Kit comprising a vial and a male connector

Abstract

The invention relates to a kit comprising a vial and a male connector (6) comprising: a male part (8) suitable for being inserted into a female connector of the vial, the male part having an outer surface (12) extending about an axis (X) and tapering towards a free end (2) of the male part (8); a sleeve (14) extending around and at a distance from the male part (8), the sleeve (14) comprising an internal thread (20) suitable for engaging with an external thread of the female connector when the male part (6) is inserted into the female connector, the outer surface (12) comprising a first frustoconical portion (12b) forming a first angle (α) with respect to the axis (X), and a second frustoconical portion (12c) extending the first frustoconical portion (12a) towards the free end (2), the second frustoconical portion (12c) forming a second angle (β) with respect to the axis (X), the second angle being smaller than the first angle (α).

Description

[0001] DESCRIPTION

[0002] TITLE: Kit including a bottle and a male connector

[0003] FIELD OF THE INVENTION

[0004] The present disclosure relates to a kit comprising a bottle and a male connector.

[0005] STATE OF THE ART

[0006] It is known to use "luer-lock" connectors to fluidly connect a first device and a second device. For this purpose, the first device comprises a female luer-lock connector, and the second device comprises a male luer-lock connector. Such connectors are used, for example, in needle devices or syringes.

[0007] The female luer-lock fitting and the male luer-lock fitting include threads adapted to engage with each other.

[0008] Furthermore, the female luer-lock fitting and the male luer-lock fitting have tapered surfaces that come into contact with each other to establish a fluid-tight connection between the first equipment and the second equipment, when the threads are engaged with each other.

[0009] The conical surface and / or the external thread of the female luer-lock connector of the first equipment may, however, have imperfections which have the consequence of compromising this seal. Such imperfections may appear in particular in the case where the first equipment is a bottle obtained by a form-fill-seal process (“blow-fill-seal” in English).

[0010] STATEMENT OF THE INVENTION

[0011] An aim of the present invention is to improve the sealing of a fluid connection between a male connector and a bottle equipped with a female connector, when the female connector of the bottle has imperfections in the threads or in the truncated sealing zone.

[0012] This object is achieved by the kit as defined in claim 1.

[0013] The kit may further have the features defined in the dependent claims, including the following features, taken alone or in combination where technically possible.

[0014] In one embodiment, the first angle is between 25 degrees and 35 degrees relative to the axis. In another embodiment, the first angle is between 10 degrees and 15 degrees relative to the axis. Preferably, the second angle is between 4 and 10 degrees relative to the axis.

[0015] Preferably:

[0016] - the first truncated portion has a first length measured parallel to the axis which is between 2 and 3 millimeters, and / or

[0017] - the second truncated portion has a second length measured parallel to the axis which is between 6 millimeters and 8 millimeters.

[0018] Preferably, the sleeve has an inner surface in which the internal thread is formed, an outer surface opposite the inner surface, and a connecting surface connecting the inner surface to the outer surface, the connector further comprising a fluid seal attached to the connecting surface.

[0019] Preferably, the connector comprises two user-grippable elements formed on the outer surface of the sleeve.

[0020] Preferably, the two gripping elements are two fins diametrically opposed with respect to the axis.

[0021] DESCRIPTION OF FIGURES

[0022] Other characteristics, aims and advantages of the invention will emerge from the following description, which is purely illustrative and non-limiting, and which must be read in conjunction with the attached drawings.

[0023] Figure 1 is a perspective view of an interconnector according to one embodiment.

[0024] Figure 2 is a side view of the interconnector of Figure 1.

[0025] Figure 3 is a sectional view of the interconnector of Figure 1.

[0026] Figure 4 is a sectional view of a male connector constituting a part of the interconnector of Figure 1.

[0027] Figure 5 is a top view of a bottle according to one embodiment, in a closed state.

[0028] Figure 6 is a side view of the bottle of Figure 5, in an open state.

[0029] Figure 7 is a sectional view of the bottle of Figure 5.

[0030] Figure 8 is a side view of an injection device according to one embodiment.

[0031] Figure 9 is a sectional view of the injection device of Figure 8.

