Saving power in an injection device

Abstract

A drug injection device (102) includes: a cartridge (104) configured to contain a quantity of drug; one or more processors (120) configured to operate at least in an active state and a dormant state, wherein the one or more processors (120) are configured to control the operation of the drug injection device (102) when the one or more processors (120) are in the active state; a component (115) disposed in the cartridge (104), the component (115) including at least two conductive surfaces (122) electrically connected to the one or more processors (120); and a drive mechanism (106) including conductive elements (124) spaced apart from the at least two conductive surfaces (122), wherein the one or more processors (120) are configured to enter the active state from the dormant state when the conductive elements (124) are in electrical contact with the at least two conductive surfaces (122).

Description

[0001] This disclosure relates to saving electricity, and more specifically to saving electricity in injection devices.

[0002] Many existing conditions require treatment with injectable medications. These injections can be administered using an injection device, either by a healthcare professional or by the patient themselves. For example, type 1 and type 2 diabetes can be managed by the patient themselves by injecting insulin doses (e.g., once or several times daily). Pre-filled disposable insulin pens or auto-injectors can be used as injection devices, for example. Alternatively, reusable pens or auto-injectors can be used. Reusable pens or auto-injectors allow empty cartridges to be replaced with new ones. Either pen or auto-injector may have a set of unidirectional needles that are replaced before each use.

[0003] This document describes systems and techniques for retaining power in injection devices. To ensure that the injection device can provide full functionality for patient use, it may be beneficial to retain as much power as possible when the device is not in use. For example, there may be situations where the injection device should be powered on during and after manufacturing, but before patient use (e.g., during electronic testing of the injection device). However, even when the power supply to the injection device is disconnected, there may be situations where the power in the power source is depleted (e.g., due to backup power loss). To prevent such power loss, the microcontroller can be configured to operate in a sleep state (e.g., a deep sleep state). In this sleep state, the microcontroller can significantly reduce and / or eliminate backup power loss from the battery. For example, the current consumed by the microcontroller when operating in sleep state may be significantly less than 10 nanoamperes. In some embodiments, by utilizing the sleep state of the microcontroller and / or by electrically isolating the microcontroller from the battery when not in use, the injection device can achieve a lifespan of approximately 4 to 5 years.

[0004] In some embodiments, the drug injection device includes a cartridge configured to contain a quantity of drug, and one or more processors configured to operate at least in an active state and a dormant state. The one or more processors are configured to control the operation of the drug injection device when the one or more processors are in the active state. The drug injection device also includes a component in the cartridge. The component includes at least two conductive surfaces electrically connected to the one or more processors. The drug injection device also includes a drive mechanism including conductive elements spaced apart from the at least two conductive surfaces. The one or more processors are configured to transition from the dormant state to the active state when the conductive elements make electrical contact with the at least two conductive surfaces. In some embodiments, the component is a stop, and the conductive element is disposed on the bottom surface of a plunger of the drive mechanism.

[0005] In some embodiments, the conductive element is configured to move toward the member and make electrical contact with the at least two conductive surfaces in response to engagement of the drive mechanism. The drive mechanism can engage during activation of the drug injection device. The electrical contact between the conductive element and the at least two conductive surfaces can activate a reset circuit in one or more processors.

[0006] In some embodiments, the drug injection device further includes one or more non-transitory computer-readable media storing instructions operable to cause the one or more processors to control the operation of the drug injection device. The one or more non-transitory computer-readable media may include ferroelectric random access memory (FRAM) configured to store data without requiring continuous power.

[0007] In some embodiments, the drug injection device includes a cartridge configured to contain a quantity of drug, and one or more processors configured to operate at least in an active state and a dormant state. The one or more processors are configured to control the operation of the drug injection device when the one or more processors are in the active state. The drug injection device also includes a sensor in communication with the one or more processors. The sensor is configured to cause the one or more processors to enter the active state from the dormant state in response to a stimulus. In some embodiments, the sensor is a magnetoresistive sensor, configured to cause the one or more processors to enter the active state when the magnetoresistive sensor stops sensing a magnetic field satisfying a threshold magnitude. The drug injection device may be configured to reside in a package including a magnet providing a magnetic field satisfying the threshold magnitude, and the one or more processors may enter the active state when the drug injection device is removed from the package. In some embodiments, the drug injection device also includes a cap configured to attach to a housing of the drug injection device. The cap may include a magnet providing a magnetic field satisfying the threshold magnitude, and the one or more processors may enter the active state when the cap is removed from the housing.

[0008] In some embodiments, the sensor includes one or both of a photodiode or a photoresistor, which is configured to cause the one or more processors to enter the enabled state when the photodiode or photoresistor senses light of a threshold intensity. In some embodiments, the sensor is a thermistor, configured to cause the one or more processors to enter the enabled state when the thermistor senses temperature of a threshold temperature. In some embodiments, the sensor is an X-ray diode, configured to cause the one or more processors to enter the enabled state when the X-ray diode senses X-ray radiation.

[0009] In some implementations, the sensor is a Wi-Fi sensor configured to cause the one or more processors to enter the enabled state when the Wi-Fi sensor detects Wi-Fi radiation. The drug injection device may be configured to reside in packaging that shields against Wi-Fi radiation, and the one or more processors may enter the enabled state when the drug injection device is removed from the packaging.

[0010] In some embodiments, the sensor is a near-field communication (NFC) sensor, configured to cause one or more processors to enter the enabled state when the NFC sensor receives an NFC signal from a computing device. The computing device may be a mobile phone. In some embodiments, the sensor includes a resonant circuit configured to cause one or more processors to enter the enabled state when the resonant circuit senses a magnetic field having a resonant frequency.

[0011] In some embodiments, a system includes a drug injection device comprising a cartridge configured to contain a quantity of drug, and one or more processors configured to operate at least in an active state and a dormant state. The one or more processors are configured to control operation of the drug injection device when the one or more processors are in the active state. The drug injection device also includes a Wi-Fi sensor in communication with the one or more processors. The Wi-Fi sensor is configured to cause the one or more processors to enter the active state from the dormant state when the Wi-Fi sensor senses Wi-Fi radiation. The system also includes packaging configured to contain the drug injection device after manufacture and before first use by a patient. The packaging includes material that shields against Wi-Fi radiation to prevent the one or more processors from entering the active state until the drug injection device is removed from the packaging.

[0012] In some embodiments, the drug injection device includes a cartridge configured to contain a quantity of drug, and one or more processors configured to operate at least in an active state and a dormant state. The one or more processors are configured to control the operation of the drug injection device when the one or more processors are in the active state. The drug injection device also includes circuitry electrically connected to the one or more processors. The circuitry includes one or more transistors and one or more fuses. The one or more transistors are configured to cause the one or more processors to enter the active state from the dormant state in response to the blowing of the one or more fuses. The one or more fuses may be blown in response to the application of a laser, which may be applied by electronics provided with the drug injection device. The heat provided by the laser may cause the one or more fuses to blow.

[0013] In some embodiments, the drug injection device includes a cartridge configured to contain a quantity of drug, and one or more processors configured to control the operation of the drug injection device. The drug injection device also includes circuitry electrically connected to the one or more processors. The circuitry includes a battery, one or more transistors, and one or more fuses. When the one or more fuses are in a non-blow state, the one or more transistors electrically isolate the one or more processors from the battery, and when the one or more fuses are blown, the one or more transistors electrically connect the one or more processors to the battery. The one or more fuses may be blown in response to the application of a laser, which may be applied by electronics provided with the drug injection device. The heat provided by the laser may cause the one or more fuses to blow.

[0014] In some embodiments, the drug injection device includes a cartridge configured to contain a quantity of drug, one or more processors configured to control the operation of the drug injection device, and a cover configured to be attached to a housing of the drug injection device. The cover includes a first inductor coil configured to be electrically connected to a power source. The drug injection device also includes circuitry electrically connected to the one or more processors. The circuitry includes a second inductor coil and a supercapacitor. The second inductor coil is configured to receive an electromagnetic field from the first inductor coil and generate power stored by the supercapacitor and supplied to the one or more processors.

[0015] Figures 1 to 9 Various examples of injection devices are shown.

[0016] Figure 10 This is a block diagram of an example computer system.

[0017] The same reference numerals in each figure represent the same elements.

[0018] The subjects described herein will be described primarily with reference to drug delivery devices such as injection devices (e.g., insulin injection devices). However, the systems and techniques described herein are not limited to such applications and can be deployed as well as injection devices that dispense other medications or other types of medical devices (e.g., pumps).

