Connector assembly and method of manufacturing the same

Abstract

The connector assembly (10) disclosed herein includes a male component (20) and a female component (40). The female component (40) includes a cylindrical body (42) extending about a central axis (C), a mating portion (44) configured to sealingly mate to a medical injection device, and a lancet (46). An annular gap (48) is formed between the cylindrical body (42) and the lancet (46) to at least partially accommodate the male component (20). The female component (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) extends straight in parallel to the central axis and has an innermost mating surface (50a) configured to detachably mate to a corresponding threaded portion (26) of the male component (20).

Description

Technical Field

[0001] This invention relates to a connector assembly comprising a convex member and a concave member that mate with each other. The invention also relates to a method for manufacturing such a connector assembly. Background Technology

[0002] Various types of connectors for connecting two medical components to each other are known and available. For example, WO2019 / 219383 discloses a connector for connecting a medical injection device to a container by screwing the sleeve of the injection device onto one end of the connector and connecting the container to the other end of the connector.

[0003] There is also a Luer lock system comprising a convex component and a concave component, the convex component and the concave component respectively having continuous threaded portions, so as to securely connect the two components by screwing through the threaded portions.

[0004] The convex and concave components of this Luer lock connector can be produced by molding. However, rotational demolding is required because threaded portions are formed on each component. Furthermore, these threaded portions complicate the mold structure and thus increase the connector's cost. Additionally, vulnerable parts of the molded component may be damaged during demolding, which involves the rotational movement of the mold core. This is particularly true when the concave component includes a needle, a pointed, hollow protrusion configured to pierce the diaphragm of a container. The needle includes a lateral opening at its tip to create a fluid connection between the medical injection device and the container attached to the Luer lock connector. Due to the presence of this opening, the tip of the needle may be damaged (e.g., torn) during rotational demolding. Summary of the Invention

[0005] In view of the disadvantages of the above-mentioned connectors, this application discloses a connector assembly as defined in the appended claims.

[0006] Specifically, this document discloses a connector assembly comprising a convex component and a concave component, wherein the convex component includes a tubular convex body extending about a central axis, the convex body including at least two threaded portions formed on the outer surface of the convex body and circumferentially spaced apart from each other about the central axis, and wherein the concave component includes: a hollow cylindrical body extending about the central axis; a proximal mating portion configured to sealably fit into a medical injection device; and a needle extending distally about the central axis from the proximal mating portion and defining an annular gap between the cylindrical body and the needle about the central axis, the annular gap being configured to at least partially receive the convex body of the convex component, and wherein the concave component further includes at least two ribs formed on the inner surface of the cylindrical body and projecting radially inward, the ribs extending straight parallel to the central axis, the ribs having an innermost mating surface configured to detachably fit into the corresponding threaded portion of the convex component. The connector assembly may be configured as a Luer lock connector assembly.

[0007] Because of the straight shape of the ribs, the concave part can be demolded without any rotation of the mold part, thus eliminating the risk of damaging the needle during demolding.

[0008] Each rib of the concave component may have a mating surface that extends obliquely relative to the central axis, such that the distance between the mating surface and the central axis increases towards the proximal mating portion. Each threaded portion of the convex component may extend obliquely relative to the central axis to mate with the corresponding rib of the concave component.

[0009] Each of the ribs in the concave component and each of the threaded portions in the convex component can extend at an angle of 2 degrees or less relative to the central axis of the needle.

[0010] The concave component may include three or four ribs that are equidistant from the central axis.

[0011] At least one of the threaded portions may include a rotation limiting portion that projects radially outward and is configured to prevent further rotation of the convex portion relative to the concave portion when the threaded portion engages with the rib of the concave portion.

[0012] At least one of the threaded portions may include a notch that is radially recessed and configured to releasably lock the engagement between the concave and convex components.

[0013] Each of the threaded portions of the convex component may include a thinner portion and a thicker portion, the thicker portion being arranged adjacent to the thinner portion around a central axis and being thicker than the thinner portion so that the thinner portion protrudes radially outward further.

[0014] Each of the ribs in the concave component may include a thinner portion and a thicker portion, the thicker portion being arranged adjacent to the thinner portion around a central axis and being thicker than the thinner portion so that the thinner portion protrudes radially inward further.

