Mechanoreceptor and free nerve fiber stimulator apparatus

Abstract

The present invention concerns a flow modulator (100) for generating a sequence of pressure pulses, said modulator (100) comprising an air inlet (2), a compressed air outlet (3), a chamber (10) and at least one opening (11 ), a rotor (4) adapted to rotate about a rotation axis, said rotor (4) comprising a first main face (5) and a second main face (6) substantially orthogonal to said rotation axis, and a lateral face (7); said rotor dividing said chamber (10) into a first semi-chamber (10') and a second semi-chamber (10"), said first semi-chamber (10') being connected to said air inlet (2) and said second semi-chamber (10") being isolated from said first semi-chamber (10') and connected to said compressed air outlet (3), said first main face (5) comprising at least one first channel (15) and said second main face (6) comprising at least one second channel (16), said first and second channels (15, 16) being non-through channels, alternately arranged, with lateral openings alternately positioned on said lateral face (7); said lateral openings of said channels (15, 16) having a cross-section of substantially square or substantially rectangular shape, the lateral wall (8) of said chamber (10) comprising at least one opening (9) arranged opposite to said lateral face (7) of said rotor (4) and pneumatically connected to said at least one opening (11) of said modulator (100).

Description

[0001] MECHANORECEPTOR AND FREE NERVE FIBER STIMULATOR APPARATUS

[0002] The present invention relates to a stimulator apparatus for mechanoreceptors and free nerve fibers, in particular for Pacinian corpuscles.

[0003] In particular, the present invention relates to a mechanoreceptor stimulator apparatus adapted to produce focal mechanical vibration and capable of achieving biological effects through the activation of biochemical processes.

[0004] More generally, the present invention relates to a mechanical-type stimulator apparatus which, according to the state of the art, is known to act on mechanoreceptors, free nerve fibers and integrins, special proteins located in the connective tissue of the human body. The significance of such particular mechanical vibration on bodily resonance and on the cognitive frequencies of the brain, although evident, is still under study.

[0005] As is known, mechanoreceptors, also known as mechanosensors, are of four types: Merkel, Ruffini, Meissner and Pacini. Mechanoreceptors have the following characteristics. They are:

[0006] - first-type exteroceptors capable of receiving exclusively external stimuli;

[0007] - unimodal, capable of being activated only by vibration;

[0008] - phasic.

[0009] For the purposes of the present invention, the most significant receptors are those with rapid adaptation (Meissner and Pacini), and, between the two types, the most important are those definable as having a high activation threshold, namely the Pacinian corpuscles.

[0010] The latter are activated within a frequency range between 60 Hz and 300 Hz (in contrast to Meissner corpuscles, which are activated between 20 and 60 Hz). Furthermore, as known in physiology, at a frequency of 300 Hz, a deformation with a minimum amplitude of just one micron is sufficient to activate Pacinian corpuscles, whereas as the frequency decreases, the amplitude of deformation of such receptors must progressively increase. As is known, Pacinian corpuscles are located in the deep layer of fat; therefore, in order to activate them by deformation, energy is required to overcome / deform the upper layers (epidermis, dermis, subdermis, fat).

[0011] It is also known that when Pacinian corpuscles are activated, they send a signal to the central nervous system to indicate the functional capacity of the muscle district represented by that group of receptors. This signal is more or less significant depending on the discharge capacity, i.e., the intensity of the signal emitted by each individual receptor, which increases in proportion to the number of activated receptors. Such receptors are present over the entire muscle but are located in greater quantity near the myotendinous junctions, with an average density of two per cm2.

[0012] Signals originating from Pacinian corpuscles through vibratory stimulation have been exploited in the treatment of pathologies affecting various muscle districts. In particular, through vibratory stimulation, biological effects can be achieved through biochemical processes. Indeed, the central nervous system (CNS) receives information through the stimulus induced by mechanical vibration applied to different muscle districts.

[0013] In particular, European patent n. EP1824439B1 disclosed a device for conditioning the coordination capability of muscle fibrils, consisting of a compressor and a flow modulator for generating a sequence of pressure pulses, a plurality of transducers for applying said pulses to the epidermis of a user, corresponding to the muscle or muscles to be treated, and a plurality of pneumatic conduits for transmitting said pulses from the system composed of compressor and modulator to the transducers. Specifically, in said device, mechanical vibration was obtained by means of a flow modulator comprising: a compression conduit and a decompression conduit mechanically connected to a modulation element. Said flow modulator comprised passages and / or channels adapted to alternately open and close said compression conduit and said decompression conduit, thereby generating, within a pneumatic chamber, a flow wave with a frequency between 40 Hz and 400 Hz, said pneumatic chamber being mechanically connected to means for signal transmission to the epidermis, for example tubes.

[0014] The above-described prior art flow modulator apparatus could operate both with compressed fluids, such as compressed air, and with incompressible fluids. However, when said apparatus operated with compressed air, it required large blowers capable of ensuring an output signal intensity sufficient to effectively stimulate, through pressure transducers positioned on the muscle district, an adequate number of mechanoreceptors, including Pacinian corpuscles.

