ADMINISTRATION DEVICE WITH DETACHABLE INDICIUM

A beneficial agent dispensing device system is provided. The beneficial dispensing device system includes a dispensing device containing a beneficial agent, an indicium coupled to and selectively decouplable from the dispensing device, the indicium indicating information related to the beneficial agent, and a securing mechanism coupled to the indicium and configurable to secure the indicium to a securable feature.

BACKGROUND

The tracking of the administration of medicaments is important in a number of settings. For instance, in medical settings, the tracking of medicaments administered to patients is important for maintaining the health of the patients and limiting malpractice liability. In many settings, tracking of medicaments administered to patients can be accomplished with people consistently entering data into computing devices, perhaps at multiple points between the acquiring of the substances and the administration of the substances. This system can be effective, but it also lends itself to human error. For instance, the person having administered the substance may expect an accompanying person to document the administration, and the accompanying person may not recognize the implicit obligation. Further, an entry made can be in error. For instance, the medication to be injected may have labels on bottles, but an entry of the data representing the drugs may be in error. Further, the identities of patients to whom the substances are administered may be in error.

In some instances, the issues can be resolved by checking multiple points of data entry, but even in those situations, it may be difficult to resolve which conflicting source is correct. Also, in medical settings, getting access to data devices that track the information may be difficult or cumbersome, for instance, in an emergency setting. Further, there exists the possibility that a health professional may forget whether the drug has been administered and to whom the drug has been administered in a room with multiple patients. Attempting to physically label individual patients to discern between the patients may be cumbersome without a convenient method to track which drug corresponds to a label and then to a patient. This may be particularly evident in a triage or emergency situation, in battlefield conditions, or in other chaotic environments in which a medicament may be administered. Such physical labels may also suffer from the same limitations as the aforementioned data entry, with the labels not being specifically associated with any particular drug or patient. Further, the labels may be difficult to arrange and dispense when necessary.

SUMMARY

The described technology provides implementations of a beneficial agent dispensing device system. The beneficial dispensing device system includes a dispensing device containing a beneficial agent, an indicium coupled to and selectively decouplable from the dispensing device, the indicium indicating information related to the beneficial agent, and a securing mechanism coupled to the indicium and configurable to secure the indicium to a securable feature.

An example method for tracking a dispensable substance in a dispensing device in accordance with the presently disclosed technology includes decoupling an indicium from the dispensing device and coupling a securing mechanism attached to the indicium to a securable feature.

DETAILED DESCRIPTIONS

Systems and methods for activating containers and tracking the contents of containers are disclosed. Containers and their contents can be difficult to track in certain circumstances. For instance, in medical environments, drug containers must be carefully handled and tracked to assure that the correct substances are administered to the correct people. In most systems, there are at least a few points where human error can defeat tracking of the substances from storage to patient.

A common type of beneficial agent administering device or dispensing device is a prefilled injection device, for instance, an autoinjector. The prefilled injection device may be for parenteral drug delivery. The dispensing device may include a body in which a dispensable substance, such as a beneficial agent (e.g., a drug or other medical composition), is contained. The system may further include a cap coupled to the dispensing device. The cap may be such that the substance cannot be removed or administered from the prefilled injection device without first removing the cap. The cap may be attached to an indicium indicating at least the identity of a dispensable substance in the injector. The indicium may also be removably coupled to a body of the dispensing device, such that the indicium can be removed from the body of the dispensing device when the cap is removed from the injector. The body may also be described as a shell.

The indicium may also include or be coupled to a securing mechanism with which the indicium may be selectively engaged at the discretion of a user to secure the indicium to a securable feature. A securable feature can include a feature of one or more of a patient (e.g., an appendage or other portion of a person or animal), an article of clothing worn by the patient, a bedpost or rail of a bed occupied by the patient, or another element in the proximity of the patient (e.g., in a patient environment) or the equivalent of the patient to whom or which the dispensable substance is administered. The securing mechanism may form a non-reversible attachment to the securable feature, meaning the securing action may not be de-secured or disconnected by simple reverse action of the same mechanism. For example, the non-reversible attachment may be removed from the patient after the securing mechanism is coupled to the patient (e.g., exclusively) by destroying or otherwise modifying the non-reversible attachment in a manner in which it is apparent that the non-reversible attachment has been severed. For example, the non-reversible attachment may include an irreversible zip tie or cable tie.

The indicium and/or the securing mechanism may include elements specific to coupling the indicium to the patient. For instance, a band or lanyard. In implementations, the securing mechanism comprises a band or lanyard adapted for selective engagement with a securable feature. The indicium may comprise a modifiable portion suitable to indicate further information related to the stored agent, such as administration time, patient name, dose, or other information. The modifiable portion may comprise a writable section, a section on which a separate label may be affixed, a section comprising punch-out alphanumeric characters, or equivalent structures. The band or lanyard may be configured to be adjustable to facilitate coupling to patients of different sizes. For instance, the lanyard may include a mechanism by which the indicium is tightened around a patient's anatomical feature, for instance, a patient's appendage such as a wrist, ankle, or the like. The cap may be an element of or attached to the indicium that remains coupled to the indicium after the injector is discarded, the cap potentially aiding in facilitating the tightening of elements of the securing mechanism coupled to the indicium. In an implementation, the securing mechanism and/or the indicium or a lanyard thereof may include a removable portion of a label (e.g., a label adhered to or integral to the dispensing device).

A cap may be coupled to the device in a safe configuration and decoupled from the dispensing device in an armed configuration. In implementations, the indicium is coupled to the cap in the safe configuration but is separable in the armed configuration. In other implementations, the indicium maintains an attachment to the dispensing device in both the safe and armed configurations.

FIG.1illustrates an example of a beneficial agent dispensing system100for administering and tracking an administration of a substance. The dispensing device102is a device that dispenses a dispensable and/or administrable substance, such as a beneficial agent or medicament, stored in the dispensing device102. The term dispensing device may also be referred to as an administration device. In an embodiment, the dispensing device102may be an injector, such as an autoinjector, or any administration or dispensing device. The dispensing device may be operable to inject the dispensable substance into a patient. The dispensing device102may be coupled to and selectively decoupled from a cap104. The cap104may be a cap of the dispensing device102that may be decoupled from the dispensing device102. In implementations, in a safe configuration, the cap104may prevent dispensing of the dispensable substance from the dispensing device102prior to removal of the decouplable cap104from the dispensing device. That is, removal of the cap104may coincide with or otherwise cause a transition between the safe configuration and an armed configuration. The transition may include “arming” or making the dispensing device102ready for injection in an armed configuration. The dispensing device102may be activated or armed when the cap104is removed simply by exposing the elements of the dispensing device102that administer or otherwise dispense the dispensable substance. Alternatively or additionally, the dispensing device102may include activating elements, for example, one or more of a retainer, safety pin, and safety catch, and the activating elements may be functionally coupled or couplable to the cap104. In this example, removing the cap104may actively remove or deactivate safety elements and facilitate administration and/or dispensing of the dispensable substance to place the dispensing device in an armed dispensing device state. The cap104may be attached or separably or fixedly coupled to an indicium106.

The indicium106may include information related to the dispensable substance, including, for example, information associated with one or more of the dispensing device102, the dispensable substance contained in the dispensing device102, instructions for use (IFU) of the dispensing device102, and/or a person to whom the dispensable substance may be administered. The indicium106may be coupled to and selectively decouplable from a portion of the dispensing device102, such as a body portion of the dispensing device102, in addition to being coupled to the cap104. For example, the indicium106may be a portion of a label that is selectively detachable or decouplable from the dispensing device102, such as by tearing a perforation105on a portion of a label. In the illustrated example, the indicium106is depicted comprising a pull tab109or pull, which a user can pull to cause the tearing or decoupling. The indicium106may be an element of a label or may be situated between a body or shell of the dispensing device102and a label prior to the decoupling of the indicium106. The indicium106may be an element of a label that is perforated and easily decouplable (the perforations to guide the tearing) or may be situated under a label including a perforated portion prior to the decoupling of the indicium106. The indicium106and/or a securing mechanism108may provide a pull or pull tab to remove an activation member or element of the dispensing device102. The activation member may be configured so that the activation member's removal will cause the dispensing device102to transition to an armed state.

The indicium106may initially be further coupled to the dispensing device102indirectly via the coupling of the indicium106to the cap104. Moreover, the indicium106may include an indication of when the substance of the dispensing device102has been dispensed and/or administered. In an implementation, removal of the indicium106from the body portion or a separate manual removal of a portion of the indicium106may expose an active timing element (e.g., a pressure-sensitive, photosensitive, or chemosensitive element) that “develops” upon exposure to light or environmental air to provide an indication of an elapsed time since the indicium106or element was removed and/or the substance was administered or otherwise dispensed. Alternatively or additionally, the indicium106may feature an area adapted to be marked by a user to indicate administration time. Alternatively or additionally, an indication of a time of use may be by writing information in a designated area or making a physical change to the indicium which doesn't require a writing instrument, such as scratching, peeling, tearing, or perforating (e.g., by punching a hole next to a selection).

