Packaging system for medical products

Abstract

A packaging system is provided that includes a holder (102) and an inner container, such as an inner tray or vial. The holder includes a top (102a) and a bottom (102b) that cooperate to form a cavity (118a, 118b) configured to contain and hold one or more medical products, such as one or more tissue samples, therein. The inner container defines an interior region configured to contain the holder therein. The holder includes a sidewall that forms the cavity, and the sidewall includes a channel (122) configured to fluidically connect the cavity to the interior region of the inner container. The packaging system can further include an outer container that includes a well configured to contain the inner container therein. The packaging system can allow for packaging of medical products in a liquid that can facilitate storage and / or preservation of the medical products.

Description

Technical Field

[0001] This invention relates generally to packaging systems for medical products, and more specifically to packaging systems for storing medical products in fluids, including packaging systems for storing tissue products in fluids at room temperature. Background Technology

[0002] When used for in vivo implantation, biological tissue typically offers improved functional performance compared to equivalent synthetic devices. However, the availability and use of tissue grafts can be limited by supply constraints and logistical issues related to the transport and / or storage of tissue grafts. Several techniques have been developed to allow the transport and storage of tissue suitable for surgical implantation. However, many developed techniques may require specialized cryopreservation equipment to store donor tissue at extremely low temperatures. Such requirements may limit facilities capable of utilizing available tissue and / or complicate the transport of tissue to the surgical facility where it will ultimately be used. Furthermore, other techniques include the preparation and storage of dried tissue. Whether dried or stored at low temperatures, such tissue products require inconvenient and time-consuming preoperative preparation to make them suitable for surgical use. Moreover, various known storage systems may be limited by the need for specific orientation of the storage system to cover the tissue in the storage fluid, maintain a fluid seal, and prevent fluid leakage.

[0003] The packaging systems and related methods described herein can help overcome some of these problems and / or improve the transport, storage, preoperative preparation, and final use of wet-preserved tissues. For example, in some suitable storage methods, tissues can be stored in preservative solutions that extend their usable shelf life. In some such storage methods, tissues can be held in the preservative solution until they are used in a medical procedure. Furthermore, the packaging systems and related methods described herein can be used for room temperature storage of tissue products. Summary of the Invention

[0004] According to one embodiment, the packaging system may include a retainer and an inner container. The retainer may include a top and a bottom that mate to form a cavity configured to receive and retain one or more medical products therein. The inner container may define an inner region configured to receive the retainer therein. The retainer may include sidewalls forming the cavity, and the sidewalls may include channels configured to fluidly connect the cavity to the inner region of the inner container.

[0005] The packaging system may include one or more of the following features: The inner container may include an inner tray comprising a first portion and a second portion, each of the first and second portions comprising an interlocking portion that forms a seal when joined together. The packaging system may also include an outer container, which may include a well configured to receive the inner container therein. The channel may be formed by an extension and a recess in the sidewall. The extension and the recess in the sidewall may be circular. At least one of the retainer, the inner container, or the outer container may be formed from a plastic material and / or via thermoforming.

[0006] The internal container may be a vial. The vial may include one or more retaining features that project inwardly into the vial and are sized to restrict movement of the retainer when accommodated within the vial. The vial may include one or more surface features configured to inhibit rolling of the vial when placed on a surface. The packaging system may further include a fluid configured to hold one or more medical products within the cavity of the retainer.

[0007] In another embodiment, a method of packaging one or more medical products may include: inserting the medical product into a cavity of a retainer; closing the retainer to seal the medical product; inserting the retainer and the medical product into a portion of an inner container; delivering liquid into the portion of the inner container; attaching another portion of the inner container to the portion of the inner container to seal the retainer and the medical product within the inner container; inserting the inner container, the retainer, and the medical product into an outer container; and covering a portion of the outer container with a sealing material.

[0008] A method of packaging one or more medical products may include one or more of the following features: Closing the retainer may include attaching a connecting portion at the bottom of the retainer to a connecting portion at the top of the retainer to seal the medical product within the cavity of the retainer. Covering the portion of the outer container with the sealing material may include forming a Tyvek seal on the outer container. The medical product may include one or more of nerve tissue, vein grafts, vascular tissue, urinary tissue, tendon, or muscle tissue. The liquid may include a solution containing about 2% to about 15% by volume dimethyl sulfoxide (DMSO) and one or more monovalent and / or divalent metal cations.

[0009] In another embodiment, a method of storing one or more medical products may include: packaging one or more medical products according to a method for packaging one or more medical products; and storing the one or more packaged medical products. The method may further include exposing the one or more packaged medical products to a temperature of approximately -85 degrees Celsius. Storing one or more packaged medical products may include exposing the one or more medical products to a temperature of approximately 15 degrees Celsius to approximately 30 degrees Celsius.

[0010] In another embodiment, a retainer for one or more medical products may include a top and a bottom pivotally connected to the top via a connection. The top and the bottom may cooperate to form a cavity configured to hold one or more medical products therein. The cavity may be fluidly connected to the outside of the retainer. One or both of the top or the bottom may include sidewalls forming the cavity. The sidewalls may include a plurality of channels for fluidly connecting the cavity to the outside of the retainer. The channels through the sidewalls may be formed by circular extensions and recesses in the sidewalls.

[0011] The retainer may include one or more of the following features. The top and bottom may each include a connecting portion configured to secure the retainer in a closed configuration when engaged. The connecting portion of the top may include a hole or a plug, and the connecting portion of the bottom may include a plug or hole configured to mate with the plug or hole of the top. The top and bottom may be formed of plastic and thermoformed.

[0012] A packaging system may include a retainer for one or more medical products and a vial. The vial may include one or more retaining features that project inwardly into the vial and are sized to restrict movement of the retainer when accommodated within the vial. The vial may include one or more surface features configured to inhibit roll-off of the vial when placed on a surface. The packaging system may further include a fluid configured to hold one or more medical products contained within the cavity of the retainer. The vial may be at least partially transparent and formed of one or more of polypropylene, high-density polyethylene, polymethylpentene, ethylene glycol-modified polyethylene terephthalate, or fluorinated ethylene-propylene. The vial may be configured to withstand temperatures ranging from about -85 degrees Celsius to about 50 degrees Celsius.

[0013] Those skilled in the art will understand that the packaging systems, medical products, and methods for storing medical products in packaging systems disclosed herein can be used for surgical procedures in humans and other vertebrates, as well as laboratory studies, comparisons, and analyses, including in vitro analyses.

[0014] Those skilled in the art will also understand that the materials, dimensions, shapes, etc., of the packaging system, the solutions (i.e., preservation solutions, rinsing solutions, etc.), and / or those methods for storing or removing medical products other than those specifically exemplified, can be used in practice with respect to this disclosure without resorting to excessive experimentation. All functional equivalents known in the art of any such materials and methods are intended to be included in this disclosure.

[0015] Other objects, features, and advantages of this disclosure will become apparent from the following detailed description. However, it should be understood that while the detailed description and examples indicate exemplary embodiments of this disclosure, they are presented by way of illustration only, as various changes and modifications within the spirit and scope of the invention will become apparent to those skilled in the art from the detailed description. It should be noted that the fact that a particular compound belongs to one formula does not imply that it does not also belong to another formula.

[0016] Unless the context otherwise requires, the singular forms “a” and “the” include the plural reference. The terms “about” and “approximately” mean nearly identical to a reference number or value. As used herein, the terms “about” and “approximately” should generally be understood to cover ±5% of the specified quantity or value. The term “or” used in the claims is used to mean “and / or” unless explicitly stated to refer only to alternatives or that the alternatives are mutually exclusive, although this disclosure supports the definition of “and / or” referring only to alternatives. As used herein, “another” may mean at least a second or more. As used herein, “adjacent” and “adjacent” are used to indicate that components are in adjacent contact, or separate but arranged close or adjacent. Furthermore, it should be noted that the terms “top” and “bottom” refer to the orientation shown in the figures. However, these terms are relative, and the relative positions or orientations of the various components discussed herein can vary depending on the viewing angle toward the component, the arrangement of the component relative to gravity, etc.