[0019] The term "drug delivery device" should encompass any type of device or system configured to dispense a dose of drug into a human or animal body. Drug doses typically range from about 1 μl to about 10 ml. Without limitation, drug delivery devices may include syringes, needle safety systems, pen syringes, autoinjectors, large-volume devices (LVDs), pumps, infusion systems, or other devices configured for subcutaneous, intramuscular, or intravascular delivery of drugs. Such devices typically include a needle, which in some embodiments may be a small-gauge needle (e.g., larger than about 24 gauges, and including 27, 29, or 31 gauges). Devices described herein may also be tailored to operate within required parameters, in combination with specific drugs. For example, with low or minimal levels of discomfort over a period of time (e.g., from about 3 seconds to about 20 seconds for syringes, and from about 5 minutes to about 60 minutes for LVDs), or under certain conditions related to human factors, shelf life, expiration date, biocompatibility, environmental factors, etc. These changes can be caused by various factors, such as the viscosity range of the drug, which is from about 3 cP to about 50 cP.

[0020] The drug or pharmaceutical preparation may be contained in a primary encapsulation or "drug container" adapted for use with a drug delivery device. The drug container may be, for example, a cartridge, syringe, reservoir, or other vessel configured to provide a suitable chamber for storing (e.g., short-term or long-term storage) one or more active pharmaceutical compounds. For example, in some cases, the chamber may be designed to store the drug for at least one day (e.g., from 1 day to at least 30 days). In some cases, the chamber may be designed to store the drug for about one month to about two years. Storage may occur at room temperature (e.g., about 20°C) or at refrigerated temperatures. In some cases, the drug container may be or may include a dual-chamber cartridge configured to separately store two or more components of a pharmaceutical preparation (e.g., drug and diluent, or two different types of drugs), one component in each chamber. In such cases, the two chambers of the dual-chamber cartridge may be configured to allow mixing between the two or more components of the drug or pharmaceutical preparation before and / or during administration to a human or animal. For example, the two chambers can be configured such that they are in fluid communication with each other (e.g., via a conduit between the two chambers) and allow the user to mix the two components as needed before dispensing. Alternatively or additionally, the two chambers can be configured to allow mixing during dispensing of the components into a human or animal body.

[0021] Figure 1 An example of an injection device 102 is shown. The injection device 102 may be a pre-filled, disposable, or reusable injection pen. The injection device 102 includes a housing 103 and a cartridge 104. The cartridge 104 is configured to contain a quantity of medication (e.g., in fluid form). In some embodiments, the cartridge 104 is a medication container, such as an insulin container. At least a portion of the cartridge 104 resides within the housing 103 and / or cartridge housing 105 of the injection device 102, so some or all of the cartridge 104 may not be readily visible.

[0022] The injection device 102 includes a drive mechanism 106 configured to dispense medication from a cartridge 104. The drive mechanism 106 includes a plunger 107 movably disposed within the cartridge 104 and a piston 108 (e.g., a plunger arm). A member 115 (e.g., a stop) is also disposed adjacent to the plunger 107 within the cartridge 104. In an initial state (e.g., before injection), the member 115 is spaced from the plunger 107 by a relatively short distance (e.g., less than 1 mm). The piston 108 is configured to move the plunger 107 from the proximal end of the cartridge 104 toward the member 115. Specifically, when the drive mechanism 106 is engaged, the piston 108 drives the plunger 107 toward the member 115, causing the plunger 107 and the member 115 to come into physical contact with each other. The piston 108 then continues traversing the cartridge 104, thereby causing the plunger 107 and member 115 to discharge and dispense fluid through a needle 109 located at the distal end of the cartridge 104. The needle 109 includes an orifice through which the fluid is dispensed. In some embodiments, the needle 109 and / or the cartridge 104 are threaded, allowing the needle 109 to be screwed onto the cartridge 104 for attachment. The needle 109 may be protected by an inner needle cap 116 and an outer needle cap 117, which may in turn be covered by a cap 118.

[0023] The dose of medication to be dispensed from the injection device 102 can be selected by rotating the dosing knob 112 (e.g., an insulin dose), and the selected dose can be displayed through the dosing window 113. In some examples, the dosing window 113 is a display, such as an electronic display. In some examples, the selected dose can be displayed in multiples of International Units (IU), one IU being the bioequivalence (e.g., 1 / 22 mg) of approximately 45.5 micrograms of medication (such as pure crystalline insulin). An example of the selected dose displayed in the dosing window 113 could be, for example, 30 IU, such as... Figure 1 As shown in the diagram. In some examples, the selected dose may be displayed in different ways (e.g., via a non-electronic display). In some examples, the dose window 113 relates to a section of the injection device 102 through or on which the selected dose is visible.

[0024] Turning the dosage knob 112 produces a mechanical click to provide acoustic feedback to the user. The numbers displayed in the dosage window 113 are printed on a sleeve contained within the housing 103 and interact mechanically with the drive mechanism 106. When the needle 109 is inserted into the patient's skin and the injection button 111 is subsequently pressed, medication is expelled from the injection device 102. This expulsion of the dose also produces a mechanical click. This mechanical click may differ from the sound produced when the dosage knob 112 is turned. The injection device 102 can be used for several injection procedures until the cartridge 104 is emptied or the injection device 102 reaches its expiration date (e.g., 28 days after first use).

[0025] In some cases, before using the injection device 102 for the first time, it may be necessary to perform a "primeshot" to remove air from the cartridge 104 and needle 109, for example, by selecting two units of the drug and pressing the injection button 111 while keeping the injection device 102 and needle 109 oriented upwards.

[0026] Injection device 102 includes a microcontroller 120, which may include one or more processors and one or more memory devices. In some embodiments, the one or more memory devices include one or more non-transitory computer-readable media storing instructions operable to cause one or more processors to perform operations (e.g., control the operation of injection device 102). In some embodiments, the one or more non-transitory computer-readable media may include ferroelectric random access memory (FRAM) configured to store data without continuous power supply. When not in use, such FRAM can be used to further reduce power consumption in injection device 102. Operations that can be performed by one or more processors may include determining the dosage of medication administered by injection device 102 (e.g., dose), recording and / or transmitting information related to the administered dose, controlling the electronic display of injection device 102, etc. Figure 1 As shown, in some embodiments, the microcontroller 120 is incorporated into component 115. The injection device may also include a power source, such as a battery, for powering the microcontroller 120, for example a coin cell battery. The battery may also be incorporated into component 115 in proximity to the microcontroller 120.

[0027] To ensure that the injection device 102 can provide full functionality for patient use, it may be beneficial to retain as much power as possible when the injection device 102 is not in use. For example, there may be situations where the injection device 102 should be powered on after it has been manufactured but before patient use. However, even when the power supply to the injection device 102 is disconnected, there may be situations where the power in the power supply is depleted (e.g., due to "vapire draw" or reserve power loss). To prevent such power loss, the microcontroller 120 can be configured to operate in a dormant state (e.g., a deep dormant state). In this dormant state, the microcontroller 120 can significantly reduce and / or eliminate reserve power loss from the battery. For example, the current consumed by the microcontroller 120 when operating in dormant state may be significantly less than 10 nanoamperes. In some embodiments, by utilizing the dormant state of the microcontroller 120 and / or by electrically isolating the microcontroller 120 from the battery when not in use, the injection device 102 can achieve a lifespan of approximately 4 to 5 years.

[0028] Microcontroller 120 can enter a sleep state in response to a command. The command may include a simple signal received by microcontroller 120 indicating that a sleep state is about to be initiated. In some embodiments, the command may include applying an input voltage or current to one or more pins of microcontroller 120. When operating in a sleep state, the functionality of microcontroller 120 may be limited. For example, microcontroller 120 may not be able to control one or more operations of injection device 102 during sleep. In some examples, microcontroller 120 may be limited in the types of commands it can receive during sleep. In some examples, microcontroller 120 may need to be reset to exit the sleep state. The various embodiments described herein relate to systems and techniques for resetting microcontroller 120, thereby allowing microcontroller 120 to exit a sleep state and enter an enabled state. In the enabled state, microcontroller 120 can resume full functionality.

[0029] In some implementations, microcontroller 120 can be configured to disable reset for a specific time period. For example, microcontroller 120 can be configured to disable reset (e.g., an additional / subsequent reset) after microcontroller 120 has been initially reset to exit a sleep state. Such functionality can be incorporated into microcontroller 120 by implementing a time delay to prevent microcontroller 120 from resetting after entering an enabled state. In some implementations, an integrated circuit (e.g., a second microcontroller) communicating with microcontroller 120 can provide this delay functionality.

[0030] In some embodiments, after the injection device 102 is manufactured, the microcontroller 120 is instructed to enter a sleep state. Thereafter, the microcontroller 120 may remain in a sleep state until the patient first uses the injection device 102.

