WO2017178963A1

WO2017178963A1 - Injection device with protective cap

Info

Publication number: WO2017178963A1
Application number: PCT/IB2017/052074
Authority: WO
Inventors: Ernesto Orofino
Original assignee: Orofino Pharmaceuticals Group SRL
Current assignee: Orofino Pharmaceuticals Group SRL
Priority date: 2016-04-13
Filing date: 2017-04-11
Publication date: 2017-10-19
Anticipated expiration: 2018-10-13
Also published as: ITUA20162551A1; AR108140A1

Abstract

An injection device (1) for an injectable solution including: a tubular body (3) inside which at least one chamber (8,9) for the injectable solution is defined, closed at the front by a closing element (2) and at the back by the grasping portion (12); at least one capsule (6,7) sliding into the tubular body (3) to eject the injectable solution; at least one duct (20,23) in communication with the containment chamber (8), for the emission of the injectable solution. The injection device (1) includes a removable protective cap (300), fitted on the closing element (2) so that the duct (20, 23) for the emission of the injectable solution is fully housed inside the protective cap (300) itself. Such solution guarantees the protection of the outlet duct until the injectable solution is used and administered.

Description

TITLE: INJECTION DEVICE WITH PROTECTIVE CAP

DESCRIPTION

This invention relates to an injection device for an injectable solution.

Hence, the invention relates to the technical field of syringes for injections or of cartridges, of the pre- filled type too, with multiple chambers too for injecting a solution that is reconstituted just before being administered .

Patent application number IT2014RM00408, always by this proprietor, represents an example of known syringes of the pre-filled double-chamber type. Such a syringe allows to inject very reduced doses of a reconstituted solution. The known syringe includes one main outlet for administering the injectable solution, and one vent outlet for ejecting a fraction of a solution. In the assembling and handling step of the syringe, ducts defining the main outlet and the vent outlet are exposed to impacts. Such an exposition implies high risks of damaging the duct thereof as it may deform until it clogs up, thus failing to inject the solution. Furthermore, being these ducts closed by a closing element (e.g. a removable wall or a breakable membrane or an opening valve) such an exposition may lead to a damage in the closing element and to a spill of the content, as in the case of syringes of the pre-filled type.

The need perceived in the injection device sector is to make available devices wherein the protection of the outlet duct is guaranteed until when the injectable solution is used and administered.

The object of this invention is to overcome the problems of the prior art taking into account the needs of the field .

Such an object is obtained by an injection device according to this invention provided with a protective cap for the outlet duct.

The solution according to this invention is particularly advantageous as the injection device results highly protected during the assembling and handling step.

The solution according to this invention is generally suitable for injection devices, and in particular for injection devices provided with two front outlet ducts. Such solution is also suitable for injection devices for very precise and reduced doses of an injectable solution (that is syringes for micro-doses for example doses of one millilitre or of one tenth of millilitre) and in particular for devices of the pre-filled type.

Such an object is obtained by an injection device according to claim 1. Dependent claims disclose preferred or advantageous embodiments of the device. The features and the advantages of the injection device according to this invention are made clear from the hereinafter related exemplary but non-limiting disclosure, according to the enclosed figures, wherein: -Figure 1 shows an axonometric projection view of an injection device in one embodiment variant;

-Figures 2A an 2B show respectively a section view and an axonometric projection view of the injection device of Figure 1 provided with protection cap according to this invention;

-Figure 3 shows an axonometric projection view of a removable cap according to this invention;

-Figure 4 shows an axonometric projection view from below of a protection cap applicable to the embodiment variant of Figure 1;

-Figure 5 shows an axonometric projection view from below of a protection cap applicable to the embodiment variant of Figure 8;

-Figure 6 shows one detail of Figure 1;

-Figure 7 shows one detail of Figure 8;

-Figure 8 shows an axonometric projection view of an injection device in one further embodiment variant;

-Figures 9A and 9B show respectively a cross section view and an axonometric projection view of the injection device of Figure 8 provided with protection cap according to this invention.

In the above mentioned Figures, same or similar elements are referred to by the same reference numbers.

Referring to the enclosed Figures, and in particular to Figures 1 and 8 an injection device is indicated by reference number 100.

In Figures 1, 2, 4, 6 one embodiment of an injection device 100 is represented, which in the specific represented example, is embodied by a single-chamber syringe. Preferably, the injection device 100 is of the pre-filled type with an injectable solution. In one alternative embodiment, the injection device 100 is a pre-filled cartridge.

