HK40013310A - Systems and methods for evaluation of scoliosis and kyphosis - Google Patents

Description

System and method for assessing scoliosis and kyphosis

Cross Reference to Related Applications

This application claims priority from co-pending U.S. provisional application serial No. 62/404578 filed on 5/10/2016 and 62/514599 filed on 2/6/2017.

Technical Field

The field of the invention is diagnostic devices and methods for orthopedic surgery, particularly for conditions associated with the spine.

Background

The background description includes information that may be useful in understanding the present invention. It is not an admission that any of the information provided herein is prior art or relevant to the presently claimed invention, or that any publication specifically or implicitly referenced is prior art.

Scoliosis is a deformity of the spine in which portions of the spine are displaced laterally. Similarly, kyphosis is a spinal deformity in which portions of the spine are displaced anteriorly and posteriorly to create a curved or "hunched" back. These deformities have a variety of causes and may occur at any stage of life. If such deformities are at risk or developing, surgical intervention may be used to arrest development and correct or reduce the deformities. Alternatively, brace treatments that attempt to reduce or prevent any additional development are typically used for patients with mild or moderate affected skeletal immaturity. In many cases, patients with mild symptoms can be simply monitored to see if any development has occurred.

Over the past decade, a number of new minimally invasive surgical interventions have been proposed that seek to stop the development of scoliosis and kyphosis without the need for spinal fusion. However, such early surgical intervention is only reasonable if significant curve development is expected. An important variable in incremental therapy to control this condition is the accurate history of progression of the spinal curvature. Thus, early detection methods for identifying scoliosis curves and kyphosis can greatly aid clinical prognosis, and thus improve treatment pathways. Given that early detection at milder stages has been treated with less invasive treatment methods, such early detection methods would be particularly helpful in reducing the number of patients presenting to health professionals for the first time with a large degree of curvature that requires more aggressive treatment.

Typically, scoliosis-induced spinal curvature is measured using a scoliometer (scoliometer), which is a specialized goniometer configured for this purpose. The measurement device spans the spine and is used by placing it on the spine of an individual who is bent forward at a 90 ° angle. The device provides an indication of the degree of left to right tilt as it moves along the spine, which in turn provides a measure of the deformity. Proper use of such devices requires a significant amount of training because the patient must be positioned correctly and the device remains upright throughout the measurement. Furthermore, the results must be read and entered manually. Thus, reproducibility and accurate tracking of patients over time are challenging.

Attempts have been made to automate at least part of this process. In some cases, mobile devices (such as smartphones) have been used because these devices typically include accelerometers that can provide accurate tilt or slope measurements and allow them to act as inclinometers. For example, U.S. patent No. 9157738 to Labelle et al discusses a device that supports a smartphone and has a "cutout" in its lower edge that accommodates the normal dorsal prominence of the vertebrae. All publications herein are incorporated by reference to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference. Where a definition or use of a term in an incorporated reference is inconsistent or contrary to the definition of that term provided herein, the definition of that term provided herein applies and the definition of that term in the reference does not apply. The smartphone's inclinometer provides a digital reading of the smartphone's left and right inclination as the device is moved along the patient's spine. International patent application No. WO2013/126352 to Franko and Lev describes a very similar device that is used in conjunction with an application running on a smartphone during patient evaluation and provides a display that mimics the appearance of a traditional scoliometer. However, neither of these devices includes provisions to ensure their proper use. Therefore, they can be improved only slightly over conventional instruments at best. Furthermore, none of these devices can be used to characterize kyphosis.

Accordingly, there remains a need for a device that can provide simple, accurate and reproducible measurements of scoliosis and/or kyphosis.

Disclosure of Invention

The following description includes information that may be useful in understanding the present invention. It is not an admission that any of the information provided herein is prior art or relevant to the presently claimed invention, or that any publication specifically or implicitly referenced is prior art.

The present subject matter provides devices, systems, and methods in which a mobile device (e.g., a smartphone equipped with an accelerometer) containing an inclinometer is held within a support structure that makes it useful for characterizing spinal deformities such as scoliosis and/or kyphosis. Such a support structure may include features (e.g., chamfered surfaces, high friction surfaces, pliable protrusions, straps, hook and loop housings, tensioning devices, detents, etc.) that secure the mobile device in the upper and lower portions, where the lower portion includes at least one but preferably two or more rollers or wheels and an interposed centrally placed cut-out or notch sized to allow the assembled device to span a typical spine. Such rollers or wheels may include encoders (e.g., optical, mechanical, and/or magnetic encoders) that provide data related to their rotation, thereby providing a measure of the distance traveled while the device is rolling. Such support devices may include additional features such as additional sensors accessible by the mobile device, centrally placed guides (such as projected LED lasers, illuminating filaments, flexible bristles, etc.) that may be used to keep the assembly device aligned during use, and supplemental battery power for the mobile device.

In use, the assembled device is placed over the subject's spine, the notch is rolled over the dorsal spinal protrusion and along all or part of the length of the spine, and the accelerometer (e.g., 3-axis, 6-axis, 9-axis, etc.) or other sensor (e.g., inclinometer, goniometer, etc.) of the mobile device provides data related to its deviation from a selected reference plane during the procedure. Measurements may be obtained from a subject in either or both of upright and forward flexion (e.g., 90 °, 45 °, etc.) positions, and measurements may also be obtained during transitions between these positions. Scoliosis may be determined by a substantial (e.g., >10 °) deviation from the horizontal as measured by bending the subject forward at an angle of approximately 90 ° from the waist. Kyphosis may be determined by a substantial (e.g., >30 °) deviation in the expected angle relative to the vertical plane and/or an abnormally abrupt change in the expected angle relative to the vertical plane during standing or the transition between the standing position and the forward curved position.

The mobile device may include a program or application (e.g., an app) that records data from accelerometers and/or other sensors provided by the mobile device or incorporated into the support structure. Such programs or applications may display such data for manual recording or, in a preferred embodiment, provide such data to a database. In some embodiments, the programs or functions may include logic functions that process data to provide a preliminary diagnosis and/or to referral a subject to a medical professional for treatment. It should be appreciated that such processing occurs locally to the mobile device (e.g., using the mobile device CPU, memory, etc.). Alternatively, such logical functions may be performed using a separate and distinct CPU in communication with the database, such as a cloud-based server, laptop, tablet, and so forth. In some embodiments, a program or application of the mobile device may provide additional features, such as displaying information that provides instructions regarding the use of the assembled device and/or provides feedback to the user regarding the proper use of the assembled device.

Various objects, features, aspects and advantages of the present subject matter will become more apparent from the following detailed description of preferred embodiments and the accompanying drawings in which like numerals represent like parts throughout the drawings.

It should be noted that any language referring to a computer should be interpreted to include any suitable combination of computing devices, including servers, interfaces, systems, databases, proxies, peer nodes, engines, controllers, or other types of computing devices operating alone or in combination. It should be understood that the computing device includes a processor configured to execute software instructions stored on a tangible, non-transitory computer readable storage medium (e.g., hard disk drive, solid state drive, RAM, flash memory, ROM, etc.). The software instructions preferably configure the computing device to provide roles, responsibilities, or other functions, as discussed below with respect to the disclosed devices. In a particularly preferred embodiment, the various servers, systems, databases or interfaces exchange data using standardized protocols or algorithms, which may be based on HTTP (hypertext transfer protocol), HTTPs (hypertext transfer protocol secure), AES (advanced encryption standard), public-private key exchanges, web services APIs (application program interface), known financial transaction protocols, or other electronic information exchange methods. Preferably, the data exchange takes place via a packet-switched network, the internet, a LAN (local area network), a WAN (wide area network), a VPN (virtual private network) or other type of packet-switched network.

It will be appreciated that the disclosed techniques provide a number of advantageous technical effects, including providing an inexpensive yet accurate and reproducible method for early determination of spinal deformities. This in turn allows for early and less invasive treatment of this condition. It should also be appreciated that the low cost and portability of such testing devices allows for widespread adoption and support in the development of telemedicine applications.

The following discussion provides a number of example embodiments of the present subject matter. While each embodiment represents a single combination of inventive elements, the inventive subject matter is considered to include all possible combinations of the disclosed elements. Thus, if one embodiment includes elements A, B and C, and a second embodiment includes elements B and D, then the subject matter of the present invention is considered to include A, B, C or the other remaining combinations of D, even if not explicitly disclosed.

Drawings

Fig. 1A-1D depict front, top, side, and top-front-side perspective views, respectively, of an embodiment of a testing device of the present subject matter.

Fig. 2A-2D depict front, top, side, and top front-side perspective views, respectively, of another embodiment of a testing device of the present subject matter.

Fig. 3A-3E depict a top perspective view, a front perspective view, a side perspective view, a top front side perspective view, and a bottom perspective view, respectively, of yet another embodiment of a testing device of the present subject matter.

