Conserving power in injection device

Abstract

To provide systems and techniques for saving power in an injection device.SOLUTION: A drug injection device comprises: a cartridge configured to hold a volume of a drug; one or more processors configured to operate in at least an enabled state and a sleep state, where the one or more processors are configured to control an operation of the drug injection device while the one or more processors are in the enabled state; a member disposed in the cartridge, the member including at least two conductive surfaces electrically connected to the one or more processors; and a drive mechanism including a conductive element spaced from the at least two conductive surfaces, where the one or more processors are configured to enter the enabled state from the sleep state when the conductive element makes electrical contact with the at least two conductive surfaces.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] The present disclosure relates to power conservation, and more particularly to power conservation in injection devices. [Background technology]

[0002] There are various diseases that require treatment by injection of medication. Such injections can be performed using an injection device, which is applied either by a medical professional or by the patient themselves. As an example, type 1 and type 2 diabetes can be treated by the patient themselves by injecting insulin doses, for example, once or multiple times per day. For example, a pre-filled, disposable insulin pen or auto-injector can be used as the injection device. Alternatively, a reusable pen or auto-injector can be used. A reusable pen or auto-injector allows the empty medication cartridge to be replaced with a new cartridge. Either type of pen or auto-injector can come with a set of one-way needles that is replaced before each use. Summary of the Invention [Problem to be solved by the invention]

[0003] Described herein are systems and techniques for conserving power in injection devices. To ensure that the injection device provides full functionality for use by a patient, it may be beneficial to store as much power as possible when the injection device is not in use. For example, there may be instances during and after manufacturing of the injection device where the injection device should be powered on before use with a patient (e.g., while testing the injection device's electronics). However, even when the injection device is powered off, there may be instances where power is lost from the power source (e.g., due to standby power loss). To prevent such power loss, the microcontroller may be configured to operate in a sleep state (e.g., a deep sleep state). In such a sleep state, the microcontroller can significantly reduce and / or eliminate standby power loss from the battery. For example, the microcontroller may consume much less than 10 nanoamps while operating in a sleep state. In some embodiments, the injection device may be capable of achieving a lifespan of approximately 4-5 years by utilizing a sleep state in the microcontroller and / or electrically isolating the microcontroller from the battery when not in use. [Means for solving the problem]

[0004] In some embodiments, the drug injection device includes a cartridge configured to hold a volume of drug and one or more processors configured to operate in at least an active state and a sleep state. The one or more processors are configured to control operation of the drug injection device while the one or more processors are in the active state. The drug injection device also includes a member within the cartridge. The member includes at least two conductive surfaces electrically connected to the one or more processors. The drug injection device also includes a drive mechanism including a conductive element spaced apart from the at least two conductive surfaces. The one or more processors are configured to enter the active state from the sleep state when the conductive element makes electrical contact with the at least two conductive surfaces. In some embodiments, the member is a stopper, and the conductive element is disposed on a lower 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 may be engaged during priming of the drug injection device. The contact can activate the reset circuitry of one or more processors.

[0006] In some embodiments, the drug injection device also includes one or more non-transitory computer-readable media storing instructions operable to cause the one or more processors to control 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 a continuous power supply.

[0007] In some embodiments, the drug injection device includes a cartridge configured to hold a volume of drug and one or more processors configured to operate in at least an active state and a sleep state. The one or more processors are configured to control operation of the drug injection device while 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 sleep 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 no longer detects a magnetic field satisfying a threshold amount. The drug injection device is configured to be within a package including a magnet that provides a magnetic field satisfying the threshold amount, and the one or more processors can enter the active state when the drug injection device is removed from the package. In some embodiments, the drug injection device also includes a cover configured to attach to a housing of the drug injection device. The cover may include a magnet that provides a magnetic field satisfying the threshold amount, and the one or more processors can enter the active state when the cover is removed from the housing.

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

[0009] In some embodiments, the sensor is a Wi-Fi sensor configured to cause the one or more processors to enter an enabled state when the Wi-Fi sensor detects Wi-Fi radiation. The drug injection device is configured to be in packaging that blocks Wi-Fi radiation, and the one or more processors can enter an 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 an 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 an enabled state when the resonant circuit detects a magnetic field having a resonant frequency.

[0011] In some embodiments, the system includes a medication injection device including a cartridge configured to hold a volume of medication and one or more processors configured to operate in at least an active state and a sleep state. The processor is configured to control operation of the drug injection device while the one or more processors are in an 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 an active state from a sleep state when the Wi-Fi sensor detects Wi-Fi radiation. The system also includes packaging configured to house the drug injection device after manufacture until first use by a patient. The packaging includes a material that blocks Wi-Fi radiation to prevent the one or more processors from entering an 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 hold a volume of drug and one or more processors configured to operate in at least an active state and a sleep state. The one or more processors are configured to control operation of the drug injection device while 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 sleep state in response to the one or more fuses being blown. The one or more fuses may be blown in response to irradiation with laser light, the laser light being irradiated by an electronic device provided with the drug injection device. The one or more fuses may be blown due to heat applied by the laser light.

[0013] In some embodiments, the drug injection device includes a cartridge configured to hold a volume of drug and one or more processors configured to control 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. The one or more transistors electrically isolate the one or more processors from the battery when the one or more fuses are not blown, and the one or more transistors electrically connect the one or more processors to the battery when the one or more fuses are blown. The one or more fuses may be blown in response to irradiation with laser light, the laser light being irradiated by an electronic device provided with the drug injection device. Heat applied by the laser light may blow the one or more fuses.

[0014] In some embodiments, the drug injection device includes a cartridge configured to hold a volume of drug, one or more processors configured to control operation of the drug injection device, and a cover configured to attach to a housing of the drug injection device. The cover includes a first induction 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 induction coil and a supercapacitor. The second induction coil is configured to receive an electromagnetic field from the first induction coil and generate electrical power that is stored by the supercapacitor and provided to the one or more processors. [Brief explanation of the drawings]

[0015] [Figure 1] 1A-1D are diagrams of various examples of injection devices. [Figure 2] 1A-1D are diagrams of various examples of injection devices. [Figure 3] 1A-1D are diagrams of various examples of injection devices. [Figure 4] 1A-1D are diagrams of various examples of injection devices. [Figure 5] 1A-1D are diagrams of various examples of injection devices. [Figure 6] 1A-1D are diagrams of various examples of injection devices. [Figure 7] 1A-1D are diagrams of various examples of injection devices. [Figure 8a] 1A-1D are diagrams of various examples of injection devices. [Figure 8b] 1A-1D are diagrams of various examples of injection devices. [Figure 9] 1A-1D are diagrams of various examples of injection devices. [Figure 10] FIG. 1 is a block diagram of an exemplary computer system. DETAILED DESCRIPTION OF THE INVENTION

[0016] Like reference symbols in the various drawings indicate like elements.

[0017] The subject matter described herein will be described largely 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 equally be implemented with injection devices that release other medications or with other types of medical devices (e.g., pumps).

[0018] The term "drug delivery device" is intended to encompass any type of device or system configured to administer a volume of a drug to the human or animal body. The volume can typically range from about 1 μl to about 10 ml. Drug delivery devices may include, without limitation, syringes, needle-safe systems, pen injectors, autoinjectors, large volume devices (LVDs), pumps, perfusion systems, or other devices configured for subcutaneous, intramuscular, or intravascular drug delivery. Such devices often include needles, which in certain embodiments may be small-gauge needles (e.g., greater than about 24 gauge, including 27, 29, or 31 gauge). In combination with a particular drug, the devices described herein may be customized to operate within required parameters, such as within a certain time period (e.g., about 3 to about 20 seconds for a syringe, about 5 to about 60 minutes for an LVD), with little or minimal discomfort, or within certain conditions related to human factors, shelf life, expiration date, biocompatibility, environmental considerations, etc. Such deformation may occur due to various factors, such as a drug with a viscosity ranging from about 3 cP to about 50 cP.

