EP3094572A1

EP3094572A1 - Injection syringe with child-resistant cap

Info

Publication number: EP3094572A1
Application number: EP15707774.4A
Authority: EP
Inventors: Jan DE BACKER SR.
Original assignee: Hubert De Backer Nv
Current assignee: Hubert De Backer Nv
Priority date: 2014-01-13
Filing date: 2015-01-13
Publication date: 2016-11-23
Also published as: WO2015104694A1; BE1021222B1

Abstract

The present invention relates to an injection syringe (1) comprising: (i) a container (2) provided with a distal end (3) with opening (5) and outflow mouth (6) and a wider proximal open end (4), (ii) a piston (8) which is mounted in said container and extends through the proximal end, and (iii) a cap (10) for closing off said outflow mouth, which cap corresponds in shape and dimension to said outflow mouth and/or to said distal end, and wherein the cap comprises an inner cap (11) and an outer cap (12) which are provided with engaging means (115, 125) for the child-resistant sealing of the outflow mouth. Furthermore, the invention relates to a kit and a method for assembling said injection syringe, and the use thereof.

Description

INJECTION SYRINGE WITH CHILD-RESISTANT CAP TECHNICAL FIELD The present invention relates to closures or covers for a dispenser unit, in particular for an injection syringe.

In particular, the invention relates to an injection syringe with a child- resistant cap at the distal end in order to prevent children from coming into contact with the contents of the injection syringe.

BACKGROUND

The child-resistant storage of medicines and household chemicals is a major concern which must be met as a preventive measure for preventing intoxication of children. This concern was first formulated by Dr. Henri J. Breault in the 60s of the twentieth century. A major breakthrough was achieved by Peter Hedgewick with the development of the Palm N Turn concept. This concept consists in opening a bottle by a combination of two distinct mo- tions: a first motion being the pressing of a cap on a bottle and a second motion being rotatingly unscrewing said cap. Such child-resistant caps have been shown so effective that some countries already enforced the mandatory use of child-resistant caps for medicine bottles in the 70s. In the quest for ever better and more efficient systems, new concepts were developed. The difficulties often reside in that a system had to be developed to create, on the one hand, a high barrier for children and, on the other hand, a low barrier for adults and elderly. Other factors relate to the child- resistant sealing or storing of liquids with therapeutic effect, or of toxic or corrosive fluids, which are dosed by means of a syringe. Possible solutions are described in, amongst others, WO 95/01924 and WO 00/18453.

WO 95/01924 discloses a dosing device with a safety system for children. The dosing device comprises a bottle and a cap which is undetachably con- nected to the neck of the bottle. The cap is further provided with an inwardly directed cylindrical guidance system which can house a complementary dispensing element. The guidance system ensures that the contents of the bottle cannot leak due to toppling of the bottle. The dosing device may further be provided with a seal which surrounds the cap.

WO 00/18453 discloses a dosing device for liquids in a container. The device provides for an intermediate screw cap which is connected to an elongated, hollow tube which, from the screw cap onwards, is mainly vertically and inwardly positioned. The vertical tube is suitable as a container for a pipette or syringe for taking in an accurately known quantity of liquid. In addition, the invention provides a surrounding cap for closing the dosing device.

Such systems, in which a syringe is comprised in a liquid container and wherein the liquid container is provided with a child-resistant seal, are, how- ever, not desirable solutions because they provide for one or more of the following shortcomings.

Known constructions provide for taking in a liquid in a syringe to be able to dispense an accurately known quantity of liquid. However, such construc- tions do not allow the liquid to be taken up in the syringe quantitatively. This is especially undesirable in view of the fact that the liquid to be dispensed often comprises one or more complex, and therefore costly, organic substances. Furthermore, taking in the liquid into the syringe is an additional operation which complicates the administration of the liquid to a subject, such as, for example, a patient or an animal. This additional operation increases the likelihood of contamination of the liquid and complicates an accurate injection of an ingredient into a subject.

Furthermore, the complexity of the construction of injection syringe in liquid container requires a relatively high material consumption and a more complex mold in order to produce the corresponding elements of the container.

