A MEDICAL APPARATUS FOR MAGNETIC APPLICATIONS

Technical Field

The invention concerns a medical apparatus for magnetic applications on biological tissues, in particular in magnetotherapy.

Background Art The use of magnetotherapy for therapeutic and cosmetic aims has been known for some time.

Briefly, this type of treatment consists in influencing the behaviour of certain types of cell by subjecting them to magnetic fields which induce weak electric currents, especially at the membrane level and to a lesser extent at the cytoplasm level.

These induced currents cause ion exchange across the cell membrane between the intracellular environment and the extracellular environment, increasing the flow of oxygen and restoring the membrane's potential.

In this way, improved oxygenation means the biological activity of the cells can be increased effectively.

In addition to producing this effect, the magnetic fields also exert direct magnetic action, orienting the cells according to the direction of the flow lines of the magnetic field.

This phenomenon favours enzymatic and cytochrome activity, and also favours penetration within the cells of the tissues by any medication which is present.

Thanks the abovementioned properties, magnetotherapy is indicated in all cases where it is useful to stimulate tissue renewal following damage thereto due to circumstances of various kinds. For this reason it is used therapeutically for example for mending bone fractures and treating dermic pathologies, such as skin sores or ulcers of vascular origin, or for reducing disfiguring scars.

In the cosmetics field, magnetotherapy is used in processes for slowing down skin aging, for example, as an anti-wrinkle treatment.

In this context, magnetotherapy is generally applied topically using a special operating head which comprises a suitable generator of magnetic fields, such as for example a simple permanent magnet or an electro-magnet connected to an electric power supply.

During treatment, the operating head is rested on the skin at the tissues to be treated and moved within a circumscribed zone about the point of application.

An operating substance is usually interposed between the operating head and the tissues, which operating substance contains an active principle capable of performing a therapeutic or cosmetic action, according to the type of treatment is being carried out.

The operating substance may take the form of an unguent, a gel or a cream which is spread on the skin at the areas to be treated. A drawback in the known technique is that numerous long therapeutic sessions are required in order to obtain significant results with apparatus of known type: this very often discourages users from using this type of treatment.

The aim of this invention is to obviate the drawbacks in the prior art within the ambit of a simple, rational and inexpensive solution.

Disclosure of Invention

The aim is attained by the invention as it is characterised in the appended claims.

In particular, the invention makes available a medical apparatus which is provided with at least one operating head comprising means for generating a magnetic field, which means are fixed to a rotating shaft at the end of which a contact body is also fixed, designed to be positioned in contact with the skin at the position of the tissues to be treated.

The rotating shaft is rotatably coupled to the operating head and connected to drive means which rotate the shaft about its own axis with alternating oscillatory motion.

Thanks to this solution, during application of the magnetic treatment, the tissues are also subjected to a contemporaneous massaging action by the contact body, which rotates solidly with the rotating shaft.

Further, since the means for generating the magnetostatic field also rotate together with the rotating shaft, the magnetic field generated manifests a movement of rotation relative to the tissues being treated, with the effect of accelerating the enzymes which protect the organism from free radicals, such as superoxide dismutase, a metalloenzyme capable of catalysing the transformation of the superoxide into H2O2. The overall effect thus caused produces a significant improvement in treatment results. In fact, the treatment time for a same result is significantly reduced, while greater penetration of any pharmacological and/or cosmetic operating substances is obtained in the tissues treated.

In a preferred aspect of the invention, the means for generating a magnetic field comprise a permanent magnet, which is fixed to the end of the rotating shaft in an interposed position between the rotating shaft and the contact body.

The contact body is preferably a convex body, the convex surface of which is designed to rest against the skin. The contact body is made from a plastic material, for example Politef, the molecular structure of which comprises a long linear chain saturated with fluorine atoms and solid chemical bonds between carbon atoms and atoms of fluorine.

In a preferred embodiment of the invention, the operating head of the medical apparatus of the invention also comprises means for emitting electromagnetic radiation, typically radiation in the visible light, ultraviolet or infrared range, which means contemporaneously subject tissues to a photocatalysis treatment.