[0015] The concave component can be configured to be hermetically connected to a medical injection device having a needle, the needle defining an internal channel configured to receive the needle, and the concave component also includes a skirt extending distally from the columnar body and beyond the tip of the needle.

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

[0017] According to the connector assembly disclosed herein, the concave part does not include a threaded portion, but includes straight ribs that mate with the threaded portion of the convex part. This eliminates the need for core rotation during demolding to produce the concave part. Since the concave part can be easily demolded by a straight pulling motion of the 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. Attached Figure Description

[0018] The embodiments of the present invention will now be described in further detail with reference to the accompanying drawings, in which:

[0019] Figure 1 This is an exploded perspective view showing a connector assembly including a convex part and a concave part to be mated together;

[0020] Figure 2 This is a side view showing the convex component;

[0021] Figure 3 This is a bottom view showing the convex component;

[0022] Figure 4 It is along Figure 3 The longitudinal sectional view of the convex component is shown by line IV-IV;

[0023] Figure 5 This is a side view showing the concave component;

[0024] Figure 6 This is a top view showing the concave component;

[0025] Figure 7 It is along Figure 6 The perspective sectional view of the concave component is shown by line VII-VII;

[0026] Figure 8 This is a side view showing the connector assembly in a mating state between the convex and concave parts;

[0027] Figures 9A to 9C It is along Figure 8 The sectional view taken by line IX-IX shows the fitting process of the convex component onto the concave component;

[0028] Figure 10 It is along Figure 9C The perspective sectional view taken by line XX shows the connector assembly in a state where the convex and concave parts are mated together. Detailed Implementation

[0029] Figure 1 This is an exploded perspective view of connector assembly 10. Assembly 10 includes a convex member 20 and a concave member 40 to be mated together. The convex member 20 includes a tubular convex body 24 extending about a central axis C. The convex body 24 is configured to insert into and detachably attach to the concave member 40, thereby forming a mating.

[0030] The concave component 40 includes a needle 46 extending about a central axis C. The needle 46 defines an internal channel that can be configured to receive the needle of a medical injection device, such as a syringe (not shown). The convex component 20 is in the form of a cap to sealably cover the needle 46 of the concave component 40, thereby protecting the needle of the medical injection device from potential contamination and / or preventing needlestick injuries when the medical injection device is attached to the concave component 40.

[0031] Reference Figures 2 to 4 The configuration of the convex component 20 is described in more detail. Figure 2 This is a side view showing the convex component 20. Figure 3 This is a bottom view of the convex member 20 as seen from the end of the convex body 24 (i.e., from the proximal end of the convex member 20). Figure 4 It is along Figure 3 The longitudinal sectional view of the convex component is shown by line IV-IV. In the following text, the term "proximal" may be used to refer to the medical injection device that is close to the concave component 40, while the term "distal" may be used to refer to the side that is far from the medical injection device.

[0032] The convex component 20 also includes a collar 28 disposed at the distal end of the convex 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 a user to securely hold the convex component 20. The collar 28 is generally disc-shaped and connects the tab 22 and the convex body 24 to each other. The collar 28 has a diameter larger than that of the convex body 24. The collar 28 may be defined by a tapered edge having a diameter that decreases toward the proximal end of the convex component 20. The size and shape of the collar 28, the tab 22, and the tapered edge can be adjusted according to the needs of those skilled in the art.

[0033] A convex body 24 defines an inner cavity 30 around a central axis C. The inner cavity 30 opens at a proximal end of the convex body 24 and is configured to receive the needle 46 of the concave member 40 when the convex member 20 mates with the concave member 40. The inner cavity 30 closes at the opposite end, thereby preventing contamination of the needle 46 of the concave member 40 and, consequently, the needle (if any) of the medical injection device. This also allows for protection of the needle and needle during storage and / or transportation.

[0034] The convex component 20 also includes at least two threaded portions 26 on the outer peripheral surface of the convex body 24. The threaded portions 26 are formed at the ends (i.e., proximal ends) of the convex body 24 and are circumferentially spaced apart from each other around the central axis C. The convex component 20 may include four threaded portions 26, as shown in the illustrated embodiment. In the case of four threaded portions 26, the threaded portions 26 are equidistant from each other, or positioned at 90° (90-degree) intervals around the central axis C. However, the convex component 26 may also include three threaded portions, or five or more threaded portions.

