EP1297898A2 - Fluid assisted particle dispenser - Google Patents

Abstract

The dispenser's storage chamber (11) in a first working position (50) is connected by opening of a seal (20) to a filling chamber (12) which is increased in volume by the medium flowing into it from the storage chamber in the subsequent second working position (51), and is then emptied through the outlet (8) in the third working position (52). <??>The filling chamber boundaries comprise a dividing wall (17) and a thrust wall (16) movable in relation to it and forming an actuating component to reduce or increase the volume of the filling chamber.

Description

The invention relates to the application of media, in particular pharmaceutical products in atomized, jet or drop form and a donor for it.

WO 96/24439 shows a disposable dispenser in which one liquid drug containing through a rubber stopper sealed glass ampoule is inserted into a sleeve that has a Breakage connection is connected to a donor. This has a protruding nose adapter with a spray nozzle at the end. A central shaft or stamp inside this adapter carries a needle in the middle, which is activated by manual pushing in the sleeve in the adapter pierces the rubber plug. The The shaft then presses the rubber stopper into the ampoule as a piston and thus generates the application pressure.

With this donor, the opening of a media room is controlled by a thin hollow needle, such as a steel needle, made is sharpened by bevel and usually a very small one Has a diameter of less than 1 mm. To make this thin and delicate Up to now, the needle was inserted into the shaft with a metal adapter provided that on the outside as a relatively thick solid metal ring the needle has been attached. It allowed one to attack Assembly tool and was by means of an annular Locking teeth pressed into the shaft. This arrangement has changed proven and was due to the reliable assembly without Damage to the sensitive tip is considered inevitable. However, it requires the metal adapter as a separate part, which the Costs and also the metal content in what is otherwise almost sorted by type Donor increased.

This disposable atomizer is very reliable and for the application liquid medication, especially for those who should be absorbed by the body very quickly, e.g. through the Nasal mucosa, with also intolerances for the Digestive tract, which could occur with oral intake, avoided become. However, there are drugs that are no longer in liquid form Time are stable.

Although there are many suggestions for powder application and dosage, this is problematic and usually only by swirling up in larger ones Air volumes possible. But there are many areas of application because targeted application is hardly possible.

US 3,756,390 relates to an injection syringe, the two by one Breakthrough foil separate spaces for liquid and Powder. A nozzle connects to the powder chamber, into the after Removing a protective cap a needle can be used. To Breaking through the release film, the two media together mixed. Then the protective cap is removed, the needle used and carried out after the air-out spraying. A similar procedure is in US 3,595,439 A for one Mixing cartridge for 2-component dental material.

GB 1 453 591 describes an ampoule which is pierceable End plug for a liquid chamber and one Has intermediate plugs to a powder chamber. When stabbing a needle connected to a drip, for example the intermediate plug pushed out so that both media can mix with each other. Through an extra channel, the Enter the mixture into the drip chamber.

JP 8-280807 A shows an adapter that is one of a Has aluminum foil sealed liquid chamber. This can placed on a container of freeze-dried pharmaceutical become. To the other side of the with a screw cap sealed adapter can be attached to a pump atomizer who pierces the aluminum foil with his suction tube and so Liquid chamber and powder container connects together. This to be assembled from three separate parts before use Dispenser is not very helpful for uncomplicated use.

TASK AND SOLUTION

The object of the invention is to provide a dispenser for dispensing to create at least two different media, the particular one easier and more cost-effective in terms of needle output is to be manufactured and assembled.

The invention defined in claim 1 enables the very thin and sensitive needle with the necessary tightness damage-free without attaching this adapter. To do this, she is between the entire central area between the two ends of the needle encompassing ribs of a larger bore in the shaft and at the end pressed into a hole with a press fit, which is a lot longer is than the needle diameter. It rests on one shoulder within this hole and can thus freely towards the outlet opening communicate. When inserting, the needle becomes the tip of it supporting end held by a collet holding a central pin has, which engages in the needle and thus a crush and Damage to the sensitive tip prevented. This is important because damage-free tip for piercing the sealing plug is just as necessary as with an injection needle to avoid that the needle penetrates the container or piston wall Detaches particles that clog the discharge opening or even into the Airways of the patient.

