Patent Description:
Parenteral medicaments are typically administered using a drug delivery device, such as an inhaler or auto-injector. In order to reduce the number of steps required to administer a dose, many parenteral medicaments are packaged in a disposable drug delivery that arrives pre-filled to a patient. This can prevent handling and dosing errors, and reduce the overall burden on the patient compared to reusable devices that must be properly loaded with the medicament prior to dosing. Disposable drug delivery devices have become much more popular than reusable devices because of their simplicity and ease-of-use. However, disposable devices must be inexpensive in order to be economically viable for patients and pharmaceutical companies to adopt. For this reason, disposable devices currently lack advanced functionalities that reusable devices enjoy, such as digital interfaces and reminder functions.

One important functionality that can been integrated into a drug delivery device is dose logging, where information about an administered dose is recorded by the device. Another important functionality is wireless connectivity, which enables data collected during a dosing event to be shared with loved ones or care providers. Together, these functionalities enable remote monitoring of treatment regimens and targeted support of patients, leading to greater medication adherence and improved medical outcomes. Based on these benefits, reusable devices have been developed with dose logging and wireless connectivity capabilities, an example of which includes the BETACONNECT™ available from Bayer (see www. com/experience-betacconect for more information).

Recently, there have been attempts to introduce advanced functionalities into disposable drug delivery devices. The Alubena™ concept has been introduced by SHL Group (Sweden) for their disposable auto-injector devices. The concept consists of a reusable 'recording unit' with dose logging and digital feedback capabilities. The device also has Bluetooth connectivity for wirelessly transmitting data when synced to a companion application on a patient's smartphone. Comparable add-on sensors with Bluetooth connectivity have been introduced for disposable inhalers as well. The problem with these solutions is that the patient now must attach the add-on recording unit to each disposable drug delivery device before use, and must remove the recording unit prior to disposing of the delivery device. The YpsoMate® Smart concept has been introduced by Ypsomed (Switzerland), and overcomes the need for an add-on unit by integrating sensors and a near field communication (NFC) tag directly into the disposable auto-injector. However, the patient must place their smartphone close to the auto-injector and use a companion app to scan the NFC tag before and after the injection in order to record a dosing event. Both of these solutions burden the patient with additional steps, nullifying the benefits that a disposable drug delivery device is meant to offer. They also require the patient to own and properly operate a smartphone for the data sharing to work, which limits their applicability in important healthcare populations such as the elderly.

Therefore, a need exists for a solution that provides advanced features possible with reusable drug delivery devices, while preserving the simplicity and ease-of-use provided by disposable drug delivery devices.

Background art is provided in <CIT>, <CIT>, <CIT>, <CIT>, <CIT> and <CIT>.

<CIT> discloses a drug delivery system that includes a drug delivery device having a reservoir and a delivery cannula having a proximal end in fluid communication with the reservoir and a distal end to be received within a patient. The drug delivery system may further include one or more sensors coupled to the drug delivery device, a wireless transmitter, and a controller coupled to the one or more sensors and the wireless transmitter. The controller may be configured to use the one or more sensors to determine a condition or an operational state of the drug delivery device, and control the wireless transmitter to wirelessly transmit one or more reports representative of the condition or the operational state of the drug delivery device. Operational states may include (i) packaged/ready for distribution; (ii) packaged/distributed; (iii) unpackaged/ready for administration; (iv) sterile barrier removed; (v) device applied; (vi) cannula injected (or inserted); (vii) drug delivery initiated; (viii) drug delivery completed; and (ix) device removed. Detection of the unpackaged state may be based on interference with a signal or increased received signals. It is also disclosed to wake up the electronics into a high activity state for delivery and reporting when the temperature is exceeding a certain threshold or upon removal of a sterile barrier.

<CIT> discloses systems and methods for processing, transmitting and displaying data received from an analyte sensor, such as a glucose sensor. In an embodiment, a method for transmitting data between a first communication device associated with an analyte sensor and a second communication device configured to provide user access to sensor-related information comprises: activating a transceiver of a first communication device associated with an analyte sensor at a first time; and establishing a two-way communication channel with the second communication device; wherein the activating comprises waking the transceiver from a low power sleep mode using a forced wakeup from the second communication device. In some embodiments, a light sensitive-sensor takes a sensor electronics module out of a low power storage mode when the light-sensitive sensor is exposed to light.

<CIT> discloses a medication delivery system that includes a medical server configured to send and receive and process data, a medication device configured to administer a preselected medication, a sensor circuit configured to detect selected parameters relating to medication delivery and transmit information, and a transmission hub configured to communicate with the medical server and the sensor circuit. The transmission hub is configured to receive a signal from the sensor circuit and exchange the information. An application is configured to enable exchange of information between the sensor circuit and the medical server. The application has a preselected set of protocols. The application monitors usage of the medication device and location of the medication device by connecting to the medication device via the transmission hub.

<CIT> discloses devices and methods for monitoring a patient's compliance with an inhaler treatment regimen. The device may monitor an inhaler's motion to determine whether the motion is characteristic of typical inhaler use. Additionally, the device may monitor a temperature of the inhaler or in proximity to the mouthpiece to determine whether a patient has used the inhaler. The devices and methods may incorporate a smart phone application that provides notifications and alerts to aid in compliance with the medication regimen.

<CIT> discloses a system for tracking and dispensing of prescription medication. A secure website is provided, and a data communication link to a computer at each healthcare facility and pharmacy. Prescriptions are ordered from the healthcare facility computer, after which labels with machine readable code are generated by the pharmacy computer for each prescription container. A verification table is generated of all ordered prescriptions over a predetermined time to each respective healthcare facility, a reader scans the machine readable code of each prescription container, and the pharmacy computer verifies that all ordered prescriptions are sorted for delivery. The verification table of the verified prescriptions sorted for delivery is uploaded to a database. Upon delivery at the healthcare facility, the verification table is downloaded from the database, a reader scans the machine readable code of each prescription container, and the healthcare facility computer verifies that all ordered prescriptions were received.

<CIT> discloses a system for managing administration of prescribed medications to patients. The system includes a server for receiving prescription fill requests which are based on prescriptions for the prescribed medications, and for causing uniquely identifiable medication packages to be produced based on the prescription fill requests and in conformity with the prescriptions. Each medication package contains a single dose of at least one of the prescribed medications. The server is further for receiving and maintaining medication package records specifying the contents of each particular medication package. The system includes an interface for providing access to the prescriptions and the medication package records for validating administration of the prescribed medications to the patients. Each single dose of prescribed medication is uniquely identifiable by identifying the medication package containing that single dose and by accessing the medication package records specifying the contents of that medication package.

The present invention is a drug delivery apparatus as defined in Claim <NUM> of the appended claims. Also provided is a communication and tracking system as defined in Claim <NUM>. Details of certain embodiments are set out in the dependent claims.

Many aspects of the present disclosure can be better understood with reference to the following drawings. The components in the drawings are not necessarily to scale. Instead, emphasis is placed on illustrating clearly the principles of the present disclosure. Furthermore, components can be shown as transparent in certain views for clarity of illustration only and not to indicate that the illustrated component is necessarily transparent. For ease of reference, throughout this disclosure identical reference numbers may be used to identify identical or at least generally similar or analogous components or features.

Specific details of several embodiments of the technology are described below with reference to <FIG>. Although many of the embodiments are described below with respect to devices, systems, and methods for tracking distribution and use of disposable drug delivery devices, other applications and other embodiments in addition to those described herein are within the scope of the technology. Additionally, several other embodiments of the technology can have different configurations, components, or procedures than those described herein. A person of ordinary skill in the art, therefore, will accordingly understand that the technology can have other embodiments with additional elements, or the technology can have other embodiments without several of the features shown and described below with reference to <FIG>.

