Patent Description:
A variety of diseases exist that require treatment by injection of a medicament. Such injection can be performed using injection devices, which are applied either by medical personnel or by patients themselves. As an example, type-<NUM> and type-<NUM> diabetes can be treated by patients themselves by injection of insulin doses, for example once or several times per day. For instance, a pre-filled disposable insulin pen or autoinjector can be used as an injection device. Alternatively, a re-usable pen or autoinjector may be used. A re-usable pen or autoinjector allows replacement of an empty medicament cartridge by a new one. Either type of pen or autoinjector may come with a set of one-way needles that are replaced before each use.

For instance, document <CIT> discloses a device for measuring the dose remaining in a drug delivery device that is used for delivering a dose to a patient.

Among other things, we describe a drug injector that includes a sensing system for determining a dosage of a medicament in a cartridge in the delivery device.

In one aspect, an injection device includes a housing and a cartridge housing, wherein the cartridge housing contains a cartridge configured to hold a volume of fluid. The cartridge has a proximal end and a distal end through which the fluid is dispensed. The injection device also includes a stopper disposed in the cartridge and configured to move from the proximal end to the distal end to cause the fluid to be dispensed through the distal end of the cartridge. The injection device also includes an electronic device disposed at the distal end of the cartridge.

The electronic device includes an emitter configured to transmit a signal toward the stopper and a receiver configured to receive reflections of the signal from the stopper. The electronic device also includes a controller configured to wirelessly transmit data related to a position of the stopper in the cartridge, wherein the controller includes a wireless transceiver and is configured to communicate signals received at the receiver to an external database. A battery is disposed in the housing, wherein the battery is electrically connected to the electronic device with electrical leads disposed in the cartridge housing.

A drug delivery device may include an electronic device which may include a sensing system for determining a dosage of a medicament in a cartridge in the delivery device. The sensing system may include an emitter and a receiver, the emitter configured to bounce a signal off of a stopper in the cartridge and the receiver configured to receive a reflection of the signal. Based on a parameter of the reflected signal, a processor may determine a position of the stopper in the cartridge. Based on the geometry of the cartridge, a processor may compute a dosage of the medicament that has been dispensed based on the position of the stopper.

The subject matter described herein will largely be described with reference to a drug delivery device such as an injection device (e.g., an insulin injection device). However, the systems and techniques described herein are not limited to such applications, and may equally well be deployed with injection devices that eject other medicaments, or with other types of medical devices (e.g., pumps).

The term "drug delivery device" shall encompass any type of device or system configured to dispense a volume of a drug into a human or animal body. The volume can typically range from about <NUM> to about <NUM>. Without limitation, the drug delivery device may include a syringe, needle safety system, pen injector, auto injector, large-volume device (LVD), pump, perfusion system, or other device configured for subcutaneous, intramuscular, or intravascular delivery of the drug. Such devices often include a needle, wherein the needle can include a small gauge needle (e.g., greater than about <NUM> gauge, and including <NUM>, <NUM>, or <NUM> gauge).

In combination with a specific drug, the presently described devices may also be customized in order to operate within required parameters. For example, within a certain time period (e.g., about <NUM> to about <NUM> seconds for injectors, and about <NUM> minutes to about <NUM> minutes for an LVD), with a low or minimal level of discomfort, or within certain conditions related to human factors, shelf-life, expiry, biocompatibility, environmental considerations, etc. Such variations can arise due to various factors, such as, for example, a drug ranging in viscosity from about <NUM> cP to about <NUM> cP.

Storage may occur at room temperature (e.g., about <NUM>-<NUM>), or refrigerated temperatures (e.g., from about <NUM>-<NUM>).

<FIG> is an exploded view of an example of an injection device <NUM>. The injection device <NUM> may be a pre-filled, disposable or reusable injection pen. The injection device <NUM> includes a housing <NUM> that contains a cartridge <NUM>. The cartridge <NUM> is configured to hold a volume of fluid. In some embodiments, the cartridge <NUM> is a medicament container, such as an insulin container. The cartridge <NUM> includes a distal end <NUM> and a proximal end <NUM>. In some embodiments, the proximal end <NUM> of the cartridge <NUM> may reside within the housing <NUM> of the injection device <NUM> and therefore may not be readily visible.

