The present invention is directed to systems for performing musculoskeletal analyses. More particularly, the present invention is directed to systems incorporating three-dimensional (3D) scans and machine learning to identify musculoskeletal abnormalities and conditions, such as fracture, deformity, asymmetry, center of gravity or rotation, and joint range of motion.
Musculoskeletal problems are significant problems in human populations, including bone fractures, scoliosis, and other deformities or anomalies. Such problems are conventionally observed using X-ray imaging. X-rays provide high contrast images of bones against other soft tissues. However, X-rays are a form of relatively high-energy electromagnetic radiation which can adversely affect organic tissue. While modern X-ray imaging devices are designed to use as little radiation as possible, repeated exposure can still cause harm to patients. For conditions such as a clavicle fracture, doctors generally rely on objective radiographic criteria not only in order to diagnose and suggest treatment, but to follow up on recovery progression over time, thereby increasing their radiation damage burden. Additionally, much the equipment for obtaining these measurements are not mobile or easily dispatched into a field setting. Furthermore, X-rays are insufficient methods of detecting or monitoring many musculoskeletal problems, because they provide only a 2-dimensional representation of bony anatomy (which fails to represent 3-dimensional nature of a deformity after a fracture) and fail to capture soft tissues (which can be critical for medical diagnosis).
While some issues, like scoliosis, are diagnosed in the field, such screening techniques are rudimentary and inaccurate, leading to inappropriate referrals and increased patient anxiety. Further confirmation and monitoring of scoliosis require additional medical imaging, such as X-ray, which has many of the problems, previously described.
Systems and methods for detection of musculoskeletal anomalies are provided. In one embodiment, a three dimensional diagnostic system includes a three dimensional scanning device capable of obtaining a three dimensional scan of a human body without emitting ionizing or other damaging radiation and a computing device in communication with the three dimensional scanning device and capable of generating a mesh from a three dimensional scan and analyzing said mesh to identify a musculoskeletal anomaly.
In a further embodiment, the three dimensional scanning device is a white light scanning camera or a LiDAR-enabled camera.
In another embodiment, the computing device is a mobile device.
In a still further embodiment, the mobile device is selected from a mobile phone, a tablet, a laptop computer, or a notebook computer.
In still another embodiment, the computing device is capable of transmitting data over a network.
In a yet further embodiment, the system further includes a remote server connected to the computing device via a network.
In yet another embodiment, a method for detecting and monitoring scoliosis includes obtaining a 3D topographic scan of a subject's body using a 3D topographic imaging device, analyzing the 3D topographic scan by identifying a plurality of key feature points on the regions of the 3D topographic scan reflecting the back of the subject, measuring a distance or angle between at least a first key feature point and a second key feature point in the plurality of key feature points, identifying scoliosis based on the distances, angles, and volumetric relationships quantified in upright and bending poses, classifying the scoliosis as in need of orthopaedic referral or not in need of orthopaedic referral, classifying the scoliosis as operative, eligible for casting and/or bracing or not in need of intervention, and treating the subject based on the classification of the scoliosis.
In a further embodiment again, the plurality of key features are selected from the group consisting of: the midsternal notch, the superior/anterior aspect of the acromioclavicular joint, the posterior/lateral border of the acromion, the C7 spinous process, the inferior angle of the scapula, the nipples, the olecranon process, the anterior superior iliac spine, greater trochanter, patella, ankle malleoli, and digits.
In another embodiment again, the treating step includes a surgical operation, other non-surgical intervention, or physical therapy.
In a further additional embodiment, the method further includes obtaining a second 3D topographic scan of the subject's body post-treatment, identifying a second plurality of key feature points in the second 3D topographic scan using a fracture detector, measuring a distance, angle, or volumetric change between at least a first key feature point and a second key feature point in the second plurality of key feature points using the fracture detector, calculating the difference in the measured distance, angles or volumetric change, and tracking the subject's recovery based on the calculated differences in distances, angles or volumetric measurements of interest.