<FIG> and <FIG> show semi-reusable medicament assemblies 10A and 10B with and without a reusable electronic module <NUM>, respectively, in accordance with an embodiment of the present technology. As shown in <FIG>, the reusable electronic module <NUM> may be operatively coupled to a disposable drug delivery device, which may be a handheld-type disposable drug delivery device or a wearable-type disposable drug delivery device. In particular, as shown, the semi-reusable medicament assembly 10A includes a handheld disposable drug delivery device 100A and the semi-reusable medicament assembly 10A includes a wearable disposable drug delivery device 100B. In some embodiments, the electronic module <NUM> connects to an outer surface of the drug delivery device 100A, 100B. In other embodiments, the electronic module <NUM> is installed within a shell of the drug delivery device 100A, 100B. In various embodiments, the disposable drug delivery device 100A, 100B contains a medicament <NUM>, a medicament viewing window <NUM>, and a medicament label <NUM>. In one embodiment, the medicament label <NUM> includes information readable by a user, such as a patient, as well as by a machine. In certain embodiments, the drug delivery device 100A, 100B includes a start switch (not shown) for initiating a delivery of the medicament <NUM> into the user. In various embodiments, as shown in <FIG>, the reusable electronic module <NUM> comprises a user interface <NUM> for providing feedback to the patient. In certain embodiments, the user interface <NUM> includes a device status indicator <NUM> and a drug delivery status indicator <NUM>.

Referring to <FIG>, the reusable electronic module <NUM> further comprises one or more engagement features <NUM> that can connect to the disposable drug delivery device 100A, 100B. In some embodiments, the engagement features <NUM> form mechanical and electrical connections when the reusable electronic module <NUM> is properly attached to the disposable drug delivery device 100A, 100B. In certain embodiments, the disposable drug delivery device 100A, 100B includes a stopping feature <NUM> through which the reusable electronic module <NUM> can physically interrupt the drug delivery process.

As noted above, the disposable drug delivery device included in the semi-reusable medicament assembly may be a handheld-type disposable drug delivery device or a wearable-type disposable drug delivery device. In certain embodiments, the reusable electronic module <NUM> is identical across distinct types of the disposable drug delivery device. In various embodiments, the semi-reusable medicament assembly 10A comprises the handheld drug delivery device 100A for administering low-volume doses of the medicament <NUM>. In some embodiments, the semi-reusable medicament assembly 10B comprises the wearable disposable drug delivery device 100B for administering high-volume doses of medicament <NUM>. In one embodiment, the wearable drug delivery device 100B has an adhesive surface <NUM> for attaching to a skin of the user and administering the medicament <NUM> over an extended period of time.

In various embodiments, a drug delivery device may include an integral electronic module. That is, the electronic module is not easily separable from the drug delivery device. In such embodiments, the entire drug delivery device, including the electronic module, may be disposable. Even where an electronic module is separable from a drug delivery device, the electronic module may be disposable. In other words, in some embodiments, an electronic module may be configured to be disposed of after being used with a single drug delivery device.

<FIG> is a block diagram illustrating in more detail components of a semi-reusable medicament assembly <NUM>, in accordance with an embodiment of the present technology. The semi-reusable medicament assembly <NUM> comprises the reusable electronic module <NUM> operatively coupled to a disposable drug delivery device <NUM>. The semi-reusable medicament assembly <NUM> may be either the handheld-type semi-reusable medicament assembly 10A or the wearable-type semi-reusable medicament assembly 10B. Accordingly, the disposable drug delivery device <NUM> may be either the handheld disposable drug delivery device 100A or the disposable drug delivery device 100B.

In various embodiments, the disposable drug delivery device comprises the medicament <NUM>, a drive mechanism <NUM> for delivering the medicament <NUM> into a user (e.g., a patient), a start switch <NUM> for the user to active the drive mechanism <NUM>, and performance sensors <NUM> for recording information related to the performance of a dosing event. In certain embodiments, the disposable drug delivery device <NUM> further comprises a power source <NUM> for providing power to electrical components contained within the operatively coupled electronic module <NUM>. In one embodiment, the power source <NUM> is a battery.

In various embodiments, the electronic module <NUM> comprises the user interface <NUM>, a memory <NUM>, one or more activation sensors <NUM>, and a processor <NUM> for controlling components and controlling/carrying out various functions of the semi-reusable medicament assembly <NUM> including those as described herein. In this regard, in some embodiments, the processor <NUM> is programmed to power on the semi-reusable electronic module <NUM> based on inputs from the activation sensors <NUM>. In one embodiment, the activation sensors <NUM> include a light sensor, a temperature sensor, and an accelerometer.

According to the claimed invention, the activation sensors <NUM> are used to determine when to activate other aspects of an electronic module or drug delivery device. This can occur to help preserve a power source of the drug delivery device, such as a battery. For example, the activation sensor <NUM> is a light sensor and a packaging of the drug delivery device prevents some or all external light outside of the packaging from entering the packaging. Accordingly, once a user removes the drug delivery device from the packaging, a signal from the light sensor will sense light that the drug delivery device is now exposed to. This can indicate that the drug delivery device will be used soon. Accordingly, the device can activate, or begin monitoring, any various performance sensors included in the drug delivery device (and its associated electronic module) only after the activation sensors have indicated that the drug delivery device has been removed from the packaging. A light sensor may be any of various types of sensors, such as proximity or depth sensors, and light sensors that sense various types of light including infrared and visible light sensors.

This may be particularly valuable where the power source does not store a lot of power. By only monitoring performance sensors for a relatively short amount of time after the drug delivery device is removed from the packaging, a smaller and cheaper power source may be utilized. A typical drug delivery device spends much more time (orders of magnitude more time) being transported, stored, etc. than it does after being removed from the packaging and before a dosing event.

In other examples, different or additional sensors than a light sensor may be used to determine that the drug delivery device has been removed from its packaging. For example, an accelerometer may be used to identify patterns of motion and acceleration typical with a drug delivery device being handled by a user and/or taken out of its packaging. A signature of movement typical of being handled or removed from packaging can also trigger activation of the performance sensors. In some embodiments, multiple sensors may be used. According to the claimed invention, a light sensor and an accelerometer is required to be activated or register a signal before the performance sensors are activated/monitored. In another example, the activation sensors may operate in a multi-level logic pattern. For example, an accelerometer may be monitored for motion to determine when a drug delivery device is being handled. When a signal is received indicating that movement, monitoring of a light sensor may begin to determine if the drug delivery device has been removed from its packaging. Only after both of these have been determined, will the performance sensors be monitored/activated.

In various embodiments, a temperature sensor may also be used, in combination with the other sensors indicated herein. For example a temperature sensor may be used in drug delivery devices in which the medicament stored therein is supposed to be stored at a particular temperature or temperature range. For example, some medicaments need to be refrigerated. In order to determine that the drug delivery device is about to be used, necessitating activation of the performance sensors, the temperature sensor may be monitored for a rise in temperature. Such monitoring may be done concurrent with other sensors (e.g., an accelerometer, a light sensor) or may be done in a multi-level logic pattern as disclosed herein.

Additionally, a wireless transceiver of the drug delivery device may be activated only after it is determined that a dosing event has occurred. This can similarly save power, allowing for a smaller and cheaper power source to be used.

The processor <NUM> may be programmed with suitable processor-executable program instructions (e.g., machine-readable instructions and/or other suitable (e.g., higher-level) programming instructions) that may be stored in the memory <NUM> or another data storage associated with the processor <NUM>. In general, the processor <NUM> may be any suitable type of a processing unit, such as a dedicated processor or a general purpose processor. In one embodiment, the processor <NUM> is a microcontroller.

In certain embodiments, the drug delivery device <NUM> includes the medicament label <NUM> and the electronic module <NUM> includes an identification element <NUM> ("ID element"). In one embodiment, the identification element <NUM> is an RFID tag. In some embodiments, the electronic module <NUM> further comprises the one or more engagement features <NUM>. In certain embodiments, the engagement features <NUM> form an electrical connection with the power source <NUM> and the performance sensors <NUM> in the drug delivery device <NUM>. In such embodiments, power is delivered to the components in the electronic module <NUM> through the engagement features <NUM>. In certain embodiments, the processor <NUM> collects information from the performance sensors <NUM> while the drive mechanism <NUM> is delivering the medicament <NUM>. In one embodiment, the processor <NUM> stores the information from the performance sensors <NUM> in the memory <NUM>.

