One-piece safety tube closure with film element

Abstract

To provide a closure with a reinforced oxygen barrier function and a container assembly equipped with the closure.SOLUTION: The closure includes: a cap body (20); a stopper (30); and a barrier layer (40). The cap body (20) is formed of a first material and defines a cavity (24) that goes through the cap body and includes an inward rim (60) extending into the cavity. The stopper (30) is disposed in the cavity and formed of a second material that is different from the first material. The top surface of the stopper is secured to the inward rim. The barrier layer (40) is formed of a third material that is different from at least the second material. The barrier layer (40) is associated with at least one of the cap body (20) and the stopper (30).SELECTED DRAWING: Figure 6

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. patent application Ser. No. 14 / 454,232, entitled "One-Piece Safety Tube Closure with Film Element," filed Aug. 7, 2014, the entire disclosure of which is incorporated herein by reference.

[0002] The present invention relates to a closure designed to maintain a vacuum within a vacuum container, and more particularly to a one-piece closure containing multiple components formed in a single molding process. The present invention also relates to a closure that includes a foil or film that enhances the oxygen barrier properties of the vacuum container. [Background technology]

[0003] A commonly used method for collecting biological specimens, such as blood, is to use a needle assembly in conjunction with an evacuated container. The evacuated container provides the necessary pressure differential to facilitate the flow of the specimen through the needle assembly and into the container where it is collected. An example of an evacuated container used for specimen collection is VACUTAINER® brand tubing, commercially available from Becton, Dickinson and Company. Evacuated tubes can be supplied with various additives to prepare the specimen for a specific test. The tubes can also be evacuated to a selected pressure below atmospheric pressure to provide a preselected volume of drawn specimen. Evacuated tubes are typically sealed with a pierceable closure that can be resealed after being punctured to receive the specimen.

[0004] One type of needle assembly that can be used with the evacuated canister can include a tubular body that holds a standard double-ended hollow needle at its distal end, with one end, or non-patient end, of the needle extending into the tubing and the other end, or patient end, of the needle extending out of the tubing. The patient end of the needle is configured to connect to a sample source, such as a patient's vein. The tubular body is configured to receive the evacuated canister, with a pierceable closure that can be pierced by the non-patient end of the needle so that a biological sample can be drawn from the patient into the canister by the vacuum in the canister.

[0005] One type of pierceable closure can include multiple parts formed in separate molding steps and then assembled together. The multiple parts can include an outer cap body portion and an inner elastomeric pierceable portion designed to seal the interior portion of the container. The elastomeric material is of a type that can reseal after piercing and after removal of the needle when specimen collection is complete. Vacuum containers often have a limited shelf life because, over time, oxygen can leak through the closure, reducing the effectiveness of the vacuum maintained within the container.

[0006] The expiration date is determined through shelf life testing conducted under known environmental conditions. The shelf life of an evacuated tube is determined by excipient stability and vacuum retention. If the environmental conditions in which the evacuated tube is stored are not consistent with those recommended by the manufacturer, the draw volume of the tube may be affected. Summary of the Invention [Problem to be solved by the invention]

[0007] There is a need in the art for a multi-component, one-piece closure that can be formed in a single molding process, thus reducing production costs, that uses less molding material, thus reducing raw material costs, and for a closure with enhanced oxygen barrier properties that increases the shelf life of the vacuum container. [Means for solving the problem]

[0008] According to an embodiment of the present invention, a closure for use with a specimen collection container includes a cap body portion formed from a first material, the cap body portion defining a cavity therethrough. The closure further includes a stopper, the stopper formed from a second material different from the first material, the stopper disposed within the cavity. The closure assembly also includes a barrier layer formed from a third material, the third material being at least different from the first material, the barrier layer associated with at least one of the cap body portion and / or the stopper. The barrier layer can be disposed across at least a portion of the cavity. According to one embodiment, the barrier layer can isolate a portion of the cap body portion from a portion of the stopper. According to another embodiment, the barrier layer can isolate a first portion of the stopper from a second portion of the stopper.

