Patent Grant
11285079
If the listings of applications provided above are inconsistent with the listings provided via an ADS, it is the intent of the Applicant to claim priority to each application that appears in the Domestic Benefit/National Stage Information section of the ADS and to each application that appears in the Priority Applications section of this application.
All subject matter of the Priority Applications and of any and all applications related to the Priority Applications by priority claims (directly or indirectly), including any priority claims made and subject matter incorporated by reference therein as of the filing date of the instant application, is incorporated herein by reference to the extent such subject matter is not inconsistent herewith.
In some embodiments, a medicinal carrier device includes: one or more sections of thermal insulation positioned to form an internal space with an adjacent first side region and an adjacent second side region; a first panel including a first phase change material positioned within the first side region of the internal space, the first side region of a size and shape to firmly contain an integral number of portable cold packs in thermal contact with the first panel; and a second panel including a second phase change material positioned within the second side region of the internal space, the second side region of a size and shape to firmly contain an integral number of portable cold packs in thermal contact with the second panel.
In some embodiments, a medicinal carrier device includes: one or more sections of thermal insulation positioned to form an internal space of a size and shape to hold medicinals; and one or more thermally conductive barriers positioned within the internal space between an interior medicinal storage region and one or more external portable cold pack storage regions, the one or more thermally conductive barriers formed from phase change material encapsulated within a thermally-conductive material, wherein the phase change material encapsulated within the one or more thermally conductive barriers has a latent heat of fusion greater than the specific heat capacity of portable cold packs equivalent to the volume of the external portable cold pack storage regions.
The foregoing summary is illustrative only and is not intended to be in any way limiting. In addition to the illustrative aspects, embodiments, and features described above, further aspects, embodiments, and features will become apparent by reference to the drawings and the following detailed description.
In the following detailed description, reference is made to the accompanying drawings, which form a part hereof. In the drawings, similar symbols typically identify similar components, unless context dictates otherwise. The illustrative embodiments described in the detailed description, drawings, and claims are not meant to be limiting. Other embodiments may be utilized, and other changes may be made, without departing from the spirit or scope of the subject matter presented here.
Easily portable medicinal carrier devices are used for transport of small volumes of medicinal materials for several hours while maintaining the interior storage region in a defined temperature range above 0 degrees C. Many medicinals, such as vaccines, antibiotics, blood products and the like, must be maintained within a predetermined temperature range in order to preserve their stability and/or efficacy. For example, medicinal carrier devices including internal medicinal storage regions between 0.5 liter (L) and 2 L volumes are used to transport medicinals such as vaccines, antibiotics, and medical treatment materials within a consistent temperature range above 0 degrees C. for periods between 3 to 8 hours. In some embodiments, the medicinal carrier devices are insulated rectangular structures, in a boxlike shape, with exterior handles or straps and a reversibly removable lid. In some embodiments, the medicinal carrier devices are used to transport medicinals that should be stored within a range between 2 degrees C. and 10 degrees C. In some embodiments, the medicinal carrier devices are used to transport medicinals that should be stored within a range between 2 degrees C. and 8 degrees C. In some embodiments, the medicinal carrier devices are used to transport medicinals that should be stored within a range between 4 degrees C. and 8 degrees C.
Generally, the medicinal storage region within a medicinal carrier device is maintained at a temperature less than ambient temperature and slightly above freezing with the addition of one or more portable cold packs containing water ice to the medicinal storage region. For example, the WHO and UNICEF provide standards (e.g. WHO/UNICEF E5 IP) for portable cold packs including the size, shape and volume of the portable cold packs for use with vaccine storage. Generally, portable cold packs approved by the WHO and UNICEF consist of plastic containers of a predefined volume that are filled with water to form ice when frozen. These portable cold packs are routinely retained in freezers prior to use within medicinal storage devices. However freezers used with portable cold packs are set to temperatures below the freezing point of water, sometimes substantially below (e.g. −20 degrees C.). This results in the portable cold packs being frozen to temperatures below, sometimes significantly below, the storage range of medicinals that should be stored within a range between 2 degrees C. and 10 degrees C. Use of portable cold packs at these very low temperatures can result in damage to the medicinals stored within medicinal storage devices, sometimes freezing the medicinals and correspondingly reducing their clinical effectiveness. Clinical use protocols exist for the conditioning of portable cold packs after removal from a freezer and prior to use with medicinals that should be stored within a range between 2 degrees C. and 10 degrees C. For example, some clinical use protocols require conditioning of portable cold packs prior to use by setting them at room temperature for a fixed period of time. For example, some clinical use protocols require conditioning of portable cold packs prior to use by setting them at room temperature until the material within the portable cold packs is partially thawed (e.g. sloshes when shaken). However, these clinical use protocols require training of personnel and time to carry out, leading to instances where they are not carried out due to lack of training and/or time pressures and the resulting possible use of a medicinal storage device with a storage region above or below the approved storage range for medicinals (e.g. a range between 2 degrees C. and 10 degrees C.).