As further shown in <FIG>, the electronic module <NUM> includes an RF transceiver <NUM>. In certain embodiments, the processor <NUM> causes the RF transceiver <NUM>, such as by sending suitable control signals(s), to wirelessly transmit the information from the performance sensors <NUM> using the RF transceiver <NUM> to a remote system, as will be described later. In certain embodiments, the electronic module <NUM> further comprises a locking feature <NUM> that physically interacts with a stopping feature <NUM> contained in the drug delivery device <NUM>. In such embodiments, the stopping feature <NUM> can be moved by the locking feature <NUM> to impede the movement of the drive mechanism <NUM>. In one embodiment, the locking feature <NUM> is controlled by the processor <NUM>.

The performance sensors <NUM> may be a variety of types of sensors, such as a pressure sensor, a vibration or acoustic sensor, a light or proximity sensor, or a flow sensor. For example, these sensors may monitor the medicament in the drug delivery device to determine when it has been delivered during a dosing event. In some embodiments, a vibration or acoustic sensor may be used to listen or sense when mechanical aspects of the drug delivery device have actuated to deliver the medicament stored therein. For example, the mechanical aspects of the drug delivery device may be configured to click or vibrate when a dosing event occurs. A flow sensor may determine that medicament has been dispensed and/or how much medicament has been dispensed.

According to the claimed invention, the performance sensors <NUM> comprise a flow sensor.

A portion of the drug delivery device that stores the medicament may be transparent or partially transparent, allowing a light or proximity sensor to monitor the medicament and used to determine if, when, and/or how much medicament is dispensed. As disclosed herein, in some embodimetns, the performance sensors may be activated and/or monitored only after the drug delivery device is removed from the packaging.

<FIG> is a cross-sectional perspective view of the handheld semi-reusable medicament assembly 10A of <FIG> and <FIG>, in accordance with an embodiment of the present technology. In one embodiment, the handheld disposable drug delivery device 100A contains multiple doses of the medicament <NUM>. In another embodiment, the handheld disposable drug delivery device 100A can only be used once and contains enough of the medicament <NUM> for a single dosing event. In various embodiments, the handheld disposable drug delivery device 100A is an injection device for subcutaneous administration of the medicament <NUM>. In some embodiments, the handheld disposable drug delivery device 100A comprises a primary container <NUM> housing the medicament <NUM>. In one embodiment, a needle <NUM> is attached to the primary container <NUM> for the medicament <NUM> to flow through. In some embodiments, the drive mechanism <NUM> is coupled to the primary container <NUM> through a plunger <NUM>. In certain embodiments, the drive mechanism <NUM> comprises a spring <NUM> attached to a drive rod <NUM>. In one embodiment, the drive rod <NUM> is coupled to the plunger <NUM>, such that the decompression of the spring <NUM> delivers a force through the drive rod <NUM>, driving the plunger <NUM> into the primary container <NUM> and pushing the medicament <NUM> out through the needle <NUM>.

Referring back to <FIG>, the drive mechanism <NUM> is activated by a start switch <NUM> located on a surface of the handheld disposable drug delivery device 100A. In certain embodiments, a forward movement of the drive mechanism <NUM> can be prevented by an activation of the stopping feature <NUM>. In some embodiment, the stopping feature <NUM> is activated by the locking feature <NUM> housed in the operatively coupled electronic module <NUM>. As explained above, the electronic module <NUM> includes the engagement features <NUM> that physically interface with the drug delivery device <NUM>, such the handheld disposable drug delivery device 100A. In certain embodiments, the engagement features <NUM> connect to performance sensors <NUM> contained within the handheld disposable drug delivery device 100A. In one embodiment, the performance sensors <NUM> include an initiation sensor <NUM> for detecting pressure on the start switch <NUM> sufficient to activate the drive mechanism <NUM>.

In one embodiment, the performance sensors <NUM> further include a completion sensor <NUM> for detecting when the drive mechanism <NUM> reaches its most distal position upon completion of a dosing event. In some embodiments, the performance sensors <NUM> communicate information to the reusable electronic module <NUM> through the engagement features <NUM>. In certain embodiments, the handheld disposable drug delivery device 100A further comprises the power source <NUM> configured to provide power to the electronic components of the semi-reusable medicament assembly 10A, including the performance sensors <NUM> and the locking feature <NUM>.

<FIG> is a cross-sectional perspective view of the reusable electronic module <NUM>, in accordance with an embodiment of the present technology. As noted above in connection with <FIG>, in certain embodiments, the reusable electronic module <NUM> comprises the one or more engagement features <NUM> on a surface of the shell. In certain embodiments, the engagement features <NUM> are designed to form mechanical and electrical connections with the drug delivery device <NUM>. In one embodiment, the engagement features <NUM> are designed to operatively connect to multiple types of drug delivery device <NUM>. In some embodiments, the reusable electronic module <NUM> further comprises the locking feature <NUM> positioned on an inner surface such that it can physically interact with the stopping feature <NUM> of an operatively coupled drug delivery device <NUM>. In certain embodiments, the reusable electronic module <NUM> further comprises the one or more activation sensors <NUM> for powering on the electronic module <NUM> upon one or more signals. In one embodiment, the one or more activation sensors <NUM> include a light sensor <NUM>, a temperature sensor <NUM>, and an accelerometer <NUM>.

With reference to <FIG>, the reusable electronic module <NUM> also comprises the previously-noted machine-readable ID element <NUM>, the RF transceiver <NUM>, and the memory <NUM> for storing information. In general, the RF transceiver <NUM> comprises one or more RF transceivers that provide a wireless connectivity capability. In certain embodiments, the RF transceiver <NUM> enables the reusable electronic module <NUM> to establish a wireless connection with at least one wireless network that may interconnect the reusable electronic module <NUM> with other wired and/or wireless network(s) (e.g., the Internet, a local area network (LAN), etc.), system(s), and/or entitie(s), such as a remote computerized system that may include one or more servers (as will be described later). In one or more embodiments, the wireless network comprises a cellular network, and the reusable electronic module <NUM> is configured to wirelessly communicate (e.g., send and receive data) over the cellular network. Those skilled in the art will appreciate that cellular networks will typically include cellular data networks for carrying wireless data communications in addition to voice communications. A general architecture of various cellular data network technologies is understood in the art. Further, the cellular network may include networks deployed by one or more wireless carriers to provide the semi-reusable medicament assembly <NUM> with a cellular service/coverage in various geographic locations (e.g., a roaming service).

In this regard, in some embodiments, the RF transceiver <NUM> includes a cellular chip/chipset <NUM> and an antenna <NUM> adapted for wireless communication over the cellular network in accordance with one or more suitable communication protocols (e.g., Code Division Multiple Access (CDMA), Global System for Mobile Communications (GSM), Time Division Multiple Access (TDMA), General Packet Radio Service (GPRS), Long Term Evolution (LTE), and/or other(s)). In other embodiments, the RF transceiver <NUM> may be instead or in addition to configured for wireless communication via other suitable type(s) wireless network(s), some examples of which include a single wireless access point/router that may connect, e.g., to the Internet, a wireless local area network (WLAN) (e.g., an <NUM>-based/Wi-Fi WLAN), a long-range Wi-Fi network, a WiMax network, and a satellite communication network.

To illustrate, the RF transceiver <NUM> may be configured such that the reusable electronic module <NUM> can wirelessly connect to a first wireless network (e.g., a cellular network) or a second wireless network (e.g., a Wi-Fi network or "hot spot"), depending, e.g., on a location of the reusable electronic module <NUM>, availability of a cellular service, and/or other factor(s). As such, in certain embodiments, the reusable electronic module <NUM> can communicate data with another entity (e.g., a remote server connected to the Internet) via either the first wireless network or the second wireless network. In this regard, the RF transceiver <NUM> may comprise multiple transceivers operating in accordance with different communication protocols/standards. As an example, the RF transceiver <NUM> may include the cellular chipset <NUM>, as noted above, as well as a wireless adapter for communications in accordance with a suitable WLAN standard (e.g., the IEEE <NUM>. 11x standard).

