Sensor and Feedback Platform for Use in Orthotic and Prosthetic Devices

Systems and methods for monitoring/measuring parameters related to the use of devices/systems in various diagnostic/therapeutic applications are provided. The systems/methods communicate monitored/measured parameters to data processing and/or data display units for review and/or responsive action. Modular units may be provided for use with orthotic devices, e.g., arm slings and orthotic boots for foot and lower leg immobilization, and in conjunction with prosthetic devices, e.g., prosthetic arms and/or legs. The sensing/feedback mechanisms may be strap-based, or mounted/associated with webbing, ratchet systems and/or other tensioning mechanisms. The sensing/feedback mechanism may include an inductive sensor that interacts with conductive material embedded in a strap to produce a signal indicating the location of the inductive sensor with respect to the strap. The position sensor may include multiple coils and multiple conductive materials may be imbedded in the strap. The conductive material may define a variable width along the X-axis (as defined by the strap). The inductive sensor may also be used to measure the distance from the coil and a conductive material that interacts with a section of the orthotic or prosthetic device along the z-axis.

BACKGROUND

1. Technical Field

The present disclosure is directed to the use of sensing systems and methods for monitoring and/or measuring parameters related to devices/systems for use in various diagnostic, therapeutic and/or prosthetic applications, and to communicating the monitored and/or measured parameters to data processing and/or data display units for review and/or responsive action. Exemplary implementations of the disclosed systems and methods relate to modular attachment apparatus/mechanisms for use with orthotic braces and prosthetic devices.

2. Background Art

The use of braces, e.g., scoliosis braces, orthotic braces and prosthetic devices, to correct and/or limit further damage or degradation to orthotic conditions has been long-standing. For example, scoliosis braces, leg braces and arm slings are frequently used to immobilize limbs that have incurred bone or soft-tissue injury. In another example, prosthetic limbs can vastly improve, or even return the quality of life to those who have sustained injuries that resulted in loss of limbs. Current treatment methods, whether orthotic braces or prosthetic devices, frequently use strap systems that require an optimum tension to facilitate proper fit and/or healing. Of note, in some cases the orthotic braces and, in particular, prosthetic devices are custom fabricated for each individual patient based on unique anatomical considerations. The information supplied to the user and/or the users' colleague(s), e.g., parent(s), is limited in terms of the use of the brace or device. Indeed, users and others involved in assisting users of such braces/devices are frequently uncertain as to whether the brace/device is being worn properly, e.g., tightened to an appropriate degree, or for an appropriate duration. As a result, care providers have no way to make informed decisions on patient wear characteristics in order to improve treatment.

In another example, adolescent idiopathic scoliosis is a medical condition characterized by a moderate to severe curvature of the spine. Current treatment methods may consist of a hard plastic brace that straightens the spine when the straps of the brace are tightened. Of note, each scoliosis brace is generally custom fabricated for each individual patient based on unique anatomical considerations. The information supplied to the user and/or the user's colleague(s), e.g., parent(s), is limited in terms of the use of the brace. Indeed, users and others involved in assisting users are frequently uncertain as to whether the brace is being worn properly, e.g., tightened to an appropriate degree, or for an appropriate duration

Use of prosthetic devices involves further challenges. Patients often find it hard to put on prosthetic devices correctly, in part because the devices often rely on the patients to tighten or otherwise don and doff the device. This difficulty can result in an uncomfortable fit and/or ineffective treatment. Patient reported data is necessary to adjust fit of prosthetics, or perhaps even change the type of device prescribed. Inaccurate information can result in improper fittings or prescriptions that will impact the patient's level of activity or adherence to therapy regimens. Health insurance reimbursement is often based on a patient's continued progress and could be in jeopardy without an appropriate or required level of adherence. Even when patients are able to correctly don and doff prescribed orthotic and/or prosthetic devices, they often have no way to keep track of and set goals for activity, steps, range of motion, to facilitate progress and/or recovery from an illness or injury.

There currently exists a gap between low-cost orthotics and prosthetics, which typically are purely mechanical devices with no electronics or sensing capabilities, and high end, expensive orthotics and prosthetics, which can provide a wealth of valuable information and feedback to users and care providers. Companies that would like to integrate sensing/feedback capabilities into their existing orthotic and prosthetic devices must often start from scratch, and are unable to utilize existing work in the field.

Furthermore, patients are currently told to pull the straps on their braces to a position that is prescribed by their orthotists. The point at which the strap is to be pulled is often marked with a marker and does not change in-between visits to the clinic. Currently there is not an effective method to measure this position automatically while the patients are away from the health care provider to ensure patients are pulling the strap to a correct point. It is hard for patients to pull to the point by themselves if the strap is behind their back, because they cannot see the mark drawn by the orthotist. Rather, the mark to which patients are to pull cannot be updated in-between visits resulting in a static target level for brace tightness.

Efforts have been made to develop compliance monitors for scoliosis braces, but commercially available efforts have failed to yield products/systems that meet the needs of users and/or medical professionals. For example, compliance monitors that have been developed-to-date suffer from shortcomings that include (i) an inability to incorporate or integrate the compliance monitor into existing brace designs, (ii) an inability to measure both compliance and quality of brace wear, and (iii) an inability to provide meaningful and/or actionable feedback to patients, colleagues of patients (e.g., parents) and/or physicians and other health care providers.

To the extent compliance monitors have been pursued, the focus-to-date (other than the work of the present inventors) has been directed to the incorporation of a temperature sensor to record how long a patient has worn the scoliosis brace. Thus, when the temperature sensor notes an elevated temperature, it is concluded that the scoliosis brace is being worn by the patient. Conversely, when an elevated temperature is absent, then it is concluded that the scoliosis brace is not being worn by the patient. As is readily apparent, the inclusion of a temperature sensor provides very limited information concerning a patient's use of a scoliosis brace. For example, no information is provided with respect to the quality of the brace's use, i.e., whether the brace is being properly worn. Moreover, the nature and quality of the information that is collected, analyzed and stored based on a temperature sensor provide little value to patients, colleagues of patients and/or physicians and other health care providers.

With reference to the patent literature, U.S. Pat. No. 6,926,667 to Khouri discloses a patient monitoring device that includes a microprocessor controller having a clock circuit and memory coupled to one or more sensors physically carried by a medical appliance, i.e., vacuum domes for enclosing the breasts of a female patient. According to the Khouri '667 patent, a pressure sensor may be provided in conjunction with one of the vacuum domes to confirm appropriate levels of negative pressure. A temperature sensor may be provided to confirm that a patient is wearing/using the medical device. A third sensor may be provided to confirm the information received from the first or second sensor. The sensors provide an electrical signal that may be timed to confirm a patient's compliance with a recommended protocol. By combining and correlating the sensor data with the clock or timer provided as part of the controller, a time chart of data may be created indicating when and for how long the patient actually wears the device.

U.S. Patent Publication No. 2009/0281469 to Conlon et al. discloses a compliance strapping that includes a predetermined adjustability, tamper deterring and indicating strapping, that is adapted, in use, to form an encircling loop. The compliance strapping is passed around an object and, for further security, the strap can be threaded through lining material or through a wearable article or medical device. The free end of the elongate member is passed through the loop, which may be a D-loop sewn into the strapping, thus forming an encircling loop of strapping. The second end is brought around to close proximity with a region of the strapping which has been passed through the loop. The tamper indicating means, referred to as a self-locking rivet, is fastened to this region of the strapping. Thus, the encircling loop cannot be broken because the region of the strapping with the self-locking rivet fastened thereto cannot pass back through the D-loop.

U.S. Pat. No. 6,540,707 to Stark et al. discloses an exercise orthosis that includes a frame, a fluid bladder held by the frame, a pressure sensor attached to the fluid bladder and a microprocessor for receiving pressure measurements from the pressure sensor. The microprocessor monitors variations in pressure and determines differences between the measured pressures and predetermined target values. The Stark '707 patent further discloses a corrective back orthosis that includes a frame, force applicators connected to the frame to apply force to the patient's spine, a sensor that measures forces associated with the force applicators, and a control unit that monitors forces measured by the sensor. The corrective back orthosis can include fluid bladders as force applicators and the control unit can include a microprocessor.

U.S. Pat. Nos. 6,890,285, 7,166,063 and 7,632,216 to Rahman et al. disclose brace compliance monitors. The Rahman patents generally disclose a brace compliance monitor that includes a compliance sensor, a signal processor, and a display. Compliance data from the Rahman systems is displayed on the display to provide the patient or subject with immediate compliance information on whether they have been wearing the brace for the specified period and in the specified manner. The brace compliance monitor may also include a secondary sensor, such as a tilt sensor, a pressure sensor, a force sensor, an acceleration sensor, or a velocity sensor. The secondary sensors may provide additional compliance data to the patient and health care provider.

Despite efforts to date, a need remains for systems and methods that effectively monitor and/or measure parameters related to the use of devices/systems in various diagnostic and/or therapeutic applications. In addition, a need remains for systems and methods that effectively communicate monitored and/or measured parameters that are collected from such devices/systems to data processing and/or data display units to facilitate review and/or responsive action. More specifically, a need remains for systems and methods that can effectively determine whether a device/system, e.g., an orthotic brace or a prosthetic device, is being properly used, both as to tightness and duration of use, and communicate this information so as to permit responsive action, whether in real-time or at a point in the future. Still further, a need remains for modular attachment mechanisms/modalities that allow broad-based application of advantageous monitoring and/or measuring functionalities across a range of diagnostic, therapeutic and/or prosthetic applications. These and other needs are satisfied by the systems and methods disclosed herein.

SUMMARY

As noted above, the present disclosure is directed to applications of systems and methods for monitoring and/or measuring parameters related to the use of devices/systems in various diagnostic and/or therapeutic applications, and to communicating the monitored and/or measured parameters to data processing and/or data display units for review and/or responsive action. In exemplary embodiments, one or more modular units are provided for use in conjunction with orthotic devices, such as arm slings and orthotic boots for foot and lower leg immobilization. Additionally, exemplary embodiments of modular unit(s) for use in conjunction with prosthetic devices, e.g., prosthetic arms and/or legs, are provided.