Medicinal carrier devices as described herein are designed for use with portable cold packs taken directly from a freezer, including a freezer maintained significantly below freezing (e.g. −20 degrees C., or −30 degrees C.) without cooling the interior storage area of the carrier below the storage range of medicinals that should be stored within a range between 2 degrees C. and 10 degrees C. The medicinal carrier devices as described herein are designed to maintain the internal medicinal storage region within a range between 2 degrees C. and 10 degrees C. during use, typically from 8-12 hours, but in some embodiments up to 36 hours, with a single set of portable cold packs taken from a freezer. A set of portable cold packs can be a single cold pack, 2 cold packs, 3 cold packs, 4 cold packs, or another integral number of cold packs depending on the embodiment. The medicinal carrier devices as described herein include phase change materials with solid-liquid transition points within the use range, e.g. a range between 2 degrees C. and 10 degrees C., positioned between the frozen portable cold packs and the medicinal storage region.
In some embodiments, the phase change materials are embedded in a solid structure to provide support and to maintain the position of the portable cold packs while the carrier is being used as transport for medicinals. For example, some embodiments utilize microencapsulated phase change material, or phase change material that is encapsulated within a polymer or plastic to form particle sizes in the 15-30 micron range (e.g. MPCM6, available from Microtek Laboratories Inc.). These microencapsulated phase change materials are further solidified in an epoxy material. For example, some embodiments include a 1:1 mixture by volume of TAP Marine Grade 314 Resin and TAP Marine Grade 143 Hardener (available from TAP Plastics, Inc.). Microencapsulated phase change material can be mixed with the epoxy mixture at a 1.5:1 ratio by weight composition and then formed into appropriate structures prior to hardening. For example, a solid phase change material including microencapsulated phase change material with a phase change temperature of 6 degrees C. mixed with the epoxy mixture at a 1.5:1 ratio by weight can be formed into a structure at least 1 cm thick to be positioned within a medicinal carrier between a portable cold pack and the medicinal storage region. Such a configuration can be utilized, for example, with portable cold packs at −25 degrees C. while maintaining the medicinal storage region of the device in a range between 2 degrees C. and 10 degrees C. The dimensions of the phase change material depend on the embodiment, and are based on factors including the desired temperature range of the medicinal storage region, the phase change material utilized, the portable cold pack size, expected starting temperature and material, and the size and shape of the internal space of the carrier.
Use of microencapsulated phase change materials solidified in an epoxy material can provide for the use of phase change materials with transition temperatures above or below that of water. For example, assuming that a storage region of a medicinal carrier device needs to be maintained in a range between 2 degrees C. and 10 degrees C., an embodiment might include a phase change material with a transition temperature in the middle of the storage range, such as approximately 6 degrees C. Use of such phase change materials with embodiments such as described herein can minimize the possibility of a medicinal storage region interior migrating outside of the optimal temperature range, even when used with portable cold packs cooled substantially below zero degrees (e.g. to −20 degrees C., or to −30 degrees C.). Use of encapsulated phase change material can also reduce the risk of leaks of phase change material even if the device is damaged. Embodiments such as described herein also provide for rapid cooling of the interior of a storage region in a device prior to use, and rapid equilibration in the appropriate temperature range (e.g. minutes to equilibrate).