[0019] The drug or agent can be contained within a primary package or "drug container" adapted for use in a drug delivery device. The drug container can be, for example, a cartridge, syringe, reservoir, or other container configured to provide a chamber suitable for storage (e.g., short-term or long-term storage) of one or more pharmaceutically active compounds. For example, in some cases, the chamber can be designed to store the drug for at least one day (e.g., from one day to at least 30 days). In some cases, the chamber can be designed to store the drug for about one month to about two years. Storage can occur at room temperature (e.g., about 20°C) or at refrigerated temperatures. In some cases, the drug container can be or include a dual-chamber cartridge configured to store two or more components of a drug formulation (e.g., a drug and a diluent, or two different types of drug) separately, one in each chamber. In such cases, the two chambers of the dual-chamber cartridge can be configured to allow mixing between the two or more components of the drug or agent before and / or during administration into a human or animal body. For example, the two chambers can be configured so that they are in fluid communication with each other (e.g., by a conduit between the two chambers) to allow the two components to be mixed by a user prior to administration, if desired. Alternatively, or in addition, the two chambers can be configured to allow the components to be mixed as they are being administered into the human or animal body.

[0020] FIG. 1 shows an example of an injection device 102. 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 hold a volume 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 is within the housing 103 and / or cartridge housing 105 of the injection device 102; therefore, some or all of the cartridge 104 is not readily visible.

[0021] The injection device 102 includes a drive mechanism 106 configured to expel a medicament from the 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 stopper) is also disposed in the cartridge 104 proximate to the plunger 107. In an initial state (e.g., before injection), the member 115 is spaced a relatively short distance (e.g., less than 1 mm) from the plunger 107. The piston 108 is configured to move the plunger 107 from the proximal end of the cartridge 104 toward the member 115. In particular, 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 across the cartridge 104, thereby displacing the plunger 107 and member 115 and dispensing the fluid through a needle 109 disposed at the distal end of the cartridge 104. The needle 109 includes an aperture through which the fluid is dispensed. In some embodiments, the needle 109 and / or the cartridge 104 are threaded to allow the needle 109 to be threadably attached to the cartridge 104. The needle 109 may be protected by an inner needle cap 116 and an outer needle cap 117, which may then be covered by a cover 118.

[0022] The drug dose (e.g., insulin dose, etc.) to be released from the injection device 102 can be selected by turning the dose knob 112, and the selected dose can be displayed by the dose window 113. In some examples, the dose 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), where 1 IU is the bioequivalent of approximately 45.5 micrograms of drug, such as pure crystalline insulin (e.g., 1 / 22 mg). An example of a selected dose displayed in the dose window 113 can be, for example, 30 IU, as shown in FIG. 1 . In some examples, the selected dose may be displayed differently, for example, by a non-electronic display. In some examples, the dose window 113 relates to a section of the injection device 102 through or at which the selected dose can be viewed.

[0023] Turning the dose knob 112 may generate a mechanical click sound to provide auditory feedback to the user. The number displayed in the dose window 113 is printed on a sleeve contained in the housing 103 that mechanically interacts with the drive mechanism 106. When the needle 109 is inserted into the patient's skin area and the injection button 111 is then pressed, medication is released from the injection device 102. The release of the dose may also generate a mechanical click sound. This mechanical click sound may be different from the sound generated when the dose knob 112 is turned. The injection device 102 can be used for multiple injection processes until the cartridge 104 is emptied or until the expiration date of the injection device 102 (e.g., 28 days after first use).

[0024] In some instances, before the first use of the injection device 102, for example, two units of medication may be injected. It may be necessary to perform a "blank shot" by selecting and holding the injection device 102 with the needle 109 pointing up and pressing the injection button 111 to remove air from the cartridge 104 and needle 109.

[0025] The 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 that store instructions operable to cause the one or more processors to perform operations (e.g., control the operation of the injection device 102). In some embodiments, the one or more non-transitory computer-readable media may include ferroelectric random access memory (FRAM), which is configured to store data without a continuous supply of power. Such FRAM is used to further reduce the power consumption of the injection device 102 when not in use. Operations that may be performed by the one or more processors may include determining the amount of medication (e.g., dosage) administered by the injection device 102, recording and / or transmitting information regarding the administered dosage, controlling an electronic display of the injection device 102, etc. As shown in FIG. 1 , in some embodiments, the microcontroller 120 is integrated into the component 115. The injection device may also include a power source, such as a battery, e.g., a coin cell battery, for powering the microcontroller 120. The battery may also be integrated into the member 115 in close proximity to the microcontroller 120 .

[0026] To ensure that the injection device 102 provides full functionality for use by a patient, it may be beneficial to store as much power as possible when the injection device 102 is not in use. For example, there may be instances when the injection device 102 should be powered on after manufacture and before use with a patient. However, even when the injection device 102 is powered off, there may be instances when power is lost from the power source (e.g., due to a "vampire draw" or standby power loss). To prevent such power loss, the microcontroller 120 may be configured to operate in a sleep state (e.g., a deep sleep state). In such a sleep state, the microcontroller 120 can significantly reduce and / or eliminate standby power loss from the battery. For example, the microcontroller 120 may consume much less than 10 nanoamps while operating in a sleep state. In some embodiments, the injection device 102 may be able to achieve a lifespan of approximately four to five years by utilizing a sleep state of the microcontroller 120 and / or by electrically isolating the microcontroller 120 from the battery when not in use.

[0027] The microcontroller 120 may enter the sleep state in response to a command. The command may include a simple signal received by the microcontroller 120 indicating that the sleep state should be initiated. In some embodiments, the command may include applying an input voltage or current to one or more pins of the microcontroller 120. When operating in the sleep state, the functionality of the microcontroller 120 may be limited. For example, the microcontroller 120 may not be able to control one or more operations of the injection device 102 while sleeping. In some examples, the microcontroller 120 may be limited in the types of commands it can receive while sleeping. In some examples, the microcontroller 120 may require a reset to exit the sleep state. Various embodiments described herein relate to systems and techniques for resetting the microcontroller 120, thereby enabling the microcontroller 120 to exit the sleep state and enter an enabled state. In the enabled state, the microcontroller 120 can resume full functionality.

[0028] In some embodiments, microcontroller 120 is configured to disable resets for a particular length of time. For example, microcontroller 120 is configured to disable resets (e.g., additional / subsequent resets) after microcontroller 120 is reset the first time to exit a sleep state. Such functionality can be built into microcontroller 120 by implementing a time delay that prevents microcontroller 120 from resetting after entering an enabled state. In some implementations, an integrated circuit (e.g., a second microcontroller) in communication with microcontroller 120 may provide such a delay functionality.

[0029] In some embodiments, the microcontroller 120 is instructed to enter a sleep state after manufacture of the injection device 102. The microcontroller 120 may then remain in a sleep state until the injection device 102 is first used by a patient.

[0030] Continuing with reference to FIG. 1 , a patient may prime the injection device 102 (e.g., by performing a “prime”) before using the injection device 102 for the first time. A prime may reset the microcontroller 120, thereby allowing the microcontroller 120 to exit its sleep state and resume full functionality. As described above, a prime may be performed to remove air from the cartridge 104 and needle 109. The patient may select a small dose (e.g., two units of medication) using the dose knob 112 and press the inject button 111 while holding the injection device 102 with the needle 109 pointing up. The prime causes the piston 108 to drive the plunger 107 toward the member 115, causing the plunger 107 and member 115 to come into physical contact with each other.

[0031] The upper surface of the member 115 includes at least two conductive surfaces 122 electrically connected to the microcontroller 120. In particular, the conductive surfaces 122 are connected to pins of the microcontroller 120 associated with a reset operation of the microcontroller 120 (e.g., pins connected to a reset circuit). When the member 115 and the plunger 107 come into physical contact during a dry shot, the conductive surfaces 122 contact a conductive element 124 incorporated into the drive mechanism 106, particularly disposed on the underside of the plunger 107. Before the dry shot is performed, the plunger 107 and the conductive element 124 may be separated from the conductive surfaces 122 by a relatively short distance (e.g., less than 1 mm). The electrical contact electrically connects the pins of the microcontroller 120, thereby activating a reset circuit of the microcontroller 120 (e.g., triggering a reset switch), which initiates a reset of the microcontroller 120. After the reset, the microcontroller 120 can enter an enabled state in which the microcontroller 120 resumes full functionality for subsequent use by the patient.

