ACUTE MEDICAL EVENTS

INCORPORATION BY REFERENCE TO ANY PRIORITY APPLICATIONS

[0001] This application is an international application of and claims the benefit of priority to U.S. provisional application no. 62/656,487, titled“Communication Enabled Device for an Autoinjector” and filed April 12, 2018, and U.S. provisional application no. 62/702,420, titled “Methods, Mediums, and Systems for Community-Engaged Medical Devices” and filed July 24, 2018, the entire disclosure of each of which is incorporated by reference herein in its entirety.

BACKGROUND

Field

[0002] The development relates generally to medical devices, such as autoinjectors, and in particular to communication enabled medical devices and providing community-oriented communication and features.

Description of the Related Art

[0003] Many people suffer from medical conditions, such as 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] Medical devices for treating severe allergic reactions, such as autoinjectors are used to treat such conditions. However, it is not always the case that a user remembers to carry his device. Moreover, even if the user carries his device, it will not always be the case that the user is able to administer a dose to himself (e.g., due to impairment, unfamiliarity with the device, or panic).

[0007] Further, other medical devices that treat sever acute events may utilize the embodiments described herein. For example, those suffering from epilepsy, seizures, opioid or other drug overdoses, etc. may similarly tailor the technology described herein for those purposes. It is with respect to these and other considerations that the present improvements may be useful.

SUMMARY

[0008] The embodiments disclosed herein each have several aspects no single one of which is solely responsible for the disclosure’s desirable attributes. Without limiting the scope of this disclosure, its more prominent features will now be briefly discussed. After considering this discussion, and particularly after reading the section entitled“Detailed Description,” one will understand how the features of the embodiments described herein provide advantages over existing systems, devices and methods for medical devices such as autoinjectors.

[0009] The following disclosure describes non-limiting examples of some embodiments. For instance, other embodiments of the disclosed systems and methods may or may not include the features described herein. Moreover, disclosed advantages and benefits can apply only to certain embodiments of the invention and should not be used to limit the disclosure.

[0010] Disclosed herein are various example embodiments of communication enabled devices for use with, or associated with, for example, medical devices such as an autoinjector. The autoinjector may be designed to deliver one or more doses of a drug in a manner that facilitates self-administration of the drug via a syringe. The autoinjector may be easy to use and intended to be used by patients or by untrained personnel. The autoinjector may be self-contained and designed to require only a few basic steps to operate. People diagnosed with severe allergies may be prescribed an epinephrine autoinjector device that must be carried with them at all times. Such users and medical devices may benefit from and use the various systems and methods described herein.

[0011] In one embodiment, the present disclosure is directed to a communication enabled device having a housing adapted and configured to receive an autoinjector therein. The communication enabled device further includes communication and sensor circuity.

[0012] Alternatively, in an alternate embodiment, the communication and sensor circuity may be incorporated directly within a body portion of the autoinjector. Alternatively, in yet another alternate 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).

[0013] 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. That is, the communication and sensor circuity is adapted and configured to transmit wireless communications upon the occurrence of one or more events. 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).

[0014] 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.

[0015] 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.

[0016] 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.

[0017] In one 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.

[0018] 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 tumed 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.

[0019] 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.

[0020] The communication enabled devices may wirelessly communicate with 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.

[0021] 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.

[0022] Embodiments described herein relate to medical devices configured to communicate on a network. Exemplary medical devices may provide features including, but not limited to:

[0023] Community-based device sharing: being able to see users with nearby devices; being able to flag for nearby users when at-risk patients are in distress but do not have a device; being able to physically respond to and assist nearby users who do not have a device with them.

[0024] Location-based device authentication: two-part device location tracking, based on (a) losing a WiFi signal for a predefined location or leaving a geofenced area with a mobile device, and (b) detecting that the device is more than a predefined distance away from the mobile device. [0025] General device tracking information on a per-user basis: retrieving user device information based on scanning a device barcode, retrieving prescription info, and having the user fill in some information; tracking emergency contacts; per-user device identification, such as in the case where a child provides authorization to a nurse, and the nurse is provided with the child’s device information and medical history - when the nurse gets authorization from the child, that child’s particular device identifies itself via audible and/or visual signals.

[0026] Automatic alerts based on device use: when a device is used, it alerts emergency medical services and the stored contacts; contacts can talk to each other to coordinate response; contacts can see if emergency service has been rendered, whether the user is being taken to a hospital, which hospital they are en route to, and their progress to the hospital.

[0027] An incentives-based community points system: users receive points for carrying device, streaks, and rendering assistance, as well as by correctly answering daily food allergy and emergency preparedness education/awareness pop quizzes; points can be redeemed for rewards in an online marketplace, or for new devices/allergy-related products; if a user offers up their own device to help a user in distress, the offering user may be granted a larger number of points than the user would receive for, e.g., carrying their device or activating a streak.

[0028] Predictive analytics: information such as device expiration and usage is tracked along with user location; inventory requirements are determined and distributors/pharmacies may be advised in real time as to what demand may be for the device; allows distributors to place products where they will be needed, especially during a shortage.

[0029] A computer-implemented method as described herein.

[0030] A non-transitory computer-readable medium storing instructions that, when executed, cause a processor to perform actions as described herein.

[0031] An apparatus comprising a non-transitory computer readable medium storing instructions and a hardware processor for executing the instructions to perform actions as described herein. [0032] A computer program product configured to provide logic for carrying out a procedure as described herein.

BRIEF DESCRIPTION OF THE DRAWINGS

[0033] 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.

[0034] FIG. 2 illustrates an exploded perspective view of the communication enabled device shown in FIG. 1.

[0035] FIG. 3 illustrates a perspective view of the communication enabled device shown in FIG. 1.

[0036] FIG. 4 illustrates a perspective view of another embodiment of a communication enabled device.

[0037] FIG. 5 illustrates a perspective view of the communication enabled device shown in FIG. 4, with a portion of the protective coating (e.g., protective wrap) shown being teared away.

[0038] 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.

[0039] FIG. 7 illustrates a perspective view of another embodiment of a communication enabled device.

[0040] 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.

[0041] FIG. 9 illustrates a schematic illustration of an example embodiment of the wireless communication network that may be used in connection with the communication enabled devices described herein.

[0042] FIGS. 10-11 illustrate exploded perspective views of an example embodiment of a protective device and an example embodiment of an autoinjector received within the protective device. [0043] FIG. 12 illustrates a perspective view of the protective device shown in FIG. 10, the protective device illustrated in a closed position.

[0044] FIG. 13 illustrates a perspective view of the protective device shown in FIGS. 10 and 11, with the protective device illustrated in an opened position.

[0045] FIG. 14 depicts a graphical user interface (GUI) presenting various capabilities of exemplary embodiments;

[0046] FIGS. 15A-15G depict exemplary embodiments for retrieving and organizing medication and device information, prescription information, and contacts, among other elements;

[0047] FIGS. 16A-16B depict a scrollable interface for presenting device usage instructions according to an exemplary embodiment;

[0048] FIGS. 17A-17B depict exemplary interfaces for interacting with community-oriented features;

[0049] FIG. 18 depicts an exemplary alert issued upon the occurrence of a medication event;

[0050] FIG. 19 is a flow chart depicting exemplary logic for performing a method according to exemplary embodiments;

[0051] FIG. 20 depicts an exemplary network embodiment;

[0052] FIG. 21 depicts an exemplary computing device suitable for use with exemplary embodiments.

[0053] FIG. 22 is a flow chart showing an embodiment of a method of analyzing information related to a medical device that may be performed by the mobile and/or client devices of FIGS. 14-21.

[0054] FIG. 23 is a flow chart showing an embodiment of a method of analyzing information related to a medical device that may be performed by the remote devices, servers and/or databases of FIGS. 9 and 20-21.

[0055] FIG. 24 is a flow chart showing an embodiment of a method performed by a database for transacting the selection of a medical device, such as an autoinjector.

[0056] FIG. 25 is a flow chart showing an embodiment of a method performed by a database for transacting the purchase of a medical device, such as an autoinjector. [0057] FIG. 26 is a flow chart showing an embodiment of a method performed by one or more electronic devices for managing a medical device, such as an autoinjector.

[0058] FIGS. 27A-27C are flow charts showing embodiments of methods for analyzing various data to determine various characteristics related to a user of a medical device and/or of the medical device, such as an autoinjector.

[0059] The foregoing and other features of the present disclosure will become more fully apparent from the following description and appended claims, taken in conjunction with the accompanying drawings. Understanding that these drawings depict only several embodiments in accordance with the disclosure and are not to be considered limiting of its scope, the disclosure will be described with additional specificity and detail through use of the accompanying drawings. 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. It will be readily understood that the aspects of the present disclosure, as generally described herein, and illustrated in the drawing, can be arranged, substituted, combined, and designed in a wide variety of different configurations, all of which are explicitly contemplated and make part of this disclosure.

DETAILED DESCRIPTION

[0060] The following detailed description is directed to certain specific embodiments of the development. In this description, reference is made to the drawings wherein like parts or steps may be designated with like numerals throughout for clarity. Reference in this specification to “one embodiment,” “an embodiment,” or “in some embodiments” means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment of the invention. The appearances of the phrases “one embodiment,” “an embodiment,” or “in some embodiments” in various places in the specification are not necessarily all referring to the same embodiment, nor are separate or alternative embodiments necessarily mutually exclusive of other embodiments. Moreover, various features are described which may be exhibited by some embodiments and not by others. Similarly, various requirements are described which may be requirements for some embodiments but may not be requirements for other embodiments.

[0061] Various example embodiments of communication enabled devices and associated systems and methods are provided. The communication enabled devices described herein may be used to house drug delivery devices or other medical devices. The communication enabled devices may be used for various suitable purposes, 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.

[0062] Further, exemplary embodiments relate to systems and methods for community-oriented communication, such as software, mobile device applications, storage mediums containing such software or applications, websites, and communication networks. Such systems and methods may be used in conjunction with the communication enabled devices that house or otherwise contain the medical device.

