EP0951362A1

EP0951362A1 - Discharge device for flowable media using a thrust piston pump

Info

Publication number: EP0951362A1
Application number: EP98904040A
Authority: EP
Inventors: Gerald Krampen; Karl-Heinz Fuchs; Hans Merk
Original assignee: Erich Pfeiffer GmbH; Ing Erich Pfeiffer GmbH
Current assignee: Aptar Radolfzell GmbH
Priority date: 1997-01-09
Filing date: 1998-01-08
Publication date: 1999-10-27
Anticipated expiration: 2018-01-08
Also published as: EP1219356A2; ATE219391T1; KR100492350B1; CA2277208C; JP4046769B2; US6321942B1; DK0951362T3; CN1250398A; EP0882516A1; ES2176960T3; DE59812015D1; AU740121B2; KR100559101B1; DE59804505D1; EP0951362B1; DE29824620U1; JP2001509070A; WO1998030335A1; JPH10338298A; EP1219356B1

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

Discharge device for flowable media by means of a push piston pump

APPLICATION AREA AND PRIOR ART

EP-B-0 311 863 (= US-A-4 964 069) by the applicant describes a discharge device in which a pump cylinder and a resilient 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 must be applied by the operator so that after this pressure point has been overcome, the liquid is discharged with a certain minimum force and speed. This training ensures that e.g. when atomizing the

Medium is present from the beginning of sufficient atomization pressure and that the pump is actuated to the end of its stroke and thus outputs the entire contents of the media store, which simultaneously forms the pump cylinder, in one or two strokes. Such disposable or multiple dispensers are important for dispensing medications that are particularly critical with regard to dispensing, contamination, preservation or other criteria.

Furthermore, it is disclosed in WO 92/00812 by the applicant to use media stores for only one discharge stroke, which are closed by a stopper that also serves as a piston, the stopper being pierced by a needle for actuation. From FR-A-1 535 293 a tamper-evident device for aerosol valves has also become known, in which predetermined breaking points are provided between the cap carrying the nozzle and a flange-like bead which can be snapped onto the container closure lid and which break before the first use.

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

TASK AND SOLUTION

It is an object of the invention to provide a discharge device for flowable media by means of a thrust piston pump, with which discharge is possible in at least two successive discharge stroke stages, in particular these discharge strokes taking place in each case with a predetermined minimum pressure and preferably being secured against one another in such a way that they cannot be carried out with a single operation, even when applying greater forces.

This object is solved by claim 1. A total of two destructible pressure point safeguards are therefore provided, each of which requires a predetermined actuating force to trigger it.

It is thus possible to administer a medication that is to act quickly in two successive strokes e.g. in both

Spray the patient's nostrils. This is particularly important for medications to treat very painful illnesses or episodes of illness, such as migraines. The drugs developed to treat these diseases are very expensive and therefore have to be very precise be used in doses. Their absorption through the nasal mucous membranes is very good and effective quickly, but should be absorbed evenly over both nostrils if possible in order to increase the rapid effectiveness even more. Particular attention should be paid to the fact that patients who are affected by a migraine attack, for example, are severely cramped with pain and therefore a safe and uncomplicated function of the discharge device is essential. All this is ensured by the multi-stroke discharge device according to the invention regardless of any external conditions.

The pressure point safety device can contain at least one predetermined breaking point. It is particularly preferably provided on a snap-in ring which, e.g. is formed on a sleeve forming an actuating button and receiving the media container via destructible material bridges. This snap-in ring makes it possible to provide the material bridges on one of the two parts to be joined, the ring which is snapped onto the other part then remaining on the other part after the separation of the material bridges.

When the first discharge stroke stage has been triggered and the first stroke has ended, a stop is preferably provided, the stop elements of which are formed, for example, in the region of the spokes carrying the ring. When the first stroke has ended, the part that is movable relative to the base body, ie the actuating sleeve with the media store, strikes a fixed stop, so that it is ensured that the second discharge stroke stage is not triggered immediately. For this purpose, an unlocking operation is first carried out, for example by rotating the two parts which are movable relative to one another. Thus, for example, the spokes remaining on the actuating sleeve and now separated from the ring can be moved into one position be rotated where they lie in the area of webs, which in turn are connected to the base body via predetermined breaking points. This rotational position can be limited by projecting wall sections in order to prevent "overturning". If a second actuation takes place, the predetermined breaking points between the web and the base body again break, so that a second discharge stroke is carried out with a minimum actuating force.