[0015] In particular, the prior art flow modulator apparatus described in patent number EP1824439B1 did not allow full utilization of the flow rate and pressure of the blowers identified for use, and due to design limitations, allowed activation of mechanoreceptors only for a very limited time. Moreover, the prior art flow modulator did not allow maximization of pressure.

[0016] Additionally, known technical models operated with blowers weighing at least 17 kg, which also required supports of about 1 kg. Furthermore, known technical models operated with blowers required to generate a flow rate of approximately 40 m3 / h.

[0017] Moreover, the total weight of the finished apparatus according to the prior art ranged between 50 kg and 85 kg. This resulted in non-portable equipment with high bulk.

[0018] Furthermore, the apparatus object of European patent n. EP1824439B1 comprised circular holes placed on the rotor and stator. In said apparatus, increasing the number of outlets on the rotor circumference leads to an increase in such circumference and thickness, hence in the size of the flow modulator. Increasing the number of circular holes positioned on the peripheral zone of the rotor circumference determines an increase in the vibration frequency but also, inevitably, an increase in the size of the rotor.

[0019] In particular, increasing the number of lateral channels of the rotor has several consequences.

[0020] The number of lateral channels can be increased according to the number of outlets or external holes intended for use, i.e. , the number of transducers intended to be provided. If only one limb is to be treated at a time, five transducers are sufficient; if both lower limbs are to be treated, at least nine are required; if both lower and upper limbs are to be treated simultaneously, at least fourteen will be needed, up to twenty.

[0021] Moreover, it is advantageous to increase the number of outlets to increase the frequency, even when using only one outlet, for example, to use the system manually for pain therapy.

[0022] Furthermore, by way of example, if a system comprises three outlets, three pulses are produced per rotation cycle; if it comprises six outlets, six pulses are produced. If the circumference allowed the use of holes of equal width and the pressure generator allowed an instantaneous flow rate sufficient to satisfy six outlets instead of three, without increasing the distance between the rotor circumference and the rotation center, a considerable advantage in flow rate would be achieved, since, for example, to produce 120 pulses, the number of rotations would be halved (20 instead of 40). Halving the number of rotations halves the rotation speed, doubling the fluid passage time between the chamber of the rotating part (rotor) and that of the stationary part (stator), thereby significantly increasing the flow rate.

[0023] However, the above-mentioned advantages are nullified if the flow rate is not sufficient to satisfy the flow requirement of the number of tubes connected to each external hole. In this case, one may decide to maintain a number of external holes / outlets higher than the number of tubes intended to be used, leaving some outlets unconnected to tubes to avoid loss of flow rate.

[0024] The above holds theoretically, since, using rotor channels with circular lateral openings, increasing frequencies or the pressure generator's flow rate does not allow maintaining valid values of flow rate and pressure.

[0025] Moreover, the information that the central nervous system receives from mechanoreceptors can be defined as the information regarding the efficiency of the muscle that the mechanoreceptors are tasked with representing. This information (i.e., the discharge capacity) varies depending on the intensity / power of such afferent signal and also depending on the number of activated receptors.

[0026] Based on the quality and quantity of the signal that the central nervous system receives from mechanoreceptors, it sends the efferent response, i.e., the neuronal firing (motor command) that allows recruitment of a greater number of motor units, hence motor neurons (and through their activation, muscle fibers).

[0027] From the above, it follows that, in order to interact with the central nervous system and modify / optimize the efferent response / command making a muscle as efficient as possible, it is essential to activate a high number of Pacinian mechanoreceptors, but it is even more important to keep them activated (deformed) for as long as possible. Indeed, if mechanoreceptors are not activated, they send no information to the Central Nervous System. It is also known that the concentration of Pacinian mechanoreceptors is approximately two per cm2. Therefore, it is essential that the potential interface with the skin (the transducer), intended to activate mechanoreceptors, be of adequate size to activate as many receptors as possible.

[0028] A characteristic of Pacinian corpuscles is that these mechanoreceptors are located in the deep fat layer. Consequently, in order to successfully activate them (deform them) through pressurized vibratory action, it is necessary to deform the epidermis, dermis, subdermis, and the layer of fat interposed before reaching them.

[0029] By way of example, considering a frequency of 120 Hz, within the activation range of Pacinian corpuscles, the duration of one working cycle is 8.33 milliseconds. This time includes two phases: a pressure phase and a decompression phase. In particular, the pressure phase, also called the push phase, is the one useful for deforming the skin and fat until activating the Pacinian receptor. This phase is symmetrical to the decompression phase and has a duration of 4.16 milliseconds.

[0030] Additionally, the longer the activation (deformation) time of each individual mechanoreceptor, the longer the time during which such receptor will send its efficiency signal / information to the central nervous system. Again, the greater the intensity of the afferent signal sent by a large number of receptors, the greater the attention the Central Nervous System will devote to the muscle district from which the signal originates. In particular, the central nervous system, depending on the "quantity" of received information, will send the necessary neural command (or efferent command) to satisfy the efficiency demonstrated by that muscle district. The more intense the control signal sent by the CNS, the greater the efferent signal, and thus the number of motor neurons (motor units) activated, and consequently the greater the number of muscle fibers at work, resulting in better performance of the treated muscle.

