Patent Description:
Spine and related musculoskeletal plus neurological pain are the highest cost chronic condition. Eighty percent (<NUM>%) of Americans experience back pain at some point in their lives, with thirty percent (<NUM>%) of U. adults suffering from low back pain within last <NUM> months. Except for a cold, back pain is the second most abundant reason for missed work days and clinician visits with total direct healthcare cost exceeding $<NUM> billion dollars a year.

Several reasons have been identified as sources of back pain, neck pain and spine misalignment, including the increasingly excessive usage of electronic devices and sports injuries. With the increase use of electronic devices, including cell phones, games and computers, many spinal misalignments occur now among a younger population, instead of in people following certain injuries or the elderly population. Excessive use of portable electronic devices can significantly increase neck and back pain because of the biomechanical force and alignment change of the cervical, thoracic and lumbar spine. A smaller range of motion between flexion and extension has also been correlated with pain and mechanical instability. Medical professionals advise that neck and back pain be reduced by maintaining a neutral position, along with appropriate exercise.

According to the recent SRS-Schwab classification which provides the mechanism to assess cervical and thoracic lumbar deformity within the framework of global spino-pelvic misalignment and clinically relevant parameters, surgical or preventive alignment correction can be made in order to minimize focal kyphosis, scoliosis and spondylolisthesis. However, there is yet any scientific evidence to support the specific alignment corresponds to a specific deformity.

A system for the analysis of a back posture is known from the state of the art. A system for the analysis of a back posture with at least three sensor units for measuring an orientation, for instance, known from document <CIT>. Current systems detect poor body posture with an electronic device that transmits a signal to a portable device that can display limited information of the body posture and notify the user of poor posture. However, these systems do not provide detailed cervical, thoracic and lumbar spine curvature and alignment index measurement and possible correction.

Therefore, there is a need for a system and method that detects and transmits detailed head, neck, and spine alignment data, as well as neurological and musculoskeletal data from other parts of the body which may be indicative of head, spine and body alignment and neurological function. The present invention addresses these as well as other needs.

In accordance with an aspect of the present invention, a system and method for monitoring and treating head, spine and body abnormalities may include a plurality of universal modules that can be fit in at different positions of the head, spine and other body part. Each module may contain multimodality sensors that can not only detect the head, cervical, thoracic, lumbar and other musculoskeletal alignment indexes, but also the body's neurological status and other physiological parameters, such as pulmonary and/or cardiovascular characters. In a further aspect, the universal capsule modules can be fit into different, specially designed carriers which are configured for different body parts whereby activation of selective sensors can differentiate physiological detection and notification functions for each body location. The system and method may also remind and assist a wearer to actively correct curvatures and may provide further interference if head and spinal mal-position or other injury or disease parameters are detected by the sensor devices.

In accordance with another aspect of the present invention, the system and method to detect head, spine and body alignment change may be combined and matched with external body photographic images focusing on a dynamic analysis of the head, cervical, thoracic and lumbar spine, pelvis and other body parts so as to define the detailed professional dynamic head, spine and body alignment parameters including cervical lordosis angle, cervical SVA, pelvic incidence, lumbar lordosis angle, pelvic tile, SVA et al. Such body photographic measurements may be equivocal to those provided by professional medical image. Medical images such as x-ray, CT and MRI, may be used to match body photographic image performed by machine learning to calibrate the initial spine or body position for each sensor module and to calculate the normal range of motion for each individual irrespective of body shape, height, or even what kind of clothes they are wearing. To that end, the system and method of the present invention includes software algorithms to calculate the angle, distance and curvature with consideration to the spine and other body parts. As a result, the system and method are designed to analyze the data from the sensor modules and provide accurate feedback that can be used by health professionals to monitor remote individual health status and notify users to prevent and correct mal-position or injury or disease status.

