TITLE OF THE INVENTION
NOVEL DEVICE TO DETECT AND MANAGE DIABETIC FOOT ULCERS.
FIELD OF THE INVENTION
The present invention is related to the field of medical devices, in particular the invention is directed to a novel device, system and processes for the detection and evaluation of diseases and disorders related to diabetes.
BACKGROUND OF THE INVENTION
The present invention relates to Novel Device to Detect and Manage Diabetic Foot Ulcers.
Diabetes is a chronic disease that affects vast number of people in India. When diabetes is present, either the body produces less or no insulin, and/or does not properly use insulin. Insulin is a hormone necessary to maintain blood sugar concentration at normal levels. When insulin is not produced or used correctly by the body, glucose remains in the bloodstream instead of being shuttled into cells for energy production, resulting in high blood glucose, or high "blood sugar" levels.
A diabetic foot ulcer is an open sore or wound that occurs in approximately 15 percent of patients with diabetes and is commonly located on the bottom of the foot. Of those who develop a foot ulcer, 6 percent will be hospitalized due to infection or other ulcer-related complication.
Prior art JP2019510544A discloses an optical measurement device is a light source with one or more wavelengths and configured to illuminate an area of tissue and capturing light reflected from the tissue at one or more illumination wavelengths And a processor configured to calculate one or more estimates of tissue vascular health based on the detector and the detected signal, and storing or reporting the tissue vascular health.
Further US10117617B2 discloses systems and methods for early detection, assessment, monitoring and prevention of pathophysiological conditions originating and/or emanating from skin or localized tissues, including but not limited to acute or chronic episodes of soft tissue pathology, wound, injury, dermatological or rheumatoid condition where bio-signal patterns, biomarkers or other identifiable elements or references would deviate from baseline. Specifically, the present invention relates to methods and systems specially designed and adapted for early detection of a latent

pathogenic bio-signal anomaly using multiple aggregated sensors before the anomaly would otherwise be detectable.
Also, CN101668447B discloses Diabetic footwear for treating neuropathic ulcers and other injuries while allowing easy access to the wound site on the plantar surface of a patient's foot includes a base portion and a sole that is either movably connected or removably connected to either the base or to a strut member. The base or strut member is maintained in position on the lower leg while the sole may be rotated, slid, or completely removed for allowing inspection and access to the plantar surface of the patient's foot.
Most of the disclosed prior arts do not provide continuous analysis of the variables such as temperature which are crucial for the management of the diabetic foot ulcer.
Based on the drawbacks of the prior art work, the current invention addresses the drawbacks in invention and there is a public need of this invention. The invented device provides us with continuous monitoring, easy to access and deduce the data and in addition to these, it has low cost.
OBJECTS OF THE INVENTION
The present invention has been developed in response to the present state of the art, and in particular, in response to the problems and needs in the art that have not yet been fully solved by currently available techniques and processes which provides with advantages of continuous monitoring, multi focal data points, quick assessment and in addition to these, it has low cost.
The main object of the present invention is to provide new device, process and methods for detecting tissue at risk of developing into an ulcer, for detecting problems with diabetic foot disease, and for evaluating the potential for wounds to heal. Thereof which obviates the drawbacks of the hitherto known prior art as detailed above.
Another object of the present invention is to provide a compact device for continuous monitoring and data assessment related to diabetic foot ulcer.
Still another object of the present invention provide with system and method that can be used to evaluate wound healing, tissue regeneration, angiogenesis, vasculogenesis, arteriogenesis, infection, inflammation, microvascular disease or alterations, or other changes in tissue characteristics.

Still another object of the present invention is to provide a device capable of collecting and analyzing the hyperspectral information determines one or more of the metabolic state of tissue to assess areas at high risk of developing into a foot ulcer or other wounded tissue to assess the potential of an ulcer or the tissue to heal.
Still another object of the present invention is to provide the a device that can be used for patients related to any age group and is inclusive of wide variety of accessibility on various form factors.
How the foregoing objects are achieved will be clear from the following brief description. In this context, it is clarified that the description provided is non-limiting and is only by way of explanation. Other objects and advantages of the invention will become apparent as the foregoing description proceeds, taken together with the accompanying drawings and the appended claims.
SUMMARY OF INVENTION
The present invention device provides us with a wearable device that have been suitably modified to incorporate the sensors enabling the continuous monitoring of the temperature wherein the temperature monitoring is continuously analyzed through the software application capable of functioning in various form factors, allowing the user to easily access the data and alerts related to Diabetic Foot Ulcers. The claimed invention device is supported with monitoring of temperature at preferably 7 specific foot points leading to proper analyses of the patient foot situation.
BRIEF DESCRIPTION OF DRAWINGS:
In order to describe the manner in which the above-recited and other advantages and features of the invention can be obtained, a more particular description of the invention briefly described above will be rendered by reference to specific embodiments thereof, which are illustrated in the appended drawings. And that the elements of similar structure or function are generally represented by reference numerals for illustrative purposes throughout the figures. Understanding that these drawings depict only typical embodiments of the invention and are not therefore to be considered to be limiting of its scope, the invention will be described and explained with additional specificity and detail through the use of the accompanying drawings in which:

