Connector assembly and connection method for attaching accessory to luer connector

Abstract

A connector assembly includes an inner connector having a first end, a second end, a sidewall extending between the first end and the second end, and a flange connected to or extending radially outward from the sidewall. The connector assembly also includes an outer connector configured to be inserted onto the inner connector, the inner connector having a first end, a second end, a sidewall extending between the first end and the second end, and a lock extending radially inward from an inner surface of the sidewall, the lock is configured to engage a flange of the inner connector, thereby securing the inner connector to the outer connector.

Description

[0001] Cross - Reference to Related Applications

[0002] This application claims priority to U.S. Utility Application No. 17 / 988,717, filed on November 16, 2022, entitled "Connector Assemblies and Connecting Methods for Attaching Accessories to Luer Connectors", the entire disclosure of which is incorporated herein by reference in its entirety. Technical Field

[0003] The present disclosure generally relates to connector assemblies and connecting methods for attaching a first component or device (such as a fluid container or a vascular access device) to a second component or device (such as an accessory device), and particularly to connector assemblies that include a universal attachment feature configured to attach to devices having different types of connectors (such as male Luer connectors or female Luer connectors). Background Art

[0004] Medical devices such as syringes, needle assemblies, infusion devices, or infusion sets are commonly used to transfer and / or store medical fluids. Such devices are typically used to transfer medical fluids to a patient through one or more vascular access devices (VADs), which may include intravenous (IV) catheters such as peripheral catheters or central venous catheters. Vascular access devices typically include access seats, ports, or valves for connecting the vascular access device to a medical fluid supply source, device, or container to transfer medical fluids from the supply source, device, or container to the patient through the vascular access device.

[0005] In many cases, needleless connector assemblies, interfaces, or arrangements are used to connect a medical fluid supply source, device, or container to the access seat, port, or valve of a vascular access device. International Organization for Standardization (ISO) 80369 - 7 defines a common connection interface for connecting a medical fluid supply source to a vascular access device, which is commonly referred to as a Luer connector. As described in further detail herein, according to the ISO standard, a male Luer connector includes a conical distal end having a taper of approximately 6%, which is configured to be inserted into the conical bore of a female Luer connector. Such Luer connection assemblies or systems can provide a leak - free connection between a medical fluid supply source, device, or container and a vascular access device. Further, such connection assemblies and systems are designed to provide protection against contamination of the medical fluids contained in the medical fluid supply source, device, or container and passing through the vascular access device.

[0006] In some examples, a simple luer connector component or system can include a male fitting and a female fitting with luer taper dimensions that meet ISO standard requirements. To enhance the security and stability of the connection between the male and female fittings, a lock can be provided, which is commonly referred to as a luer lock fitting. For example, external ridges (e.g., helical threads) can be provided on the female fitting, and the ridges are configured to be tightened onto corresponding threads provided on the inner surface of a collar that surrounds the male fitting.

[0007] In certain cases, there are accessory devices that can be connected to male and / or female needleless connectors or luer connectors. For example, such accessory devices can be attached to the access site, port, or valve of a vascular access device before and / or after using the vascular access device to protect the vascular access device from contamination. Depending on the needs of a particular clinical procedure or application, the accessory device can include, for example, a disinfecting cap, a safety component, and / or a smart device, such as a device that includes a sensor for monitoring fluid flow through the vascular access device. For example, the disinfecting cap can be a disposable cap that contains a quantity of a cleaning or disinfecting solution for sterilizing portions of the port, site, and valve of the vascular access device. An exemplary disinfecting cap is disclosed in U.S. Patent No. 10,871,246, titled "Universal Connector or Cap for Male and Female Threaded Fittings," which is incorporated herein by reference in its entirety.

[0008] These disinfecting caps and other accessory devices are typically attached to male or female luer connectors through a special design of the accessory device that includes threads capable of mating with corresponding luer threads of the luer connector. However, access sites and ports can have various different types of male or female connectors for securing the site or port to the vascular access device. Currently, practitioners often carry several types of disinfecting caps or other accessory devices so that they can cap different types of sites and ports that can be used for a particular patient. For example, caps for male and female needleless connectors and intravenous (IV) lines and hemodialysis lines can use different connector designs and may require different caps or specific accessory devices. Accordingly, a more universal connector interface is needed to more effectively attach various accessory devices to medical fluid containers and vascular access devices that include male or female luer connectors. SUMMARY OF THE INVENTION

[0009] Existing methods for attaching an accessory device, such as a sterilization cap, to another device, such as a vascular access device, using a Luer connector may have significant drawbacks. One drawback may be that there is no reliable way to attach the accessory device to the Luer connector without using the Luer threads of a needleless connector. However, when the accessory device is connected to the vascular access device via the Luer threads, the accessory device may interfere with or prevent the proper mating of the vascular access device with a medical fluid supply source, device, or container (e.g., a syringe, intravenous line, or another container). Additionally, some accessory devices do not tend to or need to contact the threads or fluid path of the vascular access device or the medical fluid supply device. A second drawback is that, in the absence of two sets of threads (i.e., male and female threads), an accessory device designed to engage the threads of a vascular access device cannot mate with both male and female Luer connectors. A third drawback may be that using multiple types of accessory devices makes sterilization more difficult and may significantly increase the number of product components that must be manufactured.

[0010] Accordingly, there is a need in the art for a universal attachment feature that can be used with both male and female Luer connectors. Ideally, the universal attachment feature can be used to attach an accessory device to the male and female Luer connectors of a vascular access device or a medical fluid supply source, device, or container. In particular, the universal attachment feature ideally comprises only a single thread or mating clip that can mate with devices including male and female Luer connectors. The connector assemblies, devices, and connection methods disclosed herein are configured to address these drawbacks and problems.

[0011] According to one aspect of the present disclosure, a connector assembly includes an inner connector having a first end, a second end, a sidewall extending between the first end and the second end, and a flange connected to or radially outwardly extending from the sidewall. The connector assembly further includes an outer connector configured to be inserted over the inner connector, the outer connector having a first end, a second end, a sidewall extending between the first end and the second end, and a lock radially inwardly extending from an inner surface of the sidewall, the lock configured to engage the flange of the inner connector to secure the inner connector to the outer connector.

[0012] According to one embodiment of the present invention, the inner connector comprises a male Luer connector.

[0013] According to one embodiment of the present invention, the inner connector includes a stem having a proximal end connected to the sidewall, a distal end projecting distally beyond the second end of the sidewall, and a body extending between the proximal end and the distal end through a space defined by the sidewall of the inner connector; and at least one thread on the inner surface of the sidewall, the at least one thread being configured to engage a corresponding thread of a female Luer connector.

[0014] According to one embodiment of the present invention, the stem includes a tapered outer surface.

[0015] According to one embodiment of the present invention, the outer connector is configured to engage the inner connector without contacting the stem or the at least one thread of the inner connector.

