DESC:FIELD OF THE INVENTION
The disclosed herein an invention of a compact smart e-sole (electronic smart sole), a monitoring simplified wearable module covering major parameters combining the weighing monitor, body composition monitor, and pulse oximetry monitoring module. It is a portable and Bluetooth Low Energy (BLE) operated device, of which output is analyzed on dedicated phone application. It can be used at healthcare clinics as well as at home for tracking daily body parameters.

BACKGROUND OF THE INVENTION
The impact of the coronavirus pandemic led to an increase in the prevalence of obesity among adults, which is associated with a greater risk of non-communicable diseases like diabetes, cardiovascular disease, lung diseases, and hypertension. India is considered the capital of diabetes. Early detection of these diseases has become critical for helping with early intervention and treatment, which may either cure the disease or improve the patient's outcome. Therefore, real-time monitoring of these comorbidities has become crucial, as it could significantly influence clinical outcomes in the event of a potential COVID infection. The basic parameters required for early detection of the above comorbidities are body mass index, heart rate, oxygen situation in the blood, body composition parameters such as fat percentage, muscle percentage, and total body water percentage. There are a wide range of body composition monitors with different technologies available in the market that provide some of these parameters, such as skinfold measurement, hydrostatic weighing, dual-energy x-ray absorptiometry, and specifically, weighing scales. Integrated body composition monitors based on bioelectric impedance working principles are widely used in healthcare centers, however these technologies come with infrastructure limitations. Monitoring devices for heart rate and blood oxygen saturation are easily available in the market, but the rate of fluctuation in the output on a real-time basis is an evident issue. These limitations illustrate the painful gap in the healthcare sector. To address this gap, the invention of smart shoes with electronic sole will play a major role. In the current healthcare scenario, body composition monitoring, weight monitoring, and pulse oximetry-heart rate monitoring have different measuring modules, and hence the cost to the patient for each parameter check-up at the healthcare centers varies widely. Even though these devices are portable in nature, they require dedicated zones in clinical setups, where these systems are installed as standalone, and tests are taken. Considering all these different modules at home for individuals' use leads to higher costs.

SUMMARY OF THE INVENTION
Described here is an electronic sole that provides real-time monitoring to the patient by assisting in maintaining health statistics charts by tracking daily body composition changes. It tracks parameters such as body weight, body mass index, body fat percentage, skeletal muscle percentage, total body water percentage, level of oxygen saturation in the blood, and pulse rate. It also helps in maintaining patient specific health charts. This module is combined in the shoe using Bluetooth, phone, and individual footbed sole sensor in each shoe. It not only provides continuous and non-invasive monitoring of health parameters, but through integrated BLE application technology, it can also provide real-time updates to healthcare professionals. In addition, it also helps patients in tracking distance travelled by each patient per kilometer during a walk or run and the number of steps walked on a daily basis. Hence, the invention enables large monitoring windows on portable, handheld, and real time basis. These measured parameters are active measurements, not passive ones. This device has a shelf life of 2 years.

In an embodiment, disclosed is a shoe for continuous measurement of a body composition of a subject in a need thereof, comprising an electronic smart sole; wherein the sole comprises a module that allows to track a parameter for maintaining health statistics charts of the subject. In another embodiment, the module comprises (a) a strain gauge working module, (b) a bioelectrical bioimpedance module, and (c) a pulse oximetry module.

The smart shoes of the present invention continuously track the parameters for maintaining health statistics charts of the subject and also measures the body composition of a subject in a need thereof.

BRIEF DESCRIPTION OF FIGURES OF THE INVENTION
Fig A: Process chart in smart shoe with electronic sole.
Fig B: Functional assembly of the footbed sole integrated in the shoe and placement of foot.
Fig C: Electronic assembly integrated in the footbed sole.

DETAILED DESCRIPTION OF THE INVENTION
Bioimpedance analysis (BIA) based technology has been widely used in the measurement of body composition parameters, which also allows the integration of body mass index and weight measurement. Bioimpedance devices detect how the body responds to small electrical currents. This is achieved by placing electrodes between the hands and/or feet. These electrodes send currents into the subject (a person in need thereof), while others receive the signal after it has passed through the body tissues. Because muscle has a higher water content, electrical currents move through it more easily than fat. The device then converts the body's response to the electrical currents into an equation that predicts various body composition parameters. There are many different bioimpedance based devices and technologies that vary widely on cost, complexity, and accuracy.

