Patent Description:
Optimum fitting of foot orthotics to a particular user can be thought of as much an art as a science. It is said that some people are helped enormously even by a rolled up piece of newspaper put in their shoe, while others require multiple visits to a podiatrist for fine-tuning, usually accomplished by adding or removing material from an orthotic. For many years the prevailing thought that "supporting the arch" was the best way to control gait but newer thinking has focused on designing orthotics to restrict and influence motion as well as improve dynamic alignment of the joints in the lower extremity.

This improved alignment reduces the rotational and vertical joint forces resulting from ground reaction forces being transmitted up the kinetic chain of the lower extremity. To restrict and influence motion, newer orthotics are constructed from semi-rigid materials that flex, bend, or rotate under load. During the stance phase of the gait cycle (from heel strike, through mid-stance, to propulsion) weight is placed on the orthotic causing a complex flexing, bending, or rotating in three planes - the sagittal, frontal, and transverse, at multiple regions on the orthotic. All of that movement occurs in the shoe, under the foot and thus is not information directly available to a clinician evaluating the effectiveness of the orthotic. Although a clinician can carefully watch a person walking back and forth while wearing a trial orthotic, the users' reported subjective experience provides the primary clues to the clinician. That often is not any more helpful than "it doesn't feel right".

It is desirable to make fitting an orthotic to an individual more science and less art. It is also desirable to reduce the need for a clinician in many cases and to lower the overall cost of getting effective orthotics on users' feet.

<CIT> discloses a sensor system for performing gait analysis of a person that includes a sensor system that includes a pair of sensor insoles that include a plurality of force sensors, an accelerometer, and a transmitter for transmitting data to a portable electronic device.

<CIT> discloses a sensor device that has an insole, a sensor body abutting the insole, pressure sensors operably mounted on the sensor body for generating a pressure data signal, and an accelerometer mounted on the insole for generating a movement data signal indicating the measuring movement of the insole.

<CIT> discloses systems and methods of developing a tissue deformation profile for a foot of a patient.

<CIT> discloses a system for analyzing gait using textile sensors.

<NPL> describes a wireless wearable system that was developed to provide quantitative gait analysis outside the confines of the traditional motion laboratory. The sensor suite includes three orthogonal accelerometers, three orthogonal gyroscopes, four force sensors, two bidirectional bend sensors, two dynamic pressure sensors, as well as electric field height sensors.

The problem is solved by an instrumented, semi-rigid orthotic. One or more flexible portions of the orthotic can have embedded or secured sensors to detect and measure flexing, bending, or rotating in three planes. The sensors can include accelerometers, gyroscopes, magnetometers, strain gauges, and force transducers at one or more locations on the orthotic. Data can be read from those sensors by a microprocessor that also can be embedded in or secured to the orthotic. Preprocessing of the data can be performed by the microprocessor and further processing can be optionally performed on an external computing device like a smart phone or tablet computer or cloud-based server. The external device can be in wired or wireless communication with the microprocessor. Results can be displayed on the portable device.

Preprocessing of the raw data can include determining the direction, magnitude and timing of flexing, bending, or rotating of the orthotic leading to data about the motions of the subtalar and midtarsal joints. Preprocessing can also extract the duration, position, velocity and acceleration of any flexing, bending, or rotating at multiple locations on the orthotic. The timing can be meaningfully expressed in terms of the point in the stance phase of a gait cycle that an event occurs. This allows measurement and recording of the bending and the motion at the same time. Comparison to data previously taken from that subject or other subjects with the same or other orthotics can be made to determine the effectiveness of the orthotic. Orthotic effectiveness is more than the user's subjective experience; it can also include achieving an optimal clinical alignment of the entire lower extremity. Further, recommendations for altering the geometry or rigidity of the orthotic can be a component of the results produced by the analysis. If the orthotic was one with variable tilt settings, the recommendation to alter the geometry could be recommending a new setting. Measuring how the foot and also the thigh move can help create an algorithm to use orthotic flexing, bending, or rotating to evaluate issues with foot, knee and ankle motion.

