Kit comprising bottle body and male connector

Abstract

The invention relates to a kit comprising a bottle body and a male fitting (6), the male fitting (6) comprising: a male part (8) adapted to be inserted into a female fitting of the bottle body, 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) adapted to mate with the external thread of the female joint when the male part (6) is inserted into the female joint, the outer surface (12) comprises a first frustoconical portion (12b) forming a first angle (alpha) 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 (beta) with respect to the axis (X), the second angle being smaller than the first angle (alpha).

Description

Technical Field

[0001] This application relates to a kit including a bottle body and a male connector. Background Art

[0002] It is known that "Luer lock" connectors can be used to fluidly connect a first device to a second device. For this purpose, the first device includes a Luer lock female connector and the second device includes a Luer lock male connector. Such connectors are used, for example, in needles or syringes.

[0003] The Luer lock female connector and the Luer lock male connector include threads adapted to engage with each other.

[0004] In addition, the Luer lock female connector and the Luer lock male connector have conical surfaces that contact each other so that when the threads engage with each other, a sealed fluid connection is established between the first device and the second device.

[0005] However, there may be defects in the conical surface and / or external threads of the Luer lock female connector of the first device, which may affect this seal. This defect may occur especially in the case where the first device is a bottle body obtained by a blow-fill-seal process. Summary of the Invention

[0006] The object of the present invention is to improve the sealing of the fluid connection between the male connector and the bottle body equipped with the female connector when the female connector of the bottle body has defects at the threads or in the frustoconical sealing area.

[0007] This object is achieved by the kit defined in claim 1.

[0008] In addition, the kit may have the features defined in the dependent claims, including the following features that can be implemented individually or in combination when technically possible.

[0009] In an 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.

[0010] Preferably, the second angle is between 4 degrees and 10 degrees relative to the axis.

[0011] Preferably:

[0012] - The first frustoconical part has a first length measured parallel to the axis and between 2 mm and 3 mm, and / or

[0013] - The second frustoconical part has a second length measured parallel to the axis and between 6 mm and 8 mm.

[0014] Preferably, the sleeve has an inner surface formed with an internal thread, an outer surface opposite to the inner surface, and a connecting surface connecting the inner surface to the outer surface, and the male connector further includes a fluid seal fixed on the connecting surface.

[0015] Preferably, the male connector includes two elements formed on the outer surface of the sleeve and grippable by a user.

[0016] Preferably, the two grippable elements are two fins that are diametrically opposed with respect to the axis. BRIEF DESCRIPTION OF THE DRAWINGS

[0017] Other features, objects, and advantages of the present invention will become apparent from the following description, which is given by way of illustration only and is not restrictive, and should be read in conjunction with the accompanying drawings, in which:

[0018] Figure 1 is a perspective view of an interconnector according to an embodiment.

[0019] Figure 2 is Figure 1 a side view of the interconnector of

[0020] Figure 3 is Figure 1 a cross-sectional view of the interconnector of

[0021] Figure 4 is a cross-sectional view of a male connector forming part of the interconnector of Figure 1

[0022] Figure 5 is a top view of a bottle body in a closed state according to an embodiment.

[0023] Figure 6 is Figure 5 a side view of the bottle body of

[0024] Figure 7 is Figure 5 a cross-sectional view of the bottle body of

[0025] Figure 8 is a side view of an injection device according to an embodiment.

[0026] Figure 9 is Figure 8 a cross-sectional view of the injection device of

[0027] Figure 10 is a side view of two devices forming an injection kit in a disassembled state according to an embodiment.

[0028] Figure 11 is Figure 10 a side view of the kit in an assembled state of​

[0029] Figure 12 is a perspective view of an interconnector according to another embodiment.

[0030] Figure 13 is Figure 12 a cross-sectional view of the interconnector of

[0031] In all the figures, like elements have the same reference numerals. DETAILED DESCRIPTION

[0032] Figures 1 to 3 Illustrated is an interconnector 1. The function of the interconnector 1 is to fluidly interconnect a first device and a second device, in other words, to establish a fluid connection enabling fluid to be transferred from the first device to the second device. As will be described below, the two devices can be a bottle body and an injection system for delivering the fluid contained in the bottle body, respectively.