Bioimpedance Spectroscopy (BIS) is like bioimpedance in which the body responds to small electric currents. However, bioimpedance spectroscopy uses more electrical current than bioimpedance analysis and processes the information differently. It’s fairly accurate but currently not available on the market and is mostly used in medical and research settings.

Electrical Impedance Myography (EIM) - Electrical impedance myography is a third method that measures the body’s response to small electrical currents. However, while BIA and BIS send currents through your whole body, EIM sends currents through smaller regions of your body. Portable devices are placed directly on different body parts to estimate the body fat percentage at those locations. More research is necessary to establish the accuracy of this method in the current market, as there is very little information available about the accuracy of these devices.

Skinfold measurement is one of the old techniques used for body composition measurement, in which skinfold callipers measure the thickness of subcutaneous fat. It involves calliper to lightly pinch the skin and underlying fat in several places. But this technique is unable to measure body mass index of the patient, hence the limitation in the parameter. Also, this method requires practice and basic anatomy knowledge. The skill of the person performing the skinfolds can vary, impacting the accuracy, hence, it involves complexity.

Another well-known older technique is hydrostatic weighing. This method, also known as underwater weighing or hydro densitometry, estimates your body composition based on its density. This technique weighs patients while submerged under water after exhaling as much air as possible from the lungs. Body density is then used to predict body fat percentage. However, it’s difficult for some individuals to be fully submerged under water. The method requires breathing out as much air as possible, then holding the breath underwater also it is available only at certain facilities. and involves holding your breath while being completely submerged in water. Air displacement plethysmography is like hydrostatic weighing, and air displacement plethysmography estimates your body fat percentage based on the density of your body. However, it uses air instead of water, it has limited availability and is much expensive.

Dual-energy x-ray absorptiometry (DEXA): as the name implies, DEXA uses X-rays of two different energies to estimate your body fat percentage. During a DEXA scan, the patient lies on your back for approximately 10 minutes while an x-ray scans over you. However, DEXAs are frequently unavailable to the public and expensive when available.

Bioimpedance analysis-based devices are easily available in the market, but due to certain limitations they are not accessible for each individual and for home use. What’s more, when they are available at a testing facility, they may be expensive and time consuming. Also, the problem is that each device extensively varies in accuracy, parameter limitations, cost and due to user-hostile if used at home. Even though some of these devices are portable in nature, still need to have one dedicated area where the system is installed, and tests are taken.

In contemporary situation of healthcare setups, body composition monitoring, weight monitoring and pulse oximetry- heart rate monitoring have different measuring modules and hence it varies widely on cost to the patient for each parameter check-up at health centres considering all three modules at home use for individual’s leads to rise in cost. Hence, it is not possible for every patient to have a personal three individual modules for home use.

The said invention is a shoe with smart electronic sole (footbed sole) that is portable and lightweight, and it enables anyone to take immediate measurements anywhere they are. The technology is more cost-effective due to the fact that the smart footbed sole can be attached to any shoe in order to accommodate the subject (person in need thereof) level of comfort. The device's integrated Bluetooth Low Energy (BLE) module enables the display of parameters on a smartphone application, thereby enhancing its user-friendliness. Patients are now able to evaluate their output in a much more convenient manner due to applications that are based on their phones. These applications continuously monitor various parameters, particularly oxygen saturation and heart rate. By incorporating many components into a single unit, the device is not only efficient in terms of speed but also in terms of how easy it is to use. Additionally, it is cost-effective.

