Container and method for preserving or transporting biological material

Abstract

A container for transporting or storing biological material includes a bag-like member (1) comprising a first layer (2) having an outer peripheral edge (3) and a second layer (4) having an outer peripheral edge (5). The outer peripheral edge of the first layer is adjacent to the outer peripheral edge of the second layer around a circumference, and a phase change material (PCM) is present between the first and second layers. The bag-like member may also include a sealed first end (6) and an opening defined in the second end (7). In an alternative embodiment, the container comprises a bowl shape.

Description

[0001] Related applications This application claims priority to U.S. Provisional Patent Application No. 63 / 545,589, filed October 25, 2023, the entire contents of which are incorporated herein by reference. Technical Field

[0002] This disclosure generally relates to containers and methods for preserving or transporting biological materials, and particularly to containers and methods for preserving or transporting biological materials using phase change materials (PCM). Summary of the Invention

[0003] One embodiment is a container for storing biological material, comprising a phase change material sealed between a first layer and a second layer, the first and second layers forming the walls of the container, the container being configured to contain and retain the biological material therein.

[0004] Another embodiment is a method for preserving biological material, comprising providing the biological material with a container according to the above embodiment, placing the biological material in the container, and preserving the biological material in the container for a period of time, preferably at least 30 minutes.

[0005] Another embodiment is a method for transporting biological material, comprising providing the biological material with a container according to the above embodiment, placing the biological material into the container, and transporting the biological material within the container. Attached Figure Description

[0006] Figure 1A -B illustrates a container for biomaterials according to some implementation schemes.

[0007] Figure 2 A container for biomaterials according to some embodiments is shown.

[0008] Figure 3 A container in the form of a bag with a drawstring is shown according to some embodiments.

[0009] Figure 4A A container with a removable top and / or bottom is shown according to some implementation schemes.

[0010] Figure 4B The diagram illustrates the relationship between [various implementation schemes] and [other schemes]. Figure 4A The container has a removable top and / or bottom.

[0011] Figure 5A -B shows different options for the shape of the pouch containing phase change material according to some implementation schemes.

[0012] Figure 6It is a graph showing the internal temperature of the container over 6 days.

[0013] Figure 7A Figures B and B show the relationship between temperature and elapsed time for organ storage in conventional ice versus storage in a container according to one implementation scheme.

[0014] Figure 8 The graph shows the relationship between organ storage temperature and elapsed time in a container using conventional ice pretreatment according to one implementation scheme.

[0015] Figure 9A -B shows a graph of the storage temperature of a preservation solution in a container containing biological material according to one embodiment, wherein (A) the container is pretreated and (B) the container is not heated to room temperature before use. Detailed Implementation

[0016] Unless otherwise stated, the singular form (“a” or “an”) refers to one or more.

[0017] As used in this article, the term “about” placed before a specific value may mean ±20% of the value, ±18% of the value, ±15% of the value, ±12% of the value, ±8% of the value, ±5% of the value, ±3% of the value, ±2% of the value, ±1% of the value, or ±0.5% of the value.

[0018] This disclosure provides a container for transporting or preserving biological material. In one aspect, the preservation of biological material is based on the container's ability to maintain an internal temperature within a target temperature range for a desired time period, while also maintaining the biological material in a state suitable for its intended use after being placed in the container. Optionally, the container provides a physical barrier to prevent the biological material from contacting external surfaces or objects. Preferably, the interior of the container is sterile. Optionally, the container has a sealing device to maintain an airtight seal after the biological material is placed therein, preventing air from entering or leaving the container. In another aspect, an outer container may be provided into which the container of the biological material is inserted, wherein the outer container provides physical protection and / or an airtight seal around the container of the biological material. In yet another aspect, the outer layer of the container provides insulation or constitutes a layer of insulating material.

[0019] like Figure 1AAs shown, according to one embodiment, the container may include: a bag-like member 1 including a first layer 2 having an outer peripheral edge 3 and a second layer 4 having an outer peripheral edge 5, the outer peripheral edge 3 of the first layer 2 being adjacent to the outer peripheral edge 5 of the second layer 4 around a circumference; and a phase change material (not shown) inserted between the first layer 2 and the second layer 4. The bag-like member 1 may also include a sealed first end 6 and an opening defined in a second end 7. The bag-like member 1 may be configured to contain and retain biological material 8. Figure 1B An alternative shape for the bag-shaped component 1 of the container in this embodiment is further shown.

