FIELD

[0001] Disclosed embodiments are related to a storage arrangement for regulating temperature of a biological sample for transport.

BACKGROUND

[0002] Storage arrangements such as containers have been used in conjunction with various insulation and temperature regulating apparatuses to limit thermal energy transfer from the contents of the storage arrangement to the ambient environment. Specifically, storage arrangements have employed phase change materials to limit thermal energy transfer. Phase change materials can be used to absorb or release thermal energy, and therefore are beneficial for use in applications where it is necessary maintain a sufficiently hot or sufficiently cold environment within the storage arrangement.

SUMMARY

[0003] According to one aspect, a storage arrangement for promoting temperature stability of a biological sample for transport is provided. The storage arrangement may include a container having an interior volume, an open end, and a closed end. The container may have a sample space inside the interior volume configured to receive the sample. The storage arrangement may include a cover configured to cover the open end of the container. The storage arrangement may include a phase change material configured to be received within the interior volume of the container such that a greater amount of the phase change material is disposed between the open end of the container and the sample space than the closed end of the container and the sample space.

[0004] According to another aspect, a storage arrangement for promoting temperature stability of a biological sample for transport is provided. The storage arrangement may include a container having an interior volume and a container sidewall with an exterior surface. The container may contain an open end and a closed end, said container having a sample space inside the interior volume configured to receive the sample. The storage arrangement may include a phase change material configured to be received within the interior volume of the container. The storage arrangement may include a cover configured to cover the open end of the container without projecting into the interior volume of the container. The cover may have a cover sidewall configured to at least partially surround at least a portion of the exterior surface of the container sidewall. The cover sidewall may be configured to extend a predetermined distance along a height of the exterior surface of the container toward the closed end of the container.

[0005] According to another aspect, a storage arrangement for promoting temperature stability of a biological sample for transport is provided. The storage arrangement may include a container with a defined interior volume. The container may contain an open end and a closed end. The container may have a sample space inside the interior volume configured to receive the sample. The storage arrangement may include a cover configured to cover the open end of the container. The storage arrangement may include a phase change material configured to be received within the interior volume of the container. The storage arrangement may include a vessel having a first compartment, a second compartment, and a baffle separating the first compartment from the second compartment. The phase change material may be held in the first and second compartment of the vessel. The baffle may prevent fluid communication between the first compartment and the second compartment of the vessel.

[0006] According to yet another aspect, a storage arrangement for promoting temperature stability of a biological sample for transport is provided. The storage arrangement may include a container having an interior volume, an open end, and a closed end. The container may have a sample space inside the interior volume configured to receive the sample. The storage arrangement may include a cover configured to cover the open end of the container. The storage arrangement may include a phase change material configured to be received within the interior volume of the container. The storage arrangement may include a sample holder configured to receive a sample receptacle and configured to be positioned in the sample space of the container. The storage arrangement may include a motor configured to rotate the sample holder such that the sample holder and motor function as a centrifuge. BRIEF DESCRIPTION OF DRAWINGS

[0007] Non-limiting embodiments that incorporate one or more aspects of the invention will be described by way of example with reference to the accompanying figures, which are not necessarily drawn to scale. For purposes of clarity, not every component may be labeled in every figure, nor is every component of each embodiment of the invention shown where illustration is not necessary to allow those of ordinary skill in the art to understand the invention. In the figures:

[0008] FIG. 1 is a perspective view of one embodiment of a storage arrangement for transport;

[0009] FIG. 2 is an exploded view of the storage arrangement of FIG. 1 along with a shipping box;

[0010] FIG. 3 is a cross-section view of the storage arrangement of FIG. 2;

[0011] FIG. 4A is a perspective view of one embodiment of a holder of a storage arrangement;

[0012] FIG. 4B is a partial cutaway view of the holder of FIG. 4A;

[0013] FIG. 4C is a bottom perspective view of the holder of FIG. 4A;

[0014] FIG. 5 is a cross-section view of another embodiment of a phase change material and associated vessel;

[0015] FIG. 6 depicts the storage arrangement of FIG. 3 with a temperature sensor; and

[0016] FIG. 7 is a cross-section view of another embodiment of a storage arrangement having a centrifuge, where a holder may form part of the centrifuge.

DETAILED DESCRIPTION

[0017] It should be appreciated that aspects of the invention disclosed herein are not limited in application to the details of the construction and the arrangement of components set forth in the following description or illustrated in the drawings. Further, the concepts disclosed herein may be arranged in any suitable combination, as the present disclosure is not limited in this respect. Also, the terminology used herein is for the purpose of description and should not be regarded as limiting.

[0018] The inventors have appreciated that samples, including biological samples, can be damaged and/or otherwise altered when exposed to temperatures above and/or below certain thresholds. When samples are stored for an extended period of time, the samples can be exposed to varying ambient temperatures. Furthermore, when samples are transported (e.g. transported through mail), the samples can also be exposed to varying ambient temperatures for extended periods of time. The inventors have recognized a need to provide a sample storage arrangement that helps to provide a desirable temperature range for the sample in order to promote quality of the sample. In some embodiments, the samples may be biological samples. However, in other embodiments, the samples may be non-biological samples.

[0019] Some aspects described herein relate to use of temperature regulating materials, including phase change materials, and/or insulating apparatuses or materials in storage arrangements such as containers. Such containers may be used for storage and/or transport of samples. The inventors have appreciated that use of phase change materials in some embodiments may be useful, as phase change materials can absorb or release thermal energy to regulate the temperature of the contents of the container. In some embodiments, insulation can be employed on the container itself to limit thermal energy transfer from the contents of the container to the ambient environment.

[0020] Storage arrangements that are employed for use in containing samples can be implemented to promote temperature stability of the samples in response to temperature fluctuations of the ambient environment. Such fluctuations may be, for example, due to shipping.

