Footwear for improvement the vascular system of a user

Abstract

The present disclosure relates to a footwear for improvement of the vascular system of a user. The present disclosure comprises a footwear for improvement the user's vascular system comprising a multilayered insole / sole and a shaft assembly, wherein the multilayered insole / sole comprises a compression module embedded, wherein the shaft comprises a vibratory module, wherein the vibratory module comprises at least one piezoelectric motor encapsulated to form a pad; wherein the compression module comprises an inflatable cell placed over a heating circuit and wherein the inflatable cell encapsulates a thermo-responsive material; wherein the compression module and / or vibratory module are configured to repeat cycles of compression / decompression / vibration in order to activate the circulation of the user's feet.

Description

D E S C R I P T I O NFOOTWEAR FOR I MPROVEMENT TH E VASCULAR SYSTEM OF A USERTECHNICAL FIELD

[0001] The present disclosure relates to a footwear for improvement the vascular system of a user.BACKGROUND

[0002] To decrease the risk of developing musculoskeletal disorders, pain, and fatigue symptoms, as well as vascular health issues, significant research has been made in wearable devices for human enhancement either for upper-body or lower-limbs.

[0003] Compressive stimuli can be promoted using wires, garments, elastic bands, and insufflated devices. The compression mechanisms include local eccentric compression, intermittent and / or sequential compressive acts from the metatarsal pad towards the calf, and lower limb uplifting using an adequate equipment. All these can be effective in a preventive action reducing muscle fatigue and pain as well as venous stenosis. Besides, a variety of pneumatic systems with inflated bladders or cuffs aiming at reducing the incidence of venous blood clot formation in the lower limb by creating pulsatile venous flow and promoting venous emptying can be found commercially. There are also commercial solutions for electrical stimuli targeting specific muscle groups consisting in isometric contractions of the lower limbs.

[0004] Lower body exoskeletons either active or passive can be used to achieve different types of compressive effects. They may also be classified according to the level that exoskeletons fit or resemble the human anthropometry. In most cases, a detection of human movement to start the appropriate response of the exoskeleton's compressive actuators is required through the application of some algorithmic approach / firmware control. Therefore, building and testing new wearable solutions to be applied in industrial and leisure time fields have been growing with the increasing ergonomic concerns of the employer and user entities.

[0005] As mentioned, there are a lot of different types of footwear, which are often marketed as therapeutic or health-enhancing, with the goal of alleviating certain foot conditions or improving overall vascular health. Here are some common types of footwear known for their potential vascular benefits:- compression socks and stockings: While not traditional footwear, compression socks and stockings are worn on the feet and lower legs to apply graduated pressure, which helps improve blood flow and reduce swelling. They are commonly used by individuals with conditions like varicose veins, deep vein thrombosis (DVT), and edema;- orthopedic shoes: orthopedic shoes are specially designed to provide better support, stability and comfort. These shoes can help with conditions like plantar fasciitis and provide better overall foot alignment, which may have indirect benefits for vascular health;- diabetic shoes: designed for individuals with diabetes, diabetic shoes offer additional cushioning and support to reduce the risk of foot ulcers and other complications related to poor circulation and neuropathy;- rocker sole shoes: these shoes have a rounded sole design that promotes a rocking motion during walking, which may help improve circulation by stimulating calf muscles and reducing the burden on feet and legs;- specialized sports shoes: certain sports shoes are designed with advanced cushioning and support systems that aim to improve overall foot health and potentially enhance circulation during physical activities.

[0006] In the document US 20170312165A1, systems, devices and methods are disclosed for providing active and / or passive compression therapy to a body part that can include a compression device worn over a compression stocking. The compression device can have a pulley based drive train that is driven by a motor to tighten and loosen compression elements, such as compression straps, in a precise, rapid, and balanced manner. Sensors can be used in the compression device and / or compression stockings to provide feedback to modulate the compression treatment parameters.

[0007] In the document WO 1998009596A1, it is disclosed a medical apparatus to increase vascular blood flow in the lower extremities of the patient. The medical apparatus is designed to increase vascular blood flow by applying a compressive force to specific regions of the foot, ankle, and / or calf. To achieve this end, the technology presented in the mentioned document has foot compression portion and calf compression portion. The two portions are connected by a severable connection. The severable connection allows the foot portion and calf portion to be used together, or allows the calf portion to be used alone. Foot compression portion is adapted to exert an upward compressive force to the sole of the foot from in front of the heel and extending past the ball of the foot under the phalanges, a downward compressive force in front of the tarsal region of the foot, a downward compressive force in the upper tarsal region of the foot, and a compressive force around the Achilles tendon. Foot compression portion is also adapted to be incapable of applying a downward compressive force in the midtarsal region of the foot. Calf compression portion is designed to apply a compressive force to the dorsal region of the calf.