Some embodiments further include a thermochromatic dye added to the solidified phase change material to indicate its current temperature. For example, a particular block of solid phase change material might not be suitable for immediate use if it has been exposed to excessive ambient temperatures (e.g. left in a hot or sunny location outside of the medicinal carrier). For example, a thermochromatic dye can indicate when a portion of a block of solidified phase change material is in contact with a portable cold pack that is currently at a temperature significantly below zero degrees C. (e.g. −20 degrees C.). In some embodiments, a thermochromatic dye in a powder form with color change properties as desired for an embodiment can be added to the microencapsulated phase change material-epoxy mixture described above at a weight equivalent to 0.5% to 1% of the microencapsulated phase change material.
In some embodiments, a medicinal carrier device includes: one or more sections of thermal insulation positioned to form an internal space with an adjacent first side region and an adjacent second side region; a first panel including a first phase change material positioned within the first side region of the internal space, the first side region of a size and shape to firmly contain an integral number of portable cold packs in thermal contact with the first panel; and a second panel including a second phase change material positioned within the second side region of the internal space, the second side region of a size and shape to firmly contain an integral number of portable cold packs in thermal contact with the second panel.
In the embodiment illustrated, an optional opening is positioned between each of the slots and the center storage region 210, the opening of a size and shape to permit a person to reversibly slide a portable cold pack into the slot or to remove the portable cold pack from the slot. For example, slot 800 is of a size, shape and position to secure a portable cold pack within the inner mass of phase change material adjacent to the center storage region 210. Opening 805 is adjacent to the slot 800, positioned so that a person can insert and remove the portable cold pack within the slot 800. Similarly, slots 810, 820, 830 have respective adjacent openings 815, 825, 835.
Surrounding the mass of phase change material 900 in the illustrated embodiment is an inner ring 910. In some embodiments, the inner ring includes additional phase change material. The additional phase change material can, for example, have a transition temperature similar to the one used in the central mass (e.g. phase change material with a transition temperature in the 2-8 degree C. range). The additional phase change material can, for example, have a transition temperature lower than the one used in the central mass (e.g. phase change material with a transition temperature in the 2-8 degree C. range but lower than the first phase change material). The additional phase change material can, for example, have a transition temperature higher than the one used in the central mass (e.g. phase change material with a transition temperature in the 2-8 degree C. range but higher than the first phase change material). In some embodiments the inner ring includes an insulation material, such as a hollow evacuated space, foam insulation, or other insulation materials as suitable for an embodiment. The inner ring 910 is surrounded by an outer ring 940, which includes insulation material, such as a hollow evacuated space, foam insulation, or other insulation materials as suitable for an embodiment. Factors considered in the selection of insulation materials for an embodiment include cost, mass, thermal insulation efficiency, and durability in an intended use case. The illustrated embodiment also includes an optional external covering 920, for example a plastic or polymer shell of a composition selected to provide a desired durability, appearance and protection to the storage portion 110 of the medical carrier device.
The storage portion 110 of the medical carrier device 100 illustrated in
In some embodiments, a medicinal carrier device includes: one or more sections of thermal insulation positioned to form an internal space of a size and shape to hold medicinals; and one or more thermally conductive barriers positioned within the internal space between an interior medicinal storage region and one or more external portable cold pack storage regions, the one or more thermally conductive barriers formed from phase change material encapsulated within a thermally-conductive material, wherein the phase change material encapsulated within the one or more thermally conductive barriers has a latent heat of fusion greater than the specific heat capacity of portable cold packs equivalent to the volume of the external portable cold pack storage regions.
Surrounding the center storage region 210 are four slots 800, 810, 820, 830, each slot of a size and shape to secure a portable cold pack. In some embodiments, a portable cold pack is an ice pack, for example a WHO-approved ice pack for medical outreach. For example, in some embodiments each slot is of a size and shape to contain a 0.6 L WHO-approved standard size ice pack. For example, in some embodiments each slot is of a size and shape to contain a 0.4 L WHO-approved standard size ice pack. Each of the slots 800, 810, 820, 830 are of a size and shape to hold the cold pack securely, including space for expansion of some materials (e.g. ice expansion relative to water).