[0021] In some embodiments, the storage arrangement may include a container that provides a defined interior volume in which a biological sample and phase change material, among other components, may be disposed. The biological sample may be additionally contained within a sample receptacle. The receptacle can serve to ensure that the biological sample is not damaged, or otherwise degraded during transport. The phase change material, hereinafter referred to as “PCM,” may help to regulate the temperature of the sample. In some embodiments, the PCM may be disposed within the container. However, in other embodiments, the PCM may be disposed outside the container, e.g. abutting against an outside surface of the container.

[0022] In some embodiments, the container may have an open end through which the sample and/or phase change material may be received. The open end may be covered with a cover. The inventors have recognized that, in some such embodiments, even if the open end is covered with a cover, the container may be vulnerable to thermal energy transfer at or around the open end of the container. In some embodiments, more thermal energy transfer may occur at or around the open end of the container relative to other locations on the container.

[0023] The inventors have recognized that in some embodiments, the storage arrangement may be disposed in certain positions during shipping such that the sample may be more vulnerable to thermal energy transfer. For example, in some embodiments, the storage arrangement may be positioned on its side which may result in subjecting the sample to more thermal energy transfer. Accordingly, in some embodiments, the storage arrangement may be configured to promote temperature stability of the sample regardless of the orientation of the storage arrangement during shipping. In some embodiments, the mass, shape, dimensional parameters, or other suitable characteristics of one or more components of the storage arrangement (e.g. PCM, cover) may be selectively chosen to promote temperature stability of the sample regardless of the orientation of the storage arrangement during shipping.

[0024] According to one aspect, a storage arrangement may be arranged such that the sample is positioned away from the open end of a container, and at least a majority of the phase change material is positioned between the open end of the container and a sample space in the container where the sample is disposed. In embodiments where the sample is held in a sample receptacle, the sample space may be configured to receive the sample receptacle. In some such arrangements, thermal energy transfer from the open end of the container may be reduced as a result of a greater amount of PCM being positioned between the sample space and the open end of the container. In some embodiments, all of the PCM is positioned between the sample space and the open end of the container. [0025] In some embodiments, the sample space and sample receptacle can be positioned within the container volume at the closed end of the container. The sample space may be positioned at a predetermined distance relative to the closed end of the container to provide sufficient space for a specified majority of the PCM to be positioned between the sample space and open end of the container. For example, in some embodiments, the amount of PCM disposed between the sample space and the open end of the container may be 51 percent, 60 percent, 70 percent, 80 percent, 90 percent, or 100 percent of the total PCM. While these percentages of PCM are disclosed, any other amount of PCM that is greater than 50 percent of the total PCM may be positioned between the sample space and open end of the container as the disclosure is not limited in this regard. In other embodiments, however, 50 percent or less of the total PCM may be positioned between the sample space and open end of the container. [0026] In some embodiments, a storage arrangement may include a vessel used to contain the PCM. The vessel may be configured to be disposed within the container. In some embodiments, the PCM may transition phases of matter at certain temperature thresholds. Therefore, the implementation of a vessel for enclosing the PCM may be beneficial to avoid leakage or undesirable positioning of the PCM within the container. In some embodiments, the vessel may contain an opening to receive the phase change material. In some embodiments, an enclosure such as a cap may be used to close the opening of the vessel. In some embodiments, once the PCM is received within the vessel, the vessel may be permanently secured and sealed with the enclosure. In another embodiment, the enclosure may serve to only temporarily seal the PCM within the vessel. In some embodiments, the enclosure may take the form of a cap. The enclosure may be coupled to the vessel using any suitable mechanical arrangement. The vessel and enclosure may also be of any suitable sizing necessary to provide sufficient volume to receive the PCM. The vessel and enclosure may also be constructed of any suitable material including, but not limited to plastic.

[0027] In some embodiments, a sample holder may also be disposed within the container.

[0028] In some embodiments, a sample holder may include a recess used to receive the sample receptacle.

[0029] In some embodiments, a sample holder may include a support surface that may be used to bear the weight of the PCM vessel. In this configuration, the sample holder may serve to prevent the sample receptacle from bearing some or all of the weight of the PCM vessel. Such an arrangement could, for example, help to prevent damage to the sample receptacle and/or sample.

[0030] In some embodiments, a storage arrangement may include an insulating cover to cover an open end of the container. Such an insulating cover may help to reduce thermal energy transfer through the open end of the container.

[0031] In some embodiments, the cover may extend a predetermined distance along the exterior of the container while also enclosing the open end of the container.

[0032] In some embodiments, a storage arrangement may include a box configured to receive the container. In some embodiments, the box may be a shipping box.

[0033] In some embodiments, a storage arrangement may include an insert configured to be received within the shipping box and configured to abut the base of the container. [0034] The inventors have recognized that, in some embodiments, a storage arrangement may be used to maintain a desired temperature range within the sample space of the container while also being subjected to varying ambient temperatures. In some embodiments, the storage arrangement may be configured to maintain the sample space temperature between 1 degrees Celsius (°C) and 22 degrees Celsius (°C) for at least 53 hours of shipping. In some embodiments, the storage arrangement may also be configured to permit the sample space temperature to rise to 25 °C for a maximum of 3 hours in a 56 hour time period. While these temperature ranges and corresponding time durations are disclosed, the storage arrangement may be configured to maintain any suitable configuration of sample spaces temperatures for any suitable time durations as the disclosure is not limited in this regard.

[0035] In some embodiments, suitable sample space temperature ranges may include, but are not limited to between -10 to 25°C, -5 to 25°C, 0 to 25°C, 1 to 25°C, 1 to 24°C, 1 to 23°C, 1 to 22°C, inclusive, or any other suitable temperature range. In some embodiments, suitable time durations may include, but are not limited to greater than or equal to 1, 2, 3, 5, 10, 15, 20, 25, 30, 40, 50, 60, 75, 100, or more hours.

[0036] The storage arrangement may be subjected to a wide variety of ambient temperatures depending on the season, with notable temperature extremes typically occurring during the summer and winter seasons. The storage arrangement may be configured to maintain a desired range of sample space temperatures while also being subjected to both a “Summer Profile” and a “Winter Profile” of ambient temperatures, where each of the profiles may contain 5 cycle periods with varying ambient temperatures and time durations, as is elaborated on below.