In another additional embodiment, the plurality of key features are selected from the group consisting of: the midsternal notch, the superior/anterior aspect of the acromioclavicular joint, the posterior/lateral border of the acromion, the C7 spinous process, the inferior angle of the scapula, the nipples, the olecranon process, the anterior superior iliac spine, greater trochanter, patella, ankle malleoli, and digits.
In a still yet further embodiment, the 3D topographic scan is accomplished using a structured light scanner or LiDAR-enabled camera.
In still yet another embodiment, the 3D topographic scan is accomplished using a mobile device.
In a still further embodiment again, the mobile device is selected from a mobile phone or tablet.
In still another embodiment again, a method for detecting and treating clavicle fractures includes obtaining a 3D topographic scan of a subject's body using a 3D topographic imaging device, identifying a plurality of key feature points on the regions of the 3D topographic scan reflecting the shoulders and back of the subject, measuring a distance between at least a first key feature point and a second key feature point in the plurality of key feature points, identifying a clavicle fracture based on the distance, classifying the clavicle fracture as operative or non-operative, and treating the subject based on the classification of the clavicle fracture.
In a still further additional embodiment, the plurality of key features are selected from the group consisting of: the midsternal notch, the acromial process, the superior/anterior aspect of the acromioclavicular joint, the posterior/lateral border of the acromion, the C7 spinous process, the inferior angle of the scapula, the nipples, the olecranon process, the anterior superior iliac spine, greater trochanter, patella, ankle malleoli, and digits.
In still another additional embodiment, the treating step includes a surgical operation.
In a yet further embodiment again, the method further includes obtaining a second 3D topographic scan of the subject's body post-operatively, identifying a second plurality of key feature points in the second 3D topographic scan using a fracture detector, measuring a distance between at least a first key feature point and a second key feature point in the second plurality of key feature points using the fracture detector, calculating the difference in the measured distances, calculating volumetric relationships within 3D scans, and tracking the subject's recovery based on the calculated differences.
In yet another embodiment again, the plurality of key features are selected from the group consisting of: the midsternal notch, the superior/anterior aspect of the acromioclavicular joint, the posterior/lateral border of the acromion, the C7 spinous process, the inferior angle of the scapula, the nipples, the olecranon process, the anterior superior iliac spine, greater trochanter, patella, ankle malleoli, and digits.
In a yet further additional embodiment, the 3D topographic scan is accomplished using a structured light scanner or LiDAR-enabled camera.
In yet another additional embodiment, the 3D topographic scan is accomplished using a mobile device.
In a further additional embodiment again, the mobile device is selected from a mobile phone or tablet.
In another additional embodiment again, a method for detecting musculoskeletal anomalies includes obtaining a 3D topographic scan of a subject's body using a 3D topographic imaging device, performing range of motion, center of gravity, asymmetry, or posture analysis on the 3D topographic scan by bisecting the scan with one or more lines and measuring a key feature along the one or more lines, and identifying a musculoskeletal anomaly based on the distance.
In a still yet further embodiment again, the 3D topographic scan is accomplished using a structured light scanner or LiDAR-enabled camera.
In still yet another embodiment again, the 3D topographic scan is accomplished using a mobile device.
In a still yet further additional embodiment, the mobile device is selected from a mobile phone or tablet.
In still yet another additional embodiment, the musculoskeletal anomaly is selected from scoliosis, back pain, neck pain, joint pain, sarcopenia, arthritis, osteoporosis, bone and soft tissue injury.
In a yet further additional embodiment again, obtaining the 3D topographic scan is accomplished by converting one or more two-dimensional images into a 3D representation of the subject's body.
