FR3089422A1 - MEDICAL DEVICE FOR TOPICAL TREATMENTS - Google Patents

Abstract

The present invention relates to a medical device for treating a fungicidal infection in a subject in need thereof, comprising: a medical container comprising a fungicidal medical composition, an applicator tip having an opening for applying said fungicidal medical composition to said subject, and a actuation mechanism for controlling said applicator tip, characterized in that said medical container is hermetically sealed with a penetrable seal; and in that said actuating mechanism comprises an actuating rod which is movable between (i) a first position in which said actuating rod closes said opening of said applicator tip, and (ii) a second position in which said tip applicator is in an open position and in which said actuating rod penetrates said penetrable lid of said medical container, thus allowing fluid communication between said medical container and said applicator tip.

Description

Description

Title of the invention: MEDICAL DEVICE FOR TOPICAL TREATMENTS

Technical area

The present invention relates to a medical device for the treatment of dermatological disorders and a method for its use. The present invention more particularly relates to a medical applicator with which a fungicidal composition can be applied for dermatological disorders, such as onychomycosis. TECHNOLOGICAL BACKGROUND

Document CN 103 764 219 discloses a medical applicator for the topical treatment of dermatological problems. A disadvantage of the devices mentioned above is the permeation of certain gases through the caps of bottles as well as the plastic of the bottle. Ethanol migrates through most plastics of thicknesses used for containers made by blow molding.

Manufacturers have developed methods to suppress permeation, such as packaging in glass ampoules or the use of plastics offering gas barrier properties, such as polyethylene terephthalate (PET). PET greatly reduces permeation when sufficient cross-section is provided in the package; however, current devices use blow molded containers in combination with conventional caps. The plugs thus become the weak point of these systems, and they often leak due to incompatible sealing (PET / aluminum) or due to loosening of the plug.

In addition, current container designs use single weld seals as a means of sealing the contents of the bottle. The size of the bottle stopper and the force with which it is tightened on the bottle therefore become essential for maintaining the force necessary to mechanically strengthen the sheet over time. Loosening the cap is often a problem and frequently results in the contents of the bottle leaking, especially when the system needs to be stored for long periods of time before use. Such an applicator is described in the German patent application DE 102 007 046 600 Al.

Some medical applicators use fibers, similar to brushes, to apply liquid medical solutions to a target area. These fibers, especially after the applicator has been used, tend to trap the liquid. This leads to rigid fibers which are linked together by components of the medical solution. Also, for onychomycosis in particular, this can lead to the transfer of a fungus from one nail to another, since it is difficult to keep these fibers sterile. For this reason, these applicators require special vigilance for appropriate use. Such applicators are described in Chinese patent CN 206 492 102 U.

Document WO 2016/142305 describes an applicator for the topical application of an acidic liquid, the applicator comprising a container containing said acidic liquid, the container comprising an opening in contact with fluid with a tip for controlled release. acidic liquid, wherein the tip comprises a plurality of fibers and an adhesive material bonding the fibers. A kit of parts for the topical application of an acidic liquid is also described, the kit of parts comprising a liquid release unit comprising a tip for controlled release of the acidic liquid, and a container unit comprising a container configured for containing the acidic liquid, wherein the container unit further comprises a liquid release member for applying the acidic liquid to the tip, wherein the tip comprises a plurality of fibers and an adhesive material bonding the fibers. Such devices, however, do not provide sufficient or reliable closure of the applicator, which allows at least partial loss of the acidic liquid by evaporation.

Therefore, it is desirable to overcome the disadvantages and disadvantages of the prior art with a skin medical applicator. It would be desirable for the skin applicator to be able to be disposed in an inverted orientation when in use, and for it to also provide a liquid and / or gas tight seal. It would be highly desirable if the medical skin applicator and its component parts could be made and assembled easily and efficiently.

Summary of the invention

The present invention relates to a medical device for the treatment of a fungicidal infection according to the claims.

In a first aspect, the present invention provides a medical device for the topical treatment of a disease in a subject in need thereof, comprising:

- a medical container comprising a medical composition,

- an applicator tip having an opening for the application of said medical composition to said subject, and

- an actuation mechanism for controlling said applicator tip.

More specifically, the present invention provides said medical device whereby said medical container is sealed with a penetrable seal; and said actuating mechanism comprises an actuating rod which is movable between (i) a first position in which said actuating rod closes said opening of said applicator tip, and (ü) a second position in which said applicator tip is in an open position and in which said actuating rod pierces said penetrable lid of said medical container, thus forming a passage to allow fluid communication between said medical container and said applicator tip.

The penetratable seal is an effective barrier for gases and solvents. Therefore, the low permeability of the medical container before use increases the life of the medical device. In addition, a tip applicator is used rather than a brush or fiber applicator. The smooth surface of a tip applicator is easier to clean and sterilize. Finally, the actuation mechanism allows a controlled application of medical doses of the fungicidal medical composition.

In the second aspect, the present invention provides a kit comprising a medical device for the topical treatment of a disease in a subject in need thereof, comprising:

- a medical container comprising a medical composition;

- an applicator tip having an opening for the application of said composition to said medical subject, an actuation mechanism for controlling said applicator tip, and a housing for a medical container.

More specifically, the present invention provides said kit, whereby said medical container is closed hermetically with a penetrable seal; and said actuating mechanism comprises an actuating rod which is movable between (i) a first position in which said actuating rod closes said opening of said applicator tip, and (ii) a second position in which said applicator tip is in an open position and into which said actuating rod penetrates said penetrable lid of said medical container, thus forming a passage to allow fluid communication between said medical container and said applicator tip.

In the third aspect, the present invention provides a method for the treatment of a fungicidal infection using a medical device comprising the steps consisting in:

[0020] - supplying a medical device comprising a medical container containing a fungicidal medical composition, an applicator tip for applying said fungicidal medical composition and an actuator for controlling said application,

- actuate the actuator to facilitate fluid communication between the medical container and the applicator tip.

DESCRIPTION OF THE FIGURES

[Fig.lA] shows a schematic overview of a possible embodiment of the medical device.

[Fig.lB] shows a schematic overview of a possible embodiment of the assembly of the medical device.

[Fig.lC] shows a possible embodiment of the actuation of the medical device.

[Fig.lD] shows a possible embodiment of the use of a possible embodiment of the medical device.

[Fig.lE] shows a schematic overview of a possible embodiment of the medical device after the penetrable seal has been pierced.

[Fig.2A] shows a longitudinal sectional view of a possible embodiment of the housing according to the present invention.

[Fig.2B] shows a side sectional view of a possible embodiment of the housing according to the present invention.

[Fig.3] shows a possible embodiment of the medical container.

[Fig.4A] shows a cross-sectional view of a possible embodiment of the sealing ring according to the present invention.

[Fig.4B] shows a perspective of a possible embodiment of the sealing ring according to the present invention.

[Fig.5A] shows a detailed perspective of a possible embodiment of an actuating rod according to the present invention.

[Fig.5B] shows a cross-sectional view of a possible embodiment of an actuating rod according to the present invention.

[Fig.6A] shows a detailed cross-sectional view of a possible embodiment of an applicator tip according to the present invention.

[Fig.6B] shows a perspective of a possible embodiment of an applicator tip according to the present invention.

[Fig.7A] shows a radial view of a possible embodiment of a plug according to the present invention.

[Fig.7B] shows an axial view of a possible embodiment of a plug according to the present invention.

[Fig.8A] shows a cross-sectional view of a possible embodiment of a nail file according to the present invention.

[Fig.8B] shows a cross-sectional view of a possible embodiment of a nail file according to the present invention.

[Fig.9A] shows a schematic overview of another possible embodiment of the assembly of the medical device.

