Transmission of data related to the use of an injection device using passive RF modulation

Abstract

The present invention relates to the transmission of data related to the use of an injection device using passive RF modulation. The implementation of the disclosed text is directed to an injection device, which includes: a reservoir, the reservoir including a wall, the wall defining a proximal end, a distal end and a tubular side; a plunger rod, the plunger rod is configured to be movable in the reservoir along a direction from the distal end to the proximal end; a radio frequency (RF) antenna, the RF antenna is attached to the tubular side and is configured to receive an interrogation signal from an external device; and a resonant component, the resonant component is configured to receive the interrogation signal from the RF antenna and generate a modulated RF signal having a frequency associated with the position of the plunger rod.

Description

[0001] This invention application is a divisional application based on an invention patent application with an application date of December 17, 2018, application number 201880089504.1 (international application number PCT / EP2018 / 085110), and name “Transmission of data related to the use of an injection device using passive RF modulation”. Background Art

[0002] An electronic injection device allows a patient to safely administer medication without constant supervision by a medical professional, while also being able to transmit treatment data to the medical professional. An electronic injection device may include a medication reservoir such as a cartridge or syringe, electronic components, a drive system, and an energy supply. The electronic components may be configured to detect use of the electronic injection device and transmit data. Use detection and data transmission may require a large amount of energy supply. The energy supply may be provided by a battery. However, a low battery condition may cause the electronic injection device to fail or malfunction, incorrect dosing, missed dosing, or even render the electronic injection device unusable by stopping the operation of the electronic components. Summary of the invention

[0003] Implementations of the present disclosure include injection devices and systems for transmitting injection device data using passive radio frequency (RF) signals. In some implementations, an injection device includes: a reservoir, the reservoir including a wall, the wall defining a proximal end, a distal end, and a sidewall; a plunger rod, the plunger rod being configured to be movable in the reservoir in a direction from the distal end to the proximal end, the injection device having a tubular side defined by a housing component, an inner or outer body component, or the medicament reservoir; a radio frequency (RF) antenna, the RF antenna being attached to the tubular side and being configured to receive an interrogation signal from an external device; and a resonant component, the resonant component being configured to receive the interrogation signal from the RF antenna and generate a modulated RF signal having a frequency associated with the position of the plunger rod. In some implementations, the resonant component includes a magnet and one or more resonators, the magnet being attached to the plunger rod, the one or more resonators being attached to the tubular side and being configured to change their RF characteristics based on at least one of a linear position and an angular position relative to the magnet. In some implementations, the resonant assembly includes a mechanical link and a strain-sensitive resonator, the mechanical link being attached to the plunger rod, the strain-sensitive resonator being attached to the tubular side, the strain-sensitive resonator being configured to change its RF characteristics based on at least one of a linear position and an angular position relative to the mechanical link. In some implementations, the mechanical link includes at least one of a spring, an eccentric element, and an eccentric disk. In some implementations, the resonant assembly includes a mechanical link and an oscillator, the mechanical link being attached to the plunger rod, the oscillator being attached to the tubular side, the oscillator being configured to change its RF characteristics based on at least one of a linear position and an angular position relative to the mechanical link. In some implementations, the mechanical link includes a beam, the beam being attached to the oscillator cantilever through a diaphragm. In some implementations, the resonant assembly includes a multi-slot patch resonator, so that the RF signal includes at least one of an identifier of the injection device and a type of medicament. In some implementations, the interrogation signal includes a plurality of interrogation signals received at regular time intervals. In some implementations, in response to receiving the plurality of interrogation signals, the resonant assembly generates a plurality of RF signals such that a frequency shift between two of the plurality of RF signals is correlated to the amount of medicament in the reservoir. In some implementations, the interrogation signal is generated in response to a trigger signal transmitted by the injection device. In some implementations, the position of the plunger rod indicates the amount of medicament in the reservoir.

[0004] According to another aspect of the present disclosure, a drug injection system includes: an external device and an injection device. The external device includes: a transmitter configured to generate an interrogation signal; a receiver configured to receive a radio frequency (RF) signal; and one or more processors configured to process the RF signal and generate result data to be displayed by the external device. The injection device includes: a reservoir including a wall defining a proximal end, a distal end, and a tubular side; a plunger rod configured to be movable from the distal end to the proximal end within the reservoir; an RF antenna attached to the tubular side and configured to receive an interrogation signal from the external device; and a resonant component configured to receive the interrogation signal from the RF antenna and generate the RF signal having a frequency associated with the position of the plunger rod.

[0005] In some implementations, the resonant assembly includes a magnet and one or more resonators, the magnet being attached to the plunger rod, the one or more resonators being attached to the tubular side and being configured to change their RF characteristics based on at least one of a linear position and an angular position relative to the magnet. In some implementations, the resonant assembly includes a mechanical linkage and a strain-sensitive resonator, the mechanical linkage being attached to the plunger rod, the strain-sensitive resonator being attached to the tubular side, the strain-sensitive resonator being configured to change its RF characteristics based on at least one of a linear position and an angular position relative to the mechanical linkage. In some implementations, the mechanical linkage includes at least one of a spring, an eccentric element, and an eccentric disk.

[0006] Specifically, the present invention relates to the following:

[0007] 1. An injection device, comprising:

[0008] a reservoir comprising a wall defining a proximal end, a distal end, and a tubular side;

[0009] a plunger rod configured to be movable within the reservoir in a direction from the distal end to the proximal end;

[0010] a radio frequency (RF) antenna attached to the tubular side and configured to receive an interrogation signal from an external device; and

[0011] A resonant assembly is configured to receive the interrogation signal from the RF antenna and generate a modulated RF signal in response to the interrogation signal, the RF signal having a frequency associated with the position of the plunger rod.

[0012] 2. An injection device according to claim 1, wherein the resonant assembly comprises a magnet and one or more resonators, wherein the magnet is attached to the plunger rod and the one or more resonators are attached to the tubular side and are configured to change their RF characteristics based on at least one of a linear position and an angular position relative to the magnet.

