EP0016431B1 - Nose clip for the prophylactic or therapeutic treatment of cattle - Google Patents

Description

The invention relates to nasal clips for the application of active substances for prophylactic or therapeutic treatments of cattle.

DE-C3-2 125464 describes nasal clips with the aid of which it is possible to deliver medicinal substances to the nasal mucosa of animals over a longer period of time. They consist of a bracket, the ends of which have devices for receiving active substances in the form of depot bodies. According to a preferred embodiment, the ends of the clasp, which carry the active ingredient, run parallel.

Attempts to wear nasal clips, the ends of which run parallel and which are described in the patent mentioned, over several weeks to months, and anatomical studies on the snout of the animal species cattle (e.g. on the snout of calves and adult cattle) showed that in the interest of one improved absorption, in order to completely avoid irritation on the nasal mucosa after long wear and thus to ensure an undisturbed application period, special embodiments of nasal clips in cattle are required. It has been shown here that the mucous membrane of the nasal septum in the nasal vestibule is best suited as the application site, especially since there is a concave recess.

The object of the invention is to overcome the disadvantages shown.

It has been found that a nose clip of the type known from DE-C3-2 125464, in which the temple ends with the devices or the surfaces of the depot bodies are inclined towards one another and rotated relative to one another, the anatomical conditions at the application site, i.e. the mucous membrane of the nasal septum Nasal atrium, largely does justice to improved absorption and does not cause any pathological changes at the application site after an application time of several weeks or longer.

The invention therefore relates to a nose clip for the prophylactic or therapeutic treatment of cattle, consisting of a hanger, the ends of which have devices for receiving active substances in the form of depot bodies, and is characterized in that either the temple ends with the devices or the surfaces of the depot body inclined towards each other and rotated towards each other. The depot body can be divided into an active substance-free, dimensionally stable applicator and an associated, active substance-containing, variable shape reservoir.

The devices or the surfaces of the depot bodies are inclined relative to one another and rotated relative to one another. These angular positions overcome the disadvantages observed when wearing the nose clips corresponding to the prior art with parallel ends and consequently also parallel surfaces of the depot bodies. A safe long-term treatment without additional effort is possible with the nose clip according to the invention.

In the above and following explanations, unless otherwise stated, "cattle" means the animal species cattle.

The invention particularly relates to a nose clip which consists of a resilient, U-shaped bracket, the ends of which are inclined and rotated relative to one another and have devices for receiving active substances in the form of depot bodies.

• Fig. 1 die Ansicht des Bügels einer Nasenspange von unten,
• Fig. 2 die Ansicht des Bügels einer Nasenspange von der Seite,
• Fig. 3 die Ansicht einer Nasenspange von vorn, teilweise geschnitten,
• Fig. 4 bis 15 verschiedene Ausführungsformen von Verbindungsteilen mit und ohne Depotkörper bzw. Applikatoren und Reservoiren,
• Fig. 16 und 17 die Ansicht einer Nasenspange von unten ohne Reservoir,
• Fig. 18 die Ansicht einer Nasenspange von unten mit Depotkörper.

11 to 18 represent examples of the nasal clip according to the invention or different embodiments of connecting parts with and without depot bodies or applicators and reservoirs, and that shows

• 1 is a view of the bracket of a nose clip from below,
• 2 is a side view of the bracket of a nose clip,
• 3 shows the view of a nose clip from the front, partly in section,
• 4 to 15 different embodiments of connecting parts with and without depot bodies or applicators and reservoirs,
• 16 and 17 the view of a nose clip from below without a reservoir,
• 18 shows the view of a nose clip from below with a depot body.

The bracket 1 of the nose clip must have a strength that enables the anatomically correct fit of the depot body during the entire wearing time. On the other hand, it has to be elastic enough to enable the insertion and removal of the nasal clip and to be able to adapt to a certain extent to the growth of, for example, a calf during the wearing period of the nasal clip.

The optimal strength and relaxation when the bracket was bent by 2.5 mm were determined by force-displacement measurements and comparison with the results of wearing tests on calves and adult cattle. It has been shown that a bracket with a force of 0.5 N to 4 N, which is only slightly less after the wearing test, is particularly suitable. The force was determined on a material testing machine with a feed rate of 10 mm / min on a path of 2.5 mm at a temperature of

As a material for the execution of the bracket, metals or plastics, such as. B. polyamide, polystyrene, preferably polypropylene and polyacetal (polyoxymethylene). The thickness of the bracket varies within certain limits and depends on the material.