The smart electronic sole comprises of three major modules, strain gauge working, bioelectrical bioimpedance and pulse oximetry, mechanism in once single unit, which allows to measure wide range of parameters for health check-up in a single unit. It provides parameters such as body mass index, body fat percentage, skeletal muscle percentage, total body water percentage, oxygen saturation level and the heart rate. For calculating and estimating these parameters, its output is based on physical features such as height, weight, gender, and an age of the measured patient. All the parameters of measured patient are displayed on phone application through Bluetooth technology. Measuring body composition helps to know body's unique structure and to identify areas to work on to improve persons overall health and wellness. In addition, this device also helps to track daily and continuous monitoring of heart rate and percentage of oxygen saturation (SpO2). These parameters help in early indication of lowering of blood oxygen level and heart rate. This also allows a person to change their diet or exercise routine to avoid the risk.

The invention is explained more fully with reference to the figures:
Fig. A Illustrates the process chart for a smart shoe with an electronic sole.
Fig. B Illustrates the functional assembly of the footbed sole integrated into the shoe and the placement of the foot.
Fig. C Illustrates the electronic assembly integrated into the footbed sole.

Fig.A- A shows how the shoe with smart electronic sole works. A subject (person in need thereof) needs to connect the shoe with mobile using Bluetooth application using a dedicated software programme. The subject need to provide inputs such as height, age, gender, weight, etc and store them in the profile section of software (mobile application). Once the shoe is connected to mobile application, the shoe continuously tracks the various parameters using different modules, wherein each module sends the data to control unit (microprocessor control board integrated with BLE module) and it sends out data to mobile application.

Fig.B -Figure shows smart shoe (13), which is encompassed with footbed sole with sensors (Fig.B - 7). The footbed sole is incorporated with two load cells (Fig.B – 2 & 5) used to measure the voltage fluctuation caused in the strain gauge when it undergoes deformation for weight measurement, two metal plate (Fig.B – 3 & 6) for continuous current flow and signal reception in bioimpedance, an oxygen saturation-heart rate sensor board (Fig.B- 1) used to measure oxygen saturation-heart rate by pulse oximetry, microprocessor control board integrated with BLE module for data processing, pedometer sensor and coin cell battery (Fig.B - 4).

The two load cells are positioned beneath the metal plate (Fig.B 5 & 6) of the footbed sole. The load cells are strategically placed at the ball and heel of the foot (Fig.B - 12) to accurately measure the maximum body pressure experienced by individuals at these specific locations. The metal plate electrodes are positioned on top of the load cell, or ball (Fig.B - 9), and heel areas of the footbed sole (Fig.B -11). This placement ensures that the measured impedance is accurate by providing adequate coverage. The SpO2-heart rate sensor is positioned beneath the Big/Great toe (Fig.B - 8) on the footbed sole (Fig.B - 7). The microprocessor control board, along with the BLE unit, pedometer sensor, coin cell battery unit, transmitter, and receiver unit, is positioned beneath the mid arch of the foot in the sole (as shown in Figure B - 10). This placement serves to safeguard the control board and its electronics by reducing the impact force exerted by the patient's foot on the sole of the footbed.

The device measures the weight of the patient in standing position with the help of two load cells incorporated in each footbed, in which two load cells (2 &5) are based on strain gauge working principle. Strain gauge load cells are a type of load cell where a strain gauge assembly is positioned inside the load cell housing to convert the load acting on them into electrical signals. The weight on the load cell is measured by the voltage fluctuation caused in the strain gauge when it undergoes deformation. When there is no load on the load cell, the resistances of each strain gauge will be the same. However, when under load, the resistance of the strain gauge varies, causing a change in output voltage. Thus, the output voltage changes of the four load cells placed under two footbed soles are measured and converted into readable values using an analogue to digital processing circuit and the achieved values are display on the phone application via Bluetooth module.

The Bioelectrical impedance is measured between both feet of a person by passing a small amount of electric current through metal plate electrodes in standing position and the voltage drop is measured across the metal plates (3 & 6). Bioimpedance is used to estimate body composition based on the different conductive and dielectric properties of various biological tissues at various current frequencies. Tissues that contain a lot of water and electrolytes are highly conductive whereas fat, bone and air-filled spaces are highly resistive. An applied electric current always follows the path of least resistance. Impedance is the frequency dependent opposition of a conductor to the flow of alternating electric current and is composed of two components resistance and reactance. Resistance is the pure opposition of the conductor to the flow of the current; a reactance is the storage of an electrical charge by a condenser for a moment in time. The body can be a series of cylinders, where resistance is proportional to the length of the cylinder and inversely proportional to the cross-sectional area of it. Metal plate electrodes are arranged so that it come in contact with tiptoes and heels of both feet of the measured person when getting on the loading plate of an electronic weighing mechanism for measuring the weight of the measured person, at that instant current terminals of a constant-current regulated (50kHz) AC power source with known current value 1-10 µA <1mA through electrodes and measuring the output voltage across the electrode and finding instantaneous impedance of the measured patient.

