EP1219356B1 - 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

AREA OF APPLICATION AND PRIOR ART

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

In the EP-B-0 311 863 (= US-A-4,964,069 ) of the Applicant is described a discharge device in which a pump cylinder and formed in the manner of a snap locking spring stop cooperate so that before the execution of a partial stroke, a certain operating pressure must be applied by the operator, so that after overcoming this pressure point of the discharge of the liquid with a certain minimum force and speed. This training ensures that, for example, when atomizing the medium from the beginning of sufficient atomization pressure is present and that the pump is actuated to its stroke end and so the entire contents of the media storage, which also forms the pump cylinder, outputs in one or two strokes. Such disposable or multiple dose dispensers are important in dispensing drugs that are particularly critical in terms of dosage, contamination, preservation or other criteria.

Furthermore, it is in the WO 92/00812 Applicant discloses using media reservoirs for only one discharge stroke, which are closed with a stopper simultaneously serving as a piston, whereby the stopper is pierced by a needle for actuation.

It is also from the FR-A-1 535 293 a. Tamper-evident for aerosol valves has become known in which predetermined breaking points are provided between the nozzle-carrying cap and a snap-on flange on the container closure flange flange, which break before the first use.

The EP-B-521,022 shows a dual atomizer in which the thrust piston pump is limited by a gate on the periphery of the housing, which is indexed for a second stroke.

From the US 4,767,416 showing a discharge device according to the preamble of claim 1, a syringe is known, the cannula is variable by a flexible intermediate member in terms of their discharge in relation to the direction of actuation of the syringe.

TASK AND SOLUTION

Especially in the application of a drug in the nostrils, it is important to direct the spray targeted to therapeutically particularly favorable places. The invention therefore aims to design a dispensing device so that the application to certain locations, e.g. Within body openings, especially on hard to reach places to allow, while the dead volume of the dispensing device should be kept low.

This object is solved by the features of claim 1.

Thus, it is in particular possible to introduce the outlet trunk in a nasal passage, in particular the inner nostril for the application of a medicament, preferably a vaccine or immunizing agent against colds, such as influenza. It is true It is already known to apply pharmaceuticals to the nasal mucous membranes and thus allow them to be absorbed by the body quickly and without stressing the gastrointestinal tract, but it is necessary, but at least advantageous, for certain medicaments, in particular the described vaccines for common colds to apply to the nasal cavity, for example to the nasal turbinates (conchae nasi). The described shape of the outlet spout allows the introduction into this area.

In order to allow insertion of the outlet spout into the corresponding curved areas of the nasal cavity, it can bend or the like, such as a bend, a kink or the like. have or branch off angled from the nozzle section. He himself also elastic or plastically flexible, i. be flexible, so that it adapts itself to the introduction into a nasal passage itself.

In a thus relatively long proboscis which, because of the small diameter of usually less than 5 mm (preferably 2-4 mm) at a length of more than 10 mm (preferably 20-30 mm) the actual dispensing device, ie usually a thrust piston pump, not included can, results in the problem of dead space, which not only uselessly absorbs the most valuable drug, but especially by widening under the pump pressure hindered the spontaneity of the pressure build-up. This is achieved in that the outlet has an inner channel, which is largely filled, except for at least one conduit for the medium of a filler. Whose end face adjacent to the outlet opening may together with the outlet opening delimitation of spray nozzle vortex channels form, these vortex channels may be included as spiral grooves in this side.

In a preferred embodiment, a disposable dual atomizer is provided for dispensing two consecutive subbatches as a spray. He has on a base body a projecting nose adapter with nozzle actuation shoulders for supporting two fingers and an in the body hineinindrückbaren operating part with an actuating sleeve and a media storage held therein, the closure piston plug can be pierced by a hollow needle. On the actuating sleeve, a ring is attached via predetermined breaking points by means of spokes, which breaks off at a first actuation while maintaining a minimum actuation pressure. The spokes strike a stop and thereby limit the first partial stroke. By rotation of the actuating sleeve of the actuating portion is brought into start position for the second stroke. There, inserted by means of material bridges intermediate webs are broken, whereby the second partial stroke is carried out while maintaining a minimum actuation force.

So there are a total of two destructible pressure point fuses provided, each of which requires a predetermined operating force to their release.