[0016] According to one embodiment of the present invention, the inner connector is configured to engage a female Luer connector having a maximum outer diameter of less than 11.0 mm, or preferably from about 9.0 mm to about 11.0 mm.

[0017] According to one embodiment of the present invention, the inner connector is a female Luer connector.

[0018] According to one embodiment of the present invention, the sidewall of the inner connector includes threads on the outer surface of the sidewall, the threads being configured to engage corresponding threads of a shield of a male Luer connector.

[0019] According to one embodiment of the present invention, the inner connector is sized such that a male Luer connector having an outer diameter of 8.0 mm to 14.0 mm, or preferably from about 9.0 mm to about 11.0 mm, can be inserted onto the inner connector.

[0020] According to one embodiment of the present invention, the outer connector is configured to engage the inner connector without contacting the threads on the outer surface of the sidewall of the inner connector.

[0021] According to one embodiment of the present invention, the inner connector and / or the outer connector is a single molded part integral with or attached to a vascular access device.

[0022] According to one embodiment of the present invention, the inner connector and / or the outer connector includes a rigid thermoplastic polymer such as polyester, polycarbonate, polypropylene, polyethylene, polyethylene terephthalate or acrylonitrile butadiene styrene.

[0023] According to one embodiment of the present invention, the inner connector includes a vascular access device, and the outer connector includes an accessory device configured to engage the vascular access device.

[0024] According to one embodiment of the present invention, the vascular access device includes at least one of a syringe, an infusion pump, an irrigation device, an intravenous drip device, or a catheter, and wherein the accessory device includes a disinfection cap, a safety device, a smart device, and / or a sensor device.

[0025] According to one embodiment of the present invention, the outer connector includes a vascular access device, and the inner connector includes an accessory device configured to engage the vascular access device.

[0026] According to one embodiment of the present invention, the vascular access device includes at least one of a syringe, an infusion pump, an irrigation device, an intravenous drip device, or a catheter, and wherein the accessory device includes a disinfection cap, a safety device, a smart device, and / or a sensor device.

[0027] According to one embodiment of the present invention, a flange connected to or radially extending outward from the sidewall of the inner connector includes a peripheral edge, and the peripheral edge includes opposing flat portions and opposing curved portions between the flat portions.

[0028] According to one embodiment of the present invention, the maximum outer diameter of the flange corresponds to the inner diameter of the sidewall of the outer connector.

[0029] According to one embodiment of the present invention, the maximum outer diameter of the flange is from about 8.0 mm to 14.0 mm, or preferably from about 9.0 mm to 11.0 mm.

[0030] According to one embodiment of the present invention, the thickness of the flange is from 0.2 mm to 2 mm.

[0031] According to one embodiment of the present invention, the flange is provided on or connected to the second end of the inner connector.

[0032] According to one embodiment of the present invention, the flange is provided on the sidewall of the inner connector between the first end and the second end of the inner connector.

[0033] According to one embodiment of the present invention, the lock includes threads radially inwardly extending from at least a portion of the inner surface of the sidewall of the outer connector.

[0034] According to one embodiment of the present invention, the threads are configured to rotatably engage the flange of the inner connector.

[0035] According to one embodiment of the present invention, the threads extend around the inner surface of the sidewall of the outer connector less than one full turn.

[0036] According to one embodiment of the present invention, the flange of the inner connector includes a peripheral edge, the peripheral edge including opposite flat portions and opposite curved portions between the flat portions, wherein the lock includes threads radially inwardly extending from at least a portion of the inner surface of the sidewall of the outer connector, and wherein the outer connector further includes at least one blocking tab radially inwardly extending from the sidewall of the outer connector and separated from the threads, the at least one blocking tab being disposed at a first end of the outer connector and configured to contact the opposite curved portions of the flange to block further advancement of the inner connector into the outer connector.

[0037] According to one embodiment of the present invention, the at least one blocking tab includes a pair of opposite blocking tabs positioned to contact the opposite curved portions of the peripheral edge of the flange when the outer connector is fully connected to the inner connector.

[0038] According to one embodiment of the present invention, the lock includes at least one snap tab configured to form a snap-fit engagement with the flange of the inner connector.

[0039] According to one embodiment of the present invention, the lock includes a locking ring having an annular sidewall, a plurality of first tabs radially inwardly extending from a first annular edge of the sidewall, and a plurality of second tabs radially inwardly extending from a second annular edge of the sidewall.

[0040] According to one embodiment of the present invention, the plurality of first tabs and the plurality of second tabs are configured to hold the flange of the inner connector by a snap-fit engagement.

[0041] According to one embodiment of the present invention, the plurality of first tabs and the plurality of second tabs are configured to hold the flange of the inner connector within a space between the first tabs and the second tabs.

[0042] According to one embodiment of the present invention, the plurality of second tabs include chamfered surfaces to facilitate insertion of the inner connector into the outer connector.

[0043] According to one embodiment of the present invention, by applying an axial force to the inner connector sufficient to deflect the plurality of second tabs away from the flange such that the flange moves into the space between the first tabs and the second tabs to insert the flange into the locking ring.

[0044] According to one embodiment of the present invention, an axial force sufficient to overcome the snap - fit engagement between the locking ring and the flange is applied to the inner connector or the outer connector, such that the inner connector can move axially relative to the outer connector to remove the flange from the locking ring.

[0045] According to one embodiment of the present invention, the distance between the first tab and the second tab corresponds to the thickness of the flange of the inner connector.

[0046] According to another aspect of the present disclosure, a vascular access device configured to connect to an accessory device includes a tubular body that defines a fluid path that at least partially extends through the tubular body, the fluid path including a proximal end portion and a distal end portion. The vascular access device further includes a male connector connected to the tubular body, the male connector including: a stem that defines a fluid path fluidly connected to the distal end portion of the fluid path of the tubular body, the stem being configured to be inserted into a fluid path of a female connector; a shroud connected to a first end of the stem and at least partially enclosing the stem; and threads extending radially inwardly from an inner surface of the shroud, the threads being configured to engage corresponding threads on an outer surface of the female connector. The vascular access device further includes a flange connected to a sidewall of the shroud or extending radially outwardly from the sidewall of the shroud, the flange being configured to engage a lock extending radially inwardly from an inner surface of a tubular sidewall of the accessory device.

[0047] According to one embodiment of the present invention, the stem includes a tapered outer surface.

[0048] According to one embodiment of the present invention, the accessory device is configured to engage the flange of the vascular access device without contacting the stem or the at least one thread.

[0049] According to one embodiment of the present invention, the vascular access device includes at least one of a syringe, an infusion pump, an irrigation device, an intravenous drip device, or a catheter, and wherein the accessory device includes a sterilization cap, a safety device, a smart device, and / or a sensor device.

