Device for peri- and / or intra-auricular therapeutic treatment

Abstract

Device for the therapeutic treatment of the ear, comprising a support (1; 2; 3; 4; 5) intended to be positioned on the mastoid (11), and / or on the pinna (12), and / or in the concha (13), and / or in the ear canal (14) of the ear (10) to be treated, a mixture of at least two nanostructures (100, 110; 200, 210; 300, 310; 400, 410; 500, 510) being positioned (101, 201; 302, 402; 303, 403; 204, 304; 305, 405, 505, 605) on said support.

Description

[0001] Device for peri- and / or intra-auricular therapeutic treatment

[0002] The present invention relates to devices for the therapeutic treatment of the ear, and in particular to a device for peri- and / or intra- auricular therapeutic treatment.

[0003] Devices for therapeutic treatment of the ear may include systems for improving hearing, either through sound amplification or through sensory stimulation of senses other than hearing, such as touch, or may relate to systems that allow cleaning of the ear, or may include devices suitable for protecting the ear from excessive noise or from the external environment.

[0004] Among the various systems, those that allow the treatment of balance problems related to the function of the vestibular reflex are particularly interesting; methods for vestibular stimulation using low- intensity electrical currents or means for infusing localized heat are known.

[0005] Document WO2021084424, filed by one of the applicants of this application, describes therapeutic devices comprising a laminar support element and at least two quantum dots, i.e. , two nanostructures, chosen from: graphene, blue-luminescent graphene, cyan-luminescent graphene, aqua-green-luminescent graphene, Perovskite coated with oleic acid and oleylamine, CdTe carboxylate, CdS / ZnS functionalized with oleic acid, where said support element is transparent to the reference electromagnetic radiation, in addition to that emitted by the human body, one side of the device being suitable for contact with the patient's epidermis, and with a mixture of at least two of the above quantum dots positioned on the opposite side with a concentration between 1.0 mg / cm2and 100.0 mg / cm2, capable of emitting photons at the reference wavelength, and with an intensity between 0.1 mW / cm2and 0.5 mW / cm2, and preferably between 0.2 mW / cm2and 0.4 mW / cm2, and in which said reference wavelength is between 280 and 740 nm, and preferably between 350 and 530 nm, when stimulated by at least one infrared, visible, or ultraviolet electromagnetic radiation.

[0006] Document US2022161053A1 describes devices and methods for photobiomodulation therapy (PBMT) intended for the diagnosis, prevention, and treatment of various conditions, including neurosensory hearing loss (SNHL) and tinnitus, through the controlled emission of therapeutic light onto specific areas of the body (e.g., ear, oral mucosa). The system includes wearable devices (e.g., earphones or headsets) equipped with light sources (LEDs or lasers), positioning and proximity sensors, and a control system that regulates parameters such as wavelength, intensity, and exposure time. The document therefore describes a therapeutic effect but through an active system, which involves the use of radiation that interacts with a modifying element.

[0007] Document US2010179469A1 describes a phototherapy device that uses OLEDs (organic light-emitting diodes) as a light source. This device is designed to treat a wide range of light-sensitive diseases and disorders, such as neonatal jaundice, acne, psoriasis, etc. The device can be inserted into an ear to inhibit bacterial or fungal growth. This document also describes a therapeutic effect using an active system.

[0008] Devices for therapeutic treatment using an active system necessarily require active components such as light sources (LEDs or lasers), electronic sensors, and control units, which involve continuous energy consumption, the need for power supply, construction complexity, and high production and maintenance costs. This approach limits the portability, autonomy, and usability of the device, especially in home settings or in the absence of supporting infrastructure.

[0009] There is therefore an unmet technical need for a passive therapeutic system, without power supply or active components, capable of using ambient light or the body's natural electromagnetic emission to generate, through appropriate structures, effective therapeutic radiation. The research that led to the development of the present invention hypothesized, based on the proven and multiple capabilities of the nanostructures described above, the possibility of creating a device for the therapeutic treatment of the earthat is capable, in a substantially non- invasive manner, of stimulating the auditory system, and in particular the vestibular reflex, so as to improve the balance of patients who, for various reasons, have deficits in this area.