[Fig.9B] shows a perspective of another possible embodiment of an actuating rod according to the present invention.

[Fig.9C] shows a perspective of another possible embodiment of an actuating rod according to the present invention.

[Fig.lOA] shows a schematic overview of a preferred embodiment of the medical device.

[Fig.lOB] shows a schematic overview of a preferred embodiment of the assembly of the medical device.

[Fig.lOC] shows a cross-sectional view of a preferred embodiment of the sealing ring according to the present invention.

[Fig.lOD] shows a detailed perspective of a preferred embodiment of the actuating rod and the spring according to a preferred embodiment of the medical device.

[Fig.lOE] shows a cross-sectional view of a preferred embodiment of the actuating rod and the spring according to a preferred embodiment of the medical device.

DETAILED DESCRIPTION OF THE INVENTION

Unless defined otherwise, all the terms used in the disclosure of the invention, including the technical and scientific terms, have the meaning as it is commonly understood by the person skilled in the art to which this invention belongs. As additional help, definitions of terms are included to better understand the teaching of the present invention.

As used here, the following terms have the following meanings:

The terms "one", "one" and "the" and "the" as used herein refer to both singular and plural referents, unless the context clearly indicates otherwise. For example, "a compartment" means one or more compartments.

The term "approximately", as used herein with reference to a measurable value, such as a parameter, a quantity, a time duration, etc., is intended to include variations of +/- 20% or less, preferably +/- 10% or less, more preferably +/- 5% or less, even more preferably +/- 1% or less, and even more preferably +/- 0.1% or minus, from and from the specified value, to the extent that such variations are appropriate to occur in the disclosed invention. However, it should be understood that the value to which the modifier "about" refers is itself also specifically described.

The terms "understand", "comprising" and "includes" and "consisting of", as used herein, are synonyms of "include", "including", "includes" or to "contain", "containing", "contains" and are inclusive or open terms that specify the presence of the following, for example a component, and do not exclude or preclude the presence of components, characteristics, d 'elements, components and additional steps not mentioned, known in the art or described therein.

The recitation of the digital ranges by end points includes all the numbers and fractions included in this range, as well as the recited end points.

The expression “% by weight”, “percentage by weight”, “% by weight” or “% by weight”, here and throughout the description, unless otherwise indicated, denotes the relative weight of the respective component relative to the total weight of the formulation.

Terms relating to orientation in space, such as "under", "below", "lower", "on", "upper" and the like can be used here to facilitate description to describe the relation of an element or a particularity with one or more other elements or particularities, as illustrated in the figures. It will be understood that the terms relating to the orientation in space are intended to encompass different orientations of the device during use or operation, in addition to the orientation shown in the figures. For example, if the device in the figures is inverted, elements described as being "under" or "below" other elements or features will then be oriented "on" the other elements or features. Thus, the example term "under" can include both an over and under orientation. The device can be oriented differently (rotation to 90 degrees or to other orientations) and the descriptors relating to the orientation in space used here interpreted accordingly. Likewise, the terms "upward", "downward", "vertical", "horizontal" and the like are used here in for explanatory purposes only, unless expressly stated otherwise.

It will be understood that, although the terms first, second, etc. can be used here to describe various elements, components, regions, layers and / or sections, these elements, components, regions, layers and / or sections should not be limited by these terms. These terms are used only to distinguish an element, component, region, layer, or section from another region, layer, or section. Thus, a first element, component, region, layer or section discussed below can be called second element, component, region, layer or section without departing from the teachings of the present invention. The order of operations (or steps) is not limited to the order presented in the claims or figures, unless otherwise indicated.

The term "sterile" means a surface and / or a device which is substantially free of foreign bodies or undesirable microorganisms. The terms "sterility" or "sterile" and their derivatives refer to a set of medical grade sterility standards, generally established by a regulatory body. To achieve desired sterility, the dosing container or other component can be fabricated (filled and sealed) at a controlled cleaning standards site, such as, for example, a "Class 100,000" site or higher. The manufacturing / filling site can be a “Class 100 site” or another sterile and / or aseptic site or with clean room conditions suitable for maintaining a desired state of cleanliness or sterility until or during distribution. /use. Alternatively, the device can be packaged and then sterilized. The term "Class 100" refers to an installation that has less than 100 particles per cubic meter of clean room / clean space. The Class 100 standard can also refer to ISO Class 5. The term "Class 100,000" means a facility that has less than 100,000 particles per cubic meter of clean room / clean space. The clean room / clean space can maintain a positive pressure environment. The positive pressure environment is configured to operate so that upon entering space, air exits the clean room, which limits the possibility of contaminants entering the clean room. Equipment to provide the desired class, such as, for example, Class 100 status includes, for example, Class 100 laminar flow workstations, Class 100 laminar flow exhaust hoods, HEPA filters and the like. The term "sterile or clean extraction surface" designates the part of the dosing container which has or maintains a desired cleanliness and / or sterility. In some embodiments, to do this, the surface can be isolated or otherwise protected from exposure to environmental conditions before and / or during use.

In certain embodiments, the medical liquid can be any medical product which is administered in liquid form; in one embodiment, it is an aqueous medical composition, and in another embodiment, it is a non-aqueous medical composition.

In a first aspect, the present invention provides a medical device for the topical treatment of a disease in a subject in need thereof, comprising:

A medical container comprising a medical composition,

An applicator tip having an opening for the application of said medical composition to said subject, and

- an actuation mechanism for controlling said applicator tip.

More specifically, the present invention provides said medical device whereby said medical container is sealed with a penetrable seal; and said actuating mechanism comprises an actuating rod which is movable between (i) a first position in which said actuating rod closes said opening of said applicator tip, and (ii) a second position in which said applicator tip is in an open position and in which said actuating rod pierces said penetrable lid of said medical container, thus forming a passage to allow fluid communication between said medical container and said applicator tip.

The advantage of said penetrable seal, which is used to seal the medical container, is a high barrier and therefore low permeability. This low permeability increases the life of the medical device, ensuring that the medical device and the composition function as intended.

The actuation mechanism has two positions. The first position will be called "closed", the second will be called "open". When the actuation mechanism is in the closed position, the actuation rod closes the applicator tip. When the actuator is in the open position, the actuator allows fluid communication between the medical container and the applicator tip along the actuator. If the actuating rod is moved from the closed position to the open position while the penetrable lid is intact, the actuating rod pierces said penetrable lid, whereby the lid becomes a penetrated lid. The penetrating seal does not seal the medical container.

This opens the medical container, allowing fluid communication between the medical container and the applicator tip. In addition, the actuating mechanism has two positions for the actuating rod. The "actuation mechanism" includes the "actuation rod", but may include additional components.

The advantage of this mechanism is an easier and cleaner application of the medical composition. In addition, it preserves the medical composition in the medical container when the medical device is not in use.

The applicator, in particular, can be arranged to deliver substantially the required dose of the medical composition (on the topical site to be treated), which avoids an overdose (or insufficiency) of the medical composition which could lead to damage the skin instead of treating it. Consequently, the present applicator, as well as the liquid release unit proposed here, allow a targeted application of the medical composition, thus facilitating the treatment of, for example, a lesion, without substantially affecting the surrounding (healthy) tissues.

