Systems and methods for testing and quality assessment of imaging devices
The described device and system address the inadequacies of current QA devices by using radiopaque accessories and a radiolucent body for precise x-ray beam assessment, ensuring accurate and objective quality assessment of x-ray images and reducing misdiagnoses.
Patent Information
- Authority / Receiving Office
- WO · WO
- Patent Type
- Applications
- Current Assignee / Owner
- BJELICA VLADIMIR
- Filing Date
- 2026-01-22
- Publication Date
- 2026-07-30
AI Technical Summary
Current quality assurance devices for imaging devices, such as digital x-ray machines, are inadequate and often lead to improper calibration, resulting in reduced diagnostic quality and potential misdiagnoses due to subjective visual inspections that cannot accurately assess symmetry or gray scale variations.
A device comprising radiopaque accessories and a radiolucent body is used to assess x-ray beam strength and panoramic image attributes, with a testing assembly and kit that includes a sensor holder and arm adapter for precise positioning, and a system with a communication interface and processor for objective quality assessment scoring.
Ensures accurate and objective quality assessment of x-ray images, reducing the risk of misdiagnoses by providing standardized pass/fail criteria and minimizing radiation exposure through optimized equipment performance.
Smart Images

Figure CA2026050107_30072026_PF_FP_ABST
Abstract
Description
SYSTEMS AND METHODS FOR TESTING AND QUALITY ASSESSMENT OF IMAGING DEVICES TECHNICAL FIELD
[0001] This application relates to quality assurance of imaging devices and, more specifically, to improvements in systems and methods for testing and quality assessment of imaging devices including, without limitation, digital radiography devices.BACKGROUND OF THE INVENTION
[0002] Imagery devices such as digital x-ray devices and digital scanning devices used in medical and similar applications require quality assessment (“QA”) devices for use, maintenance and calibration thereof.
[0003] Such x-ray and other devices are commonly utilized in, for example and without limitation, dental care facilities, veterinary care facilities, hospitals, etc. Those ones of such facilities using imaging devices on a daily basis, and relying on the same for care or other critical decisions, most needily require high-functioning QA devices. Currently, related QA devices are lacking and, often, have not advanced from rudimentary products developed in the 1950’s.
[0004] The lack of suitable QA devices is causing many operators to allow their machines to degrade and go out of calibration; thus, reducing the diagnostic quality of the images, and potentially leading to misdiagnoses or other adverse outcomes ( e.g., and without limitation, improperly fitted devices and oral applications).
[0005] Known QA devices include what is referred to in the field as a step wedge. These are used for performance of required daily QA tests. It is also known to use, for example, a metallic object intended for other purposes, such as a bib clip. In practice, a radiograph or other digitalimage of the QA device may be taken and then reviewed visually by the user. The resulting image is diagnosed subjectively by the operator performing the test on a given day.
[0006] Such visual inspection cannot determine accurate symmetry or slight variations in gray scale, both of which will greatly affect the diagnostic quality of the X-ray images taken that day.
[0007] A further shortcoming of such solutions is that they are not manufactured to perform a proper accurate QA test on digital x-ray equipment. Further, such tools are not reliable for their intended purposes of QA / calibration. Improperly calibrated x-ray devices can lead to poor imagery, which limits diagnostic efficacy, and can lead to improper treatment plans, diagnostic errors.
[0008] As such, there is a need for improvements to, and expansion upon, each of the areas described above.SUMMARY OF THE INVENTION:
[0009] A device is provided for use in performing quality assessments of x-ray images generated by an x-ray machine. The device comprises a plurality of radiopaque accessories including a stepwedge and at least one of at least one block for facilitating an assessment of the strength of an x-ray beam emitted by the x-ray machine and at least one spherical member for facilitating assessment of attributes of panoramic x-ray images. The device further comprises a body made of radiolucent material, the body configured to hold the plurality of radiopaque accessories at predetermined spaced apart locations which allow each of the plurality of radiopaque accessories to be exposed to the x-ray beam emitted by the x-ray machine without interference from any other of the plurality of radiopaque accessories.
[0010] In some embodiments, the body includes an upper portion and a lower portion releasably attached to the upper portion, with the stepwedge being carried in the lower portion of the body. The lower portion may be formed with a base having a station configured to receive the stepwedge, walls extending upwardly from the base, a cavity bounded by the lower portion walls, and the station disposed in the base below the cavity.
[0011] The device may further comprise at least one block carried in the upper portion, where the upper portion has a top, walls downwardly extending therefrom, and at least one upper portion aperture formed in a bottom surface of the upper portion walls sized to receive the at least one block.
[0012] The device may further comprise at least one spherical member carried in the lower portion, where the lower portion includes at least one lower portion aperture formed in a top surface of the lower portion walls sized to receive the at least one spherical member. The upper portion may include at least one upper portion projection extending downwardly configured to engage the at least one spherical member in the lower portion aperture.
[0013] In some embodiments, the at least one spherical member includes a first, second, and third spherical member, the at least one lower body aperture includes a first, second, and third lower body aperture, and the at least one upper portion projection includes a first, second, and third upper portion projection, wherein the first upper portion projection engages the first spherical member within the first lower portion aperture, the second upper portion projection engages the second spherical member within the second lower portion aperture, and the third upper portion projection engages the third spherical member within the third lower portion aperture. The firstspherical member may be disposed between, and forwardly of, the second and third spherical members.
[0014] The lower portion may include at least one lower portion projection extending upwardly to engage the at least one block in the upper portion aperture. The at least one block may include a first, second, third, and fourth block, the at least one upper body aperture includes a first, second, third, and fourth upper body aperture, and the at least one lower portion projection includes a first, second, third, and fourth lower portion projection, wherein the first lower portion projection engages the first block within the first upper portion aperture, the second lower portion projection engages the second block within the second upper portion aperture, the third lower portion projection engages the third block within the third upper portion aperture, and the fourth lower portion projection engages the fourth block within the fourth upper portion aperture. The first and second block may be disposed between, and forwardly of, the third and fourth block, the first and third block disposed between the first and second spherical members, and the second and fourth block disposed between the first and third spherical members.
[0015] The stepwedge may include at least three steps of varying height.
[0016] A testing assembly is provided for use in performing quality assessments of x-ray images generated by an x-ray machine. The testing assembly comprises a sensor holder configured to hold an x-ray sensor and a device releasably mounted on the sensor holder in a predetermined orientation relative to the x-ray sensor, the device including a radiopaque stepwedge for facilitating an assessment of attributes of intraoral x-ray images and a body made of radiolucent material, the body configured to hold the radiopaque stepwedge.
[0017] In some embodiments, the testing assembly comprises a device including a plurality of radiopaque accessories including at least one of at least one block for facilitating an assessment of the strength of an x-ray beam emitted by the x-ray machine and at least one spherical member for facilitating assessment of attributes of panoramic x-ray images, and a body made of radiolucent material, the body configured to hold the plurality of radiopaque accessories at predetermined spaced apart locations which allow each of the plurality of radiopaque accessories to be exposed to the x-ray beam emitted from the x-ray machine without interference from any other of the plurality of radiopaque accessories, and an arm adapter configured to attach the device to the x-ray machine in a predetermined position and orientation.
[0018] A testing kit is provided for use in performing quality assessments of x-ray images generated by an x-ray machine. The testing kit comprises a sensor holder configured to hold an x-ray sensor, a device releasably mountable on the sensor holder in a predetermined orientation relative to the x-ray sensor, the device including a plurality of radiopaque accessories including a stepwedge and at least one of at least one block for facilitating an assessment of the strength of an x-ray beam emitted by the x-ray machine and at least one spherical member for facilitating assessment of attributes of panoramic x-ray images, and a body made of radiolucent material, the body configured to hold the plurality of radiopaque accessories at predetermined spaced apart locations which allow each of the plurality of radiopaque accessories to be exposed to the x-ray beam emitted from the x-ray machine without interference from any other of the plurality of radiopaque accessories, and an arm adapter configured to attach the device to the x-ray machine in a predetermined position and orientation.
[0019] A system is provided for performing quality assessments of x-ray images generated by an x-ray machine. The system comprises a communication interface, a memory, and a processorin communications with the communication interface and the memory. The processor is configured to receive an x-ray image of a device comprising a body made of radiolucent material, the body configured to hold at least one radiopaque accessory, analyze the x-ray image using an image analysis module, and generate a quality assessment score of the x-ray image based on the results of the analysis from the image analysis module.
[0020] A method is provided for performing quality assessments of x-ray images generated by an x-ray machine. The method comprises receiving an x-ray image of a device comprising a body made of radiolucent material, the body configured to hold at least one radiopaque accessory, analyzing the x-ray image using an image analysis module, and generating a quality assessment score of the x-ray image based on the results of the analysis from the image analysis module.BRIEF DESCRIPTION OF DRAWINGS:
[0021] Embodiments disclosed herein are illustrated by way of example in the accompanying figures, in which:
[0022] FIG. 1 is a front left perspective view of an intraoral x-ray testing assembly including a phantom device releasably mounted to a sensor holder;
[0023] FIG. 2 is a top rear perspective view of the phantom device of FIG. 1 releasably mounted to and an alternate embodiment of the sensor holder;
[0024] FIG. 3 is a rear top left perspective view of the phantom device and the sensor holder of FIG. 2;
[0025] FIG. 4 is a rear top left perspective view of the phantom device according to an embodiment of the present invention;
[0026] FIG. 5 is a left side view of the phantom device shown in FIG. 4;
[0027] FIG. 6 is a right side view of the phantom device shown in FIG. 4;
[0028] FIG. 7 is a front end view of the phantom device shown in FIG. 4;
[0029] FIG. 8 is a rear end view of the phantom device shown in FIG. 4;
[0030] FIG. 9 is a top plan view of the phantom device shown in FIG. 4;
[0031] FIG. 10 is a bottom plan view of the phantom device shown in FIG. 4;
[0032] FIG. 11 is a partially exploded rear top left perspective view of the phantom device shown in FIG. 4 where the upper body of the phantom device has been partially pulled apart from the lower body of the phantom device;
[0033] FIG. 12 is a partially exploded rear bottom left perspective view of the phantom device shown in FIG. 4 where the upper body of the phantom device has been partially pulled apart from the lower body of the phantom device;
[0034] FIG. 13 is another partially exploded rear top left perspective view of the phantom device shown in FIG. 4, similar to FIG. 11, but where the upper body of the phantom device has been fully detached from the lower body of the phantom device;
[0035] FIG. 14 is another partially exploded rear bottom left perspective view of the phantom device shown in FIG. 4, similar to FIG. 12, but where the upper body of the phantom device been fully detached from the lower body of the phantom device;
[0036] FIG. 15 is a fully exploded rear top left perspective view of the phantom device shown in FIG. 4, revealing the internal components of the phantom device;
[0037] FIG. 16 is a cross sectional view of the phantom device illustrated in FIG. 4 taken along line ‘A-A’ shown in FIG. 9, revealing the internal components disposed within the assembled phantom device;
[0038] FIG. 17 is a cross sectional view of the phantom device illustrated in FIG. 4 taken along line ‘B-B’ shown in FIG. 9, revealing the internal components disposed within the assembled phantom device;
[0039] FIG. 18 is a cross sectional view of the phantom device illustrated in FIG. 4 taken along line ‘C-C’ shown in FIG. 9, revealing the internal components disposed within the assembled phantom device;
[0040] FIG. 19 is a rear top left perspective view of the phantom device illustrated in FIG.4, where the upper body of the phantom device is translucent to better reveal the internal components of the phantom device;
[0041] FIG. 20 is a rear top perspective view of the lower body of an alternate phantom device where the step wedge is integrally formed with the lower body of the phantom device;
[0042] FIG. 21 is a rear bottom perspective view of the lower body of the alternate phantom device of FIG. 20;
[0043] FIG. 22 is a rear top right perspective view of the upper body of an alternate phantom device, where the upper body is depicted upside down, and where the upper body includes alignment arms to aid in aligning the upper body with the lower body of the phantom device;
[0044] FIG. 23 is a rear top left perspective view of the lower body of an alternate phantom device to that shown in FIG. 20 with thicker inner and outer blocks;
[0045] FIG. 24 is a front bottom left perspective view of the lower body of shown in FIG.23, depicting the lower body upside down;
[0046] FIG. 25 is a rear top left perspective view of an upper body configured for coupling with the lower body of FIG. 23;
[0047] FIG. 26 is a front bottom left perspective view of the upper body shown in FIG. 25 depicting the upper body upside down;
[0048] FIG. 27 is a rear top left perspective view of the lower body of an alternate phantom device to that shown in FIG. 20, the lower body having a generally C-shape profile defined by a hollow cylinder having a radial sector removed;
[0049] FIG. 28 is a front bottom right perspective view of the lower body shown in FIG.27;
[0050] FIG. 29 is a front end view of the lower body shown in FIG. 27;
[0051] FIG. 30 is a top plan view of the lower body shown in FIG. 27;
[0052] FIG. 31 is a bottom plan view of the lower body shown in FIG. 27;
[0053] FIG. 32 is a cross sectional view of the lower body shown in FIG. 27taken along line ‘A- A’ shown in FIG. 30, revealing the internal components of the phantom device;
[0054] FIG. 33 is a top left perspective view of a sensor holder configured to hold two different sizes of sensors, according to an embodiment of the invention;
[0055] FIG. 34 is a front top right perspective view of the sensor holder of FIG. 33;
[0056] FIG. 35 is a bottom right perspective view of the sensor holder of FIG. 33;
[0057] FIG. 36 is a front end view of the sensor holder of FIG. 33;
[0058] FIG. 37 is a rear end view of the sensor holder of FIG. 33;
[0059] FIG. 38 is a left side view of the sensor holder of FIG. 33;
[0060] FIG. 39 is a right side view of the sensor holder of FIG. 33;
[0061] FIG. 40 is a top plan view of the sensor holder of FIG. 33;
[0062] FIG. 41 is a front top right perspective view of an alternate sensor holder to that shown in FIG. 33, the sensor holder being configured to hold two different sizes of sensors and being provided with a triangular sensor shelf;
[0063] FIG. 42 is a front top right perspective view of an alternate sensor holder to that shown in FIG. 33, the sensor holder being configured to hold two different sizes of sensors and being provided with an arcuate sensor shelf;
[0064] FIG. 43 is a front top right perspective view of an alternate sensor holder to that shown in FIG. 33, the sensor holder being configured to hold two different sizes of sensors and being provided with a rectangular sensor shelf;
[0065] FIG. 44 is a front top right perspective view of an alternate sensor holder to that shown in FIG. 33, the sensor holder being configured to hold two different sizes of sensors and being provided with a plurality of sensor shelves to supports the sensors in different sensor positions;
[0066] FIG. 45 is a front top right perspective view of a sensor holder according to an alternate embodiment of the invention, the sensor holder being configured to hold a single size of sensor;
[0067] FIG. 46 is a front bottom left perspective view of the sensor holder of FIG. 45;
[0068] FIG. 47 is a front top right perspective view of an alternate sensor holder to that shown on FIG. 45, the sensor holder being configured to hold a single size of sensor and having a rectangular sensor shelf running along the length of the sensor cavity;
[0069] FIG. 48 is a front top perspective view of an alternate sensor holder to that shown in FIG. 45, the sensor holder being configured to hold a single size of sensor and having a sensor wire channel angled in relation to the sensor cavity;
[0070] FIG. 49 is a front top perspective view of an alternate sensor holder to that shown in FIG. 45, the sensor holder being configured to hold a single size of sensor and having a sensor wire channel angled in relation to the sensor cavity and frustoconical protrusions;
[0071] FIG. 50 is a rear top right perspective view of an alternate sensor holder to that shown in FIG. 45, where the sensor holder includes a shallow sensor cavity for receiving phosphorous based sensors;
[0072] FIG. 51 is a rear bottom right perspective view of the sensor holder of FIG. 50;
[0073] FIG. 52 is a front top left perspective view of an alternate sensor holder to that shown in FIG. 33, the sensor holder being configured to hold three different sizes of sensors;
[0074] FIG. 53 is a front top right perspective view of the sensor holder of FIG. 52;
[0075] FIG. 54 is a front bottom left perspective view of the sensor holder of FIG. 52;
[0076] FIG. 55 is a photograph of the sensor holder of FIG. 34 showing a sensor disposed within a first sensor cavity of the sensor holder;
[0077] FIG. 56 is a photograph of an intraoral x-ray machine and a phantom device in a testing position;
[0078] FIG. 57 is a depiction of an intraoral x-ray machine aimed at an intraoral x-ray testing assembly;
[0079] FIG. 58 is a rear top left perspective view of a panoramic x-ray testing assembly including a phantom device releasably mounted to an adapter arm;
[0080] FIG. 59 is a rear top right perspective of the panoramic x-ray testing assembly of FIG. 58;
[0081] FIG. 60 is a rear top left perspective view of an adapter arm according to an embodiment of the present invention;
[0082] FIG. 61 is a front bottom right perspective view the adapter arm of FIG. 60;
[0083] FIG. 62 is a rear end view of the adapter arm of FIG. 60;
[0084] FIG. 63 is a front end view of the adapter arm of FIG. 60;
[0085] FIG. 64 is a top plan view of the adapter arm of FIG. 60;
[0086] FIG. 65 is a bottom plan view of the adapter arm of FIG. 60;
[0087] FIG. 66 is a right side view of the adapter arm of FIG. 60;
[0088] FIG. 67 is a left side view of the adapter arm of FIG. 60;
