WO2002053360A2 - Laminate for a flowable material container - Google Patents

Laminate for a flowable material container Download PDF

Info

Publication number
WO2002053360A2
WO2002053360A2 PCT/US2002/000300 US0200300W WO02053360A2 WO 2002053360 A2 WO2002053360 A2 WO 2002053360A2 US 0200300 W US0200300 W US 0200300W WO 02053360 A2 WO02053360 A2 WO 02053360A2
Authority
WO
WIPO (PCT)
Prior art keywords
layer
ethylene
tubing
copolymer
weight
Prior art date
Application number
PCT/US2002/000300
Other languages
French (fr)
Other versions
WO2002053360A3 (en
Inventor
Michael T. K. Ling
Ketan Shah
William S. Hurst
Yuan-Pang Samuel Ding
Original Assignee
Baxter International Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Baxter International Inc. filed Critical Baxter International Inc.
Priority to AT02703063T priority Critical patent/ATE522345T1/en
Priority to AU2002236711A priority patent/AU2002236711B2/en
Priority to MXPA03006107A priority patent/MXPA03006107A/en
Priority to CA002432010A priority patent/CA2432010A1/en
Priority to EP02703063A priority patent/EP1412173B1/en
Priority to JP2002554493A priority patent/JP4084663B2/en
Publication of WO2002053360A2 publication Critical patent/WO2002053360A2/en
Publication of WO2002053360A3 publication Critical patent/WO2002053360A3/en

Links

Classifications

    • BPERFORMING OPERATIONS; TRANSPORTING
    • B32LAYERED PRODUCTS
    • B32BLAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B27/00Layered products comprising a layer of synthetic resin
    • B32B27/06Layered products comprising a layer of synthetic resin as the main or only constituent of a layer, which is next to another layer of the same or of a different material
    • B32B27/08Layered products comprising a layer of synthetic resin as the main or only constituent of a layer, which is next to another layer of the same or of a different material of synthetic resin
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B32LAYERED PRODUCTS
    • B32BLAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B1/00Layered products having a general shape other than plane
    • B32B1/08Tubular products
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B60VEHICLES IN GENERAL
    • B60CVEHICLE TYRES; TYRE INFLATION; TYRE CHANGING; CONNECTING VALVES TO INFLATABLE ELASTIC BODIES IN GENERAL; DEVICES OR ARRANGEMENTS RELATED TO TYRES
    • B60C17/00Tyres characterised by means enabling restricted operation in damaged or deflated condition; Accessories therefor
    • B60C17/0009Tyres characterised by means enabling restricted operation in damaged or deflated condition; Accessories therefor comprising sidewall rubber inserts, e.g. crescent shaped inserts
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10TTECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T428/00Stock material or miscellaneous articles
    • Y10T428/13Hollow or container type article [e.g., tube, vase, etc.]
    • Y10T428/1334Nonself-supporting tubular film or bag [e.g., pouch, envelope, packet, etc.]
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10TTECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T428/00Stock material or miscellaneous articles
    • Y10T428/13Hollow or container type article [e.g., tube, vase, etc.]
    • Y10T428/1352Polymer or resin containing [i.e., natural or synthetic]
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10TTECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T428/00Stock material or miscellaneous articles
    • Y10T428/13Hollow or container type article [e.g., tube, vase, etc.]
    • Y10T428/1352Polymer or resin containing [i.e., natural or synthetic]
    • Y10T428/139Open-ended, self-supporting conduit, cylinder, or tube-type article
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10TTECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T428/00Stock material or miscellaneous articles
    • Y10T428/13Hollow or container type article [e.g., tube, vase, etc.]
    • Y10T428/1352Polymer or resin containing [i.e., natural or synthetic]
    • Y10T428/139Open-ended, self-supporting conduit, cylinder, or tube-type article
    • Y10T428/1393Multilayer [continuous layer]
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10TTECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T428/00Stock material or miscellaneous articles
    • Y10T428/31504Composite [nonstructural laminate]
    • Y10T428/31725Of polyamide
    • Y10T428/31739Nylon type
    • Y10T428/31743Next to addition polymer from unsaturated monomer[s]
    • Y10T428/31746Polymer of monoethylenically unsaturated hydrocarbon
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10TTECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T428/00Stock material or miscellaneous articles
    • Y10T428/31504Composite [nonstructural laminate]
    • Y10T428/31855Of addition polymer from unsaturated monomers
    • Y10T428/31909Next to second addition polymer from unsaturated monomers
    • Y10T428/31913Monoolefin polymer
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10TTECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T428/00Stock material or miscellaneous articles
    • Y10T428/31504Composite [nonstructural laminate]
    • Y10T428/31855Of addition polymer from unsaturated monomers
    • Y10T428/31909Next to second addition polymer from unsaturated monomers
    • Y10T428/31924Including polyene monomers
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10TTECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T428/00Stock material or miscellaneous articles
    • Y10T428/31504Composite [nonstructural laminate]
    • Y10T428/31855Of addition polymer from unsaturated monomers
    • Y10T428/31931Polyene monomer-containing

