Fluid sample collection container and lid with vented seal arrangement - Patent Application 20070122997

Abstract

A container assembly for collecting a fluid sample, the container assembly including a collection container having a first end, a second end, and a sidewall extending therebetween, the collection container defining a chamber for receiving the fluid sample. The container assembly may include a container lid coupleable to the collection container and at least partially closing a first end thereof. The container lid may include a sealing interface configured to at least partially contact the collection container when the container lid is coupled to the collection container. The sealing interface includes a textured sealing surface area configured to allow air to enter and exit the container assembly while maintaining a substantially liquid-tight seal between the container lid and the collection container when the container lid is coupled to the collection container.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Application No. 63 / 047,051, filed July 1, 2020, entitled "Fluid Sample Collection Container and Lid with Vented Seal Configuration," the entire disclosure of which is incorporated by reference in its entirety. [Background technology]

[0002] FIELD OF THE INVENTION The present disclosure relates generally to a container assembly for collecting a fluid sample. In particular, the present disclosure relates to a container assembly including a vented seal arrangement between a collection container and a container lid.

[0003] 2. Description of Related Art In order to perform clinical tests on bodily fluid samples, such as urine, it is necessary to provide a container for collecting the bodily fluid sample. These collection containers typically include a cup-shaped container with a removable lid. Once the fluid sample has been collected in the container, the lid is reapplied. The collection container can then be transported to a laboratory or other testing facility, where a sample of the collected specimen is extracted for testing purposes.

[0004] To simplify the sample extraction process, conventional collection containers use lids that not only cover and seal the collection container but also provide for the use of an extraction device that allows for the extraction of a sample of a fluid specimen. Such lids can include a receptacle or cavity that supports a tube that extends within the cavity to the bottom end of the cup-shaped container in fluid communication with the sample contained within the container. The tube or lid can include a needle so that an evacuated collection device (e.g., a sample collection tube) can be attached thereto to draw a portion of the collected sample into it without having to remove the lid. In such a configuration, the sample can be removed without spilling or contaminating the sample and / or the cavity area. Subsequent samples can be drawn from the collection container using multiple collection tubes.

[0005] However, conventional collection containers utilize an interface between the lid and the cup-shaped collection container that, when properly closed, hermetically seals the connection interface between the lid and the container. This complete seal between the container and lid can lead to the possibility of the sample collection tube underfilling when drawing fluid from the container into the evacuated collection tube. This underfilling potential arises because a vacuum is created in the headspace of the container above the fluid sample as the fluid (such as urine) is drawn from the container into the collection tube. The vacuum created in the headspace makes it more difficult for the evacuated collection tube to draw fluid from the container, resulting in the possibility of underfilling and / or slow fill times. The underfilling and / or slow fill issues can be exacerbated when older evacuated collection tubes are used, as the tube itself may not be as effective at drawing fluid from the container.

[0006] Previous designs have attempted to alleviate this problem by increasing the overall container assembly (and therefore the headspace). However, such a solution results in an unnecessarily large container assembly and adds significant material costs.

[0007] Alternatively, if the user wishes to release the vacuum, the lid must be partially removed from the collection container, which may result in significant leakage from the container during sampling, transport, and / or storage. Summary of the Invention [Problem to be solved by the invention]

[0008] In view of the above, there exists a need for a sealing arrangement between a collection container and a lid that allows for improved tube filling, regardless of the amount of fluid in the collection container, the size of the collection container, and / or the age of the tube, while still preventing leakage of fluid from the collection container during collection, transport, and / or storage. [Means for solving the problem]

[0009] According to one embodiment of the present invention, a container assembly for collecting a fluid sample includes a collection container having a first end, a second end, and a sidewall extending therebetween, and defining a chamber for receiving the fluid sample. The assembly also includes a container lid coupleable to the collection container and at least partially closing the first end thereof, the container lid including an elongated receptacle extending into the chamber of the collection container. The receptacle includes an open end defined in an upper surface of the container lid and configured to receive a sample collection tube therein. The container lid includes a sealing interface configured to at least partially contact the collection container when the container lid is coupled to the collection container. The sealing interface includes a textured sealing surface area configured to allow air to pass into and out of the container assembly while maintaining a substantially fluid-tight seal between the container lid and the collection container when the container lid is coupled to the collection container.