These and other features and advantages of the present invention will be better understood by reference to the following detailed description when considered in conjunction with the accompanying drawings where:
Turning now to the diagrams and figures, embodiments of the invention are generally directed to systems and methods to detect musculoskeletal anomalies. Systems and methods described herein can use visible spectrum light to obtain a three dimensional (3D) topographic scan of a patient and use the scan to detect musculoskeletal conditions such as, but not limited to, fractures, and/or any other musculoskeletal injury or anomaly as appropriate to the requirements of specific applications of embodiments of the invention. Specific addressable conditions include but are not limited to, scoliosis, back pain, neck pain, joint pain, sarcopenia, arthritis, osteoporosis, bone and soft tissue injury, flexibility, mobility, muscle strength, imbalances, posture analysis, body, bone, fat, muscle mass, metabolic rate, circumference and volume of various body parts. In many embodiments, the 3D scan describes the surface of the patient's body, and contains no internal information (e.g., a mesh).
By measuring particular key feature points, an accurate estimation can be made of whether or not an injury, deformity, or degeneration over time has occurred. In numerous embodiments, as supported by empirical studies, measurement of the same key feature points as performed by a human render less precise results. Many embodiments are deployed as portable devices, including as attached to or as part of a mobile phone or tablet to allow systems to be deployed outside of clinics, hospitals, or other medical facilities.
Turning to
Additionally, some embodiments obtain 3D scans of an individual in different positions, such as standing, bending, sitting, and/or any other position relevant for a particular purpose. Some embodiments obtain 3D scans taken of an individual in a bent position (e.g., Adam's Forward Bend position) to maximally expose spinal curvature. In certain embodiments, 3D scans are obtained with one or both arms, one or both legs, and/or the head/neck in a specific position that allows for measurements of particular features dependent upon specific motions or specific positions of one or more appendages. Further embodiments obtain 3D video scans of an individual, in that the 3D scan is obtained as a continuous series of images over time. Certain embodiments construct 3D images of an individual based on one or more 2D images or a video that can be converted into a single 3D representation, via stitching, reconstruction, or other method of constructing a 3D representation from one or more 2D images.
At 104 of various embodiments, 3D representations are analyzed to identify a musculoskeletal anomaly. In numerous embodiments, systems and methods described herein can identify shoulder and spinal deformities such as clavicle fractures, scoliosis, and other deformities, diseases, or anomalies. In some embodiments, analysis is accomplished by communicating scans across a network and/or via the cloud to a central server for processing, while some embodiments analyze the 3D scans locally.
In many embodiments, the 3D representation is analyzed by demarcating various lines or representations and identifying ratios, angles, torsions, rotations, or other differences between these lines.
In various embodiments, a three-dimensional plane is demarcated from the center of the midsternal notch/umbilicus and the C7 spinous process/intergluteal cleft to divide the body into halves. Palpable anatomic landmarks can be utilized as key feature points such as, but not limited to: the midsternal notch, the superior/anterior aspect of the acromioclavicular joint, the posterior/lateral border of the acromion, the C7 spinous process, the acromial process, the inferior angle of the scapula, the nipples, the olecranon process, the anterior superior iliac spine, greater trochanter, patella, ankle malleoli, and digits. Many embodiments analyze distances between these landmarks, angles formed between these landmarks, and volumetric differences between areas of interest as well as between these landmarks and the ground to demonstrate the magnitude of topographical asymmetry.
In many embodiments, volumetric asymmetry is calculated through targeted volumetric comparison of the two halves of the body utilizing aforementioned anatomic landmarks. Asymmetric dynamic motion of the limb can also be calculated by comparing the change in relationships between the aforementioned landmarks through a range of motion. Output can be represented as absolute and relative asymmetry compared to the respective contralateral body part of interest or with respect to prior measurements demonstrating change over time.
Turning to
To measure an angle of trunk rotation, such as for scoliosis, various embodiments utilize scans from a bent position (e.g., Adam's Forward Bend position). In such embodiments, slices are obtained from the 3D representations perpendicular to the mid-sagittal line along the torso and the points of largest deformity are identified in the lower back (lumbar spine) and upper back (thoracic spine). As illustrated in
Furth embodiments expand on these abilities by mapping spinal curvature from 3D representations or scans in any position, including at least one of standing, sitting, and bending.