The invention also provides a dispenser in which a liquid is used Carrier medium used for a particulate solid medium and the separately stored media only before they are released be mixed together. Under the term particulate Solid state medium is to be understood that it is not a gas, liquid, Paste or in solid form, but usually dry with one certain fluidity or flowability is present, in particular is powdery to granular. So it is possible the two media to be kept separately from each other, the active ingredient usually in the particulate medium can be present in dry form. It can e.g. is a pharmaceutical product that is in the form of a freeze-dried powder. Just before the application it is mixed with a liquid which is called Carrier medium is used. It can either be a slurry (Dispersion) or a solution that then comes together is applied, preferably as a spray, but also as a drop or beam.

Besides the advantage that the product is better in the dry powder form is durable, there is still the advantage that the liquid is chosen in this way can be that the absorption through the mucous membranes particularly is promoted. Preservatives can be dispensed with.

The particulate solid medium should best be powder, but at least flowable or free-flowing and with the liquid be easy to mix, so in the relatively short, available Intimate mixing or even solution in the liquid is possible at times is. But it is possible that the particles also in the form of so-called Microcapsules are present, i.e. from a skin covered Ingredients exist.

The most direct and immediate application after mixing is possible if the liquid is injected into the Solid medium introduced and the resulting mixture under this application pressure is output. But it is also possible that Mixing in an immediately preceding application To carry out the mixing phase. This can e.g. be taken care of that first all liquid contained in the solid medium Space is brought in before spreading begins. This can happen with especially solution-active mixtures already for a solution, at least for a good slurry of the solid medium in care of the liquid. The liquid acts as a carrier for the Solid, but can itself also have pharmaceutical effects or contribute to them.

It can be advantageous between the mixing phase and the application phase Manually overcome pressure point for the operating force be provided so that there is automatically a certain stopover results. The solid state medium is usually the space in which it is is not filled in completely. This becomes a partial one relatively large volume of gas, such as air or of an inert gas promoting the stabilization of the product. When mixing this gas can with the introduction of the liquid be compacted so that finally when they are spreading, i.e. opening the solid state storage or a mixing room already a certain There is initial pressure, e.g. for good atomization from the start at worries.

The dispenser can have a liquid space, pressure generating means for Generate a discharge pressure and to convey the liquid in a media storage for a separate from the liquid space powdery or free-flowing solid medium and one Have outlet opening for the mixture. With the pressure generating agent it can be a thrust piston pump, the cylinder of which Liquid space can be.

It is possible to front the liquid space and the media storage Operation of the dispenser to the outside and tight against each other keep complete and only by pressing both to connect with each other and with the outlet opening. This can be done by Piercing membrane-like pistons or container walls Lip valves or the like.

The building of pressure points, the building of certain Allow minimum actuators both before the start operation as well as between the mixing and spreading phases, e.g. by snap connections, but preferably by predetermined breaking points, i.e. Material bridges that can be destroyed by operating forces.

These and other features go beyond the claims from the description and the drawings, the individual Features each 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 registration into individual Sections and sub-headings limit those below statements made are not generally valid.

BRIEF DESCRIPTION OF THE DRAWINGS

Fig. 1

einen Längsschnitt durch einen Spender nach der Erfindung und,

Fig. 2 bis 4

drei Arbeitsstellungen eines weiteren bevorzugten Ausführungsbeispiels, jeweils im Längsschnitt.

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 dispenser according to the invention and,

2 to 4

three working positions of a further preferred embodiment, each in longitudinal section.