[0037] The Summer Profile is used to test the temperature stability of the storage arrangement when subjected to a hotter range of ambient temperatures that would typically be experienced during shipping in the summer months. Each cycle period of the Summer Profile is performed consecutively within the 56-hour time period. For the first cycle period, the arrangement is subjected to an ambient temperature of 40°C for 8 hours. For the second cycle period, the arrangement is subjected to an ambient temperature of 22°C for 4 hours. For the third cycle period, the arrangement is subjected to an ambient temperature of 40°C for 2 hours. For the fourth cycle period, the arrangement is subjected to an ambient temperature of 30°C for 36 hours. For the fifth cycle period, the arrangement is subjected to an ambient temperature of 40°C for 6 hours. [0038] The Winter Profile is used to test the temperature stability of the storage arrangement when subjected to a colder range of ambient temperatures that would typically be experienced during shipping in the winter months. Each cycle period of the Winter Profile is performed consecutively within the 56-hour time period. For the first cycle period, the arrangement is subjected to an ambient temperature of -10°C for 8 hours. For the second cycle period, the arrangement is subjected to an ambient temperature of 18°C for 4 hours. For the third cycle period, the arrangement is subjected to an ambient temperature of -10°C for 2 hours. For the fourth cycle period, the arrangement is subjected to an ambient temperature of 10°C for 36 hours. For the fifth cycle period, the arrangement is subjected to an ambient temperature of -10°C for 6 hours.

[0039] In some embodiments, the container provides a defined interior volume in which other components of the storage arrangement may be disposed. The container may include an open end, a closed end, and a sidewall to provide the interior volume. In some embodiments, the sidewall may include one or more interior and/or exterior walls. One or more individual compartments may be disposed between the one or more interior and/or exterior walls. The ends and sidewalls of the container may be of any suitable sizing necessary to provide sufficient interior volume to contain components of the storage arrangement as needed. The ends and sidewall of the container may also be of any suitable material composition including, but not limited to stainless steel. The shape of the container may also vary between different embodiments. In some embodiments, the container may have vertically straight sidewalls, or the sidewalls may be formed at a draft angle relative to the closed end of the container, but it would be apparent to one of skill in the art that other suitable sidewall configurations may be used. In one embodiment, the container sidewalls may take the form of a cylindrical shape, but the disclosure is not limited in this regard.

[0040] In some embodiments, the container may also have thermal insulative properties to reduce thermal energy transfer from the sample space of the container. The container may have one or more interior and/or exterior walls which form one or more individual compartments between the walls as described above. Insulation materials including, but not limited to use of a vacuum, foam, aero-gel, air, or gas, may be disposed within the compartments to limit thermal energy transfer across the walls of the container. For example, in one embodiment, the container may have only one interior and exterior wall, forming one individualized compartment in which an insulation material may be disposed. However, in another embodiment, the container may have three interior walls and three exterior walls, therefore forming three individualized compartments in which insulation materials may be disposed. One of skill in the art would recognize that any suitable number of interior walls, exterior walls, and compartments may be implemented to limit thermal energy transfer from the container. The individual compartments may be of any suitable thickness such as 1mm, 10mm, or 100mm, but the disclosure is not limited in this regard. The insulation material disposed within the compartments may also be of any suitable thickness to ensure sufficient insulation of the container sidewalls to limit thermal energy transfer, as would be apparent to one of skill in the art.

[0041] In some embodiments, the sample space of the container may be positioned within the container at the closed end. However, in certain configurations, the sample space may instead be positioned within the interior volume of the container at a predetermined distance away from the closed end of the container.

[0042] In some embodiments, a sample receptacle configured to hold the sample is provided. In one embodiment, the sample receptacle may take the form of a tube, a cube, a rectangular prism, or any other suitable shape. The sample receptacle may also be of any necessary aspect ratio to ensure sufficient volume within the receptacle to contain the sample, while also allowing the sample receptacle to be received within the sample space of the container. In one set of embodiments, the sample receptacle may have an aspect ratio of length to largest cross-sectional dimension of at least about 2: 1, at least about 3: 1, at least about 4: 1, etc. In some embodiments, the sample receptacle may be comprised of materials including, but not limited to, glass or plastics such as polypropylene.

[0043] PCMs include any substance that can be used to release or absorb thermal energy, including, but not limited to, organic, inorganic, and eutectic PCMs. Examples of organic PCMs include, but are not limited to, hydrocarbons such as alkanes (e.g. paraffins), alcohols, fatty acids, and esters. Examples of inorganic PCMs include, but are not limited to, salt hydrates, nitrates, and metallics. Eutectic PCMs include combinations of organic and inorganic PCMs in any suitable arrangement.

[0044] In some embodiments, a storage arrangement may use 0M18P from SAVENRG or the hydrocarbon n-Hexadecane as a PCM.

[0045] In some embodiments, a storage arrangement may use water as a PCM.

[0046] In some embodiments, a storage arrangement may use any PCM with a transition temperature range between 17°C and 19°C and a latent heat of fusion range between 180 Joules per gram and 220 Joules per gram. While these ranges of transition temperatures and latent heat of fusion for a PCM are disclosed, a PCM may have any suitable transition temperature and latent heat of fusion as the disclosure is not limited in this regard. In some embodiments, a PCM may have a transition temperature that is greater than or equal to -20°C, -10°C, 0°C, 10°C, 11°C, 12°C, 13°C, 14°C, 15°C, 16°C, 17°C, 18°C, 19°C, 20°C, 21°C, 22°C, 23°C, 24°C, 25°C, 30°C, 40°C, or 50°C. In some embodiments, a PCM may have a transition temperature that is less than or equal to 50°C,

40°C, 30°C, 25°C, 24°C, 23°C, 22°C, 21°C, 20°C, 19°C, 18°C, 17°C, 16°C, 15°C, 10°C,

0°C, -5°C, -10°C, or -20°C. In some embodiments, combinations of the above-referenced ranges are also possible. For example, in some embodiments, a PCM may have a transition temperature of -20 to 50°C, -10 to 40°C, 0 to 30°C, 10 to 25°C, 12 to 23°C, 14 to 21 °C, or 17 to 19°C, inclusive.