In Figures 8, 9, 5, 7 it is represented a further embodiment of one injection device 100, which in the specific represented example is embodied by a double- chamber pre-filled syringe. In one alternative embodiment, the injection device is a pre-filled cartridge. The double-chamber injection device is pre- filled with two substances, contained in two originally separated containment chambers, intended to be mixed with each other immediately before being administered to the patient. In order to mix the two substances, the two containment chambers are put in communication with each other in such a way as to enable the reconstitution of the injectable solution. In further embodiments more than two chambers may be provided in the pre-filled injection device.

Preferably, the injection device 100 (both in the single- chamber variant and in the multiple chamber variant) is suitable for the administration of a very reduced dose of an injectable solution, for example for injecting a quantity of solution smaller than 1 millilitre and preferably of, or almost of, 0.1 millilitre. Preferably the aforesaid dose is smaller than about 1/25 of the injectable solution contained inside the injection device, and preferably of 1/50. For instance, such doses are required to administer antibiotics locally, for example to inject a cephalosporin antibiotic, such as cefuroxime into the ocular room of a patient.

Referring to Figure 1, the injection device 100 includes a containment tubular body 3 closed at the front by a closing element 2 and, at the opposite side or at the back, by a grasping portion 12.

The closing element 2 and the grasping portion 12 are fixed to the tubular body 3 or are integrally made with the tubular body 3.

The tubular body 3 is the containment body of a syringe or of a cartridge, it is suitable for containing injectable substances, and preferably it is made of glass or of a transparent or substantially transparent plastic material. Preferably, the tubular body 3 is made in a single piece.

The injection device 100 includes at least one containment chamber 8 suitable for containing an injectable solution. In the embodiment variant wherein the injection device 100 is of the pre-filled type, the containment chamber 8 contains an injectable solution. The injection device 100 includes at least one capsule 7 arranged within the tubular body 3, so as to delimit the containment chamber 8. Capsule 7 is for example made of plastic material and it is such as to sealingly engage with the inner walls of the tubular body 3.

Capsule 7 is suitable for sliding inside the tubular body 3 under the action of an external pushing or pulling force. Capsule 7 is fixed to a plunger 52 so as to slide under the action of the plunger 52.

The injection device 100 includes at least one duct 20, 23 in communication with the containment chamber 8, for the emission of the injectable solution. In the represented examples the duct 20, 23 is defined within the closing device 2, however, in one embodiment variant, it may be part of the same tubular body 3.

Preferably, the injection device 100 includes a needle (not shown) , applied to the outlet duct 20, wherein the inner channel is in communication with fluid of the duct thereof .

Preferably the injection device 100 includes a removable cap 200 (shown in detail in Figure 3) applicable to the closing duct 20, 23.

The injection device 100 according to this invention includes a removable protective cap 300, fitted on the closing element 2 so that the duct 20, 23 for the emission of the injectable solution is fully housed inside the protective cap 300.

Preferably, the protective cap 300 is fitted on the closing element 2 so that no portion of the protective cap 300 contacts the duct 20, 23. Thus, between the protective cap 300 and the duct 20, 23 housed inside it there is a safety space 308, so that potential impacts on the protective cap 300 are not transmitted to the duct 20, 23. Inside the protective cap 300, the duct 20, 23 is separated from an external wall 306 of the protective cap 300 by a safety space 308.

Preferably, the duct 20, 23 for the emission of the injectable solution is closed by a plug 200 and the protective cap 300 is covering the duct 20, 23 and the plug 200, both housed inside the protective cap 300. The plug 200 is closed on one side by a bottom 201 and, on the opposite side, it is provided with an inlet opening 202.

AS shown in detail in Figure 6, the plug 200 covers at least partially the duct 20,23. In particular, the lower end of the duct 20,23 is housed inside the plug 200. Preferably, the cap 200 is friction engageable on the duct 20, 23.

Preferably, in order to improve the sealing effect, the plug 200 includes an internal relief 203 suitable to fit at least partially inside the duct 20,23.

Advantageously, in the case of the injection device 100 of the pre-filled type, the plug 200 closes the duct 20,23 avoiding the spill of the solution contained in the containment chamber 8.

Furthermore, preferably, the plug 200 includes a grasping portion 204 suitable to ease the grasping by the user. In one embodiment, the grasping portion 204 is a narrowing formed in the plug body at the bottom 201. For example, as shown in Figure 3, the grasping portion 204 includes a pair of supporting surfaces 205, preferably plane and parallel to each other.