[0008] In the document US 8827935B2, it is disclosed a method for providing a combined deep vein thrombosis and compression therapy to a patient. The method includes providing a control unit configured to condition heat transfer fluid and to selectively provide a compressed gas, providing a thermal compression device that is mountable to a select portion of the patient, and programming the control unit to supply heat transfer fluid to the thermal compression device and to supply compressed gas to the thermal compression device. This technical solution combines heating and cooling, as well as compression therapy for reducing edema, pain, and preventing deep vein thrombosis.

[0009] These facts are disclosed in order to illustrate the technical problem addressed by the present disclosure.GENERAL DESCRIPTION

[0010] The present disclosure relates to a footwear for improvement the vascular system of a user.

[0011] The footwear now disclosed improves the vascular system of a user through the use of a real-time active ergonomic monitoring system to prevent vascular health issues of the user. In one of the possible scenarios for application of this technology is the use in the industrial environment, where the user is performing repetitive working tasks. Real-time data will be delivered to the user through a global communication architecture that can include the footwear now disclosed and any other active wearable.

[0012] The association between posture and musculoskeletal injuries is intuitive, but not always easy to measure in less advanced stages, in which user's complaints are still diffuse or non-existent. The vascular health problems are also very common during standing positions. A significant effort has been made in the prevention of injuries, considering the high burden on healthcare systems, the productivity and impact on user's families. In one possible embodiment, in an industrial environment, the potential negative outcomes associated with standing work, such as lower limb discomfort and peripheral vascular issues resulting from blood pressure variations and lymph accumulation, during light-load repetitive work tasks must be considered during work shifts.

[0013] The footwear for improving the vascular system of a user complies with ISO 20345:2021 (personal protective equipment - safety footwear) and ISO 20347:2012 (personal protective equipment - occupational footwear).

[0014] The technology now disclosed comprises active technologies acting on the venous drainage and considering essential biomechanical specifications to adapt to the human body anatomy in order to avoid common trade-offs of usability. Apart from the prior art, the footwear now disclosed comprises technical features to enhance venous blood flow and promote vascular health.

[0015] The activation of the venous system indirectly triggers lymph drainage due to the contractile stimuli of the venous foot pump. Since both lymphatic and venous systems communicate when the circulatory fluids are raising up to the heart, the use of traditional strategies for stimulation can reduce the swollen limb and edema. Compressive and vibratory stimuli are thus considered two of the most important mechanisms capable of stimulating the venous foot pump.

[0016] Regarding the selected areas to do so, in an embodiment, the compression module developed for the footwear now disclosed, associated with muscle activity of the plantar fascia, is positioned in the foot pump, in a centro-medial region below the metatarsal pad. Also, it is important to act over the bimalleolar clamp, through vibration, to promote vasodilation of the calf veins, so the footwear also comprises a vibratory module. Once the venous blood had an upcoming movement towards the calf, the vibrating module placed in the malleolar arch would keep the vasodilation and muscle relaxation. In an embodiment, the vibratory module was design to be placed bilaterally in each foot evolving the bimalleolar region of the ankle.

[0017] The compression module is programmed to act preventively, for example, with one cycle for every hour of operation. At the end of the time programmed for its action, the module automatically begins to decompress. During this period of operation, the compression module promotes a direct compression on the sole of the foot that the user interprets as a sensation of massage in the metatarsal region.

[0018] The footwear will actively drain the venous blood using a combined compressive and vibrational stimulus with an estimated time for actuation and deactivation, for example of up to 42 min per hour.

[0019] Initially, three different geometries were proposed for the compression module to determine which one could be more efficient in compressing the sole of the foot. In this sense, an elliptical geometry was selected with 4 to 8 cm on the horizontal axis, preferably 5 to 7 cm, and 3 to 6 cm on the vertical axis, preferably 4 to 5 cm, to best fit the natural curvature of the plantar arch.

