Packaging for storing moist tissue

Abstract

A packaging system (10b) includes a package defining a cavity (14b) and a seal (18b) configured to be coupled to the package to fluidly seal the cavity. The packaging system can also include at least one tissue scaffold (16b) configured to be disposed within the cavity. Cavities having a single size can be configured to receive tissue scaffolds having different sizes. In addition to the cavity, the packaging system can include one or more additional reservoirs configured to hold a quantity of liquid. Such packaging systems can be used to store human or animal tissue for wet or dry storage. The invention also provides a packaged tissue sample and methods of packaging tissue.

Description

Technical Field

[0001] In general, this invention is a packaging system for tissue samples, and more specifically, a packaging arrangement for storing tissues in a liquid medium. Background Technology

[0002] Biological tissues typically offer improved functional performance when used for in vivo implantation compared to equivalent synthetic devices. However, the availability and use of tissue grafts can be limited by inherent supply constraints and logistical issues related to acquisition, transport, and storage. Various techniques have been developed that allow for the acquisition, transport, and storage of tissues suitable for surgical implantation. However, many developed techniques may require the use of specialized cryopreservation equipment to store donor tissue at extremely low temperatures. Such requirements can often limit facilities capable of utilizing available tissue and can complicate the transport of tissue to the surgical facility where it will ultimately be used. The packaging and related methods described herein overcome some of these problems and enable more convenient methods for transporting, storing, preparing for, and ultimately using wet- or dry-preserved tissues. In some suitable storage methods, tissue can be stored in an antiseptic solution that extends the usable shelf life of the tissue. In some such storage methods, tissue can be retained in the antiseptic solution until it is used in surgical procedures. Summary of the Invention

[0003] According to one embodiment, the packaging system may include a packaging body defining a cavity. The packaging system may also include a tissue support configured to be disposed within the cavity. The packaging system may further include a seal configured to engage with the packaging body to fluidly seal the cavity.

[0004] It may include one or more of the following features. The cavity may be configured to accommodate tissue scaffolds of different sizes. The cavity may include at least one groove configured to engage a corresponding tab of the tissue scaffold to hold the tissue scaffold in place within the cavity.

[0005] The tissue scaffold can be configured to support a tissue sample. The tissue scaffold can be configured to at least partially immerse the tissue sample in a liquid disposed in a cavity. The tissue scaffold can be configured to allow liquid to drain from the tissue scaffold upon removal from the cavity. The tissue scaffold may include one or more openings to allow liquid to drain from the tissue scaffold upon removal from the cavity.

[0006] A tissue scaffold may include one or more features configured to facilitate manipulation of the tissue scaffold. The tissue scaffold may be configured to support tissue samples of multiple sizes. A tissue scaffold may include one of a plurality of tissue scaffolds. Each of the plurality of tissue scaffolds may be configured to support tissue samples of different sizes. A cavity and each of the plurality of tissue scaffolds may include cooperative features to support any one of the plurality of tissue scaffolds within the cavity.

[0007] The seal may include a plastic film. The seal may include a foil seal. The seal may be configured to peel off from the package to allow access to the cavity.

[0008] According to another embodiment, a packaged tissue sample is provided, wherein the tissue sample is packaged in a tissue packaging system. The tissue packaging system may include a package body defining a cavity. The tissue packaging system may also include a tissue scaffold configured to be disposed within the cavity. The tissue packaging system may further include a seal configured to be connected to the package body to fluidly seal the cavity. The tissue sample may be supported by the tissue scaffold.

[0009] It may include one or more of the following features. The cavity may be configured to accommodate tissue scaffolds of different sizes. The tissue sample may include one or more human tissues, including but not limited to nerve tissue, vascular tissue, urinary tissue, skin tissue, tendon and muscle tissue. The tissue sample may include one or more animal tissues, including but not limited to nerve tissue, vascular tissue, urinary tissue, skin tissue, tendon and muscle tissue.

[0010] A tissue scaffold can be configured to at least partially immerse a tissue sample in a liquid disposed within a cavity. The tissue scaffold can be configured to allow liquid to drain from the tissue scaffold upon removal from the cavity. The tissue scaffold may include one or more openings to allow liquid to drain from the tissue scaffold upon removal from the cavity. The tissue scaffold may include one or more features configured to facilitate manipulation of the tissue scaffold. The tissue scaffold can be configured to support a tissue sample having one of multiple sizes. The tissue scaffold may include one of a plurality of tissue scaffolds. Each of the plurality of tissue scaffolds can be configured to support one of a plurality of tissue samples of different sizes. The cavity and each of the plurality of tissue scaffolds may include cooperative features to support any one of the plurality of tissue scaffolds within the cavity.

[0011] The seal may include a plastic film. The seal may include a foil seal. The seal may be configured to peel off from the package to allow access to the cavity.

[0012] According to another embodiment, a method of packaging tissue may include supporting a tissue sample within a tissue scaffold. The method may include placing the tissue scaffold within a cavity defined in a package. The method may include at least partially filling the cavity with liquid. The method may further include attaching a seal to the package to fluid-tighten the cavity.

[0013] It may include one or more of the following features. The tissue scaffold may be selected from multiple tissue scaffolds of different sizes. The cavity may be configured to accommodate each of the different sizes of tissue scaffolds. The tissue sample may include one or more of nerve tissue, vascular tissue, urinary tissue, tendon, and muscle tissue.

[0014] The tissue scaffold can be configured to at least partially immerse a tissue sample in a liquid disposed in a cavity. The tissue scaffold can be configured to allow liquid to drain from the tissue scaffold upon removal from the cavity. The tissue scaffold may include one or more openings to allow liquid to drain from the tissue scaffold upon removal from the cavity.

[0015] A tissue scaffold may include one or more features configured to facilitate manipulation of the tissue scaffold. The tissue scaffold may be configured to support a tissue sample selected from multiple tissue samples of different sizes. A tissue scaffold may include one of a plurality of tissue scaffolds. Each of the plurality of tissue scaffolds may be configured to support a tissue sample of a different size. A cavity and each of the plurality of tissue scaffolds may include cooperative features to support any one of the plurality of tissue scaffolds within the cavity.