[0010] Optionally, the textured sealing surface area can be formed by a chemical etching process. The container lid can be threadably engageable with the collection canister. In certain configurations, the collection canister further includes a stop ring extending circumferentially around and below the externally threaded portion of the collection canister. The container lid can also include a flange extending around its outer edge, the lower surface of the flange configured to contact the upper surface of the stop ring when the container lid is fully coupled to the collection canister. The lower surface of the flange can include a textured second sealing surface area configured to allow air to enter and exit the container assembly when the container lid is coupled to the collection canister. Optionally, the flange can include an internally threaded portion configured to allow the container lid to be threadably engaged with the externally threaded portion of the collection canister. The flange can include a plurality of ribs extending circumferentially therearound.

[0011] According to another embodiment of the present invention, a container lid for use in a container assembly for collecting a fluid sample includes a disk-shaped peripheral zone and a central zone disposed within the peripheral zone, the central zone including an elongated receptacle extending downwardly therefrom. The receptacle has an open end defined in an upper surface of the central zone and is configured to receive a sample collection tube therein. The container lid further includes a flange extending downwardly from the peripheral zone, the flange including an inner surface configured to releasably engage a collection container. At least a portion of the inner surface includes a textured sealing surface area.

[0012] In certain configurations, the textured sealing surface area is formed by a chemical etching process. The inner surface may further include a threaded portion configured to allow the container lid to be threadedly engaged with the externally threaded portion of the collection canister. The flange may also include a lower surface, which may include a textured second sealing surface area configured to allow air to enter and exit the canister assembly when the canister lid is coupled to the collection canister. Optionally, the textured second sealing surface area is formed by a chemical etching process. The flange may further include a plurality of ribs extending circumferentially therearound.

[0013] According to a further embodiment of the present invention, a method of forming a container assembly for collecting a fluid sample includes providing a collection container having a first end, a second end, and a sidewall extending therebetween and defining a chamber for receiving a fluid sample. The method also includes providing a container lid coupleable to the collection container and at least partially closing the first end thereof, wherein the container lid includes an elongated receptacle extending downwardly therefrom, the receptacle configured to receive a sample collection tube therein. The container lid further includes a flange extending around its outer edge, the inner surface of the flange having a textured sealing surface area formed thereon. When the container lid is coupled to the collection container, the textured sealing surface area of ​​the container lid contacts a surface of the collection container, allowing air to pass in and out of the container assembly while maintaining a substantially fluid-tight seal with the collection container.

[0014] In certain configurations, the method further includes forming a stop ring extending circumferentially around the collection canister. The method may further include forming a textured second sealing surface area on an underside of the flange, where the underside of the flange is configured to contact an upper surface of the stop ring when the canister lid is fully coupled to the collection canister.

[0015] Further details and advantages of the present disclosure will be understood from the following detailed description read in conjunction with the accompanying drawings. [Brief explanation of the drawings]

[0016] [Figure 1] FIG. 1 is a perspective view of a collection canister assembly according to one aspect of the present disclosure. [Figure 2] FIG. 2 is a side view of the collection canister of the collection canister assembly shown in FIG. 1. [Figure 3] 2 is a side view of the canister lid of the collection canister assembly shown in FIG. 1. [Figure 4A] 2 is a cross-sectional view of the collection canister assembly shown in FIG. 1. [Figure 4B] 2 is a detailed cross-sectional view of a portion of the collection canister assembly shown in FIG. 1. [Figure 5A] FIG. 4 is a cross-sectional view of the container lid shown in FIG. [Figure 5B] FIG. 4 is a detailed cross-sectional view of a portion of the container lid shown in FIG. 3. DETAILED DESCRIPTION OF THE INVENTION

[0017] The following description is provided to enable any person skilled in the art to make and use the described embodiments contemplated for practicing the invention. However, various modifications, equivalents, variations, and alternatives will be readily apparent to those skilled in the art. Any and all such modifications, variations, equivalents, and alternatives are intended to be within the spirit and scope of the present invention.