[0020] According to another embodiment, the container may include a bowl-shaped structure 20 comprising: a first layer 21 having an outer peripheral edge 22 and a second layer 23 having an outer peripheral edge 24, the outer peripheral edge 22 of the first layer 21 abutting the outer peripheral edge 24 of the second layer 23 around a circumference 25; and a phase change material between the first layer 21 and the second layer 23. The bowl-shaped structure 20 may be configured to contain and retain biological material 8. The container of this embodiment... Figure 2 As shown in the figure. In some embodiments, the bowl-shaped object 20 can be used, for example, to contain (hold, support, accommodate) biological materials (e.g., organs) during surgery to maintain a desired temperature while preventing the biological material from becoming too cold.

[0021] According to another implementation scheme, such as Figure 3 As shown, the container can be in the form of a bag 10, which can optionally be closed by a drawstring 9 or other suitable means (not shown) (e.g., a snap ring, magnet, folding cap, etc.). In some embodiments, the bag 10 includes a sealing reservoir, as shown in reservoir 50, which contains a phase change material. In some embodiments, the volume of reservoir 50 can be reduced as it approaches the drawstring 9 or other closure mechanism to facilitate tightening of the bag 10 near the drawstring 9. For example, the volume of reservoir 50 located near the drawstring 9 is smaller than the volume of reservoir 50 located in the middle of the bag 10. In some other embodiments, the volumes of reservoir 50 are uniform, such that the volume of any one reservoir 50 is the same as the volume of any other reservoir 50.

[0022] According to another implementation scheme, such as Figure 4AAs shown in Figure -B, the container may have a removable panel (as shown in panel 40) and a central portion (as shown in body 30). Panel 40 is configured to serve as the top and / or bottom of the container. In some embodiments, the container includes two panels 40, one for the top of the container and one for the bottom. Panel 40 and body 30 each include at least one tab 11. In some embodiments, panel 40 is configured to be selectively and detachably attached to body 30 via at least one tab 11. The tab 11 can be used to attach panel 40 to body using hook and loop fasteners (e.g., Velcro), straps, magnets, or other suitable means.

[0023] According to another implementation scheme, such as Figure 5A As shown in -B, the phase change plate 60 can be prepared by enclosing the phase change material within a sealed reservoir 50. In some embodiments, such as Figure 5A As shown, the reservoir 50 can be elliptical in shape, for example, arranged parallel to each other and substantially spanning the width of the phase change plate 60. In some other embodiments, such as Figure 5B As shown, the reservoirs 50 can be square in shape, for example, arranged in an array. In other embodiments, the reservoirs 50 can be of any shape. In some embodiments, the phase change sheet 60 includes reservoirs 50, each reservoir 50 being configured with the same shape. In other embodiments, the reservoirs 50 can be of various shapes, such that any one reservoir 50 is elliptical in shape, while any other reservoir 50 is square in shape. Phase change sheets 60 of desired size can be cut from the phase change sheet 60 to fit the design of the container by tearing or cutting between the reservoirs 50 containing the phase change material. The phase change sheet 60 can be used to form, for example, Figure 4A The body 30 and / or other structures shown herein enable the customization of containers, reservoirs, cooling surfaces, etc., to accommodate biomaterials of different sizes, shapes, etc. For example, the teachings herein can enable intraoperative cutting or tearing of the phase change sheet 60 so that healthcare providers can form containers at the point of care for accommodating organs or other biomaterials, maintaining their temperature, and / or transporting them.

[0024] As used herein, the term "biomaterial" can refer to, for example, organs, body fluids, body tissues, cells, or cell cultures, whether naturally occurring or engineered.

[0025] Biomaterials may contain living cells. In some embodiments, biomaterials may be animal-derived materials, i.e., materials derived from animals. In some embodiments, biomaterials may be materials derived from warm-blooded animals (e.g., mammals). For example, biomaterials may be materials derived from primates (e.g., humans or monkeys), pigs, dogs, or rodents (e.g., rats or mice).

[0026] In some implementations, the term "organ" refers to a part or structure of the body adapted to perform one or more specific functions. For example, an organ can be the lungs, liver, kidneys, heart, pancreas, or intestines (including the stomach and gut). The organ can be human, animal, 3D-printed, or bioengineered.

[0027] In some implementations, the body tissue can be connective tissue, muscle tissue, nervous system tissue, or epithelial tissue derived from an animal, which can be a warm-blooded animal, such as a mammal. The tissue can be human, animal, 3D-printed, or bioengineered.