[0016] The seal may include either a plastic seal or a foil seal. Attaching the seal to the package may include either adhesive bonding or heat sealing. The seal may be configured to peel off from the package to allow access to a cavity.

[0017] According to another embodiment, the packaging system may include a package body defining a cavity and one or more reservoirs. The packaging system may also include a seal configured to connect to the package body to fluidly seal the cavity and one or more reservoirs.

[0018] The system may include one or more of the following features: The cavity may be configured to support a tissue sample. The packaging system may also include one or more tissue supports configured to be disposed within the cavity. One or more tissue supports may be configured to support a tissue sample. The seal may be configured to be gradually peeled off from the package to allow gradual access to the cavity and one or more fluid reservoirs.

[0019] The packaging system may also include one or more fluid passages between the cavity and one or more reservoirs. The one or more fluid passages may include a fragile seal configured to fluidly isolate the cavity from the one or more reservoirs in a sealed state. The fragile seal may be configured to provide fluid communication between the cavity and the one or more reservoirs in a ruptured state. The fragile seal may be configured to rupture when the fluid pressure within the one or more reservoirs increases above a threshold pressure. The fragile seal may include areas of weaker bonding strength between the seal and the package body along the one or more fluid passages. The fragile seal may include a ruptureable member disposed within the one or more fluid passages.

[0020] The packaging system may also include a drain pipe between the cavity and the outside of the packaging system. The drain pipe may include a fragile seal configured to fluidly isolate the cavity from the outside of the packaging system via the drain pipe in a sealed state. The drain pipe may also include a fragile seal configured to fluidly connect the cavity to the outside of the packaging system via the drain pipe in a ruptured state.

[0021] According to a further embodiment, a packaged tissue sample is provided, wherein the tissue sample is packaged in a tissue packaging system, the packaging system including a package body defining a cavity and one or more reservoirs. The packaging system may also include a seal connected to the package body to fluidly seal the cavity and one or more reservoirs. The tissue sample is disposed within the cavity.

[0022] The system may include one or more of the following features. The packaging system may also include a tissue scaffold disposed within the cavity. The tissue scaffold may support a tissue sample disposed within the cavity. The seal may be configured to be gradually peeled off from the package to allow gradual access to the cavity and one or more fluid reservoirs.

[0023] One or more fluid passages may be provided between the cavity and one or more reservoirs. The one or more fluid passages may include a fragile seal configured to fluidly isolate the cavity from the one or more liquid reservoirs in a sealed state. The fragile seal may be configured to provide fluid communication between the cavity and the one or more reservoirs in a ruptured state. The fragile seal may be configured to rupture when the fluid pressure within the one or more reservoirs increases above a threshold pressure. The fragile seal may include areas of weaker bond strength between the seal and the package along the one or more fluid passages. The fragile seal may include a breakable member disposed within the one or more fluid passages.

[0024] The packaging system may also include a drain pipe between the cavity and the outside of the packaging system. The drain pipe may include a fragile seal configured to fluidly isolate the cavity from the outside of the packaging system via the drain pipe in a sealed state. The drain pipe may also include a fragile seal configured to fluidly connect the cavity to the outside of the packaging system via the drain pipe in a ruptured state.

[0025] Tissue samples may be at least partially disposed in a liquid. One or more reservoirs may include a cleaning solution. The cleaning solution may be configured to be at least partially transferred to the cavity via one or more fluid passages. Attached Figure Description

[0026] Figure 1A A first example implementation of a packaging system consistent with this disclosure is described;

[0027] Figure 1B It is consistent with this disclosure. Figure 1A An exploded view of an example implementation of the packaging system;

[0028] Figure 2A A second example implementation of a packaging system consistent with this disclosure is described;

[0029] Figure 2B Depicting Figure 2A An example implementation of an illustrative embodiment of a tissue scaffold in a packaging system;

[0030] Figure 3A This is an exploded view of a third exemplary embodiment of a packaging system consistent with this disclosure;

[0031] Figure 3B It is consistent with this disclosure. Figure 3A A cross-sectional view of an example implementation of the packaging system;

[0032] Figure 4A This is a top view of another example embodiment of a packaging system consistent with this disclosure;

[0033] Figure 4B It is consistent with this disclosure. Figure 4A A side view of an example implementation of the packaging system;

[0034] Figure 5A This is a top view of another example embodiment of a packaging system consistent with this disclosure;

[0035] Figure 5B It is consistent with this disclosure. Figure 5A A side view of an example implementation of the packaging system;

[0036] Figure 6A This is a top view of another example embodiment of a packaging system consistent with this disclosure;

[0037] Figure 6B It is consistent with this disclosure. Figure 6A A side view of an example implementation of the packaging system. Detailed Implementation

[0038] Generally, embodiments consistent with this disclosure relate to packaging systems. In some embodiments, the packaging system may be used to package tissue samples, for example, it may be designed for use in conjunction with various surgical procedures, such as for grafts or other purposes. In some example embodiments, the packaging system may allow tissue samples to be packaged in a liquid medium, which may facilitate the storage or preservation of the tissue. In some embodiments, the liquid may include antiseptic liquids and / or solutions. Furthermore, in some example embodiments, the packaging system consistent with this disclosure may include features that facilitate handling of the tissue sample, for example, when removing the tissue sample from the packaging and / or during other operations.

[0039] For example, refer to Figure 1A and 1B The example packaging system 10a is shown in general. Consistent with the exemplary embodiments, the packaging system 10a may typically have a blister packaging configuration, including a package body 12a defining a cavity 14a. A tissue support 16a may be configured to be disposed within the cavity 14a, and the packaging system may also include a seal 18a configured to be connected to the package body 12a to fluidly seal the cavity 14a.