[0013] 3. An injection device according to claim 1, wherein the resonant assembly includes a mechanical link and a strain-sensitive resonator, wherein the mechanical link is attached to the plunger rod and the strain-sensitive resonator is attached to the tubular side, and the strain-sensitive resonator is configured to change its RF characteristics based on at least one of a linear position and an angular position relative to the mechanical link.

[0014] 4. The injection device according to item 3, wherein the mechanical linkage comprises at least one of a spring, an eccentric element and an eccentric disc.

[0015] 5. An injection device according to claim 1, wherein the resonant assembly includes a mechanical link and an oscillator, wherein the mechanical link is attached to the plunger rod and the oscillator is attached to the tubular side, and the oscillator is configured to change its RF characteristics based on at least one of a linear position and an angular position relative to the mechanical link.

[0016] 6. An injection device according to clause 5, wherein the mechanical linkage comprises a beam attached to a cantilever of the oscillator via a diaphragm.

[0017] 7. An injection device according to any one of items 1 to 6, wherein the resonant component comprises a multi-slot patch resonator, so that the RF signal comprises at least one of an identifier of the injection device and a drug type.

[0018] 8. An injection device according to any one of clauses 1 to 7, wherein the interrogation signal comprises a plurality of interrogation signals received at regular time intervals.

[0019] 9. An injection device according to item 8, wherein in response to receiving the plurality of interrogation signals, the resonant assembly generates a plurality of RF signals such that a frequency shift between two of the plurality of RF signals is correlated to the amount of drug in the reservoir.

[0020] 10. An injection device according to any one of clauses 1 to 9, wherein the interrogation signal is generated in response to a trigger signal transmitted by the injection device.

[0021] 11. An injection device according to any one of clauses 1 to 10, wherein the position of the plunger rod indicates the amount of medicament in the reservoir.

[0022] 12. A drug injection system, comprising:

[0023] An external device, the external device comprising:

[0024] a transmitter configured to generate an interrogation signal,

[0025] a receiver configured to receive a radio frequency (RF) signal, and

[0026] one or more processors configured to process the RF signal and generate resulting data to be displayed by the external device; and

[0027] An injection device according to claim 1.

[0028] 13. A drug injection system according to claim 12, wherein the resonant component includes a magnet and one or more resonators, wherein the magnet is attached to the plunger rod and the one or more resonators are attached to the tubular side and are configured to change their RF characteristics based on at least one of a linear position and an angular position relative to the magnet.

[0029] 14. A drug injection system according to claim 12, wherein the resonant component includes a mechanical link and a strain-sensitive resonator, wherein the mechanical link is attached to the plunger rod and the strain-sensitive resonator is attached to the tubular side, and the strain-sensitive resonator is configured to change its RF characteristics based on at least one of a linear position and an angular position relative to the mechanical link.

[0030] 15. A drug injection system according to item 14, wherein the mechanical linkage comprises at least one of a spring, an eccentric element and an eccentric disc.

[0031] It should be understood that the system according to the present disclosure may include any combination of aspects and features described herein. That is, the method according to the present disclosure is not limited to the combination of aspects and features specifically described herein, but also includes any combination of aspects and features provided.

[0032] The details of one or more embodiments of the disclosure are set forth in the accompanying drawings and the description below. Other features and advantages of the disclosure will be apparent from the description and drawings, and from the claims. BRIEF DESCRIPTION OF THE DRAWINGS

[0033] Figures 1A to 1F is an exploded view of an example of a system according to the present disclosure.

[0034] Figure 2 is a block diagram of an exemplary system architecture in which implementations of the present disclosure may be performed.

[0035] Figure 3is a flow chart illustrating an exemplary process that may be performed to perform operations of the present disclosure.

[0036] Figure 4 is a schematic illustration of an exemplary computer system that can be used to perform implementations of the present disclosure.

[0037] The same reference symbols in different drawings denote the same elements. DETAILED DESCRIPTION

[0038] Implementations of the present disclosure generally relate to mechanisms and systems configured for measuring the amount of medicament within an injection device. More specifically, implementations of the present disclosure relate to a technique for determining medicament reservoir volume using passive transmission of a modulated radio frequency (RF) signal.

[0039] Among other things, we describe techniques for powering an injection device without, for example, using a battery. In some injection devices, the transmission of injection device data is based on technologies such as Bluetooth, ANT+, or passive RF identifiers / near field communications, which may be associated with high power consumption. As described in further detail herein, implementations of the present disclosure address this challenge. For example, according to an implementation, an injection device has sensing functionality integrated into an RF circuit, and the sensing information is transmitted by analog methods without the need for a battery or a wired connection to provide energy. The injection device does not require energy harvesting or energy conversion for the injection device or for communication, thereby achieving a communication range of several meters. The transmission technology allows for a simple system setup on the injection device side. The components of the injection device have no effect on the user operation of the injection device. For example, the patient does not have to replace a battery or insert an injection device for radio frequency signal transmission. An electronic injection device configured to operate without a battery has a low environmental footprint and can be manufactured as a disposable item.

[0040] Figures 1A to 1F An exploded view of an exemplary drug delivery system 100 is shown. The exemplary drug delivery system 100 can be configured to facilitate sharing of medical data using passive RF transmission. The exemplary drug delivery system 100 can include one or more injection devices 102, an external device 104, an interrogator 106, a network 108, and a server system 110.

[0041] In some implementations, the injection device 102 is a pre-filled disposable injection pen, and in some implementations, the injection device 102 is a reusable injection pen. The injection device 102 is configured to communicate with the interrogator 106. For example, the injection device 102 can be configured for frequency-based interrogation, and the interrogator 106 can transmit a frequency-based signal received from the injection device 102 to the external device 104. In some implementations, the frequency-based signal is transmitted from the injection device 102 to the external device 104 using time domain reflectometry. In some implementations, the injection device 102 can be associated with an identifier that is used by the external device 104 to uniquely identify the injection device 102, for example because the identifier is unique to the external device 104.