FIG. 4 depicts a top front perspective view of yet another embodiment of a testing device of the inventive subject matter.

FIG. 5 depicts a top front side perspective view of another embodiment of a testing device of the present subject matter.

FIG. 6 depicts the application of the test device of the present subject matter to a simulated spine.

FIG. 7 depicts a graphical user interface of a test device of the inventive subject matter in one state.

FIG. 8 depicts a graphical user interface of a test device of the inventive subject matter in another state.

FIG. 9 depicts a flow diagram of a mobile device application of the present subject matter.

FIG. 10 depicts a flow chart of a parsing algorithm of the inventive subject matter.

Fig. 11A-11E depict a top perspective view, a front perspective view, a side perspective view, and a top front side perspective view, respectively, of yet another embodiment of a testing device of the present subject matter.

Fig. 12A-12C depict a side perspective view, a rear perspective view, and a side perspective view, respectively, of a patient applying the testing device of the present subject matter to a 90 ° bend position.

Fig. 12D-12E depict exemplary graphs of lateral tilt and distance traveled data and forward tilt and distance traveled data, respectively, collected by applying the test apparatus of the present subject matter to a patient in a 90 ° flexion position.

Fig. 12F-12I depict exemplary three-dimensional, two-dimensional top view, two-dimensional side view, and two-dimensional hip view models, respectively, of a patient's spine at a 90 ° flexion position generated using data collected by a testing device of the inventive subject matter.

Fig. 13A-13B depict side and close-up views, respectively, of a test device of the present subject matter as applied to a patient in a standing position.

Fig. 13C-13D depict exemplary graphs of lateral tilt and distance traveled data and forward tilt and distance traveled data, respectively, collected by applying the test device of the present subject matter to a patient in a standing position.

Fig. 13E-13H depict exemplary three-dimensional, two-dimensional top view, two-dimensional side view, and two-dimensional hip view models, respectively, of a patient's spine in a standing position generated using data collected by a testing device of the present subject matter.

14A-14B depict an example prior art method for determining the Cobb angle.

15A-15B depict a method and results, respectively, for calculating the Kebby angle implemented by the present subject matter.

Fig. 16A-16B depict the side profile of a normal spine and a posterior ridge post.

FIG. 16C depicts an exemplary graph of the ratio of forward inclination angle to percent spine generated using data collected by the testing device of the inventive subject matter.

17A-17C depict example screenshots of a pre-scan state, a scan state, and a post-scan state, respectively, of a mobile device application of the present subject matter.

FIG. 18 depicts another flow diagram of a mobile device application of the present subject matter.

Detailed Description

The present subject matter contemplates devices, systems, and methods for assessing a spinal deformity condition. In some embodiments, a support structure for a spinal deformity testing device includes an upper portion for securing a computing device (e.g., a smartphone, a tablet, a smartwatch, etc.), a lower portion having first and second sides opposite one another, and a lower surface coupled to the first and second sides. One or more rollers (preferably four) are rotatably coupled to the lower surface, with at least a first roller positioned at or near the first side and the recess interposed between the first side and the second side. At least the first roller has an encoder which preferably provides data relating to the distance moved, direction, rolling path, speed, acceleration, relative height or relative rotation (e.g. pivoting) of the test device when in use.

In embodiments having more than one roller, it is preferred that the rollers are evenly spaced and positioned between the first and second sides (e.g., two rollers toward the first side and two rollers toward the second side; one roller toward the first side and one roller toward the second side; and so on). For a multi-roller embodiment, it is contemplated that each roller has a fixed position on the support structure, and the relative position (e.g., distance, angle, height, etc.) of each roller to the other rollers is known and recorded in the computer memory of the support structure or in an attached computing device (e.g., smartphone). In a multi-roller embodiment with articulated rollers (e.g., casters, etc.), calibration of the relative distance, angle, or height with respect to each other wheel is contemplated prior to use of the test apparatus.

Preferred rollers include wheels (thin, thick, treaded, smooth, etc.), but other rolling means (e.g., balls, bearings, rollers, combinations thereof, etc.) are also contemplated. It should be appreciated that the type of roller arrangement employed may provide additional benefits. For example, where a minimum device footprint (footprint) or contact between the device and a subject (e.g., a patient) is desired, thin wheels without a tread pattern (e.g., smooth) may be used. When more contact with the subject is desired, a wider wheel or roller may be used, for example, where the roller includes a massaging texture (e.g., tread pattern, bumps, ridges, other patterns, etc.) that relaxes the muscles around the spine of the patient when the test device is used, advantageously making the spine reading more accurate or making the subject more relaxed, soft. Similarly, it should be understood that the rollers incorporate heating or cooling elements to further relax or soothe the subject. Such soothing/relaxing features may be helpful when applying the test device to an irritable or stressful patient (e.g., elderly, children, etc.) or applying the device to livestock or wildlife (e.g., equine (horses, etc.), porcine (pigs, etc.), bovine (cows, etc.), cat, dog, etc.). In the case of ball-in-sockets, it will be appreciated that the ball is capable of multi-directional rolling and thus provides a greater range of motion and increased maneuverability for devices containing the ball.

It is contemplated that sensors may be incorporated into the test apparatus and methods of the present subject matter. For example, sensors (e.g., accelerometers, gyroscopes, magnetometers, cameras, thermal sensors, infrared sensors, pressure sensors, photoelectric sensors, X-ray sensors, acoustic sensors, inclinometers, goniometers, scoliometer, etc.) may be incorporated into the support structure described above, may be part of a computing device (e.g., a smartphone, etc.), or may be added (e.g., physically coupled, communicatively coupled, etc.) to the support structure or computing device (e.g., via a USB port, bluetooth, etc.). For embodiments of the present subject matter designed to use a sensor-rich smartphone, fewer sensors are required in the support structure, thus reducing maintenance and cost of such support structures.

It is contemplated that the support structure and computing device of the inventive subject matter are communicatively coupled (e.g., a communication link). For example, a smartphone may have a wired communication link (e.g., a USB cable, etc.), a wireless communication link (e.g., a wireless protocol, a Wi-Fi transmitter, a Wi-Fi receiver, a bluetooth transmitter, a bluetooth receiver, a ZigBee transmitter, a near field receiver, a radio frequency transmitter, a radio frequency receiver, an infrared transmitter, an infrared receiver, etc.), or both, with the support structure.

The subject matter of the present invention further includes methods for characterizing the condition of a spinal deformity in a subject (e.g., a human, an animal, a model, a mechanical device, etc.). When the subject is in a first position (e.g., prone, standing, bent 90 °, tensed, relaxed, etc.), the test device as described above is placed in a first starting position along the subject's spine (e.g., near the gluteal sulcus) such that the notch of the test device is centered on the spine. The test device is then moved (e.g., pushed, rolled, etc.) along the spine on the first roller. While moving the testing device along the spine, a first data set is collected, which is related to: a distance traveled by an encoder associated with the first roller, and at least one of (1) data relating to a first lateral tilt of the testing device (or spine) or (2) data relating to a first forward tilt of the testing device (or spine) (preferably both). When the subject is in a second position (e.g., prone, standing, bent 90 °, tensed, relaxed, etc.) different from the first position, the test device is placed in a second starting position along the subject's spine (e.g., near the gluteal sulcus) such that the notch of the test device is centered on the spine. The test device is then moved (e.g., pushed, rolled, etc.) along the spine on the first roller. While moving the testing device along the spine, a second data set is collected, the second data set being related to: a distance traveled by an encoder of the first roller, and at least one of (1) data relating to a second lateral tilt of the testing device (or spine) or (2) data relating to a second forward tilt of the testing device (or spine) (preferably both).

While the first and second sets of data collected include data relating to the first and second distances traveled by the encoder, it should be understood that additional data may be collected. For example, it is contemplated that movement (e.g., direction, velocity, acceleration, height) of the device is collected by encoders associated with the rollers of the device. From another perspective, the device tracks its movement path along the spine of the patient so that the subject's spine is mapped in three dimensions and can be rendered in various 3D models.

