Patent Description:
The life of an electronically enabled injection device can be limited by the life of its energy supply. Some electronically enabled injection devices can be kept on shelves for extended periods of time before being used. Current configurations of electronically enabled injection devices lead to idle drainage of the energy supply, such that, even if the electronically enabled injection device has not been used, long shelf life can exhaust the life of the energy supply. A low battery condition can lead to no- or malfunction of the device, or it can lead to a missed dosage, by stopping the operation of the electronic components.

<CIT> discloses a plunger head for a fluid injection device that includes a transducer disposed in the plunger head to measure a compressive force when applied to the plunger head. The plunger head also includes a microcontroller which enters a high-power mode in response to sensing application of the compressive force to the plunger head.

<CIT> discloses an injection device that includes an energy source, an electronic component, a priming component configured to generate a trigger, and a mechanism which, in response to receiving the trigger, electrically couples the energy source to the electronic component.

Implementations of the present disclosure include coupling mechanisms and systems configured for extending the life of electronically enabled injection devices by preventing idle drainage of the energy source. In accordance with one aspect of the present invention, an electronically enabled injection device includes an energy source configured to power an electronic component, a priming component configured to generate a trigger, a reactant configured to generate an instantiation signal in response to the trigger, and a sensor configured to detect and process the instantiation signal and generate an activation signal to activate the energy source.

In some implementations, the reactant is included in a bearing and the sensor is included in a plunger stopper. The injection device further includes a plunger configured to transmit the trigger to the reactant. The instantiation signal includes a thermic signal and the reactant includes two reactants configured to generate an exothermic reaction in response to the trigger. The sensor includes a temperature sensor. The temperature sensor includes a first temperature sensor configured to detect the thermic signal generated by the two reactants. The temperature sensor includes a second temperature sensor configured to detect a temperature of a medicament stored in a medicament reservoir. The activation signal is based on a temperature difference between the medicament and the exothermic reaction. The instantiation signal includes a photo-signal and the reactant includes one or more reactants configured to generate a luminescent reaction in response to the trigger. The sensor includes a photoelectric sensor. The photoelectric sensor includes a first photoelectric sensor configured to detect a photoemission generated by the luminescent reaction. The reactant includes a first reactant and a second reactant, at least one of the first reactant and the second reactant includes a fluid reactant, the first reactant and the second reactant being separated from each other by a fluid impermeable membrane that is configured to be pierced in reaction to the trigger to enable interaction between the first reactant and the second reactant. The reactant includes a first solid reactant and a second solid reactant that is distanced from the first solid reactant in a pre-priming configuration and is configured to be mechanically coupled to the first solid reactant in reaction to the trigger to enable interaction between the first solid reactant and the second solid reactant.

In accordance with another aspect of the present invention, a medicament injection system includes: an injection device and an external device that includes an external processor configured to communicate with the injection device.

It is appreciated that systems in accordance with the present disclosure can include any combination of the aspects and features described herein. That is to say that methods in accordance with the present disclosure are not limited to the combinations of aspects and features specifically described herein, but also include any combination of the aspects and features provided.

The details of one or more embodiments of the present disclosure are set forth in the accompanying drawings and the description below.

Implementations of the present disclosure are generally directed to controlled activation of an energy source of an injection device to prevent idle drainage of the energy source. More particularly, implementations of the present disclosure are directed to a mechanism configured to receive a trigger signal and in response to receiving the trigger signal, generating an instantiation signal to activate the energy source of the injection device to the electronic component.

In some injection devices, the energy source of the injection device can be activated in response to false trigger signals, prior to intended usage of the injection device, leading to idle drainage of the energy source. Accordingly, use of electronic injection devices can be hindered by idle drainage of the energy source. In some injection devices, the activation process of the energy source of the injection device can take extended periods of time after the injection device is primed. Prolonged activation processes or additional user interactions that may be required and that are not part of the standard injection workflow can render the injection devices as being unpractical. As described in further detail herein, implementations of the present disclosure address these challenges. For example, in accordance with implementations, the electronic injection device can be quickly (e.g., within seconds) activated in response to signals generated by reactants that are separated from each other until a trigger signal is initiated (e.g., during a priming step of a medicament administration) to prevent idle drainage of the energy source.