DESCRIPTION OF PREFERRED EMBODIMENTS

The dispenser 11 shown in FIG. 1 is a disposable atomizer that spreads its entire batch in one stroke. It has a housing 12, which has an elongated adapter section 13. It sticks out an oval in plan view, protruding on two sides epaulette-like actuation shoulder 14 of the housing in the middle. On the shoulder 14 closes opposite the adapter directed housing jacket 15, depending on its flatter sides has an actuating cutout 16.

Through the actuating cutout 16, the actuating surface 17 is one Sleeve 18 accessible with a finger, which is a glass ampoule 19, from Supported webs 20 in the sleeve, which takes up a liquid space 21 contains. Sleeve 18 and ampoule 19 have the shape of elongated, deep, circular cylindrical container.

At the plastic sleeve is over thin, predetermined breaking points forming, web-like material bridges 22 a ring 23 is formed, which in a snap connection 24 on the underside of the shoulder 14, adjacent to the interior 25 of the substantially hollow adapter 13, is included.

The ampoule 19 contains both the Liquid space 21 and also a media space or storage 43. Accordingly, there is in the ampoule 19 except one Media storage 43 sealing piston 26 a Separating liquid space 21 from the media store 43 Intermediate piston 55, the two in the rest state shown Separates spaces from each other. To connect them is a Wall of the ampoule 19 molded connection channel 35a provided that its exit in the media storage 43a in Idle state is completed by the intermediate piston 55.

The media space 21 in the ampoule 19 is made of one rubber-like material existing plug 26th completed, the sealing on the circular cylindrical wall of the Media room 21 is present. It is relatively elongated and has everyone of its end faces central recesses 28, which by a central web 29 are separated, which forms a pierceable membrane. The sleeve 18 and the ampoule 19 protrude centrally and centrally in the Interior of the adapter 13 and are there with the outer wall the sleeve 18 and an upper flange 30 of the ampoule 19 lateral webs 31 guided in the interior 25 of the adapter 13, and over the length of an actuation path.

A piston tappet 34 extends centrally to briefly inside the adapter 13 in front of the ampoule 19 or its closure 26 in the form of a stopper. in the Inside the plunger 34 runs a connecting channel 35 which to the Inner channel 36 of a hollow steel needle 37 connects, to which Plug turned, a tip 38 formed by chamfering is.

The shaft 34 is sealing in a nozzle section 56 of the adapter 13 used, which is integral with the housing 12 (and thus with the Adapter 13) is formed. The hemispherical adapter end is 57 also integrally formed with this, in which the nozzle-shaped outlet opening 44 is provided. The shaft contains its upper end face that cooperating with the outlet nozzle Vertebral channel formation 45. The steel needle 37 is in the shaft added almost through the entire shaft 34 to just before the upper face of which is sufficient. The needle, usually one Outside diameter less than a millimeter and one has correspondingly small wall thickness, and to form a sharp one and burr-free tip 38 is very carefully sharpened, is directly in one Bore 58 of the shaft inserted. This hole has one much larger diameter than the needle 37, however, this leads by e.g. four radially inwards from the inner wall of the bore projecting webs 59, which in the region of the end face 52 of the shaft 34 begin with an insertion bevel 60. They ensure accurate Centering and prevent the thin needle from kinking when Deploy. They range from the free end of the shaft to one Fitting bore 61, i.e. about the biggest and especially for preventing of the important central region of the needle.

At the top, i.e. end from tip 28 is needle 37 in a fitting hole 61 is pressed, which is dimensioned so that it one allows tight fit of the needle in it. A shoulder 62 in this Fitting hole forms an upper stop for pressing in the needle. The fitting bore covers the top end of the needle just above one Length that is greater than a multiple, e.g. Five times the outer diameter the needle. The fitting hole is at its upper end with the outlet chamber 46 in connection.

The spray nozzle creates a conical spray with the help of a Vertebral channel formation 45 at the front end of the shaft 34. This lies against the inside of the outlet nozzle 44, so that it is spiral Trained channels emerge that make for a swirl of them quickly through flowing liquid or mixture.