[0032] Figure 10 is a side view of two pieces of equipment forming an injection kit according to one embodiment in a disassembled state. Figure 11 is a side view of the kit of Figure 10 in an assembled state.

[0033] Figure 12 is a perspective view of an interconnector according to another embodiment.

[0034] Figure 13 is a sectional view of the interconnector of Figure 12.

[0035] Throughout the figures, similar elements have identical references.

[0036] DETAILED DESCRIPTION OF EMBODIMENTS

[0037] Figures 1 to 3 show an interconnector 1. The function of the interconnector 1 is to fluidically interconnect a first piece of equipment and a second piece of equipment, i.e. to establish a fluidic connection allowing the transfer of a fluid from the first piece of equipment to the second piece of equipment. We will see later that these two pieces of equipment can be respectively a bottle and an injection system for delivering a fluid contained in the bottle.

[0038] The interconnector 1 extends along an axis X from a first free end 2 to a second free end 4 opposite the first free end 2. The axis X is represented in Figure 2 by a dotted line.

[0039] The interconnector 1 defines a through passage forming such a fluid connection. This passage, visible in Figure 3, has a first access opening to the outside of the interconnector 1 at the first free end 2, and a second access also opening to the outside of the interconnector, at the second free end 4. The passage 3 extends along the axis. The passage is rectilinear.

[0040] The interconnector 1 comprises a first connector 6. The first connector 6 is a male connector suitable for being connected to the first equipment, more precisely to a female luer-lock connector of the first equipment.

[0041] The first connector 6 comprises an annular male part 8 ending in the first free end 2 where the first access opens.

[0042] The male part 8 has an internal surface 10 extending around the axis, so as to delimit a first portion of the aforementioned passage, and in particular to delimit the first access. The internal surface is cylindrical of revolution around the axis X.

[0043] The male part 8 further has an external surface 12 opposite the internal surface 10. The external surface extends around the internal surface 10.

[0044] Generally, the external surface 12 narrows towards the first free end 2. The external surface 12 comprises a cylindrical portion 12a of revolution around the axis X, a first frustoconical portion 12b extending the cylindrical portion 12a towards the first free end 2, and a second frustoconical portion 12c extending the first frustoconical part 12b towards the first free end 2.

[0045] The cylindrical portion 12a has a length, measured parallel to the X axis, of between 1 and 3 millimeters, for example 2 millimeters.

[0046] The cylindrical portion 12a has a constant diameter of between 3 and 5 millimeters, for example 4.35 millimeters with a tolerance of 0.05 millimeters.

[0047] The first frustoconical portion 12b has a length, measured parallel to the X axis, of between 2 and 4 millimeters, for example 2.5 millimeters.

[0048] The first truncated portion 12b has a slope forming a first angle relative to the X axis, as can be seen in particular in Figure 4.

[0049] In one embodiment, the first angle is between 25 degrees and 35 degrees relative to the X-axis, for example 30 degrees. In another embodiment, the first angle is between 10 degrees and 15 degrees relative to the X-axis, for example 12.5 degrees.

[0050] The second truncated portion 12c has a length, measured parallel to the X axis, of between 6 and 8 millimeters, for example 7 millimeters.

[0051] The second frustoconical portion 12c has a slope forming a second angle relative to the X axis. The second angle is less than the first angle. This is equivalent to saying that the second frustoconical portion 12c has a taper less than the taper of the first frustoconical portion 12b, or more familiarly that the second frustoconical portion 12c is less steep than the first frustoconical portion 12b, relative to the X axis.

[0052] The second angle is between 4 and 10 degrees from the X axis, for example 7 degrees.

[0053] The external surface 12 has a minimum diameter, at the free end 2, of between 3 and 4 millimeters, for example 3.61 millimeters with a tolerance of 0.05 millimeters.

[0054] The first connector 6 further comprises a sleeve 14 extending around and at a distance from the male part 8.

[0055] The sleeve 14 is fixed relative to the male part 8. The sleeve 14 is connected to the male part 6 by an annular connecting part 16 extending radially around the axis X. The sleeve 14 has an internal surface 18 facing the external surface 12 of the male part 8. Thus, the male part 8 and the sleeve 14 delimit between them an annular space suitable for receiving a part of the first aforementioned equipment (we will see later precisely that this part can be the neck of a bottle).