<FIG> and <FIG> illustrate exploded views of example fluid delivery systems <NUM>. The example fluid delivery systems <NUM> can be configured to assist a user in injecting a fluid (e.g., a medicament) and facilitate sharing of medical data. The example fluid delivery systems <NUM> can include an injection device <NUM> and an external device <NUM>. The injection device <NUM> can be an electronically enabled injection device configured to prevent idle drainage of an energy source <NUM>. The injection device <NUM> can be a prefilled, disposable injection pen or the injection device <NUM> can be a reusable injection pen with replaceable medicament reservoirs <NUM>. The injection device <NUM> can be configured to communicate with the external device <NUM>. The injection device <NUM> can transmit to the external device <NUM> operational data (e.g., data and time of start of usage of injection device <NUM>, temperature of injection device <NUM> during use and storage) and corresponding treatment data (e.g., amount and time of medicament dispense by the injection device <NUM>). In some implementations, the injection device <NUM> can be associated with an identifier that is used by the external device <NUM> to uniquely identify the injection device <NUM>.

The injection device <NUM> can include a housing <NUM> and a needle assembly <NUM>. The housing <NUM> can contain the energy source <NUM>, an electronic system <NUM>, a medicament reservoir <NUM>, a stopper <NUM>, a plunger rod <NUM>, a plunger head <NUM>, a bearing <NUM>, a priming component (e.g., dosage knob) <NUM>, a dosage window <NUM>, and an injection button <NUM>. The housing <NUM> can be molded from a medical grade plastic material such as a liquid crystal polymer.

The medicament reservoir <NUM> can be configured to contain a fluid medicament. The medicament reservoir <NUM> can be a conventional, generally cylindrical, disposable container like a cartridge or a syringe used to package prepared fluids such as medicaments, anesthetics and the like. The medicament reservoir <NUM> can be provided with a pair of ends, one end having a pierceable membrane, which receives an inward end of needle <NUM> in sealing engagement. A dose of the contained medicament can be ejected from the injection device <NUM> by turning the dosage knob <NUM>, and the selected dose is then displayed via dosage window <NUM>, for instance in multiples of so-called International Units (IU), wherein one IU is the biological equivalent of about <NUM> micrograms of pure crystalline medicament (e.g., <NUM>/<NUM>). An example of a selected dose displayed in dosage window <NUM> may for instance be <NUM> IUs, as shown in <FIG>. In some implementations, the selected dose can be displayed differently, for instance by an electronic display (e.g., the dosage window <NUM> may take the form of an electronic display). Turning the dosage knob <NUM> can cause a mechanical click sound to provide acoustical feedback to a user. The numbers displayed in dosage window <NUM> can be printed on a sleeve that is contained in housing <NUM> and mechanically interacts with a plunger head <NUM> that is fixed at the end of the plunger rod <NUM> and pushes the stopper <NUM> of the medicament reservoir <NUM>.

The plunger head <NUM> (e.g., a back end of the plunger rod <NUM>) can be configured to expel a portion of the fluid by displacing the stopper <NUM> contained within the medicament reservoir <NUM>, such that a position of the stopper <NUM> is associated with an amount of the fluid within the injection device <NUM>.

The bearing <NUM> can provide firm mounting to one or both ends of the plunger rod <NUM>.

The bearing <NUM> can be positioned between the plunger head <NUM> and the stopper <NUM>.