The present invention is illustrated in figure of the drawing(s) accompanying this specification. In the drawings like reference numbers/letters indicate corresponding parts in the various figures.
Figure 1 represents the graphical view of functioning of the claimed invention device.
Figure 2 represents the user interface of the current invention application.
DETAILED DESCRIPTION OF THE INVENTION
This invention disclosure describes the subject matter for patenting with specificity to meet statutory requirements. However, the description itself is not intended to limit the scope of this patent. The principles described herein may be embodied in many different forms.
Illustrative embodiments of the invention now will be described more fully hereinafter with reference to the accompanying drawings, in which some, but not all embodiments of the invention are shown. Indeed, the invention may be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided so that this disclosure will satisfy applicable legal requirements. Like numbers refer to like elements throughout. In the present description, persons have been described in the masculine gender for brevity. It may be clearly understood that the invention applies equally to persons of all genders.
A major complication associated with the diabetic demographic is diabetic foot ulcers (DFU's). Originating from diabetic neuropathy, the complication-specific symptoms are local to the foot of the affected individuals, which can arise due to several reasons but mainly develop because of numbness & poor foot hygiene. If left unchecked these symptoms may lead to ulceration in the foot of the individual, which in some cases are treatable but may even lead to amputations.
Accordingly, the present invention provides a novel device in the form factor of a sock
that solves this problem by continuous temperature monitoring of the foot through
fabric incorporated sensors technology that alerts the user in case any abnormalities are
encountered.
The claimed device is in form of wearable socks which is supported with temperature
and pressure sensors, in the disclosed device plurality of sensors placed on the wearable
device wherein each of the sensor is specifically placed at 1 cm distance from each

other. The sensors may increase or decrease depending upon the requirement of the patients.
This device is used in form pair wherein each of the wearable socks is provided with the set of sensors and both the foots variables namely the pressure and temperature are continuously monitored.
In the disclosed form the device claimed herein has 7 sensors which are to used monitor 7 specific points of the feet as depicted in Fig 1, that measure their temperature continuously and alerts the user via the app provided to them. When the socks are worn by the individual the device begins to calculate the relative difference between the corresponding data points of the left and the right foot. A comprehensive data set is created in the back end continuously.
The plurality of temperature sensors (e.g., stationary and/or contact sensors) illustratively are at discrete locations on the foot. Accordingly a thermogram may be formed by interpolating temperature data between at least two of the plurality of temperature sensors to produce approximate and physically continuous temperature readings at locations that are between the sensors.
In case an abnormal temperature difference is encountered the relative difference of that specific point is monitored for at least six to seven hours. This is done to avoid false positives, which only send an alert message to the individual if the effects persist for the aforementioned period. The user is then advised to visit a medical professional for a further course of action.
In still another embodiment of the present invention, the fabric incorporated sensors technology used in the product places these sensors by wrapping yarn around the sensors which are micro resin pods as shown in the Fig. 1
These pods are connected to an MPU6050 in an array that ultimately sends the data to the user's device via the use of Bluetooth. The application that the sensors send the data to utilize for continuous monitoring. The data is analysed by a temperature difference monitoring between the 7 data points as depicted in Fig. 2
In case of any high-temperature differences, alerts are not immediately sent to the user. The system in order to reduce false positives continuously monitors those points for a prolonged period of at least six to seven hours before it raises an alert for the user.