[0063] The systems and methods described herein may be used with various types of medical devices. The medical devices may be intended for treating severe, acute medical events such, as severe allergic reactions including but not limited to anaphylaxis, as well as seizures, drug overdoses, and the like. The medical device may be a drug delivery device, such as an autoinjector or the like, including devices in which a drug delivery needle, cannula or other tube is automatically or manually inserted into a patient. In some embodiments, the medical device may be an epinephrine autoinjector, which may deliver a dose of epinephrine to a patient undergoing a severe allergic reaction. Although exemplary embodiments described herein may refer to epinephrine autoinjectors, the present disclosure is not so limited, and may be used with any suitable medical device.

[0064] For example, the medical device may be a glucagon injector suitable for treating a diabetic incident. When a diabetic has low blood sugar, community members may be provided with notice via their mobile devices and may respond by providing an accessible glucagon pen.

[0065] As further example, the medical device may be a naloxone injector or nasal sprays for treating an opioid overdose. A monitor in the device may relay a user’s heart rate to an associated community, and the community may have visibility into whether the user’s heart rate drops to a dangerous level. Community members can then respond with a naloxone injector or nasal spray, or signal to emergency services that an overdose has occurred.

[0066] As further example, the medical device may provide an atropine or other injection for military or other nerve agents. If a user (e.g., a soldier on a battlefield) knows that they have been exposed to a nerve agent, the user can signal that they have been exposed, and the nearest person with an atropine injector can be tagged to respond.

[0067] In some embodiments, the communication enabled devices make it possible for the medical device such as a 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.

[0068] 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 application (e.g., 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.

[0069] 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.

[0070] 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.

[0071] 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.

[0072] 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.

[0073] FIGS. 1-13 relate to example embodiments of communication enabled devices and associated features. FIGS. 14-21 relate to example embodiments of various systems and methods involving the communication enabled devices and/or medical devices, such as associated software, programming, and communication networks, which may be used for community engagement and other purposes, as further described herein.

[0074] Referring to FIGS. 1-3, an example embodiment of a communication enabled device 100 is illustrated. FIGS. 1 and 2 are exploded perspective views of the communication enabled device 100 and an example embodiment of an autoinjector 50 received within the communication enabled device 100. FIG. 3 illustrates a perspective view of the communication enabled device 100.

[0075] 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, or other medical device. In one example embodiment, the autoinjector may be the Salvare™ autoinjector manufactured by Summit Street Medical, Inc. The autoinjector may be, for example, the autoinjector shown and described in U.S. Patent Application No. 15/790,263 entitled “Wearable Drug Delivery Device” and filed October 23, 2017, in International PCT Patent Application No. PCT/US2019/017824 entitled“Wearable Drug Delivery Device” and filed February 13, 2019, in U.S. Provisional Application No. 62/710,454, entitled“Wearable Drug Delivery Device” and filed February 16, 2018, and/or in U.S. Provisional Application No. 62/805,043, entitled“Wearable Drug Delivery Device” and filed February 13, 2019, the entire disclosure of each of which is incorporated by reference herein in its entirety for all purposes and forms a part of this specification. 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.

[0076] 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.

[0077] 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). [0078] 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.

[0079] 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.

[0080] 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 know 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.

[0081] 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. 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.

[0082] FIG. 4 illustrates a perspective view of another embodiment of a communication enabled device 200. FIG. 5 illustrates a perspective view of the communication enabled device 200, with a portion of the protective coating (e.g., protective wrap) shown being teared away. FIG. 6 illustrates a perspective view of the communication enabled device 200, with a portion of the protective coating (e.g., protective sleeve) shown being removed.

[0083] Referring to FIGS. 4-6, the communication enabled device 200 may carry an autoinjector 250, or other medical device. 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 264. 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.

[0084] 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 the finger portions 280, 282 formed in the body 260 and protective cover (e.g., protective sleeve 270), respectively. In use, by pulling on the device 200, 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.

[0085] 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.

[0086] For example, referring 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.

[0087] Alternatively, in some embodiments, the protective coating such as, for example, the protective sleeve 270, can be manufactured entirely or partially from a tinted film 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.

[0088] Alternatively, the window 500 formed on the autoinjector and/or the window 275 formed in the protective coating (e.g., protective sleeve 270) may be manufactured from, for example, a clear transparent or translucent material. The clear transparent or translucent material may include, for example, an ultraviolet (UV) film protector, UV absorbing compounds, or the like. In another embodiment, the protective coating such as, for example, the protective sleeve 270, can be manufactured entirely or partially from, for example, a clear transparent or translucent material including, for example, an ultraviolet (UV) film, protector, UV absorbing compounds, or the like.

[0089] While the tinted film and/or clear transparent/translucent material including UV protector 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 and/or clear transparent/translucent material including UV protector may be used in connection with the other devices 100, 300, 400 described herein, or the like. For example, it is envisioned that the entire protective cover may be manufactured from a tinted film or and/or a clear transparent/translucent material including UV protector.

[0090] Further, data related to the light exposure of the drug or medical device through the UV or other film or protective cover may be transmitted via the communication enabled device to a server, such as a database, either directly or via a mobile device. Such data may be aggregated and analyzed for determining optimal films, coatings, etc. for the medical device, for updating users of degraded or risk of degraded drug, or for other suitable uses to improve the technology.

[0091] In accordance with another aspect of the present disclosure, as will be appreciated by one of ordinary skill in the art, sterilization of drugs, such as epinephrine, is an important consideration (e.g., drug can be damaged by, for example, unwanted introduction of life and other biological agents (such as fungi, bacteria, viruses, spores, prions, etc.). Sterilization may be accomplished by, for example, microfiltration using membrane filters. In one embodiment, the protective cover, coating, and/or drug delivery device may include or be manufactured from a filter material. By incorporating a filter material into the protective cover, coating, and/or drug delivery device, the protective cover, coating, and/or drug delivery device may prevent the unwanted introduction of life or other biological agents while permitting air to pass. In this manner, for example, the drug delivery device and associated protective cover or coating may be, for example, transported (e.g., brought onto a plane, etc.) without the concern that unwanted life or other biological agents will seep into the drug thus rendering the drug delivery device non-sterile.

[0092] In use, the filter material may be any suitable material now known or hereafter developed, such as, for example, polyethylene fibers, Tyvek, cellulose ester or polyethersulfone (PES), a microfilter with a pore size of about 0.2 pm, a nanofilter with a pore size or about 20-50 nm, etc. The filter material may be incorporated into or associated with the protective cover, coating, and/or drug delivery device by any suitable means now known or herafter developed including, for example, welding, adhesive, heat stamping, molding into the protective cover, coating, and/or drug delivery device, etc.

[0093] 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.

[0094] FIG. 7 illustrates a perspective view of another embodiment of a communication enabled device 300. 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 364. 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.

[0095] 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 on the device 300, 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.

[0096] FIG. 8 illustrates an example embodiment of a communication and sensor module that can be used in connection with the communication enabled devices described herein, such as those shown in and described with respect to FIGS. 1-7. 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. [0097] 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.

[0098] 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, BFE 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, BFE while the second set of radio, antenna, and processor can be arranged to communicate using a second wireless communication scheme, such as, Wi-Fi.

[0099] 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. In some embodiments, 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.

[0100] 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.

[0101] In addition, the communication and sensor module 175 may include or be associated with, among other things, 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. [0102] 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).

[0103] 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.

[0104] 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.

[0105] 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 FED, 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. [0106] FIG. 9 illustrates a schematic illustration of an example embodiment of a wireless communication network that may be used in connection with the communication enabled devices and associated systems and methods described herein. 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 401 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 401 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.

[0107] 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, via, for example, the communication and sensor circuity, such as, for example, the communication and sensor module 175, transmit a notification (e.g., an alert) to one or more remote entities 401 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 401.

[0108] 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).

[0109] 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 401. 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 401. 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 401. 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 401 upon expiration of the autoinjector, or shortly therebefore. For example, the communication enabled devicelOO, 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 401 informing them of the expiration date of the autoinjector.

[0110] 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 401 of such.

[0111] 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 401 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 401. 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.

[0112] In some embodiments, the remote entities 401 may be a designated list of recipients. For example, the remote entities 401 may include a list of contacts such as, for example, the user’s parents, guardians, relatives, doctor, etc. In addition, the remote entities 401 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.

[0113] 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. The device 100, 200, 300 may communicate with the database 210 via the mobile device 200, the computing device 204, or the internet enabled device 206. In some embodiments, the device 100, 200, 300 may communicate directly with the database 210.

[0114] 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.

[0115] Referring to FIGS. 10-13, an example embodiment of a protective device 400, such as a cover, is illustrated. FIGS. 10 and 11 illustrate exploded perspective views of the protective device 400 and an example embodiment of an autoinjector received within the protective device 400. FIG. 12 illustrates a perspective view of the protective device 400 in a closed position. FIG. 13 illustrates a perspective view of the protective device 400 in a closed position. As will be illustrated and described herein, the protective device 400 may be adapted and configured to work with and/or receive an autoinjector 50 such as, for example, an epinephrine autoinjector. It should be understood, however, that it is envisioned that the principles of the protective device 400 may be adapted and configured to work with any autoinjector, and as such, the present disclosure should not be limited to these particular embodiments.

[0116] The protective device 400 may be adapted and configured to receive the autoinjector 50. For example, the protective device 400 may include a body 410 having an interior cavity for receiving the autoinjector 50. Referring to FIGS. 10 and 11, in one example embodiment, the body 410 of the device 400 may include a first component 420 and a second component 440. While the body 410 of the device 400 will be described and illustrated as being manufactured from two components, it should be understood that the body 410 may be manufactured from more or less components, for example, the device 400 may be manufactured from a single component having, for example, a hinged door. Alternatively, the device 400 may be manufactured from three, four, or more components coupled together.