The bearing <NUM> is configured to include components configured to activate the energy source <NUM>. One or more reactants 111a, 111b, 111c are included in the bearing <NUM>. Reactants 111a, 111b, 111c can be solid but at least one reactant is a fluid reactant (111a, 111b). The reactants 111a, 111b, 111c are configured to generate an exothermic and a luminescent reaction (e.g., chemiluminescence, crystalloluminescence, fluorescence, or phosphorescence) in response to the trigger. For example, the reactants 111a, 111b, 111c can include alkali metals and other highly electropositive metals that exothermally react when coming in contact with water, strong acids that exothermally react when coming in contact with water or strong bases that exothermally react when coming in contact with water. As another example, the reactants 111a, 111b, 111c can include fluorescent materials or phosphorescent materials that absorb light (e.g., after the injection device <NUM> is removed from a storage packaging) and then they emit light for a particular amount time. Multiple reactants 111a, 111b are stored in separate compartments that are separated from each other by a fluid (e.g., gas and/or liquid) impermeable membrane <NUM>. The fluid impermeable membrane is configured to be pierced, torn or removed in reaction to a trigger (e.g., priming displacement of the plunger <NUM>) to initiate interaction between the first reactant 111a and the second reactant 111b. In some implementations, the geometrical characteristics (e.g., interface size, volume) of the reactants 111a, 111b, 111c and the concentration of the reactants 111a, 111b, 111c can be configured to generate an instantiating signal above a first threshold and below a second threshold. The first threshold can include a detection threshold. The second threshold can be selected based on a safety for handling the injection device. For example, an increase in temperature due to the exothermic reaction can be below a temperature that might affect the stored medicament or might harm a user of the injection device <NUM>. To prevent altering the stored medicament and for safety of the injection device handling, the maximum temperature elevation can be limited to a value in a range from about <NUM> to about <NUM>.

In some implementations, a reactant 111a can include a metal container and a reactant 111b can include an electrode configured to be used for generating an exothermic reaction. The metal container can be plated with a hydrogen absorbing material. The metal container can have one or more open ends. The electrode can be received through a first open end into the metal container. The metal container can be filled with a pressurized gas (e.g., hydrogen). To trigger an exothermic reaction, a magnetic field can be applied. In some embodiments, a strength of the applied magnetic field can be depend on a dimension of the metal container. For example, the strength of the applied magnetic field can be dependent on the distance between the metal container and the electrode. In one embodiment, the hydrogen absorbing material plated on the interior wall of the metal reactant can include nickel, palladium or other metals or metal alloys capable of forming a hydride or deuteride.

In some implementations, the composition of the bearing <NUM> can be configured to transmit an instantiation signal generated by the interaction of the reactants 111a, 111b, 111c. For example, at least a portion of the bearing <NUM> that is proximal to the interface with the stopper <NUM> can be configured to be a good thermal conductor (e.g., if the reactants 111a, 111b, 111c are configured to generate an exothermic reaction) or to be optically transparent (e.g., if the reactants 111a, 111b, 111c are configured to generate a luminescent reaction).

The stopper <NUM> can be a flexible stopper, such as a rubber stopper or a rigid stopper with a sealing component. The stopper <NUM> can have an outwardly projecting rim matching the geometry and dimensions of the energy source <NUM>. The stopper <NUM> can be of a sufficient length so that the stopper <NUM> is not ripped or twisted when being engaged by the plunger head <NUM>. The stopper <NUM> can be of a sufficient volume to house the detection system <NUM>, the energy source <NUM>, and the electronic system <NUM>. The detection system <NUM> can include one or more sensors 103a, 103b, 103c. The sensor type can be configured to match the reactant type. For example, if the reactants 111a, 111b, 111c are configured to generate an exothermic reaction, the sensors 103a, 103b, 103c are configured to include temperature sensors. If the reactants 111a, 111b, 111c are configured to generate a luminescent reaction, the sensors 103a, 103b, 103c are configured to include photo sensors (e.g., a photodiode or a light dependent resistor). If the reactants 111a, 111b, 111c are configured to generate both an exothermic reaction and a luminescent reaction, a portion of the sensors 103a, 103b, 103c can be configured to include temperature sensors and another portion of the sensors 103a, 103b, 103c can be configured to include photo sensors (e.g., a photodiode or a light dependent resistor).

