Systems and methods for preparing multi-chamber container for biological materials

Abstract

Systems and methods are provided for positioning, filling, and sealing a multi-chamber container assembly with biological materials. The container assembly is positioned via a positioning apparatus. The positioning apparatus includes a first support plate coupled to a second support plate via a central member. The central member defines a separation angle between the first support plate and the second support plate. The container assembly is secured by a first securing member of the first support plate and a second securing member of the second support plate. The positioning apparatus arranges fill opening of the container assembly in a position to receive the biological material.

Description

SYSTEMS AND METHODS FOR PREPARING MULTI-CHAMBER CONTAINER FOR BIOLOGICAL MATERIALSCross-Reference to Related Applications

[0001] This application claims priority to and the filing date benefit of U.S. Provisional Patent Application No. 63 / 528,763, entitled “Systems and Methods for Preparing Multi-Chamber Container for Biological Materials,” filed July 25, 2023, the disclosure of which is incorporated herein by reference in its entirety.Background

[0002] The embodiments described herein relate to containers for storing, packaging and transporting tissue and other biological material. More particularly, the embodiments described herein relate to devices and methods for filling and sealing containers having separate but interconnected storage volumes.

[0003] Known 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., a xenograft). 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 preparing or rehydrating a tissue implant include removing the tissue implant from the sterile package and placing the tissue graft in an opened container (e.g., a basin) that contains rehydration liquid. The tissue implant is then manipulated within the open container to facilitate rehydration. Such manipulation can include, for example, manually submerging the tissue implant within the rehydration fluid (in an effort to achieve consistent rehydration), agitating the tissue implant and / or rehydration fluid, and the like. After rehydration, the tissue implant is then removed from the rehydration container for use. This procedure can result in compromised sterility (e.g., due to the repeated transfer of the tissue graft), inconsistentrehydration due to inconsistent exposure of the tissue implant in the open container, and longer rehydration times. Moreover, the packaging in the related art include only a single chamber container for storing tissue and / or biological material. Thus, when less than an entire portion of the tissue and / or biological material is needed for a particular procedure, the remaining portion is wasted and discarded since sterility is compromised after the opening of the single chamber container. Additionally, because of the repeated movement of the tissue implant (e.g., during transfer and while in the rehydration container) possible damage to the tissue implant can occur.

[0005] Yet other known procedures include rehydrating the tissue implant within a single product or volume sterile flexible pouch. Such systems and methods often provide inadequate resources and flexibility of resource options during procedures slowing down the procedures and causing waste. The loading of single packages and storing multiple single packages of biological material is also cumbersome wasting time and space.

[0006] Some known procedures for increasing the flexibility of resource options and reducing the potential wasting of unused resources utilize a container assembly that has separate storage volumes. Filling and sealing of known containers having separate storage volumes can be inefficient or impractical for use with biological materials. For example, known multi-chamber containers, such as sachets, are typically either formed about the contained product (e.g., the product is positioned and then the surrounding seals are formed) or are filled in a serial manner. With the typical serial approach, the openings of each sachet to be filled during a specific fill operation (e.g., a row of empty sachets) are oriented in the same direction (e.g., upward facing due to the sachets being suspended). Then the product is placed in the sachet, and the opening is sealed. After the sachets are sealed, the next sachets in line are advanced into position and the process is repeated. However, for container assemblies with separate storage volumes having different fill opening configurations, introducing the tissue specimen and / or biologic material in this manner can be challenging. Thus, a need exists for new and improved systems and methods for filling and sealing containers having separate but interconnected storage volumes.Summary

[0007] In some embodiments, the present disclosure is directed to a positioning apparatus for filling a container assembly. The positioning apparatus includes a first support plate that has a first securing member configured to secure a first portion of the container assembly. The positioning apparatus includes a second support plate that has a second securing member configured to secure a second portion of the container assembly. The positioning apparatus also includes a central member coupled between the first support plate and the second support plate. The first support plate and the second support plate are positioned relative to the central portion to define a separation angle. On a condition that the first portion is secured by the first securing member, a first fill opening of the first portion is positioned between the central member and the first securing member. On a condition that the second portion is secured by the second securing member. A second fill opening of the second portion is positioned between the central member and the second securing member. Additionally, the central member is between the first fill opening and the second fill opening.

[0008] In some embodiments, the separation angle is greater than or equal to ten degrees and less than or equal to 180 degrees.

[0009] In some embodiments, the separation angle is a first separation angle. At least one of the first support plate and the second support plate is movable about the central member between a first configuration and a second configuration. On a condition that the first support plate or the second support plate is in the first configuration, the first support plate and the second support plate define the first separation angle. On a condition that the first support plate or the second support plate is in the second configuration, the first support plate and the second support plate define a second separation angle. The second separation angle is greater than the first separation angle.

[0010] In some embodiments, the central member includes at least one of a hinge, a deformable hinge, a linkage, or a rolling joint.

[0011] In some embodiments, the positioning apparatus includes a support frame that defines a set of guide channels. The set of guide channels retains a first guide protrusion of the first supportplate, a second guide protrusion of the second support plate, and a central guide protrusion of the central member. The set of guide channels positions the central guide protrusion at a fdl position and at least one of the first guide protrusion or the second guide protrusion at a first lateral position on a condition that the first support plate or the second support plate is in the first configuration. The set of guide channels positions the central guide protrusion at a load position and at least one of the first guide protrusion or the second guide protrusion at a second lateral position on a condition that the first support plate or the second support plate is in the second configuration.

[0012] In some embodiments, the set of guide channels includes a lateral guide channel and a folding guide channel. The folding guide channel intersects the lateral guide channel and defines the fill position and the load position of the central guide protrusion. The fill position is above the lateral guide channel.

[0013] In some embodiments, the positioning apparatus includes a support frame. The support frame defines a support recess. The support recess retains a central guide protrusion of the central member. The first support plate and the second support plate are suspended from the central member. Additionally, the first support plate and the second support plate are pivotable relative to the support frame.

[0014] In some embodiments, the central guide protrusion includes a set of indexing features positioned to engage the support recess. The set of indexing features is positioned to establish the first support plate in a first pivot orientation about a pivot axis defined by the central member. The set of indexing features is also positioned to establish the first support plate in a second pivot orientation about the pivot axis. The first pivot orientation is different from the second pivot orientation. The separation angle between the first support plate and the second support plate is maintained at a fixed magnitude on a condition that the central guide protrusion is retained by the support recess. The second support plate is in a third pivot orientation on a condition that the first support plate is in the first pivot orientation, and the second support plate is in a fourth pivot orientation on a condition that the first support plate is in the second pivot orientation.

[0015] In some embodiments, the first pivot orientation has a slope that is greater than 90 degrees.

[0016] In some embodiments, the container assembly includes a set of ports. The first securing member receives a first port of the set of ports, and the second securing member receives a second port of the set of ports.

[0017] In some embodiments, the container assembly includes a first layer coupled to a second layer via a set of seals to define at least a first storage volume and a second storage volume. A first portion of the first layer or the second layer defines a first fill opening into the first storage volume and a second portion of the first layer or the second layer defines a second fill opening into the second storage volume. The first storage volume includes a first opening portion. The second storage volume includes a second opening portion. A hinge portion is positioned between the first storage volume and the second storage volume. The hinge portion defines a midline of the container assembly. The first fill opening is positioned between the midline and the first opening portion. The second fill opening is positioned between the midline and the second opening portion. The first fill opening is separated from the second fill opening by the hinge portion. On a condition that the first portion of the container assembly is secured by the first securing member, the hinge portion is aligned with the central member.

[0018] In some embodiments, the first storage volume is one of a set of first storage volumes arranged side-by-side along the midline, and the first opening portion is one of a set of first ports. Each first port of the set of first ports is in fluid communication with a corresponding first storage volume of the set of first storage volumes. The first securing member receives the set of first ports. The second storage volume is one of a set of second storage volumes arranged side-by-side along the midline, and the set of second storage volumes is separated from the set of first storage volumes by the hinge portion. The second opening portion is one of a set of second ports. Each second port of the set of second ports is in fluid communication with a corresponding second storage volume of the set of second storage volumes, and the second securing member receives the set of second ports.

[0019] In some embodiments, the first securing member is a clamp, and the clamp is positioned to fix a position of the first portion of the container assembly relative to the first support plate.

[0020] In some embodiments, the first support plate defines at least a first fixing feature. The first fixing feature is sized to receive the first securing member, and the first fixing feature establishes the position of the first securing feature relative to the first support plate.

