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Package of sensitive articles

Inactive Publication Date: 2005-12-08
ALTAI MEDICAL TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0006] The present invention is directed to packages of articles such as medical devices, methods of packaging such articles and is particularly directed to packaging articles which are labile when exposed to ambient oxygen concentrations or oxygen containing materials over prolonged periods of time. The present invention provides convenient, effective, and economic

Problems solved by technology

While this packaging system has been highly successful for conventional medical devices, such as catheters, stents, surgical instruments, probes, and the like, it is frequently not suitable for “hybrid” devices which contain coatings or components which are subject to oxygen degradation.
While at least some drugs presently contemplated for use will remain stable during ethylene oxide sterilization, exposure to oxygen during lengthy distribution and storage periods can adversely affect the drug.

Method used

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  • Package of sensitive articles
  • Package of sensitive articles
  • Package of sensitive articles

Examples

Experimental program
Comparison scheme
Effect test

example 1

[0048] A drug eluting stent mounted onto the balloon of a stent delivery catheter (a drug eluting stent system) is packaged in a foil pouch that has a permeable portion or patch formed of Tyvek®. The pouch is subjected to a vacuum within the inner chamber with a surrounding atmosphere of EtO gas at temperatures of 60° C. to sterilize the drug eluting stent and delivery catheter. After sterilization, the pouch is resealed with the stent and delivery system within the post seal area and the Tyvek patch outside the post-seal area. The foil pouch minimizes the light exposure as well the oxygen and moisture exposure to the sterilized contents of the container.

example 2

[0049] A drug eluting stent mounted onto the balloon of a stent delivery catheter is packaged in a Tyvek pouch along with ferrous oxide as an oxygen absorber and desiccant. The pouch is closed, subjected to ethylene oxide gas which permeates the pouch. After sterilization, the Tyvek pouch is evacuated and purged with nitrogen and air to remove essentially all EtO and then placed inside a gas impermeable foil pouch. The foil pouch is evacuated by vacuum to remove the remaining air and nitrogen gas, and then finally sealed. The foil pouch minimizes the exposure of the sterilized product within the Tyvek pouch to light and to oxygen and moisture, thus providing a long shelf life.

example 3

[0050] A drug eluting stent crimped onto a PTCA catheter or a drug eluting stent system is packaged on Tyvek pouch along with ferrous oxide oxygen absorbers and desiccant. The pouch is sterilized by ethylene oxide gas with sterilization temperatures of about 55° C. After sterilization, the sterilized Tyvek pouch with the stent system sealed inside is inserted inside a foil pouch. The foil pouch is sealed using a vacuum sealer that first purge the bag with nitrogen gas which replaces the air inside the foil pouch and that finally seal the foil pouch. This minimizes the light exposure as well as limit oxygen and moisture exposure.

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Abstract

The invention is directed to the treating, e.g. sterilizing and packaging of medical devices and other articles, particularly such devices and articles which are reactive to oxygen or moisture containing atmospheres. The sterilized package has a container which includes at least one portion which is gas permeable and at least one portion which is gas impermeable and an interior in fluid communication with the gas permeable portion. The container may be sealed by applying an impermeable patch to the permeable portion thereof or by disposing the container in an enclosure formed of impermeable material and sealing the enclosure. After exposing the container to a sterilizing gas, the gas permeable portion may be removed or sealed off from the gas impermeable portion of the container in order to provide a package which is gas impermeable and can protect one or more articles within the interior of the container against environmental gases and moisture.

Description

RELATED APPLICATIONS [0001] This application is based upon and claims priority to Provisional Application Ser. No. 60 / 537,972, filed on Jan. 20, 2004 and Provisional Application Ser. No. 60 / 540,828, filed on Jan. 29, 2004. Both applications are incorporated herein by reference in their entireties.BACKGROUND OF THE INVENTION [0002] The present invention relates generally to sterilized medical devices and packaging for sterilized medical devices. In particular, the present invention relates to the packaging of sterilized environmentally sensitive medical devices, such as drug-coated stents. [0003] Most, if not all, disposable medical devices require sterilization prior to or concurrent with packaging. The packaging, which may be in the form of a pouch, bag, tube, box, or other sealed container, will maintain the sterility of the product until it is withdrawn from the packaging for use. A particularly successful system and method for sterile packaging of medical devices relies on use o...

Claims

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Application Information

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IPC IPC(8): A61B19/02A61F2/00A61F2/86A61L2/20A61L2/26B65B55/18B65B55/19B65D75/38B65D81/20B65D81/26
CPCA61B19/026A61B2019/0267A61F2/0095A61F2/86A61L2/206A61L2/208B65D81/266A61L2202/181A61L2202/24B65B55/18B65B55/19B65D75/38B65D81/2084A61L2/26A61B50/30A61B2050/314
Inventor YAN, JOHN
Owner ALTAI MEDICAL TECH
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