Male connector suitable for connection to a female luer-lock connector

FR3139724B1Active Publication Date: 2025-07-04UNITHER PHARMA INC
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Patent Information

Application Number
FR2022009377
Authority / Receiving Office
FR · FR
Patent Type
Patents
Current Assignee / Owner
Filing Date
2022-09-16
Publication Date
2025-07-04
Estimated Expiration
2042-09-16

AI Technical Summary

Technical Problem

Existing luer-lock connectors suffer from imperfections in their threads and frustoconical sealing zones, leading to potential leaks and compromised fluid tightness, particularly in equipment manufactured through blow-fill-seal processes.

Method used

A male connector with a dual-taper design, featuring a first frustoconical portion with a steeper angle and a second less steep frustoconical portion, combined with a sleeve having an internal thread, ensures a secure fit and improved sealing by engaging with a female luer-lock connector.

Benefits of technology

The dual-taper design enhances the fluid tightness between equipment by maintaining a stable and sealed connection despite manufacturing imperfections, ensuring reliable fluid transfer without requiring modifications to existing equipment structures.

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Abstract

Male connector (6) comprising: a male part (8) suitable for being inserted into a female luer-lock connector, 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 away from the male part (8), the sleeve (14) comprising an internal thread (20) adapted to cooperate with an external thread of the female luer-lock connector when the male part (6) is inserted into the female luer-lock connector, the external surface (12) comprising a first frustoconical portion (12b) forming a first angle (α) 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 (β) relative to the axis (X), the second angle being less than the first angle (α). Figure for abstract: figure 4
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Description

Description Title of the invention: Male fitting suitable for connection to a female luer-lock fitting FIELD OF INVENTION

[0001] This disclosure relates to a male luer-lock fitting, an interconnector including this fitting and a kit including the interconnector. STATE OF THE ART

[0002] = It is known to use "luer-lock" fittings to fluidly connect a first equipment and second equipment. For this, the first equipment includes a female Luer-lock fitting, and the second piece of equipment includes a Male Luer-lock fitting. Such fittings are used, for example, in devices with needles or syringes.

[0003] The female luer-lock fitting and the male luer-lock fitting include threads adapted to be put into contact with each other.

[0004] Furthermore, the female Luer-lock fitting and the male Luer-lock fitting have conical surfaces coming into contact with each other to establish a fluidic bond watertight between the first piece of equipment and the second piece of equipment, when the threads are locked in a struggle with each other.

[0005] — The conical surface and / or the external thread of the female luer-lock fitting of the first However, equipment may have imperfections that result in com- promise this watertightness. Such imperfections can appear, in particular, in the case where the first piece of equipment is a bottle obtained by a forming process- blow-fill-seal. Description of the invention

[0006] One object of the present invention is to improve the sealing of a fluidic connection between a first piece of equipment fitted with a female Luer fitting and a second equipment, when the female Luer fitting of the first piece of equipment has imper- defects at the level of the threads or the frustoconical sealing zone