The disclosed modular units generally include one or more sensing and/or feedback mechanisms integrated into or otherwise associated therewith. In exemplary implementations, the sensing/feedback mechanisms are strap-based, i.e., mounted or otherwise associated with strap(s) that interact with an orthotic and/or prosthetic device. However, alternative means of implementation relative to orthotic/prosthetic devices are contemplated, e.g., the disclosed modular unit(s) may be mounted or otherwise associated with webbing, ratchet systems and/or other tensioning mechanisms associate with an orthotic/prosthetic device.

In exemplary embodiments, the sensing/feedback unit may be embedded in or permanently fixed to the orthotic and/or prosthetic device. The sensing/feedback unit can sense information on the tightening mechanism or device state without directly being in line with or interacting mechanically with the strap, ratchet, or other tightening mechanism. using of sensing methods, e.g., the inductive or magnetic methods described herein.

The sensing and/or feedback mechanisms associated with the disclosed modular units collect advantageous information as to use of the orthotic/prosthetic device, e.g., the quality and/or compliance of orthotic/prosthetic brace utilization by a prescribed user, step count, activity, range of motion, orientation, and/or additional metrics/measurements of interest. The underlying data collected by the disclosed sensing and/or feedback mechanisms may be the same and/or similar from application-to-application, but the disclosed modular unit(s) generally include (or communicate with) processing unit(s) that are adapted to run algorithm(s) that process such data to generate relevant metrics/measurements that address applicable use cases.

Thus, the noted information may be leveraged in various ways according to the present disclosure, e.g., providing real-time feedback to the prescribed user and his/her colleague(s) (e.g., parent(s)) and providing clinical feedback to the prescribing physician or health care provider, e.g., providing real-time or cumulatively collected information concerning brace usage and related anatomical parameters.

In exemplary implementations, the disclosed sensing and/or feedback mechanism includes force and/or positioning sensing functionality that may be associated with strap(s), webbing, ratchet(s), and/or other tensioning elements that are associated with orthotic and/or prosthetic devices. For example, the force and/or position sensing functionality may be associated with strap(s), webbing, ratchet(s), and/or other tensioning elements that are adapted to releasably fix an orthotic/prosthetic device in place. Thus, for example, a lower leg, ankle and foot orthotic brace may include one or more (e.g., three) straps for use in releasably fixing the brace relative to a prescribed user's ankle. At least one of the straps may be provided with a force sensor and/or a position sensor that is adapted to monitor and/or measure force or position, respectively. The sensor(s) may be advantageously integrated with the strap(s) (or other tensioning element, e.g., webbing or ratchet mechanism), although it is further contemplated that the sensor(s) may be detachably secured with respect thereto, e.g., using a conventional attachment mechanism such as a snap, a Velcro™ connection mechanism or the like.

The sensing/feedback mechanism may also advantageously include and/or interact with one or more communication functionalities that facilitate communication of the sensed parameters, e.g., force and/or position parameters. Exemplary communication functionalities include visual, haptic (vibratory) and/or auditory signals or cues. The foregoing signals/cues may be delivered in situ, i.e., directly from the modular unit that includes the sensing/feedback mechanism, or from a remote device, e.g., a smart/cellular phone, pager, personal digital assistant, tablet or the like. Thus, in exemplary embodiments of the present disclosure, the modular unit includes a communication capability, e.g., a short-range wireless communication transmitter that is Bluetooth compliant, that is adapted to transmit sensed/measured parameters to a remote device, e.g., a smart/cellular phone, computer or other electronic device, for processing, display and/or storage.

In exemplary embodiments, the disclosed position sensors integrated with the strap(s) of a brace are configured to measure the distance to which the strap has been pulled using inductive sensors. Thus, for example, at least one of the sensors may be an inductive sensor with coil technology and conductive material may be embedded in the strap(s). The inductive sensor(s) may advantageously interact with the conductive material producing a signal indicating the location of the inductive sensor with respect to the strap(s). In exemplary embodiments, the position sensor may include multiple coils and multiple conductive materials may be imbedded in the strap. In further exemplary embodiments, the conductive material may be shaped so as to define a variable width along the X-axis (as defined by the strap). In exemplary embodiments, the inductive sensor may be a LDC1312 unit that is commercially available from Texas Instruments (Dallas, Tex.).

In other embodiments, the inductive sensor may be used to measure the distance from the coil and a conductive material that interacts with a section of the orthotic or prosthetic device along the z-axis. The inductive sensor can sense the conductive material along the “z axis” allowing the inductive sensor to sense presence and determine the distance of the conductive material from the surface of the circuit board where the coil is located. The disclosed system and method may advantageously include and/or interact with data processing and/or analytical functionalities. Thus, the force and/or position parameters that are sensed/measured by the disclosed sensing/feedback mechanism(s) may be transmitted to a remote device (either directly or by way of an associated network) that is programmed to store, process, analyze and/or display the sensed/measured data. Various analytical tools may be supported by and/or incorporated into the disclosed systems and methods, e.g., analytics related to anatomical developments of the user, analytics related to usage frequency/duration, analytics related to force delivery, analytics related to suitability of an associated orthotic/prosthetic device in view of user growth/development/condition, and the like. The analytical results may be accessed by the prescribed user, by colleague(s) of the user (e.g., parents), and/or by the physician or health care provider(s). Historical information may be generated that may prove useful in longer-term treatment, recovery, conditioning and/or activities of the user and/or in developing a better clinical understanding of various treatment modalities and/or activity levels.

The disclosed systems and methods may be developed and delivered in conjunction with newly manufactured orthotic and/or prosthetic devices. In addition, the present disclosure contemplates retro-fitted applications of the disclosed modular units, e.g., through integration and/or association with existing or replacement straps, webbing, ratchet(s), and other tensioning mechanisms for use with existing orthotic and/or prosthetic devices. Still further, the modularity of the disclosed systems/methods permit flexibility in deployment and use of the underlying sensing/feedback mechanisms across a broad range of utilities and applications, i.e., a range of orthotic and prosthetic applications as well as other devices that may be worn and/or used by individuals, e.g., training apparatus, research devices and the like. Thus, the present disclosure provides efficient and cost-effective modular units that facilitate immediate and widespread adoption and use of the disclosed systems and methods, including adoption and/or integration at various stages of the existing supply chain for orthotic/prosthetic devices and other products/devices.

Additional features, functions and benefits associated with the disclosed systems and methods will become apparent from the detailed description which follows, particularly when read in conjunction with the appended figures.

DESCRIPTION OF EXEMPLARY EMBODIMENT(S)

According to the present disclosure, systems and methods are provided for monitoring and/or measuring parameters associated with the use of various devices/systems, e.g., orthotic devices and prosthetic devices, such as leg braces, scoliosis braces, arm slings, post-operative back braces, knee braces, prosthetic units and the like. In exemplary implementations, the disclosed systems and methods are adapted to communicate the monitored and/or measured parameters, e.g., through visual, haptic (vibratory) and/or auditory signals or cues. Moreover, the monitored and/or measured parameters may be transmitted to a remote device that is programmed to store, process, analyze and/or display the data. Various analytical tools may be supported by and/or incorporated in the disclosed systems and methods, e.g., analytics related to anatomical developments of the user, analytics related to usage frequency/duration, analytics related to force delivery, analytics related to suitability of an associated orthotic/prosthetic device in view of user growth/development/condition, and the like. The analytical results may be accessed by the prescribed user, by colleague(s) of the user (e.g., parents), and/or by the physician or health care provider(s).

Among the analytics supported by the modular units of the present disclosure, compliance of orthotic or prosthetic wear may be determined based on sensed/measured parameters according to the present disclosure and compliance information is typically used in the medical literature and in practice by physicians and other health care providers to describe the amount of time a patient wears a brace as compared to the amount of time the doctor prescribes the brace to be worn. For example, if a doctor prescribes that a brace be worn twenty three (23) hours per day, but the patient only wears the brace for twelve (12) hours per day, the patient would be deemed to be fifty two percent (52%) compliant with respect to brace wear. Among other analytics supported by the modular units of the present disclosure, the quality of orthotic or prosthetic wear may be determined based on sensed/measured parameters and is distinct from compliance. For purposes of the present disclosure, quality is a measure of how well a device (e.g., an orthotic or prosthetic device) is being worn. Quality of wear is distinguishable from compliance of wear because the device may not be tightened completely when the patient/user is wearing it. In such circumstance, the patient/user may be deemed “compliant” because the device is being worn, but the “quality” of wear is less than desirable.

The present disclosure advantageously provides systems and methods that allow the capture of metrics that may be used to evaluate a range of activities and performance parameters, e.g., compliance of device use, quality of device use, step count, user activity level, range of motion, device/user orientation, and other device- and user-related measurements. For example, the quality of wear may be determined by strap tension and/or strap position, as described herein. Of note, strap position is currently used by doctors to give patients a guide to where to tighten a brace to each day. Since the ability to reach that position can change over time (e.g., due to weight gain, eating, etc.), a better measure of quality may be achieved according to the present disclosure based on the tension of the strap, or some combination of both tension or position. Of note, the strap position is currently used by doctors to give patients a guide to where to tighten the brace to each day. For example, the tightness of the straps on a scoliosis brace needs to be adjusted based on the prescription of the physician or health care provider. For example, the position to which the strap is pulled generally needs to be changed over a period of time for proper treatment. The disclosed systems/methods are advantageously able to detect both the compliance and quality of device wear, and adapt the metrics over time as determined by the physician.

Furthermore, the disclosed systems/methods are advantageously able to measure the distance between two points on a brace and determine the distance that a strap has been pulled without physician and health care provider assistance.

