WO2020240358A1

WO2020240358A1 - Ear-protecting plaster

Info

Publication number: WO2020240358A1
Application number: PCT/IB2020/054816
Authority: WO
Inventors: Roberto LUPO; Manuele Casale; Andrea Natalizia; Michele Antonio LOPEZ; Vittorio RINALDI; Antonio MOFFA
Original assignee: Lupo Roberto; Manuele Casale; Andrea Natalizia; Lopez Michele Antonio; Rinaldi Vittorio; Moffa Antonio
Priority date: 2019-05-28
Filing date: 2020-05-21
Publication date: 2020-12-03
Also published as: IT201900007425A1

Abstract

An adhesive plaster (1) for the treatment of the human external ear, for indifferent application to the right or left ear, comprising: an upper portion (2), configured to cover the upper portion of the external auricle (for example comprising the helix); a central portion (3), configured to cover the middle portion of the external auricle (for example comprising the antihelix, the antitragus and/or the tragus) and to adhere on the mastoid region; a lower portion (4), configured to cover the lower portion of the external auricle (for example comprising the lobe). The adhesive plaster further has a dotted guiding line (10a, 10b) apt to guide a cut by the user to fit the specific anthropometry of the auricle.

Description

EAR-PROTECTING PLASTER

DESCRIPTION

Technical field of the invention

The present invention relates to an ear-protecting adhesive plaster, configured for the treatment of the external ear.

Background

The need for protecting the ear, in particular both the external auditory meatus and the auricle, exists in several circumstances.

For example, in the post-operative course linked to local, both open surgery and endoscopy operations, a medication is required to be carried for several days. Moreover, in case of viral or bacterial infective processes affecting the middle ear, such as otitis media with perforation of the tympanic membrane, the patients have to protect the organ, continuously or only with respect to the exposition to the atmospheric agents (wind or rain) or to the water during the body washing or during recreational activities such as swimming. Still, even the patients wearing acoustic prostheses complain about the discomfort to have a shower without prosthesis to avoid the contact thereof with water.

In order to satisfy said needs, a sanitary operator can apply a medication based upon gauzes and adhesive bands, in case associated to a pharmacological substance for example in ointment or gel. If the medication or the protection are performed directly by the patient, generally one resorts to extemporaneous solutions based upon cotton-wool, gauzes, covering caps made of plastic or the like.

However, generally, both when a sanitary operator is involved and when the patient provides independently, the adopted solutions do not result to be wholly satisfying, since the cover tends to detach easily and/or not to protect the ear adequately from exposure to the unwished agents. Summary of the invention

The technical problem placed and solved by the present invention then is to overcome the above-illustrated drawbacks of the known art and this is obtained through a plaster as defined in claim 1.

Preferred features of the present invention are set forth in the corresponding depending claims.

The Inventors have detected the absence, in the known art, of medical elements specifically suitable to protect the external ear after surgical operations or local pathologies. Moving from such observation, the Inventors have developed an ear-protecting plaster which has specific shape tricks to allow a reliable adhesion guided to the external organ.

In particular, the proposed plaster is configured to overlap the auricle and to adhere thereto and to the mastoid part of the skull posterior to the ear, so as to implement a hermetic cover for the external ear and to protect even the skull portion placed under the ear itself.

In the proposed dedicated shape, the plaster results even aesthetically tolerable, as less visible thanks to its adaptation to the ear shape. For this reason, moreover, the plaster interferes less with the patient’s hair and, generally, with adjacent body portions.

Advantageously, the proposed plaster has a configuration which makes it bilateral, that is applicable indifferently to the right or left ear.

Moreover, the proposed plaster has guiding means, in particular a dotted guiding line which allows a cutting of the plaster itself to adapt it to the anatomy and to the anthropometry of the specific user. The plaster, thanks to its particular composition, allows only a minimum attenuation of the sound signal, as highlighted by the measurements performed with the“electronic ear FP35 touch” equal to 2 dB, 4 Db, 5 dB, 8 dB for the frequencies 500 Hz, 1000 Hz, 2000 Flz and 4000 Hz, respectively. Based upon a preferred embodiment, the adhesive plaster is made of three layers, comprising a covering layer applied onto the not adhesive face of the plaster and a release layer arranged in contact with the adhesive face and suitable to allow an easy release of the latter at time of application to the patient.

The plaster of the invention is suitable to be used, for example, in case of tympanic perforations, otitis, inflammatory pathologies, dermatitis or wounds of various types and post-operative courses of local surgery, for the patients wearing acoustic prostheses or carrying trans-tympanic drainage.

Other advantages, features and use modes of the present invention will result evident from the following detailed description of some embodiments, shown by way of example and not for limitative purposes.