[0028] In some embodiments, the body fluid may be derived from the animal's blood, saliva, excrement, tissue fluid, or blood components, such as serum or plasma, and the animal may be a warm-blooded animal, such as a mammal.

[0029] In some implementations, the biomaterial may include one or more cells or cell cultures, such as germ cells, porcine cells, fetal cells, induced pluripotent stem cells (iPS cells), and embryonic stem cells.

[0030] Containers for preserving biological materials (e.g., ex vivo organs, such as ex vivo lungs) may be able to maintain a desired preservation temperature within the container for at least 30 minutes, at least 1 hour, at least 2 hours, at least 4 hours, or at least 6 hours, or at least 8 hours, or at least 10 hours, or at least 12 hours, or at least 14 hours, or at least 16 hours, or at least 18 hours, or at least 20 hours, or at least 22 hours, or at least 24 hours. The desired preservation temperature may depend on the application. For example, in some embodiments, the preservation temperature may be from about 0°C to about 12°C, or 4°C to 10°C, or 6°C to 10°C, from about 4°C to about 12°C, or from about 6°C to about 12°C, or from about 8°C to about 12°C, or from about 9°C to about 11°C, or about 10°C. Therefore, in some embodiments, the container for preserving biological material may be able to maintain a temperature of about 0°C to about 12°C, or about 4°C to about 12°C, or about 6°C to 12°C, or about 8°C to about 12°C, or about 9°C to about 11°C, or about 10°C within the container for at least 30 minutes, at least 1 hour, at least 2 hours, at least 4 hours, or at least 6 hours, or at least 8 hours, or at least 10 hours, or at least 12 hours, or at least 14 hours, or at least 16 hours, or at least 18 hours, or at least 20 hours, or at least 22 hours, or at least 24 hours. In some embodiments, the preservation temperature may be about 4°C to about 6°C or about 5°C. Therefore, in some embodiments, containers for preserving biological materials (e.g., ex vivo organs, such as ex vivo lungs) may be able to maintain a temperature of about 4°C to about 6°C or about 5°C within the container for at least 30 minutes, at least 1 hour, at least 2 hours, at least 4 hours, or at least 6 hours, or at least 8 hours, or at least 10 hours, or at least 12 hours, or at least 14 hours, or at least 16 hours, or at least 18 hours, or at least 20 hours, or at least 22 hours, or at least 24 hours. In some embodiments, the preservation temperature may be close to human body temperature, for example, about 36°C to about 38°C or about 37°C. Therefore, in some embodiments, containers for preserving biological materials may be able to maintain a temperature of about 36°C to about 38°C or about 37°C within the container for at least 4 hours, or at least 6 hours, or at least 8 hours, or at least 10 hours, or about 12 hours, or at least 14 hours, or at least 16 hours, or at least 18 hours, or at least 20 hours, or at least 22 hours, or at least 24 hours.

[0031] The internal volume of a container used to preserve biological material is sufficient to hold (i.e., contain and retain) the biological material. For example, a bag-like structure (such as...) Figure 1A The internal volume of the bag-like component in -B is sufficient to accommodate the entire biological material (e.g., an organ). The bowl-shaped component (e.g.) Figure 2 The internal volume of a bowl-shaped structure can be large enough to hold an entire biological material, such as an organ.

[0032] In some implementations, the container for storing biological material can be configured to contain, i.e., to contain and maintain a certain volume of physiological solution and / or supporting culture medium, as well as biological material.

[0033] Containers for storing biological materials may also include an external container, such as an external transport container, which may be, for example, an organ transport container. A bag-like component or bowl-like object may be placed inside the external container, for example, such that the walls of the external container surround the bag-like component or bowl-like object containing the biological material therein.

[0034] Containers for preserving biological materials (such as organs or blood) can be used by placing the biological material within the container, such as the internal volume of a bag-like structure or a bowl-like object, and preserving the biological material at the desired preservation temperature provided by the PCM for at least 30 minutes, at least 1 hour, at least 2 hours, at least 4 hours, or at least 6 hours, or at least 8 hours, or at least 10 hours, or at least 12 hours, or at least 14 hours, or at least 16 hours, or at least 18 hours, or at least 20 hours, or at least 22 hours, or at least 24 hours. A preferred time range is 30 minutes to 3 hours.