[0040] Consistent with this disclosure, the packaging body 12a may be formed of any suitable material, including but not limited to various plastic materials. In some embodiments, the packaging body 12a may be formed of a sterilizable plastic material, such as by gamma ray sterilization or other suitable sterilization techniques that allow sterilization of the packaging system 10a and / or anything contained within the packaging system 10a. In some embodiments, the packaging body 12a may be formed of a suitable material capable of providing an oxygen barrier, for example, preventing oxygen migration into the interior of the cavity 14a. In some embodiments, the packaging body 12a may be formed of a multilayer plastic material. The packaging body 12a may be formed by any suitable molding technique, including but not limited to thermoforming or injection molding.

[0041] The packaging body and the cavity defined therein can have any suitable shape and construction. In the example embodiment, the cavity 14a can have, for example, Figure 1A and 1B The shape is generally circular or semi-cylindrical. In some such embodiments, the package 12a may be provided with features, such as feet 20a, 20b, that stabilize the package 12a in a generally upward orientation of the opening of the cavity 14a (e.g., when the package 12a is placed on a generally horizontal surface). In other example embodiments, for example, as... Figure 2A and 3AAs shown in 3B, the packaging bodies 12b and 12c can be formed with a generally flat bottom, allowing them to be positioned in a generally stable orientation with the openings of the cavities 14b and 14c generally oriented upwards when placed on a generally horizontal surface. It should be understood that shapes and configurations different from those depicted in the embodiments can be used.

[0042] As generally discussed, the packaging system may include a tissue scaffold configured to be at least partially disposed within a cavity. In some embodiments, the tissue scaffold may be configured to be removably disposed within the cavity. Furthermore, the tissue scaffold may be dimensioned relative to the cavity such that the seal may have a generally planar construction and can be attached to the package without interference from the tissue scaffold. In other embodiments, the seal may have a contoured construction to accommodate the tissue scaffold that at least partially extends from the cavity.

[0043] Typically, tissue scaffolds are configured to support tissue samples. That is, tissue scaffolds are typically shaped to hold or position the tissue sample relative to the tissue scaffold. Therefore, in embodiments where the tissue scaffold is removably disposed within a cavity of the packaging, the tissue sample can be placed within and / or removed from the packaging by placing the tissue scaffold (supporting the tissue sample) within and / or removing the tissue scaffold (supporting the tissue specimen) from the cavity. For example, see reference... Figures 1A to 2B In some embodiments, tissue scaffolds 16a, 16b may typically be formed as open trays with recesses, indentations, or cavities (e.g., recesses 22a, 22b) that can support tissue samples (e.g., ...). Figure 1A As shown, this is achieved by placing a tissue sample 24a in the recess 22a of a tissue scaffold 16a. In some embodiments, the tissue scaffold may at least partially surround the tissue sample. For example, as... Figure 3B As shown in the embodiments, the tissue scaffold 16c may have a generally clamshell-shaped structure, wherein two or more cooperating portions of the tissue scaffold 16c may be folded around the tissue sample 24c to at least partially surround the tissue sample 24c. It should be understood that tissue scaffolds consistent with this disclosure may have various additional and / or alternative configurations that can support the tissue sample to allow the tissue sample to be removably placed within the cavity of the packaging system by removably placing the tissue scaffold within the cavity.

[0044] In addition to and / or as an alternative allowing for the removable placement of tissue samples within a cavity, tissue scaffolds can also help protect and / or retain tissue samples within the packaging system. For example, compared to the cavity of the package, a tissue scaffold can allow tissue samples to have a relatively small size for relatively positioned retention within the cavity. For example, a tissue scaffold can reduce the degree of movement of the tissue sample within the cavity (e.g., reduce the degree of shaking or lateral movement experienced by the tissue sample within the cavity). Because a tissue scaffold can support a relatively small tissue sample within a relatively large cavity, in some embodiments, the package size can be designed to facilitate user operation of the packaging system, e.g., without requiring high dexterity. Consistent with this disclosure, the packaging system can be used to accommodate any desired tissue. For example, the tissue sample may include human or animal tissue. Examples of tissues that may be used in conjunction with this disclosure include, but are not limited to, nerve tissue, vascular tissue, urinary tissue, tendon, muscle tissue, etc.

[0045] Consistent with some implementations, the tissue scaffold may be configured to at least partially immerse a tissue sample in a liquid disposed within a cavity. For example, during packaging, the cavity of the package may be at least partially filled with a liquid medium (e.g., before or after the tissue scaffold and / or tissue sample is placed within the cavity). The liquid medium may include any suitable liquid that, for example, maintains and / or preserves one or more properties of the tissue sample (e.g., increased shelf life, increased bioactivity, increased receptor acceptability, etc.) and / or facilitates the handling of the tissue sample during removal of the tissue sample from the cavity and / or during surgical handling of the tissue sample.

[0046] According to one example, the liquid facilitates the storage and / or preservation of tissue samples. According to another example, the liquid may comprise a solution containing about 2% to about 15% by volume of dimethyl sulfoxide (DMSO). The solution may also contain about 150 g / L to 2.5 g / L of sodium chloride. The solution may also contain about 0.3 g / L of potassium chloride. The solution may also contain about 0.2 g / L of calcium chloride. The solution may also contain about 0.4 g / L of sodium bicarbonate. The solution may also contain about 0.1 g / L of magnesium chloride. It should be understood that various other liquids, including but not limited to solutions containing mixtures of monovalent and divalent metal cations (e.g., sodium, potassium, magnesium, calcium, etc.), may be combined for use in embodiments consistent with this disclosure, which includes U.S. Patent Application No. 16 / 898,224 entitled "Wet Preservation of Tissue" (published in US).

[0047] The preservative solutions disclosed in U.S. Patent Application No. 16 / 939,889 (published as US 2020 / 0390088 A1), which are also entitled “Wet Preservation of Tissues”, are both incorporated herein by reference.