Indeed, methods for measuring parameters-of-interest may vary and/or evolve according to the present disclosure. The modular sensing devices described in the embodiments may also include one, or some combination of, sensors that are capable of measuring various parameters, such as force, excursion, acceleration, angular position, pressure, temperature, humidity and light. The raw value measurements provided by these sensing devices can be used to generate corresponding metrics related to wear time of an orthotic or prosthetic device, range of motion, activity (e.g., steps, speed, movement, running vs. walking), and the like. Moreover, an algorithm developed to measure compliance/quality or other parameters may be static or varied from time-to-time. For example, it may be desirable for an algorithm that is intended to measure compliance/quality to utilize different parameters and/or different target performance levels from time-to-time, e.g., based on the length of time that a user has been engaged in use of the relevant device.

Of note, the present disclosure provides systems and methods that enable measurement and communication of relevant parameters, as well as updates, refinements and/or variations in prescriptive parameters and/or targets for device use, e.g., based on determinations by health care professional(s) in view of reported measurements. Thus, the disclosed systems and methods permit health care professionals to update “prescriptions” at any time and from remote locations. For example, a health care professional is able to receive and evaluate compliance and quality of use (and/or other parameter(s)) in his/her office, and then to refine the relevant prescription so as to enhance and/or optimize device usage based on his/her professional judgment.

Moreover, the disclosed systems and methods support and enable algorithmic-based updates, refinements and/or variations in parameters and/or targets for device use, e.g., based on comparisons of device-based performance parameters and target performance levels which algorithmically translate to updated, refined and/or varied device-based usage parameters. The disclosed feedback systems and methods may be modular in design, but sensed/measured data may be user-specific, i.e., communications associated with updated, refined and/or varied usage parameters are generally specific to an individual use case, and are generally communicated by conventional communication protocols, e.g., Bluetooth communications or the like. Before describing exemplary implementations with reference to the accompanying figures, the following outline of features/functions is provided by way of overview:

Problems Addressed

1. Care providers have no way to make informed decisions on patient wear characteristics (defined below) in order to improve treatment. For example, orthotists and prosthetists often rely on patient reported data to adjust fit of braces and prosthetics, to change type of device, etc. Health insurance reimbursement is often based on the patient's level of activity or adherence to prescription regimens.2. Patients often find it hard to put on orthotics or prosthetics correctly, in part because the devices often rely on the patients to tighten or otherwise don and doff the device. This can result in an uncomfortable fit and/or ineffective treatment.3. Patients who wear orthotics and prosthetics often have no way to keep track of and set goals for activity, steps, range of motion, etc.4. There currently exists a gap between low costs orthotics and prosthetics, which typically are purely mechanical devices with no electronics or sensing capabilities, and high end, expensive orthotics and prosthetics, which can provide a wealth of valuable information and feedback to users and care providers.5. Companies who would like to integrate sensing/feedback capabilities into their existing orthotic and prosthetic devices must often start from scratch, and are unable to utilize existing work in the field.

System Description

1. Feedback and sensing module is provided that is integrated or in line with a strap or webbing material, ratchet system or other tensioning element that is typically under tension for use in orthotics and prosthetics.2. Device/module has onboard processing and feedback capabilities.3. Device/module includes some combination of the following sensorsa. Force Sensor (Load Cell using Strain Gauges Configured in Whetstone Bridge)b. Excursion Sensor (Measure distance between two points, potentially by measuring magnetic fields or by using inductive sensor coil and conductive target)c. Accelerometerd. Magnetometere. Gyroscopef. Pressure Sensorg. Temperatureh. Humidityi. Light4. Device can uses the above raw sensor values to gather metrics related to:a. Wear time of orthotic/prostheticb. Range of motion of device and/or user's body partsc. Activity (Steps, speed, movement, running vs. walking)d. Tightness (tensile force) present in strap or webbing of orthotic/prosthetice. Distance between two points on orthotic/prosthetic device and or user's bodyf. Orientation of orthotic/prosthetic device5. Raw sensor values collected by device will be transformed into metrics of importance to patients and care providers by a series of custom algorithms developed for each orthotic/prosthetic application.a. In one implementation, the raw sensor data will be sent (wirelessly) to a database and/or mobile device, where custom algorithms for each orthotic/prosthetic application will transform raw values to metrics of importanceb. This is important because the electronics and data collected by the device will be largely the same for a wide range of orthotics and prosthetics.c. What will vary based on the application is how the raw data is analyzed on the web.d. This is advantageous to developing custom hardware and sensing capabilities for each medical condition, as much of the core development work and costs can be saved.e. The frequency with which the sensor readings occur can be varied across applications to optimize for battery life and memory capacity based upon the frequency of the individual sensors needed to determine the metrics of interest for that given application.6. Device can deliver real time feedback to usersa. On board vibration, light or sound from deviceb. Live stream data from device wirelessly to smartphone or computer, which will then give feedback to users7. Device has two modes of operationa. Constant, low power modei. All day gathering of certain data (for example, steps)ii. Power down the sensors needed for feedback donning and doffing deviceb. Feedback modei. Activated by user (button press) or automatically selected based upon sensor readings (device detects it is being donned or doffed)ii. Selectively power on certain sensors/feedback mechanismsiii. Activated when patient is donning/doffing orthotic/prosthetic device8. The sleep cycle parameters (frequency of sleep and length of sleep) can be varied wirelessly (via Bluetooth) to change the average power consumption and recording frequency of the system. For example in the scoliosis implementation, the device sleeps for 6 minutes in between sensor readings, but to measure activity in a prosthetic, the device can sleep for 15 milliseconds in between sensor readings.9. Certain electronic systems can be powered on or off based on the relevant sensor readings of interest. This can be changed wirelessly (via Bluetooth) to optimize the battery life of the system.10. Device can be used with modular attachment mechanisms to integrate with wide range of orthotics and prosthetics. The electronics required for many applications remains unchanged.11. Device can deliver long-term feedback to users, by keeping track of goals and incentives.12. Battery powered13. Wireless connectivity (Bluetooth, Zigbee, Wi-Fi)

Exemplary implementations of the disclosed systems and methods are described herein. However, it is to be understood that the present disclosure is not limited by or to such exemplary implementations.

With reference toFIGS. 1A-C, top views of an exemplary strap and sensing assembly100to be used with orthotic or prosthetic devices, according to the present disclosure, are provided. InFIG. 1A, the top view of the sensing assembly104is covered by a top face102. Strap and sensing assembly100includes a chafe106that includes an aperture108for use in securing the chafe106relative to a brace, and a sensing assembly104that is movably mounted relative to chafe106. As noted above, chafe106may be secured relative to a brace using various mounting systems, e.g., a rivet or the like. In terms of brace-based mounting of chafe106, it is noted that alternative mounting techniques may eliminate the need for aperture108, as will be readily apparent to persons skilled in the art.

The chafe106can be mounted to the sensing assembly104using a mounting passage114. The mounting passage114may pass through a connector (not shown inFIG. 1A) within the housing110and through an opening116in the chafe106. In some embodiments the mounting passage can be a ring locked in a 90 degree position to the opening116of the chafe106. The mounting passage114may form an elliptical shape forming a slot or passage112configured and dimensioned to receive a strap for use with braces. Alternative structural arrangements may be employed to define a slot or passage relative to housing110, as will be readily apparent to persons skilled in the art.

The sensing assembly104includes a housing110and a gauge mechanism positioned (not shown inFIG. 1A) within the housing110that is adapted to measure the force applied to assembly100. A switch or button113typically extends through or is otherwise associated with housing110of sensing assembly104to facilitate powering up or powering down of sensing assembly104. Switch or button113interacts with electronics within housing110, as described herein.

Turning toFIG. 1B, an interior of view of the sensing assembly104showing the interior components according to the present disclosure is provided. As shown therein, strap and sensing assembly100includes housing110that defines a cavity120for receipt of operative components of the disclosed sensing system. As previously noted, the mounting passage114defines a slot or passage112that is configured and dimensioned to receive a strap for use with braces. In the exemplary implementation of assembly100, passage112is defined by the elliptical shape formed by the mounting passage114while connecting the strap106and the connector122within the housing110of the sensing assembly104. The size and geometry of passage112is selected so as to permit ease of passage of a strap associated with the disclosed system. Alternative structural arrangements may be employed to define a slot or passage relative to housing110, as will be readily apparent to persons skilled in the art.

The housing110of the sensing assembly104includes a connector122and a gauge mechanism124secured in a slot138of the connector122. The connector122includes an opening for the passage of the mounting passage114. The connector122extends perpendicular to the mounting passage114and on the opposite side of the mounting passage114the gauge mechanism124is secured to the connector in a slot138on the connector122. The gauge mechanism124extends from a first end to a second end of the housing110, parallel to the mounting passage114.

The housing110of the sensing assembly104includes a circuit board126positioned within the cavity120. The circuit board126is powered by a battery142, which is also positioned within cavity120and which is in electrical communication with circuit board126.

Battery142provides power to the various elements of sensing assembly104, as described herein.

The circuit board126may further communicate with one or more LEDs128that may be powered to provide data communication to users, caregivers and/or other healthcare providers. In instances where one or more LEDs128are included, the housing110generally includes one or more openings or windows to allow observation thereof. Circuit board126may also communicate with a speaker130that, when powered, is adapted to provide an aural signal as to performance of the brace system to users, caregivers and/or other healthcare providers. In instances where a speaker130is included, housing110generally include an opening to allow unobstructed passage of sound there through. Thus, the disclosed systems and methods of the present disclosure may be adapted to provide one or more forms of communication as to users, caregivers and/or other healthcare providers, e.g., visually observable communication (e.g., LEDs128), aural communication (e.g., speaker130), and/or tactile communication (e.g., vibratory motor144).

