The present specification generally relates to a protective storage system and method for storing pharmaceuticals, medicines and medical equipment.
Physicians often advise patients to carry their medicines with them wherever they go. However, when porting the medicines to different geographies or locations, the medicine is subjected to environmental variations, such as but not limited to variations in temperature, humidity, pressure, among others. Most medicines are required to be stored within a specified temperature, light level and/or environmental range. The specified temperature ranges need to be maintained during storage. In most cases, the specified temperature and other environmental ranges may not be compatible with the environmental conditions during the user's travel. Deviations from the specified ranges may risk the effectiveness of the medicines.
Epinephrine is an auto-injecting portable device that is used by those with severe allergies. The auto-injecting device delivers emergency treatment for an anaphylactic reaction. The device is portable and carried everywhere by its users. A well-known Epinephrine auto-injecting product instructs users to store its carrier tube within a temperature range of 15° C. and 30° C. (59° F. to 86° F.). Users are typically also instructed that auto-injectors should not be exposed to extreme heat or cold and should be protected from light. In an exemplary scenario, a user travelling for outdoor sports to a geography where mid-day temperatures may soar up to 37° C. (100° F.), would compromise the efficacy of Epinephrine, resulting in possible failure during emergency situations, which are often fatal.
Thermal and refrigerating units are often used to safely store medicines that are sensitive to environmental variations. However, such units are either not portable, are fragile, too heavy or bulky to carry around. Some portable insulating units currently available for storing medicines are known to have limitations in terms of: a need for an electrical power supply for its operation; are power-consuming resulting in a low battery life; or need constant attention from the user to monitor efficacy of the insulating units.
There is a need for low-cost, light-weight, portable systems that can overcome the above limitations and provide a storage system for protection of environmentally-sensitive medications.
The following embodiments and aspects thereof are described and illustrated in conjunction with systems, tools and methods, which are meant to be exemplary and illustrative, not limiting in scope.
In some embodiments, the present specification discloses a portable pharmaceutical storage system comprising: an insulated container defining an enclosed volume in a range of no more than 1500 cubic centimeter (cm3) wherein the container comprises a base, four sides, and a lid configured to open and close to thereby provide access to the enclosed volume; a foam layer configured to fit within the enclosed volume, wherein said foam layer comprises a first groove defining a rectangular prism volume in a range of 13 cm3 to 17 cm3; and an electronic circuit positioned within the insulated container comprising: a data acquisition unit; a processor in communication with the data acquisition unit; and a communication interface connected to the processor, wherein the electronic circuit is configured to sense environmental parameters and generate an alert based upon said sensed environmental parameters.
Optionally, the electronic circuit further comprises a power source.
Optionally, the power source is a re-chargeable battery.
Optionally, the insulated container comprises an interior surface and an exterior surface that are opposite to each other, and an insulating material is attached to the interior surface.
Optionally, a material for constructing the insulated container and the lid comprise a thermoplastic polymer.
Optionally, a material for constructing the insulated container and the lid comprise at least one of stainless steel and aluminum.
Optionally, the insulated lid comprises a lock to engage with the insulated container when the insulated lid is in a closed position. Still optionally, the lock comprises at least one pair of magnets embedded on the insulated container and the insulated lid.
Optionally, the insulated lid is detachably attached to the insulated container.
Optionally, the system further comprises one or more auto-injecting pharmaceutical devices. Still optionally, the one or more auto-injecting devices comprise Epinephrine.
Optionally, the environmental parameters include one or more of temperature, light conditions, humidity, and pressure.
Optionally, the system further comprises a temperature management module configured to actively manage a temperature inside the system, and wherein the electronic circuit is configured to control the temperature management module.
Optionally, the temperature management module comprises a Peltier device Optionally, the data acquisition unit comprises one or more sensors configured to sense one or more of temperature, light conditions, humidity, and pressure.
Optionally, the communication interface comprises at least one of a visual interface, and auditory interface, and a wireless communication interface.
Optionally, the wireless communication interface is in communication with a portable electronic device.
Optionally, the visual interface is an OLED display, and wherein the display is provided on an external surface of the system.