The indicium106may be further coupled to or include a securing mechanism108. The securing mechanism108is a mechanism used to secure the indicium106to a person. The securing mechanism108may be configurable or configured to secure the indicium to a securable feature, such as an anatomical feature of the person, for instance, an appendage of the person or an element of a patient environment. The securing mechanism108may be coupled irreversibly to a person, for instance, not allowing removal after the securing mechanism is secured without damaging the securing mechanism108. In implementations, the decoupling of the indicium106from the dispensing device102may expose the securing mechanism, allowing the securing mechanism108to be secured to the securable feature.

In various implementations, the indicium106may be coupled to the cap104and the dispensing device102. The cap104may be coupled to the dispensing device in a manner that prevents the dispensing device from dispensing. For example, the cap104and/or the dispensing device102may include arming elements that can arm the dispensing device102responsive to the cap104being removed. Decoupling of the indicium106from the dispensing device102may cause the cap104to decouple from the dispensing device102, and, consequently, cause the arming elements in one or more of the cap104and the dispensing device102to arm the dispensing device102. In the unarmed state (first or unarmed configuration), the dispensing device102may be prevented from administering or prevent the administration or dispensing of an administrable substance. In an armed state (second or armed configuration), the dispensing device is able to administer or is allowed to administer or dispense the administrable substance. In implementations in which the indicium106is coupled to both of the cap104and the dispensing device102at different locations, the decoupling of the indicium106from the dispensing device102at a location (e.g., by tearing through a label that couples the indicium106to the dispensing device102) may or may not be sufficient to cause the cap104to be removed (and arming of the dispensing device102). In this implementation, a further pull on the indicium106with a certain predefined threshold force removes the cap104to arm the dispensing device102.

Implementations are contemplated in which the dispensing device102includes a strap that is not configured to couple to an anatomical feature of a patient (e.g., that the securing mechanism108, as illustrated, is just a strap or band (e.g., an element of a lanyard) that is not for coupling to a patient). For example, the indicium106may be coupled to the cap104, or the indicium106may not be related to a specific patient. For example, in implementations where the indicium106includes instructions for use but does not include patient-specific information, there may be no need to couple the indicium106to the patient. Implementations are also contemplated in which the securing mechanism108is for securing the indicium106to things other than a patient, for example, a bed, an article of clothing, or a vehicle.

In an implementation, the securing mechanism108may include a band and a cinch coupled to the band. The cinch may be irreversibly advanceable along at least a portion of the band. The cinch may be situated on the band relative to the cap104, such that pulling the cap104when the band is engaged to an anatomical feature of a person tightens the band about the anatomical or other securable feature of the patient. In one implementation, the band is coupled at both a first end of the band and a second end of the band to the cap104, forming a band loop. The band may be threaded twice through the cinch. The securing mechanism108may receive an anatomical feature of the person between the cinch and the band loop. The securing mechanism108may then be secured to the anatomical feature by irreversibly advancing the cinch distally from the cap104. In various implementations, the cinch is stored in or adjacent to the cap or in or adjacent to an endpiece prior to the decoupling of the indicium106and/or cap104from the dispensing device102. The cinch may be disposed at a terminal end of the band prior to the decoupling of the indicium from the dispensing device102. In some implementations, the band may be decouplable from the cap104.

In another implementation in which the band is coupled at both a first end of the band and a second end of the band to the cap104, forming a band loop, the securing mechanism108receives an anatomical or other securable feature of the patient between the cinch and the cap104. The securing mechanism108may then secure the anatomical feature by irreversibly advancing the cinch proximally towards the cap104.

In implementations in which a loop is formed by the band of the securing mechanism108, the securing mechanism may include an endpiece on a distal end of the band, perhaps limiting the motion of the cinch.

In an alternative implementation, the band is coupled at a first end of the band to the cap104and a second end of the band to the cinch. In this implementation, the band may be threaded once through the cinch, forming a band loop. The securing mechanism108may receive an anatomical feature of the person between the cinch and the band loop. The securing mechanism108may then be coupled to the anatomical feature by irreversibly advancing the cinch distally from the cap104.

In still another alternative implementation, two bands may be coupled to the cap104, or a band may be threaded through the cap104to effectively make two separate bands. The second of the bands may include a coupling element, such as an adhesive. An anatomical feature may be placed between the bands, and the adhesive on a second band may be used to couple (e.g., adhere) the portion of the second band with the coupling element to a portion of the first band. This may effectively secure the anatomical feature between the coupled bands. In an implementation in which the two bands are defined by a single band having been threaded through the cap104, the band lengths may be adjusted by pulling the band through the cap to a desired length. This may allow for the coupling between the band portions (in this instance, on the same band) to more effectively secure the anatomical feature of the person.

In various embodiments, the securing mechanism108may include a wristband that is attached to the cap104. For example, the wristband can be made of a stretchable material that can be expanded while placing the wristband on the anatomical feature of a person. Other types of wristbands, such as those commonly used with wristwatches, are also contemplated. Such wristbands may include a ratchet mechanism like a zip-tie or clasp mechanism. Another type of wristband contemplated is a flexible spring band, perhaps a flexible stainless steel bistable spring band (e.g., a slap bracelet or snap bracelet). These bistable spring bands may be covered with or encased by a material more comfortable for a person's appendage, for example, one or more of fabric, silicone, or plastic. The indicium106may comprise a pin or a clip for creating a loop or attaching to a subject or an object. The indicium may be configured to form a tie to create a loop or to secure the indicium to a subject or an object.

During storage, the wristband may be retained under a label and against a shell or body of the dispensing device102, which may be an autoinjector. The label may include a perforation105along its length on either side or both sides of the wristband of the indicium106. Decoupling the indicium106and its securing mechanism108from the dispensing device may tear through the label and potentially expose a clear shell of the dispensing device. During arming of the dispensing device to allow for dispensing of a dispensable substance, a user may pull down on a looped end of the wristband, breaking the labels and tearing the wristband away from the shell of the dispensing device, effectively decoupling the indicium106and the securing mechanism108away from the body or shell of the dispensing device102. Once completely detached from the shell of the dispensing device, the user may pull on the wristband of the securing mechanism108to remove the cap104and arm the dispensing device102. The removed section of the label may then expose a clear shell of the dispensing device102underneath the label to reveal the dispensable substance contained in the dispensable device and allow a person to verify that the dispensable substance has been dispensed after activation of an active indication element after arming or administration. Alternatively, the removed section of the label may expose a second label portion. The label portion may include a time indicator or instruction for use after arming.

Implementations are contemplated in which the cinch is stored in the cap104prior to removal of the cap104from the dispensing device102.

FIGS.2A-2Fillustrate an example of a progression of using a substance dispensing system. Dispensing device202, cap204, indicium206, and securing mechanism208may comprise implementations of dispensing device102, cap104, indicium106, and securing mechanism108, respectively.FIGS.2A-2Fmay represent a self-cinching implementation. Self-cinching may involve a wristband that is coupled to itself, so pulling one end of the wristband may pull the cinch toward a user's anatomical or securable feature, such as a wrist. Self-cinching implementations may only require one hand to operate, perhaps allowing the person to whom the indicium is secured to self secure the indicium without assistance. In an implementation, one end of a wristband of the securing mechanism208may be attached securely to the cap204. The other end may be attached securely to a cinch. Both sides of the wristband may run through the cinch. The cinch may be housed in the cap during storage. An end piece may be attached securely to a looped end of the wristband for gripping and to ensure the cinch does not pull out of the cap204during arming.

Specifically,FIG.2Aillustrates an example of a beneficial agent dispensing device202in an initial safe configuration200A. The dispensing device202has the cap204coupled to the dispensing device202at an end. The indicium206is depicted in a variant comprising a pull tab209or pull attached or coupled to an endpiece240, with the securing mechanism208coupled by a perforated coupling or by a label to the dispensing device202.

FIG.2Billustrates an example of a decoupling configuration200B in which the indicium206with the securing mechanism208decouples from the dispensing device202. The decoupling may occur along the perforated coupling and/or through tearing a label. In this regard, the indicium206may comprise a strip of material detachably attached to the dispensing device202. In other examples, the indicium206may comprise a strip of material defined between two perforations of a film, wrap, or other material that may extend relative to the dispensing device202(e.g., in some examples, may extend about the entirety of the dispensing device). The indicium206, as illustrated, includes an endpiece240joined to a pull-tab209that can be used to aid in the decoupling. Also shown inFIG.2B, removal of the indicium206may expose a clear portion of the dispensing device202. This may allow a user to view and verify that the substance to be administered is present in the dispensing device202. This may also allow a user to determine if the dispensing device202has been used or is spent.