[0042] The injection device 102 may be configured to modulate the RF signal received from the interrogator 106 based on the amount of medicament stored in the injection device 102. The injection device 102 may be a pre-filled disposable injection pen, or the injection device 102 may be a reusable injection pen. The injection device 102 may include a housing 112 and a needle assembly 115. The injection device 102 may include one or more tubular sides that define any of the inner or outer walls of a component of the injection device 102, such as the housing 112 or a medicament container such as a medicament reservoir 116. The housing 112 may contain an RF modulation system 114, a medicament reservoir 116, a stopper 117, a plunger rod 118, a plunger head 119, a bearing 120, a dose knob 122, a dose window 124, and an injection button 126. The housing 112 may be molded from a medical grade plastic material such as a liquid crystal polymer.

[0043] The RF modulation system 114 may include one or more electronic components configured to modulate the RF signal received from the interrogator 106 and transmit the modulated RF signal to the interrogator 106. For example, the RF modulation system 114 may include an antenna 128, a resonator 130, a motion element 132, and a sensor 134.

[0044] The antenna 128 may be configured to communicate with the interrogator 106 by receiving and transmitting modulated RF signals while within the communication field 136. The antenna 128 may be configured for passive RF transmission. For example, the antenna 128 may be a serpentine dipole antenna. The modulated RF signal transmitted by the antenna 128 may include an indication of the amount of medication in the medication reservoir 116, a value measured by the sensor 134, and an identifier of the injection device 102.

[0045] The resonator 130 (resonant component) may be configured to modulate an RF signal received by the antenna 128. The resonator 130 may include one or more resonators aligned along the longitudinal axis 113 of the housing 112. The resonator 130 may include one of a variety of types of resonators, such as a mechanical type, a magnetic type, or a micro-electromechanical type.

[0046] The motion element 132 can be configured to be attached to the plunger rod 118, which advances in micro-step increments to dispense a specific amount of medicament. The motion element 132 can include one or more motion elements directly or indirectly attached to the plunger rod 118. The motion element 132 can include one or more of a variety of types of motion elements, such as a mechanical type, a magnetic type, or a micro-electromechanical type. In some implementations, the type of resonator 130 can depend on the type of motion element 132.

[0047] Figure 1A The exemplary RF modulation system 114 shown includes: a resonator 130, which is based on a metamaterial attached to the wall of the housing 112; and a moving element 132, which includes a magnet directly attached to or inserted into the plunger rod 118. In some implementations, the magnet is attached to the last dose nut. Metamaterials include a class of materials that are configured to have a specific set of properties. Typically, the properties are not present in the substrate, but rather result from the specific microstructure or structured combination of materials used. According to the implementations described herein, metamaterials are defined as materials that are configured to exhibit a specific response by changing one or more of their inherent properties when a physical or chemical stimulus is applied. External stimuli can be strain, magnetic fields, temperature, humidity, and pressure. In Figure 1A In the context of the example of , the metamaterial of the resonator 130 may include a magnetic film or a magnetic composite configured to modulate an RF signal according to an applied magnetic field. The resonant frequency of the resonator 130 may shift according to the angular position, linear position, or a combination of the linear position and the angular position of the moving element 132 (magnet) relative to the resonator 130. The angular displacement and / or linear displacement of the moving element 132 (magnet) is associated with a frequency shift. To determine the dosage of the medicament in the injection device 102, the interrogator 106 reads the frequency shift at regular time intervals.

[0048] Figure 1BThe exemplary RF modulation system 114 shown includes a strain-sensitive resonator 130, which is attached to the wall of the housing 112 and to the moving element 132. The strain-sensitive resonator 130 may include a strain-sensitive metamaterial, such as polytetrafluoroethylene (PTFE). The moving element 132 includes an attachment base 132a and a spring stretched between the attachment base 132a and the moving element 132. The attachment base 132a is attached to or inserted into the plunger rod 118. The resonant frequency of the strain-sensitive resonator 130 can be shifted according to the force associated with the angular position, linear position, or a combination of the linear position and the angular position of the moving element 132 (attachment base 132a) relative to the resonator 130. The angular displacement and / or linear displacement of the moving element 132 (attachment base 132a) is associated with the change in the elastic force in the spring 132b and the frequency shift. In order to determine the dosage of the medicament in the injection device 102, the interrogator 106 reads the frequency shift at regular time intervals (e.g., every few milliseconds).

[0049] Figure 1C The exemplary RF modulation system 114 shown includes a strain sensitive resonator 130, which is attached to the wall of the housing 112 and to the moving element 132. The strain sensitive resonator 130 may include a strain sensitive metamaterial, such as polytetrafluoroethylene (PTFE). The moving element 132 may include a disk with an eccentric element 132c attached to the plunger rod 118. The resonant frequency of the strain sensitive resonator 130 may be shifted according to the force associated with the angular position, linear position, or a combination of the linear position and the angular position of the moving element 132 relative to the resonator 130. For example, depending on the angular position and / or linear position of the eccentric element 132c, a specific pressure level may be applied to the strain sensitive resonator 130, which converts the pressure into a frequency shift. In order to determine the dosage of the medicament in the injection device 102, the interrogator 106 reads the frequency shift at regular time intervals.

[0050] Figure 1DThe exemplary RF modulation system 114 shown includes a strain sensitive resonator 130, which is attached to the wall of the housing 112 and to the moving element 132. The strain sensitive resonator 130 may include a strain sensitive metamaterial, such as polytetrafluoroethylene (PTFE). The moving element 132 may include an eccentric attached to the plunger rod 118. The resonant frequency of the strain sensitive resonator 130 may shift according to a force associated with an angular position, a linear position, or a combination of a linear position and an angular position of the moving element 132 relative to the resonator 130. For example, depending on the angular position and / or linear position of the moving element 132 (e.g., the edge of the eccentric), a specific pressure level may be applied to the strain sensitive resonator 130, which converts the pressure into a frequency shift. In order to determine the dosage of the medicament within the injection device 102, the interrogator 106 reads the frequency shift at regular time intervals.

