DE102019133545A1 - MEDICAL DEVICE FOR TOPICAL TREATMENTS - Google Patents

Abstract

The present invention relates to a medical device for treating a fungal infection in a subject which needs it, the device comprising: a medical container comprising a fungicidal medical composition, an applicator nozzle with an opening for applying the fungicidal medical composition to the subject and an actuation mechanism for controlling the applicator nozzle, characterized in that the medical container is sealed with a penetrable seal, and in that the actuation mechanism comprises an actuation shaft that between (i) a first position in which the actuation shaft closes the opening of the applicator nozzle , and (ii) a second position, in which the applicator nozzle is in an open position, is movable, and wherein the actuating shaft penetrates the penetrable seal of the medical container, whereby a fluid connection between the m medical container and the applicator nozzle is made possible.

Description

FIELD OF THE INVENTION

The present invention relates to a medical device for the treatment of dermatological disorders and a method for using the same. The present invention relates in particular to a medical applicator with which a fungicidal composition can be applied to dermatological disorders, such as, for example, nail fungus.

STATE OF THE ART

CN 103 764 219 discloses a medical applicator for topical treatment of dermatological problems. A disadvantage of the above-mentioned devices is the permeation of certain gases through the seals of bottles as well as the plastic of the bottle. Ethanol migrates through most plastics at the thickness used for blow molded containers.

Manufacturers have devised methods of eliminating this permeation, such as packaging in glass ampoules or by using plastics with gas barrier properties, such as polyethylene terephthalate (PET). PET significantly reduces permeation if a sufficient cross-section is provided in the packaging; however, the current devices use blow molded containers in combination with conventional caps. The caps thus become the weakest part of these systems and leak due to a leaky seal (PET / film) or as a result of the caps being released.

In addition, current container designs use conventional single welded inner seals as a means of sealing the contents of the bottle. The size of the bottle cap and the force with which it is attached to the bottle thus becomes critical in order to maintain the force for mechanically strengthening the film over time. Loosening the cap is a common shortcoming and often leads to bottle leakage - especially if the system has to be stored for a long time before use. Such an applicator is in the German patent application DE 102 007 046 600 A1 disclosed.

Some medical applicators, like brushes, use fibers to apply liquid medical solutions to a target area. These fibers tend to hold some fluid, especially after the applicator has been used. This leads to stiff fibers that stick together by components from the medical solution. Furthermore, especially with nail fungus, this can lead to a fungus being transferred from one nail to another, since these fibers are difficult to keep sterile. As a result, these applicators require a lot of maintenance for correct use. Such applicators are in the Chinese patent CN 206 492 102 U explained.

WO 2016/142305 discloses an applicator for topical application of an acidic liquid, the applicator comprising a container containing the acidic liquid, the container comprising an opening in fluid contact with a tip for controlled delivery of the acidic liquid, the tip having multiple fibers and one attached adhesive fibers adhering to the fibers. A set of parts for topical application of an acidic liquid is also disclosed, the set of parts comprising a liquid delivery unit comprising a tip for controlled delivery of the acidic liquid and a container unit comprising a container designed for the purpose containing acidic liquid, the container unit further comprising a liquid dispensing element for applying the acidic liquid to the tip, the tip comprising a plurality of fibers and an adhesive material adhering to the fibers. However, such devices do not provide adequate or reliable closure of the applicator and thus allow at least partial loss of the acidic liquid through evaporation.

It is therefore desirable to overcome the disadvantages and deficits of the prior art with a medical skin applicator. It would be desirable if the skin applicator could be placed in a reverse orientation during use and a liquid and / or gas tight seal of the applicator could be ensured. It would be highly desirable if the medical skin applicator and its components were easy and efficient to manufacture and assemble.

SUMMARY OF THE INVENTION

The present invention provides a medical device for treating fungal infections according to the claims.

• - einen medizinischen Behälter, der eine medizinische Zusammensetzung umfasst,
• - eine Applikatordüse mit einer Öffnung zum Aufbringen der medizinischen Zusammensetzung auf das Subjekt und
• - einen Betätigungsmechanismus zum Steuern der Applikatordüse.

In a first aspect, the present invention provides a medical device for topically treating a subject's disease that needs it, the device comprising:

• - a medical container comprising a medical composition,
• an applicator nozzle with an opening for applying the medicinal composition to the subject and
• - An actuating mechanism for controlling the applicator nozzle.

In particular, the present invention provides the medical device, wherein the medical container is sealed with a penetrable seal, and in that the actuation mechanism comprises an actuation shaft that between (i) a first position in which the actuation shaft closes the opening of the applicator nozzle, and (ii) a second position, in which the applicator nozzle is in an open position, is movable, and wherein the actuating shaft pierces the penetrable seal of the medical container, thereby forming a passage that fluidly connects the medical container and the applicator nozzle enables.

The penetrable seal is a good barrier against gases and solvents. As a result, the low permeability of the medical container before use increases the durability of the medical device. Furthermore, a nozzle applicator is used over a brush or fiber applicator. The smooth surface of a nozzle applicator is easier to clean and sterilize. Finally, the actuation mechanism enables controlled application of medical doses of the fungicidal medicinal composition.

• - einen medizinischen Behälter, der eine medizinische Zusammensetzung umfasst,
• - eine Applikatordüse mit einer Öffnung zum Aufbringen der medizinischen Zusammensetzung auf das Subjekt, einen Betätigungsmechanismus zum Steuern der Applikatordüse und ein Gehäuse für einen medizinischen Behälter.

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

• a medical container comprising a medical composition,
• an applicator nozzle with an opening for applying the medical composition to the subject, an actuating mechanism for controlling the applicator nozzle and a housing for a medical container.

In particular, the present invention provides the set, wherein the medical container is sealed with a penetrable seal, and in that the actuation mechanism comprises an actuation shaft that between (i) a first position, in which the actuation shaft closes the opening of the applicator nozzle, and (ii) a second position, in which the applicator nozzle is in an open position, is movable, and wherein the actuating shaft pierces the penetrable seal of the medical container, thereby forming a passage that allows fluid communication between the medical container and the applicator nozzle .

• - Bereitstellen einer medizinischen Vorrichtung, die einen medizinischen Behälter, der eine fungizide medizinische Zusammensetzung enthält, eine Applikatordüse zum Aufbringen der fungiziden medizinischen Zusammensetzung und ein Betätigungselement zum Steuern des Aufbringens umfasst,
• - Betätigen des Betätigungselements, um eine Fluidverbindung zwischen dem medizinischen Behälter und der Applikatordüse zu unterstützen.

In the third aspect, the present invention provides a method for treating a fungal infection by operating a medical device, comprising the following steps:

• Providing a medical device which comprises a medical container which contains a fungicidal medical composition, an applicator nozzle for applying the fungicidal medical composition and an actuating element for controlling the application,
• Actuating the actuating element to support a fluid connection between the medical container and the applicator nozzle.