[0009] According to one design, the cap body portion, the stopper, and the barrier layer may be formed in a multi-shot molding process that can be interrupted to apply the barrier layer within a portion of the stopper, isolating a first portion of the stopper from a second portion of the stopper.

[0010] According to another design, the cap body and stopper may be formed in a two-shot molding process, and the barrier layer may be applied in a post-molding process, the barrier layer being applied to cover at least a portion of the opening defined by the top portion of the cap and / or the top portion of the stopper.

[0011] The cap body can include an inwardly facing rim extending into the cavity, and the barrier layer can contact a portion of the inwardly facing rim and a portion of the stopper. According to one embodiment, the barrier layer can be heat-sealed to the inwardly facing rim, the stopper, or both. It can be appreciated that the barrier layer can be secured to the inwardly facing rim and / or the stopper by other well-known techniques.

[0012] According to yet another embodiment, the sealing ring can be positioned adjacent to the barrier layer within the opening defined by the upper portion of the cap body, in which the inwardly extending rim can be a stepped member having a first portion for receiving a portion of the stopper and a second portion for contacting the barrier layer, with the barrier layer sandwiched between the sealing ring and the second portion.

[0013] According to yet another embodiment, the barrier layer can include a bottom surface positioned adjacent to the top portion of the inward rim, and a portion of the stopper material positioned adjacent to the top surface of the barrier layer to mechanically lock the barrier layer into the portion of the closure. According to another embodiment, the inward rim portion can include an aperture extending therethrough, and the top surface of the barrier layer can be coined against the bottom surface of the inward rim. The barrier layer used in the coining process can be applied with a first shot of stopper material, overmolded onto a portion of the stopper material, and applied with a second shot of stopper material, or the individual components of the stopper and barrier layer can be assembled separately, and the barrier layer can be coined onto one or both of the stopper components. According to yet another embodiment, the barrier layer can be provided on the bottom surface of the stopper.

[0014] According to one embodiment, the first material can be high-density polyethylene (HDPE) or low-density polyethylene (LDPE), the second material can be a thermoplastic elastomer, such as a thermoplastic elastomer capable of resealing after being punctured by a needle cannula, and the third material can be at least one of a polymer-based and a metal-based film or foil structure. The third material can have a thickness of approximately 0.005 mm and can be formed from a substantially oxygen-impermeable material. According to one embodiment, the third material can be polyethylene terephthalate (PET) or ethylene vinyl alcohol (EVOH). According to another embodiment, the third material can include a multi-layer laminate having a central layer formed from polyethylene terephthalate (PET) or ethylene vinyl alcohol (EVOH) sandwiched between at least two polyethylene layers. It can be appreciated that the first, second, and third materials can be formed from other well-known materials having suitable physical properties to perform their intended functions.

[0015] The barrier layer may include one or more of a weak spot, a cross cut, and a slit to facilitate the passage of a needle cannula therethrough during collection of a specimen sample.

[0016] According to another embodiment of the present invention, a container assembly includes a collection container having a closed bottom, an open top, and a sidewall extending therebetween, the collection container defining an interior adapted to receive a specimen sample therein. The container assembly further includes a closure for closing the open top of the collection container. The closure includes: a cap body formed from a first material, the cap body defining a cavity therethrough; a stopper formed from a second material, the second material being different from the first material and disposed in the cavity; and a barrier layer formed from a third material, the third material being different from at least the first material, the barrier layer associated with at least one of the cap body and the stopper.

[0017] According to one design, the barrier layer can be disposed across at least a portion of the cavity. According to another design, the barrier layer can isolate a portion of the cap body from a portion of the stopper. According to yet another design, the barrier layer can isolate a first portion of the stopper from a second portion of the stopper. According to yet another design, the barrier layer can be disposed on a bottom surface of the stopper. The barrier layer can be substantially impermeable to oxygen.

