Fact Sheet: HydroMedD640™ Permanently Lubricious Coatings
[In pdf format]

Introduction
We manufacture and market hydrophilic high slip, high water absorptive, polyether hydrophilic polyurethanes designed for use as coatings of catheters, sutures, introducers, rods, valves and rubber products. HydroMed D640™ can also be coated onto silicon microdevices to reduce absorption of white cells and proteins on the devices, thereby aiding in the analysis of blood and DNA.

Typical properties of HydroMed D640™ are

HydroMed D640™ is medical grade polyether polyurethane for which we maintain lot-to-lot control and lot traceability, and product certification. Each lot is tested for slip, viscosity water content and linear absorption after 24 hours in water.

Fabrication
HydroMed D640™ is processed by traditional solvent coating methods. The polymer granules are dissolved at 1%-3% concentration in 95/5 ethanol/water or other organic solution. The catheter part is dipped into the solution for three to about twenty seconds. Most of the solvent is evaporated at room temperature in about five to thirty minutes, the device is heated in an oven to 80º for about two to fifteen minutes, depending on coating thickness, to remove the solvent.

For small batches, the polymer can be mixed with the solvent on a roller mill to dissolve the polymer. To prepare films of the polymer, a 10% solution is cast into an open mold and the solvent is evaporated at 80°C.

Appearance
Aliphatic polyether polyurethanes are usually white and remain white during storage, although some yellowing might occur over extended periods of time. Any color does not affect physical properties.

FDA Status
In specific applications the polymer has been FDA cleared for permanently lubricious coatings for urinary devices and stainless guidewires used for PIC and PICC catheters. However, it is the responsibility of the user to establish safety with FDA for their specific medical device by submitting an individual application.

Technical Service
Our technical personnel stands ready to assist you with processing, product availability, and pricing.

This information has been gathered from standard reference sources and is believed to be accurate and reliable. We make no other warranty, express or implied, that the results obtained from the use of this product or information contained herein shall be merchantable or fit for any particular purpose, or that the use of this product will not infringe any patent. It is offered solely for your consideration, investigation, and verification.
[In pdf format]