Devices, systems and methods for controlling environmental conditions of a substance

Abstract

The present invention provides devices, systems and methods for controlling the environmental conditions of a substance. [Solution] An environmental control assembly for controlling at least one environmental condition of one or more substances, wherein the one or more substances are exposed or contained in a substance container, the assembly comprising: a first containment body including an insulating material configured to provide thermal insulation to the substances; a second containment body including at least one deformable environmental control material configured to adjust at least one environmental condition of the substances, the second containment body being in at least partial physical contact with at least one of the substances and the substance container; and a housing at least partially containing the first containment body and the second containment body.

Description

[Technical Field]

[0001]

[0001] This application claims priority to U.S. Provisional Patent Application No. 62 / 749,769, entitled "Devices, Systems and Methods for Controlling and Maintaining Conditions of Substances," filed October 24, 2018, and U.S. Provisional Patent Application No. 62 / 790,485, entitled "Devices, Systems and Methods for Controlling and Maintaining Conditions of Substances," filed January 10, 2019, the disclosures of each of which are incorporated herein by reference in their entirety.

[0002]

[0002] Some embodiments of the present disclosure relate generally to targeted control of material environmental conditions. [Background technology]

[0003]

[0003] Drugs and other substances are susceptible to light, humidity, temperature, atmosphere, pressure, and other conditions. Many drugs and other substances have critical boundaries to such conditions beyond which the effectiveness of the drug may be reduced or the substance may deteriorate.

[0004]

[0004] Additionally, users must pick up medications at a pharmacy and transport them home. If the medications need to be refrigerated, users struggle to ensure that the amount of medication is refrigerated during transport to the home refrigerator. Users often use ice packs, but these do not come into contact with the medication and, as a result, do not ensure that the medication is at the proper refrigeration temperature. In some cases, direct contact of the ice pack with the medication can cause the medication to freeze, thereby degrading the medication.

[0005]

[0005] While devices exist that can maintain drug and substance containers under controlled environmental conditions, such as drug containment and delivery devices, current such devices are fairly large and typically require AC power or large batteries with limited lifespan for their operation. Other devices, such as cooling packs, require large amounts of coolant (ice or water vapor) to maintain the housing at a cool temperature.

[0006]

[0006] Currently, there is no simple, inexpensive device for maintaining medications and other temperature-sensitive substances at refrigeration temperatures (e.g., 0°C to 8°C or 2°C to 8°C) or any other desired temperature, which is portable and does not require the user to use external power or other special, unusual actions to specifically "charge" the device, and which does not require any unusual actions from the user so that the device continues to provide controlled conditions. In particular, there is a need to maintain the temperature of substances stored in a home refrigerator during a power outage. There is also a need to ensure that substances do not freeze during home or other types of refrigeration. There is also a need for a transport device that can be used to maintain the desired substance temperature when transporting the substance from the pharmacy to the home / home refrigerator and / or any time the substance is outside the refrigerator. Under virtually all such circumstances, the substance, whether contained in one or more containers or even open, is reliably maintained at a desired, predetermined temperature within a predetermined temperature range. In other words, there is a need for a device configured to maintain constant environmental conditions within the device. Summary of the Invention

[0007] In some embodiments of the present disclosure, the environmental conditions of any substance may be controlled. Environmental conditions (sometimes referred to herein as "conditions") may include light, humidity, temperature, atmosphere, pressure, or any other condition that affects the substance.

[0008]

[0008] The substance may include any material that is affected by a condition. In one non-limiting example, the substance may include a biological substance such as a drug, pharmaceutical drug, hormone, growth hormone, blood, enzyme, bodily fluid, body part, body organ, body tissue, sperm, or egg. The substance may include an analyte indicator, analyte sensor / detector, which may comprise any type of material. The analyte indicator or sensor may include, for example, a blood glucose test strip or blood glucose sensor configured to indicate blood glucose levels. The blood glucose strip may include an enzyme or any other biological substance. In another example, the analyte indicator or sensor may include a urine test strip. The analyte indicator or sensor may include a diagnostic tool based on a biological indicator, including biological substances and / or chemicals. The substance may include, for example, cosmetics such as lipstick, perfume, toiletries, hair care or skin care products, sprays, foams, lotions, and gels. The substance may include, for example, a resin, adhesive, glue, epoxy, or cyanoacrylate adhesive. A substance may include, for example, a solid, liquid, emulsion, gas, gel, granules, and powder, or a combination thereof. A substance may include multiple substances in the same or different states or phases, such as, for example, a liquid mixed with another liquid or a liquid mixed with a powder. In some embodiments, maintaining one portion of a mixture at a particular environmental condition requires less power than maintaining both portions. For example, a powdered substance has a smaller volume than the same substance in its liquid state. Therefore, maintaining a small amount of powder at a particular temperature requires less power than maintaining a larger amount of liquid at that particular temperature.

[0009]

[0009] Thus, according to one embodiment of the present disclosure, there is provided an environmental control assembly for controlling at least one environmental condition of one or more substances, the one or more substances being exposed or contained within a substance container. The assembly includes a first enclosure including a thermal insulating material configured to provide a thermal shield for the substances, and a second enclosure including at least one deformable environmental control material configured to adjust at least one environmental condition of the substances. The second enclosure is in at least partial physical contact with at least one of the substances and the substance container, and a housing at least partially includes the first enclosure and the second enclosure. In some embodiments, the environmental control material is thermally self-charging. In some embodiments, the first enclosure at least partially contains the second enclosure. In some embodiments, the second housing forms a chamber configured to receive at least one of the substance and the substance container, and the second housing is in adjacent contact with at least one of the substance and the substance container so as to minimize a void area formed between the deformable housing and at least one of the substance and the substance container.

[0010] In some embodiments, the second enclosure includes at least one compartment, and at least two types of environmental control materials are mixed together and contained in a single compartment. In some embodiments, the second enclosure includes multiple compartments, and each compartment includes a single type of environmental control material. In some embodiments, a first compartment of the second enclosure includes a first type of environmental control material and a second compartment of the second enclosure includes a second, different type of environmental control material.

[0011] In some embodiments, the environmental control material includes at least one or more types of phase change materials (PCMs). In some embodiments, a first type of PCM includes a bulk PCM and a second type of PCM includes a microencapsulated PCM. In some embodiments, one type of environmental control material includes HO. In some embodiments, the first type of environmental control material includes a PCM and the second type of environmental control material includes HO. In some embodiments, the ratio of PCM to HO ranges from about 1:1 to about 10:1 (PCM:HO).

[0012]

[0012] In some embodiments, the environmental control material includes at least two types of environmental control materials, a first environmental control material of the at least two types of environmental control materials being configured to have a high phase change temperature, and a second environmental control material of the at least two types of environmental control materials being configured to have a low phase change temperature.

[0013] In some embodiments, the heating element is configured to heat the substance. In some embodiments, the heating element is configured to heat the substance without exceeding the maximum temperature effectiveness limit of the substance. In some embodiments, the assembly includes a power source. In some embodiments, the assembly includes a locking mechanism for closing the housing. In some embodiments, the assembly includes communication means for wired or wireless communication with a remote device.

[0014] In some embodiments, the housing is made of a rigid material. In some embodiments, the housing is made of a flexible material.

[0015] In some embodiments, the first enclosure may include a selectively inflatable and / or deflatable enclosure configured to introduce air therein upon inflation and remove air therefrom upon deflation. In some embodiments, the assembly is configured to be placed within a compartment of a refrigerator sized and configured to accommodate the assembly. In some embodiments, the assembly is configured to be removable from the refrigerator compartment.

[0015]

[0016] In some embodiments, the assembly is configured for deployment and delivery by a drone.

[0017] Thus, according to one embodiment of the present disclosure, there is provided an environmental control system for controlling at least one environmental condition of one or more substances, wherein the one or more substances are exposed or contained within a substance container. The system includes an environmental control assembly and a portion where the environmental condition is not controlled. In some embodiments, the system includes a refrigerator. In some embodiments, the system includes a drug infusion device.

[0016]

[0018] Thus, according to one embodiment of the present disclosure, there is provided an environmental control assembly for controlling at least one environmental condition of one or more substances, the one or more substances being exposed or contained within a substance container, the assembly including: a first containment body including an insulating material configured to provide thermal insulation to the substances; at least one environmental control material configured to regulate at least one environmental condition of the substances; a heat distributor configured to distribute heat along the substances and / or the container; and a housing at least partially including the first containment body.

[0017]

[0019] Thus, according to one embodiment of the present disclosure, there is provided a method for controlling at least one environmental condition of one or more substances, the one or more substances being exposed or contained in a substance container, comprising insulating the substances and adjusting the at least one environmental condition of the substances with a deformable environmental control material while at least one of the substances and the substance container is in at least partial physical contact with the deformable environmental control material.