A switch or button113is associated with housing110to allow users to power up/power down the disclosed sensing system. The switch/button113communicates with an associated electronic component132that is in electronic communication with circuit board126and translates the user interaction to the electronics of the system. The circuit board126may also include a USB port133that permits porting of data/programming to and from the electronics system. USB port133is accessible through an opening (not shown inFIGS. 1A-C) defined in housing110.

In exemplary embodiments of the present disclosure, the gauge mechanism124takes the form of a strain gauge124that is positioned within housing110and that is cooperatively mounted with respect to chafe106so as to measure forces experienced thereby. For example, with reference toFIG. 1C, force can be applied along the X-axis in direction140pulling the chafe106away from the strain gauge124, causing the strain gauge124to deflect. The strain gauge124can measure the force and can communicate the force measurements to an input associated with circuit board126. The circuit board126may include processing functionality that is adapted to process the force measurements delivered by strain gauge124. The circuit board126is also generally associated with transmissive elements, e.g., transceiver elements that include antenna and other components associated with conventional data communications, so as to facilitate transmission and receipt of data associated with measurements and control inputs. In another embodiment of the present disclosure, the circuit board126sensing assembly104can include inductive coils136and134. The inductive coils136and134are cooperatively mounted with respect to chafe106so as to measure distance and position between two points on the strap. The inductive coils136and134communicates tightness measurements to an input associated with circuit board126. The circuit board126may include processing functionality that is adapted to process the tightness measurements delivered by inductive coils136and134. The circuit board126is also generally associated with transmissive elements, e.g., transceiver elements that include antenna and other components associated with conventional data communications, so as to facilitate transmission and receipt of data associated with measurements and control inputs.

Circuit board126may be in communication with one or more components that are adapted to signal users, caregivers and/or healthcare providers as to the condition and operation of the disclosed sensing system. For example, circuit board126(and battery142) may be in electronic communication with a vibration motor144that is adapted to be energized in response to control signals received and/or generated by the circuit board126. For example, if the brace associated with sensing assembly104is insufficiently cinched or otherwise in need of attention/adjustment, circuit board126may be programmed to energize vibration motor144so as to alert the user of the situation. The vibratory function of vibratory motor may involve a sustained vibratory operation, or pulsed/intermittent vibratory operation, or both depending on the programming of the circuit board.

As a non-limiting example, the strap and sensing assembly may include strain gauge functionality that functions to measure the force level experienced by a device, e.g., a prosthetic or orthotic device. Thus, two strain gauges may be provided. A beam may be associated with the strain gauges such that beam bending correlates with a linear force applied to or experienced by the device. The strain gauges may be positioned in the region of bending such that a Wheatstone bridge is established therebetween. The strain-based signal generated by the Wheatstone bridge may be compared to reference data to determine whether the strap force is within a prescribed range. Moreover, changes in the signal may be monitored to assess performance of an orthotic or prosthetic brace over time. The strain-based signal generated by the Wheatstone bridge may be fed to a differential instrumentation amplifier which may be adapted to amplify the signal, e.g., to a level that may be read by an analog-to-digital converter associated with a microcontroller, as described in greater detail below. As with the “cinching” measurements described above, the strain-based measurements may be stored in a database for use in various analytic and/or diagnostic functions, e.g., assessing the degree to which a device has been properly employed by a user. Alternative systems may be used to monitor and/or measure forces experienced by the device, as will be readily apparent to persons skilled in the art.

As noted above, the disclosed sensing assembly may support a plurality of indicating lights, e.g., LED's, that are adapted to provide a visual signal to users and other caregivers as to the status of a brace. The LED's may be aligned in corresponding rows, e.g., along the edges of the housing, and may be adapted to illuminate in different colors based on the orientation/alignment of the associated orthotic or prosthetic device. Thus, when the device is properly adjusted to a user, sensing mechanisms associated with the disclosed sensing assembly are adapted to recognize the proper orientation/alignment and to signal that information to the user, e.g., by illuminating one or more “green” LED's. Conversely, if the sensing mechanisms associated with the disclosed sensing assembly determine that the device is not properly oriented/aligned, a warning signal may be provided to the user and other caregivers, e.g., by illuminated one or more “red” LED's. In exemplary implementations, the disclosed assembly may be provided with green, yellow and red LED's to facilitate an indication of device compliance (e.g., with green LED illumination corresponding to strong compliance, red LED illumination corresponding to poor compliance, and yellow LED illumination corresponding to an intermediate level of compliance).

Beyond visual indicators, it is further contemplated that additional and/or alternative communication modalities may be implemented according to the present disclosure. For example, the disclosed sensing assembly may further (or alternatively) include haptic (e.g., vibratory) and/or auditory functionalities for communicating information concerning orthotic or prosthetic device usage. The disclosed sensing assembly may thus be adapted to deliver vibratory impulses to the user when the device is improperly positioned, such vibratory impulses varying in intensity and/or frequency as the positioning/alignment of the device is adjusted. Similarly, the disclosed sensing assembly may be adapted to deliver vibratory impulses to the user when the device is properly positioned, such vibratory impulses varying in intensity and/or frequency as the positioning/alignment of the device is adjusted. The disclosed sensing assembly may also include an aural transmitter that is adapted to transmit sound-based signals to the user based on device positioning and/or usage, with differing aural signals based on relative positioning of the device. The breadth and flexibility of the communication modalities that may be implemented according to the present disclosure will be readily apparent to persons skilled in the art in view of the present disclosure.

The sensing assemblies that are adapted to provide advantageous monitoring and feedback functionality according to the present disclosure may be incorporated into newly constructed and prescribed orthotic or prosthetic systems, retrofitted onto existing systems, and/or used in conjunction with a range of orthotic, prosthetic and other user-worn devices/systems. Indeed, although individual prosthetic devices, and to some degree orthotic devices, are custom fabricated for specific users, operative elements of these systems are relatively uniform and therefore well adapted for retroactive transition to the monitoring/feedback system of the present disclosure. Thus, the disclosed modular monitoring/feedback functionalities may be widely adapted at minimal expense to users and/or health care providers across a range of clinical/user applications.

With reference toFIG. 2, a side view (partially in section) of an exemplary implementation of the disclosed strap and sensing assembly with respect to a brace. As shown therein, chafe106is mounted with respect to a brace200using a rivet210through aperture108. The sensing assembly104is connected to the chafe106using via a mounting passage114. The sensing assembly includes104a USB port133, LEDs128, an aural communication device and/or and a tactile communication device. The mounting passage114may form an elliptical shape forming a slot or passage112configured and dimensioned to receive a strap202for use with braces. The strap202can connect a first end204of the brace200to the second end206of the brace200. The strap202may be secured to the brace using a rivet210on the first end204of the brace200. The strap202can pass under the sensing assembly104loop through the passage112and can pass over the sensing assembly104. Once over the sensing assembly104, the strap202is fixed, e.g., based on Velcro™ securement208relative to itself.

With reference toFIG. 3, an exploded view of strap and sensing assembly is provided. The strap and sensing assembly100includes a sensing assembly104, mounting passage114and chafe106. The sensing assembly104includes, a housing110and the housing110. The housing includes a top portion302and a bottom portion304. The top and bottom portion302-304of the housing110form a cavity120. A connector122, a strain gauge124, and a circuit board126are disposed within the cavity120. The mounting passage114connects the connector122to the chafe106. The mounting passage passes through an opening of the connector122and passes through an opening116of the chafe106. The mounting passage114forms an elliptical shape forming a passage112configured to receive a strap of a brace. The strain gauge124is secured to a slot138of the connector122. The circuit board126may further communicate with one or more LEDs128, speakers130and a vibratory motor144that may be powered to provide data communication to users, caregivers and/or other healthcare providers. The sensing assembly includes a switch/button113(as shown inFIGS. 1A-1C) communicates with an associated electronic component132that is in electronic communication with circuit board126and translates the user interaction to the electronics of the system.

With reference toFIG. 4A, illustrates a mounting passage embodied as a moving bar in the strap and sensing assembly according to some embodiments. Modular sensor assemblies according to the present disclosure can be mounted to various types of orthotic and/or prosthetic devices in an in-line fashion, e.g., within a cinching loop-strap system. In some embodiments, the strap and sensing assembly100include a chafe106, a sensing assembly104, a strap402, and a moving bar404as a mounting passage. The chafe106is secured to a first end of the sensing assembly104. The moving bar404is secured to the second end of the sensing assembly104. The moving bar404include two side walls414and416extending parallel to one another and connected by a bar412extending perpendicular from the two side walls414and416. The two sidewalls414and416and the bar form an rectangular shape forming a slot or passage406configured and dimensioned to receive a strap402for use with braces. The moving bar404can be secured to the sensing assembly104at a hinge point408and410(not shown) disposed in between the top and bottom portion302and304of the housing110of the sensing assembly104. The moving bar404can rotate circumferentially along an arc with a radius equal to the distance between the bar412and the top portion302of the housing of the sensing assembly104. The moving bar404can be configured to receive one end of the strap402in between the bar412and the sensing assembly104, through the passage406and loop over the bar412. One end of the strap402may extend parallel to the other end of the strap402along a Z-axis. As will be readily apparent to those skilled in the art, the embodiment is not limited to a system with releasable loop assemblies on both sides of the sensing assembly104.

With reference toFIG. 4Billustrates a mounting passage embodied as a top bar in the strap and sensing assembly according to some embodiments. In some embodiments, the strap and sensing assembly100include a chafe106, a sensing assembly104, a strap402, and a top bar418. The chafe106is secured to a first end of the sensing assembly104. The top bar418is secured to the top portion302of the sensing assembly at a second end of the sensing assembly104. The top bar418includes two side walls420and422extending parallel to one another and connected by a bar424extending perpendicular from the two side walls420and422. The two side walls420-422can be secured to the top portion302of the sensing assembly104. The bar424and the two side walls420-422can form a passage426configured to receive one end of the strap402in between the bar424and the sensing assembly104, through the passage426and loop over the bar424. One end of the strap402may extend parallel to the other end of the strap402along a Z-axis. As will be readily apparent to those skilled in the art, the embodiment is not limited to a system with releasable loop assemblies on both sides of the sensing assembly104.

