EP0951362B1 - Discharge device for flowable media using a thrust 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

In EP-B-0 311 863 (= US-A-4 964 069) by the applicant described a discharge device in which a pump cylinder and a snap lock type Interact resilient stop so that before execution a partial stroke a certain actuation pressure from the Operators must be applied so that after overcoming this pressure point the discharge of the liquid with a certain minimum force and speed. 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 that simultaneously forms the pump cylinder in one or two strokes outputs. Such single or multiple dispensers are important for dispensing medication related to dosage, Contamination, preservation or other criteria in particular are critical.

Furthermore, it is disclosed in WO 92/00812 by the applicant, Media storage for only one discharge stroke, the one plugs serving as pistons are closed at the same time, to use, with the plug for actuation by a needle is pierced.

From FR-A-1 535 293 it is also an originality assurance for aerosol valves, where between the cap carrying the nozzle and one on the Container closure lid snap-on flange-like bead Breakpoints are provided before the first use break.

EP-B-521 022 shows a double atomizer in which the Thrust piston pump through a backdrop on the circumference of the housing stroke limited, which is switched on for a second stroke becomes.

A pump atomizer is known from DE-U-296 01 047 for two consecutive discharge strokes is set up. For this, the pump cylinder is on one forming media container receiving sleeve two predetermined breaking rings provided, which come into engagement one after the other.

The second predetermined breaking ring forms a stop Completion of the first discharge stroke stage.

TASK AND SOLUTION

It is an object of the invention to provide a discharge device for flowable media using a thrust piston pump create with which it is ensured that a discharge in at least two successive discharge stroke stages take place, in particular these discharge strokes with each a predetermined minimum pressure and preferably so are secured against each other that they are also in use Do not perform larger forces with a single operation are.

This object is solved by claim 1. So there are a total of two destructible pressure point safeguards are provided, which each have a predetermined operating force for themselves Tripping required, but not by one of the Pressure point safety stop so formed from each other are decoupled that an accidental breakthrough of several Pressure point safeguards excluded during an actuation stroke is.

It ensures that a drug that is quick should work in two successive strokes e.g. in both The patient's nostrils are sprayed. This is special important for medicines to treat severe pain Diseases or episodes of illness, for example from Migraine. 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 works quickly, but should if possible evenly absorbed through both nostrils to increase the quick effectiveness. there it is particularly important to note that the patients who e.g. of a migraine attack, severe pain are cramped and therefore a safe and uncomplicated Function of the discharge device is essential. all of this is by 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 for a snap-on type Ring provided which e.g. on a push button forming, receiving the media container over destructible material bridges is formed. This snap-in Ring enables the material bridges on one of the provide two parts to be joined, then according to the separation of the material bridges on the other part snapped ring remains on this.

The stop that ends the first stroke can be stop elements have spokes on the ring. So if the First stroke is complete, this beats against the base body moving part, i.e. the actuating sleeve with the media storage, to the fixed stop so that ensures is that the second discharge stroke stage is not triggered immediately becomes. To do this, the unlocking operation is first carried out, for example by rotating the two relative to each other moving parts against each other. So for example those remaining on the actuating sleeve spokes now separated from the ring into one position be rotated where they lie in the area of webs which in turn 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. If you press it a second time, it will break again Predetermined breaking points between the web and the base body, see above that one with a minimum actuation force second discharge stroke is carried out.

For pharmaceutical applications in particular, it is important that the media storage is hermetic until first use is closed. This can be done in that the Media storage, usually a cylindrical glass ampoule a plug made of rubber-like material is closed, the pierced by a hollow needle during the first discharge stroke , which thus forms a kind of exhaust valve. The one with her the discharge channel connected or formed by it remains open on the first stroke, so that on the subsequent second Stroke the atomization can begin immediately.

WO 93/00172 shows a disposable atomizer for others Type one adjoining a nozzle section Outlet trunk with a smaller cross-section.