[0020] The thickness of the compression module made of thermoplastic elastomer material is up to 300 pm, preferably from 200 to 300 pm, more preferably from 250 pm to 300 pm. These materials and their combination with the mentioned thickness allow an increased contact level with the feet given the various types of plantar curves that can be commonly found. This will increase the massage feeling of the user. In an embodiment, the compression module comprises a heating circuit, printed in proper substrate, an inflatable cell, preferably in thermoplastic polyurethane, carefully sealed with a thermo-responsive liquid inside that would change phase once the temperature of 39°C is reached. This liquid is characterized by having a high coefficient of volumeexpansion in the phase transition at 39°C, which means that it has the capacity to inflate the cell due to high volume expansion. The compression module is placed over the heating circuit carefully encapsulated.

[0021] Regarding the technology for the vibratory module, which comprises the use of at least one piezoelectric motor, technical specifications, namely intensity, frequency, and waveform, were also defined in a range from 80 to 110 Hz, preferably from 85 to 100 Hz, more preferably from 88 to 95 Hz, quadrangular waveform, as well as the integration process in order to create the best adjustment to the supramalleolar region using a silicone pad.

[0022] The additional electronic components, which include a battery and a data acquisition board for each safety shoe, have been implemented through a casing, whose maximum dimensions have been established in accordance with the requirements of the insole's production process.

[0023] Numerous wearable devices with or without robotic assistance empowering human limbs have been developed for industrial purposes in order to reduce physical loading on the body and vascular health issues. However, common disadvantages of using them daily are related to user acceptance, movement constrains, and higher difficulty in performing actions that are not consistently part of the main working task.

[0024] In this sense, active technologies have been considered in this footwear to stimulate the plantar plexus and ankle in a more comfortable and user-friendly wearable, for example a safety shoe, that is already part of the working outfit. This will promote better user acceptance since they are already familiar with the equipment aspect. Even though these are not traditional exoskeletons, this active wearable footwear would play a role as a complement to stimulate muscle activity, increasing user's comfort, and reducing fatigue. Additionally, this will also collect data to be analyzed afterwards taking into account the ergonomic standards and the improvement of the occupational health conditions.

[0025] The technological integration that is achieved with this solution and the miniaturization of the components and electronics would promote higher standards of comfort, low weight, as well as relevant properties of breathability, flexibility, andresistance of the active components regarding the selected materials and textiles, respectively.

[0026] The footwear of present disclosure has the advantage of enhanced venous blood circulation in the feet and lower extremities; reduced swelling, edema, and discomfort; prevention of vascular-related injuries and fatigue; long-term vascular health benefits for improved overall well-being.

[0027] The disclosed footwear also is configured to repeat cycles of compression / decompression / vibration in order to activate the circulation of the feet of the user.

[0028] The present disclosure comprises a footwear for improvement the user's vascular system comprising a multilayered insole / sole and a shaft assembly, wherein the multilayered insole / sole comprises a compression module embedded, wherein the shaft comprises a vibratory module, wherein the vibratory module comprises at least one piezoelectric motor encapsulated to form a pad; wherein the compression module comprises an inflatable cell placed over a heating circuit and wherein the inflatable cell encapsulates a thermo-responsive material; wherein the compression module and / or vibratory module are configured to repeat cycles of compression / decompression / vibration in order to activate the circulation of the user's feet.

[0029] In an embodiment, the footwear further comprises a second vibratory module in the calcaneus footwear.

[0030] In an embodiment, the compression module of the footwear is covered by a flexible textile.

[0031] In an embodiment, the vibratory module of the footwear comprises two piezoelectric motors.

[0032] In an embodiment, the compression / vibration cycles performed by the footwear are not substantially simultaneous; preferably are alternated cycles.

[0033] In an embodiment, the compression module and / or vibratory module of the footwear is configured to be electronically adjustable.

[0034] In an embodiment, the footwear additionally comprises a temperature sensor and / or a sensor to monitor foot pressure, providing data for personalized vascular health assessment.

[0035] In an embodiment, the flexible textile used in the footwear is made of a lycra.

[0036] In an embodiment, the flexible textile used in the footwear is covered by a reinforcement textile.

[0037] In an embodiment, the compression module of the footwear comprises an elliptical geometry selected from 4 to 8 cm on the horizontal axis, preferably 5 to 7 cm, and from 3 to 6 cm on the vertical axis, preferably 4 to 5 cm.

[0038] In an embodiment, the thermo-responsive material of the footwear changes phase once the temperature ranges from 35 to 41°C, more preferably from 38°C to 39°C.

