Field of the I nvention

This invention concerns a system and method for a wearable electrical nerve and muscle stimulation system designed for the purposes of relieving abnormal sensations (such as burning, stinging, pain) in the feet of patients, especially diabetes patients.

Prior Art

Patients suffering from abnormal sensations in their feet (such as burning, stinging or pain) for various reasons (especially those that suffer from neuropathic pain caused by diabetes) could require transcutaneous electrical nerve stimulation (TENS) therapy to relieve these symptoms and improve their quality of life. I n the prior art, there are different kinds of TENS devices at different capacities and form factors. Some of these are large in size and designed for clinical use, while others are smaller, portable and battery-powered.

The general working principle of current TENS devices can be summarized as follows: the patient turns on the device after connecting the electrodes to different areas of the feet. The device produces low-power electrical pulses. These signals stimulate the nerve endings in the feet via the electrodes. I n this manner, natural pain relievers (endorphins) are released in the patient’s body and the patient’s abnormal symptoms are alleviated. I n the current state of the art, the electrical nerve and muscle stimulation systems are not truly wearable systems. I n order to be able to use these devices and relieve the abnormal symptoms in the feet, the patient needs to be either in a clinical environment or at home. Even if the patient is at home, he/ she needs to make special preparations in order to use the device (take off socks, connect the electrodes to the feet) .

Due to the above-mentioned disadvantages of current TENS devices, it has become necessary to develop truly wearable devices. I n addition, due to the possible medical risks to the patient owing to the patient misusing the device (for example, by the patient adjusting treatment parameters like signal intensity, frequency etc. on his/her own initiative) , it is also necessary for treatment parameters to be fixed and controlled by medical specialists through remote access.

Patent document US2012/0186101 A1 concerns a shoe insole that produces vibrations and massages a person’s feet through small electric motors. With this invention, massaging

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SUBSTITUTE SHEETS (RULE 26) via vibrating motors is possible; however, nerve stimulation via low-power electrical signals cannot be accomplished.

I n Patent document no. US20140222102A1 , the goal is to control a device producing signals for electrical muscle and nerve stimulation via a cable connected between the device and a smart phone. A cable connection between the device producing the electrical signals and the smart phone is necessary and it is not possible for a medical specialist (e.g. a physical therapy specialist, physiotherapist or a neurologist) to control the parameter set that the device will be used with.

I n patent document US2016263375A1 , a design for a shoe insole that can do foot massage for diabetes patients is mentioned. However, the invention does not allow the device to be controlled by a medical specialist (e.g. physical therapy specialist, neurologist) in certain situations.

Patent document US2008109183A1 concerns a smart show insole that can sense foot trauma in diabetes patients through pressure and temperature sensors. This invention does not focus on the relief of abnormal sensations in the patients’ feet (burning, stinging, pain etc) and does not allow the device to be controlled where necessary by a medical specialist (e.g. physical therapy specialist, neurologist) .

The article titled “The Effect of Microcurrent Electrical Stimulation on the Foot Blood Circulation and Pain of Diabetic Neuropathy” contains the results of an academic study indicating that very low-power electrical stimulation is effective in alleviating the abnormal sensations caused by diabetic neuropathy. However, it does not focus on the design of a wearable biomedical device, its control via a smart phone and does not allow a device to be remotely controlled by a medical specialist where necessary.

I n addition to alleviating the abnormal sensations in the feet, it is possible to have abnormalities in the patient’s gait as a result of diabetes-related foot problems. Such situations could occur especially in the later stages of diabetic neuropathy. This makes it necessary to sense such gait abnormalities.

Brief Explanation and Purpose of the I nvention

The proposed invention concerns a wireless, wearable electrical nerve and muscle stimulation system, which alleviates the abnormal foot sensations such as burning, stinging and pain experienced especially by diabetes patients, which caters for the above-mentioned requirements, removes the disadvantages and has additional advantages of its own.

The main purpose of the invention is to alleviate the abnormal sensations such as

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SUBSTITUTE SHEETS (RULE 26) burning, stinging and pain experienced by diabetes patients or patients that experience neuropathic pain and other abnormal sensations (burning, stinging etc.) for other reasons via the application of low-power electric shock.

The invention allows the patient to use the device anywhere because it is wearable and can be controlled via a mobile application.

The invention allows the device to be controlled by a medical specialist (e.g. a physical therapy specialist, neurologist) , thus allowing the device to be used by the patient only in accordance with the treatment parameters (signal amplitude, frequency and the like) and treatment duration specified by the specialist. At the same time, the use of the device by the patient can be checked by the medical specialist.

With the proposed invention, it is possible to sense the gait problems that patients may have through pressure and/or temperature sensors integrated into the device. The information from these sensors can be sent to the doctor and used as a gauge to help the doctor understand the progression of the patient’s neuropathic condition.

The computational infrastructure used by the medical specialist to remotely control the device can also be used to form an expert system that can propose required treatment options to the patient.

Description of the Drawings Specifying the I nvention

A description of the drawings that have been prepared to help explain the system and method for wearable electrical nerve and muscle stimulation is given in the following.

Figure 1 : General structure of the system within the scope of the invention

Figure 2 : Structure of insole

Description of the Concepts / Components / Parts of the I nvention

I n order to be able to better explain the system and method for a wearable electrical nerve and muscle stimulation developed within this invention, every part / component / concept has been separately numbered. The explanation of every number is given below.

1 . Specially designed insole placed inside the shoe

2. Smart device with the mobile application loaded on it

3. Cloud Server I nfrastructure

4. Medical specialist following up on the condition of the patient

5. Electrodes for the application of electric shock to the patient’s feet.

6. Pressure / temperature sensor

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SUBSTITUTE SHEETS (RULE 26) 7. Electronic circuit producing low-power electric shock.