[0018]

[0020] It should be noted that although the environmental control assembly is primarily described in relation to conditions involving temperature, it is understood that the present disclosure is applicable to any type of condition.

[0021] According to one embodiment of the present disclosure, the environmental control assembly includes a self-charging assembly. A self-charging assembly may include a PCM configured with a phase change temperature selected so that during normal use of the assembly by a user (i.e., without the user having to take any action other than what would necessarily be taken when using the substance), at least a portion of the PCM has sufficient time to solidify after being exposed to extreme temperatures (which may be higher or lower relative to desired conditions) that might otherwise degrade the substance. In one non-limiting example, an assembly containing a drug, including insulation and an appropriate amount of PCM with a transition temperature of 28°C, self-charges overnight. When temperatures fall below 28°C, the user simply needs to go home to allow the PCM to at least partially "recharge," while during the day, the assembly provides full daytime protection to prevent the drug from reaching temperatures above 30°C or temperatures that might degrade the drug. The self-charging assembly is also configured to be placed in a refrigerator, which in some embodiments is considered normal use and does not involve "extraneous" user intervention, as a typical use of certain medications (e.g., insulin) is to refrigerate the medication prior to use. Thus, the self-charging assembly is configured to be used in both refrigerated environments and outdoor environments or outside of a refrigerator to maintain and control the environmental conditions of a substance without the need for any non-normal user intervention.

[0019]

[0022] According to one embodiment, an insulated apparatus is provided having at least one or more insulating chambers or volumes. The insulated apparatus may also be referred to as an "environmental condition control device" or "environmental condition control assembly." At least one of the insulating chambers has a deformable surface configured to conform to the shape of (i) one or more substance-containing devices or containers (e.g., a drug injection device or any drug delivery device) or (ii) bare material disposed on the surface of the deformable surface. The substance-containing devices or containers, the drug injection device or any drug delivery device, and the bare or contained material may be collectively referred to as the "material and / or container." The deformable surface conforms to the shape of the one or more materials and / or containers when the insulating chambers are closed against each other using a locking mechanism.

[0020]

[0023] Deformation of the deformable surfaces allows for placement of any one or more substances and / or containers containing temperature-sensitive substances, having the same or different shapes. When the surfaces are closed against each other using a locking or sealing mechanism, there is thermal or physical (i.e., mechanical) contact between both deformable surfaces and the substances and / or containers. At least one insulating chamber contains at least one bulk or microencapsulated PCM and / or water.

[0021]

[0024] When the chambers are closed against one another, there is a minimal air gap between at least one or more of the substances and / or containers and the deformable surface, which allows for thermal transfer between the environmental control material (e.g., bulk PCM and / or microencapsulated PCM and / or water) and the temperature-sensitive substance and / or container, and maintains the temperature within certain predetermined temperature limits or ranges for a period of time without requiring electrical power to power the assembly.

[0022]

[0025] In some embodiments, instead of a deformable surface, a fan operates to achieve a uniform temperature inside the device, and in some embodiments, other means are used to achieve a uniform temperature across or along the substance and / or container.

[0023]

[0026] According to some embodiments, the insulated assembly may include an inflatable and / or deflatable airbag in at least one of the insulating chambers that can inflate and deflate to regulate heat transfer between the deformable surface and the substance and / or container when the two chambers are closed against each other and locked by the device locking mechanism.

[0024]

[0027] In some embodiments, the inflatable and / or deflatable airbag may include an inflatable container, which may be box-shaped or cylindrical or any other shape. The inflatable container may include an insulating chamber for the substance and / or container and a PCM or other environmental control material. The inflatable container may be configured to open to insert the substance and / or container therein, and may be configured to inflate to insulate the PCM or deflate if no insulation is desired.

[0025]

[0028] According to some embodiments, the thermal insulation device includes an insulating chamber with walls that can be rigid or flexible, or can be a flat or inflatable structure. Inside the insulating chamber, there can be at least one mass of heat bank material (i.e., a material with high heat storage capacity, i.e., an environmental control material) housed within a containment body that can be removable or permanently fixed to the interior walls of the insulating chamber, or with some sides of the insulating chamber housing the mass and another deformable / flexible side housing the mass. The insulating chamber can have an opening for placing a substance and / or container on the deformable side, or can open into two parts. The insulating chamber can be closed so that the substance and / or container are at least partially in thermal contact with the deformable side and the heat bank. Optionally, a structure or means for minimizing air between the internal substance and / or container can be provided to achieve a uniform temperature along the temperature-sensitive substance and / or container. The device can optionally include electronic components for controlling the temperature and can optionally communicate wirelessly with a remote or external device.

[0026]

[0029] According to some embodiments, the insulation assembly may include electronic components and at least one temperature sensor to enable wireless communication of the temperature within the assembly and additional parameters related to the use of the assembly, such as the event of opening the assembly.

[0027]

[0030] According to some embodiments, a home refrigerator can be configured to include an insulated chamber. The insulated chamber can include a PCM located within the insulated chamber, optionally an electrically powered thermoelectric element or both, a temperature sensor for measuring the temperature of the substance and / or container, and a controller. The thermoelectric element operates in response to the measured temperature of the substance and / or container to prevent the substance and / or container from reaching a critical temperature or exceeding a temperature range. In one non-limiting example, the thermoelectric element can be used to heat the interior of the chamber to prevent freezing. The refrigerator can include elements for detecting the presence of the substance and / or container and, optionally, the amount of the substance. This information, e.g., the amount, can be communicated to a user's smartphone or other external device or to a control unit of the refrigerator. The control unit can further communicate this information to a user's smartphone or other external device to provide wireless remote control of the substance and / or container within the insulated assembly.

[0028]

[0031] A method is provided for storing and transporting temperature-sensitive materials that does not require a user to add an auxiliary heat storage element (an element with a high heat capacity) before or during use of an insulating assembly. A method is provided for transporting temperature-sensitive materials by drone that does not require an operator to insert a heat storage element into a chamber used by the drone to transport the temperature-sensitive material. Instead, the temperature of the temperature-sensitive material is controlled by the insulating assembly (i.e., environmental condition control assembly) without the need for an auxiliary heat storage element.

[0029]

[0032] The insulating assembly can be placed in a domestic refrigerator to set the temperature of the insulating assembly to a refrigerated temperature while avoiding freezing of materials and / or containers inside the insulating assembly. The insulating device can maintain the refrigerated temperature for several hours even when the refrigerator is not functioning.

[0030]

[0033] The insulating device is further capable of being carried by a user, maintaining a refrigerated temperature, in one non-limiting example 0° to 8° C., or 2° to 8° C., for a predetermined period of time (e.g., from a few minutes to over 100 hours) without the user needing to place an ice pack or gel pack inside. In some embodiments, the insulating device may be configured to regain its ability to maintain a refrigerated temperature and avoid freezing of materials placed inside when placed back in a refrigerator, even after being in an outdoor environment for several days, without the user needing to first place the insulating device in a freezer or place an ice pack or gel pack inside.

[0031]

