IT202100013412A1 - INSOLE FOR THE STIMULATION OF PLANTAR SENSORY RECEPTORS AND RELATED METHOD - Google Patents

Description

Description of the Industrial Invention entitled:

?INSOLE FOR THE STIMULATION OF PLANTAR SENSORY RECEPTORS AND RELATED METHOD?

DESCRIPTION

The present invention relates to an insole for stimulating plantar sensory receptors, in accordance with the preamble of claim 1. In particular, an insole and a method for stimulating plantar sensory receptors of a subject's foot are illustrated. The insole can be used in a shoe, suitably arranged, so that the sole of the foot of the subject is mechanically in contact with the insole itself.

The present invention ? usable to allow a functional recovery of gait disorders and upright posture maintenance connected with the loss of plantar sensory receptors of the foot. Therefore, the present invention ? particularly useful for subjects suffering from a dysfunction of the nervous system that pu? cause numbness or partial or total loss of sensitivity, which can? be related to touch, pain, temperature, vibration and position.

Damage to sensory receptors implies a partial or total loss of sensitivity, which has various harmful effects on the subject's organism and lifestyle. In particular, this dysfunction affects the subject with motor disturbances such as sensory ataxia or other pathologies such as, for example, diabetic foot.

The first scientific works concerning the use of vibrations for therapeutic purposes were conducted by Whedon and collaborators in the article entitled ?Modification of the effects of immobilization upon metabolic and physiologic functions of normal men by the use of an oscillating bed?, published in 1949 in the American Journal of Medicine, in which the authors highlighted the positive effects obtained from the application of vibrations generated by a special oscillating bed on the abnormalities metabolic rates of patients bedridden in plaster cast immobilisation. Subsequent experimental studies demonstrated how the vibrations at 50 Hz, and with an acceleration equal to 10 g, were able to increase the area of the muscular section and to decrease the adipose tissue inside the muscle itself. To date, there are two therapeutic approaches to mechanical vibrations, namely:

? the Focal Vibration (FV) in which a powerful stimulus ? selectively applied to certain types of nerve receptors involved in motor control. It is therefore limited to single muscles or small groups of adjacent muscles; ? the Multi Focal Vibration (MFV) which affects the whole body and is applied with a posture in complete functional relief. It is applied in precise points, with defined frequencies. This application does not determine the generation and propagation of low harmonic frequencies, harmful to the structures of the human body, but only affects the stimulation of skin mechanoreceptors.

Focal Vibration (FV) allows a very precise use of the vibrational stimulus. It is used to activate the proprioceptive system of individual muscles or joints. Yes ? tried for a long time to use it for therapeutic purposes, its action on neuromuscular spindles being well known.

US patent application US5592759A describes a shoe having an insole comprising a motor, a battery and a switch. The battery powers the engine which ? controlled by the switch. The engine ? capable of generating mechanical vibrations on the sole of the foot of the subject by performing a massage which allows to increase the blood circulation of the foot and therefore to increase the comfort of the shoe.

The patent application cited above has a series of drawbacks illustrated below.

A first drawback? due to the fact that the mechanical vibrations generated by the motor do not allow effective stimulation for the functional recovery of the sensory receptors of the sole of the foot, since these mechanical vibrations do not have an adequate vibrational frequency.

A second drawback derives from the fact that the mechanical vibrations generated by the engine do not allow persistent functional recovery, since these mechanical vibrations are not applied for an adequate time.

Another drawback of the mentioned system ? due to the fact that the mechanical vibrations generated by the motor do not allow persistent functional recovery, as these mechanical vibrations are not applied with an adequate stimulation cycle.

Another drawback derives from the fact that the mechanical vibrations generated by the engine do not allow persistent functional recovery, since these mechanical vibrations are not applied with an active participation of the subject's target muscles.

Purpose of the present invention? therefore that of solving these and other problems of the known art, and in particular of indicating an insole and a method for the stimulation of plantar sensory receptors, of a subject's foot, which allow to generate mechanical vibrations with an effective vibrational frequency.