The present invention provides said medical device in particular for the application of a topical treatment, such as a treatment of a nail condition, a skin condition, a treatment of an oral health problem, a treatment of a topical problem on intimate areas, skin removal (for example, to remove a tattoo), etc. The invention also provides such a medical composition, as defined herein, in particular for use in the treatment of a topological lesion, for example in medical treatment. In addition, the invention also relates to such a medical composition per se, in particular for use in the treatment of a topological lesion, for example in a cosmetic treatment. The invention also relates to such a medical composition, in particular for use in the (acid) treatment of a skin condition, for example in the treatment of superficial lesions, in particular skin lesions, mucosal lesions and / or nail lesions, viral warts, common warts, water warts (molluscum contagiosum), corns and calluses, hyperpigmentation of the skin (such as age spots, solar lentigo, senile lentigo), acne, keratosis pilaris, actinic keratosis, ingrown toenails, onychomycosis, xanthelasma of the eyelid, psoriasis, nail fungal infections, epidermodysplasia veruciformis, caused skin condition by HPV (human papillomavirus), scars, wrinkles, and melasma. The invention also relates to such a liquid of medical composition as defined here, in particular for use in the treatment (acidic) of topical oral health problems such as mouth ulcers (canker sores) and cold sores . The invention also relates to such a liquid of medical composition as defined here, in particular for use in the (acid) treatment of topical problems in the intimate areas, mucous membranes and tissues, such as hemorrhoids and genital warts. . The invention also relates to such a medical composition as defined here, in particular for use in treatment (acid) for the purpose of removing skin such as a tattoo and / or a skin tag.

MEDICAL CONTAINER

The medical container is preferably made of an acid-resistant material. Good alternative acid-resistant materials for the medical container can be chosen from the group consisting of acid-resistant metals, chlorinated polyvinyl chloride (CPVC), ethylene chlorotrifluoroethylene (ECTLE), polytetrafluoroethylene (improved), ( Improved TEP), high density polyethylene (HDPE), polyetheretherketone (PEEK), polypropylene (PP), polysulfone (PSU), polyphenylene sulfide (PPS), polyvinyl chloride (in particular type 1 (PVC) , type 1) or type 2 (PVC, type 2)), polyvinylidene fluoride (PVDL), polytetrafluoroethylene (PTLE), polyamide-imide (PAI), ultra high molecular weight polyethylene (UHMW) and also coated metals (with an acid-resistant material, in particular an acid-resistant polymer) such as aluminum. In yet another embodiment, good materials for the container can be independently selected from the group consisting of high density polyethylene (HDPE), low density polyethylene (LDPE), polyamide (PA), polycarbonate (PC) , polyethylene terephthalate (PET) (including for example polyethylene terephthalate glycol, PETG), polymethylpentene (PMP), polyoxymethylene (POM), polypropylene (PP), polystyrene (PS), polysulfone (PSU), po lyvinyl chloride (in particular rigid (PVC HART) and flexible (PVC WEICH), styrene acrylonitrile (SAN), Tethylene-chlorotrifluoroethylene (ECTFE), ethylene-tetrafluoroethylene (ETFE), fluorinated ethylene-propylene ( FEP), polytetrafluoroethylene (PTFE), polyvinylidene fluoride (PVDF), ethylene-propylene diene rubber (EPDM), fluorocarbon rubber (FPM), and butadiene-acrylonitrile (nitrile) rubber (NBR). These materials are particularly resistant against acid ity of an acidic liquid. It has been found that, in particular polypropylene (PP) and polyethylene terephthalate (PET) (such as polyethylene terephthalate glycol (PETG), for example), do not offer good resistance to acids relative to the acids included in the acidic liquid according to the present invention, while they also show different resistance for different acids. However, the most preferred acid-resistant material is glass.

MEDICAL COMPOSITION

In one embodiment of the invention, the medical composition comprises a film-forming polymer in an amount of 1 to 25% by weight relative to the total weight of said medical composition.

In a preferred embodiment, the medical composition comprises a film-forming polymer in an amount of 2 to 24% by weight, more preferably the medical composition comprises a film-forming polymer in an amount of 3 to 23% by weight, more preferably the medical composition comprises a film-forming polymer in an amount of 4 to 21% by weight, more preferably the medical composition comprises a film-forming polymer in an amount of 5 to 20% by weight., more preferably the medical composition comprises a film-forming polymer in a amount of 5 to 19% by weight, more preferably the medical composition comprises a film-forming polymer in an amount of 5 to 18% by weight, more preferably the medical composition comprises a film-forming polymer in an amount of 5 to 17% by weight, more preferably the medical composition comprises a film-forming polymer in an amount of 5 to 16% by weight, more preferably the medical composition comprises a film-forming polymer In an amount of 5 to 15% by weight, more preferably the medical composition comprises a film-forming polymer in an amount of 6, 7, 8, 9, 10, 11, 12, 13, 14% by weight or any intermediate amount. Medical compositions comprising a film-forming polymer in amounts less than 1% by weight harden very slowly when applied as a topical treatment to nails, or do not harden at all. Medical compositions comprising a film-forming polymer in an amount greater than 25% by weight give rise to compositions which are too viscous.

This film-forming polymer is capable of hardening to form a film after application. This is beneficial for the topical treatment of nail infection. This is also advantageous for the preservation of said medical composition, since the film-forming polymer has a self-sealing effect. This film-forming polymer can seal insufficient closures when the actuator rod is in the first closed position.

In a preferred embodiment, the film-forming polymer is based on acrylates, more preferably the film-forming polymer is a copolymer comprising at least one of methyl methacrylate and ethyl acrylate, more preferably the film-forming polymer is a copolymer comprising methyl acrylate and ethyl acrylate, more preferably the film-forming polymer is poly (ethyl acrylate-methyl co-methacrylate-co-chloride of trimethylammonioethyl methacrylate). In another preferred embodiment, the film-forming polymer is a copolymer comprising an ethyl acrylate monomer and a methyl methacrylate monomer, wherein the ratio of the ethyl acrylate monomer to methyl methacrylate is from 1: 4 to 2: 1, more preferably about 1: 2. Most preferably, the film-forming polymer is poly (ethyl acrylate-methyl co-methacrylate-trimethylammonioethyl methacrylate co-chloride) 1: 2: 0.2. These polymers are known under the CAS number 33434-24-1.

In a preferred embodiment, the medical composition comprises a solvent. In another preferred embodiment, the medical composition comprises a mixture of solvents with variable volatility. In the most preferred embodiment, in combination with poly (ethyl acrylate-methyl co-methacrylate, trimethylammonioethyl methacrylate chloride), the medical composition comprises ethanol, ethyl acetate and butyl acetate. This combination is particularly suitable for providing a sufficiently liquid medical composition which quickly forms a hard film suitable for the treatment of infected nails. Appropriate amounts of solvent are 25 to 85% by weight of solvents relative to the total weight of the medical composition, more preferably 30 to 85% by weight of solvents, more preferably 35% to 85% of solvents, more preferably from 40% to 85% of solvents, more preferably from 45% to 85% of solvents, more preferably from 50% to 85% of solvents, more preferably from 55% to 85% of solvents, more preferably from 60% to 85% of solvents, more preferably from 65% to 80% of solvents, more preferably 66, 67, 68, 69, 70, 71, 72, 73, 74, 75, 76, 77, 78, 79% by weight of solvents relative to the total weight of the medical composition or any intermediate quantity.

Solvents allow easier dosing of biologically active agents. Volatile solvents allow the viscosity, the curing speed and the properties of the film-forming polymer to be optimized. The combination of ethanol, ethyl acetate and butyl acetate is particularly well suited for film-forming polymers based on acrylate. Thanks to the combination of volatilities, the speed at which the film-forming polymer hardens once applied, while maintaining sufficient viscosity before application, can be optimized.

In one embodiment, the medical composition can comprise a plasticizer. Suitable plasticizers include many commercially available plasticizers, such as monoesters and esters of polycarboxylic acid, polymeric polyesters, alkyl ethers and glycerol and glycol esters. In another preferred embodiment, the medical composition comprises triacetin. Triacetin is also known as 1,2,3-triacetoxypropane. Appropriate amounts of plasticizer are up to 5% by weight relative to the total weight of the medical composition, preferably up to 4% by weight, more preferably up to 3% by weight. Preferably at least 0.5% by weight, more preferably at least 1% by weight, most preferably at least 1.5% by weight.

