US20170299089A1 - Polyurethane-polyethylene delamination resistant tubing with gas barrier properties - Google Patents
Polyurethane-polyethylene delamination resistant tubing with gas barrier properties Download PDFInfo
- Publication number
- US20170299089A1 US20170299089A1 US15/642,668 US201715642668A US2017299089A1 US 20170299089 A1 US20170299089 A1 US 20170299089A1 US 201715642668 A US201715642668 A US 201715642668A US 2017299089 A1 US2017299089 A1 US 2017299089A1
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- United States
- Prior art keywords
- layer
- polymeric material
- inches
- polyethylene
- tube
- 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.)
- Abandoned
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- 230000004888 barrier function Effects 0.000 title claims abstract description 53
- 239000004698 Polyethylene Substances 0.000 title claims abstract description 28
- 229920000573 polyethylene Polymers 0.000 title claims abstract description 28
- 230000032798 delamination Effects 0.000 title claims description 5
- 239000000463 material Substances 0.000 claims abstract description 74
- -1 polyethylene Polymers 0.000 claims abstract description 29
- 229920002635 polyurethane Polymers 0.000 claims description 26
- 239000004814 polyurethane Substances 0.000 claims description 26
- 239000012530 fluid Substances 0.000 claims description 24
- 238000000034 method Methods 0.000 claims description 22
- 229920001684 low density polyethylene Polymers 0.000 claims description 14
- 239000004702 low-density polyethylene Substances 0.000 claims description 14
- VGGSQFUCUMXWEO-UHFFFAOYSA-N Ethene Chemical compound C=C VGGSQFUCUMXWEO-UHFFFAOYSA-N 0.000 claims description 13
- 239000005977 Ethylene Substances 0.000 claims description 13
- 229920006243 acrylic copolymer Polymers 0.000 claims description 13
- 229920000219 Ethylene vinyl alcohol Polymers 0.000 claims description 11
- 239000004721 Polyphenylene oxide Substances 0.000 claims description 11
- 150000008064 anhydrides Chemical class 0.000 claims description 11
- 229920000570 polyether Polymers 0.000 claims description 11
- 239000004952 Polyamide Substances 0.000 claims description 10
- 125000003118 aryl group Chemical group 0.000 claims description 10
- 229920002647 polyamide Polymers 0.000 claims description 10
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 10
- 229920001903 high density polyethylene Polymers 0.000 claims description 7
- 239000004700 high-density polyethylene Substances 0.000 claims description 7
- 125000001931 aliphatic group Chemical group 0.000 claims description 6
- 229920006225 ethylene-methyl acrylate Polymers 0.000 claims description 6
- 238000001125 extrusion Methods 0.000 claims description 6
- 229920006228 ethylene acrylate copolymer Polymers 0.000 claims description 5
- 238000001816 cooling Methods 0.000 claims description 2
- 229920000092 linear low density polyethylene Polymers 0.000 claims description 2
- 239000004707 linear low-density polyethylene Substances 0.000 claims description 2
- 239000000853 adhesive Substances 0.000 abstract description 27
- 230000001070 adhesive effect Effects 0.000 abstract description 27
- 239000004433 Thermoplastic polyurethane Substances 0.000 abstract description 3
- 229920002803 thermoplastic polyurethane Polymers 0.000 abstract description 3
- 239000010410 layer Substances 0.000 description 141
- 239000007789 gas Substances 0.000 description 11
- 239000004800 polyvinyl chloride Substances 0.000 description 9
- 239000000203 mixture Substances 0.000 description 8
- 229920000915 polyvinyl chloride Polymers 0.000 description 8
- 239000012790 adhesive layer Substances 0.000 description 7
- QVGXLLKOCUKJST-UHFFFAOYSA-N atomic oxygen Chemical compound [O] QVGXLLKOCUKJST-UHFFFAOYSA-N 0.000 description 4
- 230000005012 migration Effects 0.000 description 4
- 238000013508 migration Methods 0.000 description 4
- 239000001301 oxygen Substances 0.000 description 4
- 229910052760 oxygen Inorganic materials 0.000 description 4
- 238000011282 treatment Methods 0.000 description 3
- IJGRMHOSHXDMSA-UHFFFAOYSA-N Atomic nitrogen Chemical compound N#N IJGRMHOSHXDMSA-UHFFFAOYSA-N 0.000 description 2
- IAYPIBMASNFSPL-UHFFFAOYSA-N Ethylene oxide Chemical compound C1CO1 IAYPIBMASNFSPL-UHFFFAOYSA-N 0.000 description 2
- RYECOJGRJDOGPP-UHFFFAOYSA-N Ethylurea Chemical compound CCNC(N)=O RYECOJGRJDOGPP-UHFFFAOYSA-N 0.000 description 2
- GQPLMRYTRLFLPF-UHFFFAOYSA-N Nitrous Oxide Chemical compound [O-][N+]#N GQPLMRYTRLFLPF-UHFFFAOYSA-N 0.000 description 2
- 238000010521 absorption reaction Methods 0.000 description 2
- 230000008901 benefit Effects 0.000 description 2
- 239000003153 chemical reaction reagent Substances 0.000 description 2
- 239000005038 ethylene vinyl acetate Substances 0.000 description 2
- 238000012986 modification Methods 0.000 description 2
- 230000004048 modification Effects 0.000 description 2
- 229920003023 plastic Polymers 0.000 description 2
- 239000004033 plastic Substances 0.000 description 2
- 229920001200 poly(ethylene-vinyl acetate) Polymers 0.000 description 2
- 230000008569 process Effects 0.000 description 2
- 239000000126 substance Substances 0.000 description 2
- ZAMOUSCENKQFHK-UHFFFAOYSA-N Chlorine atom Chemical compound [Cl] ZAMOUSCENKQFHK-UHFFFAOYSA-N 0.000 description 1
- 229920010126 Linear Low Density Polyethylene (LLDPE) Polymers 0.000 description 1
- 229920012485 Plasticized Polyvinyl chloride Polymers 0.000 description 1
- 239000000654 additive Substances 0.000 description 1
- 239000007864 aqueous solution Substances 0.000 description 1
- 230000004323 axial length Effects 0.000 description 1
- 210000004204 blood vessel Anatomy 0.000 description 1
- 210000001124 body fluid Anatomy 0.000 description 1
- 239000007795 chemical reaction product Substances 0.000 description 1
- 239000000460 chlorine Substances 0.000 description 1
- 229910052801 chlorine Inorganic materials 0.000 description 1
- 239000013065 commercial product Substances 0.000 description 1
- 238000010276 construction Methods 0.000 description 1
- 229940079593 drug Drugs 0.000 description 1
- 239000003814 drug Substances 0.000 description 1
- 239000002355 dual-layer Substances 0.000 description 1
- 230000008030 elimination Effects 0.000 description 1
- 238000003379 elimination reaction Methods 0.000 description 1
- 239000004715 ethylene vinyl alcohol Substances 0.000 description 1
- 239000001257 hydrogen Substances 0.000 description 1
- 229910052739 hydrogen Inorganic materials 0.000 description 1