[0034] It should be understood that all combinations of the above concepts and additional concepts detailed below (provided such concepts are not mutually inconsistent) are contemplated as part of the inventive subject matter disclosed herein. Specifically, all combinations of claimed subject matter listed at the end of this disclosure are contemplated as part of the inventive subject matter disclosed herein. It should also be understood that terms explicitly employed herein, which may also be found in any disclosures incorporated by reference, should be given the meaning most consistent with the particular concept disclosed herein. The present invention provides, for example, the following items. (Item 1) 1. An environmental control assembly for controlling at least one environmental condition of one or more substances, said one or more substances being open or contained in a substance container, said assembly comprising: a first containment body including a thermal insulator configured to provide a thermal shield to the material; a second containment body including at least one deformable environmental control material configured to adjust the at least one environmental condition of the substance, the second containment body being in at least partial physical contact with at least one of the substance and the substance container; a housing that at least partially contains the first enclosure and the second enclosure. (Item 2) Item 1, wherein the environmental control material is thermally self-charging. (Item 3) 3. The assembly of claim 1 or 2, wherein the first housing at least partially encases the second housing. (Item 4) the second housing defines a chamber configured to receive at least one of the substance and the substance container; 4. The assembly of any one of items 1 to 3, wherein the second housing is in adjacent contact with at least one of the substance and the substance container so as to minimize an intervening void area formed between the deformable housing and at least one of the substance and the substance container. (Item 5) 5. The assembly of any one of items 1 to 4, wherein the second enclosure includes at least one compartment, and at least two types of environmental control materials are mixed together and contained within a single compartment. (Item 6) 5. The assembly of any one of items 1 to 4, wherein the second enclosure includes multiple compartments, each compartment containing a single type of environmental control material. (Item 7) 7. The assembly of claim 6, wherein a first compartment of the second enclosure contains a first type of environmental control material and a second compartment of the second enclosure contains a second environmental control material of a different type. (Item 8) 8. The assembly of any of items 1 to 7, wherein the environmental control material comprises at least one or more phase change materials (PCMs). (Item 9) 9. The assembly of item 8, wherein the first type of PCM comprises a bulk PCM and the second type of PCM comprises a microencapsulated PCM. (Item 10) 10. The assembly of any one of items 1 to 9, wherein one environmental control material comprises HO. (Item 11) 10. The assembly of any one of items 1 to 9, wherein the first type of environmental control material comprises a PCM and the second type of environmental control material comprises HO. (Item 12) 12. The assembly of claim 11, wherein the ratio of the PCM to HO is in the range of about 11 to about 101 (PCM HO). (Item 13) The environmental control material includes at least two types of environmental control material; a first environmental control material of the at least two types of environmental control materials having a high phase change temperature; 13. The assembly of any of items 1 to 12, wherein a second of the at least two types of environmental control materials is configured with a low phase change temperature. (Item 14) 14. The assembly of any of items 1 to 13, further comprising a heating element configured to heat the substance. (Item 15) Item 15. The assembly of item 14, wherein the heating element is configured to heat the substance without exceeding a maximum temperature effectiveness limit of the substance. (Item 16) 16. The assembly of any of items 1 to 15, further comprising a power source. (Item 17) 17. The assembly of any of items 1 to 16, further comprising a locking mechanism for closing the housing. (Item 18) 18. The assembly according to any of items 1 to 17, further comprising communication means for wired or wireless communication with a remote device. (Item 19) 19. The assembly of any of items 1 to 18, wherein the substance is selected from the group consisting of a drug, a biological substance, a hormone, a growth hormone, blood, enzymes, a body fluid, a body part, a body organ, a body tissue, sperm, an egg, an analyte indicator, a blood glucose test strip, an enzyme, a urine test strip, a biological indicator including biological substances and / or chemicals, a cosmetic product, a lipstick, a perfume, a toiletry product, a spray, a hair foam, a lotion, a gel, a resin, an adhesive, a glue, an epoxy, and a cyanoacrylate adhesive. (Item 20) 20. The assembly of any of items 1 to 19, wherein the housing is made of a rigid material. (Item 21) 20. The assembly of any of items 1 to 19, wherein the housing is made of a flexible material. (Item 22) 22. The assembly of any of items 1 to 21, wherein the first containment body comprises a selectively inflatable and / or deflatable containment body configured to introduce air therein upon inflation and to remove the air therefrom upon deflation. (Item 23) 23. The assembly of any of items 1 to 22, wherein the assembly is configured to be placed within a compartment of a refrigerator sized and configured to accommodate the assembly. (Item 24) Item 24. The assembly of item 23, wherein the assembly is configured to be removable from the refrigerator compartment. (Item 25) 25. The assembly of any of items 1 to 24, wherein the assembly is configured for attachment and delivery by a drone. (Item 26) 26. An environmental control system for controlling at least one environmental condition of one or more substances, the one or more substances being exposed or contained in a substance container, the system comprising an environmental control assembly according to any one of items 1 to 25 and a portion in which the environmental condition is not controlled. (Item 27) Item 27. The system of item 26, wherein the system includes a refrigerator. (Item 28) 27. The system of claim 26, wherein the system includes a drug infusion device. (Item 29) 1. An environmental control assembly for controlling at least one environmental condition of one or more substances, said one or more substances being open or contained in a substance container, said assembly comprising: a first containment body including a thermal insulator configured to provide a thermal shield to the material; at least one environmental control material configured to adjust the at least one environmental condition of the substance; a heat distributor configured to distribute heat along the substance and / or the container; a housing that at least partially contains the first enclosure. (Item 30) 1. A method of controlling at least one environmental condition of one or more substances, wherein the one or more substances are exposed or contained in a substance container, the method comprising: insulating the material; and adjusting the at least one environmental condition of the substance with a deformable environmental control material while at least one of the substance and the substance container is in at least partial physical contact with the deformable environmental control material.

[0032]

[0035] The principles and operation of systems, apparatus and methods according to some embodiments of the present disclosure may be better understood with reference to the drawings and the following description, which are shown for purposes of illustration only and are not intended to be limiting. [Brief explanation of the drawings]

[0033] [Figure 1A]

[0036] 1 is a schematic diagram illustrating an exemplary environmental condition control assembly in an open position, constructed and operative in accordance with some embodiments of the present disclosure. [Figure 1B] 1 is a cross-sectional view illustrating an exemplary environmental condition control assembly in a closed position, constructed and operative in accordance with certain embodiments of the present disclosure. [Figure 1C] 1 is a schematic diagram illustrating an exemplary environmental condition control assembly in an open position, constructed and operative in accordance with some embodiments of the present disclosure. [Figure 2]

[0037] 2A and 2B are schematic and cross-sectional views of an exemplary environmental condition control assembly constructed and operative in accordance with certain embodiments of the present disclosure in an open and closed position, respectively. [Figure 3A]

[0038] FIG. 3A is a schematic diagram illustrating an exemplary environmental condition control assembly, constructed and operative in accordance with some embodiments of the present disclosure, in an open state.

[0034] [Figure 3B] FIG. 3B is a cross-sectional view illustrating an exemplary environmental condition control assembly in a closed state, constructed and operative in accordance with certain embodiments of the present disclosure. [Figure 4]

[0039] FIG. 1 is a schematic diagram illustrating an exemplary environmental condition control assembly constructed and operative in accordance with some embodiments of the present disclosure. [Figure 5]

[0040] Figure 5A is a schematic diagram illustrating an exemplary environmental condition control assembly constructed and operative in accordance with some embodiments of the present disclosure in an initial operative state, Figure 5B is a schematic diagram illustrating an exemplary environmental condition control assembly constructed and operative in accordance with some embodiments of the present disclosure in a further operative state, and Figure 5C is a cross-sectional view taken along line VIC-VIC of Figure 5B showing an exemplary environmental condition control assembly constructed and operative in accordance with some embodiments of the present disclosure. [Figure 6A]

[0041] FIG. 1 is a schematic diagram illustrating an exemplary environmental condition control assembly constructed and operative in accordance with some embodiments of the present disclosure. [Figure 6B] FIG. 1 is a schematic diagram illustrating an exemplary environmental condition control assembly constructed and operative in accordance with some embodiments of the present disclosure. [Figure 7]

[0042] FIG. 1 is a schematic diagram illustrating an exemplary environmental condition control assembly incorporated within a refrigerator, constructed and operative in accordance with some embodiments of the present disclosure. [Figure 8]

[0043] FIG. 1 is a schematic diagram illustrating an exemplary environmental condition control assembly constructed and operative in accordance with some embodiments of the present disclosure. [Figure 9]

[0044] 1 is a graph illustrating exemplary performance of an environmental condition control assembly constructed and operative in accordance with some embodiments of the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0035]

[0045] 1A and 1B each illustrate an exemplary environmental condition control assembly 100 for controlling at least one environmental condition of a substance 102. FIG.

[0046] In one non-limiting example, the substance may include a biological or chemical substance, such as a drug, hormone, growth hormone, blood, enzyme, bodily fluid, body part, body organ, body tissue, sperm, or egg. The substance may include an analyte indicator, analyte sensor, and / or analyte detector, comprising any type of material. The analyte indicator or sensor may include, for example, a blood glucose test strip configured to indicate blood glucose levels or any other analyte monitoring strip configured to detect the presence of an analyte. The blood glucose strip or analyte strip may include an enzyme or any other biological or chemical substance. In another example, the analyte indicator or sensor may include a urine test strip. The analyte indicator or sensor may include any diagnostic tool based on a biological indicator, including biological and / or chemical substances. The substance may include, for example, cosmetics, such as lipstick, perfume, toiletries, hair care or skin care products, sprays, foams, lotions, and gels. The substance may include a resin, adhesive, glue, epoxy, or cyanoacrylate adhesive. The substance may be configured in any suitable form, such as, for example, a solid, liquid, emulsion, gas, gel, granules, and powder. The substance may include multiple substances in the same or different phases, such as, for example, a liquid mixed with another liquid or a liquid mixed with a powder. When the substance includes a drug, the drug may include any suitable form, such as a solid, powder, tablet, pill, capsule, gas, gel, cream, emulsion, spray, suppository, or combinations thereof, and may be delivered in any suitable manner.

[0036]

[0047] In some embodiments, the substance may be contained in a container 104 .