[0007] — This purpose is achieved by a male fitting comprising: - a male part suitable for insertion into a female luer-lock fitting, the part male exhibiting an external surface extending around an axis and narrowing towards a free end of the male part, - a sleeve extending around and at a distance from the male part, the sleeve including an internal thread suitable for cooperating with an external thread of the fitting female luer-lock fitting when the male part is inserted into the female luer-lock fitting, in which the external surface comprises a first frustoconical portion forming a first angle with respect to the axis, and a second truncated conical portion extending the first truncated conical portion towards the free end, the second truncated conical portion forming a second angle with respect to the axis, the second angle being less than the first angle. The fitting, which constitutes a first aspect of this disclosure, may also have the following characteristics, taken alone or in combination where technically possible. In one embodiment, the first angle is between 25 degrees and 35 degrees with respect to the axis. In another embodiment, the first angle is between 10 degrees and 15 degrees with respect to the axis. Preferably, the second angle is between 4 and 10 degrees relative to the axis. Preferably: - the first frustoconical portion has an initial length measured parallel to the axis which is between 2 and 3 millimeters, and / or - the second truncated cone portion has a second length measured parallel to the axis which is between 6 millimeters and 8 millimeters. Preferably, the sleeve has an internal surface in which the internal thread is formed, an external surface opposite the internal surface, and a connecting surface linking the internal surface to the external surface, the fitting further comprising a fluidic seal fixed on the connecting surface. Preferably, the fitting comprises two user-grippable elements formed on the external surface of the sleeve. Preferably, the two graspable elements are two fins diametrically opposed with respect to the axis. It is also proposed, according to a second aspect, a device comprising a male fitting according to the first aspect, and a device suitable for delivering a fluid from a piece of equipment, when the male fitting is connected to the equipment. It is also proposed, according to a third aspect, a kit including a device according to the second aspect, and a bottle including a female fitting suitable for connection to the male fitting. The bottle is preferably obtained by a form-fill-seal process, an injection process, an injection-blowing process or an extrusion-blowing process. A fourth aspect also proposes an interconnector comprising: - an initial connection according to the first aspect, - a second connection, - a passage suitable for forming a fluidic connection between a first piece of equipment and a second piece of equipment, when the first fitting is connected to a first equipment and that the second connection is connected to a second piece of equipment. It is also proposed, according to a fifth aspect, a kit including an inter-connector according to the fourth aspect, and a bottle including a female fitting suitable for connection to the first fitting. The kit according to the fifth aspect may also include a device comprising a fitting suitable for connection to the second fitting, the device being suitable for delivering fluid from the bottle when the first fitting is connected to the female fitting of the bottle and the second fitting is connected to the device. Preferably, the device of the kit according to the fifth aspect includes an injection needle for delivering the fluid, a spray nozzle for delivering the fluid as a spray, or a sterilizing filter for delivering the fluid as drops. DESCRIPTION OF THE FIGURES Other features, purposes and advantages of the invention will become apparent from the following description, which is purely illustrative and not limiting, and which should be read in conjunction with the accompanying drawings. Fig. 1 is a perspective view of an interconnector according to one embodiment. [Fig.2] is a side view of the interconnector of [Fig.1]. [Fig.3] is a cross-sectional view of the interconnector of [Fig.1]. Fig. 4 is a cross-sectional view of a male fitting forming part of the interconnector in Fig. 1. Figure 5 is a top view of a bottle according to one embodiment, in a closed state. [Fig.6] is a side view of the bottle from [Fig.5], in an open state. Fig. 7 is a cross-sectional view of the bottle from Fig. 5. Fig. 8 is a side view of an injection device according to one embodiment. Fig. 9 is a cross-sectional view of the injection device of Fig. 8. Fig. 10 is a side view of two pieces of equipment forming an injection kit according to one embodiment in a disassembled state. [Fig.11] is a side view of the kit of [Fig.10] in an assembled state. Throughout the figures, similar elements bear identical references. DETAILED DESCRIPTION OF IMPLEMENTATION METHODS Figures 1 to 3 show an interconnector 1. The function of interconnector 1 is to fluidly interconnect a first piece of equipment and a second Equipment, that is, establishing a fluidic link 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 to deliver a fluid contained in the bottle. The interconnector 1 extends along an X axis from a first free end 2 to a second free end 4 opposite the first free end 2. The X axis is represented on [Fig.2] by a dashed line. Interconnector 1 defines a through passage forming such a fluidic link. This passage, visible in [Fig. 3], has a first opening leading outside interconnector 1 at the first free end 2, and a second opening also leading outside the interconnector, at the second free end 4. The passage 3 extends along the axis. The passage is straight. The interconnector | includes a first fitting 6. The first fitting 6 is a male fitting suitable for connection to the first piece of equipment, more specifically to a female luer-lock fitting of the first piece of equipment. The first fitting 6 includes a male annular part 8 ending with the first free end 2 where the first access opens. 