It is, therefore, an aspect of the present invention to provide a method for monitoring head, spine and body abnormalities comprising a) providing a plurality of receiver units wherein each receiver unit is configured to be secured at a selected location on a wearer's body; b) mounting a universal multimodality sensor module comprising a power source, a printed circuit board including a processor, memory and communication module, and a plurality of individual sensors to each respective receiver unit, wherein one or more selected individual sensors within the each respective multimodality sensor module is powered depending upon the selected location of its respective receiver unit on the wearer's body; and c) sensing at regular intervals, using the one or more powered selected individual sensors, health data related to the head, spine or body movements of the wearer. In a further aspect, the method may also include d) communicating, via the communication module, the sensed data to a computing device including a computer processor and a computer memory; and e) comparing, via the computer processor, the sensed data with a prepopulated data range stored in the computer memory. And still further, f) delivering a notification to the wearer if the sensed data is outside of the prepopulated range so that the wearer may adjust one or more of their head, spine or body position until the sensed data returns to the prepopulated range.

In still another aspect of the present invention, each universal multimodality sensor module comprises a <NUM>-axis accelerometer, a pulse oximeter, an electromyography (EMG) sensor and a mechanomyography (MMG) sensor. The one or more of the universal multimodality sensor modules may further comprises a feedback device in communication with the computing device. When the sensed data is outside of the prepopulated range, the feedback device is triggered to deliver the notification. The feedback device may comprise one or both of a haptic device configured to vibrate and a light emitting diode (LED) configured to emit a steady light or flashing light. In a further aspect, the one or more of the universal multimodality sensor modules further comprises a speaker/microphone and auditory sensor/processor, wherein the method further includes a) recording joint friction auditory information using the speaker/microphone; b) filtering the auditory information using the auditory processor; c) amplifying the filtered auditory information; and d) communicating the amplified filtered auditory information to the computing device. The speaker/microphone may be a bone conduction speaker/microphone. Additionally or alternatively, one or more of the universal multimodality sensor modules further comprises a selectively switchable speaker/microphone, wherein the speaker/microphone can be selectively activated to record patient generated data in combination with the other sensed health data.

It is still another aspect of the present invention to provide a system for monitoring and treating head, spine and body abnormalities. The system includes a plurality of receiver units wherein each receiver unit is configured to be secured at a selected location on a wearer's body and plurality of universal multimodality sensor modules, each comprising one or more individual sensors, a power source, a printed circuit board including a processor, memory and communication module, wherein a respective multimodality sensor module is coupled with a respective receiver. One or more selected individual sensors within each respective multimodality sensor module is powered depending upon the selected location of its respective receiver unit on the wearer's body. Health data related to the head, spine or body movements of the wearer is sensed at regular intervals using the one or more powered selected individual sensors. The plurality of receiver units have contacts with configurations specific to the selected locations, the configurations causing selection of the one or more individual sensors. When the universal multimodality sensor module is coupled to the receiver unit, leads interpret the specific contacts whereby one or more of the individual sensors are selected by the processor to power to receive the health data from the wearer. The system may also include a computing device including a computer processor and a computer memory, wherein the communication module communicates the sensed data to the computer processor whereby the computer processor compares the sensed data with a prepopulated data range stored in the computer memory. The computing device may be a mobile computing device, such as a smartphone, smartwatch or tablet computer.

In another aspect, of the system of the present invention, each universal multimodality sensor module may include a <NUM>-axis accelerometer, a pulse oximeter, anelectromyography (EMG) sensor and a mechanomyography (MMG) sensor. The one or more universal multimodality sensor modules may further comprise a feedback device incommunication with the computing device. When the sensed data is outside of the prepopulated range, the feedback device is triggered to deliver the notification. The feedback device may be one or both of a haptic device configured to vibrate and a light emitting diode (LED) configured to emit a steady light or flashing light. Still further, one or more of the universal multimodality sensor modules may also include a speaker/microphone and auditory processor. Joint friction auditory information is recorded by the speaker/microphone, filtered and amplified by the auditory processor and communicated to the computing device. The speaker/microphone may be a bone conduction speaker/microphone. Additionally or alternatively, one or more of the universal multimodality sensor modules further comprises a selectively switchable speaker/microphone, wherein the speaker/microphone can be selectively activated to record patient generated data in combination with the sensed health data.

In still another aspect of the present invention, a first universal multimodality sensor module senses health data from a wearer's left arm and a second universal multimodality sensor module senses health data from a wearer's right arm. The computer processor may then compare the left arm health data to the right arm health data to analyze symmetry between the left arm and the right arm to judge the neurological and musculoskeletal status and other health data.