The current state of the art does not provide or does not adequately provide a solution to one or more of the above-mentioned problems or shortcomings. SUMMARY

To this aim, the invention provides in a first aspect an injection syringe comprising : (i) a container provided with a distal end with an opening and out- flow mouth and a wider proximal open end, (ii) a piston that is mounted in said container and extends through the proximal end, and (iii) a cap to close off said outflow mouth, said cap corresponding in shape and dimension to said outflow mouth and/or to said distal end, wherein the cap is provided with means for the child-resistant sealing of the outflow mouth.

This offers the advantage that an ingredient can be stored in a syringe and after removal of said child-resistant cap, can be arranged on a surface or inserted into a subject, such as, for example, a human or animal. In a second aspect, the present invention provides a kit comprising (A) a container with a piston and outflow mouth at the distal end; and (B) a child- resistant cap corresponding to said outflow mouth and/or to said distal end.

This offers the advantage that said container can be filled with an active in- gredient and subsequently can be sealed and stored in a child-resistant manner.

In a third aspect, the present invention provides a method for assembling an injection syringe with child-resistant cap according to the first aspect of the invention, comprising the steps of:

- providing a container with distal outflow mouth and piston;

- extruding a child-resistant cap;

- providing a therapeutic agent and/or a toxic and/or corrosive product in said container; and

- sealing said container by means of said child-resistant cap.

In a fourth aspect, the present invention provides a use of an injection syringe according to the first aspect of the invention, for the child-resistant storage of a therapeutic agent and/or a toxic and/or corrosive product in said container. DESCRIPTION OF THE FIGURES

The explicit characteristics, advantages and objectives of the present invention will become more apparent to those skilled in the technical field of the invention after reading the following detailed description of the embodiment of the invention and of the figures attached herein. The figures serve the purpose of further illustrating the invention, without restricting the scope of the invention. Figure 1 is a schematic representation of a lateral cross-sectional view of an injection syringe 1 with container 2, piston 8 and an outflow mouth 6 with means 7 corresponding to a child-resistant cap 10.

Figure 2 is a schematic representation of a cross-section (top) and a top view (bottom) of an inner cap of a child-resistant cap 10, provided with means 115, 117, 125 for sealing the outflow mouth 6 of an injection syringe 1 in a child-resistant manner.

Figure 3 is a schematic representation of a cross-section (top) of a child- resistant cap 10 and of a top view (bottom) of an outer cap of a child- resistant cap 10 with means 125 for sealing the outflow mouth 6 in a child- resistant manner, with instruction for use 13 and rough surface 14.

Figure 4 is a schematic representation of a side view (top) of a child- resistant cap 10 and rough surface 14, and a top view (bottom) of a child- resistant cap 10 with instruction for use 13 and rough surface 14.

Figure 5 is a schematic representation of a cross section of a distal end 3 with opening 5 and outflow mouth 6, and a cap 10 comprising an inner cap 11, which is clamped in an outer cap 12.

DETAILED DESCRIPTION OF THE INVENTION

Unless defined otherwise, all terms used in the description of the invention, including technical and scientific terms, have the meaning as is commonly understood by the skilled person in the technical field of the invention. For a better assessment of the description of the invention, the following terms are explicitly explained. "A", "an" and "the" refer in this document to both the singular and the plural, unless the context clearly implies otherwise. For example, "a segment" means one or more than one segment.

Where "about" or "around" is used in this document with a measurable quan- tity, a parameter, a time period or moment in time, and the like, then variations of +/-20% or less are meant, preferably +/-10% or less, more preferably +/-5% or less, even more preferably +/-1% or less, and even more preferably +/-0.1% or less than and of the cited value, insofar such variations apply to the described invention. It should, however, be understood that the value of the quantity in which the term "about" or "around" is used, is itself specifically disclosed.

The terms "comprise", "comprising', "consist of", "consisting of", "provided with", "contain", "containing", "include", "including", "encompass", "encom- passing", are synonyms and are inclusive or open terms that indicate the presence of what follows, and do not exclude or prevent the presence of other components, features, elements, members, steps, known from or described in the prior art. The citation of numerical intervals by endpoints includes all integers, fractions and/or real numbers between the endpoints, these endpoints included.