The injection device <NUM> includes a stopper <NUM> that is disposed in the cartridge <NUM>. The stopper <NUM> is configured to move from the proximal end <NUM> of the cartridge <NUM> toward the distal end <NUM> of the cartridge <NUM> to cause the fluid to be dispensed through the distal end <NUM> of the cartridge <NUM>. The injection device <NUM> also includes a needle hub <NUM> that is disposed at the distal end <NUM> of the cartridge <NUM>. A needle <NUM> can be affixed to the needle hub <NUM> proximate to the aperture <NUM> such that the fluid travels through the aperture <NUM> and the needle <NUM> when dispensed. In some embodiments, the needle hub <NUM> and the needle <NUM> are threaded such that the needle <NUM> can be screwed onto the needle hub <NUM> or the needle hub <NUM> can be screwed onto the needle <NUM>. The needle <NUM> is protected by an inner needle cap <NUM> and an outer needle cap <NUM>, which in turn can be covered by a cap <NUM>.

A drug dose (e.g., such as an insulin dose) to be ejected from injection device <NUM> can be selected by turning a dosage knob <NUM>, and the selected dose can then be displayed by a dosage window <NUM>. In some examples, the dosage window <NUM> is a display, such as an electronic display. In some examples, the selected dose can be displayed in multiples of International Units (IU), wherein one IU is the biological equivalent of about <NUM> micrograms of medicament such as pure crystalline insulin (e.g., <NUM>/<NUM>). An example of a selected dose displayed in the dosage window <NUM> may, for example, be <NUM> IUs, as shown in FIG. In some examples, the selected dose may be displayed differently, for example, by an electronic display. In some examples, the dosage window <NUM> relates to the section of the injection device through or on which the selected dosage is visible.

Turning the dosage knob <NUM> may cause a mechanical click sound to provide acoustical feedback to a user. The numbers displayed in the dosage window <NUM> are printed on a sleeve that is contained in housing <NUM> and mechanically interacts with a piston in the cartridge <NUM>. When the needle <NUM> is inserted into a skin portion of a patient, and then an injection button <NUM> is pushed, the medicament is ejected from the injection device <NUM>. Ejection of the dose may also cause a mechanical click sound. Such a mechanical click sound may be different from the sounds produced when the dosage knob <NUM> is turned.

The injection device <NUM> may be used for several injection processes until either the cartridge <NUM> is empty or the expiration date of the injection device <NUM> is reached. In some examples, before using the injection device <NUM> for the first time, it may be necessary to perform a "prime shot" to remove air from the cartridge <NUM> and the needle <NUM>, for example, by selecting two units of medicament and pressing the injection button <NUM> while holding the injection device <NUM> with the needle <NUM> oriented upwards.

The injection device <NUM> is configured to determine the volume of medicament fluid (e.g., insulin) in the cartridge <NUM>, which can represent the dosage of medicament to be administered to the patient. For example, the injection device includes an electronic device <NUM> configured to measure a position of the stopper <NUM>. The electronic device <NUM> includes an emitter <NUM> and a receiver <NUM> (shown in <FIG>) In some embodiments, one or both of the emitter <NUM> and the receiver <NUM> may be disposed in the cartridge housing <NUM>. The cartridge <NUM> and/or the cartridge housing <NUM> may be made from and/or include a material that allows the one or more waves emitted by the emitter and the reflections of the one or more waves to pass therethrough (or, e.g., pass substantially therethrough).

