The present invention relates generally to techniques for efficiently managing spine deformation treatment, and more particularly to a back brace, a system and method for efficiently managing spine deformation treatment.
Scoliosis, one type of spine deformation, affects 2-3 percent of the population, or an estimated six to nine million people in the United States. Scoliosis can develop in infancy or early childhood. However, the primary age of onset for scoliosis is 10-15 years old, occurring equally among both genders. Females are eight times more likely to progress to a curve magnitude that requires treatment. Every year, scoliosis patients make more than 600,000 visits to private doctor's offices, an estimated 30,000 children are fitted with a back brace and 38,000 patients undergo spinal fusion surgery.
Back braces are only effective in patients who have not reached skeletal maturity. If the child is still growing and his or her curve is between 25 degrees and 40 degrees, a brace may be recommended to prevent the curve from progressing. There have been improvements in brace design and the newer models fit under the arm, not around the neck. There are several different types of braces available. While there is some disagreement among experts as to which type of brace is most effective, large studies indicate that braces, when used with full compliance, successfully stop curve progression in about 80 percent of children with scoliosis. For optimal effectiveness, the brace should be checked regularly to assure a proper fit and may need to be worn 16 to 23 hours every day until growth stops.
A scoliosis curve that is 50 degrees by the time an adolescent reaches skeletal maturity (about the age of 14 or 15 for girls and 16 or 17 for boys) will continue to progress throughout adulthood. These types of curves are likely to become a severe deformity that requires surgery. Therefore, the goal of bracing is to avoid a major surgery by either stopping curve progression altogether or at least preventing it from reaching 40 or 50 degrees at the time of skeletal maturity.
Having scoliosis can be emotionally upsetting for adolescents. Scoliosis can cause adolescents stress and negatively affect their body image.
Bracing is currently the primary method for treating moderate idiopathic scoliosis (IS) during the developmental phase of growth. Accurate evaluation of patient compliance with scoliosis brace usage has been a challenge for doctors treating patients with IS. This inability to accurately measure compliance has resulted in difficulty in determining brace treatment efficacy. Previous studies have used either questionnaires to determine compliance or verbal reports on the number of hours worn to a nurse at the clinic. The number of wear hours reported in these studies was subjective and difficult to verify due to reliance on patient recall, with the possibility of false reporting. Monitoring devices were proposed that can address some of the earlier technical shortcomings and to determine the adequacy of using these devices as a reliable and accurate means of measuring the compliance of brace wear in the treatment of idiopathic scoliosis. For example, systems are known in the prior art which measure the number of hours a brace is worn by a patient using thermal and/or pressure sensors. Studies have shown that monitoring of the patient's compliance has affected positively the wearing time of the back brace.
However, recording the daily usage of the brace is not enough for monitoring a patient's progress in the treatment as the previous systems cannot measure the improvement of the patient's spine curvatures as a result of the use of the brace in the treatment. For this reason, it is not possible for such systems to provide guidance to the patient, or adapt the treatment regime.
Also, patients, especially those of younger ages, easily lose motivation to follow their treatment regime or cut corners to make their lives with the brace easier. In addition, patients have no guidance on how to correctly and efficiently use the brace, until their next appointment with their doctor. As these appointments are usually scheduled every few months, patients loose motivation and/or have no means to correct mistakes (e.g. improper fitting on the torso, or improper tightening of the fitting straps) in using the brace in the prescribed, correct way.
Despite the existence of electronic monitoring systems fitted on braces (e.g. heat and/or pressure sensors for detecting wear time of the brace), monitoring a patient's progress needs to be done by a doctor. However, this is a rather inefficient process due to rare appointments with the doctor. The clinician must determine the progress of the treatment using the patient's curve and adjust the brace accordingly. The number of wear hours reported is subjective and difficult to verify due to reliance on patient recall, with the possibility of false reporting. Also, despite being accurate, the sensory data for the duration of use of the brace, provided by the above monitoring systems is not sufficient for estimating important parameters used in judging correct use of the brace according to the prescribed treatment regime. For example, the fact that the user wears the brace for the prescribed number of hours does not guarantee that the brace is worn properly according to the doctor's instructions. Low (or some cases excessive) pressure may be applied by the brace to pressure points on the patient's spine, or even be applied at wrong pressure points because the brace is not correctly positioned, or in more extreme situations due to problems in the 3D shape of the brace, failure of the brace due to wear or improper use, or simply due to changes in the patient's body as a result of putting on or losing weight, or developing extra muscle mass due to exercising.