In a first aspect, the present invention provides an injection syringe 1 comprising : (i) a container 2 provided with a distal end 3 with opening 5 and outflow mouth 6 and a wider proximal open end 4, (ii) a piston 8 which is mounted in said container 2 and extends through the proximal end 4, and (iii) a cap 10 in order to close off said outflow mouth 6, said cap 10 corresponding in shape and dimension to said outflow mouth 6 and/or to said distal end 3, wherein the cap 10 is provided with means 115, 117, 125 for the sealing of the outflow mouth 6 in a child-resistant manner. Figure 1 is a schematic representation of a lateral cross-sectional view of an injection syringe 1 with container 2, piston 8 and an outflow mouth 6 with means 7 corresponding to a child-resistant cap 10, according to the first aspect of the present invention.

This offers the advantage that an ingredient, in the form of a liquid or liquid substance, such as, for example, a liquid, a gas or a paste, can be stored in a syringe, and after removal of said child-resistant cap, can be applied to a surface or introduced into a subject, such as, for example, a patient or ani- mal. An additional advantage is the simplicity of the configuration of the syringe with child-resistant cap, allowing easy production of such syringes using existing techniques. Furthermore, the cap may be provided with standard dimensions, as a result of which little or no modifications to known syringes or production methods are required.

An important advantage is that the risk of potentially undesired contact between the liquid and the user in such a configuration is smaller in comparison with existing systems, because the fluid during normal use of the invention does not require contact with the outer wall of the syringe, as opposed to the existing systems. As a result thereof, potential contact between liquid and operator is significantly reduced, if not non-existent.

Because the piston can quantitatively dispense the entire contents of the container, the remaining residue is minimal or negligible. In addition, the remaining residue can be sealed in a child-resistant manner after use by putting the cap back on the outflow mouth and/or'the distal end of the container. Potentially unwanted contact between liquid and operator is therefore maximally limited. According to the first aspect of the present invention, said injection syringe is, in the child-resistant state, closed off by means of a child-resistant cap.

The term "child-resistant cap" is a synonym for the term "child-resistant closure or sealing", which is known by the skilled person in the field of the pre- sent invention, in particular, closures or covers for a dispenser unit, especial- ly for an injection syringe. According to the prior art, several embodiments of a child-resistant seal are possible. In essence, a child-resistant cap comprises a cap and means 115, 117, 125 for sealing an opening, such as, for example, an outflow mouth of a syringe, in a child-resistant manner.

Most of the publicly known embodiments of a child-resistant cap define a closure which can be opened by the combination of a push-and-turn motion. Some examples are described in CA 855548, US 2013/0161207, WO 2011/075547, US 2012/0267261, DE 3331485 and CA 2746907. It goes without saying that similar child-resistant sealing systems, including those which do not make use of a push-and-turn motion, can also be advantageously used in an injection syringe with child-resistant cap according to the present invention . Preferably, said child-resistant cap meets the standardized conditions for reclosable child-resistant packaging, as defined in, amongst others, ISO 8317 (Child-resistant packaging - Requirements and testing procedures for reclosable packages), ISO 13127 (Packaging - Child resistant packaging - Mechanical test methods for reclosable child resistant packaging systems) and/or ASTM D3475 (Standard Classification for Child-Resistant Packages).

Figure 2 is a schematic representation of a cross-section (top) and a top view (bottom) of an inner cap of a child-resistant cap 10 provided with means 115, 117 for sealing the outflow mouth 6 of an injection syringe 1 in a child-resistant manner.

In a preferred embodiment, the present invention provides an injection syringe according to the first aspect of the invention, wherein said child- resistant cap comprises a, preferably concentric, inner 11 and outer cap 12. The inner cap 11 preferably comprises an outer diameter which corresponds to the inner diameter of the outer cap 12.

The inner cap 11 is comprised of a cylindrical wall 111 with a closed top surface 112 and open base surface 113. On the inner wall 111a of the cylindri- cal wall 111 of the inner cap 11, a screw-thread 117 is provided which corre- sponds to a screw-thread 7 on the circumferential outer wall of the outflow mouth 6 of the injection syringe 1. At the outer wall 111b of the cylindrical wall 111 of the inner cap 11, a lateral protrusion 114 is provided, which provides a contact surface 114a corresponding to a contact surface 124a on the inside of the outer cap 12.

The outer cap 12 is comprised of a cylindrical wall 121 with a closed top surface 122 and open base surface 123. On the side of the open base surface 123, said outer cap 12 is provided with a lateral recess 124, which provides an internal contact surface 124a corresponding to a contact surface 114a at the outer side of the inner cap 11. The lateral recess 124 ensures that the inner cap 11, when in the assembled state, remains clamped in the outer cap 12 by the enclosure of the lateral protrusion 114 of the inner cap 11 in the lateral recess 124 of the outer cap 12.

