Footwear linked to an application, for assisting in the prevention of ulcers by monitoring plantar pressure

Abstract

The present invention relates to a device for assisting in the prevention of ulcers, consisting of footwear having interchangeable cells where the plantar pressure is measured in individual areas of the sole of the foot by means of force sensors and sent via Bluetooth to be displayed in an application. The areas at risk of ulceration are thus detected and the cell is removed in order to facilitate plantar distribution, without the risk of developing diabetic foot.

Description

[0001] A FOOTWEAR FOR SUPPORTING ULCER PREVENTION THROUGH PLANTAR PRESSURE MONITORING LINKED TO AN APPLICATION

[0002] TECHNOLOGY SECTOR

[0003] The present invention relates to footwear that monitors and facilitates the distribution of plantar pressure for the prevention of ulcers in diabetic foot patients.

[0004] BACKGROUND

[0005] Diabetic foot, a serious complication of diabetes, affects 4% of people with the disease worldwide. Furthermore, 15% of patients with diabetes develop diabetic foot disease. Without proper treatment, there are risks of loss of sensation, nerve damage, and poor circulation in the affected area. This can lead to the formation of ulcers which, if severe, can result in amputation.

[0006] Patents W02006100331 and ES2221577 aim to measure plantar pressure and provide a pressure diagnosis using sensors. In the first patent, the surface is a sheet with independent, adjacent divisions that, when pressure or impact is applied to any of the zones, generate signals according to the pressure level. The second patent consists of an elastic sheet with several holes distributed in different layers. However, both patents show a lack of specification regarding the quantification and reading of the applied pressure values.

[0007] On the other hand, patent ES2611364 indicates that the use of interchangeable shock absorbers offers ease of use for the user, in addition to their 3D printing and material composition. However, the shock absorbers are distributed throughout the entire insole, without any "strategic" locations where there might be greater or lesser pressure. Furthermore, the size of these shock absorbers presents a challenge due to their minute dimensions.

[0008] To address the aforementioned problems, a shoe capable of monitoring plantar pressure during use has been invented, complemented by a reporting application. The invention is divided into two stages: the first, during the use of the shoe, involves collecting the necessary pressure data; the second stage consists of sending this data for processing and subsequent notification to the user.

[0009] a) First stage

[0010] The footwear consists of three layers, each with a specific function: the first (upper) layer contains six cells (their undersides are in contact with each sensor in the second layer), which will be in contact with the user's foot. Another unique feature of the invention is that the cells will be replaced with thinner ones if increased pressure is detected in that area, thus mitigating the force. Additionally, the heel area has two holes for the battery and a microcontroller connected to a Bluetooth module.

[0011] The second layer contains several electronic components, including resistive force sensors strategically placed around the metatarsal region of the foot. These sensors are responsible for measuring pressure.

[0012] b) Second stage

[0013] Information will be transmitted and notifications sent to the user. The data collected during the use of the footwear (first stage) will be transmitted to the mobile application, and if any anomaly is detected—that is, a higher pressure than normal—the application will notify the user about the area with the irregularity and recommend replacing the corresponding cell with one of lesser thickness. This configuration in the footwear, based on the removal of cells, will significantly reduce the incidence of ulcers, since detecting any abnormal increase in pressure will easily notify the user via their mobile phone, thus greatly preventing their development.

[0014] For the reasons mentioned above, the invention represents an improvement in the state of the art, because it offers the following advantages:

[0015] - It allows for the early detection of problems related to plantar pressure in diabetic patients, helping to prevent the formation of ulcers and other serious complications.

[0016] - It provides continuous monitoring of plantar pressure while wearing footwear, giving valuable information about the condition of the user's feet in real time.

[0017] - The ability to swap cells based on the detection of increased pressure in certain areas allows for dynamic and personalized adaptation to relieve force in those specific zones, thus reducing the risk of ulcers. - The use of resistive force sensors strategically distributed across the plantar area provides precise measurements of the pressure exerted on different parts of the foot.

[0018] - The interchangeable shock absorber system and the mobile application make the system easy to use and understand for the user, which encourages adherence to monitoring.