[0021] In some embodiments, the first support plate includes at least one indicium that is visible on a condition that the first portion of the container assembly is secured by the first securing member.

[0022] In some embodiments, the first securing member is fixed relative to the first support plate; and the second securing member is movable relative to the second support plate.

[0023] In some embodiments, the first support plate includes a first support face in contact with the first portion of the container assembly on a condition that the first portion of the container assembly is secured by the first securing member. The second support plate includes a second support face in contact with the second portion of the container assembly on a condition that the second portion of the container assembly is secured by the second securing member. The first support face and the second support face include an adhesive layer positioned to contact the container assembly. The adhesive layer is configured to removably couple the container assembly to the first support face and the second support face.

[0024] In some embodiments, the positioning apparatus includes a transitioning structure that has a first face separated from a second face by a midline ridge. The midline ridge extends between an inboard end portion and an outboard end portion. The transitioning structure is configured to transition the container assembly from a flat configuration to a folded configuration in conjunction with a movement along the midline ridge from the outboard end portion toward the inboard end portion. The inboard end portion of the transitioning structure is positioned in contact with the first support plate, the second support plate, and the central member. A first angle between the first face and the second face at the inboard end portion is equal to the separation angle defined by the central member. A second angle between the first face and the second face at the outboard end portion is greater than the first angle. The midline ridge has a first vertical height at the inboard end portion that is greater than a second vertical height at the outboard end portion.

[0025] In some embodiments, the present disclosure is directed to a method for filling a container assembly using a positioning apparatus. The container assembly has a set of separate storage volumes and a set of separate openings. The positioning apparatus includes a first support plate coupled to a second support plate via a central member. The method includes arranging the first support plate and the second support plate in a load configuration that is substantially planar and configured to receive the container assembly in a flat configuration. The method also includes placing a first portion of the container assembly into a first securing member of the positioning apparatus. The method further includes placing a second portion of the container assembly into a second securing member of the positioning apparatus. The positioning apparatus is transitioned to a fill configuration in which the first support plate and the second support plate define a separation angle that is less than 180 degrees to support the container assembly in a folded configuration. At least one opening of the set of separate openings is positioned to receive a biomaterial on a condition that the container assembly is in the folded configuration. Additionally, the method includes positioning a fill nozzle relative to the positioning apparatus so that the fill nozzle is aligned with at least one opening of the set of separate openings. The method includes conveying the biomaterial from the fill nozzle into the at least one opening of the set of separate openings. The method further includes sealing the at least one opening of the set of separate openings after the conveying the biomaterial.

[0026] In some embodiments, placing the second portion of the container assembly into the second securing member includes maintaining the container assembly in the flat configuration with the first portion of the container assembly secured by the first securing member, and moving the second securing member relative to the second support plate.

[0027] In some embodiments, transitioning the positioning apparatus to the fill configuration establishes the separation angle between the first support plate and the second support plate at less than 110 degrees and more than 70 degrees.

[0028] In some embodiments, transitioning the positioning apparatus to the fill configuration establishes the separation angle between the first support plate and the second support plate at 10 degrees or less.

[0029] In some embodiments, the method includes observing an indicium of the first support plate, and halting the conveyance of the biomaterial when the volume of the biomaterial contained within a storage volume of the set of storage volumes corresponds to the volume indicium.

[0030] In some embodiments, following the conveyance of the biomaterial into a storage volume of the set of storage volumes, the method includes clamping a portion of the container assembly between the conveyed biomaterial and the at least one opening of the set of separate openings.

[0031] In some embodiments, sealing the at least one opening of the set of separate openings includes applying a heat seal.Brief Description of the Drawings

[0032] FIG. l is a schematic illustrations of a multi-chamber container assembly, in an initial configuration, according to an embodiment.

[0033] FIG. 2 is a schematic illustration of the multi-chamber container assembly of FIG. 1, in a sealed configuration.

[0034] FIG. 3 is a schematic illustration of the multi-chamber container assembly of FIG. 3, in a partially separated configuration.

[0035] FIG. 4 is a schematic illustration of a side view of a positioning apparatus, in a fill configuration, according to an embodiment.

[0036] FIG. 5 is a schematic illustration of a side view of the positioning apparatus of FIG. 4 in a load configuration.

[0037] FIG. 6 is a schematic illustration of the side view of the positioning apparatus of FIG. 4 during the loading of a container assembly according to an embodiment.

[0038] FIG. 7 is a schematic illustration of the side view of the positioning apparatus of FIG. 4 during the loading of a container assembly according to an embodiment.

[0039] FIG. 8 is a schematic illustration of a front view of a first support plate of the positioning apparatus of FIG. 4 according to an embodiment.

[0040] FIG. 9 is a schematic illustration of the first support plate of FIG. 8 depicting the container assembly secured by the positioning apparatus of FIG. 4 according to an embodiment.

[0041] FIG. 10 is a schematic illustration of the first support plate and the container assembly of FIG. 9 depicting the container assembly during a fill operation according to an embodiment.

[0042] FIG. 11 is a schematic illustration of the first support plate and the container assembly of FIG. 9 depicting the container assembly during a sealing operation according to an embodiment.

[0043] FIG. 12 is a schematic illustration of a side view of a positioning apparatus, in a fill configuration, according to an embodiment.

[0044] FIG. 13 is a schematic illustration of a side view of the positioning apparatus of FIG. 12 in a load configuration.

[0045] FIG. 14 is a schematic illustration of a side view of a positioning apparatus depicting a first support plate in a first pivot orientation according to an embodiment.

[0046] FIG. 15 is a schematic illustration of a side view of the positioning apparatus of FIG. 14 depicting the first support plate in a second pivot orientation.

[0047] FIG. 16 is a schematic illustration of a side view of a positioning apparatus with a transitioning structure according to an embodiment.

[0048] FIG. 17 is a schematic illustration of a top view of the positioning apparatus with the transitioning structure of FIG. 16.

[0049] FIG. 18 is a flow diagram of a method for filling a container assembly according to an embodiment.Detailed Description

[0050] Generally, the present disclosure is directed to systems and methods for preparing a multi-chamber container for biological materials. More specifically, the systems and methods described herein can be used to position the fill openings of a multi-chamber container in a desired orientation to receive a biological material.

[0051] The embodiments disclosed herein relate to preparation, filling, and / or sealing of multichamber containers having fill openings of different orientations (e.g., some of the fill openings face in one direction while other fill openings face in a different direction). For example, as described below, in some container assemblies the fill openings are positioned to oppose (e.g., face) one another on either side of a midline of the container assembly when the container assembly is flat. In some containers, the fill openings are positioned to face away from one another along the outer edges of the container assembly. In either configuration, to orient the fill openings to receive the biological material, the container assembly is placed in a folded configuration (e.g., the outer edges of the container are brought closer to one another to some degree). The flexible nature of the container assembly makes it desirable to utilize a positioning apparatus as described herein to achieve the desired positioning of the container assembly. By securing the container assembly to the positioning apparatus, the fill openings of each individual storage volume of the container assembly can be oriented to receive the biological material. Once the biological material is placed in the desired individual storage volumes, the storage volumes can then be sealed prior to removal from the positioning apparatus.

[0052] As used herein, the term “biological (or biologic) material” refers to any material that is produced or derived from a living (or recently living) organism. Biological materials can include, for example, tissue specimens, tissue grafts, cells, blood, or other bodily fluids. Biological materials can also include plants, plant products, micoorganisms, genetically modified organisms (including cells and cell lines). Biological materials can also include DNA or RNA (including plasmids, oligonucleotides, cDNA) or viral vectors. Biological materials can also include material that is produced by a living (or recently living) organism, such as small or large molecule pharmaceuticals.

[0053] Other examples of biological materials include (but are not limited to) human and animal cells or cellular materials, plant materials (tissue and cellular materials), organs, organoids, biologically sourced materials (e.g., printed tissues, cells, organs, or organoids), bacteria, viruses, viral vectors, fungi, medical devices, combination devices, material for homologous or non- homologous use, and / or materials for autologous or allogenic use. In some embodiments, a biological material can include cellular material, including but is not limited to, lineage committed and non-lineage committed cells (e.g., bone lineage committed cells, osteoblasts, osteocytes, etc.), differentiated cells or non-differentiated cells (e.g., muscle cells, endothelial cells, etc.), and / or genetically modified or non-genetically modified materials. Further examples of the human or animal cellular materials include, but is not limited to, B-cells, blood cells and blood derived cells, bone cells, CAR-T cells, egg cells, engineered T-Cells, fat cells, muscle, cells, natural killer cells, nerve cells, sperm cells, stem cells (modified and un-modified, differentiated and nondifferentiated), T-cells, tumor infiltrating lymphocytes (TIL), viral vectors, viruses and bacteria. The human or animal cellular material can be modified or non-modified (such as genetically modified). Examples of the plant materials include, but is not limited to, cellulose, hemicellulose, pectin, fruit, fungi, leaves, mitochondria, plant organelles, pollen, roots, seeds, shoots, and / or stems.