[0047] In some embodiments, a PCM may have a latent heat of fusion that is greater than or equal to 20 Joules per gram, 50 Joules per gram, 100 Joules per gram, 150 Joules per gram, 160 Joules per gram, 170 Joules per gram, 180 Joules per gram, 190 Joules per gram, 200 Joules per gram, 210 Joules per gram, 220 Joules per gram, 230 Joules per gram, 240 Joules per gram, 250 Joules per gram, 300 Joules per gram, 400 Joules per gram, or 500 Joules. In some embodiments, a PCM may have a latent heat of fusion that is less than or equal to 500 Joules per gram, 400 Joules per gram, 300 Joules per gram, 250 Joules per gram, 240 Joules per gram, 230 Joules per gram, 220 Joules per gram, 210 Joules per gram, 200 Joules per gram, 190 Joules per gram, 180 Joules per gram, 170 Joules per gram, 160 Joules per gram, 150 Joules per gram, 100 Joules per gram, 50 Joules per gram, or 20 Joules per gram. In some embodiments, combinations of the above-referenced ranges are also possible. For example, in some embodiments, a PCM may have a transition temperature of 20 to 400 Joules per gram, 50 to 300 Joules per gram, 100 to 250 Joules per gram, 150 to 240 Joules per gram, 160 to 240 Joules per gram, 170 to 230 Joules per gram, or 180 to 220 Joules per gram, inclusive.

[0048] A suitable PCM implemented in a storage arrangement may include any suitable arrangement of these transition temperatures and latent heat of fusion values. [0049] The inventors have recognized a tradeoff between providing a sufficient PCM mass and enabling a compact profile. On the one hand, there may be a desire to maintain a compact profile for the storage arrangement, e.g. to permit ease of transport and/or to occupy less storage space. On the other hand, however, there may need to be a sufficient PCM mass to maintain a desired temperature range of the sample. In some embodiments, the PCM may have a mass of 300 to 800 grams, 300 to 600 grams, 300 to 520 grams, 400 to 520 grams, 425 to 520 grams, 450 to 520 grams, 460 to 520 grams, 440 to 500 grams, 450 to 470 grams, 466 grams, or any suitable mass.

[0050] In some embodiments, the dimensional parameters associated with the PCM, including height and cross-sectional dimensions (e.g. diameter in a cylindrical embodiment of the PCM), may be arranged to provide sufficient temperature stability of the sample space. The inventors have found that, in some embodiments, a larger aspect ratio of length to largest cross-sectional dimension of the PCM may be beneficial in reducing thermal energy transfer from the sample space. In some embodiments, the phase change material in solid form may have a height of greater than or equal to 5, 10, 15, 18, 19, 20, 20.32, 21, 22, 25, 30, or 40 cm. In some embodiments, the phase change material in solid form may have a height of less than or equal to 40, 30, 25, 22, 21, 20.32, 20, 19, 18, 15, 10, or 5 cm. In some embodiments, combinations of the above-referenced ranges are also possible. For example, in some embodiments, the phase change material in solid form may have a height of 5 to 30, 10 to 25, 15 to 25, 18 to 22, 19 to 21, or 10 to 40 cm, inclusive.

[0051] In some embodiments, the phase change material may have a cross-sectional dimension (e.g. diameter) of greater than or equal to 2, 3, 4, 5, 6, 6.35, 7, 7.62, 8, 9, 10, 15, 20 cm, or less than or equal to 20, 15, 10, 9, 8, 7.62, 7, 6.35, 6, 5, 4, 3, 2 cm, or ranges of 2 to 20, 3 to 20, 4 to 15, 5 to 15, 5 to 10, 6 to 8, or 1 to 15 cm, inclusive. It should be appreciated that, in other embodiments, the PCM may have other suitable height and cross-sectional dimensions.

[0052] In some embodiments, the PCM may be incorporated into the container such that the PCM occupies a specified percentage of the interior volume of the container. In some embodiments, the PCM may occupy 45 to 95 percent, 45 to 90 percent, 45 to 80 percent, 50 to 70 percent, 60 to 70 percent, 65 to 70 percent, 67 to 69 percent, or 68.2 percent of the total interior volume of the container, or any other suitable percent. It should be appreciated that, in other embodiments, the PCM may occupy a different amount of space in the interior volume of the container.

[0053] In some embodiments, the PCM may be pre-conditioned to a certain temperature in preparation for shipping and/or storage of the biological sample in the storage arrangement. The temperature to which the PCM is pre-conditioned may vary depending on the ambient temperatures that the storage arrangement may be exposed to. In some embodiments, the PCM may be pre-conditioned to temperatures including, but not limited to 10°C, 12°C, 14°C, 16°C, 18°C, 20°C, 22°C, 24°C or higher temperatures. In some embodiments, the PCM may be pre-conditioned to temperatures including, but not limited to 20°C, 18°C, 16°C, 14°C, 12°C, 10°C, 8°C, 6°C, 4°C, 2°C or lower temperatures. The PCM may be pre-conditioned to a desired temperature using any suitable method to raise or lower the PCM temperature. Further, while the above preconditioning temperatures are specified in some exemplary embodiments of the invention, it should be appreciated that the PCM may be pre-conditioned to any suitable temperature.

[0054] According to another aspect of the invention, the inventors have recognized that providing an insulating cover to cover the open end of the container may be beneficial to decrease thermal energy transfer from the sample space of the storage arrangement.

[0055] In some embodiments, a storage arrangement may include an insulating cover that does not project into the container volume but may extend a predetermined distance along the exterior walls of the container. The inventors have recognized that such a configuration may provide the benefit of allowing more of the internal container volume to be occupied by additional PCM rather than the insulating cover. This may permit a greater mass of PCM to be used, which may help to provide greater temperature stability of the sample.