Definitions

  • the present invention relates generally to closures for flowable material containers and more particularly closure assemblies for medical fluid containers.
  • Background of the Invention It is common medical practice to provide fluids to a patient either intravenously or enterally as a method of treating a patient for various medical conditions. Frequently, the fluids to be administered to a patient are contained in a flexible container.
  • One method of forming a flexible container is to seal two sheets of flexible material about the periphery of the sheets to create a fluid tight chamber.
  • a port tube assembly is frequently placed between the sheets during the sealing process to create a communication between the fluid chamber and the exterior of the container to provide a means of introducing fluid into or dispensing fluid from the container.
  • the port tube assembly typically includes an outer port tube that attaches to the sidewalls of the container and a second tube called a membrane tube that is disposed coaxially within the port tube.
  • the membrane tube has a membrane or diaphragm that seals the port tube assembly.
  • the membrane is typically punctured by a spike of a fluid administration set to place the contents of the container in fluid communication with a patient.
  • Port tubes and membrane tubes are fabricated from monolayer or multiple layered materials.
  • the port tube typically has an inner layer of polyvinyl chloride and the membrane tube has an outer layer of PNC.
  • the membrane tube is dipped in cyclohexanone or other suitable solvent and is inserted in a telescoping fashion into the port tube. The solvent melts the PNC of both the port tube and the membrane tube thereby hermetically sealing the membrane tube to the port tube.
  • Flexible PNC containers include low molecular weight additives know as plasticizers which may exude into the solutions contained in the container.
  • United States Patent ⁇ os. 5,998,019 and 5,849,843 which are incorporated herein by reference and made a part hereof, disclose replacing PNC materials in medical fluid containers with non-PNC containing materials.
  • United States Patent No. 5,356,709 discloses a non-PNC coextraded medical grade port tubing.
  • the tubing has an outer layer of a blend of polypropylene and SEBS a tie layer and a core layer of a blend of poly amide and EVA.
  • United States Patent No. 5,533,992 assigned to the same assignee of the present invention, discloses a non-PNC material for fabricating medical tubings and medical containers.
  • Polymer blends for fabricating medical tubing disclosed in the '992 Patent include polyurethane blended with one or more of the following: EVA, SEBS, PCCE, and thermoplastic copolyester elastomers.
  • a port tube provided with the container has an outer layer of a polymer blend by weight of the following four compoents: 40% polypropylene, 40% ultra low density polyethylene, 10% dimer fatty acid polymamide and 10% styrene-ethylene-butene- styrene block copolymer with maleic anhydride functionality.
  • the port tubing has an inner layer of PNC for solvent bonding to a membrane tube of PNC material.
  • the present invention provides a non-PNC port tube, a non-PNC membrane tube and a non-PNC closure assembly for use in flowable material containers such as medical and food containers.
  • the closure assembly includes a port tube and a membrane tube coaxially mounted therein.
  • the port tube has a first layer and a second layer disposed coaxially within the first layer.
  • the first layer is capable of being sealed to sidewalls of a flowable materials container and more preferably using radio frequency sealing techniques.
  • the first layer is a polymer blend of four components.
  • the first component is present in an amount by weight of from about 25% to about 50% by weight of the first layer.
  • the first component is a first polyolefin of a propylene containing polymer.
  • the second component is present in an amount by weight of from about 0 to about 50% by weight of the first layer and is a second polyolefin.
  • the second polyolefin is an ⁇ -olefin containing polymer and in a preferred form of the invention is an ethylene and ⁇ -olefin copolymer.
  • the third component is present in an amount by weight of from about 0% to about 40% by weight of the first layer and is a radio frequency ("RF") susceptible.
  • RF radio frequency
  • the RF polymer is selected from the group consisting of polyamides, ethylene acrylic acid copolymers, ethylene methacrylic acid copolymers, polyimides, polyurethanes, polyesters, polyureas, ethylene vinyl acetate copolymers with a vinyl acetate comonomer content from 18-50% by weight of the copolymer, ethylene methyl acrylate copolymers with methyl acrylate comonomer content from 18%-40% by weight of the copolymer, ethylene vinyl alcohol with vinyl alcohol comonomer content from 15%-70% by mole percent of the copolymer; and (4) from about 0% to about 40% of a first thermoplastic elastomer.
  • Particularly suitable blends are disclosed in greater detail in
  • the second layer of the port tube is disposed coaxially within the first layer and is a non- PNC material that is reactive with an organic solvent. More preferably the second layer is reactive with an aromatic solvent including cyclohexanone, toluene, tetrahydofuran, cumene, xylenes, diethyl benzene decalin, tetralin and amyl benzene to name a few.
  • the second layer is a blend of from about 25% to about 55% by weight of a thermoplastic elastomer, 20% to about 45% of a polyester polyether block copolymer, 0%-15% ethylene vinyl acetate, 0-10% of a propylene containing polymer and from 0%-35% of a polymer selected from the group consisting of acrylonitrile butadiene styrene block copolymer, styrene ethylene butene copolymer, styrene acrylonitrile copolymer and cyclic olefin or bridged polycylic olefin containing polymers.
  • the membrane tube has two layers an outer layer and an inner layer disposed coaxially within the outer layer.
  • the outer layer is reactive to organic solvents and more preferably the aromatic solvents identified above.
  • the outer layer of the membrane tube is of a material selected from the same materials as the second layer of the port tube.
  • the inner layer of the membrane tube is capable of being sealed using radio frequency sealing techniques and is selected from the same materials as set forth above for the first layer of the port tube.
  • the present invention also provides for membrane tubings having more than two layers, such as three layers or more.
  • a core layer of a thermoplastic elastomer such as a styrene and diene type copolymer such as Kraton KG 2705 sold by Shell
  • Fig. 1 is a cross-sectional view of a flexible material container and a port closure assembly.
  • Fig. 2 is a cross-sectional view of a closure assembly having a membrane tube and two- layered port tube.
  • Fig. 3 is a cross-sectional view of a closure assembly having a membrane tube and a three-layered port tube.
  • Fig. 1 shows a flowable material container 10 having sidewalls 12 sealed along peripheral edges to define a chamber 14 therebetween.
  • a closure assembly 16 provides access to the contents of the container.
  • the container 10 is preferably fabricated from a non-PNC containing material.
  • the sidewalls 12 are fabricated from a multiple component polymer alloy disclosed in detail in U.S. Patent No. 5,686,527 which is incorporated herein by reference and made a part hereof.
  • One particularly suitable polymer alloy is a blend of polypropylene, ultra-low density polyethylene, a dimer fatty acid polyamide and a styrene and hydrocarbon block copolymer.
  • the container 10 shown in Fig. 1 is particularly suitable for medical applications such as storage and delivery of IN.
  • a container can also be used to store food products or other consumable products.
  • flowable material is a material that will flow by the force of gravity.
  • Flowable materials therefore include both liquid items and powdered or granular items and the like.
  • Fig. 2 shows the closure assembly 16.
  • the closure assembly 16 has a port tube 18 and a membrane tube 20 coaxially mounted therein.
  • a fluid passageway 21 of the membrane tube 20 is sealed by a membrane 22 positioned at an intermediate portion of the membrane tube 20.
  • the membrane 22 can be punctured by a spike of an infusion set to place the contents of the container into fluid communication with, for example, the vascular system of a patient being treated.
  • the port tube 18 is a multilayered structure and more preferably has a first layer 23 and a second layer 24.
  • the first layer 23 should be of a non-PNC containing material that is capable of being sealed to the sidewalls 12 of the container 10, and preferably sealed using radio frequency sealing techniques.
  • the first layer 23 is a polymer blend of: (a) from about 25% to about 50% by weight and more preferably from about 30% to about 40% by weight, of the first layer a first polyolefin selected from the group consisting of propylene containing polymers, (b) from about 0 to about 50% by weight, and more preferably from about 5-40% by weight, of the first layer a second polyolefin of an ⁇ -olefin containing polymer or copolymer and more preferably is an ethylene and ⁇ -olefin copolymer; (c) from about 0% to about 40% by weight, and more preferably from about 10% to about 40% by weight, of the first layer a radio frequency susceptible polymer selected from the group consisting of polyamides, ethylene acrylic acid copolymers, ethylene methacrylic acid copolymers, polyimides, polyurethanes, polyesters, polyureas, ethylene vinyl acetate copolymers with a vinyl acetate comono
  • One particularly suitable blend for the port tube first layer is a four component blend having by weight the following components: from about 10% to about 40% and more preferably 30% of a dimer fatty acid polyamide, from about 0% to about 50% and more preferably from abou 0% to about 10% of an ultra low density polyethylene, from about 25% to about 50% and more preferably from about 30% to about 40% of a polypropylene and from about 10% to about 40% and more preferably 30% styrene-ethylene -butene-styrene block copolymer with maleic anhydride functionality.
  • the second layer 24 of the port tube 18 is of a non-PNC containing material that is capable of being solvent bonded to the membrane tube 20.
  • the second layer 24 is a multiple component blend of the following components by weight: from about 25% to about 55% and more preferably from 33%-52% of a thermoplastic elastomer, from about 20% to about 45% and more preferably from about 25% to about 42% of a polyester polyether block copolymer, from about 0% to about 15% and more preferably from about 5% to about 12% by weight of the second layer an ethylene copolymerized with vinyl lower alkyl esters and preferably vinyl acetate, from about 0% to about 10% by weight and more preferably from about 1% to about 5% by weight of the second layer of a propylene containing polymer and from about 0% to about 35% by weight of a polymer selected from the group consisting of acrylonitrile butadiene styrene (ABS) block copolymer, styrene
  • ABS
  • One particularly suitable blend of the second layer 24 of the port tube is a five- component blend having from about 33% to about 35% SEBS (Kraton 1660), from about 25% to about 29% polyester polyether block copolymers (Hytrel), from about 5% to about 9% ENA, from about 1% to about 3% polypropylene and from about 28% to about 32% ABS.
  • Another suitable blend of the second layer of the port tube is a four-component blend having from about 48% to about 52% SEBS, from about 36% to about 42% polyester polyether block copolymer, from about 8% to about 12% EVA and from about 1% to about 4% polypropylene.
  • the first layer 23 has a thickness greater than the second layer
  • the first layer will have a thickness of from about 15 mils to about 40 mils and more preferably from about 20 mils to about 30 mils.
  • the second layer 24 will have a thickness from about 2 mils to about 12 mils and more preferably from about 5 mils to about 10 mils.
  • the membrane tube 20 should be fabricated from a non-PNC containing material and should be capable of being bonded, preferably using solvent bonding techniques, to the port tube 18.
  • the membrane tube 20 is a multilayered structure.
  • the membrane tube 20 has an outer layer 26 and an inner layer 28.
  • the outer layer 26 is of a material selected from the same materials as set forth for the second layer 24 of the port tube.
  • the inner layer 28 of the membrane tube 20 is selected from the same materials as the first layer 22 of the port tube 18.
  • a particularly suitable inner layer of the membrane tube is a four-component blend by weight of the inner layer 28 that slightly varies from the most preferred first layer of the port tube.
  • the components are by weight of the inner layer 28 as follows: 40% polypropylene, 40% ultra-low density polyethylene, 10% polyamide and 10% SEBS. It should be understood, however, that the inner layer 28 of the membrane tube could also be selected from the same components and weight percentage ranges as set forth above for the first layer of the port tube.
  • the outer layer of the membrane tube should have a thickness from about 15 mils to about 35 mils and more preferably from about 20 mils to about 30 mils.
  • the inner layer of the membrane tube should have a thickness from about 2 mils to about 12 mils and more preferably from about 5 mils to about 10 mils.
  • Fig. 3 shows an alternate embodiment of the membrane tube having three layers.
  • Fig. 3 shows an intermediate layer 27 interposed therebetween.
  • the intermediate layer 27 preferably is a thermoplastic elastomer and more preferably an oil modified styrene-ethylene-butene-styrene block copolymer sold by the Shell Chemical Company under the product designation KRATO ⁇ G2705.
  • the intermediate layer 27 can also be a blend of from about 99% to about 70% of a thermoplastic elastomer and from about 1% to about 30% of a propylene containing polymer.
  • Suitable propylene containing polymers include homopolymers, copolymers and terpolymers of propylene.
  • Suitable comonomers are one or more ⁇ -olefins having from 2 to 17 carbons and most preferably is ethylene in an amount by weight from about 1% to about 8% by weight of the copolymer.
  • Suitable propylene containing polymers include those sold by Solvay under the tradename FORTILE ⁇ E and include from about l.O% to about 4.0% ethylene by weight of the copolymer.
  • Suitable ⁇ -olefin containing polymers include homopolymers, copolymers and interpolymers of ⁇ -olefins having from 2 to 17 carbons.
  • Suitable ethylene ⁇ -olefin copolymers have a density, as measured by ASTM D-792, of less than about 0.915 g/cc and are commonly ref erred to as very low density polylethylene (NLDPE), linear low density polyethylene (LLDPE), ultra low density polyethylene (ULDPE) and the like.
  • NLDPE very low density polylethylene
  • LLDPE linear low density polyethylene
  • ULDPE ultra low density polyethylene
  • the ethylene and ⁇ -olefin copolymers are obtained using single site catalysts. Suitable catalyst systems, among others, are those disclosed in U.S. Patent ⁇ os. 5,783,638 and 5,272,236.
  • Suitable ethylene and ⁇ -olefin copolymers include those sold by Dow Chemical
  • Suitable polyamides include those selected from a group consisting of: aliphatic polyamides resulting from the condensation reaction of di-amines having a carbon number within a range of 2-13, aliphatic polyamides resulting from a condensation reaction of di-acids having a carbon number within a range of 2-13, polyamides resulting from the condensation reaction of dimer fatty acids, and amide containing copolymers. Polyamides resulting from a ring opening operation of a cyclic amides such as a e-caprolactam is also suitable. In a preferred form of the invention the polyamide is a dimer fatty acid polyamide sold by Henkel under the tradename MACROMELT.
  • Suitable thermoplastic elastomers of the present invention include styrene and hydrocarbon copolymers, and EPDM.
  • the styrene can be substituted or unsubstituted styrene.
  • the styrene and hydrocarbon copolymers can be a block copolymer including di-block, tri- block, star block, it can also be a random copolymer and other types of styrene and hydrocarbon copolymers that are known by those skilled in the art.
  • the styrene and hydrocarbon copolymers can also contain various types of the above-identified styrene and hydrocarbon copolymers.
  • thermoplastic elastomer of the first layer 22 of the port tube 18 and the inner layer 28 of the membrane tube 20 is an SEBS di-block copolymer SEBS copolymer.
  • SEBS SEBS di-block copolymer
  • Such a copolymer is sold by Shell Chemical Company under the tradename KRATON® FG1924X.
  • the preferred thermoplastic elastomer of the second layer 24 of the port tube 18 and the outer layer 26 of the membrane tube 20 is an SEBS copolymer.
  • SEBS copolymer is sold by, for example, Shell Chemical Company under the tradename KRATON® 1660.
  • Suitable polyester polyether block copolymers have are sold by DuPont under the tradename HYYTREL and particularly HYTREL 4056.
  • vinyl lower alkyl esters include those having the formula set forth in Diagram 1:
  • the R in Diagram 1 refers to alkanes having from 1 to 17 carbons.
  • the term "vinyl lower alkyl esters” includes but is not limited to vinyl methanoate, vinyl acetate, vinyl propionate, vinyl butyrate and the like.
  • the ethylene and vinyl lower alkyl ester of the second layer 24 of the port tube 18 and the outer layer 26 of the membrane tube 20 is an ethylene and vinyl acetate copolymer having from about 12% to about 40% vinyl acetate comonomer by weight of the copolymer. Suitable ethylene and vinyl acetate copolymers are sold by Quantum under the product designations UE634 and UE697.
  • Suitable ABS copolymers include acrylonitrile butadiene styrene triblock copolymers.
  • Suitable cyclic olefin or bridged polycyclic hydrocarbon containing polymers and blends thereof can be found in copending patent application Serial No.09/393,051, and in U.S. Patent
  • these homopolymers, copolymers and polymer blends will have a glass transition temperature of greater than 50°C, more preferably from about 70°C to about 180°C, a density greater than 0.910 g/cc and more preferably from 0.910g/cc to about 1.3 g/cc and most preferably from 0.980 g/cc to about 1.3 g/cc and have from at least about 20 mole % of a cyclic aliphatic or a bridged polycyclic in the backbone of the polymer more preferably from about 30-65 mole % and most preferably from about 30-60 mole %.
  • suitable cyclic olefin monomers are monocyclic compounds having from 5 to about 10 carbons in the ring.
  • the cyclic olefins can selected from the group consisting of substituted and unsubstituted cyclopentene, cyclopentadiene, cyclohexene, cyclohexadiene, cycloheptene, cycloheptadiene, cyclooctene, cyclooctadiene.
  • Suitable substituents include lower alkyl, acrylate derivatives and the like.
  • suitable bridged polycyclic hydrocarbon monomers have two or more rings and more preferably contain at least 7 carbons.
  • the rings can be substituted or unsubstituted.
  • Suitable substitutes include lower alkyl, aryl, aralkyl, vinyl, allyloxy, (meth) acryloxy and the like.
  • the bridged polycyclic hydrocarbons are selected from the group consisting of those disclosed in the above incorporated patents and patent applications.
  • Suitable bridged polycyclic hydrocarbon containing polymers are sold by Ticona under the tradename TOPAS, by Nippon Zeon under the tradename ZEONEX and ZEONOR, by Daikyo Gomu Seiko under the tradeanme CZ resin, and by Mitsui Petrochemical Company under the tradename APEL.
  • Suitable comonomers include ⁇ -olefins having from 3-10 carbons, aromatic hydrocarbons, other cyclic olefins and bridged polycyclic hydrocarbons. It may also be desirable to have pendant groups associated with the cyclic olefin containing polymers and bridged polycyclic containing hyrdrocarbons. The pendant groups are for compatibilizing the cyclic olefin containing polymers and the bridged polycyclic hydrocarbon containing polymers with more polar polymers including amine, amide, imide, ester, carboxylic acid and other polar functional groups.
  • Suitable pendant groups include aromatic hydrocarbons, carbon dioxide, monoethylenically unsaturated hydrocarbons, acrylonitriles, vinyl ethers, vinyl esters, vinylamides, vinyl ketones, vinyl halides, epoxides, cyclic esters and cyclic ethers.
  • the monethylencially unsaturated hydrocarbons include alkyl acrylates, and aryl acrylates.
  • the cyclic ester includes maleic anhydride.
  • the port tube and the membrane tube are preferably fabricated using coextrusion techniques well known to those skilled in the polymer fabrication art.
  • the membrane tube is preferably bonded to the port tube by dipping the membrane tube in a suitable solvent such as an aromatic solvent including cyclohexanone, toluene, tetrahydofuran, cumene, xylenes, diethyl benzene, tetralin, decalin and amyl benzene to name a few.
  • Membrane tubes and port tubes were coextruded having the layered structures set forth in the table below.
  • the membrane tubes were dipped in cyclohexanone and were inserted into the membrane tubes in a telescoping fashion to form a closure assembly.
  • the closure assemblies were tested for bond strength, spike insertion force and spike removal force.
  • the bonding strength was tested by gripping the port tube at one end of an Instron tester and the membrane tube in the other end and operating the Instron at a crosshead speed of 10 in./min.
  • a two layered port tube having an outer and an inner layer was coextruded.
  • the inner layer had a thickness of 0.006 inches and was fabricated from SEBS.
  • the outer layer had a thickness of 0.026 inches and was fabricated from a polymer blend by weight of the outer layer of 35% polypropylene/5% ultra low density polyethylene/30% dimer fatty acid polyamide/30%
  • a three layered membrane tube was coextruded having an inner layer, a core layer and an outer layer.
  • the inner layer is a polymer blend by weight 30% polypropylene/35% dimer fatty acid polyamide/35% SEBS.
  • the core layer was a blend of 85% SEBS and 15% polypropylene.
  • the outer layer was 45% SEBS and 55% polypropylene.
  • the inner layer had a thickness of 0.003 inches, the core layer 0.023 inches and the outer layer 0,006 inches.
  • Polymeric sheeting was extruded from a blend by weight of 10% dimer fatty acid polyamide, 35% ultra low density polyethylene, 45% polypropylene and 10% SEBS with maleic anhydride functionality.
  • a port tube segment was inserted into an open end of the pouch and was heat sealed therein while sealing the final peripheral edge to define a container.
  • a membrane tube segment was dipped into cyclohexanone and inserted in a telescoping fashion into the port tube segment.
  • the container was bolted down proximate a mechanical tester.
  • the port tube was attached to a spike attached to a crosshead of the mechanical tester.
  • the crosshead speed of the tester was set at 20 in/min.
  • the crosshead was set to achieve the desired spike insertion depth in the port tube.
  • the tester allowed for measuring the spike insertion force and the spike removal force.
  • the average spike insertion value after 50 tests was 13.31 lbf.
  • the average spike removal force for 50 tests was 10.37 lbf.
  • the tester was also used to determine the pull force necessary to remove the port tube
  • 1 a blend by weight of the following components: of 40% polypropylene, 40% by weight ULDPE, 10 % dimer fatty acid polyamide and 10% SEBS.
  • 11 a blend by weight of the following four components: 38% polyester polyether block copolymer (Hytrel), 2% polypropylene, 10% EVA and 50% SEBS.
  • i ⁇ a blend by weight of the following five components: 27% polyester polyether block copolymer, 1% polypropylene, 7% EN A, 35% SEBS and 30% ABS.
  • IV Shell Kraton KG 2705
  • N a blend by weight of the following components: 45% polypropylene, 35% ULDPE, 10% dimer fatty acid polyamide and 10% SEBS.
  • the tubing layers are specified from outside layer, intermediate layer and inside layer. The results of these tests are reported in Table 1 below.