In some embodiments, the present specification discloses a method for storing one or more auto-injecting pharmaceutical devices, the method comprising: receiving the one or more auto-injecting pharmaceutical devices in an insulated container defining an enclosed rectangular prism volume in a range no greater than 1500 cm3, wherein the insulated container comprises a top surface covered by an insulated lid; acquiring environmental data through a data acquisition unit placed within the insulated container, wherein the environmental data includes a temperature of the enclosed volume; processing the acquired environmental data by a processor in communication with the data acquisition unit; communicating the processed data through a communication interface; and activating a cooling mechanism positioned within the enclosed volume based on the acquired environmental data.
The aforementioned and other embodiments of the present invention shall be described in greater depth in the drawings and detailed description provided below.
These and other features and advantages of the present invention will be appreciated, as they become better understood by reference to the following detailed description when considered in connection with the accompanying drawings, wherein:
In an embodiment, a portable protective storage system is provided to house environmentally-sensitive medicines. The system insulates and actively monitors ambience parameters of the medicine. The parameters may be communicated to a user through a visual, auditory, or other means. In an embodiment, parameters are communicated to a smartphone or any other portable electronic device through a wired or a wireless medium such as Bluetooth technology.
The present specification is directed towards multiple embodiments. The following disclosure is provided in order to enable a person having ordinary skill in the art to practice the invention. Language used in this specification should not be interpreted as a general disavowal of any one specific embodiment or used to limit the claims beyond the meaning of the terms used therein. The general principles defined herein may be applied to other embodiments and applications without departing from the spirit and scope of the invention. Also, the terminology and phraseology used is for the purpose of describing exemplary embodiments and should not be considered limiting. Thus, the present invention is to be accorded the widest scope encompassing numerous alternatives, modifications and equivalents consistent with the principles and features disclosed. For purpose of clarity, details relating to technical material that is known in the technical fields related to the invention have not been described in detail so as not to unnecessarily obscure the present invention. In the description and claims of the application, each of the words “comprise” “include” and “have”, and forms thereof, are not necessarily limited to members in a list with which the words may be associated.
It should be noted herein that any feature or component described in association with a specific embodiment may be used and implemented with any other embodiment unless clearly indicated otherwise.
Referring simultaneously to
In one embodiment, insulated container portion 102 has a length ranging from 252 to 254 mm, a width ranging from 125 to 127 mm, and a height ranging from 33 to 35 mm. In embodiments, an open side 103 is also referred to as a top portion 103 of container 102.
In an embodiment, an insulated lid 110 provides a cover to open side 103 of insulated container 102. In some embodiments, the lid has a length in a range of 252 mm to 254 mm, a width in a range of 125 mm to 127 mm, and a height in a range of 23 mm to 24 mm. The insulated container portion 102, in embodiments, has an equal length and width to the lid portion 110, except that the height differs in that the lid portion 110 is shorter than the container portion 102. In embodiments, the lid portion 110 of the storage system 100 is flush with the container portion 102. Optionally, the two portions (container portion 102 and lid portion 110) are sealed with O-rings.
In embodiments, it should be noted that the dimensions provided herein for container portion 102 and lid portion 110 (and therefore, the storage system 100) are meant to be exemplary only and not limiting. Therefore, it should be understood by those of ordinary skill in the art that the storage system 100 may be of any form factor, shape and size as long as it achieves the objectives of the present invention.
In an embodiment, insulation is provided within container portion 102 in the form of a soft, insulating foam 104, which is lined along the inner surface of container portion 102. In embodiments, foam 104 has a maximum length of 176 mm, a minimum length of 172 (length range 172 mm to 176 mm), a maximum width of 118 mm, a minimum width of 114 mm (width range 114 mm to 118 mm), and a maximum height of 26 mm and a minimum height of 30 mm (height range 26 mm to 30 mm). In alternative embodiments, other known methods of insulation are incorporated with container 102. In embodiments, insulated container 102 is configured to hold one or more medicines. In some embodiments, insulating foam 104 is molded to loosely fit a medicine or a medicinal device.
In other embodiments, foam 104 has “cut-away” portions or portions that can be “pinched” away to accommodate medicines and medical devices of different dimensions. Thus, a user can simply tear away perforated or pre-notched portions of foam 104 to adjust for a snug fit of different medicines and medical devices. The container of the present specification is designed to accommodate a variety of medicines and medical devices.