[0048] In some embodiments, the tissue scaffold may be configured to allow fluid to drain from the scaffold upon removal from the cavity. For example, as described above, when the tissue scaffold is at least partially disposed within the cavity, it may be configured to at least partially immerse a tissue sample in fluid. Furthermore, the tissue scaffold may be configured to allow fluid to drain from the scaffold (and thus from around the tissue sample) upon removal from the cavity. For example, the tissue scaffold may include any type of groove, hole, incision, perforation, etc., that allows fluid to drain from a recess or interior of the tissue scaffold supporting the tissue sample. Reference Figure 1B and 2B In the illustrated embodiment, tissue scaffolds 16a and 16b may include recesses 22a, 22b or one or more grooves (e.g., grooves 26a, 26b) in each tissue scaffold 16a, 16b. Grooves 26a, 26b allow fluid to drain from the tissue scaffolds 16a, 16b while still allowing the tissue scaffolds 16a, 16b to continue supporting the tissue sample. Figures 3A to 3B In a further illustrated example, the clamshell-shaped tissue scaffold 16c may include multiple pores (e.g., pore 26c) that allow fluid to drain from the interior of the clamshell-shaped tissue scaffold 16c while allowing the clamshell-shaped tissue scaffold 16c to continue supporting the tissue sample 24c. It should be understood that various additional and / or alternative configurations may be provided to allow fluid to drain from the tissue scaffold, such as allowing the tissue scaffold to continue supporting the tissue sample when it is removed from the cavity.

[0049] In some embodiments consistent with this disclosure, the tissue scaffold may include one or more features configured to facilitate manipulation of the tissue scaffold. For example, as described above, the tissue scaffold may support a tissue sample within a cavity. The tissue sample can be easily removed from the packaging system by removing the tissue scaffold from the cavity. For example, the tissue scaffold may typically have a larger size and higher structural integrity (e.g., strength, rigidity, etc.) than the tissue sample. Thus, removing the tissue scaffold still supporting the tissue sample from the cavity may be easier than removing the tissue sample from the tissue scaffold while the tissue sample is still in the cavity. Additionally, as described above, the tissue scaffold may include features such as holes, grooves, etc., which allow fluid to drain from the tissue scaffold and thereby from around the tissue sample when the tissue scaffold is removed from the cavity. For this purpose, the tissue scaffold may include one or more features that facilitate manipulation of the tissue scaffold, for example, manually and / or by means of surgical instruments such as forceps or tweezers.

[0050] Consistent with the foregoing, in various embodiments, the tissue scaffold may include features such as extensions, tabs, wings, additional material surrounding the periphery, and other suitable features that facilitate the handling and manipulation of the tissue scaffold. Reference Figures 1A to 1BIn one example embodiment, the tissue scaffold 16a may include an extension 28a from one end of the recess 22a. The extension 28a provides a convenient feature that allows for easier grasping with forceps or tweezers, for example, to remove the tissue scaffold 16a from the cavity 14a. Similarly, in Figures 2A to 2B In one embodiment, the tissue scaffold 16b is shown to include an extension 28b from the recess 22b. Consistent with this embodiment, the extension 28b may extend not only longitudinally relative to the recess 22b, but may also include a laterally extending feature. Furthermore, refer to... Figure 3A and 3B Features 28c and 28d may include tabs on opposite sides of the clamshell-shaped tissue scaffold 16c, which may allow the tissue scaffold to be grasped and manipulated more easily. Furthermore, as shown in the figures, in some embodiments, features 28c and 28d may be at least partially offset from each other, for example, to facilitate opening the clamshell-shaped tissue scaffold 16c, for example, to remove the tissue sample 24c from the tissue scaffold 16c.

[0051] As described above, tissue scaffolds can be configured to allow fluid to drain from the tissue scaffold. In some embodiments, it may be necessary to rinse the tissue sample before use (e.g., before implanting the tissue sample into a recipient). Methods for rinsing stored tissue to prepare fluids and solutions, for example, for use in a surgical setting, may depend on the storage solution used and the type of tissue being preserved. Those skilled in the art will understand such methods and rinsing fluids and their variations. For example, U.S. Patent Application No. 16 / 898,224 (published as US 2020 / 0390087 A1), entitled "Wet Preservation of Tissue," and U.S. Patent Application No. 16 / 939,889 (published as US 2020 / 0390087 A1), also entitled "Wet Preservation of Tissue," can be used.

[0052] The method and rinsing liquid disclosed in (2020 / 0390088A1) are both incorporated herein by reference. Consistent with this embodiment, the manipulation features (e.g., features 28a to 28d) not only facilitate the removal of the tissue scaffold from the cavity but also facilitate the rinsing of the tissue sample, for example by providing a convenient portion of the tissue scaffold for gripping, thereby lowering the tissue scaffold into the rinsing basin and / or swishing the tissue scaffold (and the tissue sample supported by the tissue scaffold) in a basin containing the rinsing liquid. In this respect, the tissue scaffold discharge feature also facilitates the rinsing of the tissue sample, for example by similarly allowing the rinsing liquid to drain from the tissue scaffold.

[0053] According to some embodiments consistent with this disclosure, the cavity of the packaging system may be configured to at least partially accommodate tissue scaffolds of different sizes. For example, in some cases, it may be necessary to provide tissue scaffolds with recesses sized to accommodate tissue samples of a given size. For example, it may be necessary for the recesses of the tissue scaffold to have dimensions similar to the tissue sample, e.g., to minimize movement of the tissue sample within the recess. Thus, tissue scaffolds with relatively large recesses can be used to support relatively large tissue samples, and tissue scaffolds with relatively small recesses can be used to support relatively small tissue samples. Consistent with some of these arrangements, it may be desirable to be able to use the same package with cavities of the same size, wherein the tissue scaffolds have recesses of different sizes. Furthermore, it may be desirable to be able to restrict the degrees of freedom of movement of the tissue scaffold within the cavity (e.g., to prevent the tissue sample from moving out of the recess, or otherwise moving in a manner where the tissue scaffold no longer supports the tissue sample).