The photocatalysis treatment advantageously makes it possible to increase the efficacy of the active principle contained in operating substances, typically of a medicating type, which can be applied previously to the tissues to be treated.

Like every type of molecule present in nature, every active principle is distinguished by a stable minimum energy state known as its fundamental state, and a succession of unstable excited states, each of which is characterised by a greater quantity of energy Conventionally, the term excited is used to mean the excited lower energy state of a molecule, which is generally the only state that is sufficiently long- lived to manifest perceptible effects.

The effects of any particular molecule in the excited state generally depend on the physical/chemical characteristics of the molecule. However, an active principle's molecules in the excited state are typically considerably more effective.

The function of the electromagnetic radiation emitted during the photocatalysis treatment is to provide the molecules of active principles with the energy necessary to reach their excited state. In particular the abovementioned means for emitting electromagnetic radiation can emit electromagnetic radiation with a predetermined wavelength, which depends on the active principle to be excited. For the electromagnetic radiation to exert its effect, it must in fact possess a quantity of energy equal to the energy difference between the fundamental state and the excited state of the active principle to be excited. This energy difference depends on the specific characteristics of each individual active principle, while the energy of the electromagnetic radiation depends on its wavelength. Preferably, the means for emitting electromagnetic radiation comprise a plurality of photoemitters, for example LEDs, which, when supplied with electricity by a suitable electrical circuit, emit luminous radiation comprising the wavelengths necessary to activate the excited state of the active principles. In a preferred aspect of the invention, the operating head of the medical apparatus is provided with an optical filter comprising a plurality of polarising lenses, which polarise the electromagnetic radiation generated by the

emitting means, before the electromagnetic radiation reaches the tissues to be treated.

For example, the polarising lenses may be Fresnel or di Malus lenses. The advantageous effect of polarisation is that of forcing the light waves generated by a light ray to vibrate in only one direction, perpendicular to the light ray.

Preferably, the polarising filter is associated to actuator means, which make it rotate on the operating head relative to the means for emitting electromagnetic radiation, which instead remain stationary. In this way, the advantage is obtained that medications can be photocatalysed also by birefringence, since the distance between the light source and the medications in contact with the epidermis is such that it is not affected by the direction of the light rays. With rotating polarisation, two refracted rays are obtained, which propagate in different directions: one of these is known as the ordinary ray, since it obeys the normal lays of refraction, while the other is known as the extraordinary ray, because it propagates in a direction which does not lie on the plane of incidence. In a further preferred aspect of the invention, the medical apparatus comprises a control system which monitors an index of the physiopathological condition of the user and on the basis of this index, adjusts the operating parameters of the medical apparatus. These operational parameters consist of at least the speed of rotation of the rotating head which bears the contact body, possibly the speed of rotation of the polarising filter relative to the means for emitting electromagnetic radiation, and the intensity and wavelength of the electromagnetic radiation. If the operating parameters exceed those levels the user's organism can tolerate, the user may perceive a sensation of physical suffering, which generally increases as the treatment continues over time. In particular, the control system comprises at least one sensor device which measures a chronological sequence of values of a physiological parameter of the user, and a logic unit, connected to the sensor, which extracts the desired

index for the physiopathological condition from the chronological sequence of values.

The logic unit is further designed to compare the index obtained with a reference value, possibly stored internally, in such a way as to activate suitable means for adjusting the operating parameters of the apparatus, when the index is outside a predetermined interval around the reference value.

Preferably, the sensor device is chosen such that during treatment it is capable of detecting the time intervals between the user's heart contractions, normally known as RR intervals.

The sensor device can for example comprise a fingertip blood flow monitor destined to be applied to a finger of the user, an impedance meter or a signal receiver connected to a chest-strap heart rate monitor, an ECG, an EEG (electroencephalograph) or an MCG (magnetocardiograph). In this case, the logic unit is preferably designed to extract a "heart beat variability" index, such as for example the standard deviation or the variance of the sequence of RR intervals.