[0017] The terms and expressions used are used as descriptive rather than restrictive terms, and it is not intended to exclude any equivalents of the features or parts thereof shown and described when using such terms and expressions, but it should be understood that various modifications may be made within the scope of the claimed disclosure. Attached Figure Description

[0018] According to this disclosure, Figure 1 An exemplary packaging system in a partially assembled state is shown;

[0019] According to this disclosure, Figure 2 Showing a state in which it is unassembled. Figure 1 Packaging system;

[0020] According to this disclosure, Figures 3A to 3E Show Figure 1Various views of a part of the packaging system;

[0021] According to this disclosure, Figure 4 A flowchart depicting an exemplary method for assembling a packaging system is provided;

[0022] According to this disclosure, Figure 5A Another exemplary packaging system in a partially assembled state is shown, and Figure 5B Showing a state in which it is unassembled. Figure 5A Packaging system;

[0023] According to this disclosure, Figure 6A This illustrates yet another exemplary packaging system in a partially assembled state, and Figure 6B Showing a state in which it is unassembled. Figure 6A The packaging system; according to aspects of this disclosure, Figure 6C It shows a state of being open. Figure 6A It is part of the packaging system. Detailed Implementation

[0024] Generally, various embodiments of this disclosure may relate to packaging systems. In some embodiments, the packaging system may be used to package one or more medical products, such as one or more tissue samples, neural grafts (e.g., Axogen's). Products such as Nerve Graft are designed for use in conjunction with a variety of surgical procedures. In some examples, the packaging system may allow the medical product to be packaged in a liquid that facilitates storage and / or preservation of the medical product at room temperature (e.g., ranging from about 15 degrees Celsius to about 30 degrees Celsius). In some embodiments, the liquid may include a preservative liquid and / or solution. Furthermore, in some example embodiments, the packaging system consistent with this disclosure may include features that facilitate manipulation of the medical product contained therein when removing tissue samples from the packaging and / or during other operations. Additionally, the packaging system consistent with this disclosure may include one or more materials and / or forms that allow the medical product to be packaged in one or more packaging components, such as those facilitating storage and / or preservation of the medical product at room temperature (e.g., ranging from about 15 degrees Celsius to about 30 degrees Celsius). In some aspects, the packaging system consistent with this disclosure may allow the medical product to be packaged and stored in a liquid. Medical products may be contained in one or more packaging components formed of one or more materials and / or in one or more forms, which facilitates the storage and / or preservation of the medical products, including when exposed to temperatures colder and warmer than room temperature (e.g., in the range of about -85 degrees Celsius to about 50 degrees Celsius) and / or within a temperature range suitable for storing the medical products.

[0025] Figure 1The packaging system 100 is shown in a partially assembled state, and Figure 2 A packaging system 100 in its unassembled state is shown. The packaging system 100 includes a retainer 102. The retainer 102 may hold, seal, or otherwise support one or more medical products 104. The packaging system 100 may also include an inner container, such as an inner tray 106, and an outer container, such as an outer tray 108. The inner tray 106 and the outer tray 108 may at least partially surround the retainer 102, for example, to seal or contain fluid 110, such as a preservation liquid, and / or provide a sterile barrier. Figure 1 As shown, when the packaging system 100 is assembled, fluid 110 can surround the medical product 104. In some respects, fluid 110 can help, for example, preserve the medical product 104 at room temperature. Although not shown, removable sealing material can be deposited on at least a portion of the outer tray 108 to form a barrier or coating on the outer tray 108, including protecting the sterility of the components sealed therein.

[0026] It should be noted that while reference has been made to packaging system 100 for encapsulating medical product 104, packaging system 100 can be used for any product intended to be partially or completely immersed, coated, or otherwise surrounded by a fluid. Furthermore, while reference has been made to fluid 110, it should be noted that fluid 110 can be one or more liquids that facilitate the use of medical product 104, such as one or more tissue samples (e.g., from animals, from humans, or other synthetic or cultured tissue samples), including neural grafts (e.g., Axogen's). Storage and / or preservation of Nerve Graft, etc.

[0027] For reference Figures 3A to 3EAs shown in further detail, the retainer 102 may include a generally clamshell-shaped design, such as a top 102a and a bottom 102b pivotally connected via a connector 112. In some aspects, the connector 112 may be formed by a coined hinge. For example, the connector 112 may include a material that is narrower or smaller in width and / or thickness than adjacent portions of the retainer 102. In some aspects, the connector 112 may include a denser material than adjacent portions of the retainer 102. In these aspects, the connector 112 may help maintain the orientation of the retainer 102, for example, in a closed configuration and / or in one or more open, partially open, or fully open configurations such as between the top 102a and the bottom 102b. This allows the user to open the retainer 102 so that when the user releases the retainer 102 or a portion thereof, the top 102a and the bottom 102b generally maintain their position relative to each other. For example, a user can open the retainer 102 and place it relatively flat, so that the top 102a and bottom 102b are oriented approximately 180 degrees to each other. The retainer 102 can generally maintain this orientation when the user releases the retainer 102 or a portion thereof. In another example, a user can open the retainer 102 and fold it back onto itself, so that the top 102a and bottom 102b contact each other. The retainer 102 can maintain this orientation when the user releases the retainer 102 or a portion thereof. In some embodiments including the precision hinge connection 112, the ability of the top 102a and bottom 102b to maintain their relative orientation once the user has released the retainer 102 or a portion thereof makes it easier for the user to remove the medical product 104 from the retainer 102.

[0028] The retainer 102 may be generally rectangular and may include, for example, a free end 114 opposite to the connecting portion 112. However, although not shown, the retainer 102 may be generally circular, elliptical, triangular, pentagonal, or other suitable shapes, which may or may not correspond to the medical product 104. The retainer 102 may include one or more connecting portions 116, for example, on one or more of the connecting portion 112 or the free end 114. The connecting portion 116 may include mating protrusions and recesses (e.g., plugs / holes) arranged to form a frictional fit, a push fit, a snap fit, etc., to form a releasable fixation mechanism, as shown in the reference. Figures 3A to 3E As discussed in detail below. Although the portions of the retainer 102 are referred to herein as the top and bottom, it should be noted that these terms are relative and that, during assembly, the top 102a or the bottom 102b may be higher or lower than the other portions relative to gravity.

[0029] When connecting in a closed form, such as Figure 1 and Figure 2As shown, top 102a and bottom 102b may together define and / or cooperate to form a cavity 118, for example, for receiving a medical product 104. The cavity 118 shown is typically rectangular and may be formed at least partially by sidewalls 120. The width, length, and depth of the cavity 118 may vary depending on the size, shape, or other details of the medical product 104 to be held within the cavity 118. The cavity 118 can be of any suitable shape and may or may not correspond to the shape of the medical product 104 to be contained therein. Furthermore, the retainer 102 may include one or more channels 122, for example, extending laterally through the sidewalls 120 of the retainer 102 to fluidly connect the cavity 118 to the outside of the retainer 102, for example, to an inlet / outlet of the inner tray 106 when the retainer 102 is located within the inner tray 106. Figures 3A to 3E As shown, channel 122 may be formed by extensions 124 and recesses 126 in one or more sidewalls 120 of the top 102a or bottom 120b. For example, as Figure 3C As shown, the bottom 102b may include a channel 122, and the top 102a may be sized to fit within a portion of the channel 122. On one hand, although not shown, the extension 124 and the recess 126 may be located on the top 102a and bottom 102b in a manner that is at least partially offset, for example, so that the top 102a and bottom 102b can be joined by interlocking an extension 124 from the top 102a into a recess 126 in the bottom 102b, or vice versa. For example, the extension 124 may be only partially accommodated within the recess 126, so that the opening between the top 102a and bottom 102b forms a channel 122. Furthermore, on the other hand, although not shown, the top 102a and bottom 102b may each include a sidewall 120, so that when joined in a closed configuration, the sidewalls 120 of the top 102a and bottom 102b at least partially overlap but also form the channel 122.