Figure list

• 1A shows a schematic overview of a possible embodiment of the medical device.
• 1B shows a schematic overview of a possible embodiment of the structure of the medical device.
• 1C shows a possible embodiment of the actuation of the medical device.
• 1D shows a possible embodiment of the use of a possible embodiment of the medical device.
• 1E shows a schematic overview of a possible embodiment of the medical device after the penetrable seal has been pierced.
• 2A shows a longitudinal sectional view of a possible embodiment of the housing according to the present invention.
• 2 B shows a side sectional view of a possible embodiment of the housing according to the present invention.
• 3rd shows a possible embodiment of the medical container.
• 4A shows a cross-sectional view of a possible embodiment of the sealing ring according to the present invention.
• 4B shows a perspective view of a possible embodiment of the sealing ring according to the present invention.
• 5A shows a detailed perspective view of a possible embodiment of a Actuator stem according to the present invention.
• 5B shows a cross-sectional view of a possible embodiment of an actuating shaft according to the present invention.
• 6A shows detailed cross-sectional view of a possible embodiment of an applicator nozzle according to the present invention.
• 6B shows a perspective view of a possible embodiment of an applicator nozzle according to the present invention.
• 7A shows a radial view of a possible embodiment of a cap according to the present invention.
• 7B shows an axial view of a possible embodiment of a cap according to the present invention.
• 8A shows a cross-sectional view of a possible embodiment of a nail file according to the present invention.
• 8B shows a cross-sectional view of a possible embodiment of a nail file according to the present invention.
• 9A shows a schematic overview of an alternative possible embodiment of the structure of the medical device.
• 9B shows a perspective view of an alternative possible embodiment of an actuating shaft according to the present invention.
• 9C shows a perspective view of an alternative possible embodiment of an actuating shaft according to the present invention.
• 10A shows a schematic overview of a preferred embodiment of the medical device.
• 10B shows a schematic overview of a preferred embodiment of the structure of the medical device.
• 10C shows a cross-sectional view of a preferred embodiment of the sealing ring according to the present invention.
• 10D shows a detailed perspective view of a preferred embodiment of the actuating shaft and a spring according to a preferred embodiment of the medical device.
• 10E shows a cross-sectional view of a preferred embodiment of the actuating shaft and the spring according to a preferred embodiment of the medical device.

DETAILED DESCRIPTION OF THE INVENTION

Unless otherwise defined, all terms used in the disclosure of the invention, including technical and scientific terms, have the meaning commonly understood by one of ordinary skill in the art to which the invention belongs. With further guidance, definitions of terms are included to better understand the teachings of the present invention.

• „Ein/eine/einer“ und „der/die/das“ bezeichnen, wenn im Vorliegenden verwendet, Bezeichnetes sowohl im Singular als auch im Plural, es sei denn, der Zusammenhang gibt eindeutig anderes vor. Zum Beispiel bezeichnet „ein Fach“ ein oder mehr als ein Fach.
• „Etwa“ bezeichnet, wenn im Vorliegenden verwendet, einen messbaren Wert, wie beispielsweise einen Parameter, einen Betrag, eine zeitliche Dauer und dergleichen, und soll Varianten von +/-20% oder weniger, vorzugsweise +/-10% oder weniger, bevorzugter +/-5% oder weniger, noch bevorzugter +/-1% oder weniger und noch stärker bevorzugt +/-0,1% oder weniger des spezifizierten Wertes einschließen, insoweit derartige Varianten geeignet sind, die offenbarte Erfindung durchzuführen. Es versteht sich jedoch, dass der Wert selbst, auf den sich das Attribut „etwa“ bezieht, ebenfalls speziell offenbart ist.
• „Umfassen“, „umfassend“ sowie „umfasst“ und „bestehend aus“ sind, wenn im Vorliegenden verwendet, Synonyme von „beinhalten“, „beinhaltend“, „beinhaltet“ oder „enthalten“, „enthaltend“, „enthält“ und sind einschließende oder offene Begriffe, die das Vorhandensein des darauf Folgenden spezifizieren, zum Beispiel Komponente, und das Vorhandensein weiterer, nicht angeführter Komponenten, Merkmale, Elemente, Schritte, die auf dem Fachgebiet bekannt oder im Vorliegenden offenbart sind, nicht ausnehmen oder ausschließen.
• Das Anführen numerischer Bereiche durch Endpunkte beinhaltet alle Zahlen und Bruchteile, die in diesem Bereich zusammengefasst sind, sowie die angeführten Endpunkte.

When used herein, the following terms have the following meanings:

• “One” and “the / that”, when used in the present, designate both in the singular and in the plural, unless the context clearly states otherwise. For example, "a subject" means one or more than one subject.
• “About”, when used herein, means a measurable value, such as a parameter, an amount, a duration, and the like, and is more preferred to be variants of +/- 20% or less, preferably +/- 10% or less Include +/- 5% or less, more preferably +/- 1% or less, and even more preferably +/- 0.1% or less of the specified value insofar as such variants are suitable for carrying out the disclosed invention. However, it goes without saying that the value itself, to which the attribute “about” refers, is also specifically disclosed.
• “Comprehensive”, “comprehensive”, “comprising” and “consisting of”, if used in the present case, are synonyms of “contain”, “contain”, “contain” or “contain”, “contain”, “contain” and are inclusive or open terminology that specifies the presence of the following, for example component, and does not exclude or exclude the presence of other components, features, elements, steps not known, that are known in the art or disclosed herein.
• Citing numeric ranges by endpoints includes all numbers and fractions that are summarized in this range, as well as the listed endpoints.

The term "percent by weight" or "% by weight" refers here and throughout the description to the relative weight of the corresponding component based on the total weight of the formulation, unless otherwise defined.

Terms of spatial reference, such as “below,” “below,” “lower,” “above,” “upper,” and the like, may be used herein to facilitate description of a relationship of an element or feature to other elements or features to describe how it is shown in the figures. It goes without saying that the terms of the spatial reference should also include other orientations of the device during use or operation in addition to the orientations shown in the figures. For example, if the device in the figures is turned over, elements described as “below” or “below” other elements or features would then be “above” the other elements or features. Thus, the exemplary term "under" can include an alignment above as well as below. The device may be oriented in other ways (rotated 90 degrees or in other orientations) and the spatial reference descriptors used herein are to be interpreted accordingly. Likewise, the terms "upward", "downward", "vertical", "horizontal" and the like are used herein for purposes of illustration only, unless specifically stated otherwise.

It is understood that although the terms first, second, etc. may be used herein to describe different elements, components, regions, layers and / or sections, these elements, components, regions, layers and / or sections do not are to be limited by these terms. These terms have only been used to distinguish an element, component, region, layer, or section from another region, layer, or section. Thus, a first element, a first component, a first region, a first layer or a first section, which are explained below, can be referred to as a second element, a second component, a second region, a second layer or a second section without departing from the teachings of the present invention. The sequence of operations (or steps) is not limited to the order presented in the claims or figures unless specifically stated otherwise.

The term “sterile” denotes a surface and / or a device that is essentially free of foreign substances or unwanted microorganisms. The word "sterility" or "sterile" and its derivatives refer to a defined medical sterility standard, which is typically set by a regulatory authority. In order to achieve the desired sterility, the dosing container or another component can be manufactured (filled and sealed) at a plant with a controlled standard cleanliness, such as a plant of the "Class 100,000" or better. The manufacturing / filling facility may be a "Class 100" facility or other suitable facility with sterile and / or aseptic or clean room conditions to maintain a desired state of cleanliness or sterility until or during dispensing / use. Alternatively, the device can be packaged and then sterilized. The term “class 100” refers to a facility that has fewer than 100 particles per cubic meter of clean room. The term “class 100,000” refers to a facility that has fewer than 100,000 particles per cubic meter of clean room. The clean room can maintain a positive pressure environment. The environment with positive pressure is designed to work in such a way that air flows out of the clean room when entering the room, which limits the possibility of contaminants entering the clean room. Equipment for providing the desired class, such as class 100 status, includes, for example, class 100 laminar flow workstations, class 100 laminar flow hoods, HEPA filters, and the like. The term “sterile or pure removal area” denotes the part of the dosing container that has or maintains the desired purity and / or sterility. In some embodiments, to achieve this, the surface may be sealed until and / or during use, or otherwise protected from contact with environmental conditions.

In some embodiments, the liquid medicament can be any medicament that 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.

• - einen medizinischen Behälter, der eine medizinische Zusammensetzung umfasst,
• - eine Applikatordüse mit einer Öffnung zum Aufbringen der medizinischen Zusammensetzung auf das Subjekt und
• - einen Betätigungsmechanismus zum Steuern der Applikatordüse.

In a first aspect, the present invention provides a medical device for topically treating a subject's disease, the need thereof, the device comprising:

• a medical container comprising a medical composition,
• an applicator nozzle with an opening for applying the medicinal composition to the subject and
• - An actuating mechanism for controlling the applicator nozzle.

