Communication tags for medicines
Patent Information
- Application Number
- JP2024545868
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2022-02-08
- Filing Date
- 2023-01-27
- Publication Date
- 2025-02-28
Smart Images

Figure 2025505563000001_ABST
Abstract
Description
[Background technology]
[0001] Counterfeiters sell products that are packaged to appear as if they were made by a particular manufacturer when in fact they were not. Consuming counterfeit medications may be unsafe and may prevent patients from receiving the medications they need to treat their disease or condition. As a result, such counterfeit products may pose concerns to both patients and manufacturers. Summary of the Invention
[0002] According to an exemplary embodiment of the present disclosure, a medication delivery device is provided. The medication delivery device includes a housing including a reservoir large enough to hold a medication. The medication delivery device includes an activation button for initiating an injection of the medication. The medication delivery device includes a label affixed to at least a portion of the housing. The label includes a communication tag configured to, when accessed by a mobile device, cause the mobile device to launch a web browser configured to access a uniform resource locator (URL). In some embodiments, the communication tag can be an RFID tag. In some embodiments, the communication tag can be a Near Field Communication (NFC) tag.
[0003] According to another embodiment of the present disclosure, a computerized method for verifying an aspect of a medication delivery device is provided. The method includes receiving data from a communication tag disposed on the medication delivery device. The medication delivery device includes a housing including a reservoir large enough to hold a medication. The medication delivery device includes an activation button for initiating an injection of the medication. The medication delivery device includes a label affixed to at least a portion of the housing. The label includes a tag. The method includes verifying an aspect of the medication delivery device by transmitting at least a portion of the received data to a server.
[0004] According to yet another embodiment of the present disclosure, there is provided a computerized method for tracking ownership of a medication delivery device. The method includes receiving data from a communication tag located on the medication delivery device. The medication delivery device includes a housing including a reservoir large enough to hold a medication. The medication delivery device includes an activation button for initiating injection of the medication. The medication delivery device includes a label affixed to at least a portion of the housing. The label includes a tag. The method includes transmitting at least a portion of the received data to a server. The method includes providing user authentication information to the server. The server is configured to log an entry based on the received data and the user authentication information, the entry indicating that the user was in possession of the medication delivery device at the time the data was received from the tag located on the medication delivery device. [Brief description of the drawings]
[0005] Additional embodiments of the present disclosure, as well as its features and advantages, will become more apparent by reference to the description herein taken in conjunction with the accompanying drawings, in which components are not necessarily drawn to scale. Moreover, in the drawings, like reference numerals designate corresponding parts throughout the different views. [Figure 1] FIG. 1 is a block diagram illustrating an exemplary system 100 for verifying aspects of a medication delivery device, according to some embodiments. [Diagram 2] 2 is a flow chart illustrating an exemplary computerized method 200 for validating aspects of a medication delivery device, according to some embodiments. [Diagram 3] 1 is a block diagram illustrating example information displayed on a user interface of a mobile device according to some embodiments. [Figure 4A] 13 is an example display on a user interface of a mobile device showing validation data associated with a medication delivery device according to some embodiments. [Figure 4B]13 is an example display on a user interface of a mobile device showing validation data associated with a medication delivery device according to some embodiments. [Figure 4C] 1 is an example display on a user interface of a mobile device showing a recall notice associated with a medication contained within a medication delivery device, according to some embodiments. [Figure 4D] 1 is an example display on a user interface of a mobile device showing information indicative of expiration of medication contained within a medication delivery device, according to some embodiments. [Diagram 5] FIG. 5 is a block diagram illustrating an example system 500 for tracking ownership of medication delivery devices, according to some embodiments. [Figure 6] 6 is a flow chart illustrating an exemplary computerized method 600 for tracking ownership of medication delivery devices, according to some embodiments. [Figure 7] FIG. 7 is a block diagram illustrating an example system 700 for determining example recommendations associated with a medication delivery device using logged entries, according to some embodiments. [Figure 8A] FIG. 8 is a block diagram illustrating an example system 800a for displaying first information on a user interface based on receiving user authentication information for a first user, according to some embodiments. [Figure 8B] FIG. 8 is a block diagram illustrating an example system 800b for displaying second information on a user interface based on receiving user authentication information for a second user, according to some embodiments. [Figure 9A] FIG. 9 is a block diagram illustrating an example system 900 for determining an average level of adherence using multiple logged entries from multiple users, according to some embodiments. [Figure 9B] FIG. 9 is a block diagram illustrating an example system 950 for determining an average level of adherence using multiple logged entries from a single user, according to some embodiments. [Figure 10] FIG. 10 is a block diagram illustrating an example system 1000 for tracking product distribution, according to some embodiments. [Figure 11] FIG. 11 is a block diagram illustrating an example system 1100 for detecting counterfeit products, according to some embodiments. [Figure 12] 1 is a block diagram illustrating an example system for using a patient-specific medication delivery device and an example system for using a health care provider (HCP)-specific medication delivery device, according to some embodiments. [Figure 13] FIG. 1 is a block diagram illustrating an example system for configuring dosage reminders, according to some embodiments. [Figure 14A] 1 illustrates an exemplary medication delivery device in its initial, pre-use configuration, according to some embodiments. [Figure 14B] 1 shows the drug delivery device after the end cap has been removed, but before the device has been activated to deliver a drug. [Figure 14C] 1 shows a drug delivery device after the device has been activated to deliver a drug. [Figure 15A] 1 illustrates an exemplary label including an NFC tag, according to some embodiments. [Figure 15B] 1 shows a view of the back of an exemplary label. [Figure 16] 1 illustrates an exemplary implementation of a computer system that may be used to implement any of the aspects of the techniques and embodiments disclosed herein, according to some embodiments. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0006] For the purposes of promoting an understanding of the principles of the present disclosure, reference will now be made to the embodiments illustrated in the drawings and specific language will be used to describe the same, it being understood nevertheless that no limitation of the scope of the invention is intended.
[0007] Provided herein is a technique for verifying aspects of a medication delivery device. According to some embodiments, the technique verifies aspects of the medication delivery device based on data received from a communication tag disposed on the medication delivery device. The communication tag may be an RFID tag and / or an NFC tag, or any other type of tag capable of communicating data to a reader device. For example, the data may include data indicative of an authentication code generated by the tag. According to some embodiments, the technique transmits at least a portion of the data received from the tag to a server. For example, the portion of the data may include data indicative of the authentication code. According to some embodiments, the server is configured to authenticate the authentication code and generate verification information indicative of the result of the authentication. For example, the verification information may indicate whether a source (e.g., a manufacturer and / or a supplier) of the medication delivery device has been verified, and thus whether the medication delivery device is a verified product rather than a counterfeit product.
[0008] Also provided herein is a technique for tracking ownership of a medication delivery device. According to some embodiments, the technique tracks ownership of a medication delivery device based on the time data is received from a tag placed on the medication delivery device. After receiving the data from the tag, the technique launches a website that prompts the user to provide user credentials. For example, the website may prompt the user to provide a username and password, a bearer token, a refresh token (e.g., derived from a previous authentication, such as through the use of a username and password), and / or other user credentials. According to some embodiments, the technique provides the user credentials to a server. The server is configured to log an entry based on the user credentials and the data received from the tag. For example, the server may log an entry indicating that the user associated with the provided user credentials owned the medication delivery device at the time the data was received from the tag placed on the medication delivery device. According to some embodiments, the entry may also indicate the geographic location where the data was received from the tag, information about the medication contained within the medication delivery device, and / or information about the user associated with the user credentials. This geographic location may be derived from the IP address at which the server received data from the tag and / or by location data provided by a mobile device (eg, a smartphone) associated with the user.
[0009] The inventors recognize that non-rigorously regulated drug distribution channels raise product safety and liability concerns. In particular, counterfeiters may sell drugs that are packaged to appear to be from a particular manufacturer, but are in fact counterfeit products. The inventors recognize that such counterfeit products can cause problems. For example, such products may raise safety concerns for end patients who need assurance that the drug they purchased was in fact a genuine drug manufactured by a verified manufacturer. As another example, if a counterfeit product causes one or more problems for an end patient and the patient is not aware that it is a counterfeit product, it can negatively affect the reputation of the true manufacturer (when in fact the true manufacturer had nothing to do with the problems caused by the counterfeit product).
[0010] The inventors have therefore developed a technique for verifying aspects of a medication delivery device and tracking ownership of the medication delivery device. In some embodiments, the technique can evaluate data received from a communication tag placed on the medication delivery device that indicates a unique authentication code. The authentication code changes over time in an unpredictable manner known only to a server configured to authenticate the authentication code. For example, the authentication code may change based on activity, whereby the authentication code changes each time a mobile device is brought within close range of the medication delivery device to enable the mobile device to communicate with the tag. The inventors have recognized that the use of a tag that generates such an unpredictable authentication code is useful in preventing counterfeiters from being able to successfully counterfeit at least this aspect of the medication delivery device. According to some embodiments, the technique verifies an aspect of the medication delivery device (e.g., the source of the medication delivery device) by transmitting at least a portion of the data received from the tag (e.g., the authentication code) to a server.
[0011] Although embodiments of the technology described herein describe technology for verifying aspects of and tracking ownership of a medication delivery device, it should be appreciated that such technology may be applied to any suitable type of medication container. For example, the technology described herein may be used to verify aspects of and track ownership of a pill bottle, drug vial, blister pack, or any other suitable type of medication container, although aspects of the technology are not limited in this respect. According to some embodiments, a tag is disposed on such medication container and configured to communicate with a mobile device.
[0012] In some embodiments, the communication tag may comprise any electronic circuitry configured to wirelessly communicate with a reader device. For example, the communication tag may be an RFID tag and / or an NFC tag. For ease of explanation, the remainder of this disclosure will refer to the communication tag as an NFC tag, although it should be understood that other types of wireless communication tags may also be used.
[0013] While various embodiments have been described, it will be apparent to those skilled in the art that many more embodiments and implementations are possible. Thus, the embodiments described herein are examples and are not the only possible embodiments and implementations. Furthermore, the advantages described above are not necessarily the only advantages, and it is not necessarily expected that all of the described advantages will be achieved in each embodiment.
[0014] 1 is a block diagram illustrating an exemplary system 100 for verifying aspects of a medication delivery device, according to some embodiments. The system 100 includes a medication delivery device 102 and a mobile device 106 in communication with a server 110 and a data store 112 via a network 108. It should be appreciated that the system 100 is exemplary, and that the system may have one or more components of any suitable type in addition to or in place of the components illustrated in FIG.