[0035] In some embodiments, biological materials (e.g., organs, blood, or cell cultures) can be placed in a container without initial pre-cooling of the container, i.e., reducing the temperature inside the container to below ambient or room temperature (e.g., 25°C or 20°C). However, in some other embodiments, biological materials (e.g., organs, blood, or cell cultures) can be placed in the container after initial pre-cooling, i.e., reducing the temperature inside the container to at least 2°C, at least 3°C, at least 4°C, at least 5°C, at least 6°C, or at least 7°C below ambient or room temperature (e.g., 25°C or 20°C).

[0036] Containers used for preserving biological materials (such as organs, blood, or cell cultures) can be used to transport biological materials by placing the biological materials inside the container (e.g., the internal volume of a bag-like component or a bowl-like object) and transporting the biological materials inside the container at the desired preservation temperature.

[0037] After preservation and / or transportation using containers, biological materials (e.g., organs, such as lungs, liver, kidneys, heart, pancreas, intestines (including stomach and gut)) can be transplanted into a subject (e.g., a warm-blooded animal, such as a mammal, such as a human).

[0038] The container disclosed herein for preserving biological materials can significantly reduce the costs associated with the preservation, storage, and / or transportation of biological materials. Furthermore, the container is able to maintain the biological material in a state suitable for its intended use for the duration during which it is contained within the container; for example, it allows a kidney to remain in conditions suitable for transplantation into a recipient after being contained in the container for a period of time.

[0039] Phase change materials Phase change materials (PCMs) are substances that release / absorb sufficient energy during a phase transition to provide useful heat or cooling. In some embodiments, the phase transition of a PCM occurs from one of the two fundamental states of the substance (solid and liquid) to the other. However, in other embodiments, the phase transition of a PCM may occur between non-classical states of the substance, such as between two crystalline structures, where one crystal structure becomes consistent with the other, which may be a higher or lower energy state.

[0040] In some implementations, the PCM can be an organic PCM. Non-limiting examples of organic PCMs include hydrocarbons, such as paraffin (C6H2O). n H 2n+2 ), lipids and sugar alcohols.

[0041] In some embodiments, the organic PCM may be the organic PCM disclosed in U.S. Patent Nos. 10,703,950 and 11,655,408 and US20200108367, the entire contents of each of which are incorporated herein by reference. In some embodiments, the organic PCM may be in a composition, such as one of the compositions in U.S. Patent Nos. 10,703,950 and 11,655,408 and US20200108367.

[0042] Organic PCMs can be polymerized. However, in some embodiments, organic PCMs can be non-polymerized. In some embodiments, organic PCMs may not contain hydrocarbons. In some embodiments, organic PCMs may not contain alkanes. In some embodiments, organic PCMs may not contain octadecane.

[0043] In some embodiments, the organic PCM may be selected from the group consisting of: aliphatic hydrocarbons, halogenated hydrocarbons, waxes, fats, monoglycerides, diglycerides and triglycerides, fatty alcohols, fatty acids, fatty amines, fatty amides, amino acids, amine salts, carbamates, sarcosinates, sugars, sugar alcohols, alcohols, polyesters, ethers, aldehydes, ketones and their esters, salts and mixtures.

[0044] In some embodiments, the organic PCM may be selected from waxes, fats, monoglycerides, diglycerides and triglycerides, fatty alcohols, fatty acids, fatty amines, fatty amides, amino acids, amine salts, carbamates, sarcosinates, sugars and sugar alcohols, and their esters, salts and mixtures.

[0045] In some embodiments, the organic PCM may be selected from fatty acids, fatty alcohols, fatty amines and their derivatives, with fatty acids, fatty alcohols and their derivatives being preferred, especially fatty acids and their derivatives. Suitable derivatives may be esters, amides or salts, with esters or salts being preferred, especially esters.

[0046] In some implementations, the organic PCM may be selected from fatty acids, fatty alcohols and fatty amines, as well as their esters, amides or salts.

[0047] In some embodiments, the organic PCM can be an ester or a diester. In some embodiments, the organic PCM can comprise an ester. In some embodiments, the organic PCM can be composed of an ester. In some embodiments, the organic PCM can comprise a mixture of a first ester and a second ester. In some embodiments, the PCM ester can comprise a straight-chain alcohol. In some embodiments, the PCM ester can comprise a straight-chain carboxylic acid. In some embodiments, the PCM ester can comprise both a straight-chain alcohol and a straight-chain carboxylic acid. In some embodiments, the PCM ester can comprise a monohydric alcohol. In some embodiments, the PCM ester can comprise a monohydric carboxylic acid. In some embodiments, the PCM ester can comprise both a monohydric alcohol and a monohydric carboxylic acid. In some embodiments, the organic PCM can comprise a fatty acid ester or a fatty alcohol ester. In some embodiments, the organic PCM can be composed of a fatty acid ester or a mixture of fatty acid esters.