[0035] The threaded portion 26 may be a helical protrusion extending radially outward from the outer surface of the convex body 24. Each threaded portion 26 may have a thinner portion 26a and a thicker portion 26b arranged adjacent to the thinner portion 26a around the central axis C. The thicker portion 26b is thicker than the thinner portion 26a and therefore protrudes further radially outward from the convex body 24 than the thinner portion 26a. The thinner portion 26a and the thicker portion 26b may be smoothly connected to each other in such a way that the thickness gradually increases from the thinner portion 26a to the thicker portion 26b. Alternatively, the thinner portion 26a and the thicker portion 26b may be connected to each other in such a way that the thickness increases stepwise from the thinner portion 26a to the thicker portion 26b.

[0036] Alternatively, the threaded portion 26 may also have a chamfered edge 26c adjacent to the thinner portion 26a.

[0037] The threaded portion 26 may extend at an angle relative to the central axis C so that it protrudes radially outward at a given location more than it would at a location closer to the distal end. The angle of inclination of the threaded portion 26 is determined by the corresponding draft angle of the concave member 40, as explained further below.

[0038] The threaded portion 26 may be flush with the nearest side surface of the convex body 24. Alternatively, the threaded portion 26 may extend at least beyond the nearest side surface of the convex body 24.

[0039] Now for reference Figures 5 to 7 Describe the configuration of the concave component 40. Figure 5 This is a side view showing the concave component 40. Figure 6 This is a top view of the concave member 40, that is, a view viewed from the far end of the concave member 40. Figure 7 It is along Figure 6 The perspective sectional view of the concave component 40 is shown by line VII-VII.

[0040] The concave component 40 includes a hollow cylindrical body 42 extending around a central axis C, a proximal mating portion 44 configured to fit in a seal to a medical injection device (not shown), and a needle 46 extending distally from the proximal mating portion 44 around the central axis C.

[0041] The needle 46 defines an internal channel 52 extending around a central axis C and configured to receive a needle for a medical injection device. The needle 46 also has a lateral opening 46b at or near its tip 46a. The opening 46b provides fluid communication between the medical injection device and the container when the medical injection device is connected to a container (not shown) such as a vial via a concave member 40.

[0042] The concave member 40 may further include a skirt 54 extending distally from the columnar body 42. The skirt 54 includes a ring 55 extending around a central axis C and located at the distal end of the columnar body 42, an edge 56 also extending around the central axis C, a plurality of posts 58 connecting the ring 55 and the edge 56, and a plurality of tongue portions 60 hanging from the edge 56. The edge 56 surrounds an opening configured to receive the collar 28 of the convex member 20 when the convex member 20 engages with the concave member 40. The edge 56 may be located distally away from the needle tip 46a. Because the skirt 54 extends beyond the tip 46a, it can protect the needle 46 and thus the needle of the medical injection device. However, in another embodiment, the edge 56 may be located proximally away from the needle tip 46a.

[0043] The concave component 40 may also include a wavy portion 43 extending proximally from the ring 55. The wavy portion 43 is configured to provide a firm grip for the user when manipulating the concave component 40.

[0044] The concave component 40 defines an annular gap 48 between the columnar body 42 and the needle 46 around the central axis C. The annular gap 48 is configured to accommodate the convex body 24 of the convex component 20.

[0045] The concave member 40 also includes at least two ribs 50 formed on the inner surface of the columnar body 42. The ribs 50 project radially inward from the columnar body 42. The ribs 50 extend straight parallel to the central axis C. In other words, the ribs 50 have a non-helical, unthreaded construction.

[0046] Rib 50 has an innermost mating surface 50a configured to detachably engage with one of the threaded portions 26 of the convex member 20. The mating surface 50a may extend obliquely relative to the central axis C, such 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 inclination of the mating surface 50a may be defined by an angle between 0° (0 degrees) and 2° (2 degrees) relative to the central axis C. The draft angle of the mating surface 50a of rib 50 matches the inclination angle of the threaded portion 26 of the convex member 20. Thus, the threaded portion 26 of the convex member 20 can engage with the corresponding rib 50 of the concave member 40. Considering mass production, the inclination angle of the mating surface 50a cannot be too steep. An appropriate angle can be determined by considering factors such as the material properties of the concave member 40, the width and length of the rib 50.

[0047] The method of fitting the convex part 20 onto the concave part 40 will be described below.