[0030] In some aspects, medical product 104 may include tissue. For example, medical product 104 may include human or animal tissue, or may be synthetic or cultured tissue. Examples of tissues that may be used in conjunction with this disclosure may include, but are not limited to, neural tissue or grafts (e.g., Axogen). Nerve grafts, vascular tissues, urinary tissues, tendons, muscle tissues, etc.

[0031] The retainer 102 may be located within the internal tray 106. For example... Figure 2As shown, the inner tray 106 may include a first portion 106a and a second portion 106b, which may engage with each other, for example, via a friction fit, a push fit, or a snap fit, to enclose the retainer 102, the medical product 104, and the fluid 110. The first portion 106a may include a first pouch 130a, and the second portion 106b may include a second pouch 130b. Pouches 130a and 130b may be, for example, semi-cylindrical recesses in the first portion 106a and the second portion 106b. Thus, when the first portion 106a and the second portion 106b are joined together, pouches 130a and 130b may form a generally cylindrical hollow cavity to accommodate the retainer 102, the medical product 104, and the fluid 110. The first portion 106a and the second portion 106b, as well as the pouches 130a and 130b, may be of any suitable shape and may or may not correspond to the shape of the retainer 102 to be contained therein.

[0032] The first portion 106a and the second portion 106b may each include an interlocking portion. For example, the first portion 106a may include a first interlocking portion 132a, which may be formed by a protrusion extending out of the plane formed by the first portion 106a. The second portion 106b may include a second interlocking portion 132b, which may be formed by a recess recessed into the plane formed by the second portion 106b. The connection between the first interlocking portion 132a and the second interlocking portion 132b can help form a seal between the first portion 106a and the second portion 106b, for example, inhibiting or completely preventing fluid (e.g., fluid 110) from leaking out of the inner tray 106. The interlocking portions 132a and 132b may include a generally elliptical shape, which facilitates the connection between the first portion 106a and the second portion 106b. The generally elliptical shape of the interlocking portions 132a and 132b can also form a seal that inhibits or completely prevents fluid 110 from leaking from the inner tray 106. For example, the elliptical shape of the interlocking portions 132a and 132b can generate a generally uniform radial force (e.g., a generally uniformly distributed force) between the interlocking portions 132a and 132b, and can form a sealed bag between the first portion 106a and the second portion 106b. Alternatively, the interlocking portions 132a and 132b can include one or more other shapes without limitation (e.g., generally circular, generally triangular, generally rectangular, etc.), which can also help form a seal that inhibits or completely prevents fluid 110 from leaking from the inner tray 106.

[0033] In addition, such as Figure 1 As shown, in some embodiments, the inner tray 106 may include a coupling portion 134, which may include a mating arrangement of protrusions and recesses (e.g., bolts / holes). For example, as Figure 2As shown, the first portion 106a may include a first connecting portion 134a, which may include a bolt or other suitable protrusion, and the second portion 106b may include a second connecting portion 134b, which may include a hole, opening, or other suitable recess. When the first and second portions 134a and 134b mate with each other, they can align the first and second interlocking portions 132a and 134b together and help secure the first portion 106a and the second portion 106b together. On the one hand, as Figure 2 As shown, the first portion 106a may include a tapered side portion 136a, and the second portion 106b may include a tapered side portion 136b. The tapered sides 136a and 136b may serve as interlocking portions 134a and 134b adjacent to the first and second portions 106a and 106b or at the same ends of the first and second portions 106a and 106b (e.g., adjacent to or at the same ends of bags 130a and 130b). Furthermore, when the first portion 106a and the second portion 106b are joined together to seal into the retainer 102, the retainer 102 may be at least partially secured relative to the first portion 106a and the second portion 106b. For example, one or more portions of the retainer 102 may be partially compressed or otherwise secured between the first portion 106a and the second portion 106b, so that the retainer 102 does not move substantially within the internal tray 106, for example, during storage, transport, preoperative handling, etc.

[0034] The outer tray 108 may include a generally elliptical shape. On one hand, the outer tray 108 includes a flat end 108a and a rounded end 108b. The flat end 108a and the rounded end 108b may be connected by sides 108c and 108d, which may be generally straight. The outer tray 108 includes a well 140, and the well 140 is configured to receive at least a portion of the inner tray 106. For example, the well 140 may be formed by a serrated portion of the outer tray 108 extending into the plane formed by the outer tray 108. Alternatively, although not shown, the outer tray 108 may be of any suitable shape and may correspond to or not correspond to the shape of the inner tray 106 to be received therein.

[0035] Furthermore, well 140 may include one or more layers or one or more portions with different depths. For example, well 140 may include a central portion 140a and may include one or more edge portions 140b. The central portion 140a may be deeper than the edge portions 140b. For example, the edge portions 140b may be angled (e.g., 45 degrees) to transition from the edge of the outer tray 108 and the central portion 140a. In some aspects, the outer tray 108 may include, for example, a tab or recess portion 142 adjacent to or connected to well 140. In these aspects, the inner tray 106 may be located within well 140, and although not shown, a sealing material (e.g., a seal formed of high-density spun-bound polyethylene fibers or...) may be present. A seal may be deposited on well 140 to form a sterile coating or barrier on a portion of outer tray 108, which maintains the sterility of outer tray 108 and its contents.

[0036] Since the inner tray 106 is located within the well 140 of the outer tray 108, the tapered side 136 formed by the tapered sides 136a and 136b can be aligned with or located adjacent to the recessed portion 142, such as Figure 1 As shown. The notch 142 is configured to assist a user in operating (e.g., removing) the sealing material from the outer tray 108 and opening the outer tray 108 to expose the inner tray 106 containing the retainer 102 and the medical product 104. Furthermore, the notch 142 assists the user in operating the inner tray 106 (e.g., removing one of the first portion 106a or the second portion 106b) to access the retainer 102 and the medical product 104. In another aspect, the notch 142 may assist the user in grasping, for example, a sterile coating or barrier formed above the outer tray 108, to remove the sterile coating or barrier and thus access the contents of the outer tray 108.

[0037] Returning to well 140, well 140 also helps retain any fluid 110 that may leak from the inner tray 106 during, for example, storage, transport, preoperative treatment, etc. Well 140 may also be configured to retain any fluid 110 that may leak from the inner tray 106 during operations using the packaging, such as when a user opens the packaging system 100 to remove or otherwise access the medical product 104. On one hand, well 140 may include a flat portion that forms a generally flat bottom for the outer tray 108. The flat portion facilitates the stacking or packaging of multiple packaging systems 100 during storage or transport. Furthermore, the generally flat bottom of the outer tray 108 facilitates the placement of the packaging system 100 during opening and / or use of the medical product 104, such as when the outer tray 108 is placed on a flat surface before, during, or after a medical procedure. It should be noted that the size of one or more of the retainer 102, the inner tray 106, or the outer tray 108 can be any suitable size and / or thickness. For example, as described above, the size and / or shape of the retainer 102 may or may not correspond to the size and / or shape of the medical product 104. Additionally, the size and / or shape of the inner tray 106 may or may not correspond to the size and / or shape of the retainer 102, and the size and / or shape of the outer tray 108 may or may not correspond to the size and / or shape of the inner tray 106.

[0038] Figures 3A to 3E Various views of the retainer 102 are depicted. As mentioned above, the retainer 102 includes a top 102a and a bottom 102b, which are connectable by a connecting portion 112. The retainer 102 may also include a connecting end 114. The connecting portion 112 and the connecting end 114 may include one or more connecting portions 116. For example, Figure 3A This is a top view of retainer 102, and Figure 3B This is a side view of the retainer 102. In an embodiment where the top 102a and bottom 102b are connected by a connecting portion 112, the connecting end 114 can be formed from the ends of the top 102a and bottom 102b opposite to the connecting portion 112. Therefore, the ends of the top 102a and bottom 102b forming the connecting end 114 can move relative to each other, for example, by means of movement of the top 102a and bottom 102b using the connecting portion 112. On the other hand, the top 102a and bottom 102b can be, for example, separate portions not connected by the connecting portion 112. In this respect, the top 102a and bottom 102b can be both separable and connectable, for example, via one or more connecting portions 116.