Additional aspects, advantages and novel features of the present invention will be set forth in part in the description which follows, and will in part become apparent to those in the practice of the invention, when considered with the attached figures.

The accompanying drawings form a part of this specification and are to be read in conjunction therewith, wherein like reference numerals are employed to indicate like parts in the various views, and wherein:.

Dynamic spine, including cervical alignment is the crucial component of both traumatic and non-traumatic neck and back pain. Neurosurgeons, physiotherapists and other health workers typically measure active cervical range of motion (aCROM) to ascertain a patient's health problems in terms of impairments of cervical mobility so as to determine a prognosis and to evaluate the effects of physiotherapy treatment in clinical settings. The aCROM can be expressed as a"half-cycle" motion in <NUM> of the <NUM> primary movements (including flexion, extension, right and left rotation, right and left lateral bending) or"full cycle" of motion. Current research supports an understanding that a reduction of aCROM is usually seen as a clinical feature of patients with whiplash-associated disorders (WADs) and non-traumatic neck pain, like degenerative change, and therefore, special range of motion should be evaluated. Persons without neck pain showed a larger aCROM for all movements. It is also important to note that some patients are not capable of large movements.

To that end, and with reference to the drawings, and <FIG> in particular, in accordance with an aspect of the present, a system <NUM> for monitoring and treating head, spine and body abnormaility may include a plurality of universal multimodality sensor modules <NUM> secured to/within respective receiver units <NUM>. Each receiver unit <NUM> is selectively positioned at a location on wearer <NUM>, such as via an elastic band <NUM>. (See also FIGS. <NUM>-7B; a multimodality sensor module <NUM> may be mounted onto an earpiece <NUM>/107a. Earpiece 107a may further define a channel <NUM> for receiving temple <NUM> of eyeglass/sunglasses <NUM> therethrough so as to position multimodality sensor module <NUM> about the ear and proximate temple tip <NUM>). Eachmultimodality sensor module <NUM> includes a housing <NUM> containing a power source (e.g., battery) <NUM>, printed circuit board (PCB) <NUM> and a plurality of individual sensors which may be mounted onto PCB <NUM> or within or on housing <NUM>. For example and without limitation thereto, individual sensors may include an oximeter <NUM>, a <NUM>-axis accelerometer <NUM>, an ECG sensor <NUM> and an EMG sensor <NUM>. Additional auxiliary sensors <NUM> may include an MMG sensor, a force sensor and/or a speaker/microphone.

PCB <NUM> generally includes a processor <NUM>, memory <NUM> and communication module <NUM>. By way of example only, communication module <NUM> may be configured for wireless communication (e.g., Bluetooth, LWAN (e.g., WiFi), or other similar connection) or wired connections (e.g., universal serial bus (USB) drive). With reference to <FIG>, each universal multimodality sensor module <NUM> may communicate with each other universal multimodality sensor module <NUM> and/or a computing device <NUM>, such as without limitation thereto, a mobile computing device (e.g., a smartphone, smartwatch or tablet computer) or a desktop computer (e.g., a personal computer (PC)). Computing device <NUM> may, in turn, communicate with a server over a network or cloud-based database <NUM>.

As shown in <FIG>, in accordance with another aspect of the present invention, battery <NUM> and/or communication module <NUM> may be coupled to one or more leads <NUM> on housing <NUM>. Universal multimodality sensor module <NUM> may be slidingly received within a USB adapter <NUM> whereby leads <NUM> mate with corresponding contacts on USB plug <NUM> so that universal multimodality sensor module <NUM> may be coupled to computing device <NUM> to transfer information between universal multimodality sensor module <NUM> and computing device <NUM> and to charge rechargeable battery <NUM>. Leads <NUM> may be sealed to housing <NUM> such that housing <NUM> is substantially watertight. In this manner, system <NUM> may be worn in the bath or shower without water entering and damaging the internal components of universal multimodality sensor modules <NUM>.

