Radiopaque Compounds for minimally invasive medical devices - - PowerPoint PPT Presentation

radiopaque compounds
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Radiopaque Compounds for minimally invasive medical devices - - PowerPoint PPT Presentation

Radiopaque Compounds for minimally invasive medical devices Confidential Purpose of Radiopaque Compounds Polymers: inherently transparent to x-ray Radiopaque fillers: visible under x-ray Radiopaque compounds: visible under x-ray imaging or


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Radiopaque Compounds

for minimally invasive medical devices

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Purpose of Radiopaque Compounds

Polymers: inherently transparent to x-ray Radiopaque fillers: visible under x-ray Radiopaque compounds: visible under x-ray imaging or fluoroscopy Surgeon can follow device through body

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PTCA Catheters Central Venous Catheters Foley Catheters Naso Gastric Feeding Tubes Pacemaker Lead Placement Neurovascular Catheters Diagnostic Cardiovascular Catheters

Applications

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Polymers used for Devices

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Common Radiopaque Fillers

Barium sulfate Bismuth subcarbonate Bismuth trioxide Bismuth oxychloride Tungsten

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Selecting Radiopaque Fillers

Base resin Tubing wall thickness Surface smoothness needed Color Physical properties needed in end device Where device will be used in the body Sterilization technique Economics

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Barium Sulfate (BaSO4)

First widely used in medical formulations Relatively inexpensive white powder Very process stable Must be pre-dried Loadings of 40-60% depending on polymer Require high loading for equivalent radiopacity White: easy to color but poor tinting strength

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Barium Sulfate

Typical Loading Levels

0% 10% 20% 30% 40% 50% 60% 70% Polyethylene Polypropylene Polyvinyl Chloride Polyether Block Amide Polyamide 12 Polyamide 11 Polyurethane, Aromatic Polyurethane, Aliphatic Fluorinated Ethylene… Polyketone

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Bismuth Subcarbonate (Bi2O2CO3)

White: strong pigment & difficult to color match Loadings of 30-50% by weight possible Unstable at temperatures above 400oF (yellows) Not compatible with some TPU’s

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Bismuth Subcarbonate

Typical Loading Levels

0% 10% 20% 30% 40% 50% 60% Polyethylene Polypropylene Polyvinyl Chloride Polyether Block Amide Polyamide 12 Polyamide 11 Polyurethane, Aromatic Polyurethane, Aliphatic Fluorinated Ethylene… Polyketone

NOT RECOMMENDED NOT RECOMMENDED NOT RECOMMENDED

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Bismuth Trioxide (Bi2O3)

Yellow color Turns brown at high processing temperature Can be loaded up to 60% by weight Can get gritty surfaces Compatible with most resins

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Bismuth Trioxide

Typical Loading Levels

0% 10% 20% 30% 40% 50% 60% Polyethylene Polypropylene Polyvinyl Chloride Polyether Block Amide Polyamide 12 Polyamide 11 Polyurethane, Aromatic Polyurethane, Aliphatic Fluorinated Ethylene… Polyketone

NOT RECOMMENDED

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Bismuth Oxychloride (BiOCI)

White color More temperature stable than bismuth subcarbonate Compatible with a wide range of resins “Platelet-like” particles provide smooth shiny surface Susceptible to UV degradation (requires UV stabilizer) Difficult to color (can produce a “pearlescent” finish)

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Bismuth Oxychloride

Typical Loading Levels

0% 10% 20% 30% 40% 50% 60% Polyethylene Polypropylene Polyvinyl Chloride Polyether Block Amide Polyamide 12 Polyamide 11 Polyurethane, Aromatic Polyurethane, Aliphatic Fluorinated Ethylene… Polyketone

NOT RECOMMENDED NOT RECOMMENDED NOT RECOMMENDED NOT RECOMMENDED

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Tungsten (W)

Very heavy, dark metal powder (hard to color) Compatible with virtually any resin Loading up to 90% by weight possible Can show matte finish in high loadings Very abrasive (high wear to process equipment) Filler of choice in very thin walled devices Oxidation in the presence of oxygen and heat Highly flammable (pay particular attention to drying techniques)

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Tungsten

Typical Loading Levels

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% Polyethylene Polypropylene Polyvinyl Chloride Polyether Block Amide Polyamide 12 Polyamide 11 Polyurethane, Aromatic Polyurethane, Aliphatic Fluorinated Ethylene… Polyketone

NOT RECOMMENDED NOT RECOMMENDED NOT RECOMMENDED

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Radiopaque Filler Summary