[0039] like Figure 3AAs shown, the retainer 102 includes a cavity 118 configured to receive a medical product 104 (not shown), and the cavity 118 may be formed by a sidewall 120 of one or both of a top 102a or a bottom 102b. As described above, the sidewall 120 includes a plurality of channels 122. Figure 3B As shown, channel 122 may be formed by a plurality of extensions 124 and recesses 126 in the sidewall 120, such as in the bottom 102b. With the top 102a secured to the bottom 102b, channel 122 opens to allow fluid 110 (not shown) to flow between cavity 118 and the pouch formed by the inner tray 106 when the retainer 102 is located within the inner tray 106. However, the extensions 124 and cavity 118 may be configured to hold the medical product 104 in one direction (i.e., a linear direction extending along the length of the retainer 102). Additionally, the extensions 124 and recesses 126 may be circular or include a gradual change in shape, which may help prevent damage to the medical product 104 during insertion into cavity 118, during removal from cavity 118, and / or during storage, transport, preoperative handling, etc. Furthermore, recesses 126 facilitate the operation (e.g., removal) of the medical product 104 from retainer 102. For example, a user can use tweezers, forceps or other suitable medical devices to access the medical product 104, and the medical device can pass through the indentation 126 to access the medical product 104 in the cavity 118.

[0040] The retainer 102 allows the medical product 104 to be removably placed within the cavity 118, and the retainer 102 also protects and / or retains the medical product 104 within the packaging system 100. For example, the retainer 102 can allow a medical product 104, which is relatively small in size compared to the size of the cavity 118, to be held in a desired position and / or shape within the cavity 118. For example, the retainer 102 can be configured to reduce the degree of movement of the medical product 104 within the cavity 118 (e.g., reducing the free space around the sides of the medical product 104 to minimize movement of the medical product 104 within the cavity 118). For example, the thickness of the sidewall 102 can control the width of the cavity 118, which can help limit lateral movement and / or shape changes of the medical product 104 within the cavity 118. Because the retainer 102 can support a relatively small medical product 104 within a relatively large cavity 118, in some illustrative embodiments, the dimensions of the packaging system 100 in various aspects can be designed to facilitate user operation of the packaging system 100 without requiring a high degree of dexterity. Furthermore, the external dimensions of the retainer 102 can approximate the internal dimensions of the inner retainer 106, for example, to reduce the necessary volume of fluid 110, reduce movement of the retainer 102, and help ensure that the medical product 104 remains submerged in the fluid 110. The retainer 102 also facilitates the transfer of the medical product 104 from within the retainer 102 (e.g., within a sterile area) to the treatment site (e.g., to the surgical area) without direct manipulation of the medical product 104. For example, a user can manipulate the retainer 102 to manipulate the medical product 104 without having to manipulate a smaller, more delicate medical product 104. Additionally, although not shown, the cavity 118 of the retainer 102 may include one or more layers or different depths, for example, to accommodate medical products 104 of different sizes, thicknesses, widths, lengths, etc. One or more layers or different depths can be designed to accommodate individual medical products 104, which allows a retainer 102 to be configured to accommodate different medical products 104. In these respects, the retainer 102 can help constrain the shape of the medical product 104 and / or protect the medical product 104 from damage during packaging, storage, transportation, preoperative handling, etc. The retainer 102 can also help ensure that the medical product 104 is surrounded by fluid 110 regardless of the orientation of the packaging system 100.

[0041] Figure 3C This is a perspective view of a retainer 102 in an unconnected state, such as in a partially open state. Figure 3D This is a top view of the retainer 102 in its fully open position, and Figure 3EThis is a side view of the retainer 102 in its fully open position. As shown, the top 102a includes a top cavity 118a, for example, formed by a recessed region within the top 102a (i.e., recessed in a direction extending away from the bottom 102b). The bottom 102b includes a bottom cavity 118b, for example, formed by a sidewall 120. When the top 102a and bottom 102b are joined, the top cavity 118a and the bottom cavity 118b are configured as a cavity 118 to accommodate the medical product 104 and the fluid 110.

[0042] In addition, the top 102a and bottom 102b may include forming one or more connecting portions 116. Figure 1 Features of the retainer 102. For example, top 102a may include one or more holes, openings, or recesses 116a, and bottom 102b may include one or more plugs or protrusions 116b. The one or more holes, openings, or recesses 116a and the one or more plugs or protrusions 116b may be configured to align when the retainer 102 is in a closed position, so that when top 102a is attached to bottom 102b, the plugs 116b engage in the corresponding holes 116a. It should be noted that the holes 116a may not be through holes, but may be recesses in the top 102a, which is closed at one end. In one aspect, retainer 102 may include two sets of corresponding holes 116a and plugs 116b. For example, a first hole 116a and a first plug 116b may be adjacent to the connecting portion 112, and a second hole 116a and a second plug 116b may be adjacent to the connecting end 114, such as the connecting end 114a on top 102a and the connecting end 114b on bottom 102b. In this respect, the plug 116b may be located at the opposite end of the bottom cavity 118b. Furthermore, although a hole 116a is shown on the top 102a and a plug 116b is shown on the bottom 102b, this disclosure is not limited thereto. For example, one or more holes 116a may be located on the bottom 102b, and one or more plugs 116b may be located on the top 102a. Additionally, in one aspect, the top 102a may include a hole 116a at a first end and a plug 116b at a second end. Similarly, the bottom 102b may include a plug 116b at a first end and a hole 116a at a second end, such that when the retainer 102 is closed, each hole 116a is aligned with its corresponding plug 116b.

[0043] The hole 116a and the bolt 116b may include corresponding shapes. For example, as shown, the hole 116a and the bolt 116b may include a generally cylindrical or circular cross-sectional shape, but this disclosure is not limited thereto, as the hole 116a and the bolt 116b may include a triangular cross-sectional shape, a square or rectangular cross-sectional shape, or any other suitable cross-sectional shape. As described above, the connecting portion 112 may include a precision-pressed hinge, and when the hole 116a and the bolt 116b are not connected, the connecting portion 112 may help maintain the orientation of the retainer 102, for example, in one or more open, partially open, or fully open states between the top 102a and the bottom 102b.

[0044] As described above, the packaging system 100 can be configured to contain and encapsulate one or more medical products 104, such as one or more tissue samples, neural grafts (e.g., Axogen's). The packaging system 100 can contain one or more medical products 104 in a fluid 110. The fluid 110 can be biocompatible and can withstand temperatures, for example, between approximately -85°C and approximately 50°C. Furthermore, the fluid 110 can be configured to store the medical product 104 at room temperature, for example, between approximately 15°C and approximately 30°C. Additionally, various components of the packaging system 100 can be biocompatible and can withstand temperatures, for example, between approximately -85°C and approximately 50°C. Furthermore, various components of the packaging system 100 can be configured to hold the medical product 104 and the fluid 110 at room temperature, for example, between approximately 15°C and approximately 30°C. It should be noted that the temperature exposed to the packaging system 100 and the fluid 110 can vary, for example, depending on the type and / or size of the medical product 104, the duration of storage and / or preservation, the sterilization process used in conjunction with the packaged medical product, and / or one or more other or additional factors. Those skilled in the art will understand the appropriate temperature for the type of tissue or other medical product 104 held by the packaging system 100.