[0031] Still referencing Figure 1 The patient can activate the injection device 102 before its first use (e.g., by performing a "start injection"). Starting the injection resets the microcontroller 120, allowing it to exit dormancy and resume full functionality. As described above, starting the injection removes air from the cartridge 104 and needle 109. The patient can select a small dose (e.g., two units of medication) using the dosage knob 112 and press the injection button 111 while keeping the injection device 102 oriented with the needle 109 facing upwards. Starting the injection causes the piston 108 to drive the plunger 107 toward the member 115, thereby bringing the plunger 107 and member 115 into physical contact with each other.

[0032] The top surface of component 115 includes at least two conductive surfaces 122 electrically connected to microcontroller 120. Specifically, the conductive surfaces 122 may be connected to pins of microcontroller 120 associated with reset operations of microcontroller 120 (e.g., pins connected to a reset circuit). When component 115 and plunger 107 physically contact due to initiation of injection, the conductive surfaces 122 contact conductive elements 124 incorporated in drive mechanism 106, specifically disposed on the bottom surface of plunger 107. Before initiation of injection, plunger 107 and conductive elements 124 may be spaced apart from conductive surfaces 122 by a relatively short distance (e.g., less than 1 mm). Electrical contact may electrically connect pins of microcontroller 120, thereby activating a reset circuit in microcontroller 120 (e.g., triggering a reset switch), which initiates a reset of microcontroller 120. After reset, microcontroller 120 may enter an enabled state, in which microcontroller 120 may restore full functionality for subsequent patient use.

[0033] although Figure 1 The injection device 102 shown is described as including a component 115 disposed within a cartridge 104 and including a conductive surface 122 configured to contact a conductive element 124 to reset a microcontroller 120. However, alternatively or additionally, any of a variety of other types of components including various types of conductive surfaces may be used. Examples of other types of components that may be used include annular components, disc-shaped components, pin-shaped components, etc. In some embodiments, the conductive surface may be annular, disc-shaped, and / or may be a pin extending toward the conductive element. Similarly, any of a variety of other types of conductive elements may be used alternatively or additionally for contact with the conductive surface of the component. Examples of other types of conductive elements that may be used include disc-shaped conductive elements having a diameter substantially similar to the diameter of the cartridge 104 and / or plunger 107, rod-shaped conductive elements spanning the diameter of the plunger 107, annular conductive elements, conductive elements made of conductive mesh material, etc.

[0034] In some implementations, one or more other techniques may be used to reset the microcontroller 120 and put it into sleep mode. Such techniques may be related to… Figure 1 The technology described is an alternative or supplement to it.

[0035] In some implementations, the microcontroller 120 may be configured to receive stimuli from one or more sensors, which cause the microcontroller 120 to reset and enter an enabled state from a dormant state. Figure 2 Another example of the injection device 202 is shown. The injection device 202 is substantially similar to [the previous one] except for the differences noted herein. Figure 1 The injection device 102. Specifically, one or more of the components incorporated in member 115 are related to the injection device 102. Figure 1 The components described are different.

[0036] The injection device 202 includes a magnetoresistive sensor 204 (e.g., a giant magnetoresistive sensor (GMR sensor)) electrically connected to the microcontroller 120. Specifically, the magnetoresistive sensor 204 may be connected to a pin of the microcontroller 120 associated with a reset operation (e.g., a pin connected to a reset circuit). The magnetoresistive sensor 204 is configured to provide an electrical signal based on a sensed external magnetic field. For example, in the presence of a magnetic field of a threshold magnitude, the magnetoresistive sensor 204 is configured not to provide a signal to the microcontroller 120, thereby allowing the microcontroller 120 to remain in a sleep state. When the magnetoresistive sensor 204 is no longer in the presence of a magnetic field of a threshold magnitude, the magnetoresistive sensor 204 is configured to provide a signal to the microcontroller 120, which causes the microcontroller 120 to reset and enter an enabled state. That is, when the magnetoresistive sensor 204 stops sensing a magnetic field that meets a threshold value, the magnetoresistive sensor 204 can provide a signal to the microcontroller 120, which electrically connects a specific pin of the microcontroller 120, thereby activating a reset circuit in the microcontroller 120. The reset circuit initiates a reset and allows the microcontroller 120 to enter an enabled state, in which the microcontroller 120 can restore all functions for subsequent use by the patient.

[0037] In some embodiments, the injection device 202 may be packaged in a package 210 after manufacture. The package 210 may include a contour having a shape substantially similar to that of the injection device 202, which allows the injection device 202 to be assembled within the package 210 in a predetermined orientation. The package 210 may also include a magnet 212 (e.g., a permanent magnet) positioned at or near the location of the magnetoresistive sensor 204 when the injection device 202 is located within the package 210. In some embodiments, the magnet 212 may be embedded below the surface of the package (e.g., embedded in the cardboard foam of the package).

[0038] Magnet 212 is configured to provide a magnetic field to magnetoresistive sensor 204, the magnitude of which satisfies a threshold value when injection device 202 is located in package 210. Therefore, after fabrication, injection device 202 can be placed in a dormant state and inserted into package 210. When injection device 202 remains in package 210, magnet 212 provides a magnetic field with a threshold value and prevents magnetoresistive sensor 204 from providing a reset signal to microcontroller 120.

[0039] Before the patient uses it for the first time, the patient can remove the injection device 202 from the packaging 210. When the injection device 202 is removed from the vicinity of the magnet 212, the magnetic field sensed by the magnetoresistive sensor 204 no longer meets the threshold value, and in response, the magnetoresistive sensor 204 provides a signal to the microcontroller 120, which causes the microcontroller 120 to reset and enter the enabled state.

[0040] In some embodiments, magnet 212 may be incorporated into one or more of the inner needle cap 116, outer needle cap 117, and / or cap 118 of the injection device. In such a configuration, magnet 212 is configured to provide a magnetic field to magnetoresistive sensor 204, the magnitude of which satisfies a threshold size when caps 116, 117, and / or 118 are attached to injection device 202. Before the patient's first use, the patient can remove caps 116, 117, and / or 118 from injection device 202, thereby causing the magnetic field sensed by magnetoresistive sensor 204 to no longer satisfy the threshold size, and in response, causing microcontroller 120 to reset and enter an enabled state.

[0041] Figure 3 Another example of the injection device 302 is shown. As... Figure 2 The injection device 202, except for one or more of the components incorporated in the member 115, is related to... Figure 1 Apart from the differences in the described components, the injection device 302 is similar to... Figure 1 The injection device 102 is basically similar.

[0042] The injection device 302 includes an optical sensor 304 electrically connected to the microcontroller 120. In some embodiments, the optical sensor 304 may be a photodiode (e.g., a reverse-driven light-emitting diode (LED)) and / or a photoresistor.

[0043] Optical sensor 304 can be connected to a pin of microcontroller 120 associated with a reset operation (e.g., a pin connected to a reset circuit). Optical sensor 304 is configured to provide an electrical signal based on the intensity of sensed light. For example, if light meeting a threshold intensity is detected, optical sensor 304 is configured to provide a signal to microcontroller 120 that resets microcontroller 120 and puts it into an enabled state. Specifically, optical sensor 304 can provide a signal to microcontroller 120 that electrically connects a specific pin of microcontroller 120, thereby activating a reset circuit in microcontroller 120 that initiates a reset and allows microcontroller 120 to enter an enabled state in which it can restore full functionality for subsequent patient use.

[0044] In some implementations, as described above, the microcontroller 120 can be configured to disable further resets for a specific period of time after the microcontroller 120 is reset, exits a sleep state, and enters an enabled state. Such functionality prevents the microcontroller 120 from remaining continuously in a reset state (e.g., if ambient light sensed meets a threshold intensity).

[0045] In some embodiments, cartridge 104 and component 115 are made of a transparent material that allows light to pass through, thereby allowing optical sensor 304 to detect the light. In some embodiments, cartridge 104 and component 115 may include a transparent window located near optical sensor 304.

[0046] In some embodiments, the injection device 302 may be packaged in a package after manufacturing, which limits and / or prevents light from being provided to the optical sensor 304. In some embodiments, one or more adhesives and / or covers may be applied to the outer surface of the cartridge 104, which limits and / or eliminates light from being provided to the optical sensor 304. In this way, the microcontroller 120 may remain in a dormant state when it resides in the package and / or in the presence of adhesives and / or covers. In some embodiments, the threshold intensity of light required for the optical sensor 304 to provide a reset signal to the microcontroller 120 is such that ambient light does not trigger a reset. For example, before a patient's first use, the patient may remove the injection device 302 from the package and / or remove the adhesives and / or covers, which in itself does not trigger a reset of the microcontroller 120. The patient may be guided to hold the injection device 302 under a light source (e.g., a lamp) such that light of sufficient intensity is provided to the optical sensor 304. In some embodiments, the patient may be guided to apply a laser (e.g., from a laser pointer) to the optical sensor 304 to achieve the threshold intensity of light. When light with an intensity that meets a threshold is sensed, the optical sensor 302 provides a signal to the microcontroller 120, which causes the microcontroller 120 to reset and enter an enabled state.