[0117] The illustrated protective device 400 is particularly well suited for use in various climates such as, for example, in connection with outdoor use (e.g., adventurous activities, running, biking, military use, Emergency Medical Technicians, etc.). That is, as compared to the device 100 described and illustrated in connection with FIGS. 1-3, the protective device 400 includes a more robust design made to withstand and protect the autoinjector 50 from greater impact. For example, the protective device 400 may be made with a thicker wall thickness. In one embodiment, it is envisioned that the wall thickness of the protective device 400 may be approximately double the wall thickness of device 100 (e.g., wall thickness of approximately 2-3mm as compared to approximately lmm for device 100), although other thicknesses are envisioned. Additionally, and/or alternatively, the protective device 400 may be manufactured from a stronger material, etc. For example, in one embodiment, the device 400 may be manufactured from a reinforced plastic material, such as, a high impact polycarbonate, a glass filled ABS polycarbonate, or the like. By manufacturing the protective device 400 with an increased wall thickness and/or from stronger materials, the device 400 is able to withstand increased sealing pressure, which can provide an improved seal between the first component 420 and the second component 440. Additionally, and/or alternatively, the protective device 400 may include a longer sealing interface for enabling a double seal to prevent any ingress of dust and water. As a result, the device 400 is particularly well-suited for outdoor use (e.g., adventurous activities, running, biking, military use, Emergency Medical Technicians, etc.).

[0118] In one embodiment, the first and second components 420, 440 may be adapted and configured to receive the autoinjector 50 therein. For example, in one embodiment, the first component 420 may include an outer body 422 and an interior cavity 426 having an opening 424 at one end thereof so that in use, the autoinjector 50 can be inserted into the interior cavity 426 through the opening 424. Thereafter, the second component 440 may be coupled to the first component 420 to seal the autoinjector 50 within the device 400 (e.g., within the interior cavity 426 of the first component 420 of the device 400).

[0119] In use, the first and second components 420, 440 may be removably coupled to each other. For example, during use, as required, the first and second components 420, 440 can be decoupled from each other so that the autoinjector 50 can be accessed as needed. The first and second components 420, 440 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 420, 440 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 420, 440 may include a seal for providing a water-tight seal between the first and second components 420, 440.

[0120] As illustrated in FIGS. 12 and 13, in one embodiment, the device 400 may include a band 450 such as, an elastic band, for coupling the first and second components together 420, 440. In one embodiment, the elastic band 450 couples the first and second components 420, 440 together while enabling the first and second components 420, 440 to be separated from each other during use so that the autoinjector 50 can be removed from the interior cavity 426 of the device 400. As illustrated in FIG. 13, the elastic band 450 preferably remains coupled to the first and second components 420, 440 even when the device 400 is opened and the second component 440 is detached or separated from the first component 420. Additionally, the elastic band 450 facilitates easier carrying of the device 400 such as, for example, providing a user with a convenient gripping or attachment mechanism for the user to hold, attach, tie, or the like, the device 400 to the user or a user associated item (e.g., a bike, a backpack, etc.)

[0121] As illustrated, the band 450 may pass through a pair of openings 430 formed through a bottom portion 428 of the body 410. Similarly, the band 450 may pass through a pair of openings 444 formed in a top portion 442 of the body 410. Thereafter, the band 450 may extend through one or more associated openings 448 formed in the top surface 446 of the body 410. As such, in the illustrated embodiment, the band 450 may travel through the opening 448 formed in the top surface 446 of the body 410 (e.g., second component 440), out one of the openings 444 formed in the top portion 442 of the body 410 (e.g., second component 440), down along a side of the body 410, through one of the openings 430 formed in the bottom portion 428 of the body 410 (e.g., first component 420), out the other opening 430 formed in the bottom portion 428 of the body 410, up along a side the body 410, through the other opening 444 formed in the top portion 442 of the body 410 (e.g., second component 440), and out the opening 448 formed in the top surface 446 of the body 410. As such, in use, the band 450 may couple the first and second components 420, 440 of the device 400 by partially wrapping about the first and second components 420, 440. [0122] Additionally, in some embodiments, the protective device 400 may also include a communication and sensor module, as previously described, so that in use, opening of the device (e.g., decoupling of the first and second components 420, 440) causes the device 400 to transmit a wireless notification to one or more remote entities 401.

[0123] FIGS. 14-23 depict various embodiments of devices, systems and methods that may use the various communication enabled devices and associated features described herein for analysis of medical devices, for example as described with respect to FIGS. 1-13.

[0124] FIGS. 14-16B depict an exemplary user interfaces for an application that communicates with the communication-enabled medical device to manage the user’s interactions with the medical device. FIG. 14 depicts a home screen where a user can manage information about their medical device(s) (see FIGS. 15F-15G), their prescriptions (see FIGS. 15B-15C) and people who should be contacted in the case of a medical event (FIGS. 15D-15E). FIG. 15A depicts an information summary screen providing general information about a user’s device(s). As shown in FIG. 15A, the user may opt-in to the community oriented features described herein (see FIGS. 17A and 17B). Even without community opt-in, the user may be provided with information specific to themselves, such as when their current medication will expire and the location of their medical device.

[0125] The medical device may support location-based device authentication. The medical device may work in conjunction with the user’s mobile device to provide two- part device location tracking. For example, in order to ensure that the user does not leave their medical device behind when they leave a given location, the system may send alerts based on (a) losing a WiFi signal for a predefined location or leaving a geofenced area with a mobile device, and (b) detecting that the device is more than a predefined distance away from the mobile device. In some cases, one or the other of these indications may not, by itself, be a good indication that the device has been left behind; for example, if the user is a student, the device may reside in a nurse’s cabinet at their school. In this circumstance, the system should not alert the user that they have left their device behind until the user’s mobile device leaves the school (evidenced by the mobile device losing the WiFi connection for the school, or moving outside a predefined geo-fence around the school). Similarly, if the device does lose the WiFi signal or moves outside the predefined zone, the system should not flag that the medical device has been left behind if the device is detected in close proximity to the mobile device. This capability may also help to conserve battery power on the mobile device and/or medical device, because the mobile device need not attempt to detect the proximity of the medical device while the mobile device is in the predefined or geofenced area. The interface of FIG. 15A provides a prompt allowing the threshold proximity of the device to be varied; in some embodiments, the interface may further support defining geofenced areas or predetermined locations in which the system will not check for the proximity of the device (assuming that the device was previously detected as entering the predetermined location or geofenced area).

[0126] FIGS. 15B-15D and 15F-15G allow the user to register their prescriptions and device details, respectively. The user may manually enter this information from the prescription and device, or this information may be automatically fetched into the application. The automatic fetching may be performed by retrieving the information from a server (e.g., a server belonging to the user’s physician or the device manufacturer), by scanning the information from the prescription or device (e.g., by snapping a picture of the prescription or device label and applying text recognition), by scanning a code (e.g., a barcode or QR code on the prescription or device, see FIGS. 15F-15G), or by exchanging information with an RFID or NFC (or similar) chip embedded in the prescription or medical device. If the system is unable to automatically retrieve all relevant information, the system may request that the user manually enter the missing information.

[0127] Once the device is registered and any relevant information is entered, the user may opt-in to community features. For instance, FIG. 17A depicts an example of a community points system. As the users’ device history is tracked, a user may gain or lose points. A scoreboard, as shown in FIG. 17A, may display the scores of all nearby users (or a subset of users, such as those identified as“friends” of the local user). Users may receive points for: carrying their device (as determined, e.g., based on whether the medical device reports that it is in proximity to the user’s mobile communications device throughout the day); maintaining streaks (e.g., carrying their device every day in a week, month, year, etc.); and rendering assistance to other users (see the description of FIG. 17B), among other possibilities. In some embodiments, if a user offers up their own device to help a user in distress, the offering user may be granted a larger number of points than the user would receive for, e.g., carrying their device or activating a streak. Points may be redeemed for allergy-related rewards or new medical devices.

[0128] Some embodiments provide community-based device sharing features. Once one or more users opt-in to the community features, a map may be presented (see FIG. 17B) showing the location of the current user and any other nearby users who also have registered their medical devices as pins. Optionally, a status indicator may identify whether the nearby users are carrying their medical devices. The above-described score of the users may be displayed, or the users’ avatar or pin may take on different characteristics depending on that user’s score (e.g., a relatively low-scoring user may have their name rendered in red, whereas a relatively high-scoring user may have their name rendered in gold; alternatively, a number of stars may be displayed near the user’s avatar, depending on the user’s score). The distance or travel time to the other nearby users may be displayed.

[0129] In the event that one of the users suffers a medical event requiring treatment by the medical device, the user may flag the medical event on their mobile device (e.g., by pressing an“emergency” button on the device lock screen, home screen, or in an application). Alternatively, the device may automatically detect an emergency condition, such as by detecting an elevated or low heart rate on an associated heart-rate monitor, detecting a fall with an accelerometer, detecting a cry for“help” with a microphone, etc.

[0130] Upon detecting the occurrence of a medical event, the mobile device may allow the local user to, or may automatically, flag on the map that the user is in distress. The user’s pin may flash, glow, change color, emit an audible alarm, or any other suitable action for distinguishing that the user is in distress. In some embodiments, notifications, calls, or other messages may be issued to nearby users (e.g., users within a predetermined distance or travel time of the user who is in distress).

[0131] Nearby emergency services may also be contacted to render assistance. Additionally, any emergency contacts specified by the user through the application may also be alerted, and may receive a similar notification. In some embodiments, the application may initiate a communication thread among the emergency contacts and/or emergency services, thereby allowing the emergency contacts to be informed of the distressed user’s status and to coordinate a response among themselves. Contacts may optionally be provided with information indicating if emergency service has been rendered and/or if another user has offered their medical device to the distressed user. The contacts may also be provided with information such as if the user is being taken (or has been taken) to a hospital, may be provided with identifying information (such as the address or phone number) of the hospital, and may track the distressed user’s progress towards the hospital on a map (such as the one shown in FIG. 17B). This information may be presented in the created communication thread, by alerts, or by other suitable means.