First and second data sets (e.g., data relating to first and second distances traveled and at least a portion (preferably all) of (1) the first and second lateral tilts or (2) at least one (preferably both) of the first and second forward tilts, other combinations, etc.) are provided to a database. At least some (preferably all) of the data so provided (e.g., first or second lateral tilt, first or second forward tilt, combinations thereof, etc.) is compared to the first stored value to determine the condition of the spinal deformity. Generating a report relating to a spinal deformity condition, wherein the condition is one of: (1) the presence of a scoliotic deformity, (2) the presence of a kyphosis deformity, or (3) the subject is not present with a scoliotic or kyphosis deformity. It is contemplated that a scoliotic deformity is determined to be present when either (preferably both) of the first or second lateral inclinations exceeds a threshold (e.g., 5 °, 7 °, 8 °, 9 °, 10 °, 11 °, 12 °, 13 °, 14 °, 15 °, 20 °, 25 °, 30 °), with the threshold preferably being 10 °. In some embodiments, the lateral tilt (e.g., third, fourth, fifth lateral tilt, etc.) of the subject's spine is again measured, and a scoliotic deformity is determined when an average of the measured lateral tilts (e.g., first, second, third, fourth, fifth lateral tilt, etc.) exceeds a threshold. It is contemplated that the lateral tilt of the subject's spine may be measured periodically (3 times per day, 2 times per day, 1 time per day, 4 times per week, 3 times per week, 2 times per week, 1 time per week, 4 times per month, 3 times per month, 2 times per month, 1 time per month, etc.). In such embodiments, it is contemplated that the data analyzed may be limited to analyzing the most recent measurements/readings (e.g., the previous week, the previous 3 days, the previous 2 days, the last 5 readings, the last 4 readings, the last 3 readings, the last 2 readings, etc.), or that a weight is applied to at least some measurements/readings (e.g., a higher weight is applied for the last 3 readings, the last 2 readings, the last reading, a lower weight is applied for the earliest 5 readings, the earliest 3 readings, and the earliest reading, etc.).

In a similar manner, the presence of a kyphosis deformity is determined when either (preferably both) of the first or second forward inclinations exceeds a threshold (e.g., 20 °, 25 °, 27 °, 28 °, 29 °, 30 °, 31 °, 32 °, 33 °, 34 °, 35 °, 40 °, 45 °, 50 °), wherein the threshold is preferably 30 °. It is contemplated that the forward tilt of the spine may be further measured, the measurements/readings may be averaged, or the measurements/readings may be weighted as described above. In a preferred embodiment, the mobile device (or cloud server) constructs a (e.g. digital) model of the subject's spine using at least some (preferably all) of the lateral tilt measurements and the forward tilt measurements. In a preferred embodiment, a digital image of the subject's back (e.g., a back view) is acquired and used, in part, to determine the condition of the spinal deformity or to construct a spinal model.

In some embodiments, when the report indicates a scoliotic or kyphotic deformity, the test device instructs the subject to seek medical care. The device may also send a report to a medical professional. The report generated by the device may further include or depend on a relationship between the first travel distance and at least one of (preferably both) the first lateral tilt or the first forward tilt. Further, the report may include or depend on a relationship between the second travel distance and at least one (preferably both) of the second lateral tilt or the second forward tilt. In a preferred embodiment, the report contains all or at least some of the data sets collected by the device for a particular subject over a particular time period.

One embodiment of the inventive concept is shown in fig. 1A-1D as apparatus 100. In such embodiments, the upper portion 112 of the support structure 110 includes a tensioning arm 113, the tensioning arm 113 allowing the support structure to adjustably secure mobile devices (here, mobile device 120) of different sizes and configurations. A high friction material (in the form of a flexible plastic foam, rubber, etc.) may also be provided to further secure the mobile device 120. As shown, the lower portion 114 of the support structure includes two rollers, wheels 115 and 116, one of which is located near each lower corner of the lower portion 114.

Such rollers may include encoding features (such as optical, mechanical, and/or magnetic encoders, not shown) that provide quantitative information about the rotation of the wheel or roller, thereby providing a measure of the distance traveled by the apparatus 100. This in turn provides the clinician with a location of the deformity along the spine. Such an encoder may also provide information relating to the speed and/or acceleration of the assembly device when in use. Such data may be used to monitor the use of the device 100 and ensure that it is being used correctly (e.g., by providing an alarm or other warning when the velocity and/or acceleration falls outside predetermined limits). A notch 117 is centrally disposed along the lower portion 114 between the wheels 115 and 116, and is shaped to allow easy passage through a typical spinal protrusion (spine protocol) during use. The notch 117 has an arcuate shape, and it is contemplated that such notches typically have a height of about 0.5cm to about 2.5 cm. The device 100 also has a guide feature 118 centrally disposed directly above the notch 117. The guide features 118 may be considered to be convex arrow shapes, but may also or alternatively comprise laser diodes or similar devices (e.g., devices that provide orientation and/or guide optical or visual effects) that project a beam of light downward toward the spine during use and aid in the positioning of the device 100.

It should be appreciated that providing positional information associated with lateral and/or forward tilting in the apparatus and methods of the present inventive concept provides substantial benefits not realized in the prior art. For example, the correlation of the distance traveled along the spine to the degree of lateral and/or anterior tilt may provide the clinician with information relating to the location of the spinal deformity and supplement conventional photographic and radiographic information. Additionally, velocity and/or acceleration data collected during use may be used to verify proper use of the assembly equipment and ensure integrity of the collected data. For example, speed data indicating that the assembly device is moving too fast along the spine (e.g., when data related to the rate of roller or wheel rotation exceeds a predetermined value) may trigger an alarm or warning to the user (e.g., prompting repeated measurements). Alternatively, software running on the mobile device may refuse to enter data from the assembly device until it is used correctly. To assist in this, such software may display a speed indication when the assembly device is in use.

As described above, the lower portion 114 of the support structure 110 may include additional sensors, circuitry, and/or batteries. Suitable additional sensors include high resolution accelerometers, temperature sensors, infrared sensors, pressure sensors, and/or cameras. Such sensors may be used to replace, supplement, and/or calibrate sensors provided on the mobile device 120. For example, an accelerometer on the lower portion 114 of the support structure 110 may be used to verify or correct (e.g., by calibration) the accelerometer of the mobile device 120. This advantageously allows for the use of a variety of mobile devices from different manufacturers that may utilize accelerometers and/or other sensors with different ranges and/or sensitivities.

Alternatively or in combination, the sensors of the support structure 110 may be used to verify data collected by the sensors of the mobile device 120. As shown, the support structure 110 may also include a cable 130 to interface with data and/or power ports of the mobile device 120. However, it should be understood that other mechanisms (e.g., WiFi, bluetooth, near field transmission) may be used to transmit data between the support structure 110 and the mobile device 120. Fig. 1D provides an orthogonal view of the device 100, and additionally shows a button 140, the button 140 providing a visual indication of the power state of the device 100. Such buttons may also provide control functions for device 100. For example, the button 140 may be pressed at the beginning of a diagnostic procedure to notify the apparatus 100 to start collecting data, and pressed again at the end of the diagnostic procedure to notify the apparatus 100 to stop data collection.

Both fig. 1A and 1D depict embodiments of a display screen 150 provided by a program or application (here SpineScan3D) via a mobile device 120 when in use. As shown, both the graphical and numerical displays provide information relating to the degree of lateral tilt experienced by the assembly device. Information relating to the distance traveled by the device may also be displayed. The program or application may also provide feedback to the user indicating that the display feature form of the assembled device has a pair of concentric circles in a fixed position and a dynamically updated icon (e.g., a color-coded solid circle) to provide an indication of correct or incorrect use. For example, the location of such an icon within the indicated range of acceptable locations may indicate proper use. This can be supplemented by color coding, for example, showing green for proper use. Deviation from the correct orientation of the device 100 may be indicated by moving such an icon outside the indicated acceptable range, which may be supplemented by changing color (e.g., from green to red). In some embodiments, this may be further supplemented by an audible alarm or warning.

In another embodiment shown in fig. 2A-2D, the apparatus 200 shares most of the elements of the apparatus 100, but differs in that the apparatus 200 comprises four rollers, namely wheels 215a, 215b, 216a and 216b, arranged as pairs of rollers located at or near each lower corner of the lower part of the support structure. In such embodiments, one or both of each pair of wheels (e.g., 215a-215b and 216a-216c) may include an encoding feature (such as a mechanical, optical, and/or magnetic encoder) that provides a measurement of the distance that the device has traveled during use. Further, for embodiments such as device 200 having more than two rollers, it is contemplated that the relative distance (e.g., the wheel track) of each roller with respect to each other is known and recorded in a computer memory (e.g., RAM) of the support structure, in the mobile device, or in a database accessed by an application on the mobile device.

Although the embodiments shown in fig. 1A-1D and 2A-2D depict the mobile device being fixed in a position substantially perpendicular to a plane defined by the wheels or rollers of the support structure, it should be understood that in some embodiments, the mobile device may be fixed in a plane substantially parallel to the plane of the wheels or rollers. This orientation is useful for characterizing the shape of the spine when the individual being tested is standing in an upright position or transitioning between an upright position and a forward leaning position. In some embodiments, this may be achieved by incorporating a joint or hinge at the junction of the lower and upper portions of the support structure. Such a joint or hinge mechanism may include one or more stops that fix the mobile device at a desired angle relative to the roller or wheel. In a preferred embodiment, the moving device may be fixed at an angle such that it is parallel or nearly parallel to the plane defined by the rollers or wheels. In other embodiments, the upper portion of the support structure is arranged such that the mobile device remains in this position. Such an embodiment is depicted in fig. 3A-3D, where the device 300 has primarily the elements as described in fig. 1A-1D and fig. 2A-2D.

