# US 10,370,156 B2 · One-piece safety tube closure with film element > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 10,370,156 B2 - Document ID: US10370156B2 - Status: Granted - Kind: B2 - Application number: 14/454,232 - Filed: 2014-08-07 - Published: 2016-02-11 - Granted: 2019-08-06 - Earliest claimed: 2014-08-07 - Assignees: Becton, Dickinson and Company - Applicants: Becton, Dickinson and Company - Inventors: Jean-Pierre R. Karam; Judith A. Reichenbach; Craig Owen Russ; Bradley M. Wilkinson - Web page: https://patentgrep.com/patent/US10370156B2 ## CPC - B65D 39/0052: {made in more than one piece (B65D39/02, B65D39/04, B65D39/06, B65D39/08 take precedence)} - A61B 5/15003: {for venous or arterial blood} - A61B 5/150259: {Improved gripping, e.g. with high friction pattern or projections on the housing surface or an ergonometric shape} - A61B 5/150351: {Caps, stoppers or lids for sealing or closing a blood collection vessel or container, e.g. a test-tube or syringe barrel} - A61B 5/154: {Devices} using pre-evacuated means - B01L 3/50825: {Closing or opening means, corks, bungs} - B29C 65/70: by moulding (using a particular moulding technique, see the relevant technique {, e.g. by injection B29C45/14467}) - B65D 51/002: {Closures to be pierced by an extracting-device for the contents and fixed on the container by separate retaining means} - B01L 2200/0689: Sealing - B01L 2300/042: Caps; Plugs - B01L 2300/044: pierceable, e.g. films, membranes - B01L 2300/049: Valves integrated in closure - B65D: CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES - A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D) - B01L: CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE - B29C: SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING (making preforms B29B11/00; making laminated products by combining previously unconnected layers which become one product whose layers will remain together B32B37/00 - B32B41/00) ## Abstract A closure having enhanced oxygen barrier capabilities 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 than the first material and disposed within the cavity, and a barrier layer formed from a third material, the third material being different than at least the second material and associated with at least one of the cap body and the stopper. A container assembly including a closure and a method of forming the closure is also provided. ## Claims ### Claim 1 A closure, comprising: a cap body formed from a first material, the cap body defining a cavity therethrough and including an inward rim extending into the cavity; a stopper formed from a second material and disposed within the cavity, at least a portion of the stopper contacting at least a portion of the inward rim, the second material being different than the first material, wherein the second material has resealing capabilities; and a barrier layer formed from a third material, the third material being different from at least the second material, wherein the barrier layer divides the stopper into a first portion and a second portion such that the barrier layer contacts and is secured to the inward rim and the stopper and wherein a portion of the barrier layer is sandwiched between at least one of the first portion and the second portion of the stopper and the inward rim of the cap body to mechanically lock the barrier layer therebetween. ### Claim 2 (depends on 1) The closure of claim 1, wherein the third material is different from the second material and the first material. ### Claim 3 (depends on 1) The closure of claim 1, wherein the barrier layer is disposed across at least a portion of the cavity. ### Claim 4 (depends on 1) The closure of claim 1, wherein the barrier layer isolates a portion of the cap body from a portion of the stopper. ### Claim 5 (depends on 1) The closure of claim 1, wherein the cap body, the stopper, and the barrier layer are formed in a multi-shot molding process. ### Claim 6 (depends on 1) The closure of claim 1, wherein the barrier layer is heat sealed to at least one of the inward rim and the stopper. ### Claim 7 (depends on 1) The closure of claim 1, further comprising a seal ring positioned within an opening defined by a top portion of the cap body and adjacent the barrier layer. ### Claim 8 (depends on 7) The closure of claim 7, wherein the inward rim is a stepped member having a first portion for receiving a portion of the stopper and a second portion for contacting the barrier layer, wherein the barrier layer is sandwiched between the seal ring and the second portion. ### Claim 9 (depends on 1) The closure of claim 1, wherein the barrier layer includes a bottom surface positioned adjacent a top portion of the inward rim and the first portion of the stopper is positioned adjacent a top surface of the barrier layer to mechanically lock the barrier layer within a portion of the closure. ### Claim 10 (depends on 1) The closure of claim 1, wherein a portion of the inward rim includes apertures extending therethrough and a top surface of the barrier layer is secured to a bottom surface of the inward rim. ### Claim 11 (depends on 1) 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. ### Claim 12 (depends on 11) The closure of claim 11, wherein the barrier layer is applied to cover at least a portion of an opening defined by a top portion of the cap body and/or a top portion of the first or second portions of the stopper. ### Claim 13 (depends on 1) The closure of claim 1, wherein the stopper is formed in a two-shot molding process and the barrier layer is applied within a body of the stopper. ### Claim 14 (depends on 13) The closure of claim 13, wherein the barrier layer is secured to one of the first portion and the second portion such that, when assembled, the barrier layer is located within the body of the stopper. ### Claim 15 (depends on 14) The closure of claim 