In certain embodiments, the information stored in the memory <NUM> is wirelessly received via the RF transceiver <NUM> or collected from sensors in the semi-reusable medicament assembly <NUM>, including the one or more activation sensors <NUM> in the reusable electronic module <NUM> as well as the one or more performance sensors <NUM> in the disposable drug delivery device <NUM>. <FIG> further shows the processor <NUM> that, as described previously, can control functions of the electronic components in the semi-reusable medicament assembly <NUM>, including the locking feature <NUM>, the one or more performance sensors <NUM>, the one or more activation sensors <NUM>, the RF transceiver <NUM>, and the memory <NUM>.

Referring to <FIG> and <FIG>, the reusable electronic module <NUM> and the disposable drug delivery device <NUM> function together during operation of the semi-reusable medicament assembly <NUM> by a user. In certain embodiments, the user interface <NUM> on the reusable electronic module <NUM> is configured to alert the user of the status of the delivery process based on information received from the performance sensors <NUM> in the disposable drug delivery device <NUM>. In some embodiments, the user interface <NUM> alerts the user when the drug delivery process has begun and finished. In one embodiment, the user interface <NUM> alerts the user when an error occurs before, during, or after the drug delivery process.

In certain embodiments, the processor <NUM> will activate the locking feature <NUM> when the medicament <NUM> inside the disposable drug delivery device <NUM> is no longer safe to be administered. This may occur when the reusable medicament assembly <NUM> has been stored at an inappropriate temperature, or the medicament <NUM> has surpassed its expiration date. In certain embodiments, the memory <NUM> inside the reusable electronic module <NUM> is configured to store information collected during multiple dosing events. In some embodiments, the information collected by the reusable electronic module <NUM> during a dosing event includes a patient contact, a duration of the dosing event, an amount of medicament administered, a temperature of the assembly <NUM> during the dosing event, and a timestamp of the dosing event. In one embodiment, the information collected by the reusable electronic module <NUM> is calculated and analyzed on a remote computerized system (e.g., by one or more remote servers) following a wireless communication of a raw data from the module <NUM>.

The reusable electronic module <NUM> and the disposable drug delivery device <NUM>, as shown in <FIG>, are designed for automated assembly and disassembly. This enables the reusable electronic module <NUM> to be processed and reused at scale, while each drug delivery device <NUM> is disposed of after the medicament <NUM> has been emptied and the reusable electronic module <NUM> has been separated.

In this regard, in certain embodiments, the reusable electronic module <NUM> is reversibly-attached to the disposable drug delivery device <NUM> using an adhesive. In one embodiment, the adhesive can be dissolved using a reagent or solution. In other embodiments, the reusable electronic module <NUM> is reversibly-attached to the disposable drug delivery device <NUM> using mechanical connectors, such as a latch. In one embodiment, the latch can only be released by using a special tool or machinery. The reusable electronic module <NUM> and the disposable drug delivery device <NUM> are designed to remain securely connected while possessed by a user. From the user's perspective, the semi-reusable medicament assembly <NUM> is a fully-disposable device used to deliver a medicament.

In summary, in some aspects, the present disclosure provides a semi-reusable medicament assembly that comprises: (i) a disposable drug delivery device comprising a primary container filled with a medicament and a drive mechanism for delivering the medicament into a user (e.g., a patient), (ii) a reusable electronic module comprising one or more engagement features configured to operatively couple with at least one of mechanical and/or electrical features of the disposable drug delivery device, (iii) a trigger for the user to activate the drive mechanism, (iv) a power source configured to provide power to the reusable electronic module, and (v) one or more sensors configured to capture drug delivery performance information of the disposable drug delivery device.

In some embodiments, the disposable drug delivery device <NUM> includes the medicament <NUM> in an amount of at least about <NUM> dose. In other embodiments, the device <NUM> includes the medicament <NUM> in an amount of at least <NUM> doses but no more than <NUM> doses. In yet other embodiments, the device <NUM> includes the medicament <NUM> in an amount of more than <NUM> doses.

<FIG> illustrates a flow of information within an example system architecture <NUM> for tracking distribution, dispensation, and use of the disposable drug delivery devices <NUM>, in accordance with an embodiment of the present technology. As illustrated in <FIG>, all the information flows through a centralized system <NUM>, including information related to the distribution and dispensation of the drug delivery device <NUM>, an identity of the medicament inside the drug delivery device <NUM>, as well as an identity of a patient <NUM> associated with the drug delivery device <NUM>.

In some embodiments, the centralized system <NUM> comprises a computerized system remote from the semi-reusable medicament assembly <NUM> and configured to communicate with the semi-reusable medicament assembly <NUM> (e.g., receive and send data from/to the assembly <NUM>). In general, the centralized system <NUM> may include a processing system comprising processor(s) <NUM> and a memory <NUM> operatively coupled with the processor(s) <NUM> (e.g., coupled together with the processor(s) via a bus <NUM> and/or other mechanism). The processor(s) <NUM> may comprise one or more central processing units (CPUs), dedicated processors (e.g., ASIC(s)), or general purpose processors (e.g., DSPs) configured to execute computer-readable program code or instructions. The memory <NUM> may be non-transitory computer-readable medium or media, and may be volatile or non-volatile type of data storage.

The memory <NUM> may store program logic including program instructions (e.g., machine language instructions and/or other suitable (e.g., higher-level) programming instructions) executable by the processor(s) to carry out various functions of the centralized system <NUM> as described herein. Additionally, the memory <NUM> may store any other data, such as data used by the processor(s) <NUM> in the execution of the program instructions. Any additional data may also be held in other data storage location(s) separate from the memory <NUM>. Further, components of the centralized system <NUM> may be co-located or distributed physically and/or logically across a number of different entities, such as across one or more servers (e.g., physical and/or virtual servers) and one or more data storage devices. The centralized system <NUM> may further include a number of interfaces, examples of which include input/output (I/O) interfaces, user interface(s), and communication/network interface(s). The centralized system <NUM> may include other components as well.

In particular, in some embodiments, the centralized system <NUM> includes communication interface(s) <NUM> for communicating with the semi-reusable medicament assembly <NUM> and other entities, as shown by way of example in <FIG>. In this regard, the semi-reusable medicament assembly <NUM> may communicate with the centralized system <NUM> via a wireless network <NUM>. In some embodiments, the wireless network <NUM> comprises a cellular network, and the semi-reusable medicament assembly <NUM> may be configured to establish a wireless connection with a cell tower/base station of a radio access network of the cellular network. Although not shown, the centralized system <NUM> may be coupled with the wireless network <NUM> using any suitable wireless/wired communication network(s) and/or link(s). For example, cellular networks typically provide connectivity to other networks, including the PSTN and the Internet, via their core networks.

In certain embodiments, the centralized system <NUM> may comprise a cloud-based system, as generally understood in the art of cloud computing, that may be accessible via the Internet. As such, the program logic and other components of the centralized system <NUM>, as described above, may reside on cloud server(s) and associated data storage device(s). An example of a suitable cloud computing environment for implementing the centralized system <NUM> is a web-based cloud service, such as Amazon Web Services™ available from Amazon, Inc. As such, data communications between the semi-reusable medicament assembly <NUM> and the centralized system <NUM> may be carried via the Internet and the wireless network <NUM> in accordance with any suitable communication protocols. However, in other embodiments, the centralized system <NUM> may be configured in other way(s), one example of which includes a private LAN.

As noted above, in some embodiments, the wireless network <NUM> comprises a cellular network. In other embodiments, the wireless network <NUM> may comprise another type of wireless network, preferably at least one wireless network that provides a wireless coverage over a relatively long range. This may facilitate mobility of the semi-reusable medicament assembly <NUM> and allow the assembly <NUM> to establish a wireless connection with the wireless network <NUM> for communications with the centralized system <NUM> from various locations to track the disposable drug delivery device <NUM>. In addition, as will be described later, providing wireless service via a cellular network may facilitate selectively activating and de-activating wireless connectivity of the reusable electronic module <NUM>.

As shown in <FIG>, in some embodiments, the centralized system <NUM> further includes a central database <NUM> containing a medicament assembly record <NUM>. In one embodiment, the central database <NUM> may be held in the memory <NUM>, as shown in <FIG>. In another embodiment, the central database <NUM> may be held in one or more data storages separate from the memory <NUM> and accessible by the centralized system <NUM>.