[0010] The object of the present invention is therefore a passive device for the therapeutic treatment of the ear, comprising a support intended to be positioned on the mastoid, and / or on the pinna, and / or in the concha, and / or in the ear canal of the ear to be treated, a mixture of at least two photoluminescent nanostructures being positioned on said support.

[0011] In one embodiment, the device does not include any active light source.

[0012] In one embodiment, said mixture of at least two photoluminescent nanostructures is arranged on a transparent element made of flexible material, applied in a suitable position on the support.

[0013] In another embodiment, the photoluminescent nanostructures are directly integrated into the structure of the support.

[0014] In a different embodiment, the support of the device is a protective noise-reducing cap, intended to be positioned between the concha and the entrance to the ear canal.

[0015] In another embodiment, the support of the device of the invention is a retroauricular hearing aid that hooks into the area between the ear flap and the mastoid, with a curved element that has an organ at one end for positioning in the concha and at the beginning of the ear canal.

[0016] In a further variant, the device may be of the type inserted at the entrance to the ear canal, or of the type completely inserted inside the ear canal. Further advantages and features of the device according to the present invention will be apparent from the following description of some embodiments thereof, given by way of non-limiting examples, with reference to the accompanying drawings, in which:

[0017] Figure 1 A is a perspective view of a first embodiment of the device of the invention, suitably positioned on an ear;

[0018] Figure 1 B is a front elevation view of an alternative embodiment of the device of Figure 1A;

[0019] Figure 2A is a perspective view of a second embodiment of the device of the invention, suitably positioned on an ear;

[0020] Figure 2B is a front elevation view of an alternative embodiment of the device of Figure 2A;

[0021] Figure 3A is a perspective view of a third embodiment of the device of the invention, suitably positioned on an ear;

[0022] Figure 3B is a front elevation view of a different embodiment of the device of Figure 3A;

[0023] Figure 4A is a perspective view of a fourth embodiment of the device of the invention, suitably positioned on an ear;

[0024] Figure 4B is a front elevation view of an embodiment of the device of Figure 4A;

[0025] Figure 5A is a perspective view of a fifth embodiment of the device of the invention, suitably positioned on an ear;

[0026] Figure 5B is a front elevation view of an embodiment of the device of Figure 5A.

[0027] Figure 1 A illustrates a first embodiment of the invention; the ear 10 has the mastoid process, commonly referred to as the mastoid 11 , the pinna 12, the concha 13, and the ear canal 14. The noise-reducing plug 1 is positioned at the entrance to the ear canal 14, on which the transparent element 101 made of flexible material is positioned, on which the mixture of at least two photoluminescent nanostructures is arranged. In the variant shown in Figure 1 B, the noise-reducing plug has a portion 201 of its structure designed to integrate the mixture of at least two nanostructures.

[0028] The embodiment shown in Figure 2A shows a hearing aid 2 positioned between the concha 13 and the ear canal 14; the device in question is equipped with a loudspeaker 102, a battery compartment 202, and a transparent element 302 made of flexible material on which the mixture of at least two photoluminescent nanostructures is arranged. In the variant shown in Figure 2B, the hearing aid has a portion 402 of its structure designed to integrate the mixture of at least two nanostructures.

[0029] The embodiment shown in Figure 3A shows a hearing aid 3 positioned between the concha 13 and the ear canal 14; the device in question is equipped with a battery compartment 103, an extraction wire 203, and a transparent element 303 made of flexible material on which the mixture of at least two photoluminescent nanostructures is arranged. In the variant shown in Figure 3B, portion 403 of the hearing aid's structure is designed to integrate the mixture of at least two nanostructures.

[0030] The embodiment shown in Figure 4A shows a hearing aid 4 positioned inside the ear canal 14; the hearing aid 4 is equipped with an extraction wire 104, which is the only part of the hearing aid that protrudes towards the concha 13 of the ear 10. The portion 204 of the hearing aid body 4 is highlighted, which is designed to integrate the mixture of at least two nanostructures. In the variant shown in Figure 4B, the hearing aid has a transparent element 304 made of flexible material on which the mixture of at least two photoluminescent nanostructures is arranged.

