Sample container with peelable seal and access port
Inventors
ALDEN, Madeline C. • BURLEY, Kimber L. • RAMSEY, Tara C.
Assignees
Publication Number
US-11642208-B2
Publication Date
2023-05-09
Expiration Date
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Abstract
An apparatus includes a flexible container, a port, and a support structure. 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 is characterized by a first stiffness and the second layer characterized by 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 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 port is coupled to the flexible container and allows fluid communication between the storage volume and an external volume. The support structure is configured to support the tissue specimen within the storage volume and is characterized by a third stiffness. The third stiffness is greater than the first stiffness and the second stiffness.
Core Innovation
An apparatus includes a flexible container, a port, and a support structure. The container includes a first layer coupled to a second layer to define a storage volume within which a tissue specimen can be contained, and 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 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 port is coupled to the flexible container and allows fluid communication between the storage volume and an external volume, and the support structure is configured to support the tissue specimen within the storage volume and is characterized by a third stiffness that is greater than the first stiffness and the second stiffness.
Containers and methods for storing tissue and other biological materials are described in which a tissue specimen is inserted into a storage volume defined between a first layer and a second layer and positioned between the first layer and a support structure, the edge of the first layer then coupled to the edge of the second layer to form a peelable seal that hermetically seals the storage volume. The flexible container includes a port configured to allow fluid communication between the storage volume and an external volume, and the port can be used to convey preservation or rehydration fluid and to evacuate the storage volume. The support structure provides structural support for the tissue specimen during packaging, storage, and rehydration.
The background describes known procedures that can compromise sterility, result in inconsistent rehydration, longer rehydration times, and possible damage to the tissue implant due to repeated transfer and manipulation in open containers. Known rigid trays can be bulky and less desirable for tissue storage facilities, and known sterile flexible pouches often provide inadequate support for the tissue implant. Thus, a need exists for improved containers and methods for storing, transporting, and rehydrating tissue and other biological material.
Claims Coverage
Independent claims identified: 1, 10, and 13. The following inventive features (7 total) are extracted from the independent claims.
Flexible container with peelable seal along longitudinal axis
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, 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 extends along a longitudinal axis of the flexible container, the edge of the second layer extends along the longitudinal axis, 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.
Port coupled at an end with center line aligned with longitudinal axis
A port coupled to the flexible container, the port configured to allow fluid communication between the storage volume and an external volume, the port is coupled at an end of the flexible container, a center line of the port being aligned with the longitudinal axis of the flexible container, the center line of the port being parallel to the opening defined by the edge of the first layer and the edge of the second layer.
First and second layers as laminates with barrier coating and adhesive
The first layer is a first laminate including a first substrate, a first barrier coating, and a first adhesive, the first substrate being a peelable film; and the second layer is 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.
Three-layer container with separate volume isolated by second layer
A flexible container including a first layer, a second layer, and a third layer, the second layer positioned between the first layer and the third layer, the first layer coupled to the second layer to define a storage volume within which a tissue specimen can be contained, the third layer coupled to the second layer to define a separate volume that is isolated from the storage volume by the second layer, 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 having a peelable seal suitable to hermetically seal the storage volume such that the first layer can be peeled away from the second layer to expose the storage volume.
Port providing selective fluid communication to storage volume
A port coupled to the flexible container, the port configured to allow fluid communication between the storage volume and an external volume.
Method of inserting and sealing tissue specimen with aligned port
Inserting a tissue specimen into a storage volume defined between a first layer of a flexible container and a second layer of the flexible container, the tissue specimen inserted via an opening defined by an edge of the first layer and an edge of the second layer, the edge of the first layer and the edge of the second layer extending along a longitudinal axis of the flexible container, the flexible container including a port configured to allow fluid communication between the storage volume and an external volume, the port is coupled at an end of the flexible container, a center line of the port is aligned with the longitudinal axis of the flexible container, the center line of the port is parallel to the opening defined by the edge of the first layer and the edge of the second layer; positioning the tissue specimen within the storage volume between the first layer and the second layer; 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, the peelable seal configured such that the first layer can be peeled away from the second layer to expose the storage volume.
Use of separate volume to contain a separate structure
The flexible container includes a third layer coupled to a first longitudinal edge of the second layer and to a second longitudinal edge of the second layer to define a separate volume; and a separate structure is within the separate volume.
The independent claims disclose a flexible container architecture in which first and second layers form a longitudinal peelable seal that hermetically seals a storage volume, a port coupled to the container (often at an end with its center line aligned to the longitudinal axis) enabling fluid communication, and embodiments including a third layer defining a separate, isolated volume to contain a separate structure; a corresponding method claim covers inserting a tissue specimen, positioning it between the layers, and forming the peelable hermetic seal.
Stated Advantages
Enables a single container to be used for both storage and rehydration of a tissue specimen.
Provides structural support for the tissue specimen during packaging, storage, and rehydration to limit damage to the tissue specimen.
Reduces or eliminates production of particulate matter or debris that may result from cutting or tearing the flexible container to extract the tissue specimen.
Facilitates opening the container in a predetermined fashion and/or direction and eliminates the need for extra tools for opening during use.
Allows access to the storage volume after sealing for conveying preservation or rehydration fluid and for evacuating the storage volume.
Results 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.
Implanting bone or gum tissue to address dental or periodontal issues.
Bone grafting to repair fractures.
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 (e.g., allografts, xenografts) that are stored in a dried condition within a sterile package.
Rehydration and preparation of a tissue specimen for use in a surgical procedure, including conveying rehydration or preservation fluid into the storage volume via the port and evacuating the storage volume.
Vacuum packaging of a tissue specimen via the port.
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