[0056] The inner surface 18 has a maximum diameter of between 7 and 9 millimeters, for example 8 millimeters with a tolerance of 0.1 millimeters.

[0057] The first connector 6 comprises an internal thread 20 which is formed in the internal surface 18. The internal thread 20 is adapted to cooperate with the external thread of a female luer-lock connector of the first equipment, when the male part is inserted into such a female luer-lock connector.

[0058] The 20 internal thread has a pitch of approximately 2 millimeters.

[0059] The external surface 22 of the sleeve 14 is cylindrical of revolution.

[0060] The outer surface 22 has a diameter of between 9 and 11 millimeters, preferably 10 millimeters.

[0061] The sleeve 14 further has a connecting surface 24 connecting the inner surface to the outer surface. The connecting surface is annular. Although not illustrated, a seal, for example an O-ring, may optionally be fixed to this connecting surface 24 in order to improve the sealing of the connection between the first connector 6 and a female luer-lock connector of the first equipment.

[0062] The sleeve 14 has a length, measured parallel to the X axis, of between 9 and 11 millimeters, for example 10.1 millimeters.

[0063] The first connector 6 further comprises two gripping elements 26, 28 formed on the outer surface 22 of the sleeve 14, to assist a user in rotating the sleeve 14 about the X axis. The two gripping elements 26, 28 are visible in Figures 1 and 2.

[0064] The two gripping elements 26, 28 form two fins projecting radially from the external surface 22.

[0065] The two gripping elements 26, 28 are diametrically opposed with respect to the X axis.

[0066] The male part 8 projects out of the sleeve 14 in a direction parallel to the X axis. The length of the male part 8 along the X axis is greater than the length of the sleeve 14, measured in the same direction, so that the free end of the male part 8 is further from the connecting part 16 than is the connecting surface 24. In other words, the connecting surface 24 has a position along the X axis which is between the connecting part 16 and the free end of the male part 8.

[0067] The interconnector 1 further comprises a second connector 30 suitable for being connected to a second piece of equipment (when the first connector 6 is itself connected to the first piece of equipment).

[0068] The second connector 30 comprises a second male part 32. The male part 32 is annular and ends with the second free end 4 where the second access of the passage 3 opens.

[0069] The second male part 32 has a second internal surface 34 extending around the axis X, so as to delimit a second portion of the aforementioned passage 3, and in particular to delimit the second access located at the level of the second free end 4. The second internal surface 34 is cylindrical of revolution around the axis X.

[0070] The second internal surface 34 continuously extends the internal surface 10 of the male part 8 of the first connector 6.

[0071] The second male part 32 further has a second external surface 36 opposite the second internal surface 34. The external surface 36 extends around the internal surface 34.

[0072] The second external surface 36 narrows towards the second free end 4.

[0073] The second outer surface 36 is frustoconical. Preferably, the taper of the second outer surface is 6%. In this case, the second connector is a male luer connector.

[0074] The second connection 30 does not have a threaded sleeve, unlike the first connection 6.

[0075] The second connector 30 has a length, measured parallel to the axis X between the connecting part 16 and the second free end 4, of between 8 and 9 millimeters, for example 8.45 millimeters.

[0076] The interconnector is made of a single piece. Preferably, the interconnect is made of a material such as polyethylene, polypropylene, or any material that can be thermoformed by injection and is compatible with medical use.

[0077] Bottle

[0078] With reference to Figures 5 to 7, a first piece of equipment capable of being connected to the first connector 6 of the interconnector is a bottle 40. The bottle 40 is obtained by a blow-fill-seal process. Alternatively, the bottle 40 is obtained by other plastics processing techniques, such as injection, injection-blow molding, or extrusion-blow molding.

[0079] The 40 bottle is a single-piece design. This feature allows the bottle to pose fewer problems in maintaining asepsis during subsequent use, compared to bottles with caps (which must be sterilized).

[0080] The bottle 40 is made of a deformable material, preferably an elastomer. Very preferably, this material is low-density polyethylene, which is a material with the advantage of being particularly flexible.