[0032] Although the injection device 102 shown in FIG. 1 has been described as including a member 115 disposed on the cartridge 104, the member 115 including a conductive surface 122 configured to contact a conductive element 124 to reset the microcontroller 120, any of a variety of other types of members including various types of conductive surfaces may alternatively or additionally be used. Examples of other types of members that may be used include ring-shaped members, disk-shaped members, pin-shaped members, etc. In some embodiments, the conductive surface may be ring-shaped, disk-shaped, and / or may be a pin extending toward the conductive element. Similarly, any of a variety of other types of conductive elements may alternatively or additionally be used to contact the conductive surface of the member. Examples of other types of conductive elements that may be used include disk-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, ring-shaped conductive elements, conductive elements made from a conductive mesh material, etc.

[0033] In some embodiments, one or more additional techniques may be used to reset and cause the microcontroller 120 to enter a sleep state, which may be alternative to or in addition to the techniques described with respect to FIG.

[0034] In some embodiments, the microcontroller 120 is configured to receive a stimulus from one or more sensors that causes the microcontroller 120 to reset and enter an active state from a sleep state. Figure 2 shows another example of an injection device 202. The injection device 202 is substantially similar to the injection device 102 of Figure 1, but with differences described herein. In particular, one or more of the components incorporated into member 115 differ from those described with respect to Figure 1.

[0035] The injection device 202 includes a magnetoresistive sensor 204 (e.g., a giant magnetoresistive sensor (GMR sensor)) electrically connected to the microcontroller 120. In particular, the magnetoresistive sensor 204 is 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 satisfying a threshold amount, the magnetoresistive sensor 204 is configured to not 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 satisfying the threshold amount, the magnetoresistive sensor 204 is configured to provide a signal to the microcontroller 120 that resets the microcontroller 120 and causes it to enter an enabled state. That is, when the magnetoresistive sensor 204 no longer senses a magnetic field that satisfies a threshold amount, the magnetoresistive sensor 204 may provide a signal to the microcontroller 120 that electrically connects certain pins of the microcontroller 120, thereby activating a reset circuit in the microcontroller 120 that initiates a reset and places the microcontroller 120 in an enabled state in which the microcontroller 120 can resume full functionality for subsequent use by the patient.

[0036] In some embodiments, the injection device 202 may be packaged in packaging 210 after manufacture. The packaging 210 may include a cutout having a shape substantially similar to the injection device 202, allowing the injection device 202 to fit in a predetermined orientation within the packaging 210. The packaging 210 may also include a magnet 212 (e.g., a permanent magnet) that is disposed at or near the location where the magnetoresistive sensor 204 is located when the injection device 202 is located within the packaging 210. In some embodiments, the magnet 212 is embedded below the surface of the packaging (e.g., embedded in the cardboard form of the packaging).

[0037] The magnet 212 is configured to provide a magnetic field having a magnitude that satisfies a threshold amount to the magnetoresistive sensor 204 when the injection device 202 is located within the packaging 210. Thus, after manufacture, the injection device 202 may be put to sleep and inserted into the packaging 210. While the injection device 202 is kept within the packaging 210, the magnet 212 provides a magnetic field of a magnitude that satisfies the threshold amount, preventing the magnetoresistive sensor 204 from providing a reset signal to the microcontroller 120.

[0038] Prior to the patient's first use, the patient may remove the injection device 202 from the packaging 210. When the injection device 202 is removed from proximity of the magnet 212, the magnetic field sensed by the magnetoresistive sensor 204 no longer meets the threshold amount, and in response, the magnetoresistive sensor 204 provides a signal to the microcontroller 120 that causes the microcontroller 120 to reset and enter an enabled state.

[0039] In some embodiments, the magnet 212 may be attached to the inner needle cap 116 of the injection device, the outer needle cap 116 of the injection device, or both. The magnet 212 may be incorporated into one or more of the needle cap 117 and / or cap 118. In such a configuration, the magnet 212 is configured to provide a magnetic field having a magnitude that satisfies the threshold amount to the magnetoresistive sensor 204 when the caps 116, 117, and / or 118 are attached to the injection device 202. Prior to a patient's first use, the patient may remove the caps 116, 117, and / or 118 from the injection device 202, thereby causing the magnetic field sensed by the magnetoresistive sensor 204 to no longer satisfy the threshold amount, and in response, causing the microcontroller 120 to reset and enter an enabled state.

[0040] Figure 3 shows another example of an injection device 302. Like injection device 202 of Figure 2, injection device 302 is substantially similar to injection device 102 of Figure 1, except that one or more of the components incorporated into member 115 are different from those described with respect to Figure 1.

[0041] The injection device 302 includes a light sensor 304 electrically connected to the microcontroller 120. In some embodiments, the light sensor 304 may be a photodiode (e.g., a reverse-driven light-emitting diode (LED)) and / or a photoresistor. The light sensor 304 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 light sensor 304 is configured to provide an electrical signal based on the intensity of the detected light. For example, when light satisfying a threshold intensity is detected, the light sensor 304 is configured to provide a signal to the microcontroller 120 that resets the microcontroller 120 and causes it to enter an enabled state. In particular, the light sensor 304 may provide a signal to the microcontroller 120 that electrically connects certain pins of the microcontroller 120, thereby activating a reset circuit in the microcontroller 120 that initiates a reset and causes the microcontroller 120 to enter an enabled state in which it can resume full functionality for subsequent use by the patient.

[0042] In some embodiments, as described above, microcontroller 120 is configured to disable additional resets for a specified amount of time after microcontroller 120 has reset, exited its sleep state, and entered its enabled state. Such a feature can prevent microcontroller 120 from being held in a continuous reset state (e.g., when the ambient detected light meets a threshold intensity).

[0043] In some embodiments, cartridge 104 and member 115 are made from a transparent material that allows light to pass through, thereby enabling light to be detected by optical sensor 304. In some embodiments, cartridge 104 and member 115 may include a transparent window located proximate optical sensor 304.

[0044] In some embodiments, after manufacture, the injection device 302 is packaged in packaging that reduces and / or eliminates light provided to the light sensor 304. In some embodiments, one or more stickers and / or covers may be added to the exterior surface of the cartridge 104 that reduce and / or eliminate light provided to the light sensor 304. In this manner, the microcontroller 120 is kept asleep while in the packaging and / or while the stickers and / or covers are present. In some embodiments, the threshold intensity of light required to cause the light sensor 304 to provide a reset signal to the microcontroller 120 can be such that ambient light does not trigger a reset. For example, prior to a patient's first use, the patient may remove the injection device 302 from the packaging and / or remove the stickers and / or covers, which alone will not trigger a reset of the microcontroller 120. Light of sufficient intensity provided to the light sensor 304 The patient may be instructed to hold the injection device 302 under a light source (e.g., a lamp) so that a threshold intensity of light is obtained. In some embodiments, the patient may be instructed to shine a laser light (e.g., from a laser pointer) on the light sensor 304 to obtain a threshold intensity of light. Upon detecting light having an intensity that meets the threshold, the light sensor 304 provides a signal to the microcontroller 120 that resets the microcontroller 120 and causes it to enter an enabled state.

[0045] In some embodiments, instead of or in addition to the injection device 302 including an optical sensor 304 configured to detect light, the injection device 302 may include an X-ray diode configured to cause the microcontroller 120 to enter an enabled state when the X-ray diode detects X-ray radiation. The configuration of the X-ray diode with respect to the microcontroller 120 may be substantially similar to that described above with respect to the optical sensor 304, except that the X-ray diode is configured to provide a reset signal when X-ray radiation (as opposed to light meeting a threshold intensity) is detected. In some embodiments, a user may be instructed to apply an X-ray pulse to the X-ray diode using an X-ray device. In some embodiments, the X-ray pulse is applied by a medical professional (e.g., before a patient receives the injection device 302). For example, the X-ray pulse used to reset the microcontroller 120 is applied after manufacture and before use by a patient, such as to test the injection device 302. In one or more of the embodiments described herein, one or more resets of the injection device may occur at different stages of testing and / or use (e.g., after manufacture, during testing / calibration, before first patient use, during first patient use, during subsequent patient use, etc.).

