Sample container with peelable seal and access port
Inventors
ALDEN, Madeline C. • BURLEY, Kimber L. • RAMSEY, Tara C.
Assignees
Publication Number
US-11931238-B2
Publication Date
2024-03-19
Expiration Date
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Abstract
An apparatus includes a flexible container and a port. The container includes a first layer coupled to a second layer to define a storage volume within which a tissue specimen can be contained. The first layer has a first stiffness and the second layer has a second stiffness. An edge of the first layer is spaced apart from an edge of the second layer to define an opening into the storage volume. The edges of the first and second layer form a peelable seal that hermetically seals the storage volume such that the first layer can be peeled away from the second layer to expose the storage volume. The port is coupled to the flexible container and allows fluid communication between the storage volume and an external volume.
Core Innovation
Containers and methods for storing tissue and other biological materials are described, where an apparatus includes a flexible container and a port. The container includes a first layer coupled to a second layer to define a storage volume within which a tissue specimen can be contained, the first layer and the second layer having respective stiffnesses, and an edge of the first layer spaced apart from an edge of the second layer to define an opening whose edges form a peelable seal that hermetically seals the storage volume such that the first layer can be peeled away from the second layer to expose the storage volume. The port is coupled to the flexible container and allows fluid communication between the storage volume and an external volume.
The embodiments further include a support structure configured to support the tissue specimen within the storage volume, the support structure characterized by a third stiffness that is greater than the first stiffness and the second stiffness. The support structure provides structural support for the tissue specimen during packaging, storage, and rehydration, enabling the flexible container to be used for both storage and rehydration while limiting damage to the tissue specimen.
The background identifies shortcomings of known rehydration and packaging procedures, including compromised sterility, inconsistent rehydration, longer rehydration times, and possible damage to the tissue implant from repeated movement or manipulation. Thus, a need exists for improved containers and methods for storing, transporting, and rehydrating tissue and other biological material, which the described flexible containers with peelable seals, ports, and support structures address.
Claims Coverage
The patent includes three independent claims (claims 1, 10, and 16). The following are the main inventive features recited in those independent claims.
Storage volume defined by first and second layers
A first layer and a second layer coupled to the first layer to define a storage volume configured to receive the biological material.
Second layer as a laminate with substrate stiffness
The second layer is a laminate structure including a substrate having a stiffness to support the biological material (claim 1).
Peelable seal forming hermetic closure
An opening defined by an edge of the first layer and an edge of the second layer configured to form a peelable seal that hermetically seals the storage volume such that the first layer can be peeled away from the second layer to expose the storage volume (claims 1, 10, 16).
Port for fluid communication with storage volume
A port in fluid communication with the storage volume and an external volume, providing access to the storage volume for fluid conveyance or evacuation (claim 2 dependent on claim 1; feature recited in description and dependent claims).
Support structure coupled to second layer
A support structure coupled to the second layer, the support structure having a stiffness to support the biological material, and positioned within or aligned with the storage volume (claim 10 and related dependents).
Support structure stiffer than container layers
A support structure configured to support the biological material within the storage volume, the support structure having a stiffness that is greater than a stiffness of the first layer and a stiffness of the second layer (claim 16).
Three-layer design with separate support volume
A third layer coupled to the second layer to define a separate volume aligned with the storage volume, the second layer positioned between the first layer and the third layer, enabling a captive or sealed support structure (claims 7, 13, 19, 20 dependents).
Independent claims recite a flexible container formed by first and second layers defining a storage volume, a peelable hermetic seal at an opening, and embodiments that include a laminate second layer and/or a support structure with greater stiffness than the container layers; ports and three-layer arrangements to contain or align a support structure are also claimed.
Stated Advantages
The flexible container designs can allow for a tissue specimen to be loaded and sealed at the point of loading via a peelable seal.
The loaded flexible container can be used to both store and rehydrate the tissue specimen within the same container.
A support member provides structural support for the tissue specimen during packaging, storage, and rehydration, resulting in more efficient tissue sample storage and rehydration with less damage to the tissue specimen.
The peelable seal reduces or eliminates production of particulate matter from cutting or tearing, facilitates opening in a predetermined fashion and/or direction, and eliminates the need for extra tools.
The port allows fluid communication for conveying preservation or rehydration fluids, and for evacuating the storage volume (e.g., vacuum packaging).
Documented Applications
Storing and transporting tissue and other biological material for use in tissue implant procedures.
Use in tissue implant and graft procedures including dental or periodontal implants, bone grafting to repair fractures, and tendon grafting to repair damaged ligaments and/or tendons (e.g., repair of a torn anterior cruciate ligament).
Storage and rehydration of non-autologous grafts such as allografts and xenografts, including rehydration of grafts initially stored in a dried condition.
Use in tissue banks for loading, sealing, storage, and rehydration of tissue specimens.
Storage, transport, and rehydration of a variety of tissue specimens including skin grafts, bone tissue, fiber tissue (tendon or ligament), ocular tissue (e.g., corneal implants), and bone chips including cortical, cancellous, and corticocancellous bone chips.
Vacuum packaging and conveying preservation or rehydration fluids into the storage volume via the port for preparation of the tissue specimen for surgical procedures.
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