In some implementations, the detection system <NUM> includes a single sensor 103a (as illustrated in <FIG>) or 103c (as illustrated in <FIG>) positioned at the end of the stopper <NUM> that is proximal to the bearing <NUM>. In some implementations, the detection system <NUM> includes two sensors 103a, 103b (as illustrated in <FIG>) one sensor 103A positioned at the end of the stopper <NUM> that is proximal to the bearing <NUM> and a second sensor 103B positioned at the end of the stopper <NUM> that is proximal to the medicament reservoir <NUM>. The sensor 103A positioned at the end of the stopper <NUM> that is proximal to the bearing <NUM> can be configured to detect a signal generated by the reactants 111a, 111b, 111c. The sensor 103B positioned at the end of the stopper <NUM> that is proximal to the medicament reservoir <NUM> can be configured to detect a parameter (e.g., temperature or luminance) associated with the medicament reservoir <NUM>. In some implementations, the detection system <NUM> is configured to compare the values of the signals detected by the two sensors 103A, 103B to determine a difference between the measurements. The difference in measurements can be compared to a threshold difference to filter out false positive trigger signals. The detection system <NUM> can be configured to generate an activation signal based on the measurements or the difference in measurements of the sensors 103a, 103b, 103c and transmit it to the energy source <NUM> to activate the electronic system <NUM>.

The energy source <NUM> can be a disposable or rechargeable battery, such as a <NUM>. 5V-<NUM> V silver-oxide or lithium battery (e.g., SR626, SR516, SR416) or a super capacitor. In some implementations, energy source <NUM> can include a plurality of batteries (e.g., two <NUM>. 5V batteries). The energy source <NUM> can be configured to supply energy to the electronic system <NUM> under particular conditions, such as after receiving the activation signal from the detection system <NUM>.

The electronic system <NUM> can include one or more electronic components configured to perform and/or assist with one or more functions of the injection device <NUM> (e.g., the ejection of the medicament) upon coupling with the energy source <NUM>. For example, the electronic system <NUM> can include one or more processors 128a, a sensor 128b (e.g., a sensor configured to detect a function of the injection device <NUM> or a volume of stored medicament in the medicament reservoir <NUM>), an antenna 128c, and a motor 128d. The motor 128d can be configured to advance in micro-step increments to dispense a particular amount of medicament. The sensor 128b can provide, to the one or more processors 128a, a signal (e.g., a voltage), which is proportional to the amount of medicament dispensed or amount of medicament remaining in the medicament reservoir <NUM>. The one or more processors 128a can include a microprocessor. In some implementations, the microprocessor is a microcontroller, e.g., a combination of microprocessor components and other components formed in a single package. The microprocessor can be an arithmetic and/or a logic unit array. The one or more processors 128a can process one or more signals received from the other electronic components of the electronic system <NUM> and transmit a signal to the antenna 128c. For example, the one or more processors 128a can be configured to execute operations on received data to generate output data, as described in detail with reference to <FIG>. The one or more processors 128a can be configured to determine the amount of the fluid within the injection device <NUM> based at least in part on an electrical signal and transmit the data including the amount of the fluid to the antenna 128c that can transmit it to the external device <NUM>.

The antenna 128c can be a bluetooth or near-field communication (NFC) antenna. The antenna 128c can be configured to transmit signals to the one or more processors 128a and to the external device <NUM>. The signals transmitted by the antenna 128c can include the amount of the fluid in the medicament reservoir <NUM>, values measured by the sensor 128b, and the identifier of the injection device <NUM>. The communication field <NUM> can be a bluetooth field or an NFC field, generated by the external device <NUM>. The external device <NUM> can include a bluetooth or a RF module, a transmitter, a receiver, and an external processor <NUM>. The external processor <NUM> can be configured to process the data transmitted by the injection device <NUM>. The external device <NUM> can be configured to display (e.g., through a graphical user interface) the data received from the injection device <NUM> and processed by the external processor <NUM>.

The needle assembly <NUM> includes a needle <NUM> that can be affixed to the housing <NUM>. The needle <NUM> can be covered by an inner needle cap <NUM> and an outer needle cap <NUM>, which in turn can be covered by a cap <NUM>. When needle <NUM> is stuck into a skin portion of a patient, and then injection button <NUM> is pushed, the medicament dose displayed in dosage window <NUM> can be ejected from injection device <NUM>. When the needle <NUM> of injection device <NUM> remains for a certain time in the skin portion after the injection button <NUM> is pushed, a high percentage (e.g., more than <NUM>%) of the dose is actually injected into the patient's body. Ejection of the medicament dose can generate a mechanical click sound, which can be different from the sounds produced when using dosage knob <NUM>.