Especially when applying a drug in the It is often important to nostrils to target the spray to judge particularly favorable therapeutic points. The The invention therefore also aims to provide a spreading device train that application to specific places inside body openings, especially difficult accessible places. For this purpose opposite one of a nozzle section of the base body this significantly reduced in diameter, thinner and Connect the long outlet nozzle to the end of the outlet opening preferably arranged in the form of a spray nozzle is.

This makes it possible in particular to have the outlet proboscis in one Nasal canal, especially the inner nostril for delivery to introduce a drug, preferably a vaccine. Immunization against colds, such as Flu. While it is already known to target pharmaceuticals To apply nasal mucous membranes and thus quickly and without Absorbing gastrointestinal tract load from the body let, however, it is with many medications, especially the described vaccines against colds, required, but at least advantageous, to specific them Apply areas of the nasal cavity, for example the turbinates (conchae nasi). The described form of Exhaust proboscis allows the introduction into this area.

In order to introduce the outlet proboscis into the corresponding, He can allow curved areas of the nasal cavity a bend, such as a curve, 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 pliable so that when it is introduced into a Adapts itself to this.

In the case of a relatively long proboscis because of the small Diameter of usually less than 5 mm (preferably 2 - 4 mm) a length of more than 10 mm (preferably 20-30 mm) actual spreading device, i.e. usually a push piston pump, cannot contain, there arises the problem of Dead space, which is not only the mostly very valuable drug absorbs uselessly, but above all through expansion the spontaneity of the pressure build-up under the pump pressure with special needs. According to the invention, this can be solved by that the outlet trunk has an inner channel that largely except for at least one line channel for the medium, is filled by a filler. Its at the outlet opening adjacent end face can with the outlet opening together delimit spray nozzle swirl channels, these vertebral canals as spiral grooves in this Front side can be included.

In a preferred embodiment, a disposable double atomizer to output two consecutive Partial batches created as a spray. He points to a body a protruding nose adapter with nozzle, actuation shoulders to rest two fingers and one in the Basic body pushable actuating part with a Actuating sleeve and a media storage held therein on, the sealing plunger plug of a hollow needle can be pierced. There is a on the actuating sleeve Ring attached over predetermined breaking points by means of spokes with a first actuation while maintaining a Minimum actuation pressure breaks off. The spokes hit stop and thereby limit the first partial stroke. By turning the actuating sleeve, the actuating section becomes brought into the start position for the second stroke level. There are intermediate webs inserted by means of material bridges broken out, which also maintains the second partial stroke a minimum operator.

These and other features go beyond the claims also from the description and the drawings, wherein the individual features individually or separately several in the form of sub-combinations in one embodiment of the invention and in other fields be and advantageous as well as protective designs can represent, for which protection is claimed here. The division of the application into individual sections as well Inter-headings limit those made under them Statements are not generally applicable.

BRIEF DESCRIPTION OF THE DRAWINGS

Fig. 1

einen Längsschnitt durch eine Austragvorrichtung,

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 Varianten einer Austragvorrichtung.

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

Fig. 1

a longitudinal section through a discharge device,

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 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 neck section 13, the shape and length of each Application is adapted. In the present case it is a so-called nose adapter, which is intended in one Nostril to be inserted into a patient. On his it has a discharge opening 14 in the form of an upper end Spray nozzle with an upstream angle chamber. To this is then inside the hollow nozzle section 13th a sleeve-shaped piston rod carrier 15 is provided in the a likewise hollow piston rod 16 is pressed in at the bottom. In it in turn is a piston tappet 17 in the form of one on it lower free end similar to beveled hollow steel needle an injection needle, by means of a Needle surrounding seal 18. This needle shaped plunger 17 completely penetrates the piston rod and is led 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 provided as a cylindrical, below closed and open at the top, with side flange provided glass container formed like an ampoule is. It forms both the media storage and the Pump chamber 23 so that its inner walls simultaneously the Are cylinder barrel of a thrust piston pump 46. Your butt 21 is formed by a piston plug made of rubber or rubber-like material and one in the middle Membrane 22 in the form of a middle piece with a small wall thickness has, which are pierced by the piston tappet 17 can.