Plasticizers are advantageous for optimizing the glass transition of the film-forming polymer, as well as its mechanical properties and elongation. In addition, the plasticizers affect the flow rate of the medical composition and the rate at which the film-forming polymer hardens. In one embodiment, said medical composition has a viscosity low enough to ensure fluid communication between the medical container and the applicator tip. However, the viscosity must be high enough to prevent the medical composition from exiting the medical device too quickly.

In a preferred embodiment of the invention, said medical composition is an antifungal composition. Examples of suitable antifungal agents include, for example, polyenes, for example natamycin, nystatin; allylamines, for example, naftifine, terbinafine; imidazoles, for example, bifonazole, chlotrimazole, econazole, fenticonazole, ketoconazole, miconazole, oxiconazole; triazoles, for example fluconazole, itraconazole, terconazole; tolnaftate, ciclopirox, undecylenic acid, sulbentine, and morpholines, for example, amorolfm, related morpholines described in US Patent No. 5,120,530. A preferred example of an antifungal composition is a solution of amorolfine. In a particularly preferred embodiment, said solution of medical fungicidal composition comprises amorolfine, preferably between 1 and 20% by weight of amorolfine relative to the total weight of said medical fungicidal composition, more preferably between 2.5 and 10% by weight of amorolfine, and most preferably about 3, 4, 5, 6 or 7% by weight of amorolfine. Amorolfma is a known antifungal medication based on morpholine. Its effects in the treatment of onychomycosis and other fungicidal infections are known. It can be used advantageously with film-forming polymers and is active topically on the nails.

In another preferred embodiment, said medical composition can be an acidic liquid for application to the nail or the skin, applied in particular to peel the skin or the mucous membrane, in particular the skin, by virtue of what the skin or the mucous membrane can renew itself. The treatment liquid will have an advantageous effect on the lesion to be treated; the medical composition, in particular the acid or acids in the liquid, can have a peeling effect; the liquid, especially the acid or acids, can also produce an oxidizing effect on the lesion. The medical composition can include different acidic liquids since one or more different liquids can be applied. The medical composition comprises in particular one or more acids chosen from acetic acid, trichloroacetic acid (TCA), formic acid (FA), and salicylic acid. The acid liquid can (in addition) comprise one or more acids chosen from acetic acid, hydrochloric acid (HCl) and nitric acid (HNO ₃ ). In particular, the medical composition, as contained by the medical device, can comprise one or more acids chosen from the group consisting of trichloroacetic acid, salicylic acid, formic acid, glycolic acid, acid dichloroacetic, monochloroacetic acid, acetic acid, citric acid, ascorbic acid, boric acid, nitric acid, sulfuric acid, phosphoric acid, oxalic acid, acid lactic, hydrochloric acid.

In a specific embodiment, the medical composition has a pH of less than 6, such as in the range from 2 to 6, preferably in the range from 3 to 5. In yet another embodiment, the liquid acid may in particular comprise an acid at a concentration in the range of 0.5 to 10.0% by weight, preferably 0.5 to 5.0% by weight, more preferably 0.5 to 2.0% in weight. The acidic liquid can also comprise two types of acids both at a concentration according to the ranges indicated above, such as a first acid at a concentration in the range of 0.2 to 8% by weight, and a second acid at a concentration in the range of 0.3 to 2.0% by weight. In the most preferred embodiment, the medical composition comprises acetic acid.

The medical composition may optionally include one or more other ingredients, including one or more other active ingredients. The medical composition as described here may include other ingredients commonly used in cosmetics and pharmaceuticals, such as one or more of a surfactant, a colorant, a nail penetration compound, a skin restoration compound, a microenvironmental control compound, and a fragrance.

For example, the medical composition can also comprise one or more ex-containers. An excipient is in particular an inactive substance formulated next to the active ingredient (s) of a product or of a medicament, with the aim of thickening formulations which contain such or such active ingredients. The excipients can for example also be indicated as a filler or diluent. Excipients can include, for example, one or more of binders, coatings, disintegrants, fillers, flavors, colors, lubricants, slip agents, sorbents, preservatives, sweeteners, etc. .

The medical composition may further comprise, for example, fibroin. Fibroin is a protein derived from the hydrolysis of silk fibers, naturally secreted by the Bombyx mori silkworm. Fibroin has various applications in the biomedical field, which can be attributed to its high tensile strength, controllable biodegradability, non-cytotoxicity, low antigenicity and non-inflammatory characteristics. The use of fibroin extract can help the healing process during the regeneration and repair of normal and functional nail tissue. The medical composition may also (also) comprise pentylene glycol. Pentylene glycol is used as a hydrating agent. It is a colorless liquid, with very little odor, which is soluble in both water and oil. Due to its unique molecular properties, including a well-separated charge distribution pattern, pentylene glycol exerts its hydrating activity much better than comparable chemicals, namely propylene glycol. The medical composition can also (also) comprise dimethylisosorbide. Dimethylisosorbide is a delivery enhancer that can place active ingredients where they are most needed, and is therefore used as a penetration system for the keratin nail layer. Dimethylisosorbide is a colorless liquid with excellent solvent properties. It improves the delivery of active ingredients to the upper layers of the epidermis without getting the product into the bloodstream. In addition, dimethylisosorbide improves the stability of formulations, even those that are sensitive to hydrolysis and transesterification. The one or more of fibroin, pentylene glycol and dimethylisosorbide can in particular be applied in a medical composition for the treatment of nail fungal infection.

The medical composition can also comprise, for example, azone. Azone is a colorless to yellowish liquid, comprising in particular sodium hypochlorite as the active ingredient. Azone has been used to improve percutaneous absorption. Its ability to improve penetration makes it an attractive compound for incorporation into the medical composition. Additionally or alternatively, pyrrolidones can be incorporated to improve penetration. In addition, pyrrolidones show a high effect on hydrophilic diffusers and can therefore function as enhancers of penetration into (human) skin.

The medical composition can also comprise, for example, a terpene. Terpenes are an important and diverse class of organic compounds, produced in particular by a variety of plants. Many terpenes are hydrocarbons, but oxygen-containing compounds such as alcohols, aldehydes or ketones (terpenoids) are also found. Their constituent element is the hydrocarbon isoprene, CH ₂ = C (CH ₃ ) -CH = CH ₂ . Terpene hydrocarbons therefore have the molecular formulas (C ₅ H ₈ ) _n , and they are classified according to the number of isoprene units. Vegetable oils that contain terpenes have shown promising results in vivo, inhibiting several species of bacteria. For example, cinnamon oil has shown broad spectrum activity against pyocyanic bacillus. In addition, olive leaf oil has shown beneficial properties, particularly in relation to the micro-environment, having antimicrobial properties for some species, as well as healing and supportive properties for other species. Cumene (isopropylbenzene) is a terpene which has been shown to have important anti-bacterial properties. In addition, limonene, carvone and pinene have shown beneficial effects.

