Opening and supplying system for pre-filled containers, respective filled containers, and methods for their realization

Abstract

The present invention relates to an opening and liquid supplying system (100) for pre-filled containers (10, 30) equipped with a supplying end, comprising a coupling element (20), connecting means (6) movable from a first position to a second position, and movable protection means (9); the coupling element (20) has an end (27) closed and suitable for being punched, and first guiding means (21) for guiding the movement of the connecting means (6) movable from the first position, close to the closed end (27), to the second position, apart from such end, and vice versa; the connecting means (6) have engaging means (7) for engaging with the protection means (9) so as to move integrally along a second degree of freedom, different than the first degree of freedom, and first matches (11) for the first guiding means (21). The invention relates also to a respective pre-filled container equipped with such system and the method for realize them.

Claims

1. A method for the realization of an opening and liquid supplying system (100) for containers (10, 30) equipped with a supplying end, comprising a coupling element (20), connecting means (6) movable from a first position to a second position, and movable protection means (9), the connecting means (6) being suitable for coupling with a needle holder (4) comprising the following steps: providing in the coupling element (20) a first hollow end (26), suitable for coupling with the supplying end of the container (10, 30), and a second end (27), closed and suitable for being punched; providing on the coupling element (20) a first guiding means (21) for guiding the movement of the connecting means (6) movable from the first position, close to the second end (27), to the second position, close to the first hollow end (26), and vice versa along a first degree of freedom; providing on the connecting means (6) an engaging means for engaging with the protection means (9) so as to integrally move along a second degree of freedom, different than the first degree of freedom, and first matches for the first guiding means (21), so as, during the integral movement of the protection means (9) and of the connecting means (6) according to the second degree of freedom, the first matches of the connecting means (6) move from the first position to the second position along the first guiding means (21) of the coupling element (20); providing on the coupling element (20) a second guiding means (23) for guiding the removal of the protection means (9); and providing on the protection means (9) second matches (13) corresponding to the second guiding means (23), so that the removal movement of the protection means (9) corresponds to the movement of the protection means (9) in respect with the connecting means (6); making the container, the protection means or the coupling element malleable; wherein the coupling of the coupling element (20) with at least one among the container (10, 30), the protection means (9) and the connecting means (6), occurs when the container (10, 30), the protection means (9) or the coupling element (20) is still malleable; wherein the first guiding means of the coupling element (20) comprise a first thread, and wherein the first matches of the connecting means (6) comprise a first counter thread, on an inner surface (12) of the connecting means (6) and corresponding to the first thread; wherein the second guiding means of the coupling element (20) comprise a second thread, with a direction opposite to the one of the first thread and wherein the second matches of the protection means (9) comprise a second counter thread (13), on an inner surface of the protection means (9) and corresponding to the second thread; wherein at least one among the first counter thread and the second counter thread (13) is realized by pressing respectively the connecting means (6) and the protection means on the coupling element (20) while the connecting means (6) and the protection means (9) are still malleable.

2. The method for the realization of an opening and liquid supplying system (100) according to claim 1, further comprising the following steps: providing the connecting means (6) integral with a needle holder (4) equipped with needle (1) suitable for punching the second end (27) of the coupling element (20), when the connecting means (6) are in the second position; providing a needle guard (C) for the needle holder (4), embedding at least a portion of the needle guard (C) in the protection means (9) whene protection means (9) is still malleable.

3. The method for the realization of an opening and liquid supplying system (100) according to claim 1, wherein the first guiding means are realized by pressing the connecting means (6) while still malleable on the coupling element (20).

4. The method for the realization of an opening and liquid supplying system (100) according to claim 1, further comprising the following step: realizing the second guiding means of the coupling element (20) by pressing the protection means (9) while still malleable on the coupling element (20).

5. The method for the realization of comprising an opening and liquid supplying system (100) according to the method of claim 1 further comprising a pre-filled container (10, 30).

6. The method according to the claim 5, further comprising the following step: embedding the supplying end of the container (10, 30) in the coupling element (20) when the coupling element (20) is still malleable.