[0048] In some embodiments, the organic PCM may be selected from the group consisting of: methyl decanoate, methyl undecanoate, methyl laurate, methyl myristate, methyl palmitate, methyl stearate, methyl arachidate, methyl behenate, ethyl decanoate, ethyl undecanoate, ethyl laurate, ethyl myristate, ethyl palmitate, ethyl stearate, ethyl arachidate, ethyl behenate, and mixtures thereof.

[0049] In some embodiments, the organic PCM may be selected from the group consisting of: propyl decanoate, propyl undecanoate, propyl laurate, propyl myristate, propyl palmitate, propyl stearate, propyl arachidate, propyl behenate, butyl decanoate, butyl undecanoate, butyl laurate, butyl myristate, butyl palmitate, butyl stearate, butyl arachidate, butyl behenate, and mixtures thereof.

[0050] In some embodiments, the organic PCM may be selected from the group consisting of: amyl decanoate, amyl undecanoate, amyl laurate, amyl myristate, amyl palmitate, amyl stearate, amyl arachidate, amyl behenate, hexyl decanoate, hexyl undecanoate, hexyl laurate, hexyl myristate, hexyl palmitate, hexyl stearate, hexyl arachidate, hexyl behenate, and mixtures thereof.

[0051] In some embodiments, the organic PCM may be selected from the group consisting of: heptyl octanoate, heptyl nonanoate, heptyl decanoate, heptyl undecanoate, heptyl laurate, heptyl myristate, heptyl palmitate, heptyl stearate, heptyl arachidate, heptyl behenate, octyl heptanoate, octyl octanoate, octyl nonanoate, octyl decanoate, octyl undecanoate, octyl laurate, octyl myristate, octyl palmitate, octyl stearate, octyl arachidate, octyl behenate, and mixtures thereof.

[0052] In some embodiments, the organic PCM is selected from the group consisting of: nonyl propionate, nonyl butyrate, nonyl valerate, nonyl hexanoate, nonyl heptanoate, nonyl octanoate, nonyl nonyl nonyl nonyl nonyl decanoate, nonyl undecanoate, nonyl laurate, nonyl myristate, nonyl palmitate, nonyl stearate, nonyl arachidate, nonyl behenate, decyl acetate, decyl propionate, decyl butyrate, decyl valerate, decyl hexanoate, decyl heptanoate, decyl octanoate, decyl nonyl nonyl decanoate, decyl undecanoate, decyl laurate, decyl myristate, decyl palmitate, decyl stearate, decyl arachidate, decyl behenate, and mixtures thereof.

[0053] In some embodiments, the organic PCM may be selected from the group consisting of: lauryl formate, lauryl acetate, lauryl propionate, lauryl butyrate, lauryl valerate, lauryl hexanoate, lauryl heptanoate, lauryl caprylate, lauryl nonanoate, lauryl decanoate, lauryl undecanoate, lauryl laurate, lauryl myristate, lauryl palmitate, lauryl stearate, lauryl arachidate, lauryl behenate, and mixtures thereof.

[0054] In some embodiments, the organic PCM may be selected from the group consisting of: myristyl formate, myristyl acetate, myristyl propionate, myristyl butyrate, myristyl valerate, myristyl hexanoate, myristyl heptanoate, myristyl caprylate, myristyl nonanoate, myristyl decanoate, myristyl undecanoate, myristyl laurate, myristyl myristate, myristyl palmitate, myristyl stearate, myristyl arachidate, myristyl behenate, and mixtures thereof.

[0055] In some embodiments, the organic PCM may be selected from the group consisting of: cetyl formate, cetyl acetate, cetyl propionate, cetyl butyrate, cetyl valerate, cetyl hexanoate, cetyl heptanoate, cetyl octanoate, cetyl nonanoate, cetyl decanoate, cetyl undecanoate, cetyl laurate, cetyl myristate, cetyl palmitate, cetyl stearate, cetyl arachidate, cetyl behenate, and mixtures thereof.