[0033] 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 by a dashed line in Figure 2 herein.

[0034] The interconnector 1 defines a through-channel forming such a fluid connection. As Figure 3 shown, the channel has a first inlet opening to the outside of the interconnector 1 at the first free end 2 and a second inlet also opening to the outside of the interconnector at the second free end 4. The channel 3 extends along the axis. The channel is straight.

[0035] The interconnector 1 includes a first fitting 6. The first fitting 6 is a male fitting adapted to be connected to a first device (more precisely, to a luer lock nut fitting of the first device).

[0036] The first fitting 6 includes an annular male member 8 that terminates at the first free end 2 (where the first inlet opens).

[0037] The male member 8 has an inner surface 10 extending around the axis to define a first portion of the above-mentioned channel and, in particular, to define the first inlet. The inner surface is a rotating cylinder around the axis X.

[0038] In addition, the male member 8 has an outer surface 12 opposite to the inner surface 10. The outer surface extends around the inner surface 10.

[0039] Generally, the outer surface 12 tapers towards the first free end 2.

[0040] The outer surface 12 includes a cylindrical portion 12a that rotates about an axis X, a first frustoconical portion 12b that extends the cylindrical portion 12a toward the first free end 2, and a second frustoconical portion 12c that extends the first frustoconical portion 12b toward the first free end 2.

[0041] The cylindrical portion 12a has a length measured parallel to the axis X that is between 1 millimeter and 3 millimeters, for example, 2 millimeters.

[0042] The cylindrical portion 12a has a constant diameter that is between 3 millimeters and 5 millimeters, for example, 4.35 millimeters, with a tolerance of 0.05 millimeters.

[0043] The first frustoconical portion 12b has a length measured parallel to the axis X that is between 2 millimeters and 4 millimeters, for example, 2.5 millimeters.

[0044] As Figure 4 most specifically shown, the first frustoconical portion 12b has an inclined surface that forms a first angle relative to the axis X.

[0045] In an embodiment, the first angle is between 25 degrees and 35 degrees relative to the axis X, for example, 30 degrees. In another embodiment, the first angle is between 10 degrees and 15 degrees relative to the axis X, for example, 12.5 degrees.

[0046] The second frustoconical portion 12c has a length measured parallel to the axis X that is between 6 millimeters and 8 millimeters, for example, 7 millimeters.

[0047] The second frustoconical portion 12c has an inclined surface that forms a second angle relative to the axis X. The second angle is less than the first angle. This means that the taper of the second frustoconical portion 12c is less than the taper of the first frustoconical portion 12b, or more generally, the second frustoconical portion 12c is less inclined relative to the axis X than the first frustoconical portion 12b.

[0048] The second angle is between 4 degrees and 10 degrees relative to the axis X, for example, 7 degrees.

[0049] The outer surface 12 has a minimum diameter at the free end 2 that is between 3 millimeters and 4 millimeters, for example, 3.61 millimeters, with a tolerance of 0.05 millimeters.

[0050] The first joint 6 further includes a sleeve 14 that surrounds the male member 8 and extends at a distance from the male member 8.

[0051] The sleeve 14 is fixed relative to the male member 8. The sleeve 14 is connected to the male member 8 by an annular connecting member 16 that extends radially about the axis X.

[0052] The sleeve 14 has an inner surface 18 facing the outer surface 12 of the male part 8. Thus, the male part 8 and the sleeve 14 define an annular space therebetween, which annular space is adapted to receive a part of the above-mentioned first device (which will be specifically described hereinafter, and this part may be the neck of a bottle).

[0053] The inner surface 18 has a maximum diameter between 7 mm and 9 mm, for example 8 mm, with a tolerance of 0.1 mm.

[0054] The first connector 6 includes an internal thread 20 formed in the inner surface 18. When the male part is inserted into the luer lock nut connector of the first device, the internal thread 20 is adapted to cooperate with the external thread of the luer lock nut connector.

