WO2024242991A2

WO2024242991A2 - Sample container with peelable seal and label pocket

Info

Publication number: WO2024242991A2
Application number: PCT/US2024/029658
Authority: WO
Inventors: Kimber L. BURLEY; Uzair A. RAJPUT; Tara C. RAMSEY
Original assignee: Instant Systems Inc
Current assignee: Instant Systems Inc
Priority date: 2023-05-20
Filing date: 2024-05-16
Publication date: 2024-11-28
Anticipated expiration: 2025-11-20
Also published as: WO2024242991A3

Abstract

A flexible container includes a first layer and a second layer. The second layer is coupled to the first layer via a set of seals to define a storage volume and a label volume. The seals define a storage opening between the storage volume and an external environment. The seals define a label opening between the label volume and the external environment. A first seal forms a portion of a boundary of the storage volume. The first seal is a peelable seal configured such that the first layer can be peeled away from the second layer to expose the storage volume. The second seal forms a portion of a boundary of the label volume. The first seal is between the second seal and the storage opening.

Description

SAMPLE CONTAINER WITH PEELABLE SEAL AND LABEL POCKET

Cross-Reference to Related Applications

[0001] This patent application claims priority to and the filing date benefit of U.S. Provisional Application Serial No. 63/467,938, filed May 20, 2023, entitled '‘Sample Container with Peelable Seal and Label Pocket,” which is incorporated herein by reference in its entirety.

Background

[0002] The embodiments described herein relate to containers for storing and transporting tissue and other biological material. More particularly, the embodiments described herein relate to devices and methods including containers having a product egress portion (e.g., peelable seal or port) and a label pocket.

[0003] Known biological materials, tissue implants and/or grafts are used in a variety of procedures to repair or replace damaged tissue. Such procedures can include implanting bone or gum tissue to address dental or periodontal issues, bone grafting to repair fractures, and tendon grafting to repair damaged ligaments and/or tendons (e g., repair of a tom anterior cruciate ligament), to name just a few. In many instances, the tissue implant is not taken from the patient's body (i.e., is not an autograft), but rather is from another source, such as from a human cadaver (i.e., an allograft) or an animal (i.e., axenograft). Known non-autologous grafts are often stored in a dried condition within a sterile package, and thus must be rehydrated or otherwise prepared prior to use.

[0004] Some known procedures for packaging biological material include inserting the biological material into a container via an opening. The container opening (and the end of the container) is then inserted into a vacuum sealer or other processing equipment to perform any number of desired processing steps to seal the opening. Such steps can include flushing the biological material with an inert (or sterile) gas, removing the gas from within the container (i.e., produce a vacuum within the container), and/or sealing the opening closed. Some known vacuum sealers include a thin nozzle that is placed within the opening and through which the vacuum is drawn. Upon reaching the desired vacuum conditions within the container, the nozzle is withdrawn and the plastic layers from which the container is constructed are sealed together. [0005] An important step in packaging biological materials includes labeling the product. Some known containers are flexible containers constructed from multiple plastic layers and include an external label placed on the outer surface of one of the layers. For example, some known containers may have an adhesive-backed label that is adhered to an outer surface of the container. Such configurations, however, can be susceptible to damage during transport and storage (e.g., being inadvertently peeled off, having the information thereon being altered or destroyed, etc.). Moreover, such configurations do not provide for a removable label that can be stored within a patient’s records after the biological material is used. Thus, other known containers include a separate label pocket within which the appropriate label is placed and sealed during packaging of the biological materials.

[0006] Known containers include the label pocket at the same end of the container as the opening through which the biological material is loaded. This arrangement provides advantages during later use of the product. For example, the end opposite the opening through which the biological material is loaded often includes the mechanism through which the biological materials are later removed from the container. For example, such mechanisms include a peelable seal, a port, a tear-off portion, or the like). By maintaining the product label at the end of the container opposite from where the product egress mechanisms are included, the end user can more easily remove the product without concerns that a non-sterile portion of the container (i.e., the label portion) will come into contact with the biological material.

[0007] Having the label pocket at the same end of the container as the opening through which the biological material is loaded, however, can make loading and sealing of the container more difficult. For example, in such configurations the label pocket can interfere with the entry of the vacuum nozzle or other aspects of the packaging equipment. This configuration may require, for example, that the label pocket be folded under the main portion of the container during packaging.

[0008] Thus, a need exists for improved containers and methods for packaging, storing, transporting, and deploying tissue and other biological material.

Summary

[0009] Containers and methods for storing tissue and other biological materials are described herein. In some embodiments, an apparatus includes a first layer and a second layer. The second layer is coupled to the first layer via a set of seals to define a storage volume and a label volume. The seals define a storage opening between the storage volume and an external environment. The seals define a label opening between the label volume and the external environment. A first seal forms a portion of a boundary of the storage volume. In some embodiments, the first seal is a peelable seal configured such that the first layer can be peeled away from the second layer to expose the storage volume. The second seal forms a portion of a boundary of the label volume. The first seal is between the second seal and the storage opening.

Brief Description of the Drawings

[0010] FIGS. 1-5 are schematic illustrations of a container assembly according to an embodiment, in a first configuration (FIG. 1), a second configuration (FIG. 2), a third configuration (FIG. 3), a fourth configuration (FIG. 4), and a fifth configuration (FIG. 5).

[0011] FIG. 6 is a schematic illustration of a container assembly according to an embodiment, constructed from at least three layers.

[0012] FIG. 7 is a schematic illustration of a container assembly according to an embodiment, constructed from two layers.

[0013] FIGS. 8A-8B are schematic illustrations of a container assembly according to an embodiment, including a port.

[0014] FIG. 9 is a schematic illustration of a container assembly according to an embodiment, including a port.

[0015] FIG. 10 is a schematic illustration of a container assembly according to an embodiment, including a foldable label pocket.

[0016] FIG. 11 is a schematic view of a biological material storage system according to an embodiment, including a cryogenic storage cassette with a container assembly with a folded label pocket being placed inside the cryogenic storage cassette.

[0017] FIG. 12 is another schematic view of the biological material storage system of FIG. 11, depicting a cryogenic storage cassette after a container assembly (with a folded label pocket) has been placed inside, and the cryogenic storage cassette has been closed shut. [0018] FIG. 13 is a side cross-sectional view of a container assembly according to an embodiment.

[0019] FIG. 14 is a schematic view of a vacuum sealing machine equipped with a nozzle assembly, according to an embodiment.

[0020] FIG. 15 is a schematic view of the vacuum sealing machine of FIG. 14 at one point in time during its operation, according to an embodiment.

[0021] FIG. 16 is a schematic view of the vacuum sealing machine of FIG. 14 at another point in time during its operation, according to an embodiment.

[0022] FIG. 17 is a flow chart diagram illustrating a method for loading a container assembly with a biological material, according to an embodiment.

[0023] FIG. 18 is a flow chart diagram illustrating a method for removing a biological material from a container assembly with a peelable seal, according to an embodiment.

[0024] FIG. 19 is a flow chart diagram illustrating a method for removing a biological material from a container assembly with a port, according to an embodiment.

Detailed Description

[0025] The embodiments described herein can advantageously be used in a wide variety of tissue storage, transportation, and implantation operations. In particular, the flexible container designs described herein can allow for a tissue specimen to be loaded and sealed at the point of loading (e.g., a tissue bank). The loaded flexible container includes a label within a label pocket that is advantageously configured to be removed prior to the biological material being removed. In this manner, the embodiments described herein can result in more efficient tissue packaging systems, but that are also easily and safely used at the point of delivery to the patient.

[0026] In some embodiments, an apparatus includes a first layer and a second layer. The second layer is coupled to the first layer via a set of seals to define a storage volume and a label volume. The seals define a storage opening between the storage volume and an external environment. The seals define a label opening between the label volume and the external environment. A first seal forms a portion of a boundary of the storage volume. The first seal may be a peelable seal configured such that the first layer can be peeled away from the second layer to expose the storage volume. The second seal forms a portion of a boundary of the label volume. The first seal is between the second seal and the storage opening.

[0027] In some embodiments, the second seal and the first seal are both between the storage opening and the label opening.

[0028] In some embodiments, the storage opening forms a proximal most end portion of the flexible container. In other words, the storage opening forms the portion of the flexible container located at the very' end of the container through which a tissue specimen may be inserted, and is therefore situated closest to the external environment such that no additional container structure extends beyond the storage opening at that end.