In accordance with a further aspect of the present invention, selected individual sensors within each respective multimodality sensor module are powered depending upon the selected location of its respective receiver unit on the wearer's body. In one aspect, leads <NUM> may also engage contacts within receiver units <NUM>. In accordance with an aspect of the present invention, the contacts within receiver units <NUM> may be selectively differentiated so that receiver units with specific contacts may be located at specified locations on wearer <NUM>. When universal multimodality sensor module <NUM> is coupled to a receiver unit <NUM>, leads <NUM> may interpret the specific contacts whereby processor <NUM> may selectively control which sensors <NUM>-<NUM> are powered by battery <NUM> to receive health data from the wearer. In an additional or alternative aspect, computing device <NUM> may include a software application configured to selectively communicate with each individual universal multimodality sensor module <NUM>. Wearer <NUM> (or a physician) may utilize the application to instruct each universal multimodality sensor module <NUM> which sensors <NUM>-<NUM> are to be powered and unpowered. By way of example, receiver unit 104c located at the chest of wearer <NUM> may power ECG sensor <NUM> while leaving oximeter <NUM> unpowered. Conversely, receiver unit <NUM> located proximate the knee of wearer <NUM> may power speaker/microphone <NUM> while leaving unpowered ECG sensor <NUM>.

In accordance with another aspect of the present invention, <NUM>-axis accelerometer <NUM> may be used to detect acceleration data resulting from a user tapping or double tapping any individual universal multimodality sensor module <NUM>. In this manner, a wearer can double tap a universal multimodality sensor module <NUM> when pain is sensed, such as in the back, neck or other part of the body, during motion. Further detail of the related event or activity can be optionally recorded automatically via algorithms or manually in computing device <NUM>, such as for example pain level, neurological deficit associated activities, etc. For example, a wearer can choose to record down pain lever during that moment in a scale from <NUM> to <NUM> while sensor data is uploaded to cloud-based database <NUM>. This sensor data may include head and cervical-thoracic-lumbar spine data, as well as joint and other musculoskeletal or neurological status or cardiopulmonary parameters. In a further aspect of the invention, artificial intelligence may analyze the data from universal multimodality sensor modules <NUM> and provide accurate feedback that can be used by a health professional to monitor remote individual health status and notify a wearer to prevent and correct mal-position or injury or disease status.

In this manner, sensors <NUM>-<NUM> are capable of selectively detecting position, motion, neurological signal, blood oxygen level, ECG, EMG, MMG et al. By way of example, speaker/microphone <NUM> may detect j oint friction auditory information will is collected and analyzed by processor <NUM> to determine whether there is pathological process (abrasion) between the articular cartilages. To continue this example, processor <NUM> may filter out noise with the filtered audio being then amplified. The amplified audio data may then be sent to computing device <NUM> and/or cloud-based database <NUM>. The processor unit within computing device <NUM> (or another computer connected to cloud-based database <NUM>) may analyze the audio data and, if potential pathological frequency is detected, notification may be sent to the wearer and/or a medical professional. It should be noted that system <NUM> may not only used in interrogating the skeletomuscular system, but may also be used with, for instance, the cardiovascular system to detected heart sounds, abnormal heart murmur, vascular bruits, the pulmonary system to detect breathing sounds and abnormal breathing sounds, and the gastrointestinal systems to detect bowel movement sounds. In a further example, system <NUM> may be used in conjunction with pregnant women to detect and monitor fetal movement and heartbeat.

In a further aspect of the present invention, system <NUM> may include a notification device <NUM>, such as a haptic/taptic engine and/or light emitting diode (LED). The output (e.g., sound, vibration or light) of notification device <NUM> may vary depending upon the location of the universal multimodality sensor module <NUM> chosen to issue the notification. The universal multimodality sensor module <NUM> chosen may be relevant to the need for notification. By way of example, if a notification regarding neck angle is needed, a universal multimodality sensor module <NUM> located at or near an ear may be chosen to issue an audio alarm through the speaker/microphone. Should the universal multimodality sensor module <NUM> be located on a band along the body, a vibration may be issued through the haptic/taptic engine. If universal multimodality sensor module <NUM> is located proximate hinge of <NUM> of eyeglasses/sunglasses <NUM> (See FIG. 7B) a tangent, LED light notification is used and will flash as a beam of light to lens <NUM>. In a further aspect, notification of computing device <NUM> can also be activated to either vibrate or issue a sound alarm.