Detailed Description of the I nvention

The topic of the invention, namely the system and method for a wearable electrical nerve and muscle stimulation system for alleviating the abnormal sensations such as burning, stinging and pain experienced especially by diabetic patients in their feet consists in its most basic form of a specially-designed orthopedic shoe insole that can be placed inside the patient’s shoe (1 ) , a mobile device (2) (a smart phone, tablet computer or other device with a similar function) , preferably a phone, loaded with a mobile application, which can communicate with the insole via Bluetooth or other wireless communications protocol, and which can also communicate with the cloud server infrastructure, a cloud server infrastructure (3) that stores the information concerning the patient using the insole device, the treatment parameters prescribed to the patient, which can send this information to the mobile device when needed, which can get data from the mobile application when needed, and which the medical specialist (4) following up on the patient can also access.

The specially designed orthopedic shoe insole (1 ) that can be placed inside the patient’s shoe; consists of an electronic circuit which produces the electrical signals to be applied to the patient’s feet, and which can be controlled via a microcontroller / microprocessor, a wireless communications module implementing either Bluetooth or other wireless communications protocol, at least one electrode which allows the electrical signals to be applied to the patient’s feet, or one electrode that forms part of the insole, , pressure sensors that can detect the patient’s gait, wireless communications module, pressure and temperature sensors, and a battery module supplying power to the electronic circuit producing the required signals. I n an exemplary application, 2 electrodes are integrated into the insole. This electrode number can be increased, or the electrode function can be dstributed throughout the insole with the ability to apply electric shock therapy based on the patient’s need. I n addition, all these functions can be carried out in a smart manner within the scope of a coodinated information exchange with the cloud server infrastructure at the back end.

The shoe insole (1 ) can be implemented in hardware. The microcontroller-based electronic circuit is designed and made in the format of a printed circuit board (PCB) . The circuit is integrated with a wireless communications module using Bluetooth (or other wireless communications protocol) , pressure and temperature sensors, a battery and electrodes and embedded in the bottom part of the insole. The top part of the insole consists of an orthopedic material such as memory foam, that is comfortable for the patient’s foot

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SUBSTITUTE SHEETS (RULE 26) and can be removed and cleaned. The electrodes that will send the electrical signals to the patient’s foot are located immediately below this layer.

The mobile application to be loaded on the patient’s smart phone (2) is a software component. I t can be implemented in Objective-C (for the Apple iPhone / iPad platforms) , Java (for the Android platform) , or another programming language that has similar capabilities.

The cloud server infrastructure (3) of the system consists of a hardware and software component, and can be implemented in a cloud computing environment such as Microsoft Azure, Google Cloud Platform or Amazon Web Services (AWS) . The hardware part can be implemented using enterprise class server solutions from companies like HP and I BM, or a virtualization platform such as VMWare. The smart algorithms that can contribute to the therapy process for the patient (such as neuropathy classification using pictures of the foot) can be implemented in C+ + , Java or another programming language with similar capabilities.

The working principle and application of the invention consists of the following steps:

1 . The use of the specially designed insole (1 ) and the mobile application is recommended to the patient suffering from foot problems due to diabetes or other reasons by the medical specialist (4) . The patient procures both components. (The mobile application is personally downloaded by the patient via an application storage site such as Google Playstore or the Apple AppStore) .

2. The medical specialist (4) enters and records the device parameters to be used by the patient (e.g. signal frequency, signal amplitude, treatment duration etc.) to the cloud server infrastructure (3) . I dentification information for the patient is also stored securely within this cloud server (3) .

3. When the patient wants to turn the device on while wearing the shoe, the patient first runs the mobile application (2) .

4. The mobile application (2) automatically connects to the cloud server (3) and securely downloads the treatment parameters to be used by the patient. Once this operation is complete, the patient can only use the device in accordance with the parameters downloaded from the cloud server (3) and cannot change these parameters in any way. The

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SUBSTITUTE SHEETS (RULE 26) patient can only turn the device on and off using the mobile application. Through the integrated pressure and temperature sensors the system confirms that the patient is indeed wearing the device, and the device will not function if the patient is not wearing the insole. 5. As the patient uses the device, usage data (such as the treatment duration, the actual times in the day when the device has been used, usage parameters etc.) is recorded by the mobile application (2) and sent to the cloud server infrastructure (3) . The values sensed by the pressure and temperature sensors are also sent to the mobile application (2) as they could aid in diagnosis of gait problems or advancement in the neuropathic condition of the patient.

6. The data stored in the cloud server (3) can be interpreted using various algorithms and is presented both to the patient and the medical specialist following up on the patient (4) in the form of a report. When necessary, and with the consent of both the medical specialist (4) and the patient, warnings can be sent to the patient via the mobile application to visit his/her doctor, to visit another specialist (such as an orthopedist) or to undertake the necessary foot care.

7. I n case of the data sensed by the sensors within the insole exceeding certain threshold values (e.g. in case of a patient with gait problems due to advanced stages of neuropathy) , the patient can be prompted, via the cloud server (3) and the mobile application (2) , to take a picture of his/her foot. These pictures can be uploaded to the cloud server (3) via the mobile application (2) . This data can be interpreted using the smart algorithms running within the cloud server (3) (such as artificial neural networks) and can be classified into one of the neuropathy classes commonly used within the medical community (e.g. Wagner classification) . Through such classification, it is possible to prevent the patient’s neuropathic condition from getting to a stage where it can result in the loss of a limb.

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SUBSTITUTE SHEETS (RULE 26)