[0031] The embodiment shown in Figure 5A shows a hearing aid 5 consisting of a retroauricular element 105 positioned on the mastoid 11 and surrounding the pinna 12, connected by arm 115 and articulated joint 125 to a component 205 positioned between the concha 13 and the ear canal 14. Part 405 is highlighted on element 105 and is designed to incorporate a mixture of at least two nanostructures, and part 305 of element 205 is also made in the same way. In the variant shown in Figure 5B, the hearing aid has a transparent element 605 made of flexible material on which the mixture of at least two photoluminescent nanostructures is arranged, positioned on the member 105, and a similar element 505 positioned on the member 205.

[0032] The operation of the apparatus according to the present invention will be evident from the following. Based on experience with various therapeutic applications of photoluminescent nanostructures, the inventors have thought of using the aforementioned nanostructures to activate the vestibular reflex and thus attenuate balance disorders. The device can therefore be a simple cap such as that shown in Figures 1A and 1 B, which could also be provided with a hole to allow treatment and at the same time allow sound to pass through, or, as in other embodiments, the action of the hearing aid could be combined with that of the photoluminescent nanostructures.

[0033] Since the device is passive, the photoluminescent nanostructures are capable of emitting photons at a reference wavelength, for example between 400 and 990 nm, when stimulated by at least one infrared, visible, or ultraviolet electromagnetic radiation.

[0034] In an alternative embodiment, the device includes additional photoluminescent material capable of absorbing photons under the effect of incident electromagnetic radiation and re-emitting them even after the incident electromagnetic radiation has ceased.

[0035] As can be seen from the examples provided, the position of the mixture of photoluminescent nanostructures varies and adapts to the shape and arrangement of the support on the ear. In all cases, the alternative of affixing an element made of flexible material or integrating the nanostructures into the structure of the support is considered. The first solution clearly leaves the freedom to choose the type of nanostructures to be used and to replace them if necessary; in the second case, however, the stability of the nanostructures with respect to the support is preferred.

[0036] Preliminary tests have been carried out on a prototype of the above-described perforated cap type, worn by a patient who underwent the use of a baropodometric platform, finding significant improvements in posture as a result of using the invention.

[0037] The device designed in this way allows for a wide range of applications, particularly in the treatment of balance deficits and in the stimulation of the vestibular reflex.

Claims

CLAIMS1 . Passive device for therapeutic treatment of the ear, comprising a support (1 ; 2; 3; 4; 5) intended to be positioned on the mastoid (11 ), and / or on the pinna (12), and / or in the concha (13), and / or in the auditory canal (14) of the ear (10) to be treated, a mixture of at least two nanostructures (101 , 201 ; 302, 402; 303, 403; 204, 304; 305, 405, 505, 605) on said support.

2. Device according to claim 1 , wherein no active light source is provided.

3. Device according to claim 1 or 2, wherein said mixture of at least two photoluminescent nanostructures is arranged on a transparent element made of flexible material (101 ; 302; 303; 304; 505, 605), applied in a suitable position on said support (1 ; 2; 3; 4; 5).

4. Device according to claim 1 or 2, wherein the photoluminescent nanostructures are directly integrated (201 ; 402; 403; 204; 305, 405) into the structure of the support (1 ; 2; 3; 4; 5).

5. Device according to any one of the preceding claims, wherein the support of the device is a protective noise-reducing cap (1 ) intended to be positioned between the cavity (13) and the entrance to the ear canal (14).

6. Device according to any of the preceding claims 1 to 4, wherein the support of the device of the invention is a hearing aid (5), formed by a retroauricular member (105) attached to the mastoid (11 ) and surrounding the pinna (12), connected by an arm (115) and an articulated joint (125) to a member (205) positioned between the concha (13) and the ear canal (14).

7. Device according to any of the preceding claims 1 to 4, wherein the support of the device is a hearing aid (2; 3) of the type inserted into the opening of the ear canal (14).

8. Device according to any of the preceding claims 1 to 4, wherein the support of the device is a hearing aid (4) of the type completely inserted into the ear canal (14).

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