[0081] The deformable material in particular allows a user to squeeze the bottle 40 to expel a fluid it contains.

[0082] The bottle 40 comprises a neck 42. The neck 42 is sealed by a sealing portion 44: the bottle is therefore in a closed state, visible in Figure 5. The sealing portion 44 is adapted to be able to be broken by a user, for example a rotational movement, and thus be detached from the rest of the bottle 42 so as to form an opening 46 at the neck 42 giving access to the interior of the bottle 40 from the exterior of the bottle 40. The bottle is then in an open state, as shown in Figure 6.

[0083] The neck 42 has an internal surface 48 delimiting a passage between the interior and the exterior of the bottle ending in the opening 46, and an external surface 50 opposite the internal surface.

[0084] The internal surface 48 is truncated or cylindrical.

[0085] The bottle 40 further comprises an external thread 52. The external thread 52 is formed in the external surface 50 of the neck. The external thread 52 is suitable for cooperating with the internal thread 20 of the interconnector 1.

[0086] The internal surface 48 and the external thread 52 form a female connector when the bottle is in its open state. In reality, the neck constitutes a female element suitable for receiving a male part of a male luer-lock connector or the male part 8 of the first connector 6.

[0087] The bottle can be used to store a fluid. The fluid may include a vaccine or a sterile product that can be delivered as an injection, nebulizer, or drops.

[0088] Injection device with female connector

[0089] A second piece of equipment that can be connected to the second connector 30 of the interconnector is a fluid injection device (not shown). The injection system comprises a hollow needle and a connector suitable for being connected to the second connector 30 of the interconnector 1.

[0090] The hollow needle has a beveled free end. An outlet is formed at this free end, through which a fluid can be delivered.

[0091] The injection system defines an internal passage ending in the outlet. This internal passage is placed in fluid communication with the internal passage of the interconnector, when the injection system connector is connected to the interconnector.

[0092] The injection system connector is a female connector, preferably a female luer connector. For this purpose, the female connector has an internal surface delimiting the aforementioned passage, and having a taper of around 6%.

[0093] Injection kit with interconnector

[0094] The interconnector 1 can be combined with a first equipment and a second equipment in order to form a kit. In particular, this kit can be used as follows when the first equipment is the bottle 30 described above, and the second equipment is the injection system with female connector described above.

[0095] The vial in its closed state is assumed to contain a fluid to be administered, for example a fluid comprising a vaccine.

[0096] A user breaks the sealing portion 42 of the bottle 40 by giving it a rotational movement relative to the rest of the bottle 40, thereby opening the bottle at the neck 44.

[0097] The user connects the bottle 40 to the interconnector 1. To do this, the user inserts the male part 8 of the first connector 6 of the interconnector 1 into the neck 42 of the bottle 40, so that the first access to the passage 3, formed at the free end 2 of the interconnector 1, opens into the bottle. During this insertion, the internal thread 20 of the first connector 6 comes into contact with the external thread formed on the neck of the bottle. The user rotates the interconnector 1 around its axis X relative to the bottle so that the two threads are screwed into engagement. At a certain stage of screwing, the external surface 12 of the male part 8 comes into contact with the internal surface of the neck of the bottle.The presence of the two portions 12b and 12c in the external surface 12, having different conicities, ensures a good seal between the interior of the bottle and the internal passage 3 which passes through the interconnector 1, even if the bottle in its open state has geometric imperfections. The user connects the interconnector 1 to the injection system elsewhere. For this, the user inserts the male part 32 of the second connector 30 of the interconnector 1 into the female luer connector of the injection system.

[0098] The two steps above can be done in any order.

[0099] Once these two steps have been completed, the user obtains a device in which a fluid connection can be established between the interior of the bottle and the outlet formed at the end of the injection needle, this fluid connection comprising in particular the passage 3 passing through the interconnector 1.

[0100] To expel the fluid initially contained in the bottle, the user can press two opposite sides of the bottle. The fluid passes through the neck, enters the interconnector 1 via the first access located at the first free end 2, passes through the internal passage 3 of the interconnector 1, exits through the second access located at the second free end 4, then enters the injection system before exiting through the opening formed at the end of the needle.

