EP0082154A1 - Clear, autoclavable thermoplastic formulation for medical liquid containers - Google Patents

Clear, autoclavable thermoplastic formulation for medical liquid containers

Info

Publication number
EP0082154A1
EP0082154A1 EP82901673A EP82901673A EP0082154A1 EP 0082154 A1 EP0082154 A1 EP 0082154A1 EP 82901673 A EP82901673 A EP 82901673A EP 82901673 A EP82901673 A EP 82901673A EP 0082154 A1 EP0082154 A1 EP 0082154A1
Authority
EP
European Patent Office
Prior art keywords
weight
thermoplastic
ethylene
block
polymer
Prior art date
Legal status (The legal status 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 status listed.)
Withdrawn
Application number
EP82901673A
Other languages
German (de)
English (en)
French (fr)
Inventor
Mostafa Zomorodi
Alan Jay Trieber
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Abbott Laboratories
Original Assignee
Abbott Laboratories
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 Abbott Laboratories filed Critical Abbott Laboratories
Publication of EP0082154A1 publication Critical patent/EP0082154A1/en
Withdrawn legal-status Critical Current

Links

Classifications

    • CCHEMISTRY; METALLURGY
    • C08ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08LCOMPOSITIONS OF MACROMOLECULAR COMPOUNDS
    • C08L23/00Compositions of homopolymers or copolymers of unsaturated aliphatic hydrocarbons having only one carbon-to-carbon double bond; Compositions of derivatives of such polymers
    • C08L23/02Compositions of homopolymers or copolymers of unsaturated aliphatic hydrocarbons having only one carbon-to-carbon double bond; Compositions of derivatives of such polymers not modified by chemical after-treatment
    • C08L23/10Homopolymers or copolymers of propene
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/02Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using physical phenomena
    • A61L2/04Heat
    • A61L2/06Hot gas
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/26Accessories or devices or components used for biocidal treatment
    • CCHEMISTRY; METALLURGY
    • C08ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08LCOMPOSITIONS OF MACROMOLECULAR COMPOUNDS
    • C08L23/00Compositions of homopolymers or copolymers of unsaturated aliphatic hydrocarbons having only one carbon-to-carbon double bond; Compositions of derivatives of such polymers
    • C08L23/02Compositions of homopolymers or copolymers of unsaturated aliphatic hydrocarbons having only one carbon-to-carbon double bond; Compositions of derivatives of such polymers not modified by chemical after-treatment
    • C08L23/10Homopolymers or copolymers of propene
    • C08L23/12Polypropene
    • CCHEMISTRY; METALLURGY
    • C08ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08LCOMPOSITIONS OF MACROMOLECULAR COMPOUNDS
    • C08L2205/00Polymer mixtures characterised by other features
    • C08L2205/03Polymer mixtures characterised by other features containing three or more polymers in a blend
    • CCHEMISTRY; METALLURGY
    • C08ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08LCOMPOSITIONS OF MACROMOLECULAR COMPOUNDS
    • C08L23/00Compositions of homopolymers or copolymers of unsaturated aliphatic hydrocarbons having only one carbon-to-carbon double bond; Compositions of derivatives of such polymers
    • C08L23/02Compositions of homopolymers or copolymers of unsaturated aliphatic hydrocarbons having only one carbon-to-carbon double bond; Compositions of derivatives of such polymers not modified by chemical after-treatment
    • C08L23/04Homopolymers or copolymers of ethene
    • C08L23/08Copolymers of ethene
    • C08L23/0846Copolymers of ethene with unsaturated hydrocarbons containing other atoms than carbon or hydrogen atoms
    • C08L23/0869Acids or derivatives thereof
    • CCHEMISTRY; METALLURGY
    • C08ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08LCOMPOSITIONS OF MACROMOLECULAR COMPOUNDS
    • C08L53/00Compositions of block copolymers containing at least one sequence of a polymer obtained by reactions only involving carbon-to-carbon unsaturated bonds; Compositions of derivatives of such polymers
    • CCHEMISTRY; METALLURGY
    • C08ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08LCOMPOSITIONS OF MACROMOLECULAR COMPOUNDS
    • C08L53/00Compositions of block copolymers containing at least one sequence of a polymer obtained by reactions only involving carbon-to-carbon unsaturated bonds; Compositions of derivatives of such polymers
    • C08L53/02Compositions of block copolymers containing at least one sequence of a polymer obtained by reactions only involving carbon-to-carbon unsaturated bonds; Compositions of derivatives of such polymers of vinyl-aromatic monomers and conjugated dienes