With reference toFIGS. 5A-5C, top views of exemplary implementations of the disclosed modular sensing assembly in conjunction with orthotic or prosthetic devices are provided.FIG. 5Adepicts a strap assembly that includes a “magnetic-based” sensing system in two cinching positions.FIG. 5Bdepicts a strap assembly that includes an inductive sensor based sensing system in to measure the tightness of a strap.FIG. 5Cdepicts a strap assembly that includes a “resistance-based” sensing system. Each of the disclosed sensing systems is adapted to monitor/measure the position of the strap, e.g., when used to cinch a brace/device around the body part of a user. The sensing parameter may be compared to a target reading to determine whether the brace/device is properly tightened (subject to applicable tolerances). Based on such comparison, a signal may be delivered to the user and associated caregivers (e.g., a visual, haptic and/or aural signal). Moreover, the determination may be stored in a database for use in various analytic and/or diagnostic functions, e.g., assessing the degree to which a brace has been properly employed by a user.

Turning toFIG. 5A, exemplary strap assembly500that includes a sensing assembly502that is mounted with respect to a strap504facilitates cinching of a brace (not pictured). A mounting passage506is secured to the sensing assembly502through a connector (not pictured). Magnetic sensors are embedded or otherwise associated with sensing assembly502(not pictured) and are configured/positioned so that as the output voltage of one magnetic sensor associated with sensing assembly502increases and the output voltage of the second magnetic sensor associated with the sensing assembly502decreases as the magnet508—which is embedded or otherwise associated with a region toward or at the other end of the strap504—moves relative to sensing assembly252. Thus, the difference between the two output voltages generated by the magnet sensors associated with sensing assembly502increases as magnet508moves closer to the sensing assembly502, i.e., the difference in output voltage measured by the disclosed system will vary based on the position of strap member504relative to sensing assembly502, i.e., the degree to which strap member504is “cinched” in securing the orthotic or prosthetic brace relative to a user's body part. As with the resistance-based implementation described above, the signal generated by the disclosed output voltage measurement may be amplified and transmitted to an analog-to-digital converter associated with a microcontroller.

Turning toFIG. 5B, exemplary strap assembly510includes a sensing assembly522that is mounted with respect to strap512which facilitates clinching of the brace (not pictured). First and second conductive strips514,516are embedded or otherwise associated with the strap512. The strap512can be configured to pass over the sensing assembly522through the mounting passage524. The conductive strips514,516can be of variable width. The sensing assembly522includes a circuit board520. The circuit board520includes inductive sensors including coils518,520. The sensing assembly522generates a signal based on an interaction between the coils of the inductive sensors518,520as the conductive fabrics514,516pass over or under the sensing assembly522. The signal changes as the width of the conductive strips514,516increases or decreases. The positioning/tightness of the strap512can be advantageously determined according to the present disclosure based on interaction between the conductive strips514,516embedded in or applied to the strap512and the inductive sensor in the sensing assembly522. In exemplary embodiments, the inductive sensor can measure the distance between a first point on a brace (not shown) and a second point on the opposite side of the brace (not shown), as described in greater detail below.

Turning toFIG. 5C, exemplary strap assembly526includes a sensing assembly528that is mounted with respect to a strap530which facilitates cinching of a brace (not pictured). First and second resistive fabric strips532,534are embedded or otherwise associated with strap530. The fabric-based circuit acts as a custom, flexible linear potentiometer. An electronics module is incorporated into or otherwise associated with sensing assembly528. The electronics module is adapted to amplify the signal generated based on a resistance change between opposed points along resistive strips532,534. The mounting passage536around which strap530passes is also conductive and bridges resistive strips532,534when the strap assembly510is used to secure a brace relative to a user. As the conductive mounting passage536bridges the two resistive strips532,534the resistance changes linearly. Indeed, the system functions as a Wheatstone bridge, generating a signal based on the relative positioning of the elements. Thus, the resistance measured by the disclosed system will vary based on the position of strap member530relative to conductive mounting passage536, i.e., the degree to which strap member530is “cinched” in securing the orthotic or prosthetic brace relative to a user's body part. Of note, the signal generated by the disclosed resistance measurement may be amplified (e.g., using a Texas Instruments INA126 amplifier) and transmitted to an analog-to-digital converter associated with a microcontroller.

With reference toFIGS. 6A-6Ddepict an embodiment of the strap assembly using inductive sensors to measure the position of a strap for a orthotic or prosthetic device. Turning toFIGS. 6A-6B, in exemplary embodiments, the conductive material602may be embedded in and/or applied to a surface of the strap. A sensing assembly may be mounted with respect to the strap and may include an inductive sensor. The conductive material602may be for example, foil, fabric, copper, aluminum or platinum. In exemplary embodiments, the conductive material602is shaped with variable width along the X-axis. The positioning/tightness of the strap can be advantageously determined according to the present disclosure based on interaction between the conductive material602embedded and the inductive sensor. For example, the inductive sensor may include a coil604attached to or otherwise in communication with a printed circuit board. Turning toFIG. 6Bthe inductive sensor may produce an alternating current through the coil602as the conductive material602passes over the coil604. The alternating current creates a first alternating magnetic field which induces an alternating electrical current (eddy current) in the conductive material602. The eddy current in turn creates a second magnetic field that couples with the first magnetic field created by the coil604. The inductive sensor measures the effect of a nearby conductor by measuring the frequency shift caused by the coupling of the first and second magnetic field.

Turning toFIG. 6C, the coil604can be included in the circuit board606inside the sensing assembly608. While the strap is in an initial position in clinical use, the inductive sensor may be disposed parallel to the strap along the X-axis. The sensing assembly608may interact with the conductive material602embedded in the strap610as the as the conductive material passes over the sensing assembly608. In exemplary embodiments, the inductive sensor may produce a signal based on the measured frequency shift. In exemplary embodiments, due to the variable width of the conductive material602, a variable amount of area may be exposed to the first magnetic field created by the coil604(as shown inFIGS. 6A-B). For example, with reference toFIGS. 6B and 6C, as the strap610passes over the sensing assembly608along the X-axis, a wider area of the triangle shaped conductive material602is exposed to the first magnetic field. The effect of the amount of conductive material602exposed to the first magnetic field may be used to determine the distance between the conductive material602and the coil604along the X-axis, and accordingly what position the strap610has been pulled to along the X-axis.

Turning toFIG. 6D, the conductive material602can move along the Z-axis as shown by602and602′. Consequently, the signal produced by the interaction of the sensing assembly610and the conductive material602may vary based on the distance along the Z-axis and the X-axis.

With reference toFIGS. 7A-7Ddepict an embodiment of the strap assembly using multiple conductive materials and multiple coils. As mentioned above, the conductive material can move along the X-axis and Z-axis.FIGS. 7A-Billustrate an exemplary two coil design for position sensing using inductive sensors according to exemplary embodiments of the present disclosure. Turning toFIG. 7A, in exemplary embodiments two coils702and704may be disposed in a parallel alignment along the X-axis relative to two conductive materials706and708disposed along the strap (not shown). In exemplary embodiments, in an initial position, conductive materials706and708may be disposed parallel to each other along the Y-axis. In addition, the coils702and704may be disposed parallel to each other along the Y-axis. In exemplary embodiments, the conductive material708may have variable width along the X-axis while conductive material706may have a constant width along the X-axis. For example, the conductive material708may be a triangle, spiral, circle, oval or another shape that has a variable width along the X-axis and the conductive material706may be a rectangle, square or another shape with constant width along the X-axis.

In exemplary embodiments, the inductive sensor within the sensing assembly (not shown) may generate signals that are used to calculate the distance between coil702and conductive material708and to calculate the distance between coil704and conductive material706. Since the conductive material706has a shape with constant width along the X-axis, the signal produced by coupling of the magnetic fields produced by coil704and conductive material706does not vary along the X-axis and only varies along the Z-axis. Consequently, the inductive sensor may generate signals useful in determining the relative distance between coil704and conductive material706along the Z-axis. In exemplary embodiments, the disclosed system may use the distance calculations between coil704and conductive material706along the Z-axis to compensate/refine the distance calculations between coil702and708along the X-axis.

FIG. 7Billustrates an exemplary two coil design using two conductive materials with variable width along the X-axis according to the present disclosure. In exemplary embodiments, coils702and704may be disposed parallel along the X-axis relative to the conductive materials710and712. In exemplary embodiments, in an initial position, conductive materials710and712may be disposed parallel to each other along the Y-axis. In addition, the coils702and704may be disposed parallel to each other along the Y-axis. The shapes of conductive materials710and712may both have variable width along the X-axis. In exemplary embodiments, the conductive materials710and712may be triangles.

In exemplary embodiments, the shape of conductive material710may be oriented in the opposite direction as compared to the shape orientation of conductive material712. Consequently, as the width of conductive material712increases along the X-axis, the width of conductive material210decreases along the X-axis. In exemplary embodiments, as the inductive sensor in the sensing assembly passes over the conductive materials710and712, the coils702and704will interact differently with the respective conductive materials. For example, the signal created by the magnetic field produced by the conductive material710while coupling with the magnetic field produced by the coil704will become weaker moving along the X-axis as the width of the conductive material gets smaller. Conversely, the magnetic field produced by conductive material712while coupling with the magnetic field produced by coil702will grow stronger moving along the X-axis as the width of the conductive material712increases. Consequently, the disclosed system may advantageously use the signals produced by the coupling of the magnetic fields of coil704and conductive material712to determine the distance between the coil702and conductive material710along the Z-axis. The disclosed system may also use the determined distance along the Z-axis to compensate/refine the distance measurement between the coil702and conductive material710along the X-axis. With reference toFIG. 7Cthe variable width of the conductive material714interacting with the coil716as the conductive material wraps around is depicted. As mentioned above the conductive material714is embedded or associated with a strap (not shown). Therefore, the conductive material714will wrap around along with the strap.