[0047] In some embodiments, as an alternative to or supplement to the injection device 302, which includes an optical sensor 304 configured to sense light, the injection device 302 may include an X-ray diode configured to enable the microcontroller 120 when the X-ray diode senses X-ray radiation. Except that the X-ray diode is configured to provide a reset signal when X-ray radiation (rather than light meeting a threshold intensity) is sensed, the configuration of the X-ray diode relative to the microcontroller 120 can be substantially similar to the configuration described above with respect to the optical sensor 304. In some embodiments, a user may be guided to apply an X-ray pulse to the X-ray diode using an X-ray device. In some embodiments, the X-ray pulse may be applied by a medical professional (e.g., before the patient receives the injection device 302). For example, an X-ray pulse may be applied after manufacturing but before patient use to reset the microcontroller 120 for testing the injection device 302, etc. In one or more of the embodiments described herein, one or more resetting of the injection device may occur at different stages of testing and / or use (e.g., after manufacture, during testing / calibration, before first use by a patient, during first use by a patient, during subsequent use by a patient, etc.).

[0048] Figure 4 Another example of the injection device 402 is shown. As... Figure 2 and Figure 3 The injection devices 202 and 302, except for one or more of the components incorporated in component 115, are related to... Figure 1 Apart from the differences in the described components, the injection device 402 is similar to... Figure 1 The injection device 102 is basically similar.

[0049] The injection device 402 includes a temperature-dependent resistor, such as a thermistor 404, electrically connected to the microcontroller 120. Thermistor 404 may be connected to a pin of the microcontroller 120 associated with a reset operation (e.g., a pin connected to a reset circuit). Thermistor 404 is configured to provide an electrical signal based on a sensed temperature. For example, if thermistor 404 senses a temperature that meets a threshold, it is configured to provide a signal to the microcontroller 120 that resets the microcontroller 120 and puts it into an enabled state. Specifically, thermistor 404 may provide a signal to the microcontroller 120 that electrically connects a specific pin of the microcontroller 120, thereby activating a reset circuit in the microcontroller 120 that initiates a reset and allows the microcontroller 120 to enter an enabled state in which it can restore full functionality for subsequent patient use.

[0050] In some embodiments, the injection device 402 can be maintained within a specific temperature range after it has been manufactured, during transport, and before it is received by a patient. In some embodiments, the specific temperature range may be from approximately 2°C to approximately 8°C. In some embodiments, the specific temperature range may be from approximately -4°C to approximately 4°C. A suitable temperature range can be selected based on the specific medication to ensure appropriate conditions. Maintaining the temperature range of the injection device 402 during transport may result in a threshold temperature not being met, therefore the thermistor 404 does not provide a reset signal to the microcontroller 120. Once the patient receives the injection device 402, it can be subjected to a temperature that meets the threshold temperature (e.g., room temperature). The thermistor 404 then provides a signal to the microcontroller 120, which resets the microcontroller 120 and puts it into an enabled state.

[0051] In some implementations, the threshold temperature can be relatively high (e.g., above room temperature). For example, the threshold temperature may be such that reaching the threshold temperature may require the patient to apply heat to the thermistor 404. In some examples, the patient may be guided to apply heat to the injection device 402, particularly to the portion of the injection device 404 including the thermistor 404. In some implementations, the patient may be guided to apply heat to the thermistor 404 using a heat gun and / or laser to reach the threshold temperature, thereby causing the thermistor 404 to provide a reset signal to the microcontroller 120.

[0052] Figure 5 Another example of the injection device 502 is shown. As... Figures 2 to 4 The injection devices 202, 302, and 402, except for one or more of the components incorporated in component 115, are related to... Figure 1 Apart from the differences in the described components, the injection device 502 is similar to... Figure 1 The injection device 102 is basically similar.

[0053] The injection device 502 includes a Wi-Fi sensor 504 electrically connected to the microcontroller 120. In some embodiments, the Wi-Fi sensor 504 is a ceramic antenna. The Wi-Fi sensor 504 may be connected to a pin of the microcontroller 120 associated with a reset operation (e.g., a pin connected to a reset circuit). The Wi-Fi sensor 504 is configured to provide an electrical signal based on sensed Wi-Fi radiation. For example, if the Wi-Fi sensor 504 detects Wi-Fi radiation, it is configured to provide a signal to the microcontroller 120 that causes the microcontroller 120 to reset and enter an enabled state. Specifically, the Wi-Fi sensor 504 may provide a signal to the microcontroller 120 that electrically connects a specific pin of the microcontroller 120, thereby activating a reset circuit in the microcontroller 120 that initiates a reset and allows the microcontroller 120 to enter an enabled state in which the microcontroller 120 can restore full functionality for subsequent patient use.

[0054] In some embodiments, the Wi-Fi radiation detected by Wi-Fi sensor 504 may originate from ambient Wi-Fi signals (e.g., from wireless routers, mobile electronic devices, etc.). Such Wi-Fi signals are typically prevalent in most homes and businesses. In some embodiments, the injection device 502 may be provided as part of a system including the injection device 502 and a package 510 configured to contain the injection device 502 and shield it from Wi-Fi radiation from the Wi-Fi sensor 504. The package 510 may include an electromagnetic shielding layer. The injection device 502 may be packaged after manufacture and may remain in the package 510 during transport and before being received by a patient. Once the patient receives the injection device 502, the patient can remove the injection device 502 from the Wi-Fi shielded package 510, thereby exposing the Wi-Fi sensor 504 to ambient Wi-Fi radiation. Such Wi-Fi radiation causes the Wi-Fi sensor 504 to provide a reset signal to the microcontroller 120. In some embodiments, the package 510 is made of a material such as aluminum, but other suitable materials may or may be used.

[0055] In some implementations, the Wi-Fi sensor 504 can provide a reset signal when the sensed Wi-Fi radiation meets a threshold size (e.g., threshold signal strength). In some implementations, the patient can be guided to position the injection device 502 near a Wi-Fi signal source (e.g., a wireless router, mobile electronic device, etc.) to reach the threshold size.

[0056] Figure 6 Another example of the injection device 602 is shown. As... Figures 2 to 5The injection devices 202, 302, 402, and 502, except for one or more of the components incorporated in component 115, are related to... Figure 1 Apart from the differences in the described components, the injection device 602 is similar to... Figure 1 The injection device 102 is basically similar.

[0057] The injection device 602 includes an antenna and a sensor configured to receive electromagnetic signals (e.g., radio signals), such as a radio frequency identification (RFID) sensor. Figure 6 In the example shown, the injection device 602 includes a near-field communication (NFC) sensor 604 (e.g., an NFC reader and / or an NFC antenna) electrically connected to the microcontroller 120. The NFC sensor 604 may be connected to a pin of the microcontroller 120 associated with a reset operation (e.g., a pin connected to a reset circuit). The NFC sensor 604 is configured to receive NFC signals from an NFC element 612 of a computing device (e.g., an NFC tag, NFC sensor / reader / antenna, etc.). In some embodiments, the computing device may be a mobile computing device such as a mobile phone 610 (e.g., a smartphone), but other computing devices may also be used, including but not limited to tablet computers, laptop computers, wearable electronics, etc. Before the patient's first use, the patient may be guided to position the injection device 602 near the mobile phone 610. When the injection device 602 is within a sufficient distance of the mobile phone 610, the NFC sensor 604 receives a signal from the NFC element 612. The NFC sensor 604 is then configured to provide a signal to the microcontroller 120, which causes the microcontroller 120 to reset and enter an enabled state. Specifically, the NFC sensor 604 can provide a signal to the microcontroller 120, which electrically connects a specific pin of the microcontroller 120, thereby activating a reset circuit in the microcontroller 120. The reset circuit initiates a reset and allows the microcontroller 120 to enter an enabled state, in which the microcontroller 120 can restore all its functions for subsequent use by the patient.

[0058] In some implementations, as an alternative to or supplement to the injection device 602, which includes the NFC sensor 604, the injection device 602 may include one or more other sensors configured to communicate using a short-range wireless communication protocol. For example, the injection device 602 may include a sensor comprising a Bluetooth antenna configured to detect Bluetooth signals. Similarly, the mobile phone 610 may include a Bluetooth element (e.g., including a Bluetooth antenna) configured to provide Bluetooth signals to the Bluetooth antenna. Before the patient's first use, the patient may be guided to position the injection device 602 near the mobile phone 610. When the injection device 602 is within a sufficient distance of the mobile phone 610, the Bluetooth antenna receives a signal from the Bluetooth element, which in turn provides a signal to the microcontroller 120, causing the microcontroller 120 to reset and enter an enabled state.