In particular, the present invention provides the medical device, the medical container having a penetrable seal is sealed, and in that the actuation mechanism comprises an actuation shaft which is between (i) a first position in which the actuation shaft closes the opening of the applicator nozzle and (ii) a second position in which the applicator nozzle is in an open position , is movable, and wherein the actuating shaft pierces the penetrable seal of the medical container, whereby a passage is formed which enables a fluid connection between the medical container and the applicator nozzle.

The advantage of the penetrable seal used to seal the medical container is a high barrier and thus a low permeability. This low permeability increases the durability of the medical device and ensures that the medical device and composition function as intended.

The actuation mechanism has two positions. The first position is called "closed", the second is called "open". If the actuation mechanism is in the closed position, the actuation shaft closes the applicator nozzle. When the actuation mechanism is in the open position, the actuation shaft enables fluid communication between the medical container and the applicator nozzle along the actuation shaft. If the actuating shaft is moved from the closed position to the open position while the penetrable seal is intact, the actuating shaft will pierce the penetrable seal, whereby the seal becomes a penetrated seal. The penetrated seal does not seal the medical container.

This will open the medical container, allowing fluid communication between the medical container and the applicator nozzle. Furthermore, the actuation mechanism comprises two positions for the actuation shaft. The "operating mechanism" includes the "operating shaft", but can also include other elements.

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

In particular, the applicator can be arranged to deliver substantially the required dose of the medicinal composition (to the topical site to be treated), which prevents overdosing (or a deficiency) of the medicinal composition, causing damage to the skin instead of whose treatment can lead. Consequently, the present applicator and also the liquid dispensing unit proposed herein enable the medical composition to be applied in a targeted manner, whereby the healing of, for example, a lesion is promoted, while essentially not influencing surrounding (healthy) tissue.

The present invention provides the medical device, particularly for use in a topical treatment, such as a nail disease, a skin disease, an oral health problem treatment, a topical problem in intimate areas, skin removal (e.g. to remove a tattoo), etc. The invention also provides a medical composition as defined herein, particularly for use in treating a topological lesion, such as medical treatment. Furthermore, the invention also provides such a medical composition per se, in particular for the treatment of a topological lesion, such as for example in a cosmetic treatment. The invention also provides such a medical composition, in particular for the (acid) treatment of a skin disorder, such as for example in the treatment of a superficial lesion, in particular skin lesions, mucosal lesions and / or nail lesions, viral warts, verrucae, dell warts (Mollusca contagiosa), corns and Calluses, skin hyperpigmentation (such as age spots, solar lentigo, senile lentigo), acne, keratosis pilaris, actinic keratosis, ingrown toenails, nail fungus, eyelid xanthelasma, psoriasis, nail infections, epidermodysplasia of the skin caused by HPV (human varicose vein), papilloma verucomus (nasal vesicular fibrosis) , Wrinkles and melasma. The invention also provides a medicinal composition as defined herein, particularly for use in (acid) treatment of topical oral health problems such as mouth ulcers (mouth ulcers) and lip sores. The invention also provides a medicinal composition as defined herein, particularly for use in (acid) treating topical problems in intimate areas, on mucous membranes and tissues such as hemorrhoids, genital warts. The invention also provides a medicinal composition as defined herein, particularly for use in an (acid) treatment for skin removal purposes, such as a tattoo and / or a fibroma.

MEDICAL CONTAINER

The medical container is preferably made of an acid-resistant material. Good alternative acid-resistant materials for the medical container can be selected from the group consisting of: acid-resistant metals, chlorinated polyvinyl chloride (CPVC), ethylene chlorotrifluoroethylene (ECTFE), (reinforced) polytetrafluoroethylene, (reinforced PTFE), high density polyethylene (HDPE), polyether ether ketone (PEEK), polypropylene (PP), polysulfone (PSU), polyphenylene sulfide (PPS), polyvinyl chloride (especially type 1 (PVC, type 1) or type 2 (PVC, type 2)), polyvinylidene fluoride (PVDF), polytetrafluoroethylene (PTFE) , Polyamideimide (PAI), ultra-high molecular weight polyethylene (UHMW) and also (with an acid-resistant material, especially an acid-resistant polymer) coated metals 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) (inclusive) e.g. polyethylene terephthalate glycol PETG), polymethylpentene (PMP), polyoxymethylene (POM), polypropylene (PP), polystyrene (PS), polysulfone (PSU), polyvinylchloride (especially rigid (PVC HART) and flexible (PVC SOFT), styrene acrylonitrile ( SAN), ethylene chlorotrifluoroethylene (ECTFE), ethylene chlorotrifluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polytetrafluoroethylene (PTFE), polyvinylidene fluoride (PVDF), ethylene propylene diene rubber (EPDM), fluorocarbon rubber (FPM) and acrylonitrile (nitrile) materials are particularly resistant to the acidity of an acidic liquid and it has been found that in particular polypropylene (PP) and polyethylene terephthalate lat (PET) (e.g. Polyethylene terephthalate glycol (PETG)) have good acid resistance to the acids contained in the acidic liquid according to the present invention, while also having a different resistance to other acids. Still, glass is a highly preferred acid-resistant material.

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, based on the total weight of the 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 an 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 medicinal composition comprises egg n film-forming polymer in an amount of 5 to 15% by weight, most 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 amount in between. Medicinal compositions comprising a film-forming polymer in amounts less than 1% by weight cure very slowly, or not at all, once applied to nails as a topical treatment. Medicinal compositions comprising a film-forming polymer in an amount greater than 25% by weight result in compositions that are too viscous.

This film-forming polymer can harden to a film after application. This is beneficial for the topical treatment of nail infections. This is also advantageous for the preservation of the medical composition, since the film-forming polymer has a self-sealing effect. This film-forming polymer can seal inadequate closures when the actuation shaft 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 which comprises methyl methacrylate and / or ethyl acrylate, more preferably the film-forming polymer is a copolymer which comprises methyl acrylate and ethyl acrylate, more preferably the film-forming polymer is poly (ethyl acrylate) comethyl methacrylate-co-trimethylammonioethyl methacrylate chloride). In another preferred embodiment, the film-forming polymer is a copolymer comprising ethyl acrylate monomer and methyl methacrylate monomer, the ratio of ethyl acrylate to methyl methacrylate monomer being 1: 4 to 2: 1, more preferably about 1: 2. Most preferably, the film-forming polymer is poly (ethyl acrylate-co-methyl methacrylate-cotrimethylammonioethyl methacrylate 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 a further preferred embodiment, the medicinal composition comprises a mixture of solvents with varying volatility. In the most preferred embodiment, the medicinal composition in combination with the poly (ethyl acrylate-co-methyl methacrylate-co-trimethylammonioethyl methacrylate chloride) comprises ethanol, ethyl acetate and butyl acetate. This combination is particularly suitable for providing a sufficiently liquid medical composition that quickly forms a hard film that is suitable for the treatment of infected nails. Suitable amounts of solvent are 25 to 85% by weight of solvent, based on the total weight of the medicinal composition, more preferably 30 to 85% by weight of solvent, more preferably 35% to 85% of solvent, more preferably 40% to 85% of solvent, more preferably 45% to 85% solvent, more preferably 50% to 85% solvent, more preferably 55% to 85% solvent, more preferably 60% to 85% solvent, more preferably 65% to 80% solvent, most preferably 66, 67, 68, 69, 70, 71 , 72, 73, 74, 75, 76, 77, 78, 79 wt .-% solvent, based on the total weight of the medical composition, or any amount in between.

Solvents make it easier to dose the biologically active ingredients. Volatile solvents enable the viscosity and curing speed as well as the properties of the film-forming polymer to be optimized. The combination of ethanol, ethyl acetate and butyl acetate is particularly suitable for film-forming polymers based on acrylate. Because of the combination of volatilities, the rate at which the film-forming polymer cures once applied can be optimized while maintaining sufficient viscosity before application.

