EP1219356A2 - Discharge device for flowable media using a piston pump - Google Patents

Abstract

The spray may be used eg. as a nasal spray. It has the medication stored in a sealed reservoir which is punctured by a hollow needle when the pump action is operated. This has finger-grips to operate using the thumb and first two fingers. The first pump action is limited by internal stops. The second pump action follows a simple twist of the applicator and a pump action to the bottom of the pump travel. The spray delivers two equal doses in two separate pump actions eg. a precise nasal spray for migraine.

Description

WO 93/00172 A shows a sprayer with a long, relatively thin outlet trunk.

EP-B-0 311 863 (= US-A-4 964 069) by the applicant is one Discharge device described in which a pump cylinder and a Spring stop designed in the manner of a snap lock interact in such a way that a certain one is carried out before a partial stroke is carried out Operating pressure are applied by the operator must, so that the discharge of the Liquid with a certain minimum force and speed he follows. This training ensures that e.g. when atomizing the There is sufficient atomization pressure from the beginning of the medium is and that the pump is operated to the end of its stroke and so the entire content of the media storage, which is simultaneously the pump cylinder forms in one or two strokes. Such one-time or Multiple dispensers are important for dispensing medication, those regarding dosing, contamination, preservation or others Criteria are particularly critical.

Furthermore, it is disclosed in WO 92/00812 by the applicant, media storage for only one discharge stroke, with one simultaneously as a piston serving plugs are closed, use the plug to be actuated by a needle.

It is also from FR-A-1 535 293 an originality assurance for Aerosol valves have become known between the nozzle bearing cap and a snap-on on the container lid flange-like bead predetermined breaking points are provided, that break before the first use.

EP-B-521 022 shows a double atomizer in which the thrust piston pump stroke limited by a backdrop on the circumference of the housing which is switched on for a second hub.

TASK AND SOLUTION

Especially when applying a drug in the nostrils it is important to target the spray jet therapeutically to judge favorable places. The invention therefore aims at a spreading device trained so that the application to certain Places, e.g. inside body openings, especially on difficult to access places.

This object is solved by the features of claim 1.

This makes it possible, in particular, to have the outlet trunk in a nasal passage, especially the inner nostril to deliver a Introduce medication, preferably a vaccine or immunizing agent against colds like flu. It is already known to apply pharmaceuticals to the nasal mucosa and thus quickly and without stress on the gastrointestinal tract to be absorbed by the body, but it is with many Medicines, especially the described vaccines against Colds, necessary, or at least beneficial, on them to apply certain areas of the nasal cavity, for example the turbinates (conchae nasi). The described shape of the outlet proboscis enables the introduction into this area.

In order to introduce the outlet proboscis into the corresponding, to allow curved areas of the nasal cavity, he can Angling, like a curve, a kink or the like. have or branch off at an angle from the nozzle section. He can do it himself elastic or plastically flexible, i.e. be pliable so that he the introduction into a nasal canal itself.

In the case of a relatively long proboscis because of the small Diameter of usually less than 5 mm (preferably 2 - 4 mm) at one Length of more than 10 mm (preferably 20-30 mm) the actual one Spreading device, i.e. usually a thrust piston pump, not included can, there is the problem of dead space, which is not only the most absorbs very valuable drug uselessly, but above all by expanding under the pump pressure the spontaneity of the Pressure build-up hindered. This can be solved in that the Exhaust proboscis has an inner channel that largely, except for at least one conduit for the medium, from a filler is filled out. Whose end face adjacent to the outlet opening can with the outlet opening together delimitation of spray nozzle swirl channels form, these vortex channels as spiral grooves in this face can be included.

In a preferred embodiment, a disposable double atomizer for dispensing two consecutive batches created as a spray. It has a protruding one on a base body Nose adapter with nozzle, actuation shoulders for support by two fingers and one that can be pushed into the base body Actuating part with an actuating sleeve and one held therein Media storage on, the plunger plug from a hollow needle can be pierced. There is a ring on the actuating sleeve attached over predetermined breaking points by means of spokes, which at a first Actuation while maintaining a minimum actuation pressure interrupted. The spokes hit a stop and limit thereby the first partial stroke. By turning the actuating sleeve the actuating section in the starting position for the second lifting stage brought. There are intermediate webs inserted by means of material bridges broken out, which also maintains the second partial stroke a minimum operator.