Referring to <FIG>, the emitter <NUM> is configured to transmit one or more signals <NUM> toward the proximal end <NUM> of the cartridge <NUM> where the one or more waves are reflected from the proximal end <NUM> of the cartridge <NUM> back to the receiver <NUM> located at the distal end (e.g., by bouncing off a surface of the stopper <NUM>, as described in detail below). The receiver <NUM> is configured to receive reflections <NUM> of the signal. Information related to the transmitted signal <NUM> and the reflections <NUM> of the one or more transmitted signals can be used to determine the volume of the fluid in the cartridge <NUM>. For example, the information related to the one or more transmitted signals <NUM> and the reflections <NUM> of the one or more waves can be used to determine a distance traveled by the transmitted signal <NUM>. The distance traveled by the transmitted signal <NUM> can be used to determine a volume of the fluid in the cartridge <NUM>, and the volume of the fluid in the cartridge <NUM> can be used to determine a dose of medicament administered to a patient. In some embodiments, both the emitter <NUM> and the receiver <NUM> are included as components of a single transceiver package. The one or more signals may include acoustic waves, ultrasonic waves, light waves, or any combination thereof.

In some embodiments, the information related to the one or more transmitted signals <NUM> (e.g., times of transmission, intensity at transmission) and the reflections <NUM> of the one or more transmitted signals (e.g., times of receipt, intensity at receipt) is provided to and/or received by a computing device (e.g., the computer system <NUM> of <FIG>), and the computing device uses such information to determine the volume of the fluid in the cartridge <NUM>. In some examples, the emitter <NUM> is an acoustic (e.g., ultrasonic) transmitter that is configured to transmit one or more acoustic waves (e.g., ultrasonic waves) toward the proximal end <NUM> of the cartridge <NUM>, and the receiver <NUM> is an acoustic receiver that is configured to receive reflections of the one or more acoustic waves. The computing device can identify times at which each acoustic wave is transmitted, and for each transmitted acoustic wave, times as which the corresponding reflection is received by the receiver <NUM>. With the acoustic wave velocity being known (e.g., in this case, the speed of sound), the elapsed time between transmission and receiving of the wave, sometimes referred to as time of flight (TOF), can be used to determine the distance traveled by the wave.

The distance traveled by the wave represents the distance from the emitter <NUM>, to the reflection surface (e.g., a surface of the stopper <NUM>), to the receiver <NUM>. This distance can be divided by two to determine the distance between the stopper <NUM> and the receiver <NUM>. Because the stopper <NUM> defines the boundary of the fluid near the proximal end <NUM> of the cartridge <NUM>, the determined distance represents a length of the cartridge <NUM> within which the fluid resides. The determined distance, along with the known dimensions of the cartridge <NUM>, can be used to determine the volume of the fluid in the cartridge <NUM>. For example, for a cylindrical cartridge, the volume of fluid (V) in the cartridge <NUM> is defined by the equation: <MAT> where r is the internal radius of the cartridge and D1 is the distance from the surface of the stopper <NUM> to the distal end <NUM> of the cartridge <NUM>.

In an example, the emitter <NUM> transmits an acoustic wave at a first time t1. The first time t1 (e.g., the transmission time of the acoustic wave) is provided to the computing device. The acoustic wave propagates from the emitter <NUM> toward the proximal end <NUM> of the cartridge <NUM> and is reflected off of (e.g., bounces off of) the stopper <NUM>. A reflection <NUM> of the acoustic wave (e.g., a reflected wave) propagates from the stopper <NUM> toward the receiver <NUM>. The reflected wave is received at a second time t2. The speed of the acoustic wave is the speed of sound in the liquid. The elapsed time between transmission and receiving of the acoustic wave is t2 - t1. The elapsed time is multiplied by the speed of sound to determine the distance traveled by the wave from the emitter <NUM>, to the distal end <NUM> of the cartridge <NUM>, back to the receiver <NUM>. The distance traveled is divided by two to determine the distance between the emitter <NUM>/the receiver <NUM> and the stopper <NUM>. The volume of fluid in the cartridge <NUM> (e.g., the volume of fluid enclosed in the cartridge <NUM> between the stopper <NUM> and the distal end <NUM>) is determined by multiplying the determined distance by the cross-sectional area of the cartridge <NUM>. The determined volume of fluid in the cartridge <NUM> is the dose that is to be administered to the patient.