[0055] The internal thread 20 has a pitch of approximately 2 mm.

[0056] The outer surface 22 of the sleeve 14 is rotationally cylindrical.

[0057] The outer surface 22 has a diameter between 9 mm and 11 mm, preferably 10 mm.

[0058] The sleeve 14 also has a connecting surface 24 connecting the inner surface to the outer surface. The connecting surface is annular. Although not shown, a seal (such as an O-ring) can optionally be fixed on the connecting surface 24 to improve the sealing of the connection between the first connector 6 and the luer lock nut connector of the first device.

[0059] The sleeve 14 has a length between 9 mm and 11 mm measured parallel to the axis X, for example 10.1 mm.

[0060] The first connector 6 further includes two gripping elements 26, 28 formed on the outer surface 22 of the sleeve 14 to assist the user in rotating the sleeve 14 about the axis X. The two gripping elements 26, 28 can be seen Figure 1 and Figure 2 therein.

[0061] The two gripping elements 26, 28 form two radially protruding fins on the outer surface 22.

[0062] The two gripping elements 26, 28 are diametrically opposed with respect to the axis X.

[0063] The male part 8 protrudes outside the sleeve 14 in a direction parallel to the axis X. The length of the male part 8 along the axis X is greater than the length of the sleeve 14 measured in the same direction, such that the free end of the male part 8 is further away from the connecting part 16 than the connecting surface 24. In other words, the position of the connecting surface 24 along the axis X is located between the connecting part 16 and the free end of the male part 8.

[0064] The interconnector 1 further includes a second connector 30, which is adapted to be connected to a second device (when the first connector 6 itself is connected to the first device).

[0065] The second connector 30 includes a second male member 32. The male member 32 is annular and terminates at a second free end 4 where the second inlet of the passage 3 is open.

[0066] The second male member 32 has a second inner surface 34 extending around an axis X to define a second part of the passage 3, and in particular, to define the second inlet located at the second free end 4. The second inner surface 34 is a rotationally cylindrical surface around the axis X.

[0067] The second inner surface 34 continuously extends the inner surface 10 of the male member 8 of the first connector 6.

[0068] In addition, the second male member 32 has a second outer surface 36 opposite to the second inner surface 34. The outer surface 36 extends around the inner surface 34.

[0069] The second outer surface 36 tapers towards the second free end 4.

[0070] The second outer surface 36 is frustoconical. The taper of the second outer surface is preferably 6%. In this case, the second connector is a male Luer connector.

[0071] Unlike the first connector 6, the second connector 30 does not have a threaded sleeve.

[0072] The second connector 30 has a length measured parallel to the axis X between 8 mm and 9 mm, for example 8.45 mm, between the connecting member 16 and the second free end 4.

[0073] The interconnector is made as an integral part. Preferably, the interconnector is made of a material such as polyethylene or polypropylene, or any material that can be injection thermoformed and is compatible with medical use.

[0074] Bottle body

[0075] Reference Figures 5 to 7 , the first device that can be connected to the first connector 6 of the interconnector is a bottle body 40.

[0076] The bottle body 40 is obtained by a blow-fill-seal process. In a variant, the bottle body 40 is obtained by other plastic processing techniques (such as injection molding, injection blow molding, or extrusion blow molding).

[0077] The bottle body 40 is an integral part. Compared with a bottle body including a lid (which needs to be sterilized), this feature makes the problem of maintaining sterility of the bottle body less during subsequent use.

[0078] The bottle body 40 is made of a deformable material (preferably an elastomer). Most preferably, the material is low-density polyethylene, which is a material with the particular advantage of being particularly flexible.

[0079] The deformable material particularly allows the user to squeeze the bottle body 40 to expel the fluid it contains.

