Fluid Sample Collection Container With Cap and Removal Tool for Finger Grip Luer Adapter

A container assembly including a collection container and a container lid couplable to the collection container. An elongate receptacle extends from the container lid into the collection container when the container lid is coupled to the collection container. The elongate receptacle has an open end portion defined within the container lid and is configured to receive a specimen collection tube therein. A finger grip luer adapter is removably coupled to the container lid within the elongate receptacle, the finger grip luer adapter having a needle extending therefrom. An elongate cap is removably coupled to the finger grip luer adapter and is configured to extend over at least the needle of the finger grip luer adapter, wherein an upper portion of the elongate cap extends above at least a portion of the open end portion of the elongate receptacle when coupled to the finger grip luer adapter.

BACKGROUND

Field of the Disclosure

The present disclosure relates generally to a container assembly for collecting a fluid specimen. More particularly, the present disclosure relates to a container assembly including a combined finger grip luer adapter (FGLA) cap and removal tool.

Description of the Related Art

To conduct laboratory testing on biological fluid samples such as urine, it is necessary to provide a container for collecting the fluid sample. These collection containers typically include a cup-shaped container with a removable lid. Once a fluid sample has been collected in the container, the lid is reapplied. The collection container may then be transported to a laboratory or other testing facility where a sample of the collected specimen is extracted for test purposes.

To simplify the sample extraction process, prior collection containers have used lids which not only cover and seal the collection container, but also provide for the use of an extraction device which permits the extraction of a sample of the fluid specimen. Such lids may include a receptable or cavity which supports a tube extending within the cavity to the lower end of the cup-shaped container in fluid communication with the specimen contained within the container. The tube or the lid may include an elongated receptacle housing a cannula and needle so that an air-evacuated collection device (e.g., a specimen collection tube) may be attached thereto to draw a portion of the collected sample thereinto without the need for removal of the lid. In such configurations, the sample can be removed without spilling or contaminating the sample and/or cavity area. Subsequent samples may be drawn from the collection container by using a plurality of collection tubes.

However, in prior collection containers, the cannula is provided within the elongated receptacle in the form of a finger grip luer adapter (FGLA) that is non-removably integrated into the container lid. Thus, when the user has completed all sample collection(s) and wishes to dispose of the container assembly, the entire removable lid must be disposed of in an appropriate sharps container or sharps biohazard container. Due to their large volume, removable lids will quickly fill the sharps container, necessitating frequent service by a qualified disposal firm to safely handle the sharps and/or biohazard waste. As such disposal services are far more expensive than conventional waste disposal services, health care providers generally seek to minimize the accumulated volume of sharps and/or biohazard waste.

Additionally, due to the FGLA being integrated into the lid, the patient and/or healthcare worker may be more at risk of needle-stick injuries during sample collection, transport, and/or disposal.

SUMMARY

In view of the foregoing, there exists a need for a fluid sample collection container having a reduced volume of sharps waste and which protects users and/or healthcare workers from potential needle-stick injuries.

In accordance with an embodiment of the present invention, a container assembly for collecting a fluid specimen includes a collection container defining a chamber for receiving the fluid specimen, and a container lid couplable to an open end of the collection container to at least partially close the open end thereof. The container assembly also includes an elongate receptacle extending from the container lid into the chamber of the collection container when the container lid is coupled to the open end of the collection container, the elongate receptacle having an open end portion defined within the container lid and configured to receive a specimen collection tube therein. The container assembly also includes a finger grip luer adapter removably coupled to the container lid within the elongate receptacle, with the finger grip luer adapter including a needle extending therefrom. The container assembly further includes an elongate cap removably coupled to the finger grip luer adapter and configured to extend over at least the needle of the finger grip luer adapter, wherein an upper portion of the elongate cap extends above at least a portion of the open end portion of the elongate receptacle when coupled to the finger grip luer adapter.