[0045] The packaging system 100 may include sufficient fluid 110 such that the medical product 104 is immersed in or otherwise surrounded by the fluid 110 regardless of the orientation of the packaging system 100 relative to gravity. On one hand, the fluid 110 may not completely fill the cavity formed by the inner tray 106, but the cavity may be sized such that any air bubbles within the cavity never come into contact with the medical product 104. In some respects, containing air bubbles within the inner tray 106 when opening the inner tray 106 to access the retainer 102 helps reduce the risk of fluid 110 leaking from the inner tray 106, reduces the risk of overfilling the inner tray 106, and / or helps accommodate expansion of the fluid 110, for example, if it freezes during exposure to lower temperatures.

[0046] As described above, fluid 110 may include one or more liquids that facilitate the storage and / or preservation of tissue samples immersed therein. For example, fluid 110 may facilitate the storage and / or preservation of medical product 104 at room temperature and / or other cooler or hotter temperatures (e.g., about -85 degrees Celsius to about 50 degrees Celsius). According to one example, fluid 110 may include a solution comprising about 2% to about 15% by volume, for example, 5% dimethyl sulfoxide (DMSO). The solution may also be prepared by adding about 150 g / L to about 2.5 g / L of sodium chloride. The solution may also be prepared by adding about 0.3 g / L of potassium chloride. The solution may also be prepared by adding about 0.2 g / L of calcium chloride. The solution may also be prepared by adding about 0.4 g / L of sodium bicarbonate. The solution may further be prepared by adding 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 / or divalent metal cations (e.g., sodium, potassium, magnesium, calcium, etc.), may be used in conjunction with embodiments consistent with this disclosure, which includes the preservation solutions disclosed in U.S. Patent Application No. 16 / 898224 entitled "Wet Preservation of Tissue" and U.S. Patent Application No. 16 / 939889 also entitled "Wet Preservation of Tissue," both of which are incorporated herein by reference in their entirety.

[0047] As described above, the shape of the retainer 102 helps to contain the medical product 104 in a given orientation (e.g., in a straight or linear form) to maintain stability over time and during sterilization (e.g., during radiation irradiation, as discussed further below). The retainer 102 may have a small footprint relative to the packaging system 100 to allow one or more liquid-tight containers (e.g., an inner tray 106) to be positioned around the retainer 102 while maintaining a relatively low volume of fluid 110 to keep the medical product 104 submerged and / or covered in the fluid 110. Furthermore, the smaller size of the retainer 102 and inner tray 106, and the less fluid 110, can reduce manufacturing costs. As previously described, the retainer 102 includes a channel 122 to allow the fluid 110 to interact with the medical product 104 while contained within the retainer 102, and to allow the fluid 110 to effectively flow out of the retainer 102 when the medical product 104 is removed from the inner tray 106 for use in, for example, a medical procedure. In addition, the inner tray 106 and the outer tray 108 can help to catch or retain fluid 110 when the retainer 102 is removed from the inner tray 106. For example, fluid 110 can flow out of the retainer 102 via the channel 122 and can be retained in the inner tray 106, or in the outer tray 108 if the inner tray 106 is located in the outer tray 108.

[0048] One or more components of the packaging system 100 may be formed from one or more plastic materials such as polypropylene, high-density polyethylene, polymethylpentene, ethylene glycol-modified polyethylene terephthalate, fluorinated ethylene-propylene, etc. In some aspects, the plastic material may be formed from one or more copolyesters, polymers, or other combinations of the aforementioned plastic materials. The selected plastic material may be compatible with one or more sterilization technologies, such as gamma sterilization, radiation, or other suitable sterilization technologies, so that the packaging system 100 and any contents (e.g., medical product 104, fluid 110, etc.) may be sterilized before, during, or after the assembly of the packaging system 100. For example, the packaging system 100, medical product 104, and fluid 110 may be frozen (e.g., approximately -85°C) and exposed to cold-chain gamma irradiation.

[0049] In some aspects, one or more components of the packaging system 100 may be formed of an oxygen-impermeable or oxygen-blocking material to prevent or reduce the amount of oxygen migrating into the interior of the packaging system 100 (e.g., into cavity 118), forming an oxygen barrier. Furthermore, the inner tray 106 and the outer tray 108 may form secondary barriers against any potential contaminants reaching the medical product 104 and the fluid 110. For example, the inner tray 106 may form a first barrier against any potential contaminants reaching the medical product 104 and the fluid 110, and the outer tray 108, when covered by a sealing material, may form a second barrier against any potential contaminants reaching the medical product 104 and the fluid 110. In some embodiments, one or more components of the packaging system 100 may be formed of a multilayered plastic material.

[0050] One or more components of the packaging system 100 may be thermoformed, for example, by heating a plastic sheet to a flexible molding temperature to shape the heated sheet into a desired form, and / or trimming the shaped sheet to form a component of a desired shape. Alternatively, one or more components of the packaging system 100 may be formed by injection molding. Furthermore, it should be noted that one or more components of the packaging system 100 may be formed from a different material or via a different forming process than one or more other components of the packaging system 100. Additionally, the materials selected for the various components of the packaging system 100 may depend on the type of fluid 110 used, and the type of fluid 110 used may depend on the type of medical product 104 stored in the packaging system 100. Furthermore, the materials selected for the various components of the packaging system 100 may be at least partially transparent, for example, allowing the visualization of the medical product 104.

[0051] Figure 4 This is a flowchart of a method 400 for sealing a medical product 104 within a packaging system 100. First, method 400 includes step 402, in which one or more medical products are inserted into a channel 118 of retainer 102. Then, method 400 includes step 404, which includes closing retainer 102. As described above, closing retainer 102 may include bending retainer 102 at connection 112 and aligning the connection end 114a of top 102a with the connection end 114b of bottom 102b. Alternatively, as described above, top 102a and bottom 102b may be separate from each other (i.e., retainer 102 may not include connection 112), and retainer 102 may be closed by securing top 102a to bottom 102b.

[0052] Next, method 400 includes step 406, which includes inserting the retainer 102 and the medical product 104 into a portion of the inner tray 106. As described above, the retainer 102 and the medical product 104 may be inserted into a pocket 130a of the first portion 106a or a pocket 130b of the second portion 106b. Then, method 400 includes step 408, which includes delivering fluid 110 into a portion of the inner tray 106. The fluid 110 may surround the medical product 104, for example, by flowing through one or more channels 122 into the cavity 118. Next, method 400 includes step 410, which includes attaching another portion of the inner tray 106 to the portion of the inner tray 106. As described above, step 410 may include aligning and attaching the interlocking portions 132a and 132b and the inner tray connecting portions 134a and 134b.

[0053] Then, method 400 includes step 412, in which the inner tray 106, retainer 102, and medical product 104 are inserted into the outer tray 108. For example, a person assembling the packaging system 100 may manually place the inner tray 106, retainer 102, and medical product 104 into the outer tray 108. Alternatively, a machine (e.g., a robot) may be programmed or otherwise configured to perform one or more parts of method 400, such as inserting the inner tray 106, retainer 102, and medical product 104 into the outer tray 108. Next, method 400 includes step 414, which includes covering at least a portion of the outer tray 108 with one or more sealing materials. In some aspects, step 412 can be optional. For example, in some aspects, the packaging system 100 may include the retainer 102 and the inner tray 106 without the outer tray 108. Thus, in these aspects, step 414 may be modified to include covering at least a portion of the inner tray 106 with one or more sealing materials. Furthermore, although method 400 and the steps included therein are considered relevant to packaging system 100 having inner tray 106 and outer tray 108, method 400 or a portion thereof may be applicable to other containers discussed herein (e.g., aspects of packaging system 500, aspects of packaging systems including vials 660, etc.). Additionally, it should be noted that method 400 may also include an optional step of sterilizing packaging system 100, for example by exposing packaging system 100 to a temperature of approximately -85 degrees Celsius for cold chain gamma irradiation.