[0080] The bottle body 40 includes a neck 42. The neck 42 is sealed by a sealing member 44: thus, as Figure 5 shown, the bottle body is in a closed state. The sealing member 44 is adapted to be broken by the user, for example by rotation, and thus separated from the rest of the bottle body 42, thereby forming an opening 46 in the neck 42, which opening 46 provides an entrance from the outside of the bottle body 40 into the inside of the bottle body 40. Then, as Figure 6 shown, the bottle body is in an open state.

[0081] The neck 42 has an inner surface 48 that defines a channel terminating at the opening 46 between the inside and the outside of the bottle body and an outer surface 50 opposite the inner surface.

[0082] The inner surface 48 is frustoconical or cylindrical.

[0083] The bottle body 40 further includes an external thread 52. The external thread 52 is formed on the outer surface 50 of the neck. The external thread 52 is adapted to cooperate with the internal thread 20 of the interconnector 1.

[0084] When the bottle body is in the open state, the inner surface 48 and the external thread 52 form a female connector. In fact, the neck constitutes a female element adapted to receive the male part of a Luer lock male connector or the male part 8 of the male part 6 of the first connector.

[0085] The bottle body can be used to store fluids. The fluids can include vaccines or sterile products that can be delivered in the form of injections, sprays or drops.

[0086] Injecting device with a female connector

[0087] The second device that can be connected to the second connector 30 of the interconnector is a fluid injection device (not shown).

[0088] The injection system includes a hollow needle and a connector adapted to be connected to the second connector 30 of the interconnector 1.

[0089] The hollow needle has a beveled free end. An outlet is formed at this free end through which the fluid can be delivered.

[0090] The injection system defines an internal channel terminating at the said outlet. When the connector of the injection system is connected to the interconnector, this internal channel is in fluid communication with the internal channel of the interconnector.

[0091] The connector of the injection system is a female connector, preferably a female Luer connector. To this end, the female connector has an inner surface that defines the above-mentioned channel and has a taper of approximately 6%.

[0092] Injection kit with an interconnector

[0093] The interconnector 1 can be combined with a first device and a second device to form a kit. In particular, when the first device is the previously described vial 30 and the second device is the previously described injection system with a female connector, the kit can be used as follows.

[0094] Assume that in the closed state of the vial, the vial contains the fluid to be administered, such as a fluid including a vaccine.

[0095] The user breaks the seal member 44 by rotating the seal member 42 of the vial 40 relative to the rest of the vial 40, thereby opening the vial at the neck 44.

[0096] The user connects the vial 40 to the interconnector 1. To this end, the user inserts the male member 8 of the first connector 6 of the interconnector 1 into the neck 42 of the vial 40 such that the first inlet of the channel 3 formed at the free end 2 of the interconnector 1 is open to the vial. During this insertion process, the internal thread 20 of the first connector 6 contacts the external thread formed on the neck of the vial. The user rotates the interconnector 1 about the axis X of the interconnector 1 relative to the vial such that the two threads are engaged by tightening. At a certain stage of tightening, the outer surface 12 of the male member 8 contacts the inner surface of the neck of the vial. There are two portions 12b and 12c with different tapers in the outer surface 12, which can ensure a good seal between the interior of the vial and the internal channel 3 passing through the interconnector 1 even if the vial in the open state has geometric defects.

[0097] Further, the user connects the interconnector 1 to the injection system. To this end, the user inserts the male member 32 of the second connector 30 of the interconnector 1 into the female Luer connector of the injection system.

[0098] The aforementioned two steps can be performed in any order.

[0099] Once these two steps are performed, the user obtains a device that can establish a fluid connection between the interior of the vial and the outlet formed at the end of the injection needle. This fluid connection particularly includes the channel 3 passing through the interconnector 1.

[0100] To expel the fluid initially contained in the vial, the user can squeeze two opposite sides of the vial. The fluid passes through the neck, enters the interconnector 1 through the first inlet located at the first free end 2, passes through the internal channel 3 of the interconnector 1, exits through the second inlet located at the second free end 4, then enters the injection system, and then exits through the opening formed at the end of the needle.