[0089] FIG. 68 is a rear top left perspective view of an alternate adapter arm to that shown in FIG. 60, where the extension of the adapter arm is a beam with an inverted T-shape;
[0090] FIG. 69 is a rear top perspective view of the adapter arm of FIG. 68;
[0091] FIG. 70 is another rear top left perspective view of the adapter arm of FIG. 68;
[0092] FIG. 71 is a front bottom right perspective view of the adapter arm of FIG. 68;
[0093] FIG. 72 is a rear top left perspective view of the adapter arm of FIG. 68;
[0094] FIG. 73 is a front bottom right perspective view of the adapter arm of FIG. 68;
[0095] FIG. 74 is a rear top left perspective view of an alternate adapter arm to that shown in FIG. 60, where the extension of the adapter arm includes a sloped underside;
[0096] FIG. 75 is a front bottom right perspective view of the adapter arm of FIG. 74;
[0097] FIG. 76 is a rear top left perspective view of an alternate adapter arm to that shown in FIG. 60, where the extension of the adapter arm is substantially vertical, and the mounting components include two protrusions;
[0098] FIG. 77 is a front bottom right perspective view of the adapter arm of FIG. 76;
[0099] FIG. 78 is a rear top left perspective view of an alternate adapter arm to that shown in FIG. 60, where the extension of the adapter arm is substantially vertical, and the mounting components include a single obround shaped protrusion;
[0100] FIG. 79 is a front bottom right perspective view of the adapter arm of FIG. 78;
[0101] FIG. 80 is a rear top left perspective view of an alternate adapter arm to that shown in FIG. 60, where the extension of the adapter arm is arcuate in shape, and the mounting components include a rectangular shaped protrusion;
[0102] FIG. 81 is a front bottom right perspective view of the adapter arm of FIG. 80;
[0103] FIG. 82 is a rear top left perspective view of an alternate adapter arm to that shown in FIG. 60, where the extension of the adapter arm is partially triangular, and the mounting components include a cylindrical shaped protrusion;
[0104] FIG. 83 is a front bottom right perspective view of the adapter arm of FIG. 82;
[0105] FIG. 84 is a rear top left perspective view of an alternate adapter arm to that shown in FIG, 60, where the extension of the adapter arm is sloped, and the mounting components include two cylindrical shaped protrusions;
[0106] FIG. 85 is a front bottom right perspective view of the adapter arm of FIG. 84;
[0107] FIG. 86 is a rear top left perspective view of an alternate adapter arm to that shown in FIG. 60, where the extension of the adapter arm is substantially vertical, and the mounting components are substantially horizonal;
[0108] FIG. 87 is a front bottom right perspective view of the adapter arm of FIG. 86;
[0109] FIG. 88 is a rear top left perspective view of an alternate adapter arm to that shown in FIG. 60, where the extension of the adapter arm is shaped generally as a truncated cone, and the mounting components include two cylindrical shaped protrusions;
[0110] FIG. 89 is a front bottom right perspective view of the adapter arm of FIG. 88;
[0111] FIG. 90 is a rear top left perspective view of an alternate adapter arm to that shown in Fig. 60, where the adapter arm includes a secondary mounting surface;
[0112] FIG. 91 is a front bottom right perspective view of the adapter arm of FIG. 90;
[0113] FIG. 92 is a rear top left perspective view of an alternate adapter arm to that shown in FIG. 60, where the adapter arm includes a secondary mounting surface and a clearance notch in the phantom device shelf of the adapter arm;
[0114] FIG. 93 is a front bottom right perspective view of the adapter arm of FIG. 92;
[0115] FIG. 94 is a rear top left perspective view of an alternate adapter arm to that shown in FIG. 60, where the extension of the adapter arm is partially triangular, and the adapter arm includes a secondary mounting surface;
[0116] FIG. 95 is a front bottom right perspective view of the adapter arm of FIG. 94;
[0117] FIG. 96 is a front top left perspective view of an alternate adapter arm to that shown in FIG. 60, where the adapter arm includes a secondary mounting surface with mounting components including a first cylindrical protrusion and a second cylindrical protrusion smaller in size than the first protrusion extending therefrom;
[0118] FIG. 97 is a rear bottom right perspective view of the adapter arm of FIG. 96;
[0119] FIG. 98 is a front top right perspective view of an alternate adapter arm to that shown in FIG. 60, where the adapter arm is box shaped;
[0120] FIG. 99 is a rear bottom right perspective view of the adapter arm of FIG. 98;
[0121] FIG. 100 is a photograph of a panoramic x-ray machine with a panoramic x-ray testing assembly in a ready position, where the phantom device is releasably mounted on an adapter arm;
[0122] FIG. 101 is another photograph of a panoramic x-ray machine with a panoramic x-ray testing assembly in a ready position, where the phantom device is releasably mounted on an adapter arm;
[0123] FIG. 102 is another photograph of a panoramic x-ray machine with a panoramic x-ray testing assembly in a ready position, where the phantom device is releasably mounted on an adapter arm;
[0124] FIG. 103 is a perspective view a testing assembly kit comprising a phantom device of FIG. 4, a sensor holder of FIG. 34, and an adapter arm of FIG. 72;
[0125] FIG. 104 is a schematic diagram depicting an embodiment of a system for performing image analysis and providing a quality assessment of captured x-ray images of the phantom device of FIG. 4;
[0126] FIG. 105 is a schematic diagram depicting an embodiment of the intraoral x-ray image analysis module of the processing server from the system of FIG. 104;
[0127] FIG. 106 is a schematic diagram depicting an embodiment of the panoramic x-ray image analysis module of the processing server from the system of FIG. 104;
[0128] FIG. 107 is a schematic diagram depicting an embodiment of a client terminal from the system in FIG. 104;
[0129] FIG. 108 is an example graphical user interface showing a passing quality assessment score for an intraoral x-ray machine and an associated sensor configured to be displayed on the client terminal from the system in FIG. 104;
[0130] FIG. 109 is an example graphical user interface showing an intermediate quality assessment score for an intraoral x-ray machine and an associated sensor configured to be displayed on the client terminal from the system in FIG. 104;
[0131] FIG. 110 is an example graphical user interface showing a failing quality assessment score for an intraoral x-ray machine and an associated sensor configured to be displayed on the client terminal from the system in FIG. 104;
[0132] FIG. Ill is an example graphical user interface showing a passing quality assessment score for a panoramic x-ray machine configured to be displayed on the client terminal from the system in FIG. 104;
[0133] FIG. 112 is an example graphical user interface showing a failing quality assessment score for a panoramic x-ray machine configured to be displayed on the client terminal from the system in FIG. 104;
[0134] FIG. 113 is a flowchart depicting an embodiment of a method of performing a quality assessment of an intraoral x-ray machine and an associated sensor with the example system in FIG. 104;
[0135] FIG. 114 is a flowchart depicting another embodiment of a method of performing a quality assessment of an intraoral x-ray machine and an associated sensor with the example system in FIG. 104, where deviation from reference images is further analyzed;
[0136] FIG. 115 is a flowchart depicting an embodiment of a method of performing a quality assessment of a panoramic x-ray machine with the example system in FIG. 104;
[0137] FIG. 116 is a flowchart depicting another embodiment of a method of performing a quality assessment of a panoramic x-ray machine with the example system in FIG. 104, where deviation from reference images is further analyzed; and
[0138] FIG. 117 is a flowchart depicting an embodiment of a method of constructing the phantom device of FIG. 4.SUMMARY AND DESCRIPTION:
[0139] The description, which follows, and the embodiments described therein are provided by way of illustration of an example, or examples of particular embodiments of principles and aspects of the present disclosure. These examples are provided for the purposes of explanation and not of limitation, of those principles of the disclosure. In the description that follows, like parts are marked throughout the specification and the drawings with the same respective reference numerals. Similarly, like parts that may be present in more than one instance may be similarly numbered and appended with a suffix. For example, like parts that occur more than once may be appended with an -1, -2, -3, etc..
[0140] Other aspects and features of the present application will be understood by those of ordinary skill in the art from a review of the following description of examples in conjunction with the accompanying figures. Example embodiments of the present application are not limited to any particular operating system, system architecture, mobile device architecture, server architecture, or computer programming language.
[0141] In the present application, the term “and / or” is intended to cover all possible combinations and sub-combinations of the listed elements, including any one of the listed elements alone, any sub-combination, or all of the elements and without necessarily excluding additional elements.
[0142] In the present application, the phrase “at least one of...and...” is intended to cover any one or more of the listed elements, including any one of the listed elements alone, any subcombination, or all of the elements, without necessarily excluding any additional elements, and without necessarily requiring all of the elements.
[0143] In the present application, the term “radiopaque” refers to the property of a material that absorbs or blocks the penetration of x-rays, causing it to appear white or light on radiograph! c / x-ray images. Structures or objects that are radiopaque prevent radiation from reaching the imaging receptor, making them useful for identifying dense materials such as bones or metallic objects in medical imaging. In the present application, the term “radiolucent” refers to the property of a material that allows x-rays or other forms of radiation to pass through it with minimal absorption, causing it to appear dark orblack on radiograph! c / x-ray images. Structures or objects that are radiolucent do not obstruct radiation, making them useful for identifying areas of low density, such as soft tissues or cavities, in medical imaging.
[0144] By way of general overview, there is provided systems and methods for quality assurance and maintenance of imagery devices. Such imagery devices include, without limitation, digital radiographic equipment, and other digital scanning devices including, without limitation, for use in medical and other similar applications, as well as more broadly-based digital radiographic applications.
[0145] Systems and methods disclosed herein provide improved digital X-ray equipment quality assurance, utilizing, in some embodiments, one or more 3D-printed component (which may, alternatively and in some embodiments, be machined or otherwise constructed) and cofunctioning software system(s) to determine if the imagery equipment requires servicing or hasquality issues with its current output. This ensures the imaging equipment operates at optimal performance consistently.
[0146] The systems and methods disclosed herein employ tests of symmetry and radiation beam alignment on panoramic X-rays, digital sensor functionality, and radiation beam strength during set exposure times on, for example, intraoral X-rays. The systems features a fixed hardware component, hereinafter alternatively referred to as the sensor, the phantom device or the puck, which is securely positioned using an arm attachment to, for example, a panoramic imaging machine and pins at its base, eliminating positioning errors. For sensor images, the sensor is held in a fixed holder to maintain consistent alignment with the test piece.
[0147] Once the image is captured, the test result is uploaded to a web-based platform the image is analyzed. The script may measure color intensities, evaluates symmetry by locating the center of ball bearings, and checks for deviations against predefined standards. This replaces subjective human evaluations with an objective, standardized pass / fail system. In some embodiments disclosed herein, linear deviation, magnification deviation, edge sharpness, color consistency, and pixel density may be used as criteria for quality assurance assessment.
[0148] The results are stored electronically, for example and without limitations, in the cloud, providing easy access for users. Systems and methods disclosed herein integrate all necessary hardware for both intraoral and panoramic tests into a single device.
[0149] For clarity, when using intraoral x-ray machines, a user may place a sensor in a patient’s oral cavity, and point the emitting end of the intraoral x-ray machine towards the sensor in the patient’s oral cavity. The intraoral x-ray machine is then initiated and the sensor captures animage based on the emitted x-rays. The sensor may then be removed from the patient’s oral cavity, and connected to a computer to download the captured image.
[0150] The clarity and contrast of a captured image is important to ensure that a medical professional is able to rely on the information in the captured image to provide an accurate diagnosis and / or is able to determine the next course of action. Where the clarity and contrast of a captured image is low and / or unclear, the duration and / or intensity of x-rays being emitted from the intraoral x-ray machine may be adjusted and / or increased to provide a better image. While it is advantageous to get a clearer captured image, increasing the duration and / or intensity of x-rays may lead to the patient experiencing additional radiation exposure. Even if the duration and / or intensity of x-rays being emitted by the intraoral x-ray machine are not adjusted, the need for a second captured image may still lead to additional radiation exposure for the patient.
[0151] A captured image that is unclear may be attributed to either the intraoral x-ray machine and / or the sensor. Ensuring that both the intraoral x-ray machine and the sensor is operating within normal parameters is important to reduce the potential radiation exposure to a patient. Furthermore, statute and regulations may also require that the intraoral x-ray machine and the sensor are operating within normal parameters.
[0152] Referring to FIGS. 1 to 3, there is shown a intraoral x-ray testing assembly 12. The testing assembly 12 may be used for the testing and calibration of intraoral x-ray machines 16 and the associated sensors 20. The main components of testing assembly 12 include a phantom device 100 and a sensor holder 200. In the testing assembly 12, the phantom device 100 is removably secured to sensor holder 200. The depicted sensor holder 200 includes multiple protrusions 204, and the phantom device 100 includes multiple corresponding holes 164 sized to receive theprotrusions 204, which help align and allow for the secure mounting of phantom device 100 on top of sensor holder 200. The alignment and placement of phantom device 100 on sensor holder 200 will be further discussed below.
[0153] In operation, or when using the testing assembly 12 for testing and obtaining a quality score 1312 of intraoral x-ray machine 16 and the associated sensors 20, the sensor 20 is placed within one of the sensor cavities 208 of sensor holder 200 (as depicted in FIG. 55), and is sandwiched between phantom device 100 and sensor holder 200. The emitting end 16A of the intraoral x-ray machine 16 is pointed towards the top of phantom device 100. When x-rays are emitted from the intraoral x-ray machine 16, the x-rays pass through phantom device 100, and sensor 20, located below phantom device 100, captures an image of the interior of phantom device 100. More specifically, sensor 20 is located along the path of the x-rays emitted from intraoral x-ray machine 16. The captured image of the interior of phantom device 100 may then be analyzed to determine whether intraoral x-ray machine 16 and the associated sensor 20 is operating within normal parameters. The analysis of the captured image will be further discussed below.
[0154] Referring to FIGS. 4 to 19, there is shown phantom device 100. Phantom device 100 may be considered a universal phantom device 100 that may be used for both intraoral x-ray quality assessment and also panoramic x-ray quality assessment. The main components of phantom device 100 include upper body 104 connected to a lower body 108, where cavities are present in upper body 104 to accommodate outer blocks 156 and inner blocks 160, and where cavities are present in lower body 108 to accommodate stepwedge 148 and ball bearings 152. For clarity, outer blocks 156, inner blocks 160, stepwedge 148 and ball bearings 152 may be considered interior components 120 of the phantom device 100.
[0155] In the current embodiment, upper body 104 is generally cylindrical and has a top surface that may include reference alignment ring 112 and reference alignment holes 116. Reference alignment ring 112 and reference alignment holes 116 are defined, engraved or etched into the top surface of upper body 104 and provide a reference point for a user. Specifically, reference alignment ring 112 is shaped as a circular target to allow a user to aim the emitting end 16A of intraoral x-ray machine 16 at phantom device 100. More specifically, in operation, a user may aim and / or match the emitting end 16A of intraoral x-ray machine 16 to the circular target defined by reference alignment ring 112. Reference alignment ring 112 may be of any shape to aid in the alignment and / or aiming of intraoral x-ray machine 16. For example, reference alignment ring 112 may be shaped as a bullseye, or may be a single central point. Reference alignment ring 112 may also be located on other surfaces or more than one surface of upper body 104. For example, reference alignment ring 112 may be defined, etched and / or engraved along the edge or the side surface of upper body 104. A person skilled in the art will recognize the different potential shapes, layouts, locations, and configurations of reference alignment ring 112 on any surface of upper body 104, or lower body 108.
[0156] Reference alignment holes 116 are shallow holes that are defined, engraved or etched into the top surface of upper body 104 and allow a user to determine the approximate orientation of phantom device 100, and the approximate location of lower body alignment holes 164. Specifically, when removably securing or connecting phantom device 100 to either sensor holder 200 or adapter arm 300, or other embodiments of sensor holder 200 or adapter arm 300 described below, orientation of phantom device 100 matters. The orientation of phantom device 100 relative to the sensor holder 200 or adapter arm 300 ensures that the internal components 120 of phantom device 100 are orientated in a specific manner to obtain a clear captured x-ray imagefor analysis. In the current embodiment, there are three reference alignment holes 116, specifically, reference alignment holes 116-1, 116-2 and 116-3. Reference alignment holes 116-1 and 116-2 reside along the left side of the top surface of upper body 104, and reference alignment hole 116-3 resides along the right side of the top surface of upper body 104. Specifically, reference alignment holes 116-1, 116-2 and 116-3 form three points of a triangle, where reference alignment holes 116-1 and 116-2 are in closer proximity than reference alignment hole 116-3. More specifically, reference alignment hole 116-1 corresponds generally to lower body alignment hole 164-1, reference alignment hole 116-2 corresponds generally to lower body alignment hole 164-2, and reference alignment hole 116-3 corresponds generally to lower body alignment hole 164-3, where lower alignment holes 164 dictate the orientation and alignment of phantom device 100 relative to sensor holder 200 and / or adapter arm 300. Reference alignment holes 116 may be of any shape or size and / or may be on any surface, to aid a user in determining the location and orientation of lower body alignment holes 164. For example, instead of a hole, reference alignment holes 116 may be notches or X-shaped engravings. Furthermore, there may be any number of reference alignment holes 116 present to match with any number of lower body alignment holes 164. A person skilled in the art will recognize the different potential shapes, sizes, numbers, configurations, layouts and locations of reference alignment holes 116 on either upper body 104 or lower body 108.