The media container 20 is in an actuating and receiving sleeve 25 added, which is in the form of a very elongated plastic sleeve closed at the bottom with inner support ribs is designed for the media container. Your closed Bottom 26 forms an actuating surface for the Discharge device 11. It is between ribs 45 inside of 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. It consists of three connecting bars or spokes 29 (Fig. 3), the material bridges 30 with a rotating outer ring 28 are connected. This is in one go a guide groove 42 with its circumferential position Outer circumference recorded in a snap connection 32, which in a cylindrical base section 34 of the base body, namely at its lower edge. The material bridges are designed so that when a break predetermined operating pressure (Fig. 2). A Inner rib 48 of the base section 34 places the ring 28 in its axial position.

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

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

4 can be seen in the interior of the base section 34 Walls 44 are provided which protrude downwards. she form three arc sections 49 and then extend on both sides to the circumference of the base section outside so that they form slots 43 between them. Between whose walls 44 are platelets or webs 40 which a second pressure point safety device 39 for a second stroke form. They 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.

FUNCTION (Fig. 1 to 5)

When manufacturing the discharge device, the parts assembled in the position shown in Fig. 1. The one with the Medium 24 filled media container 20 is in the actuating sleeve 25 added and its pump chamber 23 is through the Piston plug 21 tightly closed. It is in one Distance from the tip of the piston rod 17 when the Actuating sleeve is in the starting position, this is defined that the ring 28 of the first pressure point securing 27 is engaged in the snap device 32 and on the Bottom of the ribs 48 abuts.

The resulting ready-to-use discharge device is now seized by the user if necessary by using two Fingers on the actuation shoulders 35 and with the Presses thumb on the actuating surface 26. When applying a sufficient actuation 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 after is moved up. After going through the distance from the needle 17 of the empty path predetermined by the membrane 22 pierces the Needle the membrane, the piston rod 16 presses the piston plug in the media container 20 and the medium 24 is on the Discharge channel 19 in the needle and the outlet opening 14 as Spray released. This happens while the patient the neck portion 13 inserted into one of its nostrils would have.

At the end of this first discharge stroke stage, at which precisely dimensioned half of the medium is discharged, beat the Spokes 29 on the stop 37 on the underside of the walls 44 and thus limit the discharge. The discharge pressure suddenly breaks down and the atomization stops without Dripping on.

The patient can now move the nozzle section 13 into its second Insert nostril after opening the delivery device has prepared the second discharge stroke. this happens in that the actuating sleeve 25 by means of the handle 33rd (Corrugation) has rotated by approx. 30 °. From the comparison of the Figures 3 and 4 can be seen that the spokes 29 each at a distance of approximately 30 ° to the slots 43 in the walls 44 stand. They were about at the end of the first discharge stroke stage struck on these in the middle of the sections 49. she are now rotated by the rotation until they over the Slots 43 stand. The serves as a turning stop Wall section extended at the bottom, which contains the rotary stop 38 forms.

If now again the actuating sleeve 25 in Fig. 1 after is pressed above, the spokes 29 lie on the Bars 40. When the specified actuation pressure is reached the material bridges also break there for the second discharge stroke stage 41. The second discharge stroke level is also like that first run by the lower front edge of the piston rod 16 the piston plug 21 further into the media container 20 pushes in and thus the medium in the manner of a thrust piston pump through the discharge channel 19.

In the illustrated embodiment, this is the function completed. So it's a two-way disposable pump, which is disposed of after a single use. Because with one exception the media storage 20 and the steel needle 17, and possibly the Piston plug 21 all parts are made of plastic injection molding, preferably made of the same material recycling possible.