[0101] The interconnector 1 has the advantage of being able to establish a fluid connection between the injection system and the vial without changing the respective structures of these two devices. In particular, the double taper of the first connector 6 ensures that the fluid connection established between these two devices can be well sealed.

[0102] An injection kit without an interconnector

[0103] In the kit described above, the connector 6 with a double taper is included in the interconnector 1 to improve the fluid tightness of the device when the interconnector 1 is connected to the first device (vial 30) and the second device (injection system).

[0104] A connector with a double taper having the same characteristics as the first connector 6 can be included in a device other than the interconnector to obtain such an improvement in fluid tightness.

[0105] In particular, it can be in accordance with Figure 8 and Figure 9 shown in the injection system 60 of the second embodiment, a connector with a double taper having the same characteristics as the first connector 6 is included. The injection system 60 according to this second embodiment is different from the previously described injection system in that its connector is not a female Luer connector, but the previously described connector 6 (in particular including an outer surface 12 with a double taper and an internal thread 20).

[0106] As Figure 9 and Figure 10 shown, the injection system 60 according to this second embodiment can be directly connected to the previously described vial 40 without the need for an interconnector between the two. In other words, the injection system according to this second embodiment and the vial 40 form a second kit that does not require an interconnector. For this purpose, the user inserts the male part 8 of the first connector 6 of the injection system 60 into the neck 42 of the vial 40, so that the first inlet of the channel 3 formed at the free end 2 of the interconnector 1 opens towards the vial. During this insertion process, the internal thread 20 of the connector 6 contacts the external thread 52 formed on the neck 42 of the vial 40. The user rotates the injection system relative to the vial 40 so that the two threads 20, 52 are engaged by tightening. At a certain stage of tightening, the outer surface 12 of the male part 8 contacts the inner surface of the neck of the vial.

[0107] Other kits for fluid delivery

[0108] In the foregoing, two kits were presented, wherein the vial 30 is in fluid communication with an injection device provided with a needle. However, the vial 40 can be combined with other devices for delivering fluid, in particular a spray device. The spray device includes a nozzle that can deliver the fluid from the vial in the form of a nasal spray for delivering a drug or a nasal vaccine. Of course, the spray device can include a connector 6 that can be directly connected to the vial 40, or a female connector that can be connected to the second connector 30 of the interconnector 1.

[0109] Alternatively, the vial 40 can be combined with a device for delivering fluid, which includes a sterilizing filter with a porosity less than or equal to 0.22 microns. This type of filter is suitable for delivering fluid (such as a sterile drug) in the form of drops. The filter can include a connector 6 that can be directly connected to the vial 40, or a female connector that can be connected to the second connector 30 of the interconnector 1. The system obtained using the vial and the device including the filter (and, if necessary, using the interconnector 1) is a multi-dose system that can be used for several days or weeks.

[0110] Other male connector embodiments

[0111] Figure 12 A male connector 6' is shown, which differs from the male connector 6 in the following features (all other conditions being the same).

[0112] The male connector 6' includes a male part 8' that is the same as the male part 8, but the free end of the male part 8' is indented relative to the sleeve 14 in a direction parallel to the axis X. The term "indented" means that the free end of the male part 8' does not protrude from the sleeve. Instead, this free end is located inside the sleeve, at a non-zero distance from the free end of the sleeve 14, which is measured parallel to the axis X.

[0113] Referring to Figure 10 , the male connector 6' includes an annular seal 17 fixed to the connecting part 16. The seal is arranged in the space provided between the male part 8' and the sleeve 14 such that when the male part 8' is inserted into the female connector formed by the neck 42 of the vial, the neck 42 contacts the seal.

[0114] The seal is arranged at a distance from the internal thread 20 in a direction parallel to the axis X. Thus, the external thread 20 does not extend to the connecting part 16, which limits the travel distance of the neck towards the seal. This arrangement can prevent the ovalization of the seal due to excessive squeezing of the seal. When viewed in a direction parallel to the axis X, this ovalization makes the seal elliptical rather than circular. This elliptical shape impairs the sealing performance of the seal.