Fig. 3E further depicts a bottom view of the apparatus 300. In this view, LED laser 319 can be seen along bottom surface 310, in line with guide feature 318 (as described for guide feature 118 in fig. 1A-1D). Further, a printed circuit board 320 is depicted that provides additional circuitry and sensors (e.g., accelerometers, gyroscopes, magnetometers, cameras, thermal sensors, infrared sensors, pressure sensors, photoelectric sensors, X-ray sensors, acoustic sensors, inclinometers, goniometers, scoliometers, etc.) for the support structure as described above.

Fig. 4 depicts a device 400, most of which shares elements of device 100 in fig. 1A-1D. The apparatus 400 differs from the apparatus 100 at least in that the apparatus 400 does not include a guide feature (118 in fig. 1A-1D) and does not include an upper portion (112) or tensioning arm (113) as shown in fig. 1A-1D. Instead, the device 400 includes cradle portions 401a-401b (401 b not shown) and 402a-402b that are positioned opposite each other and on the other side of the mobile device 120. Accordingly, the bracket portions 401a-401b and 402a-402b serve to secure the mobile device 120 in place with the device 400 (e.g., removably couple the device 400).

Similarly, fig. 5 depicts a device 400, most of which shares elements of device 200 in fig. 2A-2D. The apparatus 500 differs from the apparatus 200 at least in that the apparatus 500 does not include a guide feature and does not include an upper or tensioning arm. Instead, the device 500 includes cradle portions 501a-501b (501 b not shown) and 502a-502b that are positioned opposite each other and on the other side of the mobile device 120. Accordingly, the cradle portions 501a-501b and 502a-502b serve to secure the mobile device 120 in place with the device 500 (e.g., removably couple the device 500).

Fig. 6 depicts an example of a test apparatus 600 (i.e., a support structure and a mobile device) as described above with respect to fig. 3A-3E (and with reference to fig. 1A-1D and 2A-2D). Here, the testing device 600 is superimposed on an exemplary spine 610 of the subject being tested. As shown, light beam 620 is used to help the user keep the device centered on spine 610 as the device moves. Spinal deformities that cause the spine to twist cause the device 600 to pivot as it moves, resulting in lateral tilt being detected by the testing device 600.

Fig. 7 and 8 depict examples of displays 700a-700b and 800a-800b provided by the SpineScan3D software during use. Fig. 7 depicts an example of a display screen provided during proper use of the device when the subject is standing and when the subject is leaning forward at an angle of approximately 90 °. As shown, the display provides information relating to the lateral tilt angle (710a-710b) of the test device, and may also provide information relating to the distance (720a-720b) the test device has been used, the degree of forward tilt (730a-730b) of the test device, a graphical depiction (740a-740b) of the trajectory followed by the test device, and a prompt (750a-750b) to the user. One of these cues is an indicator (760a-760b) that the test equipment is being located and properly used. This is in the form of a set of concentric circles and a dynamically updated icon. In FIG. 7, proper use is indicated by both the location of the icon (762a-762b) (e.g., within the "target" smaller circle (764a-764 b)) and the indication color (green). Such a display screen may also provide additional cues, such as providing a user with an indication of proper use (in this example, "holding steady movement") and a graphical depiction of the proper orientation of the subject during the testing process (e.g., distinguishing between a standing position and a bent position). FIG. 9 depicts such displays 800a-800b when a test is performed incorrectly. In this example, the display provides a warning in the form of an icon (862a-862b) and warning color (red) (860a-860b) that is located outside the target range (i.e., a smaller circle (864a-864 b)). In addition, the prompt provides guidance to the user for correcting the question (850a-850 b).

As described above, embodiments of the inventive concept may include software (such as a program or application) configured to run on a mobile device and to assist a user in performing tests and/or recording results. An example of a flow chart for such software is shown in fig. 9. As shown, after the software is installed on the mobile device, launching such an application may first provide a disclaimer regarding the use of the testing device and interpretation of the results, as well as providing an opportunity to enter information identifying the user and/or the test subject. Such software may also allow for the entry of subject specific data such as age, gender, height, weight, BMI, race or nationality, known medical conditions, family history, medications being taken, current physician and/or insurance information. Such software may also provide a instructional video (or provide a link thereto) showing the proper use of the device. In some embodiments, the software may provide verification of the user side that such an indication has been viewed and understood. The test may be performed on a subject in a forward flexion position (i.e., about 90 °), an upright position, both positions, and/or a transition between these positions. In the example shown, the test is first performed in the forward bend position. The assembled test device was placed near the natal cleft with the notch of the device centered over the spine. The test was started by pressing "start" and moving along the spine towards the neck while keeping the guide feature centered over the spine, and stopped by pressing "stop". During use, a green indicator on the display screen indicates that the test should continue, while a red indicator on the display screen indicates that at least a portion of the test needs to be repeated.

Upon completion of the first part of the test, the subject is instructed to take the next test position (standing in this example) and the process is repeated. In a preferred embodiment, when testing a subject in a standing position, the device is placed at the base of the subject's neck (e.g., T1 for the thoracic vertebra, etc.) and moved down the subject's spine toward the gluteal sulcus (e.g., see fig. 13A). It should also be understood that testing of a subject in a 90 ° bend, standing position, or any angle therebetween may begin by placing the device at the base of the subject's neck (e.g., T1 for the thoracic vertebra, etc.) and moving along the spine toward the gluteal sulcus, or by placing the device near the gluteal sulcus and moving along the spine toward the subject's neck. When the test at the last position is complete, the camera of the mobile device (or alternatively, the camera of the support structure) may be used to take a digital image of the subject's back while the subject is standing. In some embodiments of the inventive concept, a pair of cameras (e.g., a pair of cameras provided on a mobile device or a combination of a camera of a mobile device and a camera of a support structure) may be used to generate a three-dimensional image of the back of a subject. The image may be viewed manually or using image recognition software to provide additional data about the condition of the subject. Data collected during the testing process may be stored in a local database or transmitted to an offsite database and analysis (described below) performed to determine if the results are normal or require further evaluation. In the event of an outcome abnormality, the testing device may display a prompt indicating a need to visit a medical professional (e.g., an orthopedic specialist).

As described above, embodiments of the present inventive concept may include software that applies logic to the acquired data as shown in fig. 9 above to determine whether the subject has a significant spinal deformity. An example flow chart of such a process is shown in fig. 10. As shown, after the analysis is started, the results are initially queried for the presence of incorrect positioning of the subject (e.g., greater than 30 ° from the desired 90 ° deviation in the forward flexion position). Determining that the test location is incorrect may result in rejection of the result and prompt for repeat testing. Kyphosis can be determined by data relating to forward tilt (i.e., tilt in the coronal plane) exceeding a predetermined amount (e.g., 30 °) or exhibiting a sudden change (e.g., a sudden change greater than 10 °). The tilt between the left and right wheels of the test device (i.e., lateral tilt) may be used to make scoliosis-related determinations. To verify that the data is accurate and/or authentic, a measure of data consistency may be made, with inconsistencies in excess of a certain amount (e.g., 10%) being used to reject the data. For example, data relating to lateral tilt and/or forward tilt showing a rapid change (e.g., exceeding a predetermined limit of angular change over a given distance) may trigger a prompt to a user of the assembled device for repeated measurements. Alternatively, the difference in distance traveled between the left and right rollers/wheels may be correlated to a change in lateral tilt to verify that the measured lateral tilt is due to spinal curvature (rather than to improper operation of the instrument). The data determined to be consistent may be used for diagnostic purposes. This consistent data can be assessed by comparing the measured lateral tilt to current clinical guidelines (clinical guidelines). For example, a lateral tilt of more than 10 ° may be considered an indication of scoliosis. In some embodiments, the degree of lateral tilt may be used to score the degree of scoliosis and/or the severity of the deformity. In other embodiments, as these clinical guidelines evolve, the clinical guidelines used in such determinations may be dynamically updated in the test software. The test performed in the prone position may be repeated and similarly evaluated in the standing position, and such a test may be performed by acquiring one or more digital images of the subject's spine (which may be assessed by a clinician). These images can be used to derive a correlation between measurements made by the test device and the clinical performance of the test subject. If evidence of scoliosis and/or kyphosis is found, the test software logic may further generate prompts suggesting referrals to appropriate experts. In a preferred embodiment of the inventive concept, such data is stored in a database and/or transmitted to a database. Such accumulated data may be used to modify and further improve the performance of the diagnostic algorithm, for example, by correlation with clinical assessments and/or clinical outcomes of medical professionals.