[0050] According to one embodiment of the present invention, the flange includes a peripheral edge that includes opposing flat portions and opposing curved portions between the flat portions.

[0051] According to another aspect of the present disclosure, an attachment method for attaching an inner connector to an outer connector includes the step of inserting the inner connector into the outer connector, the inner connector having a first end, a second end, a sidewall extending between the first end and the second end, and a flange connected to or radially extending outward from the sidewall. The outer connector includes a lock that radially extends inward from the inner surface of the outer connector. The method further includes the step of moving the inner connector through the outer connector such that the flange of the inner connector engages the lock of the outer connector to fix the inner connector to the outer connector.

[0052] According to one embodiment of the present invention, the inner connector includes a male Luer connector or a female Luer connector.

[0053] According to one embodiment of the present invention, the inner connector includes a vascular access device, and the outer connector includes an accessory device configured to engage the vascular access device.

[0054] According to one embodiment of the present invention, the vascular access device includes at least one of a syringe, an infusion pump, an irrigation device, an intravenous drip device, or a catheter, and wherein the accessory device includes a sterilization cap, a safety device, a smart device, and / or a sensor device.

[0055] According to one embodiment of the present invention, the lock includes threads that radially extend inward from at least a portion of the inner surface of the outer connector, and wherein inserting the inner connector into the outer connector includes pressing the flange of the inner connector against the threads of the outer connector.

[0056] According to one embodiment of the present invention, moving the inner connector through the outer connector includes rotating the inner connector relative to the outer connector to pull the flange along the threads of the outer connector.

[0057] According to one embodiment of the present invention, the lock includes a locking ring, the locking ring including an annular sidewall, a plurality of first tabs radially extending inward from a first annular edge of the annular sidewall, and a plurality of second tabs radially extending inward from a second annular edge of the annular sidewall, and wherein moving the inner connector through the outer connector includes pressing the flange against the plurality of second tabs with sufficient force to deflect the second tabs away from the flange. Description of the Drawings

[0058] FIG. 1A is a cross-sectional view of an exemplary male connector known in the prior art.

[0059] FIG. 1B is an example of a female connector known in the prior art, the female connector including a septum with a slit.

[0060] Figure 2A A perspective view of an inner connector according to one aspect of the present disclosure, the inner connector including a flange configured to engage a lock of an outer connector.

[0061] Figure 2B is Figure 2A a cross-sectional view of the inner connector.

[0062] Figure 2C A front view of a syringe according to one aspect of the present disclosure, the syringe including Figure 2A the inner connector.

[0063] Figure 3A A perspective view of another example of an inner connector according to one aspect of the present disclosure, the inner connector including a flange configured to engage a lock of an outer connector.

[0064] Figure 3B is Figure 3A a cross-sectional view of the inner connector.

[0065] Figure 3C A front view of a syringe according to one aspect of the present disclosure, the syringe including Figure 3A the inner connector.

[0066] Figure 4A A perspective view of a locking ring of an outer connector according to one aspect of the present disclosure.

[0067] Figure 4B is Figure 4A a bottom view of the locking ring.

[0068] Figure 4C A cross-sectional view of an accessory device according to one aspect of the present disclosure, the accessory device including Figure 4A the locking ring.

[0069] Figure 5A A cross-sectional view of a syringe with an inner connector according to one aspect of the present disclosure, the syringe being mounted to an accessory device including a locking ring.

[0070] Figure 5B A cross-sectional view of another example of a syringe with an inner connector according to one aspect of the present disclosure, the syringe being mounted to an accessory device including a locking ring.

[0071] Figure 6 A flowchart showing a method for connecting an inner connector to an outer connector according to one aspect of the present disclosure.

[0072] Figure 7A A perspective view of another example of an outer connector including a snap ring according to one aspect of the present disclosure.

[0073] Figure 7B Cross-sectional view of an outer connector for Figure 7A the syringe.

[0074] Figure 8A Cross-sectional view of a syringe with an inner connector according to one aspect of the present disclosure, the syringe being mounted to an accessory device including an outer connector with a snap ring.

[0075] Figure 8B Cross-sectional view of another example of a syringe with an inner connector according to one aspect of the present disclosure, the syringe being mounted to an accessory device including an outer connector with a snap ring. DETAILED DESCRIPTION

[0076] The following description is provided to enable a person having ordinary skill in the art to make and use the described embodiments contemplated for carrying out the invention. However, various modifications, equivalents, variations, and alternatives will be apparent to a person having ordinary skill in the art. Any and all such modifications, variations, equivalents, and alternatives are intended to fall within the spirit and scope of the invention.

[0077] For purposes of the following description, the terms "upper", "lower", "right", "left", "vertical", "horizontal", "top", "bottom", "lateral", "longitudinal", and derivatives thereof shall relate to the invention as it is oriented in the accompanying drawings. The term "proximal" refers to the portion of a device or part that is grasped by a user or connected to another device or part. The term "distal" refers to the portion of a device or part that is opposite the proximal portion (i.e., farthest from the portion grasped by the user or connected to another part). For example, for an implantable medical device such as a catheter, the proximal portion may refer to the portion of the catheter that remains outside the patient's body and is manipulated by the user. The distal portion of the catheter may be the portion inserted into the patient's vasculature. For an object or part, such as an elongate member, the proximal end may be the end connected to another object or part. The distal end of the elongate member is opposite the proximal end and may not be connected to other objects or parts. However, it should be understood that the invention may take alternative variations and step sequences, unless expressly stated to the contrary. It should also be understood that the specific devices and processes illustrated in the drawings and described in the following specification are merely exemplary embodiments of the invention. Accordingly, the specific dimensions and other physical characteristics associated with the embodiments disclosed herein should not be considered limiting.

[0078] The present disclosure relates to a connector assembly 10 or connector interface that permits a practitioner, such as a clinician or healthcare worker, to connect a first component or device to a second component or device. As used herein, a "healthcare worker" can be a medical professional, such as a medical technician or nurse, who is trained to perform medical procedures, such as fluid delivery or blood collection procedures. As previously mentioned, the first component or device can be a medical fluid supply source, device, or container, such as a syringe barrel, needle assembly, infusion device, or irrigation device. The first component or device can also be a port, seat, or valve of a vascular access device (VAD). The second component or device can be an accessory device, such as a sterilization cap, safety device, or smart device, such as a sensor configured to monitor fluid flow.