[0056] In some embodiments, the insulating cover may be constructed of material including, but not limited to, foams such as polystyrene or polyurethane. The insulating cover may also be constructed of a combination of materials. In one embodiment, the insulating cover may interface with the container opening to provide a liquid-tight or airtight seal. In some embodiments, the insulating cover may be secured to the open end of the container by methods including, but not limited to, an interference fit, a threaded fit, a clamped fit, or any other suitable mechanical arrangement.

[0057] As disclosed herein, in some embodiments, the insulating cover may extend a pre-determined distance along the exterior walls of the container towards the closed end of the container. In some embodiments, the insulating cover may extend at least 5 mm, 10 mm, 15 mm, 20 mm, 25 mm, 30 mm, 40 mm, 45 mm, 47 mm, 49 mm, 50 mm, 55 mm, or 60 mm along the container height along the exterior walls of the container. In some embodiments, the cover may extend no more than 70 percent, 60 percent, 55 percent, 50 percent, 45 percent, 40 percent, or 30 percent of the container height. In other embodiments, the insulating cover may be arranged in other configurations, as the disclosure is not limited in this regard. [0058] In the illustrative embodiment of FIG. 1, an assembled state 100 of the storage arrangement includes an insulating cover 103 coupled to a container 102 as shown. In this embodiment, the insulating cover extends a pre-determined distance along the exterior walls of the container.

[0059] As discussed above, in some embodiments, the storage arrangement may include a vessel configured to receive the PCM. In some embodiments, an enclosure, such as a cap, may be used to close off the vessel to contain the PCM.

[0060] In some embodiments, the insulating cover may be configured to cover the vessel and the enclosure in addition to the container opening. In such a configuration, the enclosure and vessel may partially protrude past the opening of the container. In some such embodiments, the insulating cover may be configured to cover the vessel and enclosure while also remaining secured to the container opening. In some embodiments, the insulating cover may have a recess to receive the protrusion from the vessel and enclosure.

[0061] As discussed above, in some embodiments, the storage arrangement may include a holder configured to be positioned within the interior volume of the container, and configured to hold a sample. The holder may be disposed in the container in a variety of configurations. In one embodiment, the holder may abut the closed end of the container interior. In another embodiment, the holder may be positioned away from the closed end of the container at a pre-determined distance within the container volume.

[0062] In some embodiments, the storage arrangement may further comprise a shipping box that may be configured to receive the assembled state of the storage arrangement shown in FIG. 1. The shipping box may be constructed in any suitable arrangement including, but not limited to, cardboard or corrugated boxes. The shipping box may further be of sufficient sizing to allow for the box to receive the assembled state of the storage arrangement.

[0063] In some embodiments, the storage arrangement may further comprise an insert that may be disposed within the shipping box. The insert can be configured to interface with the assembled state of the storage arrangement to provide stability during shipping. In some embodiments, the insert can be constructed from foam or any other suitable material. The insert may interface in a variety of configurations with the assembled storage arrangement. The insert may interface with the storage arrangement in configurations including, but not limited to, the insert only abutting the closed end of the container, or the insert may encompass the closed end of the container and extend a pre- determined distance along the exterior walls of the container. In one embodiment, the insert may have thermally insulative properties.

[0064] As shown in the exploded view of FIG. 2, a storage arrangement may include a container 102, an insulating cover 103, a holder 104, a PCM vessel 105, an enclosure 106, and a sample receptacle 109.

[0065] In some embodiments, a storage arrangement may include a shipping box 101. In some embodiments, a storage arrangement may include an insert 108. The container 102 has an open end 151 and a closed end 152. In some embodiments, the sample receptacle 109 may be positioned within a recess of a holder 104. The holder 104 may be placed into the container 102 such that the sample receptacle is disposed near the closed end of the container. The PCM vessel 105 is inserted into the container 102 and may be placed on top of the holder 104. The insulating cover 103 is then coupled to the open end 151 of the container. The insert 108 may be positioned within the base of the shipping box, and the container 102 with cover 103 and all other components inside the container 102 may then be disposed into the insert 108 within the interior volume of the shipping box 101.

[0066] In some embodiments, at least a portion of the components of the storage arrangement may be offered in the form of a non-assembled kit to the user. When the storage arrangement is provided in this configuration, the user may follow a set of prescribed steps to properly assemble the storage arrangement as follows. First, a sample may be collected and stored in the storage receptacle. Second, the sample receptacle may be placed into the base of the holder. The holder and sample receptacle may then be positioned within the container volume. Next, the vessel containing the PCM can be placed on top of the holder within the container. Next, the insulating cover can be coupled to the open end of the container. The container with the insulating cover and the other internal components within can then be positioned inside of the shipping box. If an insert is included, the container with the insulating cover and the internal components can be positioned on the insert within the shipping box.

[0067] In some embodiments, the PCM may be pre-conditioned by exposing the PCM to a sufficiently hot or sufficiently cold ambient environment for a predetermined amount of time. In some embodiments, a user may conduct the step of pre-conditioning the PCM. [0068] The illustrative embodiment of FIG.3 shows a cross-section view of the fully assembled storage arrangement, including a shipping box 101 and an insert 108 within the shipping box. The storage arrangement includes a container 102 and a holder 104 disposed within the interior volume of the container. The container 102 includes a sample space 170 within which a sample receptacle 109 is received.

[0069] In some embodiments, the sample receptacle 109 is contained within a holder 104. The holder may be interfaced with the vessel 105 that contains the PCM 107. In some embodiments, the holder may also be interfaced with the vessel such that a storage space 171 positioned between the base of the vessel and a surface of the holder is provided, as shown in FIG. 3. The PCM is enclosed within the vessel via the enclosure 106. The insulating cover 103 is interfaced with the container opening, the vessel, and the enclosure. In this embodiment, the insulating cover extends a pre-determined distance DI along the exterior walls 112 of the container. The insert may surround the base of the container while also extending a pre-determined distance D2 along the exterior walls 112 of the container.

[0070] In some embodiments, the holder and vessel may be attached to one another during a manufacturing step prior to being supplied to a user. In some embodiments, the holder and vessel are not configured to be separable from one by a user. In other embodiments, however, the holder and vessel may be detachable from one another by a user.