14, wherein the barrier layer is supplied during a first shot of the two-shot molding process. ### Claim 16 (depends on 14) The closure of claim 14, wherein the barrier layer is supplied during a second shot of the two-shot molding process. ### Claim 17 (depends on 14) The closure of claim 14, wherein the barrier layer is secured to at least one of the first portion and the second portion of the stopper in an overmolding process. ### Claim 18 (depends on 14) The closure of claim 14, wherein a top portion of the stopper, the barrier layer, and a bottom portion of the stopper are separately assembled and wherein the barrier layer is secured to at least one of the first portion and the second portion of the stopper. ### Claim 19 (depends on 1) The closure of claim 1, wherein the stopper is formed in a molding process and the barrier layer is secured to the stopper simultaneously with the molding process. ### Claim 20 (depends on 1) The closure of claim 1, wherein the barrier layer is substantially oxygen impermeable. ### Claim 21 (depends on 1) The closure of claim 1, wherein the first material comprises at least one of high density polyethylene (HDPE) and low density polyethylene (LDPE). ### Claim 22 (depends on 1) The closure of claim 1, wherein the second material comprises a thermoplastic elastomer. ### Claim 23 (depends on 22) The closure of claim 22, wherein the thermoplastic elastomer is free from di(2-ethylhexyl)phthalate (DEHP). ### Claim 24 (depends on 23) The closure of claim 23, wherein the third material comprises 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. ### Claim 25 (depends on 1) The closure of claim 1, wherein the third material is at least one of a polymeric and metal based film or foil structure. ### Claim 26 (depends on 25) The closure of claim 25, wherein the third material has a thickness of approximately 0.005 mm. ### Claim 27 (depends on 1) The closure of claim 1, wherein the third material comprises polyethylene terephthalate (PET) or ethylene vinyl alcohol (EVOH). ### Claim 28 (depends on 1) The closure of claim 1, wherein the barrier layer includes at least one of a weak area, a cross-cut, or a slit. ### Claim 29 A container assembly, comprising: 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; and a closure for closing the open top portion of the collection container, comprising: a cap body formed from a first material, the cap body defining a cavity therethrough and including an inward rim extending into the cavity; a stopper formed from a second material and disposed within the cavity, at least a portion of the stopper contacting at least a portion of the inward rim, the second material being different from the first material, wherein the second material has resealing capabilities; and a barrier layer formed from a third material, the third material being different from at least the second material, wherein the barrier layer divides the stopper into a first portion and a second portion such that the barrier layer contacts and is secured to the inward rim and the stopper and wherein a portion of the barrier layer is sandwiched between at least one of the first portion and the second portion of the stopper and the inward rim of the cap body to mechanically lock the barrier layer therebetween. ### Claim 30 (depends on 29) The container assembly of claim 29, wherein the barrier layer is disposed across at least a portion of the cavity. ### Claim 31 (depends on 29) The container assembly of claim 29, wherein the barrier layer isolates a portion of the cap body from a portion of the stopper. ### Claim 32 (depends on 29) The container assembly of claim 29, wherein the barrier layer is substantially oxygen impermeable. ### Claim 33 A method of forming a closure for closing and sealing a container, said method comprising: providing a cap body formed from a first material, the cap body defining a cavity therethrough and including an inward rim extending into the cavity; providing a stopper formed from a second material and disposed within the cavity, at least a portion of the stopper contacting at least a portion of the inward rim, the second material being different than the first material, wherein the second material has resealing capabilities; providing a barrier layer formed from a third material, the third material being different from at least the second material; and assembling the cap body, the stopper, and the barrier layer together to form the closure such that the barrier layer divides the stopper into a first portion and a second portion such that the barrier layer contacts and is secured to the inward rim and the stopper and wherein a portion of the barrier layer is sandwiched between at least one of the first portion and the second portion of the stopper and the inward rim of the cap body to mechanically lock the barrier layer therebetween. ### Claim 34 (depends on 33) The method of claim 33, wherein the cap body, the stopper, and the barrier layer are formed in a multi-shot molding process. ### Claim 35 (depends on 33) The method of claim 33, 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. ### Claim 36 (depends on 33) The method of claim 33, wherein the barrier layer is applied to cover at least a portion of an opening defined by a top portion of the cap body and/or a top portion of the stopper. ### Claim 37 (depends on 33) The method of claim 33, wherein the barrier layer is at least one of heat sealed, secured with a seal ring, and mechanically sealed to at least one of the cap body and stopper. ### Claim 38 (depends on 33) The method of claim 33, wherein the barrier layer is provided on a bottom surface of the stopper. ### Claim 39 (depends on 33) The method of claim 33, wherein the barrier layer is substantially oxygen impermeable. ### Claim 40 (depends on 1) The closure of claim 1, wherein a portion of the barrier layer is exposed.