[0054] 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 therapeutic procedures (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., corneal 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 nontissue components. As another example, a tissue specimen or tissue graft can include bone chips including cortical bone chips, cancellous bone chips, and corti cocancel lous bone chips, and / or bone chips with viable bone lineage committed cells. Further examples of human and animal tissues include, but is not limited to, birth tissues (e.g., amnion, cord, cord blood, chorion, placenta,etc.), bones and / or products made from bones (e.g., machined allografts, ground particles, etc.), bone sources (e.g., tibia, fibula, humerus, cranial flaps, radius, ulna, pelvic bones, and joints, etc.), brain tissue, cartilages (from all sources in bodies generally from knee joints, shoulders, etc.), fascia lata, heart valves, arteries, veins, nerves, organs (e.g., lungs, hearts, liver, kidneys, etc.), reproduction tissue (e.g., semen and eggs), ribs, soft tissues (e.g., all tendons, Achilles, patellar, etc.), skin, and / or tumors.

[0055] As used herein, the term “about” when used in connection with a referenced numeric indication means the referenced numeric indication plus or minus up to 10 percent 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.

[0056] 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. 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.

[0057] 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.

[0058] 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.

[0059] FIGS. 1-3 are schematic illustrations of a multi-chamber container assembly 1001 (also referred to herein as container assembly) that can be filled using a positioning apparatus (e.g., positioning apparatus 2700, 3700, 4700, and / or 5700) or any of the methods as described herein. The container assembly 1001 is shown in an initial configuration (FIG. 1), a sealed configuration (FIG. 2), and a separating configuration (FIG. 3). The container assembly 1001 (and any of the container assemblies described herein) can be used to store any of the tissue and biological materials described herein. Additionally, the container assembly 1001 can be filled or otherwise prepared via any of the positioning apparatuses and / or methods described herein. As described herein, the container assembly 1001 provides a container that can be used for storage, transport, processing, and / or rehydration of a tissue specimen and / or biologic materials.

[0060] In some embodiments, the container assembly 1001 includes a first layer 1100, a second layer 1200 and one or more seals 1300 connecting the first layer 1100 and the second layer 1200. The one or more seals 1300 form side edges and a center seam (e.g., a fold or hinge portion 1004) of, multiple separable flexible containers 1050 (e.g., a first separable container 1051 , a second separable container 1052, a third separable container 1053, a fourth separable container 1054, a fifth separable container 1055, and / or a sixth separable container 1056).

[0061] Each of the multiple separable flexible containers 1050 includes a first end portion 1010, a second end portion 1020, and a pair of side edges 1030 between the first end portion 1010 and the second end portion 1020 (the portions are identified for the separable container 1056 in FIG. 1). Each separable flexible container 1050 defines a third axis ALO (e.g., a longitudinal axis) that extends longitudinally from the first end portion 1010 and the second end portion 1020. Each separable flexible container 1050 is constructed from the first layer 1100 and the second layer 1200 coupled together to define a storage volume (e.g., first storage volume 1061 and second storage volume 1062).

[0062] As shown in FIG. 1, when the container assembly 1001 is in the initial configuration, one or more edges (e.g., edges 111 1 and / or 1112) of the first layer 1100 is spaced apart from one or more edges (e.g., edges 1211 and / or 1212) of the second layer 1200 to define a set of openings 1071-1076 (e.g., a first fill opening 1070A and a second fill opening 1070B) fluidically coupling the storage volume (e.g., the first storage volume 1061 and the second storage volume 1062) of each of the separable flexible containers 1050 to the environment surrounding the container assembly 1001. The openings can be of any suitable size to facilitate loading of the tissue, biological material, graft and / or treatment G (e.g., a tissue graft), as described herein. In some embodiments, a support structure 1600 can be used to support the material G. In such embodiments, the opening can be a suitable size to facilitate the loading of the support structure. In some embodiments, the openings 1070 can extend across a portion of the length of an end or a side of the separable flexible container 1050. In some embodiments, the length of the opening can be less than the width of the separable container. For example, the length of the opening can be less than 75 percent of the width of the separable container, less than 60 percent of the width of the separable container, less than 50 percent of the width of the separable container, less than 40 percent of the width of the separable container, or any suitable range therein. In other embodiments, the opening 1070 can extend across substantially all of the end or side of the separable flexible container 1050.

[0063] As depicted in FIGS. 1-3, the set of openings 1071-1076 can be distributed along a center seam (e.g., a midline or a fold-line) defined by the fold portion 1004. In other words, in an embodiment wherein the fold portion 1004 is suspended or otherwise supported at a vertical apex, a first set of the separable flexible containers 1050A (e.g., the first, second, and third separable containers 1051, 1052, and 1053) extend downward and to one side of the fold portion 1004, while a second set of the separable flexible containers 1050B (e.g., the fourth, fifth, and sixth separable containers 1054, 1055, and 1056) extend downward and to the opposite side of the fold portion 1004. The first end portion 1010 of each separable flexible container 1050 is vertically above the second end portion 1020 of each separable flexible container 1050. In this position, the fill openings (e.g., the set of openings 1071-1076) face vertically upward on either side of the fold portion 1004 and are positioned to receive the biological material G that is moving in a downwarddirection. In this position, the container assembly 1001 can be described as having a “saddlebag arrangement.”

[0064] In some embodiments, as illustrated in FIGS. 1-3, each of the multiple separable flexible containers 1050 includes an opening portion (e.g., a first opening portion 1082 and a second opening portion 1084). In some embodiments, the two layers 1100, 1200 respectively are joined at the second end portion 1020 to define the opening portion of each separable flexible container 1050. The opening portions are configured to be opened following the filling of the storage volumes with the biological material (or graft) G. For example, selected opening portions can be opened to dispense the biological material (or graft) G during a medical procedure. In another example, selected opening portions can be opened to introduce a reconstitution media into the storage volume of the separable flexible container 1050.

[0065] In some embodiments, the opening portion is a port as depicted in FIGS 1-3. In some embodiments, the two layers 1100, 1200 respectively are joined at the second end portion 1020 to define the opening portion with the port 1080 positioned between the two layers 1100, 1200. The port is coupled to the second end portion 1020 of the container assembly 1001 and is configured to allow fluid communication between a volume outside of the container assembly 1001 and the storage volume. Thus, the port 1080 can be used to provide access to the storage volume 1060 and the biological material (or graft) G after the first end portion 1010 has been sealed closed. In this manner, the biological material (or graft) G can be treated with a preservation fluid or other material after being sealed into the container assembly 1001. The port 1080 can also be coupled to a vacuum source to evacuate the storage volume for storage of the biological material (or graft) G. Moreover, during a surgical procedure, the port 1080 can allow for inflow of rehydration fluid.

[0066] The port 1080 can be any suitable port that selectively provides fluid communication to the storage volume 1060. For example, the port 1080 can include a tube, a valve, and / or a cap. In some embodiments, the port 1080 can be a needle-free port. In some embodiments, the port 1080 can be a swabable connector. Similarly stated in some embodiments, the port 1080 can have external surfaces and can be devoid of recesses or crevices such that the port 1080 can be easily wiped or “swabbed” to maintain sterility during use. In some embodiments, the port 1080 can include any of the barbed, swabable valves produced by the Halkey-Roberts Corporation, such asthe 1455 series of swabable valves. In other embodiments, the port 1080 (and any of the ports described herein) need not be either a swabable connector or a needle-free port; any suitable port can be employed. In some embodiments, the port 1080 can include a male or female luer fitting. Although shown as including the port 1080, in other embodiments, the opening portion need not include a port. For example, in other embodiments, the opening portion can include a peelable seal that can be opened to facilitate removal of the biological material G. In yet other embodiments, the separable containers need not include an opening portion at the second end portion 1020. In such embodiments, access to the biological material can be at the first end portion 1010.