In certain configurations, the upper portion of the elongate cap include a finger grip portion, and the finger grip portion is configured to extend above an upper surface of the container lid when coupled to the finger grip luer adapter. The finger grip portion may include a ribbed or textured surface so as to improve a user's grip on the finger grip portion of the elongate cap. The elongate cap may include an elongate portion and a cavity, wherein the cavity extends from an open end on a distal end of the elongated portion. The distal end of the elongated portion of the elongate cap may be configured to slip-fittingly or press-fittingly couple to an upper portion of the finger grip luer adapter.

In certain embodiments, the upper portion of the finger grip luer adapter includes a ribbed or textured surface. In other configurations, the lower portion of the finger grip luer adapter is configured to be removably couplable to the elongate receptacle of the container lid. The lower portion of the finger grip luer adapter may include external threads, and the external threads may be configured to mate with a corresponding internal thread portion of the elongate receptacle. The finger grip luer adapter may be threadingly coupled to the container lid.

In other configurations, the finger grip luer adapter is removable from the container lid by way of counterclockwise rotation of the elongate cap when the elongate cap is coupled to the finger grip luer adapter. At least one of the collection container and the container lid are formed of a polymeric resin. Optionally, the elongate cap is formed of a polymeric resin.

In accordance with a further embodiment of the present invention, a container lid assembly for use with a container assembly for collecting a fluid specimen, includes an elongate receptacle having an open end portion defined within the container lid and configured to receive a specimen collection tuber therein. The container lid assembly also includes a finger grip luer adapter removably coupled to the container lid within the elongate receptacle, the finger grip luer adapter comprising a needle extending therefrom, and an elongate cap removably coupled to the finger grip luer adapter. The elongate cap is configured to extend over at least the needle of the finger grip luer adapter, in which an upper portion of the elongate cap extends above at least a portion of the open end portion of the elongate receptacle when coupled to the finger grip luer adapter.

In certain configurations, the distal end of the elongate cap is configured to slip-fittingly or press-fittingly couple to an upper portion of the finger grip luer adapter. The upper portion of the finger grip luer adapter may include a ribbed or textured surface. The lower portion of the finger grip luer adapter may be configured to be removably couplable to the elongate receptacle of the container lid. Optionally, the lower portion of the finger grip luer adapter may include external threads, which are configured to mate with a corresponding internal thread portion of the elongate receptacle. The finger grip luer adapter may be removable from the container lid by way of counterclockwise rotation of the elongate cap when the elongate cap is coupled to the finger grip luer adapter.

In accordance with yet another embodiment of the present invention, a method of forming a container assembly for collecting a fluid specimen includes providing a collection container defining a chamber for receiving the fluid specimen. The method also includes providing a container lid couplable to the collection container, wherein the container lid comprises an elongate receptacle having an open end portion defined within the container lid and configured to receive a specimen collection tube therein. The method also includes coupling a finger grip luer adapter to the container lid within the elongate receptacle, the finger grip luer adapter having a needle extending therefrom. The method further includes coupling an elongate cap to the finger grip luer adapter such that the elongate cap extends over at least the needle of the finger grip luer adapter, wherein an upper portion of the elongate cap extends above at least a portion of the open end portion of the elongate receptacle when coupled to the finger grip luer adapter.

In certain configurations, the method further requires that the finger grip luer adapter is threadingly coupled to the elongate receptacle of the container lid.

Further details and advantages of the present disclosure will be understood from the following detailed description read in conjunction with the accompanying drawings.

DESCRIPTION OF THE INVENTION

Referring toFIG.1, a fluid sample collection container assembly20in accordance with an aspect of the present disclosure is shown. Fluid sample collection container assembly20includes a collection container22and a container lid24. An exemplary collection container assembly20in accordance with the present disclosure may be used to safely collect a fluid specimen (e.g., urine), transport the fluid specimen, and draw a sample of the fluid specimen.