[0157] Referring to FIGS. 13 and 14, the bottom surface 192 of upper body 104 may include upper body protrusions 172, outer block holes 180 and inner block holes 184. Upper body protrusions 172 protrude downwards from the bottom surface 192 of upper body 104 and allow for the alignment and orientation between upper body 104 and lower body 108. Specifically, each upper body protrusion 172 is associated with a corresponding lower body bearing holes 124 andconfigured for insertion therein. In a preferred embodiment, there are three upper body protrusions 172, arranged equidistant from the circumference of upper body 104. Specifically, assuming that the bottom surface 192 of upper body 104 was a circular plane, where zero (0) degrees is towards the rear of upper body 104, a first upper body protrusion 172-1 may be located at ninety (90) degrees on the circular plane, a second upper body protrusion 172-2 may be located at zero (0) degrees, and a third upper body protrusion may be located at two hundred and seventy (270) degrees. More specifically, first upper body protrusion 172-1 would align with lower body bearing hole 124-1 in a similar corresponding location on the top surface 196 of lower body 108, second upper body protrusion 172-2 would align with lower body bearing hole 124-2 in a similar corresponding location on the top surface 196 of lower body 108, and third upper body protrusion 172-3 would align with lower body bearing hole 124-3 in a similar corresponding location on the top surface 196 of lower body 108.
[0158] Furthermore, upper body protrusions 172 aid in pushing ball bearings 152 into lower body bearing holes 124 during assembly of phantom device 100. Referring to FIG. 16, lower body bearing holes 124-1 and 124-3 surround and / or house both ball bearings 152-1 and 152-3 respectively, and upper body protrusions 172-1 and 172-3 respectively. The location of upper body protrusions 172 may be at any angle along the aforementioned circular plane of bottom surface 192 of upper body 104, or may be located anywhere on the bottom surface 192 of upper body 104, as long as there is a corresponding lower body bearing hole 124 on the top surface 196 of lower body 108 to allow the connection and alignment between upper body 104 and lower body 108 during assembly of the phantom device 100. Furthermore, the number of upper body protrusions 172 may vary along the bottom surface 192 of upper body 104, as long as there is a corresponding number of lower body bearing holes 124 on the top surface 196 of lower body 108.A person skilled in the art will recognize the different potential shapes, sizes, numbers, configurations, layouts and locations of upper body protrusions 172 on the bottom surface 192 of upper body 104.
[0159] Outer block holes 180 and inner block holes 184 are located on the bottom surface 192 of upper body 104. In a preferred embodiment, outer block holes 180 and inner block holes 184 are disposed along locations corresponding to those of upper body protrusions 172 on the previously circular plane of the bottom surface 192 of upper body 104. Specifically, the centers of outer block holes 180, inner block holes 184 and upper body protrusions 172 may be equidistant to the circumferential edge of upper body 104. In a more preferred embodiment, outer block holes 180 include outer block hole 180-1 and 180-2, and inner block holes 184 include inner block hole 184-1 and 184-2, where outer block hole 180-1 and inner block hole 180-1 are equidistant to the circumferential edge of upper body 104 with upper body protrusions 172-1 and 172-2, and are located between upper body protrusions 172-1 and 172-2, where outer block hole 180-1 is in closer proximity to upper body protrusion 172-1 than inner block hole 184-1 is to the same upper body protrusion 172-1. Similarly, inner block hole 184-1 is in closer proximity to upper body protrusion 172-2 than outer block hole 180-1 is to the same upper body protrusion 172-2. Similarly, outer block hole 180-2 and inner block hole 180-2 are equidistant to the circumferential edge of upper body 104 with upper body protrusions 172-2 and 172-3, and are located between upper body protrusions 172-2 and 172-3, where outer block hole 180-2 is in closer proximity to upper body protrusion 172-3 than inner block hole 184-2 is to the same upper body protrusion 172-3. Similarly, inner block hole 184-2 is in closer proximity to upper body protrusion 172-2 than outer block hole 180-2 is to the same upper body protrusion 172-2.
[0160] Outer block holes 180 and inner block holes 184 are associated with corresponding lower body outer block protrusions 128 and lower body inner block protrusions 132 respectively. In the current embodiment, outer block hole 180-1 corresponds with lower body outer block protrusion 128-1 on the top surface 196 of lower block 108. Outer block hole 180-2 corresponds with lower body outer block protrusion 128-2 on the top surface 196 of lower block 108. Inner block hole 184-1 corresponds with lower body inner block protrusion 132-1 on the top surface 196 of lower block 108, and inner block hole 184-2 corresponds with lower body inner block protrusion 132-2 on the top surface 196 of lower block 108. Specifically, lower body outer block protrusions 128 and lower body inner block protrusions 132 match the corresponding locations of their counterpart outer block holes 180 and inner block holes 184, and further aid in the alignment, orientation and assembly of the upper body 104 and the lower body 108.
[0161] Furthermore, similar to bearing holes 124, which contains ball bearings 152 and upper body protrusion 172, outer block holes 180 contain and / or house outer blocks 156 and lower body outer block protrusions 128, where lower body outer block protrusion 128 pushes outer block 156 into outer block hole 180. Similarly, inner block holes 184 contain and / or house inner blocks 160 and lower body inner block protrusions 132, where lower body inner block protrusions 132 push inner block 160 into inner block hole 184. Specifically, lower body outer block protrusions 128 and lower body inner block protrusions 132 aid in keeping outer blocks 156 and inner blocks 160 in place in respective outer block holes 180 and inner block holes 184. This can be seen in FIGS 17 and 18.
[0162] In the current embodiment, outer block holes 180 and inner block holes 184 are rectangular in shape, and contain similarly shaped rectangular prisms outer blocks 156 and inner blocks 160. In a preferred embodiment, outer block holes 180 and outer blocks 156 are thinner inthickness than inner block holes 184 and inner blocks 160. The thickness of outer blocks 156 and inner blocks 160 will be discussed further below, however, the shape, size of thickness of outer block holes 180 and inner block holes 184 are not limited or restricted, as long as it matches the corresponding outer blocks 156, inner blocks 160 respectively, and the corresponding lower body outer block protrusion 128 and lower body inner block protrusion 132. Furthermore, outer block holes 180 and inner block holes 184 may be in any location on the bottom surface 192 of upper body 104, as long as outer block holes 180 and inner block holes 184 correspond to lower body outer block protrusions 128 and lower body inner block protrusions 132. In addition, there may be any number of outer block holes 180 and inner block holes 184, as long as there is a corresponding lower outer block protrusion 128 and lower body inner block protrusion 132 respectively. A person skilled in the art will recognize the different potential shapes, sizes, numbers, configurations, layouts and locations of outer block holes 180 and inner block holes 184 on the bottom surface 192 of upper body 104.
[0163] Upper body 104 may further include upper body cavity 176 which is cut into the bottom surface 192 of the upper body and centrally disposed therein. In the current embodiment, the circumference of upper body cavity 176 matches that of lower body cavity 144. However, upper body cavity 176 may be of any size or depth. In other embodiments, the presence of upper body cavity 176 is to reduce the thickness of the polymer between the emitter 16A of the intraoral x-ray machine 16 and the stepwedge 148, to ensure clarity and reduction of noise in the captured x-ray image.
[0164] In the current embodiment, lower body 108 is generally cylindrical and has a top surface 196 that may include the aforementioned bearing holes 124, lower body outer protrusion 128, and lower body inner protrusion 132. Similar to the previously mentioned correspondingupper body protrusion 172, outer block hole 180 and inner block hole 184, the bearing holes 124, lower body outer protrusion 128 and lower body inner protrusion 132 may be of any size, shape, location, layout, and / or configuration, as long as the corresponding protrusions and holes in upper body 108 match. A person skilled in the art will recognize the different potential shapes, sizes, numbers, configurations, layouts and locations of bearing holes 124, lower body outer protrusion 128 and lower body inner protrusion 132.
[0165] Lower body 108 further includes lower body cavity 144 which is cut into the top surface 196 of the lower body and centrally disposed therein. At the base of lower body cavity 144 is disposed a stepwedge hole - more specifically, a rectangular shaped stepwedge hole 140for housing stepwedge 148.
[0166] Stepwedge 148 is an extruded metal radiopaque piece that is shaped as a plurality of steps, where the higher the step, the greater the thickness of the stepwedge 148 as measured from the base of stepwedge 148. The difference in thickness between the steps affects how radiopaque said thickness is to x-rays, hence providing a different result on a captured x-ray for each thickness and / or each step. In the current embodiment, stepwedge 148 has three steps, however, stepwedge 148 is not limited to three steps, and may have any number of steps. The advantage of having more steps on stepwedge 148 is that there are more thicknesses to measure, providing additional granularity and additional data points to use as part of the image analysis. However, the advantage of having less steps, but where each step has an increased surface area, is the accuracy of the information and analysis. Specifically, the larger surface area of each step allows for a more precise and consistent measurement of the image based on the thickness of a particular step. Furthermore, in a preferred embodiment, stepwedge 148 is a series of descending has (or ascending) steps. However, the layout of the steps, or the order of the steps may be in anylayout or configuration. For example, stepwedge 148 may be a series of three steps, where the middle step is the lowest step, and is flanked on a first side with the highest step, and on a second side with a height or thickness I between the lowest and highest step. Similarly, the steps may not be in a linear configuration, but may be a series of four steps in a rectangular configuration, where each step of varying thickness or height occupies a quadrant of the rectangular configuration. A person skilled in the art will recognize the different potential configurations and layouts of stepwedge 148.
[0167] In a preferred embodiment, stepwedge 148 is made of metal. In a more preferred embodiment, stepwedge 148 is made of aluminum. Metal is the preferred material, as varying levels of thickness of metals affect the radiopaqueness of x-rays, and as such, the different steps of stepwedge 148 representing different thicknesses, may provide varying contrasts when capturing an x-ray image. Other materials may be used for stepwedge 148, as long as there is the ability to vary the permeability of x-rays based on the thickness within a predefined range of acceptability. The predefined range of acceptability may be dependent on the size of the phantom device 100. In other embodiments (not shown), stepwedge 148 may be made of several different materials with different levels of permeability for x-rays and radiation. The different materials may be akin to the thickness of a specific material, and may yield similar results. A person skilled in the art will recognize the different potential materials that stepwedge 148 may be comprised of.
[0168] The bottom surface of lower body 108 may include lower body alignment holes 164 and serial plate hole 168. Lower body alignment holes 164 aid in the alignment, orientation and connection between phantom device 100 and at least one of or any embodiments of sensor holder 200 or adapter arm 300. Specifically, lower body alignment holes 164 correspond with either sensor holder protrusions 204 on sensor holder 200 or embodiments thereof, or adapter armprotrusions 304 on adapter arm 300 or embodiments thereof. By lining up lower body alignment holes 164 with either sensor holder protrusions 204 or adapter arm protrusions 304, the alignment and / or orientation of phantom device relative to sensor holder 200 or adapter arm 300 is ensured. More specifically, in a preferred embodiment, as lower body alignment holes 164 include a first lower body alignment hole 164-1, a second lower body alignment hole 164-2 and a third lower body alignment hole 164-3, where the first lower body alignment hole 164-1 and the second lower body alignment hole 164-2 are proximity to each other on the left side of the bottom surface of lower body 108, and where the third lower body alignment hole 164-3 is on the right side of the bottom surface of lower body 108, there is only one orientation that phantom device 100 can be connected to sensor holder 200 or adapter arm 300 when matching the corresponding protrusions. In other embodiments, there may be any number of lower body alignment holes 164 and / or lower body alignment holes 164 may be located anywhere on the bottom surface of lower body 108, as long as the corresponding sensor holder protrusions 204 and adapter arm protrusions 304 are correspondingly numbered and / or located at corresponding locations on sensor holder 200 and adapter arm 300 respectively. A person skilled in the art will recognize the different potential number, shape, size, layout and configuration of lower body alignment holes 164 on the bottom surface of lower body 108.
[0169] Serial plate hole 168 may be located on the bottom surface of lower body 108, and allows for the placement of a serial plate on phantom device 100. The serial plate hole 168 may be located on any surface of phantom device 100 and is not limited to the bottom surface of lower body 108. Serial plate hole 168 and a serial plate may also be optional. In a preferred embodiment, where serial plate hole 168 and serial plate are present, serial plate hole 168 and corresponding serial plate may be located on an area, such as on the bottom surface of lower body 108, where itwill not interfere with any x-ray readings when capturing an image of phantom device 100. Alternatively, the serial plate may be made out of material is that radiolucent and substantively undetectable by x-rays, such as polymer. A person skilled in the art will recognize the different potential locations, configurations, layouts of serial plate hole 168 and the corresponding serial plate, and also the different potential materials that serial plate may be.
[0170] The exterior curved surface of lower body 108 may further include panoramic layer alignment line 136. In a preferred embodiment, panoramic layer alignment line 136 is a vertical engraved line on the exterior curved surface of lower body 108. The purpose of panoramic layer alignment line 136 is to aid in the orientation of the panoramic x-ray machine 32 when performing testing. Panoramic x-ray machines 32 may include a layer alignment light, or a layer alignment laser (also referred to as a vertical mid-sagittal beam), which is projected onto a patient’s face, when the patient’s head is in a panoramic x-ray machine 32 to be scanned. For example, PLANMECA ™ machines may include the layer alignment light and / or the vertical mid-sagittal beam. The vertical mid-sagittal beam is configured to be aimed at a patient’s mid-sagittal plane to ensure a proper symmetrical and clear images. When using phantom device 100, the vertical mid-sagittal beam may be aimed and aligned with panoramic alignment line 136. In a preferred embodiment, lower body 108 may include multiple panoramic alignment lines 136 to adjust to different models of panoramic x-ray machines 32, where the vertical mid-sagittal beam may be limited in its adjustment. For clarity, the location of panoramic layer alignment line 136 is relative to the internal components 120 of phantom device 100, so as to ensure that panoramic x-ray machine 32 provides a clear picture of said internal components 120. Panoramic layer alignment line 136 is not limited to being an engraved line on the exterior curved surface of lower body 108,but may be any marking that allows the positioning and / or orientation of the vertical mid-sagittal beam with phantom device 100.
[0171] Interior components 120 of phantom device 100 include the outer blocks 156, the inner blocks 160 and the ball bearings 152. Outer blocks 156 and inner blocks 160 are preferably made of radiopaque metal and are of differing sizes. In a more preferred embodiment, outer blocks 156 and inner blocks 160 are made out of aluminum and have differing levels of radiopaqueness based on differing sizes or thickness. Specifically, inner blocks 160 may be thicker along the lateral plane than outer blocks 156 to allow for reduced permeability of x-rays and / or radiation. When panoramic x-ray machines 32 initiate and scan a patient, additional radiation and / or a stronger emission of x-rays is provided towards the rear of a patent’s head. This is to allow the x-rays and radiation to pass through a patient’s spine and other denser material to get a scan of the patient’s teeth. The increased thickness of inner blocks 160 is to compensate for the additional output of x-rays and radiation, and the location of inner blocks 160 is to mimic the placement of the spine and / or other areas surrounding the back of the neck of the patient. As such, when performing a scan on phantom device using a panoramic x-ray machine 32, the contrast and output of the thicker inner blocks 160 may be similar to those of the thinner outer blocks 156 despite the higher output of radiation and / or x-rays towards the rear of phantom device 100. In other embodiments, outer blocks 156 and inner blocks 160 may be of similar thickness, size and material, and the additional output of radiation and / or x-rays may be measured and compensated for in the image analysis of the outer block 156 and inner blocks 160. Similar to the material and composition of stepwedge 148, outer blocks 156 and inner blocks 160 may be of any material, shape, size, layout and / or configuration so long as the panoramic x-ray machine 32 is able to capture a clear image for analysis, and so long as outer blocks 156 and inner blocks 160 match the corresponding lowerbody outer block protrusion 128, lower body inner block protrusion 132 respectively and the corresponding upper body outer block hole 180 and upper body inner block hole 184. An example where corresponding lower body outer block protrusion 128 and lower block inner block protrusion 132 are thicker may be seen in lower body 108B in FIGS. 23 and 24. The corresponding upper body outer block hole 180 and upper body inner block hole 184 may be seen in upper body 104B in FIGS. 25 and 26.