A further object of the present invention ? that of indicating an insole and a method for the stimulation of plantar sensory receptors, of a subject's foot, which allow to generate mechanical vibrations for an adequate time, so as to ensure effective stimulation of plantar sensory receptors.

Another object of the present invention ? that of indicating an insole and a method for the stimulation of plantar sensory receptors, of a subject's foot, which allow to generate mechanical vibrations for an adequate stimulation cycle, so as to ensure effective stimulation of plantar sensory receptors.

A further object of the present invention ? to indicate an insole and a method for the stimulation of plantar sensory receptors, of a subject's foot, which allow to generate mechanical vibrations during the activation of the target muscles of the subject.

In extreme synthesis, the described invention consists of an insole and a method for the stimulation of plantar sensory receptors, of a subject's foot, having an adequate control of the mechanical vibrations generated by the insole itself.

Further advantageous characteristics of the present invention are the object of the attached claims which form an integral part of the present description.

The invention will come described in detail below through non-limiting embodiments with particular reference to the attached figures, in which:

Figure 1 schematically represents a system comprising at least one shoe comprising an insole for the stimulation of plantar sensory receptors, and a terminal for controlling at least one insole for the stimulation of plantar sensory receptors, according to an embodiment of the present invention;

- Figure 2 schematically exemplifies a block diagram of the slab of Figure 1;

- Figure 3 represents an example of circuit diagram for the insole of Figure 2, in accordance with another embodiment of the invention.

- Figure 4 represents an exemplary flow diagram of a method for the stimulation of plantar sensory receptors, according to the present embodiment of the invention.

Figure 1 schematically represents a system 100 comprising at least one shoe 110 comprising an insole 200 for the stimulation of plantar sensory receptors of a subject, and at least one terminal 120 for controlling at least said insole 200.

According to an embodiment of the present invention, the shoe 110 can? be for example a shoe, a boot, a boot and cos? via, originally made to include the slab 200, which will be? described in detail with reference to Figure 2. Alternatively, the shoe 110 can? be adapted to include the insole 200 after its original construction.

The insole 200 ? suitable to be mechanically connected to the sole of a foot of the subject. For example, the 200 insole can? be housed between a sole of the shoe 110 and an insole inside the shoe 110 itself. For example, the sole, the insole and the insole 200 can be mechanically connected, so that the mechanical vibrations generated by the insole 200 can propagate, through the insole, towards the foot of the subject wearing the shoe 110. Alternatively, the insole 200 can? be in direct contact with the subject's foot, if the shoe 110 does not include the insole.

Terminal 120, such as a smartphone, tablet, laptop and so on? Street ? adapted to control the slab 200 and pu? communicate with the insole 200 for example via a Bluetooth interface, a WiFi interface, a mobile network interface (GSM, UMTS, LTE, 5G), an NFC interface, a USB interface and so on? Street. In addition, the terminal 120 pu? communicate with a server designed to record the activities? carried out by the subject during the use of the insole 200 itself, for example the terminal 120 after having received information from the insole 200 can? forward that information to the server.

An operator or the subject himself, pu? control the insole 200 by means of the terminal 120, for example, by means of a specific application in which ? is it possible to set one or more? operating parameters of the insole 200. These parameters will be discussed in greater detail with reference to the method of Figure 4.

Alternatively, or in addition, the operator or the subject himself, pu? set one or more operating parameters of the insole 200 directly by means of suitable input means included in the insole 200.

Figure 2 schematically exemplifies a block diagram of the insole 200 for the stimulation of plantar sensory receptors of the subject, according to the present embodiment of the invention.

The insole 200 comprises control means 210, actuator means 220, sensor means 230, input means 240, output means 245, communication means 250 and energy accumulating means 260 operatively connected to each other. For example, the 200 insole can? be made from a sheet metal suitably shaped to be inserted into the shoe 110, which can be worn by the subject to perform certain movements. This metal sheet can be made using a hot rolled structural steel, such as S235 type steel. Such steel? low carbon content, therefore has a high ductility? which allows it to be worked by folding. In addition, at least one surface of the insole 200, mechanically in contact with the sole of the subject's foot, can be covered by one or more? of the following materials: a plastic material, a wood material and a composite material. Alternatively, the 200 insole pu? be entirely made by one or more? of said materials being such materials adequately rigid, i.e. being materials which allow effective transmission of the mechanical vibrations generated in accordance with the present invention.