[0031] As previously reported, it is necessary to consider that vibration consists of two phases: the pressurization phase (deformation of the skin tissue under pressure) and the decompression or suction phase. These phases alternate and are of equal intensity. However, while the pressurization phase is essential for deformation and activation of Pacinian corpuscles, the decompression phase is useful only because without it, vibration would not be produced, only pressure. However, high suction intensity is not useful, indeed it is detrimental to the functioning of the present invention.

[0032] As previously described, the pressure and decompression produced by the flow modulator are transferred to the applicators placed on the skin, called pressure transducers or transduction chambers, through connecting tubes or pneumatic conduits. If the connecting tubes were decompressed during the negative phase, in the subsequent positive phase, the volume of fluid required to pressurize the transducers and thus activate the mechanoreceptors through the skin would be much greater.

[0033] Moreover, it is inappropriate for the pressurized impulse of mechanical vibration to be oversized. Indeed, if muscle fibers were to stretch more than 0.12 mm, they would break. To avoid causing unnecessary damage to muscle fibers, it is therefore necessary to dose the mechanical energy, using only the necessary amount, without exceeding it.

[0034] Furthermore, it is highly advisable to use the correct amount of energy for at least two additional reasons.

[0035] Firstly, because producing mechanical energy has economic costs, and secondly, because the higher the energy delivered, the greater the acoustic pollution produced.

[0036] Therefore, there exists, in the specific field, the need for a mechanoreceptor stimulator apparatus, specifically for Pacinian corpuscles, capable of providing the necessary energy to reach and activate mechanoreceptors but not exceed it. At the same time, if receptor activation is limited in time, the signal they will emit toward the central nervous system will be modest and consequently a modest response will be obtained.

[0037] Thus, there also exists the need for a Pacinian corpuscle stimulator apparatus capable of producing a mechanical wave able to send to the central nervous system a signal of optimal intensity with the minimum possible energy expenditure and with a wave that activates the receptor for as long as possible, producing minimal noise, an undoubtedly undesirable side effect.

[0038] To this end, it must also be considered that to achieve the therapeutic effect, it is necessary to strike the skin with a pressure wave that compresses the superficial layers until deforming the mechanoreceptors, but a decompression phase strong enough to suck the skin into the transducer is neither necessary nor useful. It is simply necessary to reduce the pressure exerted so that the receptors are not stimulated, thereby generating an alternating stimulation, i.e., a vibration. In this regard, it is sufficient for a pressurized phase and a neutral phase to alternate on the mechanoreceptors. The absence of the decompression phase allows avoiding decompression of the tubes, i.e., avoiding reducing the amount of fluid present in the tubes, thus avoiding increasing the flow rate required in the tubes. The purpose of the present invention is to optimize the prior art stimulator apparatus so that it can activate a large number of Pacinian mechanoreceptors and keep them activated (deformed) for as long as possible with the necessary therapeutic energy produced by blowers or air compressors or pressure generators of various sizes.

[0039] A further purpose of the present invention is to obtain a portable Pacinian corpuscle stimulator apparatus, having modest bulk and weight even below 10 kg.

[0040] Therefore, an object of the present invention is a flow modulator for generating a sequence of pressure pulses, said modulator comprising an air inlet, a compressed air outlet, a chamber and at least one opening, a rotor adapted to rotate about a rotation axis, said rotor comprising a first main face and a second main face substantially orthogonal to said rotation axis, and a lateral face; said rotor dividing said chamber into a first semi-chamber and a second semi-chamber, said first semi-chamber being connected to said air inlet and said second semi-chamber being isolated from said first semi-chamber and connected to said compressed air outlet, said first main face comprising at least one first channel and said second main face comprising at least one second channel, said first and second channels being non-through channels, alternately arranged, with lateral openings alternately positioned on said lateral face; said lateral openings of said channels having a cross-section of substantially square or substantially rectangular shape, the lateral wall of said chamber comprising at least one opening arranged opposite to said lateral face of said rotor and pneumatically connected to said at least one opening of said modulator.

[0041] Preferably, according to the present invention, said lateral openings of said channels of said rotor may have an area between 60 and 300 mm2.

[0042] In particular, according to the present invention, the radius of said rotor may have a length between 25 and 60 mm.

[0043] Preferably, according to the present invention, said first and second channels may have equal dimensions and may be positioned at a relative distance from each other greater than the width of said channels so that the filling time of said pneumatic chamber equals half the pulsation period of said pulsed pressure wave.

[0044] Additionally, according to the present invention, said air inlet may be positioned tangentially to said lateral surface of said rotor. Moreover, the volumetric flow entering said air inlet may have a flow direction concordant or discordant with the rotation direction of said rotor. In particular, the optimal size must be calculated based on the flow rate of the pressure generator used. Depending on the pressure generator's flow rate, the volume of flow for the pressure / decom pression phase of the selected frequency in milliseconds must be calculated, multiplied by the activation time under positive pressure, and reduced by approximately 10% so that the chamber can pressurize before opening and ensure the subsequent fluid injection into the circuit.