[0172] Ball bearings 152 may be made out of stainless steel, and similar to the aforementioned outer blocks 156 and inner blocks 160, may be of any size, so long as the ball bearings 152 correspond with bearing holes 124 on lower body 108. Stainless steel is used as a generally radiopaque material to x-ray and / or radiation, and as such, creates a good sharp image on a captured x-ray image, allowing for an image analysis of the circumference of the ball bearing 152. For example, if on the captured x-ray image, there is white space surrounding the ball bearing 152, and / or if the ball bearing 152 does not match the expected circumference of ball bearing 152, then there may be technical issues with either the panoramic x-ray machine 32.
[0173] In the current embodiment, upper body 104 includes upper body protrusions 172, outer block holes 180 and inner block holes 184, and while lower body 108 includes corresponding bearing holes 124, lower body outer protrusion 128 and lower body inner protrusion 132. However, in other embodiments, the protrusions and corresponding holes may be located on either upper body 104 or lower body 108. For example, all protrusions may be located on the bottom surface 192 of upper body 104, and all corresponding holes may be located on the top surface 196 of lower body 108. Alternatively, a mixture of different protrusions and holes may be located on the bottom surface 192 of upper body 104, and a mixture of corresponding holes and protrusions may be located on the top surface 196 of lower body 108. Specifically, the associated body for theprotrusions and holes may vary. A person skilled in the art will recognize the different potential configurations and layouts of the protrusions and corresponding holes and the location of each in relation to upper body 104 and lower body 108.
[0174] Referring to FIGS. 20 to 22, in other embodiments, additional alignment protrusions 188 A may be present. In an alternate embodiment upper body 104A, alignment protrusions 188 A are present on the lower surface of upper body 104A to further align upper body 104A with lower body 108 A. Specifically, alignment protrusions 188 A may reside along the edge walls of lower body cavity 144 when upper body 104A is connected and assembled with lower body 108 A.
[0175] Furthermore, in some embodiments, the inclusion of ball bearings 152, inner blocks 160 and / or outer blocks 156 may be optional. Phantom device 100 may include at least one of the ball bearings 152, inner blocks 160 and / or outer blocks 156. In a preferred embodiment, phantom device 100 may include all three, so as to provide an optimal captured x-ray image for analysis from both intraoral x-ray machine 16 and / or panoramic x-ray machine 32. A person skilled in the art will recognize the different potential configurations and layouts of phantom device 100 based on the inclusion of each of the internal components 120.
[0176] In a preferred embodiment, upper body 104 and lower body 108 have a generally cylindrical shape, leading to the phantom device 100 having a cylindrical shape. During a panoramic x-ray, the emitter and sensor of the panoramic x-ray machine 32 rotates around the phantom device 100 in a circular orbit. The circular orbit and / or circular path of the emitter and sensor of the panoramic x-ray machine 32 is due to the x-rays taking images around a patient’s head, which is generally spherical in shape. More specifically, the emitter and sensor of thepanoramic x-ray machine 32 are opposite each other with the phantom device 100 in between the emitter and sensor, where both the emitter and sensor follow the same circular orbit on opposing ends of the orbit path. Having a cylindrical shape, provides a general approximation of the circular nature of a patient’s head, and further provides an approximately same thickness of material for the x-rays to travel through from any point along the circular orbit and / or path. In a preferred embodiment, upper body 104 and lower body 108 may also be made out of polymer. In a more preferred embodiment, upper body 104 and lower body 108 are 3D printed out of polymer. Specifically, polymer is a material that is radiolucent to x-rays, and as such, do not provide much contrast when taking an x-ray. In the preferred embodiment, the cylindrical shape of phantom device 100 and the polymer body of phantom device 100 allows for a clear and concise image of the interior components 120 of phantom device 100 without significant compensation for the image prior to analyzing the image.
[0177] In an alternate embodiment, the phantom device 100 may be a different shape or made of a different radiolucent material. For example, phantom device 100 (and hence upper body 104 and lower body 108) may formed as a hollow cylinder with a radial sector removed therefrom, where less than half of the cylinder has been cut away such that the hollow is accessible form the side of the cylinder. This is depicted in FIGS. 27 to 32. Specifically, lower body 108C may include the same lower body alignment holes 164 on the bottom surface of lower body 108C, but may have a built in stepwedge 148C in arcuate stepwedge hole 140C. An embodiment where stepwedge 148C is arcuate to match the shape of stepwedge hole 140C allows for a uniform stepwedge 148 with different thicknesses in steps, but a similar distance for each step of stepwedge 148 from the panoramic x-ray machine 32 emitter, when the emitter follows a circular path around lower body 108C. This allows for a continuous measurement / a continuous captured image aroundthe circumference of lower body 108C, as opposed to the previous embodiments with inner blocks 160 and outer blocks 156, where the measurement / image is only analyzed at the areas with inner blocks 160 and outer blocks 156. A continuous measurement also further allows for the showcase of a gradient of radiation output / x-ray output as the panoramic x-ray machine 32 outputs additional radiation and / or x-rays towards the rear of lower body 108C. Image analysis may then review the captured gradient output on the captured x-ray image.
[0178] Referring to FIGS. 33 to 40, a sensor holder 200 is depicted. Sensor holder 200 is configured to hold sensors 20 in sensor cavity 208 (as depicted in FIG. 55), and is further configured to connect to phantom device 100 for use in an intraoral x-ray testing application 12. More specifically, sensor holder 200 may be configured to have a sensor holder body 220 capable of holding two different sizes of sensors 20, a first sized sensor 20 in position A, and a second sized sensor in position B. Associated with each of position A and position B are their own respective sensor holder protrusions 204 to align and connect with phantom device 100, sensor cavities 208, sensor shelves 202, and wire channels 216. In operation, a sensor 20 of corresponding size may be placed in either sensor cavity 208-A for position A, or sensor cavity 208-B for position B. Phantom device 100 may then be connected and placed on top of sensor 20 in either sensor cavity 208-A or sensor cavity 208-B. Phantom device 100 may be aligned relative to the sensor 20 and sensor holder 200 using sensor holder protrusions 204 associated with the specified position.
[0179] For example, where a sensor 20 is placed in sensor cavity 208-A, the sensor 20 may be held up in sensor cavity 208-A with sensor shelves 212-1 A and 212-2A. Sensor shelves 212-1 A and 212-2A allow sensor 20 to sit mid-height in sensor cavity 208-A, allowing room for sensor wire 24 to be placed, and ensuring that sensor 20 may be flat and perpendicular to the bottom surface of phantom device 100 for capturing an intraoral x-ray image of phantom device 100.Sensor wire 24 may be connected to computing device 436 to capture the intraoral x-ray image, and may lie in wire channel 216-A. When placing phantom device 100 on position A of sensor holder 200, the lower body alignment holes 164 may be matched and aligned to sensor holder protrusions 204. Specifically, sensor holder protrusion 204-1A may insert into corresponding lower body alignment hole 164-1, sensor holder protrusion 204-2 A may insert into corresponding lower body alignment hole 164-2, and sensor holder protrusion 204-3 A may insert into corresponding lower body alignment hole 164-3.
[0180] Sensor cavities 208 are sized based on the different type of sensors 20 that may be used. Sensors 20 are typically reusable and interchangeable between intraoral x-ray machines 16, and as such, sensor holder 200 that fits an associated sensor 20 may be used, in conjunction with phantom device 100, for different intraoral x-ray machines 16. In the current embodiment, sensor holder 200 is configured to hold two different sizes of sensors 20, however in other embodiments as shown in FIGS. 42 to 54, other embodiments of sensor holder 200 are shown where either a single sensor 20 size may be held, or where the sensor holder 200 may be configured to hold up to three different sizes of sensors 20.
[0181] Sensor shelf 212 is shaped to accommodate the clearance required for sensor wire 24 to be attached to sensor 20, allowing sensor wire 24 to run under sensor 20 in sensor cavity 208, while sensor 20 rests on and is supported by sensor shelf 212. More specifically, sensor shelves 212 ensure that sensor 20 remains flat relative to phantom device 100 so as to obtain a clear captured image from intraoral x-ray machine 16. Without sensor shelves 212, sensor 20 may not be flat, as sensor wire 24, being underneath sensor 20, may tilt sensor 20.
[0182] Different sensors 20 may have different attachment points for sensor wire 24, and as such, sensor shelves 212 may be of different shapes to accommodate and provide adequate clearance for sensor wire 24. In a preferred embodiment, as is shown in FIGS 34 to 40, each sensor cavity 208-A and 208-B for positions A and B include their own respective pair of sensor shelves 212-1 A and 212-2 A with respect to sensor cavity 208-A, and sensor shelves 212- IB and 212-2B with respect to sensor cavity 208-B. Specifically, sensor shelves 212-1 A and 212-2 A run along the length of sensor cavity 208-A. In another embodiment, as is shown in FIG. 41, a triangular sensor shelf 212A-1A and 212A-2A (not shown) may be used and may be located on opposing corners within sensor cavity 208-A for sensor holder 200A. In yet another embodiment, as is shown in FIG. 42, a generally arcuate shaped sensor shelf 212B-1 A and 212B-2A (not shown) may be used and may be located on opposing comers within sensor cavity 208-A for sensor holder 200B. In yet another embodiment, as is shown in FIG. 43, a rectangular prism pillar shaped sensor shelf 212C-1 A and 212C-2A (not shown) may be used and may be located on opposing corners within sensor cavity 208-A for sensor holder 200C. In yet another embodiment, as is shown in FIG. 44, a similar rectangular prism shaped sensor shelf 212C-1 A may be used in conjunction with 212C-2A, 212C-3A (not shown) and 212C-4A (not shown), where each sensor shelf 212C may be located on each corner within sensor cavity 208-1 for sensor holder 200D. In yet another embodiment (not shown), three sensor shelves 212 may be provided in three corners of sensor cavity 208. Any shape, number or size of sensor shelf 212 may be used within sensor cavity 208, so long as it allows sensor 20 to lie flat while providing clearance for sensor wire 24 below sensor 20 within sensor cavity 208.
[0183] Referring to FIGS. 33 to 40, wire channels 216 further provide a channel for sensor wire 24 to extend from sensor 20 in sensor cavity 208 to client terminal 436. In embodimentswhere sensor 20 is wireless, whether via the storage of images locally on sensor 20, or via the transmission of images to client terminal 436 wirelessly, sensor holder 208 may omit sensor shelves 212 and / or wire channels 216.
[0184] Each position, A and / or B, further includes a corresponding number of sensor holder protrusions 204 extending from sensor holder body 220 in proximity to the sensor cavity 208 for said position. As previously indicated, sensor holder protrusions 204 correspond to lower body alignment holes 164 of the lower body 108 of phantom device 100 to releasably mount phantom device 100 to sensor holder 200 in a specified alignment and orientation. The alignment and orientation of phantom device 100 to sensor holder 200 aids system 400 in providing an accurate image analysis of the captured x-ray image and will be discussed further below. Specifically, sensor holder protrusion 204-1 A may correspond to lower body alignment hole 164-1, sensor holder protrusion 204-2A may correspond to lower body alignment hole 164-2 and sensor holder protrusion 204-3 A may correspond to lower body alignment hole 164-3. While the preferred embodiment uses three sensor holder protrusions 204 for each position, any number, size, and shape of sensor holder protrusions 204 may be used, so long as there is a corresponding lower body alignment hole 164 on phantom device 100 that guides a user in releasably mounting phantom device 100 in a specific orientation. A person skilled in the art will recognize the different layouts, configurations, sizes, numbers and shapes of sensor holder protrusions 204 on sensor holder 200.
[0185] Referring to FIGS. 45 to 51, embodiments of sensor holders 200E to 200J are depicted and are configured to hold a single size of sensor 200. Sensor holders 200E to 200J operate in a similar manner to those of sensor holder 200, but merely have a single position forsensor 20. As such, like reference numerals are used in FIGS 33 to 51 to depict like features and / or structures.
[0186] As previously discussed, sensor holders 200 may have different shapes, layouts and configurations of sensor shelves 212. Referring to FIG. 45, sensor holder 200E includes a sensor shelf 212E-1A and 212E-2A (not shown) that is trapezoidal in shape. Referring to FIG. 47, sensor holder 200F includes a sensor shelf 212-A and 212-B (not shown) that is similar to that of sensor holder 200. Referring to FIG. 48, sensor holder 200G includes a sensor shelf 212G-1 A and 212G-2A (not shown) that is triangular in shape, similar to that of sensor holder 200A in FIG. 41, however, sensor 200G further includes a wire channel 212G-A that is angled from sensor cavity 208. An angled wire channel 212G-A reduces bending of sensor wire 24 where sensor wire 24 is connected to sensor 20 at the same angle. Referring to FIG. 49, sensor holder 200H is similar to sensor holder 200G, however, sensor holder protrusions 204H-1A, 204H-2A and 204-3A are truncated in proximity to the top of sensor holder protrusions 204H. Specifically, sensor holder protrusions 204H may be shaped to better correspond to the hole shape of lower body alignment holes 164. As can be seen, any number of changes in size, shape, configuration, number of and layout of sensor protrusions 204, sensor shelves 212, wire channels 212 and sensor cavities 208 may be used interchangeably in different embodiments of sensor holders 200.
[0187] Referring to FIG. 50, a sensor holder 200J is depicted for use with phosphorous based sensors 20. Phosphorous based sensors 20 store images locally on the sensor 20 itself and is scanned into a computer, similar to film based x-rays, and as such does not require a wire 24. Sensor holder 200J does not include a wire channel 216 or a sensor shelf 212. Furthermore, a phosphorous based sensor 20 is thinner than a digital sensor 20, and as such, sensor cavity 208J-A is substantially shallower than those of other embodiments. Furthermore, sensor holder 200Jincludes finger hole 224A, to aid a user in retrieving phosphorous based sensor 20 from sensor holder cavity 208J-A of sensor holder 200J.
[0188] Referring to FIGS. 52 to 54, sensor holder 200K is depicted, where sensor holder 200K is configured to hold three sizes of sensors 20. Sensor holder 200K includes similar features to that of sensor holder 200, and as such, like reference numerals are used in FIGS. 33 to 40 and 52 to 54 to depict like features and / or structures.
[0189] Referring to FIG. 56, an intraoral x-ray machine 16 and the corresponding intraoral x-ray machine emitting end 16A is aimed at an intraoral x-ray testing assembly 12, where a phantom device 100 is releasably mounted to an embodiment of a sensor holder 200 configured to hold a single size of sensor 20. As will be further discussed below, server 404 of system 400 may digitally reorient the captured x-ray picture of the phantom device 100, and as such, the orientation of phantom device 100 and intraoral x-ray testing assembly 12 in relation to intraoral x-ray machine 16 is not material. However, as previously indicated, the orientation of the phantom device 100 and the interior components 120 in relation to sensor holder 200 and sensor 20 is important for the proper functioning of the image analysis module as will be made clear in the description below. Furthermore, the tilt angle of intraoral x-ray testing assembly 12 in relation to intraoral x-ray machine 16 reduces edge sharpness and as such a flat surface is recommended for the placement of intraoral x-ray testing assembly 12.
[0190] As sensor holder 200 is below phantom device 100 and in the path of radiation and / or x-rays, in order not to occlude or affect the clarity of the captured x-ray image, sensor holder 200 is preferably made out of polymer or any other material that is permeable to x-rays. In a more preferred embodiment, the sensor holder 200 is made of the same material as the upper body 104and lower body 108 of phantom device 100, so as to keep the same permeability and contrast in the captured x-ray image.
[0191] Referring to FIG. 57, another photograph depicting an intraoral x-ray machine 16 aimed at an intraoral x-ray testing assembly 12 is depicted, where phantom device 100 is releasably mounted to an embodiment of a sensor holder 200 configured to hold two sizes of sensor 20.
[0192] Referring to FIG. 58 and 59, panoramic x-ray testing assembly 28 is depicted. The main components of panoramic x-ray testing assembly 28 may include phantom device 100 releasably mounted to an adapter arm 300. Similar to intraoral x-ray testing assembly 12, where phantom device 100 is reasonably mounted to sensor holder 200 using lower body alignment holes 164 and corresponding sensor holder protrusions 204, in panoramic x-ray testing assembly 28, phantom device 100 may be releasably mounted to adapter army using the same lower body alignment holes 164 and corresponding adapter arm protrusions 304. Adapter arm 300 further includes an alignment wall 312 that partially surrounds phantom device 100 when releasably mounted for additional support. Adapter arm 300 is further configured to be releasably mounted to a panoramic x-ray machine 32 through a mounting adapter 320 on adapter arm 300 and a corresponding mounting point 36 on panoramic x-ray machine 32. Adapter arm 300 may also generally extend outwards from mounting point 36 using an extender 316 to position phantom device 100 in panoramic x-ray machine 32 in a position similar to a patient’s head.