The injection device <NUM> can be used for several injection processes until either medicament reservoir <NUM> is empty or the expiration date of injection device <NUM> (e.g., <NUM> days after the first use) is reached. Before using injection device <NUM> for the first time, it may be necessary to perform a priming operation to close a possible gap between the plunger head and the stopper, to couple the energy source <NUM> to the electric component and/or to remove air from medicament reservoir <NUM> and needle <NUM>. For instance, the priming operation can include selecting two units of medicament and pressing injection button <NUM> while holding injection device <NUM> with the needle <NUM> upwards. The impulse generated by selecting two units of medicament or pressing injection button <NUM> can trigger the electrical coupling of the energy source <NUM> with the electronic system <NUM>. For example, as illustrated in <FIG> and <FIG>, the impulse generated by selecting two units of medicament or pressing injection button <NUM> can be transmitted by the plunger rod <NUM>, leading to a shift of one of the reactants 111a from a first position to a second position (to generate a reaction), which activates the energy source <NUM> to power the electronic system <NUM>.

In some implementations, the electronic components of the electronic system <NUM> can be integrated within the housing <NUM> at a single location, or at multiple locations (e.g., within or attached to a plunger rod <NUM>, and a cavity in the plunger head <NUM>). In some implementations, as illustrated in <FIG> and <FIG>, one or more components of the electronic system <NUM> can be contained within the stopper <NUM>. In some implementations, one or more components of the electronic system <NUM> can be contained within the plunger head <NUM>.

In some implementations, the location of the energy source <NUM> and/or the location of one or more electronic components of the electronic system <NUM> can be selected independent from the coupling between the electronic system <NUM> and the energy source <NUM>. In some implementations, one or more characteristics of one or more electronic components of the electronic system <NUM> and/or one or more characteristics of the energy source <NUM> can be selected to couple and/or uncouple the electronic system <NUM> from the energy source <NUM>.

In some implementations, the housing <NUM> of the injection device <NUM> can be configured to provide thermal insulation to reduce or prevent transmission of the heat generated by the exothermal reaction to a user handling the injection device <NUM>. In some implementations, the housing <NUM> of the injection device <NUM> can be configured to be separated in multiple segments to enable a user to attach the energy source <NUM> to a component of the injection device <NUM> (e.g., plunger rod <NUM> or plunger head <NUM>) and/or attach at least a component of the electronic system <NUM> to a component of the injection device <NUM> (e.g., stopper <NUM> or plunger head <NUM>). The examples illustrated in <FIG> and <FIG>, include an energy source <NUM> attached to the plunger head <NUM>. Even though not illustrated, the energy source <NUM> can be attached to or placed in the plunger rod <NUM> and can be customized to fit into the geometry of the plunger rod <NUM>. Within the example of the energy source <NUM> attached to the plunger rod <NUM>, the connections to the electronic unit <NUM> are configured to cross the plunger head <NUM>.

In some implementations, the housing <NUM> of the injection device <NUM> can be configured to be separated or broken in multiple segments to provide a user access to the energy source <NUM>, to enable separate disposal of the energy source <NUM>. In some implementations, the medicament reservoir <NUM> to be assembled with the injection device <NUM> is manufactured with inserted stopper <NUM>, is filled with the fluid medicament and is closed with a crimp seal.

