Connector assembly and method for manufacturing the same

Abstract

The connector assembly (10) disclosed herein includes a male portion (20) and a female portion (40). The female portion (40) includes a cylindrical body (42) extending about a central axis (C), a mating portion (44) configured to sealably mate with a medical injection device, and a spike (46). An annular gap (48) is formed between the cylindrical body (42) and the spike (46) for at least partially receiving the male portion (20). The female portion (40) further includes at least two ribs (50) formed on an inner surface of the cylindrical body (42) and projecting radially inward. Each rib (50) has an innermost mating surface (50a) extending linearly parallel to the central axis and configured to releasably mate with a corresponding threaded portion (26) of the male portion (20).

Description

Technical Field

[0001] The present invention relates to a connector assembly including a male part and a female part that fit together. The present invention also relates to a method of manufacturing such a connector assembly.

Background Art

[0002] Various types of connectors for connecting two medical parts to each other are known and available. For example, WO2019 / 219383 pamphlet discloses a connector for connecting a medical syringe to a container by screwing a sleeve of a syringe into the connector at one end and connecting the container to the connector at the other end.

[0003] There is also a luer lock system including a male part and a female part, each of which is provided with a continuous screw part, and the two parts are securely connected by screwing through the screw part.

Summary of the Invention

Problems to be Solved by the Invention

[0004] The male part and the female part of such a luer lock connector can be manufactured by molding. However, due to the screw parts formed on each part, rotational demolding is performed. Also, the presence of such screw parts complicates the structure of the mold and makes the connector expensive. Furthermore, in the rotational demolding process of the mold core, there is a risk of damaging vulnerable parts of the molded part. This is particularly significant when the female part includes spikes, which are sharp hollow protrusions configured to penetrate the septum of the container. The spike includes a lateral opening at its sharp tip to form a fluid connection between the medical syringe attached to the luer lock connector and the container. Due to the presence of the opening, there is a risk that the tip of the spike is damaged (e.g., torn) when rotational demolding is performed.

Means for Solving the Problems

[0005] In view of the shortcomings of the aforementioned connectors, this application discloses a connector assembly as defined in the appended claims.

[0006] Specifically, this specification discloses a connector assembly comprising a male and a female. The male includes a tubular male body extending around a central axis, the male body including at least two threaded portions formed on the outer surface of the male body and spaced circumferentially apart from each other around the central axis. The female includes: a hollow cylindrical body extending around a central axis; a proximal mating portion configured to be sealedly fitted to a medical injection instrument; and a spike extending distally from the proximal mating portion around the central axis, defining an annular gap between the cylindrical body and the spike around the central axis, the annular gap configured to at least partially accommodate the male body of the male. The female further includes at least two ribs formed on the inner surface of the cylindrical body and projecting radially inward, the ribs extending linearly parallel to the central axis, and the ribs having an innermost mating surface configured to be detachably fitted to the corresponding threaded portions of the male. The connector assembly may be configured as a Luer lock connector assembly.

[0007] Because the ribs have a straight shape, the female part can be demolded without rotating the mold component, eliminating the risk of damaging the spikes during demolding.

[0008] Each rib of the female part may have a mating surface that extends inclined with respect to the central axis, increasing the distance between the mating surface and the central axis towards the proximal mating portion. Each threaded portion of the male part may extend inclined with respect to the central axis to mate with the corresponding rib of the female part.

[0009] Each of the ribs on the female part and each of the threaded parts on the male part may extend at an angle of 2 degrees or less with respect to the central axis of the spike.

[0010] The female portion may include three or four ribs arranged at equal intervals around the central axis.

[0011] At least one of the threaded portions may include a turn limit that protrudes radially outward and is configured to prevent further rotation of the male portion relative to the female portion when the threaded portion is fitted into the rib of the female portion.

[0012] At least one of the threaded portions may include a radially inward indentation and be configured to releasably lock the mating between the female and male portions.

[0013] Each of the threaded portions of the male part may include a thin-walled portion and a thick-walled portion, the thick-walled portion being positioned adjacent to the thin-walled portion around the central axis, being thicker than the thin-walled portion, and protruding further radially outward.

[0014] Each rib in the female portion may include a thin portion and a thick portion, the thick portion being positioned adjacent to the thin portion around the central axis, being thicker than the thin portion, and projecting further radially inward.

[0015] The female portion may be configured to be securely connected to a medical injection device having a needle. The spike defines an internal channel configured to accommodate the needle. The female portion further includes a skirt extending distally from the cylindrical body and beyond the tip of the spike.