It has been demonstrated that "heart beat variability" is an important indicator of the physiopathological condition of the cardiovascular and nervous systems in a human organism.

In particular, it has been demonstrated that "heart beat variability" is greatly accentuated in a healthy, well-functioning organism: RR intervals are extremely different from one another, while in a diseased or suffering organism, "heart beat variability" is significantly reduced: RR intervals tend to be very similar.

Further, "heart beat variability" diminishes significantly when an organism progresses from a healthy condition to a condition of suffering. Therefore by continuously monitoring this parameter, the control system can adjust the operating parameters of the medical apparatus so as to keep the index within an interval of values which correlate to a healthy condition of the user.

Alternatively, the control system can subject the user to the diagnostic method commonly known as Galvanic Skin Response (GSR).

Galvanic Skin Response is a diagnostic method which establishes a relation between the measurement of the impedance of the user's skin and the user's physiopathological condition.

In this case, the sensor device preferably comprises at least one electrode destined to be in contact with the skin of the user in the zone undergoing treatment.

The electrode measures the intensity of a weak electric current passed through the user's body, so as to extract the skin's impedance value.

Brief description of the Drawings

Further characteristics and advantages of the invention will become clear from the description below which provides a non-limiting example, with the aid of the figures illustrated in the attached tables, in which: figure 1 is a section view of an operating head which the medical apparatus of the invention can be provided with; figure 2 is section M-Il in figure 1 ; figure 3 is a schematic view of a medical apparatus provided with the operating head of figure 1 ; figure 4 is a block diagram of the functional elements of the apparatus of figure 3; figure 5 is a first alternative embodiment of the operating head in figure 1 ; figure 5a is the orthogonal projection of the view of figure 5; figure 6 is a second alternative embodiment of the operating head of figure 1 ; figure 6a is a perpendicular projection of the view of figure 6; figure 7 is a third alternative embodiment of the operating head of figure 1.

Best Mode for Carrying Out the Invention

The operating head 1 , shown in figure 1 , comprises a beaker-shaped external housing 2, the lower mouth of which is closed by a locking ring 20. A rotating shaft 3 is rotatingly coupled internally of the external housing 2, which rotating shaft 3 projects from a central hole afforded in the locking ring

20.

A permanent magnet 4 which generates a magnetostatic field is fixed to the free end of the rotating shaft 3.

The magnetic poles of the permanent magnet 4 are positioned is such a way that the magnetic axis is parallel to the axis A of the rotating shaft 3. In particular, the positive pole and the negative pole are positioned opposite and equidistant from each other relative to a longitudinal plane passing through the axis A of the rotating shaft 3.

In the illustrated example, the permanent magnet 4 is a cylindrical body comprising a blind central hole 40, inside which the end section of the rotating shaft 3 is snugly inserted .

The flat end of the rotating shaft 3 exhibits a threaded hole with which a screw 5 engages, which screw 5 rigidly fastens the permanent magnet 4 to the rotating shaft 3.

As illustrated in figure 2, the body of the permanent magnet 4 is divided into two identical semi-cylindrical portions, of which a first portion 42 and a second portion 43 are specular to each other.

The first portion 42 is a seating for the positive pole of the permanent magnet 4, while the second portion 43 is the seating for the negative pole.

A contact body 6 made of a plastic material, preferably Politef, and destined to be rested on the skin of a user at the position of the tissues to be treated, is fixed to the permanent magnet 4.

The contact body 6 is generally a rounded body provided with a suitable seating in which the permanent magnet 4 is stably fixed.

The contact body 6 is further provided with a convex surface 60 arranged on an opposite portion of the rotating shaft 3 relative to the permanent magnet 4.

The convex surface 60 is the portion of the contact body 6 destined to rest directly on the skin of the user.

In the illustrated example, the convex surface 60 of the contact body 6 is a semi-spherical dome having an apex thereof aligned to the axis A of the rotating shaft 3.

The rotating shaft 3 is connected to activating means 7, situated inside the external housing 2, which rotate the rotating shaft 3 about its own central axis A with an alternating oscillatory motion.