The term "engaging means" 115, 117 is preferably to be understood as means that are provided on the outside of an inner cap 11 and on the inside of the outer cap 12, which, when inner cap 11 and outer cap 12 are in a compressed state, limits the rotational pivoting motion of inner cap 11 rela- tive to the outer cap 12. Thus, when rotationally pivoting said outer cap 12 in the opening direction (arrow 2, 13) of the child-resistant cap 10, the inner cap 11 will be moved along. As a result, the cap 10 is screwed off the screw thread 7, and the syringe 1 is opened. Preferably, said engaging means 115, 125 are comprised as a series of one or more teeth 115a, 115b, 115c pro- vided on the inner cap 11, which with a series of one or more corresponding teeth 125a, 125b, 125c provided on the outer cap 12 engage into one another in a compressed state. Preferably, both series comprise 1 to 25 teeth, more preferably 1 to 5 teeth and even more preferably 2, 3 or 4 teeth. In a preferred embodiment, the present invention provides an injection syringe according to the first aspect of the invention, wherein said child- resistant cap comprises an inner cap 11 and an outer cap 12, and wherein corresponding engaging means 115, 125 are provided between (i) the internal, closed base surface 122a of said outer cap 12 and (ii) the external, closed base surface 112b of said inner cap 11. Preferably, said corresponding engaging means 115 and 125 are located within the internal base surface 122a of said outer cap 12, and still more preferably said engaging means are located within the external base surface 112b of said inner cap 11. In this, said engaging means 115 and 125 are provided in the axial direction of the outflow mouth in a way in which they engage each other when the outer cap

12 is pushed in and rotated. In that manner, the inner cap 11 is put in motion and the cap 10 of the screw-thread 7 is unscrewed.

This offers the advantage that the engaging means 115 and 125 do not have to be provided along the circumference between the inner 11 and outer cap

12. Preferably, said engaging means are provided along the circumferential periphery between the inner cap 11 and outer cap 12. Providing the engaging means 115 and 125 between the respective base surfaces 112 and 122 of the inner cap 11 and outer cap 12 allows dimensioning an outer cap 12, and thus also a child-resistant cap 10, with a smaller external diameter as compared to the alternative in which such engaging means 115 and 125 are provided between the cylindrical outer wall 111b of said inner cap 11 and the cylindrical inner wall 121a of said outer cap 12. As a result, it can be achieved that less material needs to be consumed during the production of the cap 10, which is very important from an ecological point of view since such syringes 1 are often intended for single use only. The dimensioning of a child-resistant cap 10 as described above, allows a cap 10 to be dimensioned with an outer diameter corresponding to the outer diameter of the container 2 of the syringe 1. This kind of arrangement simplifies the packaging of the syringes 1 having child-resistant cap 10, which is advantageous for the purpose of logistics and distribution.

In a preferred embodiment, the present invention provides an injection syringe according to the first aspect of the invention, wherein the internal base surface 112a of the inner cap 11 is provided with a cylindrical upright edge

116 having an outer diameter which corresponds to the inner diameter of the outflow mouth 6 of the injection syringe 1. This provides an improved seal of the syringe 1 so that the contents in the container 2 of the syringe 1 cannot leak to the surroundings. Figure 3 is a schematic representation of a cross-section (top) of a child- resistant cap 10 and of a top view (bottom) of an outer cap of a child- resistant cap 10 with means 125 for the child-resistant sealing of the outflow mouth 6, with instruction for use 13 and rough surface 14.

Said cap is preferably comprised of a base surface with upright edge, wherein on the inside of the upright edge, means are provided for securing a child- resistant seal, and wherein optionally on the outside of said upright edge, a rough surface is provided to improve grip onto said cap.

Figure 4 is a schematic representation of a side view (top) of a child- resistant cap 10 and rough surface 14, and a top view (bottom) of a child- resistant cap 10 with instruction for use 13 and rough surface 14. Figure 5 is a schematic representation of a cross section of a distal end 3 with opening 5 and outflow mouth 6, and a cap 10 comprising an inner cap 11, which is clamped in an outer cap 12.