In some embodiments, the stopper <NUM> includes a reflective material <NUM> that is disposed at an end of the stopper <NUM> that faces the emitter <NUM>. The reflective material <NUM> is configured to improve the signal quality of the reflected signal (e.g., by minimizing signal loss upon reflection, reducing noise in the signal, improving signal to noise ratio, etc.), thereby improving the TOF calculation.

Referring generally to <FIG> and <FIG>, in some embodiments, the emitter <NUM> is a light source that is configured to transmit light toward the stopper <NUM>, and the receiver <NUM> is a light receiver that is configured to receive reflections or remission of the light waves. In some examples, the cartridge housing <NUM> may be made from and/or include a material that allows the light waves and the reflections of the light waves to pass therethrough (or, e.g., pass substantially therethrough). In some embodiments, the cartridge <NUM> includes a transparent material, such as one or both of glass and plastic.

While the injection device <NUM> has been largely described as being configured to determine the volume of the fluid in the cartridge <NUM> using information related to the one or more transmitted signals and the reflections of the one or more signals, in some embodiments, the injection device <NUM> may include one or more components other than or in addition to the emitter <NUM> and receiver <NUM> for determining the volume of the fluid.

In some embodiments, the volume of the fluid in the cartridge <NUM> may be determined continuously as the fluid is dispensed from the injection device <NUM>. For example, when the injection button <NUM> is pushed and as the medicament is ejected from the cartridge <NUM>, the injection device <NUM> may continuously determine the volume of the fluid in the cartridge <NUM> such that the user can receive continuous feedback of the current volume of fluid in the cartridge <NUM>.

In particular, in a manner substantially similar to that described above with respect to <FIG>, information related to one or more transmitted signals (e.g., times of transmission) and the reflections of the one or more transmitted signals (e.g., times of receipt) can be provided to and/or received by the computing device. The elapsed time between transmission and receiving of the signal (e.g., the TOF) can be multiplied by the speed of the signal (e.g., the speed of sound) to determine the distance traveled by the wave. The distance traveled by the wave represents the distance from the emitter <NUM>, to the stopper <NUM>, and back to the receiver <NUM>. The distance traveled is divided by two to determine the distance between the emitter <NUM>/the receiver <NUM> and the stopper <NUM>. The volume of fluid in the cartridge <NUM> (e.g., the volume of remaining fluid enclosed in the cartridge <NUM> between the stopper <NUM> and the distal end <NUM>) is determined by multiplying the determined distance by the cross-sectional area of the cartridge <NUM>. The determined volume of fluid in the cartridge is the dose that is remaining in the cartridge <NUM> which is yet to be administered to the patient. The volume of fluid in the cartridge <NUM> can be continuously determined such that the remaining dosage is known throughout administration. Computing a dosage may be accomplished by a microcontroller <NUM> on board the injection device <NUM> or may be accomplished by an external computer system <NUM>. In some implementations, another kind of processor can be used in place of the microcontroller <NUM> on board the injection device <NUM>.

<FIG> is a cross-sectional view of a stopper <NUM> disposed in a cartridge <NUM>. The stopper includes embedded electronic components 306a, 306b, and 306c. The stopper <NUM> has a shell <NUM> and a core <NUM> with electronic devices 306a, 306b, and 306c embedded in the core <NUM>. Optional integrated sealing element <NUM> can be configured to provide a sealing interface with the cartridge upon the stopper's introduction into the cartridge <NUM>. In some instances, the shell <NUM> provides a rigid surface for interfacing with a head of a plunger. In this way, the shell <NUM> protects the electronics devices 306a, 306b, 306c from getting deformed by a push of a plunger on the stopper <NUM> as the stopper <NUM> is forced to move along the length of the cartridge <NUM>. In some instances, the shell <NUM> has heat-resistive properties which may shield the electronic components 306a, 306b, and 306c from heat produced during a heat sterilization process to sterilize the stopper <NUM> and the cartridge <NUM>. It is also contemplated that the shell and core be made of rigid or soft materials in various combinations to withstand high temperatures used during sterilization processes, while providing structure and support for the electronics and plunger. Alternatively, the shell/core can be made of one unitary piece with the electronics molded therein.

