HK1122489B - Container with a hollow needle - Google Patents

Description

Container with hollow needle

Technical Field

The present invention relates to a container for receiving and discharging a medicament into an administration device, to the production and use of the container and to the associated administration device. The medicament relates, for example, to medicaments which need to be administered parenterally, but also to oral or topical medicaments. The container according to the invention has a particularly advantageous design of the covering.

Background

In the case of parenteral administration of drugs, that is, administration avoiding the intestine of a mammal, it is usually carried out by injection or infusion. Injection is understood to mean the direct administration of a liquid, sterile medicament into the tissue or vascular system by means of a syringe and a hollow needle, whereby the gastrointestinal tract is avoided. Infusion involves the slow, usually dropwise, flow of a relatively large volume of liquid (containing the drug) into the body.

Medicaments, for example those requiring parenteral administration, are usually filled into a container after their preparation, which can receive one or more parts/doses. The container is called an overwrap.

As an outer package, glass ampoules are known, which can be opened with a special ampoule saw or which are provided with a cleavage groove for the purpose of opening. The contents of the ampoule must be delivered to a container suitable for administration, such as a syringe. It is also often necessary for residual liquid to remain in the ampoule, since otherwise aspiration of air may disadvantageously occur when the syringe is pulled out. In addition, a subsequent closure of the ampoule with the residual liquid contained therein is virtually impossible.

As further containers, so-called piercing ampoules (vials) are known from the prior art. It is pierced with a syringe at a site set for this purpose, and the syringe then aspirates the liquid located in the container. This method of associating containers is very costly, since the ampule cannot be used directly for administration, but rather the contents must be transferred from the ampule to a container suitable for administration, such as the aforementioned syringe. The opening and piercing of the ampoule and the subsequent necessary transfer into a container suitable for administration have proven to be disadvantageous, for example, in emergency situations, in which administration must take place in a time-critical manner.

Nowadays, the filling is also carried out directly into a syringe, which is provided for administration with a thin sleeve which is sheathed or glued in. By squeezing a piston movably supported in the injection container, the liquid is injected from the container through a thin cannula to the administration site. This injector has the disadvantage that it is relatively expensive due to the multi-piece construction. In order to maintain functionality also after a long storage duration, the piston and the injection container are provided with a coating, for example silicone. A substance which is independent of the actual action of the drug and which even has an adverse effect, for example in drugs with a high pH, is therefore stored and administered together with the drug.

In conjunction with parenteral medicaments, which are generally filled in ampoules, vials or finished syringes and in infusion bottles or bags, non-parenterally administered medicaments are also stored in part in ampoules or vials, since they have to be mixed, for example, with water before administration.

A container in the form of a test tube is known from US 4926915. The test tube disclosed therein represents a simplification of the ampoule or puncture ampoule, since the syringe can be mounted and filled directly. A surface that extends conically at an acute angle inward is proposed as a connecting means for connecting to the test tube.

GB 800455 a discloses two test tubes connected to one opposite content discharge end. No connection to the applicator is specified.

US 4926915 a further discloses a container in the form of a test tube comprising a Luer connector (Luer-anshluss) for connection to an ampoule. Likewise, no connection to the application device is specified.

In US 2003/0010795 a 1a container is shown which is constructed such that the triggered discharge of liquid continues automatically.

US 4328912 describes a collapsible container which is capable of automatically performing the discharge of liquid due to the particular construction of the valve.

US 2003/0015605 a1 describes a liquid-filled container in which the discharge is triggered impulsively under pressure after overcoming an initial resistance.

Disclosure of Invention

Against the background of the above-mentioned disadvantages, it is therefore the object of the present invention to provide a container for receiving and discharging a medicament or a container having an associated administration device, which simplifies the administration of the medicament and the connection to the administration device, respectively, and which is of comparatively simple construction.

The above object is solved by a container according to claim 1. Advantageous embodiments follow from the dependent claims. Advantageous production methods and advantageous applications are the subject matter of the dependent claims.