For pharmaceutical applications in particular, it is important that the media store be hermetically sealed until it is used for the first time. This can be done in that the media store, usually a cylindrical glass ampoule, is closed by a stopper made of rubber-like material which is pierced by a hollow needle during the first discharge stroke, which thus forms a kind of outlet valve. The discharge channel connected to it or formed by it remains open after the first stroke, so that atomization can begin immediately on the subsequent second stroke.

Especially when applying a medication into the nostrils, it is often important to direct the spray jet to areas that are therapeutically particularly favorable. The invention therefore also aims to design a dispensing device in such a way that it can be applied to specific locations within body openings, in particular also locations that are difficult to access. For this purpose, a nozzle section of the base body can be followed by a thin and long outlet nozzle which is considerably smaller in diameter than the nozzle body, at the end of which the outlet opening is preferably arranged in the form of a spray nozzle.

This makes it possible, in particular, to dispense the outlet proboscis in a nasal canal, in particular the inner nostril. Introduce a drug, preferably a vaccine or immunizer against colds, such as flu. Although 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, it is necessary, or at least advantageous, for many medicaments, in particular the vaccines against colds described to apply it to certain areas of the nasal cavity, for example to the nasal conchae (conchae nasi). The described shape of the outlet proboscis enables the introduction into this area.

In order to allow an insertion of the outlet trunk into the corresponding, curved areas of the nasal cavity, it can be bent, such as a curvature, a kink or the like. have or branch off at an angle from the nozzle section. It can itself be elastic or plastically flexible, i.e. be flexible so that it adapts itself to it when inserted into a nasal canal.

In the case of a relatively long proboscis because of the small

Diameter of usually less than 5 mm (preferably 2 - 4 mm) with a length of more than 10 mm (preferably 20 - 30 mm) the actual delivery device, ie usually a thrust piston pump, cannot contain the problem of dead space, which does not only uselessly absorbs the mostly very valuable medication, but above all also impedes the spontaneity of the pressure build-up by expansion under the pump pressure. This can be solved according to the invention in that the outlet trunk has an inner channel which is largely filled with a filler, with the exception of at least one line channel for the medium. Whose end face adjoining the outlet opening can together with the outlet opening form the delimitation of spray nozzle swirl channels, these vertebral canals can be contained as spiral grooves in this face.

In a preferred embodiment, a disposable double atomizer for dispensing two successive partial batches is created as a spray. It has on a base body a protruding nose adapter with a nozzle, actuation shoulders for supporting two fingers and an actuation part which can be pushed into the base body and has an actuation sleeve and a media store held therein, the plunger plug of which can be pierced by a hollow needle. A ring is attached to the actuating sleeve over predetermined breaking points by means of spokes, which tears off during a first actuation while maintaining a minimum actuation pressure. The spokes hit a stop and thereby limit the first partial stroke. By rotating the actuating sleeve, the actuating section is brought into the starting position for the second lifting stage. Intermediate webs inserted by means of material bridges are broken out, as a result of which the second partial stroke also takes place while maintaining a minimum actuation force.

These and further features emerge from the claims and also from the description and the drawings, the individual features being realized individually and in groups in the form of subcombinations in an embodiment of the invention and in other fields, and being advantageous and for Protectable versions can be represented, for which protection is claimed here. The division of the application into individual sections and subheadings do not limit the general validity of the statements made under these.

BRIEF DESCRIPTION OF THE DRAWINGS An embodiment of the invention is shown in the drawings and is explained in more detail below. The drawings show:

1 shows a longitudinal section through a discharge device,

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

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

4 is a section along the line IV in Fig.l,

Fig. 5 is a section along the line V in Fig. 4 and

6 and 7 partial longitudinal sections through variants of a

Discharge device.