[0048] In some embodiments, the container 104 may include a substance storage device or a substance delivery device. The container 104 may be configured in any suitable configuration for containing a substance therein. In some examples, the container 104 may include a device for medication injection delivery, such as an injection pen, a jet injector, and / or a syringe. Some further non-limiting example containers 104 for containing a substance may include a substance vial, a substance cartridge, an ampoule, a substance pump, a pill box, a capsule container, an inhaler, a substance ejection device, a pump-based infusion device, or a pumpless infusion device. In some embodiments, the container 104 may include a box. In some embodiments, the container 104 may include a container for storing and transporting blood glucose strips or any other analyte, such as a biological or chemical analyte monitoring strip.

[0037]

[0049] In some embodiments, the container 104 may include or be included in an environmental control sleeve such as that described in applicant's patent publication WO2016 / 011207, or an environmental condition control device such as that described in applicant's patent publication WO2017 / 090019, both of which are incorporated herein in their entireties.

[0038]

[0050] In some embodiments, the substance 102 may be contained in a container 104, which may be disposed within a containment volume 106 (also referred to as a "chamber") of an environmental control assembly 100, as shown in Figures 1A and 1B.

[0039]

[0051] As shown in FIG. C, in some embodiments, the substance 102 may be configured to be placed directly within the environmental control assembly 100 in its entirety without a container 104. In one non-limiting example, the substance 102 may include an analyte detecting strip 108 placed directly within the environmental control assembly 100.

[0040]

[0052] Environmental control assembly 100 may be employed as a carrying or shipping case. Housing 110 may be provided to house or otherwise contain or be part of an insulation enclosure 114 (i.e., first enclosure) including insulation configured to provide thermal insulation to substance 102, which may be contained within vessel 104 or may be bare. Insulation (sometimes interchangeably referred to as "insulation" or "separation") enclosure 114 may be formed as a layer of insulation material or any other structure at least partially disposed between housing 110 and deformable enclosure 118 (i.e., second enclosure).

[0041]

[0053] In some embodiments, the insulation enclosure 114 is configured to provide thermal insulation to a mass at least partially contained within the housing.

[0054] In some embodiments, the insulation may include a vacuum chamber, such as a vacuum interposed between two walls 112 formed by the insulation enclosure 114. In some embodiments, the insulation enclosure 114 may include a vacuum insulated panel (VIP), which includes an airtight enclosure surrounding an evacuated rigid core. In some embodiments, the insulation enclosure 114 may include a multi-layer material consisting of walls and a vacuum gap, commercially available as INSULON® from Concept Group (www.conceptgroupinc.com), as well as similar structures disclosed in U.S. Patent Application Publication No. 20140090737, which is incorporated herein by reference in its entirety. In some embodiments, the insulation enclosure 114 may include a relatively high vacuum structure. In one non-limiting example, the high vacuum may be approximately 10 -3 Torr or less, or about 10 -4 Torr or less, or about 10 -5 Torr or less, or about 10 -6 Torr or less, or about 10 -7 Torr or less.

[0042]

[0055] In some embodiments, the insulating material may include silicon aerogel, air, or any other gas, or other materials such as fiberglass, wool, cellulose, foam, and / or polystyrene, as one non-limiting example.

[0043]

[0056] In some embodiments, as described with reference to Figures 5A-6, the insulation housing 115 may include air trapped between two surfaces or walls, which may be rigid or flexible, to further allow for inflation or deflation of air or other gas between the two surfaces or walls.

[0044]

[0057] In some embodiments, several insulating layers and / or materials with the same or different insulating properties may be used to achieve a particular characteristic (e.g., degree of insulation in material 102, predetermined temperature to control and / or maintain environmental conditions of material 102).

[0045]

[0058] The deformable containment body 118 may reside within the insulating material enclosure 114 and may include at least one environmental control material 120 configured to adjust an environmental condition of the substance 102 and / or the container 104. In some embodiments, the environmental control material 120 is contained within the deformable material or within a deformable surface. In one non-limiting example where the environmental condition is temperature, the environmental control material 120 may include a PCM in at least partial thermal communication with the substance 102 and / or the container 104. In some embodiments, the deformable containment body 118 may include a deformable surface.

[0046]

[0059] Air is a poor thermal conductor. Thus, the formation of voids between the environmental control material 120 and the substance and / or container 104 can reduce the effectiveness of the environmental control material 120 in controlling environmental conditions. For example, when the environmental conditions include temperature, voids or gaps around the substance 102 and / or container 104 can create uneven temperature regions around the container 104 (or around the bare substance 102), i.e., uneven distribution of heat around the container 104. This unevenness reduces heat transfer, thereby causing the substance 102 and / or container 104 to unintentionally heat or cool to temperatures outside of a predetermined desired range.

[0047]

[0060] The deformable containment body 118 can be at least partially comprised of a deformable material / surface 124 (see inset in FIG. 2B ) configured to contain the substance 102 and / or container 104 in at least partial physical and / or thermal contact therewith. That is, the deformable containment body 118 is in at least partial contiguous thermal and / or physical (i.e., mechanical) contact with the substance 102 and / or container 104 in a manner that minimizes intervening voids or gaps between the deformable containment body 118 and the substance 102 and / or container 104. Thus, thermal conductivity between the substance 102 and / or container 104 and the environmental control material 120 is increased, and environmental control of the substance 102 and / or container 104 is maintained.

[0048]

[0061] In one non-limiting example where the environmentally controlled condition is temperature, the increased thermal conductivity between the substance 102 and / or container 104 and the deformable containment body 118 allows the temperature of the substance 102 and / or container 104 to be maintained within a predetermined temperature range in any environment. Such environments may include a refrigerator (domestic and / or commercial or any refrigeration) while stored therein, and further environments include outdoor or non-refrigerated environments, such as when the substance 102 is in transport or use.

[0049]

[0062] The deformable material 124 (which may include the deformable surface) may be comprised of a thin layer. In one non-limiting example, the width of the deformable material 124 may be in a range of approximately 0.1% to 1% of the thickness of the environmental control material 120. In one non-limiting example, the width of the deformable material 124 may be in a range of approximately 0.1% to 10% of the thickness of the environmental control material. In one non-limiting example, the width of the deformable material 124 may be in a range of approximately 1 micrometer to 100 micrometers.

[0050]

[0063] The deformable material 124 may include flexible fabric or any other type of flexible material that provides sufficient thermal conductivity between the substance 102 and / or container 104 and the environmental control material 120 .

[0051]

[0064] In some embodiments, the environmental control material 120 may be comprised of multiple environmental control material portions, such as a first environmental control material portion 130 and a second environmental control material portion 132. In one non-limiting example, the first portion 130 is configured with a relatively high phase change temperature, such as, but not limited to, a phase change temperature in the range of about 4° C. to 30° C., or in the range of about 20° C. to 30° C., or in the range of about 4° C. to 8° C., or in the range of about 8° C. to 20° C., and sub-ranges thereof. The second portion 132 is configured with a relatively low phase change temperature, such as, but not limited to, a phase change temperature in the range of 0° C. to 8° C., or in the range of, for example, 2° C. to 8° C., or 0° C. to 2° C., and sub-ranges thereof.

[0052]

[0065] In other words, in some embodiments, there is an upper temperature limit "Tu" that must not be exceeded to prevent degradation (e.g., overheating) of substance 102. Accordingly, first portion 130 is selected to have a first phase transition temperature that is equal to or less than Tu. For example, first portion 130 is configured to maintain an effective temperature of substance 102 when in a warm ambient environment, or when stored refrigerated and the refrigerator malfunctions. There may also be a lower temperature limit "Tl" below which degradation (i.e., supercooling or freezing) of substance 102 occurs. Accordingly, second portion 132 is selected to have a second phase transition temperature that is equal to or greater than Tl. For example, second portion 132 is configured to maintain an effective temperature of substance 102 and prevent supercooling or freezing when in a cold or even freezing ambient environment, or when substance 102 is stored in a refrigerator (or freezer), or when stored refrigerated and the refrigerator malfunctions.

[0053]

[0066] Thus, this combination of at least two portions of environmental control material can control and protect the substance from both high and low ambient temperatures. While two portions of environmental control material are described, three or more different environmental control materials can also be used. In some embodiments, the environmental control materials are pre-selected so that none of the materials will interfere with the function of the other materials when they are all placed together, or, if they might interfere, are placed in separate "chambers" or "pockets" or "containers" of the deformable containment body 118 in thermal contact with the substance 102 and / or container 104.

[0054]

[0067] In some embodiments, the environmental control material 120 includes one or more thermal energy absorbing materials.