It is contemplated that the waves emitted by the emitter can be optical, acoustic or ultrasonic in nature. In an example, a transmitter 306c transmits an acoustic wave at a first time t1. The first time t1 (e.g., the transmission time of the acoustic wave) may be provided to an external device (e.g. a controller) via a wireless transmission by a wireless transceiver 306b. The transmitter 306c and the wireless transceiver 306b may be powered by a power source 306a. The acoustic wave propagates from the transmitter in the stopper <NUM> toward the distal end (the end nearest the cap <NUM>) of the cartridge <NUM> and is reflected off of (e.g., bounces off of) a surface of the cartridge <NUM> or a reflector (not shown). A reflection of the acoustic wave (e.g., a reflected wave) propagates from the distal end of the cartridge <NUM> toward a sensor in the stopper <NUM>. The reflected wave is received at a second time t2. The speed of the acoustic wave is the speed of sound in the medicament in the cartridge (e.g., <NUM> meters per second in water). The elapsed time between transmission and receiving of the acoustic wave is t2 - t1. The elapsed time is multiplied by the speed of sound to determine the distance traveled by the wave from the transmitter, to the distal end of the cartridge <NUM>, back to the sensor. The distance traveled is divided by two to determine the distance between the stopper <NUM> and the distal end of the cartridge <NUM>. The volume of medicament in the cartridge <NUM> (e.g., the volume of medicament enclosed in the cartridge <NUM> between the stopper <NUM> and the distal end) is determined by multiplying the determined distance by the cross-sectional area of the cartridge <NUM>. The determined volume of medicament in the cartridge <NUM> is the dose that is to be administered to the patient.

Referring generally to the embodiments shown in <FIG> and <FIG>, signal transmission occurs in the opposite direction (e.g. from distal end <NUM> toward proximal end <NUM> and bouncing back) as the signals are emitted by emitter <NUM> and reflections of the signals are received by receiver <NUM>. This is advantageous as the stopper <NUM> provides a flat surface substantially equal to the cross-section of the cartridge off of which the signal may reflect (e.g. bounce back) toward the receiver. It has been found that in alternative configurations, where the emitter and receiver are placed at the proximal end and the waves bounce off the distal end, the shape and configuration of the cartridge may not provide a substantially flat surface for the waves to bounce off of. Thus, locating the emitter and receiver at the distal end, near the neck of the cartridge and allowing the waves to bounce off the substantially flat surface of the stopper leads to greater accuracy of measurements. It is also advantageous to include electronic components outside of the stopper as the cartridge may be heat sterilized without regard to damaging electronic components embedded in a stopper with the high heat. As the electronic components are located external to the stopper, the design and manufacturing of the stopper is simpler.

<FIG> is an embodiment of an electronic device <NUM> including an emitter <NUM>, a receiver <NUM>, and an energy source <NUM>. In this embodiment, the energy source <NUM> is located in the housing <NUM> of the injection device. The energy source <NUM> is electrically connected to the emitter <NUM> and receiver <NUM> by electronic leads 414a and 414b. The energy source may include a battery. The electronic leads 414a and 414b run through the cartridge housing <NUM>. The electronic leads 414a and 414b allow the energy source <NUM> to power the emitter <NUM>, the receiver <NUM>, and the microcontroller <NUM>.

The microcontroller <NUM> includes a wireless transceiver which may communicate using any known wireless communication technique including, for example Bluetooth, NFC, or radio frequencies. The microcontroller <NUM> may communicate data relating to the state of the cartridge or signals received at the receiver <NUM> to an external database. The state of the cartridge may correspond to, for example, a fill level of medicament in the cartridge or a position of the stopper. The state of the cartridge may allow measurement of an injected dose of medicament.