The medical composition can also comprise, for example, oxazolidones. Oxazolidinones are a class of antimicrobial agents that have a unique structure and significant activity against Gram-positive pathogenic bacteria. Oxazolidinones are a class of compounds containing 2-oxazolidine in the structure. Oxazolidinones represent a new class of synthetic antibacterial agents active against multiresistant Gram-positive pathogens, including methicillin-resistant staphylococcus aureus (MRSA), penicillin-resistant streptococci, and vancomycin-resistant enterococci. Consequently, oxazolidones in particular, which can control the microenvironment, can be incorporated into the medical composition. The medical composition may further comprise, for example, urea (or carbamide). Urea is an organic compound with the chemical formula CO (NH ₂ ) ₂ . Creams containing urea are well known and used as topical dermal products to promote rehydration of the skin. It also appears that urea can be indicated for psoriasis, xerosis, onychomycosis, ichthyosis, eczema, keratosis, keratoderma, corns and calluses. Its use, for example, in the treatment and / or prevention of athlete's foot can be considered as a moisturizing agent for dry skin affected by athlete's foot. The medical composition may further comprise, for example, allantoin. Allantoin is a chemical compound with the formula C ₄ H ₆ N ₄ O ₃ . It is also called 5-ureidohydantoin or glyoxyldiureide. It is a glyoxylic acid diurea. It is used for its moisturizing properties, because it increases the water content of the extracellular matrix. It also improves the scaling of the upper layers of dead skin cells, promoting a faster healing process for damaged skin. The medical composition may further include, for example, panthenol. Panthenol is the alcohol analogue of pantothenic acid (vitamin B5), and is therefore a provitamin B5. In organisms, it is rapidly oxidized to pantothenate. In the treatment (and / or prevention) for example of the athlete's foot, panthenol can be used as a humectant, emollient and moisturizer. The one or more of urea, allantoin, and panthenol can in particular be applied in the medical composition for the treatment (and / or prevention) of the athlete's foot, for example in the applicator.

APPLICATOR TIP AND ACTUATION MECHANISM

In a preferred embodiment of the invention, the actuating rod is urged towards the first position in which the actuating rod closes said opening of the applicator tip. The advantage is that moving the actuating rod to the open, unsolicited position requires action. This ensures that the medical composition is released only when desired. This also helps prevent leaks and spills. Finally, a request to the first closed position reduces the risk of human error when closing the medical container. This improves the preservation of said medical composition.

In another embodiment, the actuation mechanism comprises a spring for biasing said actuation rod in the first position. A spring is a reliable and inexpensive tool. They are well known, reliable and suitable for use in medical applications.

In one embodiment, the penetrable lid is fixed to a sealing ring, in which said sealing ring is in contact with the medical container hermetically closing said medical container effectively before the first use. This allows separate manufacturing of the penetration seal and the medical container. This also allows both the seal ring and the medical container to be separate interchangeable parts. An empty medical container can be replaced with a new container, without having to replace the seal ring, allowing the medical device to be refilled. Likewise, if the medical container is not yet empty, but the treatment is stopped, a sealing ring with penetrated seal can be replaced by a new seal ring with penetratable seal for long-term preservation of medical composition.

In one embodiment, the penetrable lid is preferably made of acid-resistant materials. In addition, the penetratable seal requires an appropriate permeability to prevent the loss of volatile substances from the medical composition. The penetrable seal must also be gas-tight after being brought into contact with the medical container. In one embodiment, the penetrable lid is an extruded or co-extruded sheet. In a more preferred embodiment, the penetratable cover comprises materials chosen from high density polyethylene (HDPE), low density polyethylene (LDPE), polyamide (PA), polycarbonate (PC), polyethylene terephthalate (PET) ) (including, for example, polyethylene terephthalate glycol, PETG), polymethylpentene (PMP), polyoxymethylene (POM), polypropylene (PP), polystyrene (PS), polysulfone (PSU), poly chloride vinyl (in particular rigid (PVC HART) and flexible (PVC WEICH), styrene acrylonitrile (SAN), ethylene-chlorotrifluoroethylene (ECTFE), ethylene-tetrafluoroethylene (ETFE), fluorinated ethylene-propylene (FEP) , polytetrafluoroethylene (PTFE), polyvinylidene fluoride (PVDF), ethylene-propylene diene rubber (EPDM), fluorocarbon rubber (FPM), and butadiene-acrylonitrile (nitrile) rubber or metals or acid-resistant alloys such as aluminum. In one embodiment more preferably, the penetrable seal comprises both a metal and polymers. The penetrable seal may also include layers of lacquer. These can be both aesthetic and functional, since a lacquer can facilitate visual inspection of the penetratable seal before first use.

In another embodiment, said actuating rod, when it is moved from the first position, closed, to the second position, open, displaces a volume of the medical composition equal to a single unit dose. This makes it easier to use the medical device. Accurate dosage is important for medical compositions, but difficult to obtain by a person not trained in the arts. As a result, a medical device that delivers unit doses is easier to use. It also improves the treatment of infections since these treatments are often dose sensitive.

In a preferred embodiment, said rod actuating rod comprises longitudinal channels to facilitate the flow of the medical composition along the actuating rod. This improves fluid communication between the tip and the medical container. These longitudinal channels are in synergy with a medical composition comprising a film-forming polymer. Wide channels are a way of ensuring that fluid communication is not blocked by small polymer films blocking passages. In addition, these longitudinal channels lead to more regular fluid communication, which is necessary for the controlled release of the medical composition, for example for unit doses.

The applicator allows the treatment of topological disorder by local contact of the applicator on the nail or the skin. This is safer and more effective than applicators who need contact with an area larger than the lesion or than applicators which serve more than the lesion. The applicator can in particular be configured to supply the medical composition to a local topical area ranging from 0.01 to 4 cm ² , for example from 0.02 to 2.5 cm ² , for example from 0.1 to 1.0 cm ² , as from 0.1 to 0.5 cm ² , by means of direct contact. Therefore, in one embodiment, the applicator tip includes a surface having a contact area or region in the range of 0.01 to 4 cm ² , preferably 0.1 to 2.5 cm ² .

In another embodiment, the applicator comprises a gripping part. Consequently, in one embodiment, the applicator comprises an applicator tip comprising a surface having for example an area or a contact area in the range of 0.01 to 4 cm ² , for example from 0.1 to 2, 5 cm, and in which the applicator comprises a grip part, in which the physical topical application comprises touching a topical area and keeping the applicator tip in physical contact with the topical area in the range from 0.2 to 5 seconds.

Assuming that the applicator has the shape of a pen, the diameter over the entire length of the pen can be substantially round. Preferably, the applicator comprises a grip part. Such a gripping part can for example comprise a triangular cross section, in particular having rounded angles. Consequently, in another even more preferred embodiment, the applicator has different cross sections, progressively passing from rounds to a grip part having a triangular cross section (and possibly becoming a substantially round cross section). The applicator may have a closure. When defining the shape of the applicator, such a closure can be included.

In a preferred embodiment, the actuating rod and / or the spring are made of a thermoplastic material. Metal springs can cause corrosion, oxidation and other adverse reactions of the medical composition. This has a negative impact on the life of the composition. Even if the medical composition remains functional, low concentrations of metal ions and complexes can act as pigments and lead to discoloration of the medical composition, as well as of the film once applied.

The applicator tip, the actuating rod and / or said spring are preferably made of an acid-resistant polymeric material. Good acid-resistant polymer materials for the applicator tip, the actuating rod and / or said spring can be independently selected from the group consisting of chlorinated polyvinyl chloride (CPVC), ethylene chlorotrifluoroethylene (ECTEE) ), polytetrafluoroethylene (improved), (improved PTEE), high density polyethylene (HDPE), polyetheretherketone (PEEK), polypropylene (PP), polysulfone (PSU), polyphenylene sulfide (PPS), chloride of chloride polyvinyl (in particular type 1 (PVC, type 1) or type 2 (PVC, type 2)), polyvinylidene fluoride (PVDF), polytetrafluoroethylene (PTFE), polyamide-imide (PAI), polyethylene to ultra-high molecular weight (UHMW) and also coated (with an acid-resistant material, in particular an acid-resistant polymer). In yet another embodiment, good materials for the applicator tip, the actuating rod and / or said spring can be independently selected from the group consisting of high density polyethylene (HDPE), low density polyethylene (LDPE) ), polyamide (PA), polycarbonate (PC), polyethylene terephthalate (PET) (including for example polyethylene terephthalate glycol, PETG), polymethylpentene (PMP), polyoxymethylene (POM), polypropylene (PP) , polystyrene (PS), polysulfone (PSU), polyvinyl chloride (in particular rigid (PVC HART) and flexible (PVC WEICH), styrene acrylonitrile (SAN), ethylene-chlorotrifluoroethylene (ECTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polytetrafluoroethylene (PTFE), polyvinylidene fluoride (PVDF), diene ethylene propylene rubber (EPDM), fluorocarbon rubber (FPM) , and butadiene-acrylonitrile (nitrile) rubber (NBR). rials are particularly resistant against the acidity of an acidic liquid. In the most preferred embodiment, the applicator tip comprises polyoxymethylene (POM).

