WO2025136774A1 - Communication tag for a drug product - Google Patents

Abstract

A structure of a label of a drug product, including a communication tag embedded within the label to be coupled to a drug delivery system, drug storage container, or another underlying device. The label includes a plurality of protrusions positioned in a configuration at least partially surrounding the communication tag. The plurality of protrusions may have a height less than the height of the communication tag relative to a top surface of the label.

Description

COMMUNICATION TAG FOR A DRUG PRODUCT

FIELD OF THE DISCLOSURE

[0001] The present disclosure relates to a label for a drug product having a communication tab. In particular, the present disclosure relates to a label for a drug product including a protection feature for a corresponding communication tab.

BACKGROUND OF THE DISCLOSURE

[0002] Counterfeiters sell products that are packaged to look as though they were manufactured by a certain manufacturer, when, in fact, they were not. Consuming counterfeit medications can be unsafe and may prevent a patient from receiving the medication that is needed to treat his or her disease or condition. As a result, such counterfeit products can pose concerns for both patients and manufacturers.

SUMMARY

[0003] The present disclosure relates to a structure of a label of a drug product, including a communication tag embedded within the label to be coupled to a drug delivery system, drug storage container, or another underlying device. The label includes a plurality of protrusions positioned in a configuration at least partially surrounding the communication tag. The plurality of protrusions may have a height less than the height of the communication tag relative to a top surface of the label.

[0004] In a first aspect of the disclosure, a label for coupling to an underlying device is disclosed. The label comprises at least one layer having a top side and a bottom side adapted to be attached to the underlying device, a communication tag attached to the at least one layer, and at least one protective protrusion positioned at least partially around a perimeter of the communication tag in a configuration. The communication tag has a first height extending above the top side of the at least one layer. The at least one protective protrusion has a second height extending above the top side of the at least one layer, the second height being less than the first height. [0005] In another aspect of the disclosure, a drug delivery device is disclosed. The drug delivery device comprises a housing and a syringe assembly arranged within the housing. The syringe assembly includes a needle having a first position within the housing and a second position in which the needle projects outwardly from the housing. The drug delivery device also comprises a plunger configured to actuate the needle from the first position to the second position and a user-graspable portion defined by the housing. The user-graspable portion includes a label having a top side, a bottom side, an embedded communication tag, and at least one protective protrusion positioned at least partially around a perimeter of the communication tag in a configuration. The at least one protective protrusion has a first height extending above the top side of the label, and the communication tag has a second height extending above the top side of the label. The second height is greater than the first height.

[0006] In various aspects of the disclosure, a first protective protrusion of the at least one protective protrusion may be positioned to a first side of the communication tag and a second protrusion of the at least one protective protrusion may be positioned to a second side of the communication tag.

[0007] In various aspects of the disclosure, at least one protective protrusion may be positioned completely around the perimeter of the communication tag.

[0008] In various aspects of the disclosure, the configuration may be a circle. The circle may have a diameter of about 4.75 mm to 4.85 mm.

[0009] In various aspects of the disclosure, the configuration may be a diamond.

[0010] In various aspects of the disclosure, the second height may be 66% or less of the first height.

[0011] In various aspects of the disclosure, the first height may be from and including about 68 gm to and including about 71 gm.

[0012] In various aspects of the disclosure, the second height is from and including about 31 gm to and including about 45 gm.

[0013] In various aspects of the disclosure, the configuration may be formed of a plurality of protective protrusions positioned at least partially around the perimeter of the communication tag. The second height may be an average of the plurality of protective protrusions. The average height may be about 42 pm.

[0014] In various aspects of the disclosure, the label may further include a tactile feature having a third height extending above the top side of the at least one layer. The third height may be less than the first height and the second height. The third height may be 53% or less of the first height. The third height may be from and including about 26 pm to and including about 37 pm. The tactile feature may include a plurality of tactile features, and the third height may be a second average height of each individual tactile feature of the plurality of tactile features. The second average height may be about 32 pm.

[0015] In various aspects of the disclosure, the label may further include a finishing layer positioned adjacent to the top side of the at least one layer.

[0016] In various aspects of the disclosure, the label may further include a first adhesive layer positioned adjacent to the bottom side of the at least one layer. The label may further include a second adhesive layer positioned adjacent to the first adhesive layer opposite the at least one layer. The label may further include an antenna layer sandwiched between the first adhesive layer and the second adhesive layer.

[0017] In various aspects of the disclosure, the at least one protective protrusion may be continuous.

[0018] In various aspects of the disclosure, the at least one protective protrusion may be semi-continuous.

[0019] In various aspects of the disclosure, the at least one protective protrusion may be discontinuous.

[0020] In various aspects of the disclosure, the at least one protective protrusion may have an elongated shape.

[0021] In various aspects of the disclosure, the at least one protective protrusion may be within a 3 mm radius of the communication tag. The at least one protective protrusion may be within a 2.5 mm radius of the communication tag. [0022] In various aspects of the disclosure, the at least one protective protrusion may have a thickness of about 0.65 mm to about 1.5 mm.

[0023] In various aspects of the disclosure, the configuration may be formed by a plurality of protursions.

[0024] In various aspects of the disclosure, the configuration may form one of a circle or a diamond.

[0025] In various aspects of the disclosure, the first height may be 31-45 pm.

[0026] In various aspects of the disclosure, the second height may be 68-71 pm.

BRIEF DESCRIPTION OF THE DRAWINGS

[0027] The above-mentioned and other features and advantages of this disclosure, and the manner of attaining them, will become more apparent and will be better understood by reference to the following description of embodiments of the invention taken in conjunction with the accompanying drawings, wherein:

[0028] FIG. l is a block diagram illustrating an exemplary system for verifying the aspect of a medication delivery device, according to some embodiments;

[0029] FIG. 2A illustrates an exemplary medication delivery device in its initial pre-use configuration, according to some embodiments;

[0030] FIG. 2B illustrates the medication delivery device of FIG. 2A after its end cap has been removed, but before the device has been activated to deliver medication;

[0031] FIG. 2C illustrates the medication delivery device of FIG. 2A after the device has been activated to deliver medication;

[0032] FIG. 3A shows an exemplary label that includes a communication tag, according to some embodiments;

[0033] FIG. 3B shows a view of the back of the exemplary label of FIG. 3A; [0034] FIG. 4A shows an exemplary label having an incorporated communication tag, the exemplary label including a plurality of tactile features and a plurality of protrusions arranged in a first configuration;

[0035] FIG. 4B shows an exemplary label having an incorporated communication tag, the exemplary label including a plurality of tactile features and a plurality of protrusions arranged in a second configuration; and

[0036] FIG. 5 is a schematic illustrating an exemplary layered structure of an exemplary label, including a plurality of tactile features having a first height, a plurality of protrusions having a second height, and an incorporated communication tag having a third height.

