Parylene is a biocompatible coating material well-suited for medical devices due to its conformal coating abilities, chemical resistance, and stability at high temperatures. It forms pinhole-free, uniform films through a vapor deposition process. There are multiple types of Parylene for various applications, and it is used to coat a wide range of implantable medical devices from catheters and stents to neurostimulators, pacemakers, and more. Parylene's bioinertness and ability to withstand sterilization make it a popular choice for enhancing the safety and longevity of medical implants and devices.

1. Parylene Coating in Biomedical
Applications
Presented By:
Mohammad Ansar
Senior Project Engineer
SCTIMST
1

2. Contents
• Introduction
• Basic Requirements for Biomedical coating materials
• What is Parylene ?
• History of Parylene
• Why Parylene in Medical applications ?
• Coating Process
• Types of Parylene
• Properties of Parylene
• Applications
• Products available on market
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3. Introduction
• Requirement of safety increases with development of new devices.
• Medical devices are getting smaller as the technology development and
hence, requirement of coating goes up
• Denser and thinner coatings Combat devices
• Coating process should be acceptable for devices
• Higher temperature integrity
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4. Basic
Requirements
for Biomedical
coating
materials
Basic
Requirements
Adhesion,
Conformal
Non-nutrient,
Corrosion
resistant
High Purity
and
No leaching
Bio compatibly
and Bio stability
UV and
Ionizing
radiation
stability
Electrical
Properties and
Low permeability
Low/No
stress
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5. What is Parylene (POLY(PARA-XYLYLENE) ?
• The chemical structure is highly ordered so that surface is very smooth with
coefficient of friction 0.13 to 0.31 where as for glass it is 1
• Most tight fitting conformal coating in the world with exceptional penetration
power
• Transparent like glass , Highly dielectric
• It can be coated up to 10% thickness of Human hair Reference Global advanced technologies
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6. History of Parylene
• 1947: First synthesized by Michael Szwarc from simple
groups containing toluene and xylene.
• 1967: Dr. Gorham synthesized Parylene from Dimer by
Chemical Vapor Deposition technique.
• 1971: First Commercialization done by Nova Tran Corp.,
presently known as Specialty Coating Systems
6Reference SCS Coatings

7. Why Parylene in Medical applications ?
• Bio compatible, antibacterial property with low coefficient of friction
• Excellent barrier material to fluid, moisture, dielectric and drugs
• It complete pin hole free encapsulation, conformal, uniform, inert continues
film
• No catalyst or solvent used (Nothing to extract)
• Can operate 350℃ and short period at 450℃
• Excellent electrical property
• Sterilization tolerant(Chemical, Steam, ETO,γ,autoclave, plasma and
H2O2) Reference – SCS coating
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8. Coating Process- Chemical vapor deposition
Sublimation/vaporization Pyrolysis Polymerization/Coating
Reference Parylene Engineering
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9. Types of Parylene
Grade: N
Properties
Low
permeability
Applications
Elastomer
coating,
Space
applications
Grade: C
Properties
Combined
electrical
properties
and moisture
resistance
Applications
Medical
applications
Grade: D
Properties
Electrical
properties
Applications
Chemical
resistant
coatings
Electrical
applications
Grade: HT/AF4
Properties
Resistant to UV
and high Temp
Applications
Weather
resistant
coatings
Grade: F/VT4
Properties
High Temp.
stability, low
dielectric constant,
low coefficient of
friction.
Applications
High Temp.
applications 9
Reference Global advanced technologies

10. General Properties
Reference Global advanced technologies
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11. Applications
Catheters Sensors and Transducers
Drug delivery devices Stents
Brain probes Pharma containers
Electro surgical devices Biochips
Hearing Aids Ocular Implants
Seals, O-rings, tubing Guide wires
Pulse generators, pacemakers, Neuro stimulators Epidermal probes
Micro chips Electrodes
Ultra sound transducers Cannaulae assemblies
Prosthetic devices Molded products
Medical electronics Cardiac assist devices
Mandrels Needles
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12. Products available on market
Device name Manufacturer Brand name
Deep brain stimulator Medtronics
ENTERRA 2
ACTIVA
Inflatable Penile Prosthesis
Boston scientific AMS 700
Pedicle device DePuySynthes Sentio MMG
Insertable cardiac monitor
Abbot Confirm Rx
Spinal Device Styker Medical, USA K140400 Stryker Spine - ES2®
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13. Products available in market
Device name Manufacturer Brand name
Spinal Assembly Zimmer Biomet, USA K132373 Biomet Spine
Cardiac Resynchronization
Therapy(CRT) Devices
St. Jude medical, USA
Quadra Assura CRT-D
Model CD3365-40C
Unify Assura CRT-D
Model CD3357-40C
Implantable Cardiovascular
Defibrillator(ICD) Devices
St. Jude medical, USA
Ellipse DR
Model CD2411-36C
Fortify Assura DR
Model CD2357-40C
Implantable Cardiovascular
Defibrillator(ICD) Devices
St. Jude medical, USA
Ellipse VR
Model CD1411-36C
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Thank you for listening