A total of two destructible pressure point safeguards are provided, which each have a predetermined actuation force for triggering them needed.

It is therefore possible to use a drug that is supposed to act quickly in two successive strokes e.g. in both patient's nostrils to spray. This is particularly important for medication to treat of very painful illnesses or episodes of illness, for example of migraines. The developed for the treatment of these diseases Medications are very expensive and therefore have to be very precise be used in doses. Your intake through the nasal mucosa is very good and effective quickly, but should be over both if possible Nostrils are evenly absorbed for quick effectiveness still increase. It is particularly important to note that the Patients who e.g. are affected by a migraine attack Pain is cramped and therefore safe and secure uncomplicated function of the discharge device is essential. This everything is through the multi-stroke discharge device according to the invention regardless of any external conditions.

The pressure point safety device can have at least one predetermined breaking point contain. It is particularly preferred on a snap-in ring provided that e.g. on a push button forming the Media container receiving sleeve over destructible material bridges is molded. This snap-in ring enables the material bridges to be provided on one of the two parts to be joined, then after the separation of the material bridges on the other part snapped ring remains on this.

When the first discharge stroke stage is triggered and the first stroke has ended, a stop is preferably provided, the Stop elements, for example in the area of the ring-bearing Spokes are formed. So when the first stroke is finished, beats the part that is movable relative to the base body, i.e. the actuating sleeve with the media storage, at a fixed stop, so that it is ensured that the second discharge stroke stage is not triggered immediately becomes. To do this, an unlocking operation is first carried out, for example by rotating the two movable relative to each other Share against each other. For example, those on the Actuating sleeve remaining, now separated from the ring Spokes are rotated to a position where they are in the area of webs lie, which in turn are connected to the base body via predetermined breaking points are. This rotational position can be caused by projecting wall sections be limited to prevent over-turning. Now if one second actuation, again break the predetermined breaking points between the web and the base body, so that one with a minimum operating force executed second discharge stroke is executed.

In particular for pharmaceutical applications, it is important that the Media storage is hermetically sealed until first use. This can be done in that the media storage, usually a cylindrical glass ampoule, through a stopper made of rubber - like Material is closed, the first discharge stroke of a hollow Needle is pierced, which thus forms a kind of outlet valve. The one with its connected or formed discharge channel remains after the first stroke open, so that in the subsequent second stroke immediately atomization can begin.

These and other features go beyond the claims from the description and the drawings, the individual Features individually or in groups in the form of Sub-combinations in one embodiment of the invention and on other areas to be realized and beneficial as well can represent protective designs for which protection here is claimed. The division of the application into individual sections as well as sub-headings limit those below statements made are not generally valid.

BRIEF DESCRIPTION OF THE DRAWINGS

Fig. 1

einen Längsschnitt durch eine Austragvorrichtung, die das Arbeitsprinzip der Vorrichtung, nicht jedoch die erfindungsgemässe Ausbildung des Auslassrüssels, zeigt,

Fig. 2

ein stark vergrößertes Detail des Bereiches II in Fig. 1,

Fig. 3

eine Ansicht der Betätigungshülse und des angeformten Ringes, in Fig. 1 gemäß Pfeil III von unten gesehen,

Fig. 4

einen Schnitt nach der Linie IV in Fig.1,

Fig. 5

einen Schnitt nach der Linie V in Fig. 4 und

Fig. 6 und 7

Teillängsschnitte durch eine erfindungsgemässe Austragvorrichtung.

An embodiment of the invention is shown in the drawings and is explained in more detail below. The drawings show:

Fig. 1

2 shows a longitudinal section through a discharge device, which shows the working principle of the device, but not the configuration of the outlet nozzle according to the invention,

Fig. 2

2 shows a greatly enlarged detail of area II in FIG. 1,

Fig. 3

2 shows a view of the actuating sleeve and the molded ring, seen from below in FIG. 1 according to arrow III,

Fig. 4

2 shows a section along line IV in FIG. 1,

Fig. 5

a section along the line V in Fig. 4 and

6 and 7

Partial longitudinal cuts through a discharge device according to the invention.