- 125000004435 hydrogen atom Chemical class [H]* 0.000 description 1
- 238000001727 in vivo Methods 0.000 description 1
- 238000010348 incorporation Methods 0.000 description 1
- 239000012948 isocyanate Substances 0.000 description 1
- 150000002513 isocyanates Chemical class 0.000 description 1
- 239000011159 matrix material Substances 0.000 description 1
- 229910052757 nitrogen Inorganic materials 0.000 description 1
- 239000001272 nitrous oxide Substances 0.000 description 1
- 239000004014 plasticizer Substances 0.000 description 1
- 229920000642 polymer Polymers 0.000 description 1
- 229920005862 polyol Polymers 0.000 description 1
- 150000003077 polyols Chemical class 0.000 description 1
- 229920003225 polyurethane elastomer Polymers 0.000 description 1
- 238000004321 preservation Methods 0.000 description 1
- 230000002265 prevention Effects 0.000 description 1
- 230000001954 sterilising effect Effects 0.000 description 1
- 238000004659 sterilization and disinfection Methods 0.000 description 1
Images
Classifications
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- F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
- F16—ENGINEERING ELEMENTS AND UNITS; GENERAL MEASURES FOR PRODUCING AND MAINTAINING EFFECTIVE FUNCTIONING OF MACHINES OR INSTALLATIONS; THERMAL INSULATION IN GENERAL
- F16L—PIPES; JOINTS OR FITTINGS FOR PIPES; SUPPORTS FOR PIPES, CABLES OR PROTECTIVE TUBING; MEANS FOR THERMAL INSULATION IN GENERAL
- F16L9/00—Rigid pipes
- F16L9/12—Rigid pipes of plastics with or without reinforcement
- F16L9/121—Rigid pipes of plastics with or without reinforcement with three layers
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- A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
- A61L29/04—Macromolecular materials
- A61L29/041—Macromolecular materials obtained by reactions only involving carbon-to-carbon unsaturated bonds
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- A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
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- A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
- A61L29/08—Materials for coatings
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- A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
- A61L29/14—Materials characterised by their function or physical properties, e.g. lubricating compositions
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/08—Tubes; Storage means specially adapted therefor
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- B32—LAYERED PRODUCTS
- B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
- B32B1/00—Layered products having a non-planar shape
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- B32B27/06—Layered 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
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- B32B27/00—Layered products comprising a layer of synthetic resin
- B32B27/30—Layered products comprising a layer of synthetic resin comprising vinyl (co)polymers; comprising acrylic (co)polymers
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- B32B7/00—Layered products characterised by the relation between layers; Layered products characterised by the relative orientation of features between layers, or by the relative values of a measurable parameter between layers, i.e. products comprising layers having different physical, chemical or physicochemical properties; Layered products characterised by the interconnection of layers
- B32B7/04—Interconnection of layers
- B32B7/12—Interconnection of layers using interposed adhesives or interposed materials with bonding properties
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- F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
- F16—ENGINEERING ELEMENTS AND UNITS; GENERAL MEASURES FOR PRODUCING AND MAINTAINING EFFECTIVE FUNCTIONING OF MACHINES OR INSTALLATIONS; THERMAL INSULATION IN GENERAL
- F16L—PIPES; JOINTS OR FITTINGS FOR PIPES; SUPPORTS FOR PIPES, CABLES OR PROTECTIVE TUBING; MEANS FOR THERMAL INSULATION IN GENERAL
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- F16L11/04—Hoses, i.e. flexible pipes made of rubber or flexible plastics
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- A61L2420/00—Materials or methods for coatings medical devices
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- B32B2307/00—Properties of the layers or laminate
- B32B2307/40—Properties of the layers or laminate having particular optical properties
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- B32B2307/00—Properties of the layers or laminate
- B32B2307/50—Properties of the layers or laminate having particular mechanical properties
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- B32B2535/00—Medical equipment, e.g. bandage, prostheses, catheter
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- B32B2597/00—Tubular articles, e.g. hoses, pipes
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- Y—GENERAL 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
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
- Y10T137/00—Fluid handling
- Y10T137/0318—Processes
Definitions
- the present invention relates to polymeric tubing typically formed by a co-extrusion process, the tubing having multiple layers of the same or different polymeric materials, each layer successively adhered to each other.
- Tubing comprised of polymeric material is used in many industrial and commercial applications including in the medical field. Various FDA compliant plastics are used, depending upon properties desired and the intended applications. Where the tubing is used to transport fluids for in vivo treatment of human patients, selection of the polymeric materials can be a factor.
- Polyvinyl chloride is one of the most widely used plastics. While structurally stable and easily formable into desired shapes, PVC is typically manufactured using plasticizers which can migrate out of the PVC matrix into bodily fluids and has other properties not ideally suited for medical treatment applications. Likewise, due to the inherent nature of plasticized PVC tubing, there arises the potential absorption of medicines and other components of aqueous fluids used in medical treatments into the sidewall of the PVC tube. Polyurethane is potentially a substitute for PVC. However, dual layer tubing comprised of polyurethane and polyethylene suffers from the inability of the two layers to remain adhered to each other under low to moderate stress, strain or mechanical manipulation conditions as well as the inability to sufficiently impede migration of oxygen through the layers.
