Sealing device for making it possible to collect a composition, packaging assembly comprising such a sealing device, collection and packaging methods

Abstract

The present invention relates to a sealing device to seal a container, the sealing device including: a tip that defines an internal passage leading to an opening and is designed to allow connection to a collection member such as an enteral syringe, a non-return valve that is associated with the tip and is designed to open during collection of the contents of the container using the collection member, at least one air-return port, and an antibacterial filter associated with said at least one port.

Claims

1. A sealing device for collecting a composition intended for enteral or nasal administration or for topical use, contained in a receptacle, comprising: a tip defining an internal passage leading to an opening designed to allow a connection to a collection member intended for enteral administration, a non-return valve associated with the tip, comprising an annular sealing membrane, and designed to open upon collection of the composition from the receptacle using the collection member and prevent any return of the composition from the collection member into the receptacle when using the collection member to collect the composition, at least one air-return port, and an antibacterial filter associated with the at least one port, and a plate contacting the interior of the receptacle and having at least one perforation for the passage of liquid and forming the seat of the non-return valve, wherein the annular sealing membrane is positioned on the plate so as to close off the at least one perforation for the passage of liquid.

2. The sealing device of claim 1, wherein the tip has at least in part a substantially conical shape.

3. The sealing device of claim 2, wherein the tip has at least in part a substantially conical shape with an approximately 6% taper and is configured as a standardized lockable screwable cone or a Luer Lock cone.

4. The sealing device of claim 1, wherein the non-return valve comprises an annular reduction to allow its deformation.

5. The sealing device of claim 1, wherein the filter is made from a hydrophobic material having a mean pore diameter below 0.3 μm.

6. The sealing device of claim 1, wherein the plate comprises at least one perforation for the passage of air.

7. The sealing device of claim 6, wherein the filter covers the at least one perforation for the passage of air and is affixed to the plate.

8. The sealing device according to claim 1, further comprising means for fastening on the receptacle, the fastening means comprising a fastening skirt, with an internal thread, arranged in order to be affixed to a neck of the receptacle.

9. The sealing device of claim 8, wherein the fastening means comprise a tamper-evident relief designed to prevent removal of the sealing device from the receptacle once the latter has been secured to the receptacle.

10. The sealing device of claim 1, further comprising a closure member connected to the remainder of the sealing device by a flexible link, the closure member configured to be equipped with a tamper-evident system.

11. The sealing device of claim 1, further comprising a base comprising an upper part and a lower part assembled together.

12. The sealing device of claim 11, wherein the upper part comprises the tip and the at least one port, and the lower part comprises the plate.

13. The sealing device of claim 11, wherein the upper part comprises, on an internal face, a sealing skirt designed to bear on the non-return valve.

14. A packaging assembly for a composition intended for enteral administration or for topical use, allowing collection thereof, comprising a receptacle for packaging the composition, secured with the sealing device of claim 1.

15. The assembly of claim 14, further comprising at least one collection member.

16. The assembly of claim 14, packaged in an individual sterile or non-sterile packaging.

17. A method for collecting a composition using a collection member in a receptacle equipped with the sealing device of claim 1, the method comprising: securing the collection member to the tip; collecting a required quantity of composition with the collection member, using a piston; removing the collection member from the tip; and optionally repeating the above steps.

18. The method of claim 17, wherein: the sealing device comprises a closure member; and the method comprises opening the closure member before securing the collection member to the tip and closing the closure member after removal of the collection member.

19. A method for packaging a composition intended for enteral administration or for topical use in a receptacle, comprising: placing the composition in the receptacle; and fastening a sealing device according to claim 1 to the receptacle.

20. The method of claim 19, further comprising associating with the receptacle at least one collection member, and providing the whole in an individual sterile or non-sterile packaging.

Description

(1) The invention may be better understood on reading the following detailed description of a non-limiting illustrative embodiment thereof and on examining the appended drawing, in which:

(2) FIG. 1 shows, schematically and in perspective, an example of a sealing device according to the invention,

(3) FIG. 2 shows, in axial, schematic and partial section, the sealing device of FIG. 1,

(4) FIG. 3 shows, schematically in bottom view, the sealing device of FIG. 1,

(5) FIG. 4 shows, schematically in top view, the sealing device of FIG. 1, the upper part removed,

(6) FIG. 5 shows, in axial section, schematically and in part, the sealing device of FIG. 1, closed and fastened on the neck of a receptacle,

(7) FIG. 6 shows, schematically and in perspective, the receptacle equipped with the sealing device of FIG. 1, closed,

(8) FIG. 7 shows, schematically, a packaging assembly comprising the receptacle of FIG. 6 and an adapted collection member,

(9) FIGS. 8 and 9 show, schematically, two steps in a method for packaging a composition in a receptacle closed by a sealing device according to the invention, and

(10) FIGS. 10 to 13 illustrate, schematically, steps in a method for collecting a composition using the sealing device according to the invention.