FIG.2Cillustrates an example of a decoupled configuration200C in which the cap204is decoupled from the dispensing device202. The decoupling of the cap204from the dispensing device202may expose elements that allow dispensing of the dispensable substance from the dispensing device202. Further, specific coupling elements between the cap204and the dispensing device202may activate administering or dispensing elements in the dispensing device202when the cap204is decoupled from the dispensing device202to arm the dispensing device202.

FIGS.2A-2Cdemonstrate a progression of the dispensing device202transitioning from an unarmed state (or first configuration or safe configuration) to an armed state (or second configuration or armed configuration). In the illustrated implementation, when the cap204is coupled to the dispensing device202, the dispensing device may be in an unarmed state. In the unarmed state, the dispensing device202may be incapable of dispensing the dispensable substance in the dispensing device202. An example implementation of an arming mechanism is illustrated inFIGS.7A-7E. In the unarmed state (first or safe configuration), the dispensing device202may be restricted or prevented from dispensing the dispensable substance (e.g., a beneficial agent or administrable substance) in the dispensing device202. In the armed state (second or armed configuration), the dispensing device202may enable dispensing of the dispensable substance. The transition from the unarmed state to the armed state may be facilitated by arming elements of the dispensing device202. These arming elements may be triggered to arm the dispensing device upon a triggering event (e.g., one or more of removing a cap204, an indicium206, and/or a securing mechanism208).

FIG.2Dillustrates an example of an engaged configuration200D in which the securing mechanism208is engaged with an anatomical feature230of a person. In this example, the anatomical feature230is an arm of a person. In this example, the anatomical feature230is inserted between a cinch originally stored in the cap204and an endpiece240joined to a band of the indicium206comprising pull-tab209.

FIG.2Eillustrates an example of a securing configuration200E in which the securing mechanism secures the anatomical feature230. In this implementation, the cinch is coupled to one end of the band with the cap204coupled to the other end of the band of the securing mechanism208. The arrow210illustrates that the cap204may be pulled to advance the cinch away from the cap and to secure the anatomical feature230between the cinch and a loop of the band.

FIG.2Fillustrates an example of a secured configuration200F in which an anatomical feature230is secured by the securing mechanism208. The indicium206comprising a pull-tab209joined to an endpiece240may be seen displaying information, while the securing mechanism208is secured to the anatomical feature230. In an alternative implementation, the indicium206omits a distinct tab or endpiece. The indicium206may visibly display information while the securing mechanism208is secured to the anatomical feature230.

FIGS.3A-3Dillustrate examples of the securing mechanism300A-300D. The securing mechanisms300A-300D may be implementations of securing mechanism108. The securing mechanisms300A-300D may comprise one or more of a cap304, a coupler312, a band314, and an endpiece340. The cap304may be an implementation of the cap104.

Specifically,FIG.3Aillustrates an example of a securing mechanism300A with a wristband at a distal end of a band314relative to the cap304. The securing mechanism300A includes a coupler312that is a cinch. The coupler312has the band314threaded through twice. The band314is coupled to the cap304at both ends. The securing mechanism300A receives an anatomical feature in a wristband formed between the coupler312and a bend315of a loop of the band314. The bend315is at a terminal end of the loop when the band314is pulled the furthest from the cap304at the terminal end, causing the sides of the loop to meet. The coupler312can be advanced distally from the cap304to secure the anatomical feature. The securing mechanism300A may be an implementation of a non-self-cinch concept. For the purposes of this specification, a non-self-cinch may include two handed operation. Therefore, operating the securing mechanism300A may involve one hand to hold the cinch and the other hand to pull on an end or wristband. The operation utilizing two hands may make it more difficult for a person to secure the indicium to herself without assistance, but it is nevertheless anticipated and may provide other benefits like ease of manufacture. In one implementation, both ends of the wristband may be threaded through the coupler312and then fixed securely to the cap. The coupler312may be housed in the cap. To tighten the wristband, the user may place the wristband around a person's wrist and then use one hand to hold the cap304and the other hand to tighten the coupler312.

FIG.3Billustrates an example of a securing mechanism300B with a wristband formed between the coupler312and the cap304. The securing mechanism300B includes a coupler312that is a cinch. The coupler312includes the band314threaded through twice. The band314is coupled to the cap304at both ends. The securing mechanism300B receives an anatomical feature in a wristband formed between the coupler312and the cap304. The coupler312may be advanced proximally towards the cap304to secure the anatomical feature. The band314includes a loop at a distal end to which an endpiece340is coupled. In this implementation, the coupler312may be stored against the endpiece340prior to the decoupling of the indicium from the dispensing device. The securing mechanism300B may be an implementation of a non-self-cinch concept.

FIG.3Cillustrates another example of a securing mechanism300C with a wristband at a distal end of a band314relative to the cap304. The securing mechanism300C includes a coupler that is a cinch. The coupler312has the band314threaded through once. The band is coupled to the cap304at one end of the band314and to the coupler312at another end of the band314. The securing mechanism300C receives an anatomical feature in a wristband formed between the coupler312and the cap304. The coupler312can be advanced distally from the cap304to secure the anatomical feature. In this implementation, pulling the cap304away from the anatomical feature may tighten the wristband to secure the anatomical feature. The securing mechanism300C may comprise an implementation of a self-cinch concept. In an implementation, the wristband loops onto itself instead of utilizing a separate coupler312component. As such, the coupler312may include securing features such as a pawl that may engage features of the band314(e.g., teeth, threads, or the like). In this regard, the coupler312and band314may act as a zip tie that irreversibly (or irreversible without evidently damaging the band314) engages an anatomical feature. The threaded part of the wristband may be hidden underneath the label during storage when still coupled to the dispensing device.

FIG.3Dillustrates an example of a securing mechanism300D in which a portion of a band314is coupled to another portion of a band314. The securing mechanism300D includes a coupler312that attaches one part of a band314with another part of the same band314or of a different band. Such coupler312may comprise an adhesive strip suitable to adhere to another portion of the band314. The anatomical feature is introduced to a wristband formed between the bands314or portions of the same band314, and the bands314or same band314are coupled at a location distal from the introduced anatomical feature to secure the anatomical feature.FIG.3Dmay be an implementation of a no-cinch system. That is, a coupling can be performed without cinching. In one implementation, the wristband may attach securely to the cap with the other ends free. In one implementation, one strap is shorter and includes an adhesive portion, such as with a removable backing. The end may be completely covered by the label before decoupling from the dispensing device, and the other strap may be longer and protrude from the end of the label for a user to grab and arm the dispensing device.

In the implementation in which the bands314are different, both may be coupled at one end to a cap304. At least the second band includes a coupler312to couple the other band314. The coupler312may comprise an adhesive patch. In an implementation in which the same band314is coupled to itself, the band314may be threaded through the cap304and may adjust the distance of the coupling from the cap304by threading the band314through the cap and adjusting the relative length of the portions of the band314before coupling of the portions of the band314. This adjustability may allow for a dynamic fitting of the securing mechanism300D to the anatomical feature.

FIGS.4A-4Dillustrate examples of systems400A-400D for coupling the cap404to the indicium406. The system described may be characterized as a simple slot or bar incorporated into the cap with other elements. The cap404and indicium406may be implementations of cap104and indicium106, respectively. Specifically,FIG.4Aillustrates a top view of an example of a system400A with a cap404including holes. The holes may be for threading a band through or for receiving other elements to couple the cap404to the indicium406. The arrows denoted “A-A” inFIG.4Aare drawn to represent thatFIG.4Ashows a top perspective relative to the side perspective ofFIGS.4B-4D.

FIG.4Billustrates a side view of an example of a system400B for coupling the cap404to the indicium406. In this implementation, the indicium406may include a T feature sewn into a lanyard of the indicium406that secures the lanyard to the cap404.

FIG.4Cillustrates a side view of a variant system400C for coupling the cap404to the indicium406. In this implementation, the indicium406includes a rod or feature rolled into the lanyard that provides interference to prevent pull-through of the lanyard through the cap404.

FIG.4Dillustrates still another side view of an example of a system400D for coupling the cap404to the indicium406. In this implementation, the indicium406includes a lanyard that is fed through a slot of the cap404and is secured at a loop by a coupling element, such as a clamp.

FIGS.5A-5Dillustrate further implementations of systems500A-500D for coupling a cap to indicium. Cap504and indicium506may be implementations of cap104and indicium106, respectively. Specifically,FIG.5Aillustrates an example of a system500A with a retractable lanyard. The retractable lanyard may be an element of an indicium506which may be coupled to a cap504.

FIG.5Billustrates an example of a system500B with a carabiner-type loop directly coupled to the cap that can be used with no lanyard. In some variations, the system500B may be modified to include a lanyard and hook. The cap504may be coupled to a carabiner of an indicium506.