In a preferred embodiment, the actuating rod and / or said spring are made of polyoxymethylene (POM). POM is a relatively inert material which advantageously exhibits good adhesion resistance, which prevents film formation on or along the actuator, while exhibiting good mechanical properties such as high resistance, rigidity, high crystallinity, good resistance to fatigue, and is sufficiently waterproof. The combination of these characteristics makes the POM particularly well suited for the parts of the assembly which come into contact with the medical composition.

In another preferred embodiment, the actuating rod and / or said spring are provided according to FIGS. 10D and 10F. This design for the actuating spring is advantageous to use in combination with thermoplastic materials, including, but not limited to, POM. Thermoplastics generally exhibit fatigue from the effect of loads applied repeatedly, such as repetitive actuation of the medical device. This makes the compression springs unwanted. The rod-spring designs according to Figures 10D, 10F and also 9B minimize the effect of fatigue.

In a preferred embodiment, said medical device further comprises a nail file. This nail file can, but is not an obligation, be attached to said medical device in any way. The advantage of the nail file is the comfort for the client to always be able to modify the application of the medical composition. In a more preferred embodiment, the medical container and the actuation mechanism are contained in a housing. This housing may further comprise a fixing means for the nail file. In the most preferred embodiment of the present invention, the nail file can be slid into the housing. The possibility of easily carrying a nail file with the medical device allows the user to adjust the application of the medical composition, as well as to use the nail file for conventional use. In addition, it can help pass the medical device off as a nail kit, since patients often prefer discretion.

In a preferred embodiment, the medical device further comprises a removable cap to protect the applicator tip. The plug can be placed on the tip to prevent damage to the tip or accidental actuation of the actuation mechanism. In a more preferred embodiment, the stopper reduces the risk of leaks or droplets of medical composition escaping from the tip. This provides comfort and cleanliness for the end user and helps preserve the medical composition. When used with a medical composition comprising a film-forming polymer, it also reduces the curing of the medical composition in unwanted locations, such as inside the tip or near the actuating mechanism.

In another preferred embodiment, the plug comprises a leaking container. This leak container tightly closes the mouthpiece opening, in particular. In a more preferred embodiment, this leak container is impermeable to liquids. In the most preferred embodiment, the leak container and its fitting on the mouthpiece opening are hermetically sealed, and therefore impermeable to liquids and gases. This prevents volatile substances, such as a solvent, from escaping the medical composition. This is advantageous for the shelf life of the medical composition. In addition, it prevents hardening of the medical composition inside the tip.

In the second aspect, the present invention provides a kit comprising a medical device for the topical treatment of a disease in a subject in need thereof, comprising:

- a medical container comprising a medical composition;

- an applicator tip having an opening for the application of said composition to said medical subject, an actuation mechanism for controlling said applicator tip, and a housing for a medical container.

More specifically, the present invention provides said kit, whereby said medical container is closed hermetically with a penetrable seal; and said actuating mechanism comprises an actuating rod which is movable between (i) a first position in which said actuating rod closes said opening of said applicator tip, and (ii) a second position in which said applicator tip is in an open position and into which said actuating rod penetrates said penetrable lid of said medical container, thus forming a passage to allow fluid communication between said medical container and said applicator tip.

This kit allows the medical device it contains to be refilled. The medical container is an exchangeable and interchangeable part. Some resistant fungal infections can take a long time to treat and may require using the value of multiple medical containers of medical composition. For these users, a kit is advantageous. The design of larger medical devices to contain a greater amount of said medical composition according to the first aspect leads to bulky, inconspicuous and inconvenient medical devices. The kit according to the second aspect does not pose these problems.

The third aspect of the present invention is a method for the treatment of an infection using a medical device, comprising the steps consisting in:

[0110] - providing a medical device comprising a medical container containing a medical composition, an applicator tip for applying said medical composition, and an actuation rod for controlling said application,

- actuate the actuating rod to facilitate the communication of fluid between the medical container and the applicator tip.

The advantage of the method compared to an application of medical compositions with vial and file is a simpler, faster and more precise application. In addition, dosage control is improved when using an actuation mechanism that produces doses of identical size.

In a preferred embodiment of said method for treating an infection, the medical container of the medical device is hermetically closed by a penetrable seal, which method further comprises:

- penetrate the penetrable seal with the actuating rod.

The advantage of this process is an extended shelf life of the medical composition in the medical container before the first use. It also allows the use of volatile, degrading, chemically reactive, or otherwise transformative or modifying components. An example of such chemically reactive components are the film-forming polymers of a preferred embodiment of the first aspect.

The invention is described in more detail by the following nonlimiting examples which illustrate the invention and are not intended, nor should they be interpreted so as to limit the scope of the invention.

EXAMPLES

It is assumed that the present invention is not limited to any embodiment described above and that certain modifications can be added to the manufacturing example presented without calling into question the appended claims. For example, the present invention has been described with reference to the topical treatment of infections, but it is clear that the invention can be applied to any topical medical composition.

These examples include preferred embodiments of the invention, and will be clarified by the figures.

EXAMPLE 1

Medical device

The entire medical device is shown in Figure IA. The medical device 1 comprises a medical container 3, which comprises a medical composition 11 suitable for the treatment of onychomycosis. The medical device comprises an applicator tip 6 and an actuating mechanism, which consists of an actuating rod 5 and a compression spring 9. The medical device further comprises a housing 2 having a tubular shape with a distal end and a proximal end and a medical container hermetically closed by a sealing ring 4 enclosed in the housing. The tip has a distal end formed for direct application of a fungicide to the nails, and a proximal end. The medical device further comprises a plug 7, which is inserted on the distal end of the tip. This isolates the pharmaceutical composition of the case. The endpiece, screwed onto the medical container, is formed to be telescopically mounted on the distal end of the housing.

Actuation mechanism

The mechanism by which the medical device is actuated is shown in Figures IC and 1D. A new medical device which has not been used is shown in Figure IA. This shows a penetrable seal which is closed, without fluid in the actuation mechanism and near the end piece. In this state, the medical device has an extended shelf life.

During the first actuation, the rod perforates the penetrable seal 10. This allows the fluid, which is the medical composition 11, to flow along the channels in the actuation rod towards the end of the end piece, through which it is applied topically. The device is actuated by applying a force to the end of the tip, preferably by pressing the medical device against a surface to which the medical composition is to be applied. When the force is released, the control rod returns to the position closed by the spring. The penetrable lid will remain open, which leads to continuous fluid communication in the channels along the actuating rod. This is illustrated in Figure 1E. The film-forming polymer forms a self-sealing film 12, especially around the tip of the tip. This improves the seal and prevents the pharmaceutical composition from leaking.

Housing

Figures 2A and 2B show a longitudinal and transverse section of the housing. This case holds the medical device together and protects other parts such as the medical container, which helps keep children safe.