[0051] Figure 1E The exemplary RF modulation system 114 shown includes a resonator 130, which is attached to the wall of the housing 112 and a moving element 132. The resonator 130 may include a micro-electromechanical system (MEMS) oscillator 130a, a cantilever 130b, and a diaphragm 130c. The moving element 132 includes a beam, which is attached to the plunger rod 118 and coupled to the resonator 130 above the diaphragm 130c. The resonant frequency of the strain sensitive resonator 130 can be shifted according to the force associated with the angular position, linear position, or a combination of linear position and angular position of the moving element 132 (beam) relative to the oscillator 130a. The angular displacement and / or linear displacement of the moving element 132 (beam) is associated with the change in the angle of the cantilever 130b, which causes a frequency shift. In order to determine the dosage of the medicament in the injection device 102, the interrogator 106 reads the frequency shift at regular time intervals.

[0052] Figure 1FThe exemplary RF modulation system 114 shown includes: a resonator 130, which defines an electrical circuit attached to the wall of the housing 112; and a moving element 132, which includes a final dose nut directly attached to the plunger rod 118. The electrical circuit can be a thin foil including a printed circuit that is configured to change its electrical characteristics based on the position of the moving element 132. The moving element 132 (final dose nut) includes an electrical conductor 132d and a pair of brushes 132e. In some implementations, the moving element 132 (final dose nut) includes an electronic component 132f, such as a smart circuit or load. The electrical conductor 132d can be configured to connect to the resonator 130 and the electronic component 132f. The electrical conductor 132d can short the resonator 130, can increase or change the load or impedance of the resonator 130, or can connect or disconnect sections of the circuit 130d, 130e. This pair of brushes 132e can be configured to provide mechanical stability during the change of the position of the moving element 132. The electrical property of the resonator 130 may change depending on the angular position, linear position, or a combination of linear and angular position of the moving element 132 (final dose nut) relative to the resonator 130. The angular displacement and / or linear displacement of the moving element 132 (final dose nut) is associated with a change in the electrical property (e.g., load, impedance, short circuit, or open circuit). In order to determine the dose of medicament in the injection device 102, the interrogator 106 is reading the change in the electrical property. The interrogator 106 may read the signal associated with the electrical property at regular time intervals by time domain reflectometry or phase coded transmission principles.

[0053] The sensor 134 may be configured to generate an RF signal modulation indicating parameters including environmental conditions and / or the type of agent. Environmental conditions may include temperature, humidity, and luminosity. The sensor 134 configured to detect environmental conditions may include a metamaterial-based resonator or a MEMS resonator. For example, a metamaterial comprising one or more of phenanthrene (temperature threshold sensing), ionic plastic crystals, metal oxides (e.g., ZnO) may be configured to detect the temperature of the injection device 102. Specifically, phenanthrene may be configured to detect a temperature threshold. A metamaterial comprising one or more of polyimide and polyvinyl alcohol (PVA) may be configured to detect the humidity of the environment surrounding the injection device 102. The type of agent may be encoded using a multi-slot patch resonator. The resonant frequency of the multi-slot patch resonator depends on the number of slots, the slot geometry, the slot width, the slot height, and the slot length. The identifier of the injection device 102 may also be encoded using a multi-slot patch resonator. The identifier of the injection device 102 may be a unique identifier that enables identification of the injection device 102 in use. To reduce the number of bits required, it may also be a sufficiently large number that can be used in conjunction with other information (such as medication type, date, geographic location) to identify the injection device 102 that is currently within the communication field 136 of the interrogator 106. In some implementations, the same "unique" identifier is issued to multiple injection devices 102 based on one or more rules that prevent two injection devices 102 from being issued the same "unique" identifier at any time and thus sharing the same communication field. For example, the injection devices 102 are issued with the same "unique" identifier and sold in different regions of the world (such as in the European Union and the United States of America). As another example, the identifier of the injection device 102 may be repeated after a certain time interval (such as after the expiration date of the medication included in the injection device 102).

[0054] In some implementations, components of the RF modulation system 114 can be integrated within the housing 112 at a single location or multiple locations (e.g., within the bearing 120 plunger rod 118 or attached to the plunger rod and a cavity in the plunger head 119). The location of one or more electronic components of the RF modulation system 114 (such as the resonator 130 and / or the motion element 132) can be selected to maximize the efficiency of the RF signal modulation. The components of the RF modulation system 114 can be molded, assembled, or welded to a specific component of the injection device 102 (e.g., the housing 112 or the plunger rod 118).

[0055] The medicament reservoir 116 can be configured to hold a fluid medicament. The medicament reservoir 116 can be a conventional, generally cylindrical disposable container, such as a cartridge or syringe for packaging a prepared fluid such as a medicament, an anesthetic, etc. The medicament reservoir 116 has a tubular side having an inner wall and an outer wall and two ends. One end (the proximal end) has a pierceable septum that receives the inner end of the needle 138 in a sealing engagement. The other end (the distal end) can be configured to be able to insert the plug 117.

[0056] By turning the dosage knob 122, a dose of the contained medicament can be expelled from the injection device 102, and the selected dose can then be displayed via the dosage window 124, for example in multiples of so-called international units (IU), where one IU is the biological equivalent of about 45.5 micrograms of pure crystalline medicament (1 / 22 mg). An example of a selected dose displayed in the dosage window 124 can be, for example, 30 IU. Figure 1A As shown. In some implementations, the selected dose can be displayed in different ways, such as with an electronic display (e.g., the dose window 124 can take the form of an electronic display). Turning the dose knob 122 can cause a mechanical click to provide acoustic feedback to the user. The number displayed in the dose window 124 can be printed on a sleeve contained in the housing 112 and mechanically interacting with the plunger head 119, which is fixed to the end of the plunger rod 118 and pushes the stopper 117 in the medicament reservoir 116. The bearing 120 can provide a secure mount to one or both ends of the plunger rod 118.

[0057] The plunger head 119 (e.g., the rear end of the plunger) can be configured to expel a portion of the fluid by moving the stopper 117 contained in the medicament reservoir 116 so that the position of the last dose nut, the position of the plunger rod 118, and the position of the stopper 117 are correlated with the amount of fluid in the injection device 102. The stopper 117 can be a flexible stopper such as a rubber stopper. The stopper 117 can have a sufficient length so that the stopper 117 is not torn or twisted when engaged by the plunger head 119.