[0059] Figure 7 Another example of the injection device 702 is shown. As... Figures 2 to 6 The injection devices 202, 302, 402, 502, and 602, except for one or more of the components incorporated in component 115, are related to... Figure 1 Apart from the differences in the described components, the injection device 702 is similar to... Figure 1 The injection device 102 is basically similar.

[0060] The injection device 702 includes a resonant circuit 704 electrically connected to a microcontroller 120. The resonant circuit 704 may be connected to a pin of the microcontroller 120 associated with a reset operation (e.g., a pin connected to a reset circuit). The resonant circuit 704 may include an inductor, a capacitor, and a rectifier diode arranged in specific values ​​such that the resonant circuit 704 is tuned to a specific frequency (e.g., a resonant frequency). The resonant circuit 704 is configured to sense a magnetic field having a specific frequency. When the resonant circuit 704 senses a magnetic field having a specific frequency, a voltage is generated in the resonant circuit 704, which causes the resonant circuit 704 to provide a signal to the microcontroller 120, which causes the microcontroller 120 to reset and enter an enabled state. Specifically, the resonant circuit 704 may provide a signal to the microcontroller 120 that electrically connects a specific pin of the microcontroller 120, thereby activating a reset circuit in the microcontroller 120 that initiates a reset and allows the microcontroller 120 to enter an enabled state, in which the microcontroller 120 can restore full functionality for subsequent patient use. In some implementations, the resonant frequency can be in the range of approximately 50 kHz to 2 MHz (e.g., 100 kHz, 1 MHz, etc.). In some implementations, the resonant frequency can be a frequency that is not typically generated by commonly available devices. In this way, accidental resets to the microcontroller can be minimized.

[0061] In some embodiments, a magnetic field with a specific (e.g., resonant) frequency can be provided by a separate electronic device. Such an electronic device can be provided to the patient along with the injection device 702. In some embodiments, such an electronic device capable of generating a magnetic field of a specific frequency can improve safety. Specifically, because a magnetic field of a specific frequency is required to reset the microcontroller 120, only those with access to the device capable of generating such a magnetic field can reset the microcontroller 120 and enable it.

[0062] Figure 8a and Figure 8b Other examples of injection devices 802 and 803 are shown. (Similar to...) Figures 2 to 7 The injection devices 202, 302, 402, 502, 602, and 702, except for one or more of the components incorporated in component 115, are related to... Figure 1 Apart from the differences in the described components, injection devices 802 and 803 are... Figure 1 The injection device 102 is basically similar.

[0063] refer to Figure 8a The injection device 802 includes circuitry 804 electrically connected to microcontroller 120. Circuitry 804 may be connected to a pin of microcontroller 120 associated with a reset operation (e.g., a pin connected to a reset circuit). Circuitry 804 may include transistor 806, fuse 808, and a power source such as battery 810. In the illustrated example, circuitry 804 is arranged such that transistor 806 is a self-conducting N-MOS field-effect transistor (FET) (e.g., a normally open N-MOS FET), but other transistors, such as P-MOS FETs, may be used alternatively. In the initial state of circuitry 804 (e.g., when fuse 808 is not blown), no reset signal is provided to microcontroller 120. When fuse 808 is blown, transistor 806 switches to apply a reset signal (e.g., in the form of an input voltage or current) to microcontroller 120, thereby resetting microcontroller 120, exiting the sleep state, and entering the enabled state. Specifically, when fuse 808 blows, transistor 806 can provide a signal to microcontroller 120, which electrically connects a specific pin of microcontroller 120, thereby activating a reset circuit in microcontroller 120. The reset circuit initiates a reset and allows microcontroller 120 to enter an enabled state, in which microcontroller 120 can restore all functions for subsequent use by the patient.

[0064] In some implementations, circuitry 804 may be arranged such that, in an initial state (e.g., when fuse 808 is not blown), transistor 806 electrically isolates microcontroller 120 from battery 810. When fuse 808 blows, transistor 806 switches to electrically connect microcontroller 120 to battery 810. In this way, microcontroller 120 can remain de-powered (e.g., as opposed to remaining in a dormant state) until ready for patient use. When connected to battery 810, microcontroller 120 can enter an enabled state, in which it can resume full functionality for subsequent patient use.

[0065] refer to Figure 8b The injection device 803 includes circuitry 814 electrically connected to microcontroller 120. Circuitry 814 may be connected to pins of microcontroller 120 associated with reset operations (e.g., pins connected to a reset circuit). Circuitry 814 may include transistor 816, fuse 818, and a power source such as battery 820. Circuitry 814 can be connected via the above-mentioned... Figure 8a The described circuit 804 operates in a substantially similar manner, except that in the illustrated example, circuit 814 is arranged such that transistor 816 is a latching N-MOS field-effect transistor (FET) (e.g., a normally closed N-MOS FET), but other transistors, such as P-MOS FETs, may be used alternatively. In the initial state of circuit 814 (e.g., when fuse 818 has not blown), no reset signal is provided to microcontroller 120. When fuse 818 blows, transistor 816 switches to apply a reset signal (e.g., in the form of an input voltage or current) to microcontroller 120, thereby resetting microcontroller 120, exiting the sleep state, and entering the enabled state. Specifically, when fuse 818 blows, transistor 816 can provide a signal to microcontroller 120, which electrically connects a specific pin of microcontroller 120, thereby activating a reset circuit in microcontroller 120. The reset circuit initiates a reset and allows microcontroller 120 to enter an enabled state, in which microcontroller 120 can restore all functions for subsequent use by the patient.

[0066] as Figure 8aIn some embodiments, circuit 814 of circuit 804 can be arranged such that, in an initial state (e.g., when fuse 818 is not blown), transistor 816 electrically isolates microcontroller 120 from battery 820. When fuse 818 blows, transistor 816 switches to electrically connect microcontroller 120 to battery 820. In this way, microcontroller 120 can remain de-powered (e.g., as opposed to remaining in a dormant state) until ready for patient use. When connected to battery 820, microcontroller 120 can enter an enabled state, in which it can resume full functionality for subsequent patient use.

[0067] Circuits 804 and 814 can have the same characteristics as... Figure 8a and 8b The configurations shown are different. For example, in some embodiments, circuits 804, 814 may include one or more additional transistors 806, 816 and / or one or more additional fuses 808, 818.

[0068] Fuse 806, 816 can be melted in response to the application of a light source (e.g., a laser source). For example, a laser can provide heat to fuse 806, 816, causing it to melt. The laser can be supplied by a separate electronic device provided with injection devices 802, 803. The patient can be guided to operate the electronic device to apply the laser to melt fuse 806, 816 before the patient first uses injection devices 802, 803. In some embodiments, cartridge 104 and member 115 are made of a transparent material that allows light to pass through, thereby allowing laser to be applied to fuse 806, 816. In some embodiments, cartridge 104 and member 115 may include a transparent window located near fuse 806, 816.

[0069] Figure 9 Another example of the injection device 902 is shown. As... Figures 2 to 8b The injection devices 202, 302, 402, 502, 602, 702, 802, and 803, except for one or more of the components incorporated in component 115, are related to... Figure 1 Apart from the differences in the described components, the injection device 902 is similar to... Figure 1 The injection device 102 is basically similar. In addition, other components are incorporated into the cover 918.

[0070] In the illustrated example, the injection device 902 is configured to harvest energy from a power source, and the harvested energy is used to power the microcontroller 120. Specifically, the injection device 902 includes a second circuit 904 configured to receive power from a first circuit 914 incorporated in a cap 918 (e.g., a needle cap).

[0071] The first circuit 914 includes a power source 917 (e.g., AC power) and a first inductor coil 916 (e.g., a primary coil). The power source 917 may be supplied by an AC power outlet, and a cover 918 may include a power cord configured to be inserted into the AC power outlet to supply AC power to the circuit 914. In some embodiments, the cover 918 may be incorporated into a mounting (e.g., a bracket) configured to support the injection device 902 when it is not in use. The power source 917 supplies power to the first inductor coil 916 to generate an electromagnetic field for reception by the second circuit 904.

[0072] The second circuit 904 generates power from the electromagnetic field generated by the first inductor 916. Specifically, the second circuit 904 includes a second inductor 906 configured to receive the electromagnetic field from the first inductor 916 and use the received electromagnetic field to generate power. The second circuit 904 also includes a capacitor, such as a supercapacitor 907, configured to store the power generated by the second inductor 906. The second circuit 904 also includes a diode 908 that allows DC current to pass through it. The supercapacitor 907 can provide the stored power to the microcontroller 120 via the diode 908. In some embodiments, the supercapacitor 907 is provided in place of a separate power source (e.g., a battery). In this way, the injection device 902 can operate without a battery (e.g., a rechargeable battery). However, in some embodiments, the supercapacitor 907 can be replaced by another power source (e.g., a rechargeable power supply), such as a rechargeable battery.