The temple ends have devices 2 for receiving active substances in the form of depot bodies. In the preferred embodiment of the invention, the devices are inclined towards one another and form an inclination angle α (FIG. 1) which is greater than 0 °. It is preferably 5 ° to 30 °, in particular 10 ° to 23 °.

The devices are also rotated relative to one another and have a torsion angle β (FIG. 3) which is preferably 2 ° to 45 ° and in particular 8 ° to 28 °. It arises from torsion of the temple ends designed as devices themselves or from torsion of the connecting parts.

The devices with the angles x and ß ensure the optimal adaptation of the nasal clip to the anatomical conditions of the nasal vestibule. The torsion angle ß at the temple end prevents errors when assembling the nose clip and when attaching it to the application site.

If the depot bodies located on the devices have surfaces which are inclined and rotated relative to one another, the angles IX and β are formed by the depot bodies, i. that is, the angles are formed on the basis of special shapes of the depot bodies.

The nose clip according to the invention is used for the application of active substances, the application taking place over a long period of time (e.g. several weeks). The active substance is therefore in the form of a depot body, the active substance as such being a depot body or forming the depot body with a carrier which delays the release of the active substance. The depot body can also consist of an active substance molding with a surrounding shell.

The depot bodies can be fixed directly on the devices 2. A connection part 3, 4, 16 (FIGS. 4 to 12), which establishes the connection between the devices at the temple end and the depot body, is preferably located on the devices 2. The side of the connecting part facing the devices preferably has the shape 3, 4, 16 shown in FIGS. 4 to 12. The diameter, thickness and shape of the plate-shaped parts 3 and 4 of the connecting part need not be identical.

Advantages of the embodiment according to the invention lie in the fact that the depot bodies can be produced as pharmaceutical active substance carriers in a separate work step on the connecting parts and, if necessary, only have to be connected to the devices 2 subsequently. This procedure significantly simplifies production.

Another advantage is that the same depot body and connecting parts can be connected to brackets of different sizes and can therefore be used on cattle of different sizes. Finally, the division of the nose clip allows the use of two different depot bodies with a bracket. Such depot bodies can differ in the release characteristics of one and the same active ingredient or in the active ingredients themselves. B. allows the separation of incompatible active ingredients.

The connecting parts 3, 4, 16 can be connected in various ways with the bracket ends 2, for. B. by welding, gluing, by a snap closure, also cup-shaped, by a snap fastener, also roller or ball joint-like. The bow ends 2 expediently have incisions as devices for receiving active substances for inserting the connecting parts. These incisions can also be shifted laterally so that their axes form an angle with the longitudinal axes of the temple ends. Brackets and connecting parts can thus be immovably connected or can also be freely connected to one another. With free mobility, the mechanical stress on the nasal mucosa is reduced, which means a further advantage of dividing the nasal clip into brackets with devices and connecting parts.

The side of the connecting part which is intended for receiving the depot body and which can also be located directly on the devices can be designed differently. The training depends in particular on the properties and shape of the depot body.

A distinction is made here between rigid depot bodies, such as those made of plastics or waxes, from elastic depot bodies, e.g. B. made of silicone rubber, polyurethane rubber, polyacrylate rubber, natural rubber, butyl rubber. Provided that suitable properties are provided, connecting parts and depot bodies can consist of the same material and can be produced in one operation. Otherwise, the connecting parts to which the depot body is subsequently applied can first be produced. While the usual manufacturing processes used in plastics technology are used for the production of stirrups and connecting parts from plastics, besides injection molding, there are also the pharmaceutically usual processes for the production of the depot bodies, such as casting and solidification and the pressing of wax-like masses, but also casting and subsequent networking. The production processes depend on the properties of the materials provided and must enable production-based production as well as the subsequent assembly of connecting parts with brackets.

If depot body and connecting parts consist of different materials and are manufactured at different times, the side of the connecting part facing the depot body must be designed such that the Depot body can be anchored on the connecting part. This is achieved in that the side facing the depot body 4 of the connecting part z. B. a pin 5 (Fig. 4), which can have one or more grooves (Fig. 5, 6, 7, 10, 12), or several pins (Fig. 9) or that this, for example, as a plate side formed one outer edge, which has an undercut 6 on the inside (FIG. 8).

Depot bodies that are mechanically weakened as a result of elution or that are removed to release the active ingredient (erosion) may require mechanical strengthening to be introduced. This mechanical consolidation can, for. B. caused by a nonwoven fabric 7. This nonwoven fabric is preferably attached to the pin 5 of the connecting part by welding, riveting 8, nailing, screwing or gluing.