Without a way to access such data for evaluating the compliance of the patient to the doctor's instructions, the doctor has to physically examine the patient for evaluating the patient's progress in the treatment (e.g. how well his spine reacts). This means that the doctor will schedule an appointment every few months without having any way to check progress in the meantime. This is standard practice, which may, however, seriously affect patient progress in the treatment as for situations of no conformance to the regime, problems with brace itself, or unexpected response of the patient's spine to the treatment, the doctor can assess the situation and make adjustments only during the physical examination. In other words, months may be lost, seriously setting back the patient in his treatment, or even aggravating the spinal deformation.
There is, therefore, the problem of facilitating doctors in efficiently monitoring and managing treatment of spinal deformations, while aiding and incentivizing and guiding patients to efficiently follow the prescribed treatment regime.
The present invention solves the problem of facilitating doctors in efficiently monitoring and managing treatment of spinal deformations, while aiding and incentivizing and guiding patients to efficiently follow the prescribed treatment regime. The invention solves the problem using real-time pressure measurements to calculate the pressure applied at selected pressure points on the patient's spine, data analysis, and scheduling of doctor interventions and appointments with the patient for optimizing the personalized treatment of the patient's spinal deformation (such as scoliosis).
A system is presented which uses pressure sensors attached on the inner surface of a brace for detecting when the brace is worn by the patient and the pressures applied by the brace at pre-determined pressure points onto the patient's torso. These points are selected by the doctor to apply pressures on the spine for forcing it to acquire its physiological curvatures and are implemented by 3D modeling of the brace to the 3D model of the patient's torso and the 3D deformations of his spine. The pressure measurements are collected and time-stamped by a wearable device wired or wirelessly connected to the sensors. The wearable device locally stores the time-stamped pressure measurements in real time and transmits them to an application running at a smartphone or other computing device used by the patient and/or his family members in case of a child patient. The patient's smartphone connects to a server and uploads the data. The server processes the data and creates metrics relating to the usage of the brace. The metrics are associated by the server with a personalized treatment regime created by the patient's doctor, using his own computing device, and communicated to the server. Both the patient and the doctor can access the processed data on the server through the applications running at the respective devices. Different views and tools for the same data are offered to the patient and his doctor in order to serve the needs of each one.
The patient can access from the server the metrics in the form of a graphical presentation, instruction on how to efficiently use the brace, advice from the doctor for correcting the application of the brace, changes in the treatment regime, and a gamification of the treatment for incentivizing him to follow the treatment. The gamification is particularly suitable to children at preadolescent age, who are presented with a video game or a gamified application, which is adapted to the patient's condition and/or preferences and uses awards related to the correct use of the brace according to the prescribed treatment regime and patient progress.
The doctor can create on the server a patient account and treatment regime, access from the server the metrics, adapt the treatment regime, send advice to the patient for correcting the application of the brace, schedule appointments with the patient at optimal times and dates that are beneficial for managing the progress of the therapy based on the metrics (e.g. for minimizing the need to order and examine a spine X-ray), and receive alerts associated with the metrics and the patient's progress.
The system runs software to implement a method along the lines described above for the system components (i.e. wearable system and sensors, patient's mobile application, server, and doctors web application) and stakeholders (i.e. the patients, and the doctor).
Beyond accessing the above needs of the patient and doctor, the system also innovates by considering both the patient's and the clinician's perspective, providing real-time monitoring and management, and addressing the patient's emotional state and needs by providing gamification and real-time metrics and advice aiming to motivate the patient to wear the brace for the prescribed time and in the correct manner.
A back brace is also presented, having one or more straps for tightening in order to adjust the pressure at each of one or more points of pressure, one pressure sensor attached to the inner side of the brace at each of the one or more points of pressure for sensing the pressure exerted to the wearer of the brace, and a wearable device connected to the sensors. The wearable device may be attached to the outside of the brace or inside a cavity formed in the material of the brace. The wearable device processes signal from the pressure sensors, communicates with a patient's computing apparatus, and informs and guides in real time, and incentivizes the patient to more efficiently wear the back brace, by at least providing indications to the patient for tightening the at least one strap by comparing a pressure value provided by each of the at least one pressure sensor with at least one calibration value, and enables a doctor to more efficiently monitor, intervene, and manage a plurality of patients and their treatments in real time.