All parts of the dispenser except the glass ampoule 19 and the Steel needle 37 are made of plastics. The liquid space 21 is filled with a liquid that is intended to be with your Flowing out with a particulate solid medium 51 in Mix media storage 43 to solve this or untangle or disperse it together with the Apply liquid. The solid state medium is one pharmaceutically active substance, mostly in powder form. The liquid mostly consists mainly of water, which is sterile and possibly physiologically adapted to the body fluid. There are but other liquids or liquid additives are also possible also promotes the effectiveness of the solid medium or can have triggering properties. There can be one Two component action between the liquid and the Solid state medium arise.

1 is in the packaging, storage and State of sale in the position shown in Fig. 1. The Liquid space 21 is filled with the liquid 50 and through the Sealing plug 26 is sealed off. The plunger 37 is tight above the web 29. This is located in the media store 43 Solid-state medium 51, but at the same time usually an even larger one Amount of air passing through the spaces between the two Particles is due, but may also be present in addition the particles do not have to be filled in too compactly.

To use the dispenser 11, the elongated adapter 13 in brought the appropriate donation position, for example in a Nostril inserted. The user grabs the donor by overlay two fingers on the shoulders 14 while his thumb on the Actuating surface 17 presses. It must be a relatively high one first Apply actuation pressure to the predetermined breaking points that the Form material bridges 22 between the ring 23 and the sleeve 18 to destroy. These also ensure tamper evidence. Most of all will but ensured that the user operated with a certain power and speed really comes to an end. A interim interruption would, for example, cause the Atomizer and possibly the mixture of substances impair or prevent full spreading.

After that, the sleeve / ampoule 18/19 moves upwards, i.e. in the inside 25 of the adapter 13. The needle-like plunger 37 pierces the web 29 in the plug 26 and the lower one End face 52 of the shaft 34, which has a slightly smaller diameter has as the media space 43, meets the end face 53 of the Sealing plug 26. This forms the piston of one Thrust piston pump, the cylinder of the glass ampoule 19 is formed.

If the needle 37 (needle) pierces the web 29 in the closure 26, it opens it mainly through the interior of the hollow needle 37 formed outlet channel 36 opposite the media storage 43. Der Shaft 34 presses the piston 26 down and compresses it in Media storage 43 located solid medium 51 and the therein contained air (or a corresponding inert gas). This will also the intermediate piston 55 is pushed down and gives the Connection channel 35a free in the ampoule wall. This could also be formed by a corresponding elevation of this wall, the would then release an overflow channel on both sides. The Liquid 50 flows from the liquid space 21 into the Media storage 43 mixes there with the medium 51 and is with the corresponding discharge pressure via the needle bore 36 Exhaust opening 44 passed. The unit sleeve / ampoule 18/19 slides, guided by the webs 31, inside 25 of the nose adapter 13 upwards. Here too is a complete discharge of the two media (plus the third medium "air") possible. The air also forms one Pre-compression, which promotes the start of the atomization phase. It if necessary, the arrangement could be made so that the medium is placed in the area of the ampoule near the bottom and the liquid about that. In this case the liquid would go down first flow, mix there with the medium and then again through the Flow the liquid chamber through to the outlet. This may a particularly intimate mixture can be brought about.

The dispenser consists of very few parts. In the one-piece Housing in which the outlet opening 44 is directly molded is the Inserted shaft 34 with the needle mounted therein. The donor will completed by the unit sleeve / ampoule 18/19 with Sealing plug 26 and intermediate piston 55 which hold the liquid and Separate media chamber.