[0045] Moreover, the chamber volume may be adjustable depending on the frequency used, either by an operator or through preset parameters based on the chamber filling time, depending on the flow capacity of the pressure generator used and the available filling time at the desired frequency, reduced by approximately 10%, given that the chamber filling time varies with frequency.

[0046] A further embodiment forming an object of the present invention is a stimulator apparatus for stimulating mechanoreceptors of the human or animal body, said apparatus comprising: a flow modulator for generating a sequence of pressure pulses, at least one pressure generator comprising suction and discharge; a compression conduit and a suction conduit, one end of which is connected respectively to the discharge and suction of said pressure generator and the other end respectively to said inlet and said outlet of said modulator; at least one transduction chamber for applying said pulses to the epidermis of a user; at least one pneumatic conduit, one end of which is connected to said opening of said modulator and the other end to said transduction chamber.

[0047] Preferably, according to the present invention, said apparatus may comprise a pressure regulation device in the suction conduit.

[0048] Moreover, according to the present invention, said at least one transduction chamber may have a thickness of 10 mm and / or a height between 0.5 mm and 2 cm.

[0049] Always according to the present invention, said at least one transduction chamber may comprise a membrane adapted to prevent fluid leakage.

[0050] The effectiveness of the device of the present invention is evident, allowing expression of the same mechanical capability of prior art modulators with a significant reduction in required energy, enabling approximately triple the activation time of mechanoreceptors, allowing greater therapeutic efficacy with significant reduction in weight, bulk, and acoustic pollution.

[0051] Furthermore, the device according to the present invention allows the use of blowers or pressure generators weighing 1.5 kg, with a flow rate of about 30 m3 / h instead of 40 m3 / h as in prior art devices, and volumes at least six times smaller than prior art devices. All this allows the realization of portable devices, with superior mechanical efficiency compared to previous ones, with much smaller dimensions and weight starting from 9-11 kg for portable models and around 35 kg for medical office models.

[0052] The invention will now be described by way of illustration but not limitation, particularly with reference to the drawings of the attached figures, in which:

[0053] Figure 1 shows a schematic view of a stimulator apparatus according to the present invention;

[0054] Figure 2 shows a perspective view of a modulator for a stimulator apparatus according to a first embodiment of the present invention;

[0055] Figure 3 shows the same perspective view of the modulator of the stimulator apparatus of Figure 2, with the interior of said modulator shown;

[0056] Figure 4 shows a first exploded perspective view of the modulator of the stimulator apparatus of Figure 2;

[0057] Figure 5 shows a perspective view of the modulator of a stimulator apparatus according to a second and preferred embodiment of the present invention;

[0058] Figures 6a-6c show a perspective view of a modulator of a stimulator apparatus according to a third embodiment of the present invention; and

[0059] Figures 7a-7b show the same perspective view of the modulator of the stimulator apparatus of Figure 5, with the interior of said modulator shown.

[0060] Referring to Figure 1 , reference numeral 1 will be assigned to a mechanoreceptor stimulator apparatus, said stimulator apparatus 1 comprising:

[0061] - at least one pressure generator 101 comprising suction and discharge;

[0062] - a flow modulator 100 for generating a sequence of pressure pulses;

[0063] - a compression conduit 102 and a suction conduit 103 mechanically connected to said modulator 100;

[0064] - a pressure regulation device 104 in the suction conduit 103; - at least one transduction chamber 13, for applying said pulses to the epidermis of a user, corresponding to the muscle or muscles to be treated, and

[0065] - at least one pneumatic conduit 12, for transmitting said pulses from the system consisting of pressure generator 101 and modulator 100 to the transduction chambers 13.

[0066] In particular, in said stimulator apparatus 1 , to avoid the decompression phase within the suction conduit 103, said pressure regulation device 104 is inserted between the flow modulator 100 and the suction of the pressure generator 101. In this way, the decompression phase is reduced. Preferably, said pressure regulation device 104 comprises an external air intake filter positioned in the suction conduit.

[0067] By way of example, considering a positive and negative pressure of 200 mbar, by introducing said air intake filter, the negative pressure can be reduced to 20-50 mbar depending on the size of the intake filter. Thus, by not decompressing said pneumatic conduits 12, the flow rate of the pressurization phase is increased. Moreover, the addition of said pressure regulation device 104 allows maintaining a closed circuit and limiting system noise. Additionally, said pressure regulation device 104 allows the entry of clean air, which reduces the operating temperature of the pressure generator 101 .

[0068] Figures 2-4 show the essential elements of a first embodiment of said modulator 100.

[0069] Referring to Figure 2, said modulator 100 comprises an air inlet 2 and a compressed air outlet 3. In particular, said air inlet 2 and said compressed air outlet 3 may be connected respectively to said compression conduit 102 and to said suction conduit 103 of at least one pressure generator 101 .

[0070] Moreover, referring to Figure 3, said modulator 100 comprises an upper part 19, a lower part 20, and a preferably cylindrical chamber 10. In particular, said upper part 19 comprises a plurality of external holes 11 .