During the manufacturing and storage of the medicament reservoir <NUM> prior to assembly with the injection device <NUM>, the energy source <NUM> is not activated. By keeping the energy source <NUM> deactivated, no idle drainage of energy can occur during manufacturing and potential long storage of the medicament reservoir <NUM>. In the subsequent step of device assembly or device priming, the energy source <NUM> of the injection device <NUM> is activated to power the electronic system <NUM>. In some implementations, the energy source <NUM> can be connected at this step of device assembly to the electronic system <NUM> to enable controls of functionality of the injection device <NUM>. Connection to the energy source <NUM> as manufacturing step allows to wake-up the electronic system <NUM> and to generate feedback signals that confirm proper system functionality. After performing such in-process controls, the energy source <NUM> may be disconnected again, or the electronic system <NUM> may be set in sleep-mode through appropriate software features that reduce energy consumption until the priming step is performed to wake-up the electronic system <NUM>.

<FIG> is a flowchart illustrating an example process <NUM> that can be executed by devices and systems described with reference to <FIG> and <FIG>. The process <NUM> begins by performing a priming operation on an injection device having an energy source uncoupled from an electronic component (<NUM>). The priming operation can be initiated by a user of the injection device. An example of a priming operation performed with the injection device can include selecting a particular number (e.g., one or two) units of medicament and pressing an injection button while holding the injection device with the needle upwards. Another example of a priming operation performed with the injection device can include pressing a priming button of the injection device configured as an electric switch. Another example of a priming operation performed with the injection device can include attaching the energy source to a component of the injection device (e.g., plunger head) and/or attaching at least a component of the electronic system to a component of the injection device (e.g., plunger head or stopper) before pressing a priming button of the injection device. In some implementations, the priming operation can include generating a trigger signal. The trigger signal can include at least one of a mechanical signal and an electrical signal.

In response to the priming operation (e.g., receiving the trigger signal), an instantiation signal is generated by a reactant or by the interaction of multiple reactants in response to the trigger signal. The instantiation signal can include a thermic signal but includes a photo-signal. At least one reactant includes a fluid reactant and is separated from another reactant by a fluid impermeable membrane. The fluid impermeable membrane is configured to be pierced in reaction to the trigger signal to enable interaction between the reactants and to generate the instantiation signal. In some implementations, both reactants include solid reactants and are distanced from each other in an initial configuration. At least one of the reactants can be configured to be displaced in reaction to the trigger signal to enable coupling and interaction with the other reactant to generate the instantiation signal.

The instantiation signal is detected by a detection system including a single sensor or a pair of sensors (<NUM>). In some implementations, the detection of the instantiation signal can include determining a difference between the measurements of two sensors (one located proximal to the reactants and another one located distal from the reactants and proximal to the medicament reservoir).

The instantiation signal or the difference in measurements is compared to an activation threshold to filter out false positive trigger signals (<NUM>). In some implementations, the instantiation signal or the difference in measurements is compared to a safety threshold, which if exceeded generates an alert indicating a malfunction of the injection device. For example, if a temperature increase exceeded a safety threshold, the alert can direct the user to avoid contact with the injection device and discard the injection device after a predetermined period of time. If the comparison indicates that the measurement is below the activation threshold, process <NUM> returns to measurement of the instantiation signal.

If the comparison indicates that the measurement is above the activation threshold, an activation signal is generated, by the detection system, to activate the electronic system (<NUM>). For example, the energy source can be coupled with the electronic component by a mechanism (e.g., gear mechanism). In some implementations, the mechanism can include one or more components (e.g., a plunger rod <NUM>, a plunger head <NUM>, as described with reference to <FIG> and <FIG>) configured to shift the energy source from one position, in which the energy source is electrically decoupled from the electronic component to a second position, in which the energy source is electrically coupled with the electronic component. In some implementations, the mechanism can include a switch configured to be activated for electrically coupling the energy source to the electronic component.

In response to coupling the energy source with the electronic component, an electric signal is generated (<NUM>). The electric signal can be generated to assist and/or perform an operation of the injection device (e.g., control an administration of a medicament) and/or measure one or more parameters associated to the injection device (e.g., amount of a medicament, temperature, etc.). The electric signal can include generation of injection device data. The injection device data can include a unique identifier for the injection device, an amount of administered medicament, an amount of medicament within a cartridge and/or injection device, a medicament temperature, a timestamp of coupling the energy source to the electronic component, a location, and/or a situation specific data for the injection device.