DESCRIPTION OF THE EMBODIMENT

(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 elongated nozzle section 13, which is adapted in shape and length to the respective application. In the present case, it is a so-called nasal adapter, which is intended to be inserted into a patient's nostril. At its upper ends it has a discharge opening 14 in the form of a spray nozzle with an upstream angular chamber. This is followed by the inside of the hollow nozzle section 13 a sleeve-shaped piston rod carrier 15 is provided, into which a likewise hollow piston rod 16 is pressed at the bottom. In turn, a piston tappet 17 in the form of a hollow steel needle, which is tapered at its lower free end, is pressed in, similar to an injection needle, by means of a seal 18 surrounding the needle. This needle-shaped piston tappet 17 penetrates the piston rod completely and is brought up to the discharge opening 14 , so its interior forms a discharge channel 19.

The pharmaceutical medium 24 to be dispensed is in one

Media container 20 is provided, which is designed as a cylindrical, closed at the bottom and open at the top, provided with a side flange glass container similar to an ampoule. At the same time, it forms the media reservoir and the pump chamber 23, so that its inner walls are simultaneously the cylinder raceway of a push piston pump 46. Your piston 21 is formed by a piston stopper, which is made of rubber or rubber-like material and has in the middle a membrane 22 in the form of a middle piece with a small wall thickness, which can be pierced by the piston tappet 17.

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

A first pressure point safety device 27 is formed on the outer circumference. It consists of three connecting webs or spokes 29 (FIG. 3) which run over material bridges 30 with a the outer ring 28 are connected. This is received in a circumferential position determined by a guide groove 42 with its outer circumference in a snap connection 32, which is provided in a cylindrical base section 34 of the base body, specifically at its lower edge. The material bridges are designed so that they break when a predetermined actuation pressure is applied (Fig. 2). An inner rib 48 of the base portion 34 defines the ring 28 in its axial position.

The base section 34 extends downward from actuation shoulders 35 which, as an overall oval surface (FIG. 4), surround the central connecting piece section 13 and have a stiffening edge 36 at the bottom.

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

In the interior of the base section 34, walls 44 can be seen from FIG. 4, which project downwards. They form three arcuate sections 49 and then extend outwards on both sides of the circumference of the base section, so that they form slots 43 between them. Between their walls 44 there are plates or webs 40 which form a second pressure point safeguard 39 for a second stroke. They are connected to the walls via material bridges 41. One of the walls 44 is elongated and forms a rotary stop 38 against which one of the spokes 29 strikes during rotation.

FUNCTION

(Fig.l to 5) During the manufacture of the discharge device, the parts are assembled in the position shown in FIG. 1. The media container 20 filled with the medium 24 is accommodated in the actuating sleeve 25 and its pump chamber 23 is sealed by the piston stopper 21. It is in one

Distance from the tip of the piston rod 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 safety device 27 is engaged in the snap device 32 and rests on the underside of the ribs 48.

The resulting ready-to-use discharge device is now gripped by the user when required by placing two fingers on the actuation shoulders 35 and pressing the actuating surface 26 with the thumb. When a sufficient actuation pressure is applied, the material bridges 30 tear, which form a predetermined breaking point, so that the actuation sleeve is now moved upward in FIG. 1 with a predetermined force and correspondingly high actuation speed. After passing through the free path predetermined by the distance of the needle 17 from the membrane 22, the needle pierces the membrane, the piston rod 16 presses the piston stopper into 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 mist. This happens while the patient has inserted the neck section 13 into one of his nostrils.

At the end of this first discharge stroke stage, at 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 suddenly collapses and the atomization stops without dripping. The patient can now insert the nozzle section 13 into his second nostril after he has prepared the discharge device for the second discharge stroke stage. This is done in that the actuating sleeve 25 has rotated by approximately 30 ° by means of the handle 33 (reefing). From the comparison of Figures 3 and 4 it can be seen that the spokes 29 are each at an approximately 30 ° distance to the slots 43 in the walls 44. At the end of the first discharge stroke stage, they were struck against them in the middle of the sections 49. You are now rotated by the rotation until they are over the slots 43. The wall section, which is elongated downwards and forms the rotary stop 38, serves as the rotary stop.