Definitions

  • the present application relates generally to medical plastic formulations and particularly to medical liquid containers such as flexible, collapsible, intra venous solution containers.
  • the materials disclosed exhibit the particular advantages of being essentially transparent, soft and flexible, essentially free of extractables, and able to resist high temperatures present in autoclaving.
  • Various materials have been utilized for intravenous solution containers in the past.
  • U.S. Patent No. 4,140,162 discloses a formulation for medical liquid containers containing both polypropylene and a block copolymer.
  • a third ingredient disclosed comprises polyethylene or polyethylene vinyl acetate.
  • the present invention is distinguished from the '162 patent by the use of ethylene methyl acrylate, which is lower in cost and provides more desirable physical properties such as improved thermal stability and a wider range of processing temperatures.
  • Other formulations of block copolymers which include polypropylene may be found in U.S. Patent No. 3,792,124. These formulations are not suitable for flexible medical liquid containers, however, in that they are ionic,
  • a clear, flexible, thermoplastic material capable of being processed into hollow shapes by conventional plas tic processing methods and subsequently autoclaved.
  • the material comprises: (A) from about 40 to 70% by weight of a polyolefin, usually polypropylene a ⁇ ir.ixed with (B) from about 5 to 40% by weight of an ethylene loweralkyl acrylate; and (C) from about 5 to 40% by weight of one of several block copolymers: ethylene butylene having terminal polystyrene units, butadiene styrene having terminal polystyrene units, an olefin elastomer of the ethylene propylene type, or butyl rubber (polybutadiene isoprene).
  • Ingredient (A) as described above is a polyolefin consisting essentially of polypropylene units. Many commercial varieties of polypropylene contain small amounts of ethylene units. This does not make a major impact on the properties of the propylene material.
  • Ingredient (B) generally comprises ethylene methyl acrylate (EMA) and is commercially available from Gulf Oil Chemicals Co., Orange, Texas, under the numbers 2205 and 2255.
  • EMA is a random copolymer consisting of a polyethylene backbone with methyl acrylate side branches. Gulf's present commercial product contains approximately 20% by weight of methyl acrylate.
  • EMA's distinguishing properties include a low melt temperature and corresponding easy heat sealability, as well as good thermal stability in the range of 600 to 630° F., and "rubbery" mechanical properties, including low stiffness, high elongation, clarity and high impact strength.
  • Table I A comparison of ethylene methyl acrylate to ethylene vinyl acetate may be seen in the following Table I:
  • EMA EMA's great thersal stability. EMA can be processed at very high temperatures; up to 600 to 630°F. without polymer breakdown anc/or chain cission. Some of the other low density polyethylene copolymers, like EVA, when mixed with high temperature- resistant plastics such as polypropylene and high density polyethylene and heated in excess of 450°F. begin to break down and liberate acids that attack netal surfaces of extrusion equipment.
  • Loweralkyl ethylene acrylates may be utilized such as ethylene ethyl acrylate and ethylene butyl acrylate, with similar results.
  • Loweralkyl is defined as an alkyl group having 1-5 carbon atoms, such as ethyl, methyl, butyl, etc.
  • the third element (C) of this novel plastic material comprises from about 5 to 40% by weight of a thermoplastic composition; usually a block copolymer of ethylene butylene having terminal polystyrene units.
  • Ethylene butylene block copolymers having terminal polystyrene units are commercially available under the trademark Kraton G® from the Shell Chemical Co.
  • Other rubbery block copolymers such as butadiene styrene having terminal polystyrene units may also be utilized.
  • the impermeable polymeric compositions disclosed in U.S. Patent 3,686,364 assigned to Polymer Corporation Limited hereby incorporated by reference, discloses a series of butadiene styrene block copolymers useful as the third element in the present application.
  • ethylene propylene dienemonomer elastomer available from Heisler Corporation under the number HC-5214, may also be used as the third ingredient of the material.
  • Table III discloses a series of examples of the above listed material, showing in particu lar, the proportionate percentages, by weight, of element A, B and C.
