WO2022266619A1

WO2022266619A1 - Autoinjector and communication device assemblies

Info

Publication number: WO2022266619A1
Application number: PCT/US2022/072929
Authority: WO
Inventors: Brian GRASSO; Matt BOMES; George Bourne
Original assignee: Falco Medical, Llc
Priority date: 2021-06-14
Filing date: 2022-06-14
Publication date: 2022-12-22

Abstract

Autoinjector and communication device assemblies are disclosed. An example assembly includes an autoinjector configured for self-administration of a dose of a drug by a user. The example assembly also includes a communication device. The communication device includes a first body defining a first interior cavity and a first opening. The autoinjector is housed in the first interior cavity. The communication device includes a second body removably coupled to the first body. The second body is configured to couple to the first component to seal the autoinj ector within the communication device prior to operation. The communication device includes a communication and sensor module that includes a sensor configured to monitor for an operating condition of the autoinjector and wireless communication components configured to transmit a wireless signal to a remote entity upon detection of the operation condition.

Description

AUTOINJECTOR AND COMMUNICATION DEVICE ASSEMBLIES

CROSS-REFERENCE

[0001] This application claims the benefit of priority to U.S. Provisional Patent Application Number 63/210,359, titled COMMUNICATION SYSTEM AND DEVICE FOR AN AUTO INJECTOR and filed June 14, 2021, the disclosure of which is hereby incorporated by reference herein in its entirety for all purposes and forms a part of this specification

FIELD OF THE DISCLOSURE

[0002] The present invention relates generally to autoinjectors and in particular to communication enabled protective housings for use with, or associated with, an autoinjector for detecting a deployment event and for transmitting a wireless notification to one or more remote entities upon detecting occurrence of the event.

BACKGROUND OF THE DISCLOSURE

[0003] Many people suffer from dangerous allergies. For example, many people are allergic to certain medicines, foods, and/or insect venom. At least 15 million people suffer from food allergies, and the incidence of these allergies is rapidly growing. In fact, according to Centers for Disease Control and Prevention, the number of children with food allergies is growing rapidly. The reason for the rapid increase in allergies remains unclear.

[0004] For some allergy sufferers, exposure to the allergen can cause a severe life threatening allergic reaction known as anaphylaxis. Symptoms of anaphylaxis occur within seconds or minutes after exposure. These symptoms include a sudden drop in blood pressure and a narrowing of airways that can block breathing. If not treated right away, anaphylaxis can be fatal.

[0005] Responding rapidly to such exposures can prevent injury and/or death. For example, in response to an exposure leading to anaphylactic shock, an injection of epinephrine (i.e., adrenaline) can provide substantial and/or complete relief from the reaction. As another example, injection of an antidote to a nerve agent can greatly reduce and/or eliminate the potential harm of the exposure. In another example, rapid injection of certain drugs, such as beta blocker, blood thinner, nitroglycerine, antihistamines, insulin, and opioids, etc., can provide substantial relief from various dangerous medical conditions.

[0006] An autoinjector is a medical device designed to deliver one or more doses of a drug in a manner that facilitates self-administration of the drug via a syringe. By design, autoinjectors are easy to use and are intended to be used by patients or by untrained personnel. Autoinjectors are typically self-contained and designed to require only a few basic steps to operate. Most people diagnosed with severe allergies are prescribed epinephrine autoinjector devices that must be carried with them at all times.

[0007] It is important that an autoinjector be easy to use and easy to access quickly in an emergency. At the same time, if an autoinjector is triggered inadvertently or prematurely, it is of no use because typically autoinjectors contain a single dosage that must be available when needed. An autoinjector that has been prematurely triggered without notice may cause a hazard because the carrier will believe they have a dosage with them only to find out too late that is not the case. [0008] It is with respect to these and other considerations that the present improvements may be useful.

SUMMARY

[0009] Disclosed herein are various example embodiments of communication enabled devices for use with, or associated with, for example, an autoinjector. In one embodiment, the present disclosure is directed to a communication enabled device comprising a housing adapted and configured to receive an autoinjector therein. The communication enabled device further includes communication and sensor circuity. In an alternate embodiment, the communication and sensor circuity may be incorporated directly within a body portion of the autoinjector. In yet another embodiment, the communication and sensor circuity may be associated with a protective cover associated with the autoinjector. As such, the communication enabled device may be configured to be reusable in its entirety (e.g., configured with a housing for removably receiving an autoinjector therein) or disposable (e.g., configured to be integrally formed with the autoinjector or associated with a protective cover encasing the autoinjector).

[0010] In either embodiment, in use, the communication enabled devices include communication and sensor circuity adapted and configured to detect an occurrence of an event and for transmitting a wireless notification to one or more remote entities upon detecting occurrence of the event. For example, in one embodiment, the communication and sensor circuity may be operatively associated with or coupled to a user’s mobile device (e.g., smartphone) so that upon the occurrence of an event such as, for example, activation of a trigger mechanism positioned on the communication enabled device or opening of the protective cover to access the autoinjector located therein, a notification (e.g., an alert) is transmitted to one or more remote entities. For example, the communication enabled devices can send a notification (e.g., email, text message, automated phone call, or the like) to designated remote entities (e.g., parent, guardian, doctor, emergency medical personnel, or the like).

[0011] In one embodiment, the present disclosure is directed to a communication enabled device for receiving an autoinjector, the communication enabled device may include a body including an interior cavity for receiving the autoinjector, a sensor for detecting an occurrence of an event, and wireless communication components for wirelessly transmitting a wireless communication. In use, upon detecting the occurrence of the event, the wireless communication components transmit a wireless notification to one or remote entities.

[0012] In another embodiment, the present disclosure is directed to a communication enabled device for receiving an autoinjector therein, the communication enabled device may include a body including an interior cavity for receiving the autoinjector and a communication and sensor module positioned within the interior cavity of the body. In use, the communication and sensor module may be adapted and configured to detect an occurrence of an event and upon detection of the occurrence of the event, transmit a wireless notification to one or remote entities.