Abstract

The present invention provides a multiple layered non-PVC containing tubing structure. The tubing structure has a first and a second layer. The first layer is of a polymer blend of: (a) from about 30% to about 50% by weight of the first layer a first polyolefin selected from the group consisting of a first propylene containing polymer, (b) from about 0 to about 50% by weight of the first layer a second polyolefin of an '-olefin containing polymer; (c) from about 0% to about 40% by weight of the first layer a radio frequency susceptible polymer selected from the group consisting of polyamides, ethylene acrylic acid copolymers, ethylene methacrylic acid copolymers, polyimides, polyurethanes, polyesters, polyureas, ethylene vinyl acetate copolymers with a vinyl acetate comonomer content from 18-50% by weight of the copolymer, ethylene methyl acrylate copolymers with methyl acrylate comonomer content from 180%-40% by weight of the copolymer, ethylene vinyl alcohol with vinyl alcohol comonomer content from 15%-70% by mole percent of the copolymer; (d) from about 5% to about 40% of a first thermoplastic elastomer. The second layer is of a non-PVC containing material and is a multiple component polymer blend of from about 25% to about 55% by weight of a second thermoplastic elastomer, 20% to about 45% of a polyester polyether block copolymer, 0-15% ethylene copolymerized with vinyl lower alkyl esters, 0-10% of a second propylene containing polymer and from 0%-35% acrylonitrile butadiene styrene block copolymer.

