the operating status of the system without having to move the focus away from the subject being inspected. In one example, a visual indicator (e.g., one or more LEDs) is positioned on the emitter to provide clearly distinguishable feedback regarding distance, alignment, or other operating status of the system.

[0029] Handle 200 tapers to the bottom of the device, which can accommodate a high voltage power supply 218, an external charging port 220, and a battery docking station 222. When trigger 202 is actuated in either X-ray or fluoroscopy mode, high voltage from power supply 218 is provided to x-ray generating unit 230 via high voltage connector assembly 228. Power generated by power supply 218 is converted to an appropriate input voltage usable by x-ray generating unit 230. This output can range from 1 kV to 120 kV, although clinical applications are typically in the 30 kV to 90 kV range.

[0030] The x-ray generating section 230 is based on an existing high voltage emitter, but is custom designed for the miniaturization required for the immediate application. An appropriate thickness of electrically insulating material is placed around the high voltage power supply 218, connector assembly 228, and x-ray generating section 230 to prevent radiation loss and maintain good beam quality. All three components 218, 228, 230 are located adjacent to each other to minimize high voltage leakage and potential interference with low voltage components in the system. In an alternative embodiment, the components 218, 228, 230 may be located in an external control section (not shown).

[0031] An appropriate layered combination of silicone rubber and epoxy encapsulates the x-ray generating section 230 (except where the x-rays are emitted into the collimator) to shield against radiation losses 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 a collimating cone 210 in the head of the device. Fluoroscopy settings include peak kilovoltage (kV), amperage (mA), and digital brightness, and are controlled by a digital control panel at the back of the neck.

[0032] The digital camera lens 212 and infrared thermal imager 214 are located immediately adjacent to the collimating cone 210 and these components are also shielded with insulation. The digital camera 214 is controlled by placing the device in digital mode using the control panel. Pictures are generated via a trigger 202 located on the handle of the device.

[0033] Similarly, the infrared thermal imaging camera 214 is controlled by placing the device in infrared mode using the control panel. Pressing and holding the trigger produces a live infrared thermal image. Digital x-ray, conventional digital visible, and thermal images can be transmitted and displayed on the external screen 112 shown in FIG. 1. Depending on the level of emitter and detector coordination described herein, x-ray images can also be transmitted directly to an external monitor for viewing. Memory 233 can be used to store any type of collected image, and such images can be encrypted at the time of capture in accordance with co-pending U.S. patent application Ser. No. 15 / 466,216, the entire contents of which are incorporated herein by reference. An audio pickup 235 may be provided for memorialization of the procedure or other purposes, and audio recordings may also be stored in memory 233, optionally in encrypted form.

[0034] The device is powered from an external plug-in power supply with an external charging port 220. The digital display, control interface and trigger are controlled via a control system microprocessor electronics 232 which is powered by a low voltage power amplifier system 234. The low voltage amplifier system 234 and microprocessor control system 232 are further advantageously located remotely from the high voltage power supply to further minimize interference.

[0035] The following table lists the various control modes that can be associated with the emitter using the buttons and toggle switches found on the control panel in Figure 3:

[0036] [Table 1]

[0037] For a variety of 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 a variety of factors and can be configured in the emitter's software. Figure 4 shows the process by which the device manages the safety lockout procedure for the X-ray emitter. The process for determining a safety lockout is as follows:

[0038] 402. The user initiates the x-ray emission process by pressing the trigger while in x-ray mode, which may be a fluoroscopic image or a still x-ray image.

[0039] 404. The distance settings are obtained from the emitter's distance settings database.

[0040] 405. The distance measurement unit is activated and captures the distance between the end of the emitter and a subject directly in front of the emitter.

[0041] 406. The distance settings and distance measurements are relayed to the emitter's ECU calculations.

[0042] In 408.408, the ECU processor uses distance measurements, distance settings, and internal generator offsets to determine if the emitter should fire.

[0043] 410. The decision to fire / alert in 410 is determined by the ECU and relayed to the hardware unit.

[0044] 412.412, if the ECU determines that a subject is too close to the emitter, the ECU will activate a warning procedure, display a message on the LCD panel, and activate any lockout warning lights.

[0045] 414. 414, once the ECU determines that the subject is at a safe distance, the emitter begins the X-ray generation and emission process and sends a signal to all internal and external components.

[0046] Because the device is free to move in three-dimensional space, the size of the cone projected from the x-ray emitter varies with distance to the target. Thus, the present invention provides control over the cone size based on the distance of the x-ray emitting device from a sensor located on the stage.

[0047] 16 illustrates a simplified diagram of an applicable x-ray source including an anode 1602 and a cathode 1604. The anode typically includes a tungsten or molybdenum target 1606. A high voltage across the anode and cathode generates x-rays at the target, forming a cone 1608 that emerges from an aperture 1610 in a casing 1612.

[0048] One embodiment of the invention includes a telescoping 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 outer chamber along a threaded inner mount. Moving the aperture closer to the source produces a wider angle, and moving it further away produces a smaller angle, as shown in Figure 17.

[0049] 18, a controller 1802 in the handheld emitter controls the telescopic aperture. Based on the following process, the controller 1802 rotates a threaded shaft 1804, so that the threads engage with grooves 1806 in the telescopic chamber 1614, moving the aperture 1610 towards and away from the x-ray source.

[0050] FIG. 19 is a diagram illustrating the control method. First, the distance between the device's X-ray origin and the X-ray sensor is calculated. If the distance is outside the allowable range for X-ray emission, the X-ray is not emitted. However, if the distance between the X-ray origin and the sensor (d s If the distance between the X-ray origin and the aperture (d a ) is then calculated and the control rotates the throttle chamber the correct distance.

[0051] R s If we let denote the radius of the X-ray radiation that touches the sensor, then the angle between the normalized vector of the sensor plate and the dispersion cone is θ=tan-1 (R s / d s ) The distance that the aperture must be from the radiation origin to emit the correct dispersion of X-rays is d a =R a / tan(θ), where R a represents the radius of the aperture. The controller causes the X-ray emitting device to emit X-rays that project a cone of angle θ onto the sensor.

[0052] While the telescoping cone adjustment mechanism described with reference to Figures 16-19 is an improved aperture, those skilled in the art will appreciate that a more conventional adjustable aperture (i.e., having translatable x-ray absorbing or blocking blades) could be used instead. The same mathematical formulas used above are applicable to this embodiment. That is, if the distance is outside the allowable range for x-ray emission, no x-rays will be emitted. Conversely, if the distance between the x-ray source and the sensor (d s ) is within an acceptable range, the aperture is automatically opened and closed to facilitate the emission of the source.

[0053] Different markets have different safety requirements. Additionally, lockouts may be adjusted for different subjects (elderly, children, otherwise healthy) to ensure there are no safety issues associated with radiation. The device also preferably includes the ability to intelligently conserve power by utilizing an inertial measurement unit (IMU), distance sensor section, and operator-driven command input. The duration of the machine's power stages can be set by the user, allowing the device to adapt to the user's particular style and rhythm.

[0054] The systems and methods described herein can also use multiple sensors for error correction and / or improved positioning. For example, when the emitter and detector / sensor are in place and the system loses track of one or more sensors on the platform. Typically, loss of tracking can cause a drop in the frames per second (FPS) of the output image. To address this situation, the emitter can include one or more inertial measurement units that can track the emitter's movement to adjust the intervening frames when necessary. The IMU can then be used to adjust the intervening frames to increase the output FPS. In some embodiments, an IMU can be used instead of or in addition to sensors on the platform, if one is available with sufficient accuracy.

[0055] Figure 5 shows a typical sequence for power management.

[0056] 502. The user initiates the power sequence of the device by pressing the emitter's physical button 208 (FIG. 2), which activates the device's electronic circuitry and transitions the device into the ON mode.

[0057] 504. When the device is picked up, it is detected by the IMU in the emitter and the power level is immediately raised to standby. This standby state initializes all power systems and raises the power charge to a medium level.

[0058] 505. When the user puts the device down or is not otherwise operated by emitter movement or control panel or control computer initiation, the device automatically powers down to the off stage after a duration of t0.

[0059] 506. The user activates the device by picking it up, either by changing a setting on the control panel itself or by bringing the device within range of a subject detected by the on-board distance sensor, which further increases the device's power level and puts the device into ready mode by fully charging the power system and making the device ready to launch.