[0071] Furthermore, referring to Figure 4, said apparatus 1 comprises a disk-shaped rotor 4 capable of rotating about a rotation axis at a frequency adjustable by an operator. Said rotor comprises a first main face 5 and a second main face 6, substantially parallel to each other and orthogonal to the rotation axis, and a lateral face 7 with non-zero lateral thickness, preferably with a thickness greater than 2 mm to prevent deformation under pressure, more preferably said thickness is between 2 and 5 mm. In particular, said rotor 4 divides said cylindrical chamber 10 into two cylindrical semi-chambers 10', 10" on two sides of said rotor 4, a first semi-chamber 10' connected to said air inlet 2 and a second semi-chamber 10" isolated from said first semi-chamber 10' and connected to said compressed air outlet 3.

[0072] Moreover, said first main face 5 comprises at least one first channel 15 and said second main face 6 comprises at least one second channel 16, said first and second channels 15, 16 being non-through channels, alternately arranged with lateral openings alternately positioned on said lateral face 7.

[0073] Referring to Figure 3, the lateral wall 8 of said chamber 10 comprises a plurality of openings 9 arranged opposite to said lateral face 7 of said rotor 4 and pneumatically connected to said plurality of external holes 11 of said modulator 100.

[0074] In particular, said at least one opening 9 has dimensions varying depending on the flow rate of the energy source. By way of example, in the case of a pressure generator with a flow rate of 30 m3 / h, said opening 9 should have an area of about 170 mm2. Such must be the cross-sectional area of the rotor channels 15, 16.

[0075] Furthermore, referring to Figure 2, said plurality of external holes 11 are mechanically connected to said plurality of openings 9 and are adapted to be connected to said at least one pneumatic conduit 12.

[0076] Moreover, referring to Figure 3, said openings 9 of said lateral wall 8 are substantially central to said lateral face 7 of said rotor 4, so as to be mechanically connected, alternately, to both said first channels 15 of said first main face 5 and said second channels 16 of said second main face 6. Indeed, when said rotor 4 rotates at a rotation frequency adjustable by an operator, the lateral openings of said first channels 15 and of said second channels 16 are alternately brought into contact with said openings 9 of said lateral wall 8, and consequently said openings 9 are alternately brought into contact with said cylindrical chamber 10 and with said compressed air outlet 3, thus generating said alternating pressure wave within said pneumatic conduits 12.

[0077] Indeed, when the lateral openings of said first channels 15 are in contact with said openings 9, the compressed air present in said cylindrical chamber 10 flows toward said pneumatic conduits 12, filling them; conversely, when the lateral openings of said first channels 15 are not in contact with said openings 9, said chamber 10 can refill with compressed air and said pneumatic conduits 12 can empty toward said compressed air outlet 3 when said openings 9 are in contact with the lateral openings of said second channels 16.

[0078] Preferably, the cross-sectional area of said channels 15, 16 is about 160 m2

[0079] In particular, the ends of said channels 15, 16 and said openings 9 have a substantially rectangular cross-sectional shape so as to obtain a greater pressure pulse and consequently greater activation of the mechanoreceptor.

[0080] In particular, said pressure flow with pulsed wave has a pulsation period equal to the rotation period (inverse of said rotation frequency) of said rotor 4 divided by the number of said openings 9.

[0081] Said first channels 15, said second channels 16 and said openings 9 are all of the same number, and the lateral opening of each first channel 15 is superimposable on a respective opening 9 of said lateral wall 8 at least at a first instant of said rotation period. Furthermore, the lateral opening of each of said second channels 16 is superimposable on a respective opening 9 at least at a second time instant of said rotation period, different from said first time instant.

[0082] In particular, the width of said lateral openings of said first and second channels 15, 16 on said lateral surface 7 may advantageously be smaller than the width of said openings 9 so that a pressure wave peak and a pressure wave minimum can be maintained for more time instants, resulting in a substantially rectangular wave shape at the output of said transducer elements 12.

[0083] In the specific case, since the lateral openings of said first and second channels 15, 16 have the same width, and the distance between said first and second channels 15, 16 is slightly greater than the width of the channels themselves 15, 16, the filling time of said pneumatic chamber 10 equals half the pulsation period of said pressure wave.

[0084] Finally, for the resulting pressure wave to activate Pacinian corpuscles, the resulting pulsation frequency must be between 40 Hz and 400 Hz.

[0085] From the above, one of the advantages of the present invention is the possibility of increasing the intensity of the pressure wave while reducing the size of the stimulator apparatus, in particular reducing the diameter and circumference of rotor 4 and chamber 10, which allows increasing the compressed air flow rate without increasing the peripheral speed of the rotor. On the contrary, the increase in flow rate and pressure is linked to an increase in the cross-sectional height of rotor 4 channels 15, 16 and openings 9, without any negative effect on the apparatus mechanics; indeed, this allows increasing the air passage area, increasing the flow rate without reducing the passage time. This allows not limiting the activation time of mechanoreceptors and not decreasing the flow rate, which is fundamental for filling the circuit that allows transferring pressure / decompression to the user’s skin.

[0086] Moreover, not increasing the circumference of rotor 4 allows moving rotor 4 via a motor with low power, guaranteeing reduced cost.