- a tube comprising an inner layer, an outer layer and a barrier layer disposed between the inner layer and the outer layer, wherein the barrier layer is bound to the outer layer by a layer of adhesive disposed between the outer layer and the barrier layer and the barrier layer is bound to the inner layer by a layer of adhesive disposed between the inner layer and the barrier layer, wherein the inner layer comprises a polyethylene, the outer layer comprises a thermoplastic polyurethane and the barrier layer comprises a material that acts as a barrier to gas.
- the barrier layer preferably comprises more than about 90% by weight of an ethylene vinyl alcohol copolymer or a polyamide or blends thereof.
- the adhesive typically comprises one or more ethylene acrylic copolymers, more typically one or more anhydride grafted ethylene acrylate copolymers and preferably one or more anhydride grafted ethylene methyl acrylate copolymers.
- the inner layer typically comprises more than about 90% by weight of a polyethylene and the outer layer comprises more than about 90% by weight of an aromatic or aliphatic polyether based polyurethane.
- the barrier layer typically comprises more than about 90% by weight of an ethylene vinyl alcohol copolymer or a polyamide or blends thereof and the adhesive comprises more than about 90% by weight of one or more ethylene acrylic copolymers,
- the barrier layer can comprise more than about 90% by weight of an ethylene vinyl alcohol copolymer or a polyamide or blends thereof and the inner layer can comprise more than about 90% by weight of a polyethylene and the outer layer can comprise more than about 90% by weight of an aromatic or aliphatic polyether based polyurethane.
- the adhesive can comprise more than about 90% by weight of one or more ethylene acrylic copolymers and the inner layer can comprise more than about 90% by weight of a polyethylene and the outer layer can comprises more than about 90% by weight of an aromatic or aliphatic polyether based polyurethane.
- the barrier layer can comprises more than about 90% by weight of an ethylene vinyl alcohol copolymer or a polyamide or blends thereof, the adhesive can comprise more than about 90% by weight of one or more ethylene acrylic copolymers, the inner layer can comprises more than about 90% by weight of a polyethylene and the outer layer can comprise more than about 90% by weight of an aromatic or aliphatic polyether based polyurethane.
- the polyethylene typically comprises one or more of a low density polyethylene, a linear low density polyethylene and a high density polyethylene and the aromatic polyether based polyurethane can comprise a polytetramethyleneglycol-based polyurethane.
- the adhesive can comprise more than about 90% by weight of one or more ethylene acrylic copolymers, the inner layer can comprise more than about 90% by weight of low density polyethylene (LDPE), the outer layer can comprise more than about 90% by weight of a polytetramethyleneglycol-based polyurethane and the middle layer can comprise more than about 90% of a material that acts as a barrier to gas.
- LDPE low density polyethylene
- the middle layer can comprise more than about 90% of a material that acts as a barrier to gas.
- the adhesive typically comprises more than about 90% by weight of one or more ethylene acrylic copolymers.
- the thickness of the polyurethane outer layer is typically between about 0.001 inches (0.0254 mm) and about 0.025 inches (0.635 mm)
- the thickness of the inner polyethylene layer is typically between about 0.001 inches (0.0254 mm) and about 0.025 inches (0.635 mm)
- the thickness of the barrier layer is typically between about 0.001 inches (0.0254 mm) and about 0.025 inches (0.635 mm).
- the inner and outer layers preferably do not visually delaminate when subjected to a stress and strain up to the tube's elastic yield point as measured in a mechanical tester at a pull rate of about 12 inches per minute at ambient conditions of 72 degrees F. (22° C.) and 50% relative humidity.
- the tube does not visually delaminate when submersed in water at 60° C. for 36 hours.
- the tube preferably has a central axial fluid flow passage through which aqueous fluid is routed, the inner layer having a radially inner wall surface that contacts the aqueous fluid the outer and inner layers resisting delamination when subjected to a stress and strain up to the tube's elastic yield point as measured in a mechanical tester at a pull rate of about 12 inches per minute at ambient conditions of 72 degrees F. (22° C.) and 50% relative humidity.
- a tube preferably does not visually delaminate after being submersed in water at 60° C. for 36 hours.
- the thickness of the adhesive disposed between the barrier layer and the outer layer is preferably between about 0.001 inches (0.0254 mm) and about 0.025 inches (0.635 mm) and the thickness of the adhesive disposed between the barrier layer and the inner layer is preferably between about 0.001 inches (0.0254 mm) and about 0.025 inches (0.635 mm)
- a medical tube for transport of aqueous fluid comprising:
- an inner layer comprising more than about 90% by weight of a polyethylene, an outer layer comprising more than about 90% by weight of a an aromatic polyether-based polyurethane, a barrier layer disposed between the outer and inner layers comprising more than about 90% by weight of a material that acts as a barrier to gas, and, an adhesive disposed between the barrier layer and the outer layer and disposed between the barrier layer and the inner layer, the adhesive comprising one or more ethylene acrylic copolymers,
- the inner and outer layers preferably do not visually delaminate when subjected to a stress and strain up to the tube's elastic yield point as measured in a mechanical tester at a pull rate of about 12 inches per minute at ambient conditions of 72 degrees F. (22° C.) and 50% relative humidity.
- the tube preferably does not visually delaminate after being submersed in water at 60° C. for 36 hours.
- the adhesive comprises one or more anhydride grafted ethylene acrylate copolymers.
- a medical tube for transport of an aqueous fluid comprising:
- an inner layer comprised of at least about 90% by weight of a polyethylene.