[0046] Figure 4 shows another example of an injection device 402. Like the injection devices 202, 302 of Figures 2 and 3, the injection device 402 is substantially similar to the injection device 102 of Figure 1, except that one or more of the components incorporated into member 115 are different from those described with respect to Figure 1.

[0047] The injection device 402 includes a temperature-dependent resistor, such as a thermistor 404, electrically connected to the microcontroller 120. The 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). The thermistor 404 is configured to provide an electrical signal based on the sensed temperature. For example, when the thermistor 404 senses a temperature that satisfies a threshold, the thermistor 404 is configured to provide a signal to the microcontroller 120 that resets the microcontroller 120 and causes it to enter an enabled state. In particular, the thermistor 404 may provide a signal to the microcontroller 120 that electrically connects certain pins of the microcontroller 120, thereby activating a reset circuit in the microcontroller 120 that initiates a reset and causes the microcontroller 120 to enter an enabled state in which it can resume full functionality for subsequent use by the patient.

[0048] In some embodiments, the injection device 402 may be maintained within a particular temperature range after manufacture, during transport, and until receipt by the patient. In some embodiments, the particular temperature range may be approximately 2°C to about 8°C. In some embodiments, the particular temperature range may be approximately -4°C to about 4°C. The appropriate temperature range may be selected based on the particular medication to ensure appropriate conditions. The temperature range that the injection device 402 is maintained in during transport may be such that the threshold temperature is not met and therefore the thermistor 404 does not provide a reset signal to the microcontroller 120. When the patient receives the injection device 402, the injection device is exposed to a temperature (e.g., room temperature) that meets the threshold temperature. The thermistor 404 then The FIFO provides a signal to the microcontroller 120 to reset it and enter a valid state.

[0049] In some embodiments, the threshold temperature may be relatively high (e.g., above room temperature). For example, the threshold temperature may require the patient to apply heat to the thermistor 404 to reach the threshold temperature. In some examples, the patient may be instructed to apply heat to the injection device 402, particularly to the portion of the injection device 402 that includes the thermistor 404. In some embodiments, the patient may be instructed to use a heat gun and / or laser to apply heat to the thermistor 404 to reach the threshold temperature, thereby causing the thermistor 404 to send a reset signal to the microcontroller 120.

[0050] Figure 5 shows another example of an injection device 502. Like the injection devices 202, 302, 402 of Figures 2-4, the injection device 502 is substantially similar to the injection device 102 of Figure 1, except that one or more of the components incorporated into member 115 are different from those described with respect to Figure 1.

[0051] 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 the detected Wi-Fi radiation. For example, when a Wi-Fi radiation is detected by the Wi-Fi sensor 504, the Wi-Fi sensor 504 is configured to provide a signal to the microcontroller 120 that resets the microcontroller 120 and causes it to enter an enabled state. In particular, the Wi-Fi sensor 504 may provide a signal to the microcontroller 120 that electrically connects certain pins of the microcontroller 120, thereby activating a reset circuit in the microcontroller 120 that initiates a reset and causes the microcontroller 120 to enter an enabled state in which it can resume full functionality for subsequent use by the patient.

[0052] In some embodiments, the Wi-Fi radiation detected by the 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 workplaces. In some embodiments, the injection device 502 is provided as part of a system that includes the injection device 502 and packaging 510 configured to house the injection device 502 and block Wi-Fi radiation from the Wi-Fi sensor 504. The packaging 510 may include an electromagnetic protective layer. The injection device 502 may be packaged after manufacture and may be kept in the packaging 510 during transport and until received by the patient. When the patient receives the injection device 502, the patient may remove the injection device 502 from the Wi-Fi-blocking packaging 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 packaging 510 is made from a material such as aluminum, although other suitable materials may additionally or alternatively be used.

[0053] In some embodiments, the Wi-Fi sensor 504 may provide a reset signal when the detected Wi-Fi emissions meet a threshold amount (e.g., a threshold signal strength). In some embodiments, the patient may be instructed to position the injection device 502 near a Wi-Fi signal source (e.g., a wireless router, a mobile electronic device, etc.) to achieve the threshold amount.

[0054] Figure 6 shows another example of an injection device 602. Like injection devices 202, 302, 402, 502 of Figures 2-5, injection device 602 is substantially similar to injection device 102 of Figure 1, except that one or more of the components incorporated into member 115 are different from those described with respect to Figure 1.

[0055] The injection device 602 includes an antenna and a sensor configured to receive an electromagnetic signal (e.g., a radio frequency signal), such as a radio frequency identification (RFID) sensor. In the example shown in FIG. 6, 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 an NFC signal from an NFC element 612 (e.g., an NFC tag, an NFC sensor / reader / antenna, etc.) of a computing device. In some embodiments, the computing device may be a mobile computing device such as a mobile phone 610 (e.g., a smartphone), although other computing devices may additionally or alternatively be used, including, but not limited to, an electronic tablet, a laptop computer, a wearable electronic device, etc. Prior to the patient's first use, the patient may be instructed to position the injection device 602 proximate to the mobile phone 610. When the injection device 602 is within 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 that causes the microcontroller 120 to reset and enter a valid state. In particular, the NFC sensor 604 may provide a signal to the microcontroller 120 that electrically connects certain pins of the microcontroller 120, thereby activating a reset circuit in the microcontroller 120 that initiates a reset and causes the microcontroller 120 to enter a valid state in which it can resume full functionality for subsequent use by the patient.

[0056] In some embodiments, instead of or in addition to the injection device 602 including 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 including 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 a Bluetooth signal to the Bluetooth antenna. Prior to the patient's first use, the patient may be instructed to position the injection device 602 proximate to the mobile phone 610. When the injection device 602 is within sufficient distance of the mobile phone 610, the Bluetooth antenna receives a signal from the Bluetooth element, which then provides a signal to the microcontroller 120 that causes the microcontroller 120 to reset and enter an enabled state.

[0057] Figure 7 shows another example of an injection device 702. Like injection devices 202, 302, 402, 502, 602 of Figures 2-6, injection device 702 is substantially similar to injection device 102 of Figure 1, except that one or more of the components incorporated into member 115 are different from those described with respect to Figure 1.

[0058] The injection device 702 includes a resonant circuit 704 electrically connected to the 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 includes a resonant frequency (RF) and an inductor, a capacitor, and a rectifier diode, which are arranged to have specific values ​​such that the resonant circuit 704 tunes 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 the 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 to reset and enter an enabled state. In particular, the resonant circuit 704 may provide a signal to the microcontroller 120 that electrically connects specific pins of the microcontroller 120, thereby activating a reset circuit in the microcontroller 120 that initiates a reset and places the microcontroller 120 in an enabled state where the microcontroller 120 can resume full functionality for subsequent use by the patient. In some embodiments, the resonant frequency may be approximately within the range of 50 kHz to 2 MHz (e.g., 100 kHz, 1 MHz, etc.). In some embodiments, the resonant frequency may be a frequency not typically generated by commonly available devices. In this manner, unintentional resets of the microcontroller may be minimized.

[0059] In some embodiments, the magnetic field having a particular (e.g., resonant) frequency is provided by a separate electronic device. Such an electronic device may 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 particular frequency may improve safety. In particular, since a magnetic field having a particular 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 cause it to enter an enabled state.

[0060] Figures 8a and 8b show other examples of injection devices 802, 803. Like injection devices 202, 302, 402, 502, 602, 702 of Figures 2-7, injection devices 802, 803 are substantially similar to injection device 102 of Figure 1, except that one or more of the components incorporated into member 115 are different from those described with respect to Figure 1.