[0087] Afurther particularly important aspect of the invention relates to the possibility of filling all pneumatic conduits 12 connected to modulator 100 with a sufficient quantity of compressed air to activate mechanoreceptors. In this regard, if the available time for compressed air to pass through pneumatic conduits 12 to transduction chambers 13 located on the subject’s skin is shorter, the receptor activation time will be shorter, the discharge capacity (afferent information, from the receptor to the Central Nervous System) will be less significant, and there will be a reduction in the available contact surface pressure. In particular, the smaller the size, within production limits, of the transduction chambers 13, if present, the better the achievable result.

[0088] In an embodiment not shown, a solid gel, preferably a water gel, may be placed between each transduction chamber 13 and the user's skin, adapted to distribute the impulse over a wider area. Preferably, said solid gel is coupled to said transduction chamber via a strap.

[0089] Proper apparatus sizing also involves proper sizing of the pneumatic chamber 10 relative to the total volume of transducer elements 12 and transduction chambers 13, depending on the capacity of the pressure generator used for air compression.

[0090] In embodiments not shown, the apparatus comprises a motorized system configured to vary the height of the pressure chamber 10 or of the pressure chamber and rotor channels 15, 16, since varying the frequency varies the chamber filling time and the opening time for emptying.

[0091] Referring to Figures 1-3, it is noted that said air inlet 2 and said compressed air outlet 3 are respectively positioned parallel to said first and second main faces 5, 6 of said rotor 4, so that the flows generated by said blower respectively toward and from said neurostimulator apparatus 1 are perpendicular to said faces 5, 6, i.e. , perpendicular to the rotation plane of said rotor. However, having an air inlet 2 where the airflow is parallel to the rotation axis of said rotor 4 and striking said rotor 4 non-homogeneously, may cause inclination of the rotor 4 itself, consequently damaging modulator 100 and affecting the maintenance cost of said apparatus 1 .

[0092] In the embodiment shown in Figures 5 and 7a-7b, said air inlet 2 is positioned tangentially to a point on the lateral surface 7 of said rotor 4, so as to generate an airflow tangential to said rotor, preferably with a direction concordant with the rotation direction of said rotor 4.

[0093] Finally, said pulsation period of the pressure flow, which, as stated, equals said rotation period of said rotor 4 divided by the number of said openings 9, may have pressure intensity varying from 50 mbar to 700 mbar without causing damage to blood vessels or risking tissue damage. Moreover, said pulsation period may be divided into three fractions.

[0094] A first fraction of said pulsation period during which the pressure intensity exiting said pneumatic conduits 12 is sufficient to stimulate the Pacinian corpuscles of a user in contact with said apparatus 1 , said pressure intensity being considered between 100 and 180 mbar.

[0095] A second fraction of said pressure flow pulsation period during which the pressure intensity exiting said pneumatic conduits 12 is sufficient to stimulate Pacinian corpuscles only in a very sensitive user with reduced fat mass, the pressure intensity being between 60 and 90 mbar.

[0096] A third fraction of said pressure wave period during which the pressure intensity exiting said pneumatic conduits 12 is insufficient to stimulate Pacinian corpuscles in any user, said pressure intensity being between 20 and 50 mbar and almost equal to atmospheric pressure. This third fraction may be used for patients requiring adaptation, for example fibromyalgics.

[0097] The above pressure wave intensities are given by way of example, since the mentioned intensities have positive effects on the strength of muscle fibers they contact. To use said device within pain treatment or other muscular pathologies, pressure waves with higher intensities should be applied.

[0098] Moreover, said pressure wave intensities have been dimensioned for the case of a normal-weight and normally sensitive user, i.e., whose Pacinian corpuscles have normal sensitivity, similar to the response of an average user. Users with fat mass above a defined percentage in weight, for example, require pressure pulses of greater intensity, sufficient to counterbalance the dispersion of pressure force on the fat mass. In particular, in the case of normally sensitive users with high fat mass, said transducer elements should deliver pressure waves with intensities of approximately 40 / 60 mbar; 70 / 80 mbar; 90 / 100 mbar; 110 / 120 mbar for reliable activation of receptors corresponding approximately to the following fat mass indices: 15-20%, 25-30%, 35-40%, >50%.

[0099] Alternatively, in non-normally sensitive subjects, the pressure intensity can be adjusted simply by asking the user when they begin to feel that the vibratory stimulus affects the muscle without causing discomfort.

[0100] In particular, the thickness of said lateral face 7 of said rotor 4 can be specifically designed during the design phase of said apparatus 1 so as to present channels 15, 16 with a cross-section larger than the holes of prior art apparatuses, thus advantageously allowing operation with pressure generators 101 smaller than those used in the prior art, and consequently enabling miniaturization of said neurostimulator apparatus 1 to make it increasingly smaller in size, transportable or portable, as shown in Figures 6a-6c.

[0101] In particular, Figure 6a shows the upper part 19 of said modulator 100 and rotor 4, Figure 6b shows the lower part 20 of said modulator 100, and Figure 6c shows the assembled modulator 100 with upper part 19 placed above lower part 20.

[0102] Referring to a second and preferred embodiment shown in Figures 7a-7b, the presence of the air inlet 2 positioned tangentially to a point on the lateral face 7 of said rotor 4 makes necessary the realization of a connection channel 14 in chamber 10 to allow positioning at the lateral wall 8 the height necessary for the realization of the air inlet 2.

