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US 6,440,364 B1Granted
Method of degassing absorbable suture products
AssigneeEthicon, Inc.
InventorsLuis E. Vera, Robert J. Cerwin, LeRoy Hugo Anderson, Vincent Foerst, John J. Karl, Lesley F. Traver, James Richard McDivitt, Jimmy Dalton Webber
Life of this patent
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Abstract
A method of sterilizing absorbable sutures using a sterilant gas such as ethylene oxide gas. The method utilizes a first degassing step, and a second degassing step at elevated temperatures to remove residual sterilant gas, diluent gas, by-products and moisture.
Claims29
A process for sterilizing a bioabsorbable medical device using a sterilant gas mixture, comprising the steps of:
- providing an bioabsorbable medical device in a pouch;
- placing the bioabsorbable medical device and pouch in a chamber of a gas sterilizer;
- pulling a first vacuum on the chamber;
- injecting moisture into the chamber;
- charging a sterilant gas comprising a gas mixture of a sterilizing gas and an inert diluent gas into the chamber and maintaining the gas mixture in the chamber for a sufficient time to effectively sterilize the bioabsorbable medical device;
- pulling a second vacuum on the chamber;
- moving the medical device to a degassing chamber;
- then degassing the bioabsorbable medical device and pouch for a first degassing cycle by subjecting the bioabsorbable medical device and pouch to a vacuum at a first sufficiently effective temperature for a sufficient time to effectively remove substantially all of the moisture from the bioabsorbable medical device;
- and,
- then degassing the bioabsorbable medical device for a second degassing cycle by maintaining the vacuum and subjecting the bioabsorbable medical device and pouch to a second sufficiently effective temperature, which is greater than said first temperature, said second temperature being maintained for a sufficient time to effectively remove substantially all of residual sterilant gas, diluent gas, sterilization byproducts, and moisture from the bioabsorbable medical device and pouch.
7 more elements
Dependencies are inferred from the claim text.