[0067] The first and second layers 1100, 1200 respectively can be constructed of any suitable material. The first layer 1100 can have a first stiffness and the second layer 1200 can have a second stiffness. In some embodiments, the stiffnesses are the same. In some embodiments the stiffnesses are different. In some embodiments the second stiffness is greater than the first stiffness. In some embodiments, the first stiffness is greater than the second stiffness. In some embodiments, the layers 1100, 1200 respectively can be constructed from the same material. In other embodiments, the layers 1100, 1200 respectively can be constructed from a different material and the second stiffness can be different than the first stiffness. In some embodiments, the first layer 1100 can be a thin, peelable film. The first layer 1100 can have any suitable thickness to provide the desired strength, flexibility, and sealing characteristics. For example, in some embodiments, the first layer 1100 can be between about 10 microns (0.010 mm) and about 2000 microns (2.0 mm). In some embodiments, the first layer 1100 can be between about 50 microns (0.050 mm) and about 200 microns (0.200 mm). In other embodiments, the first layer can be between about 50 microns (0.050 mm) and about 1001 microns (0.100 mm). The second layer 1200 can have any suitable thickness to provide the desired strength, flexibility, and sealing characteristics. For example, in some embodiments, the second layer 1200 can be between about 10 microns (0.010 mm) and about 1001 microns (2.0 mm). In some embodiments, the second layer 1200 can be between about 50 microns (0.050 mm) and about 100 microns (0.200 mm). In other embodiments, the second layer 1200 can be between about 50 microns (0.050 mm) and about 1001 microns (0.100 mm).

[0068] In some embodiments, the layers 1100, 1200 of the container assembly 1001 (or the material of any of the container assemblies described herein) can be produced out of any one ormore of the following materials: polyethylene (PE), low density polyethylene (LDPE), composites of LDPE, linear low-density polyethylene (LLDPE), high density poly ethylene (HDPE), polychlorotrifluoroethylene (PCTFE), ethylene tetrafluoroethylene (ETFE), polytetrafluoroethylene (PTFE), fluorinated ethylene propylene (FEP), polyurethane, polyimides (coats or non-coated), polyvinyl chloride (PVC), perfluoroalkoxy alkane (PF A), ethylene-vinyl acetate (EVA), polyvinylidene fluoride or polyvinylidene difluoride (PVDF), THV (a polymer of tetrafluoroethylene, hexafluoropropylene and vinylidene fluoride), PFE (Poly(fluorenylene ethynylene)), nylon, and / or composite of nylon. In some embodiments, any of the multi-chamber packaging using the materials above can be co-extruded and / or laminated. In some embodiments, any of the multi -chamber packaging using the materials above can further include aluminum foil laminate, aluminum oxide laminate, or laminated or co-extruded with aluminum oxide. In some embodiments, any of the multi-chamber container assemblies can be laminated with a layer of alder or any other suitable adhesive. In some embodiments, the material of the first layer 1100 and the material second layer 1200 are the same. In other embodiments, the material of the first layer 1100 is different from the material of the second layer 1200. For example, the material and / or thickness of the second layer 1200 may be selected such that a rigidity of the second layer 1200 is greater than the rigidity of the first layer 1100.

[0069] The materials from which the first layer 1100 and the second layer 1200 are selected to ensure that the two layers 1100, 1200 can be joined to hermetically seal the storage volume within which the biological material G (or any other stored product described herein) is stored while also retaining the desired flexibility. The two layers 1100, 1200 can be joined together at the second end portion 1020 and along the side edges 1030 by any suitable mechanism, such as, for example, by heat bonding or by an adhesive. As shown in FIG. 2, the edge 1111 of the first layer 1100 and the edge 1211 of the second layer 1200 are configured to be joined together after the biological material G is loaded into the storage volume 1060 to form a closing seal 1113. In some embodiments, the closing seal 1113 is a permanent seal that is openable by destroying the seal and / or the layers 1100, 1200. In other embodiments, the closing seal 1113 is a peelable seal that is openable by separating the first layer 1100 from the second layer 1200 with a force that is less than a force required to tear or rip a material of the first layer 1100 or the second layer 1200. Thepeelable seal can be configured to have any suitable failure (or peel) mechanism and can be of any suitable peel strength.

[0070] As shown in FIG. 1, the edge 1112 of the first layer 1100 and the edge 1212 of the second layer 1200 are configured to be joined together after the biological material G is loaded into another storage volume (e.g., the second storage volume 1062) to form a closing seal 1114. In some embodiments, the closing seal 1114 is a permanent seal that is openable by destroying the seal and / or the layers 1100, 1200. For example, the closing seal 1114 can include a heat seal between layer 1100 and layer 1200. In other embodiments, the closing seal 1114 is a peelable seal that is openable by separating the first layer 1100 from the second layer 1200 with a force that is less than a force required to tear or rip a material of the first layer 1100 or the second layer 1200. The peelable seal can be configured to have any suitable failure (or peel) mechanism and can be of any suitable peel strength.

[0071] In some embodiments, the multi-chamber container assembly 1001 includes a volume separating frangible region 1400 (see FIG. 2). The volume separating frangible region 1400 is a region that facilitates the separation of one separable flexible container 1050 (e.g., the sixth separable container 1056) from one or more other separable flexible containers 1050 as shown in FIG. 3. The frangible region 1400 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 assembly 1001 layers from one another. In some embodiments, the container assembly 1001 can include one or more longitudinal perforations 1410 positioned longitudinally between container volumes. In some embodiments, the container assembly 1001 can include one or more transverse perforations 1420 positioned transversely between containers. As shown in FIG. 3, the frangible regions are separated and a flexible container (e.g., the sixth separable container 1056) is removable from the container assembly 1001 without compromising the structure of the remaining flexible containers 1050. The separation is shown by arrows A and B in FIG. 3. While the embodiment depicted in FIGS. 1 and 2 show rectangular containers 1050 separated by an H-shaped seal with frangible region 1400 positioned therebetween other shapes of the containers, seals, and frangible regions are applicable as well.

[0072] In accordance with some embodiments, the separable flexible containers 1050 can include features of the various the containers as disclosed in Patent Pub. No. 2020 / 0008921 (the ’921 publication), titled “Sample Container with Peelable Seal and Access Port,” which is hereby incorporated by reference in its entirety. In light of the disclosure in the present application a person of ordinary skill in the art could adapt the features of the container in the ‘921 publication to be formed on as a container assembly having frangible regions forming an assembly with a set of those or other containers as discussed herein.

[0073] The container assembly 1001 can be placed in a configuration to be filled through the use of any of the positioning apparatuses described herein. In other words, using a positioning apparatus as described herein, the container assembly 1001 can be positioned in the saddlebag arrangement in order to receive a biological material (or graft) G (e.g., a treatment) through the upward facing fill openings of the individual storage volumes. For example, FIGS. 4-11 depicts a system 2000 that includes a positioning apparatus 2700 configured to position the container assembly 1001 (or any other suitable container assembly) in position to receive the biological material G.

[0074] As depicted in FIG. 4, the positioning apparatus 2700 includes a first support plate 2710 coupled to a second support plate 2720 via a central member 2702. The first support plate 2710 has a first securing member 2712. The first securing member 2712 is configured to secure a first portion 1002 of the container assembly 1001. In some embodiments, the first securing member 2712 can be a clamp, a bar lock, or other similar movable structure that secures the first portion 1002 between the first securing member 2712 and a first support face 2716 (e.g., a first upper face) of the first support plate 2710. In some embodiments, the first securing member 2712 can be a receiving structure that receives and positions a portion of the container assembly 1001. For example, the receiving structure can define an orifice sized to receive a port 1080 of the container assembly 1001. On a condition that the first portion 1002 of the container assembly 1001 is secured by the first securing member 2712, a first fill opening 1070A of the first portion 1002 is positioned between the central member 2702 and the first securing member 2712.

[0075] The second support plate 2720 has a second securing member 2722. The second securing member 2722 is configured to secure a second portion 1003 of the container assembly1001. In some embodiments, the second securing member 2722 can be a clamp, a bar lock, or other similar movable structure that secures the second portion 1003 between the second securing member 2722 and a second support face 2726 (e.g., a second upper face) of the second support plate 2720. In some embodiments, the second securing member 2722 can be a receiving structure that receives and positions a portion of the container assembly 1001. For example, the receiving structure can define an orifice sized to receive a port 1080 of the container assembly 1001. On a condition that the second portion 1003 is of the container assembly 1001 is secured by the second securing member 2722, a second fill opening 1070B of the second portion 1003 is positioned between the central member 2702 and the second securing member 2722. Additionally, as depicted, the central member 2702 is between the first fill opening 1070A and the second fill opening 1070B. Said another way, the first fill opening 1070A and the second fill opening 1070B are positioned on either side of the central member 2702 but are each oriented in the direction of the central member 2702 (as depicted in FIG. 4) and / or in a vertically upward direction (as depicted in FIGS. 9 and 10).