Positioned in a gap between the center storage region 210 and each of the four slots 800, 810, 820, 830 are thermally conductive barriers 1100, 1110, 1120, 1130. Each of the thermally conductive barriers is fabricated from phase change material encapsulated within a thermally-conductive material. In some embodiments, the thermally-conductive barriers can be fabricated from microencapsulated phase change materials (for example, available from Microtek Laboratories, Ohio USA) mixed with a resin and allowed to solidify into a rectangular, board-like structure. Each of the thermally conductive barriers 1100, 1110, 1120, 1130 illustrated in
Operation of a medicinal carrier device including thermally conductive barriers such as those described herein relies on the relatively rapid conduction of heat from the center storage region through the thermally conductive barriers to the portable cold pack. The phase change material encapsulated within each of the thermally conductive barriers has a latent heat of fusion greater than the specific heat capacity of a portable cold pack equivalent to the volume of the adjacent portable cold pack storage region. For example, relative to
In some embodiments, the phase change material encapsulated within the thermally-conductive material fabricating a thermally conductive barrier includes encapsulated phase change material having a melting temperature of 6° C. In embodiments intended for use with cold packs containing water and ice, the center storage region can be rapidly equilibrated to a temperature range between 2° C. and 8° C. using the materials and devices described herein, for example within 2 hours of placement of the portable cold packs within the device.
Some embodiments include fabrication of a portable medicinal carrier device with a liner. Wherein a liner is positioned adjacent to a thermally conductive barrier, such as between a thermally conductive barrier and a portable cold pack, it can be fabricated from a thermally-conductive material.
The liner includes an interior region that includes a plurality of slots of a size, shape and position to hold portable cold packs around a central storage region. In the embodiment illustrated in
For each gap, an amount of thermally conductive barrier material is positioned between the cold pack storage region and the central storage region that is calculated to be sufficient to have a latent heat of fusion greater than the specific heat capacity of portable cold packs equivalent to the volume of the external portable cold pack storage regions. The heat of fusion of the thermally conductive material can be approximated by the heat of fusion of the encapsulated phase change material (PCM) within the thermal barrier material. The minimum amount of PCM required in a particular section of thermally conductive barrier of a medicinal carrier device, such as a freeze-free vaccine carrier, is determined by calculating the minimum amount of heat required to raise the temperature of the expected portable cold pack (or packs in some embodiments) to be used in the adjacent region from its storage temperature to a use temperature. In many embodiments, a preferred PCM material has a melting point of 6° C. to equilibrate ice/water containing cold packs with a storage region to a temperature in the 0.5° C. to 8° C. range.
In some embodiments, a medicinal carrier device includes: one or more sections of thermal insulation positioned to form an internal space of a size and shape to hold medicinals; and one or more thermally conductive barriers positioned within the internal space to form an interior medicinal storage region and one or more external portable cold pack storage regions, the one or more thermally conductive barriers formed from phase change material encapsulated within a thermally-conductive material, wherein the one or more thermally conductive barriers have a heat capacity, volume and thermal conductivity sufficient to cool the internal space to between 0.5° C. and 8° C. in less than 2 hours from a time point when all of the external portable cold pack storage regions are filled with portable cold packs of a temperature less than minus 10° C., and to maintain the internal space to between 0.5° C. and 8° C. for at least 35 hours.
In some embodiments, a medicinal carrier device includes four portable cold pack storage regions, each of a size and shape to contain a WHO-standard sized 0.4 L ice pack. In some embodiments, a medicinal carrier device includes two portable cold pack storage regions, each of a size and shape to contain a WHO-standard sized 0.4 L ice pack. In some embodiments, a medicinal carrier device includes four portable cold pack storage regions, each of a size and shape to contain a WHO-standard sized 0.6 L ice pack and a hold time of at least 35 hours of the medicinal storage region in the 0.5° C. to 8° C. range. In some embodiments, a medicinal carrier device includes two portable cold pack storage regions, each of a size and shape to contain a WHO-standard sized 0.6 L ice pack and a hold time of at least 15 hours of the medicinal storage region in the 0.5° C. to 8° C. range.
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In a large plastic bucket, 500 grams of TAP Plastic General Purpose Epoxy Resin—Component A and 500 grams of TAP Plastic General Purpose Epoxy Resin—Component B are mixed together using a concrete/resin mixing attachment to a power drill until thoroughly combined. In several batches, 1.3 kg of microencapsulated phase change material (MPCM6D from Microtek Laboratories in Dayton, Ohio) is immediately added to the epoxy resin mixture in the bucket and mixed until smooth. A portion of the resulting doughy mixture is compressed into an aluminum/steel mold treated with a release agent (e.g. Formula Five Mold Release Wax or PolEase 2300 Release Agent) either by hand or with a tool such as a hydraulic press to ensure that the mold is completely filled and the air bubbles and voids are minimized. The mold is closed in such a way that the excess PCM-epoxy material is expelled from the mold and removed. The PCM-epoxy mixture inside the mold is allowed to cure, typically for 15-24 hours, and then the resulting panel of hardened PCM-epoxy material is removed from the mold. The measured latent heat of fusion of the PCM-epoxy material is measured to be 100 kJ/kg.