If the actuating sleeve 25 in FIG. 1 is now pushed up again, the spokes 29 lie on the webs 40. When the predetermined actuating pressure for the second discharge stroke stage is reached, the material bridges 41 also break there. The second discharge stroke stage also becomes like the first Carried out by the lower end edge of the piston rod 16 pushing the piston plug 21 further into the media container 20 and thus conveying the medium through the discharge channel 19 in the manner of a push piston pump.

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

The discharge device makes it possible to discharge the individual batches with great dosing accuracy and reliability. give; if desired, in different amounts. The partial strokes are different because of the free travel to be run when first actuated, which is taken into account in the design. It is possible to adapt the discharge device for other purposes, for example for medicaments which are intended for eyes or other application sites which occur in pairs or several times. The device can also be used for several successive applications in the form of spray or other dispensing form, for example the treatment at intervals of a few minutes on the same application site.

DESCRIPTION OF THE EMBODIMENT

(Figs. 6 and 7)

Except for the differences explained below, the discharge device 11 corresponds to that according to FIGS. 1 to 5. Reference is made to the description thereof. The same parts have the same reference numerals.

The nozzle section 13 tapers towards its end and merges into an outlet trunk 50 which is formed in one piece with it and is elongate 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 of the length of the trunk to the diameter is about 7 and should advantageously be over 5. It is circular cylindrical and has the outlet opening 15 in the form of a spray nozzle at its end. This is a hole of small diameter formed in the outlet trunk 50, which together with swirl channels 51, which are formed in the front end of a filler 52, forms a nozzle with a conical spray jet. The filler 52 is formed in one piece with the piston rod 16 and has on its outside conduit channels 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 trunk 50, which minimizes the dead space for the escaping medium. The line channels 53 are connected to the inner bore of the needle 17 via a distributor chamber 53 formed by a reduction in diameter of the filling piece / piston rod unit.

7, the outlet nozzle 50 is flexibly flexible, specifically in the region of an articulated kink 56 which lies in a central region of the outlet nozzle. It is formed in that the filler 52a in the area of the kink is reduced in diameter to such an extent that it is slightly flexible due to the flexibility of its material. The material of the outlet proboscis is also flexible enough to allow a certain hose-like bend. If necessary, bellows-like folds could be formed there to facilitate the bending. It is also possible to make the entire outlet trunk elastic or plastically flexible by appropriate choice of material. It is also possible to permanently curve or bend the outlet nozzle or to choose the orientation of the spray nozzle other than in the axial direction.

FUNCTION (Fig. 6 and 7)

To apply a medication to the nasal cavity and its side channels, especially to the nasal conchae (conchae nasi), the outlet trunk is inserted by the doctor or another qualified person and aligned accordingly. The discharge device is then actuated in the manner described above in order to carry out a first lifting section. The outlet trunk is then inserted into the second nostril and the second lifting section is triggered after it has been unlocked, if necessary.

In the case of a fixedly angled outlet proboscis, a certain hand position can be predetermined by appropriately designing the finger support shoulders 35, so that the doctor automatically hits the right place. The same applies to an eccentric nozzle arrangement. In the case of a plastically deformable outlet trunk, the doctor can align the trunk beforehand in accordance with his experience, and in the case of an elastically flexible trunk the trunk can be shaped accordingly when it is inserted into the nose. Applying a lubricant to the nozzle can help here.

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

Claims

Claims to flow device for flowable media by means of a thrust piston pump

1. discharge device for flowable media (24) by means of a thrust piston pump (46), with a base body (12) and a media reservoir (20), which forms the pump chamber (23) of the thrust piston pump (46) and in which a pump piston (21) an initial position can be moved over at least two discharge stroke stages, during which the medium (24) flows via a discharge channel (19) provided in the base body (12) to a discharge opening (14), in particular a spray nozzle, in which in the initial position and on 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.

2. Discharge device according to claim 1, characterized in that the pressure point safeguards (27, 29) contain at least one predetermined breaking point (30, 41).

3. Discharge device according to claim 1 or 2, characterized in that one of the pressure point safeguards (27) contains a snap-in ring (28), which preferably forms an actuating lever, the media container (20) receiving sleeve (25) over destructible material bridges (30 , 41) is formed.