The word “Any embodiment described herein as “exemplary” is not necessarily to be construed as preferred or advantageous over other embodiments.
The term “exemplary” is used herein to mean “serving as an example, instance, or illustration”.
The acronym “A/D” is intended to mean “Analogue to Digital”.
The acronym “App” is intended to mean “Application”.
The acronym “ASCII” is intended to mean “American Standard Code for Information Interchange”.
The acronym “ASIC” is intended to mean “Application-Specific Integrated Circuit”.
The acronym “Bluetooth LE” is intended to mean “Bluetooth Low Energy”.
The acronym “CD” is intended to mean “Compact Disc”.
The acronym “DSL” is intended to mean “Digital Subscriber Line”.
The acronym “DVD” is intended to mean “Digital Versatile Disc”.
The acronym “HIS” is intended to mean “Hospital Information System”.
The acronym “IS” is intended to mean “Idiopathic Scoliosis”.
The acronym “IMU” is intended to mean “Inertial Measurement Unit”.
The acronym “LED” is intended to mean “Light Emitting Diode”.
The acronym “Mob” is intended to mean “Mobile”.
The acronym “PACS” is intended to mean “Patient Archiving and Communication System”.
The acronym “PIF” is intended to mean “Patient Information Folder”.
The acronym “QR” is intended to mean “Quick Response”.
The acronym “RTC” is intended to mean “Real Time Clock”.
The acronym “XML” is intended to mean “eXtensible Markup Language”.
The term “mobile device” may be used interchangeably with “client device” and “portable device with wireless capabilities”.
The term “user” may be used interchangeably with “regular user”, “ordinary user”, and “client”. It may also be used to mean “user of an application” or “user of a service”. It may also be used to refer to a “patient using a device, application, or service”, or to a “doctor using a device, application, or service”, unless otherwise explicitly stated or implicitly hinted at in the description, or obvious to a reader of ordinary skill in related art that these terms refer to different things, as this is apparent by the context of the discussion in which they appear.
The term “physician” may be used interchangeably with “doctor”.
The term “system” may be used interchangeably with “device”, “computing device”, “apparatus”, “computing apparatus”, and “service”, except where it is obvious to a reader of ordinary skill in related art that these terms refer to different things, as this is apparent by the context of the discussion in which they appear. Under any circumstance, and unless otherwise explicitly stated or implicitly hinted at in the description, these six terms should be considered to have the broadest meaning i.e. that of encompassing all six.
The term “module” may be used interchangeably with “unit” or “subunit”, except where it is obvious to a reader of ordinary skill in related art that these terms refer to different things, as this is apparent by the context of the discussion in which they appear.
The term “back brace” may be used interchangeably with “brace”.
The term “treating spinal deformations” may be interpreted as “constraining the spine” or “correcting spinal deformations”, as this is apparent by the context of the discussion in which they appear.
A Back Brace Equipped with the Hardware of the Present Invention
Back brace 110 is equipped on its inner surface with one or more pressure sensors which, are securely attached to the back brace with an adhesive, at an area of contact 145 with the human torso. Area of contact 145 contains the point of pressure to be applied to the corresponding area of the patient's torso for correcting a spinal deformation and/or constraining the spine.
The pressure sensor is covered with a foam material 140, such as foam strips, which is intended to make the sensor comfortable for the patient wearing the brace 110. The pressure sensors can be placed between the inner surface of the back brace 110 and the foam strip that the patient's doctor attaches inside the brace, at the pressure points of the brace.
The pressure sensor(s) are connected to wearable device 161 which collects signals from the pressure sensor(s). Wearable device 161 is typically attached on the outside of the brace, in a manner that allows easy detachment and reattachment. Usually, the wearable device 161 is attached by Velcro® tape, at any point on the outside of the back brace (more usually at the side at waist level), or it is attached at a strap 120. In alternative exemplary embodiments, the wearable device 161 may be worn by the patient on a belt, wrist-band or the like, or carried into a pocket.