FIG. 7Dprovides graphs illustrating the Z-axis compensation process according to exemplary embodiments. In exemplary embodiments, graph718provides a depiction that illustrates distance measurements between the coil and conductive material having a constant width along the x-axis. The y-axis of graph represents the sensor reading720, while the x-axis represents the x-position722. The line724represents the sensor reading from conductive material704and coil706(as shown inFIG. 7A) moving along the x-axis in a first position on the z-axis. The line726sensor reading from conductive material704and coil706moving along the x-axis a second position on the z-axis. The graph718illustrates that the sensor reading720decreases from line724to line726, therefore the change in the distance728along z-axis can be measured by taking the difference position of line726and with the position of line724.

The graph734provides a depiction of the measurement of between the coil and conductive material with variable width along the x-axis. The y-axis of graph734represents the sensor reading720, while the x-axis represents the x-position722. The graph730measures the sensor reading720of the signal produced by the interaction of the coil702with the conductive material708(as shown inFIG. 7A). The line730indicates the sensor reading720as the conductive material interacts with the coil along the x-axis a first position on the z-axis. The line732indicates the sensor reading720as the conductive material interacts with the coil along the x-axis a second position on the z-axis. The sensor readings of lines730and732can be compensated by the determined difference in distance along the z-axis728.

With reference toFIG. 8A, an exemplary implementation of a modular sensing system800as described above is provided. The modular sensing system800includes a central electronics unit and attachment points such as clips802,804to different modular heads (not shown inFIG. 8A). These clips802,804can secure modular heads which can either be attached permanently or remain removable. The clips802and804at the bottom of modular sensing system800facilitate attachment of the modular sensing system800to a mounting device that permits attachment to an orthotic or prosthetic brace.

With reference toFIG. 8B, an exemplary of the modular sensing system800mounted to two different modular heads is provided. On a first end a mounting passage812is secured to the clip802of the modular sensing system800. The mounting passage includes an aperture812. The aperture812, permits the modular sensing system800to be attached to a strap system (not shown) in a loop fashion. The loop strap can be releasably or fixedly attached to the modular sensing system800through aperture812on one end of the strap, while the other end of the strap is fixedly attached to a brace. On a second end of the modular sensing system800is a second modular end810is secured to the clip804of the modular sensing system800. The modular end810includes an aperture814. The modular end810may be secured relative to a brace using various mounting systems using aperture814, e.g., a rivet or the like. In terms of brace-based mounting of modular end810, it is noted that alternative mounting techniques may eliminate the need for aperture814, as will be readily apparent to persons skilled in the art.

With reference toFIGS. 8C-8M, different possible types of modular attachments are provided. Turning toFIG. 8C, a mounting system818is provided including with a large rectangular aperture818that through which a strap can be threaded and looped back upon itself to releasably or fixedly attach.FIG. 8Dshows an embodiment where the mounting system is secured through a hook/clasp820end that can easily be hooked or unhooked from a ring or loop. As will be apparent to those skilled in the art, an alternative embodiment of this mounting system is the connection of such a “hook mounting system”, in-line with the feedback sensor, to physical therapy or exercise equipment to monitor and provide feedback of tension in a strap system.FIG. 8Eshows an embodiment where a mounting system is a fixed modular end822with a aperture824. The fixed modular end822may be secured relative to a brace using various mounting systems using aperture824, e.g., a rivet or the like. In some embodiments, the fixed modular end822can be rigid. In other embodiments, the fixed modular end822can be flexible.FIG. 8Fshows an embodiment where a mounting system is a pivot end826that can rotate circumferentially. The pivot end826can cooperate with the modular sensing assembly and provide sensor information about angle or rotation.FIG. 8Gshows an embodiment where a mounting system is a snap button end mounting system828including an aperture830that can be easily fixed and unfixed from a corresponding snap mounted to the brace.FIG. 8Hshows an embodiment where a mounting system is a handle832that can be secured to the brace. The handle832can include grooves834configured for a user to grasp the handle832and pull the brace in a certain direction.FIG. 8Ishows a strap end836that can be mounted on the brace. The strap end836can be made of Velcro® material or other types of webbing. The strap end836an interact with other loops or devices to tighten or loosen the brace.FIG. 8Jshows an embodiment where a mounting system is an hinged end838. The hinged end838can include an aperture842which can be used to secure itself to the brace using a rivet or the like. The hinged end838can also include a hinge840allowing the hinged end838to rotate about the hinge axis.FIG. 8Kshows an embodiment where a mounting system is a threaded end844that can be screwed into a corresponding tapped hole.FIG. 8Lshows an embodiment where a mounting system is a magnetic end846that can attach and be removed from a metal or additional magnetic attachment of a brace or modular sensing system.FIG. 8Lshows an embodiment where a mounting system is a ratcheting end848that feeds into an additional ratchet mechanism that allows incremental tightening.

With reference toFIGS. 9A-9H, multiple embodiments, of modular sensor assemblies according to the present disclosure mounted to various types of orthotic and/or prosthetic devices in an in-line fashion, e.g., within a cinching loop-strap system are depicted. With initial reference toFIG. 9A, a rear portion of an alternative scoliosis brace900is shown secured to the torso of a user902. The scoliosis brace900is cinched at the rear of user902. Rear cinching braces are generally utilized for all-day wear, i.e., rear cinching braces are frequently prescribed for up to twenty three (23) hours of usage per day). Scoliosis brace900includes first and second portions904,906that define a gap908therebetween. Of note, the “gap” defined by first and second portions904,906may be a spacing therebetween or an overlap of first and second portions904,906. Thus, as noted above, the term “gap” as used herein should be understood to embrace the relative positioning of the first and second portions, whether such relative positioning defines spacing, overlap or even side-by-side juxtaposition.

A plurality of straps are mounted with respect to scoliosis brace900to facilitate securement thereof with respect to the user's torso. In particular, exemplary scoliosis brace900includes first strap910, second strap912and third strap914. As will be readily apparent to persons skilled in the art, the present disclosure is not limited to brace implementations that include three straps. Rather, the present disclosure may be implemented with fewer or greater numbers of straps without departing from the spirit or scope of the present disclosure.

With further reference toFIG. 9A, each of the straps is fixedly mounted with respect to either the first portion904or the second portion906of scoliosis brace900. More particularly, first strap910is fixedly mounted with respect to first portion904by attachment element922and third strap914is fixedly mounted with respect to first portion904by attachment element926. In the disclosed embodiment, second strap912is fixedly mounted with respect to second portion906by attachment element924. Attachment elements922,924,926generally take the form of a rivet or like structure, thereby permitting rotational freedom so as to facilitate strap alignment in use. Sensing assemblies916,918and918are provided with respect to first, second and third straps910,912and914, respectively. Each of the sensing assemblies is mounted with respect to either first portion904or second portion906of scoliosis brace900, e.g., by way of a mounting strap that is secured relative to the brace by a rivet or the like. In the exemplary embodiment two straps are fixed with respect to the first portion904, whereas the intermediate strap is fixed with respect to the second portion906. The alternating fixation arrangement of scoliosis brace900may improve the stability and/or ease with which the scoliosis brace may be brought into a desired orientation by the user, although the present disclosure is not limited by or to the disclosed alternating fixation arrangement.

The sensing assembly906includes a mounting passage928that accommodates passage of first strap910in a “looping” fashion, thereby allowing the user902to pull on the free end of strap910to cinch second portion906relative to first portion904, thereby reducing the width of gap908. Once cinched to a desired degree, strap910is generally adapted to be detachably fixed in the desired position, e.g., by way of cooperative Velcro™ interaction in the overlapping region of strap910. Alternative fixation mechanisms may be employed to secure strap910in its cinched orientation, as will be readily apparent to persons skilled in the art. Looping, cinching and fixation mechanisms are generally provided with respect to second strap912and third strap914, thereby permitting the user to bring the first portion904and the second portion906of scoliosis brace into a desired approximation.

With reference toFIG. 9B, a rear portion of an alternative embodiment of the brace sensor mechanism is shown with a flexible lower back brace1046is provided. The flexible lower back brace1046wraps around the abdominal area of the user1050and is secured to the user's lower back area. The flexible lower back brace1046includes a first and second portions1040and1036that define gap1048there between. Thus, as noted above, the term “gap” as used herein should be understood to embrace the relative positioning of the first and second portions, whether such relative positioning defines spacing, overlap or even side-by-side juxtaposition.

A first and second strap1038,1042are mounted with respect to flexible lower back brace1046to facilitate securement thereof with respect to the user's lower back. As will be readily apparent to persons skilled in the art, the present disclosure is not limited to brace implementations that include two straps. Rather, the present disclosure may be implemented with fewer or greater numbers of straps without departing from the spirit or scope of the present disclosure. The first strap1038wraps around the abdominal area of the user1050to secure the first portion1036of the flexible lower back brace1046into place. The second strap1042wraps around the abdominal area of the user1050to secure the second portion1040of the flexible lower back brace1046. The tightening of the straps1038,1042reduces the size of the gap1048between the first and second portions1036,1040. Conversely, loosening of the straps1038,1042widens the gap1048between the first and second portions1036,1040.

A sensing assembly1044is mounted with respect to first and second strap1038,1042using a mounting passage1052and1054respectively to measure the tightness/compliance of the flexible lower back brace. The mounting passages1052,1054accommodate passage of straps1038,1042in a “looping” fashion. The straps1038,1042to a desired degree, are generally adapted to be detachably fixed in the desired position, e.g., by way of cooperative Velcro™ interaction in the overlapping region of straps. Alternative fixation mechanisms may be employed to secure the straps910in its cinched orientation, as will be readily apparent to persons skilled in the art. With reference toFIG. 9C, a front portion of an alternative embodiment of the brace sensor mechanism is shown with a flexible upper back brace1056is provided. The flexible upper back brace1056can include a first and second strap1058and1060, which wrap over the upper back area of the user1070, and secure around each arm of the user1066and1068. The flexible upper back brace1056can include a third strap and forth strap1072,1074that wrap around the torso of the user1070.