Body mass index (BMI) is one of the crucial parameters measured by the smart monitor. BMI is the most accurate way to determine the effect of a person’s body weight on an individual’s health. It is used to assess risk for diseases, especially heart disease and diabetes. As BMI increases, so does the risk of developing these and other weight-related diseases, including stroke and some cancers. BMI measurement is based on height and weight,
Body Mass Index (BMI)= weight (kg)/ Height (m2)
The Centres for Disease Control and Prevention provide the following ranges for BMI values for adults:
- Underweight: Less than 18.5
- Recommended: 18.6 to 24.9
- Overweight: 25.0 to 29.9
- Obese: 30 or greater

Fat percentage (%) is measured by passing current through patient’s body and resistance between the conductors will provide a measure of body fat between a pair of electrodes, since the resistance to electricity varies between adipose, muscular, and skeletal tissue. Fat-free mass (muscle) is a good conductor as it contains a large amount of water (approximately 73%) and electrolytes, while fat is anhydrous and a poor conductor of electric current. Body fat (adipose tissue) causes greater resistance (impedance) than fat-free mass and slows the rate at which the current travels.
Fat percentage (%) predicted from age, height, weight, gender and bioimpedance, is calculated as,
For Male,
FFM = -10.68 + 0.65H2/R + 0.26 W+ 0.02 R

For Female,
FFM = -9.53 + 0.69H2/R + 0.17W + 0.02 R
Where, FFM = Fat free mass (kg)
H = Height (cm)
W = Body weight (kg)
R = Resistance (ohm)
Percentage (%) body fat = 100 x (body weight – FFM)/ body weight
For accuracy check, fat percentage (%) can also be estimated by using BMI value, the relationship between BMI and body fat percentage in children is different than in adults due to the height-related increase in BMI in children aged 15 years and younger. So, the computing equations are different for both,
Body Fat% (Adult) = (1.39 x BMI) + (0.16 x age) – (10.34 x gender) – 9
Body Fat% (Children) = (1.20 x BMI) + (0.23 x age) – (10.8 x gender) – 5.4
where gender is 0 for female and 1 for male.

Skeletal muscle mass % is a vital parameter measured by smart monitor, as maintaining a healthy percentage of muscle mass has several benefits, such as reducing the risk of age-related muscle loss. It plays a key role in movement. Keeping the skeletal muscles healthy is important for daily functioning. This may be particularly important for older adults. The whole-body skeletal muscle mass is determined by the biometric impedance output achieved from the measured patient. Skeletal muscle mass percentage (%) is calculated by below equation,

Skeletal muscle mass (kg) = [Ht^2 /R*0.401) +1(gender* 3.825) + age * -0.071] + 5.102
where Ht is height in centimeters and R is BIA resistance in ohms. For gender, male = 1 and female = 0; and age is in years.

The individual’s Total body water (TWD) parameter is estimated from the impedance measurements because the electrolytes in the body’s water are excellent conductors of electric current. When the volume of total body water is large, the current flows more easily through the body with less resistance. The resistance to the current flow is greater in individuals with large amounts of body fat. The total body water (liters) is measured as,

TBW= 0.016 + 0.674 body weight (kg) -0.038 wt2 + 3.84-foot length (cm)2/resistance (50 kHz in Ohms)
performed best, accounting for 99.5% of the variation in TBW, with a 95% prediction interval of 165 ml. TBW = 0.144 + 15.518- foot length (cm)2/resistance (50 kHz in ohms) accounted for 96.4% of the variation and had a 95% prediction interval of 420 ml.