[0018] According to another embodiment of the present invention, a method of forming a closure for closing and sealing a container includes the steps of providing a cap body portion formed from a first material, the cap body portion defining a cavity therethrough; providing a stopper, the stopper formed from a second material, the second material different from the first material, and the stopper disposed in the cavity; providing a barrier layer formed from a third material, the third material different from at least the first material, the barrier layer associated with at least one of the cap body portion and the stopper; and assembling the cap body portion, stopper, and barrier layer together to form the closure.

[0019] According to one embodiment, the cap body, stopper, and barrier layer may be formed in a multi-shot molding process. According to another embodiment, the cap body and stopper may be formed in a two-shot molding process, and the barrier layer may be applied in a post-molding process.

[0020] According to one design, the barrier layer can be applied to cover at least a portion of the opening defined by the top portion of the cap and / or the top portion of the stopper. The cap body can include an inwardly facing rim extending into the cavity, and the barrier layer can contact a portion of the inwardly facing rim and a portion of the stopper. According to another design, the barrier layer can be provided on a bottom surface of the stopper.

[0021] The barrier layer can be at least one of heat-sealed, secured by a sealing ring, mechanically sealed, and / or coined to at least one of the cap body portion and the stopper. The barrier layer can be formed from a substantially oxygen-impermeable material. [Brief explanation of the drawings]

[0022] [Figure 1] FIG. 1 is a front view of a specimen collection container including a one-piece tube closure according to an embodiment of the present invention. [Figure 2] 2 is a cross-sectional view of a specimen collection container and closure taken along line 2-2 of FIG. 1 in accordance with an embodiment of the present invention. [Figure 3] 3 is an exploded cross-sectional side view of the tube closure of FIG. 2 in accordance with an embodiment of the present invention. [Figure 4] 2 is a cross-sectional side view of a tube closure for use with the specimen collection container of FIG. 1 in accordance with an embodiment of the present invention. [Figure 5] 2 is a cross-sectional side view of a tube closure for use with the specimen collection container of FIG. 1 in accordance with an embodiment of the present invention. [Figure 6] 2 is a cross-sectional side view of a tube closure for use with the specimen collection container of FIG. 1 in accordance with an embodiment of the present invention. [Figure 7] 2 is a cross-sectional side view of a tube closure for use with the specimen collection container of FIG. 1 in accordance with an embodiment of the present invention. [Figure 8] 2 is a cross-sectional side view of a tube closure for use with the specimen collection container of FIG. 1 in accordance with an embodiment of the present invention. DETAILED DESCRIPTION OF THE INVENTION

[0023] For purposes of the following description, the terms "upper," "lower," "right," "left," "vertical," "horizontal," "top," "bottom," "lateral," "longitudinal," and their derivatives shall refer to the present invention as it is oriented in the drawings. However, it should be understood that the present invention is capable of various alternative modifications, except where 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. Therefore, specific dimensions and other physical characteristics related to the embodiments disclosed herein are not to be considered limiting.

[0024] Reference is now made to Figures 1-2, which illustrate a specimen collection container, generally designated 10, including a closure assembly 12 for closing and sealing the container 10. The container 10 may be an evacuated container configured for use with a needle assembly for obtaining a biological specimen, such as blood, from a patient. The container may have a closed bottom 14, an open top portion 16, and a sidewall 18 extending therebetween, defining a chamber 19 for receiving the biological specimen therein. The closure assembly 12 cooperates with the open top portion 16 to seal a vacuum within the container 10 at a predetermined level to provide for the collection of a preselected volume of blood.

[0025] Now, referring to Figures 2 and 3, the closure assembly 12 includes a cap body portion 20 formed from a first material, a stopper 30 formed from a second material different from the first material, and a barrier layer 40 formed from a third material different from the first material and the second material.