[0056] In some embodiments, the organic PCM may be selected from the group consisting of: butyl decanoate, methyl laurylate, octyl laurylate, lauryl laurate, lauryl nonanoate, octyl myristate, myristyl nonanoate, nonanoate, methyl myristate, decyl lauryl palmitate, octyl palmitate, lauryl decanoate, cetyl octanoate, methyl palmitate, methyl stearate, lauryl laurate, octyl stearate, decyl palmitate, stearyl nonanoate, lauryl myristate, decyl stearate, stearyl decanoate, and cetyl palmitate. Preferably, the PCM is selected from the group consisting of: decyl laurylate, methyl stearate, methyl palmitate, lauryl laurate, and cetyl palmitate.

[0057] In some embodiments, the organic PCM may be selected from the group consisting of: stearyl formate, stearyl acetate, stearyl propionate, stearyl butyrate, stearyl valerate, stearyl hexanoate, stearyl heptanoate, stearyl octanoate, stearyl nonanoate, stearyl decanoate, stearyl undecanoate, stearyl laurate, stearyl myristate, stearyl palmitate, stearyl stearate, stearyl arachidate, stearyl behenate, and mixtures thereof.

[0058] In some embodiments, the PCM can be an inorganic PCM, such as a salt hydrate, which can be a metal inorganic salt having hydrated water molecules. In some embodiments, the inorganic PCM can have, for example, the formula (M x N y ·nH2O), where n is a positive integer, such as 1, 2, 3, etc. Non-limiting examples of inorganic PCMs include sodium sulfate decahydrate, calcium chloride hexahydrate, and sodium carbonate.

[0059] In some embodiments, PCM may be in the composition, which may also include one or more additional components selected from the group consisting of: nucleating agents, heat stabilizers, antioxidants, flame retardants, structuring agents, binders, inorganic particles (e.g., metals or metal oxides such as silicon dioxide), carbon particles, and mixtures thereof.

[0060] Nucleating agents can be used to prevent the PCM composition from becoming too cold. In some embodiments, the nucleating agent may be selected from fatty acids, fatty alcohols, fatty amides, paraffin wax, polyethers, and mixtures thereof. In some embodiments, the nucleating agent may be a wax. In some embodiments, the nucleating agent may be selected from squalane wax, behenate, stearic acid, lauric acid, myristic acid, palmitic acid, behenic acid, stearyl alcohol, stearamide, beeswax, montane wax, diatomite, graphite, fumed silica, precipitated silica, potassium dihydrogen phosphate, calcium sulfate, and mixtures thereof.

[0061] Heat stabilizers can be used to prevent or delay the thermally induced decomposition or isomerization of PCM compositions. For example, heat stabilizers can prevent or delay the formation of low molecular weight products or isomers resulting from the thermally induced decomposition or isomerization of esters. Heat stabilizers can be selected from phosphites, phosphonites, phosphates, and mixtures thereof.

[0062] Antioxidants can be used to prevent or delay the oxidation of PCM compositions. For example, antioxidants can prevent or delay the formation of products resulting from the reaction of esters with atmospheric oxygen or oxygen free radicals, which may include, for example, alcohols, aldehydes, acids, peroxides, or water. Antioxidants can be selected from phenolic antioxidants, sterically hindered phenolic antioxidants, and thioether antioxidants, and mixtures thereof.

[0063] Flame retardants can be used for fire safety purposes or to comply with fire safety regulations for certain applications of PCM compositions. Flame retardants can be selected from halogenated hydrocarbons, phosphate esters, and mixtures thereof. Flame retardants can also be selected from chloroparaffin, octadecane bromide, pentadecane bromide, nonadecanechalcone bromide, eicosane bromide, docosane bromide, and mixtures thereof. Other possible flame retardants include bis(pentabromophenyl)oxide or bis(tetrabromophenyl)oxide.

[0064] Structurers can be used to help contain PCM compositions. For example, a PCM-containing composition may change from a solid to a liquid state and vice versa multiple times during use, and a structurer can impart a structure to the liquid PCM, making it easier to contain. In some embodiments, the structurer can be a gelling agent. In some embodiments, the structurer can be selected from structured polymers, gelling polymers, thixotropic polymers, and mixtures thereof. In some embodiments, the structurer can be selected from polyamides, polyurethanes, polyethers, polyacrylates, and copolymers and mixtures thereof.