[0058] The needle assembly 115 includes a needle 138 that can be attached to the housing 112. The needle 138 can be covered by an inner needle cap 140 and an outer needle cap 142, which in turn can be covered by an outer cap 144. When the needle 138 is inserted into the skin portion of the patient and then the injection button 126 is pushed, the dose of the medicament displayed in the display window 124 can be discharged from the injection device 102. When the needle 138 of the injection device 102 remains in the skin portion for a certain time after the injection button 126 is pushed, most of the dose (e.g., more than 95% of the dose) is actually injected into the patient. The discharge of the dose of the medicament can generate a mechanical click sound, which can be different from the sound produced when the dose knob 122 is used.

[0059] The injection device 102 can be used for several injection procedures until the medication reservoir 116 is emptied or the injection device 102 reaches an expiration date (e.g., 28 days after first use). Before using the injection device 102 for the first time, it may be necessary to perform a priming operation to remove air from the medication reservoir 116 and the needle 138. For example, the priming operation may include selecting two units of medication and pressing the injection button 126 while holding the needle 138 of the injection device 102 upward. The pulse generated by selecting two units of medication or pressing the injection button 126 may trigger the modulation of the RF signal by the RF modulation system 114.

[0060] In some implementations, the external device 104 may include an interrogator 106, and in some implementations, the external device 104 may be removably attached to the interrogator 106. The interrogator 106 may be configured to transmit signals to and / or receive signals from the injection device 102. The interrogator 106 may be configured to autonomously transmit signals to the injection device 102 at a preset frequency (e.g., between 0.1 Hz and 1 Hz) during a preset time interval (e.g., during a predetermined treatment time interval or after receiving an activation signal until two consecutive RF modulated signals are identical). The external device 104 may be configured to process the modulated RF signals transmitted by the injection device 102 and transmit them to the server device 110 via the network 108.

[0061] In some implementations, the server device 110 includes at least one server 146 and at least one data storage 148. The server device 110 is intended to represent various forms of servers, including but not limited to web servers, application servers, proxy servers, network servers, and / or server pools. In general, the server system accepts requests for application services and provides such services to any number of client devices (e.g., external devices 104) over the network 108 to support monitoring the use of the injection device 102. In some implementations, a user (such as a patient or a health care provider) can access the application service to analyze past and current data associated with the use of the injection device 102. The past and current data associated with the use of the injection device 102 may include the date of injection of the medication, the expelled dose on each date, and the amount of medication remaining in the injection device 102.

[0062] Figure 2 1 is a block diagram of an example system 200 in which implementations of the present disclosure may be performed. The system 200 enables transmission of RF signals between the injection device 102 and the external device 104. The injection device 102 may include an antenna 128 and a resonator 130. The antenna 128 is configured to receive RF signals from the external device 104. The resonator 130 is configured to passively modulate the RF signal, as described in reference to FIG. Figures 1A to 1E The external device 104 includes a control module 202, an interrogator 204, and an input / output module 206. The control module 202 may be an application program downloadable from a server, the application program being configured to control one or more operations of the external device 104. For example, the operation of the external device 104 is controlled by a program executed by the control module 202. The control module 202 includes an activation component 208, a detection component 210, and an analysis component 212.

[0063] The activation component 208 may be configured to generate an activation signal that may initiate an RF communication process with the injection device 102, as described with reference to FIG. Figure 3As described. The activation of the RF communication process is an important factor that leads to the energy consumption of the external device 104, the availability and reliability of the detection near the external device 104. In some implementations, the activation signal is generated in response to receiving a wake-up signal. The wake-up signal may include a word spoken by the user of the external device 104 or a specific noise generated by the operation of the injection device 102 (e.g., a noise associated with a priming operation, a dose dialing click, or a dispensing click). In some implementations, the activation signal is generated in response to receiving a user input from the input / output module 206, the user input including a request to initiate the RF communication process with the injection device 102. In some implementations, the activation signal is generated at a preset frequency (e.g., once or more times a day), which can be updated by the user of the external device 104 to correspond to the treatment plan. The activation signal may include a trigger signal that is transmitted to the interrogator 204 to initiate the RF communication process. The activation signal may include a trigger signal that is transmitted to the energy source (e.g., a battery of the external device) to power the interrogator 204 to initiate the RF communication process. In some implementations, before activating the RF communication process, the activation component 208 provides a message to the user of the external device 104 through the input / output module 206 requesting approval to initiate the RF communication process with the injection device 102 .

[0064] The detection component 210 can be configured to generate a detection signal to control the detection of the modulated RF signal using the interrogator 204. In some implementations, the detection process can be controlled based on one or more parameters of the activation process. For example, the detection component 210 can be configured to communicate with the activation component 208 to initiate a detection operation at a specific time after the activation component 208 generates a trigger signal. The detection operation can include a pre-processing phase (e.g., echo cancellation and / or noise suppression) and an actual detection phase. In some implementations, the detection component 210 activates a filter (e.g., a bandpass filter and / or a bandstop filter) included in the external device 104 during the detection of the modulated RF signal.

[0065] The analysis component 212 may be configured to generate an analysis signal to control the analysis of the modulated RF signal detected by the interrogator 204. For example, the analysis component 212 may control the selection of a signal processing algorithm. The signal processing algorithm may include one or a combination of basic signal processing methods (e.g., discrete Fourier transform, short-time Fourier transform, discrete cosine transform, discrete-time wavelet transform), short-term and medium-term feature extraction, classifiers (e.g., k-nearest neighbor classifier, decision tree, support vector machine, artificial neural network, deep neural network), algorithms that are "trained" based on prior knowledge of expected signals, and algorithms that are based on prior knowledge of expected signals to correlate received signals with expected signals to determine a region of interest.