[0026] 2-3 , the cap body includes a first leg portion 20a and a second leg portion 20b, where the first leg portion 20a is configured to cooperate with the outer surface 18a of the sidewall 18 of the container 10, and the second leg portion 20b extends above the open top portion 16 of the container 10 when the closure assembly 12 is positioned thereon. The first leg portion 20a and the second leg portion 20b of the cap body 20 define a cavity extending therethrough, generally indicated as 24. The second leg portion 20b of the cap body 20 defines an opening 28. The cavity 24 is in communication with the opening 28. The closure assembly 12 further includes a stopper 30, which is formed from a second material and is disposed within the cavity 24. The stopper 30 is configured to seal the container 10 and to reseal after puncture by a needle (not shown) during specimen collection. The closure assembly 12 also includes a barrier layer 40 formed from a third material, the barrier layer 40 associated with at least one of the cap body portion 20 and / or the stopper 30. The barrier layer 40 is configured to cooperate with the stopper 30 to seal the container 10. The cap body portion 20, the stopper 30, and the barrier layer 40 can be assembled together to form the one-piece closure assembly 12.

[0027] The barrier layer 40 may be disposed across at least a portion of the cavity 24 and may isolate a portion of the cap body 20 from a portion of the stopper 30, or may isolate a first or upper portion 32 of the stopper 30 from a second or body portion 35 of the stopper 30.

[0028] According to one design, the cap body portion 20, the stopper 30, and the barrier layer 40 may be formed in a multi-shot molding process. This multi-shot molding process may be interrupted to apply a barrier layer within a portion of the stopper 30. According to another design, the cap body portion 20 and the stopper 30 may be formed in a two-shot molding process, and the barrier layer 40 may be applied in a post-molding process. It may be appreciated that the cap body portion 20, the stopper 30, and the barrier layer 40 may be molded and / or assembled according to any known process to form the one-piece closure assembly 12.

[0029] The collection container 10 can be formed from a single layer or multiple layers of different materials as known in the art to optimize the container's water and vapor barrier properties. Glass containers offer the longest shelf life because they maintain the vacuum in the container, but are rarely used due to economic and safety concerns. Examples of plastic materials that can be used to form the container include, but are not limited to, substantially transparent thermoplastic materials such as polycarbonate, polypropylene, and polyethylene terephthalate (PET).

[0030] Suitable materials for the cap body 20 include, but are not limited to, polypropylene, polyvinyl chloride, polyethylene, etc. According to one embodiment, the cap body 20 may be formed from high density polyethylene (HDPE) or low density polyethylene (LDPE).

[0031] The stopper 30 may be formed from any known thermoplastic elastomer. Examples of thermoplastic elastomers that may be used for the stopper 30 include, but are not limited to, silicone rubber, natural rubber, styrene butadiene rubber (SBR), ethylene-propylene dimer monomer (EPDM), polychloroprene, and the like. According to one embodiment, the second material of the stopper may be formed from a di(2-ethylhexyl) phthalate (DEHP)-free thermoplastic elastomer material.

[0032] According to the designs shown in Figures 3, 5, 6, and 7, the barrier layer 40 may be applied to cover the upper portion or second leg 20b of the cap body portion 20 and / or at least a portion of the opening 28 defined by the upper portion 32 of the stopper 30.

[0033] With continued reference to Figures 3-4 and 6-8, the cap body portion 20 can include an inwardly directed rim 60 that extends into the cavity 24. As shown in Figures 3, 6, and 7, the barrier layer 40 can be disposed in contact with a portion of the inwardly directed rim 60 and a portion of the stopper 30. According to one embodiment, the barrier layer 40 can be heat-sealed, welded, or adhesively secured to the inwardly directed rim 60, the stopper 30, or both. It can be appreciated that the barrier layer 40 can be secured to the inwardly directed rim 60 and / or the stopper by other well-known techniques.