[0068] In some embodiments, the environmental control material 120 may include a phase change material (PCM) 126. The PCM 126 may include a material with a relatively high heat of fusion that can absorb, store, and release relatively large amounts of energy by melting and solidifying (i.e., changing its layers) at specific phase transition temperatures. The PCM 126 also absorbs heat flux that may pass through the insulation containment body 114 before it reaches the substance 102 and / or container 104. The PCM 126 is configured to control and regulate the environmental conditions of the substance 102 and / or container 104. The PCM 126 may be characterized by its latent heat capacity and / or sensible heat capacity.

[0055]

[0069] A type of PCM may be characterized by its phase transition temperature, i.e., the temperature at which a first phase completely changes to a second phase, such as the temperature at which a solid completely changes to a liquid. In some embodiments, the type of PCM may be selected depending on, among other things, any one of the following parameters: the required material temperature, the time required to maintain the material at the required material temperature (or below or above a predetermined threshold temperature), and the required mode (i.e., storage of the material, typically refrigerated or off-refrigerated use, or transport mode).

[0056]

[0070] In some embodiments, the PCM 126 may include an organic PCM, an inorganic PCM, a eutectic PCM, or an aqueous PCM. Non-limiting examples of inorganic PCMs include hydrated salts, salts, metals, and alloys. Non-limiting examples of organic PCMs include paraffins, fatty acids, oils, biocompatible oils, vegetable oils, alcohols, glycols, and oleaginous substances.

[0057]

[0071] The PCM 126 may be configured in any suitable form, such as, for example, bulk or microencapsulated. Microencapsulated PCMs may include capsules that are generally small in diameter (in one non-limiting example, 1 micrometer to 1 centimeter in diameter). The PCM 126 is contained within the capsules. Microencapsulation allows for the mixing of different PCMs with different phase transition temperatures. When the PCM is in bulk form, each type of PCM may be kept separate by storing each PCM in a separate compartment, or they may be contained within the same compartment if they do not interact with each other in a way that alters the phase temperature or latent heat capacity (latent or sensible heat) of any one of them.

[0058]

[0072] In some embodiments, the first portion 130 and the second portion 132 may be kept immiscible by, for example, using microcapsules for each type of first portion 130 and second portion 132, or by using microcapsules containing the first portion 130 dispersed within the bulk material of the second portion 132 (FIG. 1B). The first portion 130 and the second portion 132 may also be made of bulk materials that are difficult to mix with each other, such as a water-based PCM for the first portion 130 and an oil-based PCM for the second portion 132, or vice versa, thereby forming immiscible layers that can be contained in the same compartment (FIG. 3B). The environmental control material 120 may also include any other suitable combination of materials.

[0059]

[0073] In some embodiments, the environmental control material 120 may include any suitable liquid. In one non-limiting example, the liquid may include water or HO-containing compounds in various phases (gas, liquid, solid). In some embodiments, the first environmental control material portion 130 may include a liquid and the second environmental control material portion 132 may include the PCM 126, as described with reference to FIGS. 1A and 1B.

[0060]

[0074] In some embodiments, a liquid (e.g., water) contained within the deformable material 120 is configured to force the deformable containment body 118 to assume and conform to the shape of the substance 102 or container 104, thereby increasing thermal and / or physical contact between the deformable containment body 118 and the substance 102 and / or container 104.

[0061]

[0075] In one non-limiting example, if assembly 100 is designated to be refrigerated or in a refrigeration temperature range (e.g., 2°C to 8°C), first portion 130 may include a PCM configured to be in a solid phase (i.e., a phase change temperature of 8°C or less), and second portion 132 may include a PCM with a phase change temperature near 0°C to 2°C, or water. Thus, when assembly 100 is in an ambient temperature above 8°C, the combination of the PCM and insulation maintains the temperature at refrigeration temperatures. Meanwhile, the PCM in second portion 132 prevents the temperature of the substance from reaching freezing temperatures even if the ambient temperature drops below freezing. This combination of respective first portion 130 and second portion 132 provides a means to maintain the substance temperature within a temperature range of 8°C or less but above freezing temperatures (e.g., 0°C or less), even if the refrigerator temperature is not well controlled.

[0062]

[0076] In some embodiments, the PCM can be configured to be at least partially flexible even when in solid form (below its phase transition temperature). In one non-limiting example, such flexible PCM in compartments is commercially available from Glacier Tekat https: / / glaciertek.com. These compartments contain PURETEMP® phase change material, commercially available from PURETEMP, 4232 Park Glen Road, Minneapolis, MN 55416, USA.

[0063]

[0077] In some embodiments, the environmental control material 120 may include a mixture of the PCM 126 and water 140. The mixture may be formed in any suitable manner, such as a dispersed wet cake type mixture or a dispersion of microcapsules including the PCM 126 and water 140.

[0064]

[0078] Any predetermined suitable ratio of the first and second environmental control material portions 130, 132 can be determined. In one non-limiting example where the first environmental control material portion 130 includes any form of PCM 126 and the second environmental control material includes water 140, the ratio of the first and second environmental control materials is about 10:90 percent, or about 20:80 percent, or about 30:70 percent, or about 40:60 percent, or about 50:50 percent, or about 60:40 percent, or about 70:30 percent, or about 80:20 percent, or about 90:10 percent.

[0065]

[0079] In some embodiments, this ratio is dependent on the environment surrounding environmental control assembly 100. In one non-limiting example, this ratio may be selected depending on the temperature stability of a domestic refrigerator in which environmental control assembly 100 is stored. For refrigerators with good temperature stability that have a low risk of freezing substance 102, the ratio is such that the majority of the volume of environmental control material comprises PCM 126 and a smaller amount of water.

[0066]

[0080] The environmental control material and portions of the environmental control material may be provided within a compartment, which may be comprised of a flexible, deformable material 124 and may contain the environmental control material 120 therein.

[0067]

[0081] As seen in FIGS. 1A-1C, the environmental control material 120 includes a mixture of water 140 and microencapsulated PCM 126 contained in a first lower compartment 150 and a second upper compartment 152, thereby forming a deformable enclosure 118 for containing the vessel 104.

[0068]

[0082] 2A and 2B, a first lower compartment 160 and a second lower compartment 162 may be provided and positioned alongside one another. A first upper compartment 170 and a second upper compartment 172 may be provided and positioned alongside one another to together form a deformable containment body 118 for enclosing the vessel 104. Each of the first lower compartment 160 and the second lower compartment 162 and the first upper compartment 170 and the second upper compartment 172 may include the same or different environmental control material 120. As can be seen in the non-limiting example of FIGS. 2A and 2B, the first lower compartment 160 and the first upper compartment 170 include the first PCM 126 bulk, while the second lower compartment 162 and the second upper compartment 172 include water.

[0069]

[0083] 3A and 3B, the first lower compartment 160 and the second lower compartment 162, respectively, can be disposed and positioned to overlap one another. The first upper compartment 172 and the second upper compartment 172, respectively, can be disposed and positioned to overlap one another, thereby together forming a deformable containment body 118 for enclosing the vessel 104. The first lower compartment 160 and the second lower compartment 162 and the first upper compartment 170 and the second upper compartment 172 can each contain the same or different environmental control material 120. As can be seen in the non-limiting example of FIGS. 3A and 3B, the first lower compartment 160 and the second upper compartment 172 contain the PCM 126, while the second lower compartment 162 and the first upper compartment 170 contain water.

[0070]

[0084] 1A-3B are examples of environmental control materials and their arrangements, and any combination or arrangement of environmental control materials may be used.

[0085] The insulating material enclosure 114 and the deformable enclosure 118 can be manufactured by any suitable process, such as by being co-injected or by being manufactured separately and then bonded together. In some embodiments, the deformable enclosure 118 can be configured to have multiple sections of environmental control material thereon, with the vessel 104 or substance 102 contacting each section substantially equally.

[0071]

[0086] In some embodiments, the deformable enclosure 118 includes an environmental control material 120 made of a deformable material, eliminating the need for a deformable material.

[0087] In some embodiments, environmental control assembly 100 may include a locking mechanism 180 (FIG. 1A) formed in any suitable manner for closing an upper portion 182 of environmental control assembly 100 against a lower portion 184 in sealing engagement, thereby forming thermal and physical contact between deformable containment body 118 and substance 102 and / or container 104. Locking mechanism 180 may include any suitable form of mechanical lock, and in one non-limiting example may include a plastic resealable zipper (e.g., ZIPLOC® or ziplock).

[0072]

[0088] In some embodiments, the environmental control assembly 100 may include a thermally self-charging assembly 100. This can be achieved by selecting an environmental control material 120 that includes passive elements, such as a PCM 126 and / or water 140, that do not require electrical power to operate. The environmental control material 120 can be selected in accordance with ambient temperature fluctuations, appropriate amounts, and maximum or minimum material temperature limits. For example, by selecting any one or more PCMs having a phase transition temperature equal to or slightly below the maximum material temperature limit and selecting an amount of PCM configured to maintain the material in a solid phase for a predetermined period of time through a combination of insulation and the PCM, the material can be safely maintained below the maximum material temperature limit for a relatively long period of time, including during use of the container 104 and / or storage within the assembly 100, and can regain its capacity without significant, non-conventional user intervention, even when exposed to temperature conditions outside (higher or lower than) the material's safe temperature.