[0019] BRIEF DESCRIPTION OF THE FIGURES

[0020] Figure 1: Shows an exploded view where the three layers are visible: the first (1), where the removable cells (6) are located and in the heel area, the battery (4) and the processing unit based on a microcontroller (5) coupled to the Bluetooth module; the second (2), where the FSR sensors (7) for each cell will be located; and the third (3), the layer that is the sole of the product. Figure 2: Shows an isometric view of the footwear in which the three layers and all the components are joined.

[0021] Figure 3: Sample of the first, second and third layers in an isometric view highlighting their shape.

[0022] Figure 4: Sample screenshots of the application interface: Home Screen, Registration, Login and Foot Map divided into zones where there is a risk of ulceration.

[0023] The elements illustrated in figures 1 to 4 correspond to:

[0024] 1 First layer

[0025] 2 Second layer

[0026] 3 Third layer

[0027] 4 Battery

[0028] 5 Microcontroller

[0029] 6 Removable cells

[0030] 7 FSR Sensors

[0031] PREFERRED EMBODIMENT OF THE INVENTION:

[0032] For the present invention, the preferred embodiment based on Diabetic Foot disease, footwear was developed to help prevent ulcerations on the sole of the foot of a diabetic patient by monitoring the plantar pressure of this.

[0033] Taking into account numerical references and various factors related to the disease and the diabetic patients for whom our invention is intended, a suitable heel height of less than 5 cm was established for this type of footwear, counting all three layers together. The width of the shoe should not be too loose, but neither should it be too tight; therefore, a width of 10-11 cm was established. Finally, the length does not exceed 29 cm. It is important that this type of footwear be custom-made. It has a third layer (3) as its base, which is a sole that acts as a shock absorber and must be made of a lightweight, flexible, and stable material. The material chosen is TPU, due to its flexibility and durability.The second layer (2) contains the electronic components, including six resistive force sensors strategically placed according to areas of the sole of the foot that are at risk of ulceration, allowing them to measure the pressure in these areas. The next layer (1), which is in contact with the user's foot, consists, firstly, in the heel area, of two boxes. One contains a microcontroller and a Bluetooth module, and the other contains the battery, which is the power source for this invention. These boxes are located within openings sized to accommodate the electronic components. The opening for the battery measures 0.426 cm wide x 3.41 cm long, and the other opening, where the electronic components are located, measures 0.575 cm wide x 4.07 cm long.This location is chosen to prevent any risk or damage to the processor from various factors, one of which is the weight exerted by the person. Finally, it also consists of six (6) interchangeable cells that will be in contact with the patient's foot, each positioned above a resistive force sensor. These cells are aligned with the areas of the sole of the foot already mentioned as being at risk of ulceration. Four of these cells do not vary much in size, while the other two, located on the ball of the foot, are larger than the others.

Claims

CLAIMS 1. Footwear for ulcer prevention support through plantar pressure monitoring linked to a mobile application, characterized by comprising three consecutive layers (1, 2 and 3), characterized in that: - the first layer (1) contains removable cells (6) and in the heel area, it has a battery (4) and a processing unit based on a microcontroller (5) coupled to a Bluetooth module, this layer is in contact with the user's foot and on its lower part is in contact with each sensor of the second layer (2); - the second layer (2) comprises electronic implements, among which are strategically located resistive force sensors (7); and - the third layer (3) is a sole.

2. Footwear for ulcer prevention support according to claim 1, characterized in that the resistive force sensors (7) in the plantar area of ​​the second layer (2) are distributed according to metatarsal regions.

3. Footwear for ulcer prevention support according to claim 1, characterized in that the resistive force sensors (7) are linked to the Bluetooth module, to transmit the information to a cell phone for processing and notification to the user.

4. Footwear for ulcer prevention support according to claim 1, characterized in that the first layer contains six removable cells (6) and the second layer (2) comprises six resistive force sensors (7).

5. Footwear for ulcer prevention support according to claim 4, characterized in that four of the removable cells do not vary much in their dimensions while the other two removable cells located in the head part of the sole of the foot are of a larger dimension than the former ones.

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