The activating means 7 can comprise, for example, an electric step motor which is commanded to cyclically activate the rotating shaft 3 to rotate in opposite directions.

Alternatively, the activating means 7 can comprise a direct current motor powered by an electrical device which cyclically inverts the supply current. It is known that by inverting the polarity of the electricity supply, an electric motor running on direct current inverts its direction of rotation.

Therefore by cyclically inverting the power supply, a cyclical oscillation of the rotating shaft 3 about its own central axis A is obtained. Otherwise, the activating means 7 can comprise a rotating electromagnet, that is, a device provided with an electric coil and a metallic rotor, which is made to perform a predetermined rotation, thanks to the magnetic field generated when the coil is excited, and is returned to a rest position by a return spring, when the coil is de-excited. As illustrated in figure 3, the above- described operating head 1 is associated to a medical apparatus 9, which comprises a casing 90 on which interface means 91 are positioned, which in the embodiment illustrated comprise a keyboard 92 and a display 93.

A microprocessor 94 is housed inside the casing 90 to manage the functioning of the apparatus 9 (see fig. 4).

In more detail, the microprocessor 94 controls and commands the functioning of the activating means 7 which rotate the rotating shaft 3. A data memory unit 95, in which the setting parameters for the apparatus 9 are stored, based on the treatment to be carried out, is associated to the microprocessor 94. In particular, this data memory unit 95 can alternatively be incorporated into the microprocessor 94, or, as in the illustrated example, can be associated to a second microprocessor 96 positioned on a removable physical support, such as for example a smart card 97. In general terms the data memory unit 95 can be any device capable of storing data and which

can be associated to the microprocessor 94 in such a way as to make the stored data available to the microprocessor.

The apparatus 9 is provided with a reader 98 for the smart card 97, in the data memory unit 95 of which are stored the user's essential data, the number of treatments to which he/she is to be subjected, and the width and speed of oscillation of the rotating shaft 3.

The medical apparatus 9 is also provided with a control system 10 which adjusts the speed of rotation of the rotating shaft 3 during use, to prevent any harmful side-effects for the user. The control system 10 comprises a sensor device 100 which, over a predetermined time interval, measures a sequence of RR intervals of the heart of the user undergoing the treatment.

Preferably, the sensor device 100 is a fingertip blood flow monitor which can be applied to a finger of the user; however, it could alternatively be an impedance meter or a receiver of signals from a chest-strap heart rate monitor, or from an ECG, an EEG or an MCG.

The sensor device 100 is connected to a processor 101 , which is programmed to process the sequence of RR intervals detected and extract a predictive index of the physiopathological condition of the user's cardiovascular system.

Preferably the predictive index is relative to the physiopathological condition of the cardiovascular system and is measured by the standard deviation or the variance of the RR intervals. A memory unit 102 in which the data processed by the processor 101 are stored is also connected to the processor 101 , so that the processor 101 can use the data again for subsequent processing.

The processor 101 is associated to the microprocessor 94 which controls the activating means 7 of the shaft 3. In particular, the processor 101 can alternatively be incorporated in the microprocessor 94, or, as in the example illustrated, can be connected to it by electronic interface means.

As an alternative or an addition to the control system 10, the apparatus 9 can also comprise a simple manual selector 11 which the user can activate manually to adjust the speed of rotation of the shaft 3 as desired.

The manual selector 11 can be connected to the microprocessor 94 which controls the operation of the device 9; or it can be directly connected to the activating means 7 of the rotating shaft 3.

If for example the activating means 7 comprise a direct-current electric motor, the manual selector 11 can belong to an electrical device which varies the voltage powering the motor. To operate the medical apparatus 9 the user must insert the suitably programmed smart card 97 into the reader 98. Upon insertion of the smart card 97, the microprocessor 94 reads the user's data and all the setting and operating parameters of the device 9.

In this way, the treatment can advantageously be performed without any need for a professional operator in attendance, since once the smart card has been programmed, the user need only insert it into the reader 98.