[0065] In some embodiments, the melting point of the PCM or PCM-containing composition may be at least about -10°C, or at least about -5°C, or at least about 0°C, or even at least about 5°C. For example, in some embodiments, the melting point of the PCM or PCM-containing composition may be about 9.5°C. In some embodiments, the melting point of the PCM or PCM-containing composition may be at most 50°C, or at most 40°C, or at most 30°C, or at most 25°C, or at most 20°C. For example, the melting point of the PCM or PCM-containing composition may be in the range of about -10°C to about 50°C, or about -5°C to about 40°C, or about 0°C to about 30°C, or about 5°C to about 20°C, or any value within these ranges. The melting point can be measured by, for example, differential scanning calorimetry (DSC).

[0066] In some embodiments, the latent heat of fusion (i.e., the latent heat of change from solid to liquid) of PCM or a PCM-containing composition can be at least 100 J / g, preferably at least 150 J / g, more preferably at least 160 J / g, and even more preferably at least 170 J / g. In some embodiments, the latent heat of fusion of PCM or a PCM-containing composition can be at most 300 J / g, preferably at most 250 J / g, more preferably at most 230 J / g, and even more preferably at most 210 J / g. In some embodiments, the latent heat of fusion of PCM or a PCM-containing composition can be in the range of 100 J / g to 300 J / g, or 100 J / g to 250 J / g, or 160 J / g to 230 J / g, or 170 J / g to 210 J / g. The latent heat of fusion can be measured, for example, by DSC.

[0067] In some embodiments, the crystallization temperature of the PCM or PCM-containing composition may be at least about -15°C, or at least about -10°C, or at least about -5°C, or at least about 0°C. In some embodiments, the crystallization temperature of the PCM composition or PCM-containing composition may be at most about 45°C, or at most about 35°C, or at most about 30°C, or at most about 25°C. In some embodiments, the crystallization temperature of the PCM or PCM-containing composition is in the range of about -15°C to about 45°C, or about -10°C to about 35°C, or about -5°C to about 25°C, or 0°C to 25°C. The crystallization temperature can be measured, for example, by DSC.

[0068] In some embodiments, the difference between the melting point and crystallization temperature of PCM or a PCM-containing composition may be less than 10°C, or less than 9°C, or less than 8°C, or less than 7°C, or less than 6°C, or less than 5°C, or less than 4°C.

[0069] In some embodiments, the PCM-containing composition may contain at least 75 wt%, or at least 80 wt%, or at least 85 wt%, or at least 90 wt%, or at least 95 wt%. In some embodiments, the PCM-containing composition may contain at most 99.99 wt%, or at most 99.9 wt%, or at most 99 wt%, or at most 95 wt%.

[0070] In some embodiments, the melting temperature of PCM or a PCM-containing composition may be about 9.5°C. In some embodiments, the crystallization temperature of PCM or a PCM-containing composition may be about 6°C. In some embodiments, the melting temperature of PCM or a PCM-containing composition may be about 9.5°C, and the crystallization temperature may be about 6°C.

[0071] Compositions containing PCM are commercially available, for example, from Croda, Inc. and PCM products, Ltd. Non-limiting examples of commercially available PCM-containing compositions include CrodaTherm. TM 5. CrodaTherm TM 6.5 CrodaTherm TM 9.5, CrodaTherm TM 19. CrodaTherm TM 21. CrodaTherm TM 24W, CrodaTherm 37. For example, CrodaTherm TM 9.5 can maintain the temperature at approximately 10°C for at least 24 hours.

[0072] The implementation schemes described herein are further illustrated by the following working examples, but are by no means limited thereto.

[0073] Example Figure 6 Temperature stability of the preservation solution during long-term storage in a PCM container. 4 L of preservation solution was cooled to 4°C and placed inside a PCM container. The container was then placed in a Styrofoam box, with the gaps filled with standard ice. The temperature between the preservation solution bag and the PCM container (blue) and the temperature inside the preservation solution bag (red) were monitored. Temperature monitoring continued for several days.

[0074] Figure 7A-B: Organ storage in conventional ice compared to lung storage in a PCM container. (A) The organ was cryopreserved and then placed in a bag containing a 4°C preservation solution. It was then placed in a cooler and the gaps were filled with conventional ice. The temperature was recorded during the approximately 20-hour storage period. (B) The organ was cryopreserved and then placed in a bag containing a 4°C preservation solution. It was then placed in a PCM container. The PCM container was then placed in a cooler, the gaps were filled with conventional ice, and the organ was stored for approximately 20 hours. In both figures, the brown line represents the removal of the organ from the storage state.