- an outer layer comprised of at least about 90% by weight of an aromatic polyether-based polyurethane
- a barrier layer disposed between the outer and inner layers comprising more than about 90% by weight of a material that acts as a barrier to gas
- an adhesive disposed between the barrier layer and the outer layer and disposed between the barrier layer and the inner layer, the adhesive comprising more than about 90% by weight of one or more ethylene acrylic copolymers, wherein the tubing does not visually delaminate after being submersed in water at 60° C. for 36 hours.
- a medical tube for transport of an aqueous fluid comprising:
- an inner layer comprised of at least about 90% by weight of a low density polyethylene
- an outer layer comprised of at least about 90% by weight of a polytetramethyleneglycol-based polyurethane
- a barrier layer disposed between the outer and inner layers comprising more than about 90% by weight of a material that acts as a barrier to gas
- an adhesive disposed between the barrier layer and the outer layer and disposed between the barrier layer and the inner layer, the adhesive comprising one or more ethylene acrylic copolymers, wherein the tubing does not visually delaminate when subjected to a stress and strain up to the tube's elastic yield point as measured in a mechanical tester at a pull rate of about 12 inches per minute at ambient conditions of 72 degrees F. (22° C.) and 50% relative humidity, and, wherein the tubing does not visually delaminate after being submersed in water at 60° C. for 36 hours.
- a method of forming a medical tube comprising an outer layer, an innermost layer and an intermediate layer disposed between the outer layer and the innermost layer, the method comprising:
- the first polymeric material is typically selected to be a polyurethane
- the second polymeric material is selected to be a polyethylene
- the third polymeric material is selected from the group consisting of an ethylene vinyl alcohol copolymer and a polyamide
- the fourth polymeric material is one or more ethylene acrylic copolymers
- the first polymeric material is preferably selected to be a polyurethane
- the second polymeric material is selected to be a polyethylene
- the third polymeric material is selected from the group consisting of an ethylene vinyl alcohol copolymer and a polyamide
- the fourth polymeric material is selected such that the medical tubing does not visually delaminate after being submersed in water at 60° C. for 36 hours.
- the adhesive typically comprises one or more anhydride grafted ethylene acrylate copolymers.
- a method of delivering an aqueous fluid to a subject comprising;
- a tube comprising an inner layer, an outer layer and a barrier layer disposed between the inner and outer layers, wherein the inner layer comprises a polyethylene, the outer layer comprises a thermoplastic polyurethane and the barrier layer comprises one or more of an ethylene vinyl alcohol copolymer and a polyamide; wherein the tube has a central fluid flow passage surrounded by the layers; routing an aqueous fluid through the central fluid flow passage of the tube, and, delivering the aqueous fluid routed through the central fluid flow passage into a blood vessel of the subject.
- the step of selecting preferably comprises:
- the tube such that a layer of an adhesive is disposed between the outer layer and the barrier layer and between the inner layer and the barrier layer.
- the step of selecting typically comprises:
- the adhesive typically comprises one or more anhydride grafted ethylene acrylate copolymers.
- the adhesive can comprise one or more anhydride grafted ethylene methyl acrylate copolymers.
- FIG. 1 is a schematic perspective view of a five-layered tube showing the outer and middle or intermediate layers broken away in order to better illustrate the construction and arrangement of the tubing;
- FIG. 2 is a cross-sectional view taken along lines 2 - 2 of the tube 10 shown in FIG. 1 .
- FIG. 1 an embodiment of a co-extruded five-layer tubing 10 according to the invention which comprises an outer layer 1 comprised of at least about 90% by weight of a polyurethane material, typically a polytetramethyleneglycol-based polyurethane one example of which is Lubrizol TPU Pellethane 2363-90AE, an inner fluid-contact layer 3 comprised of at least about 90% by weight of a polyethylene material, typically a low density polyethylene, one example of which is Westlake LDPE EM808AA, an intermediate gas barrier layer 5 comprised of at least about 90% by weight of an ethylene vinyl alcohol copolymer (EVOH), a polyamide or a mixture or blend of two or more thereof and bonding layers 7 , 9 comprised of an adhesive material that bonds the barrier layer 5 to the outer 1 and inner 3 layers.
- a polyurethane material typically a polytetramethyleneglycol-based polyurethane one example of which is Lubrizol TPU Pellethane 2363-90AE
- the gas barrier layer 5 acts as a barrier to gases generally such as oxygen, nitrogen, hydrogen, chlorine, nitrous oxide and the like.
- the adhesive layers 7 , 9 preferably comprise a material that renders the tubing 10 subsequent to extrusion resistant to delamination where the tubing does not visually delaminate after being subjected to submersion in water at 60° C. for 36 hours and subsequently mechanically flattened by manual squeezing of the tube from its normal round in cross-sectional condition to a flattened or oval shape cross-sectional shape or condition.
- the adhesive material is most preferably selected to comprise one or more ethylene acrylic copolymers, an example of which is an anhydride grafted ethylene methyl acrylate copolymer, a specific example of which is an anhydride grafted ethylene methyl acrylate copolymer such as commercially available Westlake Tymax GA 7001 (Anhydride grafted Ethylene Methyl Acrylate Copolymer).
- the outer layer of polyurethane 1 has a radially inner facing surface S 1 that binds and adheres to a radially outer facing surface S 2 of the anhydride modified acrylate adhesive layer 7 .
- the adhesive layer 7 has a radially inner facing surface S 3 that binds to the radially outer facing surface S 4 of the barrier layer 5 .
- the barrier layer 5 has a radially inner facing surface S 5 that binds to the radially outer facing surface S 6 of another layer 9 of adhesive.
- the adhesive layer 9 has a radially inner facing surface S 7 that binds to the radially outer facing surface S 8 of the inner polyethylene layer 3 .
- the intermediate barrier layer 5 adheres to the outer 1 and inner 3 layers such that the three layers 1 , 3 and 5 remain adhered to layers 7 , 9 and to each other when the tube 10 is subjected to a stress and strain up to the tube's elastic yield point as measured in a mechanical tester at a pull rate of about 12 inches per minute at ambient conditions of 72 degrees F. (22° C.) and 50% relative humidity.