FIG.5Cillustrates an example of a system500C with an indicium506that includes a lanyard integrated into a cap504that is a plastic cover, such as a thermoplastic-polyurethane aseptic cover. The integration may involve welding or co-molding.

FIG.5Dillustrates an example of a system500D with indicium506comprising a cable507with a threaded connector508. The indicium506may be directly assembled onto or threaded through the cap504.

FIG.6illustrates an example of a cap600. The cap600may be an implementation of the cap104. The cap600may include a capping element614and a coupling element616. The capping element is the element of the cap600that caps a dispensing device. The capping element614can be used to restrict access to a dispensing device and can preclude dispensing of a substance contained in the dispensing device until the cap600is removed. The coupling element616is an element of the cap600that can be used to couple the cap600to the dispensing device. The coupling element616may be specifically adapted to engage elements of the dispensing device such that the dispensing device cannot dispense its contents until the coupling element616is disengaged from elements of the dispensing device. In some implementations, decoupling the coupling element616from elements of the dispensing device may activate or arm the dispensing device. The activation or arming of the dispensing device may allow the dispensing device to dispense dispensable substances contained in the dispensing device.

FIGS.7A-7Eillustrate an example arrangement of a dispensing device700of the present disclosure teaching the basic principles of its construction and operation. The dispensing device700may be an implementation of the dispensing device102. In an implementation, the dispensing device700may be one or more of an autoinjector and an administration device, and these terms may be used interchangeably for the purposes of describing the dispensing device700. The dispensing device700comprises a shell702(hereafter, by itself or in combination with other autoinjector elements, sometimes referred to as the autoinjector housing or autoinjector body), and a needle housing712, together defining the external shell of the dispensing device700. The dispensing device700has a generally elongated cylindrical form comprising a proximal end (hereafter sometimes referred to as the proximal injection end)701comprising a needle port703, and a distal end, where the dispensing device700may be hand grasped during the injection procedure. A movable piston assembly (also referred to as the administration assembly720) separates the interior volume of the autoinjector into a pressure chamber704and a sterile needle housing712. The administration assembly720comprises a piston721, a dispensable substance (e.g., a beneficial agent) package assembly730joined to its distal end, within the pressure chamber704, and a movable needle assembly740joined at its proximal end, within the needle housing712. The needle assembly740comprises a needle741. The needle741includes a proximal sharp end, a distal sharp end, and a needle hub742. The needle741is movable between a first pre-use position and a second injection position, as will be detailed in theFIGS.7A-7E.

The package assembly730comprises a first wall731and a second wall732joined along their peripheral edges in a permanent seal fashion. The first wall731and the second wall732are further joined across the package to form a first frangible seal736defining a first compartment734adjacent to a second compartment735. A second frangible seal737separates between the compartments734-735and a fitment738that is joined to the piston721. The first compartment734and the second compartment735may be filled with at least one dispensable substance (e.g., a beneficial agent) or constituents thereof. The fitment738comprises a membrane739confronting the distal sharp end of the needle741. A spring714biases the piston assembly toward the pressure chamber704. An adhesive label715seals over the needle port703to maintain the needle741sterile until the time of use. In implementations, the dispensing device700, the first compartment734, and the second compartment735can be merged, by breaking the first frangible seal736, allowing the at least first dispensable substance constituent in the first compartment734and at least a second constituent in the second compartment735to mix and or interact. The package assembly730may comprise more than two mergeable compartments. In an implementation, a second frangible seal737of the package assembly730can be ruptured, establishing fluid communication between the dispensable substance(s) and the fitment738.

Pressure may be introduced into the pressure chamber704in the autoinjector body. The pressure is introduced from a pressure source that, when opened, creates pressure in the autoinjector body. When the pressure surpasses a first threshold value, the pressure causes the piston to overcome the spring713force displacing the administration assembly720toward the proximal injection end701. The needle assembly740moves along with the piston until the needle hub742stops against the bottom of the needle housing712. During usage of the dispensing device700, in this configuration, it is held at the distal end719while the proximal injection end701is depressed against an injection site of a subject, such that the proximal end of the needle741is inserted into the subject. An arrangement of the pressurizing mechanism of the pressure chamber704is shown inFIGS.7A-7E. After pressurization, the administration assembly720may continue its displacement toward the proximal injection end701, while the needle assembly740is stationary, causing the back end of the needle to pierce the membrane739of the fitment738, thereby establishing fluid communication between the package assembly730and the needle741. The pressure in the pressure chamber704causes the first wall731to collapse and deliver the dispensable substance(s) through the needle741. The pressure in the pressure chamber704is gradually reduced by releasing the gas within through a bleeding arrangement (not shown). After the pressure in the pressure chamber704has dropped to a limit, the spring713can displace the administration assembly720toward the distal end719of the actuation assembly770until the needle is concealed again in the needle housing712.

Specifically,FIG.7Aillustrates an example of an arrangement of a dispensing device700. In an implementation, the dispensing device includes an autoinjector body comprising a shell702and a needle housing712, which together form the exterior of the dispensing device700. An administration assembly720is disposed in the autoinjector body (hereafter can be referred to as the autoinjector housing) and comprises a piston721, accommodating a package assembly730at its distal side and a needle assembly740at its proximal side. An actuation assembly770is disposed in the pressure chamber704, comprising a support structure773, which holds in alignment a pressurized cartridge771in a confronting position to a piercing pin772. The support structure773further accommodates a compression panel774for manipulating the compartment of the administration assembly790to merge.FIG.7Billustrates a cross-section of an example of a dispensing device700in the first autoinjector state (hereafter can be referred to as the pre-use configuration). The compression panel774confronts the first compartment734on its first side and leans against a cam781at its second side. The cam781is fixed to the shell702. A latch feature782is also fixed to the shell702. The pin's772sharp end faces the pierceable region of the pressurized cartridge771and is free to move along its axis. However, in this configuration, nothing can apply an axial force to the pin772, and hence an accidental piercing of the cartridge771is not possible.

Arming trigger756is an element that causes the dispensing device700to transition to an armed state. While illustrated as a strap, the arming trigger756may be an element of a removable cap. Removal of the cap can cause the arming trigger to cause the dispensing device700to transition to an armed state. The cap may be removed when an indicium or strap is removed, or an indicium may be an element of the cap. In an implementation, the cap can be removed from the dispensing device700by pulling a strap (e.g., a lanyard or wristband), perhaps pulling the strap through a label. In an implementation, when a label is torn, it is torn at perforations in the label, the label including a removable portion that is coupled to a removable strap. The removal of the strap may facilitate the removal of the cap. The removal of the cap may arm the dispensing device700.

FIG.7Cillustrates an example of an autoinjector in a second autoinjector state and a mixing autoinjector state wherein the shell702is extended away from the needle housing712, causing the cam781to push the compression panel774, which in return depresses the administration assembly790causing its compartments to merge and establish fluid communication with the fitment738. The support structure773holds the pin772from moving upward while the latch feature782moves along with the shell702, slides over the pin's772shaft, and engages with a detent ridge775of the pin772. At this point, the pin772is retained to the shell702. A slot791in the shell702allows connecting an anchoring link (hereafter sometimes referred to as the anchoring link) such as a strap or other devices to facilitate pulling the shell702to the extended position.

FIG.7Dillustrates an example of an autoinjector in an armed state. InFIG.7D, the shell702is moved down, carrying along the pin772, which pierces the pierceable region of the pressurized cartridge771, thereby pressurizing the pressure chamber704. The pressurized cartridge771may contain carbon dioxide, nitrogen, argon, or other gasses or supercritical fluids. When the pressure in the pressure chamber704exceeds a first threshold value, the force it exerts on the piston705overcomes the spring713force, moving the piston721toward the proximal injection end701. The needle assembly740moves with the piston721until it is stopped by the needle housing712floor, at which point the needle741is fully extended. With the needle assembly740now stationary, the pressure in the pressure chamber704continues to move the piston721down, resulting in a relative movement between the needle assembly740and the piston721, causing the distal end of the needle741to pierce the package assembly730and establish fluid communication with the dispensable substance. With the pressure chamber704still pressurized, the dispensable substance is squeezed out of the package assembly730and administered via the needle741to a subject. In one arrangement, the position of the cam781relative to the compression panel774and the position of the latch feature782relative to the detent ridge775are such that a first move of the needle housing712changes the dispensing device700to the mixing dispensing device700state, where the compartments of the package assembly730are merged, and a subsequent second move moves the dispensing device700to the third autoinjector state (hereafter sometimes referred to as the armed configuration). This arrangement is particularly beneficial where the dispensable substance is ready for injection only after a certain time from mixing, such that the device can be kept in a safe, unarmed state during mixing.