[0013] In one embodiment, the communication enabled device may include a trigger mechanism for opening the body to access the autoinjector, the event being activation of the trigger mechanism so that upon activation of the trigger mechanism, the communication enabled device transmits a wireless notification to the one or more remote entities. In another embodiment, the device may include first and second components removably coupled to each other, the event being decoupling of the first and second components so that upon decoupling the first and second components, the communication enabled device transmits a wireless notification to the one or more remote entities.

[0014] In one embodiment, upon detecting the event such as, for example, accessing the autoinjector by, for example, activation of the trigger mechanism, decoupling the first and second components, removing a protective cover, or the like, an alarm (e.g., an audio alarm, a visual indicator, a combination of both, or the like) may activate. The alarm may continue for a predetermined period of time, for example, 5 seconds, 10 seconds, 20 seconds, or the like. Upon expiration of the predetermined period of time, if the alarm is not turned off, the communication enabled device may transmit the wireless communication to one or more remote entities. In this manner, the communication enabled device may include a delay prior to transmitting the wireless notification for reducing accidental or unintentional transmissions of wireless notifications.

[0015] The one or more remote entities may include a predesignated list of recipients including, for example, a user’s physician, parents, guardians, local emergency authorities, dispatch, and local hospital. The communication enabled devices may wirelessly communicate with a software application (herein an “APP”) residing on a mobile device. The communication enabled devices may communicate with the APP on the mobile device via a suitable wireless communication protocol selected from Wi-Fi, NFC, Bluetooth, Bluetooth Low Energy (BLE), and RFID.

[0016] A method for notifying one or more remote entities of a medical event is also disclosed. The method may include opening a communication enabled device for accessing an autoinjector located within the device; sensing, via a sensor positioned within the communication enabled device, opening of the communication enabled device; and transmitting, via wireless communication components positioned within the communication enabled device, a wireless notification to one or remote entities.

BRIEF DESCRIPTION OF THE DRAWINGS

[0017] FIG. 1 illustrates an exploded perspective view of an example embodiment of a communication enabled device and an example embodiment of an autoinjector received within the communication enabled device according to one aspect of the present disclosure.

[0018] FIG. 2 illustrates an exploded perspective view of the communication enabled device shown in FIG. 1 from a top perspective with a first component removed.

[0019] FIG. 3 illustrates a perspective view of the communication enabled device shown in

FIG. 1. [0020] FIG. 4 illustrates a perspective view of an alternate example embodiment of a communication enabled device according to one aspect of the present disclosure.

[0021] FIG. 5 illustrates a perspective view of the communication enabled device shown in FIG. 4, a portion of the protective coating (e.g., protective wrap) shown being tom away.

[0022] FIG. 6 illustrates a perspective view of the communication enabled device shown in FIG. 4, a portion of the protective coating (e.g., protective sleeve) shown being removed.

[0023] FIG. 7 illustrates a perspective view of another alternate example embodiment of a communication enabled device according to one aspect of the present disclosure.

[0024] FIG. 8 illustrates an example embodiment of a communication and sensor module that can be used in connection with the communication enabled devices shown in FIGS. 1-7.

[0025] FIG. 9 illustrates a schematic illustration of an example embodiment of the wireless communication scheme used in connection with the communication enabled devices.

[0026] FIG. 10 illustrates an exploded perspective view of the communication enabled device shown in FIG. 1 from a bottom perspective with a first component removed.

[0027] FIG. 11A illustrates an exploded view of an alternative embodiment of a communication enabled device according to an aspect of the present disclosure.

[0028] FIG. 11B illustrates an assembled perspective view of the communication enabled device in FIG. 11 A.

[0029] FIG. llC illustrates an isolated view of a top portion of the communication enabled device of FIG. 11 A.

[0030] The drawings are not necessarily to scale. The drawings are merely representations, not intended to portray specific parameters of the disclosure. The drawings are intended to depict exemplary embodiments of the disclosure, and therefore are not be considered as limiting in scope. In the drawings, like numbering represents like elements.

DETAILED DESCRIPTION

[0031] Various example embodiments of communication enabled devices are provided. Methods associated with such communication enabled devices are also provided. The communication enabled devices described herein may be used to house drug delivery devices for any suitable purpose, such as to protect the drug delivery device during transportation, to facilitate ease of carrying by the user, to prevent inadvertent device deployment, to provide preferred packaging for the device, or other purposes.

[0032] In some embodiments, the communication enabled devices make it possible for the drug delivery device (e.g., autoinjector, or the like, including devices in which a drug delivery needle, cannula or other tube is manually inserted into a patient, collectively referred to herein as an autoinjector without the intent to limit) located within or associated with the communication enabled device to remotely communicate with one or more remote entities. For example, in some embodiments, the communication enabled devices may remotely communicate with a user’s physician, parents, guardians, local emergency authorities, dispatch, hospital, etc., in case of an emergency. That is, in some embodiments, the communication enabled devices may automatically notify (e.g., transmit an alert) one or more remote entities when, for example, the device is opened indicating that an event requiring, for example, the autoinjector has occurred.

[0033] The remote communication or transmission of the wireless communication may be accomplished using, for example, any one of a suitable wireless communication protocol or link. In some implementations, the communication enabled devices may be coupled to or associated with an APP residing in memory on the user’s mobile device (e.g., smartphone, etc.). Alternatively, the communication enabled devices may be coupled to or associated with an APP residing on an internet enabled device. For example, one or more devices coupled to the Internet may communicate with the communication enabled devices to receive and/or transmit information. [0034] In some implementations, upon detection that the communication enabled device has been opened, the communication enabled device may transmit a wireless communication to one or more remote entities. The communication enabled devices may also incorporate one or more alarms (e.g., an audio alarm, a visual indicator, a combination of both, or the like). For example, in one embodiment, upon detecting an event such as, for example, accessing the autoinjector by, for example, opening the communication enabled device and/or accessing the autoinjector, the alarm may sound, flash, etc. for a predetermined period of time, for example, 5 seconds, 10 seconds, 20 seconds, or the like. Upon expiration of the predetermined period of time, if the alarm is not turned off, the communication enabled device may transmit the wireless communication to one or more remote entities. In this manner, the communication enabled device includes a delay for reducing accidental or unintentional transmissions of wireless notifications.