[0071] The illustrative embodiment of FIG. 4A shows one embodiment of the holder 104 configured to receive the sample receptacle and vessel containing the PCM. The holder can include a bearing surface 111 configured to receive the base of the PCM vessel. In some embodiments, this bearing surface 111 may be spaced relative to an interior bottom surface 121 of the holder. In such embodiments, the bearing surface 111 being spaced relative to the interior bottom surface 121 may serve to provide a storage space 171 (see FIG. 3) positioned between the base of the PCM vessel and the interior bottom surface of the holder 104.

[0072] FIG. 4B further shows a partial cutaway view of the holder 104 in which a recess 110 configured to hold a sample receptacle can be seen.

[0073] In some embodiments, as shown in the bottom perspective view of FIG. 4C, the base 161 of the holder may have an opening 131 through which a sample receptacle can be inserted into to place the sample receptacle into the holder recess 110. In some embodiments, the holder may include a passage 141 between the interior bottom surface 121 and the recess 110, as is described in further detail below.

[0074] According to yet another aspect of the invention, a PCM vessel may include one or more baffles that separate the vessel into distinct compartments filled with PCM. [0075] The inventors have recognized that providing at least one baffle within a PCM vessel may help to reduce thermal energy transfer from the sample space of the storage arrangement.

[0076] In some embodiments, by implementing at least one baffle within the PCM vessel, the PCM vessel is separated into individual compartments. Without wishing to be bound by theory, the inventors have recognized that these individual compartments of PCM separated by baffles may have the benefit of slowing down temperature transitioning of PCM by restricting flow of PCM between compartments as the PCT transition phases of matter.

[0077] For example, in a configuration where PCM is pre-conditioned to a cold temperature, the PCM may gradually change to a liquid state when exposed to a hot ambient environment. Without implementation of a baffle, the PCM could change to a liquid state at a faster rate since all of the PCM would be in contact. However, if the example configuration included at least one implemented baffle, the PCM would be compartmentalized, and therefore as one compartment would transition to a liquid phase, it could have a reduced effect on transitioning the remainder of PCM to a liquid phase. The inventors have appreciated that by slowing down the transitioning of PCM between phases by providing multiple compartments of PCM, the remaining compartments of PCM may be able to maintain the sample space at the desired range of temperatures for a longer duration of time.

[0078] In some embodiments, the implementation of a baffle may help to maintain a desired sample temperature range when the storage arrangement is disposed in non-ideal positions during shipping (e.g. in some embodiments, positioning the storage arrangement on its side may result in the sample being more vulnerable to thermal energy transfer compared to when the storage arrangement is upright). In such a configuration, the baffles can function to restrict the flow of PCM between compartments. The inventors have recognized that compartmentalizing the PCM may help to provide greater temperature stability of the sample space. In some embodiments, the baffle can be constructed of any suitable material such as plastic. In some embodiments, the baffle may be made of the same material as the rest of the PCM vessel. In other embodiments, the baffle is made of a different material as the rest of the PCM vessel.

[0079] The illustrative embodiment of FIG. 5 shows a cross-section view of the PCM vessel 105 containing PCM 107. The vessel may be sealed with the enclosure 106. In this illustrative embodiment, there is a first baffle 181, second baffle 182, and third baffle 183 disposed within the PCM vessel 105. The baffles define separated compartments 191, 192, 193, and 194. The baffles prevent fluid communication between the compartments. For example, the first baffle 181 prevents fluid communication between the first compartment 191 and the second compartment 192.

[0080] While there is a plurality of baffles shown in this illustrative embodiment, it should be appreciated that less or more baffles may be used to create less or more compartments of PCM. In some embodiments, only one baffle is included in the PCM vessel.

[0081] In some embodiments, the baffle may be positioned at any suitable location along the interior of the PCM vessel and may result in equal or unequal sizes of PCM compartments. The baffle may additionally be any suitable thickness.

[0082] In some embodiments, the storage arrangement may include one or more temperature sensors. The inventors have recognized that the inclusion of one or more temperature sensors may be used to monitor the temperature of the sample and/or sample space over time, e.g. during a shipping duration.

[0083] The illustrative embodiment of FIG. 6 shows a cross-section view of the fully assembled storage arrangement of FIG. 3 described above, further including a temperature sensor 172 disposed in the storage space 171. In some embodiments, the temperature sensor may be positioned within the storage space in any suitable configuration including, but not limited to, being attached to the holder by a suitable fastening means such as adhesive, being secured within the storage space via a friction fit, being freely movable within the storage space, or any other suitable configuration. While the temperature sensor is shown as positioned in the storage space in this embodiment, the temperature sensor may be positioned in other suitable locations of the storage arrangement (e.g. the temperature sensor could be positioned below the holder). In some embodiments, only one temperature sensor may be included in the storage arrangement.

In other embodiments, however, a plurality of temperature sensors may be included in the storage arrangement which may be arranged and secured in any suitable manner.

[0084] In some embodiments, the one or more temperature sensors may comprise an electronic device. In some embodiments, the electronic temperature sensors may be used to collect temperature data over a given time duration.

[0085] In some embodiments, the one or more temperature sensors may provide continuous temperature sensing without requiring user activation. For example, in some embodiments, one or more temperature sensors may be activated to start sensing temperature during a manufacturing step prior to being sent to a user.

[0086] In some embodiments, the temperature data from the temperature sensor may be cross-referenced with available shipping data to determine whether the sample was maintained at a desired temperature range during a relevant shipping time window. For example, commercial shipping companies may provide shipping data such as shipping departure and delivery times, which may be compared to time stamps associated with various temperature readings collected by the one or more temperature sensors. This may help to determine which data from the one or more temperature sensors corresponds to the time period during which the storage arrangement was shipped.