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 point. The internal surface is cylindrical in revolution around the axis X. The male part 8 further has an external surface 12 opposite the internal surface 10. The external surface extends around the internal surface 10. In general, the external surface 12 narrows towards the first free end 3. The external surface 12 comprises a cylindrical portion 12a of revolution about 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 portion 12b towards the first free end 2. The cylindrical portion 12a has a length, measured parallel to the X axis, of between 1 and 3 millimeters, for example 2 millimeters. The cylindrical portion 12a has a constant diameter between 3 and 5 millimeters, for example 4.35 millimeters with a tolerance of 0.05 millimeters. The first truncated cone portion 12b has a length, measured parallel to the X axis, of between 2 and 4 millimeters, for example 2.5 millimeters. The first truncated conical portion 12b has a slope forming a first angle with respect to the X axis, as can be seen particularly in [Fig.4]. In one embodiment, the first angle is between 25 degrees and 35 degrees with respect to the X-axis, for example 30 degrees. In another embodiment- lisation, the first angle is between 10 degrees and 15 degrees with respect to the X axis, for example 12.5 degrees. The second truncated cone portion 12c has a length, measured parallel to the X axis, of between 6 and 8 millimeters, for example 7 millimeters. The second frustoconical segment l2c has a slope forming a second angle with respect to the X-axis. The second angle is smaller than the first angle. This is equivalent to saying that the second frustoconical segment 12c has a lower taper than the first frustoconical segment 12b, or more colloquially, that the second frustoconical segment 12c is less steep than the first frustoconical segment 12b, with respect to the X-axis. The second angle is between 4 and 10 degrees relative to the X axis, for example 7 degrees. 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. The first fitting 6 also includes a sleeve 14 extending around and at a distance from the male part 8. 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 X axis. The sleeve 14 has an internal surface 18 opposite the external surface 12 of the male part 8. Thus, the male part 8 and the sleeve 14 delimit between themselves an annular space suitable for receiving a part of the first equipment mentioned above (we will see later precisely that this part can be the neck of a bottle). The internal surface 18 has a maximum diameter between 7 and 9 millimeters, for example 8 millimeters with a tolerance of 0.1 millimeters. The first fitting 6 includes an internal thread 20 which is formed in the internal surface 18. The internal thread 20 is suitable for cooperating with the external thread of a female luer-lock fitting of the first equipment, when the male part is inserted into such a female luer-lock fitting. The internal thread 20 has a pitch of approximately 2 millimeters. The external surface 22 of the sleeve 14 is cylindrical of revolution. The external surface 22 has a diameter between 9 and 11 millimeters, preferably 10 millimeters. The sleeve 14 also has a connecting surface 24 linking the inner surface to the outer surface. The connecting surface is annular. Although not shown, a sealing gasket, for example an O-ring, can optionally be fixed to this connecting surface 24 to improve the sealing of the connection between the first fitting 6 and a female luer-lock fitting of the first piece of equipment. Sleeve 14 has a length, measured parallel to the X axis, of between 9 and 11 millimeters, for example 10.1 millimeters. The first fitting 6 further includes two gripping elements 26, 28 formed on the external surface 22 of the sleeve 14, to help a user rotate the sleeve 14 around the X axis. The two gripping elements 26, 28 are visible in figures 1 and 2. The two gripping elements 26, 28 form two fins that project radially on the external surface 22. The two gripping elements 26, 28 are diametrically opposed with respect to the X axis. The interconnector 1 also includes a second fitting 30 suitable for being connected to a second piece of equipment (when the first fitting 6 is itself connected to the first piece of equipment). The second fitting 30 includes a second male part 32. The male part 32 is annular and terminates at the second free end 4 where the second access of the passage 3 opens. 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 to delimit in particular 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. The second internal surface 34 continuously extends the internal surface 10 of the male part 8 of the first fitting 6. 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. The second external surface 36 narrows towards the second free end 4. The second external surface 36 is frustoconical. Preferably, the taper of the second external surface is 6%. In this case, the second fitting is a male Luer fitting. The second fitting 30 is without a threaded sleeve, unlike the first fitting 6. The second fitting 30 has a length, measured parallel to the X axis between the connecting part 16 and the second free end 4, of between 8 and 9 millimeters, for example 8.45 millimeters. The interconnector is made from a single piece. Preferably, the interconnector is made of a material such as polyethylene, polypropylene, or any thermoformable injection-molded material compatible with medical use. Bottle With reference to figures 5 to 7, a first piece of equipment that can be connected to the first fitting 6 of the interconnector is a bottle 40. The 40 bottle is produced using a blow-fill-seal process. Alternatively, the 40 bottle can be produced using other plastics processing techniques, such as injection molding, injection blow molding, or extrusion blow molding. Bottle 40 is made of a deformable material, preferably an elastomer. The deformable material allows, in particular, a user to squeeze the bottle 40 to expel the fluid it contains. The bottle 40 includes a neck 42. The neck 42 is sealed by a sealing portion 44: the bottle is therefore in a closed state, visible in [Fig. 5]. The sealing portion 44 is adapted so that it can be broken by a user, for example by a rotational movement, and thus detached from the rest of the bottle 42 to form an opening 46 at the neck 42, giving access to the inside of the bottle 40 from the outside of the bottle 40. The bottle is then in an open state, as shown in [Fig. 6]. The neck 42 has an internal surface 48 delimiting a passage between the inside and outside of the bottle ending with the opening 46, and an external surface 50 opposite to the internal surface. The internal surface 48 is frustoconical or cylindrical. The bottle 40 further