[0035] In use, the remote entities may be predesignated recipients so that, upon detection that the communication enabled device has been opened, the designated recipients automatically receive a wireless notification. Additionally, in some embodiments, it is envisioned that other wireless communications may be transmitted between the communication enabled device and the remote entities. For example, in one embodiment, the expiration date of the autoinjector may be programmed and stored in memory associated with the communication enabled device. Thereafter, upon expiration or shortly before expiration of the medication contained within the autoinjector, the communication enabled device may transmit a wireless notification to one or more remote entities indicating that the medication is about to expire and a replacement autoinjector is needed. Such data and information may also be transmitted and/or added to a database or data repository, for example, on a cloud-based database for future access, monitoring, etc.

[0036] In addition, in some embodiments, it is envisioned that the communication enabled device may include one or more status indicators such as, for example, a light emitting diode (LED) for indicating one or more events such as, for example, that the device has been opened or that the medication is about to expire, or the like. In alternate embodiments, it is also envisioned, that the communication enabled device may transmit one or more wireless notifications to one or more remote entities upon a given occurrence. For example, in one embodiment, the communication enabled device may include one or more sensors to detect changes in conditions. Thereafter, upon detection of an occurrence or event that may alter a condition beyond, for example, a predetermined threshold, one or more wireless notification may be transmitted. For example, in one embodiment, it is envisioned that the communication enabled device may include one or more sensors for detecting damage or breakage from, for example, accidental dropping the communication enabled device. In such event, the communication enabled device may transmit a wireless communication to one or remote entities indicating that the autoinjector has been damaged and may need to be replaced.

[0037] As will be described in greater detail, the communication enabled device may include communication components configured to transmit and/or receive information including, for example, one or more processors, one or more wireless transceivers, one or more power storage components, memory, etc. [0038] Referring to FIGS. 1-3, an example embodiment of a communication enabled device 100 according to the present disclosure is illustrated. As will be illustrated and described herein, the communication enabled device 100 may be adapted and configured to work with and/or receive an autoinjector 50 such as, for example, an epinephrine autoinjector. In one example embodiment, the autoinjector may be an autoinjector such as that disclosed in U.S. Patent No. 10,661,015 titled Wearable Drug Delivery Device. It should be understood, however, that it is envisioned that the principles of the communication enabled device 100 may be easily adapted and configured to work with any autoinjector, and as such, the present disclosure should not be limited except as expressly claimed herein.

[0039] The communication enabled device 100 may be adapted and configured to receive the autoinjector 50. For example, the communication enabled device 100 may include a body 110 (FIG. 3) having an interior cavity for receiving the autoinjector 50. Referring to FIG. 1, in one example embodiment, the body 110 of the communication enabled device 100 may include a first component 120 and a second component 140. While the body 110 of the communication enabled device 100 will be described and illustrated as being manufactured from two components, it should be understood that the body 110 of the communication enabled device 100 may be manufactured from more or less components, for example, the device 100 may be manufactured from a single component having, for example, a hinged door. Alternatively, the device 100 may be manufactured from three, four, or more components coupled together.

[0040] In one embodiment, the first and second components 120, 140 may be adapted and configured to receive the autoinjector 50 therein. For example, in one embodiment, the first component 120 may include an outer body 122 and an interior cavity 126 having an opening 124 at one end thereof so that in use, the autoinjector 50 can be inserted into the interior cavity 126 through the opening 124. Thereafter, the second component 140 may be coupled to the first component 120 to seal the autoinjector 50 within the communication enabled device 100 (e.g., within the interior cavity 126 of the first component 120 of the device 100).

[0041] In use, the first and second components 120, 140 may be removably coupled to each other. For example, during use, as required, the first and second components 120, 140 can be decoupled from each other so that the autoinjector 50 can be accessed as needed. The first and second components 120, 140 can be removably coupled to each other by any suitable means now known or hereafter developed including, for example, a press-fit connection, a snap-fit connection, a latching mechanism, a hook and recess-type connection, etc. Alternatively, it is envisioned that the first and second components 120, 140 may be coupled to each other by, for example, an adhesive or other more permanent mechanism. In one embodiment, at least one of the first and second components 120, 140 may include a seal for providing a water-tight seal between the first and second components 120, 140.

[0042] As best illustrated in FIG. 3, in one embodiment, the communication enabled device 100 may include a trigger mechanism 150 for opening the communication enabled device 100. For example, in one embodiment, upon moving the trigger mechanism 150 from a first position to a second position (e.g., sliding movement, pressing movement, etc.), the first and second components 120, 140 are decoupled so that the user can access the autoinjector 50 located therein. In one embodiment, upon activation of the trigger mechanism 150 and/or decoupling of the first and second components 120, 140, the communication enabled device 100 may automatically transmit a wireless notification (e.g., alert) to one or more remote entities as will be described in greater detail below. In one embodiment, the trigger mechanism 150 may be positioned on the second component 140, although it is envisioned that the trigger mechanism 150 may be located anywhere on the communication enabled device 100.

[0043] Referring to FIGS. 1-3, the communication enabled device 100 may also include a mechanism 160 for attaching to, or being easily held by, a patient. The attachment mechanism 160 may be any suitable mechanism now known or hereafter developed. For example, as illustrated, the device 100 may include a keyhole 162 for receiving a clip, etc. As illustrated, the keyhole 162 may be formed in the second component 140, although it is envisioned that the attachment mechanism 160 may be formed anywhere on the device 100.

[0044] Referring to FIG. 2, in some embodiments, the communication enabled device 100 may include a communication and sensor module 175. For example, in one embodiment, the first and second components 120, 140 may be adapted and configured to receive a communication and sensor module 175 therein. In one embodiment, the second component 140 may include an outer body 142 and an interior cavity 146 having an opening 144 at one end thereof so that in use, the communication and sensor module 175 can be inserted into the interior cavity 146 through the opening 144 formed in the second component 140 of the device 100.