In illustrative embodiments, the centralized system <NUM> is configured to receive information related to the semi-reusable medicament assembly <NUM> from one or more information sources. Further, the centralized system <NUM> is configured to store the information related to the semi-reusable medicament assembly <NUM>. In particular, in some embodiments, the centralized system <NUM> may collect various information related to the semi-reusable medicament assembly <NUM> from a number of information sources (e.g., one or more distinct information sources), and centrally manage and store that information in a data repository, such the central database <NUM>. As will be described in more detail, in some embodiments, the information source(s) may include any of (i) a point of production of the semi- reusable medicament assembly, (ii) a point of distribution of the semi-reusable medicament assembly, (iii) a point of dispensation of the semi reusable medicament assembly, and (iv) the reusable electronic module <NUM> of the semi-reusable medicament assembly <NUM>.

In an example operation, the information related to the semi-reusable medicament assembly <NUM> includes information identifying the semi-reusable medicament assembly <NUM>. The centralized system <NUM> is configured to create (or generate) the medicament assembly record <NUM> based on the information identifying the semi-reusable medicament assembly <NUM>. Such identifying information may be collected from one or more peripheral systems at the point of production, during distribution, or at the point of dispensation. Various other information regarding the semi-reusable medicament assembly <NUM> may be then linked to, or associated with, the medicament assembly record <NUM>, such as by storing such related information in the medicament assembly record <NUM>. To illustrate, the medicament assembly record <NUM> may contain medicament information <NUM> related to an identity of the semi-reusable medicament assembly <NUM>.

Note that although <FIG> illustrates one medicament assembly record <NUM> for the semi-reusable medicament assembly <NUM>, it will be appreciated that the central database <NUM> may be configured to store a plurality medicament assembly records, each medicament assembly record being created for a respective semi-reusable medicament assembly. As such, a plurality of disposable drug delivery devices may be tracked via the centralized system <NUM>.

Referring back to <FIG>, the centralized system <NUM> may be in communication with one or more peripheral systems including, for example a logistics system <NUM> and a pharmacy system <NUM>. The centralized system <NUM> may be interconnected with the peripheral systems via any suitable landline and/or wireless networks/communication links (e.g., a wireless/landline LAN, a wide area network (WAN), etc.). In general, each of the peripheral systems may comprise at least one processor and a memory, where the memory includes instructions, such as in the form of suitable software, which the processor can execute. By way of example, as illustrated in <FIG>, the logistics system <NUM> includes a logistics software/ program logic <NUM> and the pharmacy system <NUM> includes a pharmacy software/program logic <NUM>. Each peripheral system may also include other elements, including, e.g., database(s) for storage of various data/information, such as information to be communicated to the centralized system <NUM>.

In certain embodiments, logistics information <NUM> related to the semi-reusable medicament assembly <NUM> is collected by the centralized system <NUM> from the logistics system <NUM> via the software <NUM> and stored in the medicament assembly record <NUM>. In general, as will be described later, the logistics system <NUM> may be deployed at a point of distribution of the semi-reusable medicament assembly <NUM>. In addition, prescription information <NUM> related to semi-reusable the medicament assembly <NUM> is collected from the pharmacy system <NUM> via the pharmacy software <NUM> and stored in the medicament assembly <NUM>. In this regard, when the semi-reusable medicament assembly <NUM> is dispensed by a pharmacist <NUM>, the semi-reusable medicament assembly <NUM> is associated with the patient <NUM> within the centralized system <NUM>.

As noted above, one of the information sources from which information related to the semi-reusable medicament assembly <NUM> may be collected at the centralized system <NUM> is the reusable electronic module <NUM> included in the semi-reusable medicament assembly <NUM>. More specifically, as described in connection with <FIG> and <FIG>, the reusable electronic module is configured to collect information regarding a use of the disposable drug delivery device, particularly drug delivery performance information. The information regarding the use of the disposable drug delivery device <NUM> may be provided by the reusable electronic module <NUM> to the centralized system <NUM>.

To illustrate, when the patient <NUM> uses the disposable drug delivery device <NUM> to administer a dose of medicament, the reusable electronic module <NUM> records and sends information regarding drug delivery performance <NUM>. The drug delivery performance information <NUM> is sent by the reusable electronic module <NUM> through the wireless network <NUM>. As noted above, in certain embodiments, the wireless network <NUM> comprises a cellular network. The drug delivery performance information <NUM> received from the reusable electronic module <NUM> is stored within the medicament assembly record <NUM>.

In certain embodiments, the centralized system <NUM> distributes the medicament information <NUM> and the drug delivery performance information <NUM> to the patient <NUM> and a care provider <NUM>. Such information may be important for managing treatment regimens and remotely monitoring and supporting the patient <NUM>. In further embodiments, the information contained within the medicament assembly record <NUM> is also distributed to a pharmacist <NUM> for monitoring and supporting the patient <NUM>. In some embodiments, information flows bidirectionally between the centralized system <NUM> and the information sources, including, e.g., the logistics system <NUM>, the pharmacy system <NUM>, and the reusable electronic module <NUM>.

<FIG> is a block diagram illustrating an example of a workflow and system architecture associated with a process for tracking drug disposable delivery devices, including tracking a distribution, dispensation, and use of the disposable drug delivery devices, in accordance with an embodiment of the present technology. In some embodiments, the process starts at a point of production, such as a production facility <NUM>, where information identifying the semi-reusable medicament assembly <NUM> is communicated to the centralized system <NUM>. Namely, an information from the electronic module ID element <NUM> indicative of an identity of the reusable electronic module <NUM> and an information from the medicament label <NUM> indicative of an identity of the medicament <NUM> in the disposable drug delivery device <NUM> are uploaded to the centralized system <NUM>. This results in the creation of a medicament assembly record <NUM> within the central database <NUM> (block <NUM>).

In certain embodiments, the centralized system <NUM> is directly connected to a production and assembly machinery responsible for scanning products coming off the assembly line. In other embodiments, there is a production system that connects to the machinery and sends data to the centralized system <NUM>. The process continues through distribution, where the semi-reusable medicament assembly <NUM> is tracked by logistics system 330a, 330b deployed at distribution facilities 432a, 432b, respectively. In certain embodiments, the semi-reusable medicament assembly <NUM> is tracked by executing the logistics software <NUM> when the ID element <NUM> of the reusable electronic module <NUM> is scanned. In other embodiments, the semi-reusable medicament assembly <NUM> is tracked by scanning the medicament label <NUM>. Logistics information 362a, 362b collected at each distribution facility 432a, 432b is sent to the centralized system <NUM> and linked to the appropriate medicament assembly record <NUM> associated with the semi-reusable medicament assembly <NUM> (block <NUM>).

Referring back to <FIG>, the process of tracking the disposable drug delivery device <NUM> continues at a point of dispensation of the semi-reusable medicament assembly <NUM>, such as a dispensing facility <NUM>. In the dispensing facility <NUM>, the semi-reusable medicament assembly <NUM> is tracked by executing the pharmacy software <NUM>. In some embodiments, the medicament assembly <NUM> is tracked by executing the pharmacy software <NUM> when the electronic module ID element <NUM> of the reusable electronic module <NUM> is scanned. In other embodiments, the medicament assembly <NUM> is tracked by scanning the medicament label <NUM>.

During the dispensing event, the medicament assembly <NUM> is associated with a prescription information <NUM> within the centralized system <NUM>. The prescription information <NUM> includes an identity of the patient <NUM> receiving a prescription for the disposable drug delivery device <NUM>. The prescription information <NUM> also includes a medicament identity <NUM> and the medicament information <NUM>. In certain embodiments, the pharmacy software <NUM> causes the pharmacy system <NUM> to send the prescription information <NUM>, including the medicament identity <NUM> and the patient identity <NUM>, to the centralized system <NUM>. The centralized system <NUM> links, or associates, the medicament assembly record <NUM> with a patient record <NUM> within the central database <NUM> based on the patient identity <NUM> in the prescription information <NUM> (block <NUM>). In this regard, the centralized system <NUM> may, for example, store the medicament assembly record <NUM> within the patient record <NUM>. However, in other embodiments, the association between the medicament assembly record <NUM> and the patient record <NUM> may be established in other way(s). If there is no existing patient record <NUM> for the patient identity <NUM> (e.g., no prior prescription exists on record for a given patient), the centralized system <NUM> creates a new patient record 310a that is linked to the medicament assembly record <NUM>.