It is thus possible to spray a drug that is to act quickly in two successive strokes, for example, in both nostrils of the patient. This is especially important for medications used to treat severe pain or relapses, such as migraine. The medicines developed for the treatment of these diseases are very expensive and must therefore be used very accurately. Your intake via the nasal mucous membranes is very good and fast acting, but should be absorbed evenly over both nostrils as much as possible in order to increase the rapid effectiveness. It should be noted in particular that the patients who are affected, for example, by a migraine attack, are severely cramped in pain and therefore a safe and uncomplicated function of the discharge is essential. All this is ensured by the multi-stroke discharge device according to the invention, regardless of any external conditions.

The pressure point fuse may contain at least one predetermined breaking point. Most preferably, it is provided on a snap-in ring, e.g. is formed on destructible material bridges on a forming an actuating handle, the media container receiving sleeve. This snap-in ring makes it possible to provide the material bridges on one of the two parts to be joined, in which case after the separation of the material bridges of the snapped on the other part ring remains at this.

When the first Austraghubstufe is triggered and the first stroke is completed, a stop is preferably provided, the stop elements are formed for example in the region of the ring-bearing spokes. Thus, when the Ersthub is completed, proposes to the main body movable part, ie the actuating sleeve with the media storage, to a fixed stop, so as to ensure that not equal to the second Austraghubstufe is triggered. For this purpose, an unlocking operation is performed first, for example, by rotation of the two relatively movable parts against each other. Thus, for example, remaining on the actuating sleeve, now separated from the ring spokes can be rotated to a position where they lie in the range of webs, which in turn are connected via predetermined breaking points with the body. This rotational position can by projecting wall sections be limited to prevent overspeeding. Now, if a second actuation occurs, in turn break the predetermined breaking points between the web and the body, so that a executed with a minimum actuation force second discharge stroke is performed.

In particular, for pharmaceutical applications, it is important that the media storage is hermetically sealed until it is used for the first time. This can be done by the media storage, usually a cylindrical glass ampoule, is closed by a plug of gummiartigem material which is pierced in the first discharge of a hollow needle, which thus forms a kind of outlet valve. The associated with her or formed by her discharge remains open after the first stroke, so that in the subsequent second stroke immediately the atomization can begin.

These and other features will become apparent from the claims but also from the description and drawings, wherein the individual features each alone or more in the form of sub-combinations in an embodiment of the invention and in other fields be realized and advantageous and protectable Represent embodiments for which protection is claimed here. The subdivision of the application into individual sections as well as intermediate headings does not restrict the general validity of the statements made thereunder.

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 illustrated in the drawings and will be explained in more detail below. In the drawings show:

Fig. 1

a longitudinal section through a discharge device, the working principle of the device, but not the inventive design of the outlet, shows

Fig. 2

a greatly enlarged detail of area II in Fig. 1 .

Fig. 3

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

Fig. 4

a section after the line IV in Fig.1 .

Fig. 5

a section along the line V in Fig. 4 and

6 and 7

Partial longitudinal sections through an inventive discharge.

DESCRIPTION OF THE CONSTRUCTION OF THE TRANSMISSION DEVICE (Figures 1 to 5)

The discharge device 11 shown in the drawing has a base body 12 which consists of plastic injection molding. He has a central elongated nozzle portion 13, in his inventive training in the 6 and 7 is shown and adapted in its shape and length to the particular application. In the present case, it is a so-called nose adapter, which is intended to be inserted into a nostril of a patient. At its upper ends, it has a discharge opening 14 in the form of a spray nozzle with an upstream angle chamber. At this point, a sleeve-shaped piston rod carrier 15 is provided inside the hollow nozzle portion 13, in which a likewise hollow piston rod 16 is pressed down. In turn, a piston plunger 17 in shape a hollow steel needle beveled at its lower free end similar to a hypodermic needle, by means of a seal surrounding the needle 18. This needle-shaped piston plunger 17 passes completely through the piston rod and is zoomed up to the discharge opening 14, so its interior forms a discharge channel 19.

The dispensed pharmaceutical medium 24 is provided in a medium container 20, which is formed as a cylindrical, closed down and open at the top, provided with a lateral flange glass container similar to an ampoule. It also forms the media reservoir and the pump chamber 23, so that its inner walls are simultaneously the cylinder bore of a thrust piston pump 46. Your piston 21 is formed by a piston plug, which consists of rubber or rubber-like material and in the middle has a membrane 22 in the form of a middle piece with a small wall thickness, which can be pierced by the piston plunger 17.