[0079] Both the first and second components can include male or female Luer connectors or fittings. However, the connector assembly 10 or interface disclosed herein connects the first component or device to the second component or device without using male or female Luer connectors or fittings. Instead, as described in further detail herein, the first component or device is connected to the second component or device through the connection or engagement between a radially extending flange on the inner connector 12 and a lock or locking ring on the outer connector 14, which is connected to the flange by, for example, a threaded or snap-fit engagement. In this way, the first component or device can be connected to the second component or device without contacting, contaminating, or otherwise deforming the threads or other portions of the male or female Luer connectors or fittings. In some examples, the inner connector 12 and the outer connector 14 can be configured to permanently hold attached together. In other examples, the inner connector 12 can be configured to remain removably connected to the outer connector 14 for a predetermined period of time, such as at least seven days, which is the maximum recommended use time for a sterilization cap allowed by the aseptic operating guidelines of many medical facilities. The inner connector 12 and the outer connector 14 disclosed herein can be configured to connect various male and female connectors having different sizes, dimensions, or thread profiles. Thus, the connection assembly 10 disclosed herein can be a universal connector assembly for forming a temporary, removable, or permanent engagement between various types of medical fluid containers or vascular access devices and accessory devices.

[0080] Male and female Luer connectors

[0081] As described above, the medical fluid devices, vascular access devices, and accessory devices described herein may include male or female Luer connectors of various types and sizes. As used herein, a "male connector" refers to connector 110, which includes an elongate member, such as a tubular member or rod 114, configured to be inserted into a bore, tube, or opening having an inner diameter greater than the outermost diameter of male connector 110. An exemplary male connector 110 is shown in FIG. 1A. A "female connector" refers to connector 112, which includes an opening or port 116 configured to receive an elongate member or tubular member of another object or device to connect the object or device to female connector 112. Female connector 112 may have a cap or diaphragm 118 across opening 116. An exemplary female connector 112 including diaphragm 118 with slit 120 is shown in FIG. 1B.

[0082] As used herein, a "Luer connector" refers to a connector that includes a tapered portion (e.g., a Luer taper of about 6%) for forming a friction fit between the tapered rod 114 or elongate member of male Luer connector 110 and a tapered cavity. Specifically, male Luer connector 110 may include a tapered rod 114 or elongate member having a tapered outer surface. Female Luer connector 112 may include a tapered bore or cavity (e.g., a cavity having a taper of about 6%) configured to receive and engage tapered rod 114 or elongate member to connect male Luer connector 110 to female Luer connector 112.

[0083] To secure male Luer connector 110 and female Luer connector 112 together, in some examples, male Luer connector 110 and female Luer connector 112 may include engagement structures, such as threads, for drawing male Luer connector 110 and female Luer connector 112 together. For example, as shown in FIG. 1A, male Luer connector 110 may include an annular shroud 122 extending around tapered rod 114 having an outer diameter of about 9 mm to about 11 mm. More particularly, many commercially available male Luer connectors 110 have an annular shroud 122 with an outer diameter of 9.1 mm to 9.4 mm or 10.3 mm to 10.4 mm. For example, male Luer connectors 110 from RyMed, B. Braun, Zyno, and Smith’s Medical typically have an outer diameter of about 9.1 mm to 9.4 mm. In contrast, male Luer connectors 110 from Kendall, Becton Dickinson, ICU Medicals, Baxter, and Kawasumi typically have an outer diameter of about 10.4 mm. The connection assembly 10 disclosed herein may be configured to engage and / or form a connection with any of these commercially available male Luer connectors 110.

[0084] As shown in FIG. 1A, the annular shroud 122 can include threads 124 located on the inner surface 126 of the shroud 122, the threads being configured to engage corresponding threads 128 on the outer surface 130 of the female luer connector 112. As shown in FIG. 1B, the female luer connector 112 can include threads 128 extending from the outer surface 130, the threads being positioned to engage threads 124 on the inner surface 126 of the annular shroud 122 of the male luer connector 110. Twisting the female luer connector 112 relative to the male luer connector 110 causes the corresponding threads 124, 128 to engage, which draws the male luer connector 110 and the female luer connector 112 together such that the tapered stem 114 or elongate member of the male luer connector 110 moves through the opening 116 of the female luer connector 112. In some examples, the female luer connector 112 can also include a vertical ridge 132 near the proximal end of the female luer connector 112, the vertical ridge being useable to manipulate the female connector 112 such that it is easier to twist the female luer connector 112 compared to other connectors or devices.

[0085] Many different medical devices are available on the market, such as hubs, ports, and valves, which can include different types of male luer connectors 110 or female luer connectors 112. As previously described, any of these commercially available connectors can be modified or adapted to work with the connector assembly 10 of the present disclosure. For example, the connection assembly 10 of the present disclosure can be configured to attach to a female or male Luer-Lok TM connector of Becton Dickinson and Company. The connector assembly 10 of the present disclosure can also be configured to connect to different connector designs, including but not limited to BD Q-Syte TM of Becton Dickinson and Company, BD MAxZero TM BD MaxPlus TM and SmartSite TMNeedleless connector. The connection assembly 10 can also be used with male and / or female connectors from other manufacturers, including but not limited to MicroClave® connectors (ICU Medical Inc.) and Ultrasite® connectors (B. Braun Medical Inc.). In other examples, the connection assembly can be configured to be used with one or more of the following male connectors available on the market: Kendall 200 INP; BD MP 5303-C; ICU Med 12664-28; RyMed RYM-5307HPU; B. Braun 470108; Baxter 2C8537; Kawasumi IV-0094; Zyno B2-70071-D; B.Braun 470124; Baxter 2C7462; and Smith’s Medical 536035.

[0086] Connector assembly including a threaded locking ring

[0087] Figures 2A - 5B Illustrating aspects of the connector assembly 10 or connector interface for connecting a medical fluid container such as syringe 16 (shown in Figure 2C , 3C , 5A and 5B) to an accessory device such as a sterilization cap 18 (shown in Figure 4C , 5A and 5B).

[0088] In some examples, the connector assembly 10 includes an inner connector 12 that is configured to be inserted into and engage with an outer connector 14. As shown in Figure 2C , 3C , 5A and 5B, the inner connector 12 can be integral with or connected to a medical fluid container such as syringe 16, as shown in Figure 2C , the syringe including a barrel 20 and a plunger or stopper 22 positioned within the barrel 20. The inner connector 12 can also be integral with or connected to a component of a vascular access device, such as an access seat, port, or valve of the vascular access device. As shown in Figure 4C , 5A and 5B, the outer connector 14 can be integral with or connected to an accessory device such as a sterilization cap 18, as shown in Figure 4C , the sterilization cap including a housing 24 that encloses an absorbent member or sponge 26 containing a sterilizing or cleaning solution.