[0054] Consistent with the foregoing, in embodiments where the cavity can be configured to at least partially accommodate stents of different sizes, the overall size of the stent can be independent of the dimensions of the recess used to support the tissue sample. For example, in Figures 1A to 1B In the illustrated embodiments, tissue scaffold 16a may include recesses 22a and extensions 28a. The overall dimensions of tissue scaffold 16a may be substantially similar to those of cavity 14a and / or have substantially similar cross-sectional and / or planar dimensions and / or shape to cavity 14a. Therefore, tissue scaffold 16a may be substantially locatingly confined within cavity 14a. In example embodiments, cavity 14a may be configured to at least partially accommodate different tissue scaffolds with similar overall dimensions but different sized recesses. For example, a tissue scaffold with a relatively large recess (e.g., configured to support a relatively large tissue sample) may have a relatively small extension, thus having substantially similar overall dimensions. Similarly, a tissue scaffold with a relatively small recess (e.g., configured to support a relatively small tissue sample) may have a relatively large extension. It should be understood that, in addition to having longitudinal extensions with different dimensions, tissue scaffolds with recesses of different dimensions may also have lateral extensions of different dimensions, for example, to provide substantially similar overall dimensions and / or shape.

[0055] In some embodiments, a cavity of a single size can be configured to accommodate tissue scaffolds of different sizes, while confining the tissue scaffolds in a generally positioned manner relative to the cavity. For example, as described above, different tissue scaffolds with recesses of different sizes can be provided to support tissue samples of different sizes. Regarding... Figure 1A and 1BIn the examples discussed, different tissue scaffolds with recesses of different sizes can be positioned relative to the cavity by providing different tissue scaffolds with similar overall dimensions (e.g., even though the recesses may have different sizes). Consistent with another example, the cavity and tissue scaffold may include features capable of positioning the tissue scaffold relative to the cavity. For example, such as Figure 2A As shown, the cavity 14b may include at least one groove (e.g., grooves 30a to 30d) configured to engage corresponding tabs (e.g., tabs 32a to 32b) of the tissue scaffold 16b to hold the tissue scaffold 16b in position within the cavity 14b.

[0056] Consistent with the foregoing, in some embodiments, each of the cavity and the plurality of tissue scaffolds may include cooperative features to support any one of the plurality of tissue scaffolds within the cavity. For example, the extension 28a of tissue scaffold 16a may be configured to fit within the overall dimensions of cavity 14a. Furthermore, tabs 32a, 32b may be configured to fit into slots 30a to 30d of cavity 14b. Thus, a plurality of scaffolds configured to support tissue samples of different sizes can be used with cavities of common sizes and / or configurations.

[0057] It should be understood that although the illustrated embodiment uses four slots 30a to 30d on either side of the cavity 14b, more or fewer slots may be used. Furthermore, although... Figure 2A and 2B This includes grooves on each side of the cavity and tabs on each side of the tissue scaffold. In other embodiments, the grooves may be provided only on one side of the cavity, and the tabs may be provided only on one side of the tissue scaffold. It should also be understood that the same result can be achieved using cooperative features different from those of the grooves and tabs.

[0058] In another example, in addition to spatially restricting the tissue scaffold relative to the cavity, the cooperative feature can provide an indication of the size of the tissue sample supported by the scaffold. For example, as Figure 2A As shown, each slot 30a to 30d includes an associated size mark. Consistent with this example, the size mark may correspond to the size of a tissue sample that can be held by a tissue scaffold, which can engage the slot associated with the size mark. Thus, the collaborative feature also provides a size indicator for the tissue sample.

[0059] Consistent with the foregoing, in some embodiments, a tissue scaffold may include one of a plurality of tissue scaffolds. Each of the plurality of tissue scaffolds may have different dimensions, i.e., configured to support tissue samples of different sizes (e.g., each of the plurality of tissue scaffolds may include recesses of different sizes). In some such embodiments, tissue scaffolds sized to support tissue samples of different sizes may be used with packaging cavities of the same size. However, in other embodiments, tissue scaffolds configured to support tissue samples of different sizes may themselves have different dimensions, but may be configured for use in packaging cavities of the same size (e.g., a cavity size that can accommodate tissue scaffolds of different sizes) and may include cooperative features between the tissue scaffold and the cavity to positionally constrain the tissue scaffold relative to the cavity.

[0060] In some examples, tissue scaffolds can be configured to support tissue samples of various sizes. For example, reference... Figure 1A In one embodiment, the tissue scaffold 16a may include a recess 22a sized to support a tissue sample of a given length (e.g., 15 mm in the illustrated example). Furthermore, the recess 22a may be sized to support tissue samples of a given length but with different diameters (e.g., collectively referred to as tissue samples 24d). For example, the width and depth of the recess 22a may be designed to support tissue samples of the largest diameter of the given length, and may also suitably support tissue samples of a given length with a smaller diameter compared to the largest diameter tissue sample. It should be understood that while the recess 22a may be sized to support tissue samples of a given length, the recess 22a may similarly support tissue samples of shorter lengths.

[0061] Also refer to Figures 3A to 3B In some example embodiments, a single-sized tissue scaffold 16c can be configured to support tissue samples with different lengths and / or different diameters. For example, the tissue scaffold 16c may have a clamshell-shaped construction, which can close around the tissue sample to support and hold the tissue sample within a closed recess defined by the clamshell shape. Thus, the closed recess can support both larger and smaller tissue samples while preventing the tissue sample from leaving the tissue scaffold 16c (e.g., because the tissue sample disposed within the clamshell-shaped tissue scaffold can be surrounded by the tissue scaffold on all sides).

[0062] As described above, the packaging system may include a seal configured to be attached to the package body to fluidly seal the cavity. As shown in the various illustrated embodiments, the cavity of each packaging system typically includes an open surface. The seal may be attached to the package body around the periphery of the cavity to fluidly seal the cavity and retain the tissue scaffold and tissue sample within the cavity. Furthermore, the seal not only prevents the spillage of any storage liquids that can be used in conjunction with the tissue sample, but also prevents the ingress of any contaminants, such as those that may adversely affect the tissue sample and / or jeopardize its intended use. In some embodiments, the seal may additionally provide an oxygen barrier, for example, to prevent and / or reduce oxygen intrusion into the cavity when the seal is already attached to the package body.