[0034] In addition to heat sealing and / or in an alternative design, as shown in FIG. 3, barrier layer 40 can include a bottom surface 41 positioned adjacent to an upper portion 61 of inwardly facing rim 60, and additional stopper material, or a first portion 33 of stopper material, can be provided adjacent to an upper surface 42 of barrier layer 40, sandwiching a portion 44 of barrier layer 40 between this additional stopper material 33 and inwardly facing rim 60 to mechanically lock barrier layer 40 therebetween within closure 12.

[0035] According to another design, as shown in Figure 4, a barrier layer 40 may be applied to a portion of the stopper 30 adjacent the open top portion 16 of the container 10. The barrier layer 40 may be applied by any well-known technique, as discussed above.

[0036] 7, a sealing ring 50 may be positioned within the opening defined by the upper portion or second leg 20b of the cap body 20 adjacent to the upper surface of the barrier layer 40 to secure the barrier layer 40 to an inwardly directed rim 60 and / or the upper portion 32 of the stopper 30. In this embodiment, the inwardly directed rim 60 may be a stepped member having a first portion 62 for receiving a portion of the stopper 30 and a second portion 64 for contacting the barrier layer 40, such that the barrier layer 40 is sandwiched between the sealing ring 50 and the second portion 64.

[0037] According to yet another alternative design, as shown in Figures 5 and 8, the barrier layer 40 may be positioned within the body portion 35 of the stopper 30. In the design shown in Figure 5, the multi-shot molding process that forms the stopper 30 may be interrupted, such as via an in-mold transfer step or coining process, to apply the barrier layer 40 within a portion or within the body portion 35 of the stopper 30. The barrier layer 40 then becomes an integral component of the stopper 30.

[0038] 5, second leg 20b can include third leg 20c that extends into and / or toward cavity 24 and opening 28 created by cap body 20. This third leg 20c can cooperate with top 32 of stopper 30 to secure stopper 30 within cap body 20. It can be appreciated that stopper 30 can be secured to third leg 20c by any known technique, including welding, molding, melting, adhesive application, and the like.

[0039] In the design shown in FIG. 8 , the stopper 30 may be formed from a first or top portion 33 and a second or bottom portion 34. According to one embodiment, the second portion 34 of the stopper 30 and the barrier layer 40 are positioned so that the top surface 42 of the barrier layer is positioned adjacent to the bottom surface of the inward rim 60 of the cap body portion 20. The first portion 33 of the stopper 30 may be applied as additional stopper material 33 adjacent to the inward rim 60 and adjacent to a portion of the barrier layer 40 not covered by the inward rim 60. According to one embodiment, the first portion 33 and the second portion 34 may be formed in a two-shot molding process. The barrier layer 40 may be heat-sealed, welded, and / or mechanically secured within the body portion 35 of the stopper 30. Additionally, the inward rim 60 may include an aperture 70 extending through it and the top surface 42 of the barrier layer 40. By applying a sufficiently high stress to the assembly to induce plastic flow onto the inward rim 60 and / or the surface of the stopper material 33, the barrier layer 40 can be coined onto the bottom surface 66 of the inward rim 60 or onto the stopper material 33. The coining process allows the barrier layer 40 to be positioned within the interior portion or body portion 35 of the stopper 30. The barrier layer 40 can be a plastic material such as HDPE, LDPP, or PET. According to one embodiment, the barrier layer 40 can be formed from the same material as the cap body portion 20. The barrier layer 40 can be applied into the stopper 30 by injecting the plastic barrier layer 40 with a first shot of stopper material, coined onto this first shot of stopper material, overmolded onto a portion of the stopper 30, coined simultaneously with the molding step, or applied to a second shot of stopper material in a two-shot molding process. According to yet another embodiment, each of the first and second portions 33, 34 of the stopper 30 may be molded, and the barrier layer 40 may be assembled separately between the stopper components and coined onto one or both of the first and second portions 33, 34.According to one embodiment, barrier layer 40 may have an initial thickness of approximately 0.02 mm, which is then pressed or coined to a thickness of approximately 0.003 mm. It may be appreciated that barrier layer 40 must be thick enough to provide barrier properties to stopper 30, yet thin enough so that it can be pierced by a needle.