FIG.7Eillustrates an example of an dispensing device700in a manufacturing configuration. The needle housing712assembly is sterile and ready to fill at the filling site. Special access regions793in the package assembly730allow the filling machine to fill the package and subsequently seal the channels792connecting the access regions793and the compartment734and the compartment735to prevent fluid communication there between. When filling is completed, the access regions793may be removed, and the shell702is installed on the needle housing assembly. In an implementation, in the arrangement ofFIG.7A-7D, the dispensing device700comprises: (a) a shell702including a proximal injection end701, (b) an administration assembly790, comprising the administration assembly720, the actuation assembly770, and the needle housing712, disposed within the shell702, the administration assembly790including a delivery end proximate to the proximal injection end701through which a dispensable or administrable substance housed within the administration assembly790is capable of being expelled; when in the dispensing device700state illustrated inFIGS.7A-7B(e.g., unarmed state), the administration assembly790is rendered incapable of expelling the dispensable substance; and when in the dispensing device700state (e.g., armed state) illustrated inFIG.7C, the administration assembly790is rendered capable of expelling the dispensable substance. The administration assembly790comprises a first compartment734for storing at least a first constituent of the dispensable substance and at least a second compartment735for storing at least a second constituent of the dispensable substance separate from the first constituent; and wherein at the autoinjector state illustrated inFIG.7C, the first compartment734and the at least second compartment735are merged.

FIGS.8A-8Eillustrate examples of dispensing device systems800A-800E with dispensing devices802that are armed by tearing through a label. The systems800A-800E include a dispensing device802, a cap804, an indicium806, a securing mechanism808, and an endpiece840. The securing mechanisms808(e.g., a lanyard) may include removable portions of the labels (e.g., labels adhered to or integral to the dispensing devices802) adapted to be torn for arming the dispensing devices802. Specifically,FIG.8Aillustrates an example dispensing device system800A with a dispensing device802in a prearmed state before the tearing of a label. The indicium806may be a removable portion of the label. In the illustrated implementation, the indicium806is coupled to the label by perforations indicated by dashed lines. The indicium806is shown with a generic product label containing the name of a medical agent for purposes of demonstration, but the indicium may include, without limitation, identifying information associated with one or more of a patient, the dispensing device802, and a dispensable substance contained by the dispensing device802.

FIG.8Billustrates an example dispensing device system800B with a dispensing device802on which a securing mechanism808has torn through a label comprising the indicium806. The indicium806is pulled away from the dispensing device802by pulling on an endpiece840. The pulling causes the securing mechanism808to tear through a label at perforations, but the indicium806remains coupled to the securing mechanism808. Pulling the securing mechanism808further may cause the cap804to be removed and may further cause the dispensing device802to transition to an armed state.

FIG.8Cillustrates an exploded view of an example dispensing device system800C. Specifically, the indicium806is illustrated fully separated from the securing mechanism808and the dispensing device802. Arrow899indicates that the indicium806can be removed at the perforations to make a strip. In some implementations, this strip may be coupled to the securing mechanism808such that the indicium806, when removed from the label on the dispensing device802, remains coupled to the securing mechanism808. Arrow898indicates that the securing mechanism808can be removed from the dispensing device802.

FIG.8Dillustrates an example dispensing device system800D with a dispensing device802with similarities to the example ofFIG.8C. In the dispensing device system800D, a securing mechanism808is shown in the process of tearing through a label comprising the indicium806. The securing mechanism808(e.g., a band) and the indicium806are pulled away from the dispensing device802in some implementations by pulling on an endpiece840. The pulling causes the securing mechanism808to tear through a label at perforations, but the indicium806remains coupled to the securing mechanism808. The securing mechanism808and the indicium806are shown joined above the point at which the securing mechanism808has torn through the label. The indicium806further comprises a tab807, which may be pulled to separate the indicium806from the securing mechanism808. Pulling the securing mechanism808further may cause the cap804to be removed, which may further cause the dispensing device802to transition to an armed state.

FIG.8Eillustrates an example dispensing device system800E in a fully torn and deployed configuration. In the fully torn and deployed configuration, the cap is fully decoupled from the dispensing device, and the indicium comprises an integral part of the band comprising the securing mechanism. In an alternative implementation, the indicium806may be coupled directly to the cap804instead of or in addition to the securing mechanism808. The securing mechanism808may additionally or alternatively tear through parts of the label in implementations where the indicium806is coupled to the cap804.

FIGS.9A and9Billustrate examples of states900A-900B of an example dispensing device system. Specifically,FIG.9Aillustrates an example of a dispensing device902in an unarmed state900A in which an indicium906is coupled by a cap904to the dispensing device.FIG.9Billustrates an example of a dispensing device902in an armed state900B in which the cap904is removed, decoupling the indicium906from the dispensing device902. The dispensing device902may be in an unarmed state900A or an armed state900B. In the illustrated implementation, decoupling the cap904from the dispensing device902facilitates decoupling of the indicium from the cap904. In the illustrated implementation, the dispensing device includes a slot955and a restricting element953, such as a rod or bar. The restricting element953is coupled to a securing mechanism908. In the unarmed state900A, the securing mechanism908is coupled to the dispensing device902by a combination of the slot955and the restricting element953. The restricting element953is large enough in relevant dimensions to prevent removal from the slot955. Although, as illustrated, the cap904comprises the slot955, the slot955may be a feature of any of the cap904, a body of the dispensing device902, or both.

The securing mechanism908may be further coupled to an endpiece940. Pulling the securing mechanism908and/or endpiece940may result in a removal of the cap904from the dispensing device902. The removal of the cap904may arm the dispensing device902. The removal of the cap may expose a side of the slot955and allow the restricting element953to slide out of an opening in the now open slot955, as indicated by arrow995. Before the side of the slot955is exposed, the restricting element953may be restricted from being removed from the slot955until the cap904is removed from the dispensing device902.

In the illustrated implementation, an indicium906is coupled to (or located on) the securing mechanism908. Although not illustrated, the dispensing device902may further include a label on the body of the dispensing device to which the indicium906is initially coupled in the unarmed state900A and through which the securing mechanism908tears (such as at perforations) to remove the securing mechanism908from the body of the dispensing device902. In one implementation, the indicium906may be only removable when the cap904has been removed from the dispensing device902(perhaps only removable when the dispensing device902is in the armed state900B). In the illustrated implementation, the indicium906may only be decouplable if the cap904is decoupled from the dispensing device.

FIG.10illustrates a flowchart of an exemplary method1000of tracking the use of a dispensing device, including a decouplable indicium. Decoupling operation1002decouples an indicium from a dispensing device. Implementations are contemplated in which this involves tearing the indicium away from a perforated coupling between and/or through a label covering the indicium and the dispensing device. In an implementation, decoupling operation1002decouples the indicium and/or a securing mechanism coupled to the indicium directly from the dispensing device even without decoupling the cap from the dispensing device. The decoupling operation1002may involve tearing through or otherwise removing a label that held coupled one or more of the indicia and securing mechanism to the dispensing device. The removal or tearing may reveal a clear shell of the dispensing device. Decoupling operation1004decouples a cap from the dispensing device. The cap of a dispensing device may cover dispensing elements of the dispensing device when the cap is coupled to the dispensing device. Decoupling the cap from the dispensing device may expose dispensing elements of the dispensing device and may further activate or arm dispensing elements of the dispensing device to allow the dispensing device to dispense a dispensable substance. The dispensing or administration of the dispensable substance may involve injecting drug fluids into a patient, as with an autoinjector. While the indicium may be initially coupled to the dispensing device via the cap, in some implementations, the decoupling operation1004may decouple the cap from a different portion of the dispensing device than the decoupling operation1002. For example, the cap may be decoupled or removed from an end of the dispensing device (e.g., an end with administration elements to dispense the beneficial agent and/or arming elements to arm the dispensing device), and the indicium and/or the securing mechanism may be coupled to a surface between ends of the dispensing device.

In implementations, the decoupling operation1002and the decoupling operation1004are conducted in different orders or are conducted substantially contemporaneously. For example, in implementations, the decoupling operation1002may be conducted before the decoupling operation1004, as illustrated. In implementations, the indicium and/or the securing mechanism may be coupled between the ends of a dispensing device under tension, such that decoupling operation1002causes arming of the dispensing device and the decoupling operation1004.

In other implementations, the decoupling operation1002may be conducted before the decoupling operation1004. For example, the cap may be decoupled from the dispensing device in the decoupling operation1004and may be used as a grip to decouple the indicium in the decoupling operation1002after decoupling operation1004.

An administering operation1006administers a dispensable substance to a patient from a dispensing device. The administering may be facilitated by one or more of the decoupling operations1002and/or1004allowing access to and/or arming (e.g., transitioning the dispensing device from a safe configuration to an armed configuration) the administering or dispensing elements of the dispensing device. In an implementation, the shell of the dispensing device includes a clear portion that is exposed after the decoupling operations1002and1004such that a device user can see whether the drug has been administered through the clear shell.