In one embodiment, the medicinal composition can comprise a plasticizer. Suitable plasticizers are many commonly commercially available plasticizers, such as mono- and polycarboxylic acid esters, polymeric polyesters, polyalkyl ethers, and glycerol and glycol esters. In a further preferred embodiment, the medicinal composition comprises triacetin. Triacetin is also known as 1,2,3-triacetoxypropane. Suitable amounts of plasticizers are up to 5% by weight, based on the total weight of the medicinal composition, preferably up to 4% by weight, more preferably up to 3% by weight. Preferably at least 0.5 wt%, more preferably at least 1 wt%, most preferably at least 1.5 wt%.

Plasticizers are advantageous to optimize the glass transition of the film-forming polymer as well as its mechanical properties and stretching. In addition, plasticizers affect the flow rate of the medicinal composition and the rate at which the film-forming polymer cures. In one embodiment, the medical composition has a sufficiently low viscosity to ensure the fluid connection between the medical container and the applicator nozzle. However, the viscosity must be high enough to prevent the medical composition from running out of the medical device too quickly.

In a preferred embodiment of the invention, the medicinal composition is an antifungal composition. Examples of antifungal agents that can be mentioned are, for example, polyenes, e.g. B. Natamycin, Nystatin; Allylamine, e.g. B. naftifine, terbinafine; Imidazoles, e.g. B. bifonazole, chlotrimazole, econazole, fenticonazole, ketocanazole, miconazole, oxiconazole; Triazoles, e.g. B. fluconazole, itraconazole, terconazole; Tolnaftat, ciclopirox, undecylenic acid, sulbentin and morpholines, e.g. B. Amorolfin and the related morpholines in he U.S. Patent No. 5,120,530 are disclosed. A preferred example of an antifungal composition is an amorolfine solution. In a particularly preferred embodiment, the antifungal medical composition comprises amorolfine, preferably between 1 and 20% by weight of amorolfine, based on the total weight of the antifungal medical composition, more preferably between 2.5 and 10% by weight of amorolfine and most preferably about 3 , 4, 5, 6 or 7 wt .-% amorolfine. Amorolfine is a well-known antifungal medication for morpholine. Its effects in the treatment of onychomycosis and other fungal infections are known. It can be used advantageously with film-forming polymers and is topically effective in nails.

In a further preferred embodiment, the medicinal composition can be an acidic liquid for application to the nail or the skin, which is applied in particular to peel off the skin or the mucous membrane, in particular the skin, as a result of which the skin or the mucous membrane can renew itself. The treatment fluid will have an advantageous effect on the lesion to be treated; the medicinal composition, in particular the acid (s) in the liquid, can have a peeling effect, the liquid, in particular the acid (s), can also provide an oxidizing effect on the lesion. The medical Composition can include various acidic liquids since one or more different liquids can be applied. In particular, the medicinal composition comprises one or more acids selected from acetic acid, trichloroacetic acid (TCA), formic acid (FA), and salicylic acid. The acidic liquid may (further) include one or more acids selected from acetic acid, hydrochloric acid (HCl) and nitric acid (HNO ₃ ). In particular, the medical composition, such as that contained in the medical device, may comprise one or more acids selected from the group consisting of: trichloroacetic acid, salicylic acid, formic acid, glycolic acid, dichloroacetic acid, monochloroacetic acid, acetic acid, citric acid, ascorbic acid, Boric acid, nitric acid, sulfuric acid, phosphoric acid, oxalic acid, lactic acid, hydrochloric acid.

In a special embodiment, the medicinal composition has a pH of less than 6, for example in the range from 2 to 6, preferably in the range from 3 to 5. In yet another embodiment, the acidic liquid can in particular be an acid with a concentration in the range of 0.5 to 10.0% by weight, preferably 0.5-5.0% by weight, more preferably 0.5 to 2.0% by weight. The acidic liquid may also include two types of acids, both at a concentration within the ranges given 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 from 0.3 to 2.0% by weight. In the most preferred embodiment, the medicinal composition comprises acetic acid.

The medical composition may optionally include one or more other ingredients, including one or more other active ingredients. The medicinal composition as described herein may include other ingredients commonly used in cosmetic and pharmaceutical products, such as one or more of the following: a surfactant, a dye, a nail penetrating compound, a skin regenerating compound, a compound that regulates the microenvironment and a perfume.

For example, the medical composition may further include one or more adjuvants. An adjuvant is, in particular, an inactive substance which, in addition to the active ingredients of a product or a medicament, is formulated for the purpose of increasing the volume of the formulations which contain such active ingredients. Auxiliaries can also be referred to as fillers or diluents, for example. Auxiliaries can e.g. B. include one or more of the following: binders, coatings, disintegrants, fillers, flavors, colors, lubricants, lubricants, sorbents, preservatives, sweeteners, etc.

The medicinal composition may also e.g. B. include silk fibroin. Silk fibroin is a protein derived from the hydrolysis of silk fibers that are naturally secreted by the silk spinner (Bombyx mori). There are various applications for silk fibroin in the field of biomedicine, which is due to its high tensile strength, controllable biodegradability, non-cytotoxic, low antigenic and non-inflammatory properties. The use of silk fibroin extract can support the healing process during the regeneration and repair of normal and functional nail tissues. The medicinal composition can further include (also) pentylene glycol. Pentylene glycol is used as a moisturizer. It is a colorless liquid, has a very low odor and is both water and oil soluble. Due to its unique molecular properties, including a well-separated charge distribution pattern, the moisturizing effect of pentylene glycol is much better than that of comparable chemicals, i.e. H. Propylene glycol. The medicinal composition may further include dimethyl isosorbide. Dimethylisosorbide is a transport enhancer that can place active ingredients where they are most needed and is therefore used as a penetration system into the keratin layer of the nail. Dimethyl isosorbide is a colorless liquid with excellent solvent properties. It increases the transport of active ingredients into the upper layers of the epidermis without bringing the product into the bloodstream. Furthermore, dimethyl isosorbide improves the stability of formulations, even those that are susceptible to hydrolysis and transesterification. The one or more of silk fibroin, pentylene glycol and dimethyl isosorbide can be used in particular in a medicinal composition for the treatment of nail fungus.

The medicinal composition may also e.g. B. include azon. Azone is a colorless to yellowish liquid that contains sodium hypochlorite in particular as an active ingredient. Azon has been used to enhance percutaneous absorption. Its ability to improve penetration makes it an attractive connection for incorporation into the medical composition. Additionally or alternatively, pyrrolidones can be incorporated into the medicinal composition to enhance penetration. In addition, pyrrolidones have a strong effect on hydrophilic diffusants and can therefore serve as penetration enhancer for (human) skin.

The medicinal composition may also e.g. B. include a terpene. Terpenes are a large and varied class of organic compounds that are produced in particular by a large number of plants. Many terpenes are hydrocarbons, but oxygen-containing compounds such as alcohols, aldehydes or ketones (terpenoids) can also be found. Its building block is the hydrocarbon isoprene CH ₂ = C (CH ₃ ) -CH = CH ₂ . Terpene hydrocarbons therefore have empirical formulas (C ₅ H ₈ ) _n , they are classified according to the number of isoprene units. Vegetable oils containing terpenes have shown increasing promise in vivo by inhibiting several species of bacteria. For example, cinnamon oil has shown a wide range of activity against Pseudomonas aeruginosa. Olive leaf oil also showed useful properties, especially with regard to the microenvironment, antimicrobial properties for some species and healing properties and supportive properties for other species. Cumene (isopropylbenzene) is a terpene that has been shown to have important antibacterial properties. Limonene, carvone and pinene also showed useful effects.