[0048] like Figure 1 As shown, the convex member 20 is aligned with the concave member 40 relative to the central axis C. Then, the convex member 20 is moved along the central axis C toward the concave member 40, whereby the convex body 24 is inserted into the annular gap 48 of the concave member 40 (see...). Figure 8 Because of the needle 46 of the concave component 40 and the corresponding cavity 30 of the convex component 20, center alignment between the two components can be easily established.

[0049] like Figure 8 and Figure 9A As shown, once the convex body 24 is fully inserted and the collar 28 of the convex member 20 is received by the edge 56 of the concave member 40, the threaded portion 26 is in a position to engage with the rib 50. The threaded portion 26 can be configured not to contact the end of the annular gap 58 in the fully inserted position.

[0050] Then, the convex member 20 rotates relative to the concave member 40 about the central axis C until the chamfered edge 26c of the threaded portion 26 contacts the corresponding rib 50 of the concave member 40 (see...). Figure 9B The chamfered edge 26c of the threaded portion 26 facilitates the engagement between the threaded portion 26 and the corresponding rib 50.

[0051] The convex member 20 is further rotated relative to the concave member 40 about the central axis C, such that the thicker portion 26b of the threaded portion 26 fully engages with the corresponding rib 50 of the concave member 40 (see [reference]). Figure 9C and Figure 10 Since the threaded portion 26 has a thinner portion 26a and a thicker portion 26b, the threaded portion 26 acts as a wedge, thereby making the fit between the convex member 20 and the concave member 40 reliable but releaseable when needed.

[0052] Once the convex component 20 and the concave component 40 are engaged, the needle 46 of the concave component 40 is completely covered by the convex component 20. Therefore, potential contamination through the needle 46 during storage or handling of the connector assembly 10 can be prevented.

[0053] When using a medical injection device, for example, when the needle 46 is used to pierce the septum of a vial, the convex part 20 rotates in opposite directions about the central axis C to separate the convex part 20 from the concave part 40, thereby exposing the needle 46 of the concave part 40.

[0054] Both the convex component 20 and the concave component 40 can be single pieces made of plastic (e.g., polypropylene) or any other suitable material. It should be noted that the concave component 40 according to this disclosure does not include a threaded portion near the needle 46, but instead includes a straight rib 50. Therefore, the rib 50 of the concave component 40 and the needle 46 can be produced by molding without involving rotational demolding of the mold core. For example, demolding of the concave component 40 can be performed by translating the first mold component (i.e., the core) away from the second mold component (i.e., the cavity) along the central axis C. The disclosed configuration makes translational demolding possible, thereby reducing manufacturing costs.

[0055] This is particularly advantageous because the rotational motion during demolding could damage the concave part, which is provided with needles for openings necessary for fluid communication.

[0056] By avoiding rotational demolding, simpler molds can be used to produce concave parts 40. Furthermore, the simpler mold design allows for the use of a greater number of cavities in the same molding process, thus helping to reduce manufacturing costs. It also shortens molding cycle time.

[0057] Compared to the known frictional fit between convex and concave parts, the engagement between the straight rib 50 and the threaded portion 26 according to the embodiment provides a secure lock between the two parts, thereby preventing the convex part 20 from accidentally slipping off the concave part 40, for example, during storage and / or transportation.

[0058] Additionally, according to an embodiment, the convex component 20 can be easily separated from the concave component 40 by rotating the convex component 20 about the central axis C, for example, 45 degrees or less, and then pulling it away from the concave component 40. This ensures a smoother process and a better user experience compared to known frictional mating, which requires sufficiently strong pulling force to overcome the friction between the convex and concave components.

[0059] In one embodiment, at least one of the threaded portions 26 may be provided with a rotation limiting portion to prevent the convex member 20 from rotating further from the fully engaged position. For example, the rotation limiting portion may protrude radially outward beyond the thicker portion 26b of the threaded portion 26.

[0060] In another embodiment, at least one of the threaded portions 26 may be provided with a radially inwardly recessed notch. The notch of the threaded portion 26 engages with the corresponding rib 50 of the concave member 40, allowing the user to receive tactile feedback from the convex member 20 when the threaded portion 26 reaches the mating position where the convex member 20 is fully engaged with the concave member 40. The notch also provides a locking function, thereby preventing the convex member 20 from unintentionally disengaging from the concave member 40 during handling, storage, or transport, while allowing the convex member 20 to be easily removed from the concave member 40 when needed.