[0045] FIG. 10 shows the same embodiment as FIG. 2, but from a bottom perspective view. This shows more aspects of the sensor module 175, as well as a battery 178. Also visible from this perspective is the trigger mechanism 150 used to release the first component 120 (not shown) from the second component 140, thereby triggering the sensor module 175. While it has been described and illustrated as the first component 120 receives the autoinjector 50 and the second component 140 receives the communication and sensor module 175, the present disclosure is not so limited. For example, both the autoinjector 50 and the communication and sensor module 175 may be received within the first component 120 or within the second component 140. Alternatively, the communication and sensor module 175 may be located within the first component 120 while the autoinjector 50 may be located within the second component 140. [0046] Referring to FIGS. 4-6, an alternate example embodiment of a communication enabled device 200 according to the present disclosure is illustrated. In accordance with this embodiment, the autoinjector 250 (e.g., an epinephrine autoinjector) may include a body 260, a first end 262, and a second end (occluded by sleeve 270). The autoinjector 250 may also include communication and sensor circuity such as, for example, a communication and sensor module located within the body 260 of the autoinjector 250. For example, in one embodiment, the communication and sensor circuity such as, for example, the communication and sensor module, may be located within the first end 262 of the body 260 of the autoinjector 250.

[0047] The body 260 of the autoinjector 250 may also include or be wrapped or encased by a protective covering. For example, in one embodiment, the protective covering may include a protective sleeve 270 and a protective wrap 272. In use, as illustrated in FIGS 5 and 6, during an emergency, a user may remove the protective wrap 272. For example, in one embodiment, the user may grip the autoinjector 250 by gripping finger portion 280 formed in the body 260 and finger portion 282 formed in the protective cover (e.g., protective sleeve 270), respectively. In use, by pulling these two finger portions 280 and 282 away from one another, the protective wrap 272 may tear away from the protective sleeve 270 along a perforated line 274. Thereafter, the protective sleeve 270 may be removed. In one embodiment, the protective wrap 272 may be in the form of a plastic film such as, for example, a heat-sink wrap. The protective sleeve 270 may be in the form of a more rigid protective covering. It should be understood however that alternate materials are envisioned, and thus the present disclosure should not be so limited. [0048] In use, as will be described in greater detail below, during an emergency, the communication and sensor circuity may detect activation of the device 200 by, for example, detecting removal of the wrap 272 and/or sleeve 270, and upon detection of such, transmit a wireless notification to one or more remote entities. In some embodiments, the protective wrap 272 (or entire protective sleeve 270) is made of a polymer that includes a phosphorescent filler, such as a strontium oxide aluminate based pigment. Such polymers are available from, for example, RTP Company. This helps a user locate the communication enabled device in the dark, and quickly determine if the protective wrap 272 is still intact.

[0049] Referring to FIG. 7, another alternate example embodiment of a communication enabled device 300 according to the present disclosure is illustrated. In accordance with this embodiment, the autoinjector (e.g., an epinephrine autoinjector) is substantially similar to the embodiment described above in connection with FIGS. 4-6 except as mentioned herein. As illustrated, the autoinjector may include a body, a first end 362, and a second end. The autoinjector may also include communication and sensor circuity such as, for example, a communication and sensor module. In connection with this embodiment, the communication and sensor circuity such as, for example, a communication and sensor module, may be incorporated into a cap 365 that may be coupled to or integrally formed with the protective sleeve 370.

[0050] As such, similar to the embodiment described above in connection with FIGS. 4-6, in use, the body of the autoinjector may include or be wrapped or encased by a protective covering. For example, in one embodiment, the protective covering may include a protective sleeve 370 and a protective wrap 372. In use, during an emergency, a user may remove the protective wrap 372. For example, in one embodiment, the user may grip the autoinjector by gripping the finger portion 380 and the cap 365. By pulling these elements away from one another, the protective wrap 372 may tear away from the protective sleeve 370 along a perforated line 374. Thereafter, the protective sleeve 370 may be removed. In use, as will be described in greater detail below, during an emergency, the communication and sensor circuity may detect activation of the device 300 by, for example, detecting removal of the wrap 372 and/or sleeve 370, and upon detection of such, transmit a wireless notification to one or more remote entities.

[0051] Referring to FIG. 8, regardless of which embodiment is used, the device 100, 200, 300 may include communication and sensor circuity such as, for example, a communication and sensor module 175. The communication and sensor circuity may include wireless communication components 180 for enabling the communication enabled device 100, 200, 300 to communicate (e.g., send and/or receive messages including notifications, information, data, or the like) using any of a variety of communication technologies. That is, the wireless communication components 180 may include circuity, components, etc. necessary for transmitting one or more wireless communications. For example, the wireless communication components 180 can include wireless communication circuity and/or components arranged to communicate via Wi-Fi® technology, thus enabling the communication enabled device 100, 200, 300 to communicate using Wi-Fi communication schemes. Alternatively, the wireless communication components 180 can include wireless communication circuity and/or components arranged to communicate via any other suitable wireless communication scheme such as, for example, Near Field Communications (NFC), Cellular, SMS text, Bluetooth®, Bluetooth® Low Energy (BLE), Radio Frequency Identification (RFID), or the like. As such, the communication enabled device 100, 200, 300 can communicate with external devices via a wireless communication protocol.

[0052] As illustrated, the wireless communication components 180 may include a radio 181, an antenna 182, and a processor 183. In general, the radio 181 can be any radio configured to communicate using a wireless transmission scheme, such as, for example, Bluetooth®, BLE, NFC, Wi-Fi®, etc. The antenna 182 can be coupled to the radio 181 and configured to emit and receive RF signals. For example, the antenna 182 can emit RF signals received from the radio 181 (or radio transceiver circuitry, which is not depicted for clarity) coupled between the radio 181 and the antenna 182. The antenna 182 could be any of a variety of antennas (or antenna arrays) having different shapes and/or configurations arranged to emit/receive RF signals on a frequency, range of frequencies, or the like. Furthermore, the antenna 182 could be internal to the communication enabled device 100, 200, 300 or external. The processor 183 can be any of a variety of processors (e.g., application processor, baseband processors, etc.) arranged to perform at least transmission of wireless signals associated with the communication enabled device 100, 200, 300.

