Sample container with peelable seal and access port
Inventors
ALDEN, Madeline C. • BURLEY, Kimber L. • RAMSEY, Tara C.
Assignees
Publication Number
US-11065095-B2
Publication Date
2021-07-20
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. 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 edges 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 that is greater than the first stiffness and the second stiffness.
Known procedures for preparing or rehydrating a tissue implant can result in compromised sterility, inconsistent rehydration, longer rehydration times, and possible damage to the tissue implant due to repeated transfer, movement, or manipulation within an open container. Rigid trays can be bulky and still involve open-top rehydration that can damage tissue implants, and rehydration in sterile, flexible pouches can provide inadequate support. Thus, a need exists for improved containers and methods for storing, transporting, and rehydrating tissue and other biological material.
Claims Coverage
The patent includes three independent claims, each defining a primary inventive feature related to (1) an apparatus with a flexible container, peelable seal, port, and support structure; (2) a three-layer container with a sealed support volume containing a support structure; and (3) a method for inserting, positioning, and sealing a tissue specimen.
Flexible container with peelable seal and access port
A flexible container including a first layer coupled to a second layer to define a storage volume for a tissue specimen, where an edge of the first layer is spaced apart from an edge of the second layer to define an opening and the edges are configured to form a peelable seal that hermetically seals the storage volume such that the first layer can be peeled away; a port coupled to the flexible container configured to allow 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 characterized by a third stiffness greater than the first stiffness and the second stiffness.
Three-layer flexible container with sealed support volume
A flexible container including a first layer, a second layer, and a third layer, wherein the first layer is coupled to the second layer to define a storage volume and the third layer is coupled to the second layer to define a support volume; an edge of the first layer spaced apart from an edge of the second layer to define an opening into the storage volume, the edges configured to form a peelable seal that hermetically seals the storage volume such that the first layer can be peeled away; a port coupled to the flexible container configured to allow fluid communication between the storage volume and an external volume; and a support structure within the support volume configured to support the tissue specimen within the storage volume.
Method of inserting, positioning on support structure, and forming peelable seal
A method comprising inserting a tissue specimen into a storage volume defined between a first layer and a second layer of a flexible container via an opening defined by edges of the layers, positioning the tissue specimen within the storage volume between the first layer and a support structure where the stiffness of the support structure is greater than each of the stiffness of the first layer and the stiffness of 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 such that the first layer can be peeled away to expose the storage volume.
The independent claims cover (1) a flexible, hermetically sealable storage container with a peelable seal, access port, and a stiffer support structure for tissue specimens; (2) a variant three-layer container that captures the support structure within a support volume; and (3) a method of loading a tissue specimen onto a support structure and forming a peelable hermetic seal to enclose the specimen while allowing subsequent fluid access via a port.
Stated Advantages
Allows a tissue specimen to be loaded and sealed at the point of loading and to be both stored and rehydrated within the same container.
Provides a support structure with higher stiffness to limit damage to the tissue specimen during packaging, storage, rehydration, and removal for use in a surgical procedure.
Reduces or eliminates production of particulate matter or other 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.
Enables 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 to address dental or periodontal issues, bone grafting to repair fractures, tendon grafting to repair damaged ligaments and/or tendons (for example, repair of a torn anterior cruciate ligament), and ocular tissue (for example, corneal implants).
Rehydrating and preparing tissue grafts for use in surgical procedures, including conveying rehydration fluid into a sealed storage volume via a port and maintaining fluid within the storage volume to rehydrate the tissue specimen.
Vacuum packaging and conveying preservation fluids into the storage volume via the port for preparation and storage of tissue specimens.
Loading and sealing tissue specimens at tissue banks or points of loading using a peelable seal and an access port.
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