[0132] A real-time status update may include“friendly” content to reduce stress and tension in an emergency situation. For instance, the update may include cartoon ambulances, avatars, device cartoons, etc. In some embodiments, more adult-oriented content (e.g., 3D cartoon avatars of adults) may be used when the subject in distress (or the contact) is an adult, whereas child-oriented content (e.g., hand-drawn anthropomorphic ambulances) may be used for child subjects. The system may select an age- appropriate avatar based, e.g., on the stored information about the medical device or the user.

[0133] If the application detects that the distressed user has their medical device with them (e.g., the medical device is detected in close proximity to the mobile device), the application may indicate this information on the map and/or in the notification. Alternatively, the system may refrain from issuing a notification if the user has their medical device with them. In some situations (e.g., where the user has been rendered unconscious or unable to administer the medical device themselves), the system may issue a notification and alert nearby users, even if the user has their medical device in close proximity.

[0134] Upon receiving an alert of a nearby medical event, a different user (distinct from the user in distress) may indicate through their version of the application that they intend to come to the assistance of the user in distress. Multiple users may indicate their willingness to help. The application may optionally guide the assisting user to the location of the user in distress. Once the user has rendered assistance (e.g., by providing the user in distress with their own medical device), the assisting user or the user in distress may indicate through the application that the user in distress has received treatment by the medical device. Alternatively or in addition, the application may detect (based on sensors in the medical device communicating with the mobile device running the application) that the medical device has been used. In some embodiments, medical device information for the device belonging to the assisting user may be shared with the mobile device of the user in distress, so that the distressed user’s mobile device has a record of relevant information relating to the distressed user’s treatment. Optionally, this information may be used to confirm that the assisting user has in fact used their own device to provide assistance, for purposes of community scoring.

[0135] An indication that treatment has occurred may also be forwarded to nearby users and/or emergency services. Whether treated by the assisting user or using their own medical device, the user’s emergency contacts may receive an alert, such as the one depicted in FIG. 18.

Exemplary Logic

[0136] FIG. 19 is a flow chart depicting exemplary device logic 600 for performing a method according to exemplary embodiments.

[0137] In Step 1, a user may install the application and register an account with the service. In Step 2, the user may enter demographic information and emergency contacts. In Step 3, the user may enter prescription information.

[0138] In Step 4, the user may enter medical device information, manually or by scanning a code (such as a barcode on the device). The device may optionally forward the expiration date of the medical device to a server for purposes of inventory management. Step 4 may be repeated for multiple devices. As part of step 4, the user may enter a threshold distance for their medical device, above which an alert may be sent out.

[0139] In step 5, the system may detect that the user’s medical device is more than the threshold distance away from the medical device, and may issue an alert accordingly. In some embodiments, the system may refrain from issuing the alert if the user is within a particular geo-fenced area (e.g., within the user’s home or property, workplace, school, or within a predefined distance away from these locations).

[0140] At step 6, the system may calculate a community score for the user. The system may optionally display the user on a scoreboard of other users (see FIG. 4A). At step 7, the system may process an emergency event, as described above in connection with FIG. 4B. The system may optionally forward the device usage information to a server for purposes of inventory management.

[0141] At step 8, the system may optionally request identification of the user’s medical device. In some cases, the user’s medical device may be stored in a common area with other, similar devices (e.g., a child at school may provide their ephinephrine autoinjector to a nurse, who holds the device until needed during a medical event). In these cases, it may be difficult to distinguish one particular user’s device from other, similar looking devices, although they may not have the same characteristics (e.g., the same particular formulation of drug, or dosage amount). In this situation, the system may be configured to request authorization from the user (e.g., the user under distress), in which case the user’s medical information may be provided to a requesting user (e.g., the nurse). In some cases, both the user under distress and the requesting user may be required to authenticate, in order to (1) establish that the user under distress is agreeing to share their information, and (2) establish that the receiving user is authorized to receive it. The system may check against the user’s profile to verify which requesting users are valid.

[0142] Once authenticated, the medical information may be shared with the requesting user. Furthermore, the device belonging to the user under distress may identify itself (e.g., it may issue an audible alarm, light up, vibrate, etc.) in order to identify the device that belongs to the user under distress among other, similar-looking devices.

[0143] Although the logic 600 of FIG. 19 is described from the perspective of a client device, corresponding actions may be taken on a corresponding server device to support and fulfill the actions described above. Similarly, other client devices may take corresponding actions, as described above in connection with FIGS. 17A-18.

Network Embodiments

[0144] Some exemplary embodiments may be employed in a network environment, such as the environment depicted in FIG. 20.

[0145] A user may interact with a client 700, which may be (for example) a personal computer, tablet, mobile phone, special-purpose translation device, etc. In some embodiments, the client 700 does not require interaction from a user. [0146] The client 700 may include one or more input devices 702 and one or more output devices 706. The input devices 702 may include, for example, microphones, keyboards, cameras, electronic pens, touch screens, and other devices for receiving an input sequence. The output devices 706 may include a speaker, a display device such as a monitor or touch screen, and other devices for presenting an output sequence.

[0147] The client 700 may include a memory 704, which may be a non-transitory computer readable storage medium, such as one or a combination of a hard drive, solid state drive, flash storage, read only memory, or random access memory. The memory 704 may be a representation of an input 703 and/or a representation of an output 707, as well as one or more applications. For example, the memory 704 may store an application or client 705 corresponding to the above-described logic.

[0148] The input 703 may be textual, such as in the case where the input device 702 is a keyboard. Alternatively, the input 706 may be an audio recording, such as in the case where the input device 702 is a microphone. Accordingly, the input 703 may be subjected to automatic speech recognition (ASR) logic to transform the audio recording to text that is processable by the server 712. The ASR logic may be located at the client device 700 (so that the audio recording is processed locally by the client 700 and corresponding text is transmitted to the server 712), or may be located remotely at the server 712 (in which case, the audio recording may be transmitted to the server 712 and the server 712 may process the audio into text). Other combinations are also possible - for example, if the input device 702 is a touch pad or electronic pen, the input 703 may be in the form of handwriting, which may be subjected to handwriting or optical character recognition analysis logic in order to transform the input 703 into processable text.

[0149] Similarly, a resulting output 707 from a server 712 may be in the form of text. In some embodiments, the desirable end form of the output may be something other than text, such as an audio representation of the translation. Accordingly, the output 707 may be subjected to text-to- speech (TTS) logic to transform the text into an audio recording that is presentable by the output device 706. The TTS logic may be located at the client 700 (so that the output text is processed locally by the client 700 and corresponding audio is sent to the output device 706), or may be located remotely at the server 712 (in which case, text may be processed at the server 712 and the resulting audio recording may be transmitted to the client 700). Other combinations of processing logic are also possible, depending on the desired final form for the output 707.

[0150] The client 700 may include a location component (not pictured), such as a GPS transmitter/receiver, for identifying a location of the client 700.

[0151] The client 700 may be provided with a network interface 708 for communicating with a network 710, such as the Internet. The network interface 708 may transmit the input 707 in a format and/or using a protocol compatible with the network 710 and may receive a corresponding output 707 from the network 710.

[0152] The network interface 708 may communicate through the network 710 to a server 712. The server 712 may host: delivery device logic 714 for capturing, storing, processing, and reacting to information about a medical device 720; use event logic 716 for capturing, storing, processing, and reacting to an event corresponding to a use of the medical device 720, as detected by a use sensor 736 which may be located on the medical device 720 or remote from the medical device 720; and inventory logic 718 that may interact with the delivery device logic 714, use event logic 716, and/or one or more user profiles 724 to evaluate the supply and demand of medical devices 720 in a given area, and to convey the findings to an inventory server 722.

[0153] Based on the information provided by the inventory logic 718, the inventory server 722 may automatically re-order or redistribute a supply of medical devices 720 in order to meet predicted demand. The demand may be determined based on, for example, the number of times the medical devices 720 have recently been used in the area (indicating a likelihood that a user will need to restock their personal supply), the expiration dates of medical devices 720 in the area (as stored, for example, in the device information 728 of the user profiles 724), past user-specific device restock rates as indicated by a history of device activations stored in the device information 728, the presence or absence of new users in the area as determined by the location information 732 stored in the user profiles 724, etc.

[0154] Within the user profiles 724, the server 712 may store information to be input to the delivery device logic 714, the use event logic 716, the inventory logic 718, or other logics. The user profile 724 information may also include the output of any of these logics, and/or user- specified data. The user profiles may store, for example, user-specific information pertaining to: user demographics 726 and other information about a user (such as a user avatar, logic credentials, registered clients 700, etc.); device information 728 pertaining to one or more medical devices 720 associated with the user; prescription information 730 providing any details relevant to prescriptions held by the user (e.g., an identifier for each drug or device prescribed to the user, a number of refills, refill dates, usage instructions, etc.); location information 732 representing a location of the user and/or the user’s medical device(s) 720, as determined by the user’s client 700, a location component 740 (e.g., a GPS transmitter/receiver) of the medical device 720, or any other suitable mechanism for determining location; and a list 734 of associated users and contact information for the associated users, to be contacted upon the occurrence of a use event (e.g., as determined by the use event logic).

[0155] The serer 712 may communicate with the inventory server 722, the client 700, and/or the medical device 720 via the network 710. The medical device 720 may also communicate over the network 710 via a transmitter/receiver 738. Alternatively or in addition, the medical device 720 may communicate directly with the client 700 via the transmitter/receiver 738. In some cases, the client 700 may act as a relay for the medical device 720, allowing the medical device 720 to rely upon the relatively powerful transmitter/receiver of the client for communications on the network 710, which may allow the medical device 720 (which is likely of limited size and power capacity) to have a smaller and less powerful transmitter/receiver 738.

[0156] A user of the client 700 may be an individual (human user), an entity (e.g., an enterprise, business, or third-party application), a group (e.g., of individuals or entities), or computer-executable logic.