In various embodiments, the prescription information may be broken up into two different types of information: prescription information and dispensation information. For example, the prescription information may include information about a medicament being prescribed to a patient. In such an embodiment, this information may be sent and updated to records when the medicament is prescribed and before it is actually dispensed. Accordingly, the prescription information in this embodiment may include information such as the medicament, dosing information, information about the patient, information about the pharmacy or other dispensing entity that is to dispense the medicament, time/day that the medicament is prescribed, etc. The dispensation information, then, can be related strictly to when, how, etc. the medicament (including any electronic modules and drug delivery devices associated therewith) are actually dispensed to the patient. Such information may include how the medicament is dispensed (e.g., through the mail, in person at a pharmacy), how the medicament was paid for, where the medicament was dispensed, time/day the medicament was dispensed, how much medicament was actually dispensed, identification information of the particular medicaments dispensed (including any information relating to a medicament package the medicament is stored in), etc. Accordingly, prescription information and dispensation information can include different types of information and can be updated in records at different times based on the times of prescription and actual dispensation of medicament. In some embodiments, the prescription and dispensation information are sent to a server to update a record at the same time. For example, in some embodiments, the prescription information is sent to the server to update a record at or near the dispensation event, such that there is not an update to a record or system when a drug is prescribed, but only when it is dispensed.

In certain embodiments, the dispensing facility <NUM> is a specialty pharmacy that mails the medicament to a patient's home <NUM>. The process of tracking the disposable drug delivery device <NUM> continues while it is used by the patient <NUM> to administer a dose. In some embodiments, the reusable electronic module <NUM> records the drug delivery performance information <NUM> from the one or more performance sensors <NUM> during the dosing event. The drug delivery performance information <NUM> is then wirelessly sent to the centralized system <NUM> by the reusable electronic module <NUM>. Based on an electronic module identity <NUM>, the centralized system <NUM> links the drug delivery performance information <NUM> to the appropriate medicament assembly record <NUM> (block <NUM>).

In some embodiments, the disposable drug delivery device <NUM> contains enough medicament <NUM> for multiple doses. In such embodiments, the drug delivery performance information <NUM> is recorded and sent by the electronic module <NUM> for each dosing event. In such embodiments, all of the drug delivery performance information <NUM> generated by the medicament assembly <NUM> during use is stored within the medicament assembly record <NUM>.

<FIG> is a block diagram illustrating data collection points for tracking distribution, dispensation, and use of disposable drug delivery devices, in accordance with an embodiment of the present technology. In some embodiments, information is collected by a scanner <NUM> during production, distribution, and dispensing. The first point of data collection occurs in the production facility <NUM>, where identifying information related to the medicament assembly <NUM>, including the electronic module identity <NUM> and the medicament identity <NUM>, is collected. The electronic module identity <NUM> can be collected by scanning the electronic module ID element <NUM>. In some embodiments, the electronic module ID element <NUM> is an RFID tag embedded in the electronic module <NUM>. The medicament identity <NUM> can be collected by scanning the medicament label <NUM>. In certain embodiments, the medicament label <NUM> is present on the disposable drug delivery device. In other embodiments, the medicament label <NUM> is present on a medicament package <NUM>, which can contain one or more semi-reusable medicament assemblies <NUM>.

In such embodiments, all of the medicament assemblies in the medicament package <NUM> share the same medicament identity <NUM> but have unique electronic module identities 316a, 316b. When the medicament identity <NUM> is linked, or associated with, to the electronic module identity <NUM>, a medicament assembly record <NUM> is created. In some embodiments, the medicament identity <NUM> is linked to the electronic module identity <NUM> through synchronized scanning of the medicament label <NUM> and the electronic module ID element <NUM>, respectively. In further embodiments, multiple medicament assembly records 312a, 312b are created upon synchronized scanning of the medicament label <NUM> on the medicament package <NUM> and the electronic module ID elements 230a, 230b inside the medicament package <NUM>. In such embodiments, the electronic module identities 316a, 316b result in the creation of unique medicament assembly records 312a, 312b, both of which are linked to the same medicament identity <NUM>.

Once the medicament assembly record <NUM> has been created, the medicament assembly <NUM> can be tracked through distribution and dispensing using the medicament identity <NUM> or the electronic module identity <NUM>. As described above, in various embodiments the information is collected by the scanner <NUM> during distribution and dispensing of the medicament assembly <NUM>. In certain embodiments, the medicament label <NUM> on the package <NUM> is scanned at the distribution facility <NUM>. The scan results in the logistics information <NUM> being linked to the medicament identity <NUM> indicated by the label <NUM>. The linkage of the logistics information <NUM> to the medicament identity <NUM> creates a transitive link between the logistics information <NUM> and the one or more medicament assembly records 312a, 312b that are associated with the medicament identity <NUM>.

The logistics information <NUM> may include details related to the distribution facility <NUM>, as well as details related to the courier service used to pick up and drop off the medicament package <NUM>. In certain embodiments, the medicament label <NUM> is scanned again at the dispensing facility <NUM>, which results in the prescription information <NUM> being linked to the medicament identity <NUM> indicated by the label <NUM>. The linkage of the prescription information <NUM> to the medicament identity <NUM> creates a transitive link between the prescription information <NUM> and the one or more medicament assembly records 312a, 312b that are associated with the medicament identity <NUM>. The prescription information <NUM> includes the identity of the patient <NUM> prescribed the medicament assembly <NUM>.

In some embodiments, the patient <NUM> is prescribed the medicament package <NUM> containing multiple medicament assemblies <NUM>. In various embodiments, the patient identity <NUM> in the prescription information <NUM> transitively links the medicament assembly records 312a, 312b that are associated with the medicament identity <NUM> to the patient record <NUM> in the central database <NUM>. In other embodiments, the centralized system <NUM> creates a new patient record 320a when no match exists between the patient identity <NUM> and the existing patient record <NUM>.

In reference to <FIG>, the final point of data collection is when the medicament assembly <NUM> is used to deliver the medicament <NUM> contained in the drug delivery device <NUM>. In various embodiments, the medicament assembly <NUM> is used by the patient <NUM> at the home <NUM>. In some embodiments, the medicament assembly <NUM> is taken out of the medicament package <NUM> when the patient <NUM> is ready to administer a dose. In further embodiments, each medicament assembly <NUM> is for single use, containing a single dose of the medicament <NUM>. In such embodiments, the electronic module <NUM> sends the drug delivery performance information <NUM> through the wireless network <NUM>. The drug delivery performance information <NUM> is then transitively linked to the appropriate medicament assembly record <NUM> based on the identity <NUM> of the electronic module <NUM> that wirelessly sent it.

For example, a patient may be prescribed an injectable therapy that must be taken twice a month. That patient would receive a medicament package containing two first and second medicament assemblies with the same medicament identity <NUM>. Each medicament assembly comprises a respective first and second disposable drug delivery device and a respective first and second electronic module operatively coupled to the disposable drug delivery device. When the patient uses the first semi-reusable medicament assembly , the first electronic module wirelessly sends first drug delivery performance information 366a using an RF transceiver 270a of the first electronic module. The centralized system <NUM> stores the first drug delivery performance information 366a in an appropriate medicament assembly record associated with the first semi-reusable medicament assembly, such as the medicament assembly record 312a based on the identity 316a of the electronic module that sent it. The same process occurs for the second semi-reusable medicament assembly , resulting in second drug delivery performance information 366b for the second monthly dosing event being stored in a different medicament assembly record associated with the second semi-reusable medicament assembly, such as the medicament assembly 312b. Both of the medicament assembly records 312a, 312b associated with the medicament identity <NUM> are linked to the patient record <NUM> for the patient dispensed the medicament package <NUM>.