Starting from the initial embodiment shown in Figure 1 and 8, under the pushing action of the plunger 52, after removing the plug 200, it is possible to make the capsule 7 slide and release the injectable solution out of the tubular body 3, through the duct 20,23. During the assembling step of the injection device, plane surfaces 209 of the closing element 2 are used as a supporting and pushing point by various automatic machines for assembling the components of the injection device thereof. Thus, the closing element 2, provided with at least one duct 20, 23 is highly exposed to the risk of being damaged by automatic assembling machines. In order to prevent the duct 20, 23 of the injection device 10 from being damaged during the assembling and handling step, the injection device 100 includes a removable protective cap 300, applied to cover the duct 20,23.

The protective cap 300 is closed on one side by a bottom 301 and, on the opposite side, it is provided with an inlet opening 302.

Preferably, the bottom 301 of the protective cap 300 includes at least one plane surface (e.g. the bottom 301), suitable to serve as a supporting and pushing point for the automatic machines assembling the components of the injection device 100.

As shown in detail in Figure 6 and 7, the removable protective cap 300 covers at least partially the closing element 2. In particular, the lower end of the injection device 100, provided with duct 20, 23 is housed inside the protective cap 300. Preferably, the removable protective cap 300 is snap engaged with the injection device 100.

In one embodiment, the edge 303 of the inlet opening is provided with an internal relief 304 suitable to snap engage with an external relief 24 arranged on the closing element 2.

Unlike known devices wherein the surfaces 209 of the closing element 2 are used as supporting and pushing point, in the injection device 100 provided with the protective cap 300 according to this invention, the surfaces used as supporting and pushing point by various automatic machines are the surfaces of the cap 300 itself, fox example the bottom 301.

Thus, the protective cap 300 has been drawn in such a way as to bear the strain exerted by assembling machines without detaching, deforming or getting damaged.

The protective cap 300 thus includes at least an internal rib 305.

The internal rib 305 is arranged inside the protective cap 300, protruding substantially vertically starting from the bottom 301.

The internal rib 305 has such a vertical extension to abut against an external surface 209 of the closing element 2 when the protective cap 300 is applied to the injection device 100. Preferably, the internal rib 305 is a circular wall. When the protective cap 300 is applied to the injection device 100, the inner rib 305, having circular wall shape, surrounds the outlet duct 20.

In order to further improve the protective cap 300 resistance, inner rib 305 is linked to the external wall 306 of the protective cap 300 by means of at least a pair of supporting ribs 307, preferably by means of a plurality of supporting ribs 307.

In the embodiment variant shown in Figure 2A, the duct is an outlet duct 20, connectable to a needle, for injecting a solution.

In such a variant, the injection device 100 includes an outlet duct 20, and a removable protective cap 300 covering the outlet duct 20, which is housed inside the protective cap 300.

Preferably, the outlet duct 20 is closed by a plug 200 and the protective cap 300 is covering the outlet duct 20 and the plug 200, both housed inside the protective cap 300.

In the embodiment variant shown in Figure 8, the injection device 100 includes, at the outlet duct 20, a dosing reservoir 21. Starting from the initial embodiment shown in Figure 8, under the pushing action of the plunger 52, after removing the plug 200, it is possible to make the capsule 7 slide to eject a fraction (henceforth called "first fraction") of the injectable solution out of the tubular body 3 until it reaches a pre-administering configuration wherein:

-the capsule 7 obstructs the inlet opening of the dosing reservoir 21;

-one fraction (henceforth called "second fraction") of the solution is contained inside the containment chamber 8 ; and

-the dosing reservoir 21 is filled with a fraction (henceforth called "third fraction") of injectable solution which represents the dose of solution to be administered to the patient.

Capsule 7 includes a protruding appendix 16 suitable to enter inside the dosing reservoir 21 in order to eject the third fraction of injectable solution at the administration step.

The injection device 100 of the variant of Figure 8 further includes a vent duct 23, provided in the closing element 2, to eject the second fraction and to allow the projecting appendix 16 to enter the dosing reservoir 21. Preferably, the vent duct 23 is provided in parallel with the outlet duct 20.

Preferably, the vent duct 23 is closed by a removable plug 200. The vent duct 23 is configured to be opened starting from the pre-administering configuration.

Preferably, the injection device 100 further includes a stopper 50 to the sliding of the plunger 52. The stopper 50 is suitable to abut against the grasping portion 12 at the pre-administering configuration, preventing the further advancing of plunger 52 at a precise dose of solution, for example at a dose of 0.1 ml of solution. In the embodiment variant shown in Figure 8, the injection device 100 is of the double-chamber type and includes:

-one first containment chamber 8 suitable to contain a first solid or liquid substance;

- a first 6 and second capsule 7 arranged inside the tubular body 3, in order to delimit a second containment chamber 9 therebetween) ;

- a second containment chamber 9 suitable to contain a second liquid substance, intended to be mixed inside the tubular body 3 with the first substance to reconstitute an injectable solution.