[0039] In an embodiment, the material of the inflatable cell used in the footwear is in thermoplastic film, preferably selected from a list consisting of thermoplastic polyurethane, polyvinyl fluoride, or other suitable polymer and their combinations.

[0040] In an embodiment, the footwear further comprises an encapsulation of the vibratory module.

[0041] In an embodiment, the thickness of the compression module made of thermoplastic material is up to 300 pm, preferably from 200 to 300 pm, more preferably from 250 pm to 300 pm.

[0042] In an embodiment, the vibratory module of the footwear is positioned in the shaft assembly, preferably in the supramalleolar region.

[0043] In an embodiment, the compression module of the footwear is positioned in a centro-medial region below the metatarsal pad.

[0044] In an embodiment, the footwear further comprises a battery.

[0045] In an embodiment, the footwear further comprises an adjustable strap to customize the compression level at the ankle based on the user's needs and foot anatomy.

[0046] In an embodiment, the footwear further includes moisture-wicking and breathable materials to maintain foot hygiene and comfort.

[0047] It is also described the use of the footwear in a medical and / or industrial environment.BRIEF DESCRIPTION OF THE DRAWINGS

[0048] The following figures provide preferred embodiments for illustrating the disclosure and should not be seen as limiting the scope of invention.

[0049] Figure 1: Schematic representation of an embodiment of the compression module, including the printed heating circuit properly encapsulated a), the polymeric elliptical cell b), and a flexible textile, for example lycra, covering the system elements c) and d).

[0050] Figure 2: Schematic representation of an embodiment of the vibratory module, comprising piezoelectric motors and impregnated in silicone pads (a) for better adjustment to the supramalleolar region of the feet, the respective assembly in the casing (b), and the detailed assembly using threads c).

[0051] Figure 3: Schematic representation of the mould to produce the silicone pads of the vibratory module.

[0052] Figure 4: Schematic representation of an embodiment of the encapsulation of the piezoelectric motors in the silicone pads.

[0053] Figure 5: Schematic representation of an embodiment of coupling the new piece of silicone with the textile materials.

[0054] Figure 6: Schematic representation of an exploded view of an embodiment of the footwear insole.

[0055] Figure 7: Schematic representation of an exploded view of an embodiment of the footwear shaft.

[0056] Figure 8: Schematic representation of an embodiment of the different layers of the footwear.

[0057] Throughout the figures indicated above, the following elements are indicated with the respective references:1 - reinforcement textile;2 - flexible textile;3 - encapsulation;4 - piezoelectric motor.DETAILED DESCRI PTION

[0058] The present disclosure relates to a footwear for improvement of the vascular system of a user.

[0059] The now disclosed footwear for improving the user's vascular system comprises a multilayered insole / sole and a shaft assembly, wherein the multilayered insole / sole comprises a compression module embedded, wherein the shaft comprises a vibratory module, wherein the vibratory module comprises at least one piezoelectric motor encapsulated to form a pad; wherein the compression module comprises an inflatable cell placed over a heating circuit and wherein the inflatable cell encapsulates a thermo- responsive material; wherein the compression module and / or vibratory module are configured to repeat cycles of compression / decompression / vibration in order to activate the circulation of the user's feet.

[0060] Using a safety shoe prototype designed by ICC Lavoro, the technology was tested to be integrated in the company's productive process after testing protocols and scenarios, which also includes concerns on the electronics, connectors and cables, battery, and power supply.

[0061] In an embodiment, the substrates tested for the stretchable ink were made of PET (selected), Kapton, and thermoplastic polyurethane. A tape of Kapton was used for printed heating circuit encapsulation. The temperature sensor (MAX 30205) was alsopositioned for temperature control. In an embodiment, the inflatable cell, with 3.0 mL of the Novec 649 thermo-responsive material, was positioned over both the heating circuit and the temperature sensor. In an embodiment, a flexible textile, preferably a lycra, was placed covering the insole and creating a smooth surface for contacting the feet. During the prototype development, some conditions were tested in order to achieve the best implementation in the footwear. The best geometry for the cell cavity was chosen to avoid creasing and changing the resistance values of the circuit.

[0062] In an embodiment, regarding the vibration system, at least one piezoelectric motor impregnated in a silicon pad and a textile were fixed in a case. Pressure was then applied on the fabric and not in the threads.

[0063] In an embodiment, the PCB was placed in the housing and the temperature sensor and heating system were connected to the main board.

[0064] In an embodiment, the assembly process is divided into three steps: idealization and construction of the mould; encapsulation of the motors using silicone; and final assembly (casing).