An additional example flow chart for such a process is depicted in fig. 18. It can be seen that the patient began screening in a 90 forward bend or standing position. The device of the present subject matter is used to measure and collect tilt angles and rotation rates from sensors on the device and data from encoders on the device. The collected data is verified, such as by passing the data through an error filter (e.g., inconsistent with previous results, physically impossible to read, etc.), and the user is provided with the option to save the collected data and proceed to a results page. The severity of scoliosis or kyphosis can be classified by the measured lateral tilt angle or anterior tilt angle, depending on the threshold set in the mobile application. For example, for scoliosis, a lateral inclination angle of 0 ° to 5 ° may be set to a normal range, 5 ° to 10 ° may be set to a middle range, and more than 10 ° may be set to a severe range, while for kyphosis, a forward inclination angle variation of 0 ° to 10 ° may be set to a normal range, 10 ° to 15 ° may be set to a middle range, and more than 15 ° may be set to a severe range. It should be understood that these ranges may be set by a user, or alternatively may be derived from statistical analysis of patient data (e.g., demographic data, data compiled by the apparatus of the inventive subject matter, data derived from clinical databases, data derived from predictive computer models, etc.). The collected data may be further analyzed to generate a 3D contour of the subject's spine to further visualize and examine the shape of the spine. This generation may be performed automatically by the mobile application of the inventive subject matter, or may be performed using a cloud-based server. If the 3D model or set tolerance indicates that the subject exhibits evidence of kyphosis or scoliosis, a report may be sent to the subject indicating a referral to a medical professional.

As shown in fig. 11A-11E, in some embodiments (e.g., a device 1100 having similar elements as described above with respect to fig. 1A-1D, 2A-2D, and 3A-3E), the testing device may include rollers 1110a-1110b and 1120a-1120b having tacky (tack) or adhesive (tack) surfaces that provide relatively strong but easily reversible contact with the skin surface during use. Such wheels may have the form of elongate cylinders, each cylinder extending along a main cylindrical axis about 25% or more beyond the length of the test apparatus. This extended contact area similarly improves contact with the skin surface during use, and may be adapted to take on the soothing features described above (e.g., texture, temperature, etc.). Similar to as described above, in a preferred embodiment, the distance between each wheel of the device (e.g., the distance between the closest edge, the farthest edge, the centroid, etc. of each wheel, e.g., between 1110a and 1110b, between 1110a and 1120a, between 1110a and 1120b, each combination of 1110a-1110b and 1120a-1120b, etc.) is known and recorded, for example, in a computer memory of device 1100, in a computer memory of mobile device 1130.

As shown in fig. 11A-11E, some embodiments (e.g., device 1100) may include handles 1140a-1140b (or more) positioned along an edge of the testing device. The handles 1140a-1140b may be configured to complement the shape of the grasping hand (e.g., by bowing) and/or include frictional surfaces to support simple and accurate placement during use.

The device 1100 further includes a printed circuit board 1150 that includes such circuitry: the circuitry needs to communicate with and record data from encoders (not shown) in the wheels 1110a-1110b and 1120a-1120b, and forward such data to the mobile device 1130 (e.g., memory, microcontroller unit, CPU, etc.). In a preferred embodiment, the Printed Circuit Board (PCB)1150 further includes a motion sensor (e.g., accelerometer, inclinometer, scoliometer, etc.), an LED (e.g., a guidance light to provide for application of the device to a patient), or a wireless communication transmitter or receiver (e.g., bluetooth, NFC, etc., to provide for communication with the mobile device 1130). Sensors (e.g., motion sensors, etc.) integrated in such PCBs can supplement or replace the functions of the motion sensors of the mobile phone 1130 used in the device 1100. Such sensors (e.g., motion sensors) may be used to standardize the performance of the device 1100 across different models of mobile devices, possibly using different kinds of internal hardware and software with different performance, in an effort to improve or ensure sufficient accuracy.

A test or scan of a subject may be performed on a subject in a forward bend position (i.e., about 90 °) (as shown in fig. 12A-12C), upright (as shown in fig. 13A-13B), two positions, and/or a transition between these positions (e.g., 15 ° bend, 30 ° bend, 45 ° bend, 60 ° bend, 75 ° bend, 105 ° bend, 120 ° bend, etc.). In the example shown in fig. 12A to 12C, the test was performed in the forward bending position. The assembled test device 1210 is placed near the gluteal sulcus (1230) of the subject, and the notch of the device is centered over the spine. The test is started by pressing "start" on the device 1210 and moving the device 1210 along the spine towards the neck (directional arrow 1240) while keeping the guide feature 1212 centered over the spine, and stopped by pressing "stop" on the device 1210.

During use of the device 1210, a green indicator on the display indicates that testing should continue, while a red indicator on the display indicates that at least a portion of the testing needs to be repeated. Upon completion of the first part of the test, the subject is instructed to take the next test position (in this example a standing position, e.g. fig. 13A-13B, with similarly numbered elements as described in fig. 12A-12C) and the process is repeated. When the test in the second position is complete, the camera of the mobile device (e.g., 1350 of fig. 13B) (or, alternatively, the camera of the support structure, e.g., 1360) may be used to take a digital image of the back of the subject while the subject is standing. In some embodiments of the inventive concept, a pair of cameras (e.g., a pair of cameras provided on a mobile device or a combination of a camera of a mobile device and a camera of a support structure) may be used to generate a three-dimensional image of the back of a subject. The image may be reviewed manually or using image recognition software to provide additional data regarding the condition of the subject. Data collected during the testing process may be stored in a local database or transmitted to an offsite database and analysis (described below) performed to determine if the results are normal or require further evaluation. In the event of an outcome abnormality, the testing device may display a prompt indicating a need to visit a medical professional (e.g., an orthopedic specialist).

Fig. 12D-12E depict graphs of lateral tilt versus travel distance and forward tilt versus travel distance, respectively, based on three sets of spinal scans (S1, S2, and S3) taken using the methods of fig. 12A-12C. It should be understood that clinical parameters, such as maximum vertebral body rotation (e.g., lateral, anterior, etc.), may be extracted from the measured and processed data. In a preferred embodiment, the tilt and forward angle are measured by accelerometers on the devices of the present subject matter (e.g., device 1210), while the spine position of each accelerometer reading is measured by the encoder(s) of these devices. The information gathered from these devices may include the test duration (e.g., 5.4s), spine length (e.g., 30cm), maximum inclination, and position (e.g., inclination 11.4 ° at 38% of the spine position). It should be understood that the distance traveled may be presented as an absolute distance measurement (e.g., 15cm) or a relative distance measurement (e.g., 15cm out of 30cm equals 50% position along the spine). Assuming that the lumbar region is 0% -33% of the spinal location, the lower thoracic region is 33% -66% of the spinal location, and the upper thoracic region is 66% -100%, the region maximum inclination can also be determined (e.g., maximum lumbar cone 10.9 °, lower thoracic 11.4 °, upper thoracic 5.5 °). The approximate region can be adjusted as needed to accommodate the particular size of various subjects. Similar plots of data collected by the method of fig. 13A-13B are depicted in fig. 13C-13D. It will be appreciated that such measurements cannot be obtained from a subject in a standing position by using prior art scoliometers.

Fig. 12F-12I illustrate how gyroscope data and/or angular velocity data collected during a similar scan using an assembled test device 1210, in combination with spine length and device position data, can be used to construct a three-dimensional profile (12F) of the subject's spine as well as various two-dimensional profiles (e.g., 12G top view, 12H side view, and 121 hip view). It will be appreciated that such a model can be formed when measuring axial rotation in three axes, and can be further refined by measuring axial rotation in six axes, nine axes, or even twelve axes, allowing for additional perspective views of the model. Similar plots of data collected by the method of fig. 13A-13B are depicted in fig. 13E-13H.

As mentioned above, the Cobb (Cobb) angle is a commonly used clinical parameter for diagnosing scoliosis and characterizing its development and/or response to treatment. In prior art practice, the map is determined from an X-ray image taken with the subject standing. A typical prior art method for determining the cobb angle is shown in fig. 14A-14B.

As shown in fig. 15A-15B, the cobb angle (θ + α) may be derived from Y-axis tilt and travel distance data (e.g., lateral tilt Φ at a first spine location and lateral tilt α at a second spine location), where the Y-axis tilt and travel distance data is acquired from the assembled test device when, for example, the subject is in a standing position.