A sensing assembly1064can be mounted with respect to the third strap and forth strap1072and1074. The third and fourth straps1072,1074can tighten or loosen the flexible upper back brace. The sensing assembly can be configured to sense the tightness/compliance of the flexible upper back brace. The sensing assembly1064can be mounted to the third and fourth strap using mounting passages1062,1076. The mounting passages1062,1076accommodate passage of straps1072,1074in a “looping” fashion. The straps1072,1074to a desired degree, are generally adapted to be detachably fixed in the desired position, e.g., by way of cooperative Velcro™ interaction in the overlapping region of straps.

With reference toFIG. 9D, a side portion of an alternative embodiment of the brace sensor mechanism is shown with a knee brace1104is provided. The knee brace1104, is configured to provide stabilization and control of the user's1106knee joint. The knee brace1104includes an hinged upright1080secured to a first pad, second pad, third pad and forth pad1082,1086,1098,1100respectively extending from the thigh area above the knee to the shin area below the knee. The first and second pad1082,1086are located on the upper thigh area of the user1106, above the knee. The third and fourth pad1098,1100are located in the shin area below the knee. The knee brace1104can further include a first strap, second strap, third strap and forth strap1078,1084,1096and1102. The straps can secure the respective pads to the hinged upright1080. The hinged upright can provide controlled and stabilized movement to the knee joint of the user1106.

A sensing assembly1092can be mounted to the hinged upright1080using a mounting assembly. The mounting assembly can be a hinged end1090and can include an aperture which can be used to secure itself to the hinged upright1080using a rivet or the like. The hinged end1090can also include a hinge allowing the hinged end1090to rotate about the hinge axis. In exemplary embodiments, the hinged axis will be limited to the range of the motion of the user's knee joint. The sensing assembly1092can be configured to measure range of motion of the knee.

With reference toFIG. 9E, a front portion of an alternative embodiment of the brace sensor mechanism is shown an elbow brace with an arm sling934secured to the torso of a user932is provided. The elbow brace934includes an arm sling930, attached to a strap arrangement952, which also relies on tension in the strap to facilitate immobilization of a limb, such as an arm in this embodiment. Strap940is fixedly attached at one end to the elbow area946of arm sling930, e.g., by way of a rivet, Chicago binding post or the like. Strap940wraps around the back portion of the neck (not shown) of user932, loops over the opposite shoulder to that of elbow area946and attaches to a sensor assembly936on the front side of the torso of user932. Strap940is fixedly attached to sensor assembly936at attachment mechanism954. Strap938is fixedly attached on one end to arm sling930at wrist area948, e.g., by way of a rivet, Chicago binding post or the like. Sensing assembly936includes a mounting passage942that accommodates passage of the free end of strap938in a “looping” fashion relative to sensing assembly936, thereby allowing the user932to pull on the free end of strap938to cinch the arm sling to shoulder strap940. The cinching action creates a tension in the strap that facilitates support for immobilization of the arm. The sensing assembly936provides advantageous monitoring and feedback functionality according to the present disclosure. The arm sling930can also include a first strap950to secure the sling to the user's932upper arm and a second strap944to secure the arm sling930to the user's932forearm.

In another embodiments, the sensing assembly can be disposed in the elbow area946of the elbow brace934. The sensing assembly can be configured to measure range of motion of the elbow area946.

With reference toFIG. 9F, a front portion of an exemplary orthotic foot brace956is shown secured to a user986. Foot brace956includes an outer hard shell962and an inner soft-material lining960with first and second portions988,990that overlap in an interface region974. Of note, although the exemplary embodiment ofFIG. 9Fdepicts an overlap of first and second portions988,990, alternative foot brace implementations may instead define a “gap” between first and second portions988,990. Thus, the overlap region974may take the form of a “gap” between cooperative portions of the disclosed foot brace, and references to “overlap regions” and “gaps” should be understood to embrace the relative positioning of the first and second portions, whether such relative positioning defines spacing, overlap or even side-by-side juxtaposition.

A plurality of straps are mounted with respect to foot brace956to facilitate securement thereof with respect to the user's lower leg, ankle and foot within the soft-material lining960. In particular, exemplary foot brace956includes first strap958, second strap964, third strap968, a forth strap970and a fifth strap972attached to hard shell962. As will be readily apparent to persons skilled in the art, the present disclosure is not limited to brace implementations that include four straps, or to brace implementations wherein the straps are located on the front face of the brace. Rather, the present disclosure may be implemented with fewer or greater numbers of straps without departing from the spirit or scope of the present disclosure, or to rear and/or side positioning of straps. Positioning of the straps on the front face of the foot brace may be preferable in specific usage environments, e.g., for user to easily access the strap adjustments. With further reference toFIG. 9F, each of the straps958,964,968,970and972is fixedly mounted to one side or the other of the hard shell960. More particularly, first strap958is fixedly mounted with respect to hard shell960by attachment mechanism976, second strap964is fixedly mounted with respect to hard shell960by attachment mechanism978, third strap968is fixedly mounted with respect to hard shell962by attachment mechanism980, the fourth strap970is fixedly mounted with respect to hard shell962by attachment mechanism984and fifth strap972is fixedly mounted with respect to hard shell962by attachment mechanism982. In the disclosed embodiment, second strap964releasably cooperates with sensing assembly966that is mounted with respect to hard shell962at attachment mechanism978. Sensing assembly966provides advantageous monitoring and feedback functionality according to the present disclosure, as described in greater detail below. Similarly, second strap964releasably cooperates with sensing assembly966that is mounted with respect to first portion988of brace956by mounting strap992. Sensing assembly966also provides advantageous monitoring and feedback functionality according to the present disclosure, as described in greater detail below.

In the exemplary embodiment ofFIG. 9F, each of the mounting straps958,964,968,970and972is fixedly mounted to the left side of hard shell962. However, the present disclosure in not limited to the “same side fixation” arrangement depicted inFIG. 9F, and brace-based systems may be implemented according to the present disclosure wherein the straps are fixedly mounted on alternating sides of the hard shell962in an “opposed fixation” arrangement without departing from the spirit or scope hereof. In fact, the opposed fixation arrangement of the straps relative to the hard shell962of foot brace956may improve the stability and/or ease with which the foot brace may be brought into a desired orientation by the user.

With further reference toFIG. 9F, sensing assembly966includes a mounting passage that accommodates passage of second strap964in a “looping” fashion relative to sensing assembly966, thereby allowing the user986to pull on the free end of strap964to cinch the left side relative to right side of hard shell962, thereby decreasing the gap between left side relative to right side of hard shell962. In implementations wherein a gap is defined between the first and second portions of a brace, the cinching operation will serve to reduce the gap and/or bring the two portions into a juxtaposed or overlapping orientation. Once cinched to a desired degree, second strap964is generally adapted to be detachably fixed in the desired position, e.g., by way of cooperative Velcro™ interaction in the overlapping region of strap946. Alternative fixation mechanisms may be employed to secure strap964in its cinched orientation, as will be readily apparent to persons skilled in the art. Looping, cinching and fixation mechanisms are generally provided with respect to first strap958, third strap964, forth strap970and fifth strap972, thereby permitting the user to bring the left side and the right side of hard shell962into a desired approximation.

In conventional foot brace systems, the desired cinched relationship between the left side and the right side of hard shell962is inexactly established. For example, a physician or other health care provider may apply a mark, e.g., a line, on some aspect of the foot brace system to designate the desired spatial relationship of the left and right sides of hard shell962, when in use. The user956then strives to bring the hard shell sides into alignment with the designated marking, subject to visibility limitations, parallax issues and difficulties in applying the requisite force to achieve the desired brace orientation. Moreover, conventional foot brace systems provide no ability to monitor the brace orientation over a period of use and/or identify changes to applicable parameters, e.g., the user's anatomy, that may impact on the accuracy of the initial “marking” provided by the physician or other health care provider. The disclosed systems and methods overcome the noted limitations and shortcomings of existing foot brace systems.

With reference toFIG. 9G, a prosthetic leg994that includes an upper leg portion1006, a lower leg portion1008and a foot portion1010is shown with a cone-shaped cavity1002attached at the top1004of the upper leg portion. The cone-shaped cavity1002is made of a pliable material that can receive and secure the stump portion of a leg that has been amputated, thus providing the user with an artificial leg. The pliable cone-shaped cavity1002is tightened around the stump with a conventional “loop strap” system similar to that described inFIG. 9A. Sensor assembly996is attached to an end1000of strap998. The end of sensor assembly996is attached to cone-shaped cavity1002. Again, the sensor assembly996, in-line with strap998, permits a continuous measure of parameters such as, but not limited to, tension, position, pressure and temperature with advantageous monitoring and feedback functionality according to the present disclosure.

With reference toFIG. 9H, a front view of an alternative embodiment of the brace sensor mechanism is shown with a prosthetic arm1014secured to the torso of a user1012. Prosthetic arm1014includes a conventional circular strap1030that is fixedly attached to the shoulder area1032of the prosthetic arm1014. A second conventional strap1020is fixedly attached to the circular strap1030on the backside (not shown) and wraps around the back and under the user's natural arm1022, and then extends across the user's front chest1024. The front end1026of strap1020is attached to sensor assembly1018. One end1028of sensor assembly1018is releasably attached to a connector strap1016, which is fixedly attached to circular strap1030. The tension in the straps1030,1020and1016is adjusted to achieve a fitting of the prosthetic arm1034that is physically safe, secure and comfortable to the user. The sensor assembly1018, positioned in-line with the conventional straps1020and1030permits a measure of the tension in the straps. The sensor assembly1018inFIG. 9Hprovides advantageous monitoring and feedback functionality according to the present disclosure, as described in greater detail below.