In the embodiment variant wherein the injection device 100 is of the pre-filled type, the first chamber 8 contains a first substance and the second chamber 9 contains a second substance.

Preferably, the first substance is a highly active substance, for instance a powder, a substance in granules or a sterile tablet or compacted powder. In case the first substance is solid, it may be crystallized or freeze-dried . Preferably, the second liquid substance is a solvent for injectable use.

In the embodiment of Figure 8, the containment body 3 includes one inner wall provided with a recess 10 suitable to define a bypass channel, arranged downstream from the first capsule 6. Following a pushing action by the plunger 52, the first 6 and the second capsule 7 slide in the tubular body 3 until they reach a so called reconstitution configuration wherein the two containment chambers 8 and 9 are in communication with each other through bypass 10 and the second substance 9 enters into the first chamber 8 to mix to the first substance.

Preferably, in the embodiment variant of Figure 9A, the injection device 100 includes one removable plug 200 applied to close the outlet duct 20 and an additional removable plug 200 applied to close the vent duct 23. As shown in detail in Figure 7, each removable plug 200 covers at least partially the respective duct 20, 23. Preferably, each plug 200 includes an inner relief 203 suitable to fit at least partially inside the respective duct 20,23.

In the variant of Figure 9A, the injection device 100 includes one protective cap 300 fitted on the closing element 2 so that both the outlet duct 20 and the vent duct 23 are fully housed inside the protective cap 300 itself .

Furthermore, the protective cap 300 is fitted on the closing element 2 so that no portion of cap 300 thereof contacts the outlet duct 20 or the vent duct 23. Thus, between the protective cap 300 and the ducts 20, 23 housed inside it there is a safety space 308, so that potential impacts on the protective cap 300 are not transmitted to the duct 20, 23.

As shown in detail in Figure 7, the lower end of the injection device 100, provided with outlet duct 20 and vent duct 23 is housed inside the protective cap 300. Also in the variant of Figure 9A, the protective cap 300 includes at least an internal rib 305. Preferably, the internal rib 305 has the shape of a circular wall and surrounds the outlet duct 20 when the protective cap 300 is applied to the injection device 100.

As shown in Figure 5, in the variant of Figure 9A, being the lower end of the injection device 100, and in particular the closing device 2, provided with both outlet duct 20 and vent duct 23, the internal rib 305 with circular wall shape is provided with a window 309. Window 309 is an interruption in the circular wall 305 of the internal rib suitable to house the vent duct 23. Preferably, in the variant of Figure 9A too, the internal rib 305 is linked to the external wall 306 of the protective cap 300 by means of a plurality of supporting ribs 307.

In the embodiment variant shown in Figure 9A, the injection device 100 includes an outlet duct 20 and a vent duct 23, and a protective cap 300 covering the ducts 20, 23, both housed inside the protective cap 300.

Preferably, both ducts 20, 23 are closed through a plug 200 and the protective cap 300 is covering ducts 20,23 and plugs 200, all housed inside the protective cap 300. Preferably, the plug 200 of the outlet duct 20 and the plug 200 of the vent duct 23 are joined together to form a single closing device. For instance plugs 200 are joined together through a bridge and form a single piece. Such a construction choice allows to ease the assembling operations of the injection device as both ducts 20, 23 are closed in a single step (that is the positioning of a single closing device) .

Preferably, the protective cap 300 is made of polypropilene .

Innovatively, an injection device according to this invention guarantees protection to the outlet duct (or ducts) until when the injectable solution is used and administered owing to the presence of a protective cap. Advantageously, an injection device according to this invention guarantees protection to the duct especially during the assembling and handling step. In fact, the surfaces used as a supporting and pushing point of automatic assembling machines are the surfaces of the protective cap arranged to cover the outlet duct.

Advantageously, the protective cap prevents from any risk of damage of the outlet duct, guaranteeing the injection of the solution. Furthermore, in case of syringes of the pre-filled type, the protective cap prevents from any risk of content spill.

Advantageously, the protective cap also serves as warranty anti-opening seal before the use.

Advantageously, the protective cap is drawn in such a way as to bear the strain exerted by assembling machines without detaching, deforming or getting damaged.

Subject to the principle of the invention, its embodiments and implementation details shall widely vary with respect to what has been disclosed and illustrated for exemplary non-limiting purposes, without departing from the scope of protection as defined in the enclosed claims .