[0073]

[0089] Ambient temperatures may include temperatures outside the assembly 100, such as refrigeration temperatures if the assembly 100 is stored in a refrigerator, and outdoor temperatures if the assembly 100 is placed outside a refrigerator.

[0074]

[0090] In one non-limiting example, such a thermally self-charging assembly 100 allows the insulin-containing substance 102 to maintain its effectiveness until the expiration date set by the manufacturer if maintained below 8°C. By selecting a PCM 126 with a phase change temperature close to the 8°C temperature limit, such as 7°C or 8°C, with a sufficient amount of PCM, the containment mass 106 will not exceed the 8°C limit unless the PCM 126 completely changes its phase from solid to liquid. Thus, even if the assembly 100 is placed at an ambient temperature above 8°C (e.g., room temperature) for slightly less than 12 hours or less than 24 hours, the insulin will remain below 8°C. As soon as the ambient environment returns to a temperature below the PCM's phase transition (e.g., below 7°C or 8°C), such as when the refrigerator is turned on again or the assembly 100 is returned to a functioning refrigerator, the PCM 126 will begin to solidify again without the need for the user to input electrical energy. Because it is common for users to keep unused insulin refrigerated, assembly 100 allows a user to take refrigerated insulin home from a pharmacy and place it in the refrigerator without any special, non-normal user action; all the user is required to do is remove assembly 100 from the refrigerator, go to the pharmacy, place the refrigerated insulin in assembly 100, go home, and place the insulin in the refrigerator as a user would normally do.

[0075]

[0091] The operation of the exemplary assembly 100 is illustrated in the graphs of FIG. 9. A two-day cycle is shown. The top graph 185 shows the ambient temperature changing as it cools at night and heats up during the day. The bottom graph 186 shows the temperature change within the container 104 containing the insulin pen syringe housed within the self-charging assembly 100 as the temperature continuously and cyclically rises and falls within the assembly 100. The substance temperature is maintained below the upper threshold line 187 without non-conventional intervention, thereby ensuring that the substance 102 is well within its safe temperature zone 188 and away from the danger temperature zone 189.

[0076]

[0092] Assembly 100 functioning as a self-charging assembly is highly advantageous. As described above, the temperature of substance 102 is maintained within a preferred temperature range. This is because the assembly is configured to be self-charging, eliminating the need to place it in a freezer (as is required when using traditional ice packs) or the hassle of changing cases during transport from the pharmacy to the refrigerator, thereby eliminating the risk of freezing. Because assembly 100 charges without user intervention, the user can use assembly 100 to house substance 102 uninterruptedly without the need for any special, non-routine intervention.

[0077]

[0093] 4 , assembly 100 may include any one of the following components: at least one or more temperature sensors 190 designed to monitor the temperature of containment chamber 106 and / or container 104 and / or substance 102, and / or the ambient environment outside assembly 100. In some embodiments, the components may include a presence sensor 192 designed to monitor the presence or removal of container 104 and / or substance 102 from containment chamber 106. In one non-limiting example, presence sensor 192 may include, for example, an RFID tag reader or camera, a switch, or other detector, such as an optical or electronic detector. Exemplary additional sensors may include capacitance sensors and accelerometer sensors that can be employed to detect contact with or removal of container 104 from assembly 100, thereby detecting the presence of container 104.

[0078]

[0094] In some embodiments, an external device 200 may be provided to receive signals or data from assembly 100 (e.g., from sensors 190 or 192) via a wireless transponder or any other suitable communication means 202, such as a wired USB connector port or any other wired or wireless connector port. External device 200 may include a remote device, such as a smartphone, a computer, or any device with a processor.

[0079]

[0095] Assembly 100 may include components such as a power source, e.g., a battery 206, located in any suitable location. Assembly 100 may include electronic components 208, such as thermistors, transistors, substrates, wiring, or circuitry and / or control circuits for controlling the electronic components of assembly 100. Electrical connections (not shown) may be provided between battery 206 and controller 196, electronic components 208, and any other electrical components.

[0080]

[0096] In some embodiments, assembly 100 may include components such as, for example, a memory device and / or a timer.

[0097] In some embodiments, the battery 206 may be a disposable battery. Because the passive control elements (e.g., the deformable enclosure 118, the insulating enclosure 114) do not require much power, the battery 206 may operate for a relatively long period of time, such as days, months, or years. In some embodiments, the battery 206 may be rechargeable. Charging may occur via a charging port 212 or via inductance, solar charging, or other means that allow for charge generation.

[0081]

[0098] In some embodiments, assembly 100 may include one or more indicators 220, such as, for example, an LED indicator or a small electronic display. Indicator 220 may indicate one or more environmental conditions of substance 102, such as the agent temperature or any other parameter of the agent, such as, for example, color, clarity, transparency, etc. Indicator 220 may be configured in any suitable manner, such as that described in applicant's patent publication WO 2017 / 090019, which is incorporated herein in its entirety.

[0082]

[0099] Some embodiments may include a control capacity indicator 222 configured to display the remaining control capacity provided by the environmental control material 120 to maintain the required environmental conditions. For example, the PCM 126 may absorb heat flux from the surrounding environment until an amount of the PCM 126 completely liquefies from a solid phase to a liquid phase. The amount of PCM that has not yet undergone a phase change from solid to liquid indicates the remaining thermal control capacity of the environmental control material 120. The control capacity indicator 222 may be configured as described in applicant's patent publication WO 2017 / 090019, which is incorporated herein in its entirety.

[0083]

[0100] Assembly 100 may include additional components, such as an electrically powered thermoelectric element 230 or any other heating element, heater or cooler, or fan, to further control the environmental conditions (e.g., temperature) of (internal) assembly 100. In some embodiments, controller 196 may be configured to control the operation of thermoelectric element or heater or cooler 230 in response to the temperature detected by temperature sensor 190. In some embodiments, multiple temperature sensors are used. In some embodiments, there may be at least one temperature sensor for monitoring the ambient temperature and at least one temperature sensor for monitoring the temperature inside the assembly (i.e., the temperature of substance 102). In some embodiments, thermoelectric element 230 or any other heating element or heater is configured to heat substance 102 without exceeding the maximum temperature effectiveness limit of the substance.

[0084]

[0101] Also, some of the components may be configured to not operate at certain times to conserve energy in the power supply 206. Upon detection of a predetermined event, such as the insertion of the container 104 into the assembly 100 or any other event, the components may be activated for a predetermined period of time and then shut down. In some embodiments, an accelerometer, vibration sensor, capacitance sensor, or motion and / or presence sensor 192 may be used to detect the predetermined event.

[0085]

[0102] In some embodiments, assembly 100 may include a fan 240 to further enhance the even distribution of heat within transformable containment 118, thereby achieving a uniform temperature along or around container 104 and / or substance 102. In some embodiments, fan 240 is activated by controller 196, and temperature sensor 190 determines a non-uniform temperature along container 104 and / or substance.

[0086]

[0103] In some embodiments, a camera or other optical detector or detector array or matrix 250 may be provided at any suitable location within the deformable storage 118 to image (or provide optical information regarding) the substance 102 and / or container 104 and / or deformable storage 118. The camera 250 may transmit images or other optical information (in visible or non-visible light wavelengths), which may be still or streaming images or optical information such as video, to the external device 200 via wire or wirelessly.

[0087]

[0104] In some embodiments, assembly 100 may include additional elements to improve thermal conduction between the PCM at least partially contained by deformable containment 118 and substance 102 and / or vessel 104. For example, one or more thermally conductive layers 226 or any other structure made of a generally relatively flexible thermal conductor, e.g., a metal such as copper, may be disposed within deformable containment 118.

[0088]

[0105] In some embodiments, flexible fins 260 (shown inset in FIG. 2B ) or any heat-conducting elements may be provided within the deformable containment 118. The fins 260 are flexible to fit and conform to the shape of the substance 102 and / or container 104, providing uniform heat conduction from the deformable containment to the substance 102 and / or container 104. Therefore, heat conduction is improved even when the PCM 126 is in a solid state, potentially creating any slight voids that could impair the PCM 126's ability to conform to the shape of the substance 102 and / or container 104. The flexible fins 260 may be made of a material with a relatively high thermal conductivity, such as aluminum-covered plastic or simply aluminum foil, secured inside the deformable containment 118, as one non-limiting example.