FIG. 10provides a schematic flowchart1120of exemplary data flow within the orthotic or prosthetic device in clinical calibration of the device and daily use of the device according to implementations of the present disclosure. While in clinical calibration the device may gather data in a loop1122. While in the loop the device can be set to gather data a set predetermined amount of iterations (step1124). In step1126, the device can be notified of a new state, via smartphone or other interaction with the device. In step1128the device can gather data from all the sensors and the device can repeat the loop until the device reaches the set predetermined iterations.

In step1130, the device can determine the individual sensor value ranges for each state of the device. For example, in order to determine the compliance and quality of orthotic and prosthetic device, the orthotic or prosthetic device can collect data associated with the measured metric/parameter while a user is at a clinic and compare the data associated with the measured metric/parameter collected at the clinic with data associated with the measured metric/parameter collected at a different predetermined time period in the past. The comparison can show degradation of the orthotic and prosthetic device or non-compliance by the user at a previous predetermined time period. The orthotic or prosthetic device can use the collected data to determine different states of the device. The different states can be but are not limited to: the device turned off, device is worn correctly, and the device is loose. A personalized comparative value can be established for each patient and each sensed metric/parameter. This information can also be used to optimize the sensing characteristics of the individual sensors by determining which of the sensed values changes between states and the frequency at which the sensor data must be recorded to capture the change between states. In step1132the sensors can be selected with the ability to distinguish between the states. In step1134, the configuration settings of the device can be set. While in daily use, in step1136the device can “wake” and power on selected sensors. In step1138, the sensors can sense the time and frequency in the settings. In step1140, the sensors can calculate the state of the device.

FIG. 11provides a schematic flowchart1200of exemplary data flow according to implementations of the present disclosure. The flow of data according to the present disclosure generally begins in the device/system (“Smart Strap Module1202”), where the force and/or position sensors are located. The device generally measures and/or captures sample time(s), sample force value(s) and sample position value(s). Data may be shuttled to a Bluetooth module for transmission to external devices, e.g., a computer or smartphone interface (“Smart Phone Application1204”). The Smart Phone Application1204can in turn communicate with an Internet Server1206that then communicates with a Web Portal1208. Communications may proceed in the opposite direction, i.e., originating from the Web Portal1208and ultimately reaching the Smart Strap Module1202, e.g., prescribed does, calibration data, and patient ID. Thus, the Web Portal may be associated with an external device to facilitate transfer of the data to a web-based database and associated processing capabilities. In addition, the Web Portal1208may support access and use of the data by interested parties, e.g., physicians, patients, parents and operational centers.

Thus, the disclosed device components may include sensors that are adapted to monitor and/or measure position (e.g., the resistance and magnetic systems described above) and/or tension/force (e.g., the strain gauge systems described above). The parameters measured by the disclosed sensors may be processed by a microcontroller associated with a circuit board that generally includes programming to drive the features and functions described herein. The device components also generally include appropriate data storage, e.g., a memory card such as a Micro-SD (secure digital) non-volatile memory card.

Once the microcomputer receives information from the sensor(s), the microcomputer may be programmed to actuate a variety of immediate feedback mechanisms, e.g., to notify the patient/user when certain conditions are met. Feedback mechanisms may be selected by the patient/user and customized depending on applicable variables, e.g., the type of device (e.g., prosthetic or orthotic device), the needs of the patient/user, the age/maturity of the patient/user and the like.

The device components also generally include one or more features/functions that are adapted to provide immediate feedback to users/caregivers with respect to brace use and performance. Thus, as described above, the disclosed system may include device components that are adapted to generate and deliver light signals, haptic/vibratory signals and/or sound-based signals. For example, RGB LED lights may be adapted to deliver feedback to the patient/user by changing color, intensity and/or the number of lights that are illuminated. In exemplary embodiments, the color of illumination light and/or aspects of the illumination (e.g., blinking rate) may be used to communicate information concerning the quality of device usage, as described with reference to previous embodiments. For example, a green LED may be illuminated if the quality of usage is good, a red LED may be illuminated if the quality of use is poor, and a yellow LED may be illuminated if the quality is of intermediate quality. Similarly, rapidity at which the LED is blinked may be used to signal proximity to a desired (or undesired) position of the brace. Auditory feedback may be delivered in various ways, e.g., a piezoelectric buzzer may be used to alert a patient/user of a sensed condition even if the patient/user is not looking at the device. Haptic/vibratory feedback may be particularly valuable to patients/users, e.g., when the device is located so as to be out of the user's line of sight (e.g., adjacent a patient's back), which means that the patient will not be able to see visual feedback associated with the device. Haptic/vibratory feedback may also be generated and delivered in a manner that is not apparent to others in the vicinity, thereby preserving the privacy of the patient/user.

Still further, device components associated with the present disclosure generally include elements that are adapted to support data transmission, e.g., a Bluetooth module. For example, the microcontroller of the disclosed system may be adapted to relay stored data to the Bluetooth module for output in a serial stream that can be received and read by smartphones, computers and other Bluetooth-enabled electronic devices/systems. Power is generally delivered to the disclosed device components by appropriate battery technology, e.g., rechargeable lithium polymer battery. Charging of the disclosed battery may be accomplished by way of a micro-USB connection and/or internal charging circuitry associated with the disclosed system. Information generated by the disclosed device components are advantageously transmitted, e.g., by way of a Bluetooth communications, to external processing and/or data storage units.

Bluetooth transmissions may be employed to transmit information that is sensed and processed by the device components to external systems, such as an external computer and/or smartphone.

In addition, the information that is transmitted from the disclosed device components may be routed to a network-based system, such as an online database and associated processing functionality. In exemplary implementations, the information that is collected by the device components associated with a device may be routed to an application that permits access by a physician and/or other health care provider, thereby permitting condition-related assessments and adjustments to be undertaken in a timely and effective manner without the need for frequent office visits by the patient. Interaction with and analysis of the data generated by the disclosed systems may be facilitated by appropriate user interfaces that are programmed to deliver user-friendly information display and associated processing tools. Different user interfaces may be provided for different user groups, e.g., patients and physicians/health care providers.

The information that is transmitted to external systems and the immediate feedback generated by the device components, e.g., visual, haptic and/or sound communications, may benefit the patients, their parents (and other caregivers) and doctors (and other health care providers). Still further, research organizations and/or central monitoring organizations may have access to or otherwise receive information that is generated according to the present system.

With reference toFIGS. 12A-12B, exemplary data displays that are supported by the monitoring/measuring and feedback systems of the present disclosure are illustrated, as follows:

FIG. 12Adepicts an exemplary screenshots1300and1302of a mobile application showing long-term feedback via bar graphs and a prescription display according to the present disclosure. As shown in screenshot1300, along at top of the screenshot, a “log” link is provided that allows review of the user's usage log. Below the “log” link, the display shows exemplary device usage for a series of days (7/1-6/23), including specifically the number of hours of device usage and the tightness relative to prescribed level (as a percentage). As shown in screen shot1302, along the top “profile” link is provided that allows the review of the user's usage of each strap. For example, the user can see the number of hours each strap was strapped on and the amount of tension provided to each strap.

FIG. 12Bdepicts a further exemplary screenshot1304that shows a web application for clinicians showing long-term data display and summaries, as well as prescription. The screenshot1304depicts a patient dashboard. The patient dashboard includes patient bio, data associated with various braces, prescription, feedback information and a bar graph of the usage data with the usage hours along the y-axis and the days along the x-axis. The patient bio can include date of birth, type of brace, and patient number. The data associated with the braces can include the data collected for different straps, i.e. lower and upper including position and tension information. The bar graph will indicate the total hours the device was worn along with the total hours the device was correctly worn for each day as with reference to the prescribed hours. As noted above, the modular units of the present disclosure may be used in conjunction with various prosthetic/orthotic devices and may be used to measure/sense various metrics/parameters. The measured/sensed data may be used to calculate various performance- and/or usage-related values, e.g., step count, activity, range of motion, orientation, and other measurements. The modular units may be associated with strap(s), belt(s), webbing, ratchet(s) and other tensioning devices/systems.

In some embodiments, the orthotic or prosthetic device can have a learning mode configured to compare data associated with the measured metrics/parameters collected at a particular predetermined time period with data associated with the measured metrics/parameters at another predetermined time periods in the past.

FIG. 13provides an exemplary flowchart1400that illustrates a sequence of steps by which the disclosed system/method may be determine quality and compliance of the orthotic or prosthetic device use. Alternative and/or additional metrics may be measured/calculated with respect to device use utilizing the measured data/forces. Thus, the system/method may determine whether the device is being worn (Step1402). If not, the parents and/or physician may be notified (Step1404). Conversely, if the device is being worn, the system/method determines whether the prescription as to device positioning is being satisfied (Step1406). If not, the parents and/or physician may be notified (Step1404). If so, the average force at the applicable device position is determined (Step1408). Based on the average force determination, the system/method determines if the prescription as to force is being met (Step1410). If not, the position prescription is revised to deliver the desired force level (Step1414). Conversely, if the force prescription is being met, then the prescription level is maintained (Step1412) and the system/method rechecks quality/compliance, as and when prompted, e.g., based on a preset frequency schedule. As noted above, additional/alternative metrics may be measured, calculated and reported according to the present disclosure.

The present disclosure has been described with reference to various exemplary implementations and embodiments of the advantageous systems and methods for monitoring and/or measuring parameters related to the use of devices, e.g., compliance and quality of orthotic or prosthetic device usage, step count, activity, range of motion, orientation, or other measurements. However, the present disclosure is not limited by or to the exemplary implementations and embodiments described herein. Rather, the systems and methods of the present disclosure are susceptible to many alternative implementations and embodiments without departing from the spirit or scope provided herein, as will be readily apparent to persons skilled in the art. Accordingly, the present disclosure expressly encompasses and embraces such alternative implementations and embodiments within its scope.