Based on the patient's characteristic parameters, the processor 15 activates the activating means 7, so as to make the rotating shaft 3 rotate with oscillatory motion about the axis A, at the speed and for the time predetermined for the treatment to be performed.

Typically the rotation speed is approximately 10 revolutions per second.

The contact body 6 is rested on the user's skin at the tissues to be treated, which tissues are therefore also subjected to the magnetostatic field generated by the permanent magnet 4. In this way, the rubbing of the contact body 6 against the skin massages the tissues, improving and intensifying the effect of the magnetic treatment produced by the magnetostatic field which, rotating in its turn, produces the

Hall effect.

During this treatment, the control system 10 systematically repeats the succession of stages described below, based on a regular time pattern.

The sensor device detects a sequence of RR intervals of the user's heart.

This sequence of RR intervals is made available to the processor 101 , which calculates the standard deviation as a predictive index of the physiopathological condition of the user's cardiovascular apparatus, thus obtaining a stress index. Then the processor 101 compares the standard deviation with a reference value indicative of a normal physiological condition, and stores the standard deviation value in the memory unit 102.

If comparison reveals that the standard deviation is outside a predetermined interval around the reference value, the processor 101 commands the microprocessor 94 to vary the speed of rotation of the shaft 3 in order to bring the standard deviation value back within the predetermined interval. Consequently the microprocessor 94 adjusts the speed by acting on the activating means 7 via special adjustment organs (non shown), for example through a supply voltage regulator. In particular, the abovementioned standard deviation reference value can be stored for each user in the data memory unit 95 of the smart card 97. Alternatively, the reference value can be calculated by the processor 101 during treatment, for example using the mean of the standard deviation values obtained and stored each time in the memory unit 102. Obviously the user can also adjust the speed of rotation of the rotating shaft 3 as he/she pleases, by manually adjusting the manual selector 11. In the embodiment in figure 5, the operating head 1 comprises means 12 for emitting electromagnetic radiation towards the contact body 6, in such a way that the radiation strikes the user's skin at the tissues undergoing treatment. The wavelength of the electromagnetic radiation emitted can vary between 100 nm and 15,000 nm, that is, between the wavelengths of ultraviolet and infrared radiation, and including visible light.

In this way, the operating head 1 is also capable of performing an effective photocatalysis treatment, which is generally used to increase the effectiveness of the typically medical operating substances which may have been applied previously to the skin.

In the example illustrated, the means 12 for emitting comprise a plurality of

LEDs 120 connected to the same power supply printed circuit board 121 , which is fixed to the external housing 2 of the head 1 , at the lower mouth from which the rotating head 3 projects. In particular, the LEDs 120 are arranged on the printed circuit board 121 so as to be aligned along a circumference which is coaxial with the rotating shaft

3, substantially forming a ring which surrounds it (see fig. 5a).

Further, the LEDs 120 are screened by an optical filter 122, arranged in front of the LEDs 120 and associated to the external housing 2 in such a way as to occlude the lower mouth.

In particular, the optical filter 122 is fixed to the external housing 2 by means of a pair of threaded locking rings which keep it in a fixed position in relation to the LEDs 120.

The optical filter 122 comprises a plurality of polarising lenses which polarise the electromagnetic radiation emitted by the LEDs 120 before the radiation reaches the tissues to be treated.

The polarising lenses are preferably Fresnel or di Malus lenses.

In this way, all the polarised electromagnetic radiation vibrates in the same direction, perpendicular to the direction of propagation thereof. In the present case, the microprocessor 94 of the apparatus 9 is designed to control and command both the operation of the activating means 7 of the rotating shaft 3, and the operation of the means 12 for emitting electromagnetic radiation.

In this way, depending on the treatment to which the user has to be subjected, the microprocessor 94 activates in succession and/or alternatively the rotating shaft 3 and the means 12 for emitting electromagnetic radiation, for the time necessary according to the treatment.

As in the previous case, the user's data, the type of treatment he/she has to undergo, and the operating parameters of the apparatus 9 are stored on the smart card 97, which is read by the microprocessor 94 when inserted into the reader 98.