[0089] More specifically, as shown in Figure 4CAs shown, the sponge body 26 can be a cylindrical structure or member received within the housing 24. The sponge body 26 can be formed of an absorbent material capable of absorbing a cleaning or disinfecting solution for cleaning and / or disinfecting portions of the male Luer connector 110 and female Luer connector 112 (shown in FIGS. 1A and 1B). The sponge body 26 can include a thermoplastic elastomer, such as polypropylene, polyethylene, or synthetic or natural rubber (e.g., isoprene). The sponge body 26 can be provided (i.e., pre-soaked) with the cleaning or disinfecting solution. For example, the cleaning or disinfecting solution can be an antimicrobial, antifungal, antibacterial, or antiviral solution that cleans and sterilizes the surfaces of the male Luer connector 110 and female Luer connector 112. In some examples, the cleaning solution can be isopropyl alcohol (IPA), such as approximately 70% isopropyl alcohol (IPA). In other examples, the cleaning solution can be approximately 0.5% to approximately 3.5% chlorhexidine gluconate used alone or in combination with approximately 70% IPA.

[0090] In other examples, although not shown in the current figures, the inner connector 12 can be connected to or integral with an accessory device, such as a disinfecting cap 18, and the outer connector 14 can be integral with or connected to a medical fluid container, such as a syringe 16, or a vascular access device.

[0091] Generally, the inner connector 12 and / or the outer connector 14 are one-piece parts formed by a single molding process, such as by a single injection molding process. The inner connector 12 and / or the outer connector 14 can be formed of or include a rigid material, such as a rigid thermoplastic polymer (e.g., polyester, polycarbonate, polypropylene, polyethylene, polyethylene terephthalate, or acrylonitrile butadiene styrene). In some cases, the inner connector 12 and / or the outer connector 14 are also integral with parts of the medical fluid container, vascular access device, or accessory device. In other examples, the inner connector 12 or the outer connector 14 can be a separate part that is mounted to the medical fluid container, vascular access device, or accessory device by an adhesive or mechanical fastener, as is known in the art.

[0092] As Figures 2A - 2CAs shown, the inner connector 12 may include components of a male Luer connector, such as the components of the male Luer connector 110 shown in FIG. 1A. For example, the inner connector 12 may include a tubular body or shroud 28, the tubular body or shroud including a first or proximal end 30, a second or distal end 32, and a side wall 34 extending therebetween. The size of the shroud 28 may be set to receive the tubular portion of a female Luer connector, such as the female Luer connector 112 shown in FIG. 1B, which has an outer diameter less than 11.0 mm, or preferably from about 9.0 mm to about 11.0 mm. The inner connector 12 further includes a stem 36 that defines a fluid path through the inner connector 12. The stem 36 includes a proximal end 38 connected to the proximal end 30 of the shroud 28, a distal end 40 that axially extends beyond the distal end 32 of the shroud 28, and a side wall or body 42 that extends between the proximal end 38 and the distal end 40 and extends through the space defined by the side wall 34 of the shroud 28. As previously described, the stem 36 may include a tapered outer surface configured to be inserted into a tapered cavity or bore of a female Luer connector. In some examples, the shroud 28 also includes threads 44, such as helical threads, that radially extend inwardly from the inner surface 46 of the shroud 28. As Figures 2A - 2C shown, the inner connector 12 further includes a flange 48 that radially extends outwardly from the shroud 28.

[0093] The flange 48 is generally a disk-shaped structure that includes a generally flat proximal surface 50, an opposite generally flat distal surface 52, and a peripheral edge 54 that extends between the proximal surface 50 and the distal surface 52. The peripheral edge 54 may include opposing flat portions and opposing curved portions 86 between the flat portions 88. The size of the flange 48 is selected such that the flange 48 can be inserted into the outer connector 14 for engaging the inner connector 12 to the outer connector 14. For example, the flange 48 may have a maximum outer diameter D1 (shown in Figure 4B ), corresponding to the inner diameter D2 of the outer connector 14 (shown in Figure 2B ). For example, the maximum outer diameter D1 may be from about 6.2 mm to about 6.8 mm. The flange 48 may also have a maximum thickness of from about 0.2 mm to about 1.0 mm, which is defined as the maximum axial distance between the proximal surface 50 and the distal surface 52.

[0094] The flange 48 may be disposed at various positions on the outer surface of the side wall or shroud 28. For example, as Figures 2A - 2CAs shown, the flange 48 is positioned near the proximal end 30 of the shield 28. In other examples, the flange 48 may be positioned at the midpoint of the shield 28, i.e., at an intermediate position between the proximal end 30 of the shield 28 and the distal end 32 of the shield 28. In other examples, the flange 48 may be positioned closer to the distal end 32 of the shield 28 than the proximal end 30, or at any other convenient location depending on the design of the syringe, the vascular access device, and / or the accessory device.

[0095] As Figures 3A - 3C shown, the inner connector 12 may alternatively include components of a female luer connector, such as the components of the female luer connector 112 shown in FIG. 1B. For example, the inner connector 12 may include a tubular body that includes a first or proximal end 56, a second or distal end 58, and a sidewall 60 extending therebetween. As Figure 3B shown, the sidewall 60 of the tubular body encloses a central channel 62. The most distal portion of the central channel 62 is tapered, where the taper corresponds to the taper of the outer surface of the stem 114 of the male luer connector 110 (as shown in FIG. 1A). The most distal portion of the inner connector 12 also includes threads 64 located on the outer surface 66 of the sidewall 60, such as helical threads, that are configured to engage corresponding threads of the shield 122 of the male luer connector 110 (shown in FIG. 1A). For example, the size of the threads 64 of the inner connector 12 may be set such that a male luer connector 110 having an outer diameter of 8.0 mm to 14.0 mm, or preferably about 9.0 mm to about 11.0 mm, can be inserted onto the inner connector 12. Figures 3A - 3C The inner connector 12 shown in Figures 3A - 3C also includes a flange 48 that extends radially outward from the sidewall 60. The flange 48 of the inner connector 12 is substantially the same as the previously described examples and includes a generally flat proximal surface 50, an opposite distal surface 52, and a peripheral edge 54. As in the previous examples, the peripheral edge 54 may include a curved portion 86 and a flat portion 88.

[0096] As Figures 3A - 3C shown, the flange 48 is disposed at an intermediate position between the proximal end 56 and the distal end 58 of the inner connector 12. Additionally, the flange 48 is positioned proximal to the threads 64 that extend around the most distal portion of the sidewall 60 of the inner connector 12. As Figure 3C shown, the inner connector 12 that includes components of a female luer connector is integral with the syringe barrel 20 such that fluid in the syringe barrel 20 passes through the open distal end of the syringe barrel 20 and into the channel 62 of the inner connector 12.

[0097] The connector assembly 10 of the present disclosure further includes an outer connector 14 configured to engage an inner connector 12. For example, the outer connector 14 can be configured to be inserted onto the inner connector 12 for temporarily or permanently securing the outer connector 14 to the inner connector 12. As Figure 4A and 4B shown, the outer connector 14 can be an annular body or ring that includes a first or proximal end 68, a second or distal end 70, and a sidewall 72 extending between the proximal end 68 and the distal end 70. The outer connector 14 also includes a projection, latch, lock, or similar engagement structure that extends radially inwardly from the inner surface 74 of the sidewall 70 for engaging the flange 48 of the inner connector 12 to secure the inner connector 12 to the outer connector 14.