[0053] In some embodiments, the wireless communication components 180 may be operable so that the communication enabled device 100, 200, 300 can communicate over several wireless frequencies or schemes. As such, the radio 181, antenna 182, and processor 183 could be arranged to communicate over multiple wireless communication technologies, such as, for example, BLE and Wi-Fi. In other examples, wireless communication components 180 can include multiple sets of radio, antenna, and processor. In such instances, the first set of radio, antenna, and processor can be arranged to communicate using a first wireless communication scheme, such as, BLE while the second set of radio, antenna, and processor can be arranged to communicate using a second wireless communication scheme, such as, Wi-Fi.

[0054] In addition, the communication and sensor module 175 may include one or more sensors 185 for sensing or monitoring an operating condition such as, for example, sensing activation of the trigger mechanism 150, sensing removal of the protective coating (e.g., protective wrap and/or sleeve), decoupling of the first and second components, or the like. That is, in one embodiment, as will be described in greater detail below, in use, the communication and sensor module 175 may be operatively associated with the trigger mechanism 150 so that upon activation of the trigger mechanism 150, the communication and sensor module 175 may detect activation of the trigger mechanism 150 and transmit a notification (e.g., an alert) to one or more remote entities. Alternatively, in another embodiment, the communication and sensor module 175 may be operatively associated with the communication enabled device so that upon opening the device 100, 200, 300 (e.g., decoupling of the first and second components, removal of the protective coating (e.g., protective wrap and/or sleeve), or the like), the communication and sensor module 175 may transmit a notification (e.g., an alert) to one or more remote entities. As will be appreciated, activation of the trigger mechanism 150 and/or opening of the cover 100, 200, 300 may indicate the presence of an emergency condition. In addition, the communication enabled device may further include one or more additional sensors.

[0055] Additionally, as previously mentioned, in some implementations, the communication enabled device may include delay functionality for implementing a delay before transmitting the wireless notification to minimize accidental wireless notifications. That is, for example, upon detecting the event such as, for example, accessing the autoinjector by, for example, sensing activation of the trigger mechanism 150, decoupling the first and second components 120, 140, removing the protective cover, or the like, an alarm (e.g., an audio alarm, a visual indicator, a combination of both, or the like) may activate. The alarm may continue for a predetermined period of time, for example, 5, seconds, 10 seconds, 20 seconds, or the like. Upon expiration of the predetermined period of time, if the alarm is not turned off, the communication enabled device may transmit the wireless communication to one or more remote entities. In this manner, the communication enabled device delays transmission of the wireless notification to reduce accidental or unintentional transmissions of wireless notifications.

[0056] In addition, the communication and sensor module 175 may include or be associated with, inter alia, memory 190 and a power supply 192. The power supply 192 may be any suitable power supply now known or hereafter developed. For example, the power supply 192 may be in the form of one or more batteries, one or more rechargeable batteries, etc. In use, the power supply 192 may supply power to the communication and sensor module 175.

[0057] The memory 190 may comprise an article of manufacture. In some examples, the memory 190 may include any computer readable storage medium, machine readable storage medium, or any tangible media capable of storing electronic data, including volatile memory or non-volatile memory, removable or non-removable memory, erasable or non-erasable memory, writeable or re-writeable memory, and so forth. The memory 190 may also include processor executable instructions. Examples of processor executable instructions may include any suitable type of code, such as source code, compiled code, interpreted code, executable code, static code, dynamic code, object-oriented code, visual code, and the like. The examples are not limited in this context. The memory 190 may be one or more memory chips capable of storing data and allowing any storage location to be directly accessed by a processor linked to the memory 190, such as any type or variant of Static random-access memory (SRAM), Dynamic random-access memory (DRAM), Ferroelectric RAM (FRAM), NAND Flash, NOR Flash and Solid-State Drives (SSD).

[0058] The memory 190 may be coupled to the processor 183. The processor 183 could be any of a variety of processors, such as, for example, a central processing unit, a microprocessor, a field programmable gate array, an application specific integrated circuit, or the like. The processor 183 can be arranged to execute instructions to aid in performing one or more techniques described herein.

[0059] While the communication and sensor module 175 is described and illustrated as being a single component, the present disclosure is not so limited, and it should be understood that it is envisioned that the circuity and components may be separately located on multiple components and/or circuits.

[0060] The communication enabled device 100, 200, 300 may also include one or more indicators (not shown). The indicators may be any suitable type of indicator such as a visual or audible indicator including but not limited to, an LED, neon bulb, and/or piezoelectric buzzer. In use, the indicator may, for example, be illuminated to a predefined color, illumination pattern, and/or illumination frequency, when an event is detected, for example, upon activation of the trigger mechanism 150, opening the device 100, 200, 300 (e.g., decoupling of the first and second components, removal of the protective wrap and/or sleeve, or the like), expiration of the autoinjector, etc.

[0061] Referring to FIG. 9, in one embodiment, as previously mentioned, in use, the communication enabled device 100, 200, 300 may be adapted and configured to transmit a wireless communication notification to one or more remote entities 400 upon the occurrence of a predetermined event. For example, in one example embodiment, the communication enabled device 100 may be operatively associated with the trigger mechanism 150 so that upon activation of the trigger mechanism 150, the communication enabled device 100 may, via, the communication and sensor circuity, for example, the communication and sensor module 175, transmit a notification (e.g., an alert) to one or more remote entities 400 upon detecting activation of the trigger mechanism 150. That is, as previously mentioned, in one implementation, it is envisioned that upon an emergency event, the user may activate the trigger mechanism 150 to detachably remove the first component 120 from the second component 140 to access the autoinjector 50 positioned within the communication enabled device 100. Upon detecting activation of the trigger mechanism 150 and/or decoupling of the first and second components 120, 140, the communication enabled device 100 may, via the communication and sensor circuity (for example the communication and sensor module 175) transmit a wireless notification to one or more designated remote entities. Alternatively, the communication enabled device 200, 300 may be operatively associated with the protective covering (e.g., protective sleeve and wrap) so that upon removal of the protective covering, the communication enabled device 200, 300 may use the communication and sensor circuity (for example the communication and sensor module 175) to transmit a notification (e.g., an alert) to one or more remote entities 400 upon detecting removal of the protective coating. That is, as previously mentioned, in one implementation, it is envisioned that upon an emergency event, the user may pull on opposite ends of the device 200, 300 to detachably remove the protective coating to access the autoinjector. Upon detecting removal of the protective coating, the communication enabled device 200, 300 may, via the communication and sensor circuity, such as, for example, the communication and sensor module 175, transmit a wireless notification to one or more designated remote entities 400.