Kyphosis, an exaggerated thoracic curve (also known as "bowager's hump"), comparing fig. 16A depicting the lateral profile of a normal spine with fig. 16B depicting the lateral profile of kyphosis, can also be characterized using the assembled test apparatus contemplated by the present invention. As shown in fig. 16C, the graphs of forward inclination angle and distance traveled obtained from both normal individuals and individuals with kyphosis show a clear difference. The presence and degree of kyphosis can also be derived from a three-dimensional depiction of the spine, derived from data provided by the assembled test device (examples shown in fig. 12F-12I and 13E-13H). It will be appreciated that kyphosis may occur in conjunction with scoliosis, and that characterization using the apparatus of the present inventive concept provides data that allows either or both conditions to be diagnosed from a single test procedure and without the use of X-rays.

As described above, embodiments of the inventive concept may include software (such as a program or application) configured to run on a mobile device and to assist a user in performing tests and/or recording results. In some embodiments, the software may provide a user interface that facilitates performing the assessment using the assembled test device. For example, such interfaces may provide virtual control of various device functions, result storage and access to stored results, modification of device settings, progress and/or status of checks performed by the device, and/or aggregation of scan results. It is contemplated that the mobile application of the present subject matter may be installed on a mobile device (e.g., a smartphone), such as by installing the application from a third party source (e.g., iPhoneAppstore, Google Play, etc.) or as a direct installation from a support structure of the present subject matter.

Fig. 17A-17C depict a user interface 1700 of a mobile application of the present subject matter installed on a mobile device in three states, pre-scan, scanning, and result (1700 a-1700C, respectively). In pre-scan state 1700a, a user may select scan actuator 1710 to prepare the apparatus of the present subject matter to begin scanning the spine of a patient. Additionally, a mobile device status icon (e.g., 1712) is presented to the user, for example, to indicate that the mobile device has sufficient battery power for scanning a patient and that the mobile device is communicatively coupled to the support device (e.g., support structure 110) of the present subject matter via bluetooth. An application menu (e.g., 1714) is also accessible and can be selected by the user to view, for example, a scan history (e.g., stored on the device, patient specific, stored on a cloud server, etc.), device settings (e.g., silent mode, color scheme, security settings, change user, change patient, etc.), or instructions to scan the spine of the patient using the device.

When the device is used to scan a spine of a patient, the scan state 1700b may be accessed, and the scan state 1700b has elements substantially similar to the display screens 700a-700b and 800a-800b of fig. 7 and 8.

Once the scan is complete, or if the user selects the scan history, the user may access the results state 1700 c. The user interface of the results state 1700c includes a drawing 1720, a spine feature 1722, and a results summary 1724. As shown, plot 1720 depicts a model of the patient's spine, indicating where an abnormality was detected. It is contemplated that the model may be two-dimensional, three-dimensional, or four-dimensional, and may be manipulated by a user (rotated, selected, zoomed in/out, etc.). The spine feature 1722 displays relevant data from a spinal scan of a patient. For example, as shown, the spine feature 1722 indicates the overall length of the spine being scanned, as well as the lateral tilt angle of the spine (e.g., 0-5 normal, 5-10 medium, greater than 10 severe, etc.) that exceeds a threshold value indicating scoliosis, and the angular position along the spine (e.g., 18.1cm from root, 27.1cm from root, etc.). It should be understood that the spine feature 1722 may include as many feature types and related information as possible detected for the spine (e.g., lateral tilt angle, anterior tilt angle, spine length, position along the spine, etc.; more than 2, 3, 5, 7, or 10 features, etc.). The results summary 1724 presents summary information describing the scan to the user. For example, the depicted result summary 1724 presents an anonymous patient identification (e.g., S3D _1111_170419_142508), a date on which the spine scan was performed (e.g., hours, months, days, years, etc.), and conclusions drawn based on analysis of the spine scan data (e.g., exceeded a moderate threshold, exceeded a severe threshold, normal, etc.).

Additional thresholds for identifying lateral tilt angles for scoliosis may be entered by a user or automatically populated by a device, proprietary server, or third party database of the inventive subject matter based on data (e.g., experimental data, clinical data, demographic data, patient-specific data, etc.). For example, the normal range may be 0 ° -l °, 0 ° -3 °, 0 ° -5 °, 0 ° -7 °, 0 ° -10 °, 0 ° -12 °, l ° -3 °, l ° -5 °, 1 ° -7 °, 1 ° -10 °, 1 ° -12 °, 3 ° -5 °, 3 ° -7 °, 3 ° -10 °, 3 ° -12 °, 5 ° -7 °, 5 ° -10 °, 7 ° -12 °, 10 ° -12 °, and the like. Similarly, the medium range may be 3 ° -5 °, 3 ° -7 °, 3 ° -10 °, 3 ° -12 °, 3 ° -15 °, 3 ° -17 °, 5 ° -7 °, 5 ° -10 °, 5 ° -12 °, 5 ° -15 °, 5 ° -17 °, 7 ° -10 °, 7 ° -12 °, 7 ° -15 °, 7 ° -17 °, 10 ° -12 °, 10 ° -15 °, 10 ° -17 °, 12 ° -15 °, 12 ° -17 °, 15 ° -17 °, and so on. Moreover, the severity range can be 7 degrees to 10 degrees, 7 degrees to 12 degrees, 7 degrees to 15 degrees, 7 degrees to 17 degrees, 7 degrees to 20 degrees, 7 degrees to 22 degrees, 7 degrees to 25 degrees, 10 degrees to 12 degrees, 10 degrees to 15 degrees, 10 degrees to 17 degrees, 10 degrees to 20 degrees, 10 degrees to 22 degrees, 10 degrees to 25 degrees, 12 degrees to 15 degrees, 12 degrees to 17 degrees, 12 degrees to 20 degrees, 12 degrees to 22 degrees, 12 degrees to 25 degrees, 15 degrees to 17 degrees, 15 degrees to 20 degrees, 15 degrees to 25 degrees, 17 degrees to 20 degrees, 17 degrees to 25 degrees, 20 degrees to 22 degrees, 20 degrees to 25 degrees, 22 degrees and the like.

