Patent Application
20230263701
The present invention relates the field of aesthetic, sports and rehabilitation medicine, in particular it describes a device capable of recognizing and treating, through compressive micro-vibration, certain pathologies such as cellulite, tissue recompaction, lymphatic and venous stasis, edematosis, muscle and scar contractures, shoulder-neck syndrome and pubalgia. Other fields of application of this device are the treatments aimed at athletes before and after surgery, sports massage, lymphatic drainage and the treatment of pains of different origin.
The so-called cellulite, also called “gynoid lipodystrophy”, “edematous fibrous panniculopathy”, “edematous adiposis”, “edematous-fibro-sclerotic panniculopathy”, “dermopanniculosis deformans”, “status protrusus cutis”, and “liposclerosis”, is a topographical manifestation of the skin associated with depressions or introflexions, frequent in the pelvic and abdominal area, in the hips, buttocks and thighs. It can also occur associated with nodules in the subcutaneous adipose tissue and, in more rare cases, with a suspected inflammatory state.
The great confusion about the name to be given to cellulite reflects the difficulty of correctly understanding the nature of the phenomenon. Despite the great interest in treating this condition and the huge market for topical treatments aimed at improving its appearance, cellulite is still an enigmatic condition for medical researchers.
The high incidence (80-90/o) in the female population that presents the imperfections due to cellulite in the post-pubertal age, in addition to the fact that it occurs without symptoms, make it considered a normal physiological condition. It can instead be considered within a pathological scenario noting that it is a normal condition for many, but not all, women, and that in its most severe forms it manifests itself with painful nodules on palpation that make assume inflammatory processes, it is also generally associated with an excessive accumulation of subcutaneous adipose tissue whose relationship with cardiovascular risk is unclear.
Dozens of different causes have been hypothesized such as: metabolic disorders, nutritional disorders, specific subcutaneous architectures, changes in the structure of the connective tissue, hormonal factors, genetic factors, disorders of the microcirculatory system, changes in the lymphatic system, changes in the extracellular matrix, inflammations.
The classifications of cellulite are as follows:
Several measures can help prevent cellulite. Some attention to nutrition, constant physical activity, the use of comfortable and not too tight clothes, shoes with not excessively high heels and changes in posture are the easiest remedies to implement to prevent this annoying disturbance.
In the huge market for treatments to reduce cellulite, there is a range from topical products to liposuction, although many of these treatments lack evidence of efficacy. The most common are listed:
As can be seen from the list above, which is not exhaustive, the market is saturated with treatments, among which some are present without certain results. The ineffectiveness is often due to the fact that, as explained above, the cause of cellulite and the conditions it entails is uncertain.
There are also several patents which claim treatments for the treatment of cellulite such as US 2002147467 which provides first an exfoliating treatment to maximize the absorption of the substances applied on the skin, then the administration of mechanical vibrations associated with electrical pulsations in the affected area.
EP 1844750, on the other hand, claims an instrument for aesthetic treatments, therefore not of a medical nature, which reduces cellulite through ultrasound vibrations with a frequency between 25 kHz and 50 kHz.
GB 2303552 describes a medical apparatus capable of reducing cellulite through ultrasound at a frequency of approximately 3.3 MHz which reaches a depth of 1.27-2.54 cm from the surface of the skin without overheating the part.
The patent, extended worldwide, WO2007122656, owned by Fenix Sri, a market leader in the sector of anti-cellulite and anti-blemish therapies and skin disorders in general, claims a computer-controlled vibratory device, used to treat parts of the body, whose primary feature is to apply massages by inducing mechanical oscillations by means of a plurality of massage elements which are rotatably mounted around their axis in a roller driven by an electric motor. The rotation of the roller around its shaft is controlled by the operator through an electronic control unit, selecting a program suitable for the treatment to be performed. The device described in this patent performs a massage based on the resistance opposed by the muscles located under the fat layer.
The purpose of the present invention is to propose a device and a method of personalized compressive micro-vibration on the conditions suffered by each patient which performs four actions in a synergistic way acting on the vascular system at the level of the microcirculation, on the lymphatic system, on tissue recompaction and on the analgesic effect, also resulting in a muscular effect. The operation of this device relies on a sensor capable of detecting the type of disturbance and a dedicated software that determines the best therapy to follow on a case-by-case basis.
According to the present invention, a device is provided and a method of use thereof is described for the diagnosis and non-invasive treatment of blemishes and skin disorders according to personalized methods for each patient.