[0066] The interrogator 204 may be a component integrated in or attached to the external device 104. The interrogator 204 includes an RF module 214, a CPU 216, a transmitter 218, and a receiver 220. The RF module 214 is configured to generate an RF signal. In some implementations, one or more characteristics of the RF signal are selected based on the resonator 130 of the injection device 102. For example, a pulse signal may be generated for a time domain reflectometer, a signal having a wide frequency range may be generated for a resonator 130 configured to generate frequency modulation, a limited bandwidth pulse signal may be generated for a resonator 130 configured to generate phase modulation, or a signal having multiple closely positioned frequencies (e.g., two frequencies f1 and f2) may be generated for a resonator 130 configured to generate intermodulation (e.g., harmonic frequencies n*f1±m*f2). The CPU 216 is configured to interpret and execute control signals (e.g., activation signals, detection signals, and / or processing signals) received from the control module 202, and process the modulated RF signal according to an algorithm selected by the analysis component 212. The transmitter 218 is configured to transmit the RF signal generated by the RF module 214. The receiver 220 is configured to receive the modulated RF signal generated by the injection device 102.

[0067] The output module 206 may be a standard component of the external device 104 that is controlled by the control module 202 to support RF communication with the injection device and processing of the modulated RF signal. The output module 206 includes a display 222, a hardware driver 224, and a memory 226. The display 222 may be configured to enable a user of the external device 104 to interact with the external device 104 by providing user input and receiving indications associated with the injection device 102 and treatments performed using the injection device 102. The hardware driver 224 includes a program to control the display 222. The memory 226 may be a computer-readable medium configured to store data, including the modulated RF signal received by the interrogator 204 and the results of processing the modulated RF signal.

[0068] Figure 3 It is shown that it can be obtained by referring to Figures 1 and Figure 2 Flowchart of an exemplary process 300 performed by the apparatus and system described herein. For example, process 300 may be performed by Figures 1A to 1E System 100 or Figure 2The process 300 begins by receiving a wake-up signal (302). The wake-up signal may include a user input indicating a request to initiate an RF communication process between the external device and the injection device 102. The wake-up signal may be a verbal command (e.g., a word spoken by a user of the external device), a user selection (e.g., launching an associated application), or a specific noise generated by the operation of the injection device 102 (e.g., a noise associated with a priming operation, a dose dial click, or a dispensing click). An example of a priming operation performed with the injection device may include selecting a specific number (e.g., one or two) units of a medicament and pressing an injection button while holding the needle of the injection device upward. Another example of a priming operation performed with the injection device may include pressing a priming button of the injection device configured to generate the wake-up signal. Another example of a priming operation performed with the injection device may include attaching an interrogator to the external device.

[0069] In response to receiving the wake-up signal, an activation signal is generated (304). The activation signal may include one or more trigger signals that are transmitted to one or more components of the external device (e.g., an interrogator, an energy source, and an input / output module). For example, the activation signal may include a trigger signal that is transmitted to an interrogator integrated in or attached to the external device to initiate an RF communication process with the injection device. The activation signal may include a trigger signal that is transmitted to the energy source (e.g., a battery of the external device) to power the interrogator to initiate the RF communication process. In addition, the activation signal may include a trigger signal that is transmitted to the input / output module to obtain user approval to initiate the RF communication process with the injection device.

[0070] In response to receiving the activation signal, the RF module of the interrogator (306) generates one or more interrogation signals. The interrogation signal may include an RF signal having specific characteristics. In some implementations, one or more frequency characteristics of the interrogation signal are selected based on the resonator type of the target injection device. For example, the interrogation signal may include a pulsed RF signal, a wide frequency range RF signal, a limited bandwidth pulsed signal RF signal, or an RF signal having multiple closely positioned frequencies. In some implementations, multiple interrogation signals are generated to enable detection of the amount of medicament dispersed by the injection device.

[0071] The transmitter transmits an interrogation signal to the injection device (308). In response to each interrogation signal, a modulated RF signal generated by a resonator of the injection device is received (310). For example, if multiple interrogation signals are transmitted, multiple modulated RF signals are received. The modulated RF signal may include time domain modulation, frequency modulation, phase modulation, or intermodulation. The modulation of the modulated RF signal indicates the position of the resonator relative to another (mechanical) component of the injection device (e.g., the final dose nut, the plunger rod, the plunger head, and the stopper), which is associated with the amount of medication in the medication reservoir. In some implementations, if multiple modulated RF signals are received, the frequency shift between two (consecutive) RF signals is associated with the amount of medication in the reservoir. The modulation of the modulated RF signal may indicate one or more measurements of environmental parameters (e.g., humidity and temperature).

[0072] The processor of the external device processes the modulated RF signal (312). The processing of the modulated RF signal includes determining injection device data, such as one or more parameters associated with the administration of the medicament (e.g., the amount of medicament remaining in the injection device and / or the amount of medicament dispensed) and the operating condition of the injection device. The processing of the modulated RF signal may include one or a combination of basic signal processing methods (e.g., discrete Fourier transform, short-time Fourier transform, discrete cosine transform, discrete time wavelet transform), short-term and medium-term feature extraction, classifiers (e.g., k-nearest neighbor classifier, decision tree, support vector machine, artificial neural network, deep neural network), algorithms "trained" based on prior knowledge of expected signals, and algorithms based on prior knowledge of expected signals to correlate received signals with expected signals to determine regions of interest that distinguish multiple resonators integrated in the injection device. The injection device data may be stored, transmitted to another system, or displayed to a user of the external device (314). In some implementations, a user interacting with the display of the external device may choose to terminate communication between the injection device and the external device or repeat process 300 by generating another wake-up signal.

[0073] Figure 4A schematic diagram of an exemplary computing system 400 is shown. System 400 can be used for the operations described in conjunction with the implementations described herein. For example, system 400 can be included in any or all of the server components discussed herein. System 400 includes processor 410, memory 420, storage device 430, and input / output device 440. Each of components 410, 420, 430, and 440 is interconnected using system bus 450. Processor 410 is capable of processing instructions for execution within system 400. In one implementation, processor 410 is a single-threaded processor. In another implementation, processor 410 is a multi-threaded processor. Processor 410 is capable of processing instructions stored in memory 420 or on storage device 430 to display graphical information of a user interface on input / output device 440.