[0037] Corresponding reference characters indicate corresponding parts throughout the several views. The exemplifications set out herein illustrate exemplary embodiments of the invention and such exemplifications are not to be construed as limiting the scope of the invention in any manner.

DETAILED DESCRIPTION

[0038] For the purpose of promoting an understanding of the principles of the invention, reference will now be made to the embodiments illustrated in the drawings and specific language will be used to describe the same. It will nevertheless be understood that no limitation of the scope of the invention is thereby intended. Any alterations and further modifications in the described embodiments, and any further applications of the principles of the invention as described herein are contemplated as would normally occur to one skilled in the art to which the invention relates. One embodiment of the invention is shown in great detail, although it will be apparent to those skilled in the relevant art that some features that are not relevant to the present invention may not be shown for the sake of clarity.

[0039] Provided herein are techniques for verifying an aspect of a medication delivery device. According to some embodiments, the techniques verify the aspect of the medication delivery device based on data received from a communication tag disposed on the medication delivery device. The communication tag may be a RFID tag and/or a 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 techniques transmit 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 a result of the authenticating. For example, the verification information may indicate whether a source (e.g., a manufacturer and/or supplier) of the medication delivery device is verified and, by extension, whether the medication delivery device is a verified product, as opposed to a counterfeit product.

[0040] Also provided herein are techniques for tracking possession of a medication delivery device. According to some embodiments, the techniques track possession of the medication delivery device based on a time that data was received from a tag disposed on the medication delivery device. After receiving data from the tag, the techniques launch a website prompting a user to provide user credentials. For example, the website may prompt a user to provide a username and password, a bearer token, a refresh token (e.g., derived from previous authentication, such as via using a username and password), and/or other user credentials. According to some embodiments, the techniques provide 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 a user who is associated with the provided user credentials was in possession of the medication delivery device at the time that data was received from the tag disposed on the medication delivery device. According to some embodiments, the entry may also indicate a geographical 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 geographical location may be derived from an IP address from which the server received the data from the tag, and/or by location data supplied by a mobile device (e.g., a smartphone) associated with the user.

[0041] Product safety and liability concerns arise in drug distribution channels that are not strictly regulated. For example, counterfeiters may sell medications that are packaged to look like they are from a certain manufacturer, but which are, in fact, counterfeit products. Such counterfeit products can pose problems; for example, such products can pose safety concerns for end patients who need assurance that the medication they purchased was in fact a genuine drug article manufactured by the verified manufacturer. As another example, if a counterfeit product causes one or more problems to an end patient (e.g., side effects) and the patient does not realize it is a counterfeit product, it may negatively affect the reputation of the true manufacturer.

[0042] Accordingly, techniques for verifying an aspect of a medication delivery device and for tracking possession of a medication delivery device are disclosed herein. In some embodiments, the techniques can evaluate data received from a communication tag disposed on a medication delivery device that is indicative of a unique authentication code. The authentication code changes over time in an unpredictable manner that is only known to a server configured to authenticate the authentication code. For example, the authentication code may change based on activity, such that each time a mobile device is brought within proximity to the medication delivery device to enable the mobile device to communicate with the tag, the authentication code would change. The use of a tag that generates such an unpredictable authentication code is useful for preventing counterfeiters from being able to successfully counterfeit at least this aspect of the medication delivery device. According to some embodiments, the techniques verify an aspect of the medication delivery device (e.g., a source of the medication delivery device) by transmitting at least some of the data received from the tag (e.g., the authentication code) to the server.

[0043] While embodiments of the technology described herein describe techniques for verifying an aspect of and tracking possession of a medication delivery device, it should be appreciated that such techniques may be applied to any suitable type of medication container. For example, the techniques described herein may be used to verify an aspect of and track possession of a pill bottle, a drug vial, a blister pack, or any other suitable type of medication container, as aspects of the technology are not limited in this respect. According to some embodiments, a tag is disposed on such a medication container and is configured to communicate with a mobile device.

[0044] In some embodiments, the communication tag may comprise any electronic circuit configured to communicate wirelessly with a reader device, including a mobile device or commercial reader. For example, the communication tag may be a RFID tag and/or a NFC tag.

[0045] While various embodiments have been described, it will be apparent to those of ordinary skill in the art that many more embodiments and implementations are possible. Accordingly, the embodiments described herein are examples, 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 with every embodiment.

[0046] FIG. 1 is a block diagram depicting an exemplary system 100 for verifying an aspect of a medication delivery device, according to some embodiments. System 100 includes medication delivery device 102 and mobile device 106, which communicates with server(s) 110 and data store(s) 112 via network 108. It should be appreciated that system 100 is illustrative and that a system may have one or more components of any suitable type in addition to or instead of the components illustrated in FIG. 1. For example, rather than mobile device 106, system 100 may include a commercial reader, such as a commercial NFC reader or a commercial RFID reader.

[0047] In some embodiments, the mobile device 106 is configured to receive data 124 from a near field communication tag 104 disposed on the medication delivery device 102. For example, the mobile device 106 may receive data 124 when it is in proximity to (e.g., within 10 cm, within 6 cm, within 4 cm, etc.) to the medication delivery device 102.

[0048] Medication delivery device 102 may include any suitable medication delivery device, such as an autoinjector or a pre-filled syringe, as aspects of the technology are not limited in this respect. An exemplary medication delivery device 20 is described herein in more detail, including at least with respect to FIGS. 2A-2C; however, it is also within the scope of the disclosure that medication delivery device 102 may refer to other medical devices, including pens, vials, cartridges, cartons, etc.

[0049] In some embodiments, the medication delivery device 102 optionally includes sensor(s) 122. For example, the medication delivery device 102 may include a temperature sensor configured to sense a temperature. The sensed temperature may be a temperature of the medication delivery device 102, a temperature of medication contained within the medication delivery device 102, and/or ambient temperature. The temperature sensor(s) 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. [0050] Additionally, or alternatively, the sensor(s) 122 may include sensor(s) for determining other parameters of the medication delivery device 102, such as an amount of medication remaining in the device’s reservoir, a type of medication stored within the device’s reservoir, an amount of medication selected for delivery, an amount of medication actually delivered, whether the medication delivery device is in contact with skin tissue, and the like.

[0051] In some embodiments, a communication tag 104 is disposed on the medication delivery device. For example, communication 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 of any other suitable material, as aspects of the technology described herein are not limited in this respect. An exemplary label, which incorporates a communication tag, is described herein including at least with respect to FIGS. 3A and 3B.

[0052] In some embodiments, where the communication tag 104 includes an NFC tag, the communication tag 104 may include an NFC chip coupled to NFC antenna(s). The NFC chip may take the form of any suitable NFC chip, such as but not limited to an NFC chip manufactured by NXP®. The NFC antenna(s) may take the form of any suitable NFC antenna(s), such as, but not limited to, the NFC antenna(s) manufactured Avery Dennison® or Identiv.

However, it should be appreciated that aspects of the technology described herein are not limited to any particular NFC tag or other communication tag.