[0060] 507. After a period of time t1 has elapsed without the unit being actively activated, the emitter will power itself down to a standby level.

[0061] 510. The user presses the emitter trigger 202 to initiate X-ray capture. Assuming all other safety checks are cleared, further power is applied and a stream of X-ray photons is emitted towards the subject until state 511 is reached, at which point emission is complete. However, at 510', 511' the device returns to ready mode, allowing the user to continue emitting X-ray photons indefinitely.

[0062] 511. After a time t2 during which no emitters are fired, the device automatically powers down to a standby level at 520.

[0063] The device follows the timing described above, transitioning the device from the on phase to eventually the off phase as various durations pass without active intervention to maintain or change the power state, as shown by points 508, 522, and 524. Utilizing these steps allows the device to conserve power while remaining in a ready state, without any user action.

[0064] Figure 6 illustrates the process by which the device captures simultaneous images in response to a user request. Using a setting on the emitter's control screen or specifying simultaneous capture in the control section, the emitter will begin the process of capturing any combination of x-ray, conventional digital, and thermal images. The process for capturing images is as follows:

[0065] 602. A user initiates a capture sequence on the device by pulling an emitter trigger, which starts the capture process and simultaneous imaging process for whatever sensor groupings.

[0066] 604. The emitter immediately enters X-ray standby mode and prepares the X-ray generating device to fire.

[0067] 604'. At the same time, if enabled, a conventional camera component focuses on the desired subject, which preferably occurs as soon as the trigger is pressed.

[0068] 604”. At the same time, once enabled, the thermal imager is powered on and its start-up sequence begins, which again preferably occurs immediately upon the trigger being pressed.

[0069] 606. The X-ray system initiates a safety check, as illustrated in FIG.

[0070] 608. The digital imaging camera captures conventional images of the subject, which are preferably automatically transferred to the control unit for display on an external monitor.

[0071] 610. The thermal imaging camera captures a thermal image of the subject, which is preferably automatically transferred to the control unit for display on an external monitor.

[0072] 620. In one embodiment, after both 608 and 610 are completed and all safety checks from 606 have been verified, the X-ray unit emits and generates an X-ray image in the sensor. The image is preferably automatically transferred to the control unit for display on an external monitor. Thus, the X-ray system charges, safety checks, and X-ray discharges only after all other systems have been run, minimizing operational interference.

[0073] X-ray detector implementation

[0074] The emitter described herein must be used with an X-ray detector to collect X-ray images. The emitter is not limited to detector technology and can use any available flat panel detector, even film. However, given the complete portability of the emitter, steps must be taken to ensure proper orientation of the emitter with respect to the detector to collect clear images while avoiding spurious and unwanted X-ray emissions. One option is to mount the emitter on a fixture that includes a properly aligned detector plate, similar to a conventional C-arm but smaller and more powerful. However, another option is to use the emitter on an X-ray capture stage, described below, that has built-in sensors that automatically pivot, orient, and align the emitter with the emitter to maximize exposure quality and safety.

[0075] The X-ray capture stage according to one embodiment comprises a statically fixed platform positioned at the start of surgery with 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 radiation from a separate emitter device, including a portable handheld unit as described herein. The X-ray capture stage also preferably incorporates wireless (or wired) communication capabilities to allow the captured X-ray or fluoroscopic image to be viewed on an external display monitor or any other structure for the captured image, including external storage.

[0076] There are two main embodiments of the capture stage. In a clinical embodiment, the stage tracks the radiation and simply locks out the x-ray emission if it is not aligned. Alternatively, the tracking stage not only allows or locks out the emission depending on the alignment, but also precisely tracks the position and angle of the x-ray radiation and positions and tilts the embedded sensor to capture accurate, high quality x-ray images. This arrangement uses less power, corrects for radiation tilt and perspective, holds the subject in place so the surgeon's workflow can continue uninterrupted, and x-rays can be captured without repositioning the device, subject, or surgeon.

[0077] 7 is a simplified diagram showing an x-ray capture stage according to one embodiment, which includes a platform 702 having a hollow cavity containing an embedded sensor 706. In one form, the stage may have legs 703 and be used as a table. In another form, the stage may be enclosed in a bag and placed under the patient. Thus, the platform 702 may be wrapped in a sterile drape and a surgical procedure may be performed on the platform, such as the table 105 of FIG. 1.

[0078] The capture stage cooperates with a separate X-ray emitting device 710. The X-ray emitting device may have a variety of configurations and implementations, including handheld units as detailed above, as well as wall mounted, armature mounted, and floor standing. Any implementation is compatible with an operational X-ray stage, as long as the emitter electronics system can communicate with the X-ray stage central controller interface to pivot, orient, and align.

[0079] The platform 702 is in electronic communication with the central controller 704. A display monitor 712 is electronically connected to the controller 704 and can be used to both display images and control the overall system. Typically, the user interacts with the emitters 710, but in some cases, the user can interact directly with the central controller 704 to manipulate images, set up specific capture scenarios, control parameters, and adjust other settings. The system can also use a tablet, cell phone, or any other display device electronically connected to the central controller for display purposes. The central controller 704 and the display can be integrated into one device, such as a laptop computer or other mobile computing device. Optionally, the central controller can be electronically connected to multiple displays for educational or other purposes.

[0080] FIG. 8A is a perspective view of an X-ray capture stage according to the present invention. In one specific arrangement, the stage comprises a hollow sealed shell approximately 20 inches by 30 inches (approximately 50.8 centimeters by approximately 76.2 centimeters), although the overall dimensions of the present invention may be modified to accommodate other surgical applications. The shell is provided with a cavity 800 that houses an X-ray detection sensor 706 that operates to capture X-ray radiation from an X-ray emitter. Suitable X-ray sensors are available from a variety of commercially available manufacturers. The sensor 706 is attached to a motorized movement system that is used to pan and tilt the sensor within the cavity. This motorized system ensures that the sensor is precisely positioned to provide the best image quality and capture view.

[0081] The x-ray sensor 706 is preferably mounted on a movable tray 802 that moves in a controlled motion within the cavity 800. The tray and sensor can move in the XY direction and tilt along both axes as described below. FIG. 9 shows a top view of the capture stage. The sensor 706 in the tray 802 is mounted for translation on a series of motorized rails 720, 722, allowing the sensor to be positioned anywhere along the x and y axes within the shell. At least one of the x and y tracks can be, for example, a threaded rod, each driven by a motor for precise transverse movement of the tray 802 in the x and y dimensions. As a further alternative, the xy movement of the tray can be controlled by bands 1002, 1004 in FIG. 10A. Such bands are precisely controlled by rods 1006, 1008 to translate the tray supports 1110, 1112 to the tray 808. It should be noted that although four tray supports 902, 904 are depicted in FIG. 9, a single support 1110, 1112 may be used instead, as shown in FIG. 10A.

[0082] The emitter 830 is used to measure the distances from a point 810 on the handheld unit 710 to three (or more) fixed points 830 on the stage. In FIG. 8A, these distances are depicted as D1, D2, and D3. Based on these distances, the system employs a tracking method to precisely identify the center point 801 on the sensor 706 and the angle (θ5) of emission from the source to the platform. An exemplary implementation of this tracking system would include a combination of infrared sensors in the platform and handheld unit, and gyroscopes in the stage and handheld unit to sense the angle θ5.

[0083] Several sensors work together to position the detector. When the user picks up the handheld unit, the system goes into a ready state. An infrared beacon at the corner of the platform lights up. The handheld unit's positioning and tracking camera immediately begins analyzing the infrared spectrum captured within its 140-degree field of view. The camera looks 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.

[0084] Referring to FIG. 8B, IR positioning emitter tiles 850 are located at each corner of the surgical or clinical stage. FIG. 8B shows an example of four unique tiles. If an on-board positioning beacon is used, the pattern will be different. These tiles contain multiple infrared emitters 852, usually 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 emitter across the stage, the IR positioning camera captures and analyzes the IR emissions from the tiles. Because each tile has a unique pattern, the camera can determine the exact location of the tile relative to the platform. Additionally, because each tile has a unique pattern of lights, the system can determine the exact location of the tile in XYZ space.