<FIG> and <FIG> are block diagrams illustrating an organizational relationship of information within the central database <NUM> of the centralized system <NUM>, in accordance with an embodiment of the present technology. <FIG> shows an example of the patient record 320a (see also <FIG>) being stored within the central database <NUM> alongside other patient records 320b, 320c. The patient record 320a contains patient information <NUM> related to the patient <NUM> as well as multiple medicament assembly records 312a, 312b linked to the patient identity <NUM> at the point of dispensation. Patient information <NUM> can include the patient identity <NUM>, as well as demographic, medical and treatment information related to the patient. In various embodiments, the first medicament assembly record 312a contains information related to a semi-reusable medicament assembly, including the electronic module identity 316a, medicament identity 318a and medicament information 360a. In certain embodiments, the medicament identity 318a is specific to a respective drug delivery device (denoted as "Drug Delivery Device <NUM>") that an electronic module (denoted as "Electronic Module <NUM>") with the identity 316A is operatively coupled to. In other embodiments, the medicament identity 318a is tied to a medicament package that may contain multiple drug delivery devices containing medicament having the identical medicament information 360a. The medicament information 360a can include national drug code, lot number, expiration date and dosage. In various embodiments, the medicament assembly record 312a contains logistics information 362a, prescription information 364a and the drug delivery performance information 366a.

As shown in <FIG> and described above in connection with <FIG>, a medicament package that contains multiple semi-reusable medicament assemblies may result in the creation of multiple medicament assembly records 312a, 312b, respectively. The medicament assembly records 312a, 312b will both be linked to the same patient record 320a based on the patient identity <NUM> collected from the prescription information 364a at the point of dispensation. The medicament assembly records 312a, 312b for the multiple medicament assemblies distributed and dispensed in the same medicament package may have the same medicament information 360a, logistics information 362a, and prescription information 364a. However, they will have different electronic module identities 316a, 316b and different drug delivery performance information 366a, 366b based on different medicament assemblies used by the patient in distinct dosing events. In certain embodiments, they may also have different medicament identities 318a, 318b if tracked at the drug delivery device level. In other embodiments, however, they will have the same medicament identity 318a when tracked at the medicament package level.

<FIG> shows the same exemplary patient record 320a with a third medicament assembly record 312c included in the patient record 320a. The third medicament assembly record 312c is generated upon linking, to the new medicament identity 318c, the electronic module identity 316a of the electronic module (i.e., the Electronic Module <NUM>) when that electronic module is recycled to and operatively coupled to a new disposable drug delivery device (denoted as "Drug Delivery Device <NUM>"). The identity 316a of the recycled electronic module is linked within the central database <NUM> to multiple medicament assembly records 312a, 312c based on the distinct drug delivery devices (i.e., the Drug Delivery Device <NUM> and the Drug Delivery Device <NUM>) that the recycled electronic module been operatively coupled to.

More specifically, the recycled electronic module is linked to multiple medicament identities 318a, 318c. The centralized system <NUM> maintains a registry of links between the electronic module identity 316a and the medicament identities 318a, 318c. In certain embodiments, the centralized system <NUM> only allows for one active link to exist for the electronic module identity 316a. In such embodiments, the link to the previous medicament assembly record 312a is archived. By maintaining a registry of active links, the centralized system <NUM> is able to link new logistics information 362b, prescription information 364b and drug delivery performance information 366c to the appropriate medicament assembly record 312c.

With reference to <FIG>, the present technology allows for disposable drug delivery devices to be tracked through distribution at the device-level and the package-level, providing superior oversight and security for pharmaceutical supply chains. In addition, the present technology allows for remote tracking of a usage of disposable drug delivery devices without placing any additional burden on a patient. The patient can simply use a disposable drug delivery device to administer a medicament contained therein, while drug delivery performance information is passively recorded and sent for a storage in an appropriate patient record. This enables objective and real-time monitoring of medication adherence without any setup or syncing required by the patient.

Several suitable methods are disclosed herein and discussed further below; however, these methods are provided by way of example and one of ordinary skill in the art will appreciate that one or more other suitable methods may be possible as well. With respect to the embodiments illustrated in <FIG>, a semi-reusable medicament assembly as described herein can be used to deliver a parenteral medicament to a subject. Some methods include steps for producing and using the semi-reusable medicament assembly. Additional methods include steps for tracking a distribution, dispensation, and use of the semi-reusable medicament assembly.

<FIG> is a flow diagram illustrating a method 500A for producing a semi-reusable medicament assembly, in accordance with an embodiment of the present technology. The method can begin with providing a new disposable drug delivery device (block <NUM>) containing a parenteral medicament. In some embodiments, the disposable drug delivery device may be assembled. In other embodiments, it may come pre-assembled. Further, the disposable drug delivery device may be an auto-injector for injectable therapies or an inhaler for respiratory medicaments.

The method 500A continues with providing a reusable electronic module (block <NUM>) and operatively coupling the disposable drug delivery device with the reusable electronic module (block <NUM>). The reusable electronic module may be newly-assembled or it may be recycled from another previous semi-reusable medicament assembly. In some embodiments, the assembly may undergo quality testing such as to test for a proper connection between the disposable drug delivery device and the reusable electronic module (block <NUM>). In some embodiments, a test for proper connection to the disposable drug delivery device may result in a generation of a signal by the reusable electronic module. Such signal confirms that the reusable electronic module is in mechanical and/or electrical engagement with the disposable drug delivery device. In some embodiments, the signal is an optical signal, such as in form of an LED turning on. In some embodiments, the signal is a wireless communication signal generated by the reusable electronic module. In some embodiments, if the proper connection cannot be confirmed, the medicament assembly may be disposed of and/or inspected (block <NUM>).

The method 500A continues with electronically communicating at least an information associating the disposable drug delivery device with the reusable electronic module to a remote centralized system, such as the centralized system <NUM>, configured to store that information (e.g., in a database) (block <NUM>). As described above in connection with <FIG>, information identifying the semi-reusable medicament assembly may be communicated to the remote centralized system from a production facility. In some embodiments, the identifying information may include an information read from an electronic module ID element indicative of an identity of the reusable electronic module and an information read from a medicament label indicative of an identity of the medicament contained in the disposable drug delivery device. Such information may be electronically communicated to the centralized system via suitable hardware/software deployed at the production facility.

<FIG> is a flow diagram illustrating a method 500B that may be carried out post-production of the semi-reusable medicament assembly of <FIG>, in accordance with an embodiment of the present technology. After production, the semi-reusable medicament assembly may be distributed and dispensed to a patient (blocks <NUM> and <NUM>). The patient uses the semi-reusable medicament assembly to administer one or more doses, and then disposes of the semi-reusable medicament assembly in a medical container once the disposable drug delivery device is emptied of a medicament (blocks <NUM> and <NUM>). In some embodiments, the medical container is a rigid sharps container. The patient then returns the used medicament assembly in the medical container back to an appropriate facility for recycling (block <NUM>). In some embodiments, the recycling facility is the same as the production facility. The method 500B continues with a recycling of the reusable electronic module, starting with disconnecting the electronic module from the emptied drug delivery device (block <NUM>). The used drug delivery device is then disposed of (block <NUM>), while the electronic module undergoes processing for reuse. In some embodiments, such processing includes cleaning and sterilizing the used electronic module (block <NUM>). In some embodiments, the reuse processing also includes testing functionality of the used electronic module. Once the electronic module has been fully processed, it may be connected to another new disposable drug delivery device (see blocks <NUM> and <NUM> of the method 500A).

<FIG> is a flow diagram illustrating a method <NUM> for tracking a distribution, dispensation, and use of a semi-reusable medicament assembly, in accordance with an embodiment of the present technology. The method <NUM> begins with a creation of an active association or link at a remote centralized system between a reusable electronic module and an operatively-coupled drug delivery device containing a medicament (block <NUM>). The creation of a new link results in a creation of a medicament assembly record in a central database of the centralized system (block <NUM>). The medicament assembly record contains identities of the reusable electronic module and the medicament inside the disposable drug delivery device (as obtained, e.g., from a medicament label on the disposable drug delivery device or a package containing such device). In some embodiments, logistics information is linked to the medicament assembly record based on the identity of the reusable electronic module or the medicament (block <NUM>). The medicament assembly record is then linked to a patient record based on a patient identity determined at a point of dispensation (block <NUM>).