The connection of the pressure sensors with the wearable device is typically via cables attached (e.g., with a self-adhesive tape, or other known attachment mechanism) to the back brace. In alternative exemplary implementations, the connection is wireless, avoiding the need for cables. If such a wireless connection is chosen, the pressure sensors must be selected from pressure sensors with integrated wireless capabilities or they should be connected to wireless transceivers at a close distance to or in contact with a side face of the sensors, again for avoiding using cables.
Sensor 220 may be selected from known resistive or capacitive pressure sensors. In alternative implementations, other types of pressure sensors may be used, without limiting the scope of protection of the present invention.
Microprocessor 540 may be selected from any known embedded microprocessors, Application-Specific Integrated Circuit (ASICS), and the like, etc.
Support modules 510, contain a battery 515 for powering control unit 500, a Real Time Clock (RTC) 520 for providing time-date data to processor 540, a flash memory 525 for storing pressure measurement from pressure sensors 220 and computer instructions, an Inertial Measurement Unit (IMU) 530 for detecting patient torso's motion, orientation and acceleration, an Analogue to Digital (A/D) converter 535 for converting analogue signals from pressure sensors 220 to digital signals fed to processor 540, a Bluetooth module 539 for wirelessly communicating with external computing apparatuses that receive sensory data associated with the wearing of the back brace, and battery management system 537 for managing battery charging and power use.
Flash memory 525 may be replaced or supplemented with other types of known memory modules. IMU 530 may be implemented with an accelerometer, inertial sensor, and a magnetometer, known in the prior art.
Pressure sensors 220 may be of any number matching the number of pressure points a doctor may select and connect to processor 540 via A/D converter 535.
In an alternative exemplary embodiment, pressure sensors 550 (in the illustrated example four pressure sensors 555, 560, 565, 570 are shown which may be of the same or different types) are part of control unit 500.
System Operation
Operation flow diagram 700 starts with the patient attending a first appointment for examination with his doctor 710. The doctor creates a patient account 720 using his computing apparatus (e.g. a smartphone, or any other computing apparatus), by connecting to a server.
A first system setup 730 is done (please refer to
First System Setup
Installing the Wearable Device
Wearable Device Connection with the Patient's Mobile Application
If the patient chose the Bluetooth scan option, the mobile device scans all active Bluetooth devices in the area (1017) and prompts the patient to choose the device based on its Bluetooth name (1019).
If the wearable device is discoverable from the mobile application running on the patient's mobile device (1050), then the mobile application stores the connection information to its local memory (e.g. a flash or other type of memory which stores data in any known data format in an optional database) for future connections (1060), and uploads connection information associated with the patient and his wearable device to the server (1070), before ending connecting the wearable device with the mobile application.
If the wearable device is not discoverable from the mobile application (1050), the mobile application requests the patient to reset the wearable device via pressing a reset button in the wearable device (1052). If Light Emitting Diode (LED) indications light on the mobile device (1054), the methodology branches to step 1010, else the doctor replaces the wearable device (1056) and then step 1010 is executed.
System Calibration
If the wearable device is not discoverable (1135), the mobile application on the patient's mobile device increments a counter (1190) (which was already in reset state) and repeatedly scans 1130 (e.g., for five more times) for the wearable device until a threshold number of unsuccessful scans is reached 1195 and then the mobile application ends the process.
If the wearable device is discoverable (1135), the mobile application requests the pressure data from the wearable device using a Bluetooth connection (1140). The data are retrieved through a Bluetooth communication protocol (1145), transferred/broadcasted to the mobile application (1150), stored inside the mobile application (1160) and at the mobile device's memory, calibration results are sent to the wearable device (1165), and are then uploaded to the server (1170). Then the results of the calibration are displayed to the mobile application of the patient's mobile device (1180) (or any other computing apparatus used by the patient) and in the web application accessed by the doctor (1185) using his computing device, and the process ends.
System Adjustment
If the wearable device is not discoverable (1230), the mobile application increments a counter (1235) (which was in reset state at the beginning of process 1200) and repeatedly scans (1225) until a threshold is reached (1240) (e.g. for five more times) before ending the process.