[0089]

[0106] Housing 110 may be formed in any suitable manner. In some embodiments, the housing may be made of a rigid material, such as a hard plastic, as seen in Figures 1A-4. In some embodiments, the housing may be made of a flexible, deformable material. In one non-limiting example, housing 110 may be formed in any shape, such as a cylindrical, circular, oval, spherical, or box-like shape, or any other suitable shape.

[0090]

[0107] 5A-6 , the housing 110 can be comprised of an inflatable subassembly 300. In some embodiments, the inflatable subassembly 300 also includes an insulated containment body 114. The inflatable subassembly 300 includes two spaced-apart walls 302, at least one of which is made of a deformable material. The walls 302 define a cavity 306 therebetween that can expand to provide thermal insulation for the insulated containment body 114. Upon inflation, the expanded walls 302 can compress the deformable containment body 118 disposed therein, causing the deformable containment body 118 to conform to the shape of the one or more materials 102 and / or container 104 and to be in thermal and physical contact with the one or more materials 102 and / or container 104.

[0091]

[0108] Inflatable subassembly 300 may be inflated in any suitable manner. In some embodiments, air or any other gas inlet 310 may be provided, formed with an opening 312 for admitting air (or other gas) therein. Air (or other gas) may be introduced in any suitable manner, such as by a manual or electric pump 320, typically including a piston or any other means for forcing air (or other gas) into inlet 310. Pump 320 may include a valve 330 or any other means for controlling airflow therethrough. In some embodiments, another gas may be employed besides or in addition to air to inflate inflatable subassembly 300. In some embodiments, pump 320 may include a compressed gas tank for using gas to inflate inflatable subassembly 300. In some embodiments, inlet 130 may protrude externally from housing 110, as shown in FIGS. 5A-6, while in some embodiments, inlet 310 may be inserted within housing 110, as shown in FIG. 6B.

[0092]

[0109] The flow of air and / or gas into and / or out of inflatable subassembly 300 can be controlled by controller 196 (FIG. 4) and valves 330, which can be configured to introduce air or gas or pressure into or release air or gas or pressure from inflatable subassembly 300 in response to environmental conditions or any other parameter.

[0093]

[0110] In some embodiments, air inlet 310 may be used as a mouthpiece for human inflation of inflatable subassembly 300 .

[0111] Inflatable subassembly 300 may include any suitable form of locking mechanism 180 located on at least one side of the device. In some embodiments, locking mechanism 180 may extend along edge 350 of inflatable subassembly 300 to seal edge 350. In some embodiments, locking mechanism 180 may be configured to be opened to allow removal of container 104 and / or substance 102 from assembly 100. In one non-limiting example, locking mechanism 180 may include a zipper.

[0094]

[0112] As can be seen in FIG. 5A , one or more containers 104 can be placed within the containment mass 106 of the assembly 100 when the inflatable subassembly 300 is in an initial pre-inflation (i.e., deflation) state. The inflatable subassembly 300 can be inflated to an inflated state in any suitable manner, as can be seen in FIGS. 5B and 5C . The inflated walls 302 and the void 306 therebetween form the insulating containment 114, which in turn compresses the deformable containment 118, shown here in FIG. 5C as including a first portion 130 having a first type of PCM and a second portion 132 having a second type of PCM contained in two compartments. The compressed deformable containment 118 conforms to the shape of the multiple containers 104, thus minimizing voids and providing thermal and physical contact to the containers 104.

[0095]

[0113] In some embodiments, inflatable subassembly 300 can be deflated, typically by removing air via air inlet 310. This deflatable state can be created when a rapid change in the temperature of substance 102 or containment mass 106 is required, which can be facilitated by the deflation of the insulation formed by inflated wall 302. For example, when assembly 100 is initially stored refrigerated, it may be desirable to rapidly reduce the temperature of containment mass 106 to accelerate the time it takes for the PCM to solidify and allow a refrigerated substance to be introduced therein. Thus, inflatable subassembly 300 may be deflated to remove the insulation and allow the temperature of PCM 126 to more quickly equalize with ambient temperature.

[0096]

[0114] In some embodiments, inflatable subassembly 300 may be configured to be non-deflatable and may optionally include a one-way valve or any other means for preventing deflation of inflatable subassembly 300.

[0097]

[0115] In some embodiments, the inflatable subassembly 300 includes an inflatable structure in addition to the separate insulated containment body 114 .

[0116] In some embodiments, the inflatable subassembly 300 may be configured to house substantially the entire substance 102 and / or container 104, as shown in Figures 5A-5C, and the container 104 is inserted into the assembly 100.

[0098]

[0117] Referring now to FIG. 6A , in some embodiments, inflatable subassembly 300 may contain or encase only a portion of container 104 (or substance 102). Here, container 104 is shown as including a drug injection device, such as a pen injection device 314, for delivering substance 102 (i.e., a drug) disposed with substance reservoir 318. Inflatable subassembly 300 is configured to contain only a portion of container 104. Typically, this portion includes substance reservoir 318. Inflatable subassembly 300 can be inflated via air inlet 310. In the inflated state shown in FIG. 6A , inflated walls 302 and the void 306 therebetween form insulating containment 114, which in turn compresses deformable containment 118, shown here as including a first portion 130 including a microencapsulated or bulk PCM 126 disposed in or immersed in a second portion 132 including water 140 or other PCM 126. In some embodiments, a single type of PCM 126 may be used. The compressed deformable containment body 118 conforms to the shape of the contained portion of the vessel 104, thus minimizing air gaps while in thermal and physical contact with the contained vessel portion.

[0099]

[0118] As can be seen in FIG. 6B , the container 104 may include a drug infusion device 330, which may include a catheter 332 in fluid communication with a drug reservoir 334 for delivering the substance 102 (i.e., drug) disposed within the substance reservoir 334. The infusion of the drug from the reservoir 334 to the catheter 332 may be prompted by a pump 336, which may be located proximate to the reservoir 332 as shown in FIG. 6B or remote from the reservoir 332. The inflatable subassembly 300 is configured to house only a portion of the container 104. Typically, this portion includes the substance reservoir 332. The inflatable subassembly 300 may be inflated via an air inlet 310. In the inflated state shown in FIG. 6B , the inflated walls 302 and the void 306 therebetween form the insulating containment body 114, which in turn compresses the deformable containment body 118, shown here as containing a single type of PCM 126. The compressed deformable containment body 118 conforms to the shape of the contained portion of the container 104, thus minimizing air gaps while in thermal and physical contact with the contained container portion.

[0100]

[0119] It should be noted that assembly 300 may include any one of the features described with reference to assembly 100 mutatis mutandis.

[0120] In some embodiments, an environmental control system is provided for controlling the environmental conditions of a substance, where in some parts of the system the environmental conditions are not controlled, for example as shown in Figures 6A-7.

[0101]

[0121] 7, in some embodiments, assembly 100 may be configured to be placed within a designated, climate-controlled refrigeration compartment 350 of a refrigerator 352, in one non-limiting example, a residential refrigerator. Compartment 350 may be a pre-designed, built-in feature of a commercially available refrigerator. Compartment 350 is sized and configured to accommodate assembly 100 and allow for removal of assembly 100.

[0102]

[0122] In some embodiments, compartment 350 may include components such as an electrically powered thermoelectric element or any other heater or cooler 354 to further control the environmental conditions (e.g., temperature) of assembly 100. In some embodiments, refrigerated compartment 350 may include a temperature sensor 356 to measure the temperature of container 104 and / or substance 102.

[0103]

[0123] In some embodiments, a controller 358 may be provided and configured to control operation of the thermoelectric element or heater or cooler 354 in response to the temperature detected by the temperature sensor 356. The thermoelectric element or heater or cooler 354 may be operated to prevent the substance 102 from exceeding an upper temperature limit or dropping below a lower temperature limit. In some embodiments, the refrigerated compartment 350 may include a presence detector 360 for detecting the presence of the assembly 100 and / or container 104 in the refrigerated compartment 350 or the removal of the assembly 100 and / or container 104 from the refrigerated compartment 350. Communication means 366 may be provided for transmitting signals received from the presence detector 360 and / or temperature sensor 356 to the external device 200. The signals may be received by the external device 200 directly from the presence detector 360 and / or temperature sensor 356, via a control unit 370 of the refrigerator 352 (such as a standard, off-the-shelf controller), or by any other suitable means.