The energy storage means 260 are able to supply electric energy to said control means 210, actuator means 220, sensor means 230, input means 240, output means 245 and communication means 250 and can comprise, for example, rechargeable batteries, such as such as lithium-ion batteries. The energy accumulating means 260 can comprise all the elements necessary for their recharging, such as for example rectifier electric circuits and so on. Street.

The means of communication 250 allow communication between the insole 200 and the terminal 120 and/or with the server able to record the activities? carried out by the subject while using the 200 insole itself. The communication means 250 can comprise for example a Bluetooth interface, a WiFi interface, a mobile network interface (GSM, UMTS, LTE, 5G), an NFC interface, a USB interface and so on. Street.

The actuator means 220 are able to generate mechanical vibrations for the stimulation of the plantar sensory receptors of the subject.

The stimulation of plantar sensory receptors through mechanical vibrations allows to guide a primary spindle afferent at frequencies of 20 or 30 or 100 Hz without having to use electrical stimuli or having to surgically isolate nerve fibers, but simply by applying a mechanical vibration on a single muscle. With appropriate frequencies and amplitude of vibration? It is possible both to select the activated afferents and to determine the frequencies of action potentials sent to the central nervous system of the subject. A human body can be considered as a system with many degrees of freedom? and therefore it does not vibrate as a single mass, i.e. with a single natural frequency, but each mass, or each of its components, has its own specific resonance frequency. Therefore, the application of vibrations cannot? be carried out starting from a single point of the body and then spreading the effects on the rest of the body.

There? not only does it not produce the desired results, but it also generates negative effects on the whole organism.

The optimization of the stimulation process of the plantar sensory receptors, through mechanical vibrations, is obtained by locating the vibrations in specific areas so to focus the effect of the vibration in the desired area, where? it is therefore necessary to apply the vibrations, avoiding useless dispersions. Furthermore, the mechanical vibration localized to single muscles? capable of activating the muscle-tendon proprioceptors. Since it is a completely painless and non-invasive stimulus, you can? plan the use of such therapy to improve motor control.

Experimental results have shown that a vibrational exposure focused for 10 continuous minutes, 3 times a day, for 3 consecutive days, ? adequate to obtain the maximum effect with the shortest application time. Also, yes? it has also been observed that performing a vibration for 30 continuous minutes, without performing even a very short interval, reduces its effects. Finally, the effects are noticeable only if the patient holds the muscle to be treated in a slight voluntary, isometric contraction throughout the period of application of the mechanical vibrations.

On the basis of what has been discussed above, the actuator means 220 are able to generate mechanical vibrations with a vibration frequency value between 50 and 150 Hz. This frequency interval represents the excitation frequency of the plantar sensory receptors of the subject, such as for example the corpuscles of Pacini (?100 Hz). Additionally or alternatively, the actuator means 220 are able to generate the mechanical vibrations with a sinusoidal waveform. Additionally or alternatively, the actuator means 220 are able to generate the mechanical vibrations with a propagation direction substantially perpendicular to the sole of the subject's foot.

The actuator means 220 can comprise one or more? of the following actuators: a rotating eccentric mass actuator, a resonant linear actuator and a piezoelectric actuator.

The eccentric mass actuator includes an electric motor which sets in rotation an eccentric mass which generates a centripetal force able to move the electric motor itself, thus generating the mechanical vibrations.

The resonant linear actuator comprises a magnet attached to a spring, surrounded by a coil and enclosed within a housing. The magnet, moving linearly inside the electromagnetic coil, generates these mechanical vibrations. Unlike eccentric mass actuators, linear actuators consume less energy and have a faster response time. quick.