[0065] In an embodiment, the mould was designed to encapsulate the piezoelectric motor in order to transmit the vibratory sensation and standardize the contact with the user's ankle. In an embodiment, the silicone pad is from 4 to 8 mm height, preferably from 5 to 7 mm, in which the motors are integrated, to protect and improve the efficiency of the mechanism.

[0066] In an embodiment, for the encapsulation step, Ecoflex 00-50 silicone from Smooth-on was used. It started with placing a thin layer of silicone of about 2 mm height in two mould pads and waiting 3 hours to finish the curing process. After that, the motors were placed in the mould and the rest of the silicone was added until the remaining space is fulfilled. An average of 30 g of silicone (15 g of part A and 15 g of part B) were used. Once the curing process is completed, the piezoelectric motors can be removed from the mould (a total of 6 hours of curing time).

[0067] In an embodiment, the last step consisted of coupling the new piece of silicone with the textile. The textiles herein applied are (1) the main structural lycra (grey lycra where the engines would be fixed); (2) a reinforcement textile, like black T-Lam, for thereinforcement of the wires and connections and (3) telcrocro piece to tight it up to the ankle. All textile layers were merged using 3M glue (Permanent Aerosol Spray DisplayMount™, 400 ml).

[0068] The term "comprising" whenever used in this document is intended to indicate the presence of stated features, integers, steps, components, but not to preclude the presence or addition of one or more other features, integers, steps, components or groups thereof.

[0069] The disclosure should not be seen in any way restricted to the embodiments described and a person with ordinary skill in the art will foresee many possibilities to modifications thereof. The above-described embodiments are combinable.

[0070] The following dependent claims further set out particular embodiments of the disclosure.

Claims

C L A I M S1. A footwear for improvement the user's vascular system comprising a multilayered insole / sole and a shaft assembly, wherein the multilayered insole / sole comprises a compression module embedded, wherein the shaft comprises a vibratory module, wherein the vibratory module comprises at least one piezoelectric motor encapsulated to form a pad; wherein the compression module comprises an inflatable cell placed over a heating circuit and wherein the inflatable cell encapsulates a thermo-responsive material; wherein the compression module and / or vibratory module are configured to repeat cycles of compression / decompression / vibration in order to activate the circulation of the user's feet.

2. The footwear according to the previous claim further comprising a second vibratory module in the calcaneus footwear.

3. The footwear according to any of the previous claims, wherein the compression module is covered by a flexible textile.

4. The footwear according to any of the previous claims, wherein the vibratory module comprises two piezoelectric motors.

5. The footwear according to any of the previous claims, wherein the compression / vibration cycles are not substantially simultaneous; preferably are alternated cycles.

6. The footwear according to any of the previous claims, wherein the compression module and / or vibratory module are configured to be electronically adjustable.

7. The footwear according to any of the previous claims, additionally comprising a temperature sensor and / or a sensor to monitor foot pressure.

8. The footwear according to any of the previous claims, wherein the flexible textile is covered by a reinforcement textile.

9. The footwear according to any of the previous claims, wherein the compression module comprises an elliptical geometry selected from 4 to 8 cm on the horizontal axis, preferably 5 to 7 cm, and from 3 to 6 cm on the vertical axis, preferably 4 to 5 cm.

10. The footwear according to any of the previous claims, wherein the thermo- responsive material changes phase once the temperature ranges from 35 to 41°C, more preferably from 38°C to 39°C.

11. The footwear according to any of the previous claims, wherein the material of the inflatable cell is in thermoplastic film, preferably selected from a list consisting of thermoplastic polyurethane, polyvinyl fluoride, or their combinations.

12. The footwear according to any of the previous claims, further comprising an encapsulation of the vibratory module.

13. The footwear according to any of the previous claims 11 to 12, the thickness of the compression module made of thermoplastic material is up to 300 pm, preferably from 200 to 300 pm, more preferably from 250 pm to 300 pm.

14. The footwear according to any of the previous claims, wherein the vibratory module is positioned in the shaft assembly, preferably in the supramalleolar region.

15. The footwear according to any of the previous claims, wherein the compression module is positioned in a centro-medial region below the metatarsal pad.

16. The footwear according to any of the previous claims, further comprising a battery.

17. The footwear according to any of the previous claims, further comprising an adjustable strap.

18. Use of the footwear described in any of the previous claims, in an industrial environment.

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