[0053] Communication tag 104 is configured to communicated data 124 to and/or from mobile device 106 using an corresponding wireless transmission protocol, e.g., an NFC wireless transmission protocol or another transmission protocol compatible with communication tag 104. Data 124 includes data associated with the communication 104, data associated with the medication delivery device 102, data associated with the medication contained within the medication delivery device 102, and/or data associated with the sensor(s) 122. Accordingly, the sensor(s) 122 may be communicably coupled to communication tag 104.

[0054] The data associated with the communication tag 104 includes data indicative of an authentication code 124a generated by the communication tag 104. When the mobile device 106 is placed in proximity to the communication tag, the communication tag generates an authentication code that is only known to server(s) 110. For example, a new authentication code may be generated each time mobile device 106 and/or any other suitable mobile device is placed in proximity to the medication delivery device 102 so as to enable such mobile device to communicate with communication tag 104. In some embodiments, the authentication code is encrypted prior to transmission to mobile device 106.

[0055] The data associated with the sensor(s) 122 includes data indicative of the output of the sensor(s) 122. For example, when the sensor(s) 122 include a temperature sensor, the data may indicate the temperature of the medication delivery device 102, the temperature of medication contained within the medication delivery device 102, and/or the ambient temperature.

[0056] According to some embodiments, in response to receiving data 124 from the communication 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., 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 geographical location of the mobile device 106 when it received 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 communication tag 104.

[0057] Mobile device 106 may comprise any device that receives, stores, and/or processes data 124 from communication tag 104 via a wireless signal received by a communication circuit 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 signals transmitted by a communication circuit of the medication delivery device 102, or it may be a passive signal, in which mobile device 106 senses modulations to a signal transmitted by the communication tag 104. Mobile device 106 may include a separate communication circuit configured to communicate with other devices (e.g., using long-range or cellular transmission protocols).

[0058] Mobile device 106 may further include a processing circuit and memory (not shown). The processing circuit may take the form of a processor (e.g., a microprocessor or microcontroller, field-programmable gate arrays (FPGAs) and/or digital signal processors (DSPs, or any combination of the foregoing) configured to execute logic stored in a memory to perform the operations described herein. The term “logic”, “control logic”, “instructions” or “application” as used herein may include software and/or firmware executing on any of the aforementioned processing circuits. The memory may be any suitable computer readable medium that is accessible by the processing circuit and includes both volatile and non-volatile memory. Exemplary memory includes random-access memory (RAM), read-only memory (ROM), electrically erasable programmable ROM (EEPROM), flash memory, a magnetic storage device, optical disk storage, or any other suitable medium which is configured to store data and which is accessible by the processor circuit, whether directly or indirectly via one or more intermediary devices or wired or wireless communication links. Although the preceding description assumes that the memory is separate from but communicably coupled to the processing circuit, in some embodiments the memory may also be integrated with the processing circuit. In some embodiments, instead of a processor that executes logic stored in memory, the processing circuit may take the form of hard-wired logic, e.g., a state machine and/or an application-specific integrated circuit (ASIC) that performs the functions described herein.

[0059] 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 comprise a graphical user interface (GUI) including a touchscreen display. The touchscreen display allows the user to interact with presented information, menus, buttons, and other data to provide information to the user or to receive user input from the user. Additionally, or alternatively, a keyboard, keypad, microphone, mouse pointer, or other suitable user input device may be provided.

[0060] Upon receiving data 124 from the medication delivery device 102, mobile device 106 launches a web browser 128 configured to access a uniform resource locator (URL) 132 associated with server(s) 110 via network 108. In some embodiments, a website associated with the URL 132 is displayed on the user interface 130 of the mobile device 106. Additionally, or alternatively, upon receiving data 124 the mobile device searches for and launches a previously- downloaded application program (e.g., mobile app) configured to access the URL 132. The received data 124 may then be passed to the mobile app via server(s) 110. Additionally, or alternatively, the data 124 may be directly transmitted from the medication delivery device 102 to the server(s) 110. [0061] In some embodiments, server(s) 119 include one or multiple computing devices. When server(s) 110 include multiple computing devices, the device(s) may be physically colocated (e.g., in a single room) or distributed across multiple physical locations. In some embodiments, server(s) 110 may be part of a cloud computing infrastructure. In some embodiments, one or more server(s) 110 may be co-located in a facility operated by an entity.

[0062] Network 108 may be or 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 the network 108 using one or more wired links, one or more wireless links, and/or any suitable combination thereof. Accordingly, the network 108 may be, for example, a hard-wired network (e.g., a local area network within a healthcare facility), a wireless network (e.g., connected over Wi-Fi and/or cellular networks), a cloud-based computing network, or any combination thereof.

[0063] The URL 132 may be associated with the authentication code 124a provided by communication tag 104 disposed on the medication delivery device 102. In some embodiments, the server(s) 110 include 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 communication tag 104 and the associated medication delivery device 102 is a genuine product manufactured and/or provided by a verified source (e g., a verified manufacturer, provider, etc.). In some embodiments, authentication server authenticates the authentication code 124a by decrypting the authentication code 124a (e.g., when the authentication code 124a is encrypted by communication tag 104). The authentication server then looks up the authentication code 124a in data store(s) 112 to determine whether it is authentic.

[0064] Additionally, or alternatively, server(s) 119 may query data store(s) 112 to identify additional information associated with the authentication code 124a and, by extension, the medication delivery device 102 from which the authentication code 124a was received. For example, the information may include information related to the medication contained within medication delivery device 102, such as medication name, medication dosage, recall notices, expiration date, and manufacturing lot number. The information may indicate a dose regimen and/or instructions for taking the medication. The information may include information related to one or more preceding events, such as times and/or locations of preceding events.

[0065] In some embodiments, server(s) 110 are configured to evaluate data associated with sensor(s) 122. Server(s) 110 may determine temperature-based information, such as whether the medication contained in the medication delivery device 102 is warm enough to be administered. Additionally, or alternatively, server(s) 110 may determine dosage-based information, such as an amount of medication that was dispensed and/or programmed, based on the data detected by sensor(s) 122.

[0066] In some embodiments, the server(s) 110 transmit verification data 134 to mobile device 106 (e.g., to web browser 128 and/or to a mobile app). The verification data 134 may include data indicative of the authentication of the medication delivery device 102 and/or the communication tag 104. Additionally, or alternatively, the server(s) 110 transmit additional data (not shown) to mobile device 106. The additional data includes the information associated with the sensor(s) 122 and/or the information associated with the authentication code 124a and the medication delivery device 102.

[0067] In some embodiments, at least some of the verification data 134 and/or additional data may be part of a graphical user interface or “GUI” (e.g., user interface 130) presented to the user. In some embodiments, the GUI may be presented to the user as part of the website displayed by the 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.