- Mechanical testers for measuring such stress and strain are knowing in the art, an example of which is a Lloyd LRSK Plus mechanical tester.
- Elastic yield point is the highest point at which one or more of the layers of the tubing permanently deforms or as otherwise defined in “ Introduction to Physical Polymer Science, 4 th Edition ,” L. H. Sperling (author), John Wiley & Sons (publisher), 2006, the disclosure of which is incorporated by reference in its entirety as if fully set forth herein.
- the layers 1 , 3 , 5 , 7 , 9 of such tubing 10 remain adhered to each other such that the layers do not visually delaminate after being subjected to submersion in water at 60° C. for 36 hours and subsequently mechanically flattened by manual squeezing of the tube from its normal round in cross-sectional condition to a flattened or oval shape cross-sectional shape or condition.
- the layers 1 , 3 , 5 are formed into structurally stable walls that surround and enclose a central hollow fluid passage 20 through which an aqueous solution is routed and flows along an axial A direction contacting the radially inner facing surface S 9 of the inner layer 3 .
- the adhesive layers 7 , 9 bind and hold the structural layers, inner 3 , intermediate 5 and outer 1 together.
- the inner layer 3 provides a radially inner fluid-contact surface S 9 , the thickness, of the inner layer 3 typically ranging in cross-sectional thickness T 1 of between about 0.001 inches (0.0254 mm) and about 0.025 inches (0.635 mm).
- the intermediate layer 5 typically ranges in cross-sectional thickness T 3 of between about 0.001 inches (0.0254 mm) and about 0.025 inches (0.635 mm).
- the outer layer 1 typically ranges in cross-sectional thickness T 5 of between about 0.001 inches (0.0254 mm) and about 0.025 inches (0.635 mm).
- the adhesive layers 7 , 9 typically range in cross-sectional thickness T 2 , T 4 of between about 0.001 inches (0.0254 mm) and about 0.025 inches (0.635 mm).
- the polyethylene material is preferably a branched low-density polyethylene (LDPE), such as Westlake EM808, available from Westlake Chemical Corporation.
- the polyethylene material can be a linear low density polyethylene (LLDPE) such as Dowlex 2035G, available from the Dow Chemical Company.
- LLDPE linear low density polyethylene
- the polyethylene material can also be a high-density polyethylene (HDPE), such as Chevron 9506 HDPE, Chevron 9406 HDPE, and Chevron 9503 HDPE, available from Chevron Corporation.
- the polyethylene material can be a mixture or blend of two or more of the aforementioned polyethylene materials.
- the polyurethane elastomer is typically the reaction product of a polyol and isocyanate and usually includes a combination of hard and soft segment domains.
- An aromatic polyether-based TPU or an aliphatic polyether-based TPU can be used such as a polytetramethyleneglycol-based polyurethane.
- Such examples of these TPU's include the Pellethane 2363-90 AE series available from the Lubrizol Corporation.
- each layer of tubing 10 can be controlled by conventional multi-layer extrusion tooling and equipment and typically includes a die set configured for producing multi-layer tubing such as a five-layer tube as shown in FIG. 1 .
- a suitable extrusion apparatus is selected so as to provide a uniform thickness of the layers 1 , 3 , 5 , 7 , 9 along the substantial entirety of the axial length L of all of the layers 1 , 3 , 5 , 7 , 9 .
- the polymeric materials of which the layers 1 , 3 , 5 , 7 , 9 are comprised are preferably selected so as to be manually flexible along and around the axis A of the tubing.
- the polymeric materials are also selected so as to maintain the integrity of the tubing 10 (namely delamination does not occur) and its transparency or clarity after being subjected to ethylene oxide (EtO) and gamma irradiation sterilization processes.
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Abstract
Description
- This application is a divisional of and claims the benefit of priority to U.S. application Ser. No. 13/586,288 filed Aug. 15, 2012 which is continuation-in-part of and claims the benefit of priority of U.S. application Ser. No. 13/354,029 filed Jan. 19, 2012, the disclosures of which are incorporated by reference as if fully set forth herein.
- The present invention relates to polymeric tubing typically formed by a co-extrusion process, the tubing having multiple layers of the same or different polymeric materials, each layer successively adhered to each other.
- Tubing comprised of polymeric material is used in many industrial and commercial applications including in the medical field. Various FDA compliant plastics are used, depending upon properties desired and the intended applications. Where the tubing is used to transport fluids for in vivo treatment of human patients, selection of the polymeric materials can be a factor.
- Polyvinyl chloride (PVC) is one of the most widely used plastics. While structurally stable and easily formable into desired shapes, PVC is typically manufactured using plasticizers which can migrate out of the PVC matrix into bodily fluids and has other properties not ideally suited for medical treatment applications. Likewise, due to the inherent nature of plasticized PVC tubing, there arises the potential absorption of medicines and other components of aqueous fluids used in medical treatments into the sidewall of the PVC tube. Polyurethane is potentially a substitute for PVC. However, dual layer tubing comprised of polyurethane and polyethylene suffers from the inability of the two layers to remain adhered to each other under low to moderate stress, strain or mechanical manipulation conditions as well as the inability to sufficiently impede migration of oxygen through the layers. U.S. Pat. No. 4,627,844 to Schmitt (“Schmitt”), the disclosure of which is incorporated herein by reference as if fully set forth, discloses a tri-layer tube which is embodied in a commercial product sold under the trademark “SUREPATH 151” by the Natvar Division of Tekni-Plex, Inc. As disclosed in Schmitt, an outer layer of PVC and an inner fluid-contact layer of low density polyethylene (LDPE) are co-extruded with an intermediate tie layer of ethylene vinyl acetate copolymer (EVA). However, while Schmitt greatly reduces the possibility for the migration of additives from the PVC to the fluid and absorption of components from the fluid to the PVC tubing by providing a LDPE fluid-contact layer, elimination of the PVC is preferred. Other tubing configurations are disclosed in U.S. Pat. No. 7,647,949, U.S. Pat. No. 4,211,741 and U.S. Patent Publication No. 2007/0119511, the disclosures of which are incorporated by reference as if fully set forth herein. Where medical tubing is concerned, preservation of the integrity of reagents contained in fluids being routed through the tubing can be a concern. Similarly, prevention of migration of components out of the fluids through the tubing can be an issue. In such applications, incorporation into the tubing of a layer of material comprised of a gas barrier material can be implemented for purposes of preventing migration of gases such as oxygen into the fluid thus preserving oxygen sensitive reagents in the fluid.