The container according to the invention for receiving and discharging the medicament is provided with a one-piece capsule which is closed except for the opening for discharging the medicament. The container is further designed in such a way that the entire sheath or a region of the sheath is modified in order to achieve a discharge of the medicament from the opening. The drug may be chosen to have different viscosities, for example in solution or other liquids. For example, to a medicament which requires parenteral, oral or topical administration.

According to the invention, the change of the capsule is associated with the discharge of the medicament. For example, the capsule is designed to collapse due to the choice of material and in particular in a capsule with a relatively large volume, i.e. when the medicament is discharged by capillary force and/or due to the effect of gravity, the negative pressure which builds up in the container causes at least a partial collapse of the capsule and thus a change of the capsule.

The one-piece nature should be understood in that the covering is not formed in multiple pieces. The sheath is for example made of one material or of several materials and/or has different compositions in different regions. The one-piece design of the sheath ensures inexpensive production of the device compared to a multi-part design, for example in a piston device. In addition, the application is particularly simple, sterile, rapid and not susceptible to interference. Due to the one-piece nature, for example with respect to a construction with a movable piston, the number of elements or materials contacting the product is reduced, so that compatibility with the drug can be advantageously and relatively simply ensured.

The container according to the invention additionally comprises a hollow needle in the region of the opening. In one embodiment, a hollow needle is used as the connection means to the administration set or to the medical fluid container. The connection can be made quickly and reliably by means of the hollow needle. The connection to the catheter of the administration device can be established by means of a needle, which involves means for infusion or injection, for example with a membrane or membrane, which is pierced by a hollow needle in order to empty the container into the administration device.

In an advantageous embodiment of the device according to the invention, it relates to an administration device, i.e. an infusion or injection needle or a cannula, and is used for administering a medicament to a patient via an opening. If the containers for transport and storage are used simultaneously for administering the drug, the transport process from the transport container to the container for administration is advantageously dispensed with.

The hollow needle is in one embodiment intended for direct administration, e.g. by injection. Injections are given according to the site of administration, i.e., intradermal, subcutaneous, intramuscular, intravenous, intraarterial, intracardiac, intraarticular, intrathoracic or intralumbar. The hollow needle is in one embodiment made of metal, such as medical grade stainless steel, and sharpened for use as an injection or infusion needle in humans or animals.

In one embodiment, the hollow needle is inserted or glued into a sheath in the region of the opening.

According to a further advantageous embodiment, the sheath is formed in one piece with the hollow needle. The container can therefore be produced particularly inexpensively. It is therefore advantageous that no other material comes into contact with the drug when the drug is expelled. The contact of the drug affects the material or material components during storage and expulsion. It can thus be ensured particularly simply that contact with the container material does not adversely affect the medicament contained in the container, for example by changing the pH. In addition, the container can be produced particularly simply, inexpensively and rapidly, which is advantageous in terms of production technology.

In a further advantageous embodiment of the container according to the invention, the container is designed such that the discharge of the medicament is effected or at least triggered by a pressing on at least one outer region of the sheath. For example, the capsule is designed such that the thumb presses on the associated outer region of the capsule to produce the discharge of the medicament. This allows a particularly reproducible, metered discharge of the medicament, which is present, for example, in the form of liquids of completely different viscosities. For example, the injection pressure necessary for the injection, by which the pressure acting on the capsule is generated, can thus advantageously be dispensed with an additional means for generating the pressure, for example a pump. For example, the container is tubular. The pressure acting on the tubular sheath triggers a reduction in volume. The associated reduction in volume causes the medicament received in the container to be expelled from the container and thus out through the opening. The nature of the pressure to be applied can advantageously be varied according to the hardness of the sheath chosen.

In a further advantageous embodiment, the reservoir is designed such that the discharge of the medicament automatically continues after the discharge has been triggered by pressure. This is achieved, for example, by a construction in which the relatively stiff and elastic jacket segments spring-like after reaching a certain outer curvature, according to the knackfrost principle, to an oppositely directed curvature inside the container and, on the basis of the spring properties of the jacket segments, discharge a precisely defined volume of medicament. Thus, on the one hand, automatic discharge and, on the other hand, metered discharge are achieved.