In non-limiting embodiments, the present specification is designed to be used to an auto-injecting device, such as an auto-injecting device for Epinephrine (“Epi-pens”). In embodiments, insulating foam 104 is molded to enable a friction fit of an Epinephrine container or any other medicine or medicinal device 108. In some embodiments, insulating foam 104 includes thumb grooves 122 that enable the contents of container 102 to be extracted by hand easily and quickly. In embodiments, thumb grooves 122 are adjacent to grooves 106. Each groove 122 may be configured along the length of groove 106 in insulation foam 104, where groove 106 is configured to fit the auto-injecting device 108. A length of grooves 122 may be a fraction of the length of grooves 106 along which they are configured.
An insulating or insulation layer 120, similar to the insulating foam layer 104 within container 102 may line an inner surface of lid 110. In embodiments, soft insulating foam 120 may be manufactured using polystyrene, similar to insulating foam 104. Insulating foam 120 may cover a part of or all of the inner surface area of lid 110. In embodiments, foam 120 is structured as a rectangular block that has a length in a range of 168 mm to 172 mm, a width in a range of 83 mm to 87 mm. In an embodiment, insulation layer 120 has a thickness in a range of 4 mm to 8 mm. In an embodiment, insulation layers 104 and 120 line the inner surface area of container 102 and lid 110, respectively, where one or more medicines 108 are held.
In an embodiment, at least one set of hinged mechanism 112 connects an edge of lid 110 to a corresponding edge of container 102. Lid 110 may be detachably attached to container 102. In embodiments, while hinged mechanism 112 facilitates permanent joining of lid 110 and container 102 along one edge that is at a back side of storage system 100, a locking mechanism is configured to temporarily join, and lock, lid 110 and container 102 along another edge that is at a front side of storage system 100. In one embodiment, the locking mechanism includes one or more pairs of magnets, where each pair has one magnet on the front edge of lid 110 and the other magnet on the front edge of container 102. The magnets may be embedded in the body of system 100 such that only the surface of each magnet is aligned with the surface of front edge of lid 110 and container 102. Magnets of each pair attract each other when lid 110 and container 102 are about to be closed. Once closed, the magnets keep storage system 100 intact in the closed position (shown in
In embodiments, both halves (lid 110 and container 102) of storage system 100 are lined with a sealing mechanism. The sealing mechanism enables contents of storage system 100 to be protected from the environment outside system 100, when system 100 is closed. In an embodiment, O-rings 124 are used as the sealing mechanism. O-rings 124 may be configured all around the edges of lid 110 and container 124.
In embodiments, container 102 includes an electronic circuit 116. Electronic circuit 116 may be in the form of a Printed Circuit Board (PCB). Circuit 116 may be connected to at least one data acquisition unit (not shown) that may be configured to monitor one or more types of environmental data. In embodiments, circuit 116 may be connected to data acquisition units such as, but not limited to, a humidity sensor, two or more temperature sensors, a Hall Effect sensor, a pressure sensor, and a light sensor. Sensors or data acquisition units may be placed in positions such that they are capable of measuring parameters both inside and outside of the enclosure system 100. In embodiments, temperature sensors are able to provide data on the temperature of enclosed medicine or medicinal device 108, and the temperature outside of system 100, in order to determine the potential threat to the integrity of temperature sensitive medicine/device 108 contained within system 100. In embodiments, a Hall Effect sensor is additionally connected to and communicates with a processor on circuit 116. The Hall Effect sensor detects whether storage system 100 is closed completely, or not. In the event that lid 110 is partially open for an extended period of time, the Hall Effect sensor sends a communication to the processor. The processor may be programmed to alert a user about the un-closed, open or breached state of system 100.