In particular, not only the speed to be imposed on the rotating shaft 3, but also the wavelength and the intensity of the electromagnetic radiation to be emitted, based on the operating substance used in the treatment, are stored on the smart card 97. During the treatment, regulation of the operation of the apparatus 9 is delegated to the control system 10 which, in this case, is designed to maintain the index of the physiopathological condition of the user within tolerable limits, by varying both the speed of rotation of the shaft 3 and the characteristic operating parameters of the means 12 for emitting electromagnetic radiation, for example, amplitude and wavelength, and intensity and time of exposure to the electromagnetic radiation. In the embodiment in figure 6, the optical filter 122 of the operating head 1 is connected to actuator means which rotate the optical filter 122 about the central axis A of the rotating shaft 3, thus moving the filter in relation to the LEDs 120, which remain stationary.

In the example illustrated, the actuator means comprise the rotating shaft 3. In fact, the optical filter 122 is keyed directly to the rotating shaft 3, in such a way as to be activated by the activating means 7 to perform a cyclical oscillation about the axis A in perfect synchrony with the rotating shaft 3 to which it is solidly constrained.

The rotation of the optical filter 122 allows two refracted rays to be obtained which propagate in different directions: one known as the ordinary ray, because it follows the normal laws of refraction, the other called the extraordinary ray because it propagates in a direction which does not lie on the plane of incidence.

This birefringence phenomenon favours photocatalysis of the operating substances that may have been previously applied to the skin, since the distance between the operating substances and the skin is such that it is not influenced by the direction of the light rays. To obtain this effect it is preferable for the speed of rotation of the optical filter 122 to be varied according to the operating substance used.

In the present case, this parameter is stored on the smart card 97 together with the treatment to be administered to the user, so that the microprocessor 94 of the apparatus 9 can appropriately adjust the speed of rotation of the shaft 3. As described above, the optical filter 122 of the illustrated example is fixed to the rotating shaft 3 and is therefore constrained to move at the same speed as the rotating shaft 3.

The optical filter 122 can however be associated to actuator means which make it rotate independently of, and at a different speed to, the rotating shaft 3.

In the preferred embodiment shown in figure 6a, the optical filter 122 has a transparent window 123 without polarising lenses, which faces a part of the LEDs 120 which emit electromagnetic radiation. In this way, the electromagnetic radiation passing through this transparent window 123 reaches the user's skin without being polarised.

Since the transparent window 123 moves during the rotation of the optical filter 122, the non-polarised radiation cyclically strikes different zones of the skin, thus providing the different skin zones with an adequate time interval for cellular rest. In the embodiment shown in figure 7, a sensor device 103 which replaces the sensor device 100 described for the embodiment in figure 4, is integrated in the operating head 1.

The sensor device 103 comprises a sphere 104 of electrically conductive material, for example silver, which is stably housed within the contact body 6. The sphere 104 partially projects from the convex surface 60 in such a way that it is in contact with the user's skin during use of the operating head 1. The sphere 104 is electrically connected to the processor 101 of the control system 10 via a first conducting cable 105 which electrically connects it to the rotating shaft 3, and a second conducting cable 106 which connects the rotating shaft 3 to the processor 101.

In this case, the processor 101 is designed to measure, via the sphere 104 which acts as an electrode, the intensity of a weak electric current which runs

through the user's body, in such a way as to obtain the second-by-second electrical impedance of the skin of the user during the treatment. Using a Galvanic Skin Response (GSR) method, the processor 101 then converts this electrical impedance value into an index of the physiopathological condition of the user.

This index is compared with a reference value stored in the memory unit 102, in order to adjust the treatment parameters, for example the speed of rotation of the shaft 3, the speed of the optical filter 122 and the electromagnetic radiation emissions, via the microprocessor 94, in such a way as to maintain the user's healthy condition.

It should be noted that in the example illustrated in figure 7, the control system which performs the Galvanic Skin Response (GSR) method is applied to an operating head 1 like the one illustrated in figure 6; it can however be applied to any previously-described operating head 1.