Penetrable and Resealable Lyophilization Method
AssigneeMedical Instill Technologies, Inc.
InventorDaniel Py
Life of this patent
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Abstract
Device and method for lyophilizing a substance within the device and storing therein the lyophilized substance. The device defines a chamber for receiving therein the substance to be lyophilized, a penetrable and resealable portion of the device is penetrable or pierceable by a needle for filling the device with the substance, and a resulting hole therein is resealable by transmitting radiation from a radiation source thereon. A filter is connectable in fluid communication between an interior and exterior of the chamber for permitting fluid to flow therethrough in a direction from the interior to the exterior of the chamber, and for substantially preventing contaminants from flowing therethrough in a direction from the exterior to the interior of the chamber.
Claims17
A method of filling a device with a substance to be lyophilized, lyophilizing the substance within the device, and storing the lyophilized substance within the device, the method comprising the following steps:
- providing a device including a body defining a chamber enclosed by a liquid-impermeable closure in sealing engagement therewith and a penetrable and resealable portion in fluid communication with the chamber;
- penetrating the penetrable and resealable portion with a tip of filling member such that a flow aperture of the filling member is in fluid communication with the chamber of the device;
- introducing the substance to be lyophilized through the filling member and into the chamber of the device;
- withdrawing the filling member from the penetrable and resealable portion;
- lyophilizing the substance within the chamber with the closure in engagement with the body, causing fluid to flow out of the chamber during lyophilization, and preventing contaminants from flowing into the chamber during lyophilization;
- and
- transmitting energy or radiation from a source thereof onto a penetrated region of the penetrable and resealable portion, and hermetically sealing an aperture formed by the filling member in the penetrated region of the penetrable and resealable portion.
A method comprising the following steps:
- providing a sealed empty sterile device including a body defining a chamber, and a penetrable and resealable portion forming a liquid-tight seal between the chamber and ambient atmosphere;
- penetrating the penetrable and resealable portion with a filling member and sterile filling a liquid substance to be lyophilized into the sealed, empty, sterile chamber through the penetrable and resealable portion;
- providing at least one aperture through the penetrable and resealable portion to permit fluid to flow out of the chamber;
- lyophilizing the substance within the chamber;
- and
- closing the at least one aperture and hermetically sealing the lyophilized substance within the chamber.
Dependencies are inferred from the claim text.