[0085] Optionally, or in addition to this unique IR layout, the IR emitters can be made to flash in a syncopated fashion. The frequency of the flash can be modulated to add a unique signature to each tile, allowing the pattern to be repeated in scenarios with many tiles. Due to this unique arrangement, only one corner of the unit, i.e., one positioning beacon, needs to be visible to the emitter for the system to be fully functional. Thus, the layout of the pattern allows the camera to triangulate its position in space relative to each corner. Using the triangulation data, as well as the orientation data from the emitter's IMU unit, the system can determine the center point of the emission. The stage then moves the center point to that area of ​​the stage and tilts the detector as orthogonal as possible to the emission. While the sensor is moving into position, the emitter's collimator adjusts the power of the beam to ensure that it only illuminates the detector panel.

[0086] Position information from the combination of sensors 830 is routed through a controller (i.e., 704 in FIG. 7), which interpolates the raw sensor data to an aim point on the platform. The platform then moves the sensor tray 802 to the specified point. The platform then tilts the sensors to the correct orientation (θ5) to remove as much skew as possible. That is, assuming the x-ray source of the emitter 710 emits radiation along an axis 803, the goal is to move the axis 803 as close as possible to the center point 801 of the sensor, and to make the plane of the sensor as perpendicular as possible to the axis 201, minimizing skew.

[0087] In all stage embodiments, the top cover of the platform or shell is covered with a radiolucent material (i.e., 1018 in FIG. 10A). However, the lower base of the platform (i.e., 1020 in FIG. 10A) is preferably coated with an x-ray absorbing material such as lead. This coating prevents excess x-rays from penetrating the field and being absorbed by the emitter operator. This x-ray absorbing base coating also prevents excess x-ray radiation from bouncing off the floor and scattering throughout the facility. The sides of the platform may be constructed of a radiopaque material as well.

[0088] FIG. 10B is a schematic diagram showing the band actuation stage with key components identified. The X-ray detector is shown at 1030 and the detector carrier at 1032. This particular embodiment is driven by an H-shaped belt 1040. Reference numerals 1042 and 1044 are small and large offset bearings, respectively. The belt is driven by motors 1050, 1052. The stage housing is shown at 1060, with power provided via cable 1062. The detector tilt motors are shown at 1070, 1072. The IR positioning tiles and IR emitters described with reference to FIG. 8B are shown at 850 and 852, respectively. Exemplary IR emitters described herein are active beacons, as they actively emit a signal or energy that is received by the emitter to assist in determining the position of the emitter. Alternatively or in combination, additional aspects of the methods, systems, and apparatus described herein can include passive markings or objects that assist in determining the orientation of the emitter. The systems, devices and methods can simply include a camera or emitter that records a particular pattern (e.g., a QR symbol or some unique object in the surgical field such as a clock, table, fixture, etc.) The system can use these patterns in place of or in combination with an infrared beacon to have a computer determine the location of the emitter, in the latter case where the location of the emitter is calculated by a processing device such as a computer.

[0089] 11A and 11B show the pan-tilt mechanism. In FIG. 11A, the sensor tray 802 is placed in the cavity with the sensor 706 tilted about the y-axis. In FIG. 11B, the sensor tray 802 is tilted along both the x-axis and the y-axis. This panning and tilting allows the sensor to be precisely positioned to capture an x-ray image while minimizing distortion caused by the offset angle of the light emitting element. That is, the capture stage and x-ray emitter are aligned to minimize skew and maximize capture of both x-ray and fluoroscopic images. By moving the sensor within the stage, the user can obtain clear, usable x-ray and fluoroscopic images without having to reposition the subject.

[0090] In the case of handheld emitters where the emitting device is physically separate from the stage, it is important for quality and safety reasons to position the sensor relative to the emitter. A variety of techniques can be used to achieve this goal. As shown in Figures 8 and 10, multiple position tracking instruments 830 can be attached to each end or corner of the tray. These instruments can be used at all four corners, although only one is required for accurate triangulation. These instruments can be based on ultrasonic tone generation or infrared emission. In these embodiments, acoustic or infrared signals generated at the platform are sensed by the emitter device, translating and tilting the sensor to maximize capture. In further embodiments, magnetic position and orientation sensors and detectors of the type used in surgical navigation can be utilized to orient the tray and x-ray sensor.

[0091] The x, y, pan, and tilt positioning of the tray and sensor is possible without providing a position emitter on the platform portion of the system. Figures 12A and 13 illustrate alternative systems and methods of position calculation that remove the dependency on a position emitter embedded in the platform. Alternatively, the position of the X-ray emitter relative to the capture stage and the X-ray detection sensor can be calculated based on an external position emitter. As mentioned above, the emitter can be purely handheld so that the practitioner can move the emitter in free space. Alternatively, the emitter can be movable with (or be coupled to) a support structure that maintains the position of the emitter relative to the subject without the practitioner having to continue to hold the emitter.

[0092] The process of determining the position of the X-ray emitting device according to this embodiment is as follows.

[0093] The external location emitting device(s) are mounted at fixed locations and contain an array of infrared emitters that emit an infrared pattern from the five faces of the cubic object 1202, resulting in infrared energy coming from slightly different origins.

[0094] The stage detects the infrared pattern and calculates the relative position in 3D space from the stage to the center of each infrared emitter, expressed as [xsi,ysi,zsi]=[-xei,-yei,-zei], where s is the stage, e is the infrared emitting device, and i is the index of the infrared emitting device (if multiple infrared emitters are used).

[0095] The X-ray emitting device continuously senses the infrared signal pattern and determines the relative position of the emitting device to the center of each infrared emitter in space. This relative position is relayed to the radiation position controller of each emitter. This position is considered as [xhi,yhi,zhi]=[-xei,-yei,-zei], where h represents the X-ray emitting device, e represents the infrared emitting device, and i represents the index of the infrared emitting device.

[0096] The radiation position controller receives the relative positions ([xhi, yhi, zhi]) of the X-ray emitting devices. Using these relative positions, the radiation position controller calculates the relative positions of the X-ray emitting devices with respect to the stage (FIG. 13), resulting in [xhi-xsi, yhi-ysi, zhi-zsi]. This operation is performed for each infrared emitting device (i), which can then be used to estimate the error.

[0097] After the stage applies the position along with other data contained in the original application, the stage moves and rotates the X-ray sensor plate into the correct position to capture the X-ray image.

[0098] FIG. 12B illustrates an embodiment in which the emitter 710 can apply energy to a sensor / detector 706 that is configured to move as discussed herein, but can also move to enable lateral imaging. In the embodiment shown, the sensor / detector 706 moves out of the central X-axis of the table 105 to capture a lateral view of the patient 104. However, embodiments of the sensor 706 may include structures in which the table is non-planar and configured to receive the sensor 706 above the plane in which the patient is positioned. FIG. 12B also illustrates an additional concept in which multiple detectors 706 are used as described herein. In such an embodiment, the sensor 706 is moved as described herein, but the sensor with the best working alignment is used to generate the signal.

[0099] Safety Lockout Procedures

[0100] Just as it is important to limit emissions from an emitter to a specific target distance, for a variety of practical and certification reasons, it is important to only fire the X-ray generator when the emitter is properly pointed at the capture stage. Preventing the X-ray generator from emitting photons when not pointed at 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 the reference numbers corresponding to those in Figure 14.

[0101] 1. The user initiates the capture process by sending a signal through the emitter device 110, typically by pressing a trigger. The emitter sends a data packet (D) to the controller containing a capture request, distance measurements (d1, d2, ...), and the emitter angle.

[0102] 2a. The controller verifies that the emitter is in a safe orientation.

[0103] If the controller detects that the emitter is not in a safe, valid orientation, it will send an error message to the emitter, preventing the emitter from firing and informing the user that there is a problem.

[0104] 3. The stage positions the sensor to align with the emitter. The stage tilts the sensor so that it is correctly oriented to capture a clear image. The orientation is as close as possible to the complement of the emission.

[0105] 4. After the position is determined, the stage subsequently sends a confirmation message to the controller.

[0106] 5. The controller sends a start message to the emitter, which then performs any additional safety or preparation tasks. If the emitter determines that the environment is safe to fire, it will emit X-rays.

[0107] 6a. The emitter fires a pulse of X-ray photons onto the stage for the required duration.

[0108] 6b. While emitting the X-ray photon stream, the emitter constantly streams position and angle updates to the central controller.

[0109] 6c. The controller records these position updates and relays them to the stage.

[0110] 6d. The stage rapidly and continuously updates the position and angle of the sensor, optically stabilizing the X-ray image.

[0111] 7. The sensor captures the X-ray photons emitted by the emitter and constructs an image.