Coupling operation1008couples an indicium to a person. Coupling operation1008allows information provided in the indicium to be tracked from the dispensing device to the patient. The indicium may be coupled to any securable feature, including an anatomical feature or appendage of a person. The indicium may contain information, for instance, identifying information associated with one or more of the patients, the dispensing device, and the dispensable substance contained by the dispensing device. The indicium may be coupled to the person using a securing mechanism that secures the indicium to the person. A variety of implementations are contemplated with respect to the securing mechanism. Coupling operation1008may involve inserting an anatomical feature of the person into a band of the securing mechanism.

In an implementation, coupling operation1008couples the indicium to a securable feature by advancing a cinch distally from a cap of a securing mechanism. For instance, the securing mechanism may include a band and a cinch coupled to the band. The cinch may be irreversibly advanceable along at least a portion of the band. The cinch may be situated on the band relative to the cap, such that pulling the cap when the band is engaged to an anatomical feature of a person tightens the band about an anatomical feature of the person. In one implementation, the band is coupled at both a first end of the band and a second end of the band to the cap, forming a band loop. The band may be threaded twice through the cinch. The securing mechanism may receive an anatomical feature of the person between the cinch and the band loop. The securing mechanism may then be secured to the anatomical feature by irreversibly advancing the cinch distally from the cap.

In an implementation, coupling operation1008couples the indicium to a securable feature by advancing the cinch of a securing mechanism proximally towards a cap along a band of the securing mechanism. In this implementation in which the band is coupled at both a first end of the band and a second end of the band to the cap, forming a band loop, the securing mechanism receives an anatomical feature of a person between the cinch and the cap. The securing mechanism may then secure the anatomical feature by irreversibly advancing the cinch proximally towards the cap. In various implementations, coupling operation1008involves removing a cinch or other coupler from a cap. In other implementations, the cinch or coupler may be stored in a configuration in which the coupler is adjacent to (e.g., in contacting engagement with) an endpiece.

In still another alternative implementation, the coupling operation1008couples the indicium to a person by coupling two bands or band portions. In this implementation, two bands may be coupled to the cap, or a band may be threaded through the cap to effectively make two separate bands. The second of the bands may include a coupling element, for instance, an adhesive. An anatomical feature may be placed between the bands, and the adhesive on the second band may be used to couple the portion of the second band with the coupling to a portion of the first band, such that the coupled band portions are distal from the anatomical feature. This may effectively secure the anatomical feature between the coupled bands. In an implementation in which the bands are defined by a single band having been threaded through the cap, the band lengths may be adjusted by pulling the band through the cap to a desired or predefined length. This may allow for the coupling between the band portions (in this instance, on the same band) to more effectively secure the anatomical feature of the person.

FIG.11illustrates an alternative implementation of the method1100for tracking the use of a dispensing device to dispense a beneficial agent. In this implementation, operation1102comprises a decoupling operation of removing the cap of the dispensing device, and operation1104comprises a decoupling operation of separating an indicium from the device. In implementations, the decoupling operation1102is an implementation of and includes features similar to operation1004, and decoupling operation1104is an implementation of and includes features similar to1002, except that the device is configured for decoupling of a decouplable cap to precede decoupling of a decouplable indicium. The administration operation1106is an implementation of and includes features similar to the administration operation1006. The coupling operation1108is an implementation of and includes features similar to the coupling operation1008.

FIG.12illustrates an alternative implementation of the method1200for tracking the use of a dispensing device to dispense a beneficial agent. In this implementation, operation1202comprises a decoupling operation of removing the cap of the administration device and simultaneously or substantially contemporaneously decoupling an indicium from the device. In many implementations, the decoupling operation1202is an implementation of and includes features similar to the features of operations1004and1002, except that the device is configured for the decoupling operations to comprise a single operation. The administration operation1206is an implementation of and includes features similar to the administration operation1006. The coupling operation1208is an implementation of and includes features similar to the coupling operation1008.

As used herein, a beneficial agent dispensing device system may refer interchangeably to an administration device system and/or a substance dispensing system. As used herein, a dispensing device may refer interchangeably to an administration device. As used herein, a beneficial agent may refer interchangeably to a dispensable substance.

An example beneficial agent dispensing device system is provided. The beneficial agent dispensing system includes a dispensing device containing a beneficial agent, an indicium coupled to and selectively decouplable from the dispensing device, the indicium indicating information related to the beneficial agent, and a securing mechanism coupled to the indicium and configurable to secure the indicium to a securable feature.

Another example beneficial agent dispensing device system of any preceding system is provided, wherein the dispensing device includes an autoinjector.

Another example beneficial agent dispensing device system of any preceding system is provided, wherein the dispensing device is operable to administer the beneficial agent to a patient.

Another example beneficial agent dispensing device system of any preceding system is provided, wherein the indicium provides an indication that the beneficial agent has been administered to a patient.

Another example beneficial agent dispensing device system of any preceding system is provided, wherein the securing mechanism is a non-reversible attachment.

Another example beneficial agent dispensing device system of any preceding system is provided, wherein the dispensing device is adapted to transition from a safe configuration in which the dispensing device prevents dispensing of the beneficial agent to an armed configuration in which the dispensing device allows dispensing of the beneficial agent, and wherein the indicium is removable from the dispensing device in the armed configuration.

Another example beneficial agent dispensing device system of any preceding system is provided, wherein decoupling the indicium from the dispensing device transitions the dispensing device from a safe configuration in which the dispensing device prevents dispensing of the beneficial agent to an armed configuration in which the dispensing device allows dispensing of the beneficial agent.

Another example beneficial agent dispensing device system of any preceding system is provided, the beneficial agent dispensing device system further including a cap coupled to and decouplable from the dispensing device, wherein the indicium is coupled to the cap, and wherein the dispensing device is adapted to transition to the armed configuration in response to displacement of the cap.

Another example beneficial agent dispensing device system of any preceding system is provided, the beneficial agent dispensing device system further including a label configured to tear when the indicium is decoupled from the dispensing device.

Another example beneficial agent dispensing device system of any preceding system is provided, the beneficial agent dispensing device system further including a label including the indicium.

Another example beneficial agent dispensing device system of any preceding system is provided, wherein the securing mechanism includes a band adapted for selective engagement with a securable feature.

Another example beneficial agent dispensing device system of any preceding system is provided, wherein the securing mechanism includes a cinch, the cinch being irreversibly advanceable along a portion of a band, including the indicium.

Another example beneficial agent dispensing device system of any preceding system is provided, the beneficial agent dispensing device system further including a cap coupled to the dispensing device, wherein the cinch is coupled to the cap.

Another example beneficial agent dispensing device system of any preceding system is provided, wherein the securing mechanism is configured to secure the indicium to a securable feature, and wherein motion of a cap away from the securable feature advances the cinch along a portion of the band.

Another example beneficial agent dispensing device system of any preceding system is provided, the beneficial agent dispensing device system further including a cap selectively decouplable from the dispensing device, wherein the band is coupled at a first end of the band and a second end of the band to the cap, the band threaded twice through the cinch forming a band loop, the securing mechanism configured to receive a securable feature between the cinch and the band loop, the securing mechanism configured to secure the indicium to the securable feature by the cinch being irreversibly advanced distally from the cap.

Another example beneficial agent dispensing device system of any preceding system is provided, the beneficial agent dispensing device system further including a cap selectively decouplable from the dispensing device, wherein the band is coupled at both a first end of the band and a second end of the band to the cap, the band threaded twice through the cinch, the securing mechanism configured to receive a securable feature between the cinch and the cap, the securing mechanism configured to secure the indicium to the securable feature by the cinch being irreversibly advanced proximally towards the cap.

Another example beneficial agent dispensing device system of any preceding system is provided, the beneficial agent dispensing device system further including a cap selectively decouplable from the dispensing device, wherein the securing mechanism further includes an endpiece coupled to the band distally from the cap.

Another example beneficial agent dispensing device system of any preceding system is provided, the beneficial agent dispensing device system further including a cap coupled to the dispensing device, wherein the band is coupled at a first end of the band to the cap and a second end of the band to the cinch, the band threaded once through the cinch forming a band loop, the securing mechanism to receive a securable feature between the cinch and the band loop, the securing mechanism securing to the securable feature by irreversibly advancing the cinch distally from the cap.

Another example beneficial agent dispensing device system of any preceding system is provided, wherein the indicium includes an active timing element.

Another example beneficial agent dispensing device system of any preceding system is provided, wherein the active timing element includes one of a pressure-sensitive element, a photosensitive element, or a chemosensitive element.

Another example beneficial agent dispensing device system of any preceding system is provided, the indicium further including a modifiable portion suitable to indicate information related to the dispensing of the beneficial agent.

Another example beneficial agent dispensing device system of any preceding system is provided, wherein the indicium includes an adhesive portion for securing the indicium to a securable feature.