[0061] 8a, the injection device 802 includes a circuit 804 electrically connected to the microcontroller 120. The circuit 804 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 circuit 804 may include a transistor 806, a fuse 808, and a power source, such as a battery 810. In the illustrated example, the circuit 804 is arranged such that the transistor 806 is a self-conducting N-type metal-oxide-semiconductor field-effect transistor (FET) (e.g., a normally open N-type MOSFET), although other transistors, such as a P-type MOSFET, may additionally or alternatively be used. In the initial state of the circuit 804 (e.g., when the fuse 808 is not blown), no reset signal is provided to the microcontroller 120. When the fuse 808 blows, the transistor 806 switches so that a reset signal (e.g., in the form of an input voltage or current) is applied to the microcontroller 120, thereby resetting the microcontroller 120 and causing it to exit its sleep state and enter its enabled state. In particular, when fuse 808 blows, transistor 806 may provide a signal to microcontroller 120 to electrically connect certain pins of microcontroller 120, thereby activating a reset circuit in microcontroller 120 that initiates a reset and places microcontroller 120 in an enabled state that allows microcontroller 120 to resume full functionality for subsequent use by the patient.

[0062] In some embodiments, circuit 804 may be configured such that, initially (e.g., when fuse 808 is not blown), transistor 806 connects microcontroller 120 to battery 81 0. When fuse 808 blows, transistor 806 switches such that it electrically connects microcontroller 120 to battery 810. In this manner, microcontroller 120 remains powered off (e.g., rather than being kept in a sleep state) until it is ready for use by the patient. Once connected to battery 810, microcontroller 120 can enter an enabled state in which microcontroller 120 can resume full functionality for subsequent use by the patient.

[0063] Referring to FIG. 8b, the injection device 803 includes a circuit 814 electrically connected to the microcontroller 120. The circuit 814 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 circuit 814 may include a transistor 816, a fuse 818, and a power source, such as a battery 820. In the illustrated example, the circuit 814 may operate in a manner substantially similar to the circuit 804 described above with respect to FIG. 8a, except that the circuit 814 is arranged such that the transistor 816 is a self-locking N-type metal-oxide-semiconductor field-effect transistor (FET), (e.g., a normally closed N-type MOSFET), although other transistors, such as a P-type MOSFET, may additionally or alternatively be used. In the initial state of the circuit 814 (e.g., when the fuse 818 is not blown), no reset signal is provided to the microcontroller 120. When fuse 818 blows, transistor 816 switches such that a reset signal (e.g., in the form of an input voltage or current) is applied to microcontroller 120, thereby resetting microcontroller 120 and causing it to exit a sleep state and enter an enabled state. In particular, when fuse 818 blows, transistor 816 may provide a signal to microcontroller 120 that electrically connects certain pins of microcontroller 120, thereby activating a reset circuit in microcontroller 120 that initiates a reset and causes microcontroller 120 to enter an enabled state where it can resume full functionality for subsequent use by the patient.

[0064] 8a, in some embodiments, circuit 814 is positioned 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 is blown, transistor 816 switches such that transistor 816 electrically connects microcontroller 120 to battery 820. In this manner, microcontroller 120 is kept powered off (e.g., rather than kept in a sleep state) until it is ready for use by the patient. Once connected to battery 820, microcontroller 120 can enter an enabled state in which microcontroller 120 can resume full functionality for subsequent use by the patient.

[0065] The circuits 804, 814 may have different configurations than those shown in Figures 8a and 8b. For example, in some embodiments, the circuits 804, 814 may include one or more additional transistors 806, 816 and / or one or more additional fuses 808, 818.

[0066] The fuses 806, 816 may blow in response to irradiation by a light source (e.g., a laser light source). For example, laser light may apply heat to the fuses 806, 816, causing them to blow. The laser light may be provided by a separate electronic device provided with the injection device 802, 803. Before the patient uses the injection device 802, 803 for the first time, the patient may be instructed to operate the electronic device to emit laser light to blow the fuses 806, 816. In some embodiments, the cartridge 104 and member 115 are made from a transparent material that allows light to pass through, thereby allowing the laser light to pass through. This allows the light to shine onto the fuses 806, 816. In some embodiments, the cartridge 104 and member 115 may include a transparent window located proximal to the fuses 806, 816.

[0067] Figure 9 shows another example of an injection device 902. Like injection devices 202, 302, 402, 502, 602, 702, 802, 803 of Figures 2-8b, injection device 902 is substantially similar to injection device 102 of Figure 1, except that one or more of the components incorporated into member 115 differs from those described with respect to Figure 1. Additionally, additional components are incorporated into cover 918.

[0068] In the illustrated example, the injection device 902 is configured to harvest energy from a power source and uses the harvested energy to power the microcontroller 120. In particular, the injection device 902 includes a second circuit 904 configured to receive power from a first circuit 914 integrated into a cover 918 (e.g., a needle cover).

[0069] The first circuit 914 includes a power source 917 (e.g., an AC power source) and a first induction coil 916 (e.g., a primary coil). The power source 917 may be provided by an AC outlet, and the cover 918 may include a power cord configured to plug into the AC outlet and provide AC power to the circuit 914. In some embodiments, the cover 918 is incorporated into a base (e.g., a stand) configured to support the injection device 902 when not in use. The power source 917 provides power to the first induction coil 916, causing the first induction coil 916 to generate an electromagnetic field that is received by the second circuit 904.

[0070] The second circuit 904 generates power from the electromagnetic field generated by the first induction coil 916. In particular, the second circuit 904 includes the second induction coil 906, which is configured to receive the electromagnetic field from the first induction coil 916 and generate power using the received electromagnetic field. The second circuit 904 also includes a capacitor, such as a supercapacitor 907, which is configured to store the power generated by the second induction coil 906. The second circuit 904 also includes a diode 908 that allows DC to pass. 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., in place of a battery). In this way, the injection device 902 can operate without the need for a battery (e.g., a rechargeable battery). However, in some embodiments, the supercapacitor 907 may be replaced with another power source (e.g., a rechargeable power source), such as a rechargeable battery.

[0071] When the cap 918 is within a threshold range of the member 115 (e.g., when the cap 918 is attached to the housing 103 of the injection device 902), the first induction coil 916 and the second induction coil 906 form an electromagnetic link that enables inductive charging. The first induction coil 916 and the second induction coil 906 thus act as a transformer that charges the supercapacitor 907. When the cap 918 is no longer within the threshold range of the member 115 (e.g., when the cap 918 is removed from the housing 103 before use by a patient), the electromagnetic link is temporarily broken and inductive charging is stopped. However, even when the link is broken, the power stored in the supercapacitor 907 can still be used to power the microcontroller 120. When the power stored in the supercapacitor 907 is lost, the cap 918 can be reattached to the housing 103 and the supercapacitor 907 can be recharged by inductive charging.

[0072] In some embodiments, the supercapacitor 907 is an electric double layer capacitor (EDLC) that provides relatively large electrical storage capacity (e.g., compared to conventional capacitors). Supercapacitors 907 may have much higher capacitance values ​​than conventional capacitors and can store 10 to 100 times more energy per unit volume or mass than electrolytic capacitors. Furthermore, supercapacitors 907 can accept and deliver charge at rates significantly faster than those typically provided by rechargeable batteries.

[0073] FIG. 10 is a block diagram of an exemplary computer system 100. For example, the microcontroller 120 of FIGS. 1-9 and / or the computing device of FIG. 6 (e.g., mobile phone 610) can be examples of the computer system 1000. In some implementations, an injection device may be configured to interact with a separate computer system 1000. The system 1000 includes a processor 1010, a memory 1020, a storage device 1030, and an input / output device 1040. Each of the components 1010, 1020, 1030, and 1040 can be interconnected using, for example, a system bus 1050. The processor 1010 can process instructions for execution within the system 1000. The processor 1010 can be a single-threaded processor, a multi-threaded processor, or a quantum computer. The processor 1010 can process instructions stored in the memory 1020 or the storage device 1030. The processor 1010 may perform operations such as causing the injection device to perform one or more of the operations described above.

[0074] 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 unit or a non-volatile memory unit. In some embodiments, the memory 1020 stores information related to the operations described above.