The discharge device allows the individual partial batches dispense with great dosing accuracy and reliability; if desired in different sizes Amounts. The partial strokes are because of the first actuation to pass through empty paths different, what with the Design is taken into account. It is possible to use the discharge device to adapt for other purposes, for example for medication for eyes or other paired or multiple occurring application locations are determined. Also for several successive applications in the form of spray or other output form, for example the treatment in Intervals of a few minutes on the same application site, the device can be used.

DESCRIPTION OF THE EMBODIMENT (Figs. 6 and 7)

The discharge device 11 corresponds to the one below explained differences of that according to FIGS. 1 to 5. On their description is referred to. Wear the same parts same reference numerals.

The nozzle section 13 tapers towards its end and goes into an outlet trunk 50, which is integral with this is trained and elongated and thin. Its diameter is between 3 and 4 mm or less, however usually not more than 5 mm, and it is preferably over 10 mm between 20 and 30 mm long. The ratio trunk length to diameter is about 7 and should advantageously be over 5 be. It is circular cylindrical and has at its end the outlet opening 15 in the form of a spray nozzle. This is a hole of small diameter formed in the outlet trunk 50, that along with vertebral canals 51 that go into that front end of a filler 52 are formed, a Forms nozzle with conical spray.

The filler 52 is integral with the piston rod 16 formed and has conduit channels 53 on its outside very small cross section in the form of molded longitudinal grooves. The longitudinal piece fills an inner channel 54 of the hollow one Exhaust nozzle 50 from what the dead space for the emerging Medium minimized. The line channels 53 are through one a reduction in the diameter of the filler / 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 of an articulated kink 56, which in a middle area of the outlet trunk. It is through it formed that the filler 52a in the area of the kink in Diameter is reduced so much that it is due to the flexibility of its material is slightly flexible. The material too of the outlet proboscis is so flexible that it is a allows some hose-like bend. If necessary, could bellows-like folds are molded in there to facilitate bending his. It is also possible to remove the entire trunk through appropriate choice of materials elastic or plastic to make it pliable. It is also possible to use the outlet proboscis to constantly bend or bend or align choose the spray nozzle differently than in the axial direction.

FUNCTION (Figs. 6 and 7)

For applying a drug to the nasal cavity and its Side channels, especially on the turbinates (conchae nasi) becomes the outlet trunk from the doctor or another qualified person introduced and aligned accordingly. Then the discharge device is in the previously described Actuated to perform a first lifting section. Then the outlet proboscis is inserted into the second nostril and the second stroke section triggered after this unlocked if necessary.

With a fixed angled outlet proboscis by appropriate Design of the finger support shoulders 35 a certain Hand position must be specified so that the doctor automatically hits the right place. The same goes for one eccentric nozzle arrangement. With a plastically deformable The doctor can, according to his experience, discharge nozzle Align the trunk beforehand and with an elastic and flexible one Proboscis can become corresponding when inserted into the nose to form. Here the application of a lubricant help on the outlet proboscis.

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

Claims (20)