In a further advantageous embodiment, the container has a tubular jacket. A "test tube" in the sense of the present invention is to be understood in such a way that the container extends essentially acutely owing to the weld on its end opposite the opening. This configuration makes it possible to drain the container and thus to dispense the medicament particularly easily. Particularly effective, i.e. rapid and substantially residue-free emptying of the container can be achieved, for example, by a stretching movement of the sharp end of the test tube (Streichbewegung), in particular when the medicament has a high viscosity compared to aqueous solutions. The test tube is produced, for example, by a tube, wherein the ends are closed by a flat weld or a fold, respectively, depending on the material used. The channel into the interior of the test tube container, which is present before the welding or crimping, is in one embodiment additionally advantageously used for filling the delivery possibility of the medicament, which is subsequently received in the container and is discharged if necessary via the opening provided according to the invention.

In a further advantageous embodiment, a connecting device is provided for detachably connecting the hollow needle to the container. The removability allows the container to be removed again from the application device, so that, for example, a newly filled container can be quickly added. For example, for the purpose of a detachable connection, a projection with an external thread is provided on the container, wherein the opening is provided concentrically. The hollow needle has, for example, a recess which interacts with and receives the projection. A detachable, but at the same time liquid-tight connection between the container and the hollow needle is achieved by means of an internal thread which is arranged in the recess and interacts with the external thread. The structural detachability of the connection between the container and the hollow needle ensures that the container can be easily replaced by a filled container, thus increasing the flexibility and rapidity of application and thus the user-friendliness.

In a further advantageous embodiment, the means for connecting the opening to the application device have a locking means which prevents the connection from being unintentionally released. For example, a screw mechanism is provided with a latching function, which additionally secures the screw connection in the screwed-in state by means of a latching spring element. The release is only possible after overcoming the spring action associated with the latch and unintentional release of the connection is largely prevented.

In a further advantageous embodiment of the container according to the invention, the means for detachable connection have two conically shaped surfaces which are complementary to one another. A simple and at the same time sufficiently tight connection is thus achieved. Preferably, the container is provided with a protruding portion with an outer surface extending conically towards the opening at an acute angle.

According to one embodiment, the invention relates to a luer connection (luer cone or luer lock). The so-called luer fitting is defined in ISO 594/1. It is common to refer to a joint known as a "male" joint. By providing such a connection on the container, a number of working steps are saved when administering the drug.

In a further advantageous embodiment, the connecting means are at least partially formed in one piece with the container. The container can therefore be produced particularly simply, inexpensively and rapidly, which is advantageous in terms of production technology.

The singleton is realized, for example, in a single manufacturing step or as follows: in a first production step, two parts are produced, which are subsequently welded or plugged together. The filler is then provided to a single piece unit for filling it with the medicament. The combination of two parts is advantageous in the case of the production process, which is traced back to the existing injection mold, in which the plastic or laminate hose forming the actual container is welded to the head part with the connection, or the connection has a particular complexity.

In a further advantageous embodiment, the container has a volume of less than 5 ml. A volume of less than 5ml has proved to be particularly advantageous, since the container, in particular the test tube, can be emptied effectively and uniformly in one go by simple squeezing with the thumb. It has been shown that the handling of the container and thus the administration of the medicament is particularly simple and effective.

In a further advantageous embodiment, the container consists of plastic, in particular polypropylene, PE, for example LDPE or PET. Also useful are PVC, PVF, and the like. Nowadays, also new weldable plastics are developed, which can be used advantageously for pharmaceuticals. The choice of plastic according to the invention is limited only to the extent that the manufacturability of the container according to the invention is thus ensured. The container can therefore be manufactured inexpensively. In addition, because of the relatively low welding and melting temperatures, the closure of the container can be carried out particularly without damaging the medicament after filling. Furthermore, filling information and/or failure information can be easily embossed on the outer surface of the container. These words have been long-lived.

