A - Human Necessities – 61 – L
Patent
A - Human Necessities
61
L
156/1, 217/36, 2
A61L 2/16 (2006.01) A61B 19/02 (2006.01) A61M 25/00 (2006.01)
Patent
CA 1331589
PACKAGING FOR A STERILIZABLE CALIBRATABLE MEDICAL DEVICE Abstract of the Invention The present invention provides a package for and method of packaging a sterilizable calibratable medical device including a hydratable sensor component. The device is maintained in a sterile environment during storage and in a clean environment during the calibration procedure. The package includes a manifold connected to the sensor component by plumbing. The plumbing establishes fluid communication between the manifold and the sensor component and/or between the sensor component and the ambient environment of the plumbing. The manifold, plumbing and medical device are sealed in a wrap including a gas- permeable surface. The wrap and its contents, including the interior surfaces ofthe components, are sterilizable by exposing the wrap to a gaseous sterilizationsolution and appropriately adjusting the plumbing. The medical device is hydratable by directing the hydration solution to the sensor component by means of the plumbing. In order to store the package over an extended period of time, a gas-impermeable chamber is defined which Includes the ambient environment of the plumbing. The gaseous environment of the medical device is thereby controllable. In this manner, the device is prepared for calibrated and 19 storable In the sterile environment. By connecting a reservoir including calibration solution to the plumbing, the calibration solution is directed to the sensor component without removing the medical device from Its clean environment. The temperatures to the sensor component and the solution are controlled throughout the calibration process in order to ensure that the device is calibrated in accordance with its intended use. The present Invention further discloses a solution for preparing the medical device for use. The solution is chemically compatible with the intended use of the device.
606581
Grabenkort Richard W.
Huntley Scott P.
Wecker Sheldon M.
Abbott Laboratories
Goudreau Gage Dubuc
Grabenkort Richard W.
Huntley Scott P.
Wecker Sheldon M.
LandOfFree
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