[0073] When the cap 918 is within the threshold range of component 115 (e.g., when the cap 918 is attached to the housing 103 of the injection device 902), the first inductor coil 916 and the second inductor coil 906 form an electromagnetic link, thereby allowing inductive charging. In this way, the first inductor coil 916 and the second inductor coil 906 act as transformers for charging the supercapacitor 907. When the cap 918 is no longer within the threshold range of component 115 (e.g., when the cap 918 is removed from the housing 103 before being used by a patient), the electromagnetic link is temporarily broken and inductive charging stops. However, even when the link is broken, the power stored in the supercapacitor 907 can be used to power the microcontroller 120. Once the power stored in the supercapacitor 907 is depleted, the cap 918 can be reattached to the housing 103, and the supercapacitor 907 can be recharged via inductive charging.

[0074] In some embodiments, the supercapacitor 907 is an electric double-layer capacitor (EDLC), which provides a relatively high capacity of electrical storage (e.g., compared to conventional capacitors). The supercapacitor 907 can have a significantly higher capacitance value than conventional capacitors, and the energy that can be stored per unit volume or mass is 10 to 100 times that of an electrolytic capacitor. Furthermore, the supercapacitor 907 can accept and deliver charge at a significantly higher rate than that typically provided by rechargeable batteries.

[0075] Figure 10 This is a block diagram of an example computer system 100. For example, Figures 1 to 9 microcontroller 120 and / or Figure 6 The computing device (e.g., mobile phone 610) can be an example of computer system 1000. In some embodiments, the injection device can be configured to interact with a separate computer system 1000. System 1000 includes a processor 1010, a memory 1020, a storage device 1030, and an input / output device 1040. Each of components 1010, 1020, 1030, and 1040 can be interconnected, for example, using a system bus 1050. Processor 1010 is capable of processing instructions for execution within system 1000. Processor 1010 can be a single-threaded processor, a multi-threaded processor, or a quantum computer. Processor 1010 is capable of processing instructions stored in memory 1020 or storage device 1030. Processor 1010 can perform operations such as causing the injection device to perform one or more of the operations described above.

[0076] The memory 1020 stores information within the system 1000. In some embodiments, the memory 1020 is a computer-readable medium. The memory 1020 may be, for example, a volatile memory cell or a non-volatile memory cell. In some embodiments, the memory 1020 stores information related to the operations described above.

[0077] Storage device 1030 provides high-capacity storage for system 1000. In some embodiments, storage device 1030 is a non-transitory computer-readable medium. Storage device 1030 may include, for example, a hard disk drive, an optical disk drive, a solid-state drive, a flash drive, magnetic tape, or some other high-capacity storage device. Storage device 1030 may alternatively be a cloud storage device, such as a logical storage device comprising multiple physical storage devices distributed across a network and accessed via a network. In some embodiments, information stored on memory 1020 may also be, or alternatively, stored on storage device 1030.

[0078] Input / output device 1040 provides input / output operations for system 1000. In some embodiments, input / output device 1040 includes one or more network interface devices (e.g., Ethernet card), serial communication devices (e.g., RS-232 port), and / or wireless interface devices (e.g., short-range wireless communication devices, 802.11 cards, 3G wireless modems, or 4G wireless modems). In some embodiments, input / output device 1040 includes a driver device configured to receive input data and send output data to other input / output devices, such as a keyboard, printer, and display device (e.g., dose window 113). In some embodiments, mobile computing devices, mobile communication devices, and other devices are used.

[0079] In some implementations, system 1000 is a microcontroller. A microcontroller is a device that incorporates multiple components of a computer system into a single electronic package. For example, the single electronic package may include a processor 1010, a memory 1020, a storage device 1030, and an input / output device 1040.

[0080] Despite Figure 10Example processing systems have been described; however, embodiments of the subject matter and functional operation described above can be implemented in other types of digital electronic circuit systems or computer software, firmware, or hardware, including the structures disclosed in this specification and their structural equivalents, or combinations thereof. Embodiments of the subject matter described in this specification can be implemented as one or more computer program products, such as one or more modules of computer program instructions (e.g., a computer-readable medium) encoded on a tangible program carrier, for execution by or control of their operation by a processing system. The computer-readable medium can be a machine-readable storage device, a machine-readable storage substrate, a storage device, a composition of substances affecting machine-readable propagation signals, or combinations thereof.

[0081] The term "computer system" can encompass all instruments, apparatus, and machines used for processing data, including, for example, programmable processors, computers, or multiple processors or computers. In addition to hardware, a processing system may also include code that creates the execution environment for the computer program in question, such as code that constitutes processor firmware, protocol stacks, database management systems, operating systems, or combinations thereof.

[0082] A computer program (also known as a program, software, software application, script, executable logic, or code) can be written in any programming language, including compiled or interpreted languages ​​or declarative or procedural languages, and 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. A computer program does not necessarily correspond to a file in a file system. A program can be stored as a portion of a file that holds other programs or data (e.g., one or more scripts stored in a markup language document), a single file dedicated to the program in question, or multiple coordinated files (e.g., a file storing portions of one or more modules, subroutines, or code). A computer program can be deployed to execute on one or more computers located at a single site or distributed across multiple sites interconnected by a communications network.

[0083] Computer-readable media suitable for storing computer program instructions and data include all forms of non-volatile or volatile memory, media, and storage devices, including, for 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-ROMs and DVD-ROMs). Processors and memory may be supplemented by or incorporated into dedicated logic circuitry. Components of the system can be interconnected via any form or medium of digital data communication (e.g., a communication network). Examples of communication networks include local area networks (“LANs”) and wide area networks (“WANs”), such as the Internet.

[0084] The terms "drug" or "pharmaceutical" are used herein to describe one or more pharmaceutically active compounds. As described below, a drug or pharmaceutical agent may include at least one small molecule or macromolecule or combination thereof in various types of formulations for the treatment of one or more diseases. Exemplary pharmaceutically active compounds may include small molecules; polypeptides, peptides, and proteins (e.g., hormones, growth factors, antibodies, antibody fragments, and enzymes); carbohydrates and polysaccharides; and nucleic acids, double-stranded or single-stranded DNA (including naked and cDNA), RNA, antisense nucleic acids such as antisense DNA and RNA, small interfering RNA (siRNA), ribozymes, genes, and oligonucleotides. Nucleic acids may be incorporated into molecular delivery systems such as vectors, plasmids, or liposomes. Mixtures of one or more of these drugs are also contemplated.

[0085] The drug delivery devices and drugs described herein can be used to treat and / or prevent many different types of disorders. Exemplary disorders include, for example, diabetes or diabetes-related complications (e.g., diabetic retinopathy), and thromboembolic disorders (e.g., deep vein or pulmonary thromboembolism). Other exemplary disorders include acute coronary syndrome (ACS), angina pectoris, myocardial infarction, cancer, macular degeneration, inflammation, hay fever, atherosclerosis, and / or rheumatoid arthritis.

[0086] Exemplary medicines for the treatment and / or prevention of diabetes or diabetes-related complications include insulin (e.g., human insulin, or human insulin analogs or derivatives); glucagon-like peptide-1 (GLP-1), GLP-1 analogs or GLP-1 receptor agonists, or analogs or derivatives thereof; dipeptidyl peptidase-4 (DPP4) inhibitors, or pharmaceutically acceptable salts or solvates thereof; or any mixtures thereof. As used herein, the term “derivative” means any substance that is structurally sufficiently similar to the original substance to have substantially similar functions or activities (e.g., therapeutic efficacy).

[0087] Exemplary insulin analogs are Gly(A21), Arg(B31), Arg(B32) human insulin (glargine insulin); Lys(B3), Glu(B29) human insulin; Lys(B28), Pro(B29) human insulin; Asp(B28) human insulin; human insulin wherein the proline at position B28 is replaced by Asp, Lys, Leu, Val, or Ala and wherein the Lys at position B29 can be replaced by Pro; Ala(B26) human insulin; Des(B28-B30) human insulin; Des(B27) human insulin and Des(B30) human insulin.