[0016] A manufacturing method for producing a connector assembly having the above configuration is also disclosed. According to this manufacturing method, the female part is formed by a mold including a first mold part and a second mold part, and the female part is demolded by translating the first part along the central axis relative to the second part. [Effects of the Invention]

[0017] According to the connector assembly disclosed in this specification, the female part does not include a threaded part and includes a straight rib that fits with the threaded part of the male part. Thereby, the necessity of the rotational movement of the mold core for manufacturing the female part during demolding is eliminated. In addition, since the demolding of the female part can be carried out by linearly pulling the mold core along the central axis, the number of cavities per mold can be increased, and the manufacturing cost of the connector assembly can be significantly reduced.

Brief Description of the Drawings

[0018] [Figure 1] It is an exploded perspective view showing a connector assembly including a male part and a female part that are fitted to each other. [Figure 2] It is a side view showing the male part. [Figure 3] It is a bottom view showing the male part. [Figure 4] It is a longitudinal sectional view of the male part along the cutting line IV-IV in FIG. 3. [Figure 5] It is a side view showing the female part. [Figure 6] It is a top view showing the female part. [Figure 7] It is a perspective sectional view showing the female part along the cutting line VII-VII in FIG. 6. [Figure 8] It is a side view showing the connector assembly in a state where the male part and the female part are fitted. [Figure 9A] It is a sectional view along the cutting line IX-IX in FIG. 8, and is a view showing the fitting process of the male part to the female part. [Figure 9B] It is a sectional view along the cutting line IX-IX in FIG. 8, and is a view showing the fitting process of the male part to the female part. [Figure 9C] It is a sectional view along the cutting line IX-IX in FIG. 8, and is a view showing the fitting process of the male part to the female part. [Figure 10] It is a perspective sectional view along the cutting line X-X in FIG. 9C showing the connector assembly in a state where the male part and the female part are fitted.

Embodiments for Carrying Out the Invention

[0019] Hereinafter, embodiments of the present invention will be described in more detail with reference to the accompanying drawings.

[0020] FIG. 1 is an exploded perspective view of a connector assembly 10. The assembly 10 includes a male part 20 and a female part 40, and the male part 20 and the female part 40 are fitted to each other. The male part 20 includes a tubular male part body 24 extending around a central axis C. The male part body 24 is inserted into the female part 40 and is configured to be removably attached to the female part 40, thereby forming a joint.

[0021] The female part 40 includes spikes 46 extending around the central axis C. The spikes 46 define an internal channel that can be configured to accommodate a needle of a medical injection device such as a syringe (not shown). The male part 20 is in the shape of a cap to sealably cover the spikes 46 of the female part 40, and when a medical injection device is attached to the female part 40, it protects the needle of the medical injection device from possible contamination and / or prevents injury by needle stick.

[0022] Referring to FIGS. 2 to 4, the configuration of the male part 20 will be described in more detail. FIG. 2 is a side view showing the male part 20. FIG. 3 is a bottom view of the male part 20 as seen from the tip of the male part body 24, that is, from the proximal end of the male part 20. FIG. 4 is a longitudinal sectional view of the male part along the cutting line IV-IV in FIG. 3. Hereinafter, the expression "proximal" can be used to mean close to a medical injection device attached to the female part 40, and the expression "distal" can be used to mean away from the medical injection device.

[0023] The male part 20 also includes a collar 28 provided at the distal end of the male part body 24 and a tab 22 extending distally from the collar 28. The tab 22 may be a hollow element having an elongated cylindrical shape. The tab 22 is configured to allow the user to firmly hold the male part 20. The collar 28 is generally disc-shaped and connects the tab 22 to the male part body 24. The collar 28 has a diameter larger than the diameter of the male part body 24. The collar 28 may be separated by a tapered rim having a diameter that decreases toward the proximal end of the male part 20. The dimensions and shapes of the collar 28, tab 22, and tapered rim can be adjusted as needed by those skilled in the art.

[0024] The male body 24 defines an internal cavity around the central axis C. The cavity 30 opens at the proximal end of the male body 24 and is configured to accommodate the spike 46 of the female part 40 when the male part 20 is fitted into the female part 40. The cavity 30 is closed at the opposite end, thereby preventing contamination of the spike 46 of the female part 40 and, therefore, the needle (if present) of the medical injection device. This also protects the spike and injection needle during storage and / or transport.