[0193] In operation, or when using testing assembly 28 for testing and obtaining a quality score 1424 for panoramic x-ray machine 32, the testing assembly 28 is mounted to panoramic x-ray machine 32 at mounting point 36. Mounting point 36 may generally be a chin rest or a mount for a bit fork slot / socket where a patient would generally rest their head when taking a panoramicx-ray. Panoramic x-ray machines 32 generally include a vertical mid-sagittal beam to align the emitter and sensor of panoramic x-ray machine 32 with a patient’s head. When using phantom device 100, the vertical mid-sagittal beam may be aligned with panoramic layer alignment line 136 on the exterior of phantom device 100. The emitter and sensor of panoramic x-ray machine 32 are generally on opposing sides of a patient’s head and move in a circular orbit in the same direction. As such, as the emitter moves and emits radiation and / or x-rays, the radiation and / or x-rays travel through a patient’s head and is picked up by the sensor on the opposing side of the patient’s head. By moving in a circular orbit in the same direction, the patient’s head is kept between the emitter and the sensor at all times, creating a panoramic x-ray image. The same process may be used where the patient’s head is substituted with phantom device 100 as part of testing assembly 28.
[0194] Referring to FIGS. 60 to 67, adapter arm 300 is depicted. The main components of adapter arm 300 include adapter arm protrusions 304, phantom device shelf 308, alignment wall 312, extender 316 and mounting adapter 320 (also referred to herein as primary mounting adapter 320). In this preferred embodiment of adapter arm 300, adapter arm protrusions 304 are similar to sensor holder protrusions 204 of sensor holder 200, where adapter arm protrusions 304 are configured to correspond to the shape, number, size, layout and configuration of lower body alignment holes 164 of phantom device 100. In a panoramic x-ray testing, the relative positioning and orientation of both phantom device 100 and testing assembly 28 as a whole in relation to panoramic x-ray machine 32 are important due to the operation of panoramic x-ray machine 32, and the variable output in radiation and / or x-rays as the emitter and sensor follow the circular orbital path provided by panoramic x-ray machine 32.
[0195] Phantom device shelf 308 is partially surrounded by alignment wall 312, and is configured to hold phantom device 100. Specifically, phantom device shelf 308 provides support for phantom device 100 to sit on when releasably mounted on adapter arm 300. Alignment wall 312 partially surrounds phantom device 100 when releasably mounted on adapter arm 300 and is configured to positionally hold phantom device 100 in place and to act as a guide during the mounting process of phantom device 100 to adapter arm 300. More specifically, alignment wall 312 further prevents phantom device 100 from shifting along the same plane as phantom device shelf 308. In other embodiments, alignment wall 312 may fully surround phantom device 100, or alignment wall 312 may use other means to secure phantom device 100 from shifting.
[0196] Adapter arm 300 includes extender 316. Extender 316 is configured to position phantom device 100 in the scanning area of panoramic x-ray machine 32, where a patient’s head would typically reside during scanning. Specifically, extender 316 is configured to extend from a chin rest mounting point 36 which engages with mounting adapter 320, to a location in the x, y and z plane where phantom device 100 is to reside for testing. More specifically, extender 316 is configured to extend the phantom device shelf 308, adapter arm protrusions 304 and alignment wall 312 outwards to the optimal scanning position for phantom device 300. As such, extender 316 may extend in any angle and / or direction from mounting adapter 320 to phantom device shelf 308. The shape of extender 316 may also be affected by other components of panoramic x-ray machine 32. Specifically, the shape of extender 316 may be different to accommodate for clearance of components of panoramic x-ray machine 32. The different shapes and embodiments of extender 316 will be further discussed below.
[0197] Adapter arm 300 further includes mounting adapter 320. Mounting adapter 320 may be configured to engage with panoramic x-ray machine 32 at chin rest mounting point 36.Panoramic x-ray machines 32 may have chin rests or areas upon which adapters, accessories or tools may attach to. Mounting adapter 320 may be configured to attach to said chin rest at chin rest mounting point 36, or other mounting points of panoramic x-ray machines 32. Mounting adapter 320 may include mounting adapter components 324. For example, in FIGS. 60 to 67, mounting adapter 320 may include two mounting adapter protrusions 324-2 and 324-4 and two mounting adapter extrusions 324-1 and 324-3 extending out from a central pillar. The mounting adapter protrusions 324-2 and 324-4 and mounting adapter extrusions 324-1 and 324-3 may correspond to a socket for chin rest mounting point 36. Specifically, other embodiments may include different mounting adapter components 324, as each make an model of panoramic x-ray machine 32 may have a different socket to attach chin rests or components to.
[0198] Referring to FIGS. 68 to 73, a similar embodiment of adapter arm 300A is shown, where extender 316A is of a different shape than that of extender 316 of adapter arm 300. Specifically, extender 316A is an extruded upwards sloped bar that has a cross section that is an inverse T-shape. The shape of extender 316A may be for clearance from components of panoramic x-ray machine 32. Referring to FIG. 74 and 75, extender 316B of adapter arm 300B is another embodiment of extender 316, where extender 316B is more rectangular and has a underside slope. Referring to FIG. 75 and 76, extender 316C of adapter arm 300C is another embodiment of extender 316, where extender 316C extends further in height than outwards. Furthermore, adapter arm 300C includes mounting adapter 320, which includes a mixture of a recessed indent 324C-3 and two protrusions 324C-2 and 324C-1 to correspond with associated chin rest mounting point 36. Referring to FIGS. 78 to 89, different embodiments of adapter arms 300 D to 300J are depicted, where different embodiments of extender 316, mounting adapters 320 and mounting adapter components 324 are depicted. Components that are similar use like reference numerals.
[0199] Referring to FIGS. 91 to 97, embodiments of adapter arm 300K to 300N are shown. Adapter arms 300K to 300N further include a secondary mounting point 332 on the bottom surface 328 of phantom device shelf 308. Specifically, secondary mounting point 332 may be a shallow cut out to allow secondary mounting point 332 to reside on another attachment point. For example, in some makes and models of panoramic x-ray machines 32, the chin rest may extend far enough that it allows for a secondary mounting mount 332 to engage with the chin rest to further stabilize adapter arm 300K to 300N. Alternatively, the panoramic x-ray machine 32 may include both a bite fork slot / socket and a chin rest, allowing both mounting points 320 and 332 to engage with panoramic x-ray machine 32.
[0200] Referring to FIGS. 92 and 93, phantom device shelf 308 further includes clearance notch 336. Clearance notch 336 may be included to provide clearance for other components, or where there may be additional attachments in close proximity to phantom device 100. Clearance notch 336 may also provide reference to a user / operator as to the direction and orientation of adapter arm 300 in relation to panoramic x-ray machine 32.
[0201] Referring to FIG. 98 and 99, adapter arm 300P is shown, where adapter arm 300P is box shaped. The box shaped body of adapter arm 300P acts as an extender 316P. In addition, the hollow cavity of the box shaped body acts as a mounting point 320P and a socket to surround chin rest mounting point 36 on a panoramic x-ray machine 32. Mounting adapter component 324P is a channel to allow clearance for another component of panoramic x-ray machine 32.
[0202] Based on the aforementioned embodiments of adapter arm 300, any shape, number, size, layout or configuration of extender 316, mounting adapter 320 and mounting adapter components 324 may be used to mount adapter arm 300 securely to panoramic x-ray machine 32,and to position phantom device 100 in an optimal position within panoramic x-ray machine 32 for scanning.
[0203] Referring to FIGS. 100, 101 and 102, a panoramic x-ray testing assembly 28 is releasably mounted to panoramic x-ray machine 32. As can be seen, the phantom device 100 is releasably mounted on adapter arm 300, which in turn is releasably mounted to panoramic x-ray machine 32 at the chin rest mounting point 36. The use of the adapter arm 300 allows phantom device 100 and testing assembly 28 to be fixed in an arrangement and orientation that is optimal for scanning phantom device 100.
[0204] There is also provided a system for performing the image analysis and quality assessment of the captured image from the intraoral x-ray machine 16 or from the panoramic x-ray machine 32. More specifically, systems and methods disclosed herein have been designed to pick up irregularities in the x-ray equipment. An x-ray image captured from an x-ray machine itself may be taken and analyzed to determine if there are inconsistencies in the image, color discrepancies, alignment issues, calibration concerns, false or errors in the x-ray image itself leading to if the test “Passed” or “Failed” its Quality Assurance Test. In some embodiments, criteria for pass / fail assessments may include, for example and without limitation, grayscale (intensity), linear deviation and magnification deviation, which will be further discussed below.The image analysis and quality assessment provides guidance to a user as to whether the intraoral x-ray machine 16, the associated sensor 20 and / or the panoramic x-ray machine 32 are operating within predetermined parameters to provide clear images for accurate diagnosis or actions from dentists. In a preferred embodiment, the image analysis and quality assessment is performed once a day for each intraoral x-ray machine 16, each associated sensor 20 and each panoramic x-ray machine 32, where the results of the quality assessment are logged. Where thequality assessment deems that the intraoral x-ray machine 16, associated sensor 20 and / or panoramic x-ray machine 32 are providing clear images, the server 404 may provide a passing quality assessment grade, and a dentist or staff may confidently use said intraoral x-ray machine 16, associated sensor 20 and / or panoramic x-ray machine 32 with patients.
[0205] Where the quality assessment deems that the intraoral x-ray machine 16, associated sensor 20 and / or panoramic x-ray machine 32 are providing intermediately clear images, the server 404 may provide an intermediate quality assessment grade, and a dentist or staff may continue using said intraoral x-ray machine 16, associated sensor 20 and / or panoramic x-ray machine 32 with patients, however the dentist or staff would be recommended to diagnose a potential issue with said intraoral x-ray machine 16, associated sensor 20 and / or panoramic x-ray machine 32, as the retaking of any x-ray images or the increase of the duration of the emission of x-rays to get a clearer picture for a proper diagnosis of a patient may lead to the patient being exposed to additional radiation and / or x-rays.
[0206] Where the quality assessment deems that that the intraoral x-ray machine 16, associated sensor 20 and / or panoramic x-ray machine 32 are providing unclear images, the server 404 may provide a failing quality assessment grade, and a dentist or staff would be recommended to refrain from using said intraoral x-ray machine 16, associated sensor 20 and / or panoramic x-ray machine 32 with patients, as any captured x-ray images on patients would be of poor quality, and merely exposing a patient to increased radiation and / or x-rays for a poor image that may not be beneficial for a diagnosis.
[0207] FIG. 104 depicts system 400 for performing the image analysis and quality assessment of a captured x-ray image from a phantom device 100. Specifically, server 404 ofsystem 400 is in communications with client terminal 436 via network 432. Components of system 400 will be discussed further in detail below.
[0208] More specifically, server 404 is where captured x-ray images are received and are analyzed to provide a quality analysis. Server 404 includes a processor 412 interconnecting a memory 416 and a communications interface 408. The processor can include a central -processing unit (CPU), a graphics processing unit (GPU), a microcontroller, a microprocessor, a processing core, a field-programmable gate array (FPGA), or similar. In some embodiments, the processor 412 can include multiple cooperating processors. The processor 412 can cooperate with non-transitory computer readable medium, such as the memory 416 to execute instructions to realize the functionality discussed herein.
[0209] Memory 416 can include a combination of volatile memory (e.g. Random Access Emmory or RAM) and non-volatile memory (e.g. non-volatile random-access memory, read only memory or ROM, Electrically Erasable Programmable Read Only memory or EEPROM, flash memory). All or some of the memory 416 can be integrated with processor 412. Memory 416 stores computer reasonable instructions for execution by processor 412.
[0210] It will now be apparent that each element of memory 416 can be carried out by the processor 412 executing operations. In other words, functionality described below as being carried out by a module of memory 416 or a module of server 404 can be based on any known server environment.
[0211] In some embodiments, memory 416 stores a plurality of computer-readable data and programming instructions, accessible by processor 412, in the form of software objects, such as various applications, queries or types of data for use during the execution of those applications.In particular, the execution of the instructions in memory 416 by processor 412 allow for the image analysis of captured x-ray images of phantom device 100 through either intraoral x-ray image analysis module 420 or panoramic x-ray image analysis module 424 based on the source of the captured x-ray image, and a quality analysis score 1312 being provided for said captured x-ray image based on the image analysis. The person skilled in the art will recognize the various forms of computer readable programming instructions stored in memory 416 that can be executed by processor 412 as applications.
[0212] In at least some embodiments, memory 416 stores intraoral x-ray image analysis module 420. Intraoral x-ray image analysis module 420 may operate based on a specific make and model of intraoral x-ray machine 16 and make and model of sensor 20. When analyzing a captured x-ray image of a phantom device 100, intraoral x-ray image analysis module 420 may request the make and model of the intraoral x-ray machine 16 and the make and model of the sensor 20. In addition, prior to beginning the image analysis, the size of the sensor 20 may also be selected. Intraoral x-ray image analysis module 420 may confirm the size of the sensor by comparing the size of phantom device 100 to the expected size of the selected sensor 20 in the captured x-ray image. The size of the sensor may be determined by the resolution of the captured x-ray image in comparison to the expected resolution of the x-ray image. Intraoral x-ray image analysis module 420 may also rotate the image prior to performing image analysis, to provide an image with the correct orientation for analysis.
[0213] Intraoral x-ray image analysis module 420 may be configured to include various analyzers as shown in FIG. 105, including but not limited to contrast analyzer 504, comer break analyzer 508, colour analyzer 512, edge sharpness analyzer 516, consistency analyzer 520, signal to noise ratio analyzer 524, radiation beam tile angle detection analyzer 528 and artifact analyzer532. Each of the aforementioned analyzers may be used to analyze a captured intraoral x-ray image of phantom device 100. The aforementioned analyzers may operate concurrently, sequentially in any order, or a mixture of both. Specifically, none of the analyzers depend on one another to provide inputs, outputs or additional data, and may operate independently of one another. Once each analyzer has analyzed the captured x-ray image, intraoral quality score analyzer 536 may receive the results from each analyzer and provide a quality analysis score to the user, indicating whether the image is of sufficient clarity and quality, and hence indicating whether the intraoral x-ray machine 16 and associated sensor 20 is in good working order.
[0214] Contrast analyzer 504 may be used to determine the ability of a digital sensor to produce a good quality and high definition image. After capturing each image, a sensor 20 may reset to a clear state in preparation for the capture of new x-ray images. The image receptor inside the sensor 20 may get saturated over time, and the sensor 20 may lose the ability to fully reset to a clear state after each image. The saturation over time may be gradual and may only be detected by image analysis. The contrast analyzer 504 may first identify a dark area reference section within the image, which corresponds to a region 1104 (as depicted in FIG. 108) exhibiting the highest degree of radiation penetration through the phantom device 100. Region 1104 may provide a baseline gray level that approximates the lower bound of the image’s grayscale spectrum. The software may then extract gray scale values from three additional regions 1108, 1112 and 1116, each associated with a corresponding thickness variation in stepwedge 148. Regions 1108, 1112 and 1116 may reflect incremental changes in material density and may therefore exhibit progressively lighter grayscale values relative to the dark area reference section. A contrast ratio may be computed based on differences among all four grayscale values, and the magnitude of this ratio may provide an indicator of the image’s diagnostic quality. In particular, higher contrast ratiosmay correspond to improved differentiation between structures of varying density, which indicate better definition of the overall image diagnostic quality. Stepwedge 148 may include any number of steps, and as such, the number of regions may either remain the same where a specific number of regions located on stepwedge 148 are chosen to be used, or where the number of regions located on stepwedge 148 used as part of contrast analyzer 504 may increase as well. A person skilled in the art will recognize the potential different regions based on different stepwedge 148 configurations, which may lead to potential different number of comparisons in greyscale values.
[0215] Referring to FIG. 105, corner break analyzer 508 may be used to test the sensor 20 for physical damage, and to ensure that the full sensor size and imaging surface of sensor 20 will be able to produce an image. If a sensor 20 is dropped or undergoes a similar physical shock, there may not be visible damage on the outside housing of sensor 20, but the scintillator, optic plate and / or sensor element on the inside of sensor 20 can display dead or blanked out corner areas. In said dead or blanked out areas, the image may not show details or data that may be critical for diagnosis. Liquid may also penetrate through the corners of sensor 20 where the outer housing may fail or may separate from wear and tear, and / or from age. This may also degrade the corners of the image. The comer break analyzer 508 may evaluate all four corner regions 1204 (as depicted in FIG. 109) of a displayed digital X-ray image to detect distortion, occlusion, or dead areas where there is no image. Where there is any distortion, occlusion, or dead areas, the sensor may be considered in poor shape.
