Drug delivery device with temperature measurement, and related method

Abstract

To provide a drug delivery system with temperature measurement.SOLUTION: The invention relates to a drug delivery device 10, the a drug delivery device 10 including: a housing 11; a reservoir 12 removably disposed within the housing 11 and having a sidewall defining an interior for containing a drug; a temperature sensor 30 that is configured to measure a current temperature relating to at least one of the sidewall of the reservoir 12, the housing 11 or the drug; and an output device 32 that is configured to output data relating to the current temperature.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of U.S. Provisional Patent Application No. 62 / 881,657, filed August 1, 2019, the entire contents of which are incorporated herein by reference.

[0002] The present disclosure relates generally to drug delivery systems, and more particularly to drug delivery systems that include temperature measurement. [Background technology]

[0003] Drugs can be administered through the use of drug delivery devices such as auto-injectors or on-body injectors, which may be used to help automate the injection and delivery or administration process, thereby simplifying the process for certain patient groups or subgroups for whom the use of syringe / vital combinations or pre-filled syringe systems would be inconvenient, whether due to physiological or psychological barriers, form factor, or ergonomic reasons.

[0004] Patients receive medications to treat a wide range of health conditions, which can generally be administered via injection or infusion. These injections or infusions may include intradermal, subcutaneous, intramuscular, intravenous, and intraperitoneal methods. Typically, an injection or infusion involves the use of a hollow cannula or needle through which the medication enters the patient from a container.

[0005] For subcutaneous and intramuscular injection routes, considerable attention has been paid to providing reproducible motion for the insertion of a cannula or needle through the skin to position the needle at the appropriate distance within the body, and then providing a reproducible delivery rate through the cannula or needle into the patient's body. Providing a reproducible delivery rate often involves providing reproducible motion for the plunger to move along the inside of a syringe or cartridge. Various mechanisms have been designed to control the release of stored energy to advance the needle into the patient's body and then advance the plunger relative to the syringe or cartridge bore. Springs, motors, chemical reactions, and phase-change materials have all been considered to provide the motive force for the needle and / or plunger to advance. Reproducible motion is considered essential for reproducible drug delivery.

[0006] The temperature and resulting viscosity of the drug can also affect the operation of the drug delivery components and the resulting drug delivery time. Refrigeration is required for some drugs, and patients are instructed to wait a predetermined amount of time after the drug is removed from the refrigerator before injecting. This waiting period is intended to reduce the viscosity of the drug and reduce discomfort during injection. However, other than this instruction, the patient is not provided with any feedback indicating that the drug has actually reached the desired temperature and is ready for injection. Summary of the Invention [Means for solving the problem]

[0007] According to a first aspect, a drug delivery device is disclosed that includes a housing, a reservoir removably disposed within the housing and having a sidewall defining an interior for containing a drug, a temperature sensor configured to measure a current temperature of at least one of the reservoir, the sidewall of the reservoir, the housing, or the drug, and an output device configured to output data about the current temperature.

[0008] According to some embodiments, the drug delivery device can include a controller coupled to the temperature sensor and the output device, and the controller can be programmed to compare the current temperature to a predetermined target temperature. In further embodiments, the controller can be further programmed to receive and / or output data about the current temperature and the predetermined target temperature and / or to provide a signal to a user in response to determining that the current temperature matches the predetermined target temperature.

[0009] According to some embodiments, the drug delivery device can include a drug data portion associated with the reservoir. In further embodiments, the drug delivery device can include a reader configured to read the drug data portion to determine infusion data associated with the drug, and optionally a controller coupled to the reader and the temperature sensor, the controller being programmed to receive input from the reader and compare the current temperature to a predetermined target temperature from the reader. In some variations, the drug data portion can include a machine-readable code, and the reader can be a scanner configured to read the machine-readable code.

[0010] According to some embodiments, the housing can include a bay configured to removably receive the reservoir therein. In further embodiments, the temperature sensor can be disposed adjacent to the bay, and / or the housing can include a door movable between open and closed positions, the door configured to receive the reservoir in the open position and to align the reservoir with the temperature sensor in the bay in the closed position.

[0011] According to some embodiments, the drug delivery device may further include one or more of the following aspects: a cassette configured to receive the reservoir therein, the cassette defining a window providing access to a temperature sensor to measure the current temperature; an output device which may include a display having a graduated portion providing a visual indication of the current temperature; or a drug disposed within the reservoir.

[0012] According to a second aspect, a method of delivering a medicinal product is disclosed, comprising receiving a reservoir adapted to contain a drug in a drug delivery device, measuring a current temperature of at least one of the reservoir, a sidewall of the reservoir, a housing of the drug delivery device, or the drug contained in the reservoir with a temperature sensor, and outputting data at an output device of the drug delivery device regarding the current temperature.

[0013] According to some embodiments, the method can include reading a drug data portion associated with the reservoir with a reader of the drug delivery device to determine infusion data associated with the drug contained in the reservoir. In a further embodiment, the method can include determining an infusion temperature for the drug associated with the infusion data with a controller of the drug delivery device and determining with the controller whether the current temperature matches the infusion temperature. In some variations, the output device can include a display device, and outputting the data can include displaying a visual indication of the current temperature relative to the infusion temperature on a scale portion of the display device. In some variations, reading the drug data portion with a reader of the drug delivery device can include reading a machine-readable code with a scanner.

[0014] According to some embodiments, receiving the reservoir within the drug delivery device can include receiving a cassette containing the reservoir within a bay of an autoinjector device.

[0015] According to a third aspect, a drug delivery system is disclosed, including a container having a reservoir adapted to contain a drug and a drug data portion. The system further includes a drug delivery device having a bay configured to removably receive the container therein. The drug delivery device includes a temperature sensor disposed adjacent the bay and configured to measure the temperature of the drug in the reservoir, a reader configured to read the drug data portion of the container to determine infusion data associated with the drug contained in the reservoir, an output device, and a controller. The controller is coupled to the temperature sensor, the reader, and the output device and is programmed to: determine an infusion temperature for the drug associated with the infusion data; determine whether the temperature of the drug matches the infusion temperature; and provide an indication to a user on the output device in response to a determination that the temperature of the drug matches the infusion temperature.

[0016] According to some embodiments, the drug delivery system can include one or more of the following aspects: the temperature sensor can be a non-contact temperature sensor; the temperature sensor can be an infrared temperature sensor; the output device can be a display device including a scale portion providing a visual indication of the temperature of the drug relative to the injection temperature; the drug data portion can be a machine-readable code and the reader can be a scanner configured to read the machine-readable code; the injection temperature can be an injection temperature range; the reservoir can include an opening and the container can further include a plunger stopper movable within the reservoir relative to the opening to force the drug from the reservoir through the opening; the drug delivery device can include a plunger rod having a first end in contact with the plunger stopper and an actuator coupled to the plunger rod; or the system can further include a drug disposed in the reservoir.

[0017] According to some embodiments, the container can be a pre-filled syringe, and the pre-filled syringe can further include a needle in fluid communication with the reservoir. In further embodiments, the drug delivery device can be an auto-injector device, and the container can be a cassette including a housing configured to receive the pre-filled syringe therein and defining a window providing access to a temperature sensor to determine the temperature of the drug, and / or the auto-injector device can include a door movable between an open position and a closed position, the door configured to receive the container in the open position and to align the container with the temperature sensor within a bay of the auto-injector device in the closed position.