[0025] The male part 20 also includes at least two threaded portions 26 on the outer circumferential surface of the male part body 24. The threaded portions 26 are formed at the tip (i.e., proximal end) of the male part body 24 and are spaced apart from each other in the circumferential direction around the central axis C. The male part 20 may include four threaded portions 26, as shown in the illustrated embodiment. If four threaded portions 26 are formed, they are spaced equally apart from each other, i.e., at 90° (90-degree) intervals around the central axis C. Nevertheless, the male part 20 may include three threaded portions, or five or more threaded portions.

[0026] The threaded portion 26 may be a helical projection extending radially outward from the outer surface of the male body 24. Each threaded portion 26 may have a thin portion 26a and a thick portion 26b around the central axis C, and the thick portion 26b may be positioned adjacent to the thin portion 26a. The thick portion 26b is thicker than the thin portion 26a and therefore protrudes radially outward from the male body 24 more than the thin portion 26a. The thin portion 26a and the thick portion 26b may be smoothly connected so that the thickness gradually increases from the thin portion 26a to the thick portion 26b. Alternatively, the thin portion 26a and the thick portion 26b may be connected to each other so that the thickness increases in steps from the thin portion 26a to the thick portion 26b.

[0027] Optionally, the threaded portion 26 may have a chamfered edge portion 26c adjacent to the thin-walled portion 26a.

[0028] The threaded portion 26 may be made to extend at an inclination with respect to the central axis C, so that at a given position it protrudes more radially outward than at a position closer to the distal end. As will be further explained below, the inclination angle of the threaded portion 26 is determined according to the corresponding draft angle of the female portion 40.

[0029] The threaded portion 26 may be coplanar with the nearest surface of the male body 24. Alternatively, the threaded portion 26 may extend at least beyond the nearest surface of the male body 24.

[0030] Next, the configuration of the female part 40 will be described with reference to Figures 5 to 7. Figure 5 is a side view showing the female part 40. Figure 6 is a top view showing the female part 40, that is, a view from the distal end of the female part 40. Figure 7 is a perspective cross-sectional view of the female part 40 along the cutting line VII-VII in Figure 6.

[0031] The female portion 40 includes a hollow cylindrical body 42 extending around a central axis C, a proximal fitting portion 44 configured to be sealedly fitted to a medical injection device (not shown), and a spike 46 extending distally from the proximal fitting portion 44 around the central axis C.

[0032] The spike 46 defines an inner channel 52, which extends around a central axis C and is configured to accommodate the needle of a medical injection device. The spike 46 also provides a lateral opening 46b at or near its sharp tip 46a. When the medical injection device is connected to a container (not shown), such as a vial, via the scalpel 40, the opening 46b provides fluid communication between the medical injection device and the container.

[0033] The female portion 40 may also include a skirt 54 extending distally from the cylindrical body 42. The skirt 54 extends around the central axis C and includes a ring 55 provided at the distal end of the cylindrical body 42, a rim 56 similarly extending around the central axis C, a plurality of columns 58 connecting the ring 55 and the rim 56, and a plurality of tongues 60 hanging down from the rim 56. The rim 56 surrounds an opening configured to receive the collar 28 of the male portion 20 when the male portion 20 is fitted into the female portion 40. The rim 56 may be located distal to the spike tip 46a. Since the skirt 54 extends beyond the tip 46a, the skirt 54 can protect the spike 46 and, therefore, the needle of the medical injection device. However, in another embodiment, the rim 56 may be located proximal to the spike tip 46a.

[0034] Furthermore, the female portion 40 may include a wave-relieving portion 43 that extends proximal to the ring 55. The wave-relieving portion 43 is configured to provide the user with a firm grip when handling the female portion 40.

[0035] The female part 40 defines an annular gap 48 between the cylindrical body 42 and the spike 46 around the central axis C. The annular gap 48 is configured to accommodate the male body 24 of the male part 20.

[0036] Furthermore, the female portion 40 includes at least two ribs 50 formed on the inner surface of the cylindrical body 42. The ribs 50 project radially inward from the cylindrical body 42. The ribs 50 extend linearly parallel to the central axis C. In other words, the ribs 50 have a non-threaded and non-spiral configuration.