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

On the outer circumference a first pressure point fuse 27 is formed. It consists of three connecting webs or spokes 29 ( Fig. 3 ), which are connected via material bridges 30 with a circumferential outer ring 28. This is received in a defined by a guide groove 42 circumferential position with its outer periphery in a snap connection 32 which is provided in a cylindrical base portion 34 of the body, namely at its lower edge. The Material bridges are designed so that they break when applying a predetermined operating pressure ( Fig. 2 ). An inner rib 48 of the base portion 34 secures the ring 28 in its axial position.

The base portion 34 extends downwardly from actuating shoulders 35, which are generally oval in area (FIG. Fig. 4 ) surrounding the central nozzle portion 13 and down a stiffening edge 36 have.

The spokes 29 have, as out Fig. 3 can be seen, lateral reinforcements and are stiffened by support ribs 31 in the axial direction. The outer surface of the actuating sleeve 25 has an outer handle in the form of a corrugation.

Inside the base portion 34 are made Fig. 4 provided to recognize walls 44 which project downwards. They form three arc sections 49 and then extend on both sides to the circumference of the base portion to the outside, so that they form slots 43 between them. Between the walls 44 are platelets or webs 40, which form a second pressure point fuse 39 for a second stroke. They are connected via material bridges 41 with the walls. One of the walls 44 is extended and forms a rotation stop 38 against which one of the spokes 29 strikes during one rotation.

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

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

The resulting ready-to-use dispensing device is now grasped by the user as needed by placing two fingers on the actuating shoulders 35 and pressing the actuating surface 26 with the thumb. When applying a sufficient operating pressure tear the material bridges 30, which form a predetermined breaking point, so that the actuating sleeve now with a predetermined force and accordingly high operating speed in Fig. 1 is moved upward. After passing through the predetermined by the distance of the needle 17 from the membrane 22 Leerweges the needle pierces the membrane, the piston rod 16 pushes the plunger stopper in the media container 20 and the medium 24 is released via the discharge channel 19 in the needle and the outlet opening 14 as a spray. This happens while the patient has inserted the neck portion 13 into one of his nostrils.

At the end of this first discharge stroke stage, in which exactly half of the medium is discharged, the spokes 29 strike the stop 37 on the underside of the walls 44 and thus limit the discharge. The discharge pressure breaks down suddenly and the atomization stops without dripping.

The patient may now insert the neck portion 13 into his second nostril after preparing the dispenser for the second dispensing stroke. This happens because the actuating sleeve 25 has rotated by means of the handle 33 (corrugation) by approximately 30 °. From the comparison of FIGS. 3 and 4 it can be seen that the Spokes 29 each stand at about 30 ° distance from the slots 43 in the walls 44. They were at the end of the first Austragshub stage approximately in the middle of sections 49 struck them. They are now rotated by the rotation until they are above the slots 43. As a rotation stop serves the downwardly extended wall portion which forms the rotation stop 38.

Now turn the actuating sleeve 25 in Fig. 1 When reaching the predetermined actuating pressure for the second Austragshubstufe break there also the material bridges 41. The second Austraghubstufe is also like the first executed by the lower end edge of the piston rod 16 the Plunger plug 21 pushes further into the media container 20 and thus promotes the medium in the manner of a piston pump through the discharge channel 19.

In the illustrated embodiment, so the function is completed. It is therefore a two-way disposable pump, which is disposed of after a single use. Since with the exception of the media reservoir 20 and the steel needle 17, and possibly the piston plug 21, all parts are made of plastic injection molding, preferably of the same material, recycling is possible.

The discharge device makes it possible to output the individual partial batches with high dosing accuracy and reliability; if desired from in different quantities. The partial strokes are different because of the idle paths to be traversed during the first actuation, which is taken into account in the design. It is possible to adapt the dispenser for other purposes, such as for medicines intended for eyes or other mating or multiple sites of use. Also for several successive applications in the form of spray or different output form, for example, the treatment at intervals of a few minutes to the same application site, the device can be used.

DESCRIPTION OF THE INVENTION (Figures 6 and 7)

The discharge device 11 corresponds to the explained below according to the invention training of the Fig. 1 to 5 , Their description is referred to. The same parts bear the same reference numerals.