[0068] An exemplary medication delivery device 20 is illustrated in various operational states in FIGS. 2A-2C. Examples of such a device and its operation are described in U.S. Pat. No. 8,734,394 B2 issued May 27, 2014 to Adams et al. and in U.S. Patent App. Pub. No.

2021/0093784 Al published April 1, 2021 to Adams et al., the entire disclosure of each of which is hereby incorporated herein by reference. Device 20 includes a syringe assembly 22, a drive mechanism 24, and a retraction mechanism 26. Syringe assembly 22 includes a barrel 30 forming a reservoir for holding a medication, and a piston 32 disposed within the barrel 30 for driving the medication outside the barrel. Syringe assembly 22 also includes a needle assembly 33 having a hollow injection needle 34 and a needle hub 35 which mounts needle 34 to syringe barrel 30. A lower body support member 29 coupled to device housing 38 surrounds needle 34.

Advancing piston 32 within barrel 30 toward needle 34 dispenses medication through needle 34.

[0069] Devices described herein, such as device 20, may further comprise a medication, such as, for example, within the syringe barrel 30. In another embodiment, a system may comprise one or more devices including device 20 and a medication. The term “medication” or “drug” refers to one or more therapeutic agents including but not limited to insulins, 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 galcanzeumab or lasmiditan, and any therapeutic agent that is capable of delivery by the devices described herein. The medication as used in the device may be formulated with one or more excipients. The device is operated in a manner generally as described above by a user, caregiver or healthcare professional to deliver medication to a patient. As used herein, the term “user” may refer to an operator of the devices described herein, and the term “patient” may refer to a person receiving the medication. In some cases, the user and the patient may be the same person (e.g., the patient is operating the devices described herein to give him/herself an injection). In other cases, the user and the patient may be different persons (e.g., the user may be a person providing care to the patient).

[0070] FIG. 2A illustrates device 20 in its initial, pre-use configuration. Here, an end cap 36 is secured to lower body support member 29 (which is in turn coupled to device housing 38). End cap 36 covers a proximal end opening 40 in housing 38. As used herein, distal and proximal refer to axial locations relative to an injection site when the apparatus is oriented for use at such site, whereby, for example, proximal end of the housing refers to the housing end that is closest to such injection site, and distal end of the housing refers to the housing end that is farthest from such injection site. Also as used herein, an “injection site” may refer to the exact spot on a patient’s body that is injected by a needle, as well as body tissue surrounding the spot where the needle injects (e.g., within l-5cm or l-10cm of the spot where the needle punctures the patient’s skin). Housing 38 may be formed from a plastic material and is shown extending generally longitudinally between a distal end in close proximity to an actuating button 52 and a proximal end in close proximity to the proximal end opening 40 along a longitudinal axis 48. As shown in FIG. 2B, housing 38 may comprise a user-graspable portion 37 configured to be grasped by a hand of a user, the user-graspable portion 37 extending a radial distance 41 outward from longitudinal axis 48. In some embodiments, the radial distance 41 may be between 5-10mm in length (e.g., in some embodiments, 5-8mm may be a suitable length). Also as shown in FIG. 2B, housing 38 may also comprise an outwardly-flared end portion 39 at a proximal end of the housing adjacent the proximal opening 40.

[0071] A needle guard 42 is mounted on syringe assembly 22 and covers and surrounds needle 34. End cap 36 and needle guard 42 protect the user from accidental needle pricks and also protect needle 34 from damage. When using device 20 to dispense medication, for example, injecting the medication into a patient, end cap 36 and needle guard 42 are first removed. FIG. 2B illustrates device 20 after removal of end cap 36 and needle guard 42 from syringe assembly 22, wherein the syringe assembly is in a storage position and device 20 is ready for a dispensing event.

[0072] Syringe assembly 22 is moveable relative to the medication-delivery device 20 between a storage position and an injection position. FIG. 2C illustrates device 20 after the syringe assembly 22 has been moved relative to device 20 to an injection position from its storage position that is shown in FIG. 2B. In the storage position (FIGS. 2A and 2B), needle 34 is retracted to a position such that needle 34 is disposed within housing 38 of device 20. In the injection position (FIG. 2C), needle 34 projects outwardly from housing 38 beyond proximal opening 40 in the proximal direction parallel to longitudinal axis 48 whereby needle 34 may be inserted into a patient.

[0073] Drive mechanism 24 includes a plunger 44 which engages piston 32. Drive mechanism 24 includes a spring 46 that drives plunger 44 in a translational movement. In the illustrated embodiment, spring 46 advances plunger 44 along a linear path defined by the longitudinal axis 48 of device 20. As plunger 44 is advanced, foot 50 of plunger 44 contacts piston 32. As the plunger 44 is further advanced, syringe assembly 22 is advanced along axis 48 from its storage position to its injection position. After advancement of syringe assembly 22 to its injection position, the continued proximal advancement of plunger 44 advances piston 32 proximally within barrel 30 from its initial piston position (shown in FIGS. 2A and 2B) to its final piston position (shown FIG. 2C) to cause medication to be dispensed from needle 34 in a dispensing event. Prior to any dispensing of medication and when syringe barrel 30 holds the full original volume of medication, piston 32 will be in its initial piston position. After advancing piston 32 the full extent of its travel length toward needle assembly 33, piston 32 will be in its final piston position proximate needle assembly 33 and the medication from within barrel 30 will have been discharged. In some embodiments, syringe assembly 22 will hold a single dose of medication which will be delivered in a single injection event and piston 32 will be advanced from its initial piston position to its final piston position in that single injection event to thereby deliver the entire single dose contents of syringe assembly 22. While the device is shown as a single use device, device 20 may also be configured as a multiple-use device with appropriate modifications.

[0074] The advancement of plunger 44 will generally not result in the dispensing of medication from syringe assembly 22 until after syringe assembly 22 has been advanced to the injection position. There are factors that may inhibit the medication from being dispensed before the syringe is advanced to the injection position. A factor may be the friction between piston 32 and barrel 30. Typically, piston 32 will be formed out of a rubber material and barrel 30 will be glass. The frictional resistance between these two components may be sufficient to prevent the advancement of piston 32 within barrel 30 until syringe assembly 22 is advanced to its injection position and engagement with a suitable stop member prevents the further advancement of syringe assembly 22. Additionally, the medication within the syringe may be somewhat viscous and thereby somewhat resistant to flowing out of needle 34. If necessary, modification of piston 32 and syringe barrel 30 to alter the frictional resistance of the dispensing motion of the engagement member 32 relative to syringe barrel 30 may limit or prevent the premature dispensing of medication before container 22 reaches its injection position.

[0075] To activate drive mechanism 24, a person depresses actuating button 52 at the distal end of device 20. Depressing button 52 disengages one or two elongate prongs 54 on plunger 44 from a shuttle assembly 60 thereby allowing spring 46 to expand so as to axially advance plunger 44. Spring 46 has a helical shape and surrounds prongs 54. The proximal end of spring 46 biasingly engages a flange on plunger 44.