Computer-Related Embodiments

[0157] The above-described methods may be embodied as instructions on a computer readable medium or as part of a computing architecture. FIG. 21 illustrates an embodiment of an exemplary computing architecture 836 suitable for implementing various embodiments as previously described. In one embodiment, the computing architecture 836 may comprise or be implemented as part of an electronic device. Examples of an electronic device may include those described with reference to FIG. 21, among others. The embodiments are not limited in this context.

[0158] As used in this application, the terms“system” and“component” are intended to refer to a computer-related entity, either hardware, a combination of hardware and software, software, or software in execution, examples of which are provided by the exemplary computing architecture 836. For example, a component can be, but is not limited to being, a process running on a processor, a processor, a hard disk drive, multiple storage drives (of optical and/or magnetic storage medium), an object, an executable, a thread of execution, a program, and/or a computer. By way of illustration, both an application running on a server and the server can be a component. One or more components can reside within a process and/or thread of execution, and a component can be localized on one computer and/or distributed between two or more computers. Further, components may be communicatively coupled to each other by various types of communications media to coordinate operations. The coordination may involve the uni-directional or bi-directional exchange of information. For instance, the components may communicate information in the form of signals communicated over the communications media. The information can be implemented as signals allocated to various signal lines. In such allocations, each message is a signal. Further embodiments, however, may alternatively employ data messages. Such data messages may be sent across various connections. Exemplary connections include parallel interfaces, serial interfaces, and bus interfaces.

[0159] The computing architecture 836 includes various common computing elements, such as one or more processors, multi-core processors, co-processors, memory units, chipsets, controllers, peripherals, interfaces, oscillators, timing devices, video cards, audio cards, multimedia input/output (I/O) components, power supplies, and so forth. The embodiments, however, are not limited to implementation by the computing architecture 836.

[0160] As shown in FIG. 21, the computing architecture 836 comprises a processing unit 840, a system memory 842 and a system bus 844. The processing unit 840 can be any of various commercially available processors, including without limitation an AMD® Athlon®, Duron® and Opteron® processors; ARM® application, embedded and secure processors; IBM® and Motorola® DragonBall® and PowerPC® processors; IBM and Sony® Cell processors; Intel® Celeron®, Core (2) Duo®, Itanium®, Pentium®, Xeon®, and XScale® processors; and similar processors. Dual microprocessors, multi-core processors, and other multi-processor architectures may also be employed as the processing unit 840.

[0161] The system bus 844 provides an interface for system components including, but not limited to, the system memory 842 to the processing unit 840. The system bus 844 can be any of several types of bus structure that may further interconnect to a memory bus (with or without a memory controller), a peripheral bus, and a local bus using any of a variety of commercially available bus architectures. Interface adapters may connect to the system bus 844 via a slot architecture. Example slot architectures may include without limitation Accelerated Graphics Port (AGP), Card Bus, (Extended) Industry Standard Architecture ((E)ISA), Micro Channel Architecture (MCA), NuBus, Peripheral Component Interconnect (Extended) (PCI(X)), PCI Express, Personal Computer Memory Card International Association (PCMCIA), and the like.

[0162] The computing architecture 836 may comprise or implement various articles of manufacture. An article of manufacture may comprise a computer-readable storage medium to store logic. Examples of a computer-readable storage medium may include 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. Examples of logic may include executable computer program instructions implemented using 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. Embodiments may also be at least partly implemented as instructions contained in or on a non-transitory computer-readable medium, which may be read and executed by one or more processors to enable performance of the operations described herein.

[0163] The system memory 842 may include various types of computer-readable storage media in the form of one or more higher speed memory units, such as read-only memory (ROM), random-access memory (RAM), dynamic RAM (DRAM), Double-Data- Rate DRAM (DDRAM), synchronous DRAM (SDRAM), static RAM (SRAM), programmable ROM (PROM), erasable programmable ROM (EPROM), electrically erasable programmable ROM (EEPROM), flash memory, polymer memory such as ferroelectric polymer memory, ovonic memory, phase change or ferroelectric memory, silicon-oxide- nitride-oxide- silicon (SONOS) memory, magnetic or optical cards, an array of devices such as Redundant Array of Independent Disks (RAID) drives, solid state memory devices (e.g., USB memory, solid state drives (SSD) and any other type of storage media suitable for storing information. In the illustrated embodiment shown in FIG. 21, the system memory 842 can include non-volatile memory 846 and/or volatile memory 848. A basic input/output system (BIOS) can be stored in the non-volatile memory 846.

[0164] The computer 838 may include various types of computer-readable storage media in the form of one or more lower speed memory units, including an internal (or external) hard disk drive (HDD) 850, a magnetic floppy disk drive (FDD) 852 to read from or write to a removable magnetic disk 854, and an optical disk drive 856 to read from or write to a removable optical disk 858 (e.g., a CD-ROM or DVD). The HDD 850, FDD 852 and optical disk drive 856 can be connected to the system bus 844 by a HDD interface 860, an FDD interface 862 and an optical drive interface 864, respectively. The HDD interface 860 for external drive implementations can include at least one or both of Universal Serial Bus (USB) and IEEE 694 interface technologies.

[0165] The drives and associated computer-readable media provide volatile and/or nonvolatile storage of data, data structures, computer-executable instructions, and so forth. For example, a number of program modules can be stored in the drives and memory units 846, 848, including an operating system 866, one or more application programs 868, other program modules 870, and program data 872. In one embodiment, the one or more application programs 868, other program modules 870, and program data 872 can include, for example, the various applications and/or components of the system.

[0166] A user can enter commands and information into the computer 838 through one or more wire/wireless input devices, for example, a keyboard 874 and a pointing device, such as a mouse 876. Other input devices may include microphones, infra-red (IR) remote controls, radio-frequency (RF) remote controls, game pads, stylus pens, card readers, dongles, finger print readers, gloves, graphics tablets, joysticks, keyboards, retina readers, touch screens (e.g., capacitive, resistive, etc.), trackballs, trackpads, sensors, styluses, and the like. These and other input devices are often connected to the processing unit 840 through an input device interface 878 that is coupled to the system bus 844, but can be connected by other interfaces such as a parallel port, IEEE 694 serial port, a game port, a USB port, an IR interface, and so forth.

[0167] A monitor 880 or other type of display device is also connected to the system bus 844 via an interface, such as a video adaptor 882. The monitor 880 may be internal or external to the computer 838. In addition to the monitor 880, a computer typically includes other peripheral output devices, such as speakers, printers, and so forth.

[0168] The computer 838 may operate in a networked environment using logical connections via wire and/or wireless communications to one or more remote computers, such as a remote computer 884. The remote computer 884 can be a workstation, a server computer, a router, a personal computer, portable computer, microprocessor-based entertainment appliance, a peer device or other common network node, and typically includes many or all of the elements described relative to the computer 838, although, for purposes of brevity, only a memory/storage device 886 is illustrated. The logical connections depicted include wire/wireless connectivity to a local area network (LAN) 888 and/or larger networks, for example, a wide area network (WAN) 890. Such LAN and WAN networking environments are commonplace in offices and companies, and facilitate enterprise-wide computer networks, such as intranets, all of which may connect to a global communications network, for example, the Internet.

[0169] When used in a LAN networking environment, the computer 838 is connected to the LAN 888 through a wire and/or wireless communication network interface or adaptor 892. The adaptor 892 can facilitate wire and/or wireless communications to the LAN 888, which may also include a wireless access point disposed thereon for communicating with the wireless functionality of the adaptor 892.

[0170] When used in a WAN networking environment, the computer 838 can include a modem 894, or is connected to a communications server on the WAN 890, or has other means for establishing communications over the WAN 890, such as by way of the Internet. The modem 894, which can be internal or external and a wire and/or wireless device, connects to the system bus 844 via the input device interface 878. In a networked environment, program modules depicted relative to the computer 838, or portions thereof, can be stored in the remote memory/storage device 886. It will be appreciated that the network connections shown are exemplary and other means of establishing a communications link between the computers can be used.

[0171] The computer 838 is operable to communicate with wire and wireless devices or entities using the IEEE 802 family of standards, such as wireless devices operatively disposed in wireless communication (e.g., IEEE 802.13 over-the-air modulation techniques). This includes at least Wi-Fi (or Wireless Fidelity), WiMax, and Bluetooth™ wireless technologies, among others. Thus, the communication can be a predefined structure as with a conventional network or simply an ad hoc communication between at least two devices. Wi-Fi networks use radio technologies called IEEE 802.13c (a, b, g, n, etc.) to provide secure, reliable, fast wireless connectivity. A Wi-Fi network can be used to connect computers to each other, to the Internet, and to wire networks (which use IEEE 802.3-related media and functions).

Analysis Method Embodiments

[0172] FIGS. 22-23 depict various analysis methods that may be performed by and include one or more of the various devices, systems and methods related to medical devices and/or communication enabled devices and associated features as described herein, for example the embodiments as shown in and described with respect to FIGS. 1-21. FIG. 22 is a flow chart showing an embodiment of a method 900 of analyzing information related to a medical device that may be performed by the mobile and/or client devices of FIGS. 14-21. FIG. 23 is a flow chart showing an embodiment of a method 1000 of analyzing information related to a medical device that may be performed by the remote devices, servers and/or databases of FIGS. 9 and 20-21.

[0173] Referring to FIG. 22, the method 900 may be performed by one or more processors of various electronic devices. For example, the method 900 may be performed by the mobile devices and/or software applications described with respect to FIGS. 14-18. As further example, the method 900 may be performed by the mobile device 202, the computing device 204, the internet enabled device 206, and/or other remote entities 400 described with respect to FIG. 9. As further example, the method 900 may be performed by the client 700 described with respect to FIG. 20. These and/or other devices may perform the method 900 in whole or in part.

[0174] In some embodiments, the method 900 may be performed in whole or in part by the database 210 described with respect to FIG. 9, by the server 712 and/or the inventory server 722 described with respect to FIG. 20.