[0029] In some embodiments, the first layer includes a side edge parallel to a longitudinal axis of the flexible container. The second layer includes a side edge parallel to a longitudinal axis of the flexible container. A first portion of the side edge of the first layer is sealed to a first portion of the side edge of the second layer to form a portion of the boundary of the storage volume. A second portion of the side edge of the first layer is sealed to a second portion of the side edge of the second layer to form a portion of the boundary' of the label volume. A third portion of the side edge of the first layer is unsealed from a third portion of the side edge of the second layer.

[0030] In some embodiments, a method includes 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 is inserted via a storage opening at a first end of the container. The storage opening is defined by an edge of the first layer and an edge of the second layer. The flexible container is then evacuated of gas and the edge of the of the first layer and an edge of the second layer are sealed together. The flexible container includes a material egress portion at a second end of the container. This material egress portion may be formed, for example, using a peelable seal and/or a port (to allow the inserted tissue specimen to be later removed from the flexible container). A label containing information associated with the biological material is inserted into a label pocket. The label pocket is at the second end of the container. The label pocket is sealed closed.

[0031] In some embodiments, the material egress portion includes any of a peelable seal, a port, or a frangible portion to provide access to a storage volume of the container. In some embodiments the material egress portion includes a peelable seal configured such that the first layer can be peeled away from the second layer to expose the storage volume.

[0032] As used herein, the term “abouf’ when used in connection with a referenced numeric indication means the referenced numeric indication plus or minus up to 10% of that referenced numeric indication. For example, the language “about 50” covers the range of 45 to 55. Similarly, the language “about 5” covers the range of 4.5 to 5.5.

[0033] As used herein, the term “biologic material” refers to any material that is produced or derived from a living (or recently living) organism. Biologic materials can include, for example, tissue specimens, tissue grafts, cells, blood, or other bodily fluids. Biologic materials can also include plants, plant products, mi coorganisms, genetically modified organisms (including cells and cell lines). Biologic materials can also include DNA or RNA (including plasmids, oligonucleotides, cDNA) or viral vectors. Biologic materials can also include material that is produced by a living (or recently living) organism, such as small or large molecule pharmaceuticals.

[0034] As used herein, the term “tissue specimen” or “tissue graft” refers to any material that can be used in a tissue repair procedure or other procedures which use tissue grafts (e.g., birth tissue used as patch for healing then removed). Thus, a tissue specimen or a tissue graft can include any of a skin graft, bone tissue, fiber tissue (e.g., tendon tissue, ligament tissue, or the like), ocular tissue (e.g., comeal implants), birth tissue (e.g., amnion graft), cardiovascular tissue (e.g., heart valve), tendons or the like including artificially produced tissue. A tissue specimen or a tissue graft can include a portion of tissue harvested from a donor or a structure component that includes both tissue and non-tissue material (e.g., a synthetic matrix that includes tissue therein). For example, a tissue specimen or a tissue graft can include bone tissue that also includes bone cement or other non-tissue components. As another example, a tissue specimen or tissue graft can include bone chips including cortical bone chips, cancellous bone chips, and corticocancellous bone chips, and/or bone chips with viable bone lineage committed cells.

[0035] As used herein, the term “stiffness” relates to an object's resistance to deflection, deformation, and/or displacement produced by an applied force, and is generally understood to be the opposite of the object’s “flexibility . ” For example, a layer or structure of a container with greater stiffness is more resistant to deflection, deformation and/or displacement when exposed to a force than is a layer or structure of the container having a lower stiffness. Similarly stated, a container (or layer) having a higher stiffness can be characterized as being more rigid than a container (or layer) having a lower stiffness. Stiffness can be characterized in terms of the amount of force applied to the object and the resulting distance through which a first portion of the object deflects, deforms, and/or displaces with respect to a second portion of the object. When characterizing the stiffness of an object, the deflected distance may be measured as the deflection of the portion of the object different than the portion of the object to which the force is directly applied. Said another way, in some objects, the point of deflection is distinct from the point where the force is applied.

[0036] Stiffness (and therefore, flexibility) is an extensive property of the object being described, and thus is dependent upon the material from which the object is formed as well as certain physical characteristics of the object (e.g., cross-sectional shape, thickness, boundary conditions, etc ). For example, the stiffness of an object can be increased or decreased by selectively including in the object a material having a desired modulus of elasticity, flexural modulus and/or hardness. The modulus of elasticity is an intensive property of (i.e., is intrinsic to) the constituent material and describes an object’s tendency to elastically (i.e., non- permanently) deform in response to an applied force. A material having a high modulus of elasticity will not deflect as much as a material having a low modulus of elasticity in the presence of an equally applied stress. Thus, the stiffness of the object can be decreased, for example, by introducing into the object and/or constructing the object of a material having a relatively low modulus of elasticity. Similarly, the flexural modulus is used to describe the ratio of an applied stress on an object in flexure to the corresponding strain in the outermost portions of the object. The flexural modulus, rather than the modulus of elasticity, is often used to characterize certain materials, for example plastics, that do not have material properties that are substantially linear over a range of conditions. An object with a first flexural modulus is more elastic and has a lower strain on the outermost portions of the object than an object with a second flexural modulus greater than the first flexural modulus. Thus, the stiffness of an object can be reduced by including in the object a material having a relatively low flexural modulus.

[0037] Moreover, the stiffness (and therefore flexibility) of an object constructed from a polymer can be influenced, for example, by the chemical constituents and/or arrangement of the monomers within the polymer. For example, the stiffness of an object can be reduced by decreasing a chain length and/or the number of branches within the polymer. The stiffness of an object can also be reduced by including plasticizers within the polymer, which produces gaps between the polymer chains.

[0038] The stiffness of an object can also be increased or decreased by changing a physical characteristic of the object, such as the shape or cross-sectional area of the object. For example, an object having a length and a cross-sectional area may have a greater stiffness than an object having an identical length but a smaller cross-sectional area. As another example, the stiffness of an object can be reduced by including one or more stress concentration risers (or discontinuous boundaries) that cause deformation to occur under a lower stress and/or at a particular location of the object. Thus, the stiffness of the object can be decreased by decreasing and/or changing the shape of the object.

[0039] As used herein, the words “proximal’' and “distal” refer to direction closer to and away from, respectively, the end of a container through which a tissue specimen may be inserted for storage. Thus, for example, the end of the container through which the tissue specimen is inserted may be referred to as the proximal end of the container, while the end opposite the proximal end may be referred to as the distal end of the container.

[0040] As used in this specification, specific words chosen to describe one or more embodiments and optional elements or features are not intended to limit the invention. For example, spatially relative terms — such as “beneath”, “below”, “lower”, “above”, “upper”, “proximal”, “distal”, and the like — may be used to describe the relationship of one element or feature to another element or feature as illustrated in the figures. For example, a container opening formed at the very end of the container may be referred to as a proximal most end portion, to describe the spatial relationship between that container opening and an associated external environment or processing equipment. These spatially relative terms are intended to encompass different positions (i.e., translational placements) and orientations (i.e., rotational placements) of a device in use or operation in addition to the position and orientation shown in the figures. For example, if a device in the figures is turned over, elements described as “below” or “beneath” other elements or features would then be “above” or “over” the other elements or features. Thus, the term “below” can encompass both positions and orientations of above and below. A device may be otherwise oriented (e.g., rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly. Likewise, descriptions of movement along (translation) and around (rotation) various axes includes various spatial device positions and orientations.

[0041] Similarly, geometric terms, such as "parallel", “perpendicular”, “round”, or “square”, are not intended to require absolute mathematical precision, unless the context indicates otherwise. Instead, such geometric terms allow for variations due to manufacturing or equivalent functions. For example, if an element is described as “round” or “generally round”, a component that is not precisely circular (e.g, one that is slightly oblong or is a many- sided polygon) is still encompassed by this description.

[0042] In addition, the singular forms “a”, “an”, and “the” are intended to include the plural forms as well, unless the context indicates otherwise. The terms “comprises”, “includes”, “has”, and the like specify the presence of stated features, steps, operations, elements, components, etc. but do not preclude the presence or addition of one or more other features, steps, operations, elements, components, or groups.

[0043] FIGS. 1-5 are schematic illustrations of a container assembly 100 according to an embodiment. The tissue container assembly 100 is shown in a first (or open and unloaded) configuration (FIG. 1). a second (or partially loaded) configuration (FIG. 2), a third (or loaded and sealed) configuration (FIG. 3), a fourth (label removed) configuration (FIG. 4), and a fifth (opened, material removed) configuration (FIG. 5). The container assembly 100 (and any of the container assemblies described herein) can be used to perform any of the methods described herein (see, for example, FIG. 17), and any suitable methods of preparing a tissue specimen for storage (see, for example, FIG. 5). The container assembly 100 (and any of the container assemblies described herein) can be used in connection with any methods of packaging biological materials described herein (see, for example, FIG. 11).