[0018] According to a fourth aspect, a method of delivering a medicinal product is disclosed, comprising: receiving a container including a reservoir adapted to contain a drug in a bay of a drug delivery device; measuring a temperature of the drug contained in the reservoir with a temperature sensor of the drug delivery device; determining infusion data associated with the drug contained in the reservoir; determining an infusion temperature for the drug associated with the infusion data with a controller of the drug delivery device; reading a drug data portion of the container with a reader of the drug delivery device to determine with the controller of the drug delivery device whether the temperature of the drug matches the infusion temperature; and providing an indication to a user on an output device of the drug delivery device in response to a determination that the temperature of the drug matches the infusion temperature.

[0019] According to some embodiments, the method can include one or more of the following aspects: measuring the temperature of the drug in the reservoir of the container with a temperature sensor can include measuring the temperature of the drug with a non-contact infrared temperature sensor; the drug can be contained in a pre-filled syringe received in a housing of the cassette, and measuring the temperature of the drug can include measuring the temperature of the drug through a window defined by the housing with a temperature sensor; the output device can include a display device, and providing an indication to the user can include displaying a visual indication of the temperature of the drug relative to the injection temperature on a scale portion of the display device; reading the drug data portion of the container with a reader of the drug delivery device can include reading a machine-readable code with a scanner; or receiving the container in a bay of the drug delivery device can include receiving the container in a door of the autoinjector device in an open position and aligning the container with the temperature sensor in the bay of the autoinjector device in a closed position.

[0020] The above requirements are met, at least in part, through the provision of the embodiments described in detail below, particularly when considered in conjunction with the drawings. [Brief explanation of the drawings]

[0021] [Figure 1] 1 is a diagrammatic view of an autoinjector drug delivery device according to various embodiments. [Figure 2] FIG. 1 is a side view of an embodiment of an autoinjector device including a cassette and autoinjector, showing the cassette prior to installation within the autoinjector. [Figure 3A] 3 is a front view of the autoinjector device of FIG. 2 showing the cassette installed in the autoinjector. FIG. [Figure 3B] 3 is a side view of a first side of the autoinjector device of FIG. 2 showing the cassette installed in the autoinjector. FIG. [Figure 3C] 3 is a rear view of the autoinjector device of FIG. 2 showing the cassette installed in the autoinjector. FIG. [Figure 3D] 3 is a side view of a second side of the autoinjector device of FIG. 2, showing the cassette installed in the autoinjector. FIG. [Figure 3E] FIG. 3 is an end view of a first end of the autoinjector of the autoinjector device of FIG. 2. [Figure 3F] FIG. 3 is an end view of a second end of the autoinjector of the autoinjector device of FIG. 2. [Figure 3G] 3 is a perspective view of the autoinjector device of FIG. 2 showing a user interface that indicates the temperature of a drug contained in a cassette installed therein. FIG. [Figure 3H] FIG. 1 is a cross-sectional side view of an embodiment of an autoinjector device showing a cassette installed within the autoinjector. [Figure 3I] 3 is a side cross-sectional view of a portion of the autoinjector device of FIG. 2, showing the cassette and temperature sensor installed within the autoinjector. [Figure 4] FIG. 10 is an exploded perspective view of an embodiment of a cassette. [Figure 5] 10A-10C are side cross-sectional views of embodiments of drug containers that may be provided within the cassette. [Figure 6] 1 is a diagrammatic view of an on-body injector drug delivery device according to various embodiments. DETAILED DESCRIPTION OF THE INVENTION

[0022] A drug delivery system and method is provided that monitors the temperature of a drug and provides an indication when the drug has reached an optimal viscosity based on an optimal temperature / formulation viscosity profile. The patient benefits of this system and method are twofold: optimal viscosity ensures less discomfort during injections, and wait times to administer an injection are minimized.

[0023] Medication may be injected or infused using a variety of different techniques, technologies, and systems. In one example, the medication may be loaded into a reservoir in the form of a syringe or other suitable primary container, e.g., a cartridge, and the pre-filled syringe or other container may then be combined with an auto-injector, which may be used to automate the movement of a plunger within the bore of the syringe or container and, optionally, the insertion of a cannula or needle into the patient's body. For example, the auto-injector may include a drive (e.g., a motor, spring, propellant reservoir, etc.) that, upon actuation of an actuator (e.g., pressing a button), moves the container within a housing and / or moves the plunger within the container.

[0024] Whatever form the drug delivery system takes, it remains important to follow proper storage recommendations for injecting or infusing drugs, as failure to follow these recommendations may result in reduced efficacy or incomplete delivery of the pharmaceutical product, potentially resulting in therapeutic failure. For example, storage recommendations for certain products may call for storage at low temperatures (2-8°C), i.e., refrigeration.

[0025] Given the variety of different approaches, technologies, and systems for drug delivery, there are many different options for storing the drug and associated drug delivery device. For example, the drug may be refrigerated in its (primary) container or reservoir (e.g., a pre-filled syringe, cartridge, etc.), while the associated drug delivery device (e.g., an auto-injector) may be stored at room temperature, with the reservoir being combined with the remainder of the drug delivery device at the time of use. Alternatively, the drug (located in its container or reservoir) and the associated drug delivery device may be refrigerated together. For example, the reservoir may be combined with the device before or during refrigeration, such that the associated drug delivery device is already combined for use when removed from the storage chamber. The drug-filled container and drug delivery device may be arranged in the same package (e.g., as a kit) for storage, although it is also possible that the drug-filled reservoir is not located within the drug delivery device.

[0026] Storage of certain pharmaceuticals (with or without an associated drug delivery device) at low temperatures can be important to prevent a reduction in product efficacy or incomplete or suboptimal delivery. For example, storage at low temperatures can affect the physical properties of the pharmaceutical or the operation of the drug delivery device. Certain pharmaceuticals exhibit increased viscosity at low temperatures, which can inhibit delivery or make the rate of delivery less predictable immediately after removal from the cold. Other pharmaceuticals may increase in viscosity with increasing temperature, thus making delivery more difficult or less predictable the longer the drug is at room temperature. Furthermore, storage at low temperatures can affect the patient's comfort when the drug is delivered. Certain patients may find administration of cold fluids painful. Additionally, the slower rate of injection / infusion caused by low temperatures can affect the drug and / or the device may seem painful.

[0027] Once the medication (and optionally the drug delivery device) is removed from the storage chamber, exposure to high temperatures can result in suboptimal drug delivery or delivery of a less potent medication. Depending on the storage recommendations, as discussed above, exposure to excessively high temperatures may require disposal of the medication. Exposure to excessively high temperatures may also affect components of the drug delivery device, such as the battery.

[0028] The present disclosure focuses on drug delivery devices that monitor the temperature of a drug and provide an indication that the drug is at the appropriate temperature / viscosity for delivery. In some variations, the drug delivery device can identify or accept the identification of a specific drug within the device, thereby identifying an optimal temperature / viscosity amount or range. The measured drug temperature is used to provide feedback to the user to increase usability and reduce injection discomfort. The drug delivery device can also control operation based on a determination that the drug is at the optimal temperature and associated viscosity. In some variations, the drug delivery device can be an auto-injector device and utilize a built-in sensor to measure the drug's temperature and inform the user when to perform an injection based on the viscosity profile and temperature for the specific drug.

[0029] Currently, patients are instructed to wait 30 minutes once the medication is removed from the refrigerator before performing an injection, with the goal of reducing the medication's viscosity and reducing the potential for injection discomfort associated with higher viscosities. However, this configuration does not provide the patient with feedback indicating that the medication has reached room temperature and is ready for injection. Additionally, based on the viscosity profile of some formulations, the medication may reach its optimal injection viscosity below room temperature, which should reduce patient wait time. In a drug delivery system provided herein that monitors the medication's temperature, determines the medication's injection temperature, and provides an indication to the patient when the medication has reached the injection temperature, the benefit to the patient is twofold: ensuring that the optimal viscosity is reached to reduce the potential for injection discomfort, and minimizing the wait time to perform the injection.