[0054] In one aspect, step 408 may include delivering approximately 10 mL to approximately 100 mL of fluid 110 to the inner tray 106. The amount of fluid 110 delivered to the inner tray 106 may depend on one or more of the dimensions of the retainer 102, the medical product 104, or the inner tray 106. In some aspects, if one or more of the retainer 102, the medical product 104, or the inner tray 106 is smaller, a smaller volume of fluid 110 may be delivered to the inner tray 106. Similarly, if one or more of the retainer 102, the medical product 104, or the inner tray 106 is larger, a larger volume of fluid 110 may be delivered to the inner tray 106. For example, in some aspects, step 408 may include delivering approximately 45 mL to approximately 65 mL of fluid 110 to the inner tray 106.

[0055] In some respects, one or both of the inner tray 106 and the outer tray 108 can help retain fluid 110 while the packaging system 100 is open, which can reduce the amount of fluid 110 that may leak out in the sterile areas of the medical procedure and allow for easier cleaning and / or handling. Furthermore, when the retainer 102 and the medical product 104 are removed from the inner tray 106, the channel 122 allows fluid 110 to drain from the retainer 102 and into the inner tray 106 without otherwise interfering with (e.g., not moving, bending, etc.) the medical product 104.

[0056] The various aspects of this disclosure can help contain fluid 110, and fluid 110 can help preserve one or more medical products 104 during the shelf life of the medical product. Packaging system 100 can also help ensure that fluid 110 always covers the medical product, so that the medical product is not exposed to air that could damage it. For example, retainer 102 can help hold the medical product in substantially the same position within packaging system 100. Packaging system 100 can help allow medical product 104 to be positioned in any orientation during, for example, storage, transport, preoperative preparation, etc., while still maintaining a seal to prevent liquid leakage. Retainer 102 can help maintain the mechanical properties of medical product 104 throughout its shelf life, for example by keeping medical product 104 submerged in fluid 110 or otherwise covered by fluid 110. Retainer 102 can facilitate the removal of medical product 104, for example by holding medical product 104 in a specific configuration and / or providing access to medical product 104 via channel 122. For example, medical product 104 can maintain a linear shape and can be sterilized, for example, by gamma radiation.

[0057] Furthermore, the retainer 102, along with the inner tray 106 and outer tray 108, helps maintain a sterile environment within the packaging system 100. Additionally, the retainer 102 is designed to allow a user (e.g., a physician) to remove it from the rest of the packaging system 100, while also allowing fluid 110 to drain from around the medical product 104 (e.g., through channel 122) when the user is preparing to use the medical product, for example, in an operating room environment. For example, fluid 110 and / or rinsing solution can drain from the retainer 102 and then be retained within the inner tray 106 and / or outer tray 108. Furthermore, one or more of the inner tray 106 and outer tray 108 may be designed to generate radial force upon closure (e.g., in a direction outward from the retainer 102) to facilitate the containment of fluid 110. The packaging system 100 helps ensure that the medical product 104 is covered in the fluid 110, while also reducing the amount of fluid 110 needed to immerse or otherwise cover the medical product 104. This can reduce the overall cost and / or difficulty of assembling the packaging system 100, as the fluid 110 may be expensive, difficult to obtain, difficult to produce, etc.

[0058] Figure 5A and 5B An alternative example of a packaging system 100 with similar components to the present disclosure is shown. Figure 5A A portion of the packaging system 500 in a partially assembled state is shown, while Figure 5B A packaging system 500 in an unassembled state is shown. The packaging system 500 includes a retainer 502 configured to hold one or more medical products 504. The packaging system 500 also includes an inner container, such as a capsule 550, and an outer container, such as a tray 508. The retainer 502 may be similar to the retainer 102 described above, and the tray 508 may be similar to the outer tray 108 described above. Furthermore, as... Figure 5B As shown, the packaging system 500 may include a lid 552.

[0059] like Figure 5AAs shown, retainer 502 may be located within pouch 550, and during packaging, fluid 510 may be delivered to pouch 550 to surround retainer 502 and medical product 504. Pouch 550 may include a first end 550a and a second end 550b. For example, the first end 550a may be sealed, while the second end 550b may initially be open during packaging, or vice versa, or both ends may be open. During packaging, retainer 502 and fluid 510 may be inserted into pouch 550 through the open end. The amount of fluid 510 delivered to pouch 550 may be sufficient to substantially surround retainer 502 within pouch 550. Approximately 10 mL to approximately 100 mL of fluid 510, such as approximately 45 mL to approximately 65 mL of fluid 510, may be delivered to pouch 550 to cover retainer 502. The open end, in this case the second end 550b, may then be sealed to enclose retainer 502 and fluid 510. If both ends are initially open, one of the open ends can be sealed before fluid 510 is delivered to bladder 550, while the other end can be sealed after fluid 510 has been delivered to bladder 550. In this way, bladder 550 can function similarly to inner tray 106 and contain fluid 510 around retainer 502. Bladder 550 can be formed of a suitable plastic material, such as any of the materials discussed above. One end of bladder 550 can be pre-sealed, and the other end of bladder 550 can be sealed after retainer 502 and fluid 510 have been delivered to bladder 550. Additionally, as mentioned above, fluid 510 can not completely fill bladder 550, thus allowing a small air bubble within the sealed bladder 550. This helps reduce the risk of fluid 510 leaking from bladder 550 when bladder 550 is opened to access retainer 502, helps reduce the risk of overfilling bladder 550, and / or helps contain expansion of fluid 510, for example, if frozen during exposure to lower temperatures.

[0060] like Figure 5B As shown, a sac 550, which houses the retainer 502 and the medical product 504, may be located within a tray 508, for example, within a well 540. The tray 508 can then be sealed as described above. For example, the tray 508 may include a tray sealing portion 554, which may include a sealing material (e.g., adhesive) or be configured to be bonded to a sealing material. The cap 552 may also include a sealing portion 556, which may include a sealing material (e.g., adhesive) or be configured to be bonded to a sealing material. In this respect, the cap 552 may be positioned above the tray 508, such that the sealing portions 554 and 556 are aligned with the tray 508 within the cap 552. Although not shown, the tray 508 and the cap 552 may include one or more of the features described above, such as connecting portions 134a and 134b, a notch 142, etc.

[0061] One or both of sealing portions 554 and 556 may include a sealing material. For example, in one aspect, cap 552 may include an adhesive on sealing portion 556. The adhesive may be applied by a user, may be peeled off by removing a removable film, or may be otherwise attached to and / or peeled off cap 552. Additionally or alternatively, additional mechanisms may be used to assist in attaching cap 552 and tray 508 and forming a seal between cap 552 and tray 508. When cap 554 is positioned above tray 508, tray 508 and cap 554 may seal sac 550, retainer 502, medical product 504, and liquid 510 within tray 508.

[0062] Figures 6A to 6C This illustration shows another alternative example of a system according to the present disclosure having components similar to those of the packaging system 100. Figure 6A The packaging system 600 is shown in its unassembled state, and Figure 6B A packaging system 600 in a partially assembled state is shown. The packaging system 600 includes a retainer 602 configured to hold one or more medical products 604. Figure 6A The retainer 602 is shown in a closed position, while Figure 6C The holder 602 is shown in an open configuration. The packaging system 600 also includes an inner container, such as a vial 660, configured to hold the holder 602. The packaging system 600 may further include an outer container, such as a shell 662, configured to hold the vial 660. However, it should be noted that in some aspects, the packaging system 600 includes the holder 602 and the vial 660, but not the shell 662.