Description

(1) Said aims and advantages, as well as others which will arise in the following, will be more apparent from the following description relating to a favourite embodiment of the system of the invention, given by way of example and illustrative, but not limitative, with reference to the accompanying drawings in which:

(2) FIG. 1 shows a first cutaway of the closing system of the invention in a first position, applied to a syringe;

(3) FIG. 2 shows the cutaway of the system of FIG. 1 wherein the components are seen in transparency;

(4) FIG. 3 shows a detail of FIG. 2;

(5) FIG. 4 shows a second cutaway of the system of FIG. 1, removed from the syringe;

(6) FIG. 5 shows a cutaway of the system of FIG. 1, in a second position;

(7) FIG. 6 shows a detail of FIG. 5;

(8) FIG. 7 shows the system of the invention in a first variant, wherein it is applied to a vial;

(9) FIG. 8 shows a component of the system of FIG. 7;

(10) FIG. 9 shows the system of the invention to which a standard needle is applied;

(11) FIG. 10 shows an exploded view of FIG. 9;

(12) FIG. 11 shows an exploded view in cross section of FIG. 9 applied to a standard syringe;

(13) FIG. 12 shows in cross section the system of FIG. 11, in a first position, before punching;

(14) FIG. 13 shows in cross section the system of FIG. 12, in a second position, with the needle in communication with the liquid, ready to use. Referring to FIGS. 1-6, the opening system 100 for pre-filled syringes 10 of the invention comprises connecting means 6, equipped with a first end 2 for sampling of the medical liquid from a connector 20 suitable for being punched, and equipped with a second end 3 suitable for being connected to a needle 1 for supplying the medical liquid.

(15) The needle 1 is held by a needle holder element 4, and by connecting means (for example Luer) for being connected to the connecting means 6, in turn assembled with the connector 20, and to be coupled to the syringe 10.

(16) The connecting means 6 are integral to the needle holder 4 according to the prior art (for example, by a Luer connection) and have: engaging means 7, for example at least a longitudinal rib, on at least a portion of the coupling surface 8 with protection means 9 of the needle 1, for example a cap 9.

(17) The system 100 comprises furthermore a connector or coupling element 20, suitable for coupling the container of medical liquid, for example the pre-filled syringe 10 realized by the BFS technique, by the connecting means 6 with the needle holder 4.

(18) Furthermore, the needle guard C is coupled to the cap 9, for example embedding the needle guard C into the cap 9 when the cap 9 is still hot and thus malleable; in particular this could occur embedding exclusively the base portion D of the needle guard C (FIG. 7, 9, 10).

(19) The coupling element 20 has guiding means 21, corresponding to the first matches 11 on at least a surface 12 of the connecting means 6.

(20) In particular, for example, the coupling element 20 has a substantially tubular shape, the cavity of which is coupled to the supplying end of the container (for example embeds the supplying end of the pre-filled syringe 10, in particular this may occur coupling the coupling element when is still hot and thus malleable), while its external surface has a thread 21, corresponding to a counter thread on the inner surface 12 of the connecting means 6 of the needle holder 4.

(21) Preferably, the coupling element 20 has a limit of the guiding means 21, for the first matches 11 of the connecting means 6 of the needle holder 4.

(22) As much preferably, a portion of the coupling element 20 has guiding means 23 for the first matches 13 of the cap 9, for example a thread 23 and a counter thread 13, with a direction opposite to the one of the thread 21 and of the counter thread, so that, when the operator rotates the cap 9 clockwise, this is guided along a first direction A, corresponding to the moving away of the cap 9 from the rest of the system 100, while the connecting means 6 with the needle holder 4, as above explain, are guided along a second direction B, opposed to the first direction A.

(23) In a first variant of the invention, shown in FIG. 7, the opening system 100 of the invention is applied to a vial 30, for example realized always with BFS technology, in particular of the squeeze type.

(24) The connecting means 6 of the system 100 have substantially a tubular shape, suitable for housing within it a part of the coupling element 20, and on the external surface of which there is at least a protruding element or a longitudinal rib, suitable for engage with at least a corresponding seat or longitudinal groove (not shown) on the inner surface of the cap 9 for protecting the needle 1, so that—rotating the cap 9 in order to remove it from the needle 1—the needle holder 4 rotates according to the same direction of the same cap.

(25) Even if in the attached drawings they are always shown in such way, it is not necessary that the engaging means 7 are placed in correspondence of the connecting means 6, but they must surely be placed so as to engage with the inner surface of the cap 9.