The medicinal composition may also e.g. B. include oxazolidinones. The oxazolidinones are a class of antimicrobial agents that have a unique structure and a good effect against gram-positive pathogenic bacteria. Oxazolidinones are a class of compounds that contain 2-oxazolidine in their structure. Oxazolidinones represent a new class of synthetic antibacterial agents that are effective against multi-resistant gram-positive pathogens, including methicillin-resistant Staphylococcus aureus (MRSA), penicillin-resistant streptococci and vancomycin-resistant enterococci. Oxazolidinones can thus be specifically integrated into the medical composition, since they are able to control the microenvironment. The medicinal composition may also e.g. B. include urea (or carbamide). Urea is an organic compound with the chemical formula CO (NH ₂ ) ₂ . Urea-containing creams are well known and are used as topical dermatological products to promote rehydration of the skin. Urea may also be indicated for psoriasis, xerosis, onychomycosis, ichthyosis, eczema, keratosis, keratoderma, corns and calluses. Its use e.g. B. in the treatment and / or prevention of athlete's foot can be provided as a moisturizer for dry skin, which is caused by athlete's foot. The medicinal composition may also e.g. B. Include 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 diureide of glyoxylic acid. It is used for its moisturizing properties as it increases the water content of the extracellular matrix. It also increases desquamation of the upper layers of dead skin cells and thus promotes a faster healing process for damaged skin. The medicinal composition may also e.g. B. Panthenol. Panthenol is the alcohol analogue to pantothenic acid (vitamin B5) and is therefore a provitamin of B5. In organisms, it is quickly oxidized to pantothenate. For example, in treating (and / or preventing) athlete's foot, panthenol can be used as a humectant, softener, or moisturizer. The one or more of urea, allatoin and panthenol can be used in particular in the medicinal composition for the treatment (and / or prevention) of athlete's foot, such as in the applicator.

APPLICATOR NOZZLE AND ACTUATING MECHANISM

In a preferred embodiment of the invention, the actuating shaft is biased towards the first position, the actuating shaft closing the opening of the applicator nozzle. The advantage is that moving the operating shaft to the open, non-biased position requires an action. This ensures that the medicinal composition is only delivered on request. It also helps prevent leakage and spillage. Ultimately, pre-tensioning towards the first, closed position reduces the possibility of human error when the medical container is closed. This improves the preservation of the medicinal composition.

In a further embodiment, the actuation mechanism comprises a spring for biasing the actuation shaft into the first position. A spring is an inexpensive and reliable aid. They are well known, reliable and suitable for use in medical applications.

In one embodiment, the penetrable seal is attached to a sealing ring, the sealing ring being in contact with the medical container, which effectively seals the medical container before first use. This enables the penetrable seal and the medical container to be manufactured separately. This makes both the sealing ring and the medical container separate replaceable parts. An empty medical container can be replaced with a new one without replacing the sealing ring, which means refilling the medical device allows. Likewise, for long-term preservation of the medical composition, a seal ring with a penetrated seal can be replaced by a new seal ring with a penetrable seal if the medical container is not yet empty but the treatment is interrupted.

In one embodiment, the penetrable seal is preferably made of acid-resistant materials. In addition, the penetrable seal requires a suitable permeability to prevent the loss of volatile substances from the medical composition. The penetrable seal must also be gas-tight when in contact with the medical container. In one embodiment, the penetrable seal is an extruded or coextruded film. In a more preferred embodiment, the penetrable seal comprises materials selected from the list of high density polyethylene (HDPE), low density polyethylene (LDPE), polyamide (PA), polycarbonate (PC), polyethylene terephthalate (PET) (including e.g. polyethylene terephthalate glycol) , PETG), polymethylpentene (PMP), polyoxymethylene (POM), polypropylene (PP), polystyrene (PS), polysulfone (PSU), polyvinylchloride (special rigid (PVC HART) and flexible (PVC SOFT), styrene acrylonitrile (SAN), ethylene chlorotrifluoroethylene (ECTFE), ethylene chlorotrifluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polytetrafluoroethylene (PTFE), polyvinylidene fluoride (PVDF), ethylene propylene diene rubber (EPDM), fluorocarbon rubber (FPM) and acrylonitrile (nitrile) butadiene rubber (NBR) or alloys such as alloys or acids for example aluminum, in a more preferred embodiment the penetrable seal comprises both a metal and polymers ringable seal can further comprise layers of paint. These can be both aesthetic and functional, since paint makes it easier to visually inspect the penetrable seal before first use.

In another embodiment, the actuation shaft, when moved from the first, closed position to the second, open position, shifts a volume of the medical composition that is equal to a single dose unit. This facilitates the use of the medical device. Accurate dosing is important for medicinal compositions, but difficult for non-professionals to perform. Thus, a medical device that delivers single dose units is easier to use. It also improves the treatment of infections because these treatments are often dose sensitive.

In a preferred embodiment, the actuation shaft includes longitudinal channels to facilitate the flow of the medical composition along the actuation shaft. This improves the fluid connection between the nozzle and the medical container. These longitudinal channels are synergistic with a medical composition that includes a film-forming polymer. Wide channels ensure that the fluid connection is not blocked by small polymer films that block passages. Furthermore, these longitudinal channels lead to more regular fluid connection, which is necessary for the controlled delivery of the medical composition, for example for single dose units.

The applicator enables treatment of the topological disorder by local contact of the applicator with the nail or skin. This is safer and more effective than applicators that require contact with a region larger than the lesion, or applicators that supply more than the lesion. The applicator can in particular be designed to provide the medical composition for a local topical area in the range from 0.01 to 4 cm ² , such as 0.02 to 2.5 cm ² , such as 0.1 to 1.0 cm ² , such as 0.1 to 0.5 cm ² , by means of direct contact. Thus, in one embodiment, the applicator nozzle comprises an area which has a base area or contact area in the range from 0.01 to 4 cm ² , preferably 0.1 to 2.5 cm ² .

In a further embodiment, the applicator comprises a handle part. Thus, in one embodiment, the applicator comprises an applicator nozzle that covers a surface, e.g. B. a base or contact area, in the range of 0.01 to 4 cm ² , such as 0.1 to 2.5 cm ² , and wherein the applicator comprises a handle portion, the physical topical application touching a topical Surface and keeping the applicator nozzle in physical contact with the topical surface in the range of 0.2 to 5 seconds.

Assuming that the applicator is in the form of a stick, the diameter can be substantially round over the length of the stick. The applicator preferably comprises a handle part. Such a handle part can, for. B. have a triangular cross section, in particular one that has rounded angles. Thus, in an even more preferred embodiment, the applicator comprises different cross sections, which change step by step from round to a handle part with a triangular cross section (and optionally change back to a substantially round cross section). The applicator can include a closure. Such a closure can be included when defining the shape of the applicator.

In a preferred embodiment, the actuating shaft and / or the spring are provided in a thermoplastic material. Metal springs can lead to corrosion, oxidation and other undesirable reactions of the medical composition. These adversely affect the shelf life of the composition. Even if the medical composition remains functional, small concentrations of metal ions and complexes can act as pigments and lead to discoloration of the medical composition as well as the applied film.

The applicator nozzle, the actuating shaft and / or the spring preferably consist of an acid-resistant polymer material. Good acid-resistant polymer materials for the applicator nozzle, the actuation shaft and / or the spring can be selected independently from the group consisting of: chlorinated polyvinyl chloride (CPVC), ethylene chlorotrifluoroethylene (ECTFE), (reinforced) polytetrafluoroethylene (reinforced PTFE), high-density polyethylene (HDPE ), Polyether ether ketone (PEEK), polypropylene (PP), polysulfone (PSU), polyphenylene sulfide (PPS), polyvinyl chloride (especially type 1 (PVC, type 1) or type 2 (PVC, type 2)), polyvinylidene fluoride (PVDF), polytetrafluoroethylene (PTFE), polyamideimide (PAI), ultra-high molecular weight polyethylene (UHMW) and also coated (with an acid-resistant material, especially an acid-resistant polymer). In yet another embodiment, good materials for the applicator nozzle, actuator stem and / or 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 e.g. polyethylene terephthalate glycol PETG), polymethylpentene (PMP), polyoxymethylene (POM), polypropylene (PP), polystyrene (PS), polysulfone (PSU), polyvinyl chloride (especially rigid (PVC HART) and Flexible (PVC SOFT), styrene acrylonitrile (SAN), ethylene chlorotrifluoroethylene (ECTFE), ethylene chlorotrifluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polytetrafluoroethylene (PTFE), polyvinylidene fluoride (PVDF), ethylene propylene diene rubber (EPDM), fluorocarbon nitrile rubber (PP) ) Butadiene rubber (NBR) These materials are particularly resistant to the acidity of an acidic liquid rm includes the applicator nozzle polyoxymethylene (POM).