[0216] Colour analyzer 512 may be used to determine the x-ray generator and / or tube head functionality and / or efficiency. As the tungsten element ages inside the tube head in intraoral x-ray machine 16, the radiation beam gets weaker and produces lighter images. The colour analyzer 512 may detect subtle grayscale changes within a range of 0 to 255, and these changes may indicateprogressive degradation in image brightness or tonal response associated with reductions in x-ray beam strength. By monitoring these variations, the colour analyzer 512 may derive a measurement correlated with the output performance of the x-ray source and may thereby provide an estimate of the remaining usable life of the unit. When the measured grayscale characteristics fall below a threshold associated with the production of diagnostic-quality images, the software may generate a warning to the operator. The analysis may be performed by determining average intensity values for each of the three regions 1108, 1112 and 1116. Specifically, regions 1108, 1112 and 1116 are interior regions not bordered by the edge or transitions boundaries of stepwedge 148 to avoid artifacts, such as edge sharpness. The colour analyzer 512 may compute three comparison values, namely the difference between a bright region and a medium-intensity region, the difference between the medium-intensity region and a dark region, and the difference between the darkest square and the darkest portion of the acquired image, which is typically a background region, such as region 1104. These computed values may then be compared to corresponding values derived from a reference image, allowing the system to identify deviations indicative of reduced beam strength or emerging quality concerns. Stepwedge 148 may include any number of steps, and as such, the number of regions may either remain the same where a specific number of regions located on stepwedge 148 are chosen to be used, or where the number of regions located on stepwedge 148 used as part of colour analyzer 512 may increase as well. A person skilled in the art will recognize the potential different regions based on different stepwedge 148 configurations, which may lead to potential different number of comparisons in greyscale values.
[0217] Edge sharpness analyzer 516 may be used to measure the sensor’s 20 degradation in resolution. In a preferred embodiment, where stepwedge 148 has three steps, the edge sharpness analyzer 516 may automatically identify the two principal transition edges of the stepwedge 148,namely the boundary from the thickest section to the medium section and the boundary from the medium section to the thinnest section, and may further partition each step into three analysis regions corresponding to a left square 1216, a middle square 1212, and a right square 1208 (as depicted on FIG. 109). For each targeted edge, the edge sharpness analyzer 516 may initiate sampling on the left side of the boundary and traverse to the right across the transition zone to measure the distance, in pixels or calibrated units, required for the intensity to change from the first targeted edge to the second targeted edge. As an example, the right side of left square 1216 may be a first targeted edge, and the left side of middle square 1212 may be a second targeted edge, where the distance between the first targeted edge and second targeted edge is measured. The resulting measurements may be compared against reference image data acquired under known conditions to quantify the degradation in resolution on transition boundaries. Stepwedge 148 may include any number of steps, and as such, the number of squares and transition boundaries may may increase as well. A person skilled in the art will recognize the potential different regions based on different stepwedge 148 configurations, which may lead to potential different number squares and measurements between targeted edges.
[0218] The consistency analyzer 520 may be used for measuring the sensor 20 ability to generate a diagnostic quality image throughout the entire image receptor surface of sensor 20. The sensor 20 receptor surface may exhibit non-uniform degradation. Specifically, degradation on sensor 20 receptor surface may progress at different rates across distinct portions of the sensing area. As a result, image regions that correspond to more deteriorated sensor zones may display reduced brightness consistency, lower contrast, or increased blurring, thereby diminishing diagnostic value in localized portions of the image. To assess this condition, the software may analyze the interior region of each designated region 1108, 1112 and 1116 and may subdivide thatinterior region into a 6 x 6 grid. The software may compute an intensity value and / or greyscale value for each cell in the 6 x6 grid and compare the values across all cells within the same grid to evaluate uniformity. When one or more cells deviate from other cells by more than a preset percentage threshold, the software may quantify the variation and compute a corresponding value that indicates a reduction in image quality associated with potential sensor degradation in that region.
[0219] The signal to noise ratio analyzer 524 may be used to determine the overall integrity and quality of the sensor 20. The sensor’s 20 integrated electronics, the imaging plate as well as the scintillator screen are responsible for a the creation of a sharp and high quality image, and may degrade over time. In addition, the frequency of radiation exposure may also degrade the sensor’s 20 integrated electronics, the imaging plate as well as the scintillator screen. Minor malfunctions in the components of the sensor 20 may be detected through a signal-to-noise ratio calculation performed on selected pixel regions of the captured x-ray image. In this process, the software may determine the mean brightness value for a pixel or for a small neighborhood of pixels located in regions 1108, 1112 or 1116 and divide that value by the corresponding standard deviation to obtain a signal-to-noise ratio. A reduced signal-to-noise ratio may indicate the presence of excessive noise, which may arise from sensor degradation. By monitoring these values against configurable thresholds, the system may identify early indications of malfunction that may diminish overall image quality.
[0220] The radiation beam tilt angle detection analyzer 528 may be used to determine whether the beam generator of intraoral x-ray machine 16 is aligned with the phantom device or whether the beam generator is off axis. An algorithm is used to determine whether the stepwedge 148 is off axis, as shown in the regions 1304 where the edge of stepwedge 148 may be seen at anangle. Where the beam generator of intraoral x-ray machine 16 is misaligned or off axis in relation to the phantom device 100 and sensor 20, a warning may be generated to the user to correct the orientation and axis of the beam generator in relation to the phantom device 100 and sensor 20.
[0221] The artifact analyzer 532 determines whether there are dead areas, black or white spots, or any other artifacts that may cover areas on the captured x-ray image. Artifacts appearing within an X-ray image may obstruct clinically significant structures and thereby reduce diagnostic reliability. To address this, the artifact analyzer 532 may examine the entire image to identify pixels, clusters, or localized regions that deviate from expected patterns associated with phantom device 100 or from reference images. When an artifact is detected, the software may generate a warning to the operator and may visually mark the affected region 1308, for example by outlining it in red, to highlight the compromised portion of the image. Early identification of such artifacts may reduce the likelihood of retakes and may therefore limit unnecessary radiation exposure to the patient while maintaining consistent image quality standards.
[0222] The intraoral quality score analyzer 532 receives results from each of the abovementioned analyzers, and provides a quality score 1312 for the captured x-ray image of the phantom device 100. Predetermined ranges of quality scores 1312 represent whether a quality score of a captured x-ray image of the phantom device 100 is considered a passing grade, an intermediate grade or a failing grade. For example, a quality score 1312 of between 80 to 100 may generate a passing grade, and as such, the intraoral x-ray machine 16 and associated sensor 20 may be deemed safe to operate. A quality score 1312 of between 60 to 79 may be considered an intermediate grade and may produce a warning message to the user. A corrective course of action may also be recommended to the user. Corrective courses of action will be further discussed below. A quality score 1312 of 59 or lower may be considered a failing grade, where the user isrecommend not to continue using the intraoral x-ray machine 16 and / or the associated sensor 20. Where a quality score 1312 is considered to be a failing grade, a corrective course of action may also be recommended.
[0223] Corrective course of action may be dependent on the results from the independent analyzers. As previously discussed, different analyzers are reviewing images for different aspects, which may suggest whether corrective action is recommended to be directed towards the intraoral x-ray machine 16 or the sensor 20. More specifically, poor results from the contrast analyzer 504, the comer break analyzer 508, the edge sharpness analyzer 516, the consistency analyzer 520 and the signal to noise ratio analyzer 524 may more likely suggest degradation or failure of sensor 20, whereas poor results from the colour analyzer 512, and / or the radiation beam tilt angle detection analyzer 528 may more likely suggest an issue, degradation or failure of intraoral x-ray machine 16. As such, a corrective course of action may further provide suggestions as to whether the issue lies with intraoral x-ray machine 16 or sensor 20. Other corrective course of action may also include requesting a user to properly align the intraoral x-ray machine 16 if the radiation beam tile angel detection analyzer 528 detects a tilt, or a requesting a user ensure there are no objects between the intraoral x-ray machine 16 and sensor 20 other than phantom device 100 if artifact analyzer 532 detects an artifact on the captured x-ray image of phantom device 100.
[0224] A person skilled in the art will recognize that the generation of the quality score 1312 does not require all the aforementioned analyzers to operate and provide results. In other embodiments (not shown), any number of analyzers may be used to provide results. Specifically, the generation of a quality score 1312 may use at least one analyzer.
[0225] In some embodiments, a deviation score 1316 may also be provided to the user using deviation analyzer 536. Deviation analyzer 536 requires reference images from the specific intraoral x-ray machine 16 and sensor 20 that is being tested. A predetermined number of reference images are automatically saved upon the first predetermined number of tests performed if the images are analyzed and have a quality score above a predetermined threshold. In a preferred embodiment, three images may be the predetermined number of reference images, and the predetermined threshold quality score 1312 may be 90. As such, the first three image analyses where a quality score 1312 is over 90 for a specific intraoral x-ray machine 16 and a specific sensor 20 will be saved as reference images in intraoral reference image database 540 for deviation analyzer 536 to use. If any of the images analyzed have a score 1312 of below 90 before the first three images with a quality score of over 90 are saved as reference images, the image with a score 1312 of below 90 will be logged, but will not be used as a reference image, and the deviation analyzer 536 will not proceed. More specifically, the saving of the predetermined number of reference images in intraoral reference image database 540 is a prerequisite for the operation of deviation analyzer 536.
[0226] Deviation analyzer 536 compares the captured x-ray image against the reference images in the intraoral reference image database 540. Specifically, deviation analyzer 536 may determine how much the captured x-ray image deviates from the reference images in the intraoral reference image database 540. The deviation analyzer 536 creates a score 1316 that will indicate whether the intraoral x-ray machine 16 and the sensor 20 are functioning within set limits. Deviation scores 1316 between specific value ranges indicate whether the intraoral x-ray machine 16 and sensor 20 obtain a passing grade, an intermediate grade, or a failing grade. In a preferred embodiment, if the deviation score 1316 is between 0 to 10, the intraoral x-ray machine 16 and thesensor 20 have a passing grade. If the deviation score 1316 is between 11 to 20, the intraoral x-ray machine 16 and the sensor 20 have an intermediate grade. If the deviation score 1316 is above 21, then the intraoral x-ray machine 16 and the sensor 20 have a failing grade. Similar to the quality score 1312 described above, a passing grade indicates that the intraoral x-ray machine 16 and sensor 20 are functioning within set parameters, an intermediate grade may produce a warning to the user and may indicate that a corrective action is recommended and that the intraoral x-ray machine 16 and sensor 20 may need to be monitored, and a failing grade will inform the user that immediate corrective action may be recommended.
[0227] Memory 416 may also store panoramic x-ray image analysis module 424. Panoramic x-ray image analysis module 424 may operate based on a specific make and model of panoramic x-ray machine 32. When analyzing a captured x-ray image of a phantom device 100, panoramic x-ray machine 32 may request the make and model of the panoramic x-ray machine 32.
[0228] Panoramic x-ray image analysis module 424 may be configured to include various analyzers as shown in FIG. 106, including but not limited to tilt angle detection analyzer 604, linear symmetry analyzer 608, size magnification symmetry analyzer 612, beam strength analyzer 616 and ramp up ramp down analyzer 624. Each of the aforementioned analyzers may be used to analyze a captured panoramic x-ray image of phantom device 100. The aforementioned analyzers may operate concurrently, sequentially in any order, or a mixture of both. Specifically, none of the analyzers depend on one another to provide inputs, outputs or additional data, and may operate independently of one another. Once each analyzer has analyzed the captured x-ray image, panoramic quality score analyzer 636 may receive the results from each analyzer and provide a quality analysis score 1424 to the user, indicating whether the image is of sufficient clarity and quality, and hence indicating whether the panoramic x-ray machine 32 is in good working order.
[0229] Tilt angle detection analyzer 604 may be used to ensure the proper placement and orientation of the phantom device 100 on adapter arm 300. A horizontal reference line may be drawn by tilt angle detection analyzer 604 by connecting the center of a left calibration ball 152-3 to the center of a right calibration ball 152-1 within the captured image. This may be depicted as line 1416. A second line may be drawn by tilt angle detection analyzer 604 from the center of the left calibration ball 152-3 and extended horizontally along the X-axis of the captured image, providing an idealized reference orientation. The tilt angle detection analyzer 604 may calculate the angular deviation between these two lines, and the resulting measurement may indicate whether the phantom device 100 is properly seated within the adapter arm 300, and / or whether the adapter arm 300 may be. When the measured angle exceeds a preset threshold, such as two degrees, the tilt angle detection analyzer 604 may issue a warning prompting the user to reposition the puck and repeat the test, thereby supporting consistent alignment conditions and improving the reliability of subsequent image quality assessments. If after reseating the phantom device 100 on adapter arm 300 the measured angle still continues to exceed a preset threshold, the result may be provided to panoramic quality score analyzer 632 for further consideration in quality score 1424.
[0230] Linear symmetry analyzer 608 may be used to determine the mechanical rotation accuracy of the panoramic x-ray machine 32. More specifically, linear symmetry analyzer 608 may be used to determine the whether circular path / orbit of the emitter and sensor of panoramic x-ray machine 32 is accurate. The rotation of the x-ray tube head / emitter and the sensor around the patient’s head is important to ensure both the source-to-target and target-to-detector distances are tracked and balanced. This is to ensure that the focal trough remains correctly aligned with the target jaw and teeth of the patient. Any imbalance in this motion, including deviations in the preset center-of-rotation path, may cause the left and right portions of the scan to differ in their distancefrom the rotational center, which may lead to misalignment of the focal plane and produce a distorted panoramic image. To assess this condition, the three ball bearings 152 positioned in phantom device 100 within the captured x-ray image may be used by linear symmetry analyzer 608. Specifically, linear symmetry analyzer 608 may determine the centroid of each bearing 152 based on pixel distribution and may sort the centroids of each bearing 152 from left to right to distinguish the two side bearings 152-3 and 152-1 from the central bearing 152-2. The horizontal separation along the x-axis of the image 1408 between the side bearings 152-3 and 152-1 may then be calculated and compared to the position of the central bearing 152-2 to evaluate whether the geometry exhibits the expected equal left-right balance. The resulting deviation / difference may be expressed as a percentage to normalize for pixel resolution differences between images (as different makes and models of panoramic x-rays may capture different image resolutions), and a qualitative rating such as excellent, good, or poor may be assigned based on the proximity of the calculated percentage to ideal symmetry. In other embodiments, where additional bearings 152 may be present, the linear symmetry between all bearings 152 may be analyzed.
[0231] Size magnification symmetry analyzer 612 may be used to determine the magnification balance between the left and right side of the captured x-ray image of the phantom device 100. Scan asymmetry may introduce geometric distortion in a panoramic x-ray, producing unbalanced magnification between the left and right sides of the image. To assess this condition, the size magnification symmetry analyzer 612 may detect and identify the circumferences of the bearings 152. Specifically, the number of pixels along the perimeter / circumference 1412 of each of the bearings 152 is determined and is compared against each other. The size magnification symmetry analyzer 612 may compare the circumference 1412 of each bearing 152 and calculate a percentage difference. Furthermore, the number of pixels within the perimeter / circumference ofeach bearing 152 is determined and is compared against each other as a percentage. A larger percentage difference may indicate asymmetric scaling across the scan trajectory, prompting a quality flag or operator guidance. As an example, bearing 1512 in FIG. 9 can be seen to be smaller, and will have a difference in both the number of pixels along the perimeter / circumference 1412 and the number of pixels within the perimeter / circumference in comparison to side bearings 152-3 and 152-1 in the captured x-ray image.
[0232] Beam strength analyzer 616 may be used to measure the radiation output of the tube head / emitter through the entire panoramic x-ray exposure sequence as the emitter travels the circular orbit. Fluctuations in photon output caused by an aging x-ray tube head or a malfunctioning generator control circuit may result in variable beam strength across different portions of a panoramic x-ray scan, which may in turn cause inconsistent image quality and reduced diagnostic readability. To assess beam uniformity, the beam strength analyzer 616 may analyze the captured x-ray image of the outer blocks 156 and inner blocks 160 arranged along a radial path in phantom device 100. Each of the outer blocks 156 and inner blocks 160 appear as a square within the captured image. Specifically, in the preferred embodiment where phantom device 100 includes two outer blocks 156 and two inner blocks 160, four squares are present in the captured x-ray image. The beam strength analyzer 616 may automatically locate each square using a Sobel edge detection process configured to identify regions exhibiting sufficiently steep intensity gradients, such as spike change in the gradient between the background or the polymer section of phantom device 100 and any one of the outer blocks 156 or inner blocks 160 in the captured x-ray image. A threshold for the minimum spike or change in gradient to qualify as an edge may be set. If beam strength analyzer 616 fails to detect the outer blocks 156 and inner blocks 160, beam strength analyzer 616 may fallback to predetermined coordinates of where the outer blocks 156and inner blocks 160 are expected to be based on reference images. After detecting the perimeter of each block, the software may determine its centroid and generate a smaller internal square 1416, sized at approximately forty percent of the original, to ensure that sampling occurs well within the aluminum inner block 160 and outer block 156 boundaries. The grayscale intensity of the two outer blocks 156 may then be calculated by summing the intensity values for all pixels within each generated square and dividing by the number of sampled pixels to obtain average grayscale levels on a scale of zero to 255. A delta value may be produced by subtracting one average from the other, thereby providing a measure of beam strength variation between the left and right extremes of the scan path. A properly functioning panoramic system may yield a delta value near zero, whereas increasing deviations may result in a penalty within the overall quality score 1424, indicating potential degradation in beam performance.