4. Discharge device according to one of the preceding claims, characterized in that a stop (37) is provided for ending the first discharge stroke stage.

5. Discharge device according to claim 3 and 4, characterized in that one of the stop elements forming the stop (29) in the region of the ring (28) carrying spokes (29) is formed.

6. Discharge device according to claim 3, 4 and 5, characterized in that the stop elements forming the stop (29) are reinforced on one side downwards by a molded rib.

7. Discharge device according to one of the preceding claims, characterized in that the pressure point safety device (39) for a further discharge stroke stage by an unlocking actuation, in particular a rotation of an actuating lever forming the media container (20) receiving sleeve (35) in the release position bring is.

8. Discharge device according to one of the preceding claims, characterized in that the pressure point safety device (39) for a further discharge stroke stage is designed as at least one, preferably three, via predetermined breaking points (41) connected to the base body (40), which in particular in the area of a is arranged by walls (44) of the base body (12) limited slot (43).

9. Discharge device according to claim 6 or 7, characterized in that a rotary stop (38) is provided for the unlocking actuation, which is preferably formed by a projecting wall (44) of the base body (12).

10. Discharge device according to one of claims 6 to 8, characterized by a handle (33) for the unlocking actuation, preferably a corrugation of the protruding from the base body (12) forming an actuating lever, the media container (20) receiving sleeve (35).

11. 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, from this laterally projecting actuation shoulders (35) and a substantially cylindrical base section (34) which, together with the nozzle section (13), accommodates the media store (20) and the pressure point safety devices (27, 39) and from which an actuating sleeve (25) protrudes into the base body (12).

12. Discharge device according to one of the preceding claims, characterized in that the media store (20) is tightly closed in its initial position, but is connected to the discharge channel (19) at the beginning of a further discharge lift stage, the discharge device

(11) is designed in particular as a single-use multiple nebulizer, preferably as a single-use double nebulizer for the successive administration of a medicament into both nostrils of a patient.

13. Discharge device according to one of the preceding claims, characterized in that for actuating the thrust piston pump (46) a piston rod (16) forming a closure of the media store (20), for opening the media store and for its connection to the discharge channel (19) by one hollow plunger (17), such as a hollow needle, pushes through plungable plunger plugs (21) into the media reservoir (20) as a pump plunger.

14. Discharge device according to one of the preceding claims, characterized in that an idle stroke is present between the starting position and the position in which the media store (20) is opened.

15. Discharge device, in particular according to one of the preceding claims, characterized in that a base body (12) of the discharge device (11) has a nozzle section (13) to which a considerably reduced diameter, thinner, longer compared to the nozzle section (13) Outlet trunk (50) connects, at the end of which the outlet opening (14), preferably in the form of a spray nozzle, is arranged.

16. Discharge device according to claim 15, characterized in that the outlet nozzle (50) has an inner channel (54) which is largely filled up by a filler (52) except for at least one line channel (53) for the medium (24), 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.

17. Discharge device according to claims 15 or 16, characterized in that the outlet trunk (50) with a length of more than 10 mm, preferably between 20 and 30 mm, has a diameter of less than 5 mm, preferably between 3 and 4 mm.

18. Discharge device according to one of claims 15 to 17, characterized in that the outlet trunk (50) has an angle, such as a curvature, a kink or the like. has or angled off from the connecting piece section (13), the angling preferably being formed by a flexible section (56) of the outlet nozzle (50) which, when introduced into a nasal channel, adapts itself to this.

19. Discharge device according to one of claims 15 to 18, characterized in that the outlet trunk (50) is designed for insertion into a nasal passage, in particular the inner nostril, and / or for dispensing a medicament, preferably a vaccine or immunization agent against colds how flu is trained.

20. Discharge device according to one of claims 15 to 19, characterized in that the outlet opening (14) is designed to generate a spray jet for wetting the nasal conchae (conchae nasi).

21. Discharge device according to one of claims 15 to 20, characterized in that the nozzle section (13) has a piston tappet (16) and a guide channel for contains a media container (20) forming a pump cylinder.