[0030] The autoinjector drug delivery device described herein can sense the temperature of a drug inside a prefilled syringe. In one embodiment, the autoinjector drug delivery device includes an infrared sensor powered by the device's battery. This non-contact sensor can measure the temperature of objects within its field of view, and the removable cassette or other container for the drug includes a window through which infrared light can measure the temperature of the syringe. The temperature sensor can be located adjacent to the syringe needle to accommodate temperature monitoring for all syringe types and fill volumes. The autoinjector drug delivery device's controller can be programmed to monitor the drug / syringe temperature upon insertion of the cassette or other container into the autoinjector device's receiving bay. The autoinjector drug delivery device can also include a temperature indicator that can provide a visual and / or audio indication to the user when the drug has reached the optimal injection temperature.

[0031] The cassette or other container for the drug can include a label attached or incorporated therein, configured to communicate a temperature-based viscosity profile of the drug to the autoinjector device. The label can be a passive or active device and can provide the viscosity profile directly to the autoinjector device or can provide data from which the autoinjector device can access or obtain the viscosity profile. The optimal temperature value for a preferred injection viscosity can be room temperature, but can alternatively be lower, which reduces the wait time for the drug to reach injection temperature and further improves the overall patient experience.

[0032] 1 , a drug delivery device 10, such as an autoinjector, can have a vertically oriented configuration, with some or all of the drug delivery components arranged in a stacked relationship within a housing 11 of the device 10 along a longitudinal axis L. As a more specific example, the device 10 can be configured to be actuated to inject into a user with the device 10 oriented generally perpendicular to the surface of the user's skin. The drug delivery components can include a reservoir 12 having a drug 14 contained therein, a stopper 16 disposed within the reservoir 12 and slidably movable therein along the longitudinal axis L, a drive mechanism 18 coupled to a plunger 19 for driving the stopper 16 through the reservoir 12, a needle 20 oriented along the longitudinal axis L, a fluid passage 22 fluidly coupling the reservoir 12 to the needle 20, and a needle insertion mechanism 24 configured to insert the needle 20 to a desired subcutaneous depth within the user's body. In some approaches, the needle insertion mechanism 24 can be a retractable needle receiver to expose the needle 20 or the drive mechanism to longitudinally move the needle a desired distance. For example, the drive mechanism 18 can be configured to drive movement of both the stopper 16 and the needle 20 by moving some or all of the reservoir 12, the flow channel 22, and the needle 20. As generally configured, one or more components of the device 10, such as the drive mechanism 18 and the needle insertion mechanism 24, can be operated in response to actuation of a user input device 26 accessible outside the housing 11. Suitable drive mechanisms include, but are not limited to, springs, gas sources, phase change materials, motors, or other electromechanical systems. Accordingly, the device 10 can include electronic components, such as a controller 28, to control the actuation of one or more drug delivery components. While FIG. 1 depicts components centered along the longitudinal axis L, it will be understood that one or more components can be positioned off-center from the longitudinal axis L within the housing 11 and still be considered a stacked relationship. In one example, an autoinjector drug delivery device having drug delivery components in a stacked relationship is matched with a reservoir 12 coaxially aligned with a needle 20 .As described in more detail below, device 10 can include a temperature sensor 30 coupled to controller 28 and positioned and / or oriented to measure the current temperature of at least one of reservoir 12, a sidewall of reservoir 12, housing 11, or the medicament 14 within reservoir 12. Device 10 can further include an output device 32 configured to output data about the current temperature. If desired, device 10 can also include a reader 34 configured to read, scan, or otherwise determine infusion data from a drug data portion associated with reservoir 12 to determine drug delivery data for medicament 14. An exemplary autoinjector device is described in U.S. Provisional Patent Application No. 62 / 447,174, filed January 17, 2017, which is incorporated herein by reference.

[0033] FIG. 2 illustrates an embodiment of an autoinjector system or device 100 that can be used to inject a dose of a pharmaceutical product (drug) into a patient's body, with the injection often being self-administered by the patient (user). Alternatively, the drug can be administered by a healthcare provider. As shown, autoinjector system or device 100 may include a container 201, which in the illustrated form is a removable cassette 200, and one exemplary autoinjector drug delivery device 300. Various embodiments of cassette 200 may be configured to contain a drug for injection into a user's body by autoinjector 300. In various other embodiments, cassette 200 may be configured for use in training a user to operate autoinjector 300 (a training cassette). Autoinjector 300 may be configured to automatically deliver an injection when activated by the user or other person. Various embodiments of the autoinjector 300 may have a cassette door 308 that may be made to pivot between an open position and a closed position to allow the cassette 200 to be inserted into and removed from the bay of the cassette receiving portion 306 of the autoinjector 300. In some embodiments, the cassette door 308 may include a "cassette" icon (not shown) that indicates the insertion point for the cassette 200.

[0034] 3A-3I collectively, various embodiments of autoinjector 300 may include a casing 302 having a handle portion 304 and a cassette receiving portion 306 inline with the handle portion 304. To assist patients with dexterity challenges, the handle portion 304 of the autoinjector casing 302 may define an ergonomically shaped handle 305 having a soft grip area 305S. The cassette receiving portion 306 includes the cassette door 308 (FIGS. 3B and 3D) described above. In the open position (FIG. 2), the cassette door receives the cassette 200 and aligns it with the insertion and ejection drives, and in the closed position, aligns it with the other structures and components of the autoinjector 300. The cassette door 308 may include a "cassette" icon indicating the insertion entry point for the cassette 200. The cassette-receiving portion 306 of the casing 302 may include windows 310A, 310B on its sides that align with the windows of the cassette 200 when the cassette door 308 is closed with the cassette 200 properly installed therein. In one or more embodiments, the windows 310A, 310B may be dual-layered. One or more lights (not shown) may be provided within the casing 302 to uniformly backlight the cassette window 212 and the syringe 260 disposed within the internal sleeve 220 of the cassette 200 so that a user can observe the injection cycle through the windows 310A, 310B of the autoinjector 300, i.e., the initial and final positions of the plunger stopper 264 of the syringe 260 during its movement within the cassette 200 as well as during the syringe contents (hereinafter, "drug") ejection process.

[0035] 3A, 3B, 3D, 3F, and 3G, autoinjector 300 may further include a user interface 312 and an audio speaker (not shown). User interface 312 (best shown in FIG. 3A) may be located in cassette-receiving portion 306 of casing 302 and provide various visual indicators. The audio speaker may be disposed within casing 302 and provide various audible indicators. The audio speaker may audibly communicate with the external environment through a speaker opening 314 formed in cassette-receiving portion 306 of casing 302. The visual and audible indicators produced by user interface 312 and audio speaker may inform the user of the progress of the injection process, completion of injection, the occurrence of any errors, and other information when autoinjector 300 is ready for use. The autoinjector 300 may further include one or more of a set / mute switch 315, a speed select switch 316, a start button 307, and an eject button 317. The set / mute switch 315 (FIG. 3B) may be located in the cassette receiving portion 306 of the casing 302. The mute switch 315 allows the user to turn all synthesized sounds, except error sounds, on and off and may be configured to respond in real time so that the sounds are immediately muted when the user begins the injection process and turns the mute switch off. The mute switch 315 may also be configured to slide toward a "mute" icon to mute the audio speaker. A light indicator may be provided to confirm the "mute" state. The speed select switch 316 (FIGS. 3A and 3B) may be located in the cassette receiving portion 306 of the casing 302. The speed select switch 316 may be configured to allow the user to select from multiple preset drug delivery (excretion) rates to accommodate individual patient preferences. The speed select switch 316 may include three switch positions. Other embodiments of the speed select switch may include two switch positions or four or more switch positions. In still other embodiments, the speed select switch may be infinitely variable.In some embodiments, changing the position of the switch 316 before injection changes the drug output rate during injection, while changing the position of the rate select switch 316 during injection does not change the injection rate in real time. The autoinjector 300 may also include one or more demo cassettes to allow the user to experiment with different rates of drug delivery. A start button 307 may be located at the free end of the handle 305. The button 307 may include an indentation 3071 (FIG. 3F) to optimize thumb placement on the button 307. The button 307 may be made of a translucent material that allows lighting effects to illuminate the button as a signal. An eject button 317 (FIG. 3D) may be located in the cassette receiving portion 306 of the casing 302. The eject button 317 may include an indentation 3171 to optimize finger placement on the button 317. In some embodiments, the eject button 317 may be controlled by the microprocessor 350 (FIG. 3H) of the autoinjector 300, which may be programmed to eliminate accidental input during the injection process.