<FIG> shows a schematic diagram of an example computing system <NUM>. The system <NUM> can be used for the operations described in association with the implementations described herein. For example, the system <NUM> may be included in any or all of the server components discussed herein. 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> are interconnected using a system bus <NUM>. The processor <NUM> is capable of processing instructions for execution within the system <NUM>. In one implementation, the processor <NUM> is a single-threaded processor. In another implementation, the processor <NUM> is a multi-threaded processor. The processor <NUM> is capable of processing instructions stored in the memory <NUM> or on the storage device <NUM> to display graphical information for a user interface on the input/output device <NUM>.

In another implementation, the input/output device <NUM> includes a display unit for displaying graphical user interfaces that enable a user to access data related to an item that is collected, stored and queried as described with reference to <FIG>.

The features described can be implemented in digital electronic circuitry, or in computer hardware, firmware, software, or in combinations of them. The apparatus can be implemented in a computer program product tangibly embodied in an information carrier, e.g., in a machine-readable storage device, for execution by a programmable processor; and method steps can be performed by a programmable processor executing a program of instructions to perform functions of the described implementations by operating on input data and generating output. The described features can be implemented advantageously in one or more computer programs that are executable on a programmable system including at least one programmable processor coupled to receive data and instructions from, and to transmit data and instructions to, a data storage system, at least one input device, and at least one output device. A computer program is a set of instructions that can be used, directly or indirectly, in a computer to perform a certain activity or bring about a certain result.

In addition, the logic flows depicted in the figures do not require the particular order shown, or sequential order, to achieve desirable results. In addition, other steps may be provided, or steps may be eliminated, from the described flows, and other components may be added to, or removed from, the described systems. Accordingly, other implementations are within the scope of the following claims.

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.

Alternatively, or in addition, the two chambers may be configured to allow mixing as the components are being dispensed into the human or animal body.

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.

Antibody fragments that are useful in the present disclosure include, for example, Fab fragments, F(ab')<NUM> fragments, scFv (single-chain Fv) fragments, linear antibodies, monospecific or multispecific antibody fragments such as bispecific, trispecific, and multispecific antibodies (e.g., diabodies, triabodies, tetrabodies), minibodies, chelating recombinant antibodies, tribodies or bibodies, intrabodies, nanobodies, small modular immunopharmaceuticals (SMIP), binding-domain immunoglobulin fusion proteins, camelized antibodies, and VHH containing antibodies.

A number of implementations of the present disclosure have been described.

Nevertheless, it will be understood that various modifications may be made.

Claim 1:
An injection device (<NUM>) comprising:
an energy source (<NUM>) configured to power an electronic component (<NUM>);
a priming component (<NUM>) configured to convert a mechanical impulse into a trigger;
a plunger (<NUM>, <NUM>) configured to transmit the trigger from the priming component (<NUM>) to a bearing (<NUM>);
the bearing (<NUM>) configured to provide firm mounting to an end of the plunger (<NUM>, <NUM>);
a reactant (111a, 111b, 111c) included in the bearing (<NUM>) and configured to initiate a thermochemical reaction that generates an instantiation signal transmittable through the bearing (<NUM>) in response to receiving the trigger, wherein:
the reactant (111a, 111b, 111c) is configured to shift from a first position to a second position to generate the instantiation signal; and
the instantiation signal comprises a photo-signal and the reactant (111a, 111b, 111c) comprises one or more reactants (111c) configured to generate a luminescent reaction in response to the trigger; and
the reactant (111a, 111b, 111c) comprises a first reactant (111a) and a second reactant (111b), at least one of the first reactant (111a) and the second reactant (111b) comprising a fluid reactant (111a), the first reactant (111a) and the second reactant (111b) being separated from each other by a fluid impermeable membrane (<NUM>) that is configured to be pierced in reaction to the trigger to enable interaction between the first reactant (111a) and the second reactant (111b); and
a sensor (103a, 103b, 103c) configured to detect and process the instantiation signal and generate an activation signal to activate the energy source (<NUM>), the activation signal comprising a wakeup signal to power the electronic component (<NUM>) of the injection device (<NUM>).