BODY

DESCRIPTION

The present invention relates to a device for performing electrostimulation and photobiostimulation on tissue parts of the human body, in particular though not exclusively on the inner wall of the vagina.

As is known, many women experience physical changes in their privates, particularly 0 after a natural birth or close to the time of life when menopause arrives, in addition to the onset of a wide range of ailments including, in particular, stress urinary incontinence.

These physical changes include various diseases among which, for example, vaginal laxity and vulvovaginal atrophy, which adversely affect a woman's sexual health5 leading to a reduction of the physical sensitivity, resulting in decreased sexual satisfaction during intercourse.

In order to correct vaginal laxity, it is known to resort to conventional Kegel exercises which tend to strengthen the pelvic floor muscles, but these are not always effective, or resort is made to surgery which, as known, involves significant costs0 and risks and recovery time.

Alternatively to the treatments mentioned above, treatments have also been proposed which are based on the electrostimulation of the affected muscles by applying electrical impulses through electrodes. Such known electrostimulation treatments take on different names depending on how they are performed and on the waveforms generated, such as EMS (Electro Muscle Stimulation), TENS (Transcutaneous Electrical Nerve Stimulation), MENS (Microcurrent Electrical Neuromuscular Stimulater) and VT (Transdermal Delivery). All of the above treatments need to be carried out with special equipment, handled by specialists and normally in a hospital or clinic.

In addition to electrostimulation-based treatments, also those based on photobiostimulation have been proposed in. which light energy is used to produce a photobiological effect on cells, in particular activating the respiratory chain thereof, with consequent increase in the synthesis of ATP (adenosine-triphosphate) responsible, as is known, for repairing damage to tissues.

Also said photobiostimulation treatments normally performed with equipment that generates light energy with wavelengths of between 500 nm and 1000 nm need be carried out in a hospital or clinic by specialist doctors.

It was found in the practice that the need to resort to hospitals or clinics to receive the above electrostimulation and/or photobiostimulation treatments discourages many women to carry them out, thus renouncing to improve their health.

The object of the present invention therefore is to provide patients suffering from the vaginal and urinary disorders listed above with a device that allows them to personally carry out both the electrostimulation treatment, in one of its possible types, and the photobiostimulation treatment, as well as both treatments simultaneously, in maximum privacy, even in their own homes.

These and other objects that will become apparent from the following description are achieved by the device characterized according to claim 1 below. The invention will now be better described with reference to a preferred embodiment thereof given by way of a non-limiting example and shown in the accompanying drawings, in which:

- figure 1 shows a schematic perspective view of the device as it appears for use; - figure 2 shows a schematic perspective exploded view of the detail in figure 1 ;

- figure 3 shows a block diagram of the functionality of the device of the preceding figures.

With reference to Figure 1, reference numeral 1 globally indicates the device of the invention.

In its preferred embodiment, it is a hollow substantially cylindrical body having an outer diameter of between 30 and 35 mm and a longitudinal extension between ends 2 and 3 of between 60 and 80 mm, made of biocompatible materials such as silicon and steel AISI316, as better specified hereinafter.

With reference to figure 2, body 1 includes a first end annular element 4 which, with the transversal wall 2, forms cavity 5, and a second end annular element 6 which, with the transversal wall 3, forms cavity 7.

Between the pair of end elements 4 and 6, the cylindrical body 1 includes a plurality of intermediate annular elements adapted to emit electrostimulation signals which, in the embodiment in figure 2, consist of rings 8, 9 and 10, made of steel AISI316 or the like, provided they are biocompatible, having a diameter substantially corresponding to that of body 1 and limited axial extension.

Intermediate annular elements are arranged between the above rings which area adapted to emit photobiostimulation light energy which, in the embodiment shown in figure 2, consist of rings 11 and 12, which are also made of biocompatible material with glazed outer surface that allows the passage of wavelengths of between 500nm and lOOOnm.