[0036] 3E, the cassette receiving portion 306 and cassette door 308 of the casing 302 may form a proximal end wall 318 of the autoinjector 300. The proximal end wall 318 may be configured as a wide, flat, and stable base for easily placing the autoinjector 300 on a support surface after removal of the shield remover 240 or when the autoinjector 300 does not contain a cassette 200. The portion of the proximal end wall 318 formed by the cassette door 308 may include an aperture 308A sized and shaped to allow the shield remover 240 to be removed from the cassette 200 and ejected through the aperture 308A when the cassette 200 is installed in the autoinjector 300. The proximal end wall of the autoinjector 300 may further include a target light 320. Target light 320 may be made to turn on when shield remover 240 is removed from cassette 200 and ejected through hole 308A, thereby providing a visual indication that shield remover 240 has been removed. When turned on, the target light assists the user in visualizing and selecting the injection site.

[0037] As shown in FIG. 3H, various embodiments of autoinjector 300 may include a chassis 301 disposed within a casing 302 for supporting a powered needle insertion drive 330, a powered drug ejection drive 340, a controller 350, a battery 360 for powering drives 330, 340, and controller 350, and a skin sensor 380. The term controller broadly refers to any microcontroller, computer, or processor-based device with a processor, memory, and programmable input / output peripherals generally designed to control the operation of other components and devices. It is further understood to include common auxiliary accessory devices, including memory, transceivers for communicating with other components, and devices, etc. These structural options are well known and understood in the art and need not be further described here. Controller 350 may be configured to perform one or more of the steps, actions, and / or functions described herein (e.g., by using corresponding programming stored in memory, as will be appreciated by those skilled in the art).

[0038] The casing 302 may define an ergonomically shaped handle portion 304 and a cassette receiving portion 306. The chassis 301 supports one or more cassettes 200 within the autoinjector 300 and may include support surfaces 301s for aligning the cassette 200, or a selected one of the one or more cassettes 200, with the powered needle insertion drive 330 and the powered drug ejection drive 340, respectively. The insertion drive 330 may include an insertion rack 332, an insertion drive motor 331, and an insertion drive gear train 333 for transmitting the rotational motion of the insertion drive motor 331 to drive the rack 332. The insertion rack may include a tab configuration, including, for example, proximal and distal tabs 332p and 332d, respectively, that mates with the cassette 200. The ejection drive 340 may include an ejection drive motor 341, a plunger rod 342, a lead screw 343, and an ejection drive gear train 344. Plunger rod 342 may be driven by ejection drive motor 341 through lead screw 343 and ejection drive gear train 344 to mate with plunger 264 of drug container 260 contained within cassette 200. Autoinjector 300 may be used to perform multiple injections.

[0039] Continuing with reference to FIG. 3H, the controller 350 of the autoinjector 300 may be programmed with instructions that, when executed by the controller 350, can control and monitor various operations and functions of the autoinjector 300. For example, but not limited to, the controller 350 may be programmed with instructions to control the powered insertion drive 330 and the powered ejection drive 340. Such instructions may control and monitor each step of the injection cycle and process flow, thereby automating needle insertion, drug ejection, and needle retraction, and controlling the sequence of actions performed by the user to make the injection process and drug administration more reliable, accurate, and consistent. The controller 350 may also be programmed with instructions to control audible and visual feedback to the user. An automatic power-on self-test verifies the operation of the autoinjector 300 and the remaining battery charge.

[0040] In various other embodiments, the autoinjector 300 may include other types of needle insertion drives, drug ejection drives, and means for activating and sequencing the drives. In such embodiments, the insertion drive and ejection drive may be implemented as separate and distinct mechanisms or may be combined into a single mechanism. The insertion drive and ejection drive in such embodiments may be powered indefinitely by a motor, a mechanical mechanism (e.g., a resilient member such as a spring), a gas pressure mechanism, a gas release mechanism, or any combination thereof. Various transmission mechanisms may be used to send power to the cassette to effect drug injection. Additionally, the activation and sequencing means may include various mechanisms and electromechanical configurations, which may be combined with the controller described above or used alone. In such embodiments, the autoinjector may be made reusable to perform multiple injections or may be designed for single-use disposable use.

[0041] 4 , various embodiments of cassette 200 may include an outer housing 210, an inner sleeve 220, a drug container 260 for containing a drug, a cassette cap 240, a locking cap 230, and a cover 250. Such embodiments of cassette 200 can facilitate and facilitate drug injection with an auto-injector and can be made for single-use disposability. As shown, outer housing 210 and inner sleeve 220 can define windows 211, 221, respectively, that provide visual access to drug container 260 and thereby determine the temperature of the drug contained within container 260, as described in more detail below. Windows 211, 221 can be, for example, openings extending through outer housing 210 and inner sleeve 220. In various embodiments, the locking cap 230 and cover 250 of the cassette 200 may be configured to prevent removal of the drug container 260 from the cassette 200, thereby preventing needle sticks before and after use of the cassette 200 and also preventing the drug container 260 from being removed or replaced from the cassette 200. Additionally, the locking cap 230 and cover 250 protect the drug container 260 during shipping and transport. In various embodiments, the cassette cap 240 may be configured to remove a needle shield 266 that covers an injection needle associated with the drug container 260. In various other embodiments, the cassette cap 240 may also be configured to engage the outer housing 210 of the cassette 200 such that the cassette cap 240 cannot be rotated or twisted, thereby preventing the needle shield 266 from damaging the injection needle. Various embodiments of the inner sleeve 220 may be configured to position the drug container 260 within the cassette housing 210 in either the hidden needle position or the injection needle position during an injection cycle of the autoinjector. In various other embodiments, the outer housing 210 and inner sleeve 220 of the cassette 200 may include one or more locking features that protect the drug container 260 and prevent unintentional needle exposure or damage.

[0042] The container 201 may include an identification feature that interfaces with the autoinjector 300 to communicate data about the placement of the container 201 in the autoinjector 300, information about the container 201, and / or the contents of the container 201. In one variation, the container 200 further includes a drug data portion 270 configured to provide drug delivery data to the autoinjector 300 associated with the drug 267 in the container 200. In some examples, the drug delivery data may include an optimal drug delivery temperature, which may be a specific temperature, range of temperatures, or threshold temperature corresponding to the drug 267 having a viscosity suitable for injection, an identity of the drug 267, the freshness of the drug 267, etc.

[0043] The drug data portion 270 can take any suitable form capable of providing delivery data to the autoinjector 300. In a first form, the drug data portion 270 can be a machine-readable code, such as a QR code, UPC code, etc., that can be scanned and read by the autoinjector 300. In other variations, the drug data portion 270 can be a radio frequency identification (RFID) tag that can be read by the autoinjector 300 or that can transmit drug delivery data to the autoinjector 300, or a tactile or visual code that can be deciphered by the autoinjector 300.