The communication with the microcontroller <NUM> can be one way or bidirectional. In some instances, data transferred from the sensor device to an external data base contains information which is related to the identity of the device e.g. a unique number, calibration data, production lot information, device material information, data related to storage time and production time, and information related to the sensor measurement (e.g., time of measurement, sensor measurement results like temperature, distances, light signals, acoustic signals). In some instances, data coming from the external data base device to the microcontroller <NUM> contains information regarding "wake up" signals, triggers to measure, time information, or calibration data.

<FIG> is a schematic showing the relative position of a stopper <NUM>, an emitter <NUM> and a receiver <NUM> in relation to a longitudinal axis <NUM>. The emitter <NUM> is configured to be able to emit a signal at an angle of between <NUM>° and α. Accordingly, the receiver <NUM> is configured to be able to receive a reflection of a signal after bouncing off of the stopper <NUM> at an angle of between <NUM>° and α. As the stopper <NUM> moves through the distance D1 from the proximal end <NUM> toward the distal end <NUM>, the emitter <NUM> and the receiver <NUM> has a range that enables them emit and capture the signals and reflections, respectively. In some embodiments, α is between <NUM> and <NUM>°. In other embodiments, it's between <NUM> and <NUM>° degrees. In yet other embodiments, it is between <NUM> and <NUM>°.

<FIG> is an embodiment of an electronic device <NUM> which is detachable from a cartridge <NUM> or a cartridge housing <NUM>. The emitter <NUM> and the receiver <NUM> are positioned in the detachable electronic device <NUM> so they can emit and receive signals and reflections of signals through a portion of the cartridge housing <NUM>, respectively. The cartridge housing <NUM> is typically transparent to the signals <NUM> emitted from the emitter <NUM> and the reflections of the signals <NUM> received by the receiver <NUM>. In some embodiments, the cartridge housing <NUM> is transparent to an light signal, an ultrasonic signal, and/or an acoustic signal.

The cartridge housing <NUM> includes a ridge <NUM> such that a clasp or snap portion of the electronic device <NUM> may interface with the ridge <NUM> and secure the electronic device <NUM> to the cartridge housing <NUM>. As the electronic device <NUM> may be attached and detached from the cartridge housing <NUM>, it may be calibrated upon attachment to the cartridge housing <NUM>. The calibration process typically enables the emitter and receiver to accurately determine the position of the stopper <NUM> within the cartridge <NUM>. The microcontroller <NUM> may include a memory that stores information relating to the medicament useful for calibration and dosing information.

The emitter <NUM> and the receiver <NUM> are positioned in the detachable electronic device <NUM> such that, when the detachable electronic device <NUM> is attached to the cartridge housing <NUM>, the emitter <NUM> and the receiver <NUM> are positioned such that the emitter is able to emit a signal at an angle of between <NUM>° and α in relation to the longitudinal axis of the cartridge. Accordingly, the receiver <NUM> is able to receive a reflection of a signal after bouncing off of the stopper <NUM> at an angle of between <NUM>° and α. In some embodiments, α is between <NUM> and <NUM>°. In other embodiments, it's between <NUM> and <NUM>° degrees. In yet other embodiments, it is between <NUM> and <NUM>°. Calibration may be necessary to ensure proper positioning of the emitter <NUM> and the receiver <NUM> upon attaching the detachable electronic device <NUM> to the cartridge housing <NUM>.

For example, the computer system <NUM> may be incorporated into the injection device <NUM> of <FIG>, and/or the injection device <NUM> may be configured to interact with a separate computer system <NUM> (e.g. via microcontroller <NUM> shown in <FIG>). The system <NUM> includes a processor <NUM>, a memory <NUM>, a storage device <NUM>, and an input/output device <NUM>. Each of the components <NUM>, <NUM>, <NUM>, and <NUM> can be interconnected, for example, using a system bus <NUM>. The processor <NUM> is capable of processing instructions for execution within the system <NUM>. The processor <NUM> can be a single-threaded processor, a multi-threaded processor, or a quantum computer. The processor <NUM> is capable of processing instructions stored in the memory <NUM> or on the storage device <NUM>. The processor <NUM> may execute operations such as causing the injection device <NUM> to carry out one or more of the operations described above to determine the volume of the fluid in the cartridge <NUM>.