- In accordance with the invention there is provided a tube comprising an inner layer, an outer layer and a barrier layer disposed between the inner layer and the outer layer, wherein the barrier layer is bound to the outer layer by a layer of adhesive disposed between the outer layer and the barrier layer and the barrier layer is bound to the inner layer by a layer of adhesive disposed between the inner layer and the barrier layer, wherein the inner layer comprises a polyethylene, the outer layer comprises a thermoplastic polyurethane and the barrier layer comprises a material that acts as a barrier to gas.
- The barrier layer preferably comprises more than about 90% by weight of an ethylene vinyl alcohol copolymer or a polyamide or blends thereof.
- The adhesive typically comprises one or more ethylene acrylic copolymers, more typically one or more anhydride grafted ethylene acrylate copolymers and preferably one or more anhydride grafted ethylene methyl acrylate copolymers.
- The inner layer typically comprises more than about 90% by weight of a polyethylene and the outer layer comprises more than about 90% by weight of an aromatic or aliphatic polyether based polyurethane.
- The barrier layer typically comprises more than about 90% by weight of an ethylene vinyl alcohol copolymer or a polyamide or blends thereof and the adhesive comprises more than about 90% by weight of one or more ethylene acrylic copolymers,
- The barrier layer can comprise more than about 90% by weight of an ethylene vinyl alcohol copolymer or a polyamide or blends thereof and the inner layer can comprise more than about 90% by weight of a polyethylene and the outer layer can comprise more than about 90% by weight of an aromatic or aliphatic polyether based polyurethane.
- The adhesive can comprise more than about 90% by weight of one or more ethylene acrylic copolymers and the inner layer can comprise more than about 90% by weight of a polyethylene and the outer layer can comprises more than about 90% by weight of an aromatic or aliphatic polyether based polyurethane.
- The barrier layer can comprises more than about 90% by weight of an ethylene vinyl alcohol copolymer or a polyamide or blends thereof, the adhesive can comprise more than about 90% by weight of one or more ethylene acrylic copolymers, the inner layer can comprises more than about 90% by weight of a polyethylene and the outer layer can comprise more than about 90% by weight of an aromatic or aliphatic polyether based polyurethane.
- The polyethylene typically comprises one or more of a low density polyethylene, a linear low density polyethylene and a high density polyethylene and the aromatic polyether based polyurethane can comprise a polytetramethyleneglycol-based polyurethane.
- The adhesive can comprise more than about 90% by weight of one or more ethylene acrylic copolymers, the inner layer can comprise more than about 90% by weight of low density polyethylene (LDPE), the outer layer can comprise more than about 90% by weight of a polytetramethyleneglycol-based polyurethane and the middle layer can comprise more than about 90% of a material that acts as a barrier to gas.
- The adhesive typically comprises more than about 90% by weight of one or more ethylene acrylic copolymers.
- The thickness of the polyurethane outer layer is typically between about 0.001 inches (0.0254 mm) and about 0.025 inches (0.635 mm), the thickness of the inner polyethylene layer is typically between about 0.001 inches (0.0254 mm) and about 0.025 inches (0.635 mm) and the thickness of the barrier layer is typically between about 0.001 inches (0.0254 mm) and about 0.025 inches (0.635 mm).
- The inner and outer layers preferably do not visually delaminate when subjected to a stress and strain up to the tube's elastic yield point as measured in a mechanical tester at a pull rate of about 12 inches per minute at ambient conditions of 72 degrees F. (22° C.) and 50% relative humidity.
- Preferably, the tube does not visually delaminate when submersed in water at 60° C. for 36 hours.
- The tube preferably has a central axial fluid flow passage through which aqueous fluid is routed, the inner layer having a radially inner wall surface that contacts the aqueous fluid the outer and inner layers resisting delamination when subjected to a stress and strain up to the tube's elastic yield point as measured in a mechanical tester at a pull rate of about 12 inches per minute at ambient conditions of 72 degrees F. (22° C.) and 50% relative humidity. Such a tube preferably does not visually delaminate after being submersed in water at 60° C. for 36 hours.
- In such a tube, the thickness of the adhesive disposed between the barrier layer and the outer layer is preferably between about 0.001 inches (0.0254 mm) and about 0.025 inches (0.635 mm) and the thickness of the adhesive disposed between the barrier layer and the inner layer is preferably between about 0.001 inches (0.0254 mm) and about 0.025 inches (0.635 mm)
- In another aspect of the invention there is provided a medical tube for transport of aqueous fluid comprising:
- an inner layer comprising more than about 90% by weight of a polyethylene,
an outer layer comprising more than about 90% by weight of a an aromatic polyether-based polyurethane,
a barrier layer disposed between the outer and inner layers comprising more than about 90% by weight of a material that acts as a barrier to gas, and,
an adhesive disposed between the barrier layer and the outer layer and disposed between the barrier layer and the inner layer, the adhesive comprising one or more ethylene acrylic copolymers, - In such an embodiment, the inner and outer layers preferably do not visually delaminate when subjected to a stress and strain up to the tube's elastic yield point as measured in a mechanical tester at a pull rate of about 12 inches per minute at ambient conditions of 72 degrees F. (22° C.) and 50% relative humidity.
- In such an embodiment, the tube preferably does not visually delaminate after being submersed in water at 60° C. for 36 hours.
- In such an embodiment, the adhesive comprises one or more anhydride grafted ethylene acrylate copolymers.