[0087] In some embodiments, a user may provide input as to the relevant time window for temperature monitoring. For example, after collecting a sample, a user may register details pertaining to the sample (e.g. date and/or time of sample collection) via a website, mobile application, or through another medium. Such date and/or time may then be cross-referenced with the temperature data from the one or more temperature sensors. [0088] In some embodiments, the one or more temperature sensors may be user activated. For example, in some embodiments, the electronic temperature sensors may be activated by the user through means of a sensor actuator including, but not limited to a button or switch. In such a configuration, the electronic temperature sensors may be disposed in the storage space between the vessel and holder, and the vessel and holder may be detachable from one another such that the user can then contact the sensor actuator disposed at or near the temperature sensor, thereby beginning data collection. [0089] In some embodiments, the electronic temperature sensors may be activated through insertion of a sample receptacle into a recess provided in the holder (see FIGs. 4A-C). In such an embodiment, a sample receptacle containing the sample may contact the sensor actuator to activate the electronic temperature sensors to begin data collection. As described in FIGS. 4A-C, a passage 141 may be provided between a recess 110 and an interior bottom surface 121 of a holder. In such a configuration, one or more temperature sensors may be provided in a storage space above the interior bottom surface 121 as disclosed herein. A sensor actuator may be positioned within the passage 141 such that insertion of the sample receptacle into the recess 110 may cause the sample receptacle to contact and actuate the sensor actuator. While this specific configuration is disclosed, any suitable arrangement of the temperature sensors and sensor actuators may be used as the disclosure is not so limited. [0090] In some embodiments, the temperature data collected from the temperature sensors may be transferred remotely from the temperature sensors for analysis. The data may be transmitted using any suitable method or device including, but not limited to a transmitter receiver device. In other embodiments, however, the temperature data collected from the temperature sensors may be actively transferred using the data stored in the temperature sensor. For example, an electronic temperature sensor comprising a serial port and a means of data storage may be provided, with the data collected during shipping being extractable by via the serial port upon conclusion of the shipping process. While these configurations are disclosed, the data collected by one or more temperature sensors provided in the storage arranged may be collected, extracted, and/or analyzed using any suitable method or device as the disclosure is not so limited.

[0091] In some embodiments, the one or more temperature sensors may take the form of passive (e.g. non-electronic) devices including, but not limited to, temperature indication strips (which can, e.g. be in the form of dots, lines, or any suitable shape). Such temperature indication strips may include varying chemical mixtures produced on substrates, where the chemicals may melt and/or absorb in the substrates at predetermined temperatures. In this process, the melting and/or absorption into the substrates may change the color of the strips, thereby indicating a given temperature. In some embodiments, a suitable predetermined melting temperature may be greater than or equal to -50°C, -40°C, -30°C, -20°C, -10°C, -5°C , 0°C, 1°C, 2°C, 5°C, 10°C, 15°C, 20°C, 21°C, 22°C, 23°C, 24°C, 25°C, 26°C, 30°C, 40°C, or any suitable melting temperature. In some embodiments, a suitable predetermined melting temperature may be less than or equal to 40°C, 30°C, 26°C, 25°C, 24°C, 23°C, 22°C, 21°C, 20°C, 15°C, 10°C, 5°C, 2°C, 1°C, 0°C, -5°C, -10°C, -20°C, -30°C, -40°C, -50°C, or any suitable melting temperature. [0092] The one or more passive temperature sensors may be disposed in the storage arrangement at or near the sample. For example, two temperature indication strips may be provided on the sample receptacle. The first temperature indication strip may be configured to show an indication at or below a lower threshold temperature (e.g., 1°C) and the second temperature indication strip may be configured show an indication at or above an upper threshold temperature (e.g., 25°C). While this specific configuration is disclosed, any number of passive temperature sensors may be provided and arranged in any suitable manner within the storage arrangement for use in providing temperature information of the sample. [0093] According to another aspect, in some embodiments, a storage arrangement may include a centrifuge that may centrifuge a sample receptacle that is held within the storage arrangement. The centrifuge may be sized to fit within the container of the storage arrangement. The storage arrangement may include a holder that receives and retains the sample receptacle. The holder may be connected to a motor that is configured to spin the holder, where the motor is sized to fit within the container. The holder and motor may thus combine to form a centrifuge. This functionality allows for the sample to be separated through centrifugation. In one illustrative example, if blood is held within the sample receptacle, centrifuging the blood sample may separate plasma from blood cells.

[0094] In some embodiments, the motor may automatically turn on to centrifuge the sample receptacle during a step of assembling the storage arrangement. As such, a user may not need to operate the centrifuge directly. In other embodiments, however, a user may directly operate the centrifuge, e.g. to turn the centrifuge on and/or off.

[0095] An illustrative embodiment shown in FIG. 7 shows a cross-section view of a storage arrangement having a motor 283 and holder 204 that is configured to be rotated by the motor 283, where the motor 283 is sized to fit within the container 201. The holder 204 may be configured to receive and retain a sample receptacle 209. A centrifuge may thus be formed by the motor 283 and holder 204. A drive shaft 282 may connect the motor 283 to the holder 204. A power source, such as a battery 281, may be used to power to the motor. The holder 204 is shown positioned within a sample space 270 of the container 201.

[0096] Actuation of the motor 283 may cause the holder 204 to spin, which may in turn cause the sample receptacle 209 held within the holder to spin, thereby centrifuging the sample held within the sample receptacle 209.

[0097] A support 211 may keep a bottom surface 290 of the PCM vessel 205 spaced from an interior bottom surface 292 of the container 201. The support may be attached to the PCM vessel 205, or may be attached to the container 201, or neither. The spacing created by the support 211 may give the holder 204 clearance to rotate relative to the container 201 and/or the PCM vessel 205.

[0098] In some embodiments, actuation of the motor may be triggered by an actuation sensor. An actuation sensor may be, in some embodiments, a power button or switch that a user may directly press, slide, or otherwise directly contact to turn the motor on and/or off. [0099] In other embodiments, however, the motor may automatically turn on to centrifuge the sample receptacle during a step of assembling the storage arrangement. This may allow for the motor to turn on during the packaging process without requiring the user to perform any supplementary actions to turn on the motor.