[0037] The rib 50 has an innermost mating surface 50a configured to be detachably fitted into one of the threaded portions 26 of the male portion 20. The mating surface 50a can extend at an angle with respect to the central axis C so that the distance between the mating surface 50a and the central axis C increases toward the proximal mating portion 44 or toward the closed end of the annular gap 48. The angle of the mating surface 50a may be defined by an angle between 0° and 2° with respect to the central axis C. The draft angle of the mating surface 50a of the rib 50 matches the inclination angle of the threaded portion 26 of the male portion 20. In this way, the threaded portion 26 of the male portion 20 can be fitted into the corresponding rib 50 of the female portion 40. The inclination angle of the mating surface 50a does not need to be too steep from the standpoint of mass production. An appropriate angle can be determined by taking into account several factors such as the material properties of the female portion 40, the width and length of the rib 50.

[0038] The following describes the process of fitting the male part 20 into the female part 40.

[0039] As shown in Figure 1, the male part 20 is aligned with the female part 40 with respect to the central axis C. The male part 20 is then moved toward the female part 40 along the central axis C, thereby inserting the male part body 24 into the annular gap 48 of the female part 40 (see Figure 8). The spike 46 of the female part 40 and the corresponding cavity 30 of the male part 20 easily establish central alignment between the two parts.

[0040] As shown in Figures 8 and 9A, once the male body 24 is fully inserted and the collar 28 of the male part 20 is received by the rim 56 of the female part 40, the threaded portion 26 is in a position to engage with the rib 50. The threaded portion 26 may be configured not to contact the end of the annular gap 48 when fully inserted.

[0041] Next, the male part 20 is rotated around the central axis C relative to the female part 40 until the chamfered edge 26c of the threaded part 26 contacts the corresponding rib 50 of the female part 40 (see Figure 9B). The chamfered edge 26c of the threaded part 26 facilitates engagement between the threaded part 26 and the corresponding rib 50.

[0042] The male part 20 is further rotated relative to the female part 40 around the central axis C, so that the thick portion 26b of the threaded portion 26 is fully fitted into the corresponding rib 50 of the female part 40 (see Figures 9C and 10). Since each threaded portion 26 has a thin portion 26a and a thick portion 26b, the threaded portion 26 functions as a wedge. This ensures that the mating between the male part 20 and the female part 40 is highly reliable and can be released when needed.

[0043] When the male part 20 and the female part 40 are mated together, the spike 46 of the female part 40 is completely covered by the male part 20. Therefore, the possibility of contamination via the spike 46 during storage or handling of the connector assembly 10 can be prevented.

[0044] When using a medical injection device, for example, when using the spike 46 to penetrate the partition wall of a vial, the male part 20 is rotated in opposite directions around the central axis C, separating the male part 20 from the female part 40. This exposes the spike 46 of the female part 40.

[0045] The male part 20 and the female part 40 may each be a single part made of plastic (e.g., polypropylene) or any other suitable material. Note that the female part 40 in this disclosure does not include a threaded portion near the spike 46 and includes a linear rib 50. Thus, the rib 50 of the female part 40, like the spike 46, can be manufactured by molding without rotational demolding from the mold core. For example, demolding of the female part 40 can be done by translating the first mold part (i.e., the core) so as to move it away from the second mold part (i.e., the cavity) along the central axis C. Translational demolding is made possible by the configuration disclosed herein and reduces manufacturing costs.

[0046] This is particularly advantageous because the spikes in the female part, which have openings for necessary fluid communication, can be damaged by the rotational movement during demolding.

[0047] By avoiding rotary demolding, a simpler mold can be used to manufacture the female part 40. Furthermore, a simpler mold design increases the number of cavities that can be used in the same molding process, contributing to reduced manufacturing costs. It also allows for a shorter molding cycle time.

[0048] Compared to known friction fittings between male and female parts, the engagement between the linear rib 50 and the threaded portion 26 in this embodiment provides a secure lock between the two parts. This prevents, for example, the male part 20 from accidentally slipping out of the female part 40 during storage and / or transport.

[0049] Furthermore, according to this embodiment, the male part 20 can be easily separated from the female part 40 by rotating the male part 20 around the central axis C (for example, 45 degrees or less) and then pulling it away from the female part 40. This ensures a smoother process and better usability compared to known friction fittings, which require a tensile force strong enough to overcome the friction between the male and female parts.

[0050] In one embodiment, at least one of the threaded portions 26 may include a rotation limiter to prevent the male portion 20 from rotating further from the fully engaged position. For example, the rotation limiter protrudes radially outward from the thick portion 26b of the threaded portion 26.