(26) The coupling element 20, shown in FIG. 8, has a hollow volume composed substantially by a first hollow cylinder 24, equipped with a first external diameter, and preferably also by a second hollow cylinder 25, equipped with a second external diameter, bigger than the first.

(27) On the first cylinder 24, there are guiding means 21, in the example shown in FIG. 8 a thread having a first direction, to which a counter thread on an inner surface 12 of the connecting means 6 of the needle holder 4 corresponds.

(28) The first cylinder 24 has a first end, hollow, 26 suitable for facing to towards the supplying end of the container 10 or 30, and a second end 27, closed.

(29) The second hollow cylinder 25 acts as a limit for the thread 21 for the connecting means 6.

(30) Furthermore, preferably, the second hollow cylinder 25 has on its external surface a further thread 23, having a second direction, opposed to the first, to which a second counter thread 13 on the inner surface of the cap 9 corresponds.

(31) As shown in the variant of FIGS. 11-13, the system 300 of the invention may be suitable for be applied to a syringe 40 standard, for example with a LUER connection.

(32) In such case, the system 300 of the invention comprises only connecting means 6 and a modified coupling element 20, i.e. having the inner surface 28 with Luer connection for being coupled into the known system to the standard syringe 40.

(33) In particular, the connecting means 6 have the same elements already described for the system 100.

(34) The engaging means 7 are rotated by the operator and following the thread of the guiding means 21 on the coupling element 20, as already described, punch the closed end 27 by means of the inner end 41 of the needle 1 creating the connection of the liquid within the syringe with the standard needle connected by a Luer connection.

(35) During the assembly and packaging of the container (visible in FIG. 12), a needle 301 equipped with a needle holder 304 with a standard connection, for example a Luer connection, is added.

(36) Operationally, however, when the operator takes a container 10 or 30 or 40 containing the medical liquid to which is applied the opening system 100 or 300 of the invention, such system 100 or 300 is in a first position, with the connecting means 6 apart from the supplying end of the container 10, 30 or 40 (FIGS. 1-3 and 12).

(37) During opening step, the operator acts on the cap 9, if on the container, or directly on the lugs 7 (FIGS. 12 and 13), rotating along a rotational direction, for example along a clockwise direction. In this way, the cap 9 starts rotating, engaging with the engaging means 7 of the connecting means 6. In such a way, the connecting means 6 start rotating in the same direction: in this case, clockwise. During the rotation of the connecting means 6, it is guided by the first matches 11 along the path set by the guiding means 21 of the coupling element 20 towards the supplying end of the container 10 or 30 or 40, up to punch the second end 27 of the supplying element 20 with the first end 41 of the connecting means 6 and arrive in a second position, wherein the needle 1 or 301 gets in communication with inside the container 10 (FIGS. 5, 6 and 13) for supplying.

(38) Meanwhile, also the connecting means 6 longitudinally moved towards such supplying end of the container 10, 30 or 40.

(39) In such a way, the container 10 or 30 is free from the cap 9 and from the possible needle guard C, ready to be used, with the needle 1 or 301 in contact for the first time with the medical liquid.

(40) From the description just made, it is clear, thus, that the opening system of the invention, the pre-filled container and the method for its production and assembly, subject matter of the present invention, reach the objects and realize the advantages already mentioned.

(41) During the execution, changes to the components of the system of the invention may be made, consisting, for example, in inverting the position of the guiding means and of the respective first matches with each other.

(42) In such case, the procedures described above for realizing the system of the invention will vary accordingly.

(43) It is clarified, moreover, that the present invention, although having been described with particular reference to a pre-filled single use syringe and a vial for injections, extends also to others liquid containers.

(44) It is clear that many other variations may be made to the system in question, without for this departing from the principles of novelty inherent in the inventive idea expressed here, it is also clear that, in the practical implementation of the invention, the materials, the shapes and dimensions of the illustrated details can be whatever, depending on the requirements, and replaced by others technically equivalent.

(45) Where the constructive and technical characteristics mentioned in the subsequent claims are followed by signs or reference numbers, such reference signs have been introduced with the sole aim of increasing the intelligibility of the same claims and, as a consequence, they have no limiting effect on the interpretation of each element identified by way purely of example, by such reference signs.