[0088] Exemplary insulin derivatives include, 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-Thr B29LysB30 human insulin; B30-N-palmitoyl-ThrB29LysB30 human insulin; B29-N-(N-palmitoyl-γ-glutamyl)-des(B30) human insulin; B29-N-(N-lithochyl-γ-glutamyl)-des(B30) human insulin; B29-N-(ω-carboxyheptadecanoyl)-des(B30) human insulin and B29-N-(ω-carboxyheptadecanoyl) human insulin. Exemplary GLP-1, GLP-1 analogs, and GLP-1 receptor agonists are, for example: lixumia / AVE0010 / ZP10 / Lyxumia, exenatide / Gydureon exopeptide-4 / Byetta / Bydureon / ITCA 650 / AC-2993 (a 39-amino acid peptide derived from Gila exopeptide). (produced by the salivary glands of monster), liraglutide / Victoza, semaglutide, taspoglutide, Syncria / albiglutide, Dulaglutide, rExendin-4, CJC-1134-PC, PB-1023, TTP-054, Langnatide / HM-11260C, CM-3, GLP-1Eligen, ORMD-0901, NN-9924, NN-9926, NN-9927, Nodexen, Viador-GLP-1, CVX-096, ZYOG-1, ZYD-1, GSK-2374697, DA-3091, MAR-701, MAR709, ZP-2929, ZP-3022, TT-401, BHM-034. MOD-6030, CAM-2036, DA-15864, ARI-2651, ARI-2255, exenatide-XTEN, and glucagon-Xten.

[0089] An example oligonucleotide is, for instance, mipomersen / Kynamro, a cholesterol-reducing antisense agent used to treat familial hypercholesterolemia.

[0090] Exemplary DPP4 inhibitors include vidagliptin, sitagliptin, denagliptin, saxagliptin, and berberine.

[0091] Exemplary hormones include pituitary hormones or hypothalamic hormones or regulatory peptides and their antagonists, such as gonadotropins (follicle-stimulating hormone, luteinizing hormone, human chorionic gonadotropin, fertility-stimulating hormone), growth hormone (growth hormone), desmopressin, terlipressin, gosorelin, triptorelin, leuprorelin, buserorelin, nafarelin, and goserelin.

[0092] Exemplary polysaccharides include glucosaminoglycane, hyaluronic acid, heparin, low molecular weight heparin or ultra-low molecular weight heparin or derivatives thereof, or sulfated polysaccharides (e.g., polysulfated forms of the above polysaccharides), and / or pharmaceutically acceptable salts thereof. An example of a pharmaceutically acceptable salt of polysulfated low molecular weight heparin is enoxaparin sodium. An example of a hyaluronic acid derivative is Hylan G-F20 / Synvisc, which is a sodium hyaluronate.

[0093] As used herein, the term "antibody" refers to an immunoglobulin molecule or its antigen-binding portion. Examples of antigen-binding portions of immunoglobulin molecules include F(ab) and F(ab')2 fragments, which retain the ability to bind antigens. The antibody may be a polyclonal antibody, monoclonal antibody, recombinant antibody, chimeric antibody, deimmunized or humanized antibody, fully human antibody, non-human (e.g., murine) antibody, or single-chain antibody. In some embodiments, the antibody has effector function and can repair complement. In some embodiments, the antibody has reduced or no ability to bind to the Fc receptor. For example, the antibody may be an isotype or subtype, antibody fragment, or mutant that does not support binding to the Fc receptor, for example, it has a mutagenic or missing Fc receptor-binding region.

[0094] The term "fragment" or "antibody fragment" refers to a polypeptide (e.g., antibody heavy chain and / or light chain polypeptide) derived from an antibody polypeptide molecule that does not contain the full-length antibody polypeptide but still contains at least a portion of the full-length antibody polypeptide capable of binding an antigen. Antibody fragments may include cleaved portions of the full-length antibody polypeptide, although the term is not limited to such cleaved fragments. Antibody fragments that can be used in this invention include, for example, Fab fragments, F(ab')2 fragments, scFv (single-chain Fv) fragments, linear antibodies, monospecific or multispecific antibody fragments (such as bispecific, trispecific, and multispecific antibodies (e.g., double-chain, triple-chain, and quadruple-chain antibodies)), microantibodies, chelated recombinant antibodies, tri- or bispecific antibodies, intracellular antibodies, nanobodies, small modular immunopharmaceuticals (SMIPs), binding domain immunoglobulin fusion proteins, camelified antibodies, and antibodies containing VHH. Further examples of antigen-binding antibody fragments are known in the art.

[0095] The term "complementarity-determining region" or "CDR" refers to a short polypeptide sequence within the variable region of both heavy and light chain polypeptides, primarily responsible for mediating specific antigen recognition. The term "frame region" refers to an amino acid sequence within the variable region of both heavy and light chain polypeptides; it is not a CDR sequence and is primarily responsible for maintaining the correct positioning of the CDR sequence to allow antigen binding. Although the frame region itself does not typically participate directly in antigen binding, as is known in the art, certain residues within the frame region of some antibodies can directly participate in antigen binding or can affect the ability of one or more amino acids in the CDR to interact with the antigen.

[0096] Exemplary antibodies are anti-PCSK-9 mAb (e.g., Alirocumab), anti-IL-6 mAb (e.g., Sarilumab), and anti-IL-4 mAb (e.g., Dupilumab).

[0097] The compounds described herein can be used in pharmaceutical formulations comprising (a) one or more compounds or pharmaceutically acceptable salts thereof, and (b) a pharmaceutically acceptable carrier. The compounds can also be used in pharmaceutical formulations comprising one or more other active pharmaceutical ingredients or in pharmaceutical formulations wherein the compounds of the present invention or pharmaceutically acceptable salts thereof are the sole active ingredient. Therefore, pharmaceutical formulations in this disclosure cover any formulation prepared by mixing the compounds described herein with a pharmaceutically acceptable carrier.

[0098] Pharmaceutically acceptable salts of any of the drugs described herein are also contemplated for use in drug delivery devices. Pharmaceutically acceptable salts are, for example, acid addition salts and basic salts. Acid addition salts are, for example, HCl or HBr salts. Basic salts are, for example, salts having cations selected from alkali metals or alkaline earth metals, such as Na+, or K+, or Ca2+, or ammonium ions N+(R1)(R2)(R3)(R4), wherein R1 to R4 independently represent: hydrogen, optionally substituted C1C6-alkyl groups, optionally substituted C2-C6-olefin groups, optionally substituted C6-C10-aryl groups, or optionally substituted C6-C10-heteroaryl groups. Further examples of pharmaceutically acceptable salts are known to those skilled in the art.

[0099] Pharmaceutically acceptable solvates are, for example, hydrates or alkanolates, such as methanolate or ethanolate.

[0100] Those skilled in the art will understand that various modifications (such as adjustments, additions, or removals) can be made to the substances, preparations, instruments, methods, systems, apparatuses, and embodiments described herein without departing from the full scope and spirit of the invention, which covers such modifications and any equivalents.

[0101] Several embodiments of the system and technology described herein have been proposed. However, it should be understood that various modifications can be made without departing from the spirit and scope of this system and technology. Therefore, other embodiments are also within the scope of the appended claims.

[0102] Item 1: A drug injection device (102), comprising:

[0103] A cartridge (104) configured to contain a certain amount of drug; one or more processors (120) configured to operate at least in an active state and a dormant state, wherein the one or more processors (120) are configured to control the operation of the drug injection device (102) when the one or more processors (120) are in the active state; a component (115) disposed in the cartridge (104), the component (115) including at least two conductive surfaces (122) electrically connected to the one or more processors (120); and a drive mechanism (106) including conductive elements (124) spaced apart from the at least two conductive surfaces (122), wherein the one or more processors (120) are configured to enter the active state from the dormant state when the conductive elements (124) are in electrical contact with the at least two conductive surfaces (122).

[0104] Item 2: The drug injection device (102) according to Item 1, wherein the component (115) is a stop and the conductive element (124) is disposed on the bottom surface of the plunger (107) of the drive mechanism (106).

[0105] Item 3: The drug injection device (102) according to Item 1, wherein the conductive element (124) is configured to move toward the member (115) in response to engagement of the drive mechanism (106) and to make electrical contact with the at least two conductive surfaces (122).

[0106] Item 4: The drug injection device (102) according to Item 3, wherein the drive mechanism (106) is engaged during the activation of the drug injection device (102).

[0107] Item 5: The drug injection device (102) according to Item 1, wherein the conductive element (124) makes electrical contact with the at least two conductive surfaces (122) to activate the reset circuit in the one or more processors (120).

[0108] Item 6: The drug injection device (102) according to Item 1 further includes one or more non-transitory computer-readable media (1030) storing instructions operable to cause the one or more processors (120) to control the operation of the drug injection device (102).

[0109] Item 7: The drug injection device (102) according to Item 6, wherein the one or more non-transitory computer-readable media (1030) includes a ferroelectric random access memory (FRAM) configured to store data without the need for continuous power supply.

[0110] Item 8: A drug injection device (202, 302, 402, 502, 602, 702), comprising:

[0111] A cartridge (104) configured to contain a quantity of drug; one or more processors (120) configured to operate at least in an active state and a dormant state, wherein the one or more processors (120) are configured to control the operation of the drug injection device (202, 302, 402, 502, 602, 702) when the one or more processors (120) are in the active state; and

[0112] A sensor that communicates with the one or more processors (120), wherein the sensor is configured to cause the one or more processors (120) to enter the enabled state from the dormant state in response to a stimulus.