[0112] 8. Once the X-ray emission is complete, the sensor relays the data to the control unit.

[0113] 9. The controller then cleans up the image from the sensor using a variety of well known optical enhancement techniques. Where applicable, the controller leverages stored movement data from the emitter to further enhance the output.

[0114] The above process ensures that the emitter directs radiation at the sensor and stage, as opposed to any other target. By moving the sensor into position beneath the radiation target, the user can create high resolution, flexible images of the exact desired portion of the subject, without having to reposition the subject.

[0115] Figure 15 illustrates the process by which the device captures a fluoroscopic image. The process of capturing a fluoroscopic image is quite similar to capturing a still X-ray image, but the fluoroscopic process repeats several times of radiation and image capture to create a moving image. In the process to ensure safe radiation and capture a fluoroscopic image, the symbols correspond to those in Figure 15.

[0116] 1. The user initiates the capture process by sending a signal through the emitting handle, usually by pressing a trigger. The emitter sends a data packet (D) to the controller containing the capture request, the distance measurements (d1, d2, ...) and the emitter angle.

[0117] 2a. The controller verifies that the emitter is in a safe orientation.

[0118] If the controller detects that the emitter is not in a safe, valid orientation, it will send an error message to the emitter, which will prevent the emitter from emitting light and notify the user that there is a problem.

[0119] 3. The stage positions the sensor to align with the emitter. The stage tilts the sensor so that it is correctly oriented to capture a clear image. The orientation is as close as possible to the complement of the emission.

[0120] 4. After positioning, the stage then sends a confirmation message to the controller.

[0121] 5. The controller forwards the start message to the emitter, which then performs any additional safety or preparation tasks.

[0122] In fluoroscopy mode, the emitter repeats the following steps while the emitter device continues to request additional fluoroscopy frames.

[0123] 6a. The emitter emits a pulse of X-ray photons onto the stage for the required time.

[0124] During emission of the X-ray photon stream, the emitter constantly streams position and angle updates to the central controller. If at any time during the fluoroscopy process the actuation stage detects that the emission is not being directed at the stage, it sends a termination signal to the emission device and skips directly to step 9.

[0125] 6c. The controller records these position updates and relays them to the stage.

[0126] 6d. The stage rapidly and continuously updates the sensor position and angle, optically stabilizing the X-ray image.

[0127] 7. The sensor captures the emission of X-ray photons from the emitter and constructs an image.

[0128] 8. The sensor immediately transfers the image to the control unit, where a simple cleanup process is performed and the image is displayed on an external display device. The perspective frame is stored in memory.

[0129] This process is continually repeated to produce a moving image on the external display until the user releases the trigger on the emission device.

[0130] 9. Once the user releases the trigger of the emission device, the controller "cleans up" the stored frames from the sensor using a variety of well-known enhancement techniques. If applicable, the controller further applies stored motion data from the emitter to further enhance the output. The controller then composites the perspective frames into a single video and plays it repeatedly.

[0131] The above process allows users to view live fluoroscopic images of the subject in real time. By storing the images and reprocessing them after the capture is complete, the device can create a single high-quality fluoroscopic video for later viewing and review.

[0132] Auto-adjusting collimator

[0133] As described above, the systems of the present disclosure can move the emitter to a position relative to the object and determine the position of the emitter relative to at least one position tracking element that measures the distance between the emitter and the object and prevents the emission of energy until the distance is less than a predetermined distance. In the embodiments of the systems described herein, a self-adjusting collimator can be used to optimize the profile or boundary of the emission onto the working surface of the sensor. As with other embodiments described herein, these systems can relay the position of the emitter to a motor system that adjusts the imaging sensor into operable alignment with the emitter, where relaying the position of the emitter includes using the emitter to both provide orientation data for the emitter and determine the distance from each of the multiple tracking elements. However, the use of a self-adjusting collimator can automatically maximize the emission profile on the imaging sensor.

[0134] FIG. 20 illustrates an X-ray emitter 110 directed toward a platform 114 on which an imaging sensor (not shown) is positioned to illustrate the benefits of an adjustable collimator. The perimeter of the imaging sensor's working area 116 is illustrated to illustrate the area that produces an image upon exposure of X-ray radiation. As illustrated, the profile 120 of X-ray radiation from the X-ray emitter 110 extends beyond the perimeter of the imaging sensor's working area 116, causing the X-ray emitter to be out of operative alignment with the sensor. In such a case, the system described herein will not allow the X-ray emitter 110 to be fired or initialized. The illustration in FIG. 20 is intended to illustrate the concept of the system being out of operative alignment. As discussed herein, the imaging sensor can be coupled to a motor system to allow the sensor to be moved to align with the radiation profile 120. Alternatively, the platform (or working surface) 114 can include a number of position tracking elements (not shown in FIG. 20) that allow the position and distance of the emitter 110 relative to a non-moving sensor or the working area 116 of the sensor to be measured.

[0135] 21A depicts a situation in which the emission profile 120 extends beyond the sensor 116 such that the emitter is not in operable relationship with the sensor 116. For purposes of illustration, the sensor 116 shown in FIGS. 21A and 21B is stationary, and the tracking element 118 enables the system to determine the relative position, orientation, and distance of the emitter (not shown) with respect to the sensor 116. The emission profile 120 is also illustrated as a representation of the boundaries of the emission provided by the emitter. For purposes of illustration, the profile 120 shown is the profile that would result if the axis of the emitter were orthogonal to the sensor 116.

[0136] As noted herein, in a given condition illustrated by FIG. 21A, if the system is unable to establish a workable alignment, the operator is prompted to adjust the position of the emitter. In some embodiments, the system may provide feedback, such as an audible or visual indicator of non-alignment. FIG. 21B illustrates the situation after repositioning the emitter such that the emission profile 120 falls within the bounds of the sensor 116. However, as shown, this emission profile 120 is not maximized relative to the dimensions of the sensor 116. Failure to maximize the emission profile 120 relative to the sensor may require the operator to take additional radiographic images of the subject to adjust for a smaller profile.

[0137] FIG. 22A illustrates the effect of an adjustable collimator. Again, for purposes of illustration, the emission profile represents illumination by the emitter perpendicular to the sensor. FIG. 22A shows an unadjusted emission profile 120 that would normally be considered out of operational alignment with the imaging sensor 116 since a portion of the emission area bounded by the profile 120 lies outside the sensor 116. However, one embodiment of the system described herein relies on a position tracking element 118, as well as components attached to the emitter (discussed above), to determine position information such as the orientation of the emitter and the distance between the emitter and the sensor 116. The system uses the position information to adjust the collimator on the emitter and rotate and / or scale the emission by the emitter to generate an adjusted emission profile 122. As shown, in this embodiment, the adjusted emission profile 122 is reduced in size (indicated by arrow 126) and rotated (indicated by arrow 124) to scale the emission profile 120 to an adjusted emission profile 122 that maximizes the exposure to the imaging sensor. It should be noted that the adjusted emission profile can be scaled and rotated as desired. Additionally, aspects of the system generate the adjusted profile during real-time movement of the emitter relative to the sensor 118.

[0138] 22B illustrates an unadjusted emission profile 120 along with an adjusted emission profile 122, in both cases the profile resembles an isosceles trapezoid due to the axis of the emission path not being orthogonal or normal to the sensor 116. However, in this embodiment the system uses position information to generate an adjusted profile 122 that maximizes the exposure area on the imaging sensor 116.

[0139] The embodiments disclosed herein rely on a tracking element 118 as well as a sensor within the emitting portion (as described herein). Embodiments of the system that generate the adjusted emission profile can also be used in conjunction with position data obtained from an external camera, sensor, or mechanical support to determine the relative motion between the emitting device and the imaging sensor.

[0140] FIG. 23 illustrates an adjustable collimator 130 according to one embodiment that can be used in or with an irradiator (not shown in FIG. 23). As shown, the adjustable collimator 130 can rotate and / or scale an aperture or radiation window 132 to produce a tailored radiation profile on the imaging sensor (as discussed in FIGS. 20-22B). This embodiment of the adjustable collimator 130 uses a number of blades or leaves 134 that can move and rotate to adjust the orientation of the aperture 132. The blades 134 prevent the passage of radiated energy such that energy is restricted from passing through the aperture or radiation window 132.