[0075] The storage device 1030 can provide mass storage for the system 1000. In some embodiments, the storage device 1030 is a non-transitory computer-readable medium. The storage device 1030 can include, for example, a hard disk device, an optical disk device, a solid-state drive, a flash drive, a magnetic tape, or some other mass storage device. The storage device 1030 can alternatively be a cloud storage device, e.g., a logical storage device including multiple physical storage devices distributed over and accessed using a network. In some embodiments, information stored in the memory 1020 can additionally or alternatively be stored in the storage device 1030.

[0076] The input / output device(s) 1040 provide input / output operations for the system 1000. In some embodiments, the input / output device(s) 1040 include one or more of a network interface device (e.g., an Ethernet card), a serial communication device (e.g., an RS-232 port), and / or a wireless interface device (e.g., a short-range wireless communication device, an 802.11 card, a 3G wireless modem, or a 4G wireless modem). In some embodiments, the input / output device(s) 1040 include a driver device configured to receive input data and send output data to other input / output devices, such as keyboards, printers, and display devices (e.g., dosage window 113, etc.). In some embodiments, mobile computing devices, mobile communication devices, and other devices are used.

[0077] In some embodiments, system 1000 is a microcontroller. A microcontroller is a device that houses multiple elements of a computer system in a single electronic package. For example, a single electronic package may house a processor 1010, memory 1020, storage devices 1030, and input / output devices 1040. Cut.

[0078] Although an exemplary processing system has been described in FIG. 10 , embodiments of the subject matter and functional operations described above may be embodiments of other types of digital electronic circuitry, or computer software, firmware, or hardware, including the structures disclosed herein, their structural equivalents, or one or more combinations thereof. Embodiments of the subject matter described herein may be implemented as one or more computer program products, e.g., one or more modules of computer program instructions encoded on a tangible program carrier, e.g., a computer-readable medium, for execution by or to control the operation of a processing system. The computer-readable medium may be a machine-readable storage device, a machine-readable storage substrate, a memory device, a composition affecting a machine-readable propagated signal, or a combination of one or more of these.

[0079] The term "computer system" may encompass all apparatus, devices, and machines for processing data, including, by way of example, a programmable processor, computer, or multiple processors or computers. In addition to hardware, a processing system may include code that creates an execution environment for a computer program of interest, such as code that constitutes processor firmware, a protocol stack, a database management system, an operating system, or a combination of one or more of these.

[0080] A computer program (also known as a program, software, software application, script, executable logic, or code) can be written in any form of programming language, including compiled or interpreted languages, or declarative or procedural languages, and can be implemented in any form, including as a stand-alone 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 part of a file that holds other programs or data (e.g., one or more scripts stored in a markup language document), in a single file dedicated to the program, or in multiple coordinated files (e.g., files storing one or more modules, subprograms, or portions of code). A computer program can be implemented to run on one computer or on multiple computers located at one site or distributed across multiple sites and interconnected by a communications network.

[0081] Computer-readable media suitable for storing computer program instructions and data include all forms of non-volatile or volatile memory, media, and memory devices, including, by way of example, semiconductor memory devices such as EPROM, EEPROM, and flash memory devices; magnetic disks, such as internal hard disks or removable disks, or magnetic tape; magneto-optical disks; CD-ROM and DVD-ROM disks. The processor and memory can be supplemented by, or incorporated in, special purpose logic circuitry. The components of the system can be interconnected by any form or medium of digital data communication, e.g., a communications network. Examples of communications networks include local area networks ("LANs") and wide area networks ("WANs"), e.g., the Internet.

[0082] As used herein, the term "drug" or "medicine" is used herein to describe one or more pharmaceutically active compounds. As described below, a drug or agent can include at least one small molecule or large molecule, or a combination thereof, in various types of formulations for treating one or more diseases. Exemplary pharmaceutically active compounds can 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 can be incorporated into molecular delivery systems such as vectors, plasmids, or liposomes. Mixtures of one or more of these drugs are also contemplated.

[0083] 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 complications associated with diabetes, such as diabetic retinopathy, and thromboembolic disorders, such as deep vein thromboembolism or pulmonary thromboembolism. Further exemplary disorders are acute coronary syndrome (ACS), angina pectoris, myocardial infarction, cancer, macular degeneration, inflammation, hay fever, atherosclerosis, and / or rheumatoid arthritis.

[0084] Exemplary drugs for the treatment and / or prevention of diabetes or complications associated with diabetes include insulin, e.g., human insulin, or a human insulin analog or derivative, glucagon-like peptide (GLP-1), a GLP-1 analog or GLP-1 receptor agonist, or an analog or derivative thereof, a dipeptidyl peptidase-4 (DPP4) inhibitor, or a pharmaceutically acceptable salt or solvate thereof, or any mixture thereof. As used herein, the term "derivative" refers to any substance that is sufficiently structurally similar to the original substance so as to thereby have a similar function or activity (e.g., therapeutic efficacy).

[0085] Exemplary insulin analogs are Gly(A21),Arg(B31),Arg(B32) human insulin (insulin glargine); Lys(B3),Glu(B29) human insulin; Lys(B28),Pro(B29) human insulin; Asp(B28) human insulin; human insulin in which the proline at position B28 is replaced by Asp, Lys, Leu, Val, or Ala, and in which Lys at position B29 may be replaced by Pro; Ala(B26) human insulin; Des(B28-B30) human insulin; Des(B27) human insulin and Des(B30) human insulin.

[0086] 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-myristoylLysProB29 human insulin; B28-N-palmitoyl-LysProB29 human insulin; B30-N-myristoyl-ThrB29Ly sB30 human insulin; B30-N-palmitoyl-ThrB29LysB30 human insulin; B29-N-(N-palmitoyl-γ-glutamyl)-des(B30) human insulin; B29-N-(N-lithocholyl-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: Lixisenatide / AVE0010 / ZP10 / Lyxumia, Exenatide / Exenatide. Exendin-4 / Byetta / Bydureon / ITCA650 / AC-2993 (a 39 amino acid peptide produced by the salivary glands of the Gila monster), Liraglutide / Victoza, Semaglutide, Taspoglutide, Syncria / Albiglutide, Dulaglutide, Exendin-4, CJC-1134-PC, PB-1023, TTP-054, Langrenatide Langlenatide / HM-11260C, CM-3, GLP-1 Erigen, 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.

[0087] An exemplary oligonucleotide is, for example: mipomersen / Kynamro, a cholesterol-lowering antisense therapeutic for the treatment of familial hypercholesterolemia.

[0088] Exemplary DPP4 inhibitors are Vildagliptin, Sitagliptin, Denagliptin, Saxagliptin, Berberine.

[0089] Exemplary hormones include pituitary or hypothalamic hormones or regulatory active peptides and their antagonists, such as gonadotropins (follitropin, lutropin, chorion gonadotropins, menotropins), somatropins (somatropins), desmopressin, terlipressin, gonadorelin, triptorelin, leuprorelin, buserelin, nafarelin, and goserelin.

[0090] Exemplary polysaccharides include glycosaminoglycans, hyaluronic acid, heparin, low molecular weight heparin, or ultra-low molecular weight heparin, or derivatives thereof, or sulfated forms of the aforementioned polysaccharides, e.g., polysulfated forms, and / or pharmaceutically acceptable salts thereof. An example of a pharmaceutically acceptable salt of polysulfated low molecular weight heparin is enoxaparin sodium. Examples of hyaluronic acid derivatives include Hylan G-F20 / Synvisc, sodium hyaluronate.

[0091] As used herein, the term "antibody" refers to an immunoglobulin molecule or an antigen-binding portion thereof. Examples of antigen-binding portions of immunoglobulin molecules include F(ab) and F(ab')2 fragments that retain the ability to bind antigen. Antibodies can be polyclonal, monoclonal, recombinant, chimeric, non-immunized, or humanized, fully human, non-human (e.g., murine), or single-chain antibodies. In some embodiments, antibodies have effector functions and can fix complement. In some embodiments, antibodies have reduced ability to bind or are unable to bind Fc receptors. For example, antibodies can be isotypes or subtypes, antibody fragments, or variants that do not support binding to Fc receptors, e.g., they have mutated or deleted Fc receptor binding regions.