[0044] 3H, the autoinjector 300 may include a reader 370 configured to read, scan, or otherwise interact with the drug data portion 270 to obtain delivery data. The reader 370 may be mounted to a casing 302 provided on or within the cassette support surface 301s, or in another suitable location on or adjacent the cassette receiving portion 306. The reader 370 may be coupled to the controller 350 in a manner capable of communicating signals or data to the controller 350. In some variations, the reader 370 may be a scanner configured to read a machine-readable code or an RFID tag.

[0045] As shown in FIG. 5 , medication container 260 may comprise a conventional glass or plastic syringe including a barrel 261 defining a fluid chamber or reservoir 262. Fluid chamber 262 may be filled for a treatment or may be pre-filled with a predetermined dose of medication 267. Medication 267 may have a viscosity that is dependent on the temperature of the product. Syringe 260 may further include an injection needle 265 removably or fixedly disposed at the proximal end of barrel 261 and an outwardly extending flange 263 disposed at the distal end of barrel 261. Injection needle 265 may be in communication with fluid chamber 262 to enable dispensing of the predetermined dose of medication 267 discharged from fluid chamber 262 of syringe barrel 261. Syringe 260 may further include a movable plunger stopper 264 disposed within fluid chamber 262 of barrel 260 for expelling a predetermined dose of medication 267 from chamber 261 so that the predetermined dose of medication 267 may be dispensed through injection needle 265. A protective needle shield 266, made, for example, of a non-rigid material, may cover injection needle 265.

[0046] In some embodiments, the drug contained within drug container 260 may have a viscosity of about 19 centipoise at room temperature (20-25°C (68-77°F)). In some embodiments, the drug contained within drug container 260 may have a viscosity in the range of about 1 centipoise to about 320 centipoise at room temperature. In some embodiments, the drug contained within drug container 260 may have a viscosity in the range of about 5 centipoise to about 40 centipoise at room temperature. In some embodiments, the drug contained within drug container 260 may have a viscosity in the range of about 10 centipoise to about 35 centipoise at room temperature. In some embodiments, the drug contained within drug container 260 may have a viscosity in the range of about 15 centipoise to about 30 centipoise at room temperature. In some embodiments, the drug contained within drug container 260 may have a viscosity in the range of about 20 centipoise to about 25 centipoise at room temperature. In some embodiments, the drug contained within drug reservoir 260 may have a viscosity ranging from about 16 centipoise to about 42 centipoise at room temperature. In some embodiments, the drug contained within drug reservoir 260 may have a viscosity ranging from about 1 centipoise to about 29 centipoise at room temperature.

[0047] 3H and 3I, the autoinjector 300 can further include a temperature sensor 371 configured to determine the current temperature of at least one of the reservoir 262, the sidewall of the reservoir 262, the housing 302 of the device 300, the drug 267 in the reservoir 262, or other structure or surface of the container 260. In one example, the temperature sensor 371 can be positioned within or adjacent to the bay of the cassette receiving portion 306 such that the container 201 is aligned with the temperature sensor 371 when inserted into the autoinjector 300. For example, the temperature sensor 371 can be mounted to the casing 302, provided on or in the cassette support surface 301s, or in another suitable location. In the illustrated configuration, the temperature sensor 371 is positioned adjacent the end wall 318 of the autoinjector 300 so as to be aligned with the distal end 269 of the drug container 260 proximal to its needle hub 271. This positioning allows the temperature sensor 371 to be aligned with the drug container 260 and the drug 267 received therein and measure the temperature of the drug container 260 and the drug 267 received therein, regardless of the particular shape of the container or the fill volume of the drug container 260.

[0048] The temperature sensor 371 may be coupled to the controller 350 in a manner that allows it to communicate signals or data to the controller 350. The temperature sensor 371 may take any suitable form. In some variations, the temperature sensor 371 may be non-contact and may measure the temperature of the medication 267 at a location remote from the container 201. For example, the temperature sensor 371 may be an infrared temperature sensor, such as an infrared thermopile. Other variations may include a heat-resistant detector, a thermocouple, or an assembly including a heat-sensitive label and a photodetector.

[0049] In variations in which the temperature sensor 371 is an infrared thermopile chip, the sensor measures the infrared signature of the heat source without direct contact with the heat source. These infrared thermopile chips may operate at wavelengths ranging from 0.7 μm to 1000 μm and may have a footprint of less than 2 mm by 2 mm. Such sensors may determine the ambient temperature, which may then be used to predict how long it will take for the drug 267 to reach its injection temperature. This prediction may rely on the ambient temperature as well as the thermal mass and thermal transfer properties of the drug 267, which may be included in the delivery data or accessed or obtained in response to receiving the delivery data. The controller 350 may be programmed to perform the calculation, or a lookup table may be stored in memory for access by the processor once the ambient temperature is determined. In other variations, the temperature sensor 371 may be a thermal label used in conjunction with an optical pickup or sensor. The thermal label changes appearance when a threshold temperature is reached. The label may take the form of, for example, a physical label, wax, lacquer, or liquid crystal polymer film. An optical pickup can be used to determine this change in appearance, which can then be correlated with a threshold temperature to make a temperature determination. The optical pickup may have a footprint of less than 2.5 mm x 2.5 mm and may consume less than 20 μA in active mode and 0.5 μA in low-power inactive mode. According to such an embodiment, the coupling between the label and the pickup is non-contact, thus preventing direct physical interaction between the label and the pickup.

[0050] 4, outer housing 210 and inner sleeve 220 define windows 211, 221, respectively, that provide visual access to medication container 260. As shown in FIG. 3I, when cassette 200 is inserted into the bay of cassette receiving portion 306 and door 308 is closed, windows 211, 221 are aligned within temperature sensor 371.

[0051] 3G , the user interface 312 described above can include an output device to provide various visual and / or audible indicators. For example, the user interface 312 can include a display device and / or an audio speaker. The visual and audible indicators produced by the user interface 312 can inform the user of the progress of the injection process, completion of the injection, the occurrence of any errors, and other information when the autoinjector 300 is ready for use. In one example, the output device can be configured to output data about the current temperature of at least one of the reservoir 262, a sidewall of the reservoir 262, the housing 302 of the device 300, the drug 267 in the reservoir 262, or other structure or surface of the container 260. The data may include one or more of the following: the temperature itself; a binary signal about the temperature (e.g., an indicator light or different colored lights, e.g., green and red, selectively illuminating to signal that the current temperature is at the desired temperature or within a desired range, or that the current temperature is not at the desired temperature or outside of a desired range); an audible signal responsive to the current temperature reaching a predetermined threshold; a comparison between the current temperature and a target temperature, which may be within a range of temperatures (e.g., within 2 or 4 degrees of the target temperature); an estimated time until the current temperature is expected to reach the threshold temperature;

[0052] In a further variation shown in FIG. 3G , the user interface 312 can include a drug temperature display 321 that provides a user with a visual indication of the current temperature of the drug 267. In the illustrated form, the drug temperature display 321 includes a scale 323 in the form of a thermometer configured to visually display the temperature of the drug 267 relative to a desired infusion temperature, which can be a threshold temperature, a range of temperatures, or a specific temperature. Accordingly, the controller 350 can access delivery data acquired by the reader 370 to determine the infusion temperature. The controller 350 can then gradually increase the amount of illumination or indication filling the scale 323 as the drug 267 heats until the scale 323 is fully illuminated when the temperature of the drug 267 matches the infusion temperature. A fully illuminated scale 323 can provide a visual indication to the user that the drug 267 is in an appropriate state for an infusion actuation. If desired, the scale 323 can utilize a color gradient to provide additional feedback to the user. For example, the user interface 312 may have a cooler color starting at its lower end, e.g., blue, and gradually transition to a warmer color, e.g., orange or red. Additionally, the user interface 312 may include a ready indicator 325, such as a check mark as shown, that may be illuminated or otherwise displayed by the controller 350 when the temperature of the medication 267 matches the injection temperature. Finally, as discussed above, an audio speaker may audibly communicate with the external environment through a speaker opening 314 formed in the casing 302 within the cassette receiving portion 306 to provide an audible indicator produced by the user interface 312 to notify the user when the autoinjector 300 is ready for use when the temperature of the medication 267 matches the injection temperature. Accordingly, the user interface 312 may include a volume setting switch 327 that may increase, decrease, and / or mute the audible communication.