[0098] In some examples, the engagement structure or lock can include threads 76 that extend radially inwardly from the inner surface 74 of the sidewall 72 of the outer connector 14. The threads 76 of the outer connector 14 can be configured to rotatably engage the flange 48 of the inner connector 12. Depending on the design of the inner connector 12 and / or the device or component connected to or integral with the inner connector 12, the threads 48 can be provided in a variety of different configurations. For example, as Figures 4A - 4C shown, the threads 76 can extend less than one full turn around the inner surface 74 of the sidewall 72 of the outer connector 14. In this configuration, the practitioner only needs to rotate the outer connector 14 less than one full turn relative to the inner connector 12 to fully engage the inner connector 12 within the outer connector 14. In other examples, the threads 76 can extend one full turn, two full turns, or any other suitable amount around the inner surface 74 of the sidewall 72. Generally, including additional rotation means that the inner connector 12 is more firmly engaged to the outer connector 14, making it less likely that the inner connector 12 will be removed from the outer connector 14 accidentally or inconveniently.

[0099] The outer connector 14 can also include one or more stop tabs 78 separate from the threads 76 that extend radially inwardly from the inner surface 74 of the sidewall 72. The stop tabs 78 are disposed at the proximal end 68 of the outer connector 14 and are configured to prevent the inner connector 12 from advancing further into the outer connector 14. For example, as Figure 4B most clearly shown, the outer connector 14 can include a pair of opposing stop tabs 78 that are positioned to contact opposite curved portions 86 of the peripheral edge 54 of the flange 48 when the outer connector 14 is fully connected to the inner connector 12. More specifically, as Figure 5A and 5BAs shown, the stop tab 78 is positioned such that when the inner connector 12 is fully inserted into the outer connector 14, the distal surface 52 of the flange 48 abuts against the stop tab 78. The stop tab 78 prevents the practitioner from over-tightening the inner connector 12 and the outer connector 14, thereby ensuring that the inner connector 12 is correctly positioned relative to the outer connector 14 and can be easily removed from the outer connector 14 at the appropriate time.

[0100] As Figure 4C shown, the outer connector 14 can be integral with or connected to an accessory device such as a sterilization cap 18. As previously described, the sterilization cap 18 includes a housing 24 that includes a closed end, an open end, and a side wall extending between the closed end and the open end. The sterilization cap 18 also includes a sponge body 26 positioned within the housing 24. The outer connector 14 is positioned adjacent to the open end of the housing 24. In some examples, the outer connector 14 can be integral with the housing 24 of the sterilization cap 18. Alternatively, the outer connector 14 can be attached to the housing 24 by an adhesive or a mechanical fastener, as is known in the art.

[0101] As previously described, the inner connector 12 is configured to be removably engaged with the outer connector 14 by rotational engagement between the flange 48 of the inner connector 12 and the threads 76 of the outer connector 14. Figure 5A and 5B is a cross-sectional view showing a syringe 16 including an inner connector 12 connected to a sterilization cap 18 including an outer connector 14. Specifically, as Figure 5A shown, the inner connector 12 includes components of a male Luer connector, specifically a shield 28 and a stem 36. The shield 28 and the stem 36 are positioned within and enclosed by the housing 24 of the sterilization cap 18 to protect the shield 28 and the stem 36 from contact with microorganisms, particles, dirt, dust, and other debris that could contaminate the male Luer connector components or the syringe barrel 20 connected thereto. Importantly, the outer connector 14 engages with the inner connector 12 without contacting the stem 36, the shield 28, or the threads 44 of the inner connector. Alternatively, as Figure 5A shown, the flange 48 engages with the threads 76 of the outer connector 14 and abuts against the stop tab 78 of the outer connector 14. Thus, the inner connector 12 engages with the outer connector 14 without contacting or using any components of the male Luer connector, which means that the outer connector 14 does not contaminate, deform, or otherwise damage these components of the male Luer connector. In this way, these components are preserved for use, for example, in connecting the male Luer connector to a female needleless connector when the syringe 16 is used after the sterilization cap 18 is removed.

[0102] Figure 5B shows an inner connector 12 including features of a female Luer connector connected to an outer connector 14 including features of a sterilization cap 18. AsFigure 5B As shown, the flange 48 of the inner connector 12 engages the threads 76 of the outer connector 14 and is seated against the stop tab 78 of the outer connector 14. Additionally, the outermost portion of the inner connector 12 that includes the threads 64 on the outer surface 66 of the inner connector 12 is enclosed within the housing 24 of the sterilization cap 18. Accordingly, the threads 64 of the inner connector 12 are not used to attach the inner connector 12 to the sterilization cap 18. Additionally, no portion of the sterilization cap 18 is inserted into the central passage 62 of the inner connector 12. Thus, the structures of the inner connector 12 that are used to attach the inner connector 12 to the male Luer connector after the sterilization cap 18 is removed are not contaminated, deformed, or otherwise contacted by the outer connector 14.

[0103] Method for attaching an accessory device to a Luer connector

[0104] As previously described, the connector assembly 10 of the present disclosure is configured to connect devices and components of various sizes, configurations, and designs together. The devices can include components of male or female Luer connectors. Figure 6 FIG. is a flow chart showing the steps for connecting the inner connector 12 to the outer connector 14.

[0105] To connect a device (such as a syringe 16) that includes the inner connector 12 to an accessory device (such as a sterilization cap 18) that includes the outer connector 14, in step 210, the practitioner first removes any packaging from the syringe 16 and the sterilization cap 18. For example, the practitioner can remove a protective cap or membrane from the open end of the housing 24 of the sterilization cap 18. The practitioner can also remove any caps, covers, sheaths, or other packaging from the syringe 16.

[0106] In step 212, the practitioner then pushes the inner connector 12 in the direction of arrow A1 (shown in Figure 5A and 5B ) into the outer connector 18 so that the flange 48 of the inner connector 12 contacts the threads 76 on the inner surface 74 of the outer connector 14.

[0107] In step 214, once the flange 48 contacts the threads 76, the practitioner rotates the inner connector 12 relative to the outer connector 14, as shown by arrow A2 (in Figure 5A and 5B ). Rotation of the inner connector 12 relative to the outer connector 14 causes the flange 48 to move along the threads 76, thereby pulling the inner connector 12 further into the outer connector 14.

[0108] In step 216, the practitioner continues to rotate the inner connector 12 relative to the outer connector 14 until the distal surface 52 of the flange 48 is seated against the stop tab 78 of the outer connector 14, as shown in Figure 5Aand 5B as shown. As previously described, when the flange 48 contacts the stop tab 78, the inner connector 12 is fully engaged with the outer connector 14. The stop tab 78 prevents the inner connector 12 from advancing further axially relative to the outer connector 14.