[0062] In some embodiments, during use, the communication enabled device may, via, for example, the communication and sensor circuity, such as, for example, the communication and sensor module 175, wirelessly communicate with one or more remote devices such as, for example, a user’s mobile device (e.g., smartphone) 202. For example, the communication enabled device 100, 200, 300 may communicate directly with the user’s mobile device 202 via, for example, Wi Fi, NFC, BLE, etc. Alternatively, in some embodiments, the communication enabled device 100, 200, 300 may communicate wirelessly with a computing device 204 such as, for example, a desktop computer, a server, etc., and/or an alternate internet enabled device 206 (e.g., a device linked to the Internet).

[0063] In use, upon occurrence of one or more events, the communication enabled device 100, 200, 300 may communicate or transmit wireless signals, including data, information, or information elements including indications of operating conditions to one or more remote entities 400. For example, in one embodiment, upon activation of the trigger mechanism 150 and/or decoupling of the first and second components 120, 140 with respect to each other (e.g., opening the device 100), the communication enabled device 100 may transmit a notification (e.g., an alert) to one or more remote entities 400. Alternatively, in one embodiment, upon removal of the protective covering (e.g., protective wrap and sleeve), the communication enabled device 200, 300 may transmit a notification (e.g., an alert) to one or more remote entities 400.

[0064] Alternatively, and/or in addition, in some embodiments, the communication enabled device 100, 200, 300 may transmit a notification (e.g., an alert) to one or more remote entities 400 upon expiration of the autoinjector, or shortly therebefore. For example, the communication enabled device 100, 200, 300 may include memory for storing, for example, the expiration date of the medication contained in the autoinjector. Upon expiration or nearing thereof, the communication enabled device 100, 200, 300 may transmit a notification (e.g., an alert) to one or more remote entities 400 informing them of the expiration date of the autoinjector. Alternatively, and/or in addition, in some embodiments, the communication enabled device 100, 200, 300 may transmit a notification (e.g., an alert) to one or more remote entities upon detection of one or more events. For example, the communication enabled device 100, 200, 300 may include one or more sensors for detecting, for example, damage to the autoinjector because of an accidental drop. Upon detection, the device 100, 200, 300 may transmit a notification to the one or more remote entities 400 of such.

[0065] In some embodiments, the communication enabled device 100, 200, 300 may, via, for example, the communication and sensor circuity such as, for example, the communication and sensor module 175, communicate with the one or more remote entities 400 via an APP residing on the user’s mobile device 202. That is, in one embodiment, the communication enabled device 100, 200, 300 may transmit a wireless signal to the user’s mobile device 202, which may then transmit the signal to the remote entities 400. In one embodiment, the communication enabled device 100, 200, 300 may be coupled to the user’s mobile device 202 via Bluetooth, NFC, Wi-Fi, etc.

[0066] In some embodiments, the remote entities 400 may be a designated list of recipients. For example, the remote entities 400 may include a list of contacts such as, for example, the user’s parents, guardians, relatives, doctor, etc. In addition, the remote entities 400 may include emergency medical personnel such as, for example, nearby hospital, fire-station, emergency personnel, etc. In one embodiment, using the user’s GPS on their mobile device 202, the communication enable device 100, 200, 300 may be able to transmit a notification (e.g., an alert) to the nearest emergency personnel including the user’s current position.

[0067] In some embodiments, the transmitted information or data may be stored in a database 210. The database 210 may store a profile associated with the user, which can be accessed by one or more of the designated list of recipients. The recipients may gain access to the database 210 by way of a mobile device, a computing device and/or the Internet. The profile may be password- protected so that only authorized users may gain access to the profile stored in the database 210. For example, a user may establish an account with a database provider (e.g., cloud data provider, or the like). Each such account may have permissions or roles assigned to the account. Additionally, accounts may establish alert settings (e.g., alert location (e.g., email, text, phone call, or the like). Alerts may be triggered based on occurrence of one or more events.

[0068] In accordance with another aspect of the present disclosure, as will be appreciated by one of ordinary skill in the art, certain drugs such as, for example, epinephrine, are sensitive to light. However, many autoinjectors may include a window to enable a user to view the drug positioned within the autoinjector. As such, in order to enable the user to view the drug contained within the autoinjector, the communication enabled device may include a corresponding window so that the drug contained in the autoinjector remains visible to the user.

[0069] For example, referring once again to FIGS. 4-6, the protective coating such as, for example, the protective sleeve 270, may include a corresponding window 275 so that when the protective coating (e.g., protective sleeve 270) is positioned on the autoinjector, the window 275 formed in the protective coating is aligned with the window 500 formed in the autoinjector so that the user can see the drug contained within the autoinjector. To maintain the stability of the drug however, it is desirable to control light transmission (e.g., control the amount of light passing to the drug contained in the autoinjector). In one embodiment, the window 500 formed on the autoinjector and/or the window 275 formed in the protective coating (e.g., protective sleeve 270) is tinted. For example, while remaining transparent, preferably the window 275 formed in the protective coating (e.g., protective sleeve 270) and/or the window 500 formed in the autoinjector includes a tinted film such as, for example, a brown tinted film, for reducing the amount of light transmission and thus increasing the drug’s stability and shelf-life. Alternatively, in some embodiments, the protective coating such as, for example, the protective sleeve 270, can be manufactured entirely or partially from a tinted file such as, for example, a molded plastic made of or incorporating a tinted film, so that when the protective coating (e.g., protective sleeve 270) is placed over the autoinjector, the tinted protective coating (e.g., protective sleeve 270) minimizes the amount of light transmission to the drug thus protecting the stability of the drug. While the tinted film has been described in connection with the device 200 illustrated in FIGS. 4-6, the present disclosure is not so limited and the tinted film may be used in connection with the other devices 100, 300 described herein, or the like.