[0074] The memory 420 stores information within the system 400. In one implementation, the memory 420 is a computer-readable medium. In one implementation, the memory 420 is a volatile memory unit. In another implementation, the memory 420 is a non-volatile memory unit. The storage device 430 is capable of providing mass storage for the system 400. In one implementation, the storage device 430 is a computer-readable medium. In various different implementations, the storage device 430 may be a floppy disk device, a hard disk device, an optical disk device, or a tape device. The input / output device 440 provides input / output operations for the system 400. In one implementation, the input / output device 440 includes a keyboard and / or a pointing device. In another implementation, the input / output device 440 includes a display unit for displaying a graphical user interface that enables a user to access the collected, stored, and queried data related to the item, as shown in reference Figures 1 to 1. Figure 3 Descriptive.

[0075] The features described may be implemented in digital electronic circuit systems, or in computer hardware, firmware, software, or a combination thereof. The apparatus may be implemented in a computer program product tangibly embodied in an information carrier (e.g., in a machine-readable storage device) for execution by a programmable processor, and the method steps may be performed by a programmable processor executing a program of instructions to perform the functions of the described implementation by operating on input data and generating output. The features described may be advantageously implemented in one or more computer programs that may be executed on a programmable system including at least one programmable processor coupled to receive data and instructions from and transmit data and instructions to a data storage system, at least one input device, and at least one output device. A computer program is a set of instructions that may be used directly or indirectly in a computer to perform an activity or cause a result. A computer program may be written in any form of programming language, including compiled or interpreted languages, and may be deployed 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.

[0076] Suitable processors for executing instruction programs include, for example, general-purpose and special-purpose microprocessors, and the sole processor or one of multiple processors of any type of computer. Typically, the processor will receive instructions and data from a read-only memory or a random access memory or both. The basic elements of a computer are a processor for executing instructions and one or more memories for storing instructions and data. Typically, a computer will also include one or more mass storage devices for storing data files, or be operably coupled to communicate with it; such devices include disks, such as internal hard disks and removable disks, magneto-optical disks, and optical disks. Storage devices suitable for tangibly embodying computer program instructions and data include all forms of non-volatile memory, including, for example, semiconductor memory devices (such as EPROM, EEPROM, and flash memory devices); disks (such as internal hard disks and removable disks, magneto-optical disks, and CD-ROM and DVD-ROM disks). The processor and memory can be supplemented by an ASIC (application-specific integrated circuit) or can be incorporated into an ASIC.

[0077] To provide interaction with a user, these features may be implemented on a computer having a display device (such as a CRT (cathode ray tube) or LCD (liquid crystal display) monitor) for displaying information to the user, and a keyboard and pointing device (such as a mouse or trackball) through which the user can provide input to the computer.

[0078] These features can be implemented in a computer system that includes back-end components (such as a data server), or a computer system that includes middleware components (such as an application server or an Internet server), or a computer system that includes front-end components (such as a client computer with a graphical user interface or an Internet browser), or any combination thereof. The components of the system can be connected by any digital data communication form or medium (such as a communication network). Examples of communication networks include, for example, LANs, WANs, and the computers and networks that form the Internet.

[0079] A computer system may include clients and servers. The client and server are typically remote from each other and typically interact through a network (such as the described network). The relationship between client and server arises from computer programs running on the respective computers and having a client-server relationship to each other.

[0080] In addition, the logic flows depicted in the figures do not require the particular order or sequential order shown to achieve the desired results. In addition, other steps can be provided, or steps can be removed from the described processes, and other components can be added to or removed from the described systems. Therefore, other implementations are within the scope of the following claims.

[0081] The terms "drug" or "medicament" are used synonymously herein and describe a pharmaceutical preparation containing one or more active pharmaceutical ingredients or a pharmaceutically acceptable salt or solvate thereof and optionally a pharmaceutically acceptable carrier. In the broadest sense, an active pharmaceutical ingredient ("API") is a chemical structure that has a biological effect on humans or animals. In pharmacology, a drug or medicament is used to treat, cure, prevent, or diagnose disease or to otherwise enhance physical or mental health. A drug or medicament may be used for a limited duration, or periodically for a chronic disorder.

[0082] As described below, a drug or medicament may include at least one API or a combination thereof in various types of formulations for treating one or more diseases. Examples of APIs may include small molecules (having a molecular weight of 500 Da or less); polypeptides, peptides, and proteins (e.g., hormones, growth factors, antibodies, antibody fragments, and enzymes); carbohydrates and polysaccharides; and nucleic acids, i.e., double-stranded or single-stranded DNA (including naked and cDNA), RNA, antisense nucleic acids such as antisense DNA and RNA, small interfering RNA (siRNA), ribozymes, genes, and oligonucleotides. Nucleic acids may be incorporated into molecular delivery systems (such as vectors, plasmids, or liposomes). Mixtures of one or more drugs are also contemplated.

[0083] The drug or medicament can be contained in a primary package or "drug container" adapted for use with a drug delivery device. The drug container can be, for example, a cartridge, a syringe, a reservoir or other solid or flexible vessel, which is configured to provide a suitable chamber for storing (e.g., short-term or long-term storage) one or more drugs. For example, in some cases, the chamber can be designed to store the drug for at least one day (e.g., 1 day to at least 30 days). In some cases, the chamber can be designed to store the drug for about 1 month to about 2 years. Storage can occur at room temperature (e.g., about 20 ° C) or refrigerated temperature (e.g., from about -4 ° C to about 4 ° C). In some cases, the drug container can be or can include a dual-chamber cartridge, which is configured to store two or more components (e.g., API and diluent, or two different drugs) of a drug preparation to be administered separately, one of which is stored in each chamber. In such cases, the two chambers of the dual-chamber cartridge can be configured to allow mixing between two or more components before and / or during distribution to the human or animal body. For example, the two chambers may be configured so that they are in fluid communication with each other (e.g., via a conduit between the two chambers) and allow the user to mix the two components if desired before dispensing. Alternatively or additionally, the two chambers may be configured to allow mixing when dispensing the components into a human or animal body.