Further shapes of the side of the connecting parts which carries the depot body are shown in FIGS. 9 to 12. They allow you to manufacture the connecting parts separately and on these z. B. to apply a prefabricated molding 15, which is then coated with a sleeve 9 and optionally connected in this way to the connecting part (Fig. 11 and Fig. 12). This sleeve can completely or partially encompass the connecting part (FIGS. 11 and 12) and contribute to the depot effect. The depot bodies can also be attached directly to the devices by means of such a sheath, the material of which may be elastic.

Depending on the casting technique, bores 10 or incisions 11 in the connecting parts according to FIG. 10 promote the escape of air when pouring or spraying on the depot body or when inserting the connecting parts.

The cross section of the connecting parts 3, 4, 16 can, for. B. round, elliptical, almond-shaped, oval, teardrop-shaped, oblong or kidney-shaped. It is important that the shape of the connecting parts is chosen so that the depot body can be attached to it and in turn adapt to the nasal vestibule by the angle settings described. Connecting parts and / or depot bodies with non-circular cross sections can form angles with the longitudinal axes of the temple ends, as already mentioned. Such an arrangement ensures the correct anatomical position, and confusion of the depot bodies is avoided.

The size of the connecting parts and thus the depot body depends on the weight of the animal and is preferably 15 to 25 mm in diameter.

If the depot body is divided into an active ingredient-free, dimensionally stable, optionally elastic applicator 4a and an active ingredient-containing, variable shape reservoir 12, the active ingredient-free applicator takes over the function of side 4 of the connecting part facing the depot body. In terms of function, the applicator thus represents a further embodiment of side 4 of the connecting part (cf. 4a in FIGS. 13 to 17 and 4 in FIGS. 4 to 12 and 18). The applicator can accordingly be understood as part of the depot body and as a further embodiment of side 4 of the connecting part.

In the embodiment mentioned, the clasp is made e.g. B. from a bracket 1 and two connecting parts 3, 16, on which there are two active ingredient-free, dimensionally stable applicators 4a (Fig. 16; 16 not visible). The active ingredient-free, dimensionally stable applicators 4a can also be located directly on the temple ends (FIG. 17), the temple ends being designed directly as active ingredient-free, dimensionally stable applicators 4a. The peculiarities of the angular position, as indicated, remain unaffected. The size and shape of the drug-free, dimensionally stable applicator and drug-containing reservoir depends on the weight of the animal and is also preferably 15 to 25 mm (diameter).

The drug-free system described above is preferably manufactured using injection molding technology.

The active substance-containing, shape-variable reservoirs 12 are connected to the active substance-free, dimensionally stable applicators 4a and are of the membrane type, ie. that is, the active ingredient or the active ingredients 14, optionally in the form of active ingredient-containing preparations, are surrounded by an active ingredient-free wall 13 and thus represent the reservoir 12.

The reservoir 12 (depot) can be a filled, ring-shaped hose which surrounds the applicator 4a (FIG. 13), or a filled cushion (FIG. 14) or a chamber placed on the applicator 4a (FIG. 15).

The hoses or the pillows that are prefabricated have elastic, sufficiently tear-resistant walls 13 with a thickness of 0.01 to 2.0 mm, preferably 0.1 to 1.0 mm. The chamber wall is formed on one side by the applicator 4a. The other sides of the chamber are then formed by a prefabricated wall, as already described. The latter can be shaped like a hat and have a reinforced edge 17 (FIG. 15). This edge 17 can correspond to a corresponding groove 18 (FIG. 17) of the applicator 4a. This will ensure a better binding of the z. B. designed as a hose or chamber 12 reservoirs with the applicator. The applicator 4a can have grooves 19 on its surface (FIG. 15) or bores which facilitate the distribution of the active substance (s) or their preparations 14 under the wall 13.

The active ingredient (s) or preparations are in solid, liquid, gel-like, etc. form.

The reservoirs 12 are after filling with the active ingredient (s) or their preparations in a suitable, known manner, for. B. by welding or gluing, liquid-tight closed and connected to the applicators 4a or the reservoirs are filled subsequently.