Piezoelectric actuators generate a very localized mechanical vibration. I am much more precise as they can vibrate over a wide range of frequencies, also allowing direct control of the signal amplitude. However, they are very expensive and fragile and consume a lot of energy.

These actuators allow you to generate mechanical vibrations more? intense in the stimulation direction, substantially perpendicular, of the sole of the subject's foot and moreover these actuators allow to generate mechanical vibrations having substantially sinusoidal or harmonic waveforms.

The input means 240 allow the operator and/or the subject to set one or more? operating parameters of the slab 200. The operating parameters can include one or more? of the following values: a vibration frequency value of the actuator means 220, a time duration value of the mechanical vibrations generated by the actuator means 220, the time values of an activation and deactivation sequence of the actuator means 220, i.e. the cycles of application of mechanical vibrations, the values of intensity? of the mechanical vibrations produced by the actuator means 220.

These input means 240 can comprise for example microswitches, potentiometers, USB interfaces accessible from inside and/or outside the shoe 110. For example, the operator and/or the subject can set the frequency and intensity values? of the mechanical vibrations generated by the actuator means 220 by means of potentiometers, while the application cycle can? be coded by a series of microswitches. Additionally or alternatively, these parameters can be stored in an external memory accessible via the USB interface. Additionally or alternatively, such parameters may be set by terminal 120, as previously discussed.

The output means 245 allow the operator and/or the subject to view the information output from the terminal 110 and can comprise light indicators, such as for example LEDs and/or acoustic devices, such as for example buzzers. The output means 245 can be accessible from the outside of the shoe 110 and can emit fixed or intermittent light and/or acoustic signals, so as to encode the operating status of the insole 200.

The sensor means 230 are able to generate an electrical signal to the unit? of control 210 when the foot of the subject ? resting on a support surface. The sensor means 230 can comprise one or more? of the following sensors: a strain gauge, a proximity sensor?, a switch and a piezoelectric sensor. The signal generated by the sensor means 230 can be an analog or digital signal, electrical current or voltage. For example, if the sensor means 230 comprise a strain gauge, when the shoe 110 ? in contact with the supporting surface, such as for example a floor or ground, the slab 200 undergoes a deformation which involves the variation of an electrical resistance of the strain gauge and consequently said electrical signal is generated, corresponding to the variation of an electrical voltage at the heads of the strain gauge.

The control means 210 are able to activate the actuator means 220 on the basis of said electric signal generated by the sensor means 230. For example, the control means 210 can activate the actuator means 220 in the event that the electric signal is higher than a first default threshold value. Alternatively, the control means 210 can activate the actuator means 220 in the event that the electric signal is lower than a second predefined threshold value, the first threshold value being different from the second threshold value. Alternatively, the control means 210 can activate the actuator means 220 in the event that the electric signal ? between the first threshold value and the second threshold value.

For example, the control means 210 can comprise a processor, such as a microcontroller of the Arduino type, PIC-MICROCHIP and so on. away, operationally connected to a unit? of input/output comprising all the circuit elements useful for receiving at least the electric signal from the sensor means 230 and for generating at least one electric output signal for controlling the actuator means 220. The unit? input/output can? understand, for example, AC/DC converters and vice versa, comparators, and so? Street. The control means 210 can further comprise a unit? memory, for example a flash-type solid-state memory, suitable for memorizing the operating parameters of the slab 200. In addition or alternatively, the control means 210 can comprise circuit elements such as for example amplifiers, Schmitt triggers, oscillators astable and so? away, as for example indicated in Figure 3.

Referring to Figure 3 , an example circuit diagram for the insole 200 is shown. The control means 210 comprises a Wheatstone bridge circuit 310, an amplifier circuit 320 (AMP04), a Schmitt trigger circuit 330 and a astable oscillator 340 (NE555), operationally connected to each other.