This device also monitors oxygen saturation level and pulse rate which are considered as major health parameters. It measures the percentage of hemoglobin that is oxygen saturated. Oxygen saturation should always be above 95%. However, a SpO2 reading of 92% or less results in that the blood are poorly saturated. Insufficient saturation can cause a range of adverse health conditions including chest pain, shortness of breath and increased heart rate.

Pulse rate is an estimation of the number of times a heart contracts per minute. Normal pulse rate values for adults range from 60 to 100 beats per minute (bpm). For some people, a pulse rate below 60 bpm indicates abnormally slow heart action, also known as bradycardia. Bradycardia can cause several problematic symptoms including fainting, fatigue, chest pains and memory problems. A pulse oximeter gives accurate insights on your SpO2 and pulse rate within a matter of seconds. For people with COPD, asthma, or other lung diseases, monitoring the quality of their pulse oximeter is incredibly important. Also, it plays an essential role in helping patients adjust their oxygen flow and pulse rate during exercising, daily social routine, or spending time at home.

Pulse-oximeter works on the spectrophotometry principle in which the relative absorption of red (absorbed by deoxygenated blood) and infrared (absorbed by oxygenated blood) light of the systolic component of the absorption waveform correlates to arterial blood oxygen saturations. Measurements of relative light absorption are made multiple times every second and these are processed by the machine to give a new reading every 0.5-1 second that averages out the readings over the last three seconds.

In the smart monitor device, the sensor is located at tiptoe (Fig.B - 8) of each footbed sole (Fig.B –7). light-emitting diodes, red and infrared, are positioned so that they are opposite to their respective detectors through 10-20 mm of tissue on the tiptoe. Then the red and infrared light absorbed is measured by the sensor, and then the achieved signals are processed by the controller board and the readings are displayed on the application through Bluetooth.

Fig. C shows the backside of shoe (13) which encompassed with footbed sensor. The footbed sole of the shoes is integrated with various modules, including strain gauge, bioelectrical impedance, pulse oximeter, microprocessor control board, BLE unit, pedometer sensor, coin cell battery unit, transmitter, and receiver unit.
The invention is described using certain embodiments:
In an embodiment, disclosed is a shoe for continuous measurement of a body composition of a subject in a need thereof, comprising an electronic smart sole. The sole comprises a module that allows to track a parameter for maintaining health statistics charts of the subject.

In another embodiment, disclosed is a shoe for continuous measurement of a body composition of a subject in a need thereof, comprising an electronic smart sole; wherein the sole comprises a module that allows to track a parameter for maintaining health statistics charts of the subject; wherein the module comprises a strain gauge working module.

In further embodiment, disclosed is a shoe for continuous measurement of a body composition of a subject in a need thereof, comprising an electronic smart sole; wherein the sole comprises a module that allows to track a parameter for maintaining health statistics charts of the subject; wherein the module comprises a bioelectrical bioimpedance module.

In further embodiment, disclosed is a shoe for continuous measurement of a body composition of a subject in a need thereof, comprising an electronic smart sole; wherein the sole comprises a module that allows to track a parameter for maintaining health statistics charts of the subject; wherein the module comprises a pulse oximetry module.
In another embodiment, disclosed is a shoe for continuous measurement of a body composition of a subject in a need thereof, comprising an electronic smart sole; wherein the sole comprises a module that allows to track a parameter for maintaining health statistics charts of the subject; wherein the module comprises (a) a strain gauge working module, and (b) a bioelectrical bioimpedance module.

In another embodiment, disclosed is a shoe for continuous measurement of a body composition of a subject in a need thereof, comprising an electronic smart sole; wherein the sole comprises a module that allows to track a parameter for maintaining health statistics charts of the subject; wherein the module comprises (a) a strain gauge working module, (b) a bioelectrical bioimpedance module, and (c) a pulse oximetry module.

In another embodiment, the modules measure parameters such as body weight, body mass index, body fat percentage, skeletal muscle percentage, total body water percentage, level of oxygen saturation in the blood, and pulse rate.
In another embodiment, the sole comprises a footbed sensor for providing a real-time monitoring of the subject.