  • 10% ethylene methyl acrylate was mixed with 90% polypropylene.
  • the resulting combination was then mixed in a proportion of 70% EMA polypropylene to 30% element C.
  • the resulting material exhibited the following properties, as seen in Table IV.
  • the resulting formulation was found to be highly suitable for sheet extrusion, injection molding or blow molding into flexible, transparent, autoclavable intravenous solution containers.
  • the resulting container was found to be of sufficient strength to withstand heavy impact during shipment and use, while at the same time being sufficiently flexible to collapse easily during drainage of intravenous solution from the container.
  • a block copolymer having thermoplastic rubber characteristics consisting essentially of a rubbery olefin polymer of generally equal proportions of ethylen and butylene units in terminal blocks of polystyrene was added to a rotational mixer in the amount of 40% by weight with 10% by weight of a blend of 90% polypropylen and 10% EMA.
  • the block copolymer used was Kraton 2705 sold by the Shell Chemical Company. Mechanical proper ties of Kraton 2705 are as follows:
  • the ingredients were premixed in the rotational mixer and then introduced into an extruder for extrusion into a rod.
  • the rods were then chopped into smaller pellet sized pieces.
  • the chopped pellets were utilized in the commercially available blow molding apparatus, specifically a continuous extrusion machine, with a secondary blow station manufactured by Romellog Fellbach of Oeffingen.
  • the material was found to be successfully fabricated into a transparent, flexible, collapsible intravenous solution container which was autoclavable under a typical sterilizing cycle without an distortion.
  • each polymer block A being selected from the group consisting of monoalkenyl arine polymers and hydrogenated products thereof wherein no more than 25% of the arine double bonds had been reduced and polymer block B is a hydrogenated polymer block of a C 4 -5 conjugated diene polymer wherein at least about 30% of the aliphatic unsaturation has been reduced by hydrogenation.
  • each polystyrene block has an average molecular weight between about 2,000 and 50,000 and the hydrogenated polybutadiene block has an average molecular weight between about 20,000 and 300,000.
  • alpha-beta-alpha block copolymer (hereinafter referred to as alpha-beta-alpha block copolymer) was prepared and blended with uncured butyl rubber.
  • the alpha-beta-alpha block copolymer had an alpha methyl styrene content of approximately 35% weight and a molecular weight of about 60,000.
  • Three separate blends were prepared using 30, 40 and 50 parts by weight of butyl rubber respectively with 100 parts by weight of alpha-beta-alpha block copolymer. The blending was carried out on a ⁇ iicromil, the mil rolls were at elevated temperatures in the range of about 130°C. to about 150°C. The resulting blends were then admixed with components A and B as previously described.
  • Element C comprises 10% by weight of a thermoplastic composition comprising a block copolymer having at least two monoalkenyl arine polymer blocks and at least one substantially completely hydrogenated diene polymer block.
  • polymer block A is a block copolymer having the structure polystyrene-completely hydrogenated polybutadiene-polystyrene with block molecular weights of 25,000-100,000-25,000.
  • An alternative formulation is a block copolymer of the same structure and block identity but having block molecular weights of 10,000-50,000- 10,000.
  • a block copolymer of general form polyethyl methyl styrene polybutadiene polyethyl methyl styrene was prepared with different quantities of uncured butyl rubber.
  • the alpha-beta-alpha block copolymer had an alpha methyl styrene content of approximately 35 percent by weight and a molecular weight of about 60,000.
  • the nonterminal elastomer block may be polybutadiene, or polybutadiene and butyl rubber.
  • the resulting block copolymer was then admixed with components A and B.
  • nucleating agent such as sodium benzoate or millad 3900 polyolefin clarifies both manufactured by Miniiken Corp., nay be added to the above listed formulations to improve clarity.
EP82901673A 1981-06-29 1982-04-15 Clear, autoclavable thermoplastic formulation for medical liquid containers Withdrawn EP0082154A1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US27825381A 1981-06-29 1981-06-29
US278253 1981-06-29