[0061] In yet another embodiment, each rib 50 may have a thinner portion and a thicker portion, instead of the threaded portion 26 having a thinner portion 26a and a thicker portion 26b. The thicker portion of the rib 50 is configured to project radially inward further than the thinner portion, thereby acting as a wedge to enhance the fit between the convex member 20 and the concave member 40.

[0062] This invention is not limited to the embodiments described above. The technical concepts disclosed herein are applicable to other types of connector assemblies and provide the same advantages as explained above. In one embodiment, the connector assembly may be configured as a Luer lock connector assembly.

Claims

1. A connector assembly (10) comprising a convex member (20) and a concave member (40), The convex component (20) includes a tubular convex body (24) extending about a central axis (C), the tubular convex body including at least two threaded portions (26) formed on the outer surface of the tubular convex body (24) and circumferentially spaced apart from each other about the central axis (C), and The concave component (40) includes: A hollow columnar body (42) extends around the central axis (C); The proximal mating portion (44) is configured to fit in a sealed manner into a medical injection device; and A needle (46) extends distally from the proximal mating portion (44) about the central axis (C) and defines an annular gap (48) between the columnar body (42) and the needle (46) about the central axis (C), the annular gap (48) being configured to at least partially accommodate the convex body (24) of the convex member (20). The connector assembly (10) is characterized in that: The concave component (40) further includes at least two ribs (50) formed on the inner surface of the columnar body (42) and projecting radially inward. The ribs (50) extend straight parallel to the central axis and have an innermost mating surface (50a) configured to detachably engage with the corresponding threaded portion (26) of the convex component (20).

2. The connector assembly (10) according to claim 1, wherein, Each of the ribs (50) of the concave member (40) has a mating surface (50a) that extends obliquely relative to the central axis (C), such that the distance between the mating surface (50a) and the central axis (C) increases toward the proximal mating portion (44), and wherein each of the threaded portions (26) of the convex member (20) extends obliquely relative to the central axis (C) to mate with the corresponding rib (50) of the concave member (40).

3. The connector assembly (10) according to claim 2, wherein, Each of the ribs (50) of the concave member (40) and each of the threaded portions (26) of the convex member (20) extends at an angle of 2 degrees or less relative to the central axis (C) of the needle (46).

4. The connector assembly (10) according to any one of claims 1 to 3, wherein, The concave component (40) includes three or four ribs (50) equidistant from the central axis (C).

5. The connector assembly (10) according to any one of claims 1 to 4, wherein, At least one of the threaded portions (26) includes a rotation limiting portion that projects radially outward and is configured to prevent the convex member (20) from rotating further relative to the concave member (40) when the threaded portion (26) engages with the rib (50) of the concave member (40).

6. The connector assembly (10) according to any one of claims 1 to 5, wherein, At least one of the threaded portions (26) includes a notch that is radially recessed and configured to releasably lock the engagement between the concave member (40) and the convex member (20).

7. The connector assembly (10) according to any one of claims 1 to 6, wherein, Each of the threaded portions (26) of the convex member (20) includes a thinner portion (26a) and a thicker portion (26b), the thicker portion being arranged adjacent to the thinner portion (26a) around the central axis (C) and being thicker than the thinner portion (26a) so as to project radially outwards further than the thinner portion (26a).

8. The connector assembly (10) according to any one of claims 1 to 6, wherein, Each of the ribs (50) of the concave member (40) includes a thinner portion and a thicker portion, the thicker portion being arranged adjacent to the thinner portion around the central axis (C) and being thicker than the thinner portion so as to project radially inward further than the thinner portion.

9. The connector assembly (10) according to any one of claims 1 to 8, wherein, The concave component (40) is configured to be hermetically connected to a medical injection device having a needle (46), the needle (46) defining an internal channel (52) configured to receive the needle, and the concave component (40) also includes a skirt (54) extending distally from the columnar body (42) and beyond the tip (46a) of the needle (46).

10. A method for manufacturing a connector assembly (10) according to any one of claims 1 to 9, wherein, The concave component (40) is formed by a mold comprising a first mold component and a second mold component, wherein demolding of the concave component (40) is performed by translating the first mold component relative to the second mold component along the central axis (C).

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