[0063] Similar to retainers 102 and 502, retainer 602 may be formed by a top 602a and a bottom 602b to form a cavity 618 configured to receive and enclose a medical product 604. For example, as Figure 6CAs shown, top 602a may include a top cavity 618a, and bottom 602b may include a bottom cavity 618b to form cavity 618. The width, length, and depth of cavity 618 may vary depending on the size, shape, or other details of medical product 604. As described above, one or more of top 602a and bottom 602b may include sidewalls having one or more channels. Top and bottom 602a and 602b may be separate portions or may be joined at a connection 612, which in some embodiments may include a tapered or narrowed width or thickness. For example, as described above, connection 612 may include a precision hinge. Retainer 602 may also include one or more connecting portions 616, as described above, for example, each connecting portion 616 includes one or more holes, openings, or recesses 616a in top 602a, and one or more plugs or protrusions 616b in bottom 602b, such as... Figure 6C As shown. Furthermore, as... Figure 6A As shown, the retainer 602 may include one or more central connecting portions 616c, such as four connecting portions 616c, which are formed by protrusions and recesses (e.g., pins / holes) to form frictional fits, push-fits, snap-fits, etc., to form a releasable fixing mechanism, as referenced above. Figures 3A to 3E As discussed in detail. For example, the central connecting portion 616c may be formed by one or more holes, openings, or recesses 616d in, for example, the top 602a, and one or more bolts or protrusions 616e in, for example, the bottom 602b, as... Figure 6C As shown.

[0064] In addition, such as Figure 6A As shown, the retainer 602 may include an access tab 614a at the coupling end 614. For example, one of the top and bottom tabs ( Figures 3A to 3E (and 6C) may include a portion wider than the other of the top and bottom to form a take-up tab 614a that assists the user in operating the retainer 602 (e.g., opening the retainer 602 by separating the top and bottom). On the other hand, although not shown, the top connecting end 614 may extend further in a first direction, such as laterally, than the bottom connecting end 614, and vice versa. This relatively greater extension of the top or bottom of the connecting end 614 may form a first take-up tab 614a, and the bottom connecting end 614 may extend further in a second lateral direction than the top connecting end 614 to form a second take-up tab 614a. Furthermore, although not shown, aspects of the retainer 602 (e.g., the take-up tab 614a) may be included in other components of the retainer 102, retainer 502, and / or packaging systems 100, 500, 600.

[0065] Vial 660 includes a vial cavity 664. For example, once the medical product 604 is already in the retainer 602, the retainer 602 and the medical product 604 can be inserted into the vial cavity 664 of vial 660. Figure 6A As shown, the bottom of the vial cavity 664 may include a tapered or narrowed portion 660a, for example, configured to receive part of the connection 612 of the retainer 602, which can help hold and / or secure the retainer 602 within the vial cavity 664. Furthermore, the vial 660 includes a cap 660b, which can be removed to deliver the retainer 602 and the medical product 604. The cap 660b may be a screw cap, a stopper, or other means configured to selectively seal the vial 660. For example, the vial 660 may include a thread 660c, and the cap 660b may include a corresponding internal thread (not shown). The vial 660 and cap 660b may form a liquid-tight container for a liquid (e.g., fluid 110) to help prevent fluid loss via leakage, evaporation, etc. The vial 660 and the retainer 602 within it help ensure that the medical product 604 is immersed in the preservation solution (e.g., fluid 110) regardless of the orientation of the packaging system 600. The internal dimensions of vial 660 can be similar to the external dimensions of retainer 602, for example, to reduce the necessary fluid volume, reduce movement of retainer 602, and help ensure that medical product 604 remains submerged in fluid. In this regard, vial 660 may include a non-circular cross-section (outer or inner circumference) to reduce the amount of fluid required to fill vial 660 and submerge medical product 604. Vial 660 may also include one or more indicators 666, such as indicating the volume of liquid (e.g., fluid 110) within vial 660. In this way, vial 660 can function similarly to the internal tray 106 and sac 550 and contain fluid around retainer 602. For example, as described above, fluid may not completely fill vial 660, thus creating a small air bubble within the sealed vial 660. This helps reduce the risk of fluid leakage from vial 660 when it is opened to access retainer 602, reduces the risk of overfilling, and / or helps accommodate fluid expansion, for example, if it freezes during exposure to lower temperatures.

[0066] Furthermore, vial 660 may include one or more retaining features 660d, such as internal protrusions or fins projecting inward into vial cavity 664, which can help prevent and / or reduce movement (e.g., rotation) of retainer 602 within vial cavity 664 and ensure the medical product 604 is visible, such as for irradiation or user examination. Retaining features 660d may be molded or otherwise formed during the formation of vial 660, added after vial 660 formation, etc. On one hand, retaining features 660d may include one or more retaining features 660d at the top of vial 660 and one or more retaining features 660d at the bottom of vial 660. In this respect, the retaining feature 660d at the top of vial 660 may be spaced from the thread 660c, for example, about 1 to 3 mm or about 2 mm, which helps allow vial 660 to be formed by molding. The opening of vial 660 may be wide enough to accommodate retainer 602 and allow removal of retainer 602 with a user's fingers, tweezers, etc. Furthermore, one or more portions of the cap 660b and / or the vial 660 may include one or more surface features (e.g., protrusions, grooves, etc.) and / or one or more shapes (e.g., an octagonal plane) that can help prevent the vial 660 from rolling when it is tipped over and / or when it is horizontally oriented on a surface. For example, the cap 660b may include one or more protrusions or bumps 660e that can help prevent the vial 660 from rolling when it is horizontally placed on a surface and / or help a user grasp the cap 660b, for example, when the vial 660 is opened to access the retainer 602. Alternatively or additionally, one or more portions of the vial 660, such as the bottom, may include a flat surface 660f. For example, the bottom of the vial 660 may include an octagonal bottom with eight flat surfaces 660f that can help prevent the vial 660 from rolling when it is horizontally placed on a surface and / or help a user grasp the vial 660, for example, when the cap 660b is removed. On the one hand, vial 660 may include, for example, an induced seal below cap 660b, which may help provide an additional sterile barrier. Additionally or alternatively, vial 660 may include a non-circular inner cross-section, which may reduce the amount of fluid (e.g., fluid 110) required to fill vial 660 while still accommodating retainer 602 and / or helping to maintain retainer 602 in a specific configuration within vial 660.

[0067] The shell 662 includes a well 688 configured to receive the vial 660. The shell 662 helps prevent damage to the vial 660, cap 660b, retainer 602, and medical product 604 during storage, transportation, preoperative preparation, etc. The well 688 may include one or more slots 670 configured to receive the vial 660. The well 688 may also serve as a basin for receiving the retainer 602 and medical product 604 during a rinsing step. For example, when preparing to use the medical product 604 (e.g., for implantation), the retainer 602 and medical product 604 can be removed from the vial 660 and positioned within the well 688 for rinsing with a rinsing solution. The well 688 helps retain rinsing solution and / or any liquids, solids (e.g., debris), etc., rinsed off the medical product 604. Furthermore, although not shown, the shell well 688 may include one or more filler lines or other suitable markings, for example, to help the user rinse the medical product 604. It should be noted that one or more retainers 602, vials 660, or shells 662 may be of any suitable size and / or thickness. For example, as described above, the size and / or shape of retainer 602 may or may not correspond to the size and / or shape of medical product 604. Additionally, the size and / or shape of vial 660 may or may not correspond to the size and / or shape of retainer 602, and the size and / or shape of shell 662 may or may not correspond to the size and / or shape of vial 660.