1. Discharge device for flowable media using a thrust piston pump (46), with a base body (12) and a medium reservoir (20), which forms the pump chamber (23) of the thrust piston pump (46) and in which a pump piston (21) is movable over at least two discharge stroke steps from a starting position and the medium (24) flows via a discharge channel (19) provided in the base body (12) to a discharge opening (14), particularly a spray nozzle and in the starting position and at the start of each further discharge stroke step there is a pressure point protector (27, 39) destructible by a minimum actuating force to be applied, characterized in that a fixed stop (37) separate from the destructible pressure point protector is provided for ending the first discharge stroke step and the pressure point protector (39) for a further discharge stroke step is brought into the release position by an unlocking actuation freeing the stop (37).
2. Discharge device according to claim 1, characterized in that the pressure point protectors (27, 39) 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 protectors (27) contains a snap-in ring (28), which is preferably shaped onto a sleeve (25), which receives the medium container (20) and forms an actuation pusher by means of destructible material bridges (30, 41).
4. Discharge device according to claim 3, characterized in that one of the stop elements (29) forming the stop is constructed on the spokes (29) carrying the ring (28).
5. Discharge device according to claim 3 and 4, characterized in that the stop elements (29) forming the stop are reinforced on one side in the downwards direction by a shaped-on rib.
6. Discharge device according to one of the preceding claims, characterized in that the unlocking actuation takes place by a rotation of the sleeve (35) receiving the medium reservoir (20) forming an actuating pusher.
7. Discharge device according to one of the preceding claims, characterized in that the pressure point protector (39) for a further discharge stroke step is constructed as at least one and preferably three webs (40) connected by means of predetermined breaking points (41) to the base body and which is in particular located in the vicinity of a slot (43) bounded by walls (44) of the base body (12).
8. Discharge device according to claim 5 or 6, characterized in that a turning stop (38) for the unlocking actuation is provided and is preferably formed by a projecting wall (44) of the base body (12).
9. Discharge device according to one of the claims 5 to 7, characterized by a handle (33) for the unlocking actuation, preferably a knurling of the sleeve (35) receiving the medium reservoir (20) and forming an actuation pusher projecting from the base body (12).
10. Discharge device according to one of the preceding claims, characterized in that the base body (12) has a projecting connecting piece (13) with the discharge opening (14) at the end, actuating shoulders (35) projecting laterally therefrom and a substantially cylindrical base portion (35) which, together with the connecting piece (13), receives the medium reservoir (20) and pressure point protectors (27, 39) and which projects out of the actuating sleeve (25), which can be pressed into the base body (12).
11. Discharge device according to one of the preceding claims, characterized in that the medium reservoir (20) is tightly sealed in its starting position, but connected at the start of a further discharge stroke step to the discharge channel (19), the discharge device (11) being in particular constructed as a disposable multiple atomizer, preferably as a disposable two-component atomizer for the successive administration of a medicament to the two nostrils of a patient.
12. Discharge device according to one of the preceding claims, characterized in that for the actuation of the thrust piston pump (46) a piston rod (16) presses into the medium container (20) as a pump piston a piston stopper (21) perforatable by a hollow plunger (17), such as a hypodermic needle, for opening the medium container and for its connection to the discharge channel (19) and which forms a closure for the medium container (20).
13. Discharge device according to one of the preceding claims, characterized in that an idle path is provided between the starting position and the position in which the medium container (20) is opened.
14. Discharge device according to one of the preceding claims, characterized in that a base body (12) of the discharge device (11) has a connecting piece (13), to which is connected a thin, long delivery tubule (50) with a much smaller diameter than the connecting piece (13) and on whose end is located the discharge opening (14), preferably in the form of a spray nozzle.
15. Discharge device according to claim 14, characterized in that the delivery tubule (50) has an inner channel (54), which is largely filled, with the exception of at least one line channel (53) for the medium (24), by a filler (52), whose face adjacent to the discharge opening (14) preferably cooperates with said opening for bounding the spray nozzle vortex channels (51) and in particular contains the same.
16. Discharge device according to claims 14 or 15, characterized in that, for a length of more than 10 mm, preferably between 20 and 30 mm, the delivery tubule (50) has a diameter below 5 mm, preferably between 3 and 4 mm.
17. Discharge device according to one of the claims 14 to 16, characterized in that the delivery tubule (50) has a bend, such as a curve, a kink, etc. or branches off in an angled manner from the connecting piece (13) and preferably the bend is formed by a pliable portion (56) of the tubule (50) adapting to the nose channel during insertion into the same.
18. Discharge device according to one of the claims 14 to 17, characterized in that the delivery tubule (50) is constructed for introduction into a nose channel, particularly the inner nostril and/or for the discharge of a medicament, preferably a vaccine or immunizing agent against common colds, such as influenza.
19. Discharge device according to one of the claims 14 to 18, characterized in that the discharge opening (14) is constructed for producing a spray jet for wetting the conchae nasi.
20. Discharge device according to one of the claims 14 to 19, characterized in that the connecting piece (13) contains a piston stopper (16) and a guide channel for a pump cylinder-forming medium container (20).

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