[0015] In some embodiments, the mobile device 106 is configured to receive the data 124 from a Near Field Communication (NFC) tag 104 disposed on the medication delivery device 102. For example, the mobile device 106 may receive the data 124 when in proximity (e.g., within 10 cm, within 6 cm, within 4 cm, etc.) of the medication delivery device 102.
[0016] The drug delivery device 102 may include any suitable drug delivery device, such as an autoinjector or a prefilled syringe, although aspects of the present technology are not limited in this respect. An exemplary drug delivery device 20 is described in more detail herein, including with respect to at least Figures 14A-14C.
[0017] In some embodiments, the drug delivery device 102 optionally includes a sensor 122. For example, the drug delivery device 102 may include a temperature sensor configured to sense a temperature. The sensed temperature may be a temperature of the drug delivery device 102, a temperature of a drug contained within the drug delivery device 102, and / or an ambient temperature. The temperature sensor may take the form of any suitable sensor for sensing temperature, such as, but not limited to, a thermistor (e.g., a negative temperature coefficient (NTC) thermistor or a resistance temperature detector (RTD)), a thermocouple, or a semiconductor-based temperature sensor.
[0018] Additionally or alternatively, the sensors 122 may include sensors for determining other parameters of the drug delivery device 102, such as the amount of drug remaining in the device's reservoir, the type of drug stored in the device's reservoir, the amount of drug selected for delivery, the amount of drug actually delivered, whether the drug delivery device is in contact with skin tissue, etc.
[0019] In some embodiments, the NFC tag 104 is disposed on the medication delivery device. For example, the NFC tag 104 may be incorporated into a label of the medication delivery device 102. The label may be affixed to, adhered to, or formed as part of the medication delivery device 102. The label may be paper, polymer, or made from any other suitable material, although aspects of the technology described herein are not limited in this respect. Exemplary labels incorporating NFC tags are described herein, including with respect to at least Figures 15A and 15B.
[0020] In some embodiments, the NFC tag 104 includes an NFC chip coupled to an NFC antenna. The NFC chip may take the form of any suitable NFC chip, such as, but not limited to, NFC chips manufactured by NXP®. The NFC antenna may take the form of any suitable NFC antenna, such as, but not limited to, NFC antennas manufactured by Avery Dennison® or Identiv. However, it should be recognized that aspects of the technology described herein are not limited to any particular NFC tag.
[0021] The NFC tag 104 is configured to communicate data 124 to and from the mobile device 106 using an NFC wireless transmission protocol. The data 124 includes data associated with the NFC tag 104, data associated with the medication delivery device 102, data associated with a medication contained within the medication delivery device 102, and / or data associated with the sensor 122. Thus, the sensor 122 may be communicatively coupled to the NFC tag 104.
[0022] The data associated with the NFC tag 104 includes data indicative of an authentication code 124a generated by the NFC tag 104. When the mobile device 106 is placed near the NFC tag, the NFC tag generates an authentication code known only to the server 110. For example, each time the mobile device 106 and / or any other suitable mobile device is placed near the medication delivery device 102, a new authentication code may be generated to enable such mobile device to communicate with the NFC tag 104. In some embodiments, the authentication code is encrypted prior to transmission to the mobile device 106.
[0023] The data associated with the sensor 122 includes data indicative of an output of the sensor 122. For example, if the sensor 122 includes a temperature sensor, the data may be indicative of the temperature of the drug delivery device 102, the temperature of a drug contained within the drug delivery device 102, and / or the ambient temperature.
[0024] According to some embodiments, in response to receiving the data 124 from the NFC chip 104, the mobile device determines information indicative of an event. An "event," as used herein, refers to the occurrence of a mobile device being placed in proximity to the medication delivery device 102 such that data (e.g., the data 124) is transmitted to the mobile device. The information indicative of the event may include contextual information, such as the time, date, and / or geographic location of the mobile device 106 at which the mobile device 106 received the data 124 from the medication delivery device 102. According to some embodiments, the mobile device 106 determines such contextual information based on the on-board clock, calendar, and / or GPS chip of the mobile device 106 at the time the data was received from the NFC tag 104.
[0025] The mobile device 106 may comprise any device that receives, stores, and / or processes data 124 from the NFC tag 104 via a wireless signal received by communication circuitry of the mobile device 106. Exemplary mobile devices include a smartphone, a smartwatch, a tablet, and / or a laptop. The wireless signal may be an active signal, in which the mobile device 106 receives a signal transmitted by communication circuitry of the medication delivery device 102, or a passive signal, in which the mobile device 106 senses a modulation on a signal transmitted by the NFC tag 104. The mobile device 106 may include a separate communication circuit configured to communicate with other devices (e.g., using long-range or cellular transmission protocols).
[0026] The mobile device 106 may further include processing circuitry and memory (not shown). The processing circuitry may take the form of a processor (e.g., a microprocessor or microcontroller, a field-programmable gate array (FPGA), and / or a digital signal processor (DSP), or any combination of the above) configured to execute logic stored in the memory to perform the operations described herein. As used herein, the terms "logic," "control logic," "instructions," or "application" may include software and / or firmware executed on any of the aforementioned processing circuits. The memory may be any suitable computer-readable medium accessible by the processing circuitry and including both volatile and non-volatile memory. Exemplary memories include random-access memory (RAM), read-only memory (ROM), electrically erasable programmable ROM (ERAM), and the like. The memory may be a ROM, EEPROM, flash memory, magnetic storage device, optical disk storage device, or any other suitable medium configured to store data and accessible by the processing circuitry, whether directly or indirectly, via one or more intermediate devices or wired or wireless communications links. Although the above description assumes that the memory is separate from, but communicatively coupled to, the processing circuitry, in some embodiments the memory may also be integrated with the processing circuitry. In some embodiments, instead of a processor executing logic stored in the memory, the processing circuitry may take the form of hardwired logic, e.g., a state machine and / or an application-specific integrated circuit (ASIC) that implements the functions described herein.
[0027] In some embodiments, the mobile device 106 includes a user interface 130 for displaying data and / or receiving user input. For example, the user interface 130 may include a graphical user interface (GUI) including a touchscreen display. The touchscreen display allows a user to interact with presented information, menus, buttons, and other data to provide information to the user or receive user input from the user. Additionally or alternatively, a keyboard, keypad, microphone, mouse pointer, or other suitable user input device may be provided.
[0028] Upon receiving the data 124 from the drug delivery device 102, the mobile device 106 launches a web browser 128 configured to access a uniform resource locator (URL) 132 associated with the server 110 via the network 108. In some embodiments, the website associated with the URL 132 is displayed on a user interface 130 of the mobile device 106. Additionally or alternatively, upon receiving the data 124, the mobile device searches for and launches a previously downloaded application program (e.g., a mobile app) configured to access the URL 132. The received data 124 may then be passed to the mobile app via the server 110. Additionally or alternatively, the data 124 may be transmitted directly from the drug delivery device 102 to the server 110.
[0029] In some embodiments, server 110 includes one or more computing devices. If server 110 includes multiple computing devices, the devices may be physically co-located (e.g., in a single room) or may be distributed across multiple physical locations. In some embodiments, server 110 may be part of a cloud computing infrastructure. In some embodiments, one or more servers 110 may be co-located within a facility operated by an entity.
[0030] Network 108 may be or may include a wide area network (e.g., the Internet), a local area network (e.g., a corporate Internet), and / or any other suitable type of network. Any of the devices shown in FIG. 1 may connect to network 108 using one or more wired links, one or more wireless links, and / or any suitable combination thereof. Thus, network 108 may be, for example, a hardwired network (e.g., a local area network within a medical facility), a wireless network (e.g., connected via Wi-Fi and / or cellular networks), a cloud-based computing network, or any combination thereof.
[0031] The URL 132 may be associated with an authentication code 124a provided by the NFC tag 104 disposed on the medication delivery device 102. In some embodiments, the server 110 includes an authentication server configured to authenticate the medication delivery device 102 based on the authentication code 124a. For example, the authentication server may authenticate the authentication code 124a to verify whether the NFC tag 104 and the associated medication delivery device 102 are authentic products manufactured and / or provided by a verified source (e.g., a verified manufacturer, provider, etc.). In some embodiments, the authentication server authenticates the authentication code 124a by decrypting the authentication code 124a (e.g., when the authentication code 124a is encrypted by the NFC tag 104). The authentication server may then check the authentication code 124a in the data store 112 to determine whether it is authentic.
[0032] Additionally or alternatively, the server 110 can query the data store 112 to identify additional information associated with the authentication code 124a and, therefore, the medication delivery device 102 that received the authentication code 124a. For example, the information may include information related to the medication contained within the medication delivery device 102, such as medication name, medication dosage, recall notices, expiration dates, and manufacturing lot numbers. The information may indicate a dosage regimen and / or instructions for taking the medication. The information may include information related to one or more preceding events, such as the time and / or location of the preceding event.
[0033] In some embodiments, data store 112 includes any suitable data store, such as a flat file, a data store, a multifile, or any suitable type of data storage device, although aspects of the technology described herein are not limited to any particular type of data store.
[0034] In some embodiments, the server 110 is configured to evaluate data associated with the sensor 122. The server 110 may determine temperature-based information, such as whether a medication contained within the medication delivery device 102 is warm enough to be administered. Additionally or alternatively, the server 110 may determine dosage-based information, such as an amount of medication dispensed and / or programmed, based on the data detected by the sensor 122.
[0035] In some embodiments, the server 110 transmits the verification data 134 to the mobile device 106 (e.g., to the web browser 128 and / or the mobile app). The verification data 134 may include data indicative of authentication of the medication delivery device 102 and / or the NFC tag 104. Additionally or alternatively, the server 110 transmits additional data (not shown) to the mobile device 106. The additional data includes information associated with the sensor 122 and / or information associated with the authentication code 124a and the medication delivery device 102.
[0036] In some embodiments, at least a portion of the verification data 134 and / or the additional data may be part of a GUI (e.g., user interface 130) presented to the user. In some embodiments, the GUI may be presented to the user as part of a website displayed by a web browser 128 executing on the mobile device 106. In some embodiments, the GUI may be presented to the user using an application program (different from the web browser 128) executing on the mobile device 106.
[0037] 2 is a flow chart illustrating an exemplary computerized method 200 for verifying aspects of a medication delivery device, according to some embodiments. The method 200 may be implemented on either the mobile device 106 and one or more of the server 110, whether operating independently or in cooperation with one another.