In accordance with an aspect of the present invention, a wearer may manually choose the notification method, such as through the software application on computing device <NUM>. Different forms of notification may be considered due to convenience and accessibility, as well as battery usage. There may also be an emergency mode in order to protect the wearer. In the case of an injury or disorder, including traumatic brain injury, such as head shaking movements or neck pressure of the wearer close to the extremum, sudden trembling of the entire body, unreasonable bending beyond the normal range, fall without help or other emergency scenario detected by universal multimodality sensor modules <NUM>, including but not limited to stroke, heart attack, seizure or loss of consciousness, notification device <NUM> will issue a sound (buzzer) alarm, vibration alarm, and an application notice. The alarm may also be sent to the pre-selected contacts such as a family member or medical professional/healthcare provider if an emergency were detected with no return to the normal range after a certain period depending upon the condition detected, such as traumatic brain injury, seizure, stroke, heart attack and/or spine cord injury. Emergency medication or instructions may also be provided via the software application before medical treatment arrives.

From the above discussion, it should be understood that system <NUM> may be used across a number of scenarios. For example, during sports or exercise, system <NUM> can detect and track dynamic head, spine and body part movement and stress and serve to correct the way a wearer moves that may result in injury and/or chronic disease. For the medical field, abnormal head, spine and body movement data can be collected and used to monitor and follow-up with patients with various disorders such a stroke, ADHD, Parkinson's disease, essential tremor, epilepsy, and spine and brain surgery patients.

Returning now to <FIG>, in accordance with another aspect of the present invention, an active correction brace (ACB) <NUM> may be positioned along the head, neck and back <NUM> of wearer <NUM>. ACB <NUM> includes an electronically adjustable elastic bandage that can selectively adjust the tightness degree of the bandage. Thus, should minor to moderate mal- position of the dynamic cervical and thoracic lumbar alignment be detected, the tension of ACB <NUM> may be adjusted so as to correct the wearer's body posture, including the positions of head, cervical -lumber vertebrae and pelvis, etc. As a result, head and spine biomechanical related injury and disease progression may be slowed or prevented. In the case of an injury or emergency, ACB <NUM> may be adjusted to output a correcting tension so as to intervene and prevent the excessive movement until medical personnel can arrive.

During the initial setup, cervical universal multimodality sensor modules <NUM> is worn around head area and compares the related positing to alignment from C2 to C7. <NUM>-axis accelerometer <NUM> then uses both points as reference and is calibrated by flexing, extending and rotating the head and neck from neutral position for cervical calibration. Lumbar calibration can be initialized by standing or sitting against wall. All data is securely stored in memory <NUM>, and no communication to computing device <NUM> or cloud-based database <NUM> is needed to access this calibrated data. Once calibration is completed, system <NUM> is ready for use, such as for a predetermined length of time (e.g., <NUM> week) before system <NUM> should be recalibrated. Optionally, during calibration, notification device <NUM> may be disabled to enable detection of a baseline. The notification device <NUM> may then be turned on for notification intervention as described above.

In accordance with a further aspect of the present invention, photographs of the lateral and anteroposterior (AP) head and body view can be taken by any suitable device, such as a cell phone or digital camera. These images can then be matched and compared with a medical image, such as X-ray, CT or MRI taken by a medical professional. By matching, comparing and combining the photograph and critical internal points with the medical images, analysis of head, spine and body photos provide detailed real-time head and spine alignment parameters, including cervical lordosis angle, chin-brow angle, cervical sagittal vertical axis (SVA), pelvic incidence, lumbar lordosis angle, pelvic tile, SVA, etc. (see <FIG>). The critical spine alignment indexes may then be matched, calibrated and summarized through machine-learning. Thus, all the key cervical, thoracic and lumbar alignment indexes are measured through lateral and AP head and body photos without a complete battery of professional medical images, which are expensive and carry the risk of repeated exposure to radiation.