A portable computing device such as a smartphone or tablet computer may be an example of the computer system <NUM>. In some implementations, the portable computing device runs an application for interfacing with the electronic device <NUM> on the injection device <NUM>. For example, the portable computing device may communicate with the electronic device <NUM> using one or more computer networks (e.g., wireless or wired communication networks, or a combination of the two), such the application running on the portable computing device can display information based on data received from the electronic device <NUM>. In some implementations, other types of computer systems may display information based on data received from the electronic device <NUM>. In some implementations, "cloud" computing techniques are used to communicate information between the portable computing device and the electronic device <NUM>. For example, both the portable computing device and the electronic device <NUM> may communicate with one or more cloud servers (which may be other examples of computer systems <NUM>) that act as intermediate data processing and storage facilities. A cloud computing system may also provide access, via a portable computing device, to externally stored patient, dosage, or other data.

In some embodiments, the memory <NUM> is a computer-readable medium. The memory <NUM> can, for example, be a volatile memory unit or a non-volatile memory unit. In some embodiments, the memory <NUM> stores information related to one or more of the velocity of the one or more waves transmitted by the emitter <NUM>, the dimensions of the cartridge <NUM>, and data that can be used to correlate the applied voltage across the electrodes <NUM>, <NUM> to a distance between the electrodes <NUM>, <NUM>.

In some embodiments, the storage device <NUM> is a non-transitory computer-readable medium. The storage device <NUM> can include, for example, a hard disk device, an optical disk device, a solid-date drive, a flash drive, magnetic tape, or some other large capacity storage device. The storage device <NUM> may alternatively be a cloud storage device, e.g., a logical storage device including multiple physical storage devices distributed on a network and accessed using a network. In some embodiments, the information stored on the memory <NUM> can also or instead be stored on the storage device <NUM>.

In some embodiments, the input/output device <NUM> includes one or more of network interface devices (e.g., an Ethernet card), a serial communication device (e.g., an RS-<NUM> port), and/or a wireless interface device (e.g., a short-range wireless communication device, an <NUM> card, a <NUM> wireless modem, or a <NUM> wireless modem). In some embodiments, the input/output device <NUM> includes driver devices configured to receive input data and send output data to other input/output devices, e.g., a keyboard, a printer, and display devices (e.g., such as the dosage window <NUM>). In some embodiments, mobile computing devices, mobile communication devices, and other devices are used.

In some embodiments, the system <NUM> is a microcontroller. A microcontroller is a device that contains multiple elements of a computer system in a single electronics package. For example, the single electronics package could contain the processor <NUM>, the memory <NUM>, the storage device <NUM>, and input/output devices <NUM>.

Although an example processing system has been described in <FIG>, embodiments of the subject matter and the functional operations described above can be embodiments in other types of digital electronic circuitry, or in computer software, firmware, or hardware, including the structures disclosed in this specification and their structural equivalents, or in combinations of one or more of them. Embodiments of the subject matter described in this specification can be implemented as one or more computer program products, e.g., one or more modules of computer program instructions encoded on a tangible program carrier, for example a computer-readable medium, for execution by, or to control the operation of, a processing system. The computer readable medium can be a machine readable storage device, a machine readable storage substrate, a memory device, a composition of matter effecting a machine readable propagated signal, or a combination of one or more of them.

The term "computer system" may encompass all apparatus, devices, and machines for processing data, including by way of example a programmable processor, a computer, or multiple processors or computers. A processing system can include, in addition to hardware, code that creates an execution environment for the computer program in question, e.g., code that constitutes processor firmware, a protocol stack, a database management system, an operating system, or a combination of one or more of them.

A computer program (also known as a program, software, software application, script, executable logic, or code) can be written in any form of programming language, including compiled or interpreted languages, or declarative or procedural languages, and it can be deployed in any form, including as a standalone program or as a module, component, subroutine, or other unit suitable for use in a computing environment.