[0038] In step 202, the mobile device receives data from a Near Field Communication (NFC) tag (e.g., NFC tag 104) located on a medication delivery device (e.g., medication delivery device 102). The NFC tag may include an NFC chip and one or more NFC antennas located on the medication delivery device. For example, the NFC tag may include an NFC chip and one or more NFC antennas integrated into a label of the medication delivery device. The label may be affixed to, adhered to, or formed as part of the medication delivery device. Exemplary labels incorporating NFC tags are described herein, including with respect to at least Figures 15A and 15B.
[0039] In some embodiments, the mobile device receives the data in response to coming within a proximate range of the drug delivery device. This may include coming within 10 cm, within 8 cm, within 6 cm, within 4 cm, within 2 cm, within 0-10 cm, 2-8 cm, or any suitable distance of the drug delivery device. For example, a user may tap the drug delivery device against the mobile device (or vice versa), resulting in the mobile device receiving the data from the drug delivery device. The mobile device may receive the data via a wireless signal received by communication circuitry of the mobile device. The wireless signal may be an active signal or a passive signal.
[0040] The received data may include data associated with an NFC tag disposed on the medication delivery device and / or data associated with one or more sensors associated with the medication delivery device. As described herein, including with respect to at least FIG. 1, the data associated with the NFC tag may include data indicative of an authentication code generated by the NFC tag. In some embodiments, the data indicative of the authentication code is encrypted data. In some embodiments, the data associated with the one or more sensors includes data indicative of an output of one or more sensors, such as the sensors described herein, including with respect to at least FIG. 1.
[0041] According to some embodiments, in response to receiving the data from the NFC chip, the mobile device determines information indicative of the event. Such information may include contextual information, such as the time, date, and / or geographic location of the mobile device, at which the mobile device received the data from the medication delivery device. According to some embodiments, the mobile device determines the contextual information based on one or more components of the mobile device, such as the mobile device's on-board clock, calendar, and / or GPS chip at the time the data was received from the NFC tag.
[0042] After receiving the data (e.g., in response to receiving the data), the mobile device launches a web browser configured to access a URL associated with the server. Additionally, or alternatively, the mobile device checks for and launches a previously downloaded application program (e.g., a mobile app) configured to access a URL associated with the server.
[0043] In step 204, the mobile device verifies aspects of the medication delivery device by transmitting at least a portion (e.g., some, most, or all) of the received data and / or contextual information to the server. In some embodiments, the data transmitted to the server includes data indicative of an authentication code generated by the NFC tag.
[0044] The server may be configured to authenticate the authentication code and generate verification data based on the result of the authentication. For example, the server may be configured to decrypt data indicative of the authentication code (e.g., if the data is encrypted) and query a data store for the (decrypted) authentication code. If the authentication code is found in the data store, the verification data indicates that an aspect of the medication delivery device has been verified. If the authentication code is not found in the data store, the verification data indicates that an aspect of the medication delivery device cannot be verified.
[0045] In some embodiments, the authentication code may change over time such that it is predictable to the server but relatively unpredictable to other entities (e.g., eavesdropping attackers). For example, the code may change each time an NFC tag is brought within close range of a mobile device so that the mobile device can query the NFC tag. Each time the NFC tag is queried by the mobile device, the mobile device may be configured to alert the server so that the server may track how many times the NFC tag has been queried and how the authentication code is evolving over time. In such an embodiment, the server may authenticate the authentication code by determining whether the authentication code matches a currently expected authentication code.
[0046] Verifying aspects of the drug delivery device may include verifying a source of the drug delivery device. For example, this may include verifying that a particular manufacturer produced the drug delivery device and / or that a particular supplier supplied the drug delivery device. In some embodiments, if aspects of the drug delivery device cannot be verified, this indicates that the drug delivery device was not received from a verified source (e.g., the drug delivery device is a counterfeit from a non-verified manufacturer and / or supplier). If aspects of the drug delivery device can be verified, this indicates that the drug delivery device was received from a verified source (e.g., from the correct manufacturer and / or supplier).
[0047] In some embodiments, the server is further configured to obtain the authentication code and, therefore, additional data associated with the medication delivery device. For example, the server can look up the authentication code in a data store to identify additional information regarding the medication delivery device and / or the medication contained within the medication delivery device. The additional information may include information such as medication name, medication dosage, recall notices, expiration dates, and manufacturing lot numbers. The information may indicate a dosage regimen and / or instructions for taking the medication. The information may include information related to one or more preceding events, such as the time and / or location of the preceding event.
[0048] The mobile device is configured to receive the verification data and / or additional data from the server and present at least a portion of the received data on a website displayed by a web browser or application executing on the mobile device. The mobile device may be configured to present a GUI as part of the website. Non-limiting examples of information that may be displayed on the mobile device are described herein, including with respect to at least Figures 3 and 4A-4D.
[0049] 3 is a block diagram illustrating example information that may be displayed on a user interface 130 of a mobile device 106, according to some embodiments. As shown, the information is presented as part of a website 300 displayed by a web browser (e.g., web browser 128) of the mobile device 106. However, although not shown, it should be appreciated that the information may be presented using an application program executing on the mobile device 106.
[0050] In some embodiments, information is distributed across one or more pages of the website 300 (or app). The website 300 may include a GUI with which a user may interact to navigate the pages of the website 300. For example, the GUI may include one or more buttons, scroll bars, text boxes, or any other suitable elements with which a user may interact. In some embodiments, information described herein may be presented using one or more audible messages, which may be useful for users who are blind and / or visually impaired. Such audible messages may be provided in addition to or as an alternative to visually presenting such information.
[0051] In some embodiments, the information includes information indicative of verification data 302i. As described herein, including with respect to at least FIG. 1 and FIG. 2, the verification data 302i may be obtained from a server (e.g., server 110) and may indicate whether an aspect of the drug delivery device (e.g., a source of the drug delivery device) has been verified. If an aspect of the drug delivery device cannot be verified, the verification data 302i may indicate that the drug delivery device is counterfeit. For example, a warning message may be displayed on the website 300. Additionally or alternatively, if an aspect of the drug delivery device can be verified, the verification data 302i may indicate that the drug delivery device was received from a verified source. For example, a message may be displayed on the website 300 indicating to a user that an aspect of the drug delivery device has been verified.
[0052] In some embodiments, the displayed information includes information associated with the medication delivery device and the medication contained within the medication delivery device. For example, the information includes actual data about the medication, such as the medication name 302a, dose size 302c (e.g., the size of the dose of medication contained within the medication delivery device), expiration date 302d, dose strength 302l, and / or manufacturing lot number 302f. In some embodiments, the information includes an image of the medication delivery device 302m. In some embodiments, if the medication and / or medication delivery device is recalled after distribution to the patient, the information includes a recall notice 302e. In some embodiments, the information may indicate a dosing regimen 302k and / or provide administration instructions 302g to the patient or caregiver. For example, the information may indicate that the dose of medication contained within the medication delivery device is part of a multiple dose regimen and indicate the order in which the doses should be taken. The administration instructions may include step-by-step instructions for administering the medication using the medication delivery device. Such instructions may be useful to the patient or caregiver (e.g., family member, nurse, first responder, etc.) who is administering the medication.
[0053] In some embodiments, the information includes information related to the output of one or more sensors associated with the drug delivery device. For example, the information includes a drug temperature 302b obtained as an output from one or more temperature sensors associated with the drug delivery device. In some embodiments, the information may include temperature-based information, such as whether a drug contained within the drug delivery device is warm enough to be administered. Additionally or alternatively, the information includes an activation status 302h obtained as an output from a sensor configured to determine an activation state of the drug delivery device. For example, the activation status may indicate whether the drug delivery device has been activated to dispense a drug or whether the drug delivery device has dispensed a drug. In some embodiments, the information may include dosage-based information (e.g., based on the activation status of the drug delivery device) indicating an amount of drug dispensed and / or programmed to be dispensed.
[0054] In some embodiments, the information includes information related to the NFC tag 104 disposed on the medication delivery device 102. For example, the information may indicate a previous event that occurred between the medication delivery device and a mobile device (e.g., any mobile device). As described above, an event refers to the occurrence of a mobile device being placed near the medication delivery device 102 such that data is transmitted from the medication delivery device to the mobile device. The information may include a geographic location 302j associated with the previous event and / or a time of the previous event (not shown). Additionally or alternatively, the information may indicate an NFC tag identifier 302n associated with the NFC tag 104 disposed on the medication delivery device 102.
[0055] A user may have access to at least a portion (e.g., some, most, or all) of the information displayed on website 300. As described herein, different users may have access to different portions of the information. For example, a user may provide user authentication information to gain access to user-specific information.
[0056] It should be appreciated that information 302a-n is example information and that any suitable information may be obtained and / or displayed, although aspects of the technology described herein are not limited in this respect.
[0057] 4A is an example display 400 on a user interface of a mobile device showing validation data associated with a medication delivery device, according to some embodiments. The example display 400 shows that the product has been validated. The display 400 also provides information related to the product (e.g., medication and medication delivery device), such as manufacturing lot number, expiration date, serial number, manufacturer, and dose size.
[0058] 4B is an example display 440 on a user interface of a mobile device showing validation data associated with a medication delivery device, according to some embodiments. The example display 440 indicates through graphics and text that the product has not been validated. This may indicate that the product is a counterfeit product that was not produced by the expected true manufacturer. The example display 440 also prompts the user to report the product, which may enable counterfeit tracking and help identify the source of the counterfeit product.
[0059] According to some embodiments, in addition to the alert shown on the user interface of the patient's mobile device (e.g., as shown in FIG. 4B), an alert may also be sent to the patient's healthcare provider and / or the patient's assistant (e.g., a family member) when a counterfeit product is detected. For example, the healthcare provider and / or assistant may receive the notification via a text message, via a notification on a mobile application, or via any other suitable means of communication, although aspects of the present technology are not limited in this respect. Thus, the healthcare provider can track the patient to ensure that the patient does not use counterfeit products, trace the source of the counterfeit product, replace medications with verified products to ensure that the patient adheres to their dosing regimen, and check with other patients to ensure that they have not received counterfeit products as well. Similarly, in response to receiving the alert, the patient's assistant can ensure that the patient does not take counterfeit medications and can order replacement medications to ensure that the patient continues to adhere to their dosing regimen.
[0060] 4C is an example display 460 on a user interface of a mobile device showing a recall notice associated with a medication contained within a medication delivery device, according to some embodiments. A warning message at the top of the screen indicates that the product (e.g., the medication delivery device and the medication contained within the medication delivery device) has been recalled. Also shown at the bottom of the display 460 are interactive buttons that, when selected, provide instructions on how to use the medication delivery device.
[0061] 4D is an example display 480 on a user interface of a mobile device showing information indicating the expiration of a medication contained within a medication delivery device, according to some embodiments. A warning message at the top of the screen indicates that the medication has expired and provides instructions for the user to tap the message for additional information. Again, the warning message instructs the user to tap the message for additional details regarding the recall notification.