Each movement pattern the sensors pick up during walking, swinging a golf club, a cycling stroke, or during any other movement tasks represent distinct patterns that can be grouped into categories, studied, and used in a model. With adjustable orthotics, gait patterns can be modified. Some applications will combine data from an instrumented orthotic with more traditional measurements of ground reaction forces or motion capture.

This is important because the ground reaction forces are transmitted up the entire lower extremity, often resulting in excessive loads and strains on the bones and joints of the lower extremity. These excessive loads on mal-alignment of the joints of the lower extremity can lead to injuries and poor performance in sports and other functional tasks.

The use of the data analytics can create a database used to structurally classify and develop motion metrics for different structural variations of the lower extremity.

In <FIG> a user is shown examining, on her smart phone <NUM>, the rating produced by the instrumented orthotic system <NUM> she is wearing.

<FIG> shows the positions of sensors and computing and communicating devices in an example embodiment of an instrumented orthotic. There are position, movement, and orientation sensors in a flexible forefoot area <NUM> and near the arch <NUM>. In addition, this embodiment includes a pressure or force sensor <NUM> at the heel. These devices are electrically connected to a computing unit or microprocessor <NUM>. The sensors and CPU are thin enough to be embedded in the orthotic and not interfere with its function.

<FIG> illustrates points of the gait cycle during the stance phase. The stance phase is from heel strike to toe propulsion. This is the phase in which the most useful data is obtained by the system since the orthotic is under load.

<FIG> shows a schematic representation of the instrumented orthotic of <FIG>. The electrical interconnection <NUM> is depicted in this figure.

In a much exaggerated way, <FIG> show possible flexing, bending, or rotating of the forefoot region. In attempting to control for over-pronation or over-supination, the forefoot orthotic will flex, bend, or rotate during points in the gait cycle when weight is put on the forefoot. This flexing, bending, or rotating will typically be a complex motion in three dimensions. If known, the direction and degree of flexing, bending, or rotating can inform a clinician who is trying to achieve an optimal clinical alignment of the lower extremity.

<FIG> shows a cut-away schematic view of an instrumented orthotic <NUM> of these teachings. It is shown being worn within a shoe <NUM> and supporting a foot <NUM>. While the portions of the orthotic under the toes and heel rest directly on the sole of the shoe when weight is fully applied, the orthotic can also move in relation to the sole of the shoe at various points in the gait cycle. Regions <NUM> and <NUM> have three-dimensional freedom of movement with respect to the sole <NUM> of the shoe, and ultimately to the ground. These motions can be sensed by the two sets of sensors <NUM>, <NUM> in this embodiment. Some alternative embodiments have a wireless sensor <NUM> in the shoe.

<FIG> shows a block diagram of the electronics sub-system. The sensors are connected to an integrated circuit that has a processor, memory, and communication abilities. In this example, an integrated digital signal processor (DSP) is included in the example CPU.

An electronic system, according to this block diagram, includes a microprocessor <NUM>, a forefoot <NUM>-axis accelerometer/ <NUM>-axis gyroscope <NUM>, an arch region <NUM>-axis accelerometer/ <NUM>-axis gyroscope <NUM>, and a wireless transmitter <NUM>. The components are embedded in the orthotic. Suitable components can include the Intel® Quark™ SE microcontroller, said to be the heart of the Intel Curie. The Quark™ SE CPU would be connected to a <NUM>-axis accelerometer, and <NUM>-axis gyroscope, and <NUM>-axis magnetometer IC, also embedded in the orthotic. The STMicroelectronics LSM9DS0 9DOF IMU IC would be a suitable component for this purpose. Strain gauges in two dimensions can also measure the flexing, or bending of the orthotic. The electronic system, overall, will measure and record raw sensor data, pre-process it for external analysis and analyze the data. The sensors can also be used to measure gross foot/shoe movement to follow the gait cycle. Those skilled in the art will know how to determine the point in a gait cycle a person is in from the data provided by the sensors.