[0141] The movement and rotation of the blades can be driven by any number of motors and drives. In the illustrated embodiment, the adjustable collimator 130 includes a motor assembly having a first drive 138 coupled to a proximal pivot bearing 152 and a second drive 136 coupled to a distal pivot bearing. The drives 136 and 138 adjust the rotation of the blades 134 and the size of the aperture 132. For example, rotation of the motors 136 and 138 in opposite directions causes the pivot bearings to rotate in opposite directions, resulting in movement of the blades 134 that causes the aperture 132 to open and close. In the illustrated example, movement of the first drive 138 in a clockwise direction and movement of the second drive 136 in a counterclockwise direction causes the blades 134 to move toward each other, thereby decreasing the size of the aperture 132. Similarly, when first driver 138 moves in a counterclockwise direction and second driver 136 moves in a clockwise direction, blades 134 move away from each other and the size of aperture 132 increases. When drivers 138 and 136 move in the same direction, proximal pivot bearing 150 and distal pivot bearing 152 rotate in the same direction, which rotates the blades, which causes aperture 134 to rotate.

[0142] The adjustable collimator 130 maintains the aperture 132 having a generally square shape as all of the blades 134 move to adjust the size of the aperture. Additional embodiments of the device may include any number of additional motors or actuators to control the angular orientation of the blades. In such cases, the aperture 134 is not limited to a square profile, but may take the shape of an isosceles trapezoid. Such a feature may help maintain a square emission profile (as shown in FIG. 22A) regardless of the orientation of the axis of the emission energy relative to the imaging sensor.

[0143] The embodiment of the adjustable collimator 230 shown in Figure 23 also includes a chassis or housing 140 that houses a drive mechanism (e.g., bearings, pulleys 144, belts 146, etc.) that converts the movement of gears 144 driven by motors 136, 138 into rotation and movement of the blades. Additionally, the adjustable collimator 230 includes any number of position tracking systems that allow the system to maintain information regarding the aperture size and direction of rotation. For example, the first moving 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).

[0144] FIG. 27 and FIGS. 28A and 28B illustrate another embodiment in which a radiology system having a sensor configuration as described herein can improve the quality of x-ray or fluoroscopic capture.

[0145] The quality of an X-ray or fluoroscopic capture is related to several physical attributes of the subject. These factors dictate a set of technical factors (e.g. power, current, time, etc.) that control the emission characteristics of the radiation source / emitter. It is the device operator's responsibility to combine and set these factors in such a way that the human viewing the radiological image can discern the required visual elements without exposing the subject to excessive radiation.

[0146] Setting these technology factors is complex. To relieve the operator from the burden of manually setting these technologies, existing fluoroscopy devices have implemented automated processes. A typical approach uses software or hardware dose detectors on the plate, which gradually increase the dose as radiation is added to the exposure. This traditional approach has multiple problems.

[0147] One of the major problems with traditional approaches is motion: because radiation is directed at the subject over a long period of time, any movement of the subject, the operator, the equipment, or even blood vessels within the subject creates motion artifacts that significantly degrade the image.

[0148] Another problem is not knowing the penetration requirements before exposure. Therefore, when a source emits radiation at a given power level (kV), it often does not penetrate sufficiently to form an image. This lack of image visibility results in exposure of patients, operators, and staff to radiation without a useful radiological image being obtained. In such cases, these people are exposed to excessive radiation that serves no clinical purpose.

[0149] Technological innovations in the field of fluoroscopy devices, including but not limited to the systems described herein, are resulting in a new generation of instruments with complex sensor arrays that can directly measure multiple physical factors necessary for exposure calculations.

[0150] By leveraging these sensors on any device and subject, and leveraging robust machine learning techniques, it becomes possible to calculate, before exposure, the techniques needed to create a superior capture, eliminating motion artifacts while reducing radiation dose.

[0151] The following description provides exemplary details of the invention to provide an understanding of the invention. Minor engineering adjustments can be made to practice the invention without adopting these specifications. The invention is described for use in surgical x-ray imaging, but can also be used in other medical applications, such as general medical imaging, veterinary medicine, and bone densitometry. Non-medical applications, such as industrial imaging, metal fatigue inspection, welding inspection, and security inspection, can also be used.

[0152] FIG. 24 shows an example of a conventional automated X-ray exposure process. A physician or operator initiates the exposure by requesting an X-ray (step 1). The X-ray device then evaluates the detector (step 2) to track the amount of radiation received by the imaging sensor plate. An internal measurement of the X-ray device determines if this energy is a sufficient exposure to generate an image (step 3). If the device determines that a sufficient amount of radiation has been collected (step 4a), it considers the exposure complete and displays the X-ray. If the user cancels the X-ray or if the dose accumulation is too long, the device cancels the exposure (step 4b). If not (step 4c), the device continues to emit radiation and returns to the evaluation step until an image is created, the time expires, or the user cancels the exposure.

[0153] The traditional process has several drawbacks. The two biggest are that the exposure begins without any guarantee that an image will appear, and the time it takes to evaluate the exposure can lead to motion artifacts in the final image, making the x-ray image unusable. In either case, the patient, operator, and staff are exposed to unnecessary radiation, creating a major safety hazard.

[0154] FIG. 25 and FIG. 26 illustrate an improved approach over the conventional method described in FIG. 24. The improved approach can determine the optimal technique elements to create high resolution effective radiological images without exposing the operator, staff, and patient to unnecessary or excessive radiation. By utilizing a radiological imaging device with a comprehensive sensor array and the application of machine learning techniques across the board, the system 20 can calculate and refine the technique before radiation is emitted. This allows the operator to precisely align the device and understand whether the device will be able to image tissue structures.

[0155] Figure 25 shows one example of how statistical data can be compiled for use in the image processing process of Figure 25. In practice, multiple statistical models are sent to the system 20 from a central server (shown in Figure 26). These models, called computer vision classification (1a) and estimate update (1b), are stored locally on the device and are available for use before the operator requests an exposure.

[0156] Referring to Figure 25, the process can begin with an operator initiating capture (2). The operator then aligns the emitter and tissue structures (3) using the device's positioning system and performs automatic procedure detection after completing safety checks (as described above). Depending on the exact topography of the x-ray system, CPT code information (4a) and vital signs information (4b) can be entered by the operator or extracted from other systems by automatic means.

[0157] As the system prepares to release energy for x-ray or fluoroscopic capture, two simultaneous measurement acquisitions are taking place: on-device sensor acquisition (5a) and computer vision classification (5b).

[0158] The sensor collection uses an array on the device to collect multiple input parameters including, but not limited to, source to skin distance (SSD), source to detector distance (SDD), angle of incidence, ambient temperature, x-ray tube and device temperature, etc. All of these parameters are input into an inference execution function (6).

[0159] Computer vision classification utilizes the imaging camera on the device to capture images of the subject's tissue structure. These images are passed to the CV analysis function, which uses the captured images and CV classification data stored locally on the device provided by a central server. These processes make a decision about the captured subject and pass its recommendation to the inference execution engine.

[0160] Once the inputs are collected from the device's various subsystems, those values, along with estimated value updates provided by a central server, are executed against the device's inference execution engine (6a). The output of this family of functions is the time, kV, and beam current for a given X-ray technology (7).

[0161] The device output is set to the calculated value, radiation is emitted for the given settings (8), an image is captured and processed (9), and the image is displayed to the user (10).

[0162] As soon as the X-ray is displayed to the operator, the system starts monitoring the operator's interactions with the interaction monitoring system (11). This system records every interaction the operator has with the image, including changes in brightness, sharpness, contrast, position, zoom, rotation, etc. The time the operator spends on X-ray capture and fluoroscopy capture is also recorded.

[0163] In steps 12a-12d, the system submits the capture data to a central processing system. The submitted data includes the four main components of the capture: (12a) direct measurement information such as SSD, temperature, etc., (12b) interaction heuristics such as change in lighting and time spent inspecting the capture, (12c) surgical details such as biometric information, associated CPT codes, computer vision capture and the resulting classification output, and (12d) raw capture data from the detector itself, and information associated with the capture such as machine details, software version, etc.

[0164] This captured information is stored in respective databases 13a and 13b on a central processing system for future processing.

[0165] At scheduled times, the central processing system trains a putative label (14) using advanced regression analysis. By examining the statistical relationships between the sensor data, capture data, and surgical data across a large set of universally captured x-rays, and similarly to the results of the previous estimator generation (14a), the system is able to fit the data to more accurate labels. The output of the training step is a new estimator (17).