[0062] 5 is a block diagram illustrating an example system 500 for tracking ownership of a medication delivery device, according to some embodiments. Similar to system 100, system 500 includes a medication delivery device 102 and a mobile device 106 in communication with a server 110 and a data store 112 via a network 108.
[0063] However, unlike the system 100, the system 500 is additionally or alternatively configured to track ownership of the medication delivery device 102. In some embodiments, the mobile device 106 of the system 500 is configured to receive data 124 from the medication delivery device 102, as described herein with respect to FIG. 1. After receiving the data (e.g., in response to receiving the data), the mobile device launches a web browser configured to access a URL 132 associated with the server 110. Additionally or alternatively, the mobile device 106 checks for and launches a previously downloaded application program (e.g., a mobile app) configured to access a URL 132 associated with the server 110.
[0064] The mobile device 106 transmits at least a portion (e.g., some, most, or all) of the data 124 to the server 110. In some embodiments, the portion of the data 124 includes data indicative of an authentication code generated by the NFC tag 104 and / or data indicative of an output of the sensor 122. In some embodiments, the mobile device 106 also transmits contextual information to the server 110, such as a time, date, and / or a geographic location of the mobile device 106, when the data 124 was received from the NFC tag 104 disposed on the medication delivery device 102.
[0065] In response, the website 300 is displayed on the mobile device's user interface 130. The website 300 is configured to prompt the user for user credentials 554. For example, the user may provide a username and password via one or more text boxes presented on the user interface 130. Additionally or alternatively, the user credentials may include a bearer token, a refresh token (e.g., derived from a previous authentication using the username and password), and / or other user credentials.
[0066] The mobile device 106 transmits the user authentication information to the server 110. The server 110 is configured to log an entry 556 in the data store 112 based on the user authentication information 554 and the portion of the data 124 transmitted by the mobile device 106. The entry 556 may indicate a user (e.g., a user who provided the user authentication information 554), a time when the data 124 from the medication delivery device 102 was received by the mobile device 106, a date when the data 124 was received by the mobile device 106, and / or a geographic location of the mobile device 106 when the mobile device 106 received the data 124 from the medication delivery device 102. However, it should be appreciated that the entry 556 may include less, different, and / or additional information, and aspects of the technology are not limited in this respect.
[0067] In some embodiments, the logged entries 556 may be accessed by one or more users to track patient adherence, detect potential counterfeiting, determine the time of the next dose, collect data from clinical trials, track device distribution, and / or any other suitable use case, although aspects of the technology described herein are not limited in this respect. For example, a user may access the information via a website configured to access this data.
[0068] In some embodiments, the server 110 may also consult the received user credential 554 in the data store 112 to identify additional user-specific information associated with the user credential 554. For example, the server 110 may access a dosing regimen specific to the user, past doses administered to the user, patient information associated with the user, or any other suitable user-specific information, although aspects of the technology described herein are not limited in this respect.
[0069] The server 110 may provide the patient-specific information and / or other information described herein, including the information described with respect to Figures 1-4D, to the mobile device 106. The mobile device 106 may display the information on a website displayed by a web browser and / or on an application program running on the mobile device 106. In some embodiments, certain information may be displayed only to some users (e.g., based on user credentials 554), while the same information is not displayed to other users.
[0070] 6 is a flow chart illustrating an example computerized method 600 for tracking ownership of a medication delivery device, according to some embodiments. The method 600 may be implemented on either the mobile device 106 and one or more of the server 110, whether operating independently or in cooperation with one another.
[0071] In step 602, the mobile device receives data from a Near Field Communication (NFC) tag disposed on the medication delivery device. The NFC tag may include an NFC chip and one or more NFC antennas disposed on the medication delivery device. For example, the NFC tag may include an NFC chip and one or more NFC antennas incorporated into a label of the medication delivery device. The label may be affixed to, adhered to, or formed as part of the medication delivery device. Exemplary labels incorporating NFC tags are described herein, including with respect to at least Figures 15A and 15B.
[0072] In some embodiments, the mobile device receives the data in response to coming within a proximate range of the drug delivery device. This may include coming within 10 cm, within 8 cm, within 6 cm, within 4 cm, within 2 cm, within 0-10 cm, 2-8 cm, or any suitable distance of the drug delivery device. For example, a user may tap the drug delivery device against the mobile device (or vice versa), resulting in the mobile device receiving the data from the drug delivery device. The mobile device may receive the data via a wireless signal received by communication circuitry of the mobile device. The wireless signal may be an active signal or a passive signal.
[0073] The received data may include data associated with an NFC tag disposed on the medication delivery device and / or data associated with one or more sensors associated with the medication delivery device. As described herein, including with respect to at least FIG. 1, the data associated with the NFC tag may include data indicative of an authentication code generated by the NFC tag. In some embodiments, the data indicative of the authentication code is encrypted data. In some embodiments, the data associated with the one or more sensors includes data indicative of an output of one or more sensors, such as the sensors described herein, including with respect to at least FIG. 1.
[0074] According to some embodiments, in response to receiving the data from the NFC chip, the mobile device determines information indicative of the event. Such information may include contextual information, such as the time, date, and / or geographic location of the mobile device, at which the mobile device received the data from the medication delivery device. According to some embodiments, the mobile device determines the contextual information based on an on-board clock, calendar, and / or GPS chip at the time the data was received from the NFC tag.
[0075] In step 604, the mobile device transmits at least a portion of the received data to the server. For example, the mobile device may transmit some, most, or all of the received data to the server over any suitable network. In some embodiments, the mobile device also transmits a portion of the contextual information, such as the time, date, and / or geographic location of the mobile device when the mobile device received the data from the medication delivery device, to the server.
[0076] In some embodiments, the server is configured to launch a website on the mobile device in response to receiving at least a portion of the data from the mobile device. The website is configured to prompt the user to provide user credentials using a user interface of the mobile device. For example, the user may provide a username and password using one or more text boxes displayed on the user interface. Additionally or alternatively, the user credentials may include a bearer token, a refresh token, and / or other user credentials as described herein.
[0077] In step 606, the mobile device provides the user authentication information to the server. The server is configured to log an entry based on the user authentication information and a portion of the received data (e.g., sent to the server in step 602). For example, the server may be configured to log an entry in a data store associated with the server. The entry indicates that the user was in possession of the medication delivery device at the time the data was received from the NFC tag located on the medication delivery device. For example, the entry may indicate the user authentication information, a user associated with the user authentication information, a geographic location, a time, a date, and / or any other suitable information, although aspects of the technology are not limited in this respect.
[0078] Example Application Exemplary applications of the systems and methods for verifying aspects of a medication delivery device and tracking ownership of a medication delivery device are now described, including as described above with respect to at least Figures 1-6. However, it should be recognized that the following examples are non-limiting examples, and that the systems and methods described herein may have many other suitable applications.
[0079] FIG. 7 is a block diagram illustrating an example system 700 for determining example recommendations associated with a medication delivery device using logged entries, according to some embodiments.
[0080] In this example, a server (e.g., server 110) may access a stored entry 556 that indicates when a patient (e.g., user 1) was administered a dose of a medication (e.g., an event). The server may also access additional information stored with the entry 556 related to the event and / or the patient. For example, the entry 556 may store data indicating the dose of medication delivered, the name of the medication, the patient's dosing regimen, information related to the timing of other past dosing events, and / or any other suitable information.
[0081] In some embodiments, the server uses the entry 556 and / or information stored with the entry 556 to track when the patient takes or receives medication. With that information, the server may provide assistance to the patient or the patient's caregiver (e.g., healthcare provider, family, etc.). For example, the server may detect a potential missed dose 702. The server may detect a potential missed dose if no data is received from the mobile device during a time window when the patient is expected to have taken the medication dose. The server may also suggest a time for the next medication dose 704, suggest a dosage for the next medication dose 706, and / or order a replacement medication 708.
[0082] The server may transmit data associated with these options 702-708 to the mobile device, and information indicative of the data may be displayed on the website on the user interface of the mobile device. For example, the website may provide messages to the patient, such as a message alerting the patient that the patient may have missed a dose, a message suggesting the time of the next dose, a message suggesting the amount of the next dose, and / or a message indicating that a replacement medication has been ordered.
[0083] It should be appreciated that by providing user credentials, a user may have access to patient-specific information that enables the user to track their dosing regimen, receive communications from healthcare providers, and maintain prescriptions. As shown in Figures 8A and 8B, a first user may provide first user credentials 856a specific to the first user, while a second user may provide second user credentials 856b specific to the second user.
[0084] In response to receiving the user credentials, the server is configured to provide user-specific data to the mobile device 106. Thus, the website 300 displays first information 858a specific to the first user when the first user credentials 856a are provided, and displays second information 858b specific to the second user when the second user credentials 856b are provided.
[0085] Research studies and / or clinical trials may seek to determine how well a group of patients adheres to a therapy. Relatedly, insurance companies may seek to track population-level health outcomes. By automatically logging entries associated with administration events, the techniques described herein can be used to determine the level of adherence for a group of patients.
[0086] 9A, a server and / or user (e.g., a researcher and / or insurance company) may access logged entries 926 showing dosing events for multiple patients (e.g., users 1-N). The server and / or user may use the logged entries 926 to determine an average level 940 of adherence to the dosing regimen for those patients. Additionally or alternatively, the user and / or server may access individual entries 926a-d to assess individual patients' adherence to their individual dosing regimens.
[0087] In some embodiments, a healthcare provider may seek to determine how well an individual patient adheres to a therapy. In particular, a healthcare provider may want to track when a patient takes their medication and whether the patient is adhering to their medication regimen. By automatically logging entries associated with administration events, the techniques described herein can be used to provide patient adherence information to a healthcare provider.
[0088] 9B, a server and / or user (e.g., a healthcare provider) may access logged entries 956 showing dosing events for a single patient (e.g., User 1). The server and / or user may use the logged entries 956 to determine the patient's average level of adherence 960 to their own dosing regimen. Additionally or alternatively, the user and / or server may access individual entries 956a-d to evaluate the timing and / or dosage administered to the user.
[0089] Thus, health care providers may provide better care for their patients by identifying and addressing problems that arise when patients are not adherent to their drug regimens and developing effective treatment plans.
[0090] Sales representatives who distribute drug samples (e.g., contained within drug delivery devices) to healthcare provider offices have a regulatory obligation to record which drug samples they distributed and to whom. Sales representatives typically log information about the samples, such as the drug product, manufacturing lot number, date of visit, clinic provided, etc. This process is manual and time consuming.