[0063] It should be understood that a variety of suitable materials can be used for the seal. Examples of such materials include, but are not limited to, plastic films, metal foils, and multilayer structures (e.g., plastic-laminated paper, plastic-laminated metal foil, multilayer plastic films, etc.). Furthermore, it should be understood that various techniques can be used to attach the seal to the packaging body to provide a fluid-proof seal. For example, the seal may be adhesively attached to the packaging body, head-attached to the packaging body, and / or otherwise attached to the packaging body. Additionally, it should be understood that while the illustrated embodiments have depicted the seal generally as a planar member, in other embodiments, the seal may include shape and / or contour members. In some such embodiments, the seal may include an additional cavity that, when the seal is attached to the packaging body, is at least partially aligned with a cavity in the packaging body.

[0064] In example embodiments, the seal may be configured to peel off from the package body to allow access to a cavity (e.g., to allow removal of a tissue scaffold and / or tissue sample from the cavity). For example, as described above, the seal may be attached to the package body, for example, by adhesive bonding and / or thermal bonding (e.g., heat sealing). In some embodiments, a portion of the seal may not be attached to the package body. For example, a portion of the seal may extend peripherally beyond the connection between the seal and the package body. Figure 1A and 2AAs shown, seals 18a and 18b may each include flap portions 34a and 34b. When seals 18a and 18b are attached to the package body, at least flap portions 34a and 34b may not be attached to the package body 12a and 12b and may extend beyond the connection between seals 18a and 18b and the package body 12a and 12b. Flap portions 34a and 34b provide convenient positions for gripping seals 18a and 18b to peel them off from the package body 12a and 12b. Similarly, package bodies 12a and 12b may include tabs 36a and 36b that may extend peripherally beyond the connection between seals 18a and 18b and the package body 12a and 12b. Similar to the flap portions 34a, 34b, the tab portions 36a, 36b can provide a portion of the package body 12a, 12b for gripping to peel the seals 18a, 18b from the package body 12a, 12b. Consistent with various other embodiments, the seals can be cut off or torn from the package body to allow access to the cavity (e.g., removal of tissue scaffolds and / or tissue samples).

[0065] Referring to Figures 4 through 6, according to another example, a packaging arrangement may be provided, which may include one or more reservoirs for containing one or more rinsing or cleaning solutions. For example, referring to... Figure 4A and 4B An example is an example packaging system 10d. As shown, packaging system 10d may include a packaging body 12d that defines a cavity 14d for receiving a tissue sample 24d. In some embodiments, the tissue sample 24d may be supported by a tissue scaffold 16d, while in other embodiments, the tissue sample may be supported by the cavity itself. Consistent with various embodiments, the cavity 14d and / or the tissue scaffold 16d can be configured in a manner similar to any of the aforementioned cavities and / or tissue scaffolds, and / or include various combinations of the features of the aforementioned cavities and tissue scaffolds. In other embodiments, the cavity 14d and / or the tissue scaffold 16d may have features and / or constructions different from those of the aforementioned embodiments. Furthermore, as generally mentioned, in some embodiments, packaging system 10d may not include a tissue scaffold. Consistent with this embodiment, the tissue sample 24d may be supported by the cavity 14d.

[0066] In addition to cavity 14d, packaging system 10d may include one or more additional reservoirs 40a to 40c. The one or more additional reservoirs 40a to 40c may include cavities formed in packaging body 12d, configured to contain a volume of liquid. As discussed in previous embodiments, packaging system 10d may include a seal (not shown) that surrounds one or more reservoirs 40a to 40c (in a sealed configuration) and is peelable from packaging body 12d to allow access to one or more reservoirs 40a to 40c. In some embodiments, the seal may be gradually peeled off from packaging body 12d to allow gradual access to cavity 14d and one or more reservoirs 40a to 40d. For example, the seal may be peeled off from packaging body 12d to allow access to cavity 14d. Subsequently, the seal may be peeled off from packaging body 12d to allow access to first reservoir 40a. Then, the seal may be peeled off from packaging body 12d to allow access to second reservoir 40b. Furthermore, the seal can be peeled off from the package body 12d to allow access to the third reservoir 40c. It should be understood that other configurations may also be implemented, such as peeling the seal off from the package body to expose more than one reservoir at a time.

[0067] In some embodiments, one or more reservoirs may be used to contain liquids and / or articles relating to the preparation, use, and / or implantation of tissue samples. For example, in some embodiments, preservation media, such as antiseptic solutions or treatments, may be used to preserve tissue samples. In some such embodiments, it may be necessary to rinse or clean the tissue sample before use (e.g., before implantation or other uses) to at least partially remove or replace the preservation media. In such embodiments, one or more reservoirs may contain rinsing or cleaning liquids. According to one example, during use of tissue sample 24d, tissue sample 24d may be removed from cavity 14d and may be exposed to rinsing or cleaning liquids contained in one or more reservoirs 40a to 40c, for example, by placing tissue sample 24d in one or more containers 40a to 40c and / or by immersing tissue sample 24d in liquids contained in one or more reservoirs 40a to 40c and / or by swishing in liquids contained in one or more reservoirs 40a to 40c. In one embodiment, tissue sample 24 may be sequentially exposed to liquids contained in each of the reservoirs 40a to 40c. In some embodiments, each of the reservoirs 40a to 40c may contain the same liquid. In some embodiments, one or more reservoirs 40a to 40c may contain a different liquid than the other one or more reservoirs 40a to 40c. For example, different liquids may be contained in different reservoirs to allow for sequential washing, rinsing, and / or processing of the tissue sample. Examples of rinsing and / or washing liquids may include, but are not limited to, water, saline solution, lactated Ringer's solution (LRS), phosphate buffered saline (PBS), or other suitable rinsing solutions / liquids. In addition to and / or as a substitute for liquids, one or more reservoirs may include a device or other item that may be associated with the use of the tissue sample. Thus, the packaging system 10d provides and protects both the tissue sample and the associated device or item. Other embodiments may also be used. It should be understood that although three reservoirs are depicted, this is for illustrative purposes only, as more or fewer reservoirs may be provided.

