Apparatus and methods for making, storing, and administering freeze-dried materials such as freeze-dried plasma
First Claim
1. Apparatus comprising:
- a dry freeze-dried material,a reconstituting liquid for the freeze-dried material, anda flexible container including first chamber sized and configured to hold the freeze-dried material in a dry state, a second chamber sized and configured to hold the reconstituting liquid in a wet state, a sealing wall within the flexible container sized and configured to form a barrier between the first chamber and the second chamber preventing contact between the freeze-dried material and the reconstituting liquid, and at least one valve assembly in the sealing wall operative to open a region of the sealing wall to establish fluid flow communication between the first and second chambers.
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Accused Products
Abstract
A vessel receives a liquid material, which is freeze-dried in situ within the vessel. A gas permeable material carried by the vessel provides gas transport for sublimation during drying. After freeze drying, an oxygen-free inert gas is introduced into the vessel through the gas permeable material, to occupy the interior of the vessel with the freeze-dried material. The gas permeable material is covered, to trap the oxygen-free inert gas within the vessel with the freeze-dried material. The freeze-dried material is stored in the entrapped oxygen-free inert gas within the vessel for a storage period. The vessel receives a reconstituting liquid for mixing with the freeze-dried material, and conveys the reconstituted freeze-dried material from the vessel for administration to an individual.
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Citations
40 Claims
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1. Apparatus comprising:
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a dry freeze-dried material, a reconstituting liquid for the freeze-dried material, and a flexible container including first chamber sized and configured to hold the freeze-dried material in a dry state, a second chamber sized and configured to hold the reconstituting liquid in a wet state, a sealing wall within the flexible container sized and configured to form a barrier between the first chamber and the second chamber preventing contact between the freeze-dried material and the reconstituting liquid, and at least one valve assembly in the sealing wall operative to open a region of the sealing wall to establish fluid flow communication between the first and second chambers. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13)
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14. A method comprising
providing a flexible container including first chamber holding a freeze-dried material in a dry state, a second chamber holds a reconstituting liquid for the freeze-dried material, the flexible container including an interior sealing wall sized and configured to form a barrier between the first chamber and the second chamber preventing contact between the freeze-dried material and the reconstituting liquid, and at least one valve assembly in the sealing wall operative by manipulation to open a region of the sealing wall to establish fluid flow communication between the first and second chambers, manipulating the valve assembly to open the region, and expressing the reconstituting liquid from the second chamber through the valve assembly into the first chamber into contact with the freeze-dried material.
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18. A method comprising
providing a flexible container including first chamber holding a freeze-dried material in a dry state, a second chamber holding a reconstituting liquid for the freeze-dried material, the flexible container including an interior sealing wall sized and configured to form a barrier between the first chamber and the second chamber preventing contact between the freeze-dried material and the reconstituting liquid, at least one valve assembly in the sealing wall operative by manipulation to open a region of the sealing wall to establish fluid flow communication between the first and second chambers, and an outer skirt overlaying an exterior wall of the container in a region of the sealing wall and blocking manipulation of the valve assembly, removing the outer skirt to expose the valve assembly to manipulation, manipulating the valve assembly to open the region, and expressing the reconstituting liquid from the second chamber through the valve assembly into the first chamber into contact with the freeze-dried material.
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22. A method comprising
providing a flexible container including first chamber, a second chamber, and an interior sealing wall sized and configured to form a barrier between the first chamber and the second chamber, and at least one valve assembly in the sealing wall operative by manipulation to open a region of the sealing wall to establish fluid flow communication between the first and second chambers, preparing a freeze-dried material comprising freeze-dried human plasma, placing the freeze dried material in the first chamber of the container, and placing a reconstitution liquid for the freeze dried material in the second chamber of the container.
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26. A system comprising
a vessel comprising a first end component comprising a rigid or semi-rigid material defining a first frame providing structural strength, the first end component including a gas impermeable material peripherally sealed to the first frame and spanning the frame to provide viewing into the interior space, a second end component comprising a rigid or semi-rigid material defining a second frame providing structural strength, the second end component including a gas permeable material peripherally sealed to the second frame and spanning the frame to provide gas transport to and from the interior space, a side wall component peripherally sealed to side edges of the first and second frames, the side wall component comprising a flexible, gas impermeable material, the first end component, the second end component, and the side wall component peripherally defining an interior space, and at least one port component on the side wall providing fluid communication with the interior space, and a material introduced as a liquid through the at least one port and freeze-dried in situ within the interior space.
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35. A method comprising
providing a vessel comprising a first end component comprising a rigid or semi-rigid material defining a first frame providing structural strength, the first end component including a gas impermeable material peripherally sealed to the first frame and spanning the frame to provide viewing into the interior space, a second end component comprising a rigid or semi-rigid material defining a second frame providing structural strength, the second end component including a gas permeable material peripherally sealed to the second frame and spanning the frame to provide gas transport to and from the interior space, a side wall component peripherally sealed to side edges of the first and second frames, the side wall component comprising a flexible, gas impermeable material, the first end component, the second end component, and the side wall component peripherally defining an interior space, and at least one port component on the side wall providing fluid communication with the interior space, introducing a liquid material through the first port, freeze-drying the liquid material in situ within the interior space, the gas permeable material of the second end component providing gas transport for sublimation during drying, introducing a reconstituting liquid for mixing with the freeze-dried material within the interior space through the second port, to reconstitute the freeze-dried material, and conveying the reconstituted freeze-dried material from the interior space through the third port.
Specification