[0018] For purposes of the following description, the terms "top," "bottom," "right," "left," "vertical," "horizontal," "upper," "lower," "transverse," "longitudinal," and their derivatives shall refer to the present invention as oriented in the drawings. However, it should be understood that the present invention contemplates various alternative modifications unless expressly specified to the contrary. It should also be understood that the specific devices illustrated in the accompanying drawings and described in the following specification are merely exemplary embodiments of the present invention. Accordingly, specific dimensions and other physical characteristics related to the embodiments disclosed herein are not to be considered limiting.

[0019] 1, a collection container assembly 20 according to one aspect of the present disclosure is shown. The collection container assembly 20 includes a collection container 22 and a container lid 24. The exemplary collection container assembly 20 according to the present disclosure can be used to safely collect a fluid sample (e.g., urine), transport the fluid sample, and withdraw a sample of the fluid sample.

[0020] 1 and 2, the collection container 22 generally includes a sidewall 30 extending between a first open end 32 and a second closed end 34. The sidewall 30 defines an interior chamber for receiving a fluid sample, such as urine. In one embodiment, the sidewall 30 of the container 22 includes a slightly tapered tubular container having a continuously tapered sidewall 30. The open end 32 defines a lip 33 and includes an externally threaded portion 40 therearound. The closed end 34 includes a bottom wall 35. In one embodiment, the collection chamber of the container 22 is suitable for holding biologically hazardous materials. In one embodiment, the sidewall 30 of the collection container 22 includes at least one fill level indicator, which can confirm the fluid level of a collected fluid sample.

[0021] In one embodiment, the collection container 22 and the container lid 24 may be formed from any conventional material, such as a polymeric resin. Polymeric resins are well known in the art and include, for example, polyethylene, polycarbonate, polystyrene, and similar polymeric resin materials. However, it should be understood that the collection container 22 and / or the container lid 24 may be formed from other suitable materials or may be formed from different materials.

[0022] 1 and 3, the container lid 24 generally includes a flange 50 extending around its outer edge, the flange 50 being sized to provide an interference fit with the collection canister 22 when the container lid 24 is placed over the first open end 32 of the collection canister 22. The flange 50 of the container lid 24 may include a plurality of ribs 51 disposed on the outer surface of the flange 50. The ribs 51 may provide a gripping means that allows a user or tool to more easily grasp the container lid 24 when attaching or removing the container lid 24 from the collection canister 22.

[0023] Additionally, the container lid 24 includes an elongated receptacle 52 that extends into the collection container 22 toward the bottom wall 35 of the collection container 22. The receptacle 52 includes an open end 54 and an opposite lower end 56, with a receptacle cavity 60 defined therein. In one embodiment, the receptacle cavity 60 is sized and shaped to receive a sample collection tube, e.g., an empty tube (not shown). In this manner, a fluid sample within the collection container 22 can be transferred to the sample collection tube without having to remove the container lid 24. Although not shown, in one embodiment, the receptacle 52 includes a needle or cannula configured to pierce the stopper of the sample collection tube, allowing the sample to be drawn from the collection container 22 into the sample collection tube. Because the receptacle 52 extends far into the collection container 22 when the container lid 24 is attached (as shown in FIG. 4B ), the needle is well protected within the receptacle 52, thereby reducing the risk of needlestick injury to the user.

[0024] 1 and 3, in one embodiment, the container lid 24 includes a generally disc-shaped component having an outer or peripheral zone 62 and an inner or central zone 64. A flange 50 extends downwardly from the peripheral zone 62 of the container lid 24. As shown in FIGS. 4A-5B, the flange 50 has an inner surface that includes a means or mechanism for sealingly engaging the container lid 24 with the open end 32 of the collection canister 22. In one embodiment, the flange 50 includes an internally threaded portion 68 that allows the container lid 24 to be threadedly engaged with the open end 32 of the collection canister 22 via mating threaded portions 40, 68, as shown in FIG. 4B. In another embodiment, the sealing portion of the container lid 24 may include a snap fit mechanism, a ball detent, an interference fit mechanism, a locking tab, a spring-loaded locking mechanism, a latch, or other similar mechanism to sealingly engage the container lid 24 with the collection container 22, thereby substantially preventing leakage of the fluid sample contained within the collection container 22 and container lid 24 while preventing the ingress of contaminants.