[0109] In this position, as Figure 5A shown, the stem 36 and the shroud 28 of the inner connector 12 are enclosed within the housing 24 of the sterilization cap 18. Additionally, no portion of the outer connector 14 or the sterilization cap 18 engages or contacts the threads 44 on the stem 36 or the shroud 28 of the inner connector 12. In a similar manner, for Figure 5B the inner connector 12 of the component including the female Luer connector as shown, the outermost portion of the inner connector 12 including the threads 64 on the outer surface 66 of the inner connector 12 is fully enclosed within the housing 24 of the sterilization cap 18. Additionally, no portion of the outer connector 14 or the sterilization cap 18 engages with the outer threads 64 of the inner connector 12 or is inserted into the tapered central cavity 62 or the bore of the inner connector 12.

[0110] In step 218, to remove the inner connector 12 from the outer connector 14, the practitioner rotates the inner connector 12 relative to the outer connector 14 in a direction opposite to the arrow A2 (shown in Figure 5A and 5B ), causing the flange 48 to move away from or return from the threads 76 of the outer connector 14. Once the flange 48 is released from the threads 76, the practitioner can move the inner connector 12 and the syringe 16 away from the outer connector 14 and the sterilization cap 18.

[0111] In step 220, once the inner connector 12 and the syringe 16 are removed from the outer connector 14 and the sterilization cap 18, the inner connector 12 can be connected to another accessory device or a vascular access device. In particular, the vascular access device can be used to deliver a medical fluid from the syringe barrel 20 to a patient through the vascular access device. Specifically, the practitioner can attach the inner connector 12 of the syringe 16 to the vascular access device. Then, the practitioner can expel the fluid from the syringe barrel 20 into the vascular access device by moving the plunger or the stopper 22 through the syringe barrel 20.

[0112] Connector assembly including a snap - fit lock

[0113] Figures 7A - 8B shows another example of an outer connector 314 that can be connected to the aforementioned inner connector 12, such as an inner connector 12 including a male Luer component (shown in Figures 2A - 2C and / or an inner connector 12 including a female component (shown in Figures 3A - 3Cas shown). More specifically, as in the previous example, the outer connector 314 is configured to plug onto the inner connector 12, thereby forming a releasable engagement between the inner connector 12 and the outer connector 314.

[0114] In some examples, the outer connector 314 can be an annular body that includes a first or proximal end 368, a second or distal end 370, and an annular sidewall 372 extending between the proximal end 368 and the distal end 370. The outer connector 314 also includes a protrusion, latch, lock, or similar engagement structure that extends radially inward from the inner surface 374 of the sidewall 372 and is configured to engage the flange 48 of the inner connector 12 to secure the inner connector 12 to the outer connector 314.

[0115] However, different from the previous example, the protrusion, lock, or latch of the outer connector 314 forms a snap-fit engagement with the flange 48, rather than a Figure 5A and 5B rotational or threaded engagement as described for the previous example.

[0116] More specifically, as Figure 7A and 7B shown, the lock or latch can be a snap-fit annular body or ring that includes snap tabs configured to engage the surfaces 50, 52 of the flange 48. For example, the outer connector 314 can include a first or proximal tab 380 that extends radially inward from the proximal end 368 of the sidewall 372 and a distal tab 382 that extends radially inward from the distal end 370 of the sidewall 372. The flange 48 is configured to be inserted into the outer connector 314 through the distal end 370 and over the distal tab 382. Thus, as Figure 7A and 7B shown, the distal tab 382 can include a chamfered edge 384 to facilitate the insertion of the flange 48 over the distal tab 382. The proximal tab 380 does not include a chamfered edge. The proximal tab 380 and the distal tab 382 are configured to hold the flange 48 of the inner connector 12 within the space defined by the proximal tab 380 and the distal tab 382 through a snap-fit engagement. Thus, the distance between the inner surface of the proximal tab 380 and the inner surface of the distal tab 382 can correspond to the thickness of the flange 48, as previously described, which can be from about 0.2 mm to about 1.0 mm.

[0117] For example, depending on the design of the flange 48 and / or the degree of firmness with which the flange 48 needs to be held between the tabs 380, 382, the outer connector 314 can have various different arrangements of the tabs 380, 382. For example, as Figure 7A and 7BAs shown, the outer connector 314 includes six proximal tabs 380 and six distal tabs 382. In other examples, the outer connector 314 may have fewer than six tabs 380, 382 or more than six tabs 380, 382. The tabs 380, 382 are spaced equidistantly around the perimeter of the outer connector 314. Further, as Figure 7A and 7B shown, the proximal tabs 380 are axially offset from the distal tabs 382 such that the proximal tabs 380 do not overlap or cover the distal tabs 382. However, in other examples, the proximal tabs 380 may overlap the distal tabs 382 completely or partially. Additionally, as Figure 7A and 7B shown, the arc length of the proximal tabs 380 is greater than the arc length of the distal tabs 382 such that when the flange 48 is inserted into the outer connector 314 over the distal tabs 382, the distal tabs 382 can be more easily bent or deformed. In other examples, the distal tabs 382 may be thinner and / or more flexible than the proximal tabs 380, or may include bend points, notches or living hinges such that the distal tabs 382 can be easily bent to accommodate the insertion of the flange 48 into the outer connector 314.

[0118] Figure 8A and 8B are cross-sectional views showing the syringe 16 including the inner connector 12 connected to the sterilization cap 18 including the outer connector 314. As Figure 8A shown, the inner connector 12 includes features of a male luer connector, such as a stem 36 and a shield 28. The flange 48 is held within the snap ring of the outer connector 314 between the proximal tabs 380 and the distal tabs 382. Specifically, the distal surface 52 of the flange 48 is placed against the inward-facing surface of the proximal tabs 380, thereby preventing the flange 48 from moving further into the sterilization cap 18 or through the outer connector 314.

[0119] Figure 8B shows the inner connector 12 including a female luer component connected to the outer connector 314. As previously described, the flange 48 is held within the outer connector 314 between the proximal tabs 380 and the distal tabs 382, wherein the distal surface 52 of the flange 48 is placed against the inward-facing surface of the proximal tabs 380.

[0120] To connect the inner connector 12 to the outer connector 314, the practitioner moves the syringe 16 and the inner connector 12 toward the outer connector 314, as Figure 8A and 8BAs shown by arrow A3 in [description], the flange 48 contacts the distal tab 382 of the snap ring of the outer connector 314. Due to the chamfered shape or chamfered surface 384 of the distal tab 382, the flange 48 causes the distal tab 382 to deform or deflect away from the flange 48, thereby allowing the flange 48 to move past the distal tab 382 and into the outer connector 314. The practitioner continues to axially move the inner connector 12 relative to the outer connector 314 such that the distal surface 52 of the flange 48 contacts the proximal tab 380, as Figure 8A and 8B shown. In this position, the flange 48 engages with the outer connector 314, thereby forming a secure and fluid-tight connection between the inner connector 12 and the outer connector 314.