The term "injection syringe" is synonymous with the term "syringe" or "dos- ing syringe" and should be understood as a container of a liquid mass which can be dispensed through a narrow opening in a precisely known volume, i.e. with an accuracy of +10% or -10%, preferably of +5% or -5%, relative to the volume to be dispensed. Said injection syringe may be provided with or without a injection needle.

The term "container" is synonymous with the term "vessel", "holder" and "reservoir" and is to be understood as a longitudinal element having a wall, suitable to comprise a liquid. Preferably, said container is cylindrical with a closed base surface provided with an opening with outflow mouth at the dis- tal end, and a wider, open surface at the proximal end of said cylinder. Preferably, a piston is mounted in said container, wherein the piston is provided with an operating rod which extends at least partially through the proximal end of the container. Preferably, the outer diameter of said base surface of the piston corresponds to the inner diameter of afore-mentioned cylindrical container. The term "outflow mouth" refers to an upright edge around the opening in the distal end of afore-mentioned container. Said upright edge is preferably provided with means corresponding to afore-mentioned means for the child- resistant sealing of the outflow mouth. In an alternative embodiment, said means are corresponding to afore-mentioned means for the child-resistant seal of the outflow mouth provided on the outside of the distal end of said container. Said means corresponding to afore-mentioned means for the child-resistant seal of the outflow mouth may comprise a screw-thread. In a preferred embodiment, the present invention provides an injection syringe according to the first aspect of the invention, wherein said container, piston and outflow mouth are provided in a cylindrical shape. More preferably, said container and/or outflow mouth is provided in a slightly conical shape.

Preferably, the thickness of the container wall and/or outflow mouth is situated between 0.5 mm and 3.0 mm, more preferably between 0.8 mm and 2.5 mm, even more preferably between 1 mm and 2 mm, most preferably, the thickness of the container wall is 1.2 mm, 1.4 mm, 1.6 mm, 1.8 mm, 2 mm, 2.2 mm or 2.4 mm, or any thickness therein between. This offers the advantage that in a sufficiently solid configuration, work can be done without thereby utilizing an unnecessary amount of raw material for the manufacture of said container wall and/or outflow mouth. Preferably, the ratio of length to diameter of said container is situated between 2.5 and 25, preferably between 5 and 15, more preferably between 5 and 10, and most preferably, said ratio is 5, 6, 7, 8, 9 or 10, or any value therein between. Preferably, the ratio of length to diameter of said outflow mouth is situated between 1 and 5, preferably between 2 and 4, and most preferably, said ratio is 2.0, 2.5, 3.0, 3.5, 4.0, or any value therein between.

Preferably, the ratio of length to diameter of said piston is situated between 2.5 and 25, preferably between 5 and 15, more preferably between 8 and 12 and most preferably, said ratio is 8, 9, 10, 11 or 12, or any value therein between.

Preferably, the ratio of length to diameter of said child-resistant cap is situ- ated between 1 and 5, preferably between 1 and 3, and most preferably, said ratio is 1.2, 1.4, 1.6, 1.8, 2.0, 2.2, 2.4, 2.6, 2.8, 3.0 or any value therein between.

In a preferred embodiment, the present invention provides an injection sy- ringe according to the first aspect of the invention, wherein said cap is a screw cap with instruction for use.

This offers the advantage that the user is informed about the nature of the cap and the manner in which said cap can be opened.

In a preferred embodiment, the present invention provides an injection syringe according to the first aspect of the invention, further comprising a non- reclosable child-resistant seal, such as, for example, a strip or a blister pack. Preferably, said strip or blister pack is provided for the opening of said container, more specifically for said outflow mouth. Preferably, said strip or blister pack is a film. This offers the advantage that an additional safety measure is provided in order to avoid undesired contact between the user and liquid. Also, this offers the advantage that said liquid in the container is pre- vented to leak out of said container. Said strip or blister pack can preferably be easily removed or perforated, for use, i.e. after removal of the child- resistant cap.

In a preferred embodiment, the present invention provides an injection sy- ringe according to the' first aspect of the invention, wherein said outflow mouth is provided with means for fixing an injection needle.