[0044] As shown, the container assembly (also referred to as a flexible container) includes a first end portion 101 (also referred to as a proximal most end portion), a second end portion 102 (also referred to as a distal most end portion), and a central portion 103 between the first end portion 101 and the second end portion 102. The flexible container 100 includes a pair of side edges 104 between the first end portion 101 and the second end portion 102. The flexible container 100 defines a longitudinal axis AL that extends longitudinally from the first end portion 101 and the second end portion 102. The flexible container 100 is constructed from at least a first layer 120 and a second layer 130 (see FIG. 5, where the first layer 120 is shown on top and a portion of which is capable of being peeled upwards, and the second layer 130 is shown on bottom) coupled together to define a storage volume 106 and a label pocket 116 (also referred to as a label volume). Specifically, the first layer 120 and the second layer 130 are coupled together via a set of seals to define the storage volume 106 and a label volume/pocket 116. The seals can be along the side edges 104, as shown in FIG. 1. In some embodiments, the two layers can be configured as tubular material that is flattened forming two longitudinal connections between the layers on the flattened longitudinal edges of the tubular material (e.g.. layflat tubular film).

[0045] As shown in FIG. 1, when the container assembly 100 is in the first (or opened) configuration, an edge of the first layer 120 is spaced apart from an edge of the second layer 130 to define an opening 107 into the storage volume 106. Similarly stated, the seals define a storage opening between the storage volume and an external environment. As shown in FIG. 1, the storage opening forms a portion of the container assembly 100 closest to the external environment from where a biological material may be inserted, and is also referred to as a proximal most end portion of the container assembly 100. The opening 107 can be of any suitable size and geometry to facilitate loading of the biological material M (also referred to as a tissue graft), as described herein. For example, although the opening 107 is shown as extending across (i.e., in the horizontal direction, perpendicular to the container’s longitudinal axis AL, as shown in FIG. 1) the full length of the first end portion 101 of the flexible container 100, in other embodiments, the opening 107 can extend across only a portion of the length of an end or a side of the flexible container 100. For example, instead of extending across (i.e., in the horizontal direction) as shown in FIG. 1, the opening 107 (or a portion thereof) can extend in a diagonal direction, i.e., extend at a non-perpendicular angle with respect to the container’s longitudinal axis AT,. Additionally, instead of extending along a straight path as shown in FIG. 1, the opening 107 (or a portion thereof) can extend along a curved path.

[0046] When the container assembly 100 is in the first (or opened) configuration, another edge of the first layer 120 is spaced apart from a corresponding edge of the second layer 130 to define an opening 117 into the label volume 116. Similarly stated, the seals define a label opening between the label volume and the external environment. As shown in FIG. 1. the label opening forms a portion of the container assembly 100 farthest from the external environment from where a biological material may be inserted, and is also referred to as a distal most end portion of the container assembly 100. The opening 117 can be of any suitable size to facilitate loading of the label 170, as shown in FIG. 2. For example, although the opening 117 is shown as extending across the full length (i.e., in the horizontal direction, perpendicular to the container’s longitudinal axis AL, as shown in FIGS. 1 and 2) of the second end portion 102 of the flexible container 100, in other embodiments, the opening 117 can extend across only a portion of the length of an end or a side of the flexible container 100. For example, instead of extending across (i.e., in the horizontal direction) as shown in FIG. 1. the opening 117 (or a portion thereof) can extend in a diagonal direction, i.e., extend at a non-perpendicular angle with respect to the container’s longitudinal axis AL. Additionally, instead of extending along a straight path as shown in FIG. 1 , the opening 117 (or a portion thereof) can extend along a curved path.

[0047] As shown, the set of seals includes a first seal 105 that forms a portion of a boundary of the storage volume 106. The first seal 105 may (but need not) be a peelable seal configured such that the first layer can be peeled away from the second layer to expose the storage volume 106 (see FIG. 5). Thus, in instances where the first seal 105 is peelable, the peelable seal provides an egress mechanism that allows any biological material (or a portion thereof) stored within the storage volume 106 to be subsequently removed.

[0048] The set of seals includes a second seal 115 that forms a portion of a boundary of the label volume 116. The first seal 105 is between the second seal 115 and the storage opening 107. Said another way, the label volume 116 is at the same end of the container 100 as the egress mechanism, e.g., peelable seal 105 (shown in FIGS. 1 and 5 as being defined below the container’s lateral mid-line LM, opposite the storage opening 107 defined above the lateral mid-line LM). In alternative instances where the first seal 105 is anon-peelable seal, the egress mechanism may instead be a port coupled to the first seal 105, as further described in relation to FIGS. 8 and 9 below. In either case, the container 100 may provide at least one egress mechanism (e.g., a peelable first seal 105 or a port coupled to a non-peelable first seal 105) that is physically, structurally, and/or spatially separate from the storage opening 107, this allowing the stored biological material (or a portion thereof) to be later accessed and removed from the storage volume 106 even when the storage opening 107 has been sealed closed.

[0049] The first layer 120 can be constructed of any suitable material, and has a first stiffness. For example, in some embodiments, the first layer 120 can be a thin, peelable film, such as, for example, a heat seal-coated (HSC) material, a polyethylene material, a polyvinyl chloride (PVC) material, a polyamide material, a polyester-based material, or any combination of such materials, including laminates constructed from multiple different materials. The first layer 110 can have any suitable thickness to provide the desired strength, flexibility, and sealing characteristics.

[0050] The second layer 130 can be constructed of any suitable material, and has a second stiffness. For example, in some embodiments, the second layer 130 can constructed from the same material and/or can have the same stiffness as the first layer 120. In other embodiments, the second layer 130 can be constructed from a different material and the second stiffness can be different than the first stiffness. The second layer 130 can be constructed from any suitable polymer, such as, for example, a heat seal-coated (HSC) material, a polyethylene material, a polyvinyl chloride (PVC) material, a polyamide material, a polyester-based material, or any combination of such materials, including laminates constructed from multiple different materials. The second layer 130 can have any suitable thickness to provide the desired strength, flexibility-, and sealing characteristics.

[0051] The peelable seal 105 can be configured to have any suitable failure (or peel) mechanism, and can be of any suitable peel strength. For example, in some embodiments, the peelable seal 105 can be an adhesive-based seal in which an adhesive layer pulls back from one of the first layer 120 or the second layer 130 when the first layer 120 is peeled apart from the second layer 130. In other embodiments, the peelable seal 105 can be a cohesive seal in which an adhesive layer or intermediate layer fails within itself when the first layer 120 is peeled apart from the second layer 130. The peelable seal 105 can be produced by any suitable mechanism as described herein, such as, for example, by a heat sealing operation.

[0052] The peelable seal 105 can be of any suitable geometry to facilitate the desired peel direction, peel strength, and the like. For example, in some embodiments, the peelable seal 105 can be an angled seal that provides for peel tabs that can be grasped by the user to peel the first layer from the second layer. Similarly stated, in some embodiments, the peelable seal 105 can be a chevron seal having any suitable angle.

[0053] As shown in FIG. 1 , the storage opening 107 is located within the top half of the container 100 (i. e.. above the lateral mid-line LM that divides the container 100’s longitudinal axis into two halves of equal length), while first seal 105 and the second seal 115 are located within the bottom half of the container 100 (i.e., below the lateral mid-line LM). Thus, in some embodiments, the storage opening 107 may defined by one end of the container 100 that is spatially separate and opposite to another end of the container 100 where the peelable seal 105 and the second seal 115 are defined. By including the peelable seal 105 and the second seal 1 15 at the same end of the container 100 (the end opposite the end forming the loading opening 107), the container 100 is more easily loaded and packaged with the biological material M. For example, as shown in FIG. 1, the storage/loading opening 107 is the part of the first end portion

101 that is closest to the outside environment (i.e., there is no container structure that extends beyond the opening 107 at that end), which allows the biological material M to be inserted, from the external environment and into the container 100, through the opening 107. Once the biological material M has been loaded through the storage opening 107, as shown in FIG. 2, the first end portion 101 can be placed into a vacuum sealing machine (or other container sealing equipment) without the label pocket 116 obstructing the opening 107. After being evacuated and processed, the storage opening 107 is sealed closed by the seal 108, as shown in FIG. 3.