The method <NUM> continues with an activation of a wireless connectivity in the reusable electronic module following the linkage of the medicament assembly record to the patient record (block <NUM>). In some embodiments, the wireless connectivity is activated by provisioning a cellular network access to a SIM card or another type of module that may be embedded in the reusable electronic module to identify/authenticate the reusable electronic module on a wireless network. In certain embodiments, the centralized system may be configured to send a provisioning request to a provisioning system of a wireless carrier selected, e.g., as a primary cellular service provider. The centralized system and the wireless carrier's system may be integrated or linked in various ways. Upon the receipt of the provisioning request, the wireless carrier can responsively enable the cellular network access for the SIM card of the reusable electronic module, thereby activating the wireless connectivity in the reusable electronic module. Once the wireless connectivity is activated, the reusable electronic module will be able to access the cellular network and send/receive data. The process of provisioning cellular network access by the wireless carrier may be carried out same way as is done with respect to other wireless devices for a given network access technology.

In various embodiments, the reusable electronic module uses the wireless connectivity to communicate injection performance information to the centralized system following a dosing event. The centralized system then links the injection performance information to the medicament assembly record based on the electronic module identity (block <NUM>). In certain embodiments, the electronic module identity is communicated at the beginning of a data transmission event. In some embodiments, the electronic module identity is a SIM card serial number, which is linked to an electronic module ID element within the central database of the centralized system. Confirmation of the semi-reusable medicament assembly being used and emptied results in the centralized system de-activating wireless connectivity for the electronic module (block <NUM>). In certain embodiments, the centralized system may be configured to send a de-activation request to the wireless carrier's system. Upon the receipt of the de-activation request, the wireless carrier can responsively disable the cellular network access for the SIM card of the reusable electronic module, thereby de-activating the wireless connectivity in the reusable electronic module. Once the wireless connectivity is de-activated, the reusable electronic module will no longer be able to access the cellular network and send/receive data. The process of de-activating cellular network access by the wireless carrier can be carried out same way as is done with respect to other wireless devices for a given network access technology.

In some embodiments, the disposable drug delivery device contains a single dose and confirmation of emptying is understood to occur upon wireless communication after the dosing event. In certain embodiments, the drug delivery device contains multiple doses and an amount of medicament remaining is calculated after each dosing event. After the wireless connectivity has been de-activated for the electronic module, the centralized system archives the link between the electronic module and the medicament assembly record for the emptied drug delivery device (block <NUM>). In some embodiments, this archiving step occurs upon de-activation of the wireless connectivity. In other embodiments, the archiving step occurs after the electronic module is recycled (block <NUM>). In such embodiments, the existing link is archived upon a creation of a new active link between the reusable electronic module and another new disposable drug delivery device.

In referring to <FIG> and <FIG>, the methods 500A-B and <NUM> can be combined for producing and tracking of a semi-reusable medicament assembly, in accordance with an embodiment of the present technology. In certain embodiments, any peripheral system(s) involved in the methods 500A-B are electronically connected to the centralized system responsible for carrying out method <NUM>. In such embodiments, the centralized system of the method <NUM> is networked with peripheral system(s) involved in the production, distribution, and dispensation steps of the methods 500A-B. In such embodiments, information collected by the peripheral system(s) may be generated by scanning the electronic module ID element or the medicament label during production, distribution, and dispensation. In certain embodiments, as described above in connection with the method <NUM>, the electronic module identity is linked to the medicament in the drug delivery device (block <NUM>) upon confirmation of a proper connection between the electronic module and the drug delivery device (block <NUM>). In such embodiments, these coordinated steps (blocks <NUM> and <NUM>) lead to the creation of the medicament assembly record in the central database (block <NUM>). The medicament assembly record then contains the electronic module identity and the medicament identity.

In such embodiments, information collected from the peripheral system(s) is linked to the appropriate medicament assembly record based on the scanned electronic module identity or medicament identity. For example, when a semi-reusable medicament assembly is scanned during distribution (block <NUM>), the centralized system collects the logistics information from a peripheral system at a point of distribution and links it to the appropriate medicament assembly record (block <NUM>). When the semi-reusable medicament assembly is scanned at the point of dispensation (block <NUM>), the centralized system links the medicament assembly record to the appropriate patient record (block <NUM>) based on the patient identity and prescription information collected from a peripheral system at the point of dispensation (e.g. a pharmacy system executing suitable software).

<FIG> is a flow diagram illustrating a method <NUM> for using a semi-reusable medicament assembly, in accordance with an embodiment of the present technology. The method <NUM> can begin with a user taking the semi-reusable medicament assembly out of a medicament package (block <NUM>). In some embodiments, the medicament package is a carton that contains multiple medicament assemblies. In some embodiments, the medicament assembly inside the package is kept refrigerated during storage. The method <NUM> can continue with a reusable electronic module powering on based on signals detected from the one or more activation sensors inside the electronic module (block <NUM>). In some embodiments, the activation sensors include a light sensor, a temperature sensor and an accelerometer. In certain embodiments, the electronic module will perform a quality check once powered on (<NUM>). In such embodiments, the quality check can comprise checking for an expired, counterfeit or improperly stored dose. In some embodiments, the quality check involves wireless communication with the centralized system <NUM>. In certain embodiments, a failed quality check leads to an activation of the electronic module's locking feature, which prevents administration of a medicament inside the disposable drug delivery device (block <NUM>).

The method <NUM> continues with the patient using the medicament assembly to administer a dose of the medicament. In some embodiments, the dose is administered by the patient pressing on a trigger to initiate the dosing process (block <NUM>). During the dosing process, the electronic module collects information from one or more performance sensors. In some embodiments, the performance sensors detect when the dosing event starts, when the dosing event finishes, and how much medicament was administered during the dosing event. Following completion of the dosing event, the electronic module sends information collected from the performance sensors to the centralized system (block <NUM>). In some embodiments, the electronic module will repeatedly attempt to wirelessly transmit the performance information to the centralized system (block <NUM>). Following the dosing event and the data transmission, the electronic module will automatically power off (block <NUM>). Once the drug delivery device has been completely emptied of the medicament, the patient will dispose of the medicament assembly into a medical container (block <NUM>).

In some embodiments, the drug delivery device is pre-filled with multiple doses of medicament, and the patient will put the medicament assembly back into storage until the next dosing event. In other embodiments, the drug delivery device contains a single dose and the patient disposes of the medicament assembly after a single use. The patient then returns the medical container to an appropriate facility (block <NUM>). In some embodiments, the medical container is a sharps container. In some embodiments, the medical container can hold multiple used medicament assemblies before being filled and returned to the appropriate facility. In some embodiments, the medical container can be shipped to the appropriate facility. In some embodiments, the appropriate facility is a facility where the medicament assembly was produced.

Claim 1:
A drug delivery apparatus (<NUM>) including a drug delivery device (<NUM>) for delivering a parenteral medicament (<NUM>), the drug delivery apparatus (<NUM>) comprising:
a plurality of activation sensors (<NUM>), wherein the plurality of activation sensors (<NUM>) comprises a light sensor and an accelerometer;
at least one performance sensor (<NUM>) configured to indicate a dosing event of the drug delivery device (<NUM>), wherein the at least one performance sensor (<NUM>) comprises a flow sensor;
a memory (<NUM>); and
one or more processors (<NUM>) coupled to the memory (<NUM>), wherein the one or more processors (<NUM>) are configured to:
determine that the drug delivery device (<NUM>) has been removed from a packaging of the drug delivery device (<NUM>) based on first signals from the light sensor and the accelerometer;
activate, in response to the determination that the drug delivery device (<NUM>) has been removed from the packaging, the at least one performance sensor (<NUM>);
determine based on a second signal from the at least one performance sensor (<NUM>), that a dosing event of the drug delivery device (<NUM>) has occurred; and
send drug delivery performance information (<NUM>) comprising information that the dosing event has occurred to a server, wherein the drug delivery performance information (<NUM>) is sent via a long range wireless network (<NUM>).