A biopharmaceutical advantage of the division into a dimensionally stable and dimensionally variable part is that the wall 13 of the part containing the active substance (reservoirs) can be considerably thinner than in the case of a depot body, the wall of which at the same time fulfills a partial function of the mechanical system and may be thicker for its dimensional stability must (9 in Fig. 12). A thinner wall results in easier diffusion and thus easier and higher release of active ingredient, which may be desirable depending on the purpose and type of treatment. The thickness and selection of the wall material influence the active ingredient release in a known manner. As a wall material such. As silicone rubber or copolymers of substituted ethylenes.

In contrast to an active substance-containing part of the matrix type, the active substance-containing content (the active substance itself or a corresponding preparation) of the reservoir used is free of dimensionally stable polymers, which can be advantageous from a pharmaceutical-technical point of view in terms of its manufacturability and durability.

All drug-free parts and, if applicable, the drug-containing reservoir can be prefabricated. You will then be connected. This allows the greatest possible freedom in the selection of materials both for the entire drug-free system and for the drug-containing part of the nose clip.

Since the active ingredient-containing, variable-shape reservoirs, such as. B. the hoses, pillows or chambers described are extremely flexible, they not only adapt perfectly to the active ingredient-free, dimensionally stable, possibly elastic applicators, but also to the anatomical conditions in the nasal vestibule of the cattle.

In order to avoid that the animals can tear out the nose clip by rubbing against objects, it is expedient for the bracket to lie directly against the snout's mouth. Accordingly, a nose clip for calves has a smaller bow than a nose clip for adult cattle. In addition, it may be appropriate for the connecting parts in calf clasps to have a smaller diameter.

A nose clip for calves (Fig. 18) has, for example, a temple length a of 35 mm to 45 mm and a leg depth b of 20 mm to 35 mm, the angle α is 15 °, the angle β 15 °. The side of the connecting part which serves to receive the depot body is designed as a plate with a diameter of 15 mm, on which a depot body 15 is fixed. The distance c between the depot bodies is 2 to 7 mm.

A nose clip for adult cattle has a temple length a of 55 mm to 70 mm and a thigh depth b of 40 to 55 mm. The angle IX is 15 °, the angle P. 18 °, the diameter of the plate of the connecting part 25 mm. The distance c between the depot bodies is 10 to 20 mm.

A nasal clasp for calves or cattle, with the depot bodies being divided, generally has corresponding dimensions.

Claims (12)

1. A nose-clip for the prophylactic or therapeutic treatment of cattle, comprising a bow (1) whose ends possess means (2) for taking up active ingredients being in the form of depot bodies (15), wherein either said ends of the bow with said means (2) or the surfaces of the depot bodies (15) are inclined towards each other (α) and turned to face each other (β).

2. Nose-clip as claimed in claim 1, wherein said means (2) form an inclination angle _IX from 5 to 30°, preferably 10 to 23° (Fig. 1).

3. Nose-clip as claimed in claim 1, wherein said means (2) form a torsion angle β from 2 to 45°, preferably 8 to 28° (Fig. 3).

4. Nose-clip as claimed in claim 1, wherein the depot bodies (15) are fixed directly onto said means (2).

5. Nose-clip as claimed in claim 1, wherein said means (2) are provided with connecting parts (3, 4,16) for fixing the depot bodies (Fig. 4 to 12).

6. Nose-clip as claimed in claims 1 and 5, wherein said depot bodies (15) are fixed on said means (2) at the end of the bow or on the connecting parts (3, 4, 16) by means of an optionally elastic jacket (9), which surrounds the depot bodies (15) and said means (2) or the depot bodies (15) and the connecting parts (3,4, 16) completely or partially (Fig. 11 and 12).

7. Nose-clip as claimed in claim 1, wherein the depot bodies are subdivided into a dimensionally stable, applicator (4a) free from active ingredient and a dimensionally variable reservoir (12) containing active ingredient, the reservoir being connected with the applicator.

8. Nose-clip as claimed in claim 7, consisting of a bow (1) whose ends are shaped to act as applicators (4a) (Fig. 17).

9. Nose-clip as claimed in claim 7, wherein the reservoirs (12) are shaped as tubes or pads surrounded by an elastic wall (13) (Fig. 13 and 14).

10. Nose-clip as claimed in claim 7, wherein the reservoirs (12) are shaped as chambers, one wail whereof is formed by applicator (4a) and the other walls whereof are formed by an elastic wall (13) (Fig. 15).

11. Nose-clip as claimed in claim 7, wherein the applicators (4a) have a groove (18) (Fig. 17).

12. Nose-clip as claimed in claim 7, wherein the applicators (4a) are provided with grooves (19) or with bores at their surface (Fig. 15).

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