The foot ulcer monitoring system has temperature and pressure sensors embedded inside the core regions in the 6 most vulnerable areas of the foot, wherein the placement may vary depending upon the patient requirement.
The pressure sensing system analyzes the person's gait ( i.e the way the person or subject walks) to determine the pressure points on foot (the insole region) and provides a risk score of R to the 6 regions of the foot. Where R ranges from 1 to 10.
Peripheral sensory feedback from muscle and load receptor reflexes is thought to play a significant role in regulating gait cycle timing. This sensory feedback is severely disrupted in patients with significant diabetic neuropathy, suggesting that the ability of these patients to appropriately regulate gait cycle timing should also be significantly disrupted. Indeed, neuropathic patients do exhibit increased stride-to-stride variability in gait cycle timing. The presence of long-range correlations in stride interval time series has been proposed as an indicator of a healthy nervous system's capacity to regulate gait cycle timing, independent of variability. Statistical measures quantifying these long-range correlations have been shown to be a sensitive indicator of the degeneration of central nervous system mechanisms involved in regulating gait cycle timing.
The pressure sensing system simultaneously measures the person's stride time St, Stance phase percentages such as swing phase Psw, stance phase Pst, and Double Support Pds
The neuropathy score Ns is measured using St, Psw, Pst, and Pds.
Where Ns = CV(St)+a* CV(Pst)+b*CV(Psw)+ c*CV(Pds)
Where a is stance phase correlation coefficient and its range is from 0.1 to 10
Where b is the swing phase correlation coefficient and its range is from 0.1 to 10
Where c is the double stance phase correlation coefficient and its range is from 0.1 to 10
Where CV is the coefficient of variation
The Neuropathy Score and Risk score together provide the value of the Foot Ulcer Risk
Coefficient, Z.
Where Z = Ns*R
The temperature monitoring system also monitors the same 7 vulnerable points on each foot( i.e the insole region ).
The temperature monitoring system measures the relative temperature difference of the same regions of both of the feet as described in the image the relative temperature difference between 1 and 8, AT is measured and if the temperature difference is greater than AT >1.2 degree Celsius ( battery saving feature) the prediction system starts measuring the contralateral and Tm( mean temperature) continuously, measurement of

the user's activity level in the past one hour Al, temperature decay rate Td, the temperature of the region under analysis (Tra and resting time Tr are used to predict the foot ulcer risk FR.
Where FR of a particular region is equal to FR = ((AT*Tr*(Tra-Tm)/Al )*Ts (Where the minimum threshold isAT>1.2 degrees Celsius and Tr > 20minutes)
Where Ts is the time till which the AT > 1.2 Where Al is between 1 to 10
Otherwise, FR is 0, finally, the Foot Ulcer Risk Chance, P is measured, Where P = FR*Z and if P is greater than the threshold TH then the alert is sent to the user to check that particular spot for redness, bruise, or an inflammation
In many cases, entities are described herein as being coupled to other entities. The terms "coupled" and "connected" (or any of its forms) are used interchangeably herein, and in both cases direct coupling of two entities (any non-negligible) It should be understood to be generic to (for example, without an intervening entity) and indirect coupling of two entities (with one or more intervening entities that cannot be ignored). When entities are shown to be directly coupled together, or described as being coupled together without the description of any intervening entities, those entities are not explicitly indicated otherwise by context As long as, it should be understood that they can also be linked indirectly together.
The present invention has been described briefly with reference to some drawings and a preferred embodiment purely for the sake of understanding and not by way of any limitation and the present invention includes all legitimate developments within the scope of what has been described herein before. Since other modifications and changes varied to fit particular operating requirements and environments are apparent to those skilled in the art, the invention is not considered limited to the example chosen for purposes of disclosure and covers all changes and modifications which do not constitute departures from the true spirit and scope of this invention.
This written description uses examples to disclose the invention, including the best mode, and also to enable any person skilled in the art to practice the invention, including making and using any devices or systems and performing any incorporated methods. The above are merely exemplary and illustrative of the inventive concept by, one of ordinary skill in the art in the specific embodiments described to make various modifications or additions, or a similar alternative manner, without departing from the invention. The invention, as defined in this disclosure or beyond the scope of the claims, should belong to the scope of the present invention.

Claims:

We claim
1) A device to detect and manage diabetic foot ulcer comprised of wearable sock supported with the plurality of sensors, micropods, rechargeable battery.
2) The device as claimed in claim 1, wherein the plurality of sensors are essentially RTD sensors capable of monitoring foot temperature and velostat sensors are used to monitor pressure at locations placed.
3) The device as claimed in claim 1, wherein the plurality of sensors are placed at seven distinctive points to enable the continuous monitoring of foot temperature and pressure.
4) The device as claimed in claim 1, wherein the plurality of sensors are protected with micropods.
5) The device as claimed in claim 1, wherein the battery is rechargeable.
6) The device as claimed in claim 1, wherein the plurality of sensors are placed interchangeably depending upon patient foot condition.
7) The device as claimed in claim 1, wherein the plurality of sensors are essentially placed at 1 cm gap from each other.
8) The device as claimed in claim 1, wherein the plurality of sensors measures the difference in temperature and pressure of each foot at various points continuously.
9) The device as claimed in claim 1, wherein difference in temperature and pressure points recorded is captured in various form factors and is communicated to patient after exclusion of false negatives.
10) The device as claimed in claim 1, wherein the device through integrated mobile application is able to send automated notifications and alerts to the patient