[0091] The efficiency of this process may be improved by using the techniques described herein. As shown in FIG. 10, the sales representative may tap the medication delivery device to the mobile device 106. The website 300 prompts the sales representative to enter authentication information 1056, and upon providing the authentication information, the system logs the information. For example, the system logs the visit date 1058a, the manufacturing lot number 1058b, the medication name 1058c, and the clinic 1058d. However, it should be appreciated that any suitable information may be logged, and aspects of the present technology are not limited in this respect.
[0092] The sales representative may later access the logged information by providing his / her authentication information 1056 and the website 300 displays the logged information via the user interface 130 on the mobile device 106.
[0093] In some embodiments, customs and border agents may check the medication delivery device to determine if it is counterfeit. Figure 11 is a block diagram illustrating an example system 1100 for detecting counterfeit products, in accordance with some embodiments of the present technology.
[0094] The representative may tap the medication delivery device to the mobile device 106, which launches a website 300 that prompts the representative for their authentication information 1156. After the authentication information is provided, the website 300 may display information about previous events 1158. For example, this information may include previous geolocations 1158a and 1158b (e.g., determined from IP addresses) where the NFC tag was previously tapped. Such information may not generally be available to the public.
[0095] Customs and border agents may use the geolocation information to determine the likelihood that a medication delivery device is counterfeit. For example, if the information indicates that the NFC tag was previously tapped on another counterfeit device and that only a short period of time has passed since the NFC tag was tapped, then the medication delivery device is likely counterfeit.
[0096] In some embodiments, customs and border agents may provide information to the website 300, such as information to report counterfeit products. This information may be used to trace the origin of the counterfeit products.
[0097] In clinical trials, researchers often provide the drug to be tested to a first subset of a patient population and a placebo to a second subset of the patient population. This allows researchers to measure the effectiveness of the drug in treating a condition compared to the placebo. To prevent potential bias, researchers "double-blind" the distribution of the drug and placebo. That is, neither the patient nor the healthcare provider distributing the product to the patient knows whether the product being administered to a particular patient is a drug or a placebo. In such double-blind drug trials, all external labels for the dispensed drug containers may look the same regardless of whether the container contains a drug or a placebo.
[0098] Despite identical external container labeling, an NFC tag may be incorporated into the label of each drug container, allowing patients to retain individual serialization of the drug container. By tapping a mobile device to a drug container before administering a product (e.g., drug or placebo), an entry is logged that stores information about the patient and information identifying the product contained in the container. Thus, back-end researchers can track which patients took the drug being tested and which patients took the placebo. That is, once data from a clinical trial is unblinded, researchers can determine which patients took the placebo and which patients took the active ingredient based on the logged entries that store information about the patient and information identifying the product contained in the container.
[0099] Additionally or alternatively, researchers may easily communicate with patients participating in clinical trials by updating a website accessed by the patients, i.e., when a patient taps their medication container to their mobile device (or vice versa), a website is launched that displays information indicating updates to the clinical trial.
[0100] According to some embodiments, the drug delivery device may be configured for use by a patient. For example, as shown in FIG. 12, a patient drug delivery device 1202 of an exemplary system 1200 includes a patient NFC tag 1204. When a mobile device 106 is placed near the patient drug delivery device 1202, a website 300 is launched on the user interface 130 of the mobile device 106.
[0101] According to some embodiments, in response to receiving data from the patient NFC tag 1204, the website 300 displays patient information 1206. The patient information 1206 may include, for example, information regarding the patient drug delivery device, information regarding medications contained within the patient drug delivery device, instructions regarding how to use the patient drug delivery device, the patient's dosing schedule, patient medical history information, or any other suitable general or patient-specific information such as information described herein, including with respect to at least FIG.
[0102] Additionally or alternatively, the medication delivery device may be configured for use by a healthcare provider (HCP). For example, as shown in FIG. 12, the HCP medication delivery device 1222 of the exemplary system 1220 includes an HCP NFC tag 1224. When the mobile device 106 is placed near the HCP medication delivery device 1222, the website 300 is launched on the user interface 130 of the mobile device 106.
[0103] According to some embodiments, in response to receiving data from the HCP NFC tag 1224, the website 300 displays HCP information 1226. The HCP information 1226 may include, for example, medical literature 1226a, prescription information 1226b, patient demo 1226c, or any other suitable general or HCP-specific information such as information described herein, including with respect to at least FIG. 3. In some embodiments, the prescription information 1226b includes information that describes how and when to prescribe to a patient. In some embodiments, the patient demo 1226c includes features that allow the HCP to demonstrate to the patient how something should be done medically or electronically. For example, the patient demo 1226c may include functionality that allows the HCP to show the patient how to electronically sign a Health Insurance Portability and Accountability Act (HIPAA) form. Alternatively or additionally, the patient demo 1226c may facilitate the HCP and patient to find and actually electronically sign the appropriate HIPAA form. The electronically signed form may then be stored in an appropriate electronic repository, such as an Electronic Health Record (EHR) system.
[0104] A patient may recognize that they will receive a reminder to take their medication. For example, some medications need to be stored in a refrigerator to prevent spoilage. When it is time to take a dose of medication, the patient is instructed to remove the medication (e.g., medication delivery device) from the refrigerator and allow it to sit at room temperature for a specified duration (e.g., 15 minutes, 20 minutes, 30 minutes, 40 minutes, 50 minutes, 60 minutes, or any other suitable duration). Some patients recognize that they will receive a reminder that they are ready to take their medication after the specified duration. Additionally or alternatively, some patients will recognize a general reminder to take their medication according to their medication regimen (e.g., multiple times a day, daily, weekly, etc.).
[0105] 13 illustrates an example system 1300 for configuring a dosing reminder according to the techniques described herein. As described herein, according to some embodiments, after the mobile device 106 is placed near the medication delivery device 102, a website 300 is launched on the user interface 130 of the mobile device 106.
[0106] According to some embodiments, the website 300 is configured to prompt the user to enter contact information 1302 for configuring dosage reminders. For example, the website 300 may display options for configuring dosage reminders 1314 via one or more communication platforms 1312. The user may then enter their contact information 1302 for each communication platform 1312. For example, the user may provide a phone number for receiving dosage reminders via short message service (SMS) text, an email address for receiving dosage reminders via email, a username for receiving dosage reminders via a messaging platform, or any suitable contact information for any suitable communication platform, although aspects of the technology described herein are not limited in this respect.
[0107] After the user provides the contact information, according to some embodiments, the server (e.g., server 110) provides the user with a code via the communication platform 1312. For example, if the user provided a phone number, the user may receive the code via a text message. The website 300 may prompt the user to enter the code via the user interface 130 to verify that the patient owns the communication platform 1312 (e.g., email account, phone number, messaging platform) associated with the provided contact information.
[0108] According to some embodiments, after the dosage reminder is configured, the user receives a dosage reminder 1314 via the communication platform 1312. The dosage reminder 1314 reminds the user to take their medication at the appropriate time. For example, the user may receive a dosage reminder after a certain duration (e.g., 30 minutes) has elapsed since the medication was removed from the refrigerator. In this case, the dosage reminder may indicate that the medication is warm and ready for use. Additionally or alternatively, the user may receive dosage reminders at certain times each day or at certain times each week. Such dosage reminders may help the user adhere to their medication regimen.
[0109] Additionally or alternatively, when setting up a dose reminder for the first time via the website 300 or upon receiving a dose reminder via the communications platform 1312, the user may be provided with an option to enter the injection site the user used in their most recent injection. For example, when setting up a dose reminder for the first time via the website 300, the website may include a user input field that allows the user to select from multiple options for the injection site, such as left arm, right arm, left abdomen, right abdomen, left thigh, and / or right thigh. Additionally or alternatively, the website 300 may allow the user to type free text indicating the injection site the user used in their most recent injection. When receiving a dose reminder via the communications platform 1312, the dose reminder may include a similar user input field or the dose reminder may include a link to a website that includes a similar user input field. When a user provides information regarding the injection site that the user used in their most recent injection, this information may be stored by a server (e.g., server 110) in a log of previously used injection sites, potentially in association with other injection-related data, such as the date and / or time of the previous injection associated with the previous injection site, the type of medication injected, and / or the amount of medication injected. This logged information may be accessed by the user upon request, or may be presented to the user with each medication reminder to remind the user as to which injection site the user used in their most recent injection. In this manner, the logged information may assist the user in effectively rotating injection sites and avoiding over-use of a particular injection site, which may increase the risk of complications (e.g., infection or scarring) and / or reduce the effectiveness of the injected medication.
[0110] An exemplary drug delivery device 20 is illustrated in various operational states in Figures 14A-14C. Examples of such devices and their operation are described in U.S. Patent No. 8,734,394 (B2), issued May 27, 2014 to Adams et al., and U.S. Patent Application Publication No. 2021 / 0093784 (A1), published April 1, 2021 to Adams et al., the entire disclosures of each of which are incorporated herein by reference. The device 20 includes a syringe assembly 22, a drive mechanism 24, and a retraction mechanism 26. The syringe assembly 22 includes a barrel 30 forming a reservoir for holding the drug, and a piston 32 disposed within the barrel 30 for driving the drug out of the barrel. The syringe assembly 22 also includes a needle assembly 33 having a hollow injection needle 34 and a needle hub 35 that mounts the needle 34 to the syringe barrel 30. A lower body support member 29, which is coupled to a device housing 38, surrounds the needle 34. Advancing a piston 32 within the barrel 30 towards the needle 34 causes medication to be dispensed through the needle 34.
[0111] The devices described herein, such as device 20, may further include a medicament, such as, for example, in syringe barrel 30. In another embodiment, a system may include one or more devices, including device 20, and a medicament. The term "medicament" or "drug" refers to one or more therapeutic agents, including but not limited to insulin, insulin analogs such as insulin lispro or insulin glargine, insulin derivatives, GLP-1 receptor agonists such as dulaglutide or liraglutide, glucagon, glucagon analogs, glucagon derivatives, gastric inhibitory polypeptide (GIP), GIP analogs, GIP derivatives, combined GIP / GLP-1 agonists such as tirzepatide, oxyntomodulin analogs, oxyntomodulin derivatives, therapeutic antibodies, including but not limited to IL-23 antibody analogs or derivatives such as mirikizumab, IL-17 antibody analogs or derivatives such as ixekizumab, therapeutic agents for pain-related treatments such as galcanezumab, lasmiditan, and any therapeutic agent that may be delivered by the devices described herein. Agents such as those used in the devices may be formulated with one or more excipients. The device is operated by a user, caregiver, or medical professional in a manner generally as described above to deliver medication to a patient. As used herein, the term "user" may refer to an operator of a device described herein, and the term "patient" may refer to a person receiving a medication. In some cases, the user and the patient may be the same person (e.g., the patient is operating a device described herein to give themselves an injection). In other cases, the user and the patient may be different people (e.g., the user may be a person providing care to the patient).