DESCRIPTION OF THE STRUCTURE OF THE DISCHARGE DEVICE (Fig. 1 to 5)

The discharge device 11 shown in the drawing has a base body 12, which consists of plastic injection molding. It has a central one elongated nozzle section 13, in its inventive Training is shown in Figs. 6 and 7 and in its shape and length is adapted to the respective application. In the present Case it is a so-called nose adapter, which is intended to to be inserted into a patient's nostril. On his at the upper ends it has a discharge opening 14 in the form of a spray nozzle with an upstream angular chamber. Following this is in Inside the hollow nozzle section 13, a sleeve-shaped piston rod carrier 15 provided in the also a hollow piston rod 16 is pressed in below. In turn, a piston rod 17 is in shape a hollow steel needle, bevelled at its lower free end similar to an injection needle, by means of a die Needle surrounding seal 18. This needle-shaped piston tappet 17th penetrates the piston rod completely and is up to the discharge opening 14 brought up, so its interior forms a discharge channel 19.

The pharmaceutical medium 24 to be dispensed is in a media container 20 provided, which as a cylindrical, closed at the bottom and similarly open glass container with a flange at the top an ampoule is formed. It also forms the media store and the pump chamber 23 so that its inner walls simultaneously are the cylinder race of a thrust piston pump 46. Your butt 21 is formed by a piston plug made of rubber or rubber-like material and in the middle a membrane 22 in Form of a centerpiece with a small wall thickness, which of the Piston tappet 17 can be pierced.

The media container 20 is in an actuating and receiving sleeve 25 added that in the form of a very elongated below closed plastic sleeve with inner support ribs for the media container is trained. Its closed bottom 26 forms an actuating surface for the discharge device 11. It is between ribs 45 inside the nozzle section together with the media container guided and axially movable therein.

A first pressure point safety device 27 is formed on the outer circumference. she consists of three connecting webs or spokes 29 (Fig. 3) that over Material bridges 30 connected to a circumferential outer ring 28 are. This is in a circumferential position determined by a guide groove 42 with its outer circumference in a snap connection 32 recorded in a cylindrical base portion 34 of the Basic body, and that is provided on the lower edge thereof. The Material bridges are designed so that when a break predetermined operating pressure (Fig. 2). An inner rib 48 the base portion 34 defines the ring 28 in its axial position.

The base portion 34 extends from actuation shoulders 35 down, which as a total oval surface (Fig. 4) the middle nozzle section 13 surround and down a stiffening edge 36th exhibit.

As can be seen from FIG. 3, the spokes 29 have lateral ones Reinforcements and are in the axial direction by support ribs 31st stiffened. The outer surface of the actuating sleeve 25 has one outer handle in the form of corrugation.

4 can be seen in the interior of the base section 34 Walls 44 are provided which protrude downwards. They form three Arch sections 49 and then each extend on both sides Extent of the base section to the outside so that it is between them Form slots 43. Are located between the walls 44 Platelets or webs 40 which a second pressure point protection 39 for form a second hub. You are over material bridges 41 with the Walls connected. One of the walls 44 is extended and forms a rotary stop 38 on which one of the spokes 29 at one Rotation strikes.

BASIC FUNCTION OF THE DISCHARGE DEVICE (Fig. 1 to 5)

In the manufacture of the discharge device, the parts in the Fig. 1 shown assembled. The one with the medium 24 filled media container 20 is received in the actuating sleeve 25 and its pump chamber 23 is sealed by the piston plug 21 locked. It is at a distance from the top of the Piston tappet 17 when the actuating sleeve is in the starting position is located, which is defined in that the ring 28 of the first pressure point fuse 27 is engaged in the snap device 32 and on the underside of the ribs 48 abuts.

The resulting ready-to-use discharge device is now available at Grasped need by the user by putting two fingers on the Actuating shoulders 35 and with the thumb on the actuating surface 26 presses. When applying sufficient actuation pressure tear the material bridges 30, which is a predetermined breaking point form, so that the actuating sleeve now with predetermined force and accordingly high operating speed in Fig. 1 after is moved up. After passing through the distance of the needle 17th the needle is pierced by the empty path predetermined by the membrane 22 the membrane, the piston rod 16 presses the piston plug into the Media container 20 and the medium 24 is via the discharge channel 19 released in the needle and the outlet opening 14 as a spray. This happens while the patient is the nozzle section 13 in one had inserted his nostrils.