[0115] The seal of the male connector 6' is optional. This seal can be included in the male connector 6 discussed previously.

[0116] Figure 12 and Figure 13 The male connector shown is part of the interconnector, but can also be part of another type of device connected to the bottle body.

Claims

1. A kit, comprising a bottle body (40) and a male connector (6), Among them, wherein the bottle body (40) is obtained by a blow-fill-seal process and comprises: - a neck (42) including an external thread (52), - a sealing member (44) that seals the neck (42) and is adapted to be broken by a user to expose an opening defined by the neck (42), the opening providing an entrance from the outside of the bottle body (40) into the interior of the bottle body (40), and wherein the male connector (6) comprises: - a male member (8) adapted to be inserted into a female connector after the sealing member (44) is broken, the male member having an outer surface (12) that extends around an axis (X) and tapers towards the free end (2) of the male member (8), - a sleeve (14) that extends around the male member (8) and is spaced apart from the male member (8), the sleeve (14) including an internal thread (20) adapted to cooperate with the external thread when the male member (6) is inserted into the female connector, characterized in that the outer surface (12) comprises a first frustoconical portion (12b) forming a first angle (α) with respect to the axis (X) and a second frustoconical portion (12c) extending towards the free end (2) from the first frustoconical portion (12a), the second frustoconical portion (12c) forming a second angle (β) with respect to the axis (X), the second angle being less than the first angle (α).

2. The kit according to claim 1, wherein The first angle (α) is between 25 degrees and 35 degrees with respect to the axis (X).

3. The kit according to claim 1, wherein, The first angle (α) is between 10 degrees and 15 degrees with respect to the axis (X).

4. The kit according to any one of the preceding claims, wherein, The second angle (β) is between 4 degrees and 10 degrees with respect to the axis (X).

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

6. The kit according to any one of the preceding claims, wherein, The sleeve (14) has an inner surface (18) formed with the internal thread (20), an outer surface (22) opposite to the inner surface (18), and a connecting surface (24) connecting the inner surface (18) to the outer surface (22), and the male connector (6) further comprises a fluid seal fixed to the connecting surface (24).

7. The kit according to any one of the preceding claims, wherein, The male connector (6) comprises two elements (26, 28) formed on the outer surface (22) of the sleeve (14) that can be grasped by a user.

8. The kit according to the preceding claim, wherein, The two graspable elements (26, 28) are two fins that are diametrically opposite with respect to the axis.

9. The kit according to any one of the preceding claims, comprising a device that includes the male connector and is adapted to convey fluid from the bottle body when the male connector (6) is connected to the female connector.

10. The kit according to the previous claim, wherein, The device includes an injection needle, a spray nozzle, or a sterilizing filter. The injection needle is used to deliver fluid, the spray nozzle is used to deliver fluid in the form of a spray, and the sterilizing filter enables the fluid to be delivered in the form of drops.

11. The kit according to any one of the preceding claims, comprising an interconnector (1), the interconnector (1) including the male connector (6), a second connector (30), and a channel (3), the channel (3) being capable of forming a fluid connection between the bottle body and the other device when the male connector (6) is connected to the bottle body and the second connector (30) is connected to the other device.

12. The kit according to any one of the preceding claims, further comprising a syringe, the syringe including a male Luer connector adapted to be connected to the female connector, the syringe being adapted to withdraw fluid from the bottle body when the male Luer connector is connected to the female connector.

13. The kit according to any one of the preceding claims, wherein, The male connector includes: - an annular connecting member (16) that extends radially around the axis (X) to connect the male member to the sleeve, - a seal (17) that is fixed to the connecting member (16) and is disposed between the male member (8) and the sleeve such that when the male member (8) is inserted into the female connector, the neck contacts the seal, and the seal is spaced apart from the internal thread (20) in a direction parallel to the axis (X).

14. The kit according to any one of the preceding claims, wherein, The free end of the male member (6) is recessed relative to the sleeve in a direction parallel to the axis (X).

15. The kit according to any one of the preceding claims, wherein, The bottle body (40) is made of low-density polyethylene.

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