In a preferred embodiment, the actuating shaft and / or the spring are provided from polyoxymethylene (POM). POM is a relatively inert material, which advantageously has good resistance to adhesion, which prevents the formation of a film on or along the actuator, while also showing good mechanical properties such as high strength, rigidity, high crystallinity and good fatigue resistance, and is sufficiently impermeable. The combination of these properties makes POM particularly well suited to the parts of the assembly that come into contact with the medical composition.

In a further preferred embodiment, the actuating shaft and / or the spring according to the 10D and 10F provided. This actuator spring design is advantageous to use in combination with thermoplastic materials, including, but not limited to, POM. Thermoplastic materials generally exhibit fatigue under the action of repeated loads, such as the repeated actuation of the medical device. This makes compression springs undesirable. The shaft-spring designs according to the 10D and 10F and also 9B minimize the fatigue effect.

In a preferred embodiment, the medical device further comprises a nail file. This nail file can, but need not, be attached to the medical device in any way. The advantage of the nail file is the convenience for the customer to be able to change 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 can further comprise means for attaching the nail file. In the most preferred embodiment of the present invention, the nail file can be pushed into the housing. The ability to easily carry a nail file along with the medical device allows the user to adjust the application of the medical composition as well as use the nail file for regular purposes. In addition, this can help disguise the medical device as a nail care set because patients often prefer discretion.

In a preferred embodiment, the medical device further comprises a removable cap for protecting the applicator nozzle. The cap can be placed over the nozzle, preventing damage to the nozzle or accidental actuation of the actuation mechanism. In a more preferred embodiment, the cap reduces the possibility of leaking liquid or droplets of the medicinal composition escaping from the nozzle. This provides convenience and cleanliness for the end user, helps maintain the medicinal composition. When used with a medicinal composition that is a film-forming Including polymer, it also reduces curing of the medical composition in undesirable locations such as the interior of the nozzle or near the actuation mechanism.

In a further preferred embodiment, the cap comprises an outlet container. This outlet container seals in particular the nozzle opening. In a more preferred embodiment, this outlet container is impermeable to liquids. In the most preferred embodiment, the outlet container and its fit over the nozzle opening are hermetically sealed and thus impermeable to liquids and gases. This prevents volatile components, such as solvents, from escaping from the medical composition. This is advantageous for the durability of the medical composition. It also prevents the medical composition from hardening in the interior of the nozzle.

• - einen medizinischen Behälter, der eine medizinische Zusammensetzung umfasst,
• - eine Applikatordüse mit einer Öffnung zum Aufbringen der medizinischen Zusammensetzung auf das Subjekt, einen Betätigungsmechanismus zum Steuern der Applikatordüse und ein Gehäuse für einen medizinischen Behälter.

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

• a medical container comprising a medical composition,
• an applicator nozzle with an opening for applying the medical composition to the subject, an actuating mechanism for controlling the applicator nozzle and a housing for a medical container.

In particular, the present invention provides the set, wherein the medical container is sealed with a penetrable seal, and in that the actuation mechanism comprises an actuation shaft that between (i) a first position, in which the actuation shaft closes the opening of the applicator nozzle, and (ii) a second position, in which the applicator nozzle is in an open position, is movable, and wherein the actuating shaft pierces the penetrable seal of the medical container, thereby forming a passage that allows fluid communication between the medical container and the applicator nozzle .

This set enables the medical device that includes it to be refilled. The medical container is a replaceable part. Some resistant fungal infections can take a significant amount of treatment time and may require the use of the contents of multiple medical containers with the medicinal composition. A set is advantageous for these users. The design of larger medical devices, which contain more of the medical composition, according to the first aspect leads to voluminous, indiscreet and unwieldy medical devices. A set according to the second aspect does not have these disadvantages.

• - Bereitstellen einer medizinischen Vorrichtung, die einen medizinischen Behälter, der eine medizinische Zusammensetzung enthält, eine Applikatordüse zum Aufbringen der medizinischen Zusammensetzung und einen Betätigungsschaft zum Steuern des Aufbringens umfasst,
• - Betätigen des Betätigungsschafts, um die Fluidverbindung zwischen dem medizinischen Behälter und der Applikatordüse zu unterstützen.

The third aspect of the present invention is a method for treating an infection by operating a medical device, comprising the following steps:

• Providing a medical device comprising a medical container containing a medical composition, an applicator nozzle for applying the medical composition and an actuating shaft for controlling the application,
• - Actuate the actuator stem to aid fluid communication between the medical container and the applicator nozzle.

The advantage of the method over the use of the medicinal composition by means of vials and files is that it is easier, faster and more precise to use. Furthermore, the control of the dosage is better if an actuating mechanism is used which produces cans of similar size.

• - Durchdringen der durchdringbaren Dichtung mit dem Betätigungsschaft.

A preferred embodiment of the method for treating an infection, wherein in the medical device the medical container is sealed with a penetrable seal, the method further comprising:

• - Penetrating the penetrable seal with the actuating shaft.

The advantage of this method is a long shelf life of the medical composition in the medical container before its first use. This also enables the use of volatile, decomposing, chemically reactive or otherwise changing components. An example of such chemically reactive components are the film-forming polymers of a preferred embodiment of the first aspect.

The invention is further described by the following non-limiting examples, which further illustrate the invention and are not intended to limit the scope of the invention and are also not to be interpreted as such.

EXAMPLES

It is assumed that the present invention is not in the form described above implementation is limited and that some modifications can be added to the illustrated manufacturing example without re-evaluating the appended claims. For example, the present invention has been described with reference to the topical treatment of infections, but it will be appreciated that the invention can be applied to any topical medicinal composition.

These examples include preferred embodiments of the invention and are illustrated by the figures.

EXAMPLE 1

Medical device

The arrangement of the medical device is in 1A shown. The medical device 1 includes a medical container 3rd which is a medical composition 11 which is suitable for the treatment of onychomycosis. The medical device includes an applicator nozzle 6 and an actuation mechanism consisting of an actuation shaft 5 and a compression spring 9 consists. The medical device further includes a housing 2nd , which has a tubular shape with a distal end and a proximal end and a medical container through a sealing ring 4th is sealed, which is enclosed in the housing. The nozzle has a distal end formed for the direct application of a fungicide to nails and a proximal end. The medical device also includes a cap 7 that sits on the distal end of the nozzle. This seals the pharmaceutical composition against the housing. The nozzle screwed onto the medical container is formed such that it is telescopically mounted on the distal end of the housing.

Operating mechanism

The mechanism by which the medical device is operated is shown in FIGS 1C and 1D shown. A new medical device that has not been used is in 1A shown. This shows a penetrable seal that is closed with no fluid in the actuation mechanism and near the nozzle. In this state, the medical device has a long shelf life.

During the first actuation, the shaft pierces the penetrable seal 10th . This allows fluid that is the medical composition 11 is to flow along the channels in the actuating shaft to the nozzle tip through which it is applied topically. The device is actuated by applying a force to the nozzle tip, preferably by pressing the medical device down against a surface to which the medical composition is to be applied. When the force is released, the actuator stem is returned to the closed position by the spring. The penetrable seal will remain open, resulting in a permanent fluid connection in the channels along the actuation shaft. This is in 1E shown. The film-forming polymer becomes a self-sealing film 12 form, especially around the tip of the nozzle. This improves sealing and prevents leakage of the pharmaceutical composition.

casing

The 2A and 2 B show a longitudinal and a cross section of the housing. This housing holds the medical device together and protects the other parts, such as the medical container, which promotes child safety.