In another embodiment, the strain gauge working module consists of a load cell; wherein the bioelectrical bioimpedance module consists of a metal plate; and wherein the pulse oximetry module consists of an oxygen saturation-heart rate sensor board.
In still another embodiment, the strain gauge working module comprises of at least one load cell for measuring weight.

In still another embodiment, the strain gauge working module comprises of two load cells for measuring weight.

In still another embodiment, the bioelectrical bioimpedance module comprises at least one metal plate for measuring bioelectrical impedance.

In still another embodiment, the bioelectrical bioimpedance module comprises two metal plates for measuring bioelectrical impedance.

In still another embodiment, the strain gauge working module comprises at least two load cells and of which the first load is positioned beneath the first metal plate of the bioelectrical bioimpedance module; and the second load cell is positioned beneath the second metal plate the bioelectrical bioimpedance module for measuring weight of the subject.

In still another embodiment the bioelectrical bioimpedance module comprises at least two metal plates and of which the first metal plate is positioned on top of the load cell, and beneath the ball of the foot; and the second metal plate is positioned on top of the load cell and beneath the heel of the foot for measuring bioelectrical impedance.

In still another embodiment, the oxygen saturation-heart rate is positioned beneath the big toe of the foot in the sole for measuring pulse oximetry.

In another embodiment, the smart sole further comprises of a microprocessor control board integrated with a Bluetooth low energy (BLE) unit, a pedometer sensor, and a coin cell battery.

In still another embodiment, the microprocessor control board is integrated with the Bluetooth low energy (BLE) unit, a pedometer sensor, and a coin cell battery is positioned beneath the mid arch of the foot in the sole.

In still another embodiment, the microprocessor control board is integrated with a pedometer sensor positioned beneath the mid arch of the foot in the sole.

In still another embodiment, the microprocessor control board is integrated with a coin cell battery positioned beneath the mid arch of the foot in the sole.

In still another embodiment, the Bluetooth low energy enables measured parameter output on the phone application.
,CLAIMS:
1. A shoe for continuous measurement of a body composition of a subject in a need thereof, comprising an electronic smart sole.
2. The shoe of claim 1, wherein the sole comprises a footbed sensor for providing a real-time monitoring of the subject.
3. The shoe of claim 2, wherein the footbed sensor comprises a module that allows to track a parameter for maintaining health statistics charts of the subject.
4. The shoe of claim 3, wherein the module comprises: (a) a strain gauge working module, (b) a bioelectrical bioimpedance module, and (c) a pulse oximetry module.
5. The shoe of claim 4, wherein the said modules measure parameters such as body weight, body mass index, body fat percentage, skeletal muscle percentage, total body water percentage, level of oxygen saturation in the blood, and pulse rate.
6. The shoe of claim 4, wherein the strain gauge working module consists of a load cell; wherein the bioelectrical bioimpedance module consist of a metal plate; and wherein the pulse oximetry module consists of an oxygen saturation-heart rate sensor board.
7. The shoe of claim 3, wherein the footbed sensor further comprises a microprocessor control board integrated with a Bluetooth low energy (BLE) unit, a pedometer sensor, and a coin cell battery.
8. The shoe of claim 6, wherein the bioelectrical bioimpedance module comprises at least two metal plates and of which the first metal plate is positioned on top of the load cell, and beneath the ball of the foot; and the second metal plate is positioned on top of the load cell and beneath the heel of the foot for measuring bioelectrical impedance.
9. The shoe of claim 6, wherein the strain gauge working module comprises at least two load cells and of which the first load is positioned beneath the first metal plate of the bioelectrical bioimpedance module; and the second load cell is positioned beneath the second metal plate the bioelectrical bioimpedance module for measuring weight of the subject.
10. The shoe of claim 6, wherein the oxygen saturation-heart rate sensor board is positioned beneath the big toe of the foot for measuring pulse oximetry.
11. The shoe of claim 7, wherein the microprocessor control board is integrated with the Bluetooth low energy (BLE) unit, the pedometer sensor, and the coin cell battery is positioned beneath mid arch of the foot in the sole.
12. The shoe of claim 7, wherein the Bluetooth low energy enables measured parameter output on the phone application.