Computer readable media suitable for storing computer program instructions and data include all forms of non-volatile or volatile memory, media and memory devices, including by way of example semiconductor memory devices, e.g., EPROM, EEPROM, and flash memory devices; magnetic disks, e.g., internal hard disks or removable disks or magnetic tapes; magneto optical disks; and CD-ROM and DVD-ROM disks.

Exemplary insulin derivatives are, for example, B29-N-myristoyl-des(B30) human insulin; B29-N-palmitoyl-des(B30) human insulin; B29-N-myristoyl human insulin; B29-N-palmitoyl human insulin; B28-N-myristoyl LysB28ProB29 human insulin; B28-N-palmitoyl-LysB28ProB29 human insulin; B30-N-myristoyl-ThrB29LysB30 human insulin; B30-N-palmitoyl- ThrB29LysB30 human insulin; B29-N-(N-palmitoyl-gamma-glutamyl)-des(B30) human insulin; B29-N-(N-lithocholyl-gamma-glutamyl)-des(B30) human insulin; B29-N-(ω-carboxyheptadecanoyl)-des(B30) human insulin and B29-N-(ω-carboxyhepta¬decanoyl) human insulin. Exemplary GLP-<NUM>, GLP-<NUM> analogues and GLP-<NUM> receptor agonists are, for example: Lixisenatide / AVE0010 / ZP10 / Lyxumia, Exenatide / Exendin-<NUM> / Byetta / Bydureon / ITCA <NUM> / AC-<NUM> (a <NUM> amino acid peptide which is produced by the salivary glands of the Gila monster), Liraglutide / Victoza, Semaglutide, Taspoglutide, Syncria / Albiglutide, Dulaglutide, rExendin-<NUM>, CJC-<NUM>-PC, PB-<NUM>, TTP-<NUM>, Langlenatide / HM-11260C, CM-<NUM>, GLP-<NUM> Eligen, ORMD-<NUM>, NN-<NUM>, NN-<NUM>, NN-<NUM>, Nodexen, Viador-GLP-<NUM>, CVX-<NUM>, ZYOG-<NUM>, ZYD-<NUM>, GSK-<NUM>, DA-<NUM>, MAR-<NUM>, MAR709, ZP-<NUM>, ZP-<NUM>, TT-<NUM>, BHM-<NUM>. MOD-<NUM>, CAM-<NUM>, DA-<NUM>, ARI-<NUM>, ARI-<NUM>, Exenatide-XTEN and Glucagon-Xten.

Those of skill in the art will understand that modifications (such as, for example, adjustments, additions, or removals) of various components of the substances, formulations, apparatuses, methods, systems, devices, and embodiments described herein may be made without departing from the full scope of the present inventive concepts, which encompass such modifications.

Claim 1:
An injection device (<NUM>) comprising:
a housing (<NUM>),
a cartridge housing (<NUM>) containing a cartridge (<NUM>),
the cartridge (<NUM>) configured to hold a volume of fluid, the cartridge (<NUM>) having a proximal end (<NUM>) and a distal end (<NUM>) through which fluid is dispensed;
a stopper (<NUM>) disposed in the cartridge (<NUM>) and configured to move from the proximal end (<NUM>) to the distal end (<NUM>) to cause the fluid to be dispensed through the distal end (<NUM>) of the cartridge (<NUM>); and
an electronic device (<NUM>) disposed at the distal end (<NUM>) of the cartridge (<NUM>), the electronic device (<NUM>) comprising
an emitter (<NUM>) configured to transmit a signal (<NUM>) toward the stopper (<NUM>);
a receiver (<NUM>) configured to receive reflections (<NUM>) of the signal (<NUM>) from the stopper (<NUM>); and
a controller (<NUM>) configured to wirelessly transmit data related to a position of the stopper (<NUM>) in the cartridge (<NUM>), wherein the controller (<NUM>) includes a wireless transceiver and is configured to communicate signals received at the receiver (<NUM>) to an external database, characterized by
a battery (<NUM>) disposed in the housing (<NUM>), wherein the battery (<NUM>) is electrically connected to the electronic device (<NUM>) with electrical leads (414a, 414b) disposed in the cartridge housing (<NUM>).