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Parylene Coating in Biomedical
Applications
Presented By:
Mohammad Ansar
Senior Project Engineer
SCTIMST
1
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
2
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
3
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
4
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
5
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
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
7
Coating Process- Chemical vapor deposition
Sublimation/vaporization Pyrolysis Polymerization/Coating
Reference Parylene Engineering
8
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
General Properties
Reference Global advanced technologies
10
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
11
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®
12
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
13
14
Thank you for listening

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Parylene coating in biomedical applications

  • 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 2
  • 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 3
  • 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 4
  • 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 5
  • 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 7
  • 8. Coating Process- Chemical vapor deposition Sublimation/vaporization Pyrolysis Polymerization/Coating Reference Parylene Engineering 8
  • 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 10
  • 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 11
  • 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® 12
  • 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 13
  • 14. 14 Thank you for listening