Claims

PROPRIE TOR : OROFINO PHARMACEUTICALS GROUP S . R . L . CLAIMS

1. An injection device (1) for an injectable solution, including :

-a containment tubular body (3), closed at the front by a closing element (2) and at the back by a grasping portion (12), inside which at least one containment chamber (8, 9) is defined;

-at least one capsule (6, 7) being arranged inside the tubular body (3) in order to delimit the containment chamber (8, 9), said capsule being suitable to slide inside the tubular body (3) to eject the injectable solution;

- at least one duct (20, 23) to eject at least one fraction of the injectable solution, being provided for on the closing element (2) and in communication with the containment chamber (8);

characterized by including a removable protective cap (300), being fitted on the closing element (2) so that the duct (20, 23) for the emission of the injectable solution is fully housed inside the protective cap (300) itself .

2. The injection device (1) according to claim 1, wherein between the protective cap (300) and the duct (20, 23) housed inside it there is a safety space (308), namely the duct (20,23) is separated from an external wall (306) of the protective cap (300) by a safety space (308) .

3. The injection device (1) according to claim 1 or 2, wherein the protective cap (300) includes at least one internal rib (305) protruding substantially vertically starting from an internal bottom (301) .

4. The injection device (1) according to claim 3, wherein the internal rib (305) has such a vertical extension to abut against an external surface (209) of the closing element (2) when the protective cap (300) is applied to the injection device (100) .

5. The injection device (1) according to claim 3 or 4, wherein the internal rib (305) is a circular wall suitable to at least partially surround the duct (20) when the protective cap (300) is applied to the injection device (100) .

6. The injection device (1) according to any claim 3 to 5, wherein the internal rib (305) is connected to an external wall (306) of the protective cap (300) by means of a plurality of support ribs (307) .

7. The injection device (1) according to any preceding claim, wherein the protective cap (300) is snap engageable with the injection device (100) .

8. The injection device (1) according to any preceding claim, wherein the duct (20, 23) is closed by a plug (200), and the protective cap (300) is covering both the duct (20, 23) and the plug (200) so that both are housed inside the protective cap (300) .

9. The injection device (1) according to claim 8, wherein the plug (200) is friction engaged with the duct (20,

23) .

10. The injection device (1) according to claim 8 or 9, wherein the plug (200) includes an internal relief (203) suitable to insert itself at least partially inside the duct (20, 23) .

11. The injection device (1) according to any claim 8 to 10, wherein the plug (200) includes a grasping portion

(204) provided with a pair of support surfaces (205) .

12. The injection device (1) according to any preceding claim, including:

-a dosing reservoir (21) in communication with the containment chamber (8) and suitable to contain a fraction of the injectable solution;

- a capsule (7) including a protruding appendix (16) suitable to enter the dosing reservoir (21) in order to eject said fraction of solution;.

- an outlet duct (20), to eject the fraction of solution, being provided for in the closing element (2) and in communication with the containment chamber (8) through the dosing reservoir (21); a vent duct (23), to eject a second fraction of solution, being provided for in the closing element (2) and in communication with the containment chamber (8); wherein the protective cap (300) is fitted on the closing element (2) so that both the outlet duct (20) and the vent duct (23) are fully housed inside the protective cap (300) itself.

13. The injection device (1) according to claim 12, wherein both the outlet duct (20) and the vent duct (23) are closed by a plug (200) and the protective cap (300) is covering the ducts (20, 23) and the plugs ] (200), being all housed inside the protective cap (300) .

14. The injection device (1) according to claim 12 or 13, wherein the protective cap (300) includes an internal rib (305) in the shape of a circular wall and provided with a window (309) suitable to house the vent duct (23) .

15. The injection device (1) according to any claim 12 to 14, wherein the plug (200) of the outlet duct (20) and the plug (200) of the vent duct (23) are joined to each other to form a single closing device.

16. The injection device (1) according to any claim 12 to 15, including:

- a first (8) and second (9) containment chambers being hermetically separated from one another;

- a first substance, contained in the first containment chamber ( 8 ) ; - a first (6) and second capsule (7) being arranged inside the tubular body (3), in order to delimit the second containment chamber (9) therebetween in the tubular body (3);

- a second substance, contained inside the second containment chamber (9), intended to be mixed inside the tubular body (3) with the first substance for reconstitute the injectable solution;

- a bypass channel (10) between the first (8) and the second (9) containment chamber suitable to allow mixing the first substance and the second substance in order to reconstitute the injectable solution;