[0112] FIG. 14A illustrates the device 20 in its initial, pre-use configuration, where an end cap 36 is fixedly attached to a lower body support member 29 (which is coupled to a device housing 38). The end cap 36 covers a proximal end opening 40 of the housing 38. As used herein, distal and proximal refer to axial locations relative to an injection site when the device is oriented for use at the injection site, thus, for example, the proximal end of the housing refers to the end of the housing closest to such injection site, and the distal end of the housing refers to the end of the housing furthest from such injection site. Also, as used herein, "injection site" can refer to the exact spot on the patient's body that is injected by the needle, as well as the body tissue surrounding the spot where the needle injects (e.g., within 1-5 cm or 1-10 cm of the spot where the needle pierces the patient's skin). The housing 38 may be formed from a plastic material and is shown extending generally longitudinally along a longitudinal axis 48 between a distal end immediately adjacent the activation button 52 and a proximal end immediately adjacent the proximal end opening 40. As shown in FIG. 14B, the housing 38 may include a user-graspable portion 37 configured to be grasped by a user's hand, the user-graspable portion 37 extending outwardly from the longitudinal axis 48 a radial distance 41. In some embodiments, the radial distance 41 may be 5-10 mm in length (e.g., in some embodiments, 5-8 mm may be a suitable length). Also, as shown in FIG. 14B, the housing 38 may also include an outwardly flared end portion 39 at the proximal end of the housing adjacent the proximal opening 40.
[0113] A needle guard 42 is mounted on the syringe assembly 22 to cover and surround the needle 34. The end cap 36 and needle guard 42 protect the user from accidental needle sticks and also protect the needle 34 from damage. When using the device 20 to dispense a medication, e.g., to inject the medication into a patient, the end cap 36 and needle guard 42 are first removed. FIG. 14B illustrates the device 20 after removing the end cap 36 and needle guard 42 from the syringe assembly 22, with the syringe assembly in a stored position and the device 20 ready for a dispensing event.
[0114] The syringe assembly 22 is movable relative to the drug delivery device 20 between a stored position and an injection position. Figure 14C illustrates the device 20 after the syringe assembly 22 has been moved relative to the device 20 from its stored position shown in Figure 14B to the injection position. In the stored position (Figures 14A and 14B), the needle 34 is retracted to a position such that the needle 34 is disposed within the housing 38 of the device 20. In the injection position (Figure 14C), the needle 34 protrudes outwardly from the housing 38 in a proximal direction parallel to the longitudinal axis 48 and beyond the proximal opening 40, thereby allowing the needle 34 to be inserted into a patient.
[0115] The drive mechanism 24 includes a plunger 44 that engages the piston 32. The drive mechanism 24 includes a spring 46 that drives the plunger 44 in a translational motion. In the illustrated embodiment, the spring 46 advances the plunger 44 along a linear path defined by a longitudinal axis 48 of the device 20. As the plunger 44 advances, a foot 50 of the plunger 44 contacts the piston 32. As the plunger 44 advances further, the syringe assembly 22 advances along the axis 48 from its retracted position to its injection position. After the syringe assembly 22 has advanced to its injection position, continued proximal advancement of the plunger 44 advances the piston 32 proximally within the barrel 30 from its initial piston position (shown in FIGS. 14A and 14B ) to its final piston position (shown in FIG. 14C ) during a dispense event, causing the medicament to be dispensed from the needle 34. Prior to any dispensing of medication, and when the syringe barrel 30 holds the entire original volume of medication, the piston 32 will be in its initial piston position. After advancing the piston 32 to its entire length of travel toward the needle assembly 33, the piston 32 will be in its final piston position adjacent the needle assembly 33, and the medication from within the barrel 30 will have been expelled. In some embodiments, the syringe assembly 22 will hold a single dose of medication to be delivered in a single injection event, and the piston 32 advances from its initial piston position to its final piston position during that single injection event, thereby delivering the entire single dose contents of the syringe assembly 22. Although the device is shown as a single use device, the device 20 may also be configured as a multiple use device, with appropriate modifications.
[0116] Advancement of the plunger 44 will generally not result in dispensing of medicament from the syringe assembly 22 until the syringe assembly 22 is advanced to the injection position. There are factors that may prevent medicament from being dispensed before the syringe is advanced to the injection position. The factor may be friction between the piston 32 and the barrel 30. Typically, the piston 32 will be formed of a rubber material and the barrel 30 will be glass. The frictional resistance between these two components may be sufficient to prevent advancement of the piston 32 within the barrel 30 until the syringe assembly 22 is advanced to its injection position and engagement with a suitable stop member prevents further advancement of the syringe assembly 22. Additionally, the medicament within the syringe may be somewhat viscous and therefore somewhat resistant to flowing out of the needle 34. If desired, modification of the piston 32 and syringe barrel 30 to change the frictional resistance of the dispensing motion of the engagement member 32 relative to the syringe barrel 30 may limit or prevent premature dispensing of medicament before the container 22 reaches its injection position.
[0117] To activate drive mechanism 24, a user depresses an activation button 52 on the distal end of device 20. Depressing button 52 disengages one or two elongated protrusions 54 on plunger 44 from shuttle assembly 60, thereby allowing spring 46 to expand and advance plunger 44 axially. Spring 46 has a helical shape and surrounds protrusions 54. A proximal end of spring 46 biasingly engages a flange on plunger 44.
[0118] The shuttle assembly 60 may include an upper shuttle member 62 and a lower shuttle member 64. The shuttle members 62, 64 are secured together in the final assembly. In the final assembly, the upper shuttle member 62 captures the button 52 and the spring 46 to limit the axial movement of these components in the distal direction. The projection 54 engages a surface on the upper shuttle 62 when the device is in the state shown in FIGS. 14A and 14B. Depressing the button 52 causes a tab on the button 52 to engage with a ramp (not shown) on the projection 54, urging the projection 54 inwardly to disengage the projection 54 from the upper shuttle member 62. After the projection 54 is disengaged, the spring 46 exerts a biasing force on a flange of the plunger 44 to advance the plunger 44 from the position shown in FIG. 14B to the position shown in FIG. 14C as the spring 46 transitions from a compressed state to an expanded state. As plunger 44 advances, it moves syringe assembly 22 to an injection position which then advances piston 32 to dispense the medication as discussed above.
[0119] After the dispensing event is completed, the retraction mechanism 26 optionally moves the syringe assembly 22 from the injection position shown in FIG. 14C back to the retracted position. More specifically, the retraction mechanism is adapted to move the medicament container from the injection position to the retracted position with a retraction motion. The retracted position may be similar to the retracted position in that the syringe assembly is retracted into the housing 38, such that the needle 34 no longer proximally protrudes from the proximal opening 40 but is disposed entirely within the housing 38. In some embodiments, the retracted position may be the same as the retracted position. However, in other embodiments, the syringe assembly 22 in the retracted position may be located slightly proximal or distal relative to the syringe assembly in the retracted position. In the illustrated embodiment, the retraction mechanism includes a spring 66, a syringe carrier, and a rotating member 70 acting as a follower. In still other embodiments, the device 20 may not include a retraction mechanism 26 such that the syringe assembly remains indefinitely in its injection position until it is manually removed or repositioned by the user after the medicament has been dispensed.
[0120] The plunger 44 may include an outrigger (not shown) that unlocks the rotating member 70 when the plunger 44 nears the end of its proximal travel. The rotating member 70 is rotatably secured to the lower shuttle member 64 by engagement between a latch and a latch recess in the lower shuttle member 64. The outrigger unlocks the member 70 by depressing the latch. A spring 66 is torsionally preloaded and has one end engaged with the member 70 and an opposing end engaged with the shuttle assembly 60. Upon depression of the latch, the spring 66 urges the member 70 to rotate.
[0121] The member 70 is rotatable within the housing 38 but is not axially movable relative to the housing 38. Other embodiments may also include an axially movable member 70. The rotation of the member 70 acts as a delay mechanism that prevents the retraction mechanism 26 from retracting the syringe assembly 22 until the syringe assembly has finished delivering its dose of medication. The rotational speed of the member 70 may be adjusted by adjusting the viscosity of the grease disposed on or around the surface of the member 70 that is in contact with the housing 38, with more viscous grease resulting in slower rotation and less viscous grease resulting in faster rotation. A radial flange on the rotating member 70 may engage a ledge in the housing member 38 to limit the proximal movement of the member 70. The spring 66 may also be compressively preloaded so that it is initially in a compressed state. In this compressed state, spring 66 may exert an axial, torsional, or both force proximally on member 70 to bias member 70 proximally, thereby maintaining member 70 in an axial position in which a radial flange of member 70 engages an internal ridge of housing member 38.
[0122] The shuttle assembly 60 may include an axially extending channel or rib that engages a corresponding feature on the housing member 38 to allow the shuttle assembly 60 to move axially within the housing 38 but prevent relative rotation of the shuttle assembly 60 with respect to the housing member 38. The shuttle assembly 60 is biased distally by a spring 66 but is prevented from moving distally by engagement of a latch (not shown) prior to activation of the drive mechanism 24. Once the rotating member 70 has completed its rotation, it disengages the previously mentioned latch, thus allowing the shuttle assembly 60 to move distally under the biasing force of the spring 66.
[0123] As the shuttle assembly 60 moves distally, it carries the syringe assembly 22 distally, moving the syringe assembly 22 back to the retracted position. Also, as the shuttle assembly 60 moves, the spring 66 transitions from its compressed state to its expanded state. The spring 66 biases the retraction mechanism 26 distally, thereby maintaining the syringe assembly 22 in its retracted position after the injection event. In some embodiments, the spring 46 of the drive mechanism 24 may also transition from an expanded state to a compressed state as the shuttle assembly 60 moves distally. Locking features, such as detents on the shuttle assembly 60 and recesses on the housing 38 members, additionally provide a locking engagement to secure the syringe assembly 22 with the needle 34 disposed within the housing 38 in the retracted position after the injection event, whereby the user may then dispose of or otherwise handle the device 20 in a safe manner.