[0092] The term "fragment" or "antibody fragment" does not include a full-length antibody polypeptide, but still contains at least a portion of a full-length antibody polypeptide that is capable of binding to an antigen. "Antibody fragments" refers to polypeptides derived from antibody polypeptide molecules (e.g., antibody heavy and / or light chain polypeptides), including those derived from antibody polypeptide molecules (e.g., antibody heavy and / or light chain polypeptides). Antibody fragments can include cleaved portions of full-length antibody polypeptides, although the term is not limited to such cleaved fragments. Antibody fragments useful in the present invention include, for example, monospecific or multispecific antibody fragments such as Fab fragments, F(ab')2 fragments, scFv (single-chain Fv) fragments, linear antibodies, bispecific, trispecific, and multispecific antibodies (e.g., diabodies, triabodies, tetrabodies), minibodies, chelating recombinant antibodies, tribodies or bibodies, intrabodies, nanobodies, small modular immunopharmaceuticals (SMIPs), binding domain immunoglobulin fusion proteins, camelized antibodies, and VHH-containing antibodies. Further examples of antigen-binding antibody fragments are known in the art.

[0093] The term "complementarity-determining region" or "CDR" refers to short polypeptide sequences within the variable regions of both heavy and light chain polypeptides that are primarily responsible for mediating specific antigen recognition. The term "framework region" refers to amino acid sequences within the variable regions of both heavy and light chain polypeptides that are not CDR sequences but are primarily responsible for maintaining the correct positioning of the CDR sequences to enable antigen binding. Although framework regions themselves are generally not directly involved in antigen binding, as is known in the art, certain residues within the framework regions of a particular antibody may be directly involved in antigen binding or may affect the ability of one or more amino acids within the CDRs to interact with the antigen.

[0094] 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).

[0095] The compounds described herein can be used in pharmaceutical preparations comprising (a) the compound or its pharmaceutically acceptable salt, and (b) a pharmaceutically acceptable carrier.The compounds can also be used in pharmaceutical preparations that contain one or more other active pharmaceutical ingredients, or in pharmaceutical preparations in which the compound or its pharmaceutically acceptable salt is the only active ingredient present.Therefore, the pharmaceutical preparations of the present disclosure encompass any preparation that is made by mixing the compounds described herein and a pharmaceutically acceptable carrier.

[0096] Pharmaceutically acceptable salts of any of the drugs described herein are also contemplated for use in the drug delivery device. Pharmaceutically acceptable salts include, for example, acid addition salts and basic salts. Acid addition salts include, for example, HCl or HBr salts. Basic salts include, for example, salts having a cation selected from alkali or alkaline earth metals, such as Na, K, or Ca, or ammonium ions N(R)(R)(R)(R), where R to R are independently hydrogen, an optionally substituted C-C alkyl group, an optionally substituted C-C alkenyl group, an optionally substituted C-C aryl group, or an optionally substituted C-C heteroaryl group. Further examples of pharmaceutically acceptable salts are known to those skilled in the art.

[0097] Pharmaceutically acceptable solvates are, for example, hydrates or alkanolates, such as methanolates or ethanolates.

[0098] Modifications (e.g., adjustments, additions, or removals) of the various components of the materials, formulations, apparatus, methods, systems, devices, and embodiments described herein are not intended to be limiting unless expressly stated and should not be construed as limiting the full scope of the inventive concept. Those skilled in the art will recognize that modifications may be made without departing from the scope and spirit of the present invention, and that the full scope and spirit of the inventive concept encompasses all such modifications and any equivalents thereof.

[0099] Numerous embodiments of the systems and techniques described herein have been presented. However, it will be understood that various modifications may be made without departing from the spirit and scope of such systems and techniques. Accordingly, other embodiments are within the scope of the following claims.

[0100] Clause 1: A drug injection device (102) comprising: a cartridge (104) configured to hold a volume of medication; one or more processors (120) configured to operate in at least an active state and a sleep state, wherein the one or more processors (120) are configured to control operation of the medication injection device (102) while in the active state; a member (115) disposed in the cartridge (104), the member (115) including at least two conductive surfaces (122) electrically connected to one or more processors (120); a drive mechanism (106) including a conductive element (124) spaced apart from at least two conductive surfaces (122); wherein the one or more processors (120) are configured to enter an active state from a sleep state when the conductive element (124) makes electrical contact with at least two conductive surfaces (122).

[0101] Clause 2: A drug injection device (102) according to clause 1, wherein the member (115) is a stopper and the conductive element (124) is disposed on the underside of the plunger (107) of the drive mechanism (106).

[0102] Clause 3: A drug injection device (102) as described in Clause 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 at least two conductive surfaces (122).

[0103] Clause 4: The drug injection device (102) of clause 3, wherein the drive mechanism (106) is engaged during priming of the drug injection device (102).

[0104] Clause 5: A drug injection device (102) as described in clause 1, wherein a reset circuit of one or more processors (120) is activated when the conductive element (124) comes into electrical contact with at least two conductive surfaces (122).

[0105] Clause 6: A drug injection device (102) as described in clause 1, further comprising one or more non-transitory computer-readable media (1030) storing instructions operable to cause one or more processors (120) to control the operation of the drug injection device (102).

[0106] Clause 7: A drug injection device (102) as described in Clause 6, wherein the one or more non-transitory computer-readable media (1030) includes a ferroelectric random access memory (FRAM) configured to store data without a continuous power supply.

[0107] Clause 8: A drug injection device (202, 302, 402, 502, 602, 702) comprising: a cartridge (104) configured to hold a volume of medication; one or more processors (120) configured to operate in at least an active state and a sleep state, wherein the one or more processors (120) are configured to control operation of the drug injection device (202, 302, 402, 502, 602, 702) while in the active state; a sensor in communication with one or more processors (120), the sensor configured to cause the one or more processors (120) to enter an active state from a sleep state in response to a stimulus; The drug injection device.

[0108] Clause 9: A drug injection device (202) as described in clause 8, wherein the sensor is a magnetoresistive sensor (204) configured to cause one or more processors (120) to enter an enabled state when the magnetoresistive sensor (204) no longer detects a magnetic field that satisfies a threshold amount.

[0109] Clause 10: A drug injection device (202) as described in clause 9, wherein the drug injection device (202) is configured to be within a package (210) including a magnet (212) that provides a magnetic field that satisfies a threshold amount, and the one or more processors (120) enter an enabled state when the drug injection device (202) is removed from the package (210).

[0110] Clause 11: A drug injection device (202) as described in clause 9, further comprising caps (116, 117, 118) configured to be attached to the housing (103) of the drug injection device (202), the caps (116, 117, 118) comprising magnets (212) that provide a magnetic field that satisfies a threshold amount, and wherein the one or more processors (120) enter an enabled state when the caps (116, 117, 118) are removed from the housing (103).

[0111] Clause 12: A drug injection device (302) as described in clause 8, wherein the sensor includes one or both of a photodiode or a photoresistor configured to cause one or more processors (120) to enter an enabled state when the photodiode or photoresistor detects light that satisfies a threshold intensity.

[0112] Clause 13: A drug injection device (402) as described in clause 8, wherein the sensor is a thermistor (404) configured to cause one or more processors (120) to enter an enabled state when the thermistor (404) detects a temperature that satisfies a threshold value.

[0113] Clause 14: A drug injection device (302) as described in clause 8, wherein the sensor is an X-ray diode configured to cause one or more processors (120) to enter an enabled state when the X-ray diode detects X-ray radiation.

[0114] Clause 15: A drug injection device (502) as described in clause 8, wherein the sensor is a Wi-Fi sensor (504) configured to cause one or more processors (120) to enter an enabled state when the Wi-Fi sensor (504) detects Wi-Fi radiation.

[0115] Clause 16: A drug injection device (502) as described in clause 15, wherein the drug injection device (502) is configured to be within a packaging (510) that blocks Wi-Fi radiation, and the one or more processors (120) enter an enabled state when the drug injection device (502) is removed from the packaging (510).