The housing is a semi-open tube shape. The distal opening 21st allows medical containers and other parts to be placed within the housing. The outermost edge near the opening is with a guide 23 equipped for mounting the nozzle on the housing. The proximal, closed end has a convex closure 22 on. The side of the housing also includes a recess 25th which is suitable for holding a nail file. This depression is shaped to hold the nail file, with the edges of the depression 26 prevent the file from moving sideways. The depression goes into an opening 24th in the case through which the nail file can be pushed. In this way, the nail file near the medical container is largely contained in the housing. This further limits the movement of the nail file. The recess has a greater thickness in the form of a button near the opening 27th on. This ensures that the nail file cannot slide in and out of the housing without applying a minimum of force.

Medical container

The medical container is in 3rd shown. It is a medicine bottle 31 made of amber glass. The medical container is open 33 and includes a thread 32 . This thread to be picked up 32 fits the receiving thread 65 the nozzle and allows the actuation mechanism, sealing ring and medical container to remain closed unless force is applied once they are assembled.

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

Sealing ring

A cross-sectional view and a side view of the sealing ring are shown in FIG 4A respectively 4B shown. The sealing ring 4th is a cylindrical plastic ring with a largely uniform inner diameter D _I and a largely uniform outside diameter D _{E '} . The sealing ring has a distal and a proximal end. The proximal end of the ring includes a penetrable seal 10th .

The plastic ring is formed by injection molding a high density polyethylene. Injection molding uses an entry point, a point at which the polymer is injected into the mold. The entry point 41 of the polymer lies on the edge of the ring where it is flattened. This flattening of the ring simplifies injection molding. It is important that the entry point is not radial, as the radial flat surfaces of the ring must be smooth for functionality. Since the entry point is typically not smooth, the entry point must be axial. This flattening leads to a smaller outside diameter D _E . The ring also includes a small rib 42 that improves the seal between the side of the ring and the inside of the nozzle. A penetrable film is attached to the proximal end of the sealing ring. Furthermore, the inside diameter near this penetrable film Do is smaller than D _I .

The penetrable film 10th comprises three layers: a gold-colored 2k lacquer, an aluminum layer and a polymer layer. The gold-colored lacquer weighs approximately 1.5 g / m ² . The aluminum layer is made of soft, annealed aluminum and the layer is approximately 37 µ thick. The polymer layer is a coextrusion coating that weighs 30 g / m ² . The total weight of the film is 130 g / m ² , with an average thickness of 68 µ. The film has good mechanical properties, especially a very low permeability for a wide variety of volatile substances. Damage to the penetrable seal, such as scratches, is visible due to the contrast between the gold-colored paint and the aluminum and polymer layers.

Operating shaft

A perspective view of the shaft is in 5A shown and a side view of the actuating shaft is in 5B shown. The shaft 5 is a narrow, elongated plastic element. It has a distal end, a center and a proximal end, the distal end passing through the distal opening of the nozzle.

The distal end of the shaft has a distal tip 51 and a distal base 52 on. Both the distal tip and the distal base are tubular. The distal tip has an outer radius D _A that is smaller than the inner radius of the distal opening of the nozzle. The distal base has an outer radius D _B that is larger than the inner radius of the distal opening of the nozzle. When the distal base of the shaft is pressed against the distal opening of the nozzle, no fluid can flow through it, which includes the closed position of the actuating shaft. However, when the stem is pushed in the proximal direction, space is created for fluid to flow past the stem through the nozzle, which is then the open position of the actuation stem.

The middle of the shaft has the largest outside diameter. Instead of being tubular, the center and the proximal ends of the shaft consist of four equally spaced wings 54 . Longitudinal channels lie between these wings 53 so that the pharmaceutical fluid can flow past. On the distal side, the wings have a central outer diameter that is slightly larger than the diameter of the spiral. More proximally, the wings have an outer diameter that is smaller than the diameter of the spiral. This allows the coil to fit the distal end while the proximal end of the actuator shaft bends the coil when proximal pressure is applied. The coil will then provide a reaction pressure that biases the actuator stem toward the closed position.

The proximal end of the shaft contains a recess 55 in one of the wings. This depression is suitable for shifting fluid based on the Archimedean principle. The volume of the depression is associated with the single dose of the medication, which is provided as a result of the displaced volume of liquid upon a single actuation of the actuation shaft. The proximal tip 56 the shaft is a flat surface. This flat surface is not perpendicular to the axis of the shaft, but is instead angled to provide a sharp corner to pierce the coil.

jet

In 6A a side view of the nozzle can be seen. In 6B a perspective view of the nozzle is shown. The nozzle 6 is a tubular cone-like structure with a smooth surface. It is made of polyoxymethylene (POM) and has a white opaque color. The nozzle has a distal end formed for the direct application of a fungicide to nails and a proximal end. The nozzle has a distal opening 61 for applying a fungicidal medicinal composition and a proximal opening for attaching to the housing. The inner diameter at the distal end is significantly smaller than the inner diameter at the proximal end.

The nozzle has a base 62 on that has an outside diameter D _K has, which is approximately equal to the inner diameter of the housing. The nozzle also has a guide 63 on that matches the fit of the case and from a rib 64 with an inner diameter that is equal to the outer diameter of the fit. This guide-and-fit mechanism ensures a good seal between the housing and the nozzle.

An internal thread is located inside the base of the nozzle near the proximal end 65 that with the external thread 32 of the medical container fits together. The sealing ring 4th is at the distal end of the medical container 3rd placed, the film seals the medical container. The coil is then placed on the distal end of the sealing ring, followed by the shaft, which is placed on the coil. The arrangement of the shaft, the spiral, the sealing ring and the medical container can be placed in the nozzle, after which the medical container can be screwed in. This nozzle-container arrangement can then be mounted telescopically in the housing. The thread is characterized by DIN 1689 / GL18 with a pitch of 3 mm.

Starting from the distal end of the nozzle, a series of increasing inner diameters is arranged so that the distal opening 61 the smallest inside diameter D _N which is slightly larger than the outer diameter D _A the distal tip of the operating shaft is, however, smaller than the outer diameter D _B of the operating shaft. The second inside diameter D _C is larger than the outside diameter D _B of the operating shaft. The diameter then continues to increase in order to hold the wings of the actuating shaft and then even more to hold the sealing ring. The nozzle also includes a flat tubular surface 67 on which the sealing ring rests when the nozzle-container assembly is assembled.

cap

The cap 7 is a rounded knotted cone that looks transparent and dark blue. It is manufactured by injection molding polymethyl methacrylate, PET, polyoxymethylene or a copolymer thereof. The cap has six planes of symmetry. The cap has a smooth inner and outer surface. The outside of the cap has two opposite handles 71 which include concave depressions in the exterior of the cap. The inside of the cap has an outlet container 72 on which is a tubular shape 73 with a sloping edge 75 having. When the cap is placed on the nozzle, the tip of the nozzle is in the sloping edge 75 This outlet container fits and thus pushes the tube shape outwards and ensures a firm fit at the end of the slope 74 . This prevents leakage from the nozzle into the rest of the cap. Furthermore, the inner surface of the cap is reinforced by six ribs, which are parallel to the axis of the cone and are hexagonal.

Nail file

The nail file 8th is in 8A and 8B drawn. In this example, the nail file is cuboid, but this is not necessary for its function. It has rounded tips 81 to prevent accidental injuries. The side with the largest base of the cuboid is rough in order to enable the filing of nails. Both flat sides of the file have the same grain size and they can both be used to file 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 25th of the housing.

feather

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

Example 2

The second example corresponds to the arrangement of a medical device 9A . This medical device comprises a housing 2 ' , a medical container 3rd , a spring and stem arrangement 5 ' , a nozzle 6 ' and a cap 7 ' . The housing 2 ' , the medical container 3rd , the nozzle 6 ' and the cap 7 ' have different designs, but their functionality is identical to the medical device according to Example 1.