<FIG> shows a high level flow chart of the steps in an example operation of the described system embodiment. After starting S99, steps S100 and S101 implement a loop continuously reading data from the sensors to track the gait phase. When a heel strike is detected S101, the data is read and is recorded S102. A rapid spike in deceleration around the heel strike indicates the start of the stance phase. This occurs until toe-off is detected in step S104, ending the stance phase. After several steps, preprocessing is done that can organize and compress the data.

With the complete data for a stance phase, and optionally data from the swing phase, recorded, the operation extracts salient features of the data including flex, bend, or rotate direction, magnitude, timing, duration and the acceleration of flexing, bending, or rotating S105. The preprocessing and analysis in this embodiment includes taking the combination of raw data from the various sensors to create a normalized, coherent record of the motions and forces for each gait cycle.

In step S105. <NUM> the relative timing point in the stance phase is aligned and associated with the movement data. The relative orthotic movement data can be aligned on a timeline with the stance phase of the gait cycle for analysis. A person may vary their speed even on a step-by-step basis; therefore the wall-clock time when a relevant data point is captured can be difficult to match for multiple steps from multiple persons. The more useful timing is the point in the gait cycle that a particular event occurs. Establishing a time normalized gait cycle permits comparison of multiple trials to each other.

In step S106 the salient data is compared to data from many trials with many users and many orthotic geometries to produce a rating of effectiveness S107. Data from trials with individuals with known foot problems and known optimum orthotics, including trials with alternant, non-optimum orthotics, are used for comparison. Comparisons to data previously taken from other subjects or the current subject with the same or other orthotics can be made to determine the effectiveness of the orthotic. Furthermore this data can be compared to data taken on bone and joint motion in a human performance lab. That data can be analyzed with neural nets or by classification and clustering techniques as taught in Seiner <CIT>, Designation of a Characteristic of a Physical Capability by Motion Analysis Systems and Methods, to produce a rating of the effectiveness of an orthotic for a wearer. It can also be used to construct a predictive model for improved treatment.

The operation can optionally include step S108 and generate a recommendation for an improved orthotic for the tested user. By further analysis and comparison, S108 produces a recommendation to alter the geometry of the orthotic in an attempt to provide a better fit to a user and achieve an improved alignment. This improved alignment would help the user in achieving optimal clinical alignment of the lower extremity (reducing the rotational and vertical forces being transmitted up the kinetic chain of the lower extremity as a result of ground reaction forces). Recommendations to modify the geometry of the orthotic can include: suggesting a completely new orthotic or adding to or removing material on the present orthotic as traditionally done by podiatrists or orthotists. It could also include a setting change for a variable orthotic, or it could provide information to make a 3D printing of an optimized orthotic. If the user is still walking and still in the trial, the process repeats, starting back at S100.

The orthotic and the sole of the shoe have relative freedom of motion between them. As part of the analysis, the location of the ground can be determined by assuming it is a plane generally tangent to the earth and knowing the location of the shoe at a heel strike. To calculate realtive motion between the floor and the orthotic by effectively doing a 3D comparing of the location, motion and orientation of the shoe from the same information for one or more regions of the orthotic, shoe-orthotic relative motion can be determined.

Some of the steps of <FIG> are carried out by an instrumented orthotic, particularly by firmware and software executing on the embedded microprocessor <NUM>. However, to keep the cost, size, and power dissipation low, many subsequent steps may be carried out by an application executing on a smart phone, tablet computer or other external computing device including a remote server <NUM>. In that case, raw, preprocessed or partially analyzed data may be transmitted from the orthotic to a nearby computing and display device. In some embodiments data may be sent from the phone to a server and database via the cloud and the information returned from the server may supply the final information to have the phone display to a user.