[0068] refer to Figures 5A to 5B And 6A to 6B, according to further examples, one or more reservoirs are capable of fluidly engaging with the cavity. For example, one or more reservoirs are capable of fluidly engaging with the cavity while the seal remains engaged and / or connected to at least a portion of the package. For example, refer to Figure 5A and 5BAn example of a packaging system 10e is shown, including a cavity 14e and a reservoir 40d. As shown, the cavity 14e can be configured to hold tissue samples with or without a tissue scaffold. Consistent with this embodiment, the packaging system 10e may include a fluid passage 42a between the cavity 14e and the reservoir 40d. For example, a seal (not shown) can be connected to the package body 12e in such a way that the connection of the seal to the package body 12e in the region of the fluid passage 42a is weaker than the connection to the surrounding portion of the package body. Consistent with this embodiment, applying pressure to the cavity 14e or the reservoir 40d can cause an increase in pressure within the cavity 14e and / or the reservoir 40d. The increase in pressure can cause the connection between the seal and the package body 12e to fail along the fluid passage 42a. Failure of the connection between the seal and the package body 12e along the fluid passage allows fluid communication between the cavity 14e and the reservoir 40d.

[0069] In one example, pressure may be applied to the reservoir 40d, for example, by squeezing the packaging system 10e in a region of the reservoir 40d. The applied pressure may cause an increase in the pressure of the rinsing solution and / or other liquids within the reservoir 40d, which may cause the bond between the seal and the package 12e to fail in the region of the fluid passage 42a. This failure of the bond between the seal and the package in the fluid passage region may allow fluid communication between the reservoir 40d and the cavity 14e via the fluid passage 42a. In some embodiments, once the fluid passage 42a has been opened (e.g., due to the failure of the bond between the seal and the package 12e), the increased pressure within the reservoir 40d may allow at least a portion of the fluid to transfer from the reservoir 40d into the cavity 14e. In some embodiments, this transfer of at least a portion of the fluid from the reservoir to the cavity may initiate rinsing and / or washing of the tissue sample. It should be understood that the fluid passage 42a may represent a line and / or region of relatively weak bond between the seal and the package. In some embodiments, the seal may not be bonded to the package in the fluid passage region. Furthermore, a relatively thin seam can be provided between the seal and the package body across the entire fluid passage (e.g., in one or more areas between the connection of the fluid passage and the connection between the fluid passage and the reservoir). In such an embodiment, an increase in pressure will not cause the connection between the seal and the package body to fail along the entire fluid passage, but only to cause failure of the connection between the seal and the package body along a relatively small area of ​​the fluid passage, thereby providing a fluid passage for direct fluid communication between the cavity and the reservoir. Consistent with any of the foregoing arrangements, the reservoir can be fluidly isolated from the cavity until the fluid passage is opened due to failure of the connection between the seal and the package body.

[0070] Also refer to Figure 6A and 6BIn some embodiments, the packaging system 10f may include more than one reservoir (e.g., reservoirs 40e to 40g) that is in fluid communication with the cavity 14f via one or more corresponding fluid passages (e.g., fluid passages 42b to 42d). For example, the cavity 14f and the reservoirs 40e to 40g may be formed in the packaging body 12f in a manner generally discussed above with respect to one or more of the foregoing example embodiments. The cavity 14f may be configured to hold tissue samples with and / or without the use of a tissue scaffold. One or more reservoirs 40e to 40g may include one or more fluids (e.g., they may include the same fluid and / or one or more different fluids in each reservoir) that may be at least partially transferred to the cavity 14f via one or more fluid passages 42b to 42d. Thus, tissue samples may be exposed to more than one different fluid and / or tissue samples may be sequentially exposed to fluids (e.g., sequential rinsing, etc.).

[0071] In some embodiments, one or more fluid passages may include areas where the seal (not shown) is weakly bonded to the package 12f compared to the surrounding area. Therefore, pressure applied to the fluid within one or more reservoirs 40e to 40g can cause localized failure of the bond along the respective fluid passage. In other embodiments, the fluid passage may represent areas along the seal that are not bonded to the package 12f, except for discrete areas, such as between the connection between the fluid passage and the reservoir and the connection between the fluid passage and the cavity. Such discrete areas may represent fragile seals. The fragile seals may maintain fluid isolation between the cavity 14f and the respective reservoirs 40e to 40g until one or more fragile seals break (e.g., by applying force to one or more respective reservoirs). In some embodiments, one or more fluid passages 42b to 42d may include channels formed in the package and / or seal. Consistent with such embodiments, the fluid passages may include discrete fragile seals, for example, which fluidly isolate the respective reservoir and cavity until the respective fragile seal breaks (e.g., by applying pressure to one or more respective reservoirs). The fragile seal may comprise any material that fluidly seals a fluid passage but can burst or rupture by applying pressure to the individual reservoirs. In some embodiments, the fragile seal may rupture under pressure applied to the reservoir that is lower than the pressure that could cause failure at the connection between the seal and the package. Thus, the fragile seal may rupture to provide fluid communication between one or more reservoirs and the cavity without otherwise impairing the packaging system. While separate fluid passages are depicted between each reservoir and the cavity, it should be understood that in some embodiments, at least a portion of the fluid passages may be common. For example, each reservoir may be connected to a common fluid passage leading to the cavity via one or more feed passages and / or directly via its respective fragile seal.

[0072] In some implementations, the cavity may include a drain pipe, for example, which may provide fluid communication with the outside of the packaging system. For example, such as... Figure 6A and 6B In the example shown, cavity 14f may include drain pipe 44, which provides fluid communication with the outside of packaging system 10f. In some embodiments, drain pipe 44 may include a fragile seal consistent with any of the aforementioned fragile seals (e.g., a region of relatively weak bonding between the seal and package 12f, a fragile component disposed within the drain pipe, etc.). As described above, in some embodiments, pressure may be applied to the reservoir, for example, which may open the fluid passage between the reservoir and the cavity (e.g., by breaking the fragile seal and / or causing the bonding between the seal and the package, etc.). Furthermore, once the fluid passage between the reservoir and the cavity is opened, the increased pressure on the reservoir may cause an increase in pressure within the cavity. In some embodiments, the resulting increase in pressure within the cavity may cause drain pipe 44 to open (e.g., by breaking the fragile seal and / or causing the bonding between the seal and the package). Thus, the cavity may be in fluid communication with the outside of the packaging system. This allows at least a portion of the fluid within one or more reservoirs to be transferred into the cavity, for example, by providing a drain tube for any fluid already in the cavity (and / or previously transferred from the reservoirs). Thus, in some such embodiments, fluid can be flushed from the cavity, for example, by displacing the cavity with fluid from one or more reservoirs. Furthermore, the method can be used to sequentially rinse and / or process tissue samples with liquid from the reservoirs.