[0076] The second securing member 2722 is separated from the first securing member 2712 by a distance along the first axis ALA (FIG. 4) (e.g., the lateral axis) of the positioning apparatus 2700. The central member 2702 is between (e.g., laterally between) the first securing member 2712 and the second securing member 2722. In some embodiments, the second securing member 2722 and the first securing member 2712 can be located at the same position along the second axis VA (e.g., the vertical axis) of the positioning apparatus 2700.

[0077] Although FIG. 5 shows the first securing member 2712 being at an end portion of the first support plate 2710 and the second securing member 2722 being at an end portion of the second support plate 2720, in other embodiments, a securing member can include multiple portions to secure a container assembly at multiple locations along a support plate. For example, in some embodiments, the first securing member 2712 and / or the second securing member 2722 can be formed as a set of clamps 2713 (FIG. 9). The set of clamps 2713 can be positioned by a set of fixing features 2711 (e.g., notches or protrusions) (FIG. 8) defined by the first support plate 2710. For example, each clamp of the set of clamps 2713 can be sized to be received by the set of fixing features 2711. The fixing features 2711 can be arranged such that the positioned clamps 2713 engage a seal portion 1300 along the side edges of the container assembly 1001.

[0078] In addition to the first securing member 2712 and / or the second securing member 2722, in some embodiments, the first support face 2716 and / or the second support face 2726 include an adhesive layer that is positioned to contact the container assembly 1001. The adhesive layer is configured to removably couple the container assembly 1001 (e.g., the second layer 1200 (FIG. 1) of the container assembly 1001) to the first support face 2716 and / or the second support face 2726. The adhesion of the second layer 1200 to the positioning apparatus 2700 can facilitate a separation of the first layer 1100 from the second layer 1200 during a filling operation, thereby establishing each of the separable flexible containers 1050 in a position to receive the biological material G.

[0079] The first support plate 2710 and the second support plate 2720 are positioned relative to the central member 2702 to define a separation angle (depicted in FIG. 4 as a first separation angle AoSi) therebetween. The separation angle can indicate the angular distance between a first lower face 2718 of the first support plate 2710 and a second lower support face 2728 of the second support plate 2720. In some embodiments, the separation angle can be zero degrees on a condition that the first lower face 2718 and the second lower face are placed in contact with one another. In some embodiments, the separation angle can be greater than or equal to ten degrees. In some embodiments, the separation angle can be less than or equal to 180 degrees. For example, in some embodiments the separation angle is in the range of 45 degrees to 100 degrees (e.g., 60 degrees to 90 degrees).

[0080] FIG. 4 depicts the positioning apparatus 2700 in a fill configuration in which the separation angle is the first separation angle AoSi, which establishes and supports the container assembly 1001 in a folded (or partially folded) configuration (e.g., in a position to be filled with the biological material G). The first separation angle AoSi is less than 180 degrees. For example, the first separation angle AoSi can be in the range of zero degrees to 90 degrees. In some embodiments, the central member 2702 is rigidly formed to maintain the separation angle between the first support plate 2710 and the second support plate 2720 at a fixed magnitude on condition that the positioning apparatus 2700 is in the fill configuration. Similarly stated, in some embodiments, the central member 2702 and / or other portions of the positioning apparatus 2700 can include one or more features (e.g., protrusions, shoulders, or hard stops) that limit the range of rotation of the first support plate 2710 relative to the second support plate 2720. For example, in some embodiments, the first separation angle AoSi can be in the range of 85-95 degrees oncondition that the positioning apparatus 2700 is in the fill configuration. The positioning apparatus can include range-limiting features that limit movement of the first support plate 2710 relative to the second support plate 2720 to prevent the first separation angle AoSi from being less than 85 degrees.

[0081] In some embodiments, the central member 2702 is formed to facilitate changes in the separation angle. The central member 2702 can include a hinge, a deformable hinge, a linkage, and / or a rolling joint. The central member 2702 can, thus, facilitate a pivoting of the first support plate 2710 and / or the second support plate 2720 about a third axis ALO (FIG. 8) (e.g., a longitudinal axis). Therefore, the first support plate 2710 and / or the second support plate 2720 is movable about the central member 2702 between a first configuration as depicted in FIG. 4 and a second configuration as depicted in FIGS. 5-7. On a condition that the first support plate 2710 and / or the second support plate 2720 is in the first configuration as depicted in FIG. 4, the first support plate 2710 and the second support plate 2720 define the first separation angle AoSi and the positioning apparatus 2700 is in the fill configuration.

[0082] In some embodiments, the first support plate 2710 and / or the second support plate 2720 are movable about the central member 2702 to transition between the first configuration and the second configuration as depicted in FIGS. 5-7. On a condition that the first support plate 2710 and / or the second support plate 2720 is in the second configuration as depicted in FIGS. 5-7, the first support plate 2710 and the second support plate 2720 define a second separation angle A0S2 and the positioning apparatus 2700 is in a load configuration. In the second (or load) configuration, the first support plate 2710 and the second support plate 2720 can be substantially planar relative to one another. In other words, with the first support plate 2710 and the second support plate 2720 in the second configuration, the positioning apparatus 2700 can be substantially flat across a width along the first axis ALA (e.g., a length along the lateral axis). As such, the second separation angle A0S2 can be within five degrees of 180 degrees. Therefore, the second separation angle A0S2 is greater than the first separation angle AoSi.

[0083] By way of illustration, FIGS. 6-11 depict the loading of the container assembly 1001 onto the positioning apparatus 2700 followed by filling and sealing of the container assembly 1001 the according to some embodiments. As depicted in FIG. 6, the first support plate 2710 and thesecond support plate 2720 are arranged so that the positioning apparatus 2700 is in the load configuration. In the load configuration, the first support face 2716 and the second support face 2726 are substantially planar such that the container assembly 1001 is received in a flat configuration (e.g., unfolded). The first portion 1002 of the container assembly 1001 is placed (e.g., via a lateral movement) into the first securing member 2712 (or a portion thereof). For example, the first opening portion 1082 of the first storage volume 1061 can be positioned within the first securing member 2712. Additionally, a midline defined by the fold portion 1004 of the container assembly 1001 is aligned with the central member 2702. In other words, the hinge portion of the container assembly 1001 is aligned with the central member 2702 on a condition that the first portion 1002 of the container assembly 1001 is secured by the first securing member 2712. The second portion 1003 of the container assembly 1001 is then placed into the second securing member 2722. For example, the container assembly 1001 can be maintained in a flat or substantially flat configuration with the first portion 1002 secured by the first securing member 2712. In other words, the second opening portion 1084 of the second storage volume 1062 can be positioned within the second securing member 2722 (or a portion thereof). The second securing member 2722 (or a portion thereof) can then be moved relative to the second support plate 2720 as depicted in FIG. 7. In other words, in some embodiments, the first securing member 2712 can be fixed relative to the first support plate 2710, while the second securing member 2722 is movable relative to the second support plate 2720.

[0084] In some embodiments, the first storage volume 1061 of the first portion 1002 of the container assembly 1001 is one of a set of first storage volumes arranged side-by-side along the midline defined by the fold portion 1004 (e.g., the hinge portion). The opening portion of each of the first storage volumes is configured as a port 1080. In such embodiments, the first securing member 2712 receives each port 1080 of the first storage volumes. Similarly, the second storage volume 1062 of the second portion 1003 of the container assembly 1001 is one of a set of second storage volumes arranged side-by-side along the midline. The opening portion of each of the second storage volumes is configured as a port 1080 and is received by the second securing member 2722.

[0085] With the container assembly 1001 secured by both the first securing member 2712 and the second securing member 2722, the positioning apparatus 2700 can be transitioned (e.g., via amovement of the first support plate 2710 and / or the second support plate 2720 about the central member 2702) to the fill configuration (as depicted in FIGS. 4 and 9). On a condition that the positioning apparatus 2700 is in the fill configuration, the first support plate 2710 and a second support plate 2720 define a separation angle (e.g., the first separation angle AoSi) that is less than 180 degrees (e.g., less than 110 degrees and more than 55 degrees). In some embodiments, transitioning the positioning apparatus 2700 to the fill configuration establishes the separation angle between the first support plate 2710 and the second support plate 2720 at 10 degrees or less. The transition of the positioning apparatus 2700 to the fill configuration supports the container assembly 1001 in the folded configuration in which the fill openings (e.g., openings 1071-1076 as depicted in FIG. 1) of the separable flexible containers 1050 are positioned to receive the biological material G.

