Container with biological materials having multiple sealed portions
Inventors
RAMSEY, Tara C. • Rajput, Uzair
Assignees
Publication Number
US-11950591-B2
Publication Date
2024-04-09
Expiration Date
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Abstract
An apparatus is disclosed having a first layer coupled to a second layer via a plurality of seals to define a storage volume that is separable by at least one intermediate seal into a first volume and a second volume. The intermediate seal is applicable after a material is introduced into the storage volume storage. The apparatus includes a first opening into the storage volume and a second opening into the storage volume. The first opening and the second opening are positioned near opposite edges. The apparatus also includes a first frangible region positioned along the intermediate seal and configured for separation of the first volume and the second volume.
Core Innovation
An apparatus comprising a first layer coupled to a second layer via a plurality of seals to define a storage volume that is separable by at least one intermediate seal into a first volume and a second volume is disclosed. The intermediate seal is applicable after a material is introduced into the storage volume such that the target material is stored within the first volume and the second volume, and a frangible region extends along the intermediate seal to allow physical separation of the container into a first container portion and a second container portion. The apparatus includes a first opening into the storage volume and a second opening into the storage volume positioned near opposite edges, and the plurality of seals can include a peelable seal at a tapered tip to produce a second opening by peeling the first layer from the second layer.
The embodiments address shortcomings of known containers and systems by providing containers for storing, handling, packaging, and transporting biological materials that facilitate removal of portions while maintaining hermetic or fluidic isolation and that enable quality control sampling. The background identifies problems with known ports that increase container size and storage volume, can catch on surrounding structures and be a point of failure, and with known multi-container systems and tube/valve switching that are cumbersome and can introduce errors in associating QC samples with primary storage.
Claims Coverage
This patent includes one independent claim with four main inventive features.
Layered container defining a sealed storage volume
A first layer and a second layer coupled together by a plurality of seals to form a container having end portions and opposing edges that define a storage volume between the first layer and the second layer.
First opening positioned at first end portion
A first opening into the storage volume positioned at the first end portion and suitable to receive a material.
Intermediate seal and frangible region separating volumes
At least one intermediate seal extending between the first edge and the second edge that separates the storage volume into a first volume and a second volume, the intermediate seal being applicable after material introduction, together with a frangible region extending along the intermediate seal allowing physical separation of the container into first and second container portions.
Tapered second container portion with peelable tip opening
The second container portion includes a tapered portion extending to a tip at the second end portion, and the plurality of seals includes a peelable seal at the tip configured such that the first layer can be peeled away from the second layer to produce a second opening at the tip.
The independent claim covers a layered sealed container with defined ingress, a post-fill intermediate seal to form paired volumes, a frangible region for manual separation into two container portions (one tapered), and a peelable tip for producing an opening at the tapered portion.
Stated Advantages
Allows a port or other portions of the container to be removed while maintaining the stored material in a hermetically sealed or fluidically isolated condition.
Facilitates quality control testing and record keeping by allowing a predetermined volume of the storage container to be removed from the primary storage portion after the container has been filled.
Improves storage robustness and avoids port-related failures and long-term port leaking by providing removable portions and tapered dispensing features.
Enables efficient transportation and storage by reducing container footprint associated with protruding ports and by providing separable portions for controlled dispensing.
Documented Applications
Storing, handling, packaging, and transporting biological materials, including tissue specimens, biologic material, compounded and non-compounded pharmaceuticals, cells, blood, and related media.
Loading and sealing material at the point of loading (e.g., a tissue bank or a cell culturing system) and facilitating cryogenic freezing, storage, transport, processing, defrosting, and rehydration of the material.
Facilitating quality control (QC) testing and record keeping by allowing a predetermined separable volume to be removed as a QC sample that is representative of the primary portion.
Dispensing material from a separable tapered portion for controlled release during use or quality control operations.
Use in material preparation systems including conveying fluids into or out of the storage volume via ports for rehydration, washing, preservation, or evacuation.
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