- In another aspect of the invention there is provided, a medical tube for transport of an aqueous fluid comprising:
- an inner layer comprised of at least about 90% by weight of a polyethylene.
an outer layer comprised of at least about 90% by weight of an aromatic polyether-based polyurethane,
a barrier layer disposed between the outer and inner layers comprising more than about 90% by weight of a material that acts as a barrier to gas, and,
an adhesive disposed between the barrier layer and the outer layer and disposed between the barrier layer and the inner layer, the adhesive comprising more than about 90% by weight of one or more ethylene acrylic copolymers,
wherein the tubing does not visually delaminate after being submersed in water at 60° C. for 36 hours. - In another aspect of the invention, there is provided a medical tube for transport of an aqueous fluid comprising:
- an inner layer comprised of at least about 90% by weight of a low density polyethylene,
an outer layer comprised of at least about 90% by weight of a polytetramethyleneglycol-based polyurethane,
a barrier layer disposed between the outer and inner layers comprising more than about 90% by weight of a material that acts as a barrier to gas, and,
an adhesive disposed between the barrier layer and the outer layer and disposed between the barrier layer and the inner layer, the adhesive comprising one or more ethylene acrylic copolymers,
wherein the tubing does not visually delaminate when subjected to a stress and strain up to the tube's elastic yield point as measured in a mechanical tester at a pull rate of about 12 inches per minute at ambient conditions of 72 degrees F. (22° C.) and 50% relative humidity, and,
wherein the tubing does not visually delaminate after being submersed in water at 60° C. for 36 hours. - In another aspect of the invention there is provided, a method of forming a medical tube comprising an outer layer, an innermost layer and an intermediate layer disposed between the outer layer and the innermost layer, the method comprising:
- selecting a first polymeric material having a selected structural stability;
- selecting a second polymeric material that is inert to aqueous fluids;
- selecting a third polymeric material that acts as a barrier to gas;
- selecting a fourth polymeric material that readily bonds and adheres to the first and second polymeric materials on co-extrusion and cooling of the materials;
- co-extruding the selected first, second, third and fourth polymeric materials to form the medical tubing in a configuration that has an outer layer comprising at least about 90% by weight of the first polymeric material, an inner layer comprising at least about 90% weight of the second polymeric material, a layer disposed between the inner and outer layers that comprises at least about 90% by weight of the third polymeric material, a layer of the fourth material disposed between the outer layer and the layer of the third polymeric material and a layer of the fourth material disposed between the inner layer and the layer of the third polymeric material.
- In such a method, the first polymeric material is typically selected to be a polyurethane, the second polymeric material is selected to be a polyethylene, the third polymeric material is selected from the group consisting of an ethylene vinyl alcohol copolymer and a polyamide and the fourth polymeric material is one or more ethylene acrylic copolymers,
- In such a method, the first polymeric material is preferably selected to be a polyurethane, the second polymeric material is selected to be a polyethylene, the third polymeric material is selected from the group consisting of an ethylene vinyl alcohol copolymer and a polyamide and the fourth polymeric material is selected such that the medical tubing does not visually delaminate after being submersed in water at 60° C. for 36 hours.
- In such a method, the adhesive typically comprises one or more anhydride grafted ethylene acrylate copolymers.
- In another aspect of the invention there is provided, a method of delivering an aqueous fluid to a subject comprising;
- selecting a tube comprising an inner layer, an outer layer and a barrier layer disposed between the inner and outer layers, wherein the inner layer comprises a polyethylene, the outer layer comprises a thermoplastic polyurethane and the barrier layer comprises one or more of an ethylene vinyl alcohol copolymer and a polyamide;
wherein the tube has a central fluid flow passage surrounded by the layers;
routing an aqueous fluid through the central fluid flow passage of the tube, and, delivering the aqueous fluid routed through the central fluid flow passage into a blood vessel of the subject. - The step of selecting preferably comprises:
- selecting the tube such that a layer of an adhesive is disposed between the outer layer and the barrier layer and between the inner layer and the barrier layer.
- The step of selecting typically comprises:
- co-extruding the outer, inner and barrier layers and adhesive layers to form the tube and selecting the adhesive to comprise more than about 90% by weight of one or more ethylene acrylic copolymers.
- The adhesive typically comprises one or more anhydride grafted ethylene acrylate copolymers.
- The adhesive can comprise one or more anhydride grafted ethylene methyl acrylate copolymers.