[0054] Thus, as shown in FIGS. 1-3, the first end portion 101 (which includes the storage opening 107) is located at one end of the container 100 that gets placed closest to external processing equipment when evacuating, processing, and/or sealing the storage volume 106 once the biological material M has been inserted. As shown in FIG. 2, while the storage volume 106 is being evacuated, processed, and/or sealed by external equipment (which occurs after insertion of the biological material M as previously described), there is no obstruction from the second end portion 102 (including the label opening 117 and the label pocket 116) because the first end portion 101 and the second end portion 102 are located at two different ends of the container 100.

[0055] The label opening 117 located at the second end portion 102 is sealed closed by the seal 118. As shown in FIGS. 1-3, because the first end portion 101 and the second end portion

102 are located at tw o different ends of the container 100, the second end portion 102 can be placed into a vacuum sealing machine (or other container sealing equipment) to seal the label opening 117 without the storage opening 107 or the storage volume 106 obstructing the label opening 117. The sealing of the label opening 117 by the seal 118 may (but need not) be carried out using the same vacuum sealing machine (or other container sealing equipment) that was also used to seal the storage opening 107. For example, if the same vacuum sealing machine is used to seal both the storage opening 107 and the label opening 117, the container 100 can be flipped along its longitudinal axis (through either manual or automated means), after the storage opening 107 has been sealed, to place the second end portion 102 into the vacuum sealing machine for evacuating, processing, and/or sealing the label volume 116.

[0056] While in some embodiments the first end portion 101 and the second end portion 102 are located at opposite ends of the container 100 (such as shown in FIGS. 1-3), in other embodiments the first end portion 101 and the second end portion 102 can be located at two different ends of the container 100 that do not directly oppose each other. In the latter situation, for example, the first end portion 101 can be located at one end of the container 100 that is aligned along the container's longitudinal axis, whereas the second end portion 102 can be located at another end of the container 100 that is offset at an angle with respect to the container's longitudinal axis. In some embodiments, the offset angle can be a particular angle between -90 degrees and 90 degrees with respect to the container’s longitudinal axis.

[0057] Additionally, each of the first end portion 101 and the second end portion 102 can have its own respective associated geometry and/or curvature. For example, while FIGS. 1-3 depict embodiments where the first end portion 101 and the second end portion 102 are substantially rectangular, that need not be the case in other embodiments.

[0058] In some embodiments, the container 100 and any of the biological materials or other structures therein can be configured to promote spatial uniformity of the vacuum. Specifically, to reduce the likelihood that the layers will be in contact with each other and may prevent the gas from being evacuated in all spatial regions of the container, in some embodiments, the biological materials can be processed to include grooves or channels to place distal portions of the storage volume 106 in fluid communication with the vacuum nozzle. In other embodiments, the biological material can be supported by a tray or support member within the storage volume. Such trays or support members can be similar to those shown and described in U.S. Patent No. 11,065,095 (the ’095 patent), titled '‘Sample Container with Peelable Seal and Access Port,” which is hereby incorporated by reference in its entirety. In such embodiments the tray or support member can include grooves or channels to place distal portions of the storage volume 106 in fluid communication with the vacuum nozzle.

[0059] The central portion 103 includes a frangible region 126 that facilitates the separation of the label pocket 116 from the remainder of the container as show n by the arrow AA in FIG. 4. The frangible region 126 can include perforations, thinning of material, stress risers suitable to directional tearing, adhesive attached otherwise detached containers or any other suitable mechanism for separating portions. In some embodiments, at least one of the first layer and the second layer includes a frangible region. In other embodiments, both of the layers include a frangible region. As shown, the frangible region 126 is between the first seal 105 and the second seal 115.

[0060] In some embodiments, the layers between the first seal 105 and the second seal 115 are coupled together (e.g., via an edge seal, as shown in FIG. 1). In other embodiments, however, the two layers are not coupled together, thus providing a peel tab or comer of the layer to facilitate peeling apart the peelable seal. In yet other embodiments, the flexible container can be constructed from three or more layers. For example, FIG. 6 is a schematic illustration of a container assembly 200 according to an embodiment. The container assembly 200 (and any of the container assemblies described herein) can be used in connection with any methods of packaging biological materials described herein.

[0061] As shown, the container assembly (also referred to as a flexible container) includes a first end portion 201 (also referred to as a proximal most end portion), a second end portion 202 (also referred to as a distal most end portion), and a central portion 203 between the first end portion 201 and the second end portion 202. The flexible container 200 includes a pair of side edges 204 between the first end portion 201 and the second end portion 202. The flexible container 205 is constructed from at least a first layer 220, a second layer 230, and a third layer 240 coupled together to define a storage volume 206 and a label pocket 216 (also referred to as a label volume). Specifically, the first layer 220 and the second layer 230 are coupled together via a set of seals to define the storage volume 206. The first layer 220 and the third layer 240 are coupled together via a set of seals to define label volume/pocket 216. The seals can be along the side edges 204 and the side edges 214.

[0062] As shown, when the container assembly 200 is in the first (or opened) configuration, an edge of the first layer 220 is spaced apart from an edge of the second layer 230 to define an opening 207 into the storage volume 206. Similarly stated, the seals define a storage opening between the storage volume and an external environment. As shown in FIG. 6, the storage opening forms a portion of the container assembly 200 closest to the external environment from where a biological material may be inserted, and is also referred to as a proximal most end portion of the container assembly 200. The opening 207 can be of any suitable size to facilitate loading of the biological material M (also referred to as a tissue graft), as described herein. For example, although the opening 207 is shown as extending across (i.e., in the horizontal direction as shown in FIG. 6) the full length of the first end portion 201 of the flexible container 200, in other embodiments, the opening 207 can extend across only a portion of the length of an end or a side of the flexible container 200.

[0063] When the container assembly 200 is in the first (or opened) configuration, another edge of the first layer 220 is spaced apart from an edge of the third layer 240 to define an opening 217 into the storage volume 216. Similarly stated, the seals define a label opening between the label volume and the external environment. As show n in FIG. 6, the label opening forms a portion of the container assembly 200 farthest from the external environment from where a biological material may be inserted, and is also referred to as a distal most end portion of the container assembly 200. The opening 217 can be of any suitable size to facilitate loading of the label (not shown). For example, although the opening 217 is shown as extending across the full length (i.e., in the horizontal direction as show n in FIG. 6) of the second end portion 202 of the flexible container 200, in other embodiments, the opening 217 can extend across only a portion of the length of an end or a side of the flexible container 200.

[0064] As shown, the set of seals includes a first seal 205 that forms a portion of a boundary of the storage volume 206. The first seal 205 may (but need not) be a peelable seal configured such that the first layer can be peeled away from the second layer to expose the storage volume 206. The set of seals includes a second seal 215 that forms a portion of a boundary of the label volume 216. The first seal 205 is betw een the second seal 215 and the storage opening 207. Said another way, the label volume 216 is at the same end of the container 200 as the egress mechanism, e.g., peelable seal 205 as shown in FIG. 6. In alternative instances where the first seal 205 is a non-peelable seal, the egress mechanism may instead be a port coupled to the first seal 205, as further described in relation to FIGS. 8 and 9 below.

[0065] The first layer 220, the second layer 230 and the third layer 240 can be constructed of any suitable materials as described herein. For example, each of the first layer 220, the second layer 230, and the third layer 240, respectively, can be constructed from a corresponding material to provide a particular stiffness, which may be the same as or different from any of the two other layers. In instances where the first seal 205 is a peelable seal, for example, the first layer 220 can be constructed from a stiffer material than the second layer 230 and/or the third layer 240, to facilitate a user’s ability to peel away the first layer 220 to expose the storage volume 206. [0066] The peelable seal 205 can be configured to have any suitable failure (or peel) mechanism, and can be of any suitable peel strength, as described herein. The peelable seal 205 can be of any suitable geometry to facilitate the desired peel direction, peel strength, as described herein.

[0067] In alternative instances where the first seal 205 is a non-peelable seal, one or more of the first layer 220, the second layer 230, and the third layer 240 can be constructed from the same materials and/or with the same stiffness, to facilitate interchangeability of specific materials used for the different layers.

[0068] The central portion 203 includes a frangible region 226 that facilitates the separation of the label pocket 216 from the remainder of the container. The frangible region 226 can include perforations, thinning of material, stress risers suitable for directional tearing, adhesive attached otherwise detached containers or any other suitable mechanism for separating portions. In some embodiments, at least one of the first layer and the second layer includes a frangible region. In other embodiments, both of the layers include a frangible region. As shown, the frangible region 226 is between the first seal 205 and the second seal 215.