(11) The sealing device 1, shown in FIGS. 1 to 5, is intended to be fastened to a receptacle 10, which may be seen, in particular, in FIG. 5 or 6. This receptacle 10 contains a composition for enteral administration or for topical use, the preservative concentration of which is lowered or even zero.

(12) The sealing device 1 comprises a dispensing tip 2 defining an internal passage 3 extending along a longitudinal axis X. The internal passage 3 leads to an opening 4 forming the free end of the tip 2. The latter is designed to allow a connection to a collection member, such as an enteral syringe 20, which may be seen in FIG. 7.

(13) The sealing device 1 further comprises a non-return valve 5 associated with the tip 2, designed to open upon collection of the contents of the receptacle using the collection member, which may be seen in particular in FIGS. 2, 4 and 5. The non-return valve 5 prevents any return of fluid to the interior of the receptacle and also prevents the ingress of air in the absence of a collection member.

(14) The sealing device 1 also comprises at least one air-return port 6, of which there are nine in this example. At least one antibacterial filter 7, aimed at reducing bacterial contamination, is associated with the ports 6. A filter 7 of this type makes it possible systematically to filter the air entering the receptacle via the ports 6, preventing contamination of the composition contained in the receptacle. Thus, by virtue of the invention, it is possible to perform a multiple-dose collection or multiple collections of a composition contained in a receptacle via the sealing device 1 without contaminating the composition remaining in the receptacle, preventing the return of potentially contaminated composition to the interior of the receptacle and by virtue of the filtration of any air entering the receptacle owing to the reduced pressure created upon collection of the solution.

(15) The ports 6 are, for example, each of circular form.

(16) In the example illustrated, the tip 2 has at least in part a substantially conical form about the longitudinal axis X, being slightly flared toward the exterior closer to its opening 4, as may be seen in FIG. 2. The taper may be approximately 6%. In particular, the tip 2 may be a “lockable standardized cone” or “luer lock cone” tip, the latter form with a locking collar 8 further allowing locking of the collection member in the tip 2, in a manner known per se.

(17) The non-return valve 5 is composed of a sealing membrane 27 made from a flexible polymeric material, for example an elastomeric or silicone material, having an annular form about the axis X, as may be seen in particular in FIG. 4. An annular reduction 9 facilitates deformation thereof in the axis X of the receptacle.

(18) The filter 7 is advantageously made from a hydrophobic material, so as to prevent the exit of liquid via the ports 6. The filter 7 has, for example, a mean pore diameter less than 0.3 μm.

(19) In the sealing device 1 illustrated, the latter comprises, as may be seen more particularly in FIG. 3 or 5, a plate 11 intended to be in contact with the interior 73 of the receptacle and having at least one perforation 12 for the passage of air and at least one perforation 13 for the passage of liquid. In the example illustrated, the perforations 12 and 13 are distributed annularly about the central axis X, the perforations 12 forming ring portions located radially at the exterior relative to the perforations 13, arranged, also, in a ring portion about the longitudinal axis X. In this example, the number of perforations 13 is six, it being possible for this number to be reduced or increased without departing from the scope of the invention, particularly to be between three and six, so as to permit the passage of air without having to exert an excessive pulling force on the syringe at the time of collection. The number of perforations 12 is three, each perforation 12 having separations 14 that may play a part in holding the underlying filter 7.

(20) In this example, the filter 7 or the filters 7, covers (cover) the perforations 12 for the passage of air and are affixed, particularly by gluing or welding, to the plate 11. A filter 7 is shown in FIG. 4. The filter 7 may be a single filter and have an annular form of diameter and dimensions such that it covers all the perforations 12 for the passage of air. In a variant, the filters may be three in number, as in this example, a single filter 7 being shown, however, in FIG. 4. Each filter 7 covers a perforation 12 for the passage of air.

(21) The angular extent of the perforations 12 for the passage of air is sufficient for the perforations to be at least partially superposed over at least a portion of the ports 6.

(22) The upper and lower parts together delimit an annular chamber where air is able to circulate between the ports 6 and the perforations 12 at the time of air return.

(23) The sealing membrane 27 is in this example positioned on the plate 11 so as, at rest, as may be seen in FIG. 4, to close off the perforations 13. The central portion, of discoid form, of the plate 11 thus forms the seat of the non-return valve 5. The sealing membrane is advantageously glued, in particular using ultrasound.

(24) In the example illustrated, the sealing device 1 further comprises means 15 for fastening on the receptacle. The fastening means 15 may comprise, as illustrated, a fastening skirt 16 having an internal thread 17 arranged in order to be fastened to an externally threaded neck of the receptacle, as may be seen in FIG. 5.

(25) The fastening means 15 advantageously comprise a tamper-evident relief 18, which may be seen in FIGS. 2 and 5, designed to prevent removal of the sealing device 1 from the receptacle 10 once it has been secured to the receptacle. As may be seen in FIG. 5, this tamper-evident relief may have the form of an annular flute, and the receptacle 10 may, meanwhile, comprise a catching bead 21 that complements the tamper-evident relief 18, over which the flute snap fits upon completion of the screwing of the fastening means.