The housing has a semi-open tubular shape. The distal opening 21 allows the placement of medical containers and other parts inside the housing. The outermost edge near the opening is provided with a groove 23 for mounting the end piece on the housing. The closed proximal end has a convex closure 22. The side of the housing further includes a notch 25 adapted to hold a nail file. This notch is shaped to hold said nail file, the edges of the notch 26 preventing the file from moving laterally. The notch opens into an opening 24 in the housing, through which the nail file can be slid. In this way, the nail file is mainly contained inside the case, next to the medical container. This further limits the movement of the nail file. The notch has a greater thickness near the opening in the form of a button 27. This ensures that the nail file cannot slide in and out of the case without the application of a minimum quantity. by force.

Medical container

The medical container is shown in Figure 3. It is an amber glass medicine bottle 31. The medical container is open 33 and has a thread 32. This male thread 32 fits with the thread 65 of the nozzle, which allows the actuating mechanism, the sealing ring and the medical container to remain closed, unless a force is applied once assembled.

The medical container comprises a medical composition 11 suitable for treating onychomycosis. The medical composition consists of 6.4% by weight of amorolfine hydrochloride, 15% by weight of a film-forming polymer, 1.2% by weight of triacetin, 5.5% butyl acetate, 16.5 % ethyl acetate and 55.4% ethanol. The film-forming polymer is poly (ethyl acrylate-methyl eco-methacrylate-trimethylammonioethyl methacrylate chloride) 1: 2: 0.2.

Watertight ring

A cross-sectional view and a side view of the sealing ring are shown in Figures 4A and 4B, respectively. The sealing ring 4 is a plastic cylindrical ring with an essentially uniform internal diameter D and an essentially uniform external diameter D _E. The seal ring has a distal end and a proximal end. The proximal end of the ring includes a penetratable seal 10.

The plastic ring is formed by injection molding of high density polyethylene. Injection molding uses an entry point, a point where the polymer is injected into the matrix. The entry point 41 of the polymer is along the edge of the ring, where it is flattened. This flattening of the ring facilitates injection molding. It is important that the entry point is not radial, since the radial planar surfaces of the ring must be smooth for its functionality. Since the entry point is generally not smooth, the entry point should be axial. This flattening leads to a smaller outside diameter, D _E. The ring also comprises a small rib 42 which improves the closure between the side of the ring and the inside of the end piece. At the proximal end of the sealing ring, a penetratable sheet is attached. In addition, the inside diameter near this penetratable sheet D _o is smaller than D _b

The penetratable sheet 10 comprises 3 layers: a 2k gold colored lacquer, a layer of aluminum and a layer of polymer. The gold-colored lacquer weighs approximately 1.5 g / m ² . The aluminum layer consists of flexible tempered aluminum and the layer has a thickness of about 37μ. The polymer layer is a coextrusion coating which weighs 30 g / m ² . The total weight of the sheet is 130 g / m ² , with an average thickness of 68 μ. The sheet offers good mechanical properties, in particular very low permeability for a wide range of volatile products. Damage to the penetrable seal such as scratches is visible due to the contrast between the gold lacquer and the layers of aluminum and polymer. Actuating rod

A perspective of the rod is shown in Figure 5A and a side view of the actuating rod is shown in Figure 5B. The rod 5 is a narrow longitudinal plastic element. It has a distal end, a center and a proximal end, where the distal end passes through the distal opening of the tip.

The distal end of the rod has a distal tip 51 and a distal base 52. The distal end and the distal base both have tubular shapes. The distal tip has an outside radius D _A smaller than the inside radius of the distal opening of the endpiece. The distal base has an outside radius D _B greater than the inside radius of the distal opening of the endpiece. When the distal base of the rod is pressed against the distal opening of the nozzle, no fluid can pass, which is the closed position of the actuating rod. However, if the rod is pushed in the proximal direction, there is space for fluid to flow past the rod through the nozzle, which is the open position of the actuating rod.

The center of the rod has the largest outside diameter. Rather than tubular, the central and proximal ends of the rod consist of four equidistant wings 54. Between these wings are longitudinal channels 53, so that the pharmaceutical fluid can circulate. At the distal side, the wings have a central outside diameter slightly greater than the diameter of the coil. More proximally, the wings have an outside diameter smaller than the diameter of the coil. This allows the coil to lodge around the distal end while the proximal end of the actuator rod bends the coil when proximal pressure is applied. The coil then provides a reactive pressure which urges the actuating rod towards the closed position.

The proximal end of the rod contains a notch 55 in one of the wings. This notch is designed to move the fluid, based on the Archimedes principle. The volume of the notch is related to the single dose of medical product that is supplied during a single actuation of the actuating rod, due to the volume of liquid that is displaced. The proximal end 56 of the rod is a flat surface. This flat surface is not perpendicular to the axis of the stem, but is inclined to provide an acute angle for piercing the sheet.

End cap

A side view of the tip is shown in Figure 6A. A perspective of the tip is shown in Figure 6B. End piece 6 is a tubular cone-shaped structure with a smooth surface. It is made of polyoxymethylene (POM) and has an opaque white color. The tip has a distal end formed for direct application of a fungicide to the nails, and a proximal end. The tip has a distal opening 61 for the application of a fungicidal medical composition and a proximal opening, for attachment to the housing. The inside diameter at the distal end is considerably smaller than the inside diameter at the proximal end.

The tip has a base 62, which has an outside diameter D _K , which is substantially identical to the inside diameter of the housing. The endpiece further comprises a groove 63, corresponding to the key of the housing, consisting of a crest 64 having an inside diameter equal to the outside diameter of the key. This groove and key mechanism ensures good closure between the housing and the end piece.

Inside the base of the tip, near the proximal end, there is an internal thread 65 which corresponds to the external thread 32 of the medical container. The sealing ring 4 is placed on the distal end of the medical container 3, with the sheet hermetically closing the medical container. The coil is then placed on the distal end of the seal ring, followed by the rod which is placed in the coil. The assembly of the rod, the coil, the sealing ring and the medical container can be placed in the nozzle, after which the medical container can be screwed. This tip-container assembly can then be mounted telescopically in the housing. The thread is characterized by DIN 168 GL18 with a pitch of 3 mm.

From the distal end of the endpiece, it has a series of increasing internal diameters, so that the distal opening 61 has the smallest internal diameter D _n , slightly larger than the external diameter D _A from the distal end of the actuating rod, but less than the outside diameter D _B of the actuating rod. The second internal diameter D _c is larger than the external diameter D _B of the actuating rod. The diameter then increases further to be able to contain the wings of the actuating rod, and even more to contain the sealing ring. In addition, the end piece comprises a flat tubular surface 67 on which the sealing ring rests when the end piece-container assembly is assembled.

Plug

The plug 7 is a knotty rounded cone of transparent and dark blue appearance. It is manufactured by injection molding of polymethylmethacrylate, PET, polyoxymethylene or a copolymer thereof. The cap has six planes of symmetry. The cap has a smooth exterior and interior surface. The outside of the plug has two opposing gripping areas 71, comprising concave notches on the outside of the plug. The interior of the plug has a leak container 72 which is tubular in shape 73 with an inclined edge 75. When the plug is placed on the tip, the tip of the tip is inserted inside the inclined edge 75 of this leaking container, pushing the tubular shape outward and ensuring a tight fit at the end of the inclination 74. This makes it possible to prevent a leaking nozzle from leaking into the rest of the stopper . In addition, the inner surface of the stopper is reinforced by six grooves parallel to the axis of the cone, placed hexagonally.

Nail file

The nail file 8 is shown in Figures 8A and 8B. In this example, the nail file is parallelepiped, but this is not essential for its function. It has 81 rounded ends to prevent accidental injury. The side with the largest surface of the parallelepiped is rough, to allow filing of the nails. The two flat sides of the file have the same grain, and can both be used to file the nails. The narrow edge 82 is smooth. The external dimensions of the nail file are slightly smaller than the internal dimensions of the nail file holder 25 of the housing.