[0121] To remove the inner connector 12 from the outer connector 314, the practitioner can grasp the syringe 16 with one hand and the sterilization cap 18 with the other hand, and pull the syringe 16 away from the sterilization cap 18. When sufficient force is applied to the syringe 16 and the sterilization cap 18, the flange 48 presses against the distal tab 382, causing the distal tab 382 to deform or deflect away from the flange 48. Once the distal tab 382 is deflected or deformed away from the flange 48, the practitioner can pull the inner connector 12 away from the outer connector 314, thereby releasing the syringe 16 from the sterilization cap 18.

[0122] While examples of the connectors, connector assemblies, interfaces, systems, and methods of the present disclosure have been shown in the drawings and described in detail above, other examples will be apparent and readily achievable to those skilled in the art without departing from the scope and spirit of the invention. Accordingly, the foregoing description is intended to be illustrative rather than restrictive. The invention described above is defined by the appended claims, and all changes that fall within the meaning and equivalents of the claims will be included within their scope.

Claims

1. A connector assembly, comprising: An inner connector, the inner connector including a first end, a second end, a sidewall extending between the first end and the second end, and a flange connected to or radially outwardly extending from the sidewall; And An outer connector, the outer connector being configured to be inserted onto the inner connector, including a first end, a second end, a sidewall extending between the first end and the second end of the outer connector, and a lock radially inwardly extending from an inner surface of the sidewall of the outer connector, the lock being configured to engage the flange of the inner connector to thereby fix the inner connector to the outer connector.

2. The connector assembly according to claim 1, wherein, The inner connector includes a male Luer connector, the male Luer connector including: A stem, the stem including a proximal end connected to the sidewall of the inner connector, a distal end projecting distally beyond the second end of the sidewall of the inner connector, and a body extending between the proximal end and the distal end through a space defined by the sidewall of the inner connector; and At least one thread on an inner surface of the sidewall of the inner connector, the at least one thread being configured to engage a corresponding thread of a female Luer connector.

3. The connector assembly according to claim 2, wherein, The outer connector is configured to engage the inner connector without contacting the stem or the at least one thread of the inner connector.

4. The connector assembly according to claim 1, wherein, The inner connector is a female Luer connector, and wherein the sidewall of the inner connector includes threads on an outer surface of the sidewall, the threads being configured to engage corresponding threads of a shield of the male Luer connector.

5. The connector assembly according to claim 4, wherein, The outer connector is configured to engage the inner connector without contacting the threads on the outer surface of the sidewall of the inner connector.

6. The connector assembly according to claim 1, wherein, The inner connector includes a vascular access device, and the outer connector includes an accessory device configured to engage the vascular access device.

7. The connector assembly according to claim 6, wherein, The vascular access device includes at least one of a syringe, an infusion pump, an irrigation device, an intravenous drip device, or a catheter, and wherein the accessory device includes a sterilization cap, a safety device, a smart device, and / or a sensor device.

8. The connector assembly according to claim 1, wherein, The flange connected to or radially outwardly extending from the sidewall of the inner connector includes a peripheral edge, the peripheral edge including opposing flat portions and opposing curved portions between the flat portions.

9. The connector assembly according to claim 1, wherein, The lock includes threads radially inwardly extending from at least a portion of an inner surface of the sidewall of the outer connector.

10. The connector assembly according to claim 9, wherein, The threads extend less than a full turn around the inner surface of the sidewall of the outer connector.

11. The connector assembly according to claim 1, wherein, The flange of the inner connector includes a peripheral edge, the peripheral edge including opposing flat portions and opposing curved portions between the flat portions, wherein the lock includes threads radially inwardly extending from at least a portion of an inner surface of the sidewall of the outer connector, and Wherein, the outer connector further includes at least one blocking tab that extends radially inward from a sidewall of the outer connector and is separated from the thread, the at least one blocking tab being disposed at a first end of the outer connector and configured to contact opposite curved portions of the flange to block further advancement of the inner connector into the outer connector.

12. The connector assembly according to claim 1, wherein, The lock includes a locking ring that includes an annular sidewall, a plurality of first tabs that extend radially inward from a first annular edge of the sidewall, and a plurality of second tabs that extend radially inward from a second annular edge of the sidewall.

13. The connector assembly according to claim 12, wherein, The plurality of first tabs and the plurality of second tabs are configured to hold the flange of the inner connector by snap-fit engagement.

14. The connector assembly according to claim 12, wherein, The plurality of second tabs include chamfered surfaces to facilitate insertion of the inner connector into the outer connector.

15. The connector assembly according to claim 12, wherein, By applying an axial force to the inner connector sufficient to deflect the plurality of second tabs away from the flange such that the flange moves into a space between the first tabs and the second tabs to insert the flange into the locking ring, and wherein, by applying an axial force to the inner connector or to the outer connector sufficient to overcome the snap-fit engagement between the locking ring and the flange, the inner connector can be axially moved relative to the outer connector to remove the flange from the locking ring.

16. A vascular access device configured to be connected to an accessory device, the vascular access device comprising: A tubular body that defines a fluid path that extends at least partially through the tubular body, the fluid path including a proximal end portion and a distal end portion; A male connector connected to the tubular body, the male connector including: A stem that defines a fluid path fluidly connected to a distal end portion of the fluid path of the tubular body, the stem being configured to be inserted into a fluid path of a female connector; A shroud connected to a first end of the stem and at least partially enclosing the stem; and Threads that extend radially inward from an inner surface of the shroud and are configured to engage corresponding threads on an outer surface of the female connector; and A flange connected to or extending radially outward from a sidewall of the shroud, the flange being configured to engage a lock that extends radially inward from an inner surface of a tubular sidewall of the accessory device.

17. The vascular access device according to claim 16, wherein, The accessory device is configured to engage the flange of the vascular access device without contacting the stem or the at least one thread.

18. The vascular access device according to claim 16, wherein, The vascular access device includes at least one of a syringe, an infusion pump, an irrigation device, an intravenous drip device, or a catheter, and wherein, the accessory device includes a sterilization cap, a safety device, a smart device, and / or a sensor device.

19. An attachment method for attaching an inner connector to an outer connector, comprising: Insert the inner connector into the outer connector, the inner connector including a first end, a second end, a sidewall extending between the first end and the second end, and a flange connected to or radially outwardly extending from the sidewall, the outer connector including a lock radially inwardly extending from the inner surface of the outer connector; and move the inner connector through the outer connector such that the flange of the inner connector engages the lock of the outer connector to fix the inner connector to the outer connector.

20. The method according to claim 19, wherein, The inner connector includes a vascular access device, and the outer connector includes an accessory device configured to engage the vascular access device.

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