The embodiment shown has a wireless transceiver for communicating with an external computing device such as a smart phone <NUM> or tablet computer or cloud-based server. After preliminary preprocessing under the control of software executing on the embedded microprocessor, the data is wirelessly sent to the external device for further processing and analysis. Steps S99 through S102 or alternatively S99 through S104 might be performed on the orthotics' electronics with the other steps performed on an external device or remote server and database. As mentioned, in some embodiments, the microprocessor may have sufficient computing power to perform more of, or all of, the steps of the analysis. If some data or all data is sent to a remote server with a database, the server may analyze the current data in light of other data from the same subject or in light of an aggregation of data including data from other subjects.

The recommendation for an improved orthotic can include directing setting changes on a variable or adjustable orthotic. Teachings for adjustable orthotics include <CIT>; <CIT>; <CIT>; and <CIT> <FIG> show views of an example variable orthotic from <CIT>, Adjustable Forefoot Posting for Orthotic. Tilt settings on this device are changed by turning a selector wheel <NUM>.

If an adjustable orthotic can have its setting changed electrically, the recommended change could be directly transmitted back to the orthotic to directly institute a geometry change. This might be practical if done when there is no weight on the post position.

With enough computing power embedded in an orthotic that can dynamically alter its geometry, the external electronic computing device may become optional. In some embodiments the external portable electronic device such as a smart cellphone, tablet, or special purpose unit can be used primarily to display results.

Variations can include versions that are connected by wires to a worn external computing device. The number of locations instrumented for measurement can vary. Sensors can include strain gauges and flex sensors, resistive, piezoelectric, and others. Another variation is a flexible printed circuit board with the electronic computers soldered onto it. The flexible circuit board could be permanently or temporarily adhered to any orthotic to transform it into an instrumented orthotic.

In some cases the relative position and movement between the sole of the shoe and the orthotic may be deemed to be a useful measurement, a wireless sensor could be imbedded into a shoe or temporary secured to either the inside or outside of the sole as depicted in <FIG>and <FIG> as element <NUM>. The sensors and computing within the orthotic could be used to instrument the shoe, or a much simpler, less power consuming electronics might be used.

Data could be transmitted directly to the external computing device or, saving power, may be sent to the orthotic directly above it. There are many suitable wireless technologies that can be used to achieve this including near field transmission.

These teachings can also be applied to other orthotic devices where there is independence of movement between the body and the orthotic. For example "An adjustable orthotic brace" - <CIT>, describes a dynamically changing leg brace.

Previous work, including <CIT>, provide enabling information including the use of inertial sensors attached to a shoe to measure foot position and orientation in 3D.

In some embodiments there may not be a local device doing significant computing but being used primarily as an output display device. In other embodiments there may not be a local computing device communicating with the instrumented orthotic. The instrumented orthotic may be transmitting to the Internet or other destination via cellular communications. WIFI or other technology. In other embodiments there may be no server connection necessary.

Claim 1:
An instrumented orthotic (<NUM>) comprising:
a) an orthotic plate of a foot-conforming shape having at least a portion of its forefoot area that is semi-flexible during normal locomotion, the orthotic plate being configured to be worn in a shoe (<NUM>) of a user such that there is freedom of movement between the orthotic plate and the shoe (<NUM>);
b) an electronic system embedded in the orthotic plate comprising:
a set of sensors (<NUM>) configured to measure:
position, movement, and orientation of a region (<NUM>) in the flexible forefoot area; and
bending of the orthotic plate in two dimensions; and
a CPU and memory in electronic communication with the set of sensors, wherein the memory contains a program that reads sensor data; and
c) a processor (<NUM>) configured to measure a flexing in the orthotic plate and ground reaction forces transmitted up a lower extremity of the user based at least on the sensor data read from the set of sensors in the orthotic plate.