[0069] As shown, a portion of the second layer 230 can be uncoupled from the first layer. Specifically, the first layer 220 includes a first portion 224a of the side edge that is sealed to a first portion of the side edge of the second layer 230 to form a portion of the boundary of the storage volume 206. Similarly, a second portion 224b of the side edge of the first layer is sealed to a side edge of the third layer to 240 form a portion of the boundary of the label volume 216. A third portion 224c of the side edge of the first layer is unsealed from either the second layer 230 or the third layer 240.

[0070] In some embodiments, the first layer or the second layer can include a notch 227 or “thumb hole’⁷ or “finger notch” to facilitate grasping the layer to peel open the seal 205.

[0071] In some embodiments a container can be constructed from two layers, while also including an unsealed (or non-joined) region to facilitate easy removal of the label pocket and subsequent peeling of the egress seal. For example, FIG. 7 is a schematic illustration of a container assembly 300 according to an embodiment. The container assembly 300 (and any of the container assemblies described herein) can be used in connection with any methods of packaging biological materials described herein. [0072] As shown, the container assembly (also referred to as a flexible container) includes a first end portion 301 (also referred to as a proximal most end portion), a second end portion 302 (also referred to as a distal most end portion), and a central portion 303 between the first end portion 301 and the second end portion 302. The flexible container 300 includes a pair of side edges 304 between the first end portion 301 and the second end portion 302. The flexible container 305 is constructed from at least a first layer 320 and a second layer 330 coupled together to define a storage volume 306 and a label pocket 316 (also referred to as a label volume). Specifically, the first layer 320 and the second layer 330 are coupled together via a set of seals to define the storage volume 306. The first layer 320 and the second layer 330 are coupled together via a set of seals to define label volume/pocket 316. The seals can be along the side edges 304 and can be unsealed at the central portion 303.

[0073] As shown, when the container assembly 300 is in the first (or opened) configuration, an edge of the first layer 320 is spaced apart from an edge of the second layer 330 to define an opening 307 into the storage volume 306. Similarly stated, the seals define a storage opening between the storage volume and an external environment. As shown in FIG. 7, the storage opening forms a portion of the container assembly 300 closest to the external environment from where a biological material may be inserted, and is also referred to as a proximal most end portion of the container assembly 300. The opening 307 can be of any suitable size to facilitate loading of the biological material M (also referred to as a tissue graft), as described herein. For example, although the opening 307 is shown as extending across (i.e., in the horizontal direction as shown in FIG. 7) the full length of the first end portion 301 of the flexible container 300, in other embodiments, the opening 307 can extend across only a portion of the length of an end or a side of the flexible container 300.

[0074] When the container assembly 300 is in the first (or opened) configuration, another edge of the first layer 320 is spaced apart from a corresponding edge of the second layer 330 to define an opening 317 into the label volume 316. Similarly stated, the seals define a label opening between the label volume and the external environment. As shown in FIG. 7, the label opening forms a portion of the container assembly 300 farthest from the external environment from where a biological material may be inserted, and is also referred to as a distal most end portion of the container assembly 300. The opening 317 can be of any suitable size to facilitate loading of the label (not shown). For example, although the opening 317 is shown as extending across (i.e., in the horizontal direction as shown in FIG. 7) the full length of the second end portion 302 of the flexible container 300, in other embodiments, the opening 317 can extend across only a portion of the length of an end or a side of the flexible container 300.

[0075] As shown, the set of seals includes a first seal 305 that forms a portion of a boundary of the storage volume 306. The first seal 305 may (but need not) be a peelable seal configured such that the first layer can be peeled away from the second layer to expose the storage volume 306. The set of seals includes a second seal 315 that forms a portion of a boundary of the label volume 316. The first seal 305 is between the second seal 315 and the storage opening 307. Said another way, the label volume 316 is at the same end of the container 300 as the egress mechanism, e.g., peelable seal 305 as shown in FIG. 7. In alternative instances where the first seal 305 is a non-peelable seal, the egress mechanism may instead be a port coupled to the first seal 105, as further described in relation to FIGS. 8 and 9 below.

[0076] The first layer 320, the second layer 330 and the third layer 340 can be constructed of any suitable materials as described herein. For example, each of the first layer 320, the second layer 330, and the third layer 340, respectively, can be constructed from a corresponding material to provide a particular stiffness, which may be the same as or different from any of the two other layers. In instances where the first seal 305 is a peelable seal, for example, the first layer 320 can be constructed from a stiffer material than the second layer 330 and/or the third layer 340, to facilitate a user’s ability to peel away the first layer 320 to expose the storage volume 306.

[0077] The peelable seal 305 can be configured to have any suitable failure (or peel) mechanism, and can be of any suitable peel strength, as described herein. The peelable seal 305 can be of any suitable geometry to facilitate the desired peel direction, peel strength, as described herein.

[0078] In alternative instances where the first seal 305 is a non-peelable seal, one or more of the first layer 320, the second layer 330, and the third layer 340 can be constructed from the same materials and/or with the same stiffness, to facilitate interchangeability of specific materials used for the different layers.

[0079] The central portion 303 includes a frangible region 326 that facilitates the separation of the label pocket 316 from the remainder of the container. The frangible region 326 can include perforations, thinning of material, stress risers suitable for directional tearing, adhesive attached otherwise detached containers or any other suitable mechanism for separating portions. In some embodiments, at least one of the first layer and the second layer includes a frangible region. In other embodiments, both of the layers include a frangible region. As shown, the frangible region 326 is between the first seal 305 and the second seal 315.

[0080] As shown, a portion of the second layer 330 can be uncoupled from the first layer. Specifically, the first layer 320 includes a first portion 324a of the side edge that is sealed to a first portion of the side edge of the second layer 330 to form a portion of the boundary of the storage volume 306. Similarly, a second portion 324b of the side edge of the first layer is sealed to a side edge of the second layer to 330 form a portion of the boundary of the label volume 316. A third portion 324c of the side edge of the first layer is unsealed from the second layer 330.

[0081] Although the egress mechanisms are shown and described as being a peelable seal in other embodiments, a flexible container can include any suitable opening or mechanism for removing the material. For example, in some embodiments, any of the containers described herein can include another frangible region (e g., a cut-line, tear notches, etc.) to facilitate cutting or tearing open the pouch. In other embodiments, any of the containers described herein can include a port. For example, FIG. 8A (container 400) and FIG. 9A (container 500) show examples of containers including a port and a label pocket.

[0082] The port can be coupled to the end portion of the container assembly that includes the label pocket. The port can be used to provide access to the storage volume and the biological materials after the first end portion (e.g., the end portion 101) has been sealed closed. In this manner, a tissue specimen can be treated with a preservation fluid or other material after being sealed into the container assembly. Moreover, during a surgical procedure, the port can allow for inflow of rehydration fluid.

[0083] In addition or as an alternative to being coupled to the end portion of the container assembly that includes the label pocket, the port can also be coupled to any one of the seals (or a portion thereof) that form a boundary’ of the storage volume, such as the first seal 405 as shown in FIG. 8A. In instances where the first seal 405 is a non-peelable seal, the port can be used as a product egress mechanism to allow a biological material (or a portion thereof) stored within the storage volume to be extracted or removed from the container assembly. For example, after the label pocket 416 is separated from the remainder of the container along a frangible region 426 (as shown by the arrow AA in FIG. 8B), the port coupled to the first seal 405 (and thereby coupled to the separated remainder of the container) becomes exposed. This allows the biological material M housed inside the storage volume 406 to be extracted (e.g., fluidically) without requiring any of the seals that form boundaries of the storage volume to be tom apart to expose the storage volume.

[0084] As previously described in relation to FIGS. 1-5, the flexible container 100 has a frangible region 126 that can facilitate the separation of the label pocket 116 from the remainder of the container (as shown by the arrow AA in FIG. 4). For example, the frangible region 126 can include perforations, thinning of material, stress risers suitable to directional tearing, adhesive attached otherwise detached containers or any other suitable mechanism for separating portions of the container. In addition or as an alternative to allowing the label pocket 1 16 to be separated at the frangible region 126, in some embodiments, the container 100 can have sufficient flexibility at or near the frangible region 126 to allows the label pocket 116 to be folded back, along the frangible region 126, into the remainder of the container. One example implementation of this feature is illustrated in connection with FIGS. 3 and 10-12, discussed further below. Allowing the label pocket 116 to be folded back into the remainder of the container (in addition or as an alternative to separability), at or near the frangible region 126, advantageously reduces the cross-sectional area occupied by the flexible container 100 once folded, which facilitates ease of storage and transport.