Description

ASSEMBLY FOR A FLOWABLE MATERIAL CONTAINER
DESCRIPTION
Technical Field
The present invention relates generally to closures for flowable material containers and more particularly closure assemblies for medical fluid containers. Background of the Invention It is common medical practice to provide fluids to a patient either intravenously or enterally as a method of treating a patient for various medical conditions. Frequently, the fluids to be administered to a patient are contained in a flexible container. One method of forming a flexible container is to seal two sheets of flexible material about the periphery of the sheets to create a fluid tight chamber. A port tube assembly is frequently placed between the sheets during the sealing process to create a communication between the fluid chamber and the exterior of the container to provide a means of introducing fluid into or dispensing fluid from the container. The port tube assembly typically includes an outer port tube that attaches to the sidewalls of the container and a second tube called a membrane tube that is disposed coaxially within the port tube. The membrane tube has a membrane or diaphragm that seals the port tube assembly. The membrane is typically punctured by a spike of a fluid administration set to place the contents of the container in fluid communication with a patient.
Port tubes and membrane tubes are fabricated from monolayer or multiple layered materials. The port tube typically has an inner layer of polyvinyl chloride and the membrane tube has an outer layer of PNC. To assemble the port tube assembly, the membrane tube is dipped in cyclohexanone or other suitable solvent and is inserted in a telescoping fashion into the port tube. The solvent melts the PNC of both the port tube and the membrane tube thereby hermetically sealing the membrane tube to the port tube.
There has been a great effort by many manufacturers of medical articles to replace PNC materials with non-PNC containing materials. Flexible PNC containers include low molecular weight additives know as plasticizers which may exude into the solutions contained in the container. United States Patent Νos. 5,998,019 and 5,849,843, which are incorporated herein by reference and made a part hereof, disclose replacing PNC materials in medical fluid containers with non-PNC containing materials.
United States Patent No. 5,356,709, assigned to the same assignee of the present invention, discloses a non-PNC coextraded medical grade port tubing. The tubing has an outer layer of a blend of polypropylene and SEBS a tie layer and a core layer of a blend of poly amide and EVA. United States Patent No. 5,533,992, assigned to the same assignee of the present invention, discloses a non-PNC material for fabricating medical tubings and medical containers.
Polymer blends for fabricating medical tubing disclosed in the '992 Patent include polyurethane blended with one or more of the following: EVA, SEBS, PCCE, and thermoplastic copolyester elastomers.
The present assignee is presently marketing a container for storing, shipping and delivering of medical fluids. A port tube provided with the container has an outer layer of a polymer blend by weight of the following four compoents: 40% polypropylene, 40% ultra low density polyethylene, 10% dimer fatty acid polymamide and 10% styrene-ethylene-butene- styrene block copolymer with maleic anhydride functionality. The port tubing has an inner layer of PNC for solvent bonding to a membrane tube of PNC material.
Summary of the Invention
The present invention provides a non-PNC port tube, a non-PNC membrane tube and a non-PNC closure assembly for use in flowable material containers such as medical and food containers.
The closure assembly includes a port tube and a membrane tube coaxially mounted therein. The port tube has a first layer and a second layer disposed coaxially within the first layer. In a preferred form of the invention the first layer is capable of being sealed to sidewalls of a flowable materials container and more preferably using radio frequency sealing techniques.
In a preferred form of the invention the first layer is a polymer blend of four components. The first component is present in an amount by weight of from about 25% to about 50% by weight of the first layer. The first component is a first polyolefin of a propylene containing polymer. The second component is present in an amount by weight of from about 0 to about 50% by weight of the first layer and is a second polyolefin. The second polyolefin is an α-olefin containing polymer and in a preferred form of the invention is an ethylene and α-olefin copolymer. The third component is present in an amount by weight of from about 0% to about 40% by weight of the first layer and is a radio frequency ("RF") susceptible. The RF polymer is selected from the group consisting of polyamides, ethylene acrylic acid copolymers, ethylene methacrylic acid copolymers, polyimides, polyurethanes, polyesters, polyureas, ethylene vinyl acetate copolymers with a vinyl acetate comonomer content from 18-50% by weight of the copolymer, ethylene methyl acrylate copolymers with methyl acrylate comonomer content from 18%-40% by weight of the copolymer, ethylene vinyl alcohol with vinyl alcohol comonomer content from 15%-70% by mole percent of the copolymer; and (4) from about 0% to about 40% of a first thermoplastic elastomer. Particularly suitable blends are disclosed in greater detail in
U.S. Patent No. 5,686,527 which is incorporated herein by reference and made a part hereof. The second layer of the port tube is disposed coaxially within the first layer and is a non- PNC material that is reactive with an organic solvent. More preferably the second layer is reactive with an aromatic solvent including cyclohexanone, toluene, tetrahydofuran, cumene, xylenes, diethyl benzene decalin, tetralin and amyl benzene to name a few. In a preferred form of the invention the second layer is a blend of from about 25% to about 55% by weight of a thermoplastic elastomer, 20% to about 45% of a polyester polyether block copolymer, 0%-15% ethylene vinyl acetate, 0-10% of a propylene containing polymer and from 0%-35% of a polymer selected from the group consisting of acrylonitrile butadiene styrene block copolymer, styrene ethylene butene copolymer, styrene acrylonitrile copolymer and cyclic olefin or bridged polycylic olefin containing polymers.
In one preferred form of the invention, the membrane tube has two layers an outer layer and an inner layer disposed coaxially within the outer layer. The outer layer is reactive to organic solvents and more preferably the aromatic solvents identified above. The outer layer of the membrane tube is of a material selected from the same materials as the second layer of the port tube. Likewise, the inner layer of the membrane tube is capable of being sealed using radio frequency sealing techniques and is selected from the same materials as set forth above for the first layer of the port tube.
The present invention also provides for membrane tubings having more than two layers, such as three layers or more. In a preferred embodiment, a core layer of a thermoplastic elastomer such as a styrene and diene type copolymer such as Kraton KG 2705 sold by Shell
Chemical Co.
These and other aspects and attributes of the present invention will be discussed with reference to the following drawings and accompanying specification.
Brief Description of the Drawings
Fig. 1 is a cross-sectional view of a flexible material container and a port closure assembly.
Fig. 2 is a cross-sectional view of a closure assembly having a membrane tube and two- layered port tube. Fig. 3 is a cross-sectional view of a closure assembly having a membrane tube and a three-layered port tube.
Detailed Description of the Invention
The present invention is susceptible of embodiments in many different forms. Preferred embodiments of the invention are disclosed with the understanding that the present disclosure is to be considered as exemplifications of the principles of the invention and are not intended to limit the broad aspects of the invention to the embodiments illustrated.
Fig. 1 shows a flowable material container 10 having sidewalls 12 sealed along peripheral edges to define a chamber 14 therebetween. A closure assembly 16 provides access to the contents of the container. The container 10 is preferably fabricated from a non-PNC containing material. In a preferred form of the invention the sidewalls 12 are fabricated from a multiple component polymer alloy disclosed in detail in U.S. Patent No. 5,686,527 which is incorporated herein by reference and made a part hereof. One particularly suitable polymer alloy is a blend of polypropylene, ultra-low density polyethylene, a dimer fatty acid polyamide and a styrene and hydrocarbon block copolymer. The container 10 shown in Fig. 1 is particularly suitable for medical applications such as storage and delivery of IN. solutions, peritoneal dialysis solutions, pharmaceutical drugs and blood and blood components to name a few. It is contemplated that such a container can also be used to store food products or other consumable products. What is meant by "flowable material" is a material that will flow by the force of gravity.
Flowable materials therefore include both liquid items and powdered or granular items and the like.
Fig. 2 shows the closure assembly 16. The closure assembly 16 has a port tube 18 and a membrane tube 20 coaxially mounted therein. A fluid passageway 21 of the membrane tube 20 is sealed by a membrane 22 positioned at an intermediate portion of the membrane tube 20. For medical applications, the membrane 22 can be punctured by a spike of an infusion set to place the contents of the container into fluid communication with, for example, the vascular system of a patient being treated.
In a preferred form of the invention the port tube 18 is a multilayered structure and more preferably has a first layer 23 and a second layer 24. The first layer 23 should be of a non-PNC containing material that is capable of being sealed to the sidewalls 12 of the container 10, and preferably sealed using radio frequency sealing techniques. In a preferred form of the invention the first layer 23 is a polymer blend of: (a) from about 25% to about 50% by weight and more preferably from about 30% to about 40% by weight, of the first layer a first polyolefin selected from the group consisting of propylene containing polymers, (b) from about 0 to about 50% by weight, and more preferably from about 5-40% by weight, of the first layer a second polyolefin of an α-olefin containing polymer or copolymer and more preferably is an ethylene and α-olefin copolymer; (c) from about 0% to about 40% by weight, and more preferably from about 10% to about 40% by weight, of the first layer a radio frequency susceptible polymer selected from the group consisting of polyamides, ethylene acrylic acid copolymers, ethylene methacrylic acid copolymers, polyimides, polyurethanes, polyesters, polyureas, ethylene vinyl acetate copolymers with a vinyl acetate comonomer content from 18-50% by weight of the copolymer, ethylene methyl acrylate copolymers with methyl acrylate comonomer content from 18%-40% by weight of the copolymer, ethylene vinyl alcohol with vinyl alcohol comonomer content from 15%-70% by mole percent of the copolymer; and (d) from about 0% to about 40% by weight, and more preferably from 10% to about 40% by weight, of the first layer of a thermoplastic elastomer.
One particularly suitable blend for the port tube first layer is a four component blend having by weight the following components: from about 10% to about 40% and more preferably 30% of a dimer fatty acid polyamide, from about 0% to about 50% and more preferably from abou 0% to about 10% of an ultra low density polyethylene, from about 25% to about 50% and more preferably from about 30% to about 40% of a polypropylene and from about 10% to about 40% and more preferably 30% styrene-ethylene -butene-styrene block copolymer with maleic anhydride functionality.
The second layer 24 of the port tube 18 is of a non-PNC containing material that is capable of being solvent bonded to the membrane tube 20. In a preferred form of the invention the second layer 24 is a multiple component blend of the following components by weight: from about 25% to about 55% and more preferably from 33%-52% of a thermoplastic elastomer, from about 20% to about 45% and more preferably from about 25% to about 42% of a polyester polyether block copolymer, from about 0% to about 15% and more preferably from about 5% to about 12% by weight of the second layer an ethylene copolymerized with vinyl lower alkyl esters and preferably vinyl acetate, from about 0% to about 10% by weight and more preferably from about 1% to about 5% by weight of the second layer of a propylene containing polymer and from about 0% to about 35% by weight of a polymer selected from the group consisting of acrylonitrile butadiene styrene (ABS) block copolymer, styrene ethylene butene copolymer, styrene acrylonitrile copolymer and cyclic olefin or bridged polycylic olefin containing polymers.
One particularly suitable blend of the second layer 24 of the port tube is a five- component blend having from about 33% to about 35% SEBS (Kraton 1660), from about 25% to about 29% polyester polyether block copolymers (Hytrel), from about 5% to about 9% ENA, from about 1% to about 3% polypropylene and from about 28% to about 32% ABS.
Another suitable blend of the second layer of the port tube is a four-component blend having from about 48% to about 52% SEBS, from about 36% to about 42% polyester polyether block copolymer, from about 8% to about 12% EVA and from about 1% to about 4% polypropylene. As shown in the Figures, the first layer 23 has a thickness greater than the second layer
24. In a preferred form of the invention the first layer will have a thickness of from about 15 mils to about 40 mils and more preferably from about 20 mils to about 30 mils. The second layer 24 will have a thickness from about 2 mils to about 12 mils and more preferably from about 5 mils to about 10 mils.