[0040] Referring back to FIGS. 1-2 , the first material forming the cap body 12 can be a rigid material, and the cap body 12 can include an outer surface configured to interface with an external source, such as a human hand or a machine, to remove the closure from the container. The outer surface can include surface irregularities 13 to aid in gripping the closure. According to one embodiment, the first material forming the cap body 12 can be high-density polyethylene (HDPE) or low-density polyethylene (LDPE), the second material forming the stopper 30 can be a thermoplastic elastomer, such as a thermoplastic elastomer capable of resealing after being pierced by a needle cannula, and the third material forming the barrier layer 40 can be a film or foil layer. The barrier layer 40 can be a polymer-based and / or metal-based film or foil structure. The barrier layer 40 can have a thickness of approximately 0.005 mm and can be formed from polyethylene terephthalate (PET) or ethylene vinyl alcohol (EVOH). According to one embodiment, the third material can include a multi-layer laminate having a central layer formed from polyethylene terephthalate (PET) or ethylene vinyl alcohol (EVOH) sandwiched between a pair of polyethylene layers. It can be appreciated that the first, second, and third materials can be formed from other well-known materials having suitable physical properties to perform their intended functions.

[0041] The specimen sample container 10 can be a vacuum container, and the third material forming the barrier layer 40 can be formed from a material that enhances the oxygen barrier properties of the vacuum container 10. The barrier layer 40 can substantially reduce oxygen migration therethrough and, therefore, can be substantially oxygen impermeable. Use of the barrier layer 40 can result in a reduction in the amount of thermoplastic elastomeric or second material used to form the stopper 30, resulting in reduced material costs. The barrier layer 40 can include one or more of a weakness spot, a crosscut, and a slit 48 (FIGS. 3-7) to facilitate needle cannula entry therethrough during specimen sample collection.

[0042] According to another embodiment of the present invention, a method for forming a closure 12 for closing and sealing a container 10 includes providing a cap body 20 formed from a first material, the cap body 20 defining a cavity 24 therethrough and having a top portion or second leg 20b defining an opening 28, the cavity 24 communicating with the opening 28. The method further includes providing a stopper 30 formed from a second material and disposed within the cavity 24. The stopper 30 is configured to seal the container 10 and to reseal after puncture by a needle. The method also includes providing a barrier layer 40 formed from a third material and associated with at least one of the cap body 20 and the stopper 30. The barrier layer 40 is configured to cooperate with the stopper 30 to seal the container 10. The method further includes assembling the cap body portion 20 , the stopper 30 , and the barrier layer 40 together to form the one-piece closure 12 .

[0043] In accordance with another embodiment of the present invention, reference is made to FIGS. 1-2, which illustrate a container assembly, generally designated 100, including a collection container 10 having a closed bottom 14, an open top portion 16, and a sidewall 18 extending therebetween. The container 10 is adapted to receive a specimen sample therein. The container assembly 100 includes a closure assembly 12 for closing and sealing the open top portion 16 of the collection container 10. The closure assembly 12 includes a cap body 20 formed from a first material, the cap body defining a cavity 24 therethrough. The cap body 20 includes a first leg 20a configured to cooperate with the sidewall 18 of the container 10 to secure the cap body 20 thereto. The cap body 20 also has an upper portion or second leg 20b that defines an opening 28, and the cavity 24 communicates with the opening 28. The closure assembly 12 further includes a stopper 30, formed from a second material and disposed within the cavity 24. The stopper 30 is configured to seal the container 10 and to reseal after puncture by a needle. The closure assembly 12 further includes a barrier layer 40, formed from a third material and associated with at least one of the cap body 20 and the stopper 30, configured to cooperate with the stopper to seal the container 10.