In the present embodiment, the sensor means 230 comprise a strain gauge S1 connected to a Wheatstone bridge circuit 310. The electrical signal generated by the sensor means 230, i.e. output from the Wheatstone bridge circuit 310, is amplified by an amplifier circuit 320 with gain selectable by means of a first potentiometer POT2. After being amplified, the electrical output signal from the amplifier circuit 320 is compared by the Schmitt trigger circuit 330 with the first threshold value equal to an electrical voltage of zero Volt (0V), i.e. the value of the electrical signal in the absence of deformation of the slab 200. The Schmitt trigger circuit 330 outputs a two-level signal: low, for example zero Volts (0V) and high, for example five Volts (5V).

When the electric signal generated by the sensor means 230 ? higher than the first threshold value (0V), or when the subject's foot is resting on the support surface, the output signal to the Schmitt trigger circuit 330, which controls an astable oscillator circuit 340, is high. Instead, when the electric signal generated by the sensor means 230 ? lower than the first threshold value (0V), or when the subject's foot is not? resting on the support surface, the output signal to the Schmitt trigger circuit 330, which controls the astable oscillator circuit 340, is Bass.

The employee and/or the subject, through the input means 240, or by acting on a second potentiometer POT3 of the astable oscillator circuit 340, can vary the duration of the electrical signals at the output of the astable oscillator circuit 340, or can? carry out a PWM modulation of the signals which command the actuator means 220, which in the present embodiment of the invention comprise a motor with a rotating eccentric mass.

In this way ? advantageously is it possible to vary the speed? of rotation of the motor with rotating eccentric mass, allowing the actuator means 220 to generate mechanical vibrations having an effective vibrational frequency, for example, comprised between 50 and 150 Hz. Advantageously, the mechanical vibrations are generated only when the subject's foot is ? in support, or during the walk of the subject: there? it allows to stimulate the sensory plantar receptors during the activation of the target muscles of the limb in support only, while the limb in swing does not undergo any stimulus.

With reference to Figure 4, a method is described for the stimulation of plantar sensory receptors of a subject's foot, the sole of the foot being mechanically in contact with an insole 200, in accordance with the present embodiment of the invention.

At step 400 an initialization phase is performed, in which the insole 200 is initialized. During this phase, for example, the control means 210 perform all the operations necessary to activate the actuator means 220 and the sensor means 230.

At step 410 an acquisition phase is carried out in which the insole 200 acquires from the operator and/or from the subject one or more? operating parameters.

The operating parameters can include one or more? of the following values: a vibration frequency value of the actuator means 220, a time duration value of the mechanical vibrations generated by the actuator means 220, the time values of an activation and deactivation sequence of the actuator means 220, i.e. the cycles of application of mechanical vibrations, the values of intensity? of the mechanical vibrations produced by the actuator means 220.

For example, the operating parameters can be acquired via the input means 240. Additionally or alternatively, these parameters can be stored in an external memory accessible via the USB interface. Additionally or alternatively, such parameters may be set by terminal 120, as previously discussed.

At step 420 an activation step is performed in which the control means 210 activate the actuator means 220 on the basis of the electric signal generated by the sensor means 230, the electric signal being generated when the foot of said subject ? resting on a support surface.

For example, the control means 210 can activate the actuator means 220 in the event that the electric signal is higher than the first predefined threshold value. Alternatively, the control means 210 can activate the actuator means 220 in the event that the electric signal is lower than the second predefined threshold value, the first threshold value being different from the second threshold value. Alternatively, the control means 210 can activate the actuator means 220 in the event that the electric signal is between the first threshold value and the second threshold value.

For example, the first predefined threshold value and/or the second predefined threshold value can be determined by considering the weight of the subject wearing the shoe 110, so as to activate the actuator means 220 only when the subject wearing the shoe 110 is effectively walking on the supporting surface, i.e. avoiding activating the actuator means 220 when the shoe 110 ? only placed on the support surface without being worn, or when the foot? in pendulum.

At step 430, the control means 210 verifies whether to continue the activation of the actuator means 220. During this step, for example, the control means 210 can count the number of application cycles of the mechanical vibrations performed and so on. Street. If so, step 410 is performed, otherwise step 440 is performed.

At step 440, the control means 210 perform a termination phase in which all the operations necessary to terminate the acquisition and activation phase are performed. During this step can the control means 210 signal the inoperative state? of the insole 200, for example through light indicators, such as LED lights, included in the output means 245.