The membrane tube 20 should be fabricated from a non-PNC containing material and should be capable of being bonded, preferably using solvent bonding techniques, to the port tube 18. In a preferred form of the invention the membrane tube 20 is a multilayered structure. The membrane tube 20 has an outer layer 26 and an inner layer 28. The outer layer 26 is of a material selected from the same materials as set forth for the second layer 24 of the port tube. Likewise the inner layer 28 of the membrane tube 20 is selected from the same materials as the first layer 22 of the port tube 18.
A particularly suitable inner layer of the membrane tube is a four-component blend by weight of the inner layer 28 that slightly varies from the most preferred first layer of the port tube. The components are by weight of the inner layer 28 as follows: 40% polypropylene, 40% ultra-low density polyethylene, 10% polyamide and 10% SEBS. It should be understood, however, that the inner layer 28 of the membrane tube could also be selected from the same components and weight percentage ranges as set forth above for the first layer of the port tube.
In a preferred form of the invention the outer layer of the membrane tube should have a thickness from about 15 mils to about 35 mils and more preferably from about 20 mils to about 30 mils. The inner layer of the membrane tube should have a thickness from about 2 mils to about 12 mils and more preferably from about 5 mils to about 10 mils.
Fig. 3 shows an alternate embodiment of the membrane tube having three layers. In addition to the outer layer 26 and inner layer 28 shown in Fig. 2, Fig. 3 shows an intermediate layer 27 interposed therebetween. The intermediate layer 27 preferably is a thermoplastic elastomer and more preferably an oil modified styrene-ethylene-butene-styrene block copolymer sold by the Shell Chemical Company under the product designation KRATOΝ G2705. The intermediate layer 27 can also be a blend of from about 99% to about 70% of a thermoplastic elastomer and from about 1% to about 30% of a propylene containing polymer.
Suitable propylene containing polymers include homopolymers, copolymers and terpolymers of propylene. Suitable comonomers are one or more α-olefins having from 2 to 17 carbons and most preferably is ethylene in an amount by weight from about 1% to about 8% by weight of the copolymer. Suitable propylene containing polymers include those sold by Solvay under the tradename FORTILEΝE and include from about l.O% to about 4.0% ethylene by weight of the copolymer.
Suitable α-olefin containing polymers include homopolymers, copolymers and interpolymers of α-olefins having from 2 to 17 carbons. Suitable ethylene α-olefin copolymers have a density, as measured by ASTM D-792, of less than about 0.915 g/cc and are commonly ref erred to as very low density polylethylene (NLDPE), linear low density polyethylene (LLDPE), ultra low density polyethylene (ULDPE) and the like. In a preferred form of the invention, the ethylene and α-olefin copolymers are obtained using single site catalysts. Suitable catalyst systems, among others, are those disclosed in U.S. Patent Νos. 5,783,638 and 5,272,236. Suitable ethylene and α-olefin copolymers include those sold by Dow Chemical
Company under the AFFINITY tradename, Dupont-Dow under the ENGAGE tradename, Exxon under the EXACT tradename and Phillips Chemical Company under the tradename MARLEX.
Suitable polyamides include those selected from a group consisting of: aliphatic polyamides resulting from the condensation reaction of di-amines having a carbon number within a range of 2-13, aliphatic polyamides resulting from a condensation reaction of di-acids having a carbon number within a range of 2-13, polyamides resulting from the condensation reaction of dimer fatty acids, and amide containing copolymers. Polyamides resulting from a ring opening operation of a cyclic amides such as a e-caprolactam is also suitable. In a preferred form of the invention the polyamide is a dimer fatty acid polyamide sold by Henkel under the tradename MACROMELT.
Suitable thermoplastic elastomers of the present invention include styrene and hydrocarbon copolymers, and EPDM. The styrene can be substituted or unsubstituted styrene. The styrene and hydrocarbon copolymers can be a block copolymer including di-block, tri- block, star block, it can also be a random copolymer and other types of styrene and hydrocarbon copolymers that are known by those skilled in the art. The styrene and hydrocarbon copolymers can also contain various types of the above-identified styrene and hydrocarbon copolymers.
The styrene and hydrocarbon copolymers can be functionalized by carboxylic acid groups, anhydrides of carboxylic acids, esters of carboxylic acids, epoxy groups and carbon monoxide. In a preferred form of the invention the thermoplastic elastomer of the first layer 22 of the port tube 18 and the inner layer 28 of the membrane tube 20 is an SEBS di-block copolymer SEBS copolymer. Such a copolymer is sold by Shell Chemical Company under the tradename KRATON® FG1924X.
The preferred thermoplastic elastomer of the second layer 24 of the port tube 18 and the outer layer 26 of the membrane tube 20 is an SEBS copolymer. Such a copolymer is sold by, for example, Shell Chemical Company under the tradename KRATON® 1660.
Suitable polyester polyether block copolymers have are sold by DuPont under the tradename HYYTREL and particularly HYTREL 4056.
The term "vinyl lower alkyl esters" include those having the formula set forth in Diagram 1:
Figure imgf000010_0001
Diagram 1
The R in Diagram 1 refers to alkanes having from 1 to 17 carbons. Thus, the term "vinyl lower alkyl esters" includes but is not limited to vinyl methanoate, vinyl acetate, vinyl propionate, vinyl butyrate and the like. In a preferred form of the invention the ethylene and vinyl lower alkyl ester of the second layer 24 of the port tube 18 and the outer layer 26 of the membrane tube 20 is an ethylene and vinyl acetate copolymer having from about 12% to about 40% vinyl acetate comonomer by weight of the copolymer. Suitable ethylene and vinyl acetate copolymers are sold by Quantum under the product designations UE634 and UE697.
Suitable ABS copolymers include acrylonitrile butadiene styrene triblock copolymers. Suitable cyclic olefin or bridged polycyclic hydrocarbon containing polymers and blends thereof can be found in copending patent application Serial No.09/393,051, and in U.S. Patent
Nos. 5,218,049, 5,854,349, 5,863,986, 5,795,945, 5,792,824; EP 0 291,208, EP 0 283,164, EP 0 497,567 which are incorporated in their entirety herein by reference and made a part hereof. In a preferred form of the invention these homopolymers, copolymers and polymer blends will have a glass transition temperature of greater than 50°C, more preferably from about 70°C to about 180°C, a density greater than 0.910 g/cc and more preferably from 0.910g/cc to about 1.3 g/cc and most preferably from 0.980 g/cc to about 1.3 g/cc and have from at least about 20 mole % of a cyclic aliphatic or a bridged polycyclic in the backbone of the polymer more preferably from about 30-65 mole % and most preferably from about 30-60 mole %.
In a preferred form of the invention, suitable cyclic olefin monomers are monocyclic compounds having from 5 to about 10 carbons in the ring. The cyclic olefins can selected from the group consisting of substituted and unsubstituted cyclopentene, cyclopentadiene, cyclohexene, cyclohexadiene, cycloheptene, cycloheptadiene, cyclooctene, cyclooctadiene. Suitable substituents include lower alkyl, acrylate derivatives and the like.
In a preferred form of the invention, suitable bridged polycyclic hydrocarbon monomers have two or more rings and more preferably contain at least 7 carbons. The rings can be substituted or unsubstituted. Suitable substitutes include lower alkyl, aryl, aralkyl, vinyl, allyloxy, (meth) acryloxy and the like. The bridged polycyclic hydrocarbons are selected from the group consisting of those disclosed in the above incorporated patents and patent applications. Suitable bridged polycyclic hydrocarbon containing polymers are sold by Ticona under the tradename TOPAS, by Nippon Zeon under the tradename ZEONEX and ZEONOR, by Daikyo Gomu Seiko under the tradeanme CZ resin, and by Mitsui Petrochemical Company under the tradename APEL.
Suitable comonomers include α-olefins having from 3-10 carbons, aromatic hydrocarbons, other cyclic olefins and bridged polycyclic hydrocarbons. It may also be desirable to have pendant groups associated with the cyclic olefin containing polymers and bridged polycyclic containing hyrdrocarbons. The pendant groups are for compatibilizing the cyclic olefin containing polymers and the bridged polycyclic hydrocarbon containing polymers with more polar polymers including amine, amide, imide, ester, carboxylic acid and other polar functional groups. Suitable pendant groups include aromatic hydrocarbons, carbon dioxide, monoethylenically unsaturated hydrocarbons, acrylonitriles, vinyl ethers, vinyl esters, vinylamides, vinyl ketones, vinyl halides, epoxides, cyclic esters and cyclic ethers. The monethylencially unsaturated hydrocarbons include alkyl acrylates, and aryl acrylates. The cyclic ester includes maleic anhydride.
The port tube and the membrane tube are preferably fabricated using coextrusion techniques well known to those skilled in the polymer fabrication art. The membrane tube is preferably bonded to the port tube by dipping the membrane tube in a suitable solvent such as an aromatic solvent including cyclohexanone, toluene, tetrahydofuran, cumene, xylenes, diethyl benzene, tetralin, decalin and amyl benzene to name a few.
EXAMPLES
Membrane tubes and port tubes were coextruded having the layered structures set forth in the table below. The membrane tubes were dipped in cyclohexanone and were inserted into the membrane tubes in a telescoping fashion to form a closure assembly. The closure assemblies were tested for bond strength, spike insertion force and spike removal force. The bonding strength was tested by gripping the port tube at one end of an Instron tester and the membrane tube in the other end and operating the Instron at a crosshead speed of 10 in./min.
A two layered port tube having an outer and an inner layer was coextruded. The inner layer had a thickness of 0.006 inches and was fabricated from SEBS. The outer layer had a thickness of 0.026 inches and was fabricated from a polymer blend by weight of the outer layer of 35% polypropylene/5% ultra low density polyethylene/30% dimer fatty acid polyamide/30%
SEBS with maleic anhydride functionality.
A three layered membrane tube was coextruded having an inner layer, a core layer and an outer layer. The inner layer is a polymer blend by weight 30% polypropylene/35% dimer fatty acid polyamide/35% SEBS. The core layer was a blend of 85% SEBS and 15% polypropylene. The outer layer was 45% SEBS and 55% polypropylene. The inner layer had a thickness of 0.003 inches, the core layer 0.023 inches and the outer layer 0,006 inches.
Polymeric sheeting was extruded from a blend by weight of 10% dimer fatty acid polyamide, 35% ultra low density polyethylene, 45% polypropylene and 10% SEBS with maleic anhydride functionality.
Two rectangularly-shaped sheets of the polymeric sheeting were placed into registration and sealed along 3 peripheral edges to define a pouch. A port tube segment was inserted into an open end of the pouch and was heat sealed therein while sealing the final peripheral edge to define a container. A membrane tube segment was dipped into cyclohexanone and inserted in a telescoping fashion into the port tube segment.
The container was bolted down proximate a mechanical tester. The port tube was attached to a spike attached to a crosshead of the mechanical tester. The crosshead speed of the tester was set at 20 in/min. The crosshead was set to achieve the desired spike insertion depth in the port tube. The tester allowed for measuring the spike insertion force and the spike removal force. The average spike insertion value after 50 tests was 13.31 lbf. The average spike removal force for 50 tests was 10.37 lbf. These measurements were made after the spike dwelled in the membrane tube for 24 hours.
The tester was also used to determine the pull force necessary to remove the port tube
from the container or to otherwise damage the container or port tube. The port tube was inserted into the tester with the container bolted down. The average pull force for 28 tests was
30.04 lbf. This test was conducted prior to steam sterilizing the container. The value for 30 test after the container was steam sterilized was 42.68 lbf.
The components of individual tubing layers are designated as follows in Table 1:
1= a blend by weight of the following components: of 40% polypropylene, 40% by weight ULDPE, 10 % dimer fatty acid polyamide and 10% SEBS.
11= a blend by weight of the following four components: 38% polyester polyether block copolymer (Hytrel), 2% polypropylene, 10% EVA and 50% SEBS. iπ= a blend by weight of the following five components: 27% polyester polyether block copolymer, 1% polypropylene, 7% EN A, 35% SEBS and 30% ABS. IV= Shell Kraton KG 2705
N= a blend by weight of the following components: 45% polypropylene, 35% ULDPE, 10% dimer fatty acid polyamide and 10% SEBS.
The tubing layers are specified from outside layer, intermediate layer and inside layer. The results of these tests are reported in Table 1 below.
Figure imgf000013_0001
From the foregoing, it will be observed that numerous variations and modifications may be effected without departing from the spirit and scope of the invention. It is to be understood that no limitation with respect to the specific apparatus illustrated herein is intended or should be inferred. It is, of course, intended to cover by the appended claims all such modifications as fall within the scope of the claims.