- The drawings depict one or more embodiments of the invention that are shown by way of examples of the invention wherein:
-
FIG. 1 is a schematic perspective view of a five-layered tube showing the outer and middle or intermediate layers broken away in order to better illustrate the construction and arrangement of the tubing; -
FIG. 2 is a cross-sectional view taken along lines 2-2 of thetube 10 shown inFIG. 1 . - There is shown in
FIG. 1 an embodiment of a co-extruded five-layer tubing 10 according to the invention which comprises anouter layer 1 comprised of at least about 90% by weight of a polyurethane material, typically a polytetramethyleneglycol-based polyurethane one example of which is Lubrizol TPU Pellethane 2363-90AE, an inner fluid-contact layer 3 comprised of at least about 90% by weight of a polyethylene material, typically a low density polyethylene, one example of which is Westlake LDPE EM808AA, an intermediategas barrier layer 5 comprised of at least about 90% by weight of an ethylene vinyl alcohol copolymer (EVOH), a polyamide or a mixture or blend of two or more thereof andbonding layers barrier layer 5 to the outer 1 and inner 3 layers. Thegas barrier layer 5 acts as a barrier to gases generally such as oxygen, nitrogen, hydrogen, chlorine, nitrous oxide and the like. Theadhesive layers tubing 10 subsequent to extrusion resistant to delamination where the tubing does not visually delaminate after being subjected to submersion in water at 60° C. for 36 hours and subsequently mechanically flattened by manual squeezing of the tube from its normal round in cross-sectional condition to a flattened or oval shape cross-sectional shape or condition. The adhesive material is most preferably selected to comprise one or more ethylene acrylic copolymers, an example of which is an anhydride grafted ethylene methyl acrylate copolymer, a specific example of which is an anhydride grafted ethylene methyl acrylate copolymer such as commercially available Westlake Tymax GA 7001 (Anhydride grafted Ethylene Methyl Acrylate Copolymer). - As shown in
FIG. 1 the outer layer ofpolyurethane 1 has a radially inner facing surface S1 that binds and adheres to a radially outer facing surface S2 of the anhydride modifiedacrylate adhesive layer 7. Theadhesive layer 7 has a radially inner facing surface S3 that binds to the radially outer facing surface S4 of thebarrier layer 5. Thebarrier layer 5 has a radially inner facing surface S5 that binds to the radially outer facing surface S6 of anotherlayer 9 of adhesive. Theadhesive layer 9 has a radially inner facing surface S7 that binds to the radially outer facing surface S8 of theinner polyethylene layer 3. Theintermediate barrier layer 5 adheres to the outer 1 and inner 3 layers such that the threelayers layers tube 10 is subjected to a stress and strain up to the tube's elastic yield point as measured in a mechanical tester at a pull rate of about 12 inches per minute at ambient conditions of 72 degrees F. (22° C.) and 50% relative humidity. Mechanical testers for measuring such stress and strain are knowing in the art, an example of which is a Lloyd LRSK Plus mechanical tester. Elastic yield point is the highest point at which one or more of the layers of the tubing permanently deforms or as otherwise defined in “Introduction to Physical Polymer Science, 4th Edition,” L. H. Sperling (author), John Wiley & Sons (publisher), 2006, the disclosure of which is incorporated by reference in its entirety as if fully set forth herein. - The
layers such tubing 10 remain adhered to each other such that the layers do not visually delaminate after being subjected to submersion in water at 60° C. for 36 hours and subsequently mechanically flattened by manual squeezing of the tube from its normal round in cross-sectional condition to a flattened or oval shape cross-sectional shape or condition. - As shown in
FIGS. 1 and 2 , thelayers hollow fluid passage 20 through which an aqueous solution is routed and flows along an axial A direction contacting the radially inner facing surface S9 of theinner layer 3. Theadhesive layers - The
inner layer 3 provides a radially inner fluid-contact surface S9, the thickness, of theinner layer 3 typically ranging in cross-sectional thickness T1 of between about 0.001 inches (0.0254 mm) and about 0.025 inches (0.635 mm). Theintermediate layer 5 typically ranges in cross-sectional thickness T3 of between about 0.001 inches (0.0254 mm) and about 0.025 inches (0.635 mm). Theouter layer 1 typically ranges in cross-sectional thickness T5 of between about 0.001 inches (0.0254 mm) and about 0.025 inches (0.635 mm). Theadhesive layers - The polyethylene material is preferably a branched low-density polyethylene (LDPE), such as Westlake EM808, available from Westlake Chemical Corporation. The polyethylene material can be a linear low density polyethylene (LLDPE) such as Dowlex 2035G, available from the Dow Chemical Company. The polyethylene material can also be a high-density polyethylene (HDPE), such as Chevron 9506 HDPE, Chevron 9406 HDPE, and Chevron 9503 HDPE, available from Chevron Corporation. The polyethylene material can be a mixture or blend of two or more of the aforementioned polyethylene materials.
- The polyurethane elastomer (TPU) is typically the reaction product of a polyol and isocyanate and usually includes a combination of hard and soft segment domains. An aromatic polyether-based TPU or an aliphatic polyether-based TPU can be used such as a polytetramethyleneglycol-based polyurethane. Such examples of these TPU's include the Pellethane 2363-90 AE series available from the Lubrizol Corporation.
- The respective thickness of each layer of
tubing 10 can be controlled by conventional multi-layer extrusion tooling and equipment and typically includes a die set configured for producing multi-layer tubing such as a five-layer tube as shown inFIG. 1 . Such a suitable extrusion apparatus is selected so as to provide a uniform thickness of thelayers layers - The polymeric materials of which the
layers - The foregoing description is intended to illustrate and not limit the scope of the invention, those skilled in the art will realize that equivalents thereof are contemplated by the description above and that changes and modifications may be made thereto without departing from the spirit of the invention, all such equivalents, changes and modifications falling within the scope of the claims hereof.
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US15/642,668 US20170299089A1 (en) | 2012-01-19 | 2017-07-06 | Polyurethane-polyethylene delamination resistant tubing with gas barrier properties |
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US13/354,029 US20130190714A1 (en) | 2012-01-19 | 2012-01-19 | Multi-layered tubing |
US13/586,288 US9702486B2 (en) | 2012-01-19 | 2012-08-15 | Polyurethane-polyethylene delamination resistant tubing with gas barrier properties |
US15/642,668 US20170299089A1 (en) | 2012-01-19 | 2017-07-06 | Polyurethane-polyethylene delamination resistant tubing with gas barrier properties |
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US13/586,288 Active 2034-07-16 US9702486B2 (en) | 2012-01-19 | 2012-08-15 | Polyurethane-polyethylene delamination resistant tubing with gas barrier properties |
US13/686,197 Abandoned US20130186469A1 (en) | 2012-01-19 | 2012-11-27 | Multi-layered tubing |
US15/642,668 Abandoned US20170299089A1 (en) | 2012-01-19 | 2017-07-06 | Polyurethane-polyethylene delamination resistant tubing with gas barrier properties |
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- 2012-08-15 US US13/586,288 patent/US9702486B2/en active Active
- 2012-11-27 US US13/686,197 patent/US20130186469A1/en not_active Abandoned
-
2017
- 2017-07-06 US US15/642,668 patent/US20170299089A1/en not_active Abandoned
Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
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US11055597B2 (en) * | 2017-10-13 | 2021-07-06 | Magnum Magnetics Corporation | RFID magnet and method of making |
Also Published As
Publication number | Publication date |
---|---|
US9702486B2 (en) | 2017-07-11 |
US20130186469A1 (en) | 2013-07-25 |
US20130190723A1 (en) | 2013-07-25 |
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