[0124] 15A shows an exemplary label 1500 including an NFC tag 1504. In some embodiments, the label 1500 is wrapped around an exterior surface of the medication delivery device. For example, the exemplary label may be wrapped around an exterior surface of the user-gripable portion 37 of the medication delivery device 20. The label 1500 may include a flexible paper and / or plastic material that may be attached to the exterior surface of the device 20. The label 1500 may be attached using any of a variety of methods, including but not limited to using adhesives, adhesive films (e.g., polyurethane films), magnetic attachments, clip-on attachments, ultrasonic bonding / welding, injection molding / in-mold labeling, laser bonding / welding, and the like. The label 1500 may be printed with information about the device 20 and / or the medication stored within the device 20, such as medication name, manufacturer name, manufacturing batch / lot number, expiration date, usage and / or storage instructions, amount of medication stored therein, and the like.
[0125] In some embodiments, an NFC tag 1504 is incorporated into the label 1500. As described above, a mobile device may be placed near the NFC tag 1504 to receive data from the NFC tag 1504. The label 1500 may include a graphic 1502 that indicates the location of the NFC tag 1504 within the label 1500. For example, a user may tap a mobile device against a medication delivery device near the graphic 1502 to query the NFC tag 1504.
[0126] 15B shows a view of the back side of label 1500. As shown, label 1500 comprises NFC tag 1504. According to some embodiments, NFC tag 1504 comprises chip 1510 and antenna 1512. According to some embodiments, NFC tag 1504 may have any suitable dimensions. For example, NFC tag 1504 may have a width (and / or length) of at least 8 mm, at least 10 mm, at least 12 mm, at least 14 mm, at least 16 mm, at least 18 mm, at least 20 mm, at least 22 mm, at least 24 mm, at least 26 mm, at least 28 mm, at least 30 mm, between 8 mm and 30 mm, between 10 mm and 24 mm, or between 12 mm and 22 mm.
[0127] According to some embodiments, the NFC chip 1510 may comprise a processing circuit. The processing circuit 1510 may take the form of a processor (e.g., a microprocessor or microcontroller, a field programmable gate array (FPGA) and / or a digital signal processor (DSP), or any combination of the above) configured to execute logic stored in a memory (not shown) to perform the operations described herein. As used herein, the terms "logic," "control logic," "instructions," or "application" may include software and / or firmware executed on any of the foregoing processing circuits.
[0128] In some embodiments, the NFC chip 1510 may include an on-board temperature sensor and need not be mounted on a flexible substrate that allows the chip to bend. The NFC chip may have any suitable thickness, such as, for example, a thickness of about 1 mm or greater.
[0129] The label 1500 also includes an NFC antenna 1512 communicatively coupled to the NFC chip 1510. In addition to communicating data to an external device, the NFC antenna 1512 can also be used to inductively and wirelessly collect power from the external device.
[0130] An exemplary implementation of a computer system 1600 that may be used to implement any of the aspects of the techniques and embodiments disclosed herein is illustrated in FIG. 16. The computer system 1600 may include one or more processors 1610, one or more non-transitory computer-readable storage media (e.g., memory 1620 and one or more non-volatile storage media 1630), and a display 1640. The processor 1610 may control writing and reading data to and from the memory 1620 and the non-volatile storage device 1630 in any suitable manner, as the inventive aspects described herein are not limited in this respect. To implement the functions and / or techniques described herein, the processor 1610 may execute one or more instructions stored in one or more computer-readable storage media (e.g., memory 1620, storage media, etc.), which may function as a non-transitory computer-readable storage medium that stores instructions for execution by the processor 1610.
[0131] Code used for the techniques described herein, for example, to identify patients for inclusion in a clinical trial, may be stored on one or more computer readable storage media of computer system 1600. Processor 1610 may execute such code to provide any of the techniques for recognizing objects described herein. Any other software, programs, or instructions described herein may also be stored and executed by computer system 1600. It will be understood that computer code may be applied to any aspect of the methods and techniques described herein. For example, computer code may be applied to interact with an operating system to recognize objects through conventional operating system processes.
[0132] The various methods or processes outlined herein may be coded as software executable on one or more processors using any one of a variety of operating systems or platforms. Additionally, such software may be written using any of a number of suitable programming languages and / or programming or scripting tools, and may be compiled as executable machine code or intermediate code that runs on a virtual machine or suitable framework.
[0133] In this regard, the various inventive concepts may be embodied as at least one non-transitory computer-readable storage medium (e.g., a computer memory, one or more floppy disks, compact disks, optical disks, magnetic tapes, flash memories, circuitry in a field programmable gate array or other semiconductor device, etc.) encoded with one or more programs that, when executed on one or more computers or other processors, implement various embodiments of the invention. The non-transitory computer-readable medium or media may be portable such that the one or more programs stored thereon may be loaded into any computer resource to implement various aspects of the invention as discussed above.
[0134] The terms "program," "software," and / or "application" are used herein in a generic sense to refer to any type of computer code or set of computer-executable instructions employed to program a computer or other processor to implement various aspects of the embodiments as discussed above. Additionally, according to one aspect, it should be understood that one or more computer programs that, when executed, perform the methods of the present invention need not reside on a single computer or processor, but may be distributed in a modular manner among different computers or processors to implement various aspects of the present invention.
[0135] Computer-executable instructions may be in many forms, such as program modules, executed by one or more computers or other devices. Generally, program modules include routines, programs, objects, components, data structures, etc. that perform particular tasks or implement particular abstract data types. Typically the functionality of the program modules may be combined or distributed as desired in various embodiments.
[0136] Also, data structures may be stored in a non-transitory computer-readable storage medium in any suitable form. A data structure may have fields that are related through their locations within the data structure. Such relationships may be achieved by allocating storage to the fields that in turn have locations within the non-transitory computer-readable medium that convey the relationships between the fields. However, any suitable mechanism may be used to establish relationships between information in fields of a data structure, including through the use of pointers, tags, or other mechanisms that establish relationships between data elements.
[0137] Various inventive concepts may be embodied as one or more methods, examples of which are provided. The acts performed as part of a method may be ordered in any suitable manner. Thus, while shown as sequential acts in the exemplary embodiments, embodiments may be constructed in which acts are performed in an order different from that illustrated, which may include performing some acts simultaneously.
[0138] The indefinite articles "a" and "an" as used herein in the specification and claims should be understood to mean "at least one" unless expressly stated otherwise. When used herein in the specification and claims, the phrase "at least one" in connection with a list of one or more elements should be understood to mean at least one element selected from any one or more of the elements in the list of elements, and does not necessarily include at least one of each and every element specifically listed in the list of elements, nor does it exclude any combination of elements in the list of elements. This allows for the optional presence of elements other than those specifically identified in the list of elements to which the phrase "at least one" refers, whether related or unrelated to those specifically identified elements.
[0139] The phrase "and / or" as used herein in the specification and claims should be understood to mean "either or both" of the elements so conjoined, i.e., elements that are conjunctively present in some cases and disjunctively present in other cases. Multiple elements listed with "and / or" should be interpreted in the same manner, i.e., "one or more" of the elements so conjoined. Other elements other than the elements specifically identified by the "and / or" clause may optionally be present, whether related to those elements specifically identified or not. Thus, as a non-limiting example, a reference to "A and / or B," when used in conjunction with open-ended language such as "comprising," in one embodiment refers to only A (optionally including elements other than B), in another embodiment refers to only B (optionally including elements other than A), in yet another embodiment refers to both A and B (optionally including other elements), and so forth.
[0140] As used herein and in the claims, "or" should be understood to have the same meaning as "and / or" as defined above. For example, when separating items in a list, "or" or "and / or" should be interpreted as inclusive; that is, to include at least one, but not only two or more, of a plurality or list of elements, and, optionally, to include additional items not listed. Only terms clearly indicated to the contrary, such as "only one of" or "exactly one of," or, when used in the claims, "consisting of," refer to the inclusion of exactly one element of a plurality or list of elements. In general, as used herein, the term "or" should be interpreted as indicating an exclusive choice (i.e., "one or the other but not both") when followed by an exclusive term, such as "either," "one of," "only one of," or "exactly one of." "Consisting essentially of," when used in the claims, shall have its ordinary meaning as used in the field of patent law.
[0141] In the claims, the use of ordinal terms such as "first," "second," "third," etc. to modify a claim element does not, by itself, imply any priority, precedence, or ordering of one claim element relative to another claim element, or the temporal order in which acts of a method are performed. Such terms are used merely as labels to distinguish an element of one claim having a particular name from another element having the same name (in the absence of the use of the ordinal term).
[0142] The phraseology and terminology used herein is for the purpose of description and should not be regarded as limiting. The use of "including," "comprising," "having," "containing," "involving," and variations thereof are meant to encompass the items listed thereafter as well as additional items.
[0143] Although several embodiments of the present invention have been described in detail, various modifications and improvements will readily occur to those skilled in the art. Such modifications and improvements are intended to be within the spirit and scope of the present invention. Accordingly, the foregoing description is by way of example only and is not intended to be limiting.