In a further advantageous embodiment, the container consists of a laminate. Thus creating other possibilities for compatibility. For example, an aluminum foil can be inserted into the container housing, which does not contact the product itself, but forms an increased oxygen barrier and thus advantageously influences the product stability. In addition, preprinted labels (in-mold labels) can be placed in the housing, which in turn can have a barrier function. Thereby even eliminating the application of labels and eliminating the need for glue, which may spread into the product.

According to a further advantageous embodiment, the container is at least partially transparent. The filling level or emptying can thus advantageously be controlled.

According to a further advantageous embodiment, the container is coated. For example, the inner surface of the capsule that is in contact with the drug is coated with a chemically neutral coating, such as silica. It is thus achieved that the container, owing to the coating, achieves glass-like properties in this respect without the disadvantages associated with glass: such as the risk of injury when opening and retrieving glass ampoules, etc.

In a further advantageous embodiment, the covering of the container is at least partially elastic. This makes it possible for the sleeve to spring back when the pressure acting on the sleeve is removed and, for example, to be emptied in a jerky manner in a plurality of similar successive movements of the container. The emptying can thus be carried out particularly simply.

According to a further embodiment, the means for connecting can additionally interact with a closure defined for this purpose, so that a particularly easy closure of the container according to the invention is achieved, for example in comparison with the ampoules described at the outset. The closure member is, for example, a separate injection-molded part which is screwed or slipped onto the aforementioned hollow needle. In another embodiment, the closure is connected in one piece with the capsule and is produced in one processing step together with the container in order to prevent contamination of the medicament contained in the container. The container can therefore be produced simply and inexpensively together with the closure. The closure means comprise, for example, a screw cap or a plug cap and a section welded to the capsule and provided with a relief groove.

The method according to the invention for producing a container has a step in which the container is produced in an injection molding, blow molding or extrusion blow molding step. The container can therefore be produced inexpensively, if appropriate together with the closure and/or the means for detachable connection to the application device. In another manufacturing method, the housing and the head member are manufactured separately and welded to each other. In addition, the advantageous singleness for the filler and the user can be achieved in that the two components are produced separately by the manufacturer, but already assembled to form a single part (for example, a plug and subsequently welded).

Drawings

FIGS. 1a and 1b show an embodiment of a container according to the invention;

fig. 2a and 2b show a form of container according to the invention in which the region of the sheath is designed to collapse automatically.

Fig. 1a shows a first embodiment of the container 1 according to the invention, comprising a one-piece capsule 6 in the form of a test tube. A liquid (not shown) containing a (typically parenteral) medicament is contained in the envelope 6. By squeezing the envelope 6, for example with a finger, in the region of the container 1, the (generally parenteral) medicament or liquid is expelled from the container 1 through the opening 4. The sheath 6 is closed in a gas-tight and liquid-tight manner on the side opposite the opening 4 by a flat weld 2, so that the shape of the test tube is obtained. The connection of the opening 4 of the container to a dispensing device, not shown, comprises a conical projection 5 formed on the sleeve. Its extension is indicated in fig. 1a by a dashed line, since it is partly surrounded by an internally threaded sleeve 3, which is also part of the coupling mechanism. The conical projection can be without a sleeve and thus form a so-called Luer male connection (Luer male). If the sleeve is provided with an internal thread, a construction corresponding to a so-called Luer Lock (Luer Lock) type of joint is obtained. The conically tapering projection 3 as part of the connection means is intended to be connected to a complementary connection element as an infusion or injection needle of an administration set (not shown) in order to connect them in a fluid-conducting manner on the one hand and in a sealing manner and detachably on the other hand.

The opening 4 is closed, for example, at the discharge point by a cleavage groove, into which an optionally shaped cleavage aid 7 is injection-molded; or by a directly cast film or membrane, which can be pierced, for example, by a sharp object.