[0075] Figure 8 Pre-treatment of organs stored in PCM containers. Place the PCM containers in a cooler and fill the gaps with regular ice. Keep this in place for 1 hour, then place the cold-preserved organs from the 4°C preservation solution bags into the PCM containers. Monitor the temperature for approximately 20 hours.

[0076] Figure 9A -B: Storage of the preservation solution in the PCM container. (A) The PCM container was pretreated by placing it in a cooler and filling the gaps with regular ice. The 4°C preservation solution bag was then placed into the pretreated PCM container, and the temperature was monitored for approximately 20 hours. (B) The PCM container was not fully warmed to room temperature before the 4°C preservation solution bag was placed inside and stored in a cooler with the gaps filled with regular ice. The brown box indicates the storage time.

[0077] While the foregoing relates to specific preferred embodiments, it should be understood that the invention is not limited thereto. Those skilled in the art will appreciate that various modifications can be made to the disclosed embodiments, and these modifications are intended to fall within the scope of the invention.

[0078] All publications, patent applications and patents cited in this specification are incorporated herein by reference in their entirety.

Claims

1. A container for storing biological material, comprising a phase change material sealed between a first layer and a second layer, the first layer and the second layer forming the walls of the container, the container being configured to contain and retain the biological material therein.

2. The container according to claim 1, further comprising an outer transport container wall.

3. A container for storing biological materials, comprising: A bowl-shaped object comprising a first layer having an outer peripheral edge and a second layer having an outer peripheral edge, the outer peripheral edge of the first layer being adjacent to the outer peripheral edge of the second layer around a circumference; wherein the bowl-shaped object is configured to contain and retain the biomaterial therein; and A phase change material located between the first layer and the second layer.

4. The container according to any one of the preceding claims, wherein the phase change material is an organic phase change material (PCM).

5. The container according to claim 4, wherein the phase change material is octyl laurate.

6. The container according to any one of claims 1-3, wherein the phase change material is an inorganic phase change material.

7. The container according to claim 6, wherein the inorganic phase change material is a salt hydrate.

8. The container according to any one of the preceding claims, wherein the container is capable of maintaining a temperature of at least about 8°C to about 12°C for at least 8 hours.

9. The container according to any one of the preceding claims, wherein the container is capable of maintaining a temperature of about 10°C for at least 8 hours.

10. The container according to any one of the preceding claims, wherein the phase change material has a melting point of about 9.5°C.

11. The container according to any one of the preceding claims, wherein the biomaterial comprises an organ, body fluid, body tissue, cell, or cell culture.

12. The container according to any one of the preceding claims, wherein the biological material is an organ selected from the group consisting of the lungs, heart, kidneys, liver, pancreas and small intestine.

13. The container of claim 11, wherein the biomaterial comprises blood.

14. The container of claim 12, wherein the biomaterial is a lung.

15. The container of claim 11, wherein the biomaterial comprises one or more cells or cell cultures selected from the group consisting of germ cells, porcine cells, fetal cells, induced pluripotent stem cells (iPS cells), and embryonic stem cells.

16. The container according to any one of the preceding claims, wherein the bag-shaped member or the bowl-shaped member is further configured to contain and maintain a volume of physiological solution or supporting culture medium therein.

17. A method for preserving biological material, comprising providing the biological material with a container as described in any one of the preceding claims, placing the biological material into the container, and preserving the biological material in the container for a period of time.

18. A method of transporting biological material, comprising providing the biological material with a container as described in any one of the preceding claims, placing the biological material into the container, and transporting the biological material within the container.

19. The method according to claim 17 or 18, wherein the organ of the biomaterial is an ex vivo organ.

20. The method of claim 19, wherein the organ is a lung.

21. The method according to any one of claims 17-20, wherein the container maintains the temperature of the biomaterial at a temperature of 0°C to 12°C for at least 5 hours.

22. The method according to any one of claims 17-20, wherein the container maintains the temperature of the biomaterial at a temperature of 0°C to 12°C for at least 10 hours.

23. The method according to any one of claims 17-20, wherein the container maintains the temperature of the biomaterial at a temperature of 0°C to 12°C for at least 15 hours.

24. The method according to any one of claims 17-20, wherein the container maintains the temperature of the biomaterial at a temperature of 0°C to 12°C for at least 20 hours.

25. The method according to any one of claims 17-24, wherein the method does not involve cooling the container before placing the biological material into the container.

26. The method according to any one of claims 17-24, wherein the method comprises cooling the container before placing the biological material into the container.

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