Claims

CLAIMS WE CLAIM:
1. A multiple layered non-PNC containing tubing structure comprising: a first layer of a polymer blend of: (a) from about 30% to about 50% by weight of the first layer a first polyolefin selected from the group consisting of polypropylene and polypropylene copolymers, (b) from about 0% to about 50% by weight of the first layer a second polyolefin of an α-olefin containing polymer; (c) from about 0% to about 40% by weight of the first layer of a radio frequency susceptible polymer selected from the group consisting of polyamides, ethylene acrylic acid copolymers, ethylene methacrylic acid copolymers, polyimides, polyurethanes, polyesters, polyureas, ethylene vinyl acetate copolymers with a vinyl acetate comonomer content from 18-50% by weight of the copolymer, ethylene methyl acrylate copolymers with methyl acrylate comonomer content from 18%-40% by weight of the copolymer, ethylene vinyl alcohol with vinyl alcohol comonomer content from 15%-70% by mole percent of the copolymer; (d) from about 0% to about 40% of a first thermoplastic elastomer; and a second layer of a non-PVC containing material of a multiple component polymer blend.
2. The tubing of claim 1 wherein the second layer is coaxially mounted within the first "layer.
3. The tubing of claim 1 wherein the first layer is coaxially mounted within the second layer.
4. The tubing of claim 1 wherein the polymer blend comprises by weight of the second layer: from about 25% to about 55% by weight of a second thermoplastic elastomer, from about 20% to about 45% of a polyester polyether block copolymer, from about 0% to about 15% ethylene copolymerized with vinyl lower alkyl esters, from about 0% to aboutl0% of a propylene containing polymer and from about 0% to about 35% of a polymer selected from the group consisting of acrylonitrile butadiene styrene block copolymer, styrene ethylene butene copolymer, styrene acrylonitrile copolymer, cyclic olefin containing polymers and bridged poly cy lie olefin containing polymers.
5. The tubing of claim 1 wherein the polyamide is selected from a group consisting of: aliphatic polyamides resulting from the condensation reaction of di-amines having a carbon number within a range of 2-13, aliphatic polyamides resulting from a condensation reaction of di-acids having a carbon number within a range of 2-13, ring opening reactions of cyclic amides, polyamides resulting from the condensation reaction of dimer fatty acids, and amide containing copolymers.
6. The tubing of claim 1 wherein the polyamide is a dimer fatty acid polyamide.
7. The tubing of claim 1 wherein the first polyolefin is a propylene copolymerized with a monomer selected from the group consisting of α-olefins having from 2-17 carbons.
8. The tubing of claim 7 wherein the first polyolefin is a propylene and ethylene copolymer having an ethylene content of from about 1% to about 8% by weight of the first polyolefin.
9. The tubing of claim 1 wherein the first thermoplastic elastomer is selected from the group consisting of a first styrene and hydrocarbon copolymer.
10. The tubing of claim 9 wherein the first thermoplastic elastomer is maleic anhydride functionalized.
11. The tubing of claim 10 wherein the first thermoplastic elastomer is a styrene-ethylene- butene-styrene block copolymer.
12. The tubing of claim 11 wherein the first thermoplastic elastomer is selected from the group consisting of styrene and hydrocarbon diblock copolymers, styrene and hydrocarbon block copolymers and styrene and hydrocarbon star block copolymers.
13. The tubing of claim 10 wherein the first thermoplastic elastomer is functionalized with a group selected from the group consisting of carboxylic acid, esters of carboxylic acids, anhydrides of carboxylic acids, epoxides, and carbon monoxide.
14. The tubing of claim 13 wherein the first thermoplastic elastomer is maleic anhydride functionalized.
15. The tubing of claim 4 wherein the second styrene and hydrocarbon copolymer is selected from the group consisting of styrene and hydrocarbon diblock copolymers, styrene and hydrocarbon triblock copolymers, styrene and hydrocarbon star block copolymers and blends of the same.
16. The tubing of claim 15 wherein the second thermoplastic elastomer is a styrene- ethylene-butene-styrene block copolymer.
17. The tubing of claim 1 wherein the second polyolefin is an α-olefin copolymerized with a ethylene monomer.
18. The tubing of claim 17 wherein the second polyolefin is an ethylene and α-olefin copolymer.
19. The tubing of claim 18 wherein the ethylene and α-olefin copolymer is obtained using a single site catalyst.
PCT/US2002/000300 2001-01-08 2002-01-04 Laminate for a flowable material container WO2002053360A2 (en)

Priority Applications (6)

Application Number Priority Date Filing Date Title
AT02703063T ATE522345T1 (en) 2001-01-08 2002-01-04 LAMINATE FOR A CONTAINER FOR FLOWING MATERIALS
AU2002236711A AU2002236711B2 (en) 2001-01-08 2002-01-04 Laminate for a flowable material container
MXPA03006107A MXPA03006107A (en) 2001-01-08 2002-01-04 Assembly for a flowable material container.
CA002432010A CA2432010A1 (en) 2001-01-08 2002-01-04 Assembly for a flowable material container
EP02703063A EP1412173B1 (en) 2001-01-08 2002-01-04 Laminate for a flowable material container
JP2002554493A JP4084663B2 (en) 2001-01-08 2002-01-04 Laminates for containers for flowable materials

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US09/756,351 2001-01-08
US09/756,351 US6652942B2 (en) 2001-01-08 2001-01-08 Assembly for a flowable material container

Publications (2)

Publication Number Publication Date
WO2002053360A2 true WO2002053360A2 (en) 2002-07-11
WO2002053360A3 WO2002053360A3 (en) 2004-02-26

Family

ID=25043085

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2002/000300 WO2002053360A2 (en) 2001-01-08 2002-01-04 Laminate for a flowable material container

Country Status (8)

Country Link
US (2) US6652942B2 (en)
EP (1) EP1412173B1 (en)
JP (1) JP4084663B2 (en)
AT (1) ATE522345T1 (en)
AU (1) AU2002236711B2 (en)
CA (1) CA2432010A1 (en)
MX (1) MXPA03006107A (en)
WO (1) WO2002053360A2 (en)

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2005254508A (en) * 2004-03-09 2005-09-22 Fujimori Kogyo Co Ltd Laminated film and packaging bag
DE102006023301A1 (en) * 2006-05-18 2008-02-28 Raumedic Ag Medical work equipment, medical assembly with such work equipment and use of such a medical work equipment
WO2009045483A2 (en) * 2007-10-02 2009-04-09 Meissner Filtration Products, Inc. Radio frequency weldable multilayer tubing and method of making the same
US8840920B2 (en) 2004-12-15 2014-09-23 Dupont Teijin Films U.S. Limited Partnership Composite structure including a low vinyl acetate layer
US9662869B2 (en) 2007-02-08 2017-05-30 Meissner Filtration Products, Inc. Multilayer film, method of making the same and containers formed from the same

Families Citing this family (22)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20030012909A1 (en) * 2000-03-10 2003-01-16 Stephane Jung Double-layer pipe
US6652942B2 (en) * 2001-01-08 2003-11-25 Baxter International Inc. Assembly for a flowable material container
EP1379212A2 (en) * 2001-02-20 2004-01-14 Pall Corporation Container for biological fluid
US6974447B2 (en) * 2001-04-17 2005-12-13 Baxter International Inc. High gas barrier receptacle and closure assembly
JP2004060986A (en) * 2002-07-29 2004-02-26 Ube Ind Ltd Flexible heat exchanger and manufacturing method for the same
JP4060222B2 (en) * 2003-03-26 2008-03-12 株式会社大塚製薬工場 Chemical container
AU2004231389B8 (en) * 2003-04-23 2009-10-01 Otsuka Pharmaceutical Factory, Inc. Drug solution filling plastic ampoule and production method therefor
EP1635638A1 (en) * 2003-06-20 2006-03-22 Pall Corporation Processing of platelet-containing biological fluids
DE602004022075D1 (en) * 2003-10-21 2009-08-27 Novo Nordisk As RESERVOIR DEVICE WITH INTEGRATED FASTENER
EP1682069B1 (en) * 2003-10-21 2009-07-08 Novo Nordisk A/S Reservoir device with inclined needle
US20050208271A1 (en) * 2004-03-17 2005-09-22 Fasching Rainer J Bonding method for micro-structured polymers
CN1964689A (en) * 2004-06-07 2007-05-16 诺和诺德公司 Reservoir with liquidly applied seal
CA2580686C (en) * 2004-10-08 2013-01-22 Robert L. Mcgee Thermoplastic olefin polymer blend and adhesive films made therefrom
WO2007115802A2 (en) * 2006-04-06 2007-10-18 Fresenius Medical Care Deutschland Gmbh Tube for medical purposes
US7964829B2 (en) * 2006-12-20 2011-06-21 Tyco Healthcare Group Lp Apparatus and method for making bag assembly
US20090309828A1 (en) * 2008-06-17 2009-12-17 Searete Llc, A Limited Liability Corporation Of The State Of Delaware Methods and systems for transmitting instructions associated with user parameter responsive projection
US8502121B2 (en) * 2009-06-17 2013-08-06 Covidien Lp Radiofrequency welding apparatus
US8151851B2 (en) 2009-06-17 2012-04-10 Tyco Healthcare Group Lp Apparatus for making bag assembly and method thereof
FR2963890B1 (en) * 2010-08-17 2013-03-08 Sartorius Stedim Biotech Sa BIOPHARMACEUTICAL DEVICE FOR SINGLE USE IN THE PREPARATION, STORAGE, TRANSPORT OF A BIOPHARMACEUTICAL PRODUCT AND CORRESPONDING MULTILAYER TUBE.
US8337734B2 (en) 2010-09-10 2012-12-25 Carefusion 303, Inc. Non-stick medical tubing
US8398572B2 (en) 2010-09-21 2013-03-19 Covidien Lp Bladder tube connection
US9062803B2 (en) * 2013-03-22 2015-06-23 Tekni-Plax, Inc. Extrudable multilayer tubing