[0175] One or more processors of the various devices may execute a set of instructions stored in memory to perform the method 900. The one or more processors and one or more memories may be any of those described herein, for example the processors and/or memory 704 of the client 700, the processor and/or memory of one or more of the remote entities 401, or the processor and/or memory of the mobile device of FIGS. 14-18. In some embodiments, the processors and/or memories associated with the method 1000 may be used with the method 900.

[0176] The method 900 begins with step 905 where first information is received from a communication enabled device, such as the communication enabled devices shown in and described with respect to FIGS. 1-13. The first information may be received by the various mobile or other devices as described above. The first information may be related to the medical device, and may include any of the information described herein, such as that described with respect to FIGS. 1-21 and as further discussed below in the section“Data Analysis.” For example, the first information may be related to information on type of medical device, use of the medical device, level of drug or medicament in the device, tracking information, age of the medical device, sensor information, proximity of the communication enabled device to the mobile device, data related to calculating scores related to user compliance with using, carrying, etc. the medical device, and/or other information as described herein. The first information may be received using the various communication systems described herein, for example a receiver of the mobile device.

[0177] The method 900 then moves to step 910 where the first information is analyzed. The first information may be electronically communicated to, and analyzed using, the processor and/or memory of the mobile device or other electronic device. The first information may be analyzed for relevance, parsed for relevant data to transmit, analyzed for ripeness for transmission, conditioned for sending wirelessly to a remote device or entity, and/or other analyses. In some embodiments, step 910 may not be performed in the method 900.

[0178] The method 900 then moves to step 915 where the second information is transmitted to a remote device. The second information may be transmitted by the communications system as described, for example a transmitter thereof, of the mobile device. The second information may be the results of the data analysis of the first information performed in step 910. In some embodiments, the second information may be the same as the first information, for example where step 910 is omitted or where no change is made to the first information in step 910. The second information may be transmitted to the various remote servers, databases, computing devices, etc. as described herein.

[0179] The method 900 then moves to step 920 where third information is received from the remote device. The third information may be received by the same electronic device, for example the mobile device, as used in steps 905, 910, and/or 915. The third information may be data related to analysis of the transmitted second information in step 915. The third information may be analysis results from a remote server, processor, database, etc. as described herein. The third information may be analysis related to information on contemporarily available medical devices, pricing, availability, safety features, instructions for use, methods of use, product specifications, comparison to other available products, purchaser reviews, any and all drug-related information, news information, deals, regional availability, adverse reactions or events, insurance information, lifestyle-integration, tracking information, information related to data-based recommendations for various purposes, replacement or expiration of the medical device, sensor information, proximity of the communication enabled device to the mobile device, data related to calculating scores related to user compliance with using, carrying, etc. the medical device and/or other information as described herein.

[0180] The method 900 then moves to step 925 where the third information is analyzed. The third information may be electronically communicated to, and analyzed using, the processor and/or memory of the mobile device or other electronic device. The third information may be analyzed for relevance, parsed for relevant data to output, analyzed for ripeness for output, conditioned for outputting, and/or other analyses. In some embodiments, step 925 may not be performed in the method 900.

[0181] The method 900 then moves to step 930 where the results of the analysis of the third information are output. Thus information may be output related to contemporarily available medical devices, pricing, user scores, other users’ scores from the relevant community, etc. as described. The results may be shown on the screen of the mobile device for viewing by a user. The results may be electronically communicated to a user, for example to a user’s email, by text message, or other means. The results may be communicated visually, audibly, and/or using tactile means such as vibrations. In some embodiments, the third information itself is output in step 930, for example where step 925 is omitted or where the third information has not been change in step 925.

[0182] Referring to FIG. 23, the method 1000 may be performed by various electronic devices. For example, the method 1000 may be performed by the computing device 204, the internet enabled device 206, the database 210, and/or other remote entities 400 described with respect to FIG. 9. As further example, the method 1000 may be performed by the server 712, and/or the inventory server 722 described with respect to FIG. 20. These and/or other devices may perform the method 1000 in whole or in part. The methods 900 and 1000 may be each performed by separate electronic devices that are communicating with each other. Thus, the methods 900 and 1000 may be performed in conjunction with each other but with each method 900, 1000 being performed by a separate entity.

[0183] In some embodiments, the method 1000 may be performed in whole or in part by the mobile devices and/or software applications described with respect to FIGS. 14- 18, by the mobile device 202 described with respect to FIG. 9, and/or by the client 700 described with respect to FIG. 20.

[0184] One or more processors of the various devices may execute a set of instructions stored in memory to perform the method 1000. The one or more processors and one or more memories may be any of those described herein, for example the processor and/or memory of the storage database 210, or the processing unit 840 and/or the memories 842 or 884. In some embodiments, the processors and/or memories associated with the method 900 may be used with the method 1000.

[0185] The method 1000 begins with step 1005 where first information is received from a remote device regarding the medical device. The first information may be any of the information described herein, such as the first information described with respect to the method 900 or any of the information described below in the section“Data Analysis.” The first information may be received by any of the computing devices, servers, databases, mobile devices, websites, etc. as described herein. Such data may be input manually to the remote device by a user, such into a desktop computer, phone, etc. The first information may be related to information on type of medical device, use of the medical device, level of drug or medicament in the device, tracking information, age of the medical device, sensor information, proximity of the communication enabled device to the mobile device, data related to calculating scores related to user compliance with using, carrying, etc. the medical device, and/or other information as described herein. In some embodiments, the first information received in step 1005 may relate to medical devices for sale or otherwise available, as further described below in the section“Data Analysis.”

[0186] The method 1000 next moves to step 1010 where the first information is analyzed. The first information may be compared to other information in one or more databases related to the medical device, as further described below in the section“Data Analysis.” For example, such analysis may relate to medical device availability, adverse events associated with similar medical devices, statistics related to other users’ of similar medical devices, etc.

[0187] The method 1000 next moves to step 1015 where the results of the analysis in step 1010 are output. In step 1015 the results may be transmitted to the mobile device or other electronic device, which may be the same or different from the electronic device form which the first information was received in step 1005. The results may be wirelessly transmitted using the various communications systems described herein.

Data Analysis Algorithms

[0188] The various systems, devices and methods described herein may incorporate a variety of different types of data analysis. The analyses described herein may be performed by or with the various systems, devices and methods described with respect to FIGS. 1-23. Specific example embodiments of data analysis methods that may include any of the following features are shown in and described with respect to FIGS. 24-27C.

[0189] Some embodiments of the analysis systems, devices and methods may be used to provide results of the analysis for an internet-accessible database, such as via an informational website. For example, the internet- accessible database may be provided that contains user-accessible real-time information on contemporarily available medical devices, such as epinephrine autoinjectors or epinephrine delivery mechanisms, that are available to pharmacies, patients, distributors, or any purchasers of such products. The information may be related to pricing, availability, safety features, instructions for use, methods of use, product specifications, comparison to other available products, purchaser reviews, any and all drug- related information containing but not limited to storage recommendation, expiration information, etc., mainstream media opinions or exposes on manufacturers, payer policy decisions, exclusive deals or promotions, regional availability of products based on server location from which website is being accessed, testimonials, success stories, adverse reactions or events, any information deemed necessary for a buyer to make a purchase decision, and/or other suitable information.

[0190] The functionality of the internet- accessible database may contain but is not limited to leveraging curated data to determine a range of prices from lowest to highest in the local area and global area, the ability for users of the database via internet access to purchase products and be re-directed to an alternate site in which the user may complete the purchase, the ability to receive information about a user’s personal information in order to produce the most cost-effective option for the user whether that be the lowest global price or local price, or the ability to track real-time price changes, the ability to receive and store patient prescriptions and medical information, and/or other curated data.

[0191] In some embodiments, the internet- accessible database may be automated. The database may include and/or use systems and methods for a medication analysis system used to search for information by collecting information or subsets of information from available relevant internet information such as real-time prices of auto-injectors, pre-filled syringes, or other related epinephrine delivery systems or technologies such as epinephrine nasal sprays or orally disintegrating epinephrine tablets.

[0192] Some embodiments of the database may use analysis systems that include user-inputted insurance information on a per user and/or family basis and/or geographical information to determine variations in affordability relative to insurance coverage of different medication offerings. Some embodiments may accept financial measurement on whether or not an individual plan or family plan has utilized its deductible in any amount and account for such financials to determine the best pricing for epinephrine products or other medical devices.

[0193] In some embodiments, the database may automate a ratings system to compare offerings based on curated performance data, and other data related to efficacy, safety, ease-of-use, compliance, lifestyle-integration such as temperature sensitivity, light exposure, material durability, dosage reproducibility via delivery system, intramuscular versus subcutaneous delivery metrics, and other industry-specific or user-reported data containing but not limited to compliance, steps to activate, voice instruction usefulness, lacerations, or death.

[0194] Some embodiments may include a mobile application. The mobile application may be a native iOS application, native Android application or a Progressive Web Application, or any other application able to be accessed by a mobile computing device with connection to a global network.

[0195] Some embodiments of the database may include tracking capabilities. For example, a mobile application may be able to curate many forms of data in real-time and aggregate such data in perpetuity so long as such data remains to be collected on a user’s personal device. The data may contain but is not limited to location, weather, temperature, time, date, weight, GPS, meals consumed, Body Mass Index, body composition, purchases, and any other information that might help determine the best epinephrine delivery system for the user’s specific needs and lifestyle.

[0196] In some embodiments, a mobile application may have the ability to curate any of the aforementioned data and aggregate it for analysis. The analysis may result in algorithmic capabilities to determine a data-based recommendation for various purposes, for example when to replace the user’s epinephrine delivery mechanism because of potentially compromised drug stability or otherwise. The mobile application may show the lifespan of the product by way of metric analysis, and/or show in real-time based on the aforementioned data how the product’s lifespan has been affected. The application may notify the user when he/she should begin considering replacing the device. The application may be interlinked with a purchasing algorithm from the internet- accessible database. The user may be enabled to purchase another product upon expiration or when the product has been deemed unsafe to use by the algorithm.