[0086] Following the transition to the fill configuration, a fill nozzle 2800 can be positioned relative to the positioning apparatus 2700 as depicted in FIG. 10. The fill nozzle 2800 can be aligned with at least one fill opening (e.g., the first fill opening 1070A) of the first portion 1002 of the container assembly 1001. In some embodiments, the number of fill nozzles 2800 can coincide with the number of separable flexible containers 1050 to be filled during the operation. As such, a single fill nozzle 2800 can be used to sequentially fill each of the separable flexible containers 1050 or more than one separable flexible container 1050 can be filled simultaneously using more than one fill nozzle 2800. Once the fill nozzle 2800 is positioned in alignment with the fill opening of at least one separable flexible container 1050, the biological material G can be conveyed (e.g., dispensed) from the fill nozzle into the fill opening (e.g., the first fill opening 1070A).

[0087] As depicted in FIGS. 8-11, in some embodiments, the first support plate 2710 (e.g., the first support face 2716) optionally includes or defines at least one indicium 2715. The indicia 2715 are visible on the condition that the first portion 1002 of the container assembly 1001 is secured by the first securing member 2712 as depicted in FIGS. 9-11. The indicia 2715 can, for example, be a series of graduated lines, dots, lights, holes, and / or other similar features that can be used to determine the positioning of the container assembly 1001 relative to the positioning apparatus 2700 and / or convey information about a condition of the separable flexible containers 1050. The indicia 2715 can be visible through the container assembly 1001, between the separable flexible containers 1050, and / or to the sides of the separable flexible containers 1050. During thedispensing of the biological material G, the indicia 2715 can, for example, be observed to determine a fill level of the storage volume (e g., the first storage volume 1061) being filled. Accordingly, the conveyance of the biological material G can be halted when the volume of the biological material G contained within the storage volume corresponds to a selected volume indicium 2715.

[0088] As depicted in FIG. 11, following the conveyance of the biological material G into the storage volume, the fill opening (e.g., the first fill opening 1070A) can be sealed. In some embodiments, a closure clamp 2705 can be used to clamp a portion of the container assembly 1001 between the conveyed biomaterial G and the fill opening. With the closure clamp 2705 in place, a heat seal can be applied to form a seal 1301. In other words, a heat seal can be applied across the first end portion 1010 of the separable flexible containers 1050 containing the biological material G. In some embodiments, the two layers 1100, 1200 can be joined together at the first end portion 1010 to close the fill openings by any suitable mechanism, such as, by an adhesive.

[0089] In some embodiments, the positioning apparatus includes a support frame to facilitate repeatable movement of the positioning apparatus between its various configurations. For example, FIGS. 12 and 13 depict a system 3000 in which a positioning apparatus 3700 uses a support frame 3730 to support and position the first support plate 3710 and the second support plate 3720. FIG. 12 depicts the positioning apparatus 3700 in a fill configuration, and FIG. 13 depicts the positioning apparatus 3700 in a load configuration. The support frame 3730 can, thus, guide the transition between the load configuration and the fill configuration.

[0090] The first support plate 3710 can include any of the features, elements, and / or can perform any of the functions described above with reference to the first support plate 2710. Similarly, the second support plate 3720 can include any of the features, elements, and can perform any of the functions described above with reference to the second support plate 2720. For example, the first support plate 3710 is movably coupled to the second support plate 3720 via the central member 3702. The first support plate 3710 includes the first securing member 3712, while the second support plate 3720 includes the second securing member 3722. The first support plate 3710 and the second support plate 3720 are positioned relative to the central member 3702 to define a separation angle as previously described herein.

[0091] As depicted in FIGS. 12 and 13, the support frame 3730 can include at least one vertical side 3731 . The support frame 3730 defines a set of guide channels 3732. The guide channels 3732 retain a first guide protrusion 3714 of the first support plate 3710. The guide channels 3732 retain a second guide protrusion 3724 of the second support plate 3720. Additionally, the guide channels retain a central guide protrusion 3703 of the central member 3702. On a condition that the first support plate 3710 and / or the second support plate 3720 is in the first configuration, as depicted in FIG. 12, the guide channels 3732 position the central guide protrusion 3703 at a fill position PF and the first guide protrusion 3714 and / or the second guide protrusion 3724 at a first lateral position LPi. Said another way, the guide channels 3732 are configured (e.g., shaped and sized) such that the central guide protrusion 3703 is at the fill position PF and the first guide protrusion 3714 and / or the second guide protrusion 3724 at the first lateral position LPi on condition that the first support plate 3710 and / or the second support plate 3720 is in the first configuration. On the condition that the central guide protrusion 3703 is at the fill position PF the first support plate 3710 and the second support plate 3720 define a first separation angle AoSi as described herein. In some embodiments, the support frame 3730 (or the guide channels defined therein) can include one or more detents to maintain the first guide protrusion 3714 and / or the second guide protrusion 3724 at the first lateral position LPi. In this manner, the positioning apparatus 3700 can be securely maintained in the fill configuration.

[0092] As depicted in FIG. 13, on a condition that the first support plate 3710 and / or the second support plate 3720 is in the second configuration, the guide channels 3732 position the central guide protrusion 3703 at a load position PL and the first guide protrusion 3714 and / or the second guide protrusion 3724 at a second lateral position LP2. Said another way, the guide channels 3732 are configured (e.g., shaped and sized) such that the central guide protrusion 3703 is at the load position PL and the first guide protrusion 3714 and / or the second guide protrusion 3724 at the second lateral position LP2 on condition that the first support plate 3710 and / or the second support plate 3720 is in the second configuration. On the condition that the central guide protrusion 3703 is at the load position PL the first support plate 3710 and the second support plate 3720 define a second separation angle A0S2 as described herein. Additionally, the load position PL is vertically lower than the fill position PF, and the second lateral position LP2 is laterally outward of the first lateral position LPi. Said another way, a lateral distance between the first guide protrusion 3714and the second guide protrusion 3724 is greater at the second lateral position LP2 then at the first lateral position LPi.

[0093] In some embodiments, the set of guide channels 3732 includes a lateral guide channel 3733 and a folding guide channel 3734. The folding guide channel 3734 intersects the lateral guide channel 3733. In some embodiments, a midline of the folding guide channel 3734 is perpendicular to the lateral guide channel 3733. However, in some embodiments, the folding guide channel 3734 can have a curved midline. The folding guide channel 3734 defines the fill position PF and the load position PL of the central guide protrusion 3703. The fill position PF is above the lateral guide channel 3733 along the second axis VA.

[0094] In some embodiments, the container assembly 1001 is supported in such a manner that the first portion 1002 is positioned to receive the biological material G and then the container assembly 1001 is pivoted to put the second portion 1003 in a position to receive the biological material G. For example, FIGS. 14 and 15 depict a system 4000 in which a positioning apparatus 4700 uses a support frame 4732 to suspend and position the first support plate 3710 and the second support plate 3720. FIG. 14 depicts the first portion 1002 of the container assembly 1001 in a position to be filled, and FIG. 15 depicts the second portion 1003 of the container assembly 1001 in a position to be filled.

[0095] The first support plate 4710 can include any of the features, elements, and / or can perform any of the functions described above with reference to the first support plate 2710. Similarly, the second support plate 4720 can include any of the features, elements, and can perform any of the functions described above with reference to the second support plate 2720. For example, the first support plate 4710 is movably coupled to the second support plate 4720 via the central member 4702. The first support plate 4710 includes the first securing member 4712, while the second support plate 4720 includes the second securing member 4722. The first support plate 4710 and the second support plate 4720 are positioned relative to the central member 4702 to define a separation angle as previously described herein.