Preferably, said outflow mouth is provided with a Luer lock or screw-thread for clamping and/or fixing said injection needle. In a preferred embodiment, said injection needle is provided onto said outflow mouth and the internal length of said child-resistant cap is of a sufficient size to include said injection needle. This offers the advantage that said injection needle is protected in a child-resistant way to prevent undesired contact. In a preferred embodiment, the present invention provides an injection syringe according to the first aspect of the invention, wherein said container and/or said cap are made out of a plastic material.

Preferably, said plastic material is a thermoplastic material. This offers the advantage that said container and/or said cap can be produced easily and on a large scale by means of known extrusion techniques and extrusion installations.

In a preferred embodiment, the present invention provides an injection sy- ringe according to the first aspect of the invention, wherein said plastic is polyethylene.

In a preferred embodiment, the present invention provides an injection syringe according to the first aspect of the invention, wherein said container has a content comprised between 1 mL and 250 mL.

More preferably, said content is between 1 mL and 100 mL, even more preferably between 2 mL and 25 mL, most preferably, said content is 2 mL, 4 mL, 6 mL, 8 mL, 10 mL, 15 mL, 20 mL or 25 mL, or any value therein be- tween.

This offers the. advantage that said container is suitable for comprising therapeutic agents such as, for example, medicines, and that said therapeutic agents in a treatment may be administered in a suitable amount to a sub- ject, such as, for example human or animal.

In a preferred embodiment, the present invention provides an injection syringe according to the first aspect of the invention, comprising a therapeutic agent and/or a toxic and/or corrosive product in said container. This is advantageous because undesired contact between said therapeutic agent and/or toxic and/or corrosive product on the one hand, and children or unauthorized persons on the other hand, is preferably avoided since such contact could result in potentially life-threatening intoxication and/or burns.

Said therapeutic agent and/or toxic and/or corrosive product is preferably a medicine or a household product such as, for example, but not limited to, cleaning agents, disinfectants, agriculture toxins, rust removers, dishwasher products, drain cleaners, toilet cleaners, (concentrated) bleaches, turpentine, brush cleaners, teak oil, petroleum, etc.

In a preferred embodiment, the present invention provides an injection syringe according to the first aspect of the invention, wherein said container and piston are provided cylindrically, and wherein said container comprises one or more compartments.

This offers the advantage that one or more liquid agents in separate compartments can be stored for use in sequential applications and/or treatments.

In a preferred embodiment, the present invention provides an injection syringe according to the first aspect of the invention, wherein said injection syringe is provided with a liquid filling and wherein the ratio of the viscosity of said liquid filling with respect to the surface cross section of the outflow mouth is greater than 10 cps/mm², preferably greater than 25 cps/mm², and more preferably greater than 50 cps/mm². Most preferably, said ratio is between 100 cps/mm² and 1000 cps/mm², and more specifically, said ratio is equal to 100 cps/mm², 200 cps/mm², 300 cps/mm², 400 cps/mm², 500 cps/mm², 600 cps/mm², 700 cps/mm², 800 cps/mm², 900 cps/mm², 1000 cps/mm², or any value therein between. This offers the advantage that said liquid filling will not or little spontaneously leak out of said dosing syringe.

In a preferred embodiment, the present invention provides an injection syringe according to the description in the above paragraphs, wherein said respective compartments comprise a different composition. In a second aspect, the present invention provides a kit comprising (A) a series of two or more containers 2 with piston 8 and outflow mouth 6 at the distal end 3, wherein said containers 2 are optionally laterally connected by means of one or more breakable point or line connections; and (B) a series of two or more child-resistant caps 10 corresponding to said outflow mouth 6 and/or to said distal end 3, wherein said child-resistant caps 10 are optionally laterally connected by means of one or more breakable point or line connections. More specifically, said kit comprises a series of two or more injection syringes 1 according to the first aspect of the invention, wherein said containers 2 and/or said child-resistant caps 10, respectively, by means of one or more, optionally breakable, point or line connections are laterally connected. Preferably, said series comprises 2 to 8 injection syringes 1, more preferably said series comprises 4 injection syringes 1.

In a preferred embodiment, the present invention provides a kit according to the second aspect of the invention, wherein said kit comprises elements A and B: (A) a container with piston and outflow mouth at the distal end; and (B) a child-resistant cap corresponding to said outflow mouth and/or to said distal end.

This offers the advantage that said kit can easily be used for the filling of said container with a therapeutic agent or a toxic or corrosive product, and subsequently sealing in a child-resistant manner said outflow mouth and/or at said distal end by means of the enclosed child-resistant cap.