At the end of this first discharge stroke stage, at which the dimensions are precisely measured Half of the medium is discharged, the spokes hit 29 on the Stop 37 on the underside of the walls 44 and limit thus the discharge. The discharge pressure suddenly collapses and the atomization stops without dripping.

The patient can now place the neck section 13 in his second nostril insert after having the discharge device on the second discharge lifting stage has prepared. This happens because the actuating sleeve 25 rotated by the handle 33 (corrugation) by approx. 30 ° Has. From the comparison of Figures 3 and 4 it can be seen that the Spokes 29 each at about 30 ° distance to the slots 43 in the Walls 44 stand. You were at the end of the first discharge stroke stage struck against these in the middle of the sections 49. she are now rotated by the rotation until they over the Slots 43 stand. The bottom stop serves as a turning stop extended wall section, which forms the rotary stop 38.

If now again the actuating sleeve 25 in Fig. 1 upwards is pressed, the spokes 29 lie on the webs 40. At Reaching the specified actuation pressure for the second The discharge lifting stage also breaks the material bridges 41 there. The second Discharge stroke is also carried out like the first by the lower one Front edge of the piston rod 16 the piston plug 21 further into the Media container 20 presses in and thus the medium in the manner of a Thrust piston pump promotes through the discharge channel 19.

In the illustrated embodiment, the function is ended. So it is a two-way disposable pump that after disposed of once. With the exception of the Media storage 20 and the steel needle 17, and possibly the piston plug 21 all parts are made of plastic injection molding, namely recycling is possible, preferably of the same material.

The discharge device allows the individual partial batches to be carried output great dosing accuracy and reliability; if desired from in different amounts. The partial strokes are due to the free travel to be run through when first activated different what is considered in the design. It is possible to adapt the discharge device for other purposes, for example for medicines that are paired for eyes or others multiply occurring application locations are determined. Also for several successive applications in the form of spray or other output form, for example the treatment at intervals a few minutes on the same application site, the device is used.

DESCRIPTION OF THE INVENTION (Figs. 6 and 7)

The discharge device 11 corresponds to the one explained below Training according to the invention according to FIGS. 1 to 5. On their Description is referenced. The same parts carry the same Reference numerals.

The nozzle section 13 tapers towards its end and goes in an outlet trunk 50, which is integrally formed with this and elongated and thin. Its diameter is between 3 and 4 mm or less, but usually not more than 5 mm, and it is over 10 mm, preferably between 20 and 30 mm long. The Ratio length to diameter is about 7 and should be advantageous be over 5. He is circular cylindrical and has on his End the outlet opening 15 in the form of a spray nozzle. This is an in the outlet trunk 50 molded hole of the small diameter, the together with vertebral channels 51, which in the front end of a Filler 52 are formed, a nozzle with a conical spray forms.

The filler 52 is integrally formed with the piston rod 16 and has conduits 53 of very small cross-section on its outside in the form of molded longitudinal grooves. The longitudinal piece fills an inner channel 54 of the hollow outlet trunk 50 from which the dead space minimized for the escaping medium. The line channels 53 are by means of a reduction in the diameter of the filling piece / piston rod unit formed distribution chamber 53 to the inner bore of the Needle 17 connected.

In Fig. 7, the outlet nozzle 50 is flexible, namely in the area an articulated kink 56, which in a central region of the Exhaust nozzle is. It is formed in that the filler 52a in Area of the kink is reduced in diameter so that it is slightly flexible due to the flexibility of its material. That too The material of the outlet proboscis is flexible enough to be a certain amount allows hose-like bend. If necessary, could Bellows-like folds can be molded in there to facilitate bending. It is also possible the entire outlet trunk by appropriate To make material choice elastic or plastically pliable. It is also possible to permanently bend or bend the outlet proboscis or the orientation of the spray nozzle other than in the axial direction choose.