[0076] Shuttle assembly 60 may include an upper shuttle member 62 and a lower shuttle member 64. Shuttle members 62, 64 are fixed together in the final assembly. In the final assembly, upper shuttle member 62 captures button 52 and spring 46 limiting the axial movement of these parts in the distal direction. Prongs 54 engage surfaces on upper shuttle 62 when the device is in the condition shown in FIGS. 2A and 2B. Depressing button 52 causes tabs on button 52 to engage ramps (not shown) on prongs 54 to bias prongs 54 inwardly to disengage prongs 54 from upper shuttle member 62. After prongs 54 have been disengaged, spring 46 exerts a biasing force on a flange on plunger 44 to advance plunger 44 from the position shown in FIG. 2B to the position shown in FIG. 2C as spring 46 transitions from its compressed state to an expanded state. As plunger 44 is advanced, it moves syringe assembly 22 to the injection position and then advances piston 32 to dispense medication as discussed above.

[0077] After the dispensing event is complete, retraction mechanism 26 optionally moves syringe assembly 22 from the injection position shown in FIG. 2C back to a retracted position. More specifically, the retraction mechanism is adapted to move the medication container from the injection position to the retracted position in a retraction movement. The retracted position may be similar to the storage position in that the syringe assembly is drawn back into the housing 38 such that needle 34 no longer projects proximally from proximal opening 40 and is disposed entirely within housing 38. In some embodiments, the retracted position may be the same as the storage position. In other embodiments, however, a syringe assembly 22 in the retracted position may be located slightly proximal or distal to a syringe assembly in the storage position. In the illustrated embodiment, the retraction mechanism includes a spring 66, a syringe carrier and a rotary member 70 that acts as a follower. In yet other embodiments, the device 20 may include no retraction mechanism 26 such that the syringe assembly remains in its injection position indefinitely after the medication has been dispensed, until the syringe assembly is manually removed or repositioned by a user.

[0078] Plunger 44 may include an outrigger (not shown) which unlocks rotary member 70 as plunger 44 nears the end of its travel in the proximal direction. Rotary member 70 is rotationally secured to lower shuttle member 64 by engagement between a latch and a latching recess in lower shuttle member 64. The outrigger unlocks member 70 by depressing the latch. Spring 66 is torsionally preloaded and has one end engaged with member 70 and an opposite end engaged with shuttle assembly 60. Upon depression of the latch, spring 66 causes member 70 to rotate.

[0079] Member 70 is rotatable within housing 38 but is not axially moveable relative to housing 38. Other embodiments may include a member 70 that is also axially movable. The rotation of member 70 serves as a delay mechanism to prevent retraction mechanism 26 from retracting syringe assembly 22 until after the syringe assembly has finished delivering its dose of medication. The speed of rotation of member 70 may be adjusted by adjusting a viscosity of grease disposed on or around surfaces of member 70 that are in contact with housing 38 - a more viscous grease results in slower rotation, while a less viscous grease results in faster rotation. A radial flange on rotary member 70 may engage a ledge within housing member 38 to limit the proximal movement of member 70. Spring 66 may also be compressively preloaded such that it is initially in a compressed state. In this compressed state, spring 66 may exert an axial force, torsional force, or both forces on member 70 to bias member 70 proximally to thereby maintain member 70 in an axial position where the radial flange of member 70 engages the interior ledge of housing member 38.

[0080] Shuttle assembly 60 may include axially extending channels or ribs that engage corresponding features on housing member 38 that allow shuttle assembly 60 to move axially within housing 38 but which prevent the relative rotation of shuttle assembly 60 relative to housing member 38. Shuttle assembly 60 is biased in the distal direction by spring 66 but is prevented from moving distally by engagement of a latch (not shown) before activation of drive mechanism 24. When rotary member 70 completes its rotation, it disengages the aforementioned latch, thus allowing shuttle assembly 60 to move distally under the biasing force of spring 66.

[0081] As shuttle assembly 60 moves distally, it carries syringe assembly 22 distally and moves it back to the retracted position. Also, as shuttle assembly 60 moves, spring 66 transitions from its compressed state to an expanded state. Spring 66 biases the retraction mechanism 26 distally and thereby maintains syringe assembly 22 in its retracted position after an injection event. In some embodiments, as shuttle assembly 60 moves distally, spring 46 of drive mechanism 24 may also transition from an expanded state to a compressed state. A locking mechanism such as a detent on the shuttle assembly 60 and a recess on the housing 38 member may additionally provide a locking engagement to secure syringe assembly 22 in the retracted position with needle 34 disposed within housing 38 after an injection event whereby the user may then dispose or otherwise handle device 20 in a safe manner.

[0082] FIG. 3 A shows an exemplary label 1500 that includes a communication tag 1504. In some embodiments, the label 1500 is wrapped around an external surface of a medication delivery device. For example, the exemplary label may be wrapped around the external surface of user-graspable portion 37 of medication-delivery device 20. The label 1500 may comprise a flexible paper and/or plastic material that may be attached to the exterior surface of device 20. Label 1500 may be attached using any of a variety of methods, including (but not limited to) using adhesive, adhesion film (e.g., polyurethane films), magnetic attachments, clip-on attachments, ultrasonic bonding / welding, injection molding / in-mold labeling, laser joining / welding, and the like. Label 1500 may be printed with information regarding the device 20 and/or regarding the medication stored within device 20, such as the medication’s name, manufacturer name, manufacturing batch / lot number, expiration date, instructions for use and/or storage, the amount of medication stored therein, and the like.

[0083] In some embodiments, a communication tag 1504 is incorporated in label 1500. As described above, a mobile device may be placed in proximity to the communication tag 1504 to receive data from the communication tag 1504. The label 1500 may include a graphic 1502 that indicates a position of the communication tag 1504 within the label 1500. For example, a user may tap a mobile device against the medication delivery device near the graphic 1502 to query the communication tag 1504.

[0084] FIG. 3B shows a view of the back surface of label 1500. As shown, label 1500 comprises the communication tag 1504. According to some embodiments, the communication tag 1504 comprises chip 1510 and antenna(s) 1512. According to some embodiments, the communication tag 1504 may have any suitable dimensions. For example, the communication tag 1504 may have a width (and/or length) of at least 8mm, at least 10mm, at least 12mm, at least 14mm, at least 16mm, at least 18mm, at least 20mm, at least 22mm, at least 24mm, at least 26mm, at least 28mm, at least 30mm, between 8mm and 30mm, between 10mm and 24mm, or between 12mm and 22mm. [0085] According to some embodiments, the chip 1510 may comprise a processing circuit. Processing circuit 1510 may take the form of a processor (e.g., a microprocessor or microcontroller, field-programmable gate arrays (FPGAs) and/or digital signal processors (DSPs, or any combination of the foregoing) configured to execute logic stored in a memory (not shown) to perform the operations described herein The term “logic”, “control logic”, “instructions” or “application” as used herein may include software and/or firmware executing on any of the aforementioned processing circuits.