In a preferred embodiment, the present invention provides a kit according to the second aspect of the invention, wherein said container with piston and outflow mouth, and said child-resistant cap are provided in one packaging.

- providing a container with distal outflow mouth and piston; - extruding a child-resistant cap;

- closing off said container by means of said child-resistant cap.

In a preferred embodiment, the present invention provides a method according to the third aspect of the invention, wherein said outflow mouth is provided with a non-reclosable child-resistant seal, such as, for example, a strip or a blister pack.

In a preferred embodiment, the present invention provides a method according to the third aspect of the invention, wherein an injection needle is fixed in or on said outflow mouth, before said outflow mouth with injection needle is closed by means of a child-resistant cap.

In a preferred embodiment, the present invention provides a method according to the third aspect of the invention, wherein an injection needle is provided on said outflow mouth and wherein said cap seals said injection needle in a child-resistant manner.

In a fourth aspect, the present invention provides a use of an injection syringe according to the first aspect of the invention, for the child-resistant storage of a therapeutic agent and/or a toxic and/or corrosive product in said container.

Claims

Injection syringe (1) comprising : (i) a container (2) provided with a distal end (3) with opening (5) and outflow mouth (6) and a wider proximal open end (4), (ii) a piston (8) which is mounted in said container (2) and extends through the proximal end (4), and (iii) a cap (10) for closing off said outflow mouth (6), which cap (10) corresponds in shape and dimension to said outflow mouth (6) and/or to said distal end (3), characterized in that said cap (10) is provided with means (115, 117, 125) for the child-resistant sealing of said outflow mouth (6), wherein said child-resistant cap comprises an inner cap (11) and an outer cap (12), and wherein corresponding engaging means (115, 125) are provided between (i) the closed, internal base surface (122a) of said outer cap (12) and (ii) the closed, external base surface (112b) of said inner cap (11).

Injection syringe (1) according to claim 1, wherein said cap (10) comprises a screw cap with instructions for use (13) .

Injection syringe (1) according to claim 1 or 2, further comprising a non-reclosable child-resistant seal, such as, for example, a strip or a blister pack.

Injection syringe (1) according to at least one of claims 1 to 3, wherein said outflow mouth (6) is provided with means for fixing an injection needle.

Injection syringe (1) according to at least one of claims 1 to 4, wherein said container (2) and/or said cap (10) are made out of a plastic material.

6. Injection syringe (1) according to claim 5, wherein said plastic is polyethylene.

7. Injection syringe (1) according to at least one of claims 1 to 6, wherein said container (2) has a content between 1 mL and 250 mL.

8. Injection syringe (1) according to at least one of claims 1 to 7, com- prising a therapeutic agent and/or a toxic and/or corrosive product in said container.

9. Injection syringe (1) according to at least one of claims 1 to 8, wherein said container (2) and piston (8) are provided cylindrically, and wherein said container (2) comprises one or more compartments.

10. Injection syringe (1) according to at least one of claims 1 to 9, wherein said respective compartments comprise a different composition. 11. Kit comprising :

A. a series of two or more containers (2) with piston (8) and outflow mouth (6) at the distal end (3), wherein said containers (2) optionally are laterally connected by means of one or more breakable point or line connections; and

B. a series of two or more child-resistant caps (10) corresponding to said outflow mouth (6) and/or to said distal end (3), wherein said child-resistant caps (10) optionally are laterally connected by means of one or more breakable point or line connections.

12. Kit according to claim 11, wherein said container (2) with piston (8) and outflow mouth (6), and said child-resistant cap (10) are provided in one packaging. 13. Method for assembling an injection syringe (1) with child-resistant cap

(10) according to at least one of claims 1 to 13, comprising the steps of:

- providing a container (2) with distal outflow mouth (6) and piston (8);

- extruding a child-resistant cap (10) ; - providing a therapeutic agent and/or a toxic and/or corrosive product in said container ; and

- closing off said container (2) by means of said child-resistant cap (10).

Method according to claim 13, wherein an injection needle is provided on said outflow mouth (6), and wherein said cap (10) seals said injection needle in a child-resistant manner.

15. Use of an injection syringe (1) according to at least one of claims 1 to 10, for the child-resistant storage of a therapeutic agent and/or a toxic and/or corrosive product in said container (2).