Low Aspect Ratio Staged Closure Devices, Systems, and Methods for Freeze-Drying, Storing, Reconstituting, and Administering Lyophilized Plasma
First Claim
1. A multifunctional lyophilization device comprising:
- a staged closure lid;
a frame;
a gas permeable membrane; and
an impermeable film.
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Accused Products
Abstract
The inventive device and methods described herein address the introduction of a safe and effective freeze-dried biological product, and particularly a plasma product, to a subject in need thereof. The present invention relates to a multifunctional, staged closure device, which also is described as a lyophilization container for plasma (LCP). The device and methods described herein address how to reproducibly achieve a low moisture and substantially oxygen-free atmosphere within a finally hermetically sealed biocompatible low aspect plastic vessel within a standard shelf-stoppering freeze dryer. The present inventive device and methods provide a freeze-dried plasma product that is fully traceable, preserves the constituent plasma activity, is readily prepared in a sterile fashion, is stable, ensures ease of storage and permits rapid reconstitution and delivery to a patient.
34 Citations
20 Claims
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1. A multifunctional lyophilization device comprising:
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a staged closure lid; a frame; a gas permeable membrane; and an impermeable film. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12)
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13. A staged shelf stoppered closure system for freezing, freeze-drying, and sealing freeze-dried biological material within a freeze dryer comprising:
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a biological material; a unidirectional staged closure lid; a frame that peripherally encircles an interior space; a gas permeable membrane; and an impermeable film. - View Dependent Claims (14, 15)
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16. A method of using a multifunctional lyophilization device comprising a unidirectional staged closure lid and a gas permeable membrane to prepare and preserve a biological material comprising:
freezing, freeze-drying, and sealing the biological material within a shelf stoppering freeze dryer. - View Dependent Claims (17, 18, 19, 20)
Specification