[0070] FIGS. 11A-11C depict an alternative embodiment showing a communication enabled device 600 that is adapted for easy access and carrying. This embodiment has a first component 610 and a second component 620 that are configured to house an autoinjector similar to autoinjector 50 of the previous figures. Components 610 and 620 are drawn together and held in place around the autoinj ector using strap 700, which is weaved through holes in the first and second components. Specifically, first component 610 features a bottom hole 640 through a bottom portion furthest away from the second component 620. The second component 620, which is shown in isolation view in FIG. 11C, has lateral holes 630 on either side of a circular or spherical top portion and a top hole 650 centered in between the lateral holes 630 at the top end of the second component 620.

[0071] As best shown in FIG. 11A, the strap 700 is weaved in the top hole 650 of the second component 620, out through a first lateral hole 630 in a first side of the second component, through the bottom hole 640 of the first component 610, in through a second lateral hole 630 on the opposite side of the second component, and back up through the top hole 650. A cinch 800 is used to draw the second component 620 down against the first component 610 by sliding along the portions of strap 700 that are extending through the top hole 650. A release 810 is pressed to allow the cinch 800 to travel along the strap extensions. The first component 610 has an upper opening 612 to receive a male sealing extension 622 of the second component 620 when the cinch 800 is drawn down against the top of the second component 620 as shown in FIG. 11B. In this configuration, the autoinjector 50 (not shown) is securely stored inside the housing formed by the first and second components 610, 620.

[0072] In use, a user receives the communication enabled device in the configuration shown in FIG. 11B. The strap extensions 700 can be used to carry the device, and may have a ring or other fixture on the end to attach them to something carried by the user. To access the autoinjector, the user presses the release 810, slides the cinch 800 away from the second component 620, and then pulls the second component 620 away from the first component 610. Though not shown, it will be understood that a communication and sensor module such as communication and sensor module 175 discussed above could be housed within either the first component 610 or the second component 620 and configured so a to detect when the male sealing extension 622 is removed from the upper opening 612. Detection of this even could result in a signal being send via the communication module to a nearby cellular device as discussed above in association with FIG. 9. [0073] The foregoing discussion has been presented for purposes of illustration and description and is not intended to limit the disclosure to the form or forms disclosed herein. For example, various features of the disclosure are grouped together in one or more aspects, embodiments, or configurations for the purpose of streamlining the disclosure. However, it should be understood that various features of the certain aspects, embodiments, or configurations of the disclosure may be combined in alternate aspects, embodiments, or configurations. Moreover, the following claims are hereby incorporated into this Detailed Description by this reference, with each claim standing on its own as a separate embodiment of the present disclosure. The drawings are for purposes of illustration only and the dimensions, positions, order and relative to sizes reflected in the drawings attached hereto may vary.

Claims

CLAIMS We claim:

1. A communication enabled device for an autoinjector, the device comprising: a body including an interior cavity for receiving the autoinjector; a sensor for detecting an occurrence of an event; and wireless communication components for wirelessly transmitting a wireless communication; wherein, upon detecting the occurrence of the event, at least one of the wireless communication components transmit a wireless notification to one or remote entities.

2. The device of claim 1, further comprising a trigger mechanism for opening the body to access the autoinjector, the event being activation of the trigger mechanism so that upon activation of the trigger mechanism, the wireless communication components transmit a wireless notification to the one or more remote entities.

3. The device of claim 1, wherein the body includes first and second components removably coupled to each other, the event being decoupling of the first and second components so that upon decoupling the first and second components, the wireless communication components transmit a wireless notification to the one or more remote entities.

4. The device of claim 1, wherein the one or more remote entities includes one of a user’s physician, parents, guardians, local emergency authorities, dispatch, and local hospital.

5. The device of claim 1, wherein the wireless communication components wirelessly communicate with an APP residing on a mobile device.

6. The device of claim 5, wherein the wireless communication components communicate with the APP on the mobile device via a suitable wireless communication protocol selected from Wi-Fi, NFC, Bluetooth, Bluetooth Low Energy (BLE), and RFID.

7. The device of claim 1, wherein the body includes a first component and a second component defining the interior cavity for receiving the autoinjector.

8. The device of claim 1, further comprising memory for storing an expiration date of the autoinjector, the wireless communication components transmitting a signal upon expiration of the autoinjector.

9. A communication enabled device for an autoinjector, the device comprising: a body including an interior cavity for receiving the autoinjector; and a communication and sensor module positioned within the interior cavity, wherein the communication and sensor module is adapted and configured to detect an occurrence of an event and upon detection of the occurrence of the event, transmit a wireless notification to one or remote entities.

10. The device of claim 9, further comprising a trigger mechanism for opening the body to access the autoinjector, the event being activation of the trigger mechanism so that upon activation of the trigger mechanism, the communication and sensor module transmits a wireless notification to the one or more remote entities.

11. The device of claim 9, wherein the body includes first and second components removably coupled to each other, the event being decoupling of the first and second components so that upon decoupling the first and second components, the communication and sensor module transmits a wireless notification to the one or more remote entities.

12 The device of claim 9, wherein the one or more remote entities includes one of a user’s physician, parents, guardians, local emergency authorities, dispatch, and local hospital.

13. The device of claim 9, wherein the communication and sensor module includes wireless communication components for wirelessly communicating with an APP residing on a mobile device.

14. The device of claim 13, wherein the communication and sensor module communicates with the APP on the mobile device via a suitable wireless communication protocol selected from Wi-Fi, NFC, Bluetooth, Bluetooth Low Energy (BLE), and RFID.

15. The device of claim 9, wherein the body includes a first component and a second component defining an interior cavity for receiving the autoinjector.

16. The device of claim 9, wherein the communication and sensor module further comprises memory for an expiration date of the autoinjector, the communication and sensor module transmitting a signal upon expiration of the autoinjector.

17. A method for notifying one or more remote entities of a medical event, the method comprising: opening a communication enabled device for accessing an autoinjector located within the device; sensing, via a sensor positioned within the communication enabled device, opening of the communication enabled device; and transmitting, via a wireless communication component positioned within the communication enabled device, a wireless notification to one or remote entities.