In various embodiments, systems and methods described herein can quantify static and dynamic asymmetry of the body to assist as a decision aid for medical decision making or personal wellness monitoring. For example, shoulder deformity after isolated clavicle fracture can be detected utilizing this methodology. In some embodiments, when diagnosing clavicle fracture, a structured-light scanner captures the three-dimensional shape of the shoulder girdle bilaterally. Non-traumatic musculoskeletal deformity, such as that in scoliosis, may also be captured utilizing similar methodology. In some embodiments, scoliotic deformity may be quantified by capturing the three-dimensional shape of the spine in upright and bending poses. Data captured from three-dimensional scans and then uploaded to a photogrammetric musculoskeletal software for analysis of three-dimensional measurements of anatomical relationships based upon specific landmarks.
In some embodiments, these palpable and visible anatomic landmarks are validated through academic clinical trials. For example, for a clavicle fracture, the specific landmarks include suprasternal notch, superior/anterior aspect of the acromioclavicular joint, posterior/lateral border of the acromion, inferior angle of the scapula, and C7 spinous process. Distance and the angles formed between these chosen landmarks are analyzed with the software to demonstrate the magnitude of topographical asymmetry compared to the injured and uninjured side. The injured and uninjured shoulder girdles are compared, with each patient to serve as their internal reference. The relative difference in the shoulder ptosis defined by these anatomic landmarks, specifically the distance from the midsternal notch to the acromial clavicular joint can identify displaced clavicle fractures that would benefit from operative management without the use of radiation. Further, the difference in distance and angles formed by the aforementioned landmarks is analyzed to monitor the restoration of anatomy or persistence of deformity to monitor the healing of their fracture without the use of radiation. Manual surface measurements of the landmarks are not as predictive due to a lack of sensitivity, thus validating the digital technology and methods. The restoration of anatomy or presence of persistent deformity after clavicle fracture as identified by described methodologies have predictive clinical relevance in terms of pain and return to function defined by objective outcome scores.
In an exemplary embodiment assessing scoliosis, upright and bending scans are used in conjunction to quantify three-dimensional scoliotic deformity. First, the location of the hip joints is estimated using the center of mass of each leg. The mid-point between the two estimated hip joints is then found to estimate the central sacral vertical line. The circumference of the torso is calculated transversely from cranial to caudal, and orthogonal line is drawn through the center of mass of the circumference on the transverse plane with the largest asymmetry. This line is projected onto a coronal plane and compared to the projection of the central sacral vertical line on the same coronal plane to calculate trunk shift. Next, a circumference is drawn transversely around the neck, and an orthogonal line is drawn through the center of mass of this circumference. The orthogonal line is projected onto the same coronal plane previously used in the trunk shift calculation, and is compared to the projection of the central sacral vertical line to determine coronal balance. Shoulder balance and clavicle angle are calculated using the anterior or posterior acromioclavicular joints, dependent on which is most prominent on a particular patient. In the case that these landmarks are not easily seen, the apex of each shoulder is compared to generate the same calculation. For calculation of angle of trunk rotation, splines are drawn from the estimated location of the hips to the center of the shoulder as determined from anterior to posterior. Lines are drawn from one side to another, and the angle of the back is compared to the coronal line created by the splines along the back. The largest angle in the lumbar spine is the lumbar angle of trunk rotation, and the largest angle in the thoracic spine is the thoracic angle of trunk rotation.
The aforementioned clinical scenarios, are just examples of utilization of these methods detects and monitor musculoskeletal abnormalities or conditions. Other clinical applications of similar methods include but are not limited to neck and back pain/injury, arthritis, osteoporosis, sarcopenia, soft tissue injury, laxity, and/or muscle atrophy/hypertrophy.