[0166] Similar to the label training step (14), the x-ray and fluoroscopic capture data, surgical details data, and classification data are trained using a classification refinement process (15) that takes advantage of the large capture cross-sections obtained from the large number of input x-rays to produce more accurate classifications (16).

[0167] Depending on the topography of the on-site X-ray machine, the central processing system sends new estimates (18) and classifications (19) to the devices as soon as possible. These updates are subsequently loaded into the devices' local storage (1a) and (1b), where new algorithms are applied to further improve the accuracy of the automatic exposure and reduce the dose.

[0168] FIG. 27 illustrates an additional embodiment of an X-ray system using a non-eye tracking element such as an electromagnetic tracking sensor 252. Although four sensors 252 are shown in the example of FIG. 27, any number of sensors 252 can be used as needed. The system can operate with one sensor 252, but additional sensors can be used for redundancy. In operation, the electromagnetic sensor 252 generates an electromagnetic field and forms a tracking space in an area formed around the X-ray sensor 254 (e.g., the operating table space 250). The emitter 110 includes one or more receivers that inductively couple with the magnetic field generated by the sensor 252. The sensor 252 allows the emitter 110 to be non-eye tracking, so that the sensor 252 can be located within the workspace 250. Alternatively, the sensor 252 can be visible or its location can be marked on or around the workspace 250. The non-eye tracking allows for applications in full body imaging. Additionally, the non-eye tracking allows for a reduction in the size of the structure housing the X-ray sensor 254. Any number of electromagnetic tracking field emitters and sensors may be used in place of, or in addition to, the tracking emitters described above.

[0169] Electromagnetic sensors and their operation are described in U.S. Patent Nos. 4,054,881, 6,762,600, 6,624,626, 6,400,139, 6,377,041, and 6,369,564, each of which is incorporated herein in its entirety. Such electromagnetic tracking systems are available from Polhemus, Inc. (Vermont, USA) and NDI, Inc. (Ontario, Canada).

[0170] Electromagnetic tracking systems (EM systems) are highly susceptible to interference from surrounding metal objects and induction motors. Therefore, an embodiment of an X-ray system using an EM system includes one or more additional inertial measurement units (IMUs). In use, an X-ray system with EM tracking starts in a calibrated state. This calibration can be carried over from a previous use or calibrated directly from the factory. During use of the X-ray system, tracking of the X-ray emitter relative to the X-ray detector is performed by both the EM sensor and the IMU. Typically, one or more IMUs are placed on the X-ray emitter and (optionally) an IMU is placed on the X-ray detector. The differential positioning data provided by the EM tracking and the IMU are generally consistent. At any time, if both sets of data do not match, the system can infer transient interference in the EM system and signal an error condition. During this error condition, the system can use the IMU data to smooth out any interference and generate the best positioning condition. Typically, this inference is sufficient to smooth out the EM data and maintain system functionality. Once the transient interference subsides, the IMU data and the EM sensor data will match again.

[0171] As an additional aspect, an X-ray system with EM tracking can utilize X-ray emissions to actively and continuously update its calibration. In such a case, the collimation / beam angle of the X-ray emissions from the emitter can computationally determine the true position of the X-ray emitter when the emissions were emitted. The system can then use the true position calculated from the emissions to determine if an offset is needed in the EM positioning system.

[0172] FIG. 28 illustrates an imaging system according to another embodiment described herein using a portable X-ray emitter 110. The X-ray emitter 110 can be freestanding or mounted on a boom-type structure that allows up to six degrees of freedom. As described above, the X-ray emitter 110 is configured with a positioning system that uses any number of position tracking elements 264 positioned around an imaging sensor 262 that receives X-ray radiation from the emitter 110 to generate an X-ray image. The imaging sensor 262 can be positioned within a housing 260 that defines a working area for positioning an imaging subject. Alternatively, the sensor 262 can be positioned on a platform structure or other structure, as described above.

[0173] The position tracking element 264 communicates with an X-ray positioning control system 266 configured to determine the relative positions of the image sensor 262 and the emitter 110. The X-ray positioning system 266 may be any of a variety of positioning systems, including but not limited to the positioning systems described herein, and may use line-of-sight emitters, non-line-of-sight sensors, or a combination thereof.

[0174] 28 also illustrates the emitter 110 as having one or more cameras 282 adjacent to the emitter window 280. Embodiments of the system can include the emitter 110 having dual stereo cameras 282, 284 positioned around the perimeter of the emitter window 280. Alternatively, a single camera 282 or 284 can be used. As shown, the emitter 110 can optionally include a lidar sensor 286 for additional positioning, imaging, and depth sensing capabilities, as well as additional sensors disclosed herein.

[0175] The one or more cameras 282 and / or 284 send signals to the processor 268, which uses the camera signals to generate an image of the field of view from the emitter 110. The processor 268 is also configured to use positioning data from the positioning system controller 266 to generate a first virtual representation of the imaging sensor 262 and overlay this image on the image of the field of view from the emitter 110, as described below. The image of the imaging sensor 262 and the first virtual representation can be viewed on one or more display devices 270. In one embodiment, the display device 270 comprises a screen provided on a portion of the emitter 110. Alternatively or in combination, the display device can be a monitor in the examination area. In addition, the processor 268 can enable broadcasting of the virtualized image to enable remote viewing of the virtualized image. In an additional embodiment, the x-ray positioning system 266 can be combined with the processor 268.

[0176] 29 and 30 illustrate an initial stage of an attempt to capture an x-ray image of an individual patient 104 adjacent to the image sensor 262 of the image sensing housing 260 where the individual patient 104 obscures a large portion of the housing 260 and / or image sensor profile 262. This is illustrated for illustrative purposes, as the same principles would apply even if the image obtained were of a torso region (e.g., leg, shoulder, torso, etc.) where the torso region obscures the image sensor 262 such that the x-ray operator cannot visually verify the alignment of the body / torso region on the housing 260 with the contour of the image sensor 262. FIG. 30 illustrates where the projection of x-ray radiation 290 produces a radiation projection region 292 on the person 104. However, in some embodiments, the x-ray system allows the operator to determine the contour of the projection region 292 using the light field produced by the emitter 110. This allows the operator to visualize the x-ray radiation region without generating x-ray radiation.

[0177] As shown in FIG. 30, because the x-ray detector housing 260 / sensor 262 is obscured by the patient's torso 104, an operator may inadvertently misposition the x-ray emitter 110 such that the radiation projection area 292 / light field is unknowingly misaligned with the image sensor 262. This misalignment results in an x-ray image with an impaired view of the projection area 292. By positioning the camera 282 adjacent to the emitter window 280, the camera can obtain a similar view as the emitter window 280. In an embodiment of the system, the camera(s) 282 may use image stabilization or actuators to shift the viewpoint of the camera image so that it is always viewed normal to the imaging sensor.

[0178] FIG. 31 depicts a display of a first virtual representation 274 of the boundary of the imaging sensor 262 on the display 270. As shown, the image 272 allows the x-ray user to view the area of ​​the human 104 aligned with the imaging sensor 262. The image 272 can be a still capture image, a real-time video, or a video segment as the user manipulates settings prior to emitting x-ray energy from the emitter. As shown, the viewpoint of the camera 282 matches or is close enough to the viewpoint of the radiation window 280 so that the view of the image 272 corresponds to the final x-ray image. The system shown in FIG. 31 can also optionally display a virtual representation of the light field / x-ray projection area on the monitor 270 in addition to displaying the light field (as shown in FIG. 30) on the patient 104 prior to emitting x-ray radiation from the emitter.

[0179] 32 and 33 show additional examples of image 272 superimposed with a virtual image 274 of the boundary of the imaging sensor. Also, FIG. 32 and 33 show a second virtual image 276 representing the area where the x-ray radiation emitted from the emitter is incident on the person and the image sensor. If the system uses a light field projection from the emitter, the second virtual image 276 can correspond to the light field projection on the patient. In this manner, the operator can use both virtual images 274 and 276 to ensure that the intended subject of the x-ray image is within the overlapping area. FIG. 32 illustrates a situation where the emitter (not shown in FIG. 32) is normal to the subject and the image sensor. FIG. 33 illustrates a system according to one embodiment where the camera image 272 is shifted in perspective to appear normal to the patient and image sensor by movement of the camera over the emitter or by digital processing of the image. 33, however, illustrates the skew of the projected x-ray projection area through the skew of the second virtual image 276 representing the x-ray emission area. This feature allows the user to recognize when looking at the monitor 270 that the emitter is not positioned normal to the subject.