Another example beneficial agent dispensing device system of any preceding system is provided, wherein the dispensing device is adapted to transition from a safe configuration in which the dispensing device prevents dispensing of the beneficial agent to an armed configuration in which the dispensing device allows dispensing of the beneficial agent, and wherein the indicium is secured to the dispensing device in the safe configuration, and the indicium includes a pull configured to displace an activation member of the dispensing device and to transition the dispensing device to the armed configuration by the displacement.

Another example beneficial agent dispensing device system of any preceding system is provided, the beneficial agent dispensing device system further including a cap selectively decouplable from the dispensing device, wherein the indicium is secured to the cap, the indicium further directly decouplable from the dispensing device at a position on the dispensing device other than the cap.

An example method for tracking a dispensable substance in a dispensing device is provided. The method includes decoupling an indicium from the dispensing device and coupling a securing mechanism attached to the indicium to a securable feature.

Another example method of any preceding method is provided, the decoupling the indicium from the dispensing device including decoupling the indicium from a direct coupling between the indicium and the dispensing device and decoupling a cap selectively decouplable from the dispensing device from a direct coupling between the cap and the dispensing device.

Another example method of any preceding method is provided, the method further including decoupling a cap from the dispensing device, responsive to the decoupling of the indicium, wherein the coupling the securing mechanism to the securable feature includes inserting a securable feature into a band coupled at both ends of the band to the cap; and tightening the band about the securable feature.

Another example method of any preceding method is provided, wherein the band is threaded twice through a cinch and wherein the tightening includes advancing the cinch towards the cap.

Another example method of any preceding method is provided, wherein the band is threaded twice through a cinch and wherein the operation of tightening includes advancing the cinch away from the cap.

Another example method of any preceding method is provided, the coupling the indicium to the securable feature including inserting a securable feature into a band coupled at one end of the band to a cap and another end of the band to a cinch, the band threaded once through the cinch, wherein the operation of tightening includes advancing the cinch away from the cap.

Another example method of any preceding method is provided, the coupling the indicium to the securable feature including inserting a securable feature between a first band coupled at a first side of the first band to a cap and a second band coupled at a first side of the second band to the cap, the second band having an adhesive portion distal from the cap and adhering the adhesive portion of the second band to a portion of the first band distal from the securable feature.

An example system for tracking a dispensable substance in a dispensing device is provided. The system includes means for decoupling an indicium from the dispensing device and means for coupling a securing mechanism attached to the indicium to a securable feature.

Another example system of any preceding system is provided, the means for decoupling the indicium from the dispensing device including means for decoupling the indicium from a direct coupling between the indicium and the dispensing device and means for decoupling a cap selectively decouplable from the dispensing device from a direct coupling between the cap and the dispensing device.

Another example system of any preceding system is provided, the system further including means for decoupling a cap from the dispensing device, responsive to the decoupling of the indicium, wherein the means for coupling the securing mechanism to the securable feature includes means for inserting a securable feature into a band coupled at both ends of the band to the cap, the system further including means for tightening the band about the securable feature.

Another example system of any preceding system is provided, wherein the band is threaded twice through a cinch and wherein the means for tightening include means for advancing the cinch towards the cap.

Another example system of any preceding system is provided, wherein the band is threaded twice through a cinch and wherein means for tightening include means for advancing the cinch away from the cap.

Another example system of any preceding system is provided, the means for coupling the indicium to the securable feature including means for inserting a securable feature into a band coupled at one end of the band to a cap and another end of the band to a cinch, the band threaded once through the cinch, wherein the means for tightening include means for advancing the cinch away from the cap.

Another example system of any preceding system is provided, the means for coupling the indicium to the securable feature including means for inserting a securable feature between a first band coupled at a first side of the first band to a cap and a second band coupled at a first side of the second band to the cap, the second band having an adhesive portion distal from the cap, the means for coupling to the indicium to the securable feature further including means for adhering the adhesive portion of the second band to a portion of the first band distal from the securable feature.

An example administration device system is provided. The administration device system includes an administration device containing an administrable substance, wherein the administration device is adapted to transition from a first configuration to a second configuration, a cap coupled to the administration device, and an indicium including information related to the administrable substance, wherein the indicium is decouplable from the administration device and wherein the decoupling of the indicium from the administration device causes the administration device to transition from the first configuration to the second configuration.

An example administration device system is provided. The administration device system includes an administration device containing an administrable substance, wherein the administration device is adapted to transition from a first configuration to a second configuration, an indicium including instructions for use of one or more of the administrable substance and the administration device, and a cap coupled to the administration device and the indicium, wherein the cap activates arming elements within the administration device when the cap is decoupled from the administration device, the arming elements operable to transition the administration device from the first configuration to the second configuration.

An example administration device system is provided. The administration device system includes an administration device containing an administrable substance, wherein the administration device is adapted to transition from a first configuration in which the administrable substance cannot be administered to a second configuration in which the administrable substance can be administered, an indicium including information related to the administrable substance, and a cap coupled to the administration device and the indicium, wherein the cap is adapted to arm arming elements within the administration device when the cap is decoupled from the administration device, the arming elements operable to transition the administration device from the first configuration to the second configuration.

An example administration device system is provided. The administration device system includes an administration device containing an administrable substance, wherein the administration device is adapted to transition from a first configuration in which the administrable substance cannot be dispensed to a second configuration in which the administrable substance can be dispensed, an indicium including information related to the administrable substance, and a cap coupled to the administration device and the indicium, wherein the cap activates arming elements within the administration device when the cap is decoupled from the administration device, the arming elements operable to transition the administration device from the first configuration to the second configuration.

An example administration device system is provided. The administration device system includes an administration device containing an administrable substance, wherein the administration device is adapted to transition from a first configuration in which the administrable substance cannot be dispensed to a second configuration in which the administrable substance can be dispensed, a cap coupled to the administration device, and an indicium including information related to the administrable substance coupled to one or more of the cap and the administration device, wherein the cap activates arming elements within the administration device when the cap is removed from the administration device to transition the administration device from the first configuration to the second configuration, and wherein decoupling the indicium from the one or more of the cap and the administration device decouples the cap from the administration device.

An example administration device system is provided. The administration device system includes an administration device containing an administrable substance, wherein the administration device is adapted to transition from a first configuration in which the administrable substance cannot be dispensed to a second configuration in which the administrable substance can be dispensed, a cap coupled to the administration device, and an indicium including information related to the administrable substance coupled to the cap, wherein decoupling the indicium from the administration device decouples the cap from the administration device and wherein the cap activates arming elements within the administration device when the cap is removed from the administration device to transition the administration device from the first configuration to the second configuration, and wherein decoupling the cap from the administration device facilitates decoupling of the indicium from the cap.

Another example administration device system of any preceding system is provided, the administration device system further including a label, wherein the indicium is integral to the label before the indicium is decoupled.

Another example administration device system of any preceding system is provided, wherein the label further includes perforations, the perforations configured to tear when the indicium is decoupled.

Another example administration device system of any preceding system is provided, the administration device system further including a band coupled to the cap and the indicium and a label that covers the band prior to decoupling the band from the administration device, wherein the band is adapted to tear through the label when the band is decoupled from the administration device.

Another example administration device system of any preceding system is provided, wherein the label includes perforations operable to guide the tearing of the band through the label.

Another example administration device system of any preceding system is provided, wherein a portion of the label remains coupled to the band after decoupling of the indicium from the administration device.

Another example administration device system of any preceding system is provided, wherein the indicium cannot be decoupled from the cap while the cap is coupled to the administration device.

Another example administration device system of any preceding system is provided, wherein the indicium includes a writable section.

Another example administration device system of any preceding system is provided, wherein the indicium includes a manually modifiable portion to manually indicate information related to the administrable substance.

Another example administration device system of any preceding system is provided, wherein the indicium includes an active timing element.

Another example administration device system of any preceding system is provided, wherein the active timing element includes one or more of a pressure-sensitive element, a photosensitive element, and a chemosensitive element.

Another example administration device system of any preceding system is provided, the administration device system further including a restricting element, wherein one or more of the cap and the administration device include a slot, the slot partially defined by the coupling of the cap to the administration device, wherein decoupling the cap from the administration device exposes a side of the slot, and wherein the restricting element is restricted from being removed from the slot until the side of the slot is exposed.

Another example administration device system of any preceding system is provided, the administration device system further including a securing mechanism coupled to the indicium, wherein the securing mechanism is a non-reversible attachment.

Another example administration device system of any preceding system is provided, wherein the securing mechanism includes a band adapted for selective engagement with an anatomical feature of a patient.

Another example administration device system of any preceding system is provided, wherein the securing mechanism includes a cinch member that is irreversibly advanceable along a portion of a band of the indicium.

Another example administration device system of any preceding system is provided, wherein the cinch is stored within the cap prior to decoupling of the cap from the administration device.

Another example administration device system of any preceding system is provided, wherein the cinch is advanced by pulling the cap away from an anatomical feature secured by the securing mechanism.