[0103] In particular, Figure 7a shows the upper part 19 of said modulator 100 according to a second and preferred embodiment and Figure 7b shows the lower part 20 of said modulator 100.

[0104] By way of example, a neurostimulator apparatus 1 operating with a 1.5 kg pressure generator is capable of delivering a pressure of 320 mbar with a flow rate of 30 m3 / h, having a rotor 4 with a lateral face 7 height of 3 mm with 18 mm channels for quick connectors accommodating pneumatic conduits of 12 mm external and 10 mm internal diameter, the apparatus 1 weighs approximately 10 kg and has dimensions of 370 mm x 430 mm x 190 mm, resulting in a weight reduction compared to prior art apparatuses which weigh between 50 and 85 kg. Such a device can be produced with five, nine or ten external output holes, which can be doubled. Moreover, a device with fourteen external holes can be produced using the same pressure generator, on a standalone cart, suitable for medical offices or gyms, with dimensions of 43x43x120 cm and a weight of 35 kg.

[0105] The dimensions of the flow modulators can be produced, by way of indication, with 90 mm diameter and 60 mm height and variable weight depending on the material, approximately 400 g for five external holes, 100 mm diameter and 70 mm height (weight variable depending on the material); for nine or ten external holes, approximately 500 g and 100 mm diameter; dimensions of 110 mm diameter, 80 mm height and approximately 600 g for a device with fourteen external holes; dimensions of 150 mm diameter and 90 mm height, weight variable depending on the material, approximately 750-800 g for a device with twenty external holes.

[0106] All these devices have similar dimensions depending on the flow rate of the pressure generator chosen for use.

[0107] By way of example, considering a 30 m3 / h pressure generator, the apparatus has a pressurization and decompression chamber volume between 0.010 I and 0.040 I, preferably the pressurization chamber volume is 0.028 I.

[0108] Moreover, the cross-section of the lateral openings of said channels 15, 16 must be rectangular.

[0109] Furthermore, in the system according to the present invention, it is useless to increase the size of the recess by increasing the circumference. Indeed, doubling the radius doubles the circumference. If the rotation time were the same, the peripheral speed would double and the time during which a fixed-size recess placed on the circumference would face an opening 9 of chamber 10 would be halved. If the recess size were doubled, the time during which the recess would face opening 9 would be the same. Therefore, increasing the recess size by increasing the circumference is useless.

[0110] However, it is necessary to use channels with a rectangular cross-section to maintain constant instantaneous flow with a fixed radius.

[0111] By way of example, to produce 300 Hz with a rotor with 10 outlets (comprising 20 channels on the rotor, 10 openings on the chamber) 30 rotations per second are required; with a rotor with 20 outlets (comprising 40 channels on the rotor, 20 openings on the chamber) 15 rotations per second will be required. Thus, by halving the peripheral speed, the passage time of a rectangle, for example with a base of 3 mm instead of 6 mm, will be equal, and the amount of flow will be compensated in height. For example, if the channel section was previously 6x15 mm, it must become 3x30 mm, and the flow will be compensated by doubling the channel cross-section height.

[0112] Increasing frequency (pressure / decompression phases per revolution) is a great advantage, but increasing outlets leads to increasing the distance between the rotation center and the channels placed on the rotor's periphery, as occurred in prior art documents. The ratio is directly proportional; therefore, using circular channels, increasing the number of outlets provides an advantage if one wants to increase the outlets but provides no advantage regarding pressure and flow, since doubling the number of outlets halves the fluid passage time in the conduits.

[0113] Moreover, in prior art documents, since the passage hole is circular, the overlapping by intersection during rotation of two holes greatly reduces fluid passage, unlike what happens with lateral rectangular holes.

[0114] Therefore, a system with rectangular channels instead of circular holes provides enormous advantages. The first is that even doubling the number of outlets avoids increasing the rotor size. In particular, the increase in size can be limited to the fixed part only, i.e. , the upper part 19 and lower part 20 of modulator 100, leaving rotor 4 the same size even on instruments with a greater number of holes. The parts that will coincide during rotation will be rectangular; if the number of outlets is doubled, the dimensions of the rectangular channels will be reduced by 50% in width, but these dimensions will be compensated by the height of the rectangles, absolutely maintaining the air passage area at the same peripheral speed. The compression chamber volume can remain the same. Models with different numbers of outlets will have volumetric parameters for the pressurization chamber that are very efficient, by way of indication but not limitation for the present invention, between 70,000 and 130,000 mm3.

[0115] But the greatest therapeutic advantage of having rotor openings of rectangular type derives from the fact that mechanoreceptors in general, and Pacinian corpuscles like others, follow the all-or-nothing principle, i.e., either they are activated or they are not. A circular hole overlapping another initially allows a small volume of air to pass, which gradually increases as the two holes coincide, then significantly decreases as the midpoint is passed, the point allowing full flow. Preliminarily, two rectangular holes can have a larger area for the same radius. The area of a circle with a 5 mm diameter is 20% less than that of a square with the same diameter but can also be 200% less than that of a rectangle with a base equal to the diameter. The advantage in flow is enormous.