[0233] Beam alignment analyzer 620 may verify that the collimator of panoramic x-ray machine 32 are properly set to create a well aligned photon beam path. Specifically, beam alignment analyzer 620 may assess panoramic x-ray image quality in terms of contrast, sharpness, and definition by monitoring gradual shifts attributable to collimator misalignment over time. Three predetermined analysis zones 1420 may be located at the two upper corners of the image and at the center of the upper region, and each zone 1420 may be processed to compute an average grayscale intensity on a scale from 0 to 255 by summing the intensities of all pixels within the zone and dividing by the total pixel count. The resulting zone averages may be compared against corresponding values from a previous image to detect changes indicative of alignment drift that may reduce contrast and edge definition. An uneven variation among the three zone values may be interpreted as a change in beam alignment, and any deviation from expected uniformity may bemapped to a penalty that reduces an overall quality score 1424, thereby providing a quantitative indicator of image quality degradation.
[0234] Ramp up ramp down analyzer 624 may measure the range where radiation exposure is increased throughout the penetration of the cervical spine. Specifically, panoramic x-ray machines 32 may increase the amount of radiation and / or x-rays towards the rear of a patient’s head in order to scan through the cervical spine. Misalignment of system geometry or variation in the effective scan range may adversely affect image quality in the central region of a panoramic x-ray where increased radiation is emitted by panoramic x-ray machine 32. To evaluate this condition, a test may be performed in a manner similar to the beam strength analyzer 616, but applied to the two inner blocks 160 of the phantom device 100. For each of the inner blocks 160, the ramp up ramp down analyzer 624 may determine an average grayscale value on a scale from 0 to 255 by summing the grayscale intensities of all pixels within a defined interior sampling region 1416 and dividing by the total number of sampled pixels. The two resulting averages may then be subtracted to generate a delta value that represents the difference in radiation strength between the left inner block 160-2 and right inner block 160-1 regions 1416 of the scan. In a preferred embodiment, a functioning panoramic system may exhibit a centered radiation distribution such that the delta value approaches zero, while any deviation from zero may be interpreted as an indication of misalignment or range-width variation, and may be assigned a penalty that lowers an overall quality score 1424 associated with the test.
[0235] Panoramic quality score analyzer 632 operates in a similar fashion as the previously described intraoral quality score analyzer 532, and provides a quality score 1424 for the captured panoramic x-ray image of phantom device 100. Similar ranges of quality scores 1424 are used as quality scores 1312.
[0236] Panoramic deviation analyzer 636 also operates in a similar fashion as the previous described intraoral deviation analyzer 536, and provides a deviation score 1428 for the captured panoramic x-ray image of phantom device 100 in comparison with reference images of good quality stored in panoramic reference image database 640. Similar ranges of deviation scores 1428 may be used as deviation scores 1324. In an alternate embodiment, a deviation score 1428 of between 11 to 30 may provide a warning grade, and a deviation score 1428 of 31 or greater may generate a failing grade.
[0237] Referring to FIG. 104, in at least some embodiments, memory 416 stores logs 428 (also referred to herein as logs database 428). The logs database 428 may be configured to record each captured image from intraoral x-ray machine 16, sensor 20 and / or panoramic x-ray machine 36, the resulting image analysis, quality scores 1312 and / or 1424, and deviation scores 1316 and / or 1428. This database may store entries that include event identifiers, timestamps, images and scores. In some embodiments, the logs database 428 may provide functionality for filtering and aggregating log data to support analytics or reporting. The database may optionally integrate with external monitoring tools or dashboards to enable real-time visibility into system performance.
[0238] In the current embodiment, intraoral x-ray image analysis module 420, panoramic x-ray image analysis module 424 and log database 148 are each stored / hosted on memory 416 of server 404. However, in other embodiments, each of the aforementioned modules or databases may be hosted or stored on separate servers and / or computing devices in any combination. For example, intraoral x-ray image analysis module 420 may reside on an external server, whereas panoramic x-ray image analysis module 424 may reside on server 404. In addition, analyzers in each module may also reside on separate servers. Separation of storage / hosting may have advantages, such as being able to take advantage of individual processors on each computingdevice, however there may be added communication duration and additional points of failure. For ease of explanation, the current embodiment depicts the modules and databases residing on the same server 404, however a person skilled in the art will recognize the different potential configurations and layouts of components, modules, and databases when distributed and store / hosted in different computing devices.
[0239] Turning now to communications interface 408, it allows for processor 412 to communicate with network 432. Communications interface 408 includes suitable hardware (e.g. transmitters, receivers, network interface controllers and the like) allowing server 404 to communicate with other components in system 400, such as client terminal 436. The specific components of communications interface 408 may be selected based on the type of network or other links server 404 may be required to communicate over.
[0240] Server 404 may also include input devices that connect to processor 412, such as a keyboard and mouse, as well as output devices, such as a display. Alternatively, or in addition, the input and output devices can be connected to processor 412 via communications interface 408 via another computer device. In other words, input and output devices can be local to server 404 or remote.
[0241] In the preferred embodiment, network 432 is a wide area network (WAN) but a person skilled in the art will recognize that network 432 is not particularly limited in its configuration. Network 432 may be any form of network, including a local area network (LAN), or the Internet, and may be accessed by computers, mobile devices or the components of system 400. Computers, such as server 404, and client terminal 436 can operate in a networked environment using logical connections to one or more remote computers or other devices, such asa server, a router, a network personal computer, a personal computer, a peer device or other common network node, a wireless telephone or wireless personal digital assistant. In the current embodiment, network 432 may be implemented over the Internet. The standards or protocols used for the network may include any form of transmission, such as Transmission Control Protocol / Intemet Protocol (TCP / IP), User Datagram Protocol / Intemet Protocol (UDP / IP), Hyper Text Markup Language (HTML) and Hyper Text Transfer Protocol (HTTP). In addition, any desired levels and types of security and encryption protocols are contemplated and can be implemented over network 432. A person skilled in the art will recognize the different potential network types and different potential network configurations that may be used, along with the different standards and protocols of transmission within the network, and the different forms of security and encryption protocols available. Furthermore, as the data being transmitted between components of system 400, including between server 404 and client terminal 436 may be considered confidential information, privileged information, sensitive personal information and / or real-time location data, industry standards for encryption in flight and encryption at rest may be applied or used.
[0242] In a preferred embodiment, communication between the components of system 400 occur over network 432. Specifically, communication between any one of the intraoral x-ray image analysis module 420 or panoramic x-ray image analysis module 424 or other instructions to be executed by processor 412, with any one of the other components of system 400 external to server 404, communicate using communications interface 408 over network 432. A person skilled in the art will recognize the other potential functions or instructions provided to processor 412 that may use communications interface 408 and network 432.
[0243] Server 404 and client terminal 436 may each be a computer device such as, but not limited to, a server a desktop computer, a laptop computer, a kiosk, a cell phone, a tablet, a mobile device, or other suitable device. In a preferred embodiment, server 404 is a server, and client terminal 436 is a desktop computer or laptop computer. A person skilled in the art will also appreciate that other, different configurations of server 404 and client terminal 436 are contemplated. It will also occur to a person skilled in the art that system 400 may include more than one client terminal 436 interacting with server 404, and in alternate embodiments where databases and modules are located external to server 404, system 400 may include more than one server.
[0244] Server 404 and client terminal 546 may include input devices and output devices. In the present embodiment, server 404 and client terminal 436 may include a display that outputs graphical user interfaces. Specifically, client terminal 436 may include a display with a graphical user interface for a user to interact with the intraoral x-ray image analysis module 420 and / or panoramic x-ray image analysis module 424. The user may also substantially immediately open access an annotated image, detailing, for example, the nature of the failure. If there was a Fail, then the system will detail to the user the nature of the failure. All records will be kept with time, date, and location of the x-ray ensuring a complete and comprehensive data log of all quality assurance tests performed on the radiography equipment.
[0245] Referring to FIG. 107, an embodiment of client terminal 436 is depicted, where image analysis application 716 is local on client terminal 436. In this embodiment, client terminal 436, includes processor 704 interconnecting a memory 712 and a communications interface 708. Communications interface 708 is connected to network 432 to communicate with server 404 and other terminals or devices of system 400. Communications interface 708 is also connected topanoramic x-ray machine 34 and / or sensor 20. Processor 704, memory 712 and communications interface 708 are similar to processor 412, memory 416 and communications interface 408 in function, configuration, arrangement, variations and embodiments, however, memory 712 does not include the modules and databases stored in memory 416. Rather, memory 712 stores image analysis application 716. When executed by processor 704, image analysis application 716 provides a graphical user interface allowing a user to input data to be sent to intraoral x-ray image analysis module 420 and / or panoramic x-ray image analysis module 424, and an output display area to display the resulting response from intraoral x-ray image analysis module 420 and / or panoramic x-ray image analysis module 424.
[0246] In the current embodiment, interactive response application 716 is local to client terminal 436, however, in other embodiments, image analysis application 716 may be an application hosted elsewhere on a separate system or server 404, where client terminal 436 may remotely access image analysis application 716. Specifically, where the image analysis application 716 may be hosted external to client terminal 436, client terminal 436 may view the graphical user interface of image analysis application 716 through browser or through other means of providing display information from an external computing device to client terminal 436. In an alternative embodiment, the graphical user interface may be provided as a web application. In yet another alternative embodiment, the image analysis application 716 may be local on client terminal 436 where information is transmitted between server 404 and the respective client terminal 436 through a secure connection or via an Application Programming Interface (API).
[0247] A person skilled in the art will recognize the different configurations and arrangements of local applications, and / or remotely hosted applications including the different embodiments of image analysis application 716 and the different configurations and arrangementsof applications being hosted on server 404, and its effect on the arrangement of components, applications and modules in system 400. A person skilled in the art will recognize image analysis application 716 may be modified to operate on any operating system. Specifically, image analysis application 716 is an application that may be modified to operate on the operating system of client terminal 436. For example, client terminal 436 may operate on a Microsoft Windows operating system, and image analysis application 716 may be a Windows application. Alternatively, client terminal 436 may be a mobile device and may operate on an Android operating system, and image analysis application 716 may be an Android app. A person skilled in the art will recognize that other operating systems, including, but not limited to, Apple iOS, Apple iPadOS, and ChromeOS may also be contemplated for client terminal 436, and correspondingly different compatibilities of application for image analysis application 716 are contemplated. Furthermore, in an embodiment where the applications are hosted on server 404 as part of memory 416, a person skilled in the art will recognize that providing the graphical user interface is operating system agnostic. In addition, in all embodiments, a person skilled in the art will recognize that system 400 does not need to be homogenous in operating systems, but rather all applications, terminals and devices may interoperate with different operating systems. Specifically, system 400 is cross-platform capable and may operate regardless of different operating systems in its components.
[0248] Referring to FIG. 113, an example method 800 of performing a quality assessment of an intraoral x-ray machine 16 and an associated sensor 20 is provided. Method 800 depicts the use and operation of phantom device 100, sensor holder 200 as part of a intraoral x-ray testing assembly 12 and the quality assessment of a captured x-ray image of phantom device 100 using intraoral x-ray machine 16 and sensor 20.
[0249] At step 805, a user may position a phantom device 100 on a corresponding sensor holder 200 so that alignment holes 164 of the phantom device 100 align with complementary features of the holder 200, thereby releasably mounting phantom device 100 onto holder 200 as intraoral x-ray testing assembly 12 and aligning the orientation of phantom device 100 with sensor 20 in sensor cavity 208. The assembly 12 may be situated on a fixture or flat support surface that is compatible with the intraoral x-ray machine to reduce any off tilt axis of view during image acquisition. Where provided, visual alignment marks 112 on the phantom device may be used to coarsely aim the tube head / emitter toward the phantom device’s 100 target region before initiating the x-ray machine 16. At step 810, the operator may initiate an intraoral x-ray exposure for the testing assembly 12. At step 815, the sensor 20 may capture and store an x-ray image of the phantom device 100. The resulting image file or dataset may be transferred to server 404 for analysis, either directly from the sensor 20 via sensor wire 24 or via export from the client terminal 436. The captured image may include sufficient field of view to encompass the phantom device’s 100 analysis regions so that intraoral x-ray image analysis module 420 can locate and evaluate target features.
[0250] At step 820, an intraoral x-ray image analysis module 420 may process the captured image to compute a quality assessment score 1312. The module 420 may execute one or more analyzers, which may include, for example, a contrast analyzer 504, corner break analyzer 508, colour analyzer 512, edge sharpness analyzer 516, consistency analyzer 520, signal-to-noise ratio analyzer 524, radiation beam tilt-angle detection analyzer 528 and / or artifact analyzer 532. Each analyzer may operate independently on designated regions of interest associated with the phantom device’s 100 geometric elements, specifically the stepwedge 148, in the captured x-ray image and may output one or more metrics for aggregation using intraoral quality score analyzer 536.
[0251] At step 825, the score may be calculated by a quality score analyzer 536 that weights selected metrics from the analyzers executed in step 820, and aggregates to display a quality assessment score 1312 for intraoral x-ray machine 16 and / or sensor 20. The user interface on image analysis application 716 may display the score with contextual annotations, including highlights of regions contributing to deductions, so that a technician can identify likely causes and determine whether additional checks are warranted. Corrective recommend actions or suggestions as to the likely fault may also be provided.
[0252] At step 855, the server 404 may store the captured image, derived metrics, and quality score 1312 in a logs database 428 for auditability and longitudinal analysis. Entries may include timestamps, equipment identifiers, and operator or site identifiers when provided. The retention policy may specify the archival period and access controls consistent with organizational requirements or applicable standards.
[0253] Referring to FIG. 114, an alternate embodiment of method 800 is provided as method 800A. Specifically, method 800A depicts a method of performing a quality assessment of an intraoral x-ray machine 16 where deviation from reference images is further analyzed. For convenience, like reference numerals are used in FIGS. 113 and 114 to depict like steps. Method 800A is similar in all material respects to method 800 except that steps 830, 835, 840, 845 and 850 are added after step 825 and prior to step 855.
[0254] For greater clarity, steps 805, 810, 815, 820, 825 and 855 are performed as described above in the context of method 800 shown in FIG. 113. Subsequent to step 825, at step 830, the processor 412 of server 404 may determine whether a sufficient number of reference images are available for the corresponding intraoral x-ray machine 16 and sensor 20 configuration.This determination may rely on checking a reference image database 540 to confirm that a predetermined minimum count of previously validated images exists for the specific intraoral x-ray machine 16 and sensor configuration 20, each reference image having met a required quality score 1312 threshold during earlier assessments. The availability of such reference images may allow the processor 412 to perform comparative or deviation-based analysis using deviation analyzer 536 depicted at step 835.
[0255] At step 840, the processor 412 may receive and display a deviation score 1316 of the intraoral x-ray machine 16 and / or the associated sensor 20 based on the analysis conducted in step 835. The deviation score 1316 may be mapped to predefined threshold categories to indicate a passing, intermediate or failing condition. A graphical user interface on image analysis application 716 may present the score along with optional annotations that highlight the regions contributing to deviation, thereby assisting technicians in understanding potential sources of performance changes. Corrective recommend actions or suggestions as to the likely fault may also be provided.
[0256] Returning to step 830, if the minimum number of reference images is not available in reference image database 540 for the intraoral x-ray machine 16 and sensor configuration 20, the current captured x-ray image may be considered to be stored as a reference image in reference image database 540 for future deviation score calculations by deviation analyzer 536. At step 845, processor 412 may determine whether the captured x-ray image is of sufficient quality score to qualify as a reference image. If the captured image satisfies the quality score threshold, it may be considered a suitable candidate for inclusion in the reference image set to be used in deviation analysis and may be stored in reference image database 540. This is depicted at step 850.
[0257] At step 855, in addition to the quality score 1312, if a deviation score 1316 was generated, the deviation score 1316 is logged in logs 428 as well.
[0258] Referring to FIG. 115, a method 800B of performing a quality assessment of a panoramic x-ray machine 32 is depicted. The method 800B is similar to method 800 of FIG. 115, however, a panoramic x-ray machine 32 is subj ect to the quality assessment rather than an intraoral x-ray machine 16. For convenience, like reference numerals are used in FIGS. 113 and 115 to depict like steps. Method 800B is similar in all material respects to method 800 except that steps 805, 810, 820 and 825 are replaced with steps 805B, 810B, 820B and 825B respectively.
[0259] For greater clarity, step 815 and 855 are performed as described in the context of method 800 shown in FIG. 113. Step 805B replaces step 805 and occurs after step 855. Specifically, step 805B includes positioning the phantom device 100 on an adapter arm 300 that corresponds with the mounting points of a panoramic x-ray machine 36, such that alignment holes 164 of the phantom device 100 align with complementary protrusions 304 on adapter arm 300, thereby releasably mounting phantom device 100 onto adapter arm 300 as panoramic x-ray testing assembly 28. The testing assembly 28 may be releasably mounted on a mounting point 36 of panoramic x-ray machine 32. Vertical mid-sagittal beam of panoramic x-ray machine 32 may then be projected onto phantom device 100, and aligned with panoramic layer alignment line 136.