[0096] As depicted in FIGS. 14 and 15, the support frame 4730 defines a support recess 4735. The support recess 4735 is sized to retain the central guide protrusion 4703 of the central member 4702. The central guide protrusion 4703 is positioned equidistant between the first support plate4710 and the second support plate 4720. Due to the central guide protrusion 4703 being retained by the support recess 4735, the first support plate 4710 and the second support plate 4720 are suspended from the central member 4702. Insofar as the first support plate 4710 and the second support plate 4720 have a single point of contact (e.g., the central guide protrusion 4703) with the support frame 4730, the first support plate 4710 and the second support plate 4720 are pivotable relative to the support frame 4730. Said another way, the first support plate 4710 is pivotable between a first pivot orientation (FIG. 14) and a second pivot orientation (FIG. 15), while the second support plate 4720 is pivotable between a third pivot orientation (FIG. 14) and a fourth pivot orientation (FIG. 15). Accordingly, the fill openings e.g., the first fill opening 1070A and / or the second fill opening 1070B can be positioned to receive the biological material G by pivoting the support plates 4710, 4720 relative to the support frame 4730. As such, the separation angle between the first support plate 4710 and the second support plate 4720 is maintained at a constant fixed magnitude while the central guide protrusion 4703 is retained by the support recess 4735.

[0097] In some embodiments, the central guide protrusion 4703 includes a set of indexing features 4704. The indexing features 4704 are positioned to engage a corresponding feature (e.g., a hollow, a detent, a cutout, a protrusion, or other feature sized to engage the corresponding indexing features defined by the support recess 4735. For example, the indexing features 4704 can extend radially outward from the central guide protrusion 4703 and engage a protrusion or a cutout of the support recess 4735. The indexing features 4704 are positioned to establish the first support plate 4710 in the first pivot orientation (FIG. 14) about a pivot axis defined by the central member 4702 (e.g., by the inner face of the central guide protrusion 4703 and the support recess 4735). The second support plate 4720 is in a third pivot orientation on a condition that the first support plate 4710 is in the first pivot orientation. In some embodiments, the first pivot orientation and / or the fourth pivot orientation has a downward slope that is greater than 90 degrees (e.g., is an overhang), as depicted in FIGS. 14 and 15. As such, the first layer 1100 of the container assembly 1001 can be drawn downward away from the first support plate 4710 in response to a gravitational pull, which can result in an increase separation between the first layer 1100 and the second layer 1200 of the first portion 1002 of the container assembly 1001. The increased separation between the first layer 1100 and the second layer 1200 can facilitate maintaining the fill openings (e.g., fillopening 1071-1073) of the separable flexible containers 1050 of the first portion 1002 of the container assembly 1001 . This, in turn, can facilitate the receipt of the biological material G.

[0098] Following the introduction of the biological material to the separable flexible containers 1050 of the first portion 1002 of the container assembly 1001, the first support plate 4710 can be pivoted to the second pivot orientation established by the indexing features 4704. The second pivot orientation can be up to 10 degrees below parallel so that the biological material G is retained within the corresponding storage volumes. On a condition that the first support plate 4710 is in the second pivot orientation, the second support plate 4720 is, as depicted in FIG. 15 in the fourth pivot orientation. In the fourth pivot orientation, the second support plate 4720 secures the second portion 1003 of the container assembly 1001 so that the first layer 1100 of the container assembly 1001 can be drawn downward away from the second support plate 4720 in response to a gravitational pull. This can result in an increase separation between the first layer 1100 and the second layer 1200 of the second portion 1003 of the container assembly 1001. The increased separation between the first layer 1100 and the second layer 1200 can facilitate maintaining the fill openings (e.g., fill opening 1074-1076) of the separable flexible containers 1050 of the first portion 1002 of the container assembly 1001. This, in turn, can facilitate the receipt of the biological material G.

[0099] In some embodiments, the positioning apparatus can be adapted for use with an automated machine through the inclusion of a transition structure. The positioning apparatus can be used to transition the container assembly 1001 from a flat configuration to a folded configuration and to position the container assembly 1001 on the support plates and a position to receive the biological material G. For example, FIGS. 16 and 17 depict a system 5000 in which uses a transitioning structure 5740 to facilitate use of the positioning apparatus with an automated machine for filling each of the separable flexible containers 1050.

[0100] In some embodiments, the transition structure 5740 has a first face 5741 that is separated from a second face 5742 by a midline ridge 5743. The midline ridge 5743 extends between an inboard end portion 5744 and an outboard end portion 5745. The transitioning structure is shaped to transition the container assembly 1001 from a flat configuration (e.g., nonfolded or substantially planar) to a folded configuration (e g., a saddlebag arrangement) inconjunction with a longitudinal movement MLO of the container assembly 1001 along the midline ridge 5743. For example, the container assembly 1001 can be placed on the outboard end portion 5745 of the transitioning structure 5740 in a substantially flat configuration. The degree of fold of the container assembly 1001 increases in conjunction with the longitudinal movement MLO along the midline ridge 5743 toward the inboard end portion 5744.

[0101] As depicted in FIGS. 16 and 17, the inboard end portion 4744 of the transitioning structure 5740 is positioned in contact with the first support plate 5710, the second support plate 5720 and the central member 5702. A first angle between the first face 5741 and the second face 5742 at the inboard end portion 5744 is equal to the separation angle defined by the central member 5702 between the first support plate 5710 and the second support plate 5720. In other words, the movement along the midline ridge folds the container assembly 1001 to match the separation angle. As such, upon the transition from being supported by the transitioning structure 5740 to being supported by the support plates 5710, 5720, the container assembly 1001 has already been folded to the desired degree.

[0102] In some embodiments, a second angle between the first face 5741 and the second face 5742 at the outboard end portion 5745 is greater than the first angle. For example, the second angle can be within five degrees of 180 degrees. Said another way, the outboard end portion 5745 has a greater length along the first axis ALA than the inboard end portion 5744. Said yet another way, the transitioning structure 5740 narrows from the outboard end portion 5745 toward the inboard end portion 5744. Additionally, the midline ridge has a first vertical height Hi at the inboard end portion 5744. The first vertical height Hi is greater than a second vertical height H2 at the outboard end portion 5745. The second vertical height H2 can, for example, have a negligible magnitude such that the outermost edge of the outboard end portion 5745 is substantially flat.

[0103] FIG. 18 is a flow chart of a method 60 filling a container assembly using a positioning apparatus according to an embodiment. The method 60 may, in an embodiment, be performed via any of the systems described herein, such as systems 2000, 3000, 4000, and 5000. However, it should be appreciated that in various embodiments, aspects of the method 60 may be accomplished via additional embodiments of the system systems or components thereof as described herein.Accordingly, the method 60 may be implemented on any container assembly using any positioning apparatus as described herein.

[0104] As depicted at 61, the method 60 includes arranging the first support plate and the second support plate in a load configuration that is substantially planar and configured to receive the container assembly in a flat configuration. As depicted at 62, the method 60 includes placing a first portion of the container assembly into a first securing member of the positioning apparatus. As depicted at 63, the method 60 includes placing a second portion of the container assembly into a second securing member of the positioning apparatus. As depicted at 64, the method 60 includes transitioning the positioning apparatus to a fill configuration in which the first support plate and the second support plate define a separation angle that is less than 180 degrees to support the container assembly in a folded configuration. At least one opening of the set of separate openings is positioned to receive a biological material on a condition that the container assembly is in the folded configuration. As depicted at 65, the method 60 includes positioning a fill nozzle relative to the positioning apparatus so that the fill nozzle is aligned with at least one opening of the plurality of separate openings. As depicted at 66, the method 60 includes conveying the biomaterial from the fill nozzle into the at least one opening of the plurality of separate openings. As depicted at 67, the method 60 includes sealing the at least one opening of the plurality of separate openings after the conveying the biomaterial.

[0105] While the discussion herein has been directed to the introduction of biological material into the container assembly, it is appreciated that other materials could be introduced in the various packaging as well. For example, any of the containers or container assemblies described can store pharmaceutical ingredients (including active pharmaceutical ingredients, dilutents, preservatives, inert components, or other pharmaceutical ingredients). Such pharmaceutical ingredients can be packaged and stored in any of the containers or container assemblies described herein for storage, distribution, and later compounding, mixing, or other pre-delivery preparation steps.

[1001] In accordance with various embodiments, each of the containers within the various container assemblies can include passages that extend between the various container volumes. In this way, liquid, paste, gelatounous or similar materials could flow between one or more of theconnected volumes as a single volume is filled. Once filled, one or more seals could be used to seal each of the volumes.

[1002] While some 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.

[1003] Although some 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 positioning apparatus for filling a container assembly, the positioning apparatus comprising: a first support plate having a first securing member, the first securing member being configured to secure a first portion of the container assembly; a second support plate having a second securing member, the second securing member being configured to secure a second portion of the container assembly; and a central member coupled between the first support plate and the second support plate, the first support plate and the second support plate positioned relative to the central member to define a separation angle, wherein: on a condition that the first portion is secured by the first securing member, a first fill opening of the first portion is positioned between the central member and the first securing member, on a condition that the second portion is secured by the second securing member, a second fill opening of the second portion is positioned between the central member and the second securing member, and the central member is between the first fill opening and the second fill opening.