[0180] FIG. 34A shows an X-ray system according to another embodiment that uses both non-eye tracking elements such as electromagnetic tracking sensor 252 and eye tracking elements 264 as described above. Again, any variation of the system disclosed herein can include either non-eye tracking elements, eye tracking elements, or a combination of elements. FIG. 34A also illustrates an X-ray emitter 110 having a screen 270 at the end of the unit 110 opposite the body 111 that carries the hardware and emission device of the unit. In such an example, the emission window is located on the bottom surface of the body 111, as shown at 290, such that the emission or camera field of view 290 is directed away from the body 111. The emitter 110 operates as discussed herein that can use any number of sensors 252 and / or 264 as needed. In operation, the sensors 252 and / or 264 enable the system 266 to determine the relative position of the emitter 110 with respect to the image sensor 254. As discussed above, the emitter 110 includes one or more cameras (not shown in FIG. 34A ) that send signals to the processor 268, which generates an image of the field of view from the emitter 110 using the camera signals that can be displayed on the emitter 110 via the monitor 270 or via a separate monitor. In the embodiment of the emitter 110 shown in FIG. 34A , the emitter includes a first trigger 113 and a second trigger 115 that allow a user to grasp the emitter in different configurations depending on the x-ray image desired. Additionally, the emitter 110 can include any number of elements (e.g., side profiles, graphics, etc.) to provide a physical visual indication of where the x-ray radiation is exiting the emitter 110.

[0181] 34B and 34C illustrate the emitter 110 shown in FIG. 34A, with the grip 119 of the emitter 110 located between the body 111 and the monitor 270. This configuration allows the emitter 110 to be activated in two different configurations. FIG. 34B shows the configuration in which the emitter 110 is held over the subject / patient so that the emission and the camera field of view 290 are directed toward the bottom. In such a case, the operator can view not only the image 272 but also the image sensor's virtual image 274 on the monitor 270 while using the control switch 306. The first activation trigger (shown in FIG. 34A) can be accessed by gripping the grip 119 with the same hand. In FIG. 34C, the operator points the bottom of the body 110 toward the subject to be imaged, as shown by the field of view 290. In this embodiment, the operator can view the monitor 270 and adjust the control knob 306 while accessing the second trigger 115 with his thumb. It should be noted that the monitors shown in Figures 34A-34C can provide the same information as those shown in Figures 33A or 33B.

[0182] Another aspect of the system and method includes the simultaneous capture of a digital photograph (through a camera) and a corresponding X-ray image of the area of ​​interest. The combination of the digital image and its corresponding X-ray image is useful for documentation purposes, allowing future AI workloads and classification algorithms to better identify the orientation and tissue structure of the X-ray image. Furthermore, if the digital image and the corresponding X-ray image are not combined, the operator is forced to use their best guess as to the orientation and alignment of the X-ray source relative to the X-ray detector of the previously taken X-ray image while observing the previous image. Unfortunately, this often results in the need for retakes. It is estimated that over 22% of retakes are due to simple misalignment. Integrating the X-ray image with a digital image of the subject / body part can improve the results of subsequent X-ray images. In another aspect of the system and method, the imaging system can include a depth-sensing camera. For example, the emitter can include a LIDAR array (e.g., 256 pixels) to determine the depth. This depth (thickness) and shape of the tissue structure can be used to refine the size of the tissue depicted.

[0183] FIG. 35 illustrates a system and method according to another embodiment for improving an operator's ability to take x-ray images. As described above, the systems and devices of the present disclosure can use a positioning system to display a dynamic view of the x-ray detector 262 via the display 270. In the embodiment shown in FIG. 35, the emitter 110 includes a large display 270 that allows the operator to observe a real-time dynamic view of the work surface 260 / imaging sensor 262. As shown, the display 270 can be segmented to provide multiple views of different information rather than a single window. For example, as shown, the display 270 can display past x-ray images and additional information as described below. The emitter 110, as shown in FIG. 35, is in a tablet-like form with a back surface 170 that includes, but is not limited to, an emitter window, one or more cameras, lidar, or similar components. The emitter tablet 110 can also include any number of ergonomic elements, such as finger / hand openings 174 that facilitate positioning of the emitter 110 and allow ergonomic access to the controls 172. As an additional embodiment, the information provided on a display associated with emitter 110 may also be provided on an external display or monitor separate from the emitter 110 unit.

[0184] FIG. 36A illustrates an example of the system described in FIG. 35 with various information displayed on the display 270 of the tablet emitter 110. It should be noted that while the system described herein may include the use of a positioning system (discussed above), the elements and information provided on the optional visual display 270 may be applied to any x-ray system, including but not limited to conventional C-arm imaging systems. Again, the back surface 170 of the table emitter 110 includes one or more apertures for an emitter, camera lens, lidar, or other components shown on the emitter in FIG. 32. Additionally, the camera system / lens may be configured to capture images or video from a viewpoint that matches or is close to the viewpoint of any x-ray image captured by the tablet emitter 110.

[0185] FIG. 36A illustrates a display 270 that includes multiple subset displays 180, 182, 184, 186. These displays may provide information regarding the patient, the physician, or other data associated with the patient and / or the x-ray image in the information display 180. The display 270 may also include an information display 184 to guide the operator in taking the x-ray image. The display 270 may also include a working display 182 that allows real-time visualization of a work surface / enclosure 260 that houses an imaging sensor (not shown), a first virtual image 274 that represents the imaging sensor, and a second virtual image 276 that represents the imaging sensor and / or the area of ​​x-ray radiation emitted from the emitter 110 that is incident on the human. The display 270 also includes an x-ray display 186 that may be used to display x-rays obtained during an examination. In this illustration, the x-ray display 186 is blank.

[0186] The subset displays shown in Figure 36A are exemplary and the disclosure includes any combination of subset displays as well as single displays. Typically, the operator can change the display using controls 172 on the unit.

[0187] FIG. 36A illustrates the pre-x-ray state, and FIG. 36B illustrates the operator receiving information regarding the type of x-ray image required. As described below, the information display 184 can display information to the operator, such as a setup image showing the ideal positioning of the person 104 / body part. The setup image can optionally also show recommended positions for the operator, emitter, and / or accessories. The image shown in FIG. 36B also shows a recommended orientation of the emitter, although alternative images are within the scope of this disclosure. For example, the information display can also display an exemplary orthogonal photo of a photo of a desired tissue structure, so that the operator gets a preview of how the subject / tissue structure being examined should appear in the viewfinder / working display 182.

[0188] 36B may also include a virtual or vector tissue representation 190 of the desired location of the body part intended to be imaged by the system. This virtual tissue representation 190 may consist of an orthogonal image, a vector rendering of a set image, or may consist of a separate virtual image. In any case, the virtual representation 190 is intended to assist the operator in positioning the patient prior to x-ray capture.

[0189] FIG. 36C illustrates the use of a virtual representation 190 to position the patient's body part 109 so that an operator can proceed with x-ray image capture to generate an x-ray image 186. As described herein, by providing such information to the operator, even a minimally trained individual can capture x-ray images that are typically required when performing a human evaluation. Additionally, embodiments of the system can compare the captured x-ray image 186 to any suitable reference image from the library described above. The system can include the use of artificial intelligence to compare the captured x-ray image 186 to the reference x-ray images and provide a score to guide the operator as to the desirability of the captured x-ray image. In some embodiments, the system can prompt the operator to recapture additional x-ray images using different positioning and / or x-ray emission settings.

[0190] It should be noted that any of the virtual representations (e.g., 190, 274, 276, etc.) can be triggered on or off depending on the operator's preference. Additionally, the system further includes an option to provide a visual representation of only the overlapping regions of 190, 274, 276 to allow the operator to ensure alignment of the body parts and emitters with the image sensor.

[0191] The systems and methods described herein that provide visual as well as virtual images provide a dynamic view in real time, giving the operator an image of the tissue structures imaged prior to generating the x-rays. In addition, the system can guide the operator to a particular x-ray view by overlaying a representation of the subject's tissue structures, corrected for the active area of ​​the image sensor, directly onto the image display and view. Such a system can increase the clinical utilization of the system when the operator is not a physician or experienced x-ray technician.

[0192] For example, the reference images may assist the user in capturing the best view or views commonly needed for evaluating a body part. Thus, the system may be networked with a database or library of data that guides the operator in taking one or more appropriate x-ray images.