Fig. 1b shows a further embodiment 1' of a cuvette-shaped container according to the invention. It differs from embodiment 1 primarily in the different design of the sheath in the area of the opening. Furthermore, a hollow needle 9 according to the invention is shown, which is used to connect the container to an administration set, i.e. to place it, for example, in an infusion bag. The hollow needle and the sheath are formed in one piece.

Fig. 2a and 2b show a further embodiment 1 ″ of the container according to the invention. The container is provided with a jacket 6' which makes full use of the knackfrost principle when expelling the drug. Fig. 2b shows a sectional view of the sheath 6'. The upper half of the capsule shown in the figure resiliently jumps inwards, and after exceeding a certain curvature under the initial external pressure, the inwardly directed spring action produces a squeezing effect on the medicament located in the capsule 6' and causes the medicament to be expelled through the opening. Due to the predetermined spring action, the discharge takes place automatically and reproducibly in accordance with the first triggering pressure acting on the capsule 6'. Thereby always discharging the same amount of liquid. In cross section, it can be seen that the upper half of the sheath enters the other half after pressing and therefore cannot return to the original shape.

Fig. 3 shows the embodiment shown in fig. 1, including the associated infusion or injection needle 10. The connecting means 12 provided on the infusion or injection needle 10 has an inner surface which extends conically inwards at an acute angle such that it is complementary to the outer surface 5 of the connecting means of the container 1. The releasable connection between the container 1 and the needle 10 is established by the engagement of the two surfaces 5, 12 of the connecting means. The connection is additionally secured by a threaded connection between the internal thread of the sheath 3 and an external thread 12 provided on the connection part 11 of the needle.

Fig. 4 shows an application of the container 1' of fig. 1 b. The hollow needle 9 is intended to be connected to an infusion bag or an infusion bottle 14, wherein a membrane or membrane 13 of the infusion bag or bottle 14 is pierced in order to insert the drug in the container 1' into the bag or bottle 14.

Claims (11)

1. Container (1, 1 ', 1 ") for receiving and discharging a medicament, having a volume of less than 5ml, the container (1, 1 ', 1") having a closed, one-piece, tube-shaped envelope (6, 6 ') in addition to an opening (4) for discharging the medicament, wherein the container (1, 1 ', 1 ") is designed in such a way that the discharge of the medicament is achieved by changing at least one region of the envelope (6, 6 '), characterized in that: the container has a hollow needle in the region of the opening (4), wherein the hollow needle is formed in one piece with a covering (6, 6'), and wherein the container can be emptied once by pressing with the thumb and has a relatively hard and elastic covering section which, after reaching a certain external curvature, springs over to an opposite curvature directed toward the interior of the container according to the Knackfrost principle.

2. The container of claim 1, wherein said needle is an infusion or injection needle as the administration device.

3. A container (1, 1 ', 1 ") according to claim 1, wherein the container (1, 1', 1") is constructed such that the discharge of the medicament is effected by means of a pressure acting on at least one outer region of the envelope (6).

4. A container (1, 1 ', 1 ") according to claim 3, wherein the container (1, 1', 1") is constructed such that the discharge of the medicament is at least triggered by a pressure acting on at least one outer region of the envelope (6).

5. A container (1, 1 ', 1 ") according to claim 4, wherein the container (1, 1', 1") is constructed such that the expelling of the medicament is automatically continued after triggering the expelling of the medicament.

6. A container (1, 1 ', 1 ") according to claim 1, wherein said container (1, 1', 1") is made of plastic.

7. A container (1, 1 ', 1 ") according to claim 1, wherein the container (1, 1', 1") has a laminate.

8. A container (1, 1 ', 1 ") according to claim 1, wherein said container (1, 1', 1") is constructed to be at least partially transparent.

9. A container (1, 1 ', 1 ") according to claim 1, wherein said container (1, 1', 1") is partially coated.

10. A container (1, 1 ', 1 ") according to claim 6, wherein said container (1, 1', 1") is made of polypropylene, PE or PET.

11. A container (1, 1 ', 1 ") according to claim 10, wherein said container (1, 1', 1") is made of LDPE.