Sample container with peelable seal and access port
Inventors
ALDEN, Madeline C. • BURLEY, Kimber L. • RAMSEY, Tara C.
Assignees
Publication Number
US-12336900-B2
Publication Date
2025-06-24
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
An apparatus and related methods provide a flexible container formed from a first layer coupled to a second layer to define a storage volume within which a tissue specimen can be contained, where an edge of the first layer is spaced apart from an edge of the second layer to define an opening into the storage volume and the edge of the first layer and the edge of the second layer are 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. The apparatus further includes a port coupled to the flexible container that allows fluid communication between the storage volume and an external volume, and a support structure configured to support the tissue specimen within the storage volume, the support structure having a stiffness greater than the first stiffness and the second stiffness.
The invention addresses shortcomings in known storage and rehydration procedures for tissue implants, where removal of a tissue implant from sterile packaging and manipulation in open containers can result in compromised sterility, inconsistent rehydration, longer rehydration times, and damage to the tissue implant; rigid trays can be bulky and flexible pouches can provide inadequate support. The described containers and methods allow a tissue specimen to be loaded and sealed via a peelable seal and to be stored and rehydrated within the same container while a support structure provides structural support to limit damage to the tissue specimen.
Claims Coverage
Independent claims identified: claim 1 (apparatus), claim 13 (three-layer apparatus), and claim 15 (method). Twelve inventive features are extracted from these independent claims.
Flexible container defining a storage volume
A flexible container including a first layer coupled to a second layer to define a storage volume within which a tissue specimen can be contained.
Opening defined by spaced edges along longitudinal axis
An edge of the first layer spaced apart from an edge of the second layer to define an opening into the storage volume, the edge of the first layer and the edge of the second layer extending along a longitudinal axis of the flexible container.
Peelable seal hermetically sealing the storage volume
The edge of the first layer and the 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.
Support structure to support tissue specimen
A support structure configured to support the tissue specimen on a condition that the tissue specimen is within the storage volume.
First and second layers characterized by stiffnesses
The first layer is characterized by a first stiffness and the second layer is characterized by a second stiffness, as recited in dependent provisions tied to the apparatus features.
Support structure with greater stiffness
The support structure is characterized by a third stiffness that is greater than the first stiffness and the second stiffness.
First and second layers formed as laminates
The first layer can be a first laminate including a first substrate, a first barrier coating, and a first adhesive with the first substrate being a peelable film, and the second layer can be a second laminate including a second substrate, a second barrier coating, and a second adhesive, the second substrate being a different material than the first substrate.
Third layer defining a separate volume
A flexible container configuration in which a third layer is coupled to longitudinal edges of the second layer to define a separate volume, the second layer positioned between the first layer and the third layer, and the separate volume aligned with or isolated from the storage volume as recited.
Separate volume sized to receive support structure and sealed
The separate volume is sized to receive the support structure and is sealed on a condition that the support structure is positioned therein, including embodiments where an edge of the third layer is sealed to the edge of the second layer to seal the separate volume.
Support structure with hydration openings
A support structure positioned within the storage volume that defines a series of hydration openings to permit fluid to reach portions of the tissue specimen facing the support structure.
Support structure with raised side edge and manipulation tab
A support structure including a bottom surface configured to receive the tissue specimen, a raised side edge extending away from the bottom surface that surrounds and maintains the tissue specimen during movement, and a manipulation tab that can include an indicium associated with the tissue specimen.
Method of inserting tissue specimen and forming peelable seal
A method comprising inserting a tissue specimen into the storage volume via the opening defined by the edges extending along a longitudinal axis with the tissue supported by the support structure, and coupling the edge of the first layer to the edge of the second layer to form a peelable seal that hermetically seals the storage volume such that the first layer can be peeled away to expose the storage volume.
The independent claims cover apparatus features for a flexible container formed from first and second layers (and optionally a third layer) with a longitudinal opening and a peelable hermetic seal, a port for fluid communication, and a support structure having greater stiffness (including specific support structure geometries and hydration openings), as well as a method of inserting a tissue specimen and forming the peelable seal.
Stated Advantages
Allows a tissue specimen to be loaded and sealed at the point of loading via a peelable seal.
Provides a single container usable for both storage and rehydration of a tissue specimen.
Support structure provides structural support to limit damage to the tissue specimen during packaging, storage, and rehydration.
Reduces or eliminates particulate matter or debris that may result from cutting or tearing the flexible container to extract the tissue specimen.
Facilitates opening in a predetermined fashion and can eliminate the need for extra tools to open the container assembly.
Can result in more efficient tissue sample storage and rehydration with less damage to the tissue specimen.
Documented Applications
Storing and transporting tissue and other biological material.
Use in tissue implant procedures, including implanting bone or gum tissue, bone grafting to repair fractures, and tendon grafting to repair damaged ligaments and/or tendons.
Storing tissue grafts in a sealed container and rehydrating tissue specimens within the same flexible container.
Vacuum packaging of tissue specimens via a port coupled to the flexible container.
Rehydration of tissue specimens for use in a surgical procedure via a port that allows inflow of rehydration fluid.
Packaging and storage of a variety of tissue specimen types identified in the disclosure, including skin grafts, bone tissue, fiber tissue (e.g., tendon tissue, ligament tissue), ocular tissue (e.g., corneal implants), and bone chips.
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