The assembly of the dispenser according to Fig. 3 is very simple. Through the novel design of the shaft 34, the needle without the annular adapter 39 can be mounted as shown in FIG. 1. The ribs 59 guide the needle as it enters bore 58 without making it too large Oppose longitudinal resistance. Only when the needle is passed between the ribs over most of its length them into the fitting bore 61, where they are sealing and also mechanical is pressed in against being pulled off. The needle stands how to recognizes from the drawing only over a relatively small part of theirs Length, usually less than a third, from the shaft 34. So is the section most at risk of buckling, which is in the middle of the Needle lies when applying the force to press it into the Fitting bore 61 already guided against buckling between the ribs.

It is particularly important that the sensitive tip 28 of the needle in the Pressing process is not damaged. Therefore, with one Tool worked that the needle with a kind from the outside Grips collet (in the area protruding from the shaft), but additionally has a center pin that goes into the needle bore engages and so the needle against crushing and damage to the Lace secures.

The pre-assembled shaft can then partially with its upper beveled offset end are pressed into the socket 56.

The pre-assembled unit from the sleeve and inserted ampoule 19 is attached to the housing 12 via the snap lock 24. Was before the ampoule was first filled with the liquid, after which the Intermediate piston 55 attached and then the solid medium in the overlying media storage 43a has been filled. After that the plug 26 was placed.

The reference applies to the exemplary embodiments according to FIGS. 2 to 4 to the detailed description of Fig. 1. Only the differences are described below.

The main difference is that of sleeve 18 and ampoule 19 existing unit containing the media. The sleeve 18, which means the predetermined breaking ring 32 is attached to the housing 12 contains the Liquid space 21 in its lower, its bottom 17 facing Area. There is a plastic plunger 37a formed centrally in the Sleeve protrudes upwards and has a cross-shaped cross section.

An inner sleeve 19a is inserted in a piston-like sealing manner, which has a pierceable membrane 29a on its bottom. This Sleeve seals off the liquid space from above. she is by means of a predetermined breaking ring 32 into the interior 25 of the nose adapter 13 used. The predetermined breaking ring works with material bridges 33 such as Breaking ring 23 described. The inner sleeve 19a forms a cylinder for a storage / mixing chamber 43a which is upward from a conversely sleeve-shaped, serving as a piston plug 26a is completed.

In the course of the manufacture of the dispenser 11 according to FIGS. 2 to 4, the Liquid 50 is filled into the liquid space 21 and the solid medium 50 in the media storage 43a. This is through the Sealing plug 26a closed. The inner sleeve 19a is in accordance with Art a piston inserted into the sleeve 18, which thus the cylinder one second thrust piston pump on this dispenser forms and closes the Liquid space 21 upwards.

When actuated, the predetermined breaking closure 32 is broken first. Then the plunger 37a penetrates through the membrane 29a and sets over the channels formed in its cross-section the connection between the liquid space 21 and the media reservoir 43a. The the Piston-like lower part of the fluid chamber 21, which reduces the size Inner sleeve 19a conveys the liquid 50 into the media storage space 43a, which thereby enlarges by being under the resulting Media pressure pushes the plug 26a upward.

Fig. 3 shows the end of this mixing phase, in which the liquid and the Solid state medium mix. It is ended by how 3 shows the bottom of the inner sleeve 19a on the bottom 17 of the sleeve 18th is applied. It is then only a common mixing space 43a available. The air previously present in the media space 43a can be depending on the resistance of the sealing plug 26a more or compress less and maintain a basic pressure in the mixing chamber receive.

The predetermined breaking lock 32 can be set so that the user when he has reached the position shown in Fig. 3, a new, must apply increased pressure. This ensures that in the mixing chamber 43a a sufficient time for mixing, if necessary Solution of the components arises.

As shown in FIG. 4, the predetermined breaking fastener 32, the needle 37, then breaks penetrates through the bottom 29a of the plug 26a, which thereafter of the end face 52 of the shaft 34 is contacted and in the manner of a Piston into the inner sleeve 19c forming a pump cylinder is pushed in. This will make the mixture 50/51 from the Mixing chamber 43d over that formed by the needle bore 36 Exhaust channel transported to the outlet opening 44 and there under the Application pressure atomized or otherwise output. The The application phase could be activated by means of a rotation Stop in addition to or instead of the predetermined breaking ring 32 in time be delimited. It is also possible to use a piercing needle instead Rotary slide valve to be used, which is opened by this rotation.