For incorporation into vaccine carriers that use 0.4 L ice packs (see the World Health Organization's PQS Devices Catalog, section E005: Coolant Packs for Insulated Containers for many examples), a panel with dimensions 165 mm×95 mm×6 mm is produced. The dimensions may vary somewhat depending upon the exact dimensions of the type of vaccine carrier being modified to use the panel for freeze protection. For incorporation into vaccine carriers that use 0.6 L ice packs, a panel with dimensions 190 mm×120 mm×8 mm is generally produced, dimensions vary somewhat for particular carrier models. Panels of different dimensions can be made with different-sized molds. Alternatively, panels can be made different sizes by shaping (e.g. cutting, routing, sanding) other panels.
PCM-resin panels are made as described in Example 1 except that the epoxy components are replaced with casting polyurethane components A and B (e.g. TAP Plastic Quik-Cast Polyurethane Resin system) and the cure times are reduced to 30-60 minutes.
Four 165 mm×95 mm×6 mm PCM-epoxy panels fabricated as described in Example 1 are placed inside the inner liner of a modified 1.7 L vaccine carrier (see the World Health Organization's PQS Devices Catalog, section E004: Insulated Containers for many examples) that uses four 0.4 L ice packs as portable cold packs. The liner is modified to allow space for the incorporation of the PCM-epoxy panels as barriers between the ice packs and the vaccine storage space in the center of the carrier, which increases the length of the sides of the carrier at least as much as the thickness of two PCM-epoxy panels and the thickness of any plastic coating that protects the panel. The panels are inserted into the liner and the vaccine carrier is assembled. The exterior walls of the carrier are filled with polyurethane foam using standard practices to form a freeze-free vaccine carrier.
Under ambient temperatures in the range from 10° C. to 43° C. and following standard thermal performance testing methods (e.g. those described in World Health Organization PQS Type-Testing Protocol Document WHO/PQS/E004/VC02-VP.1—Vaccine Carrier with Freeze-Prevention Technology, which is incorporated herein by reference), the temperature inside the vaccine storage space of the carrier does not drop below 0° C. when loaded and used with 0.4 L ice packs filled with water and frozen to minus 25° C. The assembled vaccine carrier cools down to 10° C. within 2 hours of adding ice packs frozen to minus 25° C. The assembled vaccine carrier maintains a temperature between 0° C. and 10° C. for at least 30 hours.
A separate freeze-carrier vaccine of the same dimensions, with similar thermal performance, is also produced using polyurethane-based PCM panels as described in Example 2.
A freeze-free vaccine carrier is prepared as described in Example 3, but an additional 90 mm×90 mm×6 mm panel is placed inside the inner liner at the bottom (floor) of the vaccine storage chamber. The resulting freeze-free vaccine carrier is thermally tested and shown to cool down to 10° C. within 2 hours of adding ice packs frozen to minus 25° C. The assembled vaccine carrier maintains a temperature between 0° C. and 10° C. for at least 30 hours.
A separate freeze-carrier vaccine of the same dimensions, with similar thermal performance, is also produced using polyurethane-based PCM panels as described in Example 2.
Four 190 mm×165 mm×8 mm PCM-epoxy panels fabricated as described in Example 1 are placed inside the inner liner of a modified 3.4 L vaccine carrier (see the World Health Organization's PQS Devices Catalog, section E004: Insulated Containers for many examples) that uses four 0.6 L ice packs and assembled and tested as described in Example 3. Upon loading with four water-filled ice packs at minus 25° C., the carrier cools down to 10° C. within 2 hours of adding ice packs and maintains a temperature between 0 and 10° C. for over 40 hours.
A separate freeze-carrier vaccine of the same dimensions, with similar thermal performance, is also produced using polyurethane-based PCM panels as described in Example 2.