Similarly, additional thresholds for identifying the forward inclination angle of kyphosis may be entered by a user or automatically populated by a device, proprietary server, or third party database of the inventive subject matter based on data (e.g., experimental data, clinical data, demographic data, patient-specific data, etc.). For example, the normal range may be 0 ° -11 °, 0 ° -13 °, 0 ° -15 °, 0 ° -17 °, 0 ° -20 °, 0 ° -22 °, 0 ° -23 °, 0 ° -25 °, 0 ° -27 °, 0 ° -30 °, 0 ° -32 °, 10 ° -13 °, 10 ° -15 °, 10 ° -17 °, 10 ° -20 °, 10 ° -22 °, 10 ° -23 °, 10 ° -25 °, 10 ° -27 °, 10 ° -30 °, 10 ° -32 °, 13 ° -15 °, 13 ° -17 °, 13 ° -20 °, 13 ° -22 °, 13 ° -23 °, 13 ° -25 °, 13 ° -27 °, 13 ° -30 °, 13 ° -32 °, 15 ° -17 ° -and, 15-20 degrees, 15-22 degrees, 15-23 degrees, 15-25 degrees, 15-27 degrees, 15-30 degrees, 15-32 degrees, 17-20 degrees, 17-22 degrees, 17-23 degrees, 17-25 degrees, 17-27 degrees, 17-30 degrees, 17-32 degrees, 20-22 degrees, 20-23 degrees, 20-25 degrees, 20-27 degrees, 20-30 degrees, 20-32 degrees, 23-25 degrees, 23-27 degrees, 23-30 degrees, 23-32 degrees, 25-27 degrees, 25-30 degrees, 25-32 degrees, 27-30 degrees, 27-32 degrees, 30-32 degrees and the like. Similarly, the medium range may be 10 ° -13 °, 10 ° -15 °, 10 ° -17 °, 10 ° -20 °, 10 ° -22 °, 10 ° -23 °, 10 ° -25 °, 10 ° -27 °, 10 ° -30 °, 10 ° -32 °, 10 ° -33 °, 10 ° -35 °, 10 ° -37 °, 10 ° -40 °, 13 ° -15 °, 13 ° -17 °, 13 ° -20 °, 13 ° -22 °, 13 ° -23 °, 13 ° -25 °, 13 ° -27 °, 13 ° -30 °, 13 ° -32 °, 13 ° -33 °, 13 ° -35 °, 13 ° -37 °, 13 ° -40 °, 15 ° -17 °, 15 ° -20 °, 15 ° -22 °, 15 ° -23 °, or a combination thereof, 15-25 degrees, 15-27 degrees, 15-30 degrees, 15-32 degrees, 15-33 degrees, 15-35 degrees, 15-37 degrees, 15-40 degrees, 17-20 degrees, 17-22 degrees, 17-23 degrees, 17-25 degrees, 17-27 degrees, 17-30 degrees, 17-32 degrees, 17-33 degrees, 17-35 degrees, 17-37 degrees, 17-40 degrees, 20-22 degrees, 20-23 degrees, 20-25 degrees, 20-27 degrees, 20-30 degrees, 20-32 degrees, 23-25 degrees, 23-27 degrees, 23-32 degrees, 20-33 degrees, 20-35 degrees, 20-37 degrees, 20-40 degrees, 25 degrees to 27 degrees, 25 degrees to 30 degrees, 25 degrees to 32 degrees, 25 degrees to 33 degrees, 25 degrees to 35 degrees, 25 degrees to 37 degrees, 25 degrees to 40 degrees, 27 degrees to 30 degrees, 27 degrees to 32 degrees, 27 degrees to 33 degrees, 27 degrees to 35 degrees, 27 degrees to 37 degrees, 27 degrees to 40 degrees, 30 degrees to 32 degrees, 30 degrees to 33 degrees, 30 degrees to 35 degrees, 30 degrees to 37 degrees, 30 degrees to 40 degrees, 32 degrees to 33 degrees, 32 degrees to 35 degrees, 32 degrees to 37 degrees, 32 degrees to 40 degrees, 33 degrees to 37 degrees, 33 degrees to 40 degrees, 35 degrees to 37 degrees, 35 degrees to 40 degrees, 37 degrees and the like. Moreover, the severity range can be 17-20 degrees, 17-22 degrees, 17-23 degrees, 17-25 degrees, 17-27 degrees, 17-30 degrees, 17-32 degrees, 17-33 degrees, 17-35 degrees, 17-37 degrees, 17-40 degrees, 17-42 degrees, 17-43 degrees, 17-45 degrees, 17-47 degrees, 17-50 degrees, 17-52 degrees, 17-53 degrees, 17-55 degrees, 17-57 degrees, 17-60 degrees, 20-22 degrees, 20-23 degrees, 20-25 degrees, 20-27 degrees, 20-30 degrees, 20-32 degrees, 23-25 degrees, 23-27 degrees, 23-30 degrees, 23-32 degrees, 20-33 degrees, 20-35 degrees, 20-37 degrees, 20-40 degrees, 20-42 degrees, 20-43 degrees, 20-45 degrees, 20-47 degrees, 20-50 degrees, 20-52 degrees, 20-53 degrees, 20-55 degrees, 20-57 degrees, 20-60 degrees, 25-27 degrees, 25-30 degrees, 25-32 degrees, 25-33 degrees, 25-35 degrees, 25-37 degrees, 25-40 degrees, 25-42 degrees, 25-43 degrees, 25-45 degrees, 25-47 degrees, 25-50 degrees, 25-52 degrees, 25-53 degrees, 25-55 degrees, 25-57 degrees, 25-60 degrees, 27-30 degrees, 27-32 degrees, 27-33 degrees, 27-35 degrees, 27-37 degrees, 27-40 degrees, 27-42 degrees, 27-43 degrees, 27-45 degrees, 27-47 degrees, 27-50 degrees, 27-52 degrees, 27-53 degrees, 27-55 degrees, 27-57 degrees, 27-60 degrees, 30-32 degrees, 30-33 degrees, 30-35 degrees, 30-37 degrees, 30-40 degrees, 30-42 degrees, 30-43 degrees, 30-45 degrees, 30-47 degrees, 30-50 degrees, 30-52 degrees, 30-53 degrees, 30-55 degrees, 30-57 degrees, 30-60 degrees, 32-33 degrees, 32-35 degrees, 32-37 degrees, 32-40 degrees, 32-42 degrees, 32-43 degrees, 32-45 degrees, 32-47 degrees, 32-50 degrees, 32-52 degrees, 32-53 degrees, 32-55 degrees, 32-57 degrees, 32-60 degrees, 33-35 degrees, 33-37 degrees, 33-40 degrees, 33-42 degrees, 33-43 degrees, 33-45 degrees, 33-47 degrees, 33-50 degrees, 33-52 degrees, 33-53 degrees, 33-55 degrees, 33-57 degrees, 33-60 degrees, 35-37 degrees, 35-40 degrees, 35-42 degrees, 35-43 degrees, 35-45 degrees, 35-47 degrees, 35-50 degrees, 35-52 degrees, 35-53 degrees, 35-55 degrees, 35-57 degrees, 35-60 degrees, 37-40 degrees, 37-42 degrees, 37-43 degrees, 37-45 degrees, 37-47 degrees, 37-50 degrees, 37-52 degrees, 37-53 degrees, 37-55 degrees, 37-57 degrees, 37-60 degrees, 40-42 degrees, 40-43 degrees, 40-45 degrees, 40-47 degrees, 40-50 degrees, 40-52 degrees, 40-53 degrees, 40-55 degrees, 40-57 degrees, 40-60 degrees, 45-60 degrees, 50-60 degrees, 55-60 degrees, more than 60 degrees and the like.

It should be appreciated that the results state 1700c may further include additional information, such as identifying the user/operator of the device during the scan, identifying that the scan data or results are inconsistent with other scan data or results for a particular patient, or indicating that additional analysis is available or needed. For example, the result status 1700c may further instruct the user or patient to seek medical attention or to schedule an appointment with a medical professional (e.g., based on the patient's medical insurance, selected from a trusted medical service provider, an in-network (in-network) provider, medical service provider expertise, the location of the patient or device relative to the medical service provider, availability of the medical service provider, facilities needed for patient treatment, facilities available at the medical service provider, etc.). The results state 1700c may also instruct the user/patient to make further comments by the healthcare professional regarding the spine scan data, or whether the patient has completed the instructions issued by the mobile application.

It should also be understood that the results of a scan or the results of all scans having diagnostic value (e.g., indicative of scoliosis, kyphosis, other spinal deformities) may be forwarded to a relevant database, such as a database maintained by a particular subject's medical service provider, veterinary care provider, sports organization, academic organization, and so forth. Similarly, the mobile application of the inventive subject matter can receive relevant subject-related data from such third-party databases (e.g., a particular subject's medical service provider, veterinary care provider, sports organization, academic organization, etc.). It should also be understood that the mobile application of the inventive subject matter forwards all collected and received data to a proprietary cloud-based server for further data analysis (e.g., big data analysis, identifying false positives, false negatives, refinement algorithms for identifying spinal deformities, for identifying other spinal conditions). In these proprietary embodiments, it is contemplated that such data compilation and big data analytics may be provided to third parties as subscription services.

In another embodiment of the inventive concept, the testing device may utilize the difference in travel between the left wheel or roller and the right wheel or roller to evaluate an image (such as a photograph or radiograph) of the test subject. In such embodiments, the test device may be centered on and moved along the length of a portion of the image representing the spine. The lateral curvature of the spine represented in the image results in different rates of movement between the left and right wheels or rollers. For example, when the test apparatus is moved over that portion of the image, an image showing a spine bent to the right will result in the left wheel or roller traveling a shorter distance than the right wheel or roller. Such data may be collected from encoders incorporated into the wheels or rollers (as described above). These differences can be used to calculate the cobb angle that is typically used to characterize scoliotic deformities. In this manner, the test device of the present inventive concept can be used to derive clinically useful information from current data and archived data when the patient is not immediately available. It will be appreciated that an application or program running on a mobile device incorporated into the assembled test device may have a mode for testing a subject in the field and a separate mode for characterizing such stored data.

It should also be appreciated that using a ball (e.g., ball-in-socket) as a roller further allows the orientation of the device to be mapped or recorded by the device. For example, while using wheels requires detecting differences in speed, acceleration, and distance traveled between wheels on the device in order to discern the motion of the device, tracking the roll of one ball allows the device to directly tell the direction in which each ball (e.g., the angle of the device) is moving at any given moment.

As described above, many mobile devices (e.g., smartphones, tablets, etc.) include sensors other than accelerometers that may be used in conjunction with a support structure to help assess scoliosis and/or kyphosis. For example, magnetic field sensors may be used to help test the orientation of the device and/or to help sense the passage of a magnetic encoder. Infrared sensors (such as proximity sensors) may be used to determine that the testing device is being used on the actual test subject, thereby improving the quality of the test database by preventing submission of spurious data. Similarly, spectral analysis of image data acquired as part of a test procedure may be used to verify that the same subject identifier is not used for multiple subjects, or that the same test subject is not present under different identities.

It should also be understood that while the devices, systems, and methods of the inventive subject matter are believed to be useful for detecting spinal disorders in a patient (e.g., a human), it is also contemplated that the inventive subject matter may be used to characterize the condition of spinal deformities in an animal (e.g., a vertebrate), as well as to model or virtual devices for training, providing training or guidance to medical personnel. It should also be understood that the subject matter of the present invention may also be applied to detect anomalies (e.g., tension in the coupling, buckling (bucking), mechanical fatigue in the stem, etc.) in mechanical structures or robotic limbs/appendages (e.g., robotic arms, etc.). In such embodiments, it is expected that forward pitch, lateral pitch, and travel path tolerances will be communicated based on the mechanical properties of the material or structure being evaluated.