In many embodiments, the analysis is based on a machine learning model. In many embodiments, the machine learning model is trained from 3D scans of individuals, including individuals with new anomalies as well as individuals with categorized anomalies, such as clavicle fracture, scoliosis, a deformity, and/or any other anomaly. Further embodiments further include treatment prognostics or outlook, such as probable outcome from surgical intervention, physical therapy, sports medicine, pharmacological/pharmaceutical therapy (e.g., pain management), and/or other clinical treatment.
Returning to
At 106, embodiments may also generate recommendations for further evaluation by a specialist. For example, in scoliosis, a primary care provider or school nurse may obtain a three-dimensional scan and use the information obtained to determine whether referral to or discussion with an orthopaedic specialist is indicated.
Ongoing monitoring occurs at 108 of many embodiments. During ongoing monitoring, these embodiments follow up with a patient or individual via out-of-office surveys (e.g., patient-reported outcome measures, or PROM) or in-office examination, such as for freedom of movement, range of motion, QuickDASH, or any other applicable metric for a particular musculoskeletal anomaly identified within the individual. In some embodiments, the ongoing monitoring includes additional scans, such as acquired at 102, which can allow for some embodiments to analyze and make additional recommendations for treatment or care based on any changes to an individual's condition.
It should be noted that in various embodiments, certain features of method 100 may be omitted, repeated, and/or completed in a different order (included in parallel or at substantially the same time). For example, obtaining a 3D scan 102 can include having obtained a 3D scan, such that the 3D scan is performed by a different entity and stored or transmitted to a system for analysis. Additionally, multiple analyzing 3D representation 104 features can be used, such that different parameters or different areas or regions of the scan can be analyzed as necessary for the determining a deformity, break, and/or other anomaly. Similarly, multiple treatment recommendations 106 can be made, should multiple anomalies be discovered. In many embodiments, the analysis 104 and recommendation 106 features can be accomplished simultaneously and/or with a single machine learning model.
Turning to
Many embodiments deploy the 3D scanning device 202 is in communication with a computing device 204. In certain embodiments, the computing device 204 is capable of storing and transmitting data, including transmitting data over a network. In certain embodiments, the 3D scanner (e.g., white light scanner or LiDAR system) is innate to the device, while some embodiments utilize deploy the 3D scanner peripheral device attached to the computing device 204. In certain embodiments, the communication between the 3D scanning device 202 and the computing device 204 is a wired communication, such as via USB, serial, audio, RCA, HDMI, coaxial, and/or other form of wired communication, while some embodiments use wireless communication, such as Bluetooth, wi-fi, RF, or other wireless communication systems.
In many embodiments a computing device 204 is a mobile or portable device, such as a mobile phone, tablet, laptop/notebook computer, to allow portability and ease of operation outside of a medical facility. Various embodiments analyze an acquired 3D scan for skeletal anomalies (e.g., broken bone, deformity, etc.) locally, while in some embodiments, computing device 204 is connected to a network 206 (e.g., wired or wireless) to allow communication of a 3D scan to other devices, such as a server 208.
In embodiments connected to a server 208 allow for a higher processing power and/or storage capacity for 3D scans. In such embodiments, a server 208 analyzes such scans to diagnose and/or make recommendations for treatment and/or ongoing care.
Turning to
Additionally, many embodiments are capable of identifying persistent deformities over time. Turning to
Turning to
Additionally,
Additionally, various embodiments are capable of making treatment suggestions or recommendations. As seen in Tables 1A-1G illustrate information regarding various subjects, including demographic information, SRS Scores, and various scores obtained from radiography, 3D scans, and output including recommendations for intervention. A full description of the headings are illustrated in Table 2.
Although the following embodiments provide details on certain embodiments of the inventions, it should be understood that these are only exemplary in nature, and are not intended to limit the scope of the invention.