[0085] As discussed, FIG. 3 shows the flexible container 100 in a loaded and sealed configuration. In embodiments where the frangible region 126 of the container provides for foldability, FIG. 10 shows one example of how the label pocket 116 (housing an inserted label) can be folded upwards, as illustrated by the arrows AA in FIG. 10, such that the label pocket 1 16 is folded back into the remainder of the container. In the example of FIG. 10, the label pocket 116, once folded back, occupies only a portion of the cross-sectional area (dashed box CSA in FIG. 10) already occupied by the remainder of the container. In other examples (not illustrated), the label pocket 116, once folded, may be partially (but not fully) encompassed within the cross-sectional area already occupied by the remainder of the container.

[0086] After the label pocket 116 has been folded back into the remainder of the container as shown in FIG. 10, FIG. 11 illustrates an example of how the flexible container 100 with a folded label pocket 116 can be placed inside of a cryogenic cassette 1200 for storage and/or transport. As shown in FIG. 11, the cryogenic cassette 1200 can be sized to receive (as indicated by arrow AA) the container 100. The cryogenic cassette 1200 can include a body portion 1210 and a cover 1220. At least one of the body portion 1210 or the cover 1220 can define an observation aperture 1230. The cryogenic cassette 1200 can support the (loaded and folded) container 1 0. and the container 100 can further be in fluid contact with an environment surrounded cry ogenic cassette 1200 on a condition that the (loaded and folded) container 100 is positioned within the cryogenic cassette 1200.

[0087] As shown in FIG. 12, the folded label 116 of the container 100, upon positioned inside the cryogenic cassette 1200, is aligned with the observation aperture 1230. Being aligned with the observation aperture 1230 as depicted in FIG. 12, the label 116 can display crucial information about the container 100 without necessitating the removal of the container from the cryogenic cassette 1200, or even the opening of the cryogenic cassette 1200. By facilitating the gathering of information about the stored container 100 without requiring handling of that container, the likelihood of damaging the sample container is advantageously reduced and/or eliminated during storage and/or transport.

[0088] The port can be any suitable port that selectively provides fluid communication to the storage volume. In some embodiments, the port can be a needle-free port. In some embodiments, the port can be a sw abable connector. Similarly stated in some embodiments, the port can have external surfaces and can be devoid of recesses or crevices such that the port can be easily wiped or '‘swabbed” to maintain sterility during use. In some embodiments, the port can be a swabable, needle-free port.

[0089] Although the container 100 is shown and described as having the storage volume and the label pocket being at separate locations along the longitudinal axis of the flexible container, in other embodiments, a container can include a label pocket in any suitable location. Similarly stated, the storage volume and the label pocket can be overlapping when viewed along the longitudinal axis. For example, FIG. 13 is a side cross-sectional view⁷ of a container assembly 600 according to an embodiment.

[0090] As shown, the container assembly (also referred to as a flexible container) includes a first end portion 601 (also referred to as a proximal most end portion) and a second end portion 602 (also referred to as a distal most end portion). The flexible container 600 includes a pair of side edges between the first end portion 601 and the second end portion 602. The flexible container 600 defines a longitudinal axis AL that extends longitudinally from the first end portion 601 and the second end portion 602. The flexible container is constructed from at least a first layer, a second layer, a second layer coupled together to define a storage volume

606 and a label pocket 616 (also referred to as a label volume). Specifically, the first layer and the second layer are coupled together via a set of seals to define the storage volume 606 and the first layer and the third layer are coupled together via a set of seals to define the label volume/pocket 616.

[0091] As shown, when the container assembly 600 is in the first (or opened) configuration, an edge of the first layer is spaced apart from an edge of the second layer to define an opening

607 into the storage volume 606. Similarly stated, the seals define a storage opening between the storage volume and an external environment. As shown in FIG. 13, the storage opening forms a portion of the container assembly 600 closest to the external environment from where a biological material may be inserted, and is also referred to as a proximal most end portion of the container assembly 600. The opening 607 can be of any suitable size to facilitate loading of the biological material M (also referred to as a tissue graft), as described herein. For example, although the opening 607 is shown as extending across the full length of the first end portion 601 of the flexible container 600, in other embodiments, the opening 607 can extend across only a portion of the length of an end or a side of the flexible container 600.

[0092] When the container assembly 600 is in the first (or opened) configuration, another edge of the first layer is spaced apart from a corresponding edge of the third layer to define an opening 617 into the label volume 616. Similarly stated, the seals define a label opening between the label volume and the external environment. As shown in FIG. 13, the label opening forms a portion of the container assembly 600 farthest from the external environment from where a biological material may be inserted, and is also referred to as a distal most end portion of the container assembly 600. The opening 617 can be of any suitable size to facilitate loading of the label 670. For example, although the opening 617 can extend across the full length of the second end portion 602 of the flexible container 600, in other embodiments, the opening 617 can extend across only a portion of the length of an end or a side of the flexible container 600.

[0093] As shown, the set of seals includes a first seal 605 that forms a portion of a boundary of the storage volume 606. The first seal 605 may (but need not) be a peelable seal configured such that the first layer can be peeled away from the second layer to expose the storage volume 606. The peelable seal 605 can be configured to have any suitable failure (or peel) mechanism, and can be of any suitable peel strength, as described herein. The peelable seal 605 can be of any suitable geometry to facilitate the desired peel direction, peel strength, and the like.

[0094] In use, the first end portion 601 can be placed into a vacuum sealing machine without the label pocket 616 obstructing the opening 607. The vacuum sealer’s (or associated processing equipment’s) nozzle can be inserted into the storage opening 607 only. After being evacuated and processed, the opening 607 is sealed closed. While the storage opening 607 is being evacuated and processed, the label opening 617, which is located at the opposite end of the container 600 as the storage opening 607, is maintained outside of the vacuum sealer. Similarly, the label opening 617 is sealed closed. The sealing of the label opening 617 may (but need not) be carried out using the same vacuum sealer (or associated processing equipment) that was previously used to seal the storage opening 607. For example, if the same vacuum sealing machine is used to seal both the storage opening 607 and the label opening 617, the container 600 can be flipped along its longitudinal axis (through either manual or automated means), after the storage opening 607 has been sealed, to place the label opening 617 into the vacuum sealing machine without the storage volume 606 obstructing the opening 617.

[0095] In some embodiments, the label 670 can also serve to support the biological materials. Said another way, the label 670 can function as a tray or support member. Such trays or support members can be similar to those shown and described in U.S. Patent No. 11,065,095 (the ’095 patent), titled “Sample Container with Peelable Seal and Access Port,” which is hereby incorporated by reference in its entirety.

[0096] FIG. 14 is a perspective view of a vacuum sealer 1900 equipped with a nozzle assembly 1920 according to an embodiment. The vacuum sealer 1900 can be any suitable vacuum sealer that evacuates a container (or a particular volume within the container) and seals one or more openings of the container to maintain the contents of the container in a vacuum sealed configuration. The vacuum sealer can be, for example, the Accu-Seal Model 8000 Series sealer, the AVS-20 vacuum sealer produced by AmeriVacs or any other suitable vacuum sealer. The vacuum sealer 1900 includes a housing 1901 that defines an internal volume 1902 within which various components of the vacuum sealer are contained. The vacuum sealer 1900 includes a vacuum source (not shown), a linear actuator 1905, a nozzle assembly 1920, a first sealing bar 1910, and a second sealing bar 1911. As described in more detail below, the vacuum source is coupled to one or more containers via the nozzle assembly 1920 such that during a packaging operation the gaseous contents of the container can be evacuated. The first sealing bar 1910 and the second sealing bar 1911 can be moved together to capture the opposing layers of the container about an opening through which a nozzle 1940 is extended into the container. When the container is sufficiently evacuated the nozzle assembly 1920 is retracted to remove the nozzle 1940 from within the container and the first sealing bar 1910 and the second sealing bar 1911 press against the opposing layers and form a heat seal to hermetically seal the container.

[0097] The nozzle assembly 1920 includes a support member 1925, two nozzle blocks 1930, and two nozzles 1940. The support member 1925 has a first end portion and a second end portion and is removably coupled to the linear actuator 1905. Specifically, the linear actuator can be a piston actuator having an actuator mount 1907 to which the support member 1925 is removably coupled. When the support member 1925 is coupled to the linear actuator 1905, movement of the actuator produces a similar movement of the support member 1925 (and therefore the nozzles 1940). Specifically, when the actuator mount 1907 is moved linearly (such as shown by the arrow⁷ BB in FIG. 16), the support member 1925 is moved in a similar manner.