[0025] As shown in FIG. 2 , the collection canister 22 further includes a stop ring 38 extending circumferentially around the collection canister 22 below the externally threaded portion 40. The stop ring 38 includes an upper surface 39. When the canister lid 24 is secured to the collection canister 22, the stop ring 38 is configured to prevent over-torque / over-rotation of the canister lid 24 on the collection canister 22. Additionally, in one embodiment, the stop ring 38 functions as a second sealing surface to prevent fluid leakage from the collection canister 22. In particular, with reference to FIG. 4B , the lower surface 66 of the flange 50 is configured to contact the upper surface 39 of the stop ring 38 when the canister lid 24 is fully connected to the collection canister 22. In this manner, the upper surface 39 functions as a stop to prevent over-rotation of the canister lid 24, thereby preventing the sealing surface 70 on the canister lid 24 from over-tightening (or "bottoming out") the lip 33 of the collection canister 22. Additionally, the interface between upper surface 39 of stop ring 38 and lower surface 66 of flange 50 acts as a second sealing surface in the event of fluid leakage through the interface between sealing surface 70 and lip 33 .

[0026] As described above, in conventional container lids and collection containers, the connection interface between the lid and container is typically completely sealed against the ingress and egress of not only fluid(s) but also air. This complete seal between the container and lid can cause the sample collection tube to become underfilled when fluid is drawn from the container into the evacuated collection tube because a vacuum is created in the container's headspace above the fluid sample as the fluid is drawn from the container. However, referring to Figures 5A and 5B, a container lid 24 according to one embodiment of the present disclosure is shown in greater detail, configured to prevent or substantially reduce the creation of a vacuum in the headspace of a collection container to which it is coupled.

[0027] 5B, the sealing interface 70 of the container lid 24 includes a sealing surface area 72. The sealing surface area 72 is a textured or roughened portion of the sealing interface 70 that provides ventilation to the headspace above the fluid sample in the collection container 22. In this manner, when the fluid sample is drawn from the collection container assembly 20 through an empty tube (not shown), a vacuum is not created in the headspace, thereby allowing the empty tube to be filled without the resistance normally caused by such a vacuum.

[0028] The textured sealing surface region 72 allows air to pass in and out of the collection canister assembly 20, but has sufficiently low permeability that fluid leakage is substantially prevented or minimized, even when the collection canister assembly 20 is tilted or compressed during shipping. The texture on the sealing surface region 72 may be formed by any suitable method, such as a chemical etching process during injection molding of the canister lid 24. Examples of suitable textures include Mold-Tech MT11000, MT11010, and MT11020. However, it should be understood that other weaves and / or methods of producing such weaves may be utilized in accordance with the present disclosure.

[0029] 5B shows the sealing surface area 72 as extending along a defined portion of the sealing interface 70, it should be understood that the sealing surface area 72 may extend more or less across the sealing interface 70 of the container lid 24. Additionally and / or alternatively, although not shown, it should be understood that the collection receptacle 22 may include a textured sealing surface area at the sealing interface between the collection receptacle 22 and the container lid 24.

[0030] 5B , in one embodiment of the present disclosure, the container lid 24 further includes a second sealing surface region 74 on the underside 66 of the flange 50. Similar to the sealing surface 72 described above, the second sealing surface region 74 is textured to allow air to pass into and out of the collection container assembly 20 when the underside 66 of the flange 50 contacts the upper surface 39 of the stop ring 38 when the container lid 24 is fully connected to the collection container 22. Thus, while the interface between the upper surface 39 and the lower surface 66 functions to prevent both over-tightening and fluid leakage between the container lid 24 on the collection container 22, the textured second sealing surface 74 may allow breathability to avoid the formation of a vacuum in the headspace above the fluid sample.

[0031] Additionally, the texture on the second sealing surface region 74 may be formed by any suitable method, such as, for example, a chemical etching process during injection molding of the container lid 24. As with the sealing surface region 72, examples of suitable textures include, for example, Mold-Tech MT11000, MT11010, and MT11020. However, it should be understood that other textures and / or methods of producing such textures may be utilized in accordance with the present disclosure. Additionally and / or alternatively, although not shown, it should be understood that the top surface 39 of the stop ring 38 may include a textured sealing surface region at the sealing interface between the collection container 22 and the container lid 24.