[0086] In some embodiments, the chip 1510 may be equipped with an on-board temperature sensor and need not be mounted on a flexible substrate that enables the chip to bend. The chip may have any suitable thickness, such as, for example, a thickness of approximately 1 mm or more. Label 1500 also includes antenna(s) 1512 that are communicably coupled with the chip 1510. In addition to communicating data to an external device, antennas 1512 may also be used to harvest power inductively and wirelessly from said external device.

[0087] Now referring to FIGS. 4A and 4B, a close-up view of an exemplary label 1500 is illustrated. As described above, communication tag 1504 is positioned within label 1500. Label 1500 may include one or more tactile features 1514 which may facilitate a user’s grip on label 1500 and/or the underlying device, such as device 20 described above. The tactile features may be arranged as a plurality of discrete dots. Protrusion(s) 1515 (also referred to herein as “protective protrusion(s)), may be arranged in a configuration 1516 around communication tag 1504. Configuration 1516 may form a circular shape (FIG. 4A) or a diamond shape (FIG. 4B) in which communication tag 1504 is positioned within a middle portion of the configuration 1516 as shown. In other embodiments, configuration 1516 may form a square shape, a rectangular shape, an oval shape, a U-shape, or any other shape which at least partially surrounds communication tag 1504. Protrusion(s) 1515 making up configuration 1516 may be, for example, continuous, semi -continuous, or discontinuous. When continuous, configuration 1516 may have a structure that has a closed perimeter, such as a circle, a rectangle, a polygon, or other shapes (whether regular or irregular). When semi -continuous, configuration 1516 may have a structure also having a perimeter, but the perimeter may be broken at one or more locations. A semi-continuous configuration may include, for example, two or more segments or arcs that form an imaginary perimeter but are disconnected from each other. When discontinuous, configuration 1516 may have a structure having one or more segments or arcs that do not necessarily form an imaginary perimeter (e.g., other than discrete dots). Diamond-shaped configurations are an example. Although discontinuous, the segments or arcs collectively enclose communication tag 1504. In some embodiments, protrusion(s) 1515 may be elongated in shape to form configuration 1516. In embodiments having a plurality of protrusions 1515 forming configuration 1516, the protrusions may each be identical, similar, or different from all or some of the other protrusions in configuration 1516.

[0088] Referring to FIG. 4A, the circular configuration 1516 may have a diameter of about 4 mm to about 5 mm. In some embodiments, the circular configuration 1516 may have a diameter of about 4.5 mm to about 5 mm. In some embodiments, the circular configuration 1516 may have a diameter of about 4.7 mm to about 4.9 mm or about 4.75 mm to about 4.85. In some embodiments, the circular configuration may have a diameter of about 4.8 mm (e.g., 4.815 mm). As shown, circular configuration 1516 is positioned so that the communication tag 1504 is generally positioned in the middle of the circular configuration 1516. The thickness of the protrusion(s) 1515 forming configuration 1516 may be about 0.5 mm to about 1.5 mm. In some embodiments, the thickness of the protrusion(s) 1515 forming configuration 1516 may be about 0.65 mm to about 1.5 mm. In some embodiments, the thickness of the protrusion(s) 1515 forming configuration 1516 may be about 1.0 mm. The thickness of the protrusion(s) as discussed herein may also be described as the thickness of a wall of the configuration 1516. In other words, the thickness of the wall of the configuration 1516 at least partially surrounding communication tag 1506 may be about 0.5 mm to about 1.5 mm.

[0089] While the measurements above are described in reference to the circular configuration of FIG. 4A, the same metrics may apply to the diamond shaped configuration of FIG. 4B or any other shaped configuration. For example, protrusion(s) making up any configuration, including a diamond-shaped configuration illustrated in FIG. 4B or another configuration shape, may have a thickness of about 0.5 mm to about 1.5 mm. In some embodiments, the corresponding configuration may have a wall having a thickness of about 0.5 mm to about 1.5 mm. In other embodiments, the corresponding configuration may have a wall having a set of protrusions, which may result in the wall of the corresponding having a thickness of about 1 mm to about 3 mm, for example. In other embodiments, the corresponding configuration may not have walls, but instead have one or more protrusions arranged in a pattern at least partially surrounding the communication tag, such as the diamond-shaped configuration illustrated in FIG. 4B.

[0090] Regardless of the shape or arrangement of the configuration, the protrusion(s) forming the configuration may be within a 3 mm radius of the center of the communication tag. For example, in some embodiments, the protrusion(s) forming the configuration may be within about a 1 mm radius of the center of the communication tag. In some embodiments, the protrusion(s) forming the configuration may be within about a 2 mm radius of the center of the communication tag. In some embodiments, the protrusion(s) forming the configuration may be within about a 2.5 mm radius of the communication tag.

[0091] Label 1500 may include a plurality of layers, as shown in schematic FIG. 5. For example, label 1500 may include a central base layer 1518 which provides the basic structure of label 1500. Central base layer 1518 may include facestock, i.e., a paper, film fabric, foil, or other material suitable and/or configured to serve as a base layer of a label. A first adhesive layer 1520 may be positioned proximal of central base layer 1518 relative to underlying device 20 (FIGS. 2A-2C). In other words, first adhesive layer 1520 may be configured to facilitate adhesion of label 1500 to underlying device 20 (FIGS. 2A-2C) and/or to antenna layer 1512, which is described above. A second adhesive layer 1522 may facilitate attachment of antenna layer 1512 to first adhesive layer 1520 so that antenna layer 1512 is sandwiched between first adhesive layer 1520 and second adhesive layer 1522.

[0092] Primer, ink, and/or varnish may be applied as a finishing layer 1524 on a distal surface of central base layer 1518 opposite first adhesive layer 1520. Finishing layer 1524 may include graphics, text, or a finish including visual indicators for identification of label 1500 and underlying device 20 (FIGS. 2A-2C) described above. As discussed in reference to FIGS. 4A- 4C, label 1500 may include one or more tactile features 1514 to facilitate grip of the label 1500 and/or underlying device 20 (FIGS. 2A-2C). In some embodiments, label 1500 may include a first plurality of tactile features 1514. Label 1500 may also include a second set of protrusions 1515, in the form of a configuration 1516 (FIGS. 4A-4B), which at least partially surrounds communication tag 1504. In some embodiments, label 1500 may include a plurality of protrusions 1515. As shown in FIG. 5, communication tag 1504 is embedded within or attached to central base layer 1518. In some embodiments, finishing layer 1524 may also extend over the distal surface of communication tag 1504.