(26) The fastening means 15 further comprise a sealing skirt 19 capable of coming into sealed internal contact with the neck of the receptacle, as may be seen in particular in FIG. 5.

(27) The sealing device 1 according to the invention also comprises a closure member 25, the role of which is to close the opening 4 of the tip 2 in a sealed manner. In the example illustrated, the closure member 25 consists in a cap connected by a flexible link 26, such as a film hinge, to the base 100 of the sealing device. The closure member 25 comprises a sealing lip 35 capable of forming the seal around the opening 4 of the tip 2 in order to prevent any leakage when the sealing device 1 is closed. A tamper-proof system, which is not shown in the figures to improve the clarity of the drawing, is also provided.

(28) At its periphery, on its interior surface, the cap has an annular bead 31 capable of snap-fitting into a corresponding flute 30 of the base 100, provided on an upright forming a projection around the air-return ports 6.

(29) The base 100 comprises an upper part 50 and a lower part 60 assembled together, in this example by snap-fitting using complementary snap-fitting reliefs 51 and 52, formed, respectively, on the upper 50 and lower 60 parts, in a circular form in a peripheral region of said parts. When assembled, the upper 50 and lower 60 parts together define three distinct zones. A first, exterior zone 61 defines the aforesaid annular chamber that allows the passage of air. A second, intermediate zone 62, which is likewise annular, allows holding of the non-return valve 5, and a third zone 63, which is substantially cylindrical, allows the passage of liquid. The intermediate zone 62 prevents any communication between the zones 61 and 63.

(30) In this example, the upper part 50 of the sealing device comprises the tip 2 and the air-return ports 6. As may be seen in particular in FIG. 2, the upper part 50 comprises, on an internal face 54, a sealing lip 55 bearing on the sealing membrane 27 of the non-return valve 5, on the annular reduction 9. When a reduced pressure is exerted, only the part 4 radially inside this annular reduction of the membrane 27 is deformed. The dimensions of the upper part may be optimized so as to avoid the stagnation of liquid and to prevent contamination at the time of the subsequent collection.

(31) The lower part 60 comprises the plate 11 and also the means 15 for fastening to the receptacle.

(32) FIG. 5 shows the neck 72 of the receptacle 10 having an external screw thread 73, which enables it to interact with the internal screw thread 17 of the fastening skirt 16 of the sealing device 1.

(33) FIGS. 6 and 7 show an example of a packaging assembly 70 according to the invention.

(34) In the example illustrated, the receptacle 10 consists in a glass vial having a threaded neck, for example of 27 mm diameter.

(35) The receptacle or the neck may be different without departing from the scope of the invention. In the example illustrated in FIG. 7, the packaging assembly 70 comprises a collection member 20 consisting in an enteral syringe of luer lock type and also an individual package 71 for packaging the assembly.

(36) It is not a departure from the scope of the invention if the packaging 71 comprises, in particular, a plurality of collection members 20.

(37) FIGS. 8 and 9 illustrate steps in a packaging method according to the invention. The step illustrated in FIG. 8 consists in placing the composition L in the receptacle 10. The packaging method then comprises the step illustrated in FIG. 9, consisting in fastening the sealing device 1, particularly, in this example, by screwing on the neck 72 of the receptacle 10.

(38) The packaging method may also comprise the step consisting in associating at least one collection member 20 with the receptacle 10 equipped with the sealing device 1 and in optionally arranging the whole in a totally or partially sterile or non-sterile individual package 71, as illustrated in FIG. 7.

(39) FIGS. 10 to 13 show a method for collecting the composition L using a collection member.

(40) First, the closure member 25 of the sealing device 1 is opened, as illustrated in FIG. 10, and then the collection member 20 is secured to the tip 2, in this example by means of screwing, as illustrated in FIG. 11. Next, by turning the receptacle upside down, the required quantity of composition L is collected with the collection member 20, by drawing on the piston of the collection member as illustrated in FIG. 12.

(41) At the time of collection, a reduced pressure is created within the receptacle and the sealing membrane 27 is deformed from its seat. Simultaneously, air penetrates the receptacle 10 via the ports 6, filtered by the filter 7. Lastly, the collection member 20 is removed and, as illustrated in FIG. 13, the closure member 25 is re-closed, the quantity of composition contained in the receptacle 10 having reduced by the quantity collected and being available for one or more subsequent uses, without contamination of the composition L.

(42) Of course, the invention is not limited to the example just described.

(43) In particular, the receptacle may be equipped with a plunger tube and/or have an elastic flexible wall. An additional non-return valve may be positioned near the tip. An additional non-return valve of this type for dry contact may be equipped with a lockable standardized screwable cone specific for enteral administration.

(44) Throughout the description, the expression “comprising a” must be understood as a synonym for “comprising at least one”, unless specified to the contrary.