[0116] Clause 17: The sensor is a Near Field Communication (NFC) sensor (604) that 9. The drug injection device (602) of clause 8, wherein the NFC sensor (604) is configured to cause the one or more processors (120) to enter an enabled state upon receiving an NFC signal from the drug injection device.

[0117] Clause 18: The drug injection device (602) of clause 17, wherein the computing device is a mobile phone (610).

[0118] Clause 19: A drug injection device (602) as described in clause 8, wherein the sensor includes a Bluetooth antenna configured to cause one or more processors (120) to enter an enabled state when the Bluetooth antenna receives a Bluetooth signal from the computing device.

[0119] Clause 20: A drug injection device (702) as described in clause 8, wherein the sensor includes a resonant circuit (704) configured to cause one or more processors (120) to enter an enabled state when the resonant circuit (704) detects a magnetic field having a resonant frequency.

[0120] Clause 21: A drug injection device (502) comprising: a cartridge (104) configured to hold a volume of a drug; one or more processors (120) configured to operate in at least an active state and a sleep state, wherein the one or more processors (120) are configured to control operation of the medication injection device (502) while in the active state; and a Wi-Fi sensor (504) in communication with one or more processors (120), the Wi-Fi sensor (504) configured to cause the one or more processors (120) to enter an active state from a sleep state when the Wi-Fi sensor (504) detects a Wi-Fi emission; a drug injection device (502) including: a packaging (510) configured to house the drug injection device (502) after manufacture until first use by a patient, the packaging (510) including a material that blocks Wi-Fi radiation to prevent one or more processors (120) from entering an enabled state until the drug injection device (502) is removed from the packaging (510); A system including:

[0121] Clause 22: A drug injection device (802, 803) comprising: a cartridge (104) configured to hold a volume of a drug; one or more processors (120) configured to operate in at least an active state and a sleep state, wherein the one or more processors (120) are configured to control operation of the drug injection device (802, 803) while in the active state; a circuit (804, 814) electrically connected to one or more processors (120), the circuit (804, 814) including one or more transistors (806, 816) and one or more fuses (808, 818), the one or more transistors (806, 816) configured to cause the one or more processors (120) to enter an enabled state from a sleep state in response to the one or more fuses (808, 818) being blown; The drug injection device comprising:

[0122] Clause 23: A drug injection device (802, 803) according to clause 22, wherein one or more fuses (806, 816) are blown in response to irradiation with laser light.

[0123] Clause 24: A drug injection device (802, 803) according to clause 23, wherein the laser light is irradiated by an electronic device provided together with the drug injection device (802, 803).

[0124] Clause 25: A drug injection device (802, 803) according to clause 23, wherein the heat applied by the laser light causes one or more fuses (806, 816) to blow.

[0125] Clause 26: A drug injection device (802, 803) comprising: a cartridge (104) configured to hold a volume of medication; one or more processors (120) configured to control the operation of the drug injection device (802, 803); a circuit (804, 814) electrically connected to 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), the one or more transistors (806, 816) electrically isolating the one or more processors (120) from the battery (810, 820) when the one or more fuses (808, 818) are not blown, and the one or more transistors (806, 816) electrically connecting the one or more processors (120) to the battery (810, 820) when the one or more fuses (808, 818) are blown; The drug injection device comprising:

[0126] Clause 27: A drug injection device (802, 803) according to clause 26, wherein one or more fuses (808, 818) are blown in response to irradiation with laser light.

[0127] Clause 28: A drug injection device (802, 803) according to clause 27, wherein the laser light is irradiated by an electronic device provided together with the drug injection device (802, 803).

[0128] Clause 29: A drug injection device (802, 803) according to clause 27, wherein the heat applied by the laser light causes one or more fuses (808, 818) to blow.

[0129] Clause 30: A drug injection device (902) comprising: a cartridge (104) configured to hold a volume of medication; 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 a drug injection device (902), the cover (918) including a first induction coil (916) configured to be electrically connected to a power source (917); a circuit (904) electrically connected to one or more processors (120), the circuit (904) including a second induction coil (906) and a supercapacitor (907), the second induction coil (906) configured to receive an electromagnetic field from the first induction coil (916) and generate power that is stored by the supercapacitor (907) and provided to the one or more processors (120); 1. A drug injection device comprising:

Claims

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

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

3. 2. The drug injection device (102) of claim 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).

4. The medication injection device (102) of claim 3, wherein the drive mechanism (106) is engaged during priming of the medication injection device (102).

5. 10. The drug injection device (102) of claim 1, wherein the conductive element (124) making electrical contact with at least two conductive surfaces (122) activates a reset circuit of one or more processors (120).

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 one or more processors (120) to control the operation of the drug injection device (102).

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

8. 1. A drug injection device (202, 302, 402, 502, 602, 702) comprising: a cartridge (104) configured to hold a volume of medication; one or more processors (120) configured to operate in at least an active state and a sleep state, the one or more processors (120) configured to control operation of the drug injection device (202, 302, 402, 502, 602, 702) while in the active state; a sensor in communication with one or more processors (120), the sensor configured to cause the one or more processors (120) to enter an active state from a sleep state in response to a stimulus; The drug injection device.

9. 9. The drug injection device (202) of claim 8, wherein the sensor is a magnetoresistive sensor (204) configured to cause one or more processors (120) to enter an enabled state when the magnetoresistive sensor (204) no longer detects a magnetic field that satisfies a threshold amount.

10. A drug injection device (502) comprising: a cartridge (104) configured to hold a volume of a drug; one or more processors (120) configured to operate in at least an active state and a sleep state, the one or more processors (120) configured to control operation of the drug injection device (502) while in the active state; and a Wi-Fi sensor (504) in communication with one or more processors (120), the Wi-Fi sensor (504) configured to cause the one or more processors (120) to enter an active state from a sleep state when the Wi-Fi sensor (504) detects Wi-Fi radiation; a drug injection device comprising: a package (510) configured to house the drug injection device (502) after manufacture until first use by a patient, the package (510) including a material that blocks Wi-Fi radiation to prevent one or more processors (120) from entering an enabled state until the drug injection device (502) is removed from the package (510); A system including:

11. A drug injection device (802, 803) comprising: a cartridge (104) configured to hold a volume of medication; one or more processors (120) configured to operate in at least an active state and a sleep state, the one or more processors (120) configured to control operation of the drug injection device (802, 803) while in the active state; a circuit (804, 814) electrically connected to one or more processors (120), the circuit (804, 814) including one or more transistors (806, 816) and one or more fuses (808, 818), the one or more transistors (806, 816) configured to cause the one or more processors (120) to enter an enabled state from a sleep state in response to the one or more fuses (808, 818) being blown; The drug injection device comprising:

12. 12. The drug injection device (802, 803) of claim 11, wherein the one or more fuses (806, 816) are blown in response to irradiation with laser light.

13. A drug injection device (802, 803) comprising: a cartridge (104) configured to hold a volume of medication; one or more processors (120) configured to control the operation of the drug injection device (802, 803); A circuit (804, 814) electrically connected to 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), the one or more transistors (806, 816) electrically isolating the one or more processors (120) from the battery (810, 820) when the one or more fuses (808, 818) are not blown, and the one or more transistors (806, 816) electrically isolating the one or more processors (120) from the battery (810, 820) when the one or more fuses (808, 818) are blown. a circuit (804, 814) electrically connecting one or more processors (120) to a battery (810, 820); The drug injection device comprising:

14. 14. The drug injection device (802, 803) of claim 13, wherein the one or more fuses (808, 818) are blown in response to irradiation with laser light.

15. A drug injection device (902) comprising: a cartridge (104) configured to hold a volume of medication; 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 a drug injection device (902), the cover (918) including a first induction coil (916) configured to be electrically connected to a power source (917); a circuit (904) electrically connected to one or more processors (120), the circuit (904) including a second induction coil (906) and a supercapacitor (907), the second induction coil (906) configured to receive an electromagnetic field from the first induction coil (916) and generate power that is stored by the supercapacitor (907) and provided to the one or more processors (120); The drug injection device comprising:

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