[0093] Protrusion(s) and/or tactile feature(s) may be included in one of the layers of label 1500 as described herein. For example, protrusion(s) and/or tactile feature(s) may be included as a texture characteristic of one of finishing layer 1524 or central base layer 1518. In other embodiments, protrusion(s) and/or tactile feature(s) may be included as a texture characteristic of another layer of label 1500. In other embodiments, protrusion(s) and/or tactile feature(s) may be added to label 1500 as a separate layer and attached to the label via adhesive, embedding between two layers, bonding material, or another method known in the art. While the height of the protrusion(s) and/or tactile feature(s) is described relative to a surface of finishing layer 1524 herein, such definition does not necessarily mean that said protrusion(s) and/or tactile feature(s) begin at the surface of finishing layer 1524 or are attached to the surface of finishing layer 1524. Instead, such reference point should be considered a reference point alone.

[0094] Tactile feature(s) 1514 have a first height Hi defined from the distal surface 1526 of finishing layer 1524 to a distal surface 1528 of tactile feature(s) 1514. Protrusion(s) 1515 of configuration 1516 have a second height H2 defined from distal surface 1526 of finishing layer 1524 to a distal surface 1530 of protrusion(s) 1515. Communication tag 1504, including overlaid central base portion 1518, has a third height H3 defined from distal surface 1526 of finishing layer 1524 to a distal surface 1532 of communication tag 1504 with overlaid central base portion 1518. As shown, configuration 1516 may include at least a first protrusion 1515 on a first side 1534 of communication tag 1504 and a second protrusion 1515 on a second side 1536 of communication tag 1504.

[0095] Still referring to FIG. 5, height Hi may be the shortest of heights Hi, H2, and H3. In other words, height Hi of tactile feature(s) 1514 may be less than height H2 of protrusion(s) 1515 and height H3 of communication tag 1504. In some embodiments, height Hi of tactile feature(s) 1514 is 53% or less of height H3 of communication tag 1504. In some embodiments, height Hi of tactile feature(s) 1514 may be the same or greater height as height H2 of protrusion(s) 1515. Height Hi may be, for example, 26-37 pm. In other words, height Hi may be about 26 pm, about 27 pm, about 28 pm, about 29 pm, about 30 pm, about 31 pm, about 32 pm, about 33 pm, about 34 pm, about 35 pm, about 36 pm, or about 37 pm. In other embodiments, tactile feature(s) 1514 may include a height less than or greater than the exemplary heights specified above.

[0096] As illustrated in FIG. 5, height H2 may be the intermediate height between Hi and H3. In other words, height H2 of protrusion(s) 1515 may be greater than the height Hi of tactile feature(s) 1514 and less than height H3 of communication tag 1504. In some embodiments, height H₂ of protrusion(s) 1515 may be 66% or less of height H3 of communication tag 1504. In some embodiments, height H2 of protrusion(s) 1515 may be the same or less height as height Hi of tactile feature(s) 1514. Height H2 may be, for example, 31-45 pm. In other words, height H2 may be about 31 pm, about 32 pm, about 33 pm, about 34 pm, about 35 pm, about 36 pm, about 37 pm, about 38 pm, about 39 pm, about 40 pm, about 41 pm, about 42 pm, about 43 pm, about 44 pm, or about 45 pm. In other embodiments, protrusion(s) 1515 may include a height less than or greater than the exemplary heights specified above.

[0097] Height H3 is the greatest height of heights Hi, H2, and H3. In other words, height H3 of communication tag 1504 is greater than height Hi of tactile feature(s) 1514 and height H2 of protrusion(s) 1515. Height H3 may be, for example, 68-71 pm. In other words, H3 may be about 68 pm, about 69 pm, about 70 pm, or about 71 pm. The height H3 of communication tag 1504 may be about 23-40 pm greater than height H2 of protrusion(s) 1515 forming configuration 1516 around communication tag 1504.

[0098] The height difference between height H2 of protrusion(s) 1515 and height H3 of communication tag 1504 facilitates protection of communication tag 1504 from damage and/or breakage during application of the label 1500 to underlying device 20 (FIGS. 2A-2C) and during use of underlying device 20 (FIGS. 3A-3C). In other words, in some embodiments, during application of label 1500 to underlying device 20 or during use of underlying device 20, protrusion(s) 1515 may serve to absorb and/or offset all or some of the force applied to communication tag 1504 to prevent or mitigate full application of said force to communication tag 1504, which may otherwise result in damage or breakage. In other embodiments, during application of label 1500 to underlying device 20 or during use of underlying device 20, protrusion(s) 1515 may serve to absorb and/or offset all or some of the force resulting from shear stress to prevent or mitigate full application of said force to communication tag 1504, which may otherwise result in damage or breakage. In that respect, a protrusion 1515 is also referred to herein as a “protective protrusion” in that it provides protection for communication tag 1504.

[0099] While this invention has been described as having exemplary designs, the present invention can be further modified within the spirit and scope of this disclosure. This application is therefore intended to cover any variations, uses, or adaptations of the invention using its general principles. Further, this application is intended to cover such departures from the present disclosure as come within known or customary practice in the art to which this invention pertains.

[00100] Various aspects are described in this disclosure, which include, but are not limited to, the following aspects:

[00101] (1) A label for coupling to an underlying device, the label comprising: at least one layer having a top side and a bottom side adapted to be attached to the underlying device; a communication tag attached to the at least one layer, the communication tag having a first height extending above the top side of the at least one layer; at least one protective protrusion positioned at least partially around a perimeter of the communication tag in a configuration, the at least one protective protrusion having a second height extending above the top side of the at least one layer, the second height being less than the first height.

[00102] (2) The label of aspect 1, wherein a first protective protrusion of the at least one protective protrusion is positioned to a first side of the communication tag and a second protective protrusion of the at least one protective protrusion is positioned to a second side of the communication tag.

[00103] (3) The label of any one of aspects 1-2, wherein at least one protective protrusion is positioned completely around the perimeter of the communication tag.

[00104] (4) The label of any one of aspects 1-3, wherein the configuration is a circle.

[00105] (5) The label of aspect 4, wherein the circle has a diameter of about 4.8 mm.

[00106] (6) The label of any one of aspects 1-3, wherein the configuration is a diamond.

[00107] (7) The label of any one of aspects 1-6, wherein the second height is 66% or less of the first height. [00108] (8) The label of any one of aspects 1-7, wherein the first height is from and including about 68 pm to and including about 71 pm.

[00109] (9) The label of any one of aspects 1-8, wherein the second height is from and including about 31 pm to and including about 45 pm.

[00110] (10) The label of any one of aspects 1-9, wherein the configuration is formed of a plurality of protective protrusions positioned at least partially around the perimeter of the communication tag.

[00111] (11) The label of aspect 10, wherein the second height is an average height of the plurality of protective protrusions.

[00112] (12) The label of aspect 11, wherein the average height is about 42 pm.

[00113] (13) The label of any one of aspects 1-12, the label further including a tactile feature having a third height extending above the top side of the at least one layer, the third height being less than the first height and the second height.

[00114] (14) The label of aspect 13, wherein the third height is 53% or less of the first height.