If the wearable device is discoverable (1230), the mobile application requests the pressure data from the wearable device using the Bluetooth connection (1245) and it displays the pressure values live on the screen of the mobile app (1250). The patient then gradually tightens the straps of the back brace based on the indications of the application (1255). If the values of the pressure sensor readings have not reached the calibration values from the tightening of the straps (1260), and the straps have not been tightened to the prescribed points (1290), the mobile application requests pressure data from the wearable device using the Bluetooth connection (1245) and checks if the straps have been tightened to the end (1280) If the straps have been tightened to the end (1280), it is indicated to change the back brace (1285) and methodology 1200 ends. If the straps have not been tightened to the end (1280), step 1245 is executed. If the straps have been tightened to the prescribed points (1290), an indication is given to correct (1292) the back brace and to book a new appointment with the doctor (1294), and the methodology ends.
If the pressure values have reached the calibration values from the tightening of the straps (1260), adjustment results are stored in the mobile application 1260, are uploaded to the server (1270), and the methodology ends.
Patient Access to Data
The patient can use an application running on his smartphone (or at any computing device he uses) to access the metrics from the server, instruction on how to efficiently use the brace, advice from the doctor for correcting the application of the brace on the patient's torso, changes in the treatment regime, and a gamification of the treatment for incentivizing him to follow the treatment.
In a first aspect, the patient's application motivates young adolescents to increase compliance in the prescribed use of the brace through actual wearing metrics, achievements and badges. The patient's application also provides analytics (e.g. charts, graphs, etc.) for the patient's daily, weekly, monthly and yearly activity. This is complemented by instructions on the correct use of the brace, advice from his doctor relating the treatment, and reminders of scheduled appointments.
In a second aspect, the patient's application uses gamification, which is particularly suitable for children of pre-adolescent age. This aspect, the patient's application presents to the child patient a game, which is adapted to the patient's treatment regime and progress (as provided by the usage metrics) and uses awards related to the correct personalized use of the brace.
An example game consists of an incremental game where the patient can oversee an ant hive. The purpose of the game is to expand the ant hive by purchasing ants. The game has two currencies: “leaves” and “strawberries”. The ants collect leaves. The player can trade them in order to purchase more ants for the hive. Furthermore, the player can collect more leaves by tapping the screen. The hive has an upper limit in the ant population at a specific level. The user can upgrade the hive level using the second currency (strawberries). The only way the user can collect strawberries is by wearing its back brace for the prescribed time. Furthermore, the app has a set of achievements and awards in order to increase the wearing time of the brace. Other games can be created and presented to child patients for selecting their preferred one and further boost their incentivization. Other game scenarios can be accommodated without limiting the scope of protection of the invention.
Doctor Access to Data
The doctor can create on the server (using his computing device) a patient account and a personalized treatment regime, and access from the server the metrics, adapt the treatment regime, send advice to the patient for correcting the application of the brace, schedule appointments with the patient at optimal times and dates that are beneficial for managing the progress of the therapy based on the metrics, and receive alerts associated with the metrics and the patient's progress.
The above actions and related data may optionally be shared with other software and systems used by the doctor (e.g. calendar applications, Patient Archiving and Communication System (PACS), Patient Information Folder (PIF), Hospital Information System (HIS), etc.).
Software Architecture
The system is based on following software modules:
The embedded software running at the wearable device performs at least one of the following:
The patient application performs at least one of the following:
The server software performs at least one of the following:
Other functions may also be performed by the software, as is apparent to any person skilled in the art.
The patient and doctor software applications may be written in any computer language (high-level, descriptive—e.g. eXtensible Markup Language (XML), low-low level, assembly language, etc.) or combination of computer languages.
The server software may be written in any computer language or combination of computer languages and be offered as a web application, or as web services.
The patient's application and the server software are designed to inform and guide the patient in real time, and also to incentivize the patient to more efficiently wear the back brace.
The doctor's application and the server software are designed to allow the doctor to more efficiently monitor, intervene, and manage any number of patients and their treatments in real time.
Hardware Architecture
In an alternative exemplary embodiment, system 1300 consists only of wearable device 1340 and the patient's computing apparatus 1330, and server 1310 and doctor's computing apparatus 1320 are external modules or systems.