[0098] The support member 1925 can be removably coupled to the actuator mount 1907 by any suitable mechanism that facilitates convenient and repeatable coupling and decoupling. In some embodiments, the support member 1925 is configured to be coupled to and decoupled from the linear actuator 1905 (and more specifically, from the movable actuator mount 1907 of the linear actuator) by hand. For example, in some embodiments, the support member 1925 includes on or more mounting holes and is coupled to studs (not shown) extending from the actuator mount 1907 by nuts 1929 that are easily installed and removed by hand (e g., knurled nuts with a large diameter, wing nuts, or the like). In some embodiments, the support member 1925 is coupled to the actuator mount 1907 by a lever-actuated cam lock mechanism (not shown). In other embodiments, the support member 1925 is coupled to the actuator mount 1907 by a magnetic coupling that can be easily enabled or disabled to allow convenient and repeatable removal. In this manner, as described herein, the entire nozzle assembly 1920 can be quickly removed from the vacuum sealer 1900 for sterilization.

[0099] .Each nozzle block 1930 is coupled to the support member 1925 and provides a fluidic connection between the vacuum source (not shown) and the nozzle 1940. In some embodiments, the nozzle block 1930 includes a vacuum supply fitting and a nozzle fitting. In some embodiments, the nozzle blocks 1930 can be adjustably mounted to the support member 1925. In this manner, the position of each nozzle 1940 relative to the other nozzle(s) 1940 can be adjusted to accommodate containers having different sizes (e.g., widths). For example, in some embodiments, the nozzle block 1930 is configured to be moved relative to the support member 1925 along a longitudinal axis of the support member 1925 to allow mounting in a number of different positions.

[0100] Each nozzle 1940 has a first end portion and second end portion. The first end portion is coupled to the nozzle block 1930 and the second end portion is configured to be placed within or adjacent to an opening into a container to evacuate the gaseous contents of the container. Referring to FIG. 15, the second end portion of the nozzle 1940 is positioned between a first sealing bar 1910 and a second sealing bar 1911 on condition that the linear actuator 1905 is in an advanced position. When the linear actuator 1905 is in the advanced position, the second end of the nozzle 1940 is placed through a particular opening 1107 of a flexible container 1100.

[0101] FIG. 17 shows a flow chart diagram 10 illustrating a method for loading a flexible container 1100 with a biological material M and label L. The container 1100 can be any of the containers described herein.

[0102] At operation 12, the flexible container 1100 is first loaded with the biological material M. Specifically, the biological material M is inserted, through the storage opening 1107, into the storage volume 1106 of the container 1100. As previously described, the storage opening 1107 is located at one end of the container 1 100 that is opposite the label opening 1117 located at another end of the container 1100.

[0103] In operation 14, the storage volume 1106 is hermetically sealed. To seal the storage opening 1107, in one embodiment, the loaded container 1 100 is placed with the opening 1107 between the first sealing bar 1910 and the second sealing bar 1911 of the vacuum sealer 1900 (as shown in FIG. 15). The vacuum sealer 1900 can be one part of a larger container processing equipment that includes additional components (such as a label printer). While the storage opening 1107 is placed between the first sealing bar 1910 and the second sealing bar 1911. the label opening 11 17, which is located at the opposite end of the container 1100 as the storage opening 1107, is maintained outside of the vacuum sealer 1900. When the linear actuator 1905 of the vacuum sealer 1900 is in the advanced position, the second end of the nozzle 1940 is within the opening 1107. The vacuum is applied to the nozzle 1940 to evacuate a portion of the contents from the storage volume 1106 of the container 1100, and the sealing bars are moved together to create a temporary seal by pressing on the container on to the nozzle such that the vacuum is pulled efficiently from within the container, as shown by the arrows AA in FIG. 16. The sealing bars are moved together along a first axis. Upon completion of the vacuum operation, the linear actuator 1905 is moved from the advanced position to the retracted position, as shown by the arrow BB in FIG. 16. Thus, the linear actuator 1905 and the nozzle assembly 1920 are moved along a second axis, normal to the first axis. This causes the second end portion of the nozzle 1940 to be removed from the storage opening 1107. The sealing bars can then produce a heat seal to close the opening 1107.

[0001] In operation 16, the flexible container 1100 is loaded with the label L. Specifically, the label L is inserted, through the label opening 1117, into the label volume 1116 of the container 1100. This may be done either manually, or automatically using a container processing equipment equipped with a label printer and insertion device (in addition being equipped with the vacuum sealer 1900).

[0104] In operation 18, the label volume 1116 is sealed. The sealing of the label opening 1117 may (but need not) be carried out using the same vacuum sealer 1900 that was previously used to seal the storage opening 1107. For example, if the same vacuum sealing machine is used to seal both the storage opening 1107 and the label opening 1117, the container 1100 can be flipped along its longitudinal axis (through either manual or automated means), after the storage opening 1107 has been sealed, to place the label opening 1117 into between the first sealing bar 1910 and the second sealing bar 1911 of the vacuum sealer 1900. When the linear actuator 1905 of the vacuum sealer 1900 is in the advanced position, the second end of the nozzle 1940 is within the opening 1117. The vacuum is applied to the nozzle 1940 to evacuate a portion of the contents from the label volume 1116 of the container 1100, and the sealing bars are moved together to create a temporary seal by pressing on the container on to the nozzle such that the vacuum is pulled efficiently from within the container. The sealing bars are moved together along a first axis. Upon completion of the vacuum operation, the linear actuator 1905 is moved from the advanced position to the retracted position. Thus, the linear actuator 1905 and the nozzle assembly 1920 are moved along a second axis, normal to the first axis. This causes the second end portion of the nozzle 1940 to be removed from the label opening 1117. The sealing bars can then produce a heat seal to close the opening 1117. [0105] FIG. 18 shows a flow chart diagram 20 illustrating a method for removing a biological material M from a flexible container 1100 that also stores a label L. The container 1 100 can be any of the containers described herein that includes a peelable seal for forming a boundary of the storage volume.

[0106] In operation 22, the flexible container 1100, loaded with a biological material M and a label L is received. The biological matenal M is housed within the storage volume 1106 of the container 1100. The label L is housed within the label volume 1116 of the container 1100.

[0107] In operation 24, the label volume 1116 containing the label L is tom or separated from the rest of the container 1100 (which includes the storage volume 1106 containing the biological material M). For example, as previously described, the container 1100 may include a frangible region that facilitates the separation of the label volume 1116 from the remainder of the container.

[0108] In operation 26, the remainder of the container 1100, which now does not include the label volume 1116 that was tom off in operation 24, is accessed to expose the peelable first seal 1115 that forms a boundary of the storage volume 1106. In some embodiments, this involves accessing a portion of the one or more layers of the container 1100 near the frangible region (where the label volume 1116 was previously tom off) so that the peelable first seal 1115 can be accessed for peeling.

[0109] In operation 28, the peelable first seal 1 115 (now exposed) is peeled to create an opening through which the storage volume 1106 may be accessed. In some embodiments, an opening can be created at the location of the peelable first seal 1115 by peeling one or more layers of the container 1100 away from the other layers.

[0110] In operation 30, the biological material M is retrieved or extracted from the storage volume 1106.

[0111] FIG. 19 shows a flow chart diagram 40 illustrating a method for removing a biological material M from a flexible container 1100 that also stores a label L. The container 1100 can be any of the containers described herein that includes a port as an egress mechanism (as an alternative or in addition to a peelable seal for forming a boundary of the storage volume). [0112] In operation 42, the flexible container 1100, loaded with a biological material M and a label L is received. The biological material M is housed within the storage volume 1106 of the container 1100. The label L is housed within the label volume 1116 of the container 1100.

[0113] In operation 44, the label volume 1116 containing the label L is tom or separated from the rest of the container 1100 (which includes the storage volume 1 106 containing the biological material M as well as the port forming an egress mechanism). For example, as previously described, the container 1100 may include a frangible region that facilitates the separation of the label volume 1116 from the remainder of the container.

[0114] In operation 46, the remainder of the container 1100, which now does not include the label volume 1116 that was tom off in operation 44, is accessed to expose the port coupled to the storage volume 1106. In some embodiments, this involves accessing a portion of the one or more layers of the container 1100 near the frangible region (where the label volume 1 116 was previously tom off) so that the port can be accessed for egress of the biological material.

[0115] In operation 48, the biological material M is retrieved or extracted from the storage volume 1 106, through the port.

[0116] While various embodiments have been described above, it should be understood that they have been presented by way of example only, and not limitation. Where methods and/or schematics described above indicate certain events and/or flow patterns occurring in certain order, the ordering of certain events and/or operations may be modified. While the embodiments have been particularly shown and described, it will be understood that various changes in form and details may be made.