[0100] In some embodiments, the actuation sensor may detect that a certain step of assembling the storage arrangement has occurred, and in response, trigger the motor to turn on. In one illustrative example shown in FIG. 7, the storage arrangement includes an actuation sensor 280 positioned at a top surface 214 of the PCM vessel 205 that faces the cover 203. When the cover 203 is moved to the closed position to cover the opening 215 of the container 201, the actuation sensor 280 is activated, which then triggers the motor 283 to turn on. In some embodiments, the actuation sensor 280 is a switch, such as a normally open momentary switch. When the cover 203 is moved to the closed position on the container 201, an inner surface 212 of the cover 203 may contact and close the switch 280. Closure of the switch 280 may close a circuit that includes the battery 281, wire 284 and motor 283, and thus the motor may turn on.

[0101] While one illustrative example of the actuator sensor is a momentary switch, it should be appreciated that other types of sensors may be used. For example, the actuator sensor may be a toggle switch or any other suitable switch, an optical sensor, hall effect sensor, a proximity sensor, or any other suitable sensor.

[0102] The sensor 280 may be disposed in any location such that the sensor activates during an assembly step of the storage arrangement. While the actuation sensor 280 is positioned on a top surface 214 of the PCM vessel 205 in the illustrative embodiment of FIG. 7, it should be appreciated that the sensor may be positioned on other surfaces of the PCM vessel (such as a side or bottom surface of the PCM vessel), on the container 201, on the cover 203, on an insert in which the container 201 sits (e.g. see insert 108 in FIG. 3), on a shipping box (e.g. see shipping box 101 in FIG. 3) or any on any other suitable component.

[0103] In some embodiments, the actuation sensor may be positioned on a side surface of the PCM vessel. The sensor may activate when the PCM vessel 205 is inserted into the container 201, for example due to contact and/or proximity with an inner side wall of the container 201.

[0104] In some embodiments, the actuation sensor may be positioned on a bottom surface of the PCM vessel. The sensor may activate when the PCM vessel 205 is inserted into the container 201, for example due to contact and/or proximity with an inner bottom surface of the container 201.

[0105] In some embodiments, the actuation sensor may be disposed on the bottom internal surface of the container 201. The sensor may activate when the PCM vessel 205 is inserted into the container, for example due to contact and/or proximity with a bottom surface of the PCM vessel 205.

[0106] In some embodiments, when the storage arrangement is disassembled, e.g. if the user removes the PCM vessel 205 from the container 201 and/or removes the cover 203 from the container 201, the actuation sensor could automatically deactivate and cause the motor to turn off.

[0107] In some embodiments, such as the illustrative embodiment shown in FIG. 7, the motor may be positioned in a recess 206 in the PCM vessel. In some cases, at least partially surrounding the motor with PCM material may help to offset heat generated from the motor and decrease the amount of heat transferred to the sample.

[0108] In some embodiments, the battery may be designed such that it runs out of power after the sample has separated but before the sample is retrieved from the storage arrangement. This may help to increase energy efficiency and decrease internal heat generation (e.g., from the motor).

[0109] In some embodiments, the holder may hold the sample receptacle at a position that is offset from the rotation axis of the motor shaft 282. In other embodiments, however, the holder may hold the sample receptacle in alignment with the rotation axis of the motor shaft 282.

[0110] While the battery is shown at the top of the container 201 and PCM vessel 205 in the illustrative embodiment of FIG. 7, it should be appreciated that the battery may be disposed in other locations. In some embodiments, the battery may be located at a side of the PCM vessel and/or container, at a bottom of the PCM vessel and/or container, or any other suitable location.

[0111] In some embodiments, the power source may be mounted to the same component as the motor. For example, in the embodiment of FIG. 7, the battery 281 and the motor 283 may both be mounted to the PCM vessel 205. However, in other embodiments, the power source may be mounted to a different component of the storage arrangement. Assembling the storage arrangement together may cause the power source to electrically connect to the motor, thus turning the motor on. In one illustrative embodiment, the power source may be disposed in/on the shipping box 101 or the container 201. The power source may connect to the motor via a connector that becomes electrically connected to the motor during assembly of the storage arrangement. In one example where the power source disposed in the shipping box, one or more electrical contacts that are electrically connected to the motor may align and connect with the connector when the PCM vessel and container are placed into the shipping box, thereby electrically connecting the power source with the motor. In another example where the power source is disposed in the container, one or more electrical contacts that are electrically connected to the motor may align and connect with the connector when the PCM vessel is placed into the container, thereby electrically connecting the power source with the motor. The connector and contacts may thus form an actuation sensor, where the sensor activates when the connector and contacts are connected, and deactivates when the connector and contacts are disconnected.

[0112] In some embodiments, the motor 283 may be permanently or removably attached to the PCM vessel 205 such that when the PCM vessel 205 is moved in and out of the container 201, the motor 283 moves along with the PCM vessel 205. The holder 204 may be permanently or removably rotatably coupled to the motor 283 such that the holder also moves along with the motor and PCM vessel 205 as the PCM vessel 205 is moved in and out of the container 201. Similar to the motor, the battery 287 and wiring 284 may also be permanently or removably attached to the PCM vessel 205.

[0113] In some embodiments, the process of assembling the storage arrangement, e.g. for shipping, includes inserting the sample receptacle 209 into the sample holder 204, inserting an assembly consisting of a sample receptacle 209, sample holder 204, motor 283, PCM vessel 205, and battery 281, into the container 201, and placing a cover 203 on said container. With the cover attached, the container 201 may be placed into a shipping box (see, e.g. shipping box 101 in FIG. 3). The shipping box may include an insert (see, e.g. insert 108 in FIG. 3) that receives the container 201. In other embodiments, a user may first couple the insert to the container while outside the shipping box, and then everything is placed into the shipping box.

[0114] While the present teachings have been described in conjunction with various embodiments and examples, it is not intended that the present teachings be limited to such embodiments or examples. On the contrary, the present teachings encompass various alternatives, modifications, or equivalents, as will be appreciated by those of skill in the art. Accordingly, the foregoing description is by way of example only.