[0197] The application may be a mobile version of the internet-accessible database. Such application may be incorporated with any and all automated techniques for personalizing a user’s experience with their autoinjector or other epinephrine delivery product. The mobile application may be enabled to connect to temperature sensors in the form of stickers, other commercially available products, or otherwise to collect data. The mobile application may be able to connect to ultrasound products to determine a Skin to Muscle Distance (STMD) and use such information to output data regarding which product is best for a particular user. Such determination may be based on needle measurements, dosage variability in commercially available epinephrine delivery mechanisms, and/or other factors. The mobile application may be able to connect to sensors that understand the product has been used and automatically notify emergency responders and/or those within their emergency contact information.

[0198] In some embodiments, both the database, such as an informational website, and the mobile application features, as separate entities and as mutually integrated entities may be integrated into community building database platform, such as a website, that seeks to generate ambassadors to promote affiliate products that align with diverse, patient lifestyles. Such embodiments may use or be included with various platforms and associated features, for example those features available at www.bantamcompany.com. The mobile application may have the ability to incorporate an informational database, such as a website, in desktop and mobile form. An informational database can serve in desktop and mobile form. The informational database can be built into mobile application in both desktop and mobile form. [0199] FIGS. 24-27C are flow charts showing embodiments of methods that may be incorporated in, and/or performed by, the various methods and electronic devices and systems described herein. The specific algorithms and methods shown in FIGS. 24-27C may incorporate any of the features and information described above with respect to data analyses.

[0200] FIG. 24 is a flow chart showing an embodiment of a method 1100 performed by a database for transacting the selection of a medical device, such as an autoinjector. The method 1100 may be performed on and/or with any of the electronic devices or systems described herein. The particular embodiment is that of a website, however other implementations may be used, such as mobile applications, kiosks, internet- accessible databases, etc.

[0201] The method 1100 begins with step 1110 where a database receives user information. The database may be a website or may be in communication with a website. The user information may be input manually by a user or automatically retrieved from a memory, for example based on the user’s identification.

[0202] The method 1100 may then move to step 1115 or directly to step 1120. In step 1115, the user is asked if they have a medical condition, such as an allergy. This may be a button on a website. The method may move from step 1115 to step 1120. In step 1120 user information may be collected, for example health plan/insurance, age, weight, height, residence, etc., or any of the other information described herein.

[0203] In some embodiments, from step 1120 the method 1100 may then move to step 1135 where the information collected in step 1135 is automated. The information in step 1120 may first be collected manually. Upon repeated usage by the user, the information may be automatically inputted and/or updated with any new insurance coverage or rates, etc. This may be an automatic update to the information provided by accessing remote databases. The method may then move back to step 1120 to complete the information collection, and on to step 1125 as described.

[0204] In step 1125, available medical device products, such as autoinjectors, may be output to the user. These may be commercially available devices. In some embodiments, from step 1125 the method 1100 may then move to step 1130 where updated insurance information may be used to determine various costs, such as out-of-pocket costs, etc. This may be an automatic update to the information provided by accessing remote databases. The method may then move back to step 1125 to complete the output of information.

[0205] From step 1125, the method moves to step 1140 where cost comparisons are displayed to the user. The database, such as a website, may display on the screen of the electronic device out-of-pocket and/or other costs associated with the available products. This information may be based on insurance, cash or other types of purchases by the user.

[0206] The method 1100 then moves to step 1145 where a user selection of one or more of the medical devices is received, such receiving a selection of one or more epinephrine autoinjectors, that the user may desire to purchase. This may complete the “choice” algorithm performed by the method 1100.

[0207] FIG. 25 is a flow chart showing an embodiment of a method 1200 performed by a database for transacting the purchase of a medical device, such as an autoinjector. The method 1200 may be performed on and/or with any of the electronic devices or systems described herein. The particular embodiment is that of a website, however other implementations may be used, such as mobile applications, kiosks, internet- accessible databases, etc.

[0208] The method 1200 begins with step 1205 where a database prompts a user for a selection of a medical device for purchase. Step 1205 may be a visual indication output to a screen for viewing by a user. Step 1205 may be a request sent to a remote database or memory for automatically receiving a selection of a choice after performing the method 1100 or step 1145 thereof. The method 1220 then moves to step 1210 where the database prompts a user for information related to whether the user has a prescription for the chosen medical device. The user may be the person inputting the information or another person. The user may be prompted in step 1210 similarly to step 1205.

[0209] The method 1200 then moves to step 1215 or 1220. In step 1215, the database receives an indication that the user has a prescription. After step 1215, the method 1200 moves to step 1235. In step 1220, the database receives an indication that the user does not have a prescription. After step 1220, the method 1200 may move to step 1225 where the database queries the user regarding the need for a prescription. The database may receive the requested information in step 1225. After step 1225, the method 1200 may end or the method 1200 may continue to step 1230, depending on the information received in step 1225. Alternatively, after step 1220, the method 1200 may move directly to step 1230.

[0210] In step 1230, the database may direct the user to a telemedic query, which may be a live visitation with a provider, such as an appropriately licensed prescriber. This may be a video conference, audio call, text chat box, etc. provided to the user by the database, for example on the screen of the electronic device and/or in the website. In some embodiments, the query may be a questionnaire output on the screen for the user to respond to by selecting or inputting data. The database may facilitate transmitting of the prescription from the provider to the user.

[0211] The method 1200 then moves to step 1235 where the database queries the user as to purchase procedure. As shown, the database may prompt the user if they would like to purchase the medical device at a physical pharmacy or store, or online, such as through the same website or another website.

[0212] After step 1235, the method 1200 may then move to step 1240 where the database receives a selection of the user’s desire to buy the medical device at a physical pharmacy. The method then moves to step 1245 where the database outputs information related to local pharmacies that have the available medical device. In step 1245, the database may query other databases, electronics devices, memories, etc. to determine the locations and/or availability of the selected medical device.

[0213] Alternatively, after step 1235, the method 1200 may then move to step 1250 where the database receives a selection of the user’s desire to buy the medical device online. The method then moves to step 1255 where the database receives the user’s prescription. The user may upload the script in this step. After step 1255, the method 1200 may move to step 1260 where the database contracts with a third party to fill the order, or the method 1200 may move to step 1265 where the database fills the order and provides for shipment of the medical device to the user. In steps 1260 and 1265, the database may transmit information to remote databases, devices, etc. to have the order filled.

[0214] FIG. 26 is a flow chart showing an embodiment of a method 1300 performed by one or more electronic devices for managing a medical device, such as an autoinjector. The method 1300 may be performed by an application on a mobile device. The method 1330 may be performed by a mobile device that is in communication with the various communication enabled storage/carrying devices described herein.

[0215] The method 1300 begins with step 1305 where various data related to the medical device is received by the electronic device. The data may be some or all of the data shown and listed in step 1305 of FIG. 26, and/or any other information described herein. The data in step 1305 may be received automatically at the electronic device, or it may be received manually, for example by manual input by a user of the mobile application, or by manual input by a user of the database via an interface such as a website on a desktop computer. In some embodiments, the communication enabled devices described herein may transmit the data, or information related to the data, to the electronic device.

[0216] The method 1300 then moves to step 1310 where the data is analyzed to determine the adequacy of the medical device. Step 1310 may include analysis of the various data listed in step 1310 of FIG. 26. Depending on the results of the analysis of step 1310, the method may move to step 1315, 1330, 1335, or 1340. If the system determines the user may need a new medical device or a different medical device the method may move to step 1315, 1330, 1335, or 1340. If the system determines that the current medical device is adequate, the method 1300 may return to step 1305, which may be over some period of time to repeat step 1305 such as daily, weekly, monthly, every six months, annually, etc.

[0217] In step 1315, an alert may be provided related to a change in the drug health or potency, or other attributes of the medical device. The mobile device may output an alert or push notification for display on the screen and/or audible alert. The alert may indicate a certain percentage change in the drug health/potency, for example since purchase of the medical device and/or since the last alert. The method then moves to step 1325 where an option to access choice or purchase methods is output to the user, such as respectively the method 1100 or the method 1200. Step 1325 may provide a link to access the database, such as a link to a website, or it may display the website, etc. for the desired next step. The electronic device may receive an indication from the user whether to select or buy another medical device, or the electronic device may automatically display one or the other options based on the user’s information. [0218] In step 1330, an alert is provided when different delivery mechanism specification is recommended based on the analysis in step 1310. The electronic device may output an alert on the screen visually, or audibly, etc. Such alert may be based on a change in the user’s data, medical device information, health needs, etc. The delivery mechanism specification may include other medication consumption routes such as oral, topical, nasal, injection, etc. After step 1330, the method 1300 moves to step 1345 as described below.

[0219] In step 1335, data is analyzed to determine commercially available medical device products. The data in step 1310 may be analyzed, or the results of analysis in step 1310 may be analyzed. The electronic device may receive manual inputs or automated data to filter the available products.

[0220] In step 1340, data related to use of the medical device is received. Such data may be received automatically or manually. The data may relate to any of the data listed in step 1340 shown in FIG. 26.

[0221] After steps 1330, 1335, and 1340, the method 1300 moves to step 1345 where access to a medical device choice method is provided. The electronic device may output a screen that will perform the method 1100 as described herein.

[0222] FIGS. 27A-27C are flow charts showing embodiments of methods for analyzing various data to determine various characteristics related to a user of a medical device and/or of the medical device, such as an autoinjector.

[0223] FIG. 27A is a flow chart showing an embodiment of a method 1400A for determining a delivery mechanism for a user. The method 1400A may be used with or in conjunction with the method 1300, for example where the data in step 1305 is the“skin to muscle” distance data to eventually determine the optimal delivery mechanism in steps 1325 or 1345, as described herein.