Brief description of figures

The drawings reported in the enclosed figures will be referred to, wherein:

■ Figure 1 illustrates very schematically the anatomy of a human external ear;

^■ Figure 2 is a front view of a preferred embodiment of a plaster according to the present invention, in particular shown on the side of a non-adhesive face thereof;

■ Figure 2A shows a cross-section view of the plaster of Figure 2, performed according to the line A-A of the latter, which illustrates a multi-layered preferred configuration thereof; the thickness of the layers is represented magnified and not necessarily in proportion;

^■ Figure 3 shows the same view of Figure 2, wherein some preferred sizes are indicated

^■ Figure 4 is a schematic representation in front view of a first embodiment variant of the plaster of Figure 2; ^■ Figure 5 is a schematic representation in front view of a second embodiment variant of the plaster of Figure 2; and

^■ Figure 5A is a schematic representation in front view of an additional embodiment variant of the plaster of Figure 5.

Detailed description of preferred embodiments of the invention

Figure 1 shows a schematic drawing illustrating the anatomy of a human external ear, useful as reference, even as terminological reference, for the following description.

Figures 2 and 2A relate to a preferred embodiment of an adhesive plaster according to the present invention, designated as a whole with 1.

The plaster 1 has a multi-layer shaped main body. Advantageously, the main body of the plaster 1 results to be symmetrical with respect to a longitudinal axis L which defines even a prevailing development direction thereof.

In particular, as shown in Figure 2A, in the present embodiment the plaster 1 provides an external protective layer 11 , preferably transparent and preferably made of supporting material to keep the shape of an intermediate layer 10. The external layer 11 can be of film or pellicle type and/or of “peel-off’ type. The external layer 11 is applied to a not adhesive face 101 of the main, or intermediate, layer 10, the latter bearing a counter-lateral face 102 provided with adhesive 103. An additional protective layer 12 then is applied at the adhesive face 102 of the main layer 10. Such additional internal layer 12 is of “peel-off’ type and, to this purpose, it can have a non-stick coating 120, for example a silicone coating, to allow an easy separation from the main layer 10 at time of use. The internal layer 12 can be made of two or more portions, in case separated according to a longitudinal cutting in direction L or in transversal direction T.

Figure 2 shows an upper front view of the plaster 1 , that is the latter is shown from the side of the external layer 11. All three layers 10, 11 and 12, in the present example, have the same front shape, as shown in Figure 2. Embodiment variants can provide a different shape for the external 11 and internal 12 layers. For example, the latter could be in form of a continuous strip whereon a plurality of main layers 10 are applied in sequence. In such case, the real plaster is constituted by the main layer 10 and in case by the external protection layer 11 and a plurality of such plasters are provided indeed in form of strip or roll.

Each layer of the multi-layer main body of the plaster 1 - and in particular the external 11 and main 10 layers of the present embodiment - is advantageously made of one single piece.

The front shaping of the main body, and in particular of the layer 10, defines a plurality of regions, in particular:

^■ an upper region 2 with arched or roundish convex peripheral profile, in particular a semi-circular, bell-shaped or parabolic profile; such region 2 defines a top 21 of the main body of the plaster 1 ;

^■ a central region 3 defined by two side fins, or tabs, 31 and 32, each one with a substantially trapezoidal profile, projecting with respect to the upper portion 2;

^■ a lower region 4 with an arched peripheral profile, advantageously with transversal extension decreasing towards a bottom 41 of the main body of the plaster 1 ; such lower region 4 can have a peripheral profile with substantially catenary-like or parabolic geometrical shape.

Based upon the present embodiment, the upper region 2 is configured to cover the upper portion of the external auricle (for example comprising the helix in Figure 1 ).

The central region 3 is preferably configured to cover both the middle portion of the external auricle (for example comprising the antihelix, the antitragus and/or the tragus in Figure 1 ) and the mastoid region. In particular, depending upon the fact that the plaster 1 is applied on the right or left ear the tab or fin 31 or 32 is used to fasten the plaster at the mastoid part of the side skull posterior to the ear itself. In specific uses, both fins 31 and 32 can be used, in particular by using one thereof even to adhere to the temporo-zygomatic portion of the skull.

The lower region 4 e advantageously configured to cover the lower portion of the external auricle (for example comprising the lobe in Figure 1 ).

It will be appreciated that the plaster of the invention, and in particular the plaster 1 of the herein described embodiment, can protect the whole volume of an external ear, indifferently right or left ear, and fasten onto the user’s skin. Advantageously, the plaster 1 , for example at the main layer 10, bears one or a plurality of, in particular dotted, guiding lines. In the present example, two guiding lines are provided, designated respectively with 100a and 100b. Each guiding line 100a, 100b follows the overall peripheral profile of the main body of the plaster 1 as described above. Therefore, the guiding lines 100a and 100b are concentric, that is defined one inside the other one onto the surface of the application layer. Said guiding lines are suitable to allow a cut by the user, to fit the specific anthropometry of the user itself and thus they allow to size in a personalized way the plaster by removing the portions exceeding the required size. With reference to Figure 3, exemplifying sizes of the plaster 1 are:

- longitudinal extension LL comprised in a range of 8-12 cm, preferably equal to about 10 cm;

- maximum transversal extension B in direction T orthogonal to the axis L comprised in a range of 6-10 cm, preferably equal to about 8 cm.

