Infla10® Pulse™Also Known As
Poly(para-xylylene), Poly(2-chloro-p-xylylene) (for Parylene C), Chemical Vapor Deposited Polymer, CVD Polymer Coating, Conformal Barrier Coating, Xylylene Polymer
Definition
Parylene coating is a specialized polymer conformal coating applied through chemical vapor deposition (CVD) that forms a protective, ultra-thin, pinhole-free barrier on medical devices and prostheses.1 This biocompatible coating provides exceptional durability by creating a uniform layer that conforms precisely to any substrate geometry, including complex surfaces and sharp edges.2 The coating process involves three discrete steps: vaporization of the raw parylene dimer, pyrolysis to create monomeric gas, and deposition as a thin transparent polymer film at room temperature.3 Parylene coating significantly enhances prosthesis longevity by providing superior protection against moisture, bodily fluids, chemicals, and electrical interference while maintaining biocompatibility and bio-stability in physiological environments.4
Clinical Context
Parylene coating is clinically utilized to enhance the performance and longevity of various medical implants and prosthetic devices, particularly those subjected to harsh physiological environments.1 The coating is especially valuable for prostheses that require protection against corrosion, moisture infiltration, and biofilm formation while maintaining biocompatibility with surrounding tissues.2 Patient selection criteria typically include those requiring long-term implantable devices where device failure would necessitate invasive revision surgery.3
In surgical procedures, parylene-coated prostheses demonstrate superior resistance to degradation from bodily fluids and sterilization processes, with coating thicknesses typically ranging from hundreds of angstroms to several millimeters depending on the application requirements.4 The coating process is performed at ambient temperatures in vacuum deposition equipment, allowing for uniform application even on thermally sensitive components.5
Clinical outcomes show that parylene-coated implants exhibit reduced inflammatory responses, enhanced corrosion resistance, and improved overall durability compared to uncoated alternatives.6 The coating’s ability to prevent moisture ingress and provide electrical insulation makes it particularly valuable for electronic implants and prostheses with integrated sensors or actuators.7