[0224] The method 1400A begins with step 1405 where an indication is received that a user would like to determine the skin to muscle distance. The method 1400A then moves to step 1410 where an ultrasound machine measures the skin to muscle distance of the user. Various suitable ultrasound machines known in the art may be used. The ultrasound machine may be used with a pressure similar to that used by the user for injections with an injection device. The surface may be mimicked in some embodiments. [0225] The method 1400A then moves to step 1415 where data related to the ultrasound measurements in step 1410 are transmitted to and/or received by a network server, such as a cloud database, that is in communication with the user’s mobile device. The information may be received by the mobile application on the mobile device for processing. The method 1400 then moves to step 1420 where the data is analyzed to determine the best delivery mechanism. Step 1420 may be similar to steps 1330, 1325, 1345 or other steps as described in the method 1300. These and other steps form the method 1300 may be performed after performing the step 1420 of the method 1400A.

[0226] FIG. 27B is a flow chart showing an embodiment of a method 1400B for determining the health of a drug in a medical device. The method 1400B may be used with or in conjunction with the method 1300, for example where the data in step 1305 is related to the drug or medicament, to eventually determine the potency or safety of the drug in steps 1315 or other steps of the method 1300, as described herein.

[0227] As shown in FIG. 27B, the method 1400B begins with step 1425 where a request is received to analyze the drug health. This may be a manual or automatic, for example scheduled, request. The request may be received by any of the various communication enabled devices described herein. The request may be sent by any of the various electronic devices, mobile devices, servers, databases etc. described herein.

[0228] The method then moves to steps 1430, 1435 and/or 1440 where respectively the temperature exposure, light exposure and device/drug age are analyzed. The analysis in steps 1430 and 1435 may use the analysis of step 1445 to analyze the data based on sensor input from sensors adhered to the device or from mobile data. In some embodiments, steps 1430 or 1435 may be combined with step 1445. Steps 1430, 1435 and/or 1445 may be performed by the communication enable device, the mobile device, the servers or databases, and/or other devices and systems described herein.

[0229] In step 1440, the age of the medical device and/or drug is analyzed. The analysis in step 1440 may use the analysis of step 1450 to continuously measure the age from the date that the device was purchased or the drug was filled to the current date. In some embodiments, step 1440 may be combined with step 1450. Step 1440 and 1450 may be performed by the communication enable device, the mobile device, the servers or databases, and/or other devices and systems described herein.

[0230] The method 1400B then moves to step 1455 where data is transmitted for receipt by a database, such as a website or mobile application. The data may relate to or be analysis of the temperature, light, or age attributes analyzed in prior steps. Step 1455 may be performed by the communication enable device, the mobile device, the servers or databases, and/or other devices and systems described herein. The data may be transmitted form the communication enabled device, to the mobile device, to a network or server database, which may be an internet-accessible database, such as via a website.

[0231] The method 1400B then moves to step 1460 where the data is analyzed to determine the potency and/or safety of the drug, or other attributes related to the health of the drug. Step 1460 may include or be similar to various actions of step 1315 in the method 1300. In step 1460, the electronic device, such as a mobile device, may provide an alert regarding any negative or positive results of the data analysis, for example by text, email, push notification etc. as described herein.

[0232] FIG. 27C is a flow chart showing an embodiment of a method 1400C for analyzing the personal data of a user or potential user of a medical device, such as an autoinjector. The method 1400B may be used with or in conjunction with the method 1300, for example where the data in step 1305 is related to the personal or other data of the user, to eventually determine the recommended delivery mechanism in steps 1315 or 1345 or other steps of the method 1300, as described herein.

[0233] As shown in FIG. 27C, the method 1400C begins with step 1465 where a request is received to analyze the user’s data. This may be a manual or automatic, for example scheduled, request. The request may be received by any of the various electronic devices described herein, such as the mobile devices, servers, remote databases, etc. The request may be sent by any of the various electronic devices, mobile devices, servers, databases etc. described herein.

[0234] The method 1400C next moves to step 1470 where the data from step 1465 is collected. The data may be automatically collected. The data may relate to any of the list of data shown in step 1470 of FIG. 27C, and/or other data. In step 1470 the electronic device or database, etc. may receive permission from the user to access such data. Step 1470 may include the mobile device or remote database communicating with and receiving data from other databases to access the various user data.

[0235] The method then moves to step 1475 where the user data is analyzed to determine the user needs for an adequate drug delivery mechanism, such as epinephrine delivery mechanism. Step 1460 may include or be similar to various actions of step 1330 in the method 1300. In step 1475, the electronic device, such as a mobile device, may provide an alert regarding any results of the data analysis, for example by text, email, push notification etc. as described herein. The alert may refer to a recommended change in delivery mechanism or other information related to the delivery mechanism.

[0236] The foregoing description has broad application. While the present disclosure makes reference to certain embodiments, numerous modifications, alterations, and changes to the described embodiments are possible without departing from the sphere and scope of the present disclosure, as defined in the appended claim(s). Accordingly, it is intended that the present disclosure not be limited to the described embodiments, but that it has the full scope defined by the language of the following claims, and equivalents thereof.

[0237] The discussion of any embodiment is meant only to be explanatory and is not intended to suggest that the scope of the disclosure, including the claims, is limited to these embodiments. In other words, while illustrative embodiments of the disclosure have been described in detail herein, it is to be understood that the inventive concepts may be otherwise variously embodied and employed, and that the appended claims are intended to be construed to include such variations, except as limited by the prior art.

[0238] 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.

[0239] What has been described above includes examples of the disclosed architecture. It is, of course, not possible to describe every conceivable combination of components and/or methodologies, but one of ordinary skill in the art may recognize that many further combinations and permutations are possible. Accordingly, the novel architecture is intended to embrace all such alterations, modifications and variations that fall within the spirit and scope of the appended claims.

General Notes on Terminology

[0240] Some embodiments may be described using the expression “one embodiment” or“an embodiment” along with their derivatives. These terms mean that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment. The appearances of the phrase“in one embodiment” in various places in the specification are not necessarily all referring to the same embodiment. Moreover, unless otherwise noted the features described above are recognized to be usable together in any combination. Thus, any features discussed separately may be employed in combination with each other unless it is noted that the features are incompatible with each other.

[0241] With general reference to notations and nomenclature used herein, the detailed descriptions herein may be presented in terms of program procedures executed on a computer or network of computers. These procedural descriptions and representations are used by those skilled in the art to most effectively convey the substance of their work to others skilled in the art.

[0242] A procedure is here, and generally, conceived to be a self-consistent sequence of operations leading to a desired result. These operations are those requiring physical manipulations of physical quantities. Usually, though not necessarily, these quantities take the form of electrical, magnetic or optical signals capable of being stored, transferred, combined, compared, and otherwise manipulated. It proves convenient at times, principally for reasons of common usage, to refer to these signals as bits, values, elements, symbols, characters, terms, numbers, or the like. It should be noted, however, that all of these and similar terms are to be associated with the appropriate physical quantities and are merely convenient labels applied to those quantities.

[0243] Further, the manipulations performed are often referred to in terms, such as adding or comparing, which are commonly associated with mental operations performed by a human operator. No such capability of a human operator is necessary, or desirable in most cases, in any of the operations described herein, which form part of one or more embodiments. Rather, the operations are machine operations. Useful machines for performing operations of various embodiments include general purpose digital computers or similar devices.

[0244] Some embodiments may be described using the expression "coupled" and "connected" along with their derivatives. These terms are not necessarily intended as synonyms for each other. For example, some embodiments may be described using the terms “connected” and/or“coupled” to indicate that two or more elements are in direct physical or electrical contact with each other. The term "coupled,” however, may also mean that two or more elements are not in direct contact with each other, but yet still co-operate or interact with each other.

[0245] Various embodiments also relate to apparatus or systems for performing these operations. This apparatus may be specially constructed for the required purpose or it may comprise a general purpose computer as selectively activated or reconfigured by a computer program stored in the computer. The procedures presented herein are not inherently related to a particular computer or other apparatus. Various general purpose machines may be used with programs written in accordance with the teachings herein, or it may prove convenient to construct more specialized apparatus to perform the required method steps. The required structure for a variety of these machines will appear from the description given.

[0246] It is emphasized that the Abstract of the Disclosure is provided to allow a reader to quickly ascertain the nature of the technical disclosure. It is submitted with the understanding that it will not be used to interpret or limit the scope or meaning of the claims. In addition, in the foregoing Detailed Description, it can be seen that various features are grouped together in a single embodiment for the purpose of streamlining the disclosure. This method of disclosure is not to be interpreted as reflecting an intention that the claimed embodiments require more features than are expressly recited in each claim. Rather, as the following claims reflect, inventive subject matter lies in less than all features of a single disclosed embodiment. Thus the following claims are hereby incorporated into the Detailed Description, with each claim standing on its own as a separate embodiment. In the appended claims, the terms "including" and "in which" are used as the plain-English equivalents of the respective terms "comprising" and "wherein," respectively. Moreover, the terms "first," "second," "third," and so forth, are used merely as labels, and are not intended to impose numerical requirements on their objects.

[0247] As used herein, an element or step recited in the singular and proceeded with the word“a” or“an” should be understood as not excluding plural elements or steps, unless such exclusion is explicitly recited. Furthermore, references to one embodiment or some embodiments of the present disclosure are not intended to be interpreted as excluding the existence of additional embodiments that also incorporate the recited features.

[0248] The phrases“at least one”,“one or more”, and“and/or”, as used herein, are open-ended expressions that are both conjunctive and disjunctive in operation. The terms “a” (or“an”),“one or more” and“at least one” can be used interchangeably herein. All directional references are only used for identification purposes to aid the reader’s understanding of the present disclosure, and do not create limitations, particularly as to the position, orientation, or use of this disclosure. Connection references (e.g., engaged, attached, coupled, connected, and joined) are to be construed broadly and may include intermediate members between a collection of elements and relative to movement between elements unless otherwise indicated. As such, connection references do not necessarily infer that two elements are directly connected and in fixed relation to each other. Identification references (e.g., primary, secondary, first, second, third, fourth, etc.) are not intended to connote importance or priority, but are used to distinguish one feature from another. 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.