includes an external thread 52. The external thread 52 is formed in the external surface 50 of the neck. The external thread 52 is designed to cooperate with the internal thread 20 of the interconnector 1. The internal surface 48 and the external thread 52 form a female connection when the bottle is open. In fact, the neck constitutes a female element designed to receive a male part of a male Luer-lock fitting or the male part 8 of the first fitting 6. The vial can be used to store a fluid. The fluid may include a vaccine or a sterile product that can be delivered by injection, nebulization, or drops. Injection device with female fitting A second piece of equipment that can be connected to the second fitting 30 of the interconnector is a fluid injection device (not shown). The injection system includes a hollow needle and a fitting to be connected to the second fitting 30 of the interconnector |. The hollow needle has a beveled free end. An exit is formed at this free end, through which a fluid can be delivered. The injection system defines an internal passage ending at the outlet. This internal passage is brought into fluidic communication with the internal passage of the interconnector when the injection system fitting is connected to the interconnector. The injection system fitting is a female fitting, preferably a female Luer fitting. For this purpose, the female fitting has an internal surface defining the aforementioned passage, and exhibiting a taper of approximately 6%. Injection kit with interconnector Interconnector 1 can be combined with a first piece of equipment and a second piece of equipment to form a kit. In particular, this kit can be used as follows when the first piece of equipment is the vial 30 described previously, and the second piece of equipment is the injection system with female fitting described previously. It is assumed that the bottle in its closed state contains a fluid to be administered, for example a fluid including a vaccine. A user breaks the sealing part 42 of the bottle 40 by rotating it relative to the rest of the bottle 40, thus opening the bottle at the neck 44. The user connects the bottle 40 to the interconnector 1. To do this, the user inserts the male part 8 of the first fitting 6 of the interconnector 1 into the neck 42 of the bottle 40, so that the first access point 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 fitting 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 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.The presence of the two portions 12b and 12c in the external surface 12, having different conicities, ensures a good seal between the inside of the bottle and the internal passage 3 which passes through the interconnector |, even if the bottle in its open state has geometric imperfections. The user connects the interconnector 1 to the injection system at a different location. To do this, the user inserts the male part 32 of the second fitting 30 of the interconnector 1 into the female Luer fitting of the injection system. The two preceding steps can be carried out in any order. Once these two steps are completed, the user obtains a device in which a fluidic link is established between the inside of the vial and the outlet formed at the tip of the injection needle, this fluidic link including in particular passage 3 passing through the interconnector |. To expel the fluid initially contained in the bottle, the user can squeeze 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. The interconnector 1 has the advantage of allowing a fluid connection to be established between the injection system and the bottle without requiring any modification to the respective structures of these two pieces of equipment. In particular, the double taper of the first fitting 6 ensures that the fluid connection established between these two pieces of equipment is completely leak-proof. Injection kit without interconnector In the kit as described above, a double taper 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 piece of equipment (bottle 30) and to the second piece of equipment (injection system). However, it is possible to incorporate a double-tapered fitting with the same characteristics as the first fitting 6 in equipment other than an interconnector to obtain this improvement in fluid sealing. In particular, it is possible to include a double-tapered fitting having the same characteristics as the first fitting 6 in an injection system 60 according to a second embodiment shown in figures 8 and 9. The injection system 60 according to this second embodiment differs from the injection system as described above in that its fitting is not a female luer fitting, but the fitting 6 as described above (including in particular the external surface 12 with double taper 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 Figures 9 and 10. In other words, the injection system according to this second embodiment forms a second kit with the bottle 40 that does not require an interconnector. To do this, the user inserts the male part 8 of the first fitting 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 fitting 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 and 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. Other kits for delivering a fluid In the preceding section, two kits were proposed in which the vial 30 is connected via fluidic communication to injection devices equipped with a needle. However, the vial 40 can be combined with other devices for delivering a fluid, in particular a spray device. The spray device includes a spray nozzle for delivering fluid from the vial as a nasal spray for the administration of a nasal medication or vaccine. The spray device can, of course, include the fitting 6, which connects directly to the vial 40, or a female fitting that connects to the second fitting 30 of the interconnector 1. Alternatively, the bottle 40 can be combined with a device for dispensing a fluid that includes a sterilizing filter with a porosity of 0.22 microns or less. This type of filter is suitable for dispensing fluid in droplet form, such as a sterile medication. The filter may include a fitting 6 that connects directly to the bottle 40, or a female fitting that connects to the second fitting 30 of the interconnector 1. The system obtained from the bottle and the device including the filter (and, where applicable, from the interconnector 1) is a multi-dose system that can be used for several days or several weeks.