Additional sensors and data acquisition units are incorporated that monitor environmental data and communicate with the processor on circuit 116. Environmental data may include data pertaining to temperature, humidity, pressure, light conditions, or any other form of environmental data. A processor, such as a micro-processing unit, may be mounted on circuit 116. The processor may be in communication with the data acquisition unit. In an embodiment, the processor may also be connected to a communication interface. The communication interface may be a wired or a wireless interface. In embodiments, electronic circuit 116 is configured to sense environmental parameters through the data acquisition unit. The sensed parameters are logged and processed by the processor. When temperature, humidity, light, and pressure thresholds for the enclosed medicine are met or exceeded, the processor may generate alerts for the user of storage system 100 through a wired interface, a wireless interface, or through visual or auditory queues. In an example, if Epinephrine Auto-injectors are being stored within system 100, the system would alert the user if temperatures rise above 30 degrees Celsius or fall below 15 degrees Celsius inside of container 102. In embodiments, the alerts are generated when the monitored parameters cross pre-defined threshold for at least one parameter. In embodiments, the thresholds can be pre-defined based on the sensitivity of the medicines that are intended to be stored in system 100. Thresholds may be also programmed by a user through a software application associated with system 100. In embodiments, the application may provide a predefined list from where the user can choose using an interface on a computer or smartphone. In an embodiment, a threshold is defined as a range. Thresholds may be pre-defined for temperatures, humidity levels, pressures, and light conditions.
While an example has been provided for use of the storage system of the present specification with an Epi-pen, it should be noted by those of ordinary skill in the art, that a similar container may be used to store other sensitive medications and medical devices, such as, but not limited to insulin and glucose monitors, fertility medicines and devices, and any other medication requiring storage under environmentally stable conditions.
In an embodiment, the communication interface includes one of or a combination of: a visual interface, such as an LED; an auditory interface, such as a piezo transducer buzzer; a wireless interface, such as a Bluetooth communication interface; or any other type of a communication interface. In an embodiment, a wired or a wireless communication interface is in communication with a portable electronic device such as a smartphone. A smartphone application or any other program may be implemented on the portable electronic device to remotely process the monitored data. An exemplary smartphone companion application could include the ability to alert the user if environmental conditions are predicted to be critical for contents of system 100. An application that provides weather updates on the smartphone may be used to predict critical environmental conditions. An exemplary use of a smartphone companion application could be to alert the user if they forget system 100 with the enclosed medicine/device 108, such as by detecting a loss of bluetooth connection that was previously established and maintained between system 100 and the user's smartphone. Furthermore, the application or program may enable the user to electronically configure and track monitoring parameters within system 100. For example, the user may configure threshold temperature to be in a first range for one type of medicine, and in a second range for another type of medicine. The application or program may be further configured to present the user with different types of data to infer when and where a type of medicine may be at risk. The data may be related to different locations and geographies of the user while travelling. The application or program may include a graph of certain environmental factors in order to provide the user of system 100 with data based on location and time. The application or program may also warn the user of system 100 of weather conditions that are potentially harmful to the enclosed medicine given a location.
In embodiments, circuit 116 further includes a power source 118. Power source 118 may power the electronic components of circuit 116 and other components connected to circuit 116. In an embodiment, power source 118 is at least one light-weight battery. In an embodiment, the battery/batteries is/are re-chargeable. In some embodiments, a micro-USB 126 port is provided on the outer surface of storage system 102, such as on the outer surface of container 102. Micro-USB 126 may be used to plug in a charger to charge power source 118. The batteries used for power source 118 may be lithium-ion or lithium-polymer type batteries. The processor may also monitor the aforementioned battery and alert the user of system 100 if the battery becomes low on charge.
Referring simultaneously to
In an embodiment, the processed information may indicate that at least one of monitored data has crossed at least one corresponding threshold for that data. In this case, the communication interface may communicate to the user in the form of an alert. In an embodiment, the processed data is further used to actively manage environmental conditions within system 100/200/300, in order to maintain the conditions within a range that prolongs useful life of the medicines or any other content of system 100/200/300.
The above examples are merely illustrative of the many applications of the system of present invention. Although only a few embodiments of the present invention have been described herein, it should be understood that the present invention might be embodied in many other specific forms without departing from the spirit or scope of the invention. Therefore, the present examples and embodiments are to be considered as illustrative and not restrictive, and the invention may be modified within the scope of the appended claims.
The present specification relies on U.S. Patent Provisional Application No. 62/412,892, entitled “Storage System and Method”, filed on Oct. 26, 2016, for priority, which is expressly incorporated herein by reference.
Number | Date | Country | |
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62412892 | Oct 2016 | US |