In one embodiment, collection container22and container lid24may be formed from any conventional material such as, e.g., a polymeric resin. Polymeric resins are well known in the art and include, for example, polyethylene, polycarbonate, polystyrene, and similar polymeric resinous materials. However, it is to be understood that collection container22and/or container lid24may be formed of other appropriate materials, and may be formed of different materials.

Collection container22generally includes a sidewall30extending between a first, open end (not shown) and a second, closed end34. Sidewall30defines an interior chamber for receiving a fluid specimen such as, e.g., urine. In one embodiment, sidewall30of collection container22comprises a slightly tapering, tubular vessel having continuous, tapered sidewalls30. In one embodiment, the collection chamber of container22is suitable for holding biologically hazardous materials. In one embodiment, sidewall30of collection container22may include at least one fill level indicator which identifies a fluid level of a collected fluid specimen.

Container lid24generally includes a flange50extending around its outer rim, with flange50being sized to provide a tight fit upon the collection container22when container lid24is placed over the first, open end of collection container22. In one embodiment, container lid24includes a generally disc-shaped component having an outer or peripheral zone62and an inner or central zone64. Flange50extends downward from peripheral zone62of container lid24. As is shown inFIG.2, flange50includes an inner surface which includes a means or mechanism for sealingly engaging container lid24with the collection container22. In one embodiment, flange50includes an interior threaded portion, thereby enabling container lid24to be threadingly connectable to a corresponding exterior threaded portion of the collection container22. In other embodiments, the sealing portion of container lid24may include a snap fit mechanism, a ball detent, an interference fit mechanism, locking tabs, a spring loaded locking mechanism, a latch, or other similar mechanism to sealingly engage container lid24to collection container22, thereby substantially preventing a fluid specimen contained within collection container22and container lid24from leaking out, while also preventing contaminants from entering.

Referring toFIG.2, container lid24also includes an elongate receptacle52extending from the central zone64into collection container22and towards the second, closed end34of collection container22. Receptacle52includes an open end portion54and an opposing lower end portion56, with a receiving cavity60defined therein. In one embodiment, receiving cavity60is sized and shaped to receive a specimen collection tube such as, e.g., an evacuated tube (not shown). In this way, a fluid specimen within collection container22can be transferred to the specimen collection tube without the need to remove container lid24.

Referring still toFIG.2, a finger grip luer adapter (FGLA)80is positioned within a central portion59of the receptacle52. Specifically, FGLA80includes an upper portion82and a lower portion84. Upper portion82is configured to extend upward toward receiving cavity60and may include ribbed or textured outer sidewalls. On the other hand, in one embodiment, lower portion84includes external threads, which are configured to mate with a corresponding internal thread portion58of the receptacle52. In this way, the FGLA80may be removably secured to the receptacle52via a threaded interface. Alternatively, in another embodiment, FGLA80may be removably secured to receptacle52by way of a press-fit or slip-fit connection.

Additionally, FGLA80includes a needle86extending upward from upper portion82and into the receiving cavity60. In one embodiment, a retractable sleeve88may extend over needle86. While not shown, needle86is configured to pierce the stopper of a specimen collection tube that is inserted into receptacle52by a user. In this way, a fluid specimen may be drawn from the collection container22into the specimen collection tube through the lower end portion56of receptacle52and FGLA80, thereby enabling the user to collect the fluid specimen without necessitating removal of the container lid24from collection container22.

FIG.2further shows a combined FGLA cap and removal tool100in accordance with an aspect of the present disclosure. As will be described in detail hereinbelow, FGLA cap and removal tool100serves the dual purpose of protecting all users from needle-stick injuries and substantially reducing sharps waste when the fluid sample collection container assembly20is to be discarded.