[0101] The interconnector 1 has the advantage of allowing a fluid connection to be established between the injection system and the bottle without having to modify the respective structures of these two pieces of equipment. In particular, the double taper of the first connector 6 makes it possible to ensure that the fluid connection established between these two pieces of equipment is properly sealed.

[0102] Injection kit without interconnector

[0103] In the kit as described above, a double-tapered fitting 6 is incorporated into the interconnector 1 to improve the fluidic sealing of the device resulting from the connection of the interconnector 1 to the first equipment (bottle 30) and to the second equipment (injection system).

[0104] It is however possible to incorporate a double taper fitting having the same characteristics as the first fitting 6 in equipment other than an interconnector to obtain this improvement in fluid sealing.

[0105] In particular, it is possible to include a double-tapered connector having the same characteristics as the first connector 6 in an injection system 60 according to a second embodiment shown in FIGS. 8 and 9. The injection system 60 according to this second embodiment differs from the injection system as described previously by the fact that its connector is not a female luer connector, but the connector 6 as described previously (including in particular the double-tapered external surface 12 as well as the internal thread 20). The injection system 60 according to this second embodiment can be connected directly to the bottle 40 described previously, without requiring an interconnector between the two, as shown in FIGS. 9 and 10. In other words, the injection system according to this second embodiment forms with the bottle 40 a second kit not requiring an interconnector.To do this, the user inserts the male part 8 of the first connector 6 of the injection system 60 into the neck 42 of the bottle 40, so that the first access to the passage 3, formed at the free end 2 of the interconnector 1, opens into the bottle. During this insertion, the internal thread 20 of the connector 6 comes into contact with the external thread 52 formed on the neck 42 of the bottle 40. The user rotates the injection system relative to the bottle 40 so that the two threads 20, 52 are engaged by screwing. At a certain stage of screwing, the external surface 12 of the male part 8 comes into contact with the internal surface of the neck of the bottle.

[0106] Other kits for delivering fluid

[0107] In the above, two kits have been proposed in which the bottle 30 is placed in fluid communication with injection devices provided with a needle. However, the bottle 40 can be combined with other devices for delivering a fluid, in particular a spray device. The spray device comprises a spray nozzle for delivering a fluid emanating from the bottle in the form of a nasal spray for the delivery of a drug or nasal vaccine. Of course, the spray device can comprise the connector 6 directly connectable to the bottle 40, or a female connector connectable to the second connector 30 of the interconnector 1.

[0108] Alternatively, it is possible to combine the bottle 40 with a device for delivering a fluid comprising a sterilizing filter with a porosity less than or equal to 0.22 microns. This type of filter is suitable for delivering a fluid in the form of drops, such as a sterile medication. The filter may comprise the connector 6 directly connectable to the bottle 40, or a female connector connectable to the second connector 30 of the interconnector 1. The system obtained from the bottle and the device comprising the filter (and where appropriate from the interconnector 1) is a multidose system which can be used for several days or several weeks.

[0109] Other embodiments of male connector

[0110] Figure 12 shows a 6' male connector, which differs from the 6 male connector by the following characteristics (all other things being equal).

[0111] The male connector 6' comprises a male part 8' identical to the male part 8 except that the free end of the male part 8' is set back relative to the sleeve 14 in a direction parallel to the X axis. By "set back" is meant that the free end of the male part 8' does not protrude from the sleeve. On the contrary, this free end is located inside the sleeve at a non-zero distance from the free end of the sleeve 14, this distance being measured parallel to the X axis.

[0112] Referring to Figure 10, the male connector 6' comprises an annular seal 17 fixed to the connecting part 16. This seal is arranged in the space provided between the male part 8' and the sleeve 1, so that the neck 42 of the bottle comes into contact with the seal when the male part 8 is inserted into the female connector formed by the neck 42.

[0113] The seal is arranged at a distance from the internal thread 20 in a direction parallel to the X axis. Thus, the external thread 20 does not extend to the connecting portion 16, which limits the movement stroke of the neck towards the seal. This arrangement prevents ovalization of the seal which would be caused by excessive crushing of the seal. This ovalization gives the seal an oval shape when viewed in a direction parallel to the X axis, instead of taking a circular shape. This oval shape compromises the sealing performance of the seal.