[0053] So configured, the controller 350 of the autoinjector 300 is coupled to the temperature sensor 371, the reader 370, and the output device of the user interface 312. The controller 350 is programmed to receive signals containing the delivery data from the reader 370 and determine the infusion temperature for the medication 267 in the container 201, such as by receiving the infusion temperature or by referencing a stored or remote table. The controller 350 is also programmed to receive signals indicative of the current temperature measurement of the medication 267 from the temperature sensor 371 and compare the current temperature of the medication 267 to the infusion temperature. The controller 350 is then programmed to control the operation of the output device of the user interface 312 to provide a visual or audible indication to the user of the autoinjector 300 of the comparison result, as described above, indicating whether the temperature of the medication 267 is below or matches the infusion temperature. The controller 350 may also be programmed to lock the operation of the autoinjector 300 in response to determining that the temperature of the medication 267 is below (or above) the injection temperature.

[0054] While the above disclosure has been described with reference to the structure and operation of an autoinjector drug delivery device, the present disclosure is also suitable for and can be incorporated into on-body drug delivery devices. As shown in Figure 6, on-body injectors 400 can have a horizontally oriented configuration, with the drug delivery components generally disposed along a horizontal plane P within the housing 401 of the device 400. In these devices 400, the housing 401 has a low profile that is wider than it is tall so that when a user places the housing 401 on the skin, the components spread out over an area of ​​the skin rather than overlapping as in the above embodiments. The drug delivery component may include a reservoir 402 having a drug 404 contained therein, which may be removably disposed within the housing 401, a stopper 406 disposed within the reservoir 402 and slidably movable therein along a horizontal plane P, a drive mechanism 408 coupled to a plunger 410 for driving the stopper 406 through the reservoir 402, a needle 412 oriented along an axis X extending generally perpendicular to the horizontal plane P, a fluid channel 414 fluidly coupling the reservoir 402 to the needle 412, and a needle insertion mechanism 416 configured to insert the needle 412 to a desired subcutaneous depth within a user's body. As generally configured, one or more components of the device 400, such as the drive mechanism 408 and the needle insertion mechanism 416, may be operable in response to activation of a user input device 418 accessible externally of the housing 401. Accordingly, the device 400 may include electronic components, such as a controller 419, for controlling the operation of one or more of the drug delivery components. It will be understood, of course, that some components can be partially or wholly disposed above or below a horizontal plane P extending generally centrally through the housing 401 and still be considered to have a horizontally oriented configuration. Suitable drive mechanisms include, but are not limited to, springs, gas sources, phase change materials, motors, or other electromechanical systems. In these variations, the device 400 can include a temperature sensor 420 and reader 422, whose operation is similar to that described above with respect to the autoinjector embodiment.The temperature sensor 420 is coupled to the controller 419 and is positioned and oriented to measure the current temperature of at least one of the reservoir 402, a sidewall of the reservoir 402, the housing 401, or the drug 404 within the reservoir 402. The reader 422 can be configured to read, scan, or otherwise determine infusion data from a drug data portion associated with the reservoir 402 to determine drug delivery data for the drug 404. The device 400 can further include an output device 424 configured to output data about the current temperature. An exemplary on-body injector device is described in U.S. Provisional Patent Application No. 62 / 536,911, filed July 25, 2017, which is incorporated herein by reference.

[0055] The above description describes various devices, assemblies, components, subsystems, and methods of use related to drug delivery devices. The devices, assemblies, components, subsystems, methods, or drug delivery devices may further include or be used in conjunction with drugs, including, but not limited to, the drugs identified below and their generic and biosimilar equivalents. As used herein, the term drug may be used interchangeably with other similar terms and may refer to any type of pharmaceutical or therapeutic material, including traditional and non-traditional medicines, nutraceuticals, supplements, biologics, biologically active agents and compositions, large molecules, biosimilars, bioequivalents, therapeutic antibodies, polypeptides, proteins, small molecules, and generic drugs. Non-therapeutic injectable materials are also encompassed. Drugs may be in liquid form, lyophilized form, or reconstituted from a lyophilized form. The following list of exemplary drugs should not be considered exhaustive or limiting.

[0056] The drug is contained in a reservoir. In some cases, the reservoir is a primary container that is filled or pre-filled with the agent for treatment. The primary container can be a vial, cartridge, or pre-filled syringe.

[0057] In some embodiments, the reservoir of the drug delivery device may be loaded with or used in conjunction with a colony-stimulating factor such as granulocyte colony-stimulating factor (G-CSF). Such G-CSF agents include, but are not limited to, Neulasta® (pegfilgrastim, PEGylated filgastim, PEGylated G-CSF, PEGylated hu-Met-G-CSF) and Neupogen® (filgrastim, G-CSF, hu-Met-G-CSF).

[0058] In other embodiments, the drug delivery device may contain or be used in conjunction with an erythropoiesis-stimulating agent (ESA), which may be in liquid or lyophilized form. An ESA is any molecule that stimulates red blood cell production. In some embodiments, the ESA is an erythropoiesis-stimulating protein. As used herein, "erythropoiesis-stimulating protein" refers to any protein that directly or indirectly causes activation of the erythropoietin receptor, for example, by binding to the receptor and causing receptor dimerization. Erythropoiesis-stimulating proteins include erythropoietin and variants, analogs, or derivatives thereof that bind to and activate the erythropoietin receptor, antibodies that bind to and activate the erythropoietin receptor, or peptides that bind to and activate the erythropoietin receptor. Erythropoiesis-stimulating proteins include Epogen® (epoetin alfa), Aranesp® (darbepoetin alfa), Dynepo® (epoetin delta), Mircera® (methoxypolyethylene glycol epoetin beta), Hematide®, MRK-2578, INS-22, Retacrit® (epoetin zeta), Neorecormon® (epoetin beta), Silapo® (epoetin zeta), and Binocrit® (epoetin alfa). Epoetin alpha, epoetin beta, epoetin iota, epoetin omega, epoetin delta, epoetin zeta, epoetin theta, and epoetin delta, PEGylated erythropoietin, carbamylated erythropoietin, and molecules or variants or analogs thereof.