In one embodiment, FGLA cap and removal tool100includes a finger grip portion102. Finger grip portion102is configured to extend outside of the receiving cavity60and above the central zone64of container lid24to allow for easy access by the user. Additionally, in one embodiment, the finger grip portion102may be ribbed, textured, or otherwise treated so as to improve the user's hold on the finger grip portion102. The FGLA cap and removal tool100may be formed of any appropriate material or materials such as, e.g., a polymeric resin. Examples of polymeric resins include, e.g., polyethylene, polycarbonate, polystyrene, and similar polymeric resinous materials. However, it is to be understood that FGLA cap and removal tool100may be formed of other appropriate materials, and may be formed of two or more different materials.

FGLA cap and removal tool100also includes an elongated bottom portion104. A distal end of the elongated portion104is open, and a cavity106is formed within the elongated portion104. The cavity106extends from the open end of elongated portion104toward the finger grip portion102. As is shown inFIG.2, a lower section of cavity106of elongated portion104is configured to be slip-fit or press-fit over the upper portion82of FGLA80such that the elongated portion104is removably secured to upper portion82of FGLA80. As disclosed above, the upper portion82may include ribbed or textured outer sidewalls, which may aid in providing a secure interface between the FGLA80and the FGLA cap and removal tool100. Additionally and/or alternatively, the inner sidewall of elongated portion104may also be ribbed or textured. Furthermore, in another embodiment, the lower section of cavity106of elongated portion104may include a threaded portion configured to mate with a complimentary threaded portion on the upper portion82of the FGLA80.

As is shown inFIG.2, the cavity106is sized so as extend over the needle86of FGLA80. In this way, when FGLA cap and removal tool100is in position on FGLA80, the FGLA cap and removal tool100acts to protect all users (e.g., patients and healthcare workers) from potential needle stick injuries, as needle86is completely enclosed within cavity106. As the FGLA cap and removal tool100is slip-fit or press-fit onto FGLA80, the user can remove the FGLA cap and removal tool100by applying an upward pulling force via the finger grip portion102. Conversely, the user can replace the FGLA cap and removal tool100over the FGLA80by applying a downward pushing force via the finger grip portion102.

However, while FGLA cap and removal tool100may be slid onto (or removed from) FGLA80via axial force relative to the FGLA80, the interface between lower section of cavity106of elongated portion104and the upper portion82of FGLA80is sufficiently constricted so as to transfer rotational force applied by the user via finger grip portion102onto the FGLA80. That is, if the user rotates the FGLA cap and removal tool100in a counterclockwise direction, lower portion84of FGLA80will unthread from internal thread portion58of receptacle52. As the user continues to rotate the FGLA cap and removal tool100, the FGLA80will eventually disconnect entirely from receptacle52, leaving the FGLA80secured to only the FGLA cap and removal tool100. In this way, the FGLA80(and the incorporated needle86) are separable from the container lid24, with the needle86being enclosed within the elongated bottom portion104of FGLA cap and removal tool100.

Once removed, the user may then dispose of both the FGLA cap and removal tool100and the attached FGLA80in an appropriate sharps container or sharps biohazard container. As discussed above, conventional container lids typically used in specimen extraction via evacuated tubes include a finger grip luer adapter (FGLA) that is non-removably integrated into the container lid. Thus, the entire lid assembly must be disposed of within a sharps container or sharps biohazard container. However, in accordance with embodiments of the present disclosure, only the FGLA cap and removal tool100and removable FGLA80need be disposed of in a sharps container or sharps biohazard container, thereby greatly reducing the volume (and subsequent cost) of sharps waste, as the container lid24and collection container22may be disposed of separately as standard medical waste.

Referring toFIGS.3A-3D, various in-use views of fluid sample collection container assembly20in accordance the present disclosure are shown.FIG.3Aillustrates fluid sample collection container assembly20prior to or after fluid sample collection, wherein FGLA cap and removal tool100is positioned on the needle and FGLA (not shown). In this way, the FGLA cap and removal tool100protects all users from the needle housed within the receiving cavity60of container lid24.