[0117] Although various embodiments have been described as having particular features and/or combinations of components, other embodiments are possible having a combination of any features and/or components from any of embodiments as discussed above. Aspects have been described in the general context of medical devices, and more specifically tissue packaging devices, but inventive aspects are not necessarily limited to use in medical devices and tissue packaging.

Claims

What is claimed is:

1 . A flexible container for storing a biological material, comprising: a first layer; and a second layer coupled to the first layer via a plurality of seals to define a storage volume and a label volume, the plurality of seals defining a storage opening between the storage volume and an external environment, the plurality of seals defining a label opening between the label volume and the external environment, a first seal from the plurality of seals forming a portion of a boundary' of the storage volume, the first seal being a peelable seal configured such that the first layer can be peeled away from the second layer to expose the storage volume, a second seal from the plurality of seals forming a portion of a boundary of the label volume, the first seal being between the second seal and the storage opening.

2. The flexible container of claim 1, wherein the second seal and the first seal are both between the storage opening and the label opening.

3. The flexible container of claim 1, wherein the storage opening forms a first end portion of the flexible container.

4. The flexible container of claim 1 , wherein the storage opening forms a proximal most end portion of the flexible container.

5. The flexible container of any of claims 1-4, wherein: the first layer includes a side edge parallel to a longitudinal axis of the flexible container; the second layer includes a side edge parallel to a longitudinal axis of the flexible container; a first portion of the side edge of the first layer is sealed to a first portion of the side edge of the second layer to form a portion of the boundary of the storage volume; a second portion of the side edge of the first layer is sealed to a second portion of the side edge of the second layer to form a portion of the boundary of the label volume; and a third portion of the side edge of the first layer is unsealed from a third portion of the side edge of the second layer.

6. The flexible container of claim 5, wherein: the third portion of the of the side edge of the first layer and the third portion of the side edge of the second layer are between the first seal of the plurality' of seals and the second seal of the plurality of seals.

7. The flexible container of claim 6, wherein at least one of the first layer and the second layer includes a frangible region between the first seal of the plurality of seals and the second seal of the plurality of seals.

8. The flexible container of claim 6, wherein: the first layer includes a first frangible region between the first seal of the plurality of seals and the second seal of the plurality⁷ of seals; and the second layer includes a second frangible region between the first seal of the plurality of seals and the second seal of the plurality of seals.

9. The flexible container of claim 8, wherein the first frangible region is offset from the second frangible region.

10. The flexible container of claim 6, wherein at least one of the first layer or the second layer includes a notch.

11. The flexible container of claim 3, wherein the first end portion is located at one end of the flexible container that is most proximal to an external processing equipment for sealing the storage opening upon insertion of the biological material into the storage volume.

12. The flexible container of claim 1, wherein the storage opening forms a first end portion of the flexible container and the label opening forms a second end portion of the flexible container, the first end portion and the second end portion located opposite each other on the flexible container.

13. The flexible container of claim 1, wherein: the storage opening is configured for insertion of a tissue specimen, from the external environment, into the flexible container; the first seal forms a part of an egress mechanism associated with the flexible container; and the egress mechanism does not include and does not form a part of the storage opening configured for insertion of the tissue specimen.

14. The flexible container of claim 1, wherein: the storage opening is configured for insertion of a tissue specimen, from the external environment, into the flexible container; and the first seal forms a part of an egress mechanism associated with the flexible container, the egress mechanism being spaced apart from the storage opening.

15. The flexible container of claim 1, wherein: the storage opening is configured for insertion of a tissue specimen, from the external environment, into the flexible container and the label opening is configured for insertion of a label, from the external environment, into the flexible container; and the label opening is located at a different end of the flexible container as the storage opening.

16. The flexible container of claim 15, wherein the label opening and the storage opening are located on opposite ends of a longitudinal axis of the flexible container.

17. The flexible container of claim 1, wherein the storage volume and the label volume are defined to overlap with each other along a longitudinal axis of the flexible container.

18. The flexible container of claim 1, wherein the storage volume and the label volume are defined to not overlap with each other along a longitudinal axis of the flexible container.

19. The flexible container of claim 1, wherein the second seal and the first seal are both between the storage opening and the label opening, and the second seal and the first seal are both included at a same end of the flexible container that is opposite another end of the flexible container for forming the storage opening.

20. The flexible container of claim 1, wherein the storage opening forms a first end portion of the flexible container, the first end portion configured for placement into an external processing equipment without the label volume obstructing the storage opening.

21. The flexible container of claim 1, further comprising a port.

22. The flexible container of claim 21. wherein the port is coupled to an end portion of the flexible container that includes the label volume.

23. The flexible container of claim 21, wherein the port forms a part of an egress mechanism associated with the flexible container.

24. The flexible container of claim 21, wherein the port is configured to provide access from the external environment to both the storage volume and the stored biological material when a first end portion of the flexible container that forms the storage opening is in a sealed state.

25. The flexible container of claim 21, wherein the port includes a needle-free port.

26. The flexible container of claim 21. wherein the port includes a swabable connector.

27. A method, comprising: inserting a tissue specimen into a storage volume of a flexible container, the storage volume defined between a first layer of the flexible container and a second layer of the flexible container, the tissue specimen inserted via a first opening defined at a first end of the flexible container opposite a second opening located at a second end of the flexible container; hermetically sealing the storage volume, via a processing equipment, by placing the first end of the flexible container that includes the first opening into a vacuum sealer associated with the processing equipment while maintaining the second end of the flexible container outside of the vacuum sealer; inserting a label into a label volume defined between the first layer of the flexible container and the second layer of the flexible container, the label inserted via the second opening defined between the label volume and the external environment; and sealing the label volume, wherein the hermetically sealed storage volume is defined by a set of seals including at least a first seal that forms a portion of a boundary’ of the storage volume, and wherein the sealed label volume is defined a set of seals including at least a second seal that forms a portion of a boundary' of the label volume, the second seal being betw een the first seal and the second opening through which the label was inserted.

28. The method of claim 27, wherein the first seal is a peelable seal configured to allow the first layer of the flexible container to be peeled away from the second layer of the flexible container, after the storage volume has been hermetically sealed, to expose the storage volume.

29. The method of claim 27, wherein a portion of the first seal is coupled to a port that forms a part of an egress mechanism associated with the flexible container, the egress mechanism configured to allow the inserted tissue specimen to be removed from the hermetically sealed storage volume.

30. The method of claim 29. wherein the port is further coupled to the second end of the flexible container.

31. The method of claim 27, wherein placing the first end of the flexible container that includes the first opening into a vacuum sealer comprises positioning at least a portion of the flexible container between a first bar of the vacuum sealer and a second bar of the vacuum sealer.

32. The method of claim 27, further comprising: positioning the tissue specimen within the storage volume between the first layer and the second layer.

33. A method, comprising: receiving a flexible container containing a biological material and a label, the flexible container including a first layer and a second layer, the second layer coupled to the first layer via a plurality' of seals that define both a storage volume and a label volume w ithin the flexible container, the biological material being within the storage volume, the storage volume being defined by at least a first peelable seal from the plurality of seals, the label being within the label volume, the label volume being defined by at least a second seal from the plurality' of seals, the first peelable seal being between the second seal and an end portion of the flexible container; separating the label volume from a remainder of the flexible container that includes the storage volume; accessing at least a portion of the first layer or a portion of the second layer from the remainder of the flexible container that includes the storage volume to expose the first peelable seal; peeling, at the exposed first peelable seal, the first layer away from the second layer or the second layer away from the first layer to expose the storage volume by creating an opening; and retrieving, via the opening, the biological material from the storage volume.

34. The method of claim 33, wherein the storage volume and the label volume are defined to not overlap with each other along a longitudinal axis of the flexible container.

35. A method, comprising: receiving a flexible container containing a biological material and a label, the flexible container including a first layer and a second layer, the second layer coupled to the first layer via a plurality of seals that define both a storage volume and a label volume within the flexible container, the biological material being within the storage volume, the storage volume being defined by at least a first seal from the plurality of seals, the label being within the label volume, the label volume being defined by at least a second seal from the plurality of seals, the first seal being between the second seal and an end portion of the flexible container, a portion of the first seal being coupled to a port housed within the flexible container; separating the label volume from a remainder of the flexible container that includes at least the storage volume and the port; retrieving, via the port, the biological material from the storage volume.

36. The method of claim 35, wherein: the port housed within the received flexible container is spaced apart from the second seal; and separating the label volume from the remainder of the flexible container exposes an egress mechanism associated with the port, the egress mechanism allowing the biological material to be removed from the storage volume.