[0073] While some of the foregoing exemplary embodiments have been described in the context of packaging systems for tissue samples, it should be understood that the principles, features, and / or advantages described herein are equally applicable to packaging of other materials. Furthermore, while some of the foregoing exemplary embodiments have been described in the context of packaging systems for tissue samples stored in liquid media, it should be understood that the principles, features, and / or advantages described herein are equally applicable to tissue storage where liquid media are not required. Therefore, this disclosure should not be limited to any of the disclosed exemplary embodiments and should be given the full scope of the appended claims.

Claims

1. A packaging system, comprising: The packaging body is defined by a cavity; Multiple tissue scaffolds, each configured to be disposed within the cavity, wherein the multiple tissue scaffolds have a variety of different sizes; as well as A seal configured to be connected to the package body to fluidly seal the cavity. The cavity is configured to accommodate each of the plurality of tissue scaffolds having different sizes.

2. The packaging system of claim 1, wherein the cavity includes at least one slot configured to engage a corresponding tab of the tissue scaffold to hold the tissue scaffold in position within the cavity.

3. The packaging system of claim 1, wherein the tissue scaffold is configured to support a tissue sample.

4. The packaging system of claim 1, wherein the tissue scaffold is configured to support a tissue sample and fit within the cavity to at least partially immerse the tissue sample in a liquid disposed within the cavity.

5. The packaging system of claim 4, wherein the tissue scaffold is configured to allow the liquid to drain from the tissue scaffold when removed from the cavity.

6. The packaging system of claim 5, wherein the tissue scaffold includes one or more openings to allow the liquid to drain from the tissue scaffold when it is removed from the cavity.

7. The packaging system of claim 1, wherein the tissue scaffold includes one or more features configured to facilitate manipulation of the tissue scaffold.

8. The packaging system of claim 1, wherein the plurality of tissue scaffolds are configured to support tissue samples of various sizes.

9. The packaging system of claim 1, wherein each of the plurality of tissue scaffolds and the cavity includes cooperative features to support any one of the plurality of tissue scaffolds within the cavity.

10. The packaging system of claim 1, wherein the seal comprises a plastic film.

11. The packaging system of claim 1, wherein the seal comprises a foil seal.

12. The packaging system of claim 1, wherein the seal is configured to be peelable from the package body to allow access to the cavity.

13. A packaged tissue sample, wherein the tissue sample is packaged in a tissue packaging system, the tissue packaging system comprising: The packaging body is defined by a cavity; Multiple tissue scaffolds are configured to be disposed within the cavity; as well as A seal connected to the package body to fluidly seal the cavity. The plurality of tissue scaffolds includes tissue scaffolds of different sizes, wherein the cavity is configured to accommodate each of the plurality of tissue scaffolds of different sizes, and wherein each of the plurality of tissue scaffolds is configured to support the tissue sample.

14. The packaged tissue sample of claim 13, wherein the tissue sample comprises one or more of nerve tissue, vascular tissue, urinary tissue, tendon or muscle tissue.

15. The packaged tissue sample of claim 13, wherein the tissue scaffold of the tissue packaging system is configured to at least partially immerse the tissue sample in a liquid disposed in the cavity.

16. The packaged tissue sample of claim 15, wherein the tissue scaffold of the tissue packaging system is configured to allow the fluid to drain from the tissue scaffold upon removal from the cavity.

17. The packaged tissue sample of claim 16, wherein the tissue scaffold of the tissue packaging system includes one or more openings to allow the fluid to drain from the tissue scaffold when it is removed from the cavity.

18. The packaged tissue sample of claim 13, wherein the tissue scaffold of the tissue packaging system includes one or more features configured to facilitate manipulation of the tissue scaffold.

19. The packaged tissue sample of claim 13, wherein the tissue scaffold of the tissue packaging system is configured to support the size of the tissue sample.

20. The packaged tissue sample of claim 13, wherein the seal of the tissue packaging system comprises a plastic film.

21. The packaged tissue sample of claim 13, wherein the seal of the tissue packaging system comprises a foil seal.

22. The packaged tissue sample of claim 13, wherein the seal of the tissue packaging system is detachable from the package to allow access to the cavity.

23. A method of organizing packaging, comprising: Select tissue scaffolds from multiple tissue scaffolds of different sizes; The tissue sample is supported by a selected tissue scaffold; The tissue scaffold is placed within a cavity defined in the packaging body, wherein the cavity is configured to accommodate each of the tissue scaffolds having different sizes; The cavity is at least partially filled with liquid; as well as A seal is attached to the package to fluid seal the cavity.

24. The method of claim 23, wherein the tissue sample comprises one or more of nerve tissue, vascular tissue, urinary tissue, tendon, or muscle tissue.

25. The method of claim 23, wherein the tissue scaffold is configured to at least partially immerse the tissue sample in a liquid disposed in the cavity.

26. The method of claim 25, wherein the tissue scaffold is configured to allow the fluid to drain from the tissue scaffold upon removal from the cavity.

27. The method of claim 26, wherein the tissue scaffold includes one or more openings to allow the fluid to drain from the tissue scaffold when it is removed from the cavity.

28. The method of claim 23, wherein the tissue scaffold includes one or more features configured to facilitate manipulation of the tissue scaffold.

29. The method of claim 23, wherein the seal comprises one of a plastic film seal and a foil seal.

30. The method of claim 23, wherein attaching the seal to the package body comprises one of adhesive bonding and heat sealing.

31. The method of claim 23, wherein the coupled seal is configured to peel off from the package to allow access to the cavity.

Images