[0059] Among certain exemplary proteins are the specific proteins described below, including fusions, fragments, analogs, variants, or derivatives thereof: OPGL-specific antibodies (also referred to as RANKL-specific antibodies, peptibodies, etc.), peptibodies, and related proteins, including fully humanized and human OPGL-specific antibodies, particularly fully humanized monoclonal antibodies; myostatin-binding proteins, peptibodies, and related proteins, including myostatin-specific peptibodies; and IL-4 receptor-specific antibodies, peptibodies, and related proteins, particularly those that inhibit activities mediated by binding of IL-4 and / or IL-13 to their receptors. Interleukin 1-receptor 1 ("IL1-R1")-specific antibodies, peptibodies, related proteins, etc.; Ang2-specific antibodies, peptibodies, related proteins, etc.; NGF-specific antibodies, peptibodies, related proteins, etc.; CD22-specific antibodies, peptibodies, related proteins, etc., particularly dimers of human-mouse monoclonal hLL2 gamma chain disulfide bound to human-mouse monoclonal hLL2 kappa chain, e.g., epratuzumab (CAS Registry Number 501423-23-0). Human CD22-specific antibodies, including but not limited to, humanized and fully human antibodies, including but not limited to, humanized and fully human monoclonal antibodies, particularly including but not limited to, human CD22-specific IgG antibodies, such as human CD22-specific fully humanized antibodies; IGF-1 receptor-specific antibodies, peptibodies, and related proteins, including but not limited to, anti-IGF-1R antibodies; B-7-related protein 1-specific antibodies, peptibodies, and related proteins, including but not limited to, those that inhibit the interaction of B7RP-1 with ICOS, the natural receptor for B7RP-1 on activated T cells, including but not limited to, a B7RP-specific fully human monoclonal IgG2 antibody; HuMax, e.g., 146B7; IL-15 specific antibodies, peptibodies, related proteins, etc., including, but not limited to, IL-15 antibodies and related proteins, particularly humanized monoclonal antibodies; human IFNIFN-γ-specific antibodies, peptibodies, related proteins, etc., including but not limited to, IFN-γ-specific antibodies, and including but not limited to, fully human anti-IFN-γ antibodies; TALL-1-specific antibodies, peptibodies, related proteins, etc., and other TALL-specific binding proteins; parathyroid hormone ("PTH")-specific antibodies, peptibodies, related proteins, etc.; thrombopoietin receptor ("TPO-R")-specific antibodies, peptibodies, related proteins, etc.; hepatocyte growth factor / scatter factor (HGF / SF):cMet axis, such as fully human monoclonal antibodies that neutralize HGF / SF. Hepatocyte growth factor ("HGF")-specific antibodies, peptibodies, related proteins, etc., including those targeting (HGF / SF:c-Met); TRAIL-R2-specific antibodies, peptibodies, related proteins, etc.; activin A-specific antibodies, peptibodies, proteins, etc.; TGF-β-specific antibodies, peptibodies, related proteins, etc.; amyloid β protein-specific antibodies, peptibodies, related proteins, etc.; and those that bind c-Kit and / or other stem cell factor receptors. Proteins including, but not limited to, c-Kit-specific antibodies, peptibodies, related proteins, etc.; OX40L-specific antibodies, peptibodies, related proteins, etc., including, but not limited to, proteins that bind to OX40L and / or other ligands of the OX40 receptor; Activase® (alteplase, tPA), Aranesp® (darbepoetin alfa), Epogen® (epoetin alfa, or erythropoietin), GLP-1, Avonex® (interferon beta-1a), Bexxar® (tositumomab, an anti-CD22 monoclonal antibody), Betaseron® (interferon-beta), Campath® (alemtuzumab, an anti-CD52 monoclonal antibody), Dynepo® (epoetin delta), Velcade® (bortezomib), MLN0002 (anti-α4β7mAb), MLN1202 (anti-CCR2 chemokine receptor mAb), Enbrel® (etanercept, TNF receptor / Fc fusion protein, TNF blocker), Eprex® (epoetin alfa), Erbitux® (cetuximab, anti-EGFR / HER1 / c-ErbB-1), Genotropin® (somatropin, human growth hormone), Herceptin® (trastuzumab, anti-HER2 / neu(erbB2) receptor mAb), Humatrope® (somatropin, human growth hormone), Humira® (adalimumab), Vectibix® (panitumumab), Xgeva® ®) (denosumab), Prolia® (denosumab), Enbrel® (etanercept, TNF-receptor / Fc fusion protein, TNF blocker), Nplate® (romiplostim), rilotumumab, ganitumab, conatumumab, brodalumab, insulin in solution, Infergen® (interferon alfacon-1), Natrecor® (nesiritide, recombinant human B-type natriuretic peptide (hBNP), Kineret® (anakinra), Leukine® (sargamostim, rhuGM-CSF), LymphoCide® (epratuzumab, anti-CD22 mAb), Benlysta™ (lymphostat B, belimumab, anti-BlyS mAb), Metalyse® (tenecteplase, t-PA analog), Mircera® (methoxypolyethylene glycol-epoetin beta), Mylotarg® (gemtuzumab ozogamicin), Raptiva® (efalizumab), Cimzia® (certolizumab pegol, CDP870), Soliris™ (eculizumab), pexelizumab (anti-complement C5), Numax® (MEDI-524), Lucentis® (ranibizumab), Panorex® (17-1A, edrecolomab), Trabio® (lerdelimumab), TheraCimhR3 (nimotuzumab), Omnitarg (pertuzumab, 2C4), Osidem® (IDM-1), OvaRex® (B43.13), Nuvion® (vigilizumab), cantuzumab mertansine (huC242-DM1), NeoRecormon® (epoetin beta), Neumega® (oprelvekin, human interleukin-11), Orthoclone OKT3® (muromonab-CD3, anti-CD3 monoclonal antibody), Procrit® (epoetin alfa), Remicade® (infliximab, anti-TNFα monoclonal antibody), Reopro® (abciximab, anti-GP IL6 receptor monoclonal antibody), Actemra® (anti-IL6 receptor mAb), Avastin® (bevacizumab), HuMax-CD4 (zanolimumab), Rituxan® (rituximab, anti-CD20 mAb), Tarceva® (erlotinib), Roferon-A® (interferon alfa-2a), Simulect® (basiliximab), Prexige® (lumiracoxib), Synagis® (palivizumab), 146B7-CHO (anti-IL15 antibody, see U.S. Pat. No. 7,153,507), Tysabri® (natalizumab, anti-α4 integrin mAb), Valortim® (MDX-1303, anti-anthrax protective antigen mAb), ABthrax™, Xolair® (omalizumab), ETI211 (anti-MRSA mAb), IL-1 trap (Fc portion of human IgG1 and extracellular domains of both IL-1 receptor components (type I receptor and receptor accessory protein)), VEGF trap (IgG1 Ig domain of VEGFR1 fused to Fc), Zenapax® (daclizumab), Zenapax® (daclizumab, anti-IL-2Rα mAb), Zevalin® (ibritumomab tiuxetan), Zetia® (ezetimibe), Orencia® (atacicept, TACI-Ig), anti-CD80 monoclonal antibody (galiximab), anti-CD23mAb (lumiliximab), BR2-Fc (huBR3 / huFc fusion protein, soluble BAFF antagonist), CNTO148 (golimumab, anti-TNFα mAb), HGS-ETR1 (mapatuzumab, human anti-TRAIL receptor-1 mAb), HuMax-CD20 (ocrelizumab, anti-CD20 human mAb), HuMax-EGFR (zalutumumab), M200 (volociximab, anti-α5β1 integrin mAb), MDX-010 (ipilimumab, anti-CTLA-4 mAb, and VEGFR-1 (IMC-18F1), anti-BR3 mAb, anti-C. difficile toxin A and toxin BC mAbs MDX-066 (CDA-1) and MDX-1388), anti-CD22 dsFv-PE38 conjugate (CAT-3888 and CAT-8015), anti-CD25 mAb (HuMax-TAC), anti-CD3 mAb (NI-0401), adecatumumab, anti-CD30 mAb (MDX-060), MDX-1333 (anti-IFNAR), anti-CD38 mAb (HuMax CD38), anti-CD40L mAb, anti-Cripto mAb, anti-CTGF idiopathic pulmonary fibrosis stage 1 fibrogen (FG-3019), anti-CTLA4 mAb, anti-eotaxin 1 mAb (CAT-213), anti-FGF8 mAb, anti-ganglioside GD2 mAb, anti-ganglioside GM2 mAb, anti-GDF-8 human mAb (MYO-029), anti-GM-CSF receptor mAb (CAM-3001), anti-HepC mAb (HuMax HepC), anti-IFNα mAb (MEDI-545, MDX-1103), anti-IGF1R mAb, anti-IGF-1R mAb (HuMax-Inflam), anti-IL12 mAb (ABT-874), anti-IL12 / IL23 mAb (CNTO1275), anti-IL13 mAb (CAT-354), anti-IL2Ra mAb (HuMax-TAC), anti-IL5 receptor mAb, anti-integrin receptor mAb (MDX-018, CNTO95), anti-IP10 ulcerative colitis mAb (MDX-1100), BMS-66513, anti-mannose receptor / hCGβ mAb (MDX-1307), anti-mesothelin dsFv-PE38 conjugate (CAT-5001), anti-PD1 mAb (MDX-1106(ONO-4538)), anti-PDGFRα antibody (IMC-3G3), anti-TGFβmAb(GC-1008), TRAIL-2 mAb (HGS-ETR2), TWEAK mAb, VEGFR / Flt-1 mAb, ZP3 mAb (HuMax-ZP3)