Claims

Claims

1. Male connector (6) comprising: - a male part (8) suitable for insertion into a luer-lock connector female, 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 away from the male part (8), the sleeve (14) comprising an internal thread (20) specific to cooperate with an external thread of the female luer-lock fitting when the male part (6) is inserted into the female luer-lock fitting, characterized in that the external surface (12) comprises a first truncated portion (12b) forming a first angle (a) relative to the axis (X), and a second truncated portion (12c) extending the first truncated portion (12a) towards the free end (2), the second truncated portion (12c) forming a second angle (B) by relative to the (X) axis, the second angle being less than the first angle (has).

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

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

4. A male connector according to any one of the preceding claims, in which the second angle (f) is between 4 and 10 degrees per relative to the (X) axis.

5. A male connector according to any preceding claim, in which: - 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 male connector (6) according to any one of the preceding claims preceding, wherein the sleeve (14) has an internal surface (18) in which the internal thread (20) is formed, an external 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) comprising furthermore a fluid seal fixed on the connecting surface (24).

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

8. Male connector (6) according to the preceding claim, in which the two gripping elements (28, 30) are two diametrically opposed fins opposite relative to the axis.

9. Device comprising: - a male connector (6) according to one of claims 1 to 8, and - a device capable of delivering a fluid from a equipment, when the male connector (6) is connected to the equipment.

10. Kit comprising: - a device according to the preceding claim, - a bottle comprising a female connector suitable for connection to the male connector (6).

11. Kit according to the preceding claim, in which the bottle is obtained by a form-fill-seal process, a process injection, an injection-blow molding process or a process extrusion blow molding.

12. Interconnector (1) comprising: - a first connection (6) according to any one of claims 1 to 8, - a second connection (30), - a passage (3) suitable for forming a fluid connection between a first equipment and a second equipment, when the first connection (6) is connected to a first piece of equipment and that the second connection (30) is connected to a second device.

13. Kit comprising: - an interconnector (1) according to the preceding claim, - a bottle comprising a female connector suitable for connection to the first connection (6).

14. Kit according to the preceding claim, further comprising: - a device comprising a connector suitable for being connected to the second connection (30), the device being capable of delivering a fluid in origin of the bottle when the first fitting is connected to the fitting female of the bottle and that the second connector is connected to the device.

15. Kit according to the preceding claim, in the device comprises a injection needle to deliver the fluid, a spray nozzle to deliver the fluid as a spray, or a sterilizing filter to deliver the fluid as drops.