Spring

The spring 9 is a compression spring. The compression spring is not drawn in detail.

Example 2

The second example corresponds to the assembly of a medical device according to FIG. 9A. This medical device comprises a housing 2 ’, a medical container 3, a rod-spring assembly 5’, a nozzle 6 ’and a plug 7’. The case 2 ’, the medical container 3, the tip 6’ and the cap 7 ’show different designs, but are functionally identical to the medical device according to Example 1.

Compared to Example 1, Example 2 presents a rod-spring assembly 5 'which replaces the actuating rod 5, the separate spring 9 and the separate sealing ring 4. The spring assembly- rod 5 'comprises a fixing ring 4' which functions in a similar manner to the sealing ring 4. This fixing ring 4 'remains fixed on top of the medical container 3' during use. The penetratable seal 10 ’is fixed to the proximal side of the fixing ring 4’. A spring mechanism 9 ’is attached to the distal side of the fixing ring 4’, to which the actuating rod is connected. The actuating rod comprises a distal base 52 ’and a distal tip 51’, which perform the same function as in example 1. The penetratable seal must be pierced manually before first use. Alternatively, a tip adapted to break the penetrable lid can be attached to the proximal side of the spring mechanism 9 '(not shown).

Advantageously, this set contains fewer parts and, more importantly, fewer small parts. This promotes security and ease of assembly of the pen. In addition, the spring-rod assembly can be made of plastic or other materials. This means that the medical composition does not come into contact with metal. This is necessary for certain medical compositions in order to avoid oxidation or other undesirable reactions, and improves the life and stability of the medical composition.

Example 3

The third example corresponds to the assembly of a medical device according to FIG. 9A, completely identical to example 2, with the exception of the spring-rod assembly 5 ". The new rod-spring assembly is shown in Figure 9C.

This rod-spring assembly again includes a 4 ”fixing ring, to which a penetratable cover (not shown) is fixed on the proximal side and a 9” spring mechanism is fixed on the distal side. The actuator rod is attached to the 9 "spring mechanism and includes a 51" distal tip and a 52 "distal base. The penetrable lid must be pierced manually before the first use.

As in Example 2, this set contains fewer parts. In addition, the 9 ”spring mechanism can be produced from a variety of materials, including plastics and sufficiently elastic metals. This allows the pen to be used in combination with medical compositions which are sensitive to materials.

Example 4

The third example corresponds to the assembly of a medical device according to FIG. 10A. The assembly is shown telescopically in Figure 10B. This medical device comprises a housing 2, a medical container 3, a spring-loaded assembly 5 ”, a sealing ring 4”, a nozzle 6 and a plug 7 and a nail file 8. The housing 2, the medical container 3, the nozzle 6, the plug 7 and the nail file 8 shown are identical to Example 1.

The spring-rod assembly 5 '”is similar to the actuation rod 5 of Example 1, including a distal tip 51”', a distal base 52 '”, longitudinal channels 53'”, four equidistant wings 54 '”, a notch 55'” and a proximal end 56 ”. However, rather than being actuated by a separate spring 9, two wings 54 ”’ are provided with a spring mechanism 9 ’”. The 5 ″ rod spring assembly is preferably made of polyoxymethylene (POM) to provide sufficient elasticity and mechanical strength, as well as good fatigue resistance of the material.

The rod-spring assembly 5 ″ is accompanied by a sealing ring 4 ″. The sealing ring 4 ”'is similar to the sealing ring 4 of Example 1, encompassing the annular structure as well as the penetratable cover 10. However, rather than an internal diameter D, which is largely uniform and a smaller internal diameter D _o near the penetrable seal, the sealing ring 4 '”has a gradual transition between the internal diameter D, distal and the internal diameter D _o proximal near the penetratable cover. This allows the 9 '”spring mechanism, when providing outward pressure, to bias the spring-rod assembly to the closed position.

Advantageously, this assembly requires fewer parts and the medical composition does not come into contact with metals. In addition, the penetrable lid can always be replaced by exchanging sealing rings. The design of the rod, in particular the longitudinal shape with longitudinal channels 53 "and the notch 55" allow good control of the dosage.

Claims (1)

Claims [Claim 1] Medical device for the topical treatment of a disease in a subject in need thereof, comprising: - a medical container comprising a medical composition, - an applicator tip having an opening for the application of said medical composition to said subject, and - an actuation mechanism for controlling said applicator tip, characterized in that said medical container is hermetically sealed with a penetrable seal; and in that said actuating mechanism comprises an actuating rod which is movable between (i) a first position in which said actuating rod closes said opening of said applicator tip, and (ii) a second position in which said tip applicator is in an open position and in which said actuating rod pierces said penetrable lid of said medical container, thus forming a passage to allow fluid communication between said medical container and said applicator tip. [Claim 2] The medical device according to claim 1, wherein said medical composition comprises a film-forming polymer in an amount of 1 to 25% by weight relative to the total weight of said medical composition. [Claim 3] A medical device according to any one of the preceding claims 1-2, wherein said actuating mechanism comprises a spring for biasing said actuating rod in said first position, preferably a thermoplastic spring. [Claim 4] A medical device according to any one of the preceding claims 1-3, wherein said actuating rod, when moved from the first closed position to the second open position displaces a volume of the medical composition equal to a single unit dose of said medical composition. [Claim 5] A medical device according to any one of the preceding claims 1-4, wherein said actuating rod is biased towards said first position in which said actuating rod closes said opening of said applicator tip. [Claim 6] A medical device according to any one of the preceding claims 1-5, wherein said penetrable seal comprises a aluminum layer. [Claim 7] A medical device according to any one of the preceding claims 1-6, further comprising a sealing ring, which comprises said penetratable seal, adapted to hermetically seal said medical container before first use. [Claim 8] A medical device according to any one of the preceding claims 1-7, wherein said medical container is a glass container. [Claim 9] A medical device according to any one of the preceding claims 1-8, wherein said medical composition is a fungicidal solution, preferably comprising amorolfine, more preferably between 1 and 20% by weight of amorolfine relative to the total weight of said medical composition. [Claim 10] A medical device according to any one of the preceding claims 1-9, wherein said actuator rod includes longitudinal channels to facilitate the flow of the medical composition along the actuator rod. [Claim 11] A medical device according to any one of the preceding claims 1-10, wherein said medical device further comprises a nail file. [Claim 12] A medical device according to any one of the preceding claims 1-11, wherein said medical device further comprises a removable cap adapted to protect the applicator tip. [Claim 13] Kit comprising a medical device for the topical treatment of a disease in a subject in need thereof, comprising: - a medical container comprising a medical composition; - an applicator tip having an opening for applying said composition to said medical subject, an actuation mechanism for controlling said applicator tip, and a housing for a medical container, characterized in that said medical container is hermetically sealed with a penetrable seal; and in that said actuating mechanism comprises an actuating rod which is movable between (i) a first position in which said actuating rod closes said opening of said applicator tip, and (ii) a second position in which said tip applicator is in an open position and in which said actuating rod pierces said penetrable lid of said medical container, thus forming a passage to allow fluid communication between said medical container and said applicator tip. [Claim 14] A method of treating an infectious disease using a medical device comprising the steps of: - provide a medical device comprising a medical container containing a fungicidal medical composition, an applicator tip for applying said fungicidal medical composition, and an actuating rod for controlling said application, - actuate the actuating rod to facilitate fluid communication between the medical container and the applicator tip. [Claim 15] Method for treating a fungicidal infection according to claim 14, in which the medical container of the medical device is hermetically sealed by a penetrable seal, which method further comprises: - penetrate the penetrable lid with the actuating rod. 1/8