Compared to Example 1, Example 2 has a spring and shaft arrangement 5 ' on that the operating shaft 5 who have favourited separate spring 9 and the separate sealing ring 4th replaced. The spring shaft arrangement 5 ' includes a mounting ring 4 ' which is similar to the sealing ring 4th works. This mounting ring 4 ' remains on the top of the medical container during use 3 ' attached. The penetrable seal 10 ' is on the proximal side of the mounting ring 4 ' appropriate. On the distal side of the mounting ring 4 ' is a spring mechanism 9 ' attached to which the operating shaft is connected. The actuation shaft includes a distal base 52 ' and a distal tip 51 ' which perform the same function as in Example 1. The penetrable seal must be pierced manually before first use. Alternatively, on the proximal side of the spring mechanism 9 ' a pin (not shown) may be arranged, which is suitable for breaking the penetrable seal.

Advantageously, this arrangement contains fewer parts and, more importantly, fewer small parts. This promotes the safety and ease of assembling the pen. In addition, the spring-shaft arrangement can be produced from plastic or other materials. This means that the medical composition does not come into contact with metal. This is necessary with some medical compositions to prevent oxidation or other undesirable reactions and to improve the durability and stability of the medical composition.

Example 3

The third example corresponds to the arrangement of a medical device 9A and is except for the spring and shaft arrangement 5 " completely identical to example 2. The new spring and stem arrangement is in 9C shown.

This spring-shaft arrangement again comprises a fastening ring 4 " , on the proximal side a penetrable seal (not shown) and on the distal side a spring mechanism 9 " is appropriate. The operating shaft is on the spring mechanism 9 " attached and includes a distal tip 51 " and a distal base 52 " . The penetrable seal must be pierced manually before first use.

As in Example 2, this arrangement contains fewer parts. In addition, the spring mechanism 9 " are produced from various materials, including sufficiently elastic plastics and metals. This allows the pen to be used in combination with medical compositions that are sensitive to materials.

Example 4

The third example corresponds to the arrangement of a medical device 10A . The arrangement is in 10B shown exploded. This medical device comprises a housing 2nd , a medical container 3rd , a spring and stem arrangement 5 "' , a sealing ring 4 '" , a nozzle 6 and a cap 7 as well as a nail file 8th . The housing 2nd , the medical container 3rd , the nozzle 6 , the cap 7 and the nail file 8th shown are identical to Example 1.

The spring-shaft arrangement 5 '" is similar to the operating shaft 5 of Example 1 and includes a distal tip 51 "' , a distal base 52 "' , longitudinal channels 53 '" , four equally spaced wings 54 '" , a deepening 55 '" and a proximal end 56 '" . Instead of using a separate spring 9 to be operated are two wings 54 '" with a spring mechanism 9 '" Mistake. The spring-shaft arrangement 5 '" is preferably made of polyoxymethylene (POM) to provide sufficient elasticity and strength as well as good resistance to material fatigue.

The spring-shaft arrangement 5 '" is from a sealing ring 4 '" accompanied. The sealing ring 4 '" is similar to the sealing ring 4th of Example 1 and includes the ring structure and the penetrable seal 10th . Instead of a largely uniform inner diameter D _I and a smaller inner diameter Do near the penetrable seal has the sealing ring 4 '" however, a gradual transition between the distal inner diameter D _I and the proximal outer diameter Do near the penetrable seal. This enables the spring mechanism 9 '" to bias the spring-stem assembly toward the closed position upon providing external pressure.

The arrangement advantageously requires fewer parts and the medical composition does not come into contact with metals. In addition, the penetrable seal can still be replaced by exchanging sealing rings. The design of the shaft, in particular the longitudinal shape together with the longitudinal channels 53 '" and recesses 55 ''' , enable good dosing control.

QUOTES INCLUDE IN THE DESCRIPTION

This list of documents listed by the applicant has been generated automatically and is only included for the better information of the reader. The list is not part of the German patent or utility model application. The DPMA assumes no liability for any errors or omissions.

Patent literature cited

• CN 103764219 [0002]
• DE 102007046600 A1 [0004]
• CN 206492102 U [0005]
• WO 2016/142305 [0006]
• US 5120530 [0039]

Claims (15)

A medical device for topical treatment of a disease of a subject in need thereof, the device comprising: a medical container comprising a medical composition, an applicator nozzle with an opening for applying the medical composition to the subject and an actuating mechanism for Controlling the applicator nozzle, characterized in that the medical container is sealed with a penetrable seal, and in that the actuation mechanism comprises an actuation shaft which between (i) a first position in which the actuation shaft closes the opening of the applicator nozzle, and (ii ) a second position, in which the applicator nozzle is in an open position, is movable, and wherein the actuating shaft pierces the penetrable seal of the medical container, whereby a passage is formed to establish a fluid connection between the medical container lter and the applicator nozzle. Medical device after Claim 1 , wherein the medical composition comprises a film-forming polymer in an amount of 1 to 25 wt .-%, based on the total weight of the medical composition. Medical device according to one of the preceding Claims 1 to 2nd wherein the actuating mechanism comprises a spring for biasing the actuating shaft into the first position, preferably a thermoplastic spring. Medical device according to one of the preceding Claims 1 to 3rd wherein the actuating shaft, when moved from the first, closed position to the second, open position, displaces a volume of the medical composition that is equal to a single dose unit of the medical composition. Medical device according to one of the preceding Claims 1 to 4th , wherein the actuating shaft is biased towards the first position, wherein the actuating shaft closes the opening of the applicator nozzle. Medical device according to one of the preceding Claims 1 to 5 , wherein the penetrable seal comprises an aluminum layer. Medical device according to one of the preceding Claims 1 to 6 , further comprising a sealing ring which comprises the penetrable seal and is suitable for sealing the medical container before the first use. Medical device according to one of the preceding Claims 1 to 7 , wherein the medical container is a glass container. Medical device according to one of the preceding Claims 1 to 8th , wherein the medicinal composition is a fungicidal solution which preferably comprises amorolfine, more preferably between 1 and 20% by weight of amorolfine, based on the total weight of the medicinal composition. Medical device according to one of the preceding Claims 1 to 9 , wherein the actuation shaft comprises longitudinal channels to facilitate the flow of the medical composition along the actuation shaft. Medical device according to one of the preceding Claims 1 to 10th wherein the medical device further comprises a nail file. Medical device according to one of the preceding Claims 1 to 11 wherein the medical device further comprises a removable cap adapted to protect the applicator nozzle. A set comprising a medical device for topical treatment of a subject's disease in need thereof, the set comprising: a medical container comprising a medical composition, an applicator nozzle with an opening for applying the medical composition the subject, an actuating mechanism for controlling the applicator nozzle and a housing for a medical container, characterized in that the medical container is sealed with a penetrable seal, and in that the actuating mechanism comprises an actuating shaft which is between (i) a first position, in which the actuation shaft closes the opening of the applicator nozzle, and (ii) a second position in which the applicator nozzle is in an open position is movable, and wherein the actuation shaft pierces the penetrable seal of the medical container, thereby forming a passage to allow fluid communication between the medical container and the applicator nozzle. Method for treating an infectious disease by operating a medical device, comprising the following steps: Providing a medical device comprising a medical container containing a fungicidal medicinal composition, an applicator nozzle for applying the fungicidal medical composition and an actuating element for controlling the application, actuating the actuating shaft to establish a fluid connection between the medical container and the applicator nozzle support. Method of treating a fungal infection after Claim 14 wherein the medical container in the medical device is sealed by a penetrable seal, the method further comprising: penetrating the penetrable seal with the actuating shaft.

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