2. The positioning apparatus of claim 1, wherein: the separation angle is greater than or equal to ten degrees and less than or equal to 180 degrees.

3. The positioning apparatus of claim 1, wherein: the separation angle is a first separation angle; at least one of the first support plate and the second support plate is movable about the central member between a first configuration and a second configuration; on a condition that the first support plate or the second support plate is in the first configuration, the first support plate and the second support plate define the first separation angle;on a condition that the first support plate or the second support plate is in the second configuration, the first support plate and the second support plate define a second separation angle; and the second separation angle is greater than the first separation angle.

4. The positioning apparatus of claim 3, wherein: the central member includes at least one of a hinge, a deformable hinge, a linkage, or a rolling joint.

5. The positioning apparatus of claim 3, further comprising: a support frame defining a plurality of guide channels, wherein: the plurality of guide channels retains a first guide protrusion of the first support plate, a second guide protrusion of the second support plate, and a central guide protrusion of the central member, the plurality of guide channels position the central guide protrusion at a fill position and at least one of the first guide protrusion or the second guide protrusion at a first lateral position on a condition that the first support plate or the second support plate is in the first configuration, and the plurality of guide channels position the central guide protrusion at a load position and at least one of the first guide protrusion or the second guide protrusion at a second lateral position on a condition that the first support plate or the second support plate is in the second configuration.

6. The positioning apparatus of claim 5, wherein: the plurality of guide channels include a lateral guide channel and a folding guide channel; the folding guide channel intersects the lateral guide channel; the folding guide channel defines the fill position and the load position of the central guide protrusion; and the fill position is above the lateral guide channel.

7. The positioning apparatus of claim 3, further comprising: a support frame, the support frame defining a support recess, wherein: the support recess retains a central guide protrusion of the central member, the first support plate and the second support plate are suspended from the central member, and the first support plate and the second support plate are pivotable relative to the support frame.

8. The positioning apparatus of claim 7, wherein: the central guide protrusion includes a plurality of indexing features positioned to engage the support recess; the plurality of indexing features are positioned to establish the first support plate in a first pivot orientation about a pivot axis defined by the central member; the plurality of indexing features are positioned to establish the first support plate in a second pivot orientation about the pivot axis; the first pivot orientation is different from the second pivot orientation; the separation angle between the first support plate and the second support plate is maintained at a fixed magnitude on a condition that the central guide protrusion is retained by the support recess; the second support plate is in a third pivot orientation on a condition that the first support plate is in the first pivot orientation; and the second support plate is in a fourth pivot orientation on a condition that the first support plate is in the second pivot orientation.

9. The positioning apparatus of claim 8, wherein: the first pivot orientation has a slope that is greater than 90 degrees.

10. The positioning apparatus of claim 1, wherein: the container assembly includes a plurality of ports; the first securing member receives a first port of the plurality of ports; and the second securing member receives a second port of the plurality of ports.11 . The positioning apparatus of claim 1 , wherein: the container assembly includes a first layer coupled to a second layer via a plurality of seals to define at least a first storage volume and a second storage volume, a first portion of the first layer or the second layer defines a first fill opening into the first storage volume and a second portion of the first layer or the second layer defines a second fill opening into the second storage volume; the first storage volume includes a first opening portion; the second storage volume includes a second opening portion; a hinge portion is positioned between the first storage volume and the second storage volume; the hinge portion defines a midline of the container assembly; the first fill opening is positioned between the midline and the first opening portion; the second fill opening is positioned between the midline and the second opening portion; the first fill opening is separated from the second fill opening by the hinge portion; and on a condition that the first portion of the container assembly is secured by the first securing member, the hinge portion is aligned with the central member.

12. The positioning apparatus of claim 11, wherein: the first storage volume is one of a plurality of first storage volumes arranged side-by- side along the midline; the first opening portion is one of a plurality of first ports; each first port of the plurality of first ports is in fluid communication with a corresponding first storage volume of the plurality of first storage volumes; the first securing member receives the plurality of first ports; the second storage volume is one of a plurality of second storage volumes arranged side- by-side along the midline; the plurality of second storage volumes is separated from the plurality of first storage volumes by the hinge portion; the second opening portion is one of a plurality of second ports;each second port of the plurality of second ports is in fluid communication with a corresponding second storage volume of the plurality of second storage volumes; and the second securing member receives the plurality of second ports.

13. The positioning apparatus of claim 1, wherein: the first securing member is a first clamp; and the first clamp is positioned to fix a position of the first portion of the container assembly relative to the first support plate.

14. The positioning apparatus of claim 1, wherein: the first support plate defines at least a first fixing feature; the first fixing feature is sized to receive the first securing member; and the first fixing feature establishes the position of the first securing feature relative to the first support plate.

15. The positioning apparatus of claim 1, wherein: the first support plate includes at least one indicium that is visible on a condition that the first portion of the container assembly is secured by the first securing member.

16. The positioning apparatus of claim 1, wherein: the first securing member is fixed relative to the first support plate; and the second securing member is movable relative to the second support plate.

17. The positioning apparatus of claim 1, wherein: the first support plate includes a first support face in contact with the first portion of the container assembly on a condition that the first portion of the container assembly is secured by the first securing member; the second support plate includes a second support face in contact with the second portion of the container assembly on a condition that the second portion of the container assembly is secured by the second securing member;the first support face and the second support face include an adhesive layer positioned to contact the container assembly; and the adhesive layer is configured to removably couple the container assembly to the first support face and the second support face.

18. The positioning apparatus of claim 1, further comprising: a transitioning structure having a first face separated from a second face by a midline ridge that extends between an inboard end portion and an outboard end portion, the transitioning structure being configured to transition the container assembly from a flat configuration to a folded configuration in conjunction with a movement along the midline ridge from the outboard end portion toward the inboard end portion wherein: the inboard end portion of the transitioning structure is positioned in contact with the first support plate, the second support plate, and the central member, a first angle between the first face and the second face at the inboard end portion is equal to the separation angle defined by the central member, a second angle between the first face and the second face at the outboard end portion is greater than the first angle, and the midline ridge has a first vertical height at the inboard end portion that is greater than a second vertical height at the outboard end portion.

19. A method for filling a container assembly using a positioning apparatus, the container assembly having a plurality of separate storage volumes and a plurality of separate openings, the positioning apparatus including a first support plate coupled to a second support plate via a central member, the method comprising: arranging the first support plate and the second support plate in a load configuration that is substantially planar and configured to receive the container assembly in a flat configuration; placing a first portion of the container assembly into a first securing member of the positioning apparatus; placing a second portion of the container assembly into a second securing member of the positioning apparatus;transitioning the positioning apparatus to a fill configuration in which the first support plate and the second support plate define a separation angle that is less than 180 degrees to support the container assembly in a folded configuration, at least one opening of the plurality of separate openings is positioned to receive a biomaterial on a condition that the container assembly is in the folded configuration; positioning a fill nozzle relative to the positioning apparatus so that the fill nozzle is aligned with at least one opening of the plurality of separate openings; conveying the biomaterial from the fill nozzle into the at least one opening of the plurality of separate openings; and sealing the at least one opening of the plurality of separate openings after the conveying the biomaterial.

20. The method of claim 19, wherein: placing the second portion of the container assembly into the second securing member includes: maintaining the container assembly in the flat configuration with the first portion of the container assembly secured by the first securing member, and moving the second securing member relative to the second support plate.

21. The method of claim 19, wherein: transitioning the positioning apparatus to the fill configuration establishes the separation angle between the first support plate and the second support plate at less than 110 degrees and more than 70 degrees.

22. The method of claim 19, wherein: transitioning the positioning apparatus to the fill configuration establishes the separation angle between the first support plate and the second support plate at 10 degrees or less.

23. The method of claim 19, further comprising: observing an indicium of the first support plate; andhalting the conveyance of the biomaterial when the volume of the biomaterial contained within a storage volume of the plurality of separate storage volumes corresponds to the indicium.

24. The method of claim 19, further comprising: following the conveyance of the biomaterial into a storage volume of the plurality of separate storage volumes, clamping a portion of the container assembly between the conveyed biomaterial and the at least one opening of the plurality of separate openings.

25. The method of claim 19, wherein: sealing the at least one opening of the plurality of separate openings includes applying a heat seal.

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