[0144] Various aspects are described in this disclosure, including but not limited to the following aspects. 1. A medication delivery device comprising: a housing with a reservoir large enough to hold a medication; an activation button for initiating injection of the medication; and a label affixed to at least a portion of the housing, the label comprising a communication tag configured to cause the mobile device to launch a web browser configured to access a uniform resource locator (URL) when the label is accessed by a mobile device. 2. The medication delivery device of aspect 1, wherein the label comprises at least one of paper and a polymer. 3. The medication delivery device of aspect 1 or 2, wherein the tag comprises an antenna and an NFC chip. 4. A medication delivery device according to any one of aspects 1 to 3, wherein the URL is associated with an authentication server and includes an authentication code provided by the tag. 5. The medication delivery device of aspect 4, wherein the authentication server authenticates the authentication code of the URL to authenticate the medication delivery device. 6. The drug delivery device of any one of aspects 1-5, wherein the drug delivery device further comprises a drug retained in the reservoir. 7. The drug delivery device according to any one of aspects 1-6, wherein the drug delivery device comprises a single-use drug delivery device. 8. The drug delivery device according to any one of aspects 1-6, wherein the drug delivery device comprises a multi-use drug delivery device. 9. The medication delivery device of embodiment 8, wherein the actuator button is rotatable relative to the housing to select a dose size of the medication for injection. 10. A computerized method for verifying an aspect of a medication delivery device, the method comprising: receiving data from a communication tag disposed on the medication delivery device, the medication delivery device comprising a housing having a reservoir large enough to hold a medication, an activation button for initiating injection of the medication, and a label affixed to at least a portion of the housing, the label comprising the tag; and verifying an aspect of the medication delivery device by transmitting at least a portion of the received data to a server. 11. The computerized method of aspect 10, wherein the data received from the tag includes an encrypted code. 12. The computerized method of aspect 10 or 11, wherein verifying an aspect of the medication delivery device includes verifying a source of the medication delivery device. 13. The computerized method of any one of aspects 10-12, further comprising receiving validation data from the server, the validation data indicating authenticity of the aspect of the medication delivery device. 14. The computerized method of embodiment 13, further comprising presenting, via a user interface, information indicative of the validation data. 15. The computerized method of aspect 14, further comprising presenting, via a user interface, additional information associated with at least one of the medication and the medication delivery device. 16. The computerized method of aspect 15, wherein the additional information includes at least one of a name of the medication, a temperature of the medication, a dose size, a dose strength, an image of the medication delivery device, a unique identifier associated with the tag, an expiration date of the medication, a manufacturing lot number, a recall notice, instructions for administering the medication, a previous geographic location of the medication delivery device, and an activation status of the medication delivery device. 17. The computerized method of any one of aspects 14-16, further comprising, upon receiving data from the tag, launching a web browser configured to access a uniform resource locator (URL) associated with the server, the URL including at least one of information indicative of the verification data and the additional information. 18. The computerized method of any one of aspects 15-17, wherein the drug delivery device further comprises a sensor configured to acquire at least a portion of information associated with at least one of the drug and the drug delivery device, and the method further comprises receiving information associated with at least one of the drug and the drug delivery device. 19. A non-transitory computer-readable storage medium comprising instructions, the instructions being operable, when executed by one or more processors on a computing device, to cause the one or more processors to perform a computerized method according to any one of aspects 10-18. 20. A system comprising: a memory storing instructions; and a processor configured to execute the instructions to implement the computerized method of any one of aspects 10-18. 21. A computerized method for tracking ownership of a medication delivery device, comprising: receiving data from a communication tag disposed on the medication delivery device, the medication delivery device comprising a housing having a reservoir large enough to hold a medication, an activation button for initiating injection of the medication, and a label affixed to at least a portion of the housing, the label comprising the tag; transmitting at least a portion of the received data to a server; and providing user authentication information to the server, the server being configured to log an entry based on the received data and the user authentication information, the entry indicating that the user was in possession of the medication delivery device at the time the data was received from the tag disposed on the medication delivery device. 22. The computerized method of aspect 21, wherein the entry further indicates the geographic location of the user at the time the data was received from the tag located on the medication delivery device. 23. The computerized method of aspect 21 or 22, further comprising detecting a potential missed dose when data is not received from the tag within an expected time. 24. The computerized method of aspect 21 or 22, wherein the server is configured to detect a potential missed dose when an entry is not logged within an expected time. 25. The computerized method of any one of aspects 21-24, further comprising suggesting at least one of a timing and an amount of a next medication administration based on the logged entries. 26. The computerized method of any one of aspects 21-24, wherein the server is configured to detect at least one of timing and next medication administration based on logged entries. 27. The computerized method of any one of aspects 21-26, further comprising ordering a replacement medication or reminding the user to order a replacement medication based on the logged entry. 28. The computerized method of any one of aspects 21-26, wherein the server is configured to at least one of order a replacement medication and remind the user to order a replacement medication based on the logged entries. 29. The computerized method of any one of aspects 21-28, wherein the server is configured to log a plurality of entries relating to a plurality of users and provide a report regarding an average level of adherence to the drug regimen among the plurality of users. 30. The computerized method of any one of aspects 21-29, further comprising launching a website configured to prompt the user to provide user authentication information before providing the user authentication information to the server. 31. The computerized method of aspect 30, wherein the website is further configured to prompt the user to provide contact information associated with the communication platform, and the computerized method further includes providing, via the communication platform, a reminder for the user to take a dose of the medication. 32. The computerized method of any one of aspects 21-31, further comprising: receiving first user authentication information regarding the first user; and providing first information to the first user based on the first user authentication information. 33. The computerized method of embodiment 32, further comprising receiving second user authentication information relating to a second user and providing second information to the second user based on the second user authentication information, wherein the second information is different from the first information. 34. The computerized method of aspect 33, wherein the first information includes first instructions for using the medication delivery device and the second information includes second instructions for using the medication delivery device, the first instructions being different from the second instructions. 35. A non-transitory computer-readable storage medium comprising instructions, the instructions being operable, when executed by one or more processors on a computing device, to cause the one or more processors to perform a computerized method described in any one of aspects 21-34. 36. A system comprising: a memory for storing instructions; and a processor configured to execute the instructions to implement a computerized method according to any one of aspects 21 to 34.
Claims
1. 1. A drug delivery device comprising: a housing having a reservoir large enough to hold the medicament; an activation button for initiating injection of the medication; a label affixed to at least a portion of the housing, the label comprising a communication tag configured to cause the mobile device to launch a web browser configured to access a uniform resource locator (URL) when the label is accessed by a mobile device.
2. The medication delivery device of claim 1 , wherein the label comprises at least one of paper and a polymer.
3. The medication delivery device of claim 1 or 2, wherein the tag comprises an antenna and an NFC chip.
4. The medication delivery device of any one of claims 1 to 3, wherein the URL is associated with an authentication server and includes an authentication code provided by the tag.
5. The medication delivery device of claim 4 , wherein the authentication server authenticates the authentication code of the URL to authenticate the medication delivery device.
6. A drug delivery device according to any preceding claim, further comprising a drug held in the reservoir.
7. The drug delivery device of any one of claims 1 to 6, wherein the drug delivery device comprises a single use drug delivery device.
8. The drug delivery device of any one of claims 1 to 6, wherein the drug delivery device comprises a multi-use drug delivery device.
9. The medication delivery device of claim 8 , wherein the actuator button is rotatable relative to the housing to select a dose size of the medication for injection.
10. 1. A computerized method for validating an aspect of a medication delivery device, comprising: receiving data from a communication tag disposed on the medication delivery device, the medication delivery device comprising: a housing having a reservoir large enough to hold the medicament; an activation button for initiating injection of the medication; receiving a label affixed to at least a portion of the housing, the label comprising the tag; and verifying the aspect of the medication delivery device by transmitting at least a portion of the received data to a server.
11. The computerized method of claim 10 , wherein the data received from the tag includes an encrypted code.
12. 12. The computerized method of claim 10 or 11, wherein verifying the aspect of the medication delivery device comprises verifying a source of the medication delivery device.
13. The computerized method of any one of claims 10 to 12, further comprising receiving validation data from the server, the validation data indicating authenticity of the aspect of the medication delivery device.
14. 14. The computerized method of claim 13, further comprising presenting, via a user interface, information indicative of the verification data.
15. 15. The computerized method of claim 14, further comprising presenting additional information associated with at least one of the medication and the medication delivery device via the user interface.
16. 16. The computerized method of claim 15, wherein the additional information includes at least one of a name of the medication, a temperature of the medication, a dose size, a dose strength, an image of the medication delivery device, a unique identifier associated with the tag, an expiration date of the medication, a manufacturing lot number, a recall notice, instructions for administering the medication, a previous geographic location of the medication delivery device, and an activation status of the medication delivery device.
17. 17. The computerized method of claim 14, further comprising: upon receiving the data from the tag, launching a web browser configured to access a Uniform Resource Locator (URL) associated with the server, the URL including at least one of the information indicative of the verification data and the additional information.
18. the medication delivery device further comprising a sensor configured to obtain at least a portion of the information associated with at least one of the medication and the medication delivery device; The computerized method of any one of claims 15 to 17, wherein the method further comprises receiving the information relating to at least one of the medication and the medication delivery device.
19. A non-transitory computer readable storage medium comprising instructions, the instructions being operable, when executed by one or more processors on a computing device, to cause the one or more processors to perform the computerized method of any one of claims 10 to 18.
20. A system comprising a memory for storing instructions and a processor configured to execute said instructions to perform the computerized method of any one of claims 10 to 18.
21. 1. A computerized method for tracking ownership of a medication delivery device, comprising: receiving data from a communication tag disposed on the medication delivery device, the medication delivery device comprising: a housing having a reservoir large enough to hold the medicament; an activation button for initiating injection of the medication; receiving a label affixed to at least a portion of the housing, the label comprising the tag; transmitting at least a portion of the received data to a server; and providing user authentication information to the server, wherein the server is configured to log an entry based on the received data and the user authentication information, the entry indicating that a user was in possession of the medication delivery device at the time the data was received from the tag located on the medication delivery device.
22. 22. The computerized method of claim 21, wherein the entry further indicates a geographic location of the user at the time the data was received from the tag located on the medication delivery device.
23. 23. The computerized method of claim 21 or 22, further comprising detecting a potential missed dose when data is not received from the tag within an expected time.
24. 23. The computerized method of claim 21 or 22, wherein the server is configured to detect a potential missed dose when an entry is not logged within an expected time.
25. 25. The computerized method of any one of claims 21 to 24, further comprising suggesting at least one of a timing and amount of a next medication administration based on the logged entries.
26. 25. The computerized method of any one of claims 21 to 24, wherein the server is configured to detect at least one of the timing and the next medication administration based on the logged entries.
27. 27. The computerized method of any one of claims 21 to 26, further comprising ordering a replacement medication or reminding the user to order the replacement medication based on the logged entries.
28. 27. The computerized method of any one of claims 21 to 26, wherein the server is configured to at least one of order the replacement medication and remind the user to order the replacement medication based on the logged entries.
29. 29. The computerized method of any one of claims 21 to 28, wherein the server is configured to log a plurality of entries relating to a plurality of users and provide a report on an average level of adherence to a drug regimen among the plurality of users.
30. 30. The computerized method of any one of claims 21 to 29, further comprising launching a website configured to prompt a user to provide said user authentication information before providing said user authentication information to said server.
31. the website is further configured to prompt the user to provide contact information associated with a communications platform; 31. The computerized method of claim 30, further comprising providing, via the communication platform, a reminder for the user to take a dose of the medication.
32. Receiving first user authentication information relating to a first user; The computerized method of any one of claims 21 to 31, further comprising: providing first information to the first user based on the first user authentication information.
33. receiving second user authentication information relating to a second user; 33. The computerized method of claim 32, further comprising: providing second information to the second user based on the second user authentication information, the second information being different from the first information.
34. 34. The computerized method of claim 33, wherein the first information includes first instructions for using the medication delivery device and the second information includes second instructions for using the medication delivery device, the first instructions being different from the second instructions.
35. A non-transitory computer readable storage medium comprising instructions, the instructions being operable, when executed by one or more processors on a computing device, to cause the one or more processors to perform the computerized method of any one of claims 21 to 34.
36. A system comprising a memory for storing instructions and a processor configured to execute said instructions to perform the computerized method of any one of claims 21 to 34.
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