Family Cites Families (132)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US2324237A (en) 1941-03-19 1943-07-13 Reichel John Container
US2342215A (en) 1942-08-03 1944-02-22 Harold N Perelson Dispensing and sealing stopper
US2562389A (en) 1945-11-03 1951-07-31 Shellmar Products Corp Bag and method
US2894510A (en) 1954-02-25 1959-07-14 Fenwal Lab Inc Sealing closures for fluid containers
US2808829A (en) 1955-04-06 1957-10-08 Cutter Lab Blood transfusion equipment
US3030952A (en) 1956-12-24 1962-04-24 Baxter Don Inc Solution administration device and method of forming the same
US2940444A (en) 1958-10-06 1960-06-14 Abbott Lab Container
US3161310A (en) 1960-10-14 1964-12-15 Baxter Don Inc Parenteral solution container
US3442737A (en) 1963-12-16 1969-05-06 Petro Tex Chem Corp Bonding poly(butene-1)
US3514359A (en) 1965-10-11 1970-05-26 Huels Chemische Werke Ag Process of uniting objects of polybutene-(1)
DE1604675C3 (en) 1966-03-24 1973-11-15 Peralt Anstalt, Vaduz Device for the edge-side Ver bind two flat plastic sheeting
SE315696B (en) 1968-11-21 1969-10-06 Habia Kg
US3589422A (en) 1969-03-17 1971-06-29 Baxter Laboratories Inc Sealed bag for liquids
BE789972A (en) 1971-10-20 1973-02-01 Baxter Laboratories Inc OPENING OF ACCESS, SUITABLE TO BE PIERCED, FOR CONTAINERS INTENDED TO SERVE FOR PARENTERAL SOLUTIONS
US3788374A (en) 1972-01-26 1974-01-29 Jintan Terumo Co Parenteral solution bag
US3869338A (en) 1972-03-14 1975-03-04 Union Carbide Corp Tubing for cryogenic use
US3866631A (en) 1972-07-06 1975-02-18 Imp Eastman Corp Hose construction
US3861973A (en) 1973-02-27 1975-01-21 Rilsan Corp Polyamide hose and preparation thereof
US3900640A (en) 1973-10-29 1975-08-19 Amerace Corp Hollow, multi-layered, cross-linked plastic structures and process for producing same
US3928110A (en) 1974-03-11 1975-12-23 Goodyear Tire & Rubber Film bonding using a solvent saturated cloth wick
US3911051A (en) 1974-04-25 1975-10-07 Richardson Co Cross-linked ultra high molecular weight polyethylene and S-B copolymer composition and process for molding
US3951148A (en) 1974-05-29 1976-04-20 Pharmachem Corporation Blood component storage bag and glycerolizing set therefor
US3963026A (en) 1974-11-19 1976-06-15 Pharmachem Corporation Blood component storage bag and glycerolizing set therefor
US3978859A (en) 1975-01-23 1976-09-07 Cutter Laboratories, Inc. Closure member for pierceable access ports
US3991912A (en) 1975-01-23 1976-11-16 Ricardo Hurtado Soto Flexible package with counter-pressure dispenser
US3986507A (en) 1975-04-16 1976-10-19 Inpaco Parenteral container
US4049034A (en) 1976-07-14 1977-09-20 Baxter Travenol Laboratories, Inc. Attaching means and method for attaching flexible tubing to a plastic container
US4137117A (en) 1977-03-10 1979-01-30 American Hospital Supply Corporation Method of making a solvent-bonded joint
US4201208A (en) 1977-11-30 1980-05-06 Abbott Laboratories Sterile connecting device
US4187893A (en) 1978-07-19 1980-02-12 Abbott Laboratories Combined additive and administration port for a container
US4240481A (en) 1979-03-05 1980-12-23 Baxter Travenol Laboratories, Inc. Seal for flexible container having flexible, generally conical portions
JPS5841964Y2 (en) 1979-05-18 1983-09-22 テルモ株式会社 plastic pharmaceutical liquid containers
US4327726A (en) 1979-08-15 1982-05-04 Baxter Travenol Laboratories, Inc. Connector member for dissimilar materials
US4340049A (en) 1979-10-18 1982-07-20 Baxter Travenol Laboratories, Inc. Breakaway valve
US4386622A (en) 1979-10-18 1983-06-07 Baxter Travenol Laboratories, Inc. Breakaway valve
US4441538A (en) 1979-12-26 1984-04-10 Abbott Laboratories Flexible container with integral ports and diaphragm
US4547900A (en) 1979-12-26 1985-10-15 Abbott Laboratories Flexible container with integral ports and diaphragm
US4303067A (en) 1980-01-21 1981-12-01 American Hospital Supply Corporation Medical liquid bag having an improved additive port
IT8034810V0 (en) 1980-01-22 1980-01-22 Lena Paolo SYNTHETIC BAG CONTAINER FOR HUMAN BLOOD AND ITS FRACTIONS, PERFUSIONAL SOLUTIONS, DIALYTIC SOLUTIONS AND FOR FOOD AND CHEMICAL LIQUIDS IN GENERAL
US4465488A (en) 1981-03-23 1984-08-14 Baxter Travenol Laboratories, Inc. Collapsible multi-chamber medical fluid container
SE443089B (en) 1981-05-07 1986-02-17 Birger Hjertman DEVICE FOR ASTAD COMMUNICATION OF A LIQUID CONNECTION WITH THE INTERIOR OF A LIQUID CONTAINER
US4412573A (en) 1981-12-28 1983-11-01 Baxter Travenol Laboratories, Inc. Injection site
US4393909A (en) 1981-12-28 1983-07-19 Baxter Travenol Laboratories, Inc. Universal administration port
US4484916A (en) 1982-01-20 1984-11-27 American Hospital Supply Corporation Medical solution container and port construction
JPS58155867A (en) 1982-03-12 1983-09-16 テルモ株式会社 Drill needle and medical container with drill needle
SE456637B (en) 1982-04-13 1988-10-24 Gambro Lundia Ab HEATER RELIABLE CLUTCH
NL8202952A (en) 1982-07-22 1984-02-16 Medistad Holland METHOD FOR MANUFACTURING A BAG FOR INFUSION OR TRANSFUSION FLUID, AND SO MANUFACTURED BAG
US4588396A (en) 1982-10-22 1986-05-13 Stroebel Maurice G Apparatus for gravity feed of liquid under constant hydrostatic pressure
US4479989A (en) 1982-12-02 1984-10-30 Cutter Laboratories, Inc. Flexible container material
GB8300475D0 (en) 1983-01-08 1983-02-09 Boots Co Plc Container
US5776116A (en) 1983-01-24 1998-07-07 Icu Medical, Inc. Medical connector
DE3305365C2 (en) 1983-02-17 1989-06-29 Fresenius AG, 6380 Bad Homburg Storage bag
US4523691A (en) 1983-04-08 1985-06-18 Abbott Laboratories Port structure for I.V. container
US4632673A (en) 1983-06-15 1986-12-30 Hantaaki Oy Pierceable port for containers
SE437348B (en) 1983-07-29 1985-02-25 Pharmacia Ab CLOSING DEVICE FOR THE FLUID DUMP CONNECTION OF AN OPENING OF A FLUIDUM CONTAINER OR FLUIDUM PIPE
SE442264B (en) 1983-12-23 1985-12-16 Bengt Gustavsson AMPOULE
US4576602A (en) 1984-02-08 1986-03-18 Abbott Laboratories Blow molded container with integral administration port
SE455044B (en) 1984-05-09 1988-06-20 Alfastar Ab STERILE SYSTEM
US4676775A (en) 1984-06-27 1987-06-30 David M. Roxe Fluid administration apparatus and method
US4607671A (en) 1984-08-21 1986-08-26 Baxter Travenol Laboratories, Inc. Reconstitution device
US4723956A (en) 1984-09-14 1988-02-09 Baxter Travenol Laboratories, Inc. Port free container
US4586928A (en) 1984-10-09 1986-05-06 Miles Laboratories, Inc. Pivoting frangible valve for plastic bags
US4610374A (en) 1984-10-29 1986-09-09 Dougherty Brothers Company Apparatus for mixing flowable materials in sealed containers
US4666549A (en) 1985-08-29 1987-05-19 Phillips Petroleum Company Polymer welding process and composition
JPS63139726A (en) 1986-12-01 1988-06-11 Nitsushiyoo:Kk Welding method for thermoplastic resin
US4917684A (en) 1986-09-01 1990-04-17 Japan Medical Supply Co., Ltd. Protective cover for inlet/outlet ports of the plastic bag used for medical purpose
US4857129A (en) 1987-07-31 1989-08-15 Plastic Welding Technologies, Inc. Method of bonding thermoplastic material using radio frequency energy
US4838875A (en) 1987-12-09 1989-06-13 Somor Andrew T Method and apparatus for dealing with intravenous fluids
US4869384A (en) 1988-01-12 1989-09-26 International Medication Systems Limited Package for toxic and dangerous drugs
US5114768A (en) 1988-06-02 1992-05-19 Hewlett-Packard Company Surfaces with reduced protein interactions
ATE179632T1 (en) 1988-06-02 1999-05-15 Piero Marrucchi DEVICE FOR TREATING AND TRANSFERING SUBSTANCES BETWEEN ENCLOSED ROOMS
US5251982A (en) 1988-07-08 1993-10-12 Ab Tetra Pak Discharging device for a packaging container
US5125919A (en) 1988-08-31 1992-06-30 Clintec Nutrition Company Wedge-shaped port for flexible containers
US4969883A (en) 1989-01-03 1990-11-13 Gilbert Michael D Medicament vial end cap membrane piercing device
CA2010320C (en) * 1989-02-20 2001-04-17 Yohzoh Yamamoto Sheet or film of cyclo-olefin polymer
JP2923302B2 (en) 1989-05-17 1999-07-26 テルモ株式会社 Tubular body with diaphragm
US5259894A (en) 1990-01-26 1993-11-09 Sampson Richard K Method for solvent bonding non-porous materials to automatically create variable bond characteristics
US5071413A (en) 1990-06-13 1991-12-10 Utterberg David S Universal connector
US5088995A (en) 1990-06-22 1992-02-18 Baxter International Inc. Port and closure assembly including a resealing injection site for a container
US5084042A (en) 1990-06-29 1992-01-28 Mcgaw, Inc. Medical solution container outlet port with improved pierceable diaphragm
US5272236A (en) 1991-10-15 1993-12-21 The Dow Chemical Company Elastic substantially linear olefin polymers
US5222950A (en) 1990-07-16 1993-06-29 Eisenberg Melvin I Quick release tamper evident closure device
US5167816A (en) 1990-08-20 1992-12-01 Abbott Laboratories Sterile coupling device for drug container
US5137527A (en) 1990-09-20 1992-08-11 Clintec Nutrition Co. Enteral-specific spike/bag port system
US5188628A (en) 1990-11-06 1993-02-23 Sandoz Ltd. Closure device for enteral fluid containers
US5533992A (en) * 1990-12-31 1996-07-09 Patel; Indrajit Material for medical grade products and products made therefrom
CA2062238C (en) 1991-03-19 1996-06-25 Rudolf Bucheli Closure for reagent container
US5308347A (en) 1991-09-18 1994-05-03 Fujisawa Pharmaceutical Co., Ltd. Transfusion device
US5303751A (en) 1991-10-04 1994-04-19 Fresenius Ag Spiked bag packaging system
US5783638A (en) * 1991-10-15 1998-07-21 The Dow Chemical Company Elastic substantially linear ethylene polymers
US5259843A (en) 1991-11-14 1993-11-09 Kawasumi Laboratories Inc. Medical connector for attaching to liquid introducing tube
US5416142A (en) 1991-12-17 1995-05-16 Oatey Company Method of bonding and bonding compositions
US6149997A (en) * 1992-01-30 2000-11-21 Baxter International Inc. Multilayer coextruded material for medical grade products and products made therefrom
US5330464A (en) 1992-03-11 1994-07-19 Baxter International Inc. Reliable breakable closure mechanism
CA2093560C (en) 1992-04-10 2005-06-07 Minoru Honda Fluid container
US5356709A (en) * 1992-05-14 1994-10-18 Baxter International, Inc. Non-PVC coextruded medical grade port tubing
US5336351A (en) 1992-07-14 1994-08-09 Tuf-Tite, Inc. Method for connecting a pipe connector to a hard plastic pipe
US5810398A (en) 1992-10-02 1998-09-22 Pall Corporation Fluid delivery systems and methods and assemblies for making connections
US5391150A (en) 1992-12-28 1995-02-21 Richmond; Frank IV bag with needleless connector ports
US5342345A (en) 1993-01-04 1994-08-30 Denco, Inc. Solution bag with plastic connecting tube
US5395365A (en) 1993-03-22 1995-03-07 Automatic Liquid Packaging, Inc. Container with pierceable and/or collapsible features
US5514123A (en) 1993-04-01 1996-05-07 Abbott Laboratories Sterile formed, filled and sealed flexible container
US5334180A (en) 1993-04-01 1994-08-02 Abbott Laboratories Sterile formed, filled and sealed flexible container
US5792824A (en) * 1993-05-21 1998-08-11 Asahi Kasei Kogyo Kabushiki Kaisha Cyclic conjugated diene polymer and method of producing same
US5795945A (en) * 1993-06-16 1998-08-18 Asahi Kasei Kogyo Kabushiki Kaisha Polymer containing a cyclic olefin monomer unit
US6146362A (en) 1993-08-27 2000-11-14 Baton Development, Inc. Needleless IV medical delivery system
US5591337A (en) 1993-09-14 1997-01-07 Baxter International Inc. Apparatus for filtering leukocytes from blood cells
US5423794A (en) 1993-09-28 1995-06-13 Abbott Laboratories Intravenous container with siphoning port
US5540674A (en) 1993-09-28 1996-07-30 Abbott Laboratories Solution container with dual use access port
US5849843A (en) * 1993-11-16 1998-12-15 Baxter International Inc. Polymeric compositions for medical packaging and devices
US6461696B1 (en) * 1993-11-16 2002-10-08 Baxter International Inc. Multi-layered polymer based moisture barrier structure for medical grade products
US5998019A (en) 1993-11-16 1999-12-07 Baxter International Inc. Multi-layered polymer structure for medical products
US5458593A (en) 1993-11-24 1995-10-17 Bayer Corporation Dockable bag system and method
TW364910B (en) * 1993-12-27 1999-07-21 Hoechst Ag Polymer alloy
US5496291A (en) * 1994-03-30 1996-03-05 Spencer; Dudley W. C. Ionomeric modified poly-ether-ester plastic tube for use in conveying medical solutions and the like
MX9606273A (en) 1994-06-17 1998-03-31 Allied Signal Inc Articles comprising extruded polyamide-grafted low density polyethylene blends.
JPH0852196A (en) 1994-08-09 1996-02-27 Material Eng Tech Lab Inc Transfusion container having connecting port for medicine
US5584825A (en) 1994-12-01 1996-12-17 Isolyser Co., Inc. Closure delivery system
US5520641A (en) 1995-02-06 1996-05-28 Minnesota Mining And Manufacturing Company IV injection and sampling site having septum with multiple openings
US5810768A (en) 1995-06-07 1998-09-22 Icu Medical, Inc. Medical connector
US6127009A (en) 1996-05-08 2000-10-03 Pactiv Corporation Dispenser unit, process for manufacturing the same and its use
WO1998000286A1 (en) * 1996-07-03 1998-01-08 Baxter International Inc. Method of sealing a port tube in a container
US5728087A (en) 1996-07-30 1998-03-17 Bracco Diagnostics, Inc. Universal flexible plastic container with multiple access ports of inverted Y shape configuration
US5779832A (en) 1996-11-25 1998-07-14 W. R. Grace & Co.-Conn. Method and apparatus for making a peelable film
US5772652A (en) 1997-05-14 1998-06-30 Comar, Inc. Stab cap for a vial having a puncturable seal
US6019750A (en) 1997-12-04 2000-02-01 Baxter International Inc. Sliding reconstitution device with seal
US6022344A (en) 1997-12-04 2000-02-08 Npbi International B.V. Cryopreservation bag
US6019751A (en) 1998-01-20 2000-02-01 Bracco Research Usa Universal connector and a medical container
US6132413A (en) 1998-03-06 2000-10-17 Baxter International Inc. Breakable cannula assemblies and methods for manipulating them
US6179821B1 (en) 1998-06-18 2001-01-30 Glenn A. Caspary Membrane port for a container
US6869653B2 (en) * 2001-01-08 2005-03-22 Baxter International Inc. Port tube closure assembly
US6652942B2 (en) * 2001-01-08 2003-11-25 Baxter International Inc. Assembly for a flowable material container