In this embodiment, the mixing phase of the Application phase to be spatially and temporally separated, although everything essentially follows one another directly, so no danger there is that the solid medium is damaged in the mixed phase. It is also possible to have these two phases on two different ones Distribute actuation strokes instead of two axially one after the other horizontal lifting sections. It is also possible to go through corresponding subdivision or sequence of strokes one at a first stroke premixed batch in two consecutive Applying partial application strokes, for example, for a medication to be applied in succession to both nostrils of a patient. Also a multiple dispenser or reloadable dispenser according to the above principle described is possible.

Claims (10)

Dispenser for media with a media space (43), which is closed by means of a closure (26), a thin hollow steel needle, preferably with an outer diameter of less than 1 mm and a beveled, being used as a plunger (37) for piercing the closure of the media space (21) Tip (38) is provided, characterized in that the steel needle is inserted without adapter into a shaft (34) of the dispenser (11) which supports it, wherein it seals in a fitting bore (61) at its end facing away from the tip (38) is used, the length of which is greater than the outer diameter of the needle, with this end it rests against a shoulder (62) which limits the press-in length in the fitting bore (61) and in its central region over a length until it emerges from the shaft (34) , which corresponds to a multiple of the outer diameter of the needle, is guided between ribs (59) inside a larger bore (50), which at its beginning has an insertion bevel (60) for the needle fweisen. Dispenser according to claim 1, characterized in that the length of the fitting bore (61) is at least twice as large as the outer diameter of the needle. Dispenser according to claim 1 or 2, characterized in that the length over which the steel needle (37) is guided between ribs (59) corresponds to more than five times the outer diameter of the needle. Dispenser according to one of the preceding claims, characterized in that the interior of the hollow needle forms a receptacle for a holding and filling pin of a gripping device which grips the needle for pressing in from the outside in the manner of a collet. Dispenser according to one of the preceding claims, characterized in that it contains a push piston pump, the cylinder of which is preferably formed by a liquid space (21), the piston (26) of the push piston pump forming the closure in particular being irreversible to form a disposable dispenser and / or between the liquid space (21) and the media space (43) a shut-off device (27, 29; 41), which is opened by the dispenser actuation, in particular as a result of the application pressure, is formed, which may be formed by the needle (37). Dispenser according to claim 5, characterized in that the shaft (34) has an end face (52) which displaces the piston (26). Dispenser according to claim 5 or 6, characterized in that the liquid space (21) and the media store (43) are arranged axially in succession in a cylindrical container (19) and one below the other and to the outside by closures (26, 55) in the form of stopper-like pistons ( 26, 55) are completed, in particular at least one of the pistons opening a connecting channel (35a) between the liquid space (21) and the media reservoir (43) via a slide or piercing control that is dependent on the piston position. Dispenser according to one of claims 5 to 7, characterized in that at least a first actuation stroke or actuation stroke section and for dispensing a second actuation stroke or section are provided for connecting the media spaces and for mixing the media with one another, which in particular can be actuated separately by a manually actuated one Stop and / or are delimited from each other by pressure point means (32). Dispenser according to one of claims 6 to 13, characterized in that the media spaces (21, 43a) are arranged axially one after the other, preferably a separating element (19c, 29a) being arranged between them and / or at least one of the media spaces (43a) at least partial volume adaptation to the volume of the mixture, for example by moving a piston (26a) and / or a connecting channel (35, 36, 66) between the liquid space (21) and the media reservoir, a guide device (80) for acceleration, swirling and / or distribution of the liquid jet entering the media store is assigned. Dispenser according to one of the preceding claims, characterized in that it is an atomizer with an atomizing nozzle (44).

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