The device comprises a transportable console provided with at least a pair of recesses, possibly heated by a resistance inside the recess which, operating with infrared light, also has a bactericidal function, which are configured to each house a corresponding handpiece.
The handpieces are the tool through which an operator performs treatment on a patient's skin tissues.
Advantageously, the presence of at least one larger handpiece, larger in size, suitable for carrying out the treatment on the body is provided, while the smaller handpiece, smaller in size, is specifically configured for the treatment of the face or other anatomical parts with an articulated conformation.
Each handpiece comprises a rotating cylinder on whose external surface a plurality of rotating elements independent of each other are movably connected.
In some preferred embodiments, the rotating elements of the larger handpiece are spheres, ovoids or cylinders, arranged as a honeycomb, made of gel with a hardness between 5 shore and 100 shore, preferably 35 shore. The rotating elements of the smaller handpiece, on the other hand, are spheres, ovoids or cylinders, arranged in a “V” shape, made of hypoallergenic silicone with a surface treatment suitable for obtaining a predetermined surface roughness. The roughness has the purpose of obtaining a peeling and stretching effect on the patient's skin.
The preferred embodiment of the smaller handpiece, i.e. the one dedicated to facial treatments, provides that the rotating elements of the cylinder are arranged so as to impart a converging or diverging force with respect to the center line of the cylinder itself which constitutes the neutral point. Right at this point, advantageously, a ring nut is provided which, rotating around the longitudinal axis of said cylinder, is adapted to modify the angle of incidence of said rotating elements, or to cause them to compress or dilate the patient's skin. This feature has evident wrinkle smoothing effects, with efficacy comparable to injections of hyaluronic acid or botulinum, but obtaining the same advantageous result without infiltrations, injections or other invasive interventions.
The rotating elements of the larger handpiece, on the other hand, in an even more advantageous embodiment, have an external surface provided with a plurality of recesses in the shape of a spherical cap able to create a suction effect when pressed onto the patient's skin. In other words, they have a “golf ball” geometry. When the recesses are pressed against the patient's skin, they adhere to it thanks to the sucker effect due precisely to the geometry of the rotating elements. When the cylinder, by rotating, causes the recesses attached sucker-like to the patient's skin to detach, a sucking of the tissues is generated which has beneficial effects on the treatment of the blemishes associated with the conditions that cause cellulite. Advantageously, the treatment is performed thanks to the simultaneity of rotation, vibration and the pressure that the operator imparts perpendicularly on the patient's tissues, compressing them.
The pressure is regulated by the experience of the operator, or, in a more equipped version of the present invention, by an indicator light placed on the handle of the handpieces on the side in view of the operator when in action. Said light signaler consists of a plurality of LED lights adapted to be progressively turned on with the increase of the pressure exerted by the operator on the body of the patient and vice versa.
The rotation and vibration frequency is regulated by the operator through the communication interface, preferably integrated in the console and possibly also replicated on the back of the handpieces, which acts on a rotation and vibration adjustment device integrated in each handpiece.
Optionally, it will be possible to independently adjust the rotation frequency and the vibration frequency of the handpiece cylinders.
The method of using the device involves the following steps:
Even more advantageous embodiments of the handpieces provide for the provision on them of at least one of the following accessories:
The advantages of the present invention are clear in the light of the foregoing description and will be even more so thanks to the accompanying figures and to the description of the preferred embodiment.
The invention will hereinafter be described in at least one preferred embodiment thereof by way of non-limiting example with the aid of the accompanying figures, in which:
With reference to
It is provided with a console 1 provided with wheels and handles for easy transport and with electrical connection means for powering the integrated components. At the top, said console 1 is provided with a pair of recesses 1.1-1.2 of which one suitable for housing a larger handpiece 3 and a smaller one suitable for housing a smaller handpiece 4.
The difference in size between the handpieces 3-4 is due to several factors, but mainly to the fact that the larger handpiece 3 is specifically designed to perform treatments on larger areas of the patient's body, while the smaller handpiece 4 is suitable for being applied on the face or on other anatomical parts with an articulated conformation.
Both said handpieces 3-4 contain a relative cylinder 3.7-4.7 which rotates and turns, at predetermined frequencies. On the external surface of each cylinder 3.7-4.7, independent rotating spheres 3.64.6 are movably engaged.