Light energy emitters are inserted in the component material of said rings 11 and 12. Said rings have each an outer diameter substantially corresponding to that of body 1 and an axial extension substantially equal to ¼ of the overall axial extension of body 1.

Said intermediate annular elements 8, 9, 10, 11 and 12 and the end elements 4 and 6 are axially joined together by conventional means that give mechanical stability to the cylindrical body 1, forming a longitudinal stacking and a watertight inner chamber 13, through conventional means and materials.

Advantageously, the axial connection of the annular elements 8, 9, 10, 11 and 12 with each other and with the end elements 4 and 5 may be made by ultrasonic welding.

A support 14 is accommodated in said inner chamber 13, comprising an electronic control unit CPU for the command and control of the device whose power is via a conventional battery, not shown, or accumulator, which is also not shown, which is accommodated on the same support 14, the latter rechargeable through conventional means, such as wireless technology, which are accommodated into cavity 7 of the end element 6.

Alternatively, the power supply of the device can be made via cable as better specified hereinafter.

Switching on and off of the device may be carried out by a manual button switch schematically indicated with reference numeral 15 on the end portion 4 or by wireless commands given remotely, as will be appreciated from the following description.

In order to carry out the treatments, device 1 is placed by the patient in the vagina and at the end of the treatment, it is manually removed by exerting traction on a rod indicated with reference numeral 16 in figures 1 and 2, fixed to the end wall 2 of the device. Rod 16, preferably made of silicone, can be rigid or, alternatively, flexible in the form of a cord.

In a further alternative, the cord may be in the form of a cable also usable for remote transmission of the electric commands to the device or also to power the device itself from the outside without having to accommodate batteries or accumulators, as well as the CPU itself and the electrical pulse generator inside the device in cavity 13. With reference to figure 3, showing the operation of the device in blocks, reference numeral 17 schematically shows the rechargeable battery or accumulator for the power supply of CPU 18 for the control and operation of the device.

The recharge may be made with a wireless system, schematized with reference numeral 19 in Fig. 3, which may also optionally comprise a special base, not shown, in which the sterilization of the device may be carried out.

Reference numeral 20 schematically shows the electrical pulse generator which, conventionally, depending on the type of electrostimulation to be used in the device, EMS (Electro Muscle Stimulation), TENS (Transcutaneous Electrical Nerve Stimulation), MENS (Microcurrent Electrical Neuromuscular Stimulater) or VT (Transdermal Delivery) are sent to the conductinive rings 8, 9 and 10.

Preferably, but not exclusively, in the device according to the invention, microcurrents are used for the electrostimulation having a rectangular, biphasic, symmetric, compensated waveform with intensity ranging between 10 and 500 μΑ, belonging to the technology referred to as MENS, which are believed to be effective, without being invasive, for stimulating the formation of connective tissue with collagen and elastic fibers.

CPU 18 itself also controls emitters 11A and 12A associated with the annular elements 11 and 12 for the photobio stimulation signals in the form of light energy with wavelength of between 500 and 1000 nm.

According to the invention, through a special programming of CPU 18, the device according to the invention may be actuated to emit electrostimulation impulses only, through rings 8, 9, 10, or photobiostimulation impulses only, through the emitters of rings 11 and 12, at the patient's choice and depending on the condition to be treated. In the case of electrostimulation impulses, due to the presence of three annular elements 8, 9 and 10, this may also be carried out through dynamic radio frequency technology as described in EP 2.329.784.

Alternatively, using a different program present in CPU 18, the electrostimulation may be performed simultaneously with the photobiostimulation, developing a particular effectiveness thanks to the synergy of the combination of the two treatments.

The choice of the functional and operational program may be carried out by the user, for example by setting in device 1 a suitable Bluetooth interface, indicated with reference numeral 21 in figure 3, adapted to make CPU 18 and the programs therefore communicate, in a conventional manner, with a corresponding application which may be set on a conventional mobile phone, such as a smartphone, tablet or any other device provided with BT interface. The device may be subjected to further variations other than those specifically described without departing from the scope of the invention as claimed hereinafter.