18. The method of claim 17, wherein sensing opening of the communication enabled device includes sensing activation of a trigger mechanism positioned on the device for opening the device to access the autoinjector.

19. The method of claim 17, wherein sensing opening of the communication enabled device includes sensing decoupling of first and second components of the device.

20. The method of claim 17, wherein transmitting a wireless notification to one or remote entities includes transmitting wireless information to an APP residing on a user’s mobile device.

21. An assembly for monitoring access to an autoinjector, the assembly comprising: an autoinjector configured for self-administration of a dose of a drug by a user; and a communication device comprising: a first body defining a first interior cavity and a first opening, wherein the autoinjector is housed in the first interior cavity; a second body removably coupled to the first body, wherein the second body is configured to couple to the first body to seal the autoinjector within the communication device prior to operation; and a communication and sensor module comprising: a sensor configured to monitor for an operating condition of the autoinjector; and wireless communication components configured to transmit a wireless signal to a remote entity upon detection of the operation condition.

22. The assembly of claim 21, wherein the second body of the communication device defines a second interior cavity, and wherein the communication and sensor module is configured to be housed in the second interior cavity.

23. The assembly of claim 21, wherein the operating condition occurs when the first body and the second body of the communication device are decoupled from each other.

24. The assembly of claim 21, wherein the communication device further comprises a trigger mechanism configured to enable the user to decouple the second body from the first body to open the communication device.

25. The assembly of claim 24, wherein the operating condition occurs when the trigger mechanism is moved from a first position to a second position.

26. The assembly of claim 21, wherein the operating condition occurs when a protective wrap is removed from the communication device.

27. The assembly of claim 21, wherein the communication device defines a keyhole 162 configured to receive a clip to enable the user to easily carry and access the autoinjector and the communication device.

28. The assembly of claim 21, wherein the communication device is further configured to emit an alarm in response to the sensor detecting the operating condition, wherein the alarm is configured to be turned off by the user.

29. The assembly of claim 28, wherein, the communication device includes a delay function that requires the autoinjector to be in the operating condition for at least a predetermined period of time before the wireless communication components transmit the wireless signal.

30. The assembly of claim 29, wherein the communication device is configured to emit the alarm during the predetermined period of time.

31. The assembly of claim 21, wherein the communication device further comprises memory configured to store an expiration date of the autoinjector, and wherein the wireless communication components are configured to transmit an expiration signal upon expiration of the autoinjector.

32. The assembly of claim 21, wherein the communication device further comprises a strap to draw the first body and the second body together.

33. The assembly of claim 32, wherein each of the first body and the second body of the communication device defines one or more holes through which the strap extends to draw the first body and the second body together.

34. The assembly of claim 33, wherein the first body of the communication device defines a bottom hole and the second body of the communication device defines lateral holes and a top hole, wherein the lateral holes include a first lateral hole and a second lateral hole.

35. The assembly of claim 34, wherein the strap is weaved in the top hole of the second body, out through the first lateral hole of the second body, through the bottom hole of the first body, in through the second lateral hole of the second body, and back up through the top hole.

36. The assembly of claim 32, wherein the communication device further comprises a cinch configured to draw the second body against the first body of the communication device by sliding the cinch along a portion of the strap that extends through the second body.

37. The assembly of claim 36, wherein the communication device further comprises a release that is configured to be pressed to allow the cinch to travel along the strap.

38. An assembly for monitoring access to an autoinjector, the assembly comprising: an autoinjector including a first end and a second end and configured for self- administration of a dose of a drug by a user; a protective covering for the autoinjector that includes a protective sleeve and a protective wrap, wherein the protective sleeve and the protective wrap are connected together via a perforated line, wherein the protective wrap is configured to tear away from the protective sleeve along the perforated line when the user pulls the first end away from the second end; and a communication and sensor module comprising: a sensor configured to monitor for an operating condition of the autoinjector that occurs when the protective wrap is tom away from the protective sleeve; and wireless communication components configured to transmit a wireless signal to a remote entity upon detection of the operation condition.

39. The assembly of claim 38, wherein each of the first end and the second end of the assembly includes a respective finger portion that facilitates a grip of the user when pulling the first end away from the second end.

40. The assembly of claim 38, wherein the protective sleeve is formed of material that is more rigid than that of the protective wrap.

41. The assembly of claim 40, wherein the protective wrap is a plastic film.

42. The assembly of claim 41, wherein the plastic film is a heat-sink wrap.

43. The assembly of claim 41, wherein the protective wrap is made of a polymer that includes a phosphorescent filler to facilitate the user in locating the autoinjector in the dark and determining whether the protective wrap remains intact.

44. The assembly of claim 43, wherein the phosphorescent filler is a strontium oxide aluminate based pigment.

45. The assembly of claim 38, wherein the autoinjector includes a first window to enable the user to view the drug housed within the autoinjector, and wherein the protective sleeve includes a second window that aligns with the first window when the protective sleeve remains connected to the protective wrap.

46. The assembly of claim 45, wherein at least one of the first window or the second window is tinted to control an amount of light passing to the drug to maintain a stability of the drug.

47. The assembly of claim 38, further comprising a cap that defines a keyhole configured to receive a clip to enable the user to easily carry and access the autoinjector.

48. The assembly of claim 38, wherein the communication and sensor module is further configured to emit an alarm in response to the sensor detecting the operating condition, wherein the alarm is configured to be turned off by the user.

49. The assembly of claim 48, wherein, to reduce accidental or unintentional transmission of the wireless signal to the remote entity, the communication and sensor module includes a delay function that requires the autoinjector to be in the operating condition for at least a predetermined period of time before the wireless communication components transmit the wireless signal.

50. The assembly of claim 49, wherein the communication and sensor module is configured to emit the alarm during the predetermined period of time.

51. The assembly of claim 38, wherein the communication and sensor module further comprises memory configured to store an expiration date of the autoinjector, and wherein the wireless communication components are configured to transmit an expiration signal upon expiration of the autoinjector.