Another difference between the handpieces 3-4 is represented by the type of said spheres 3.6-4.6. Both types of spheres have a hardness between 5 shore and 100 shore, preferably 35 shore, but, while the spheres 3.6 of the larger handpiece 3 are made of gel and are arranged as a honeycomb, the spheres 4.6 of the smaller handpiece 4 are made of silicone, they are arranged in a “V” shape and have a surface finish that makes them rough so as to perform a peeling and stretching of the patient's face skin.
Finally, the smaller handpiece 4 is characterized in that the spheres 4.6 which are located in the upper portion of the cylinder 4.7 rotate in the opposite direction to the spheres 4.6 located in the lower portion of the cylinder 4.7. This means that, with respect to a neutral point, towards which the thrust of the spheres 4.6 converges or from which it diverges, a relaxing or recompacting effect of the skin tissue is obtained. Just at this neutral point there is a ring nut 4.7.1 which, if rotated by the operator acting on the handpiece 4, changes the rotation angle of the spheres 4.6, thus obtaining the converging or diverging effect.
The operation of the device object of the present invention is semi-automatic in that it makes use of advanced software capable of setting the treatment parameters in real time, following any change in the mechanical features of the skin tissue undergoing treatment.
This is made possible by the fact that each handpiece 3-4 is provided with an electrical energy absorption sensor 3.1-4.1, possibly combined with pressure and/or rpm sensors, which detects the amount of electrical energy absorbed by the relative handpiece 3-4 to obtain the desired rotation and vibration frequency. This absorption varies according to the mechanical resistance of the patient's skin tissue. Said sensors 3.1-4.1 send the detected data to a control unit 5 programmed with the aforementioned software which processes them and verifies that the resistance the desired rotation and vibration frequency is not excessive or too mild for the mechanical resistance of the tissue on which said handpiece 3-4 acts.
To regulate in real time the frequency of this rotation and of this vibration, the control unit 5 acts on a device for adjusting the rotation and vibration 3.2-4.2 integrated in each of said handpieces 3-4.
Let's assume now that we need to perform a relaxing treatment on the back of a patient, let's put a sportsman, suffering from muscle contractures.
The operator first performs a parameter setting step, selecting a frequency range of rotations and vibrations (always between a minimum of 20 Hz, preferably 40 Hz and a maximum of 700 Hz, preferably 355 Hz). The range is set through a specific communication interface 2, integrated in said console 1. The operator, based on his/her experience, selects the frequency according to age, musculature and the condition suffered. In the example in question this will be quite high.
At this point, a second test step follows in which, by grasping the larger handpiece 3 and placing its cylinder 3.7 in contact with a point on the patient's back, the electrical energy absorption sensor 3.1, possibly combined with pressure and/or rpm sensors, of the larger handpiece 3 sends the detected data to the control unit 5. From the latter, by comparing the electricity absorption data and the rotation and vibration frequency data set by the operator, the control unit communicates, via the communication interface, the correctness or otherwise of the frequency range of the rotations and vibrations set by the operator.
Treatment can now be administered in the third step of the treatment method. In this step, the operator runs across the patient's back with the larger handpiece 3, applying a predetermined pressure perpendicular to the patient's skin tissue. The applied pressure force is communicated to the operator by a light signaler 3.4 constituted by a plurality of LED lights adapted to be progressively turned on with the increase of the pressure exerted by the operator on the body of the patient and vice versa.
During this third step of administration of the therapy, if the electric energy absorption sensor 3.1 should detect an area of greater mechanical strength typically due to a muscle contracture, the control unit 5 that processes the data sent by said electric energy absorption sensor 3.1, sends a command to increase the frequency of rotations and vibrations to the device 3.2 for adjusting the frequency of the larger handpiece 3, until a lower mechanical resistance is detected.
The therapy causes the vascularization of the tissues and therefore the raising of their temperature and the consequent redness. Thanks to the visual analysis of the patient's back, the operator can check the homogeneity of the therapy on the whole part to be treated.
At the end of the treatment, thanks to a quick release mechanism 3.9 located laterally to the handle 50 of the handpiece 3, the cylinder 3.7 inside the handpiece 3 can be disconnected so as to be able to extract the cylinder 3.7 and sanitize it in all its parts, spheres 3.6 included.
Finally, it is clear that modifications, additions or variants may be made to the invention described thus far which are obvious to a man skilled in the art, without departing from the scope of protection that is provided by the appended claims.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/IB2020/056521 | 7/10/2020 | WO |