[0044] It can be appreciated that each of the above-disclosed embodiments results in a closure assembly having increased oxygen barrier properties to aid in the containment of a given vacuum within the vacuum vessel. It can also be appreciated that each of the above-disclosed embodiments can be formed as a one-piece assembly, which reduces manufacturing and assembly costs. While specific embodiments of the present invention have been described in detail, those skilled in the art will recognize that various modifications and alternatives to those details can be developed in light of the overall teachings of the present disclosure. Accordingly, the specific arrangements disclosed are intended to be illustrative only and not limiting as to the scope of the invention.

Claims

1. a cap body formed from a first material, the cap body defining a cavity therethrough, the cavity having an interior surface, the cap body including an inwardly extending rim extending into the cavity; a stopper formed from a second material and disposed within the cavity, the second material being a thermoplastic elastomer configured to reseal after being punctured by a needle, the second material being different from the first material, and a top surface of the stopper being secured to the inwardly facing rim; and a barrier layer formed from a third material, the third material being different from at least the second material, the barrier layer separating a first portion of the stopper from a second portion of the stopper, the barrier layer extending through the cavity and contacting the interior surface of the cavity, and separating an exterior of the second portion of the stopper from the interior surface of the cavity; and A closure comprising:

2. 10. The closure of claim 1, wherein the third material is different from the second material and the first material.

3. 10. The closure of claim 1, wherein the barrier layer is disposed across at least a portion of the cavity.

4. 10. The closure of claim 1, wherein the cap body, the stopper, and the barrier layer are formed in a multi-shot molding process.

5. 10. The closure of claim 1, wherein the cap body and the stopper are formed in a two-shot molding process and the barrier layer is applied in a post-molding process.

6. 10. The closure of claim 1, wherein the stopper is formed in a two-shot molding process and the barrier layer is applied within the body of the stopper.

7. 7. The closure of claim 6, wherein the stopper is formed from a first portion and a second portion, and the barrier layer is coined onto one of the first portion and the second portion such that, when assembled, the barrier layer is positioned within the body portion of the stopper.

8. 8. The closure of claim 7, wherein the barrier layer is applied during the first shot of the two-shot molding process.

9. a collection container having a closed bottom, an open top portion, and a sidewall extending therebetween, the collection container defining an interior adapted to receive a specimen sample therein; a closure for closing the open top portion of the collection container; and the closure comprises: a cap body formed from a first material, the cap body defining a cavity therethrough, the cavity having an interior surface, the cap body including an inwardly extending rim extending into the cavity; a stopper formed from a second material and disposed within the cavity, the second material being a thermoplastic elastomer configured to reseal after being punctured by a needle, the second material being different from the first material, and a top surface of the stopper being secured to the inwardly facing rim; and a barrier layer formed from a third material, the third material being different from at least the second material, the barrier layer separating a first portion of the stopper from a second portion of the stopper, the barrier layer extending through the cavity and contacting the interior surface of the cavity, and separating an exterior of the second portion of the stopper from the interior surface of the cavity; and 10. A container assembly comprising:

10. 10. The container assembly of claim 9, wherein the third material is different from the second material and the first material.

11. 10. The container assembly of claim 9, wherein the barrier layer is disposed across at least a portion of the cavity.

12. 10. The container assembly of claim 9, wherein the cap body, the stopper, and the barrier layer are formed in a multi-shot molding process.

13. 10. The container assembly of claim 9, wherein the cap body and the stopper are formed in a two-shot molding process and the barrier layer is applied in a post-molding process.

14. 10. The container assembly of claim 9, wherein the stopper is formed in a two-shot molding process and the barrier layer is applied into the body of the stopper.

15. 15. The container assembly of claim 14, wherein the stopper is formed from a first portion and a second portion, and the barrier layer is coined onto one of the first portion and the second portion such that, when assembled, the barrier layer is positioned within the body portion of the stopper.

16. 16. The container assembly of claim 15, wherein the barrier layer is applied during a first shot of the two-shot molding process.

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