[0113] Item 9: The drug injection device (202) according to Item 8, wherein the sensor is a magnetoresistive sensor (204), the magnetoresistive sensor being configured to cause the one or more processors (120) to enter the enabled state when the magnetoresistive sensor (204) stops sensing a magnetic field that satisfies a threshold size.

[0114] Item 10: The drug injection device (202) according to Item 9, wherein the drug injection device (202) is configured to reside in a package (210) including a magnet (212) providing a magnetic field satisfying a threshold size, wherein the one or more processors (120) enter the enabled state when the drug injection device (202) is removed from the package (210).

[0115] Item 11: The drug injection device (202) according to Item 9 further includes a cap (116, 117, 118) configured to be attached to the housing (103) of the drug injection device (202), the cap (116, 117, 118) including a magnet (212) providing a magnetic field satisfying the threshold size, wherein the one or more processors (120) enter the enabled state when the cap (116, 117, 118) is removed from the housing (103).

[0116] Item 12: The drug injection device (302) according to Item 8, wherein the sensor includes one or both of a photodiode or a photoresistor, wherein one or both of the photodiode or photoresistor are configured to cause the one or more processors (120) to enter the enabled state when the photodiode or photoresistor senses light that meets a threshold intensity.

[0117] Item 13: The drug injection device (402) according to Item 8, wherein the sensor is a thermistor (404) configured to cause the one or more processors (120) to enter the enabled state when the thermistor (404) senses a temperature that meets a threshold.

[0118] Item 14: The drug injection device (302) according to Item 8, wherein the sensor is an X-ray diode, the X-ray diode being configured to cause the one or more processors (120) to enter the enabled state when the X-ray diode senses X-ray radiation.

[0119] Item 15: The drug injection device (502) according to Item 8, wherein the sensor is a Wi-Fi sensor (504) and the Wi-Fi sensor is configured to cause the one or more processors (120) to enter the enabled state when the Wi-Fi sensor (504) senses Wi-Fi radiation.

[0120] Item 16: The drug injection device (502) according to Item 15, wherein the drug injection device (502) is configured to reside in a package (510) that shields against Wi-Fi radiation, wherein the one or more processors (120) enter the enabled state when the drug injection device (502) is removed from the package (510).

[0121] Item 17: The drug injection device (602) according to Item 8, wherein the sensor is a near field communication (NFC) sensor (604), the near field communication sensor being configured to cause the one or more processors (120) to enter the enabled state when the NFC sensor (604) receives an NFC signal from a computing device.

[0122] Item 18: The drug injection device (602) according to Item 17, wherein the computing device is a mobile phone (610).

[0123] Item 19: The drug injection device (602) according to Item 8, wherein the sensor is a Bluetooth antenna, the Bluetooth antenna being configured to cause the one or more processors (120) to enter the enabled state when the Bluetooth antenna receives a Bluetooth signal from a computing device.

[0124] Item 20: The drug injection device (702) according to Item 8, wherein the sensor includes a resonant circuit (704) configured to cause the one or more processors (120) to enter the enabled state when the resonant circuit (704) senses a magnetic field having a resonant frequency.

[0125] Item 21: A system comprising:

[0126] Drug injection device (502), the drug injection device comprising:

[0127] A cartridge (104) configured to contain a quantity of medication; one or more processors (120) configured to operate at least in an active state and a dormant state, wherein the one or more processors (120) are configured to control the operation of the medication injection device (502) when the one or more processors (120) are in the active state; and a Wi-Fi sensor (504) communicating with the one or more processors (120), wherein the Wi-Fi sensor (504) is configured to cause the one or more processors (120) to enter the active state from the dormant state when the Wi-Fi sensor (504) senses Wi-Fi radiation; and a package (510) configured to contain the medication injection device (502) after manufacture and before the patient's first use, wherein the package (510) includes material to shield against Wi-Fi radiation to prevent the one or more processors (120) from entering the active state until the medication injection device (502) is removed from the package (510).

[0128] Item 22: A drug injection device (802, 803), comprising:

[0129] A cartridge (104) configured to contain a quantity of drug; one or more processors (120) configured to operate at least in an active state and a dormant state, wherein the one or more processors (120) are configured to control the operation of the drug injection device (802, 803) when the one or more processors (120) are in the active state; and a circuit (804, 814) electrically connected to the one or more processors (120), the circuit (804, 814) including one or more transistors (806, 816) and one or more fuses (808, 818), wherein the one or more transistors (806, 816) are configured to cause the one or more processors (120) to enter the active state from the dormant state in response to the one or more fuses (808, 818) being blown.

[0130] Item 23: The drug injection device (802, 803) according to Item 22, wherein one or more fuses (806, 816) are melted in response to laser application.

[0131] Item 24: The drug injection device (802, 803) according to Item 23, wherein the laser is applied by an electronic device provided together with the drug injection device (802, 803).

[0132] Item 25: The drug injection device (802, 803) according to Item 23, wherein the heat provided by the laser causes one or more fuses (806, 816) to melt.

[0133] Item 26: A drug injection device (802, 803), comprising:

[0134] A cartridge (104) configured to contain a quantity of drug; one or more processors (120) configured to control the operation of the drug injection device (802, 803); and a circuit (804, 814) electrically connected to the one or more processors (120), the circuit (804, 814) including a battery (810, 820), one or more transistors (806, 816), and one or more fuses (808, 818), wherein when the one or more fuses (808, 818) are in a non-fuse state, the one or more transistors (806, 816) electrically isolate the one or more processors (120) from the battery (810, 820), and when the one or more fuses (808, 818) are blown, the one or more transistors (806, 816) electrically connect the one or more processors (120) to the battery (810, 820).

[0135] Item 27: The drug injection device (802, 803) according to Item 26, wherein one or more fuses (808, 818) are melted in response to laser application.

[0136] Item 28: The drug injection device (802, 803) according to Item 27, wherein the laser is applied by an electronic device provided together with the drug injection device (802, 803).

[0137] Item 29: The drug injection device (802, 803) according to Item 27, wherein the heat provided by the laser causes one or more fuses (808, 818) to melt.

[0138] Item 30: A drug injection device (902), comprising:

[0139] A cartridge (104) configured to contain a quantity of drug; one or more processors (120) configured to control the operation of the drug injection device (902); a cover (918) configured to be attached to a housing (103) of the drug injection device (902), wherein the cover (918) includes a first inductor (916) configured to be electrically connected to a power source (917); and a circuit (904) electrically connected to the one or more processors (120), the circuit (904) including a second inductor (906) and a supercapacitor (907), wherein the second inductor (906) is configured to receive an electromagnetic field from the first inductor (916) and generate power stored by the supercapacitor (907) and supplied to the one or more processors (120).

Claims

1. A drug injection device (102), comprising: a cartridge (104) configured to hold a quantity of a drug; one or more processors (120) configured to operate in at least an active state and a dormant state, wherein the one or more processors (120) are configured to control operation of the drug injection device (102) when the one or more processors (120) are in the active state; a member (115) disposed in the cartridge (104), the member (115) comprising at least two electrically conductive surfaces (122) electrically connected to the one or more processors (120); and a drive mechanism (106) comprising an electrically conductive element (124) spaced apart from the at least two electrically conductive surfaces (122), wherein the drive mechanism is separated and spaced apart from the member (115) in a dormant state and is urged to contact and move the member (115), and wherein the one or more processors (120) are configured to enter the active state from the dormant state in response to the drive mechanism (106) contacting the member (115) when the electrically conductive element (124) is in electrical contact with the at least two electrically conductive surfaces (122).

2. The drug injection device (102) of claim 1, wherein the member (115) is a stopper and the electrically conductive element (124) is disposed on a bottom surface of a plunger (107) of the drive mechanism (106).

3. The drug injection device (102) of claim 1, wherein the electrically conductive element (124) is configured to move toward the member (115) and into electrical contact with the at least two electrically conductive surfaces (122) in response to activation of the drive mechanism (106).

4. The drug injection device (102) of claim 3, wherein the drive mechanism (106) is configured to be activated during priming of the drug injection device (102).

5. The drug injection device (102) of claim 1, wherein electrical contact between the electrically conductive element (124) and the at least two electrically conductive surfaces (122) causes a reset circuit in the one or more processors (120) to be activated.

6. The drug injection device (102) of claim 1, further comprising one or more non-transitory computer-readable media (1030) storing instructions operable to cause the one or more processors (120) to control operation of the drug injection device (102).

7. The drug injection device (102) of claim 6, wherein the one or more non-transitory computer-readable media (1030) comprise ferroelectric random access memory (FRAM) configured to store data without continuous power.

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