From the above and in accordance with an aspect of the present invention, a wearer's neurological status may be evaluated by system <NUM> through a minimal mental status exam including testing of <NUM> cranial nerve functions, a motor and sensation test, and coordination and gait assessment. Universal multimodality sensor modules <NUM> and the software application on computing device <NUM> can evaluate each component of the entire neurological system. Baseline and updated photographs, along with voice and sensor data, combined with the left and right asymmetric pattern enable a determination as to whether the wearer has any neurological deficits.

By way of example, the minimal mental status exam including orientation questions to time, place and person, short term and long term memory can evaluated by preset question options in the software application. Language evaluation can be performed by comprising real- time voice recordings with the pre-reordered baseline standard voice, and assisted by nonverbal hint in the application to determinate dysphagia or other oral impairment. The psychiatric evaluation can be performed through the software application using standard test batteries. The <NUM> cranial nerve tests include visual acuity and visual field. Pupil reaction can be evaluated by comparing baseline bilateral pupil size and reactive pupil size, shape and reactive pattern under flashlights emitted from computing device <NUM>. Ocular movement innervated by the cranial nerve (CN) <NUM>, <NUM>, <NUM> can be recognized by bilateral eye neutral position and then movement pattern to all peripheral lateral directions by computing device <NUM>. Facial sensation by CN5 is tested by touch feeling and reaction to the bilateral three facial zones to light touch. Facial pattern can be recognized by comparing baseline facial photos with and without smile with real-time facial photos taken by computing device <NUM> to see left and right asymmetric pattern difference. The bilateral hearing is evaluated by reaction to the sounds of different tone with different frequency and intensity. The open mouth view are taken to see the baseline and updated real-time photos after pronouncing particular sounds to see the left and right symmetric pattern change. Frontal view head and body photos may be taken to evaluate left and right shoulder height difference with and without the shoulder shrugging. The motor strength and motion pattern of bilateral body, upper and lower extremities can be performed by bilateral universal multimodality sensor modules <NUM> positioned around the left and right body, upper extremities like wrists and lower extremities like ankles. Movement pattern and speed difference may be compared, in addition to pressure data detected by the pressure sensor in computing device <NUM> after applying pressure on a designated screen area. The sensation is evaluated by a response to the preset vibration of the universal multimodality sensor module <NUM> or computing device <NUM> in different parts of the body and limb areas. The coordination function is detected by motion pattern and speed from the universal multimodality sensor module <NUM> to response to the upper and lower extremities coordination tests like hand-to-nose test or by detecting the accuracy of touching a still and moving object on the screen of computing device <NUM>. Gait is evaluated by universal multimodality sensor modules <NUM> which acquire data including, but not limited to the gait speed, pattern, turning, initial, stop and rest break. The neurological exam, along with symmetry monitoring may be used to detect stroke, attention deficit/hyperactivity disorder (ADHD), Parkinson's disease, essential tremor, epilepsy and/or to monitor spine and brain surgery patients.

Claim 1:
A system for monitoring and treating head, spine and body health status, comprising: a) a plurality of receiver units (<NUM>) wherein each receiver unit (<NUM>) is configured to be secured at a selected location on a wearer's body; and b) a plurality of universal multimodality sensor modules (<NUM>), each comprising one or more individual sensors, a power source (<NUM>), a printed circuit board (<NUM>) including a processor (<NUM>), memory (<NUM>) and communication module (<NUM>), wherein a respective multimodality sensor module (<NUM>) is coupled with a respective receiver, characterized in that,
one or more selected individual sensors within said each respective multimodality sensor module (<NUM>) is powered depending upon said selected location of its respective receiver unit (<NUM>) on said wearer's body;
wherein health data related to the head, spine or body movements of the wearer (<NUM>) is sensed at regular intervals using said one or more powered selected individual sensors;
characterized in that
the plurality of receiver units (<NUM>) have contacts with configurations specific to the selected locations, the configurations causing selection of the one or more individual sensors; and
when the universal multimodality sensor module (<NUM>) is coupled to the receiver unit (<NUM>), leads (<NUM>) interpret the specific contacts whereby one or more of the individual sensors are selected by the processor (<NUM>) to power to receive the health data from the wearer (<NUM>).