The spigot portion 13 tapers towards its end and merges into an outlet spout 50 integrally formed therewith and elongate and thin. Its diameter is between 3 and 4 mm or below, but usually not more than 5 mm, and it is over 10 mm, preferably between 20 and 30 mm long. The ratio Reussellänge to diameter is about 7 and should be advantageous over 5. He is circular cylindrical and has at its end the outlet opening 15 in the form of a spray nozzle. This is a small diameter hole formed in the outlet spout 50 which, together with swirling channels 51 formed in the front end of a filler 52, forms a nozzle with a conical spray jet.

The filler 52 is formed integrally with the piston rod 16 and has on its outer side ducts 53 of very small cross-section in the form of molded-in longitudinal grooves. The longitudinal piece fills an inner channel 54 of the hollow outlet spout 50, which minimizes the dead space for the exiting medium. The ducts 53 are over a by a diameter reduction of the unit filler / piston rod formed distribution chamber 53 connected to the inner bore of the needle 17.

at Fig. 7 the outlet trunk 50 is flexibly flexible, in the region of a hinged kink 56, which lies in a central region of the outlet. It is formed by the fact that the filler 52a is reduced in diameter in the region of the kink in that it is easily flexible due to the flexibility of its material. The material of the outlet spout is flexible enough that it allows a certain hose-like bend. Optionally, bellows-like folds could be molded to facilitate bending. It is also possible to make the entire outlet trunk by appropriate choice of material elastic or plastic flexible. It is also possible to permanently bend or angle the outlet trunk or to select the orientation of the spray nozzle other than in the axial direction.

FUNCTION (Figures 6 and 7)

For administering a drug into the nasal cavity and its side channels, in particular to the nasal conchae (nasopharynx), the outlet trunk is inserted by the doctor or another competent person and aligned accordingly. Thereafter, the discharge device is operated in the manner previously described to perform a first stroke section. Thereafter, the outlet trunk is inserted into the second nostril and the second lift section triggered after it has been unlocked, if necessary.

In a fixed angled outlet trunk 35, a certain hand position can be given by appropriate design of the finger support shoulders, so that the doctor automatically hits the right place.

The same applies to an eccentric nozzle arrangement. In a plastically deformable outlet, the doctor can according to his experience align the trunk in advance and in an elastically flexible trunk this can form accordingly when inserted into the nose. Here, applying a lubricant to the outlet can help.

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

Claims (9)

1. Discharge device for flowable media (24) using a piston pump (46) for discharge, having a basic element (12) and a medium reservoir (20) forming the pump chamber (23) of the piston pump (46), said basic element (12) having a support section (13) adjoined by a thin and long outlet nozzle (50) considerably reduced in diameter relative to the support section (13), at the end of which outlet nozzle is arranged the outlet opening (14), where the orientation of the outlet opening can be selected to diverge from the axial direction of the outlet nozzle,
   characterized in that
   the outlet nozzle (50) has an inner channel (54) substantially filled by a filler section (52) except for at least one line channel (53) for the medium (24).
2. Discharge device according to Claim 1, characterized by an off-center arrangement of the outlet opening (14).
3. Discharge device according to Claim 1 or 2, characterized in that the end face of the filler section adjoining the outlet opening (14) interacts with the outlet opening to delimit the spray nozzle swirl channels (51) and in particular contains the latter.
4. Discharge device according to one of the preceding claims, characterized in that the outlet nozzle (50) has, with a length of more than 10 mm, preferably between 20 and 30 mm, a diameter of less than 5 mm, preferably between 3 and 4 mm.
5. Discharge device according to one of the preceding claims, characterized in that the outlet nozzle (50) has an angled section, such as a curve, a kink or the like, or branches off at an angle from the support section (13).
6. Discharge device according to Claim 5, characterized in that the angled section is formed by a flexible section (56) of the outlet nozzle (50).
7. 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 of nasal conchae.
8. Discharge device according to one of the preceding claims, characterized in that the support section (13) contains a piston plunger (16) and a guide channel for a media container (20) forming a pump cylinder.
9. Discharge device according to one of the preceding claims, characterized in that it is designed as a one-way double-acting atomizer, where in particular inside its pump chamber a pump piston (21) is movable from a starting position over at least two discharge stroke stages, during which stages the medium (24) flows via a discharge channel (19) provided inside the basic element (12) to an outlet opening (14) inside which are provided at the starting position and at the start of every further discharge stroke stage a pressure-point safety device (27, 29) destructible by a minimum actuating force to be applied and preferably a stop (37) to end the first discharge stroke stage.

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