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
None

Cited By (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2005254508A (en) * 2004-03-09 2005-09-22 Fujimori Kogyo Co Ltd Laminated film and packaging bag
US8840920B2 (en) 2004-12-15 2014-09-23 Dupont Teijin Films U.S. Limited Partnership Composite structure including a low vinyl acetate layer
DE102006023301A1 (en) * 2006-05-18 2008-02-28 Raumedic Ag Medical work equipment, medical assembly with such work equipment and use of such a medical work equipment
US9662869B2 (en) 2007-02-08 2017-05-30 Meissner Filtration Products, Inc. Multilayer film, method of making the same and containers formed from the same
US10899114B2 (en) 2007-02-08 2021-01-26 Meissner Filtration Products, Inc. Multilayer film, method of making the same and containers formed from the same
WO2009045483A2 (en) * 2007-10-02 2009-04-09 Meissner Filtration Products, Inc. Radio frequency weldable multilayer tubing and method of making the same
WO2009045483A3 (en) * 2007-10-02 2011-09-15 Meissner Filtration Products, Inc. Radio frequency weldable multilayer tubing and method of making the same
US9682526B2 (en) 2007-10-02 2017-06-20 Meissner Filtration Products, Inc. Radio frequency weldable multilayer tubing and method of making the same
US10131109B2 (en) 2007-10-02 2018-11-20 Meissner Filtration Products, Inc. Radio frequency weldable multi-layer tubing and method of making the same

Also Published As

Publication number Publication date
EP1412173B1 (en) 2011-08-31
EP1412173A2 (en) 2004-04-28
US6652942B2 (en) 2003-11-25
US20020132077A1 (en) 2002-09-19
WO2002053360A3 (en) 2004-02-26
MXPA03006107A (en) 2004-05-04
JP4084663B2 (en) 2008-04-30
CA2432010A1 (en) 2002-07-11
JP2004525787A (en) 2004-08-26
US20040086675A1 (en) 2004-05-06
US7329445B2 (en) 2008-02-12
ATE522345T1 (en) 2011-09-15
AU2002236711B2 (en) 2006-04-13

Similar Documents

Publication Publication Date Title
AU2002236711B2 (en) Laminate for a flowable material container
AU2002236711A1 (en) Laminate for a flowable material container
US6869653B2 (en) Port tube closure assembly
AU2002243476A1 (en) Port tube and closure composition, structure and assembly for a flowable material container
CA2444758C (en) High gas barrier receptacle and closure assembly
US20030176847A1 (en) Contoured tubing closure
KR20040041154A (en) A steam-sterilizable multilayer film and containers made thereof
JP5382986B2 (en) Heparin injection solution
AU2005237130B2 (en) Port tube and closure composition, structure and assembly for a flowable material container

Legal Events

Date Code Title Description
AK Designated states

Kind code of ref document: A2

Designated state(s): AE AG AL AM AT AU AZ BA BB BG BR BY BZ CA CH CN CO CR CU CZ DE DK DM DZ EC EE ES FI GB GD GE GH GM HR HU ID IL IN IS JP KE KG KP KR KZ LC LK LR LS LT LU LV MA MD MG MK MN MW MX MZ NO NZ OM PH PL PT RO RU SD SE SG SI SK SL TJ TM TN TR TT TZ UA UG UZ VN YU ZA ZM ZW

AL Designated countries for regional patents

Kind code of ref document: A2

Designated state(s): AT BE CH CY DE DK ES FI FR GB GR IE IT LU MC NL PT SE TR

DFPE Request for preliminary examination filed prior to expiration of 19th month from priority date (pct application filed before 20040101)
121 Ep: the epo has been informed by wipo that ep was designated in this application
WWE Wipo information: entry into national phase

Ref document number: 2432010

Country of ref document: CA

WWE Wipo information: entry into national phase

Ref document number: 2002236711

Country of ref document: AU

WWE Wipo information: entry into national phase

Ref document number: PA/a/2003/006107

Country of ref document: MX

Ref document number: 2002554493

Country of ref document: JP

WWE Wipo information: entry into national phase

Ref document number: 2002703063

Country of ref document: EP

REG Reference to national code

Ref country code: DE

Ref legal event code: 8642

WWP Wipo information: published in national office

Ref document number: 2002703063

Country of ref document: EP