[0032] While several embodiments of fluid sample collection container assemblies are shown in the accompanying figures and described in detail above, other embodiments will be apparent to and readily made by those skilled in the art without departing from the scope and spirit of the present invention. For example, it should be understood that the present disclosure contemplates that, to the extent possible, one or more features of any embodiment may be combined with one or more features of any other embodiment. Accordingly, the foregoing description is intended to be illustrative and not limiting.

Claims

1. 1. A container assembly for collecting a fluid sample, comprising: a collection container having a first end, a second end, and a sidewall extending therebetween and defining a chamber for receiving the fluid sample; and a container lid coupleable to the collection container and at least partially closing the first end thereof, the container lid including an elongated receptacle extending into the chamber of the collection container, the receptacle including an open end defined in a top surface of the container lid and configured to receive a sampling tube therein; the container lid includes a sealing interface configured to at least partially contact the collection container when the container lid is coupled to the collection container; the sealing interface includes a textured sealing surface area configured to maintain a substantially fluid-tight seal between the container lid and the collection canister when the canister lid is coupled to the collection canister while allowing air to enter and exit the canister assembly; the container lid includes a flange extending around an outer edge thereof; the underside of the flange includes a textured second sealing surface area configured to allow air to enter and exit the container assembly when the container lid is coupled to the collection container. Container assembly.

2. The container assembly of claim 1 , wherein the textured sealing surface area is formed by a chemical etching process.

3. The container assembly of claim 1 , wherein the container lid is threadably engageable with the collection container.

4. 10. The container assembly of claim 1, wherein the collection canister further includes a stop ring extending circumferentially around and below the externally threaded portion of the collection canister.

5. A container assembly as described in claim 4, wherein the lower surface of the flange is configured to contact the upper surface of the stop ring when the container lid is fully coupled to the collection container.

6. 10. The container assembly of claim 1, wherein the textured second sealing surface area is formed by a chemical etching process.

7. The container assembly of claim 1 , wherein the flange includes an internally threaded portion configured to allow the container lid to be threadably coupled to an externally threaded portion of the collection container.

8. The container assembly of claim 1 , wherein the flange includes a plurality of ribs disposed on an outer surface thereof.

9. 1. A container lid for use in a container assembly for collecting a fluid sample, comprising: a disk-shaped peripheral zone; a central zone disposed within the peripheral zone and including an elongated receptacle extending downwardly therefrom, the receptacle having an open end defined on an upper surface of the central zone and configured to receive a sampling tube therein; a flange extending downwardly from the peripheral zone; the flange includes an inner surface configured to releasably engage a collection canister, at least a portion of the inner surface including a textured sealing surface area; and the flange further includes a lower surface including a second textured sealing surface area configured to allow air to pass through and exit the canister assembly when the canister lid is coupled to the collection canister. container lid.

10. 10. The container lid of claim 9, wherein the textured sealing surface area is formed by a chemical etching process.

11. 10. The container lid of claim 9, wherein the inner surface further comprises a threaded portion configured to allow the container lid to be threadedly engaged with an externally threaded portion of a collection container.

12. 10. The container lid of claim 9, wherein the textured second sealing surface area is formed by a chemical etching process.

13. 10. The container lid of claim 9, wherein the flange includes a plurality of ribs disposed on an outer surface thereof.

14. 1. A method of forming a container assembly for collecting a fluid sample, comprising: providing a collection container having a first end, a second end, and a sidewall extending therebetween and defining a chamber for receiving the fluid sample; providing a container lid connectable to the collection container and at least partially closing the first end thereof, wherein the container lid includes an elongated receptacle extending downwardly therefrom, the receptacle configured to receive a sampling tube therein, the container lid further including a flange extending around an outer periphery thereof, the inner surface of the flange having a textured sealing surface area formed thereon; forming a stop ring extending circumferentially around the collection container; forming a textured second sealing surface area on the underside of the flange; Including, When the container lid is coupled to the collection canister, the textured sealing surface area of ​​the container lid contacts a surface of the collection canister, allowing air to pass in and out of the canister assembly while maintaining a substantially fluid-tight seal with the collection canister, and the lower surface of the flange is configured to contact an upper surface of the stop ring when the container lid is fully coupled to the collection canister. method.

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