[0068] Additionally, the well 688 may include one or more protrusions 672a, 672b, 672c, which may be connected by relatively narrow or shallow grooves 670. The protrusions 672a, 672b, 672c and the grooves 670 help secure the vial 660 within the housing 662. The protrusions 672a, 672b, 672c also help mitigate impacts on the vial 660 within the housing 662, for example by providing an opening between the exterior of the housing 662 and the vial 660. In one aspect, the protrusions 672a, 672b, 672c may be located at the ends and central portion of the well 688. The housing 662 may further include one or more recesses or tabs 674 (e.g., similar to recess 142) that help a user grasp or otherwise manipulate (e.g., open) the housing 662. The notch 674 or tab can extend from the remainder of the housing 662 at an angle (e.g., between approximately 180 degrees and 0 degrees, approximately 135 degrees, approximately 90 degrees, approximately 45 degrees, approximately 30 degrees, approximately 15 degrees, etc.). Furthermore, in some aspects, the notch 674 or tab can extend from the remainder of the housing 662 at an angle greater than 180 degrees before or after being operated by the user, such as when the housing 662 is opened. Additionally, although not shown, a cap or sealing material may be included around the periphery of the housing well 688 to seal the housing well 688. The cap or sealing material may not be attached to the notch or tab 674, which helps the user separate the cap or sealing material from the housing 662 when opening the packaging system 600. For example, a polyurethane foil cap may be located above the housing well 688. Alternatively or additionally, the cap, seal, or bladder may be located around the entire housing 662. In these respects, the cap can help form a sterile barrier around or inside the shell 662, which facilitates the safe storage, transportation, and pre-operative handling of the packaging system 600, for example, similar to Figure 5B The cover 552 is shown. Furthermore, although not shown, the housing 662 may include one or more connecting portions 134a and 134b, as referenced. Figure 1 and 2 The discussion; or the sealing parts 554 and 556, as referenced. Figure 5A and 5B The discussion includes, for example, measures to help attach the cover to the shell 662. In one example, the shell 662 may include a snap-on cap to seal the vial 660 within the shell 662. In another example, the shell 662 may be sealed to enclose the vial 660, retainer 602, and medical product 604, after which the packaging system 600 may be placed within the capsule and sealed. In yet another example, the shell 662 may be replaced by a capsule or other external container to help form a sterile barrier around the vial 660.

[0069] Although not shown, one or more components of packaging systems 100, 500, and 600 may include spaces for including one or more markings, such as those printed, debossed, embossed, stamped, or otherwise formed on the component. For example, one or more markings may identify one or more medical products 104, 504, and 604 or otherwise provide information to the user (e.g., packaging data, expiration date, compatibility factors, storage instructions, etc.).

[0070] Similar to packaging system 100, packaging systems 500 and 600 help hold one or more medical products in a specific orientation and help ensure that one or more medical products are submerged or otherwise covered in fluid, for example, to help preserve one or more medical products during packaging, storage, transportation, preoperative preparation, etc. Furthermore, packaging systems 500 and 600 help seal one or more medical products and fluids within a sterile area. Packaging systems 500 and 600 help maintain fluid during opening of packaging systems 500 and 600, and also help maintain fluid during the use of one or more medical products in medical procedures.

[0071] The aspects discussed herein, such as packaging systems 100, 500, and 600, facilitate the holding of one or more medical products in a desired orientation (e.g., linearly). For example, depending on the medical product contained, it may be necessary to prevent the medical product itself from bending back, becoming disorganized, curling, deforming, etc. Furthermore, the aspects discussed herein, such as packaging systems 100, 500, and 600, can facilitate the retention of fluid (e.g., fluid 110) within the packaging system, even when exposed to varying temperatures. Additionally, the aspects discussed herein, such as packaging systems 100, 500, and 600, facilitate the retention of fluid so that the fluid surrounds one or more medical products regardless of the orientation of the packaging system. The aspects discussed herein, such as packaging systems 100, 500, and 600 (and the fluid held therein), can be designed to withstand varying temperatures and temperature transitions, such as from room temperature to -85 degrees Celsius and back to room temperature, and / or colder or warmer temperatures. Furthermore, the aspects discussed herein, such as packaging systems 100, 500, and 600, may be at least partially transparent, for example, to allow the user to visualize one or more medical products held therein. Additionally, the aspects discussed herein, such as packaging systems 100, 500, and 600, may facilitate the retention of liquids (e.g., liquid 110 or rinsing solution) when one or more portions of the packaging system are opened and / or when the held medical products are handled and / or removed.

[0072] Other embodiments of this disclosure will be apparent to those skilled in the art in light of the description and practice of the embodiments disclosed herein. While certain features of this disclosure have been discussed in the context of exemplary systems, apparatus, and methods, this disclosure is not limited thereto and includes substitutions and variations of the examples herein based on the general principles disclosed. The description and examples are to be considered exemplary only, and the true scope and spirit of this disclosure are indicated by the following claims.

Claims

1. A packaging system comprising: A retainer comprising a top and a bottom that mate to form a cavity, the cavity being configured to accommodate and retain one or more medical products therein; and An inner container, which is a vial, defines an inner region configured to receive the retainer therein, wherein the inner container includes one or more retaining features that project inwardly into the inner region, and wherein the dimensions of the one or more retaining features are designed to restrict movement of the retainer when it is received within the inner region of the inner container; The retainer includes a sidewall forming the cavity, and the sidewall includes a channel configured to fluidly connect the cavity to the interior region of the inner container.

2. The packaging system as claimed in claim 1, wherein, The internal container includes an internal tray, which includes a first part and a second part, wherein the first part and the second part each include an interlocking part that forms a seal when connected together.

3. The packaging system of claim 1 or 2, further comprising: An outer container, wherein the outer container includes a well configured to contain the inner container therein.

4. The packaging system as described in claim 1 or 2, wherein, The channel is formed by the extension and recess in the sidewall.

5. The packaging system of claim 4, wherein, The extension and the indentation in the sidewall are circular.

6. The packaging system as claimed in claim 1 or 2, wherein, At least one of the retainer, the inner container, or the outer container is formed of a plastic material and / or by thermoforming.

7. The packaging system as claimed in claim 1 or 2, wherein, The plurality of retaining features include one or more retaining features at the top of the vial, and wherein the plurality of retaining features include one or more retaining features at the bottom of the vial.

8. The packaging system of claim 7, wherein, The vial includes one or more protrusions, grooves, or flat surfaces on its outer surface, the one or more protrusions, grooves, or flat surfaces being configured to inhibit the rolling of the vial when it is placed on the surface.

9. The packaging system of claim 1 or 2, further comprising a fluid configured to retain one or more medical products within the cavity of the retainer.

10. The packaging system of claim 2, wherein, The top and the bottom are pivotally connected by a connecting portion located at their respective ends, wherein the ends of the top and the bottom opposite the connecting portion are free ends, wherein the free end of one of the top or the bottom includes a mating protrusion, and wherein the free end of the other of the top or the bottom includes a recess configured to receive the mating protrusion to releasably secure the top and the bottom together.

11. A method of packaging one or more medical products, the method comprising: A medical product is inserted into the cavity of a retainer, wherein the retainer includes a top, sidewalls, and a bottom that mate to form the cavity, the cavity being configured to receive and retain the medical product therein, and wherein the sidewalls include channels configured to fluidly connect the cavity to an internal region of an inner container, the inner container being a vial; Close the retainer to seal the medical product; The retainer and the medical product are inserted into a portion of the inner container, wherein the inner container defines an inner region configured to receive the retainer therein, wherein the inner container includes one or more retaining features that project inwardly into the inner region, and wherein the dimensions of the one or more retaining features are designed to restrict movement of the retainer when it is received within the inner region of the inner container; Liquid is delivered into said portion of the internal container; Connect another portion of the inner container to the first portion of the inner container to enclose the retainer and the medical product within the inner container; Insert the inner container, the retainer, and the medical product into the outer container; and A portion of the outer container is covered with sealing material.

12. The method of claim 11, wherein, Closing the retainer includes attaching a connecting portion at the bottom of the retainer to a connecting portion at the top of the retainer to seal the medical product into the cavity of the retainer.

13. The method of claim 11, wherein, Covering the portion of the outer container with the sealing material includes forming a Tavik seal on the outer container.

14. The method of claim 11, wherein, The medical products include one or more of the following: nerve tissue, vein grafts, vascular tissue, urinary tissue, tendon or muscle tissue.

15. The method of claim 11, wherein, The liquid includes a solution containing 2% to 15% by volume dimethyl sulfoxide (DMSO) and one or more monovalent and / or divalent metal cations.

16. A method for storing one or more medical products, said method include: The method of claim 11 is used to package one or more medical products; and Store one or more of the packaged medical products.

17. The method of claim 16, further comprising: Expose one or more packaged medical products to a temperature of -85 degrees Celsius.

18. The method of claim 17, wherein, Storing the one or more packaged medical products includes exposing the one or more medical products to temperatures between 15 degrees Celsius and 30 degrees Celsius.

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