[0193] For example, the database may include a library of images and other educational materials to assist the operator. For example, the library may include a view name, any number of reference x-ray images, any number of reference photographs, and any number of patient alignment photographs. One purpose of such information is to visually guide the operator through the imaged anatomy before producing the x-ray.

[0194] 37A is a diagram illustrating an example of a description of a data element or record 312 that is part of a database intended to interact with an X-ray imaging system. As described herein, the database and visual display may be used in a system that tracks the relative positioning of an emitter with respect to an image sensor. Alternatively, the database and images may be used with conventional X-ray equipment, including but not limited to C-arms, and other radiographic equipment.

[0195] 37A illustrates the individual data fields of an exemplary record 312. For example, such data fields may include a view name 314, an organizational structure 316, one or more reference x-rays 318 (such as images from an academic or other reference source), settings of a system in communication with a database (so that an operator does not have to adjust settings for different captures), a reference x-ray image 322 taken by the system or a similar system, an orthogonal image 324, a settings image 328, and ancillary information 328. The list of data fields is intended for illustrative purposes only. Any combination of data fields or additional data fields are within the scope of this disclosure.

[0196] 37B and 37C show an example of three records 312, each having various data fields consisting of descriptive text (314, 316, 328, 330), x-ray system settings (320), x-ray reference images (318, 322), and visual images (324, 326). As an example, when a caregiver requires x-ray images for a patient follow-up, the system can receive the records 312 from an appropriate database. The records 312 are then displayed as described above to guide the operator to obtain the desired images for the follow-up examination. As described above, the individual records 312 can be standard x-ray views or the caregiver can select the desired record and select the desired x-ray image. In an additional aspect, when an operator is initially examining a human (e.g., in a field setting such as a normal patient intake, an accident scene, or a triage situation), the operator can indicate the tissue structure requiring examination, and the system can then pull or receive the associated records to guide the operator to take the required x-ray images.

[0197] The information provided above in Figures 37A-37C is an example of X-ray image information that can assist an operator in obtaining a proper X-ray image and / or operating the X-ray emitter 110 and / or the X-ray system.

[0198] FIG. 38 illustrates a display 270 according to an additional embodiment configured to assist an operator in obtaining fluoroscopic images in an initial screening of a person. In this example, an operator is provided with a tissue representation 240 from which any number of tissue sites can be selected to receive information that aids in obtaining a desired x-ray. The operator can then select one or more tissue sites that require x-ray imaging. As an example, in the embodiment illustrated in FIG. 38, the operator selects an ankle site 242 on the tissue representation 240. Thus, the operator may then be prompted with various informational images from a database or library, such as those illustrated in FIG. 37B, that show various standard positions of the ankle required to obtain x-ray images. Thus, the operator can use the informational display, as well as the virtual overlays described above, to track the position of the patient's ankle and obtain x-ray images for later evaluation by a medical caregiver.

[0199] In another embodiment, the display 270 can include a tissue representation 240 that is comprised of textual information to allow an operator to identify a tissue site. Additionally, the tissue representation 240 can be comprised of a subset of tissue sites rather than the entire body.

[0200] The display 270 of FIG. 38 can also include a variety of additional data, including, but not limited to, patient data 244, operator / physician information 245, a database of patients scheduled for examination 246, and a history section 247 of past x-ray captures by the operator.

[0201] The systems and methods described herein that provide visual as well as virtual images provide a dynamic view in real time, giving the operator an image of the tissue structures imaged prior to generating the x-rays. In addition, the system can guide the operator to a particular x-ray view by overlaying a representation of the subject's tissue structures, corrected for the active area of ​​the image sensor, directly onto the image display and view. Such a system can increase the clinical utilization of the system when the operator is not a physician or experienced x-ray technician.

[0202] In further aspects of the system, the system may include one or more processors that use artificial intelligence to match the captured x-ray image to the reference image 318 and / or template image 322 to determine if the captured x-ray matches the reference image of the requested x-ray. If the artificial intelligence indicates a sufficient match (e.g., by a similarity score), the operator may move on to capturing the next image. If there is a poor match, the system may alert the operator and retake the image.

[0203] The above description provides exemplary details of the invention to allow for an understanding of the invention, however, routine engineering adjustments can be employed to practice the invention without departing from the spirit or scope of the invention. Additionally, although the invention is described for use in surgical x-ray imaging, it can also be used in other medical applications such as general medical imaging, veterinary medicine, and bone densitometry. The system and method can also be used in non-medical applications such as industrial imaging, metal fatigue inspection, welding inspection, security inspection, and the like.

Claims

1. 1. A method for an operator to obtain a radiological image of a person or body part, comprising: positioning an irradiating device at a predetermined distance from a work surface, the work surface including an imaging sensor, the irradiating device including a camera system and an aperture opening configured to pass radiant energy; orienting the irradiation device so that the aperture opening and the camera system face toward the work surface; transmitting a signal from the camera system to a display and displaying an image of the work surface on the display; providing at least one informational image on the display for viewing by the operator, the at least one informational image including a recommended positioning of a person or body part; directing the radiant energy toward the imaging sensor to generate a radiological image of the person or body part, and displaying the radiological image on the display; A method for an operator to obtain a radiological image of a person or body part, comprising:

2. The method of claim 1 , further comprising providing a virtual tissue representation of the body part on the radiological image, the virtual tissue representation being overlaid on the work surface on the radiological image.

3. 10. The method of claim 1, wherein the imaging sensor comprises a sensing perimeter, the method further comprising displaying a virtual sensing perimeter on the display, the virtual sensing perimeter being overlaid on the work surface and corresponding to the sensing perimeter.

4. 10. The method of claim 1, further comprising displaying a virtual radiation perimeter on the display, the virtual radiation perimeter being overlaid on the work surface and corresponding to a radiation perimeter of the radiant energy from the aperture opening.

5. The method of claim 1, wherein the step of providing at least one information image further includes the step of providing an instruction message on the display, the instruction message including a text instruction or a video instruction.

6. The method of claim 1 , wherein the images include at least one non-video image.

7. The method of claim 1 , further comprising providing informational data on the display, the informational data including data associated with the human.

8. 7. The method of claim 6, wherein the display comprises a plurality of subset displays, the image of the work surface being displayed on a first subset display and the radiological image being displayed on a second subset display.

9. The method described in claim 1, wherein the step of providing at least one information image includes a step of selecting one or more images from a first database containing a plurality of radiological image information.

10. 10. The method of claim 1, further comprising the step of displaying a tissue representation on the display before positioning the radiation device, the tissue representation having one or more tissue sites, and the display configured to allow the operator to select one or more tissue sites to pre-select the at least one informational image provided on the display for viewing by the operator.

11. The method of claim 1 , further comprising performing a comparison of the radiographic image with a reference radiographic image and providing feedback to the operator based on the comparison.

12. 1. A system for obtaining a radiological image of a body part on a work surface having an X-ray image sensor, comprising: an irradiation device including a camera system and an aperture opening configured to pass radiant energy, the irradiation device comprising a display configured to display an image of the work surface generated by the camera system; Equipped with the radiation device is configured to communicate with a database containing a plurality of radiographic informational data to display at least one informational image for viewing by an operator of the radiation device, the at least one informational image including a recommended positioning of the body part; the display is configured to display a virtual tissue representation of the body part on the image of the work surface, the display being configured to provide the radiological image after the radiant energy is emitted onto the body part and the x-ray image sensor. A system for obtaining a radiological image of a body part on a work surface having an x-ray image sensor.

13. The system of claim 12, wherein the step of providing at least one information image further includes the step of providing an instruction message on the display.

14. The system of claim 13 , wherein the instructional message comprises a text instruction or a video instruction.

15. The system of claim 12 , wherein the at least one informational image comprises a video image.

16. The system described in claim 12, wherein the at least one information image includes a recommended positioning of the body part, and the images include at least one non-video image.

17. The system of claim 12 , further comprising providing informational data on the display, the informational data including data associated with the body part or the person.

18. 13. The system of claim 12, wherein the display comprises a plurality of subset displays, the image of the work surface being displayed on a first subset display and the radiological image being displayed on a second subset display.

19. The system of claim 18, wherein the at least one information image is displayed on a third subset display.

20. 13. The system of claim 12, wherein the radiation device is in communication with a first database containing a plurality of radiographic images, and the at least one information image comprises one or more images from the first database containing a plurality of radiographic images.

Images