BACKGROUND: Diagnosis and management of adolescent idiopathic scoliosis (AIS) currently relies on in-person clinical and radiographic examination. Characterization of deformity in adolescent idiopathic scoliosis (AIS) is typically described by metrics such as trunk shift, coronal balance, clavicle angle, and angle of trunk rotation. Structural analysis of 3D scans of patients in forward bend position provides an opportunity to further characterize this deformity. White-light 3D scanning (WL3D) can generate high quality 3D representations of surface anatomy using a mobile device. It was hypothesized that WL3D would provide accurate deformity assessments compared to scoliometer and radiographic measurements. Additionally, this study describes a novel measurement method for AIS deformity characterization.
Methods: Prospective enrollment included patients 10 to 18 years old with AIS, who had a scoliosis radiograph within 30 days of clinic presentation and no history of spinal surgery. 3D scans were taken in the upright and Adams forward bend positions, after which patients completed the SRS-30. Image processing software was used to make 3D measurements of trunk shift, coronal balance, and clavicle angle in upright position and angle of largest trunk rotation (ATR) as detected in the lumbar and thoracic spine in bending position. Modeling software was used to make axial slices of the torso orthogonal to the line of curvature created by the patient's back. The slice passing through the area with the largest angle of trunk rotation was analyzed. A line representing the “horizon” was drawn axially from left to right mid-sagittal line, and a perpendicular line was drawn from the posterior axis of rotation of the trunk to the horizon line. Bilateral circumferential distance along the posterior edge from mid-sagittal line to the axis of rotation and the area created by each posterior quadrant was measured to quantify asymmetry. 3D trunk shift, coronal balance, clavicle angle were compared to their analogous radiographic measurements, and ATR was correlated to cobb angle from radiographs and angle of trunk rotation as measured by a scoliometer (SM).
RESULTS: Sixty-three patients were included in the study. Mean coronal Cobb angle was 33.1°, range: 10 to 100 degrees. Correlations between the clavicle angle, shoulder height, trunk shift, and coronal balance measurements taken from 3D topographical and radiographic measurements were 0.95, 0.85, and 0.71 respectively. Correlations between cobb angle and 3D ATR were 0.7 overall (
Patients with surgical curves (CM>40°) had significantly larger axial area asymmetry. Patients with at least bracing range curves (CM>20°) had significantly larger axial area asymmetry compared to those with Cobb angle <20°. CM and total SRS score had a correlation of −0.5. Difference in quadrant area had a correlation of −0.53 with total SRS. Difference in circumferential distance had a correlation of −0.5 with total SRS.
CONCLUSION: Obtaining a 3D scan of patients with AIS offers an opportunity to further characterize deformity beyond currently accepted metrics. Portable 3D scanning identifies clinically relevant scoliotic deformity and is more predictive of radiographic cobb angle than scoliometer examination. This new modality can facilitate scoliosis screening and monitoring without in-person clinic visits or radiation exposure.
While the above description contains many specific embodiments of the invention, these should not be construed as limitations on the scope of the invention, but rather as an example of one embodiment thereof. Accordingly, the scope of the invention should be determined not by the embodiments illustrated, but by the appended claims and their equivalents.
This application claims priority to U.S. Provisional Application Ser. No. 63/130,291, entitled “Systems and Methods for Detection of Musculoskeletal Anomalies” to DeBaun et al., filed Dec. 23, 2020 and U.S. Provisional Application Ser. No. 62/968,884, entitled “Systems and Methods for Fracture Detection” to DeBaun et al., filed Jan. 31, 2020; the disclosures of which are hereby incorporated by reference in their entireties.
This invention was made with Government support under TR003142 awarded by the National Institutes of Health. The Government has certain rights in this invention.
Filing Document | Filing Date | Country | Kind |
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PCT/US21/16088 | 2/1/2021 | WO |
Number | Date | Country | |
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63130291 | Dec 2020 | US | |
62968884 | Jan 2020 | US |