It will be appreciated that the present invention solves the problem of facilitating doctors in efficiently monitoring and managing treatment of spinal deformations, while aiding and incentivizing patients to efficiently follow the prescribed treatment regime. It solves the problem using real-time pressure measurements, data analysis, and scheduling of doctor interventions and appointments with the patient for optimizing the personalized treatment of the patient's spinal deformation. As described herein according to the embodiments, a wearable device and pressure sensors are attached to the inside of a back brace, for collecting, timestamping and sending pressure measurements to a server, using a patient computing apparatus as a relay. The server creates metrics, and manages treatment, giving access to processed data to the patient's doctor and to the patient, and offering gamification for patient incentivization to the use of the brace according to the treatment regime prescribed by the doctor. Processed data created by the server are presented to the patient and doctor computing devices.
The present innovative solution can also be implemented by software written in any programming language, or in an abstract language (e.g., a metadata-based description which is then interpreted by a software or hardware component). The software running in the above-mentioned hardware, effectively transforms a general-purpose or a special-purpose hardware or computing device, apparatus or system into one that specifically implements the present innovative solution. In another aspect an embedded system is used for the wearable device.
Alternatively, the present innovative solution can be implemented in Application Specific Integrated Circuits (ASIC) or other hardware technology.
The above exemplary embodiment descriptions are simplified and do not include hardware and software elements that are used in the embodiments but are not part of the current invention, are not needed for the understanding of the embodiments, and are obvious to any user of ordinary skill in related art. Furthermore, variations of the described system architecture are possible, where, for instance, some servers may be omitted or others added.
Various embodiments of the invention are described above in the Detailed Description. While these descriptions directly describe the above embodiments, it is understood that those skilled in the art may conceive modifications and/or variations to the specific embodiments shown and described herein. Any such modifications or variations that fall within the purview of this description are intended to be included therein as well. Unless specifically noted, it is the intention of the inventor that the words and phrases in the specification and claims be given the ordinary and accustomed meanings to those of ordinary skill in the applicable art(s).
The foregoing description of a preferred embodiment and best mode of the invention known to the applicant at this time of filing the application has been presented and is intended for the purposes of illustration and description. It is not intended to be exhaustive or limit the invention to the precise form disclosed and many modifications and variations are possible in the light of the above teachings. The embodiment was chosen and described in order to best explain the principles of the invention and its practical application and to enable others skilled in the art to best utilize the invention in various embodiments and with various modifications as are suited to the particular use contemplated. Therefore, it is intended that the invention not be limited to the particular embodiments disclosed for carrying out this invention, but that the invention will include all embodiments falling within the scope of the appended claims.
In one or more exemplary embodiments, the functions described may be implemented in hardware, software, firmware, or any combination thereof. If implemented in software, the functions may be stored on or transmitted over as one or more instructions or code on a computer readable medium. Computer-readable media includes both computer storage media and communication media including any medium that facilitates transfer of a computer program from one place to another. A storage media may be any available media that can be accessed by a computer. By way of example, and not limitation, such computer-readable media can comprise RAM, ROM, EEPROM, CD-ROM or other optical disk storage, magnetic disk storage or other magnetic storage devices, or any other medium that can be used to carry or store desired program code in the form of instructions or data structures and that can be accessed by a computer. Also, any connection is properly termed a computer-readable medium. For example, if the software is transmitted from a website, server, or other remote source using a coaxial cable, fiber optic cable, twisted pair, digital subscriber line (DSL), or wireless technologies such as infrared, radio, and microwave, then the coaxial cable, fiber optic cable, twisted pair, DSL, or wireless technologies such as infrared, radio, and microwave are included in the definition of medium. Disk and disc, as used herein, includes compact disc (CD), laser disc, optical disc, digital versatile disc (DVD), floppy disk and blu-ray disc where disks usually reproduce data magnetically, while discs reproduce data optically with lasers. Combinations of the above should also be included within the scope of computer-readable media.
The previous description of the disclosed exemplary embodiments is provided to enable any person skilled in the art to make or use the present invention. Various modifications to these exemplary embodiments will be readily apparent to those skilled in the art, and the generic principles defined herein may be applied to other embodiments without departing from the spirit or scope of the invention. Thus, the present invention is not intended to be limited to the embodiments shown herein but is to be accorded the widest scope consistent with the principles and novel features disclosed herein.
This application claims the benefit of U.S. Provisional Patent Application No. 63/137,765 filed on Jan. 15, 2021.
Number | Date | Country | |
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63137765 | Jan 2021 | US |