[00115] (15) The label of any one of aspects 13-14, wherein the third height is from and including about 26 pm to and including about 37 pm.

[00116] (16) The label of any one of aspects 13-15, wherein the tactile feature includes a plurality of tactile features and the third height is a second average height of each individual tactile feature of the plurality of tactile features.

[00117] (17) The label of aspect 16, wherein the second average height is about 32 pm.

[00118] (18) The label of any one of aspects 1-17, further including a finishing layer positioned adjacent to the top side of the at least one layer.

[00119] (19) The label of any one of aspects 1-18, further including a first adhesive layer positioned adjacent to the bottom side of the at least one layer.

[00120] (20) The label of aspect 19, further including a second adhesive layer positioned adjacent to the first adhesive layer opposite the at least one layer. [00121] (21) The label of aspect 20, further including an antenna layer sandwiched between the first adhesive layer and the second adhesive layer.

[00122] (22) The label of aspect 1, wherein the at least one protective protrusion is continuous.

[00123] (23) The label of aspect 1, wherein the at least one protective protrusion is semi- continuous.

[00124] (24) The label of aspect 1, wherein the at least one protective protrusion is discontinuous.

[00125] (25) The label of any one of aspects 1-24, wherein the at least one protective protrusion has an elongated shape.

[00126] (26) The label of any one of aspects 1-25, wherein the at least one protective protrusion is within a 3 mm radius of the communication tag.

[00127] (27) The label of aspect 26, wherein the at least one protective protrusion is within a 2.5 mm radius of the communication tag.

[00128] (28) The label of any one of aspects 1-27, wherein the at least one protective protrusion has a thickness of about 0.65 mm to about 1.5 mm.

[00129] (29) A drug delivery device comprising: a housing; a syringe assembly arranged within the housing, the syringe assembly including a needle having a first position within the housing and a second position in which the needle projects outwardly from the housing; a plunger configured to actuate the needle from the first position to the second position; and a user- graspable portion defined by the housing, the user-graspable portion including a label having a top side, a bottom side, an embedded communication tag, and at least one protective protrusion positioned at least partially around a perimeter of the communication tag in a configuration, the at least one protective protrusion having a first height extending above the top side of the label and the communication tag having a second height extending above the top side of the label, the second height being greater than the first height.

[00130] (30) The drug delivery device of aspect 29, wherein the configuration is formed by a plurality of protective protrusions. [00131] (31) The drug delivery device of any one of aspects 29-30, wherein the configuration forms one of a circle or a diamond.

[00132] (32) The drug delivery device of any one of aspects 29-31, wherein the first height is 31-45 pm.

[00133] (33) The drug delivery device of any one of aspects 29-32, wherein the second height is 68-71 pm.

Claims

WHAT IS CLAIMED IS

1. A label for coupling to an underlying device, the label comprising: at least one layer having a top side and a bottom side adapted to be attached to the underlying device; a communication tag attached to the at least one layer, the communication tag having a first height extending above the top side of the at least one layer; at least one protective protrusion positioned at least partially around a perimeter of the communication tag in a configuration, the at least one protective protrusion having a second height extending above the top side of the at least one layer, the second height being less than the first height.

2. The label of claim 1, wherein a first protective protrusion of the at least one protrusion is positioned to a first side of the communication tag and a second protrusion of the at least one protective protrusion is positioned to a second side of the communication tag.

3. The label of any one of claims 1-2, wherein at least one protective protrusion is positioned completely around the perimeter of the communication tag.

4. The label of any one of claims 1-3, wherein the configuration is a circle.

5. The label of claim 4, wherein the circle has a diameter of about 4.8 mm.

6. The label of any one of claims 1-3, wherein the configuration is a diamond.

7. The label of any one of claims 1-6, wherein the second height is 66% or less of the first height.

8. The label of any one of claims 1-7, wherein the first height is from and including about 68 pm to and including about 71 pm.

9. The label of any one of claims 1-8, wherein the second height is from and including about 31 gm to and including about 45 gm.

10. The label of any one of claims 1-9, wherein the configuration is formed of a plurality of protective protrusions positioned at least partially around the perimeter of the communication tag.

11. The label of claim 10, wherein the second height is an average height of the plurality of protective protrusions.

12. The label of claim 11, wherein the average height is about 42 gm.

13. The label of any one of claims 1-12, the label further including a tactile feature having a third height extending above the top side of the at least one layer, the third height being less than the first height and the second height.

14. The label of claim 13, wherein the third height is 53% or less of the first height.

15. The label of any one of claims 13-14, wherein the third height is from and including about 26 pm to and including about 37 gm.

16. The label of any one of claims 13-15, wherein the tactile feature includes a plurality of discrete tactile features and the third height is a second average height of each individual tactile feature of the plurality of discrete tactile features.

17. The label of claim 16, wherein the second average height is about 32 gm.

18. The label of any one of claims 1-17, further including a finishing layer positioned adjacent to the top side of the at least one layer.

19. The label of any one of claims 1-18, further including a first adhesive layer positioned adjacent to the bottom side of the at least one layer.

20. The label of claim 19, further including a second adhesive layer positioned adjacent to the first adhesive layer opposite the at least one layer.

21. The label of claim 20, further including an antenna layer sandwiched between the first adhesive layer and the second adhesive layer.

22. The label of any one of claims 1-21, wherein the at least one protective protrusion is continuous.

23. The label of any one of claims 1-22, wherein the at least one protective protrusion is semi-continuous.

24. The label of any one of claims 1-23, wherein the at least one protective protrusion is discontinuous.

25. The label of any one of claims 1-24, wherein the at least one protective protrusion has an elongated shape.

26. The label of any one of claims 1-25, wherein the at least one protective protrusion is within a 3 mm radius of the communication tag.

27. The label of claim 26, wherein the at least one protective protrusion is within a 2.5 mm radius of the communication tag.

28. The label of any one of claims 1-27, wherein the at least one protective protrusion has a thickness of about 0.65 mm to about 1.5 mm.

29. A drug delivery device comprising: a housing; a syringe assembly arranged within the housing, the syringe assembly including a needle having a first position within the housing and a second position in which the needle projects outwardly from the housing; a plunger configured to actuate the needle from the first position to the second position; and a user-graspable portion defined by the housing, the user-graspable portion including a label having a top side, a bottom side, an embedded communication tag, and at least one protective protrusion positioned at least partially around a perimeter of the communication tag in a configuration, the at least one protective protrusion having a first height extending above the top side of the label and the communication tag having a second height extending above the top side of the label, the second height being greater than the first height.

30. The drug delivery device of claim 29, wherein the configuration is formed by a plurality of protective protrusions.

31. The drug delivery device of any one of claims 29-30, wherein the configuration forms one of a circle or a diamond.

32. The drug delivery device of any one of claims 29-31, wherein the first height is 31-45 pm.

33. The drug delivery device of any one of claims 29-32, wherein the second height is 68-71 pm.