From the description given, the advantages of the present invention are therefore evident.

The present invention advantageously makes it possible to produce an insole and a method for stimulating plantar sensory receptors of the subject's foot through the generation of mechanical vibrations with a vibrational frequency that can be easily set by the operator and/or by the subject himself.

A further advantage of the present invention ? that of indicating an insole and a method for the stimulation of plantar sensory receptors, of the subject's foot, through the generation of applicable mechanical vibrations for a time that can be easily set by the operator and/or by the subject himself.

The method and the insole for the stimulation of plantar sensory receptors of the subject's foot according to the present invention advantageously allow to generate mechanical vibrations for an effective stimulation cycle.

A further advantage of the present invention ? that of indicating an insole and a method for the stimulation of plantar sensory receptors, of the subject's foot, which through the sensor means allow to generate mechanical vibrations during the activation of the target muscles during the subject's walking.

Naturally, the principle of the invention remaining the same, the embodiments and construction details can be widely varied with respect to what? been described and illustrated purely by way of non-limiting example, without thereby departing from the scope of protection of the present invention defined by the attached claims.

Claims (13)

1. Insole (200) for the stimulation of plantar sensory receptors, said insole (200) being able to be mechanically connected to the sole of a foot of a subject and comprising control means (210), actuator means (220) and sensor means (230) operatively connected to each other, said actuator means (220) being able to generate mechanical vibrations for the stimulation of said plantar sensory receptors, said insole (200) being characterized in that said sensor means (230) are able to generate an electric signal to said control means (210) when the foot of said subject is? resting on a support surface, said control means (210) being capable of activating said actuator means (220) on the basis of said electric signal. 2. Insole (200) according to claim 1, wherein said actuator means (220) are able to generate said mechanical vibrations with a vibration frequency value between 50 and 150 Hz. 3. Insole (200) according to claims 1 or 2, wherein said actuator means (220) are able to generate said mechanical vibrations with a sinusoidal waveform. 4. Solothurn (200) according to one or more? of claims 1 to 3, wherein said actuator means (220) are able to generate said mechanical vibrations with a propagation direction substantially perpendicular to the sole of the foot of said subject. 5. Solothurn (200) according to one or more? of claims 1 to 4, wherein said actuator means (220) comprise one or more? of the following actuators: a rotating eccentric mass actuator, a resonant linear actuator and a piezoelectric actuator. 6. Solothurn (200) according to one or more? of claims 1 to 5, wherein said sensor means (210) comprise one or more? of the following sensors: a strain gauge, a proximity sensor?, a switch and a piezoelectric sensor. 7. Solothurn (200) according to one or more? of claims 1 to 6, comprising wireless communication means (250) adapted to communicate with a terminal (120) adapted to control said insole (200). 8. Footwear (110) for the stimulation of plantar sensory receptors of a subject's foot, said footwear (110) comprising an insole (200) according to one or more? of claims 1 to 7. 9. Method for stimulating plantar sensory receptors of a subject's foot, the sole of the foot being mechanically in contact with an insole (200) comprising control means (210), actuator means (220) and sensor means (230) operatively connected to each other, said actuator means (220) being capable of generating mechanical vibrations for the stimulation of said plantar sensory receptors, said method being characterized in that said control means (210) activate said actuator means (220) on the basis of an electric signal generated by said sensor means (230), said electric signal being generated when the foot of said subject ? resting on a support surface. 10. Method according to claim 9, wherein said mechanical vibrations have a vibration frequency value between 50 and 150 Hz. 11. Method according to claims 9 or 10, wherein said mechanical vibrations have a sinusoidal waveform. 12. Method according to one or more? of claims from 9 to 11, wherein said mechanical vibrations have a propagation direction substantially perpendicular to the sole of the foot of said subject. 13. System (100) comprising at least one shoe (110) comprising an insole (200) according to one or more? of claims 1 to 6, said system (100) comprising at least one terminal (120) for controlling at least said insole (200).