Referring toFIG.3B, when the user wishes to the expose the needle and FGLA within receiving cavity60in order to collect a fluid sample via, e.g., an evacuated tube, the FGLA cap and removal tool100may be pulled upward, thereby releasing the slip-fit or press-fit connection between the FGLA and the elongated portion104. After collection of the fluid sample, the FGLA cap and removal tool100may be returned to the position shown inFIG.3A.

When all necessary fluid sample(s) have been collected from the collection container22and the user wishes to discard of the fluid sample collection container assembly20, the user may rotate the FGLA cap and removal tool100in a counter-clockwise direction, as is shown inFIG.3C. As described above, such rotation allows for the separation of the FGLA from the container lid24, with the needle of the FGLA still being protected within the elongated portion104of the FGLA cap and removal tool100, as is shown inFIG.3D. The user may then discard of the combined FGLA cap and removal tool100and FGLA into an appropriate sharps container or sharps biohazard container, while the remaining portions of the fluid sample collection container assembly20(i.e., the collection container22and the container lid24) may be disposed of in a standard medical waste container.

Next, referring toFIG.4, a container lid assembly200for use with a fluid sample collection container assembly in accordance with another aspect of the present disclosure is shown. In the embodiments described above with respect toFIGS.2-3D, the fluid sample collection container assembly20included an FGLA cap and removal tool100that at least partially extends above a top surface64of the container lid24, thereby enabling the user to grip the FGLA cap and removal tool100without reaching into the receiving cavity60. However, in the embodiment shown inFIG.4, container lid assembly200includes a FGLA cap and removal tool202, the uppermost point of which extends below a top surface204of the container lid assembly200.

Referring still toFIG.4, the container lid assembly200includes an elongate receptacle211, which is configured to extend into a collection container (not shown). An opening212is formed in the top surface204of the container lid assembly200above the elongate receptacle211, while a lower portion213extends below the elongate receptacle211. While not shown inFIG.4, is to be understood that the lower portion213may be configured to receive a finger grip luer adapter (FGLA), similar to FGLA80shown and described with respect toFIG.2, with the FGLA cap and removal tool202configured to extend over portions of the FGLA to protect from needle stick injuries and/or enable removal of the FGLA without needle exposure.

Elongate receptacle211includes cut-out portions208at an upper end portion thereof, with the cut-out portions208defining an open end portion214accessible to the fingers of the user. When installed, an upper portion of the FGLA cap and removal tool202extends within an upper receiving cavity205and above at least a portion of the open end portion214, while a lower portion of the FGLA cap and removal tool202extends within a lower receiving cavity206, which lies below the open end portion214. The upper receiving cavity205is defined between the opening212and a juncture210of the elongate receptacle211, while the lower receiving cavity206is defined between the juncture210and the lower surface of the elongate receptacle211. When combined, the upper receiving cavity205and lower receiving cavity206are sized and shaped to receive a specimen collection tube such as, e.g., an evacuated tube (not shown). In this way, a fluid specimen within the collection container can be transferred to the specimen collection tube without the need to remove container lid assembly200.

Due to the cut-out portions208formed in the container lid assembly200, the FGLA cap and removal tool202need not include a gripping portion which extends above the top surface204in order for a user to access the FGLA cap and removal tool202. However, because the needle of the FGLA is housed within the lower receiving cavity206of the elongate receptacle211, the user is substantially protected from needle stick injuries when installing or removing the FGLA cap and removal tool202.

While several embodiments of a fluid sample collection container assembly are shown in the accompanying figures and described hereinabove in detail, other embodiments will be apparent to, and readily made by, those skilled in the art without departing from the scope and spirit of the invention. For example, it is to be understood that this disclosure contemplates, to the extent possible, that one or more features of any embodiment can be combined with one or more features of any other embodiment. Accordingly, the foregoing description is intended to be illustrative rather than restrictive.