[0051] In another embodiment, at least one of the threaded portions 26 may be provided with a radially inward indentation. By the indentation of the threaded portion 26 engaging the corresponding rib 50 of the female portion 40, the user can receive tactile feedback from the male portion 20 when the threaded portion 26 reaches the mating position in which the male portion 20 fully engages with the female portion 40. The indentation can also provide a locking function, thereby allowing the male portion 20 to be easily removed from the female portion 40 when needed, while simultaneously preventing the male portion 20 from unintentionally detaching from the female portion 40 during handling, storage, or transport.

[0052] In yet another embodiment, instead of the threaded portion 26 having a thin portion 26a and a thick portion 26b, each rib 50 may have a thin portion and a thick portion. The thick portion of the rib 50 is configured to protrude more radially inward than the thin portion, thereby acting as a wedge to reinforce the fitting between the male portion 20 and the female portion 40.

[0053] The present invention is not limited to the embodiments described above. The technical concepts disclosed herein are applicable to other types of connector assemblies and offer similar advantages as described above. In one embodiment, the connector assembly may be configured as a Luer lock connector assembly.

Claims

1. A connector assembly (10) including a male part (20) and a female part (40), The male part (20) includes a tubular male part body (24) extending around the central axis (C), and the male part body includes at least two threaded parts (26) formed on the outer surface of the tubular male part body (24) and arranged circumferentially apart from each other around the central axis (C). The female part (40) is: A hollow cylindrical body (42) extending around a central axis (C); A proximal fitting portion (44) configured to fit securely into a medical injection device; A spike (46) extends distally from the proximal fitting portion (44) around the central axis (C), wherein the spike (46) defines an annular gap (48) around the central axis (C) between the cylindrical body (42) and the spike (46), and the annular gap (48) is configured to at least partially accommodate the male body (24) of the male portion (20), and Includes, The female portion (40) is formed on the inner surface of the cylindrical body (42) and further includes at least two ribs (50) projecting radially inward, the ribs (50) extending linearly parallel to the central axis, and the ribs (50) have an innermost fitting surface (50a) configured to be detachably fitted onto the corresponding threaded portion (26) of the male portion (20). A connector assembly (10) characterized by the following:

2. The assembly (10) according to claim 1, characterized in that each of the ribs (50) of the female portion (40) has a fitting surface (50a) that extends inclined with respect to the central axis (C), the distance between the fitting surface (50a) and the central axis (C) increases toward the proximal fitting portion (44), and each of the threaded portions (26) of the male portion (20) extends inclined with respect to the central axis (C) and fits into the corresponding rib (50) of the female portion (40).

3. The assembly (10) according to claim 2, characterized in that each rib (50) of the female part (40) and each threaded part (26) of the male part (20) extends at an angle of 2 degrees or less with respect to the central axis (C) of the spike (46).

4. The assembly (10) according to any one of claims 1 to 3, characterized in that the female portion (40) includes three or four ribs (50) arranged at equal intervals around a central axis (C).

5. The assembly (10) according to any one of claims 1 to 4, characterized in that at least one of the threaded portions (26) includes a rotation limiting portion, the rotation limiting portion protruding radially outward and configured to prevent further rotation of the male portion (20) relative to the female portion (40) when the threaded portion (26) is fitted into the rib (50) of the female portion (40).

6. The assembly (10) according to any one of claims 1 to 5, characterized in that at least one of the threaded portions (26) includes a radially inward recessed notch and is configured to releasably lock the mating between the female portion (40) and the male portion (20).

7. The assembly (10) according to any one of claims 1 to 6, characterized in that each threaded portion (26) of the male portion (20) includes a thin portion (26a) and a thick portion (26b) around the central axis (C), the thick portion (26b) is positioned adjacent to the thin portion (26a) and protrudes radially outward from the thin portion (26a).

8. The assembly (10) according to any one of claims 1 to 6, characterized in that each of the ribs (50) of the female portion (40) includes a thin portion and a thick portion around a central axis (C), the thick portion being positioned adjacent to the thin portion and projecting radially inward from the thin portion.

9. The female portion (40) is configured to be sealably connected to a medical injection device having a needle, the spike (46) defines an inner channel (52) configured to accommodate the needle, and the female portion (40) further includes a skirt (54) extending distally from the cylindrical body (42) beyond the tip (46a) of the spike (46), characterized in that the assembly (10) according to any one of claims 1 to 8.

10. A manufacturing method for producing an assembly (10) according to any one of claims 1 to 9, wherein the female portion (40) is formed by a mold including a first mold component and a second mold component, and the female portion (40) is demolded by translating the first mold component relative to the second mold component along a central axis (C).

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