[0104]

[0124] In some embodiments, substance 102 may include food, and assembly 100, in any of the configurations shown herein in FIGS. 1A-8, may be configured to control the temperature of the food. For example, food may be in the form of any solid and / or liquid or combination and placed within assembly 100 at a relatively high temperature (e.g., above 60° C.) and held within assembly 100 for extended periods of time, such as from several hours to 24 hours or more, or even several days. Food may be maintained at a desired temperature in a cordless or off-grid environment and kept warm and intact within assembly 100, which functions as a lunchbox. Similarly, for example, food may be placed within assembly 100 at a relatively low temperature (e.g., below 10° C., or even below 0° C.) and held therein for extended periods of time, such as from several hours to 24 hours or more, or even several days, keeping the food cool and fresh. The housing 110 may be made of a rigid material (FIGS. 1A-1C), or may be made of a deformable material and / or may be made of an inflatable subassembly 300 (FIGS. 5A-6).

[0105]

[0125] It should be appreciated that in some embodiments, assembly 100 can be configured to be used for multiple containers 104, even on a large scale. In one non-limiting example, assembly 100 can be sized and configured to accommodate dozens or even hundreds of containers 104. In some embodiments, assembly 100 can also be configured as a medication cabinet or medication transport box for safely transporting medications for extended periods of time (days, weeks, or even months). The medication cabinet or box can include any one of the components (e.g., sensor temperature) described herein.

[0106]

[0126] In some embodiments, assembly 100 may be sized to be handheld and / or portable. In one non-limiting example, assembly 100 may be sized to fit into a backpack or suitcase, or any other typical means for a user to transport supplies. In one non-limiting example, assembly 100 may be sized to fit into a user's pocket, purse, and / or handbag, for example. In some embodiments, assembly 100 may be configured and sized to be delivered by a drone. Because substance 102 and / or container 104 are at least partially contained within assembly 100, delivery by drone or any other suitable delivery means does not require the drone to be equipped with a separate auxiliary thermal storage element.

[0107]

[0127] Assembly 100 is configured to provide uniform heat distribution, i.e., temperature along substance 102 and / or container 104. In the embodiment of Figures 1A-7, this is achieved by providing a deformable containment body 118 that conforms to the shape of substance 102 and / or container 104, thereby minimizing voids. Deformable containment body 118 can be configured as a heat distribution means.

[0108]

[0128] 8 , uniform heat distribution can be achieved in other suitable manners. For example, assembly 100 can include insulating containment 114 and environmental control material 120 in at least partial thermal communication with substance 102 and / or container 104. Assembly 100 can include uniform heat distributor 400 for uniformly distributing heat by any means of thermal conduction, thermal convection, and / or thermal radiation. In one non-limiting example, distributor 400 can include fan 402 for blowing air unintentionally trapped around substance 102 and / or container 104 along substance 102 and / or container 104, thereby preventing uneven heat distribution along substance 102 and / or container 104.

[0109]

[0129] While the present disclosure has been described with respect to a limited number of embodiments, it should be understood that any combination of the whole or partial embodiments may be used, and that the optimum dimensional relationships of the various parts of the present invention, including variations in size, material, shape, form, function and mode of operation, assembly and use, will be readily apparent and obvious to those skilled in the art, and that all relationships equivalent to those shown in the drawings and described herein are intended to be encompassed by the present invention.

[0110]

[0130] Accordingly, the foregoing description is considered as merely illustrative of the principles of the invention, and since numerous modifications and changes will readily occur to those skilled in the art, it is not intended to limit the invention to the exact construction and operation shown and described, and therefore, all suitable modifications and equivalents may be employed and are within the scope of the invention.

[0111]

[0131] While certain preferred embodiments of the present invention have been described with reference to the accompanying drawings, it will be understood that the invention is not limited to those precise embodiments and that various changes and modifications may be made thereto by those skilled in the art without departing from the scope and spirit of the invention as defined by the appended claims.

[0112]

[0132] Further modifications of the present invention will occur to those skilled in the art, and all such modifications are deemed to be within the spirit and scope of the present invention as defined by the appended claims.

[0113]

[0133] While the present invention has been described with respect to a limited number of embodiments, it will be appreciated that many variations, modifications, and other applications of the present invention are possible.

[0134] While various inventive embodiments have been described and illustrated herein, those skilled in the art will readily envision various other means and / or structures for performing the functions and / or obtaining one or more of the results and / or advantages described herein, and each such variation and / or modification is deemed to be within the scope of the inventive embodiments described herein. More generally, those skilled in the art will readily appreciate that all parameters, dimensions, materials, and configurations described herein are intended to be examples, and that the actual parameters, dimensions, materials, and / or configurations will depend on the specific application or applications in which the inventive technology is used. Those skilled in the art will recognize and be able to ascertain, using no more than routine experimentation, equivalents to the specific inventive embodiments described herein. Accordingly, it should be understood that the above-described embodiments are presented by way of example only, and that, within the scope of the appended claims and their equivalents, inventive embodiments may be practiced otherwise than as specifically described and claimed. Inventive embodiments of the present disclosure are directed to each individual feature, system, article, material, kit, and / or method described herein. Furthermore, any combination of two or more such features, systems, articles, materials, kits, and / or methods is within the inventive scope of the present disclosure, provided that such features, systems, articles, materials, kits, and / or methods are not mutually inconsistent. Some embodiments may be distinguished over the prior art due to the specific absence of one or more features / elements / functions (i.e., claims directed to such embodiments may include negative limitations).

[0114]

[0135] Also, various inventive concepts may be embodied as one or more methods, examples of which have been provided. The acts performed as part of a method may be ordered in any suitable manner. As such, embodiments may be constructed in which acts are performed in an order different from that shown, including performing some acts simultaneously even though the illustrated embodiments show acts as sequential.

[0115]

[0136] All references to published or other literature, including but not limited to patents, patent applications, articles, web pages, books, etc., mentioned anywhere in this application are incorporated herein by reference in their entirety, and all definitions defined and used herein should be understood to supersede dictionary definitions, definitions in documents incorporated by reference, and / or ordinary meanings of the defined terms.

[0116]

[0137] As used herein and in the claims, the indefinite articles "a" and "an" should be understood to mean "at least one" unless expressly specified otherwise. As used herein and in the claims, the term "and / or" should be understood to mean "either or both" of the elements so coordinated, i.e., elements that may be present conjunctively or disjunctively. Multiple elements listed with "and / or" should be construed in the same manner, i.e., "one or more" of the elements so coordinated. Other elements, whether related or unrelated to the elements specifically identified by the "and / or" clause, may optionally be present other than the elements specifically identified by the clause. Thus, as one non-limiting example, when used with open-ended expression such as "comprising," a reference to "A and / or B" may, in one embodiment, refer to A only (optionally including elements other than B); in another embodiment, to B only (optionally including elements other than A); in yet another embodiment, to both A and B (optionally including other elements), etc.

[0117]

[0138] As used herein and in the claims, "or" should be understood to have the same meaning as "and / or" as defined above. For example, when separating listed items, "or" or "and / or" should be interpreted as inclusive, i.e., including at least one element of a list of elements, but also including multiple elements, and optionally including additional unlisted elements. In contrast, explicit terms such as "only one of" or "exactly one of," or, when used in the claims, "consisting of," only mean including exactly one element of a list of elements. In general, the term "or" as used herein should be interpreted to indicate exclusive alternatives (i.e., "one or the other, but not both") only when accompanied by terms indicating exclusivity, such as "either," "one of," "only one of," or "exactly one of." When "consisting essentially of" is used in the claims, it shall have its ordinary meaning as used in the field of patent law.

[0118]

[0139] The phrase "at least one," as used herein and in the claims in connection with a list of one or more elements, should be understood to mean at least one selected from any one or more of the elements in the list of elements, but not necessarily including at least one of each and every element specifically listed within the list of elements, and not excluding any combination of elements in the list of elements. This definition also allows for the optional presence of elements other than those specifically identified within the list of elements to which the phrase "at least one" refers, whether related or unrelated to the specifically identified elements. Thus, as one non-limiting example, "at least one of A and B" (or, equivalently, "at least one of A or B" or, equivalently, "at least one of A and / or B") can refer in one embodiment to A (and optionally including elements other than B), where B is absent, at least one, optionally including more than one, B; in another embodiment to B (and optionally including elements other than A), where A is absent, at least one, optionally including more than one, A; in yet another embodiment to A (and optionally including more than one), and B (and optionally including other elements), where A is at least one, optionally including more than one, and B (and optionally including other elements), where B is at least one, optionally including more than one, etc.

[0119]

[0140] In the claims and the foregoing specification, transitional phrases such as "comprising," "including," "carrying," "having," "containing," "involving," "holding," "composed of," and the like, are to be understood to be open-ended, i.e., to mean including, but not limited to. Only the transitional phrases "consisting of" and "consisting essentially of" shall be closed or semi-closed transitional phrases, respectively, as set forth in the United States Patent Office Manual of Patent Examining Procedures, Section 2111.03.

Claims

[Claim 1] The invention as described in the drawings of this application.

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