[0116] Moreover, in rectangular holes, the fluid passage volume is several times greater from the start and can immediately activate receptors and keep them active for longer.

[0117] In particular, increased efficiency is guaranteed by the realization of the flow modulator with rectangular channels of determined proportions but also variable geometry, by determining the geometry necessary for various models, by the ability to manage the filling and discharge phases of the circuits through a well-studied external connection system. Moreover, all this has led to the reduction of the final instrument dimensions in terms of bulk, weight, and reduction of energy required for mechanoreceptor activation.

[0118] Moreover, to optimize the system, modulator 100 is connected to the outside in the decompression phase via said pressure regulation device positioned in the suction conduit 103.

[0119] More specifically, exploiting the flow modulator mechanism, air from the outside enters the closed-loop flow to reduce the intensity of decompression in the tubes during the negative phase so that this phase brings the tubes to rest but not into decompression. By way of example, having a pressure generator with a capacity of 320 mbar positive and the same negative, it will be useful to reduce only the decompression action, bringing it from 320 mbar negative down to a maximum of 150 mbar negative.

[0120] In an embodiment not shown, said pressure regulation device 104 comprises a three-way system, one branch connected to the pressure generator, one to the flow modulator outlet, and the third to the outside, and may also perform a silencing function. Indeed, said pressure regulation device can have a dual function: allowing air into the circuit and allowing it to exit while limiting the produced noise.

[0121] Therefore, when the decompression phase is activated, the decompression will be less strong because the return air will be too much compared to what the pressure generator can absorb to satisfy circuit equilibrium. For this reason, excess air must be expelled outside, otherwise it would clog the system. This is possible through the external connection, which must necessarily be equipped with a silencing system for the expelled vibrating air.

[0122] Moreover, the circuit connection opening to the outside must be at least 20 mm2. In the foregoing, preferred embodiments of the present invention have been described and variants suggested, but it is understood that experts in the field may make modifications and changes without departing from the scope of protection defined by the attached claims.

[0123] In particular, the apparatus according to the present invention may use any other compressed gas or incompressible fluid instead of air, the necessary modifications falling within the ordinary skill of a technician in the field.

Claims

CLAIMS1. Flow modulator (100) for generating a sequence of pressure pulses, said modulator (100) comprising an air inlet (2), a compressed air outlet (3), a chamber (10) and at least one opening (11 ), a rotor (4) adapted to rotate about a rotation axis, said rotor (4) comprising a first main face (5) and a second main face (6) substantially orthogonal to said rotation axis, and a lateral face (7); said rotor dividing said chamber (10) into a first semichamber (1 O') and a second semi-chamber (10"), said first semi-chamber (1 O') being connected to said air inlet (2) and said second semi-chamber (10") being isolated from said first semi-chamber (10') and connected to said compressed air outlet (3), said first main face (5) comprising at least one first channel (15) and said second main face (6) comprising at least one second channel (16), said first and second channels (15, 16) being non-through channels, alternately arranged, with lateral openings alternately positioned on said lateral face (7); said lateral openings of said channels (15, 16) having a cross-section of substantially square or substantially rectangular shape, the lateral wall (8) of said chamber (10) comprising at least one opening (9) arranged opposite to said lateral face (7) of said rotor (4) and pneumatically connected to said at least one opening (11 ) of said modulator (100).

2. Modulator (100) according to the preceding claim, characterized in that said lateral openings of said channels (15, 16) of said rotor (4) have an area between 60 and 300 mm2.

3. Modulator (100) according to any of the preceding claims, characterized in that the radius of said rotor (4) has a length between 25 and 60 mm.

4. Modulator (100) according to any of the preceding claims, characterized in that said first and second channels (15, 16) have equal dimensions and are positioned at a relative distance from each other greater than the width of said channels (15, 16).

5. Modulator (100) according to any of the preceding claims, characterized in that said air inlet (2) is positioned tangentially to said lateral surface of said rotor (4).

6. Stimulator apparatus (1 ) for stimulating mechanoreceptors of the human or animal body, said apparatus (1 ) comprising:a flow modulator (100) for generating a sequence of pressure pulses according to any of the preceding claims, at least one pressure generator (101 ) comprising suction and discharge; a compression conduit (102) and a suction conduit (103), one end of which is connected respectively to the discharge and suction of said pressure generator (101 ) and the other end respectively to said inlet (2) and said outlet (3) of said modulator (100); at least one transduction chamber (13) for applying said pulses to the epidermis of a user; at least one pneumatic conduit (12), one end of which is connected to said opening (11 ) of said modulator (100) and the other end to said transduction chamber (13).

7. Stimulator apparatus (1 ) according to the preceding claim, characterized by comprising a pressure regulation device (104) in the suction conduit (103).

8. Stimulator apparatus (1 ) according to any of claims 6-7, characterized in that said at least one transduction chamber (13) has a thickness of 10 mm and / or a height between 0.5 mm and 2 cm.

9. Stimulator apparatus (1 ) according to any of claims 6-8, characterized in that said at least one transduction chamber (13) comprises a membrane adapted to prevent fluid leakage.

Images