[0060] In some embodiments, the drug delivery device may contain or be used in conjunction with a sclerostin antibody, such as, but not limited to, romosozumab, brosozumab, or BPS804 (Novartis), or in other embodiments, a monoclonal antibody (IgG) that binds to human proprotein convertase subtilisin / kexin type 9 (PCSK9). Such PCSK9-specific antibodies include, but are not limited to, Repatha® (evolocumab) and Praluent® (alirocumab). In other embodiments, the drug delivery device may contain or be used in conjunction with rilotumumab, bixalomer, trebananib, ganitumab, conatumumab, motesanib diphosphate, brodalumab, vidupiprant, or panitumumab. In some embodiments, the reservoir of the drug delivery device may be loaded with, or the device may be used in conjunction with, IMLYGIC® (talimogene laherparepvec) or another oncolytic HSV for the treatment of melanoma or other cancers, including but not limited to, OncoVEXGALV / CD; OrienX010; G207, 1716; NV1020; NV12023; NV1034; and NV1042. In some embodiments, the drug delivery device may contain, or be used in conjunction with, an endogenous tissue inhibitor of metalloproteinase (TIMP), such as, but not limited to, TIMP-3. Antagonistic antibodies of the human calcitonin gene-related peptide (CGRP) receptor, such as, but not limited to, erenumab, and bispecific antibody molecules targeting the CGRP receptor and other headache targets, may also be delivered using the drug delivery devices of the present disclosure. Additionally, bispecific T cell-engaging (BiTE®) antibodies, such as, but not limited to, BLINCYTO® (blinatumomab), can be used in or with the drug delivery devices of the present disclosure. In some embodiments, the drug delivery devices may contain or be used with APJ large molecule agonists, such as, but not limited to, apelin or analogs thereof.In some embodiments, a therapeutically effective amount of anti-thymic stromal lymphopoietin (TSLP) or a TSLP receptor antibody is used in or with the drug delivery device of the present disclosure.

[0061] It will be appreciated that elements in the figures are illustrated for simplicity and clarity and have not necessarily been drawn to scale. For example, the dimensions and / or relative positions of some elements in the figures may be exaggerated relative to other elements to help improve understanding of various embodiments of the present invention. Also, common but well-understood elements that are beneficial or necessary to commercially feasible embodiments are often not depicted so as not to distract from the views of these various embodiments. The same reference numbers may be used to describe the same or similar parts. Furthermore, while several examples are disclosed herein, any feature from any example may be combined with or substituted for other features from other examples. Moreover, while several examples are disclosed herein, changes may be made to the disclosed examples without departing from the scope of the claims.

[0062] Although the drug delivery devices, assemblies, components, subsystems, and methods have been described in terms of exemplary embodiments, they are not limited to the exemplary embodiments. This detailed description should be construed as exemplary only and does not describe every possible embodiment of the present disclosure. Many alternative embodiments can be implemented using either current technology or technology developed after the filing date of this patent, and such embodiments will still fall within the scope of the claims that define the invention disclosed herein.

[0063] Those skilled in the art will appreciate that numerous modifications, variations, and combinations can be made to the above-described embodiments without departing from the spirit and scope of the invention disclosed herein, and that such modifications, variations, and combinations should be construed as falling within the scope of the inventive concept.

Claims

1. Housing and a reservoir removably disposed within the housing and having a sidewall defining an interior for containing a drug; a temperature sensor configured to measure a current temperature of at least one of the reservoir, the sidewall of the reservoir, the housing, or the medicament; an output device configured to output data about the current temperature; 1. A drug delivery device comprising:

2. 10. The drug delivery device of claim 1, further comprising a controller coupled to the temperature sensor and the output device, the controller being programmed to compare the current temperature with a predetermined target temperature.

3. The drug delivery device of claim 2 , wherein the controller is further programmed to receive and / or output data about the current temperature and the predetermined target temperature.

4. 4. The drug delivery device of claim 2 or 3, wherein the controller is further programmed to provide a signal to a user in response to determining that the current temperature matches the predetermined target temperature.

5. The drug delivery device of any one of claims 1 to 4, further comprising a drug data portion associated with the reservoir.

6. The drug delivery device of claim 5 , further comprising a reader configured to read the drug data portion to determine infusion data associated with the drug.

7. 7. The drug delivery device of claim 6, further comprising a controller coupled to the reader and the temperature sensor, the controller being programmed to receive input from the reader and compare the current temperature with a predetermined target temperature from the reader.

8. 8. The drug delivery device of claim 6 or 7, wherein the drug data portion comprises a machine-readable code, and the reader comprises a scanner configured to read the machine-readable code.

9. The drug delivery device of any one of claims 1 to 8, wherein the housing further comprises a bay configured to removably receive the reservoir therein.

10. The drug delivery device of claim 9 , wherein the temperature sensor is positioned adjacent to the bay.

11. 11. The drug delivery device of claim 9 or 10, wherein the housing includes a door movable between an open position and a closed position, the door configured to receive the reservoir in the open position and to align the reservoir with the temperature sensor within the bay in the closed position.

12. 12. The drug delivery device of claim 1, further comprising a cassette configured to receive the reservoir therein, the cassette defining a window providing access to the temperature sensor for measuring the current temperature.

13. The drug delivery device of any one of claims 1 to 12, wherein the output device comprises a display including a graduated portion providing a visual indication of the current temperature.

14. The drug delivery device of any one of claims 1 to 13, further comprising the drug disposed in the reservoir.

15. 1. A method of delivering a pharmaceutical agent, comprising: receiving a reservoir adapted to contain a drug within the drug delivery device; measuring a current temperature of at least one of the reservoir, a sidewall of the reservoir, a housing of the drug delivery device, or a drug contained within the reservoir with a temperature sensor; outputting data on an output device of the drug delivery device about the current temperature; A method comprising:

16. 16. The method of claim 15, further comprising reading a drug data portion associated with the reservoir with a reader of the drug delivery device to determine infusion data associated with the drug contained within the reservoir.

17. determining an infusion temperature for the drug associated with the infusion data at a controller of the drug delivery device; determining with the controller whether the current temperature matches the injection temperature; 17. The method of claim 16, further comprising:

18. 18. The method of claim 17, wherein the output device includes a display device, and outputting data includes displaying a visual indication of the current temperature relative to the injection temperature on a scale portion of the display device.

19. The method of any one of claims 16 to 18, wherein reading the drug data portion with the reader of the drug delivery device comprises reading a machine-readable code with a scanner.

20. The method of any one of claims 15 to 19, wherein receiving the reservoir in the drug delivery device comprises receiving a cassette containing the reservoir in a bay of an autoinjector device.

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