FUNCTION (Figs. 6 and 7)

For applying a drug to the nasal cavity and its Side channels, especially on the nasal conchae (conchae nasi) the outlet trunk from the doctor or another qualified person introduced and aligned accordingly. Then the discharge device actuated by a first in the manner previously described Execute lifting section. After that, the outlet proboscis becomes the second Nostril inserted and the second stroke section triggered after this may have been unlocked.

With a fixed angled outlet proboscis by appropriate Design of the finger support shoulders 35 a certain hand position be specified so that the doctor automatically hits the right place.

The same applies to an eccentric nozzle arrangement. At a plastically deformable outlet proboscis can the doctor according to his Experience align the trunk beforehand and with an elastic Bendable proboscis can become corresponding when inserted into the nose to form. Here the application of a lubricant to the Help outlet proboscis.

With the special shape of the discharge device with outlet nozzle is one very effective application to certain areas of the nasal mucosa or in certain areas of the nose and nasal cavities possible, the execution with two successive strokes also serves the nasal application.

Claims (13)

Discharge device for flowable media (24) for the discharge thereof by means of a push piston pump (46), with a base body (12) and a media reservoir (20), which forms the pump chamber (23) of the push piston pump (46), in which the base body (12) has a nozzle section (13), which is followed by a thin, long outlet nozzle (50) which is considerably smaller in diameter than the nozzle section (13), at the end of which the outlet opening (14), preferably in the form of a spray nozzle, is arranged, thereby characterized in that the orientation of the outlet opening (14) can be selected deviating from the axial direction of the outlet nozzle. Discharge device according to claim 1, characterized by an eccentric arrangement of the outlet opening (14). Discharge device according to claim 1 or 2, characterized in that the outlet nozzle (50) has an inner channel (54) which, apart from at least one line channel (53) for the medium (24), is largely filled by a filler (52), the end face of which adjoins the outlet opening (14) preferably interacts with the outlet opening to delimit spray nozzle swirl channels (51) and in particular contains them. Discharge device according to one of the preceding claims, characterized in that the outlet nozzle (50) has a diameter of less than 5 mm, preferably between 3 and 4 mm, with a length of more than 10 mm, preferably between 20 and 30 mm. Discharge device according to one of the preceding claims, characterized in that the outlet nozzle (50) has a bend, such as a curvature, a kink or the like. has or branches off at an angle from the nozzle section (13). Discharge device according to claim 5, characterized in that the bend is formed by a flexible section (56) of the outlet nozzle (50). Discharge device according to claim 6, characterized in that the flexible section is designed to adapt itself to this when it is introduced into a nasal channel. Discharge device according to one of the preceding claims, characterized in that the outlet trunk (50) is designed for insertion into a nasal channel, in particular the inner nostril, and / or for dispensing a medicament, preferably a vaccine or immunization agent against colds, such as flu , Discharge device according to one of the preceding claims, characterized in that the outlet opening (14) is designed to generate a spray jet for wetting the nasal conchae (conchae nasi). Discharge device according to one of claims 15 to 20, characterized in that the nozzle section (13) contains a piston tappet (16) and a guide channel for a media container (20) forming a pump cylinder. Discharge device according to one of the preceding claims, characterized in that it is designed as a one-way, two-way atomizer, in particular in its pump chamber a pump piston (21) being movable from an initial position via at least two discharge stroke stages, during which the medium (24) Via a discharge channel (19) provided in the base body (12) flows to an outlet opening (14), in which, in the starting position and at the beginning of each further discharge stroke stage, a pressure point safety device (27, 29) which can be destroyed by a minimum actuating force to be applied is provided and preferably a stop (37) is provided to end the first discharge stroke stage. Discharge device according to one of the preceding claims, characterized in that the base body (12) has a projecting nozzle section (13) with the discharge opening (14) at the end, actuating shoulders (35) projecting laterally therefrom and an essentially cylindrical base section (34), which, together with the nozzle section (13), accommodates the media store (20) and the pressure point safeguards (27, 39) and from which an actuating sleeve (25) protrudes into the base body (12). Discharge device according to one of the preceding claims, characterized in that the media store (20) is tightly closed in its starting position, but is connected to the discharge channel (19) at the beginning of a further discharge lift stage, the discharge device (11) being in particular a disposable multiple atomizer, preferably is designed as a single-use, two-way nebulizer for the sequential administration of a medicament into both nostrils of a patient.

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