Publications (1)

Publication Number Publication Date
EP0082154A1 true EP0082154A1 (en) 1983-06-29

Family

ID=23064285

Family Applications (1)

Application Number Title Priority Date Filing Date
EP82901673A Withdrawn EP0082154A1 (en) 1981-06-29 1982-04-15 Clear, autoclavable thermoplastic formulation for medical liquid containers

Country Status (9)

Country Link
EP (1) EP0082154A1 (pt)
JP (1) JPS58501035A (pt)
BR (1) BR8207774A (pt)
CA (1) CA1191985A (pt)
ES (1) ES8403500A1 (pt)
IT (1) IT1153547B (pt)
PH (1) PH18514A (pt)
WO (1) WO1983000158A1 (pt)
ZA (1) ZA823100B (pt)

Families Citing this family (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS5974153A (ja) * 1982-10-21 1984-04-26 Dainippon Plastics Co Ltd 樹脂組成物
EP0164190A3 (en) * 1984-04-05 1986-10-22 Exxon Research And Engineering Company Sterilizable packages and processes
US4568723A (en) * 1984-11-08 1986-02-04 Mobil Oil Company Blends of polypropylene, polycarbonate and a saturated styrene-ethylene-butylene-styrene rubber
CA1326723C (en) * 1987-09-04 1994-02-01 David Romme Hansen Polymeric composition
EP0330151A3 (en) * 1988-02-23 1991-07-03 Nissho Corporation Bag for the storage of blood platelets
US5849843A (en) * 1993-11-16 1998-12-15 Baxter International Inc. Polymeric compositions for medical packaging and devices
US5723543A (en) * 1996-09-26 1998-03-03 Shell Oil Company Block copolymers with improved overmolding adhesion
US6183460B1 (en) 1998-01-22 2001-02-06 Baxter International Inc. Multi-use solution container having flaps
ES2545078T3 (es) * 2005-08-26 2015-09-08 Becton Dickinson And Company Métodos de esterilización de dispositivos de sellado elastomérico
JP5428856B2 (ja) * 2007-05-25 2014-02-26 株式会社クラレ 熱可塑性重合体組成物

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3361852A (en) * 1965-09-15 1968-01-02 Union Carbide Corp Ternary polypropylene compositions containing ethylene/propylene and ethylene/vinyl ester copolymers
US4107130A (en) * 1976-06-07 1978-08-15 Shell Oil Company Multicomponent polyolefin-block copolymer-polymer blends
GB2007685B (en) * 1977-10-11 1982-05-12 Asahi Dow Ltd Composition for drawn film cold drawn film made of said composition and process for manufacture of said film

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See references of WO8300158A1 *

Also Published As

Publication number Publication date
ES513453A0 (es) 1983-08-16
CA1191985A (en) 1985-08-13
ZA823100B (en) 1983-03-30
PH18514A (en) 1985-08-02
JPS58501035A (ja) 1983-06-30
IT8222101A0 (it) 1982-06-28
ES8403500A1 (es) 1983-08-16
WO1983000158A1 (en) 1983-01-20
BR8207774A (pt) 1983-05-31
IT1153547B (it) 1987-01-14

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Inventor name: TRIEBER, ALAN JAY

Inventor name: ZOMORODI, MOSTAFA