Although described above in terms of incorporating a mobile device, in embodiments of the inventive concept, the support structure may include a display that allows direct use of the support structure to perform the analysis functions described above. In such embodiments, the support structure may include an internal CPU and/or provide communication capabilities with an external CPU. Such external CPUs may include a CPU of a mobile device in communication with but not coupled to the support structure, a CPU of a laptop computer, a CPU of a tablet computer, a CPU of a wearable computer, a CPU of a desktop computer, and/or a CPU of a computer at a physically separate location. Communication with such an external CPU may be provided through a wired connection (e.g., a USB or Firewire cable) or a wireless connection. Suitable wireless connections and/or protocols include WiFi communication, bluetooth communication, infrared communication, radio communication, and microwave communication. In some embodiments, communication with such an external CPU may be provided over the Internet, for example using a commercial ISP or wireless service provider.

It will be apparent to those skilled in the art that many more modifications besides those already described are possible without departing from the inventive concepts herein. The inventive subject matter, therefore, is not to be restricted except in the spirit of the appended claims. Moreover, in interpreting both the specification and the claims, all terms should be interpreted in the broadest possible manner consistent with the context. In particular, the terms "comprises" and "comprising" should be interpreted as referring to elements, components, or steps in a non-exclusive manner, indicating that the referenced elements, components, or steps may be present, or utilized, or combined with other elements, components, or steps that are not expressly referenced. If the specification claims refer to at least one selected from the group consisting of a, B, c.

Claims (40)

1. A support structure for test equipment, comprising:

an upper portion configured to secure a mobile device; and

a lower portion having a first side and a second side opposite one another and a lower surface coupled to both the first side and the second side, wherein the lower surface includes a first roller positioned at or near the first side, a second roller positioned at or near the second side, and a notch interposed between the first roller and the second roller, and wherein at least one of the first roller and the second roller includes an encoder.

2. The support structure of claim 1, wherein the first roller and the second roller each comprise an encoder.

3. The support structure of claim 1 or 2, further comprising a sensor.

4. The support structure of claim 3, wherein the sensor is selected from the list consisting of: accelerometers, gyroscopes, magnetometers, cameras, thermal sensors, infrared sensors, and pressure sensors.

5. The support structure of any one of claims 1-4, further comprising a communication link configured to provide communication with the mobile device.

6. The support structure of claim 5, wherein the communication link is selected from the group consisting of a cable and a wireless communication method, wherein the wireless communication method comprises one of a wireless protocol, a WiFi transmitter, a WiFi receiver, a Bluetooth transmitter, a Bluetooth receiver, a ZigBee transmitter, a near field receiver, a radio frequency transmitter, a radio frequency receiver, an infrared transmitter, or an infrared receiver.

7. The support structure of any one of claims 1 to 6, wherein the encoder is configured to provide data relating to a distance, speed or acceleration of movement of the support structure as it rolls on the first roller.

8. The support structure of any one of claims 1 to 7, wherein either of the first or second rollers comprises a pair of wheels.

9. The support structure of any one of claims 1-8, further comprising a hinge joining the upper portion to the lower portion.

10. The support structure of claim 9, wherein the hinge comprises at least one stop.

11. The support structure of claim 9, wherein the hinge is configured to secure the top in a first position relative to the lower portion and a second position relative to the lower portion, wherein the first position and the second position are orthogonal to each other.

12. The support structure of any one of claims 1-11, further comprising an alignment feature centrally located along the notch.

13. The support structure of claim 12, wherein the alignment feature is a lighting device oriented to project a light beam through a central portion of the recess along a line perpendicular to the plane of the lower surface.

14. A test device for determining a spinal deformity in a subject, comprising:

a mobile device comprising an accelerometer, a display, and a CPU; and

a support structure comprising an upper portion configured to secure the mobile device, a lower portion having a first side and a second side opposite each other, and a lower surface coupled to the first side and the second side, wherein the lower surface comprises: a first roller positioned at or near the first side, a second roller positioned at or near the second side, and a notch interposed between the first roller and the second roller, and wherein at least one of the first roller and the second roller comprises an encoder.

15. The test apparatus of claim 14, wherein the first roller and the second roller each comprise an encoder.

16. The test apparatus of claim 14 or 15, further comprising a sensor.

17. The test apparatus of claim 16, wherein the sensor is selected from the list consisting of: accelerometers, gyroscopes, magnetometers, cameras, thermal sensors, infrared sensors, and pressure sensors.

18. The test device of any one of claims 14 to 17, further comprising a communication link configured to provide communication with the mobile device.

19. The test device of claim 18, wherein the communication link is selected from the group consisting of a cable and a wireless communication method, wherein the wireless communication method comprises one of a wireless protocol, a WiFi transmitter, a WiFi receiver, a bluetooth transmitter, a bluetooth receiver, a ZigBee transmitter, a near field receiver, a radio frequency transmitter, a radio frequency receiver, an infrared transmitter, or an infrared receiver.

20. A test apparatus according to any of claims 14 to 19, wherein the encoder is configured to provide data relating to a distance moved by the support structure as the support structure rolls on the first roller.

21. The test apparatus of any one of claims 14 to 20, wherein either of the first roller or the second roller comprises a pair of wheels.

22. The test apparatus of any one of claims 14-21, further comprising a hinge joining the upper portion to the lower portion.

23. The test apparatus of claim 22, wherein the hinge comprises at least one stop.

24. The test apparatus of claim 22, wherein the hinge is configured to secure the top in a first position relative to the lower portion and a second position relative to the lower portion, wherein the first position and the second position are orthogonal to each other.

25. The test apparatus of any one of claims 14-24, further comprising an alignment feature centrally located along the notch.

26. The test apparatus of claim 25, wherein the alignment feature is an LED laser oriented to project a beam of light through a central portion of the recess along a line perpendicular to the plane of the lower surface.

27. A method for characterizing a malformed condition of a subject's spine, comprising:

placing the test device of claim 14 in a first starting position along the spine of the subject while the subject is in a first test position such that the notch of the test device is centered on the spine;

moving the test device along the spine on the first roller;

while moving the test device, the following data is collected: data relating to a first travel distance from the encoder associated with the first roller of the test apparatus, and at least one of (1) data relating to a first lateral tilt from the test apparatus or (2) data relating to a first forward tilt from the test apparatus;

placing the test device at a second starting position along the spine such that the notch of the test device is centered on the spine when the subject is in a second testing position;

moving the test device along the spine on the first roller;

while moving the test device, the following data is collected: data relating to a second distance of travel from the encoder associated with the first roller of the test apparatus, and at least one of (1) data relating to a second lateral tilt from the test apparatus or (2) data relating to a second forward tilt from the test apparatus;

providing data relating to the first and second travel distances and at least one of (1) the first and second lateral inclinations or (2) the first and second forward inclinations to a database;

comparing data relating to any one of (1) the first lateral tilt or the second lateral tilt, or (2) the first forward tilt or the second forward tilt to first stored values to determine a condition of a spinal deformity; and is

Generating a report relating to a condition of the spinal deformity, wherein the condition is one of: (1) the presence of a scoliotic deformity, (2) the presence of a kyphosis deformity, or (3) the subject does not have a scoliosis or a kyphosis deformity.

28. The method of claim 27, further comprising the step of acquiring a digital image of the back of the subject.

29. The method of claim 27 or 28, wherein the presence of a scoliotic deformity is determined when either of the first or second lateral tilt exceeds 10 °.

30. The method according to any one of claims 27 to 29, wherein the presence of a kyphosis is determined when either of the first or second forward inclinations exceeds 30 °.

31. The method of any one of claims 27 to 30, wherein the first starting position is at or near the gluteal cleft.

32. The method of any one of claims 27-31, wherein the second starting position is at or near the T1 thoracic vertebra of the patient's spine.

33. The method of any one of claims 27-32, further comprising the step of prompting the subject for medical care when the report indicates a scoliotic or kyphotic deformity.

34. The method of any one of claims 27 to 33, further comprising the step of sending the report to a medical professional.

35. The method of claim 34, wherein the report includes a relationship between the first travel distance and at least one of the first lateral tilt or the first forward tilt.

36. The method of claim 34, wherein the report includes a relationship between the second travel distance and at least one of the second lateral tilt or the second forward tilt.

37. A method according to any of claims 27 to 36, wherein speed-related data is collected from the encoder.

38. A method according to any one of claims 27 to 37, wherein data relating to acceleration is collected from the encoder.

39. A method of characterizing a spinal deformity condition in a subject using the device of claim 14.

40. A method of detecting kyphosis or scoliosis of a subject's spine using the apparatus of claim 14.