A freeze-free vaccine carrier is prepared as described in Example 4, but an additional 157 mm×157 mm×8 mm panel is placed inside the inner liner at the bottom (floor) of the vaccine storage chamber. The resulting freeze-free vaccine carrier is thermally tested and shown to shown to cool down to 10° C. within 2 hours of adding ice packs frozen to minus 25° C. The assembled vaccine carrier maintains a temperature between 0° C. and 10° C. for at least 30 hours.
A separate freeze-carrier vaccine carrier of the same dimensions, with similar thermal performance, is also produced using polyurethane-based PCM panels as described in Example 2.
The minimum amount of PCM required in a thermally conductive barrier of a medicinal carrier device, such as a freeze-free vaccine carrier, is determined by calculating the minimum amount of heat required to raise the temperature of the expected portable cold pack to be used from its storage temperature to a use temperature.
For example, where ice packs are used as portable cold packs, they are available in standard sizes (e.g. 0.4 L or 0.6 L) and often stored in a minus 25° C. freezer prior to use in a carrier. At the start of use, the temperature of a minus 25° C. ice pack is raised to 0° C. (this is often called “conditioning the ice”) within a carrier incorporating thermally conductive barrier material to expedite the conditioning process. To calculate the amount of heat required to condition an ice pack, the weight of the ice (kg) is multiplied by the heat capacity of ice (kJ/kg/° C.) and then multiplied by 25° C. (the temperature differential from minus 25° C. to 0° C.). For example, a 0.6 L ice pack requires at least 0.6 kg×2 kJ/kg/° C.×25° C. or 30 kJ of heat to condition it. With a latent heat of fusion of PCM-resin material of 100 kJ/kg, at least 0.33 kg of PCM-resin material is needed for each ice pack used in the freeze-free vaccine carrier. More PCM-resin may be needed depending upon the efficiency of the phase change while heat is being transferred to the ice pack.
Using this calculation, PCM-resin quantities can be tuned for different sized ice packs and different starting ice temperatures as needed. The minimum volume of a thermally conductive barrier material for an embodiment can similarly be calibrated to other types of portable cold packs (e.g. PCM continuing cold packs) or ice-containing cold packs stored at other temperatures (e.g. minus 10° C. or minus 50° C. may be expected in some situations).
An uncured PCM-resin mixture as described in Example 1 and Example 2 is added directly to the underside of an unassembled medicinal carrier inner liner to form a thermally conductive barrier between a portable cold pack and the inner storage space. The PCM-resin mixtures is allowed to cure and the medicinal carrier is assembled and tested. Testing shows that medicinal carriers manufactured by this method have similar thermal performance to freeze-free medicinal carriers manufactured with PCM-resin panels of similar thickness and weight.
While various aspects and embodiments have been disclosed herein, other aspects and embodiments will be apparent to those skilled in the art. The various aspects and embodiments disclosed herein are for purposes of illustration and are not intended to be limiting, with the true scope and spirit being indicated by the following claims.
If an Application Data Sheet (ADS) has been filed on the filing date of this application, it is incorporated by reference herein. Any applications claimed on the ADS for priority under 35 U.S.C. §§ 119, 120, 121, or 365(c), and any and all parent, grandparent, great-grandparent, etc. applications of such applications, are also incorporated by reference, including any priority claims made in those applications and any material incorporated by reference, to the extent such subject matter is not inconsistent herewith. The present application claims the benefit of the earliest available effective filing date(s) from the following listed application(s) (the “Priority Applications”), if any, listed below (e.g., claims earliest available priority dates for other than provisional patent applications or claims benefits under 35 USC § 119(e) for provisional patent applications, for any and all parent, grandparent, great-grandparent, etc. applications of the Priority Application(s)). The present application claims benefit of priority of U.S. Provisional Patent Application No. 62/518,374, entitled FREEZE-FREE MEDICINAL TRANSPORT CARRIERS, naming FONG-LI CHOU, BRIAN L. PAL, MATTHEW W. PETERS, NELS R. PETERSON, AND DAVID J. YAGER as inventors, filed 12 Jun. 2017, which was filed within the twelve months preceding the filing date of the present application or is an application of which a currently co-pending priority application is entitled to the benefit of the filing date.
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