[0114] The 6' male fitting gasket is optional. It can be incorporated into the 6' male fitting discussed previously.

[0115] The male connector shown in Figures 12-13 is part of an interconnector, but could alternatively be part of another type of device to be connected to the bottle.

Claims

CLAIMS 1. Kit comprising a bottle (40) and a male connector (6), in which the bottle (40) is obtained by a forming-filling-sealing process, and comprises: - a neck (42) comprising an external thread (52), - a sealing portion (44) which seals the neck (42) and which is capable of being broken by a user so as to reveal an opening delimited by the neck (42) giving access to the interior of the bottle (40) from the exterior of the bottle (40), and in which the male connector (6) comprises: - a male part (8) suitable for being inserted into the female connector after breaking the sealing part (44), the male part having an external surface (12) extending around an axis (X) and narrowing towards a free end (2) of the male part (8), - a sleeve (14) extending around and at a distance from the male part (8), the sleeve (14) comprising an internal thread (20) suitable for cooperating with the external thread when the male part (6) is inserted into the female connector, characterized in that the external surface (12) comprises a first frustoconical portion (12b) forming a first angle (a) relative to the axis (X), and a second frustoconical portion (12c) extending the first frustoconical portion (12a) towards the free end (2), the second frustoconical portion (12c) forming a second angle (B) relative to the axis (X), the second angle being less than the first angle (a).

2. Kit according to claim 1, wherein the first angle (a) is between 25 degrees and 35 degrees relative to the axis (X).

3. Kit according to claim 1, wherein the first angle (a) is between 10 degrees and 15 degrees relative to the axis (X).

4. Kit according to any one of the preceding claims, in which the second angle (B) is between 4 and 10 degrees relative to the axis (X).

5. Kit according to any one of the preceding claims, wherein: - the first truncated portion (12b) has a first length measured parallel to the axis which is between 2 and 3 millimeters, and / or - the second truncated portion (12c) has a second length measured parallel to the axis which is between 6 millimeters and 8 millimeters.

6. A kit according to any preceding claim, wherein the sleeve (14) has an inner surface (18) in which the internal thread (20) is formed, an outer surface (22) opposite the inner surface (18), and a connecting surface (24) connecting the inner surface (18) to the outer surface (22), the connector (6) further comprising a fluid seal fixed to the connecting surface (24).

7. Kit according to any one of the preceding claims, in which the male connector (6) comprises two elements (26, 28) which can be grasped by a user, formed on the external surface (22) of the sleeve (14).

8. Kit according to the preceding claim, in which the two gripping elements (26, 28) are two fins diametrically opposed with respect to the axis.

9. Kit according to any one of the preceding claims, comprising a device, the device comprising the male connector and being capable of delivering a fluid from the bottle, when the male connector (6) is connected to the female connector.

10. Kit according to the preceding claim, in which the device comprises an injection needle for delivering the fluid, a spray nozzle for delivering the fluid in the form of a spray, or a sterilizing filter for delivering the fluid in the form of drops.

11. Kit according to any one of the preceding claims, comprising an interconnector (1), the interconnector (1) comprising the male connector (6), a second connector (30) and a passage (3) suitable for forming a fluid connection between the bottle and other equipment, when the male connector (6) is connected to the bottle and the second connector (30) is connected to the other equipment.

12. A kit according to any preceding claim, further comprising a syringe comprising a male luer connector adapted to be connected to the female connector, the syringe being adapted to draw fluid from the bottle when the male luer connector is connected to the female connector.

13. A kit according to any preceding claim, wherein the male connector comprises: - an annular connecting part (16) extending radially around the axis (X) to connect the male element to the sleeve, - a seal (17) fixed on the connecting part (16) and arranged between the male part (8) and the sleeve, so that the neck comes into contact with the seal when the male part (8) is inserted into the female connector, the seal being at a distance from the internal thread (20) in a direction parallel to the axis (X).

14. Kit according to any one of the preceding claims, in which the free end of the male part (6) is set back from the sleeve in a direction parallel to the axis (X).

15. Kit according to any one of the preceding claims, in which the bottle (40) is made of low density polyethylene.

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