[0260] Step 810B replaces step 810 and occurs after step 805B. Specifically, step 810B includes initiating panoramic x-ray machine 32. Step 820B replaces step 820 and occurs after step 815. Specifically, step 820B includes the panoramic x-ray image analysis module 424 processing the captured image to computer a quality assessment score 1424. The module 424 may execute one or more analyzers, which may include, a tilt angle detection analyzer 604, a linear symmetry-n-analyzer 608, a size magnification symmetry analyzer 612, a beam strength analyzer 616, a beam alignment analyzer 620, and / or a ramp up ramp down analyzer 624. Each analyzer may operate independently on designated regions of interest associated with the phantom device’s 100 geometric elements in the captured x-ray image, specifically the ball bearings 152, inner blocks 160 and outer blocks 156, and may output one or more metrics for aggregation using a panoramic quality score analyzer 632.
[0261] Step 825B replaces step 825 and occurs after step 820B. Specifically, step 825B includes receiving and displaying the resulting aggregated quality score 1424 from quality core analyzer 632 at image analysis application 716 on client terminal 436. Displaying the quality score 1424 on a graphical user interface on image analysis application 716 may include displaying the score with contextual annotations, including highlights of regions contributing to deductions, so that a technician can identify likely causes and determine whether additional checks are warranted. Corrective recommend actions or suggestions as to the likely fault may also be provided.
[0262] Referring to FIG. 116, an alternate embodiment of method 800 A is provided as method 800C. Specifically, method 800C depicts a method of performing a quality assessment of a panoramic x-ray machine 32 where deviation from reference images is further analyzed. For convenience, like reference numerals are used in FIGS. 114 and 116 to depict like steps. Method 800C is similar in all material aspects to method 800A except that steps 805, 810, 820, 825 and 840 are replaced with steps 805B, 810B, 820B, 825B and 840C respectively. Steps 805B, 810B, 820B and 825B are also similar in all material aspects to method 800B of FIG. 115, and as such like reference numerals are used in FIGS. 115 and 116 to depict steps 805B, 810B, 820B and 825B.
[0263] For clarity, steps 805B, 81 OB, 820B and 825B are performed as described above in the context of method 800B shown in FIG. 115, and steps 815, 830, 835, 845, 850 and 855 are performed as described above in the context of method 800A shown in FIG. 114. Step 840C replaces step 840 and occurs after step 835. Specifically, step 840C includes the processor 412 receiving and displaying deviation score 1428 of panoramic x-ray machine 32 based on the analysis conducted in step 835 by panoramic deviation analyzer 636. The deviation score 1428 may be mapped to predefined threshold categories to indicate a passing, intermediate or failing condition. A graphical user interface on image analysis application 716 may present the score along with optional annotations that highlight the regions contributing to deviation, thereby assisting technicians in understanding potential sources of performance changes. Corrective recommend actions or suggestions as to the likely fault may also be provided. Subsequent step 855 may log deviation score 1428 in log database 428.
[0264] Referring to FIG. 117, a method of constructing and / or assembling phantom device 100 is provided. At step 905, upper body 104, lower body 108 and interior components 120 of phantom device 100 may be provided for assembly, the interior components 120 including, for example, a stepwedge 148 sized for a stepwedge hole 140, bearings 152 sized for bearing holes 124, and outer blocks 156 and inner blocks 160 sized for corresponding outer block holes 180 and inner block holes 184 respectively.
[0265] At step 910, interior components may be placed into respective receptacles of lower body 108, including locating stepwedge 148 within stepwedge hole 140 formed at a base of lower body cavity 144, positioning bearings 152 within bearing holes 124, outer blocks 156 and inner blocks 160 within the outer block holes 180 and inner block holes 184 of upper body 104. In someembodiments, the aforementioned interior components 120 may further be secured into their respective holes through the use of adhesive or other adhering means.
[0266] At step 915, protrusions on upper body 104, such as upper protrusions 172, may be aligned with corresponding bearing holes 124 or other receiving features on lower body 108, and any complementary protrusions on the lower body, such as lower outer protrusions 128 and lower inner protrusions 132, may be aligned with the corresponding outer block holes 180 and inner block holes 184 in the upper body.
[0267] At step 920, the aligned protrusions, including upper protrusions 172 and any lower body protrusions such as 128 and 132, may be inserted into their corresponding holes or recesses 124, 180 and 184 so that interior components are pushed to their seated depth within lower body 108 and upper body 104. The mating geometry of these features may generate a controlled interference or compression that maintains the positional stability of bearings 152, outer blocks 156, and inner blocks 160 within their corresponding holes or recesses 124, 180 and 184. More specifically, the upper protrusion 172 pushes bearings 152 downwards into corresponding bearing hole 124 to achieve both mating upper body 104 to lower body 108, and to hold bearings 152 at the bottom of bearing hole 124. Similarly, lower body outer protrusion 128 and lower body inner protrusion 132 pushes outer blocks 156 and inner blocks 160 respectively into corresponding upper body outer block hole 180 and upper body inner block hole 184 to achieve both mating upper body 104 to lower body 108, and to hold outer blocks 156 and inner blocks 160 in place towards the top of upper body outer block hole 180 and upper body inner block hole 184.
[0268] At step 925, the upper body 104 may be secured to lower body 108 to complete the assembly of phantom device 100. The securing action optionally relies on frictional engagementof protrusions 172, 128, 132 within holes 124, 180, 184, adhesive bonding along the bottom surface 192 of upper body 104 and the top surface 196 of lower body 108 between the upper body 104 and lower body 108 interface adjacent to cavities 176 and 144, or other mechanical retention that preserves dimensional stability for subsequent intraoral or panoramic imaging.
[0269] As will be evident from above, phantom device 100 is a universal device that includes internal components 120 that may be used for both intraoral x-ray machine 16 quality assessment and panoramic x-ray machine 32 assessment. More specifically, intraoral x-ray machine 16 quality assessment may use intraoral x-ray image analysis module 420 and stepwedge 148, whereas panoramic x-ray machine 32 may use panoramic x-ray image analysis module 424, inner blocks 160 and outer blocks 156. In the preferred embodiment, the placement and configuration of the stepwedge 148, the inner blocks 160 and the outer blocks 156 allow for phantom device 100 to be used for both types of x-ray machines without the internal components 120 interfering with each other during either one of the x-ray tests. However, in other embodiments, where only intraoral x-ray quality assessment is to be done, a phantom device containing a stepwedge 148 may be used in conjunction with sensor holder 200 and intraoral x-ray image analysis module 420 may be used. Similarly, in other embodiments, where only panoramic x-ray quality assessment is to be done, a phantom device containing inner blocks 160 and outer blocks 156 may be used in conjunction with adapter arm 300 and panoramic x-ray image analysis module 424 may be used. A person skilled in the art will recognize the different potential configurations and layouts for phantom device 100.
[0270] While various embodiments in accordance with the principles disclosed herein have been described above, it should be understood that they have been presented by way of example only, and are not limiting. Thus, the breadth and scope of the invention(s) should not be limitedby any of the above-described exemplary embodiments, but should be defined only in accordance with the claims and their equivalents issuing from this disclosure. Furthermore, the above advantages and features are provided in described embodiments, but shall not limit the application of such issued claims to processes and structures accomplishing any or all of the above advantages.
[0271] It will be understood that the principal features of this disclosure can be employed in various embodiments without departing from the scope of the disclosure. Those skilled in the art will recognize, or be able to ascertain using no more than routine experimentation, numerous equivalents to the specific procedures described herein. Such equivalents are considered to be within the scope of this disclosure and are covered by the claims.
[0272] Additionally, the section headings herein are provided as organizational cues. These headings shall not limit or characterize the invention(s) set out in any claims that may issue from this disclosure. Specifically and by way of example, although the headings refer to a “Field” such claims should not be limited by the language under this heading to describe the so-called technical field. Further, a description of technology in the “Background” section is not to be construed as an admission that technology is prior art to any invention(s) in this disclosure. Neither is the “Brief Summary” to be considered a characterization of the invention(s) set forth in issued claims. Furthermore, any reference in this disclosure to “invention” in the singular should not be used to argue that there is only a single point of novelty in this disclosure. Multiple inventions may be set forth according to the limitations of the multiple claims issuing from this disclosure, and such claims accordingly define the invention(s), and their equivalents, that are protected thereby. In all instances, the scope of such claims shall be considered on their own merits in light of this disclosure, but should not be constrained by the headings set forth herein.
[0273] The use of the word “a” or “an” when used in conjunction with the term “comprising” in the claims and / or the specification may mean “one,” but it is also consistent with the meaning of “one or more,” “at least one,” and “one or more than one.” The use of the term “or” in the claims is used to mean “and / or” unless explicitly indicated to refer to alternatives only or the alternatives are mutually exclusive, although the disclosure supports a definition that refers to only alternatives and “and / or.” Throughout this application, the term “about” is used to indicate that a value includes the inherent variation of error for the device, the method being employed to determine the value, or the variation that exists among the study subjects.
[0274] As used in this specification and claim(s), the words “comprising” (and any form of comprising, such as “comprise” and “comprises”), “having” (and any form of having, such as “have” and “has”), “including” (and any form of including, such as “includes” and “include”) or “containing” (and any form of containing, such as “contains” and “contain”) are inclusive or open-ended and do not exclude additional, un-recited elements or method steps.
[0275] As used herein, words of approximation such as, without limitation, “about”, “substantial” or “substantially” refers to a condition that when so modified is understood to not necessarily be absolute or perfect but would be considered close enough to those of ordinary skill in the art to warrant designating the condition as being present. The extent to which the description may vary will depend on how great a change can be instituted and still have one of ordinary skilled in the art recognize the modified feature as still having the required characteristics and capabilities of the unmodified feature. In general, but subject to the preceding discussion, a numerical value herein that is modified by a word of approximation such as “about” may vary from the stated value by at least ±1, 2, 3, 4, 5, 6, 7, 10, 12 or 15%.
[0276] The term “or combinations thereof as used herein refers to all permutations and combinations of the listed items preceding the term. For example, “A, B, C, or combinations thereof is intended to include at least one of: A, B, C, AB, AC, BC, or ABC, and if order is important in a particular context, also BA, CA, CB, CBA, BCA, ACB, BAC, or CAB. Continuing with this example, expressly included are combinations that contain repeats of one or more item or term, such as BB, AAA, AB, BBC, AAABCCCC, CBBAAA, CABABB, and so forth. The skilled artisan will understand that typically there is no limit on the number of items or terms in any combination, unless otherwise apparent from the context.
[0277] All of the compositions and / or methods disclosed and claimed herein can be made and executed without undue experimentation in light of the present disclosure. While the compositions and methods of this disclosure have been described in terms of preferred embodiments, it will be apparent to those of skill in the art that variations may be applied to the compositions and / or methods and in the steps or in the sequence of steps of the method described herein without departing from the concept, spirit and scope of the disclosure. All such similar substitutes and modifications apparent to those skilled in the art are deemed to be within the spirit, scope and concept of the disclosure as defined by the appended claims.
Claims
1. CLAIMS:
1. A device for use in performing quality assessments of x-ray images generated by an x-ray machine, the device comprising:a plurality of radiopaque accessories including:a step wedge; andat least one of:at least one block for facilitating an assessment of the strength of an x-ray beam emitted by the x-ray machine; andat least one spherical member for facilitating assessment of attributes of panoramic x-ray images; anda body made of radiolucent material, the body configured to hold the plurality of radiopaque accessories at predetermined spaced apart locations which allow each of the plurality of radiopaque accessories to be exposed to the x-ray beam emitted by the x-ray machine without interference from any other of the plurality of radiopaque accessories.
2. The device of claim 1, wherein the body includes an upper portion and a lower portion releasably attached to the upper portion, the stepwedge being carried in the lower portion of the body.
3. The device of claim 2, wherein the lower portion is formed with a base, the base having a station formed therein configured to receive the stepwedge.
4. The device of claim 3, wherein the lower portion further includes:walls extending upwardly from the base;a cavity bounded by the lower portion walls; andthe station disposed in the base below the cavity.
5. The device of any one of claims 2 to 4 further comprising at least one block carried in the upper portion.
6. The device of claim 5, wherein the upper portion has a top, walls downwardly extending therefrom, and at least one upper portion aperture formed in a bottom surface of the upper portion walls sized to receive the at least one block.
7. The device of any one of claims 2 to 6 further comprising at least one spherical member carried in the lower portion.
8. The device of claim 7, wherein the lower portion includes at least one lower portion aperture formed in a top surface of the lower portion walls sized to receive the at least one spherical member.
9. The device of claim 8, wherein the upper portion includes at least one upper portion projection extending downwardly configured to engage the at least one spherical member in the lower portion aperture.
10. The device of claim 9, wherein the at least one spherical member includes a first, second and third spherical members, the at least one lower body aperture includes a first, second and third lower body apertures, the at least one upper portion projection includes a first, second and third upper portion projections, wherein the first upper portion projection engaging the first sphericalmember within the first lower portion aperture, the second upper portion projection engaging the second spherical member within the second lower portion aperture, the third upper portion projection engaging the third spherical member within the third lower portion aperture.
11. The device of claim 10, wherein the first spherical member is disposed between, and forwardly of, the second and third spherical members.
12. The device of claim 11, wherein the lower portion includes at least one lower portion projection extending upwardly to engage the at least one block in the upper portion aperture.
13. The device of claim 12, wherein the at least one block includes a first, second, third and fourth block, the at least one upper body aperture includes a first, second, third and fourth upper body aperture, the at least one lower portion projection includes a first, second, third and fourth lower portion projections, wherein the first lower portion projection engaging the first block within the first upper portion aperture, the second lower portion projection engaging the second block within the second upper portion aperture, the third lower portion projection engaging the third block within the third upper portion aperture, and the fourth lower portion projection engaging the fourth block within the fourth upper portion aperture.
14. The device of claim 13, wherein the first and second block is disposed between, and forwardly of, the third and fourth block, the first and third block disposed between the first and second spherical members, the second and fourth block disposed between the first and third spherical members.
15. The device according to any one of claims 1 to 14, wherein the stepwedge includes at least three steps of varying height.
16. A testing assembly for use in performing quality assessments of x-ray images generated by an x-ray machine, the testing assembly comprising:a sensor holder configured to hold an x-ray sensor; anda device releasably mounted on the sensor holder in a predetermined orientation relative to the x-ray sensor, the device including a radiopaque stepwedge for facilitating an assessment of attributes of intraoral x-ray images and a body made of radiolucent material; the body configured to hold the radiopaque stepwedge.
17. A testing assembly for use in performing quality assessments of x-ray images generated by an x-ray machine, the testing assembly comprising:a device including:a plurality radiopaque accessories including at least one of:at least one block for facilitating an assessment of the strength of an x-ray beam emitted by the x-ray machine; andat least one spherical member for facilitating assessment of attributes of panoramic x-ray images; anda body made of radiolucent material, the body configured to hold the plurality of radiopaque accessories at predetermined spaced apart locations which allow each of the plurality of radiopaque accessories to be exposed to the x-ray beam emitted from the x-ray machine without interference from any other of the plurality of radiopaque accessories; andan arm adapter configured to attach the device to the x-ray machine in a predetermined position and orientation.
18. A testing kit for use in performing quality assessments of x-ray images generated by an x-ray machine, the testing assembly comprising:a sensor holder being configured to hold an x-ray sensor;a device releasably mountable on the sensor holder in a predetermined orientation relative to the x-ray sensor, the device including:a plurality of radiopaque accessories including:a step wedge; andat least one of:at least one block for facilitating an assessment of the strength of an x-ray beam emitted by the x-ray machine; andat least one spherical member for facilitating assessment of attributes of panoramic x-ray images; anda body made of radiolucent material, the body configured to hold the plurality of radiopaque accessories at predetermined spaced apart locations which allow each of the plurality of radiopaque accessories to be exposed to the x-ray beam emitted from the x-ray machine without interference from any other of the plurality of radiopaque accessories;an arm adapter configured to attach the device to the x-ray machine in a predetermined position and orientation.
19. A system for performing quality assessments of x-ray images generated by an x-ray machine, the system comprising:a communication interface;a memory;a processor in communications with the communication interface and the memory, the processor configured to:receive an x-ray image of a device comprising a body made of radiolucent material, the body configured to hold at least one radiopaque accessory;analyze the x-ray image using an image analysis module;generate a quality assessment score of the x-ray image based on the results of the analysis from the image analysis module.
20. A method of performing quality assessments of x-ray images generated by an x-ray machine, the method comprising:receiving an x-ray image of a device comprising a body made of radiolucent material, the body configured to hold at least one radiopaque accessory;analyzing the x-ray image using an image analysis module;generating a quality assessment score of the x-ray image based on the results of the analysis from the image analysis module.