Another example administration device system of any preceding system is provided, wherein the band is coupled at both a first end of the band and a second end of the band to the cap, forming a band loop, the band threaded twice through the cinch, the securing mechanism to receive an anatomical feature of a person between the cinch and the band loop, the securing mechanism securing to the anatomical feature by irreversibly advancing the cinch distally from the cap.

Another example administration device system of any preceding system is provided, wherein the band is coupled at both a first end of the band and a second end of the band to the cap, forming a band loop, the band threaded twice through the cinch, the securing mechanism to receive an anatomical feature of a person between the cinch and the cap, the securing mechanism securing to the anatomical feature by irreversibly advancing the cinch proximally towards the cap.

Another example administration device system of any preceding system is provided, the securing mechanism further including an endpiece at a bend of a band loop located distally from the cap.

Another example administration device system of any preceding system is provided, wherein the band is coupled at a first end of the band to the cap and a second end of the band to the cinch, the band threaded once through the cinch, forming a band loop, the securing mechanism to receive an anatomical feature of a person between the cinch and the band loop, the securing mechanism securing to the anatomical feature by irreversibly advancing the cinch distally from the cap.

Another example administration device system of any preceding system is provided, wherein the cinch member is stored in the cap or adjacent to an endpiece of the band prior to decoupling of the indicium from the administration device.

Another example administration device system of any preceding system is provided, wherein the band includes an adhesive portion for securing the indicium to a patient.

Another example administration device system of any preceding system is provided, wherein the indicium is secured to the administration device in the first configuration of the administration device, and wherein the indicium is selectively removable from the administration device to provide a pull to remove the cap, causing the arming trigger to transition the administration device to an armed state the administration device prior to injection of the administrable substance to a patient.

Another example administration device system of any preceding system is provided, wherein the indicium is further directly decouplable from the administration device at a position on the administration device other than the cap.

Another example administration device system of any preceding system is provided, wherein the indicium includes a portion with instructions for use of the administration device.

An example substance dispensing system is provided. The substance dispensing system includes a dispensing device containing a dispensable substance, an indicium for providing an indication of the dispensable substance, wherein the indicium is decouplable from the dispensing device, and a securing mechanism coupled to the indicium for securing the indicium to a patient.

Another example substance dispensing system of any preceding system is provided, wherein the dispensing device includes an autoinjector.

Another example substance dispensing system of any preceding system is provided, wherein the dispensable substance is a beneficial substance and wherein the dispensing device is operable to administer the beneficial substance to the patient.

Another example substance dispensing system of any preceding system is provided, wherein the indicium further provides an indication that the substance has been administered to the patient.

Another example substance dispensing system of any preceding system is provided, wherein the securing mechanism is a non-reversible attachment.

Another example substance dispensing system of any preceding system is provided, wherein the indicium is secured to a cap of the dispensing device, wherein the dispensing device is armed for an administration of the dispensable substance by transitioning from a first configuration in which the cap is coupled to the dispensing device to a second configuration where the cap is removed from the dispensing device.

Another example substance dispensing system of any preceding system is provided, wherein the indicium includes a band adapted for selective engagement with an anatomical feature of the patient.

Another example substance dispensing system of any preceding system is provided, wherein the indicium is secured to a cap of the dispensing device that is decouplable from the dispensing device, wherein the securing mechanism includes a cinch member that is irreversibly advanceable along a portion of a band of the indicium.

Another example substance dispensing system of any preceding system is provided, wherein the cinch is stored within the cap prior to decoupling of the cap from the dispensing device.

Another example substance dispensing system of any preceding system is provided, wherein the cinch is advanced by pulling the cap away from an anatomical feature secured by the securing mechanism.

Another example substance dispensing system of any preceding system is provided, wherein the band is coupled at both a first end of the band and a second end of the band to the cap, forming a band loop, the band threaded twice through the cinch, the securing mechanism to receive an anatomical feature of the patient between the cinch and the band loop, the securing mechanism securing to the anatomical feature by irreversibly advancing the cinch distally from the cap.

Another example substance dispensing system of any preceding system is provided, wherein the band is coupled at both a first end of the band and a second end of the band to the cap, forming a band loop, the band threaded twice through the cinch, the securing mechanism to receive an anatomical feature of the patient between the cinch and the cap, the securing mechanism securing to the anatomical feature by irreversibly advancing the cinch proximally towards the cap.

Another example substance dispensing system of any preceding system is provided, the securing mechanism further including an endpiece at a bend of a band loop located distally from the cap.

Another example substance dispensing system of any preceding system is provided, wherein the band is coupled at a first end of the band to the cap and a second end of the band to the cinch, the band threaded once through the cinch, forming a band loop, the securing mechanism to receive an anatomical feature of the patient between the cinch and the band loop, the securing mechanism securing to the anatomical feature by irreversibly advancing the cinch distally from the cap.

Another example substance dispensing system of any preceding system is provided, wherein the indicium includes an adhesive portion for securing the indicium to the patient.

Another example substance dispensing system of any preceding system is provided, wherein the indicium is secured to the dispensing device in a safe configuration of the dispensing device, and wherein the indicium is selectively removable from the dispensing device to provide a pull to remove an activation member of the dispensing device to arm the dispensing device prior to injection of the dispensable substance to the patient.

Another example substance dispensing system of any preceding system is provided, wherein the indicium is secured to a cap of the dispensing device that is decouplable from the dispensing device, the indicium further directly decouplable from the dispensing device at a position on the dispensing device other than the cap.

An example method for tracking a dispensable substance in a dispensing device having a decouplable indicium is provided. The method includes decoupling the indicium from the dispensing device and coupling the indicium to an anatomical feature of a patient using a securing mechanism coupled to the decouplable indicium.

Another example method of any preceding method is provided, the decoupling the indicium from the dispensing device including decoupling a cap of the dispensing device coupled to the indicium from the dispensing device and decoupling the indicium from a direct coupling between the indicium and the dispensing device at a location on the dispensing device other than the cap.

Another example method of any preceding method is provided, the operation of coupling indicium to the anatomical feature including inserting an anatomical feature of the patient into a band coupled at both ends of the band to a cap and tightening the band about the anatomical feature.

Another example method of any preceding method is provided, wherein the band is threaded twice through a cinch and wherein the tightening includes advancing the cinch towards the cap.

Another example method of any preceding method is provided, wherein the band is threaded twice through a cinch and wherein the tightening includes advancing the cinch away from the cap.

Another example method of any preceding method is provided, the operation of coupling the indicium to the anatomical feature including inserting an anatomical feature of the person into a band coupled at one end of the band to a cap and another end of the band to a cinch, the band threaded once through the cinch, wherein the operation of tightening includes advancing the cinch away from the cap.

Another example method of any preceding method is provided, the operation of coupling the indicium to the anatomical feature including inserting an anatomical feature of the patient between a first band coupled at a first side of the first band to a cap and a second band coupled at a first side of the second band to the cap, the second band having an adhesive portion distal from the cap and adhering the adhesive portion of the second band to a portion of the first band distal from the anatomical feature.

An example system for tracking a dispensable substance in a dispensing device having a decouplable indicium is provided. The system includes means for decoupling the indicium from the dispensing device and means for coupling the indicium to an anatomical feature of a patient using a securing mechanism coupled to the decouplable indicium.

Another example system of any preceding system is provided, the means for decoupling the indicium from the dispensing device including means for decoupling a cap of the dispensing device coupled to the indicium from the dispensing device and means for decoupling the indicium from a direct coupling between the indicium and the dispensing device at a location on the dispensing device other than the cap.

Another example system of any preceding system is provided, the means for coupling indicium to the anatomical feature including means for inserting an anatomical feature of the patient into a band coupled at both ends of the band to a cap and means for tightening the band about the anatomical feature.

Another example system of any preceding system is provided, wherein the band is threaded twice through a cinch and wherein the means for tightening include means for advancing the cinch towards the cap.

Another example system of any preceding system is provided, wherein the band is threaded twice through a cinch and wherein the means for tightening includes means for advancing the cinch away from the cap.

Another example system of any preceding system is provided, the means for coupling the indicium to the anatomical feature including means for inserting an anatomical feature of the person into a band coupled at one end of the band to a cap and another end of the band to a cinch, the band threaded once through the cinch, wherein the means for tightening include means for advancing the cinch away from the cap.

Another example system of any preceding system is provided, the means for coupling the indicium to the anatomical feature including means for inserting an anatomical feature of the patient between a first band coupled at a first side of the first band to a cap and a second band coupled at a first side of the second band to the cap, the second band having an adhesive portion distal from the cap, the means for coupling the indicium to the anatomical feature further including means for adhering the adhesive portion of the second band to a portion of the first band distal from the anatomical feature.

A number of implementations of the described technology have been described. Nevertheless, it will be understood that various modifications can be made without departing from the spirit and scope of the recited claims.