Based upon an embodiment variant shown schematically in Figure 4, the plaster 1 can have a not adhesive medical element 5 applied at the face 102 of the main layer 10. Such element 5 is apt to protect the anatomical site of the user and for example it is implemented with sterile gauze, cotton wool or other material with analogous features, as in the traditional plasters. Such element 5 can even comprise a pharmacological substance, for example in form of liquid, ointment or gel. Preferably, the element 5 has circular or substantially roundish front shape and it extends mainly inside the central region 3.

Based upon another embodiment variant shown schematically in Figure 5, the plaster 1 comprises an application upper tab 6, arranged at the top 21 of the main body. The tab 6 has a substantially polygonal, in particular quadrangular, front profile and it can extend according to, and at, the longitudinal axis L.

The tab 6 can be present only at the external layer 11 , to ease the removal thereof upon use.

The tab 6 can have a length FI according to the axis L equal to about 1 cm.

In an embodiment variant, the tab 6, and/or an additional tab, can extend at the bottom 41 of the main body, at one or more of the layers constituting the plaster 1 .

In the variant of Figure 5A, the tab, herein designated with 60, has guiding lines associated with both guiding lines 100a and 100b, for greater use simplicity.

A procedure for applying the plaster 1 can provide the following phases: removing a first portion of the internal layer 12, applying the main layer 10 onto the portion to be treated, removing the other portion of the internal layer 12, finishing the adhesion of the layer 10 on the patient’s skill, lifting gently the external protective layer 11 and removing it completely.

The present invention has been described sofar with reference to preferred embodiments. It is to be meant that other embodiments belonging to the same inventive core may exist, as defined by the protective scope of the herebelow reported claims.

Claims

1. An adhesive plaster (1 ) for the protection of the external ear,

which adhesive plaster (1 ) is configured to overlap the auricle by adhering thereto and to the mastoid region posterior to the ear so as to implement a hermetic cover for the external ear and to protect even a skull portion placed under the ear itself, said adhesive plaster (1 ) having a flat main body with a shaped front profile defining:

^■ an upper region (2) with a convex, arched or roundish peripheral profile - in particular a semi-circular, bell-shaped or parabolic profile - which upper region (2) defines a top (21 ) of said main body;

^■ a central region (3) bearing two side fins, or tabs (31 , 32), each one protruding with respect to said upper portion (2) and preferably having a substantially trapezoidal profile;

B a lower region (4) with an arched peripheral profile, with transversal extension decreasing towards a bottom (41 ) of said main body, which lower region (4) preferably has a peripheral profile with a substantially parabolic geometric shape,

wherein said main body has at least a closed guide line (100a, 100b) at the front, defining a cutting path to reduce the sizes of the main body itself as a function of an anthropometry of the user.

2. The adhesive plaster (1 ) according to claim 1 , wherein:

^■ said upper region (2) is shaped to cover the upper portion of the external auricle, in particular comprising the helix;

■ said central region (3) is shaped to cover the middle portion of the external auricle, for example comprising the antihelix, the antitragus and/or the tragus and each one of said fins (31 , 32) is arranged so as to adhere to a mastoid part of the skull posterior to the ear and one of said side fins (31 , 32) can adhere to the temporo-zygomatic portion of the skull;

■ said lower region (4) is shaped to cover the lower portion of the external auricle, for example comprising the lobe.

3. The adhesive plaster (1 ) according to any one of the preceding claims, wherein said main body has a prevalent longitudinal development direction (L) and it is preferably symmetrical with respect thereto, so as it can be applied indifferently on a right or left ear.

4. The adhesive plaster (1 ) according to any one of the preceding claims, wherein said main body has a multi-layer construction, in particular comprising: an external protective layer (11 ), preferably transparent and preferably of film or pellicle type and/or of“peel-off’ type; and intermediate main layer (10), bearing a non-adhesive face (101 ) whereon said external protective layer (11 ) is applied; an internal non-stick protective layer (12), applied at an adhesive face (102) of said main layer (10).

5. The adhesive plaster (1 ) according to the preceding claim, bearing an application tab (6) configured to allow una separation between two adjacent layers of said main body and preferably arranged at a top (21 ) or a bottom (41 ) of said main body.

6. The adhesive plaster (1 ) according to the preceding claim, wherein the tab (6) has secondary guiding lines, associated with both guiding lines (100a, 100b).

7. The adhesive plaster according to claim 5 or 6, wherein the tab (6) and/or an additional tab can extend at the bottom (41 ) of the main body, at one or more of the layers constituting the plaster (1 ).

8. The adhesive plaster (1 ) according to any one of claims 4 to 7, wherein the internal layer (12) can be made in two or more portions, in case separated according to a cut along a longitudinal direction (L) or along a transversal direction (T).

9. The adhesive plaster (1 ) according to any one of the preceding claims, bearing a medical element (5), for example gauze or cotton, applied at an adhesive face (102) of said main body.

10. The adhesive plaster (1 ) according to any one of the preceding claims, having a longitudinal extension (LL) comprised in a range of about 8-12 cm, preferably equal to about 10 cm, and/or a maximum transversal extension (B) comprised in a range of about 6-10 cm, preferably equal to about 8 cm.