[0084] The medicine or medicament contained in the drug delivery device as described herein can be used to treat and / or prevent many different types of medical disorders. The example of obstacle includes, for example, diabetes or complications associated with diabetes (such as diabetic retinopathy), thromboembolic disorders (such as deep vein or pulmonary thromboembolism). Another example of obstacle is acute coronary syndrome (ACS), angina pectoris, myocardial infarction, cancer, macular degeneration, inflammation, hay fever, atherosclerosis and / or rheumatoid arthritis. The example of API and medicine is those as described in the following manual: such as Rote Liste 2014 (for example, but not limited to, main group (main group) 12 (antidiabetic drugs) or 86 (tumor drugs)) and Merck Index, the 15th edition.

[0085] Examples of APIs for treating and / or preventing type 1 or type 2 diabetes or complications associated with type 1 or type 2 diabetes include insulin (e.g., human insulin, or human insulin analogs or derivatives); glucagon-like peptide (GLP-1), GLP-1 analogs or GLP-1 receptor agonists, or analogs or derivatives thereof; dipeptidyl peptidase-4 (DPP4) inhibitors, or pharmaceutically acceptable salts or solvates thereof; or any mixture thereof. As used herein, the terms "analogs" and "derivatives" refer to polypeptides having a molecular structure that can be formally derived from the structure of a naturally occurring peptide (e.g., the structure of human insulin) by deleting and / or exchanging at least one amino acid residue present in a naturally occurring peptide and / or by adding at least one amino acid residue. The added and / or exchanged amino acid residues can be codable amino acid residues or other naturally occurring residues or purely synthetic amino acid residues. Insulin analogs are also referred to as "insulin receptor ligands." Specifically, the term "derivative" refers to a polypeptide having a molecular structure that is formally derived from the structure of a naturally occurring peptide (e.g., the structure of human insulin), wherein one or more organic substituents (e.g., fatty acids) are combined with one or more amino acids. Optionally, one or more amino acids present in the naturally occurring peptide may have been deleted and / or replaced by other amino acids (including non-encodable amino acids), or amino acids (including non-encodable amino acids) have been added to the naturally occurring peptide.

[0086] Examples of insulin analogs are Gly(A21), Arg(B31), Arg(B32) human insulin (insulin glargine); Lys(B3), Glu(B29) human insulin (insulin glulisine); Lys(B28), Pro(B29) human insulin (insulin lispro); Asp(B28) human insulin (insulin aspart); human insulin in which the proline at position B28 is replaced by Asp, Lys, Leu, Val or Ala and in which the 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.

[0087] Examples of insulin derivatives are, for example, B29-N-myristoyl-des(B30) human insulin, Lys(B29)(N-tetradecanoyl)-des(B30) human insulin (insulin detemir, ); B29-N-palmitoyl-des(B30) human insulin; B29-N-myristoyl human insulin; B29-N-palmitoyl human insulin; B28-N-myristoylLysB28ProB29 human insulin; B28-N-palmitoyl-LysB28ProB29 human insulin; B30-N-myristoyl-ThrB29LysB30 human insulin; B30-N-palmitoyl-ThrB29LysB30 human insulin; B29-N-(N-palmitoyl-γ-glutamyl)-des(B30) human insulin, B29-N-ω-carboxypentadecanoyl-γ-L-glutamyl-des(B30) human insulin (insulindegludec, ); 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.

[0088] Examples of GLP-1, GLP-1 analogs and GLP-1 receptor agonists are, for example, lixisenatide (Lyx ), Exendin-4, Liraglutide (a 39-amino acid peptide produced by the salivary glands of the Gila monster) Semaglutide, Taspoglutide, Albiglutide Dulaglutide rExendin-4, CJC-1134-PC, PB-1023, TTP-054, Langlenatide / HM-11260C, CM-3, GLP-1Eligen, ORMD-0901, NN-9924, NN-9926, NN-9927, Nodexen, Viador-GLP-1, CVX-096, ZY OG-1, ZYD-1, GSK-2374697, DA-3091, MAR-701, MAR709, ZP-2929, ZP-3022, TT-401, BHM-03 4. MOD-6030, CAM-2036, DA-15864, ARI-2651, ARI-2255, Exenatide-XTEN and Glucagon-Xten.

[0089] Examples of oligonucleotides are e.g. Mipomersen sodium It is a cholesterol-reducing antisense therapeutic used to treat familial hypercholesterolemia.

[0090] Examples of DPP4 inhibitors are Vildagliptin, Sitagliptin, Denagliptin, Saxagliptin, Berberine.

[0091] Examples of hormones include pituitary hormones or hypothalamic hormones or regulatory activity peptides and their antagonists, such as gonadotropins (follicle-stimulating hormone, luteinizing hormone, chorionic gonadotropin, tocopherol), somatropine (growth hormone), desmopressin, terlipressin, gonadorelin, triptorelin, leuprorelin, buserelin, nafarelin and goserelin.

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

[0093] 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, which retain the ability to bind antigens. The antibody can be a polyclonal antibody, a monoclonal antibody, a recombinant antibody, a chimeric antibody, a deimmunized or humanized antibody, a fully human antibody, a non-human (e.g., mouse) antibody, or a single-chain antibody. In some embodiments, the antibody has effector functions and can fix complement. In some embodiments, the antibody has reduced or no ability to bind to Fc receptors. For example, the antibody can be an isotype or subtype, an antibody fragment or a mutant, and the antibody does not support binding to Fc receptors, for example, it has a mutagenic or missing Fc receptor binding region. The term antibody also includes antigen binding molecules based on tetravalent bispecific tandem immunoglobulins (TBTI) and / or dual variable region antibody-like binding proteins with cross-binding region orientation (CODV).

[0094] The term "fragment" or "antibody fragment" refers to a polypeptide derived from an antibody polypeptide molecule (e.g., an antibody heavy chain and / or light chain polypeptide) that does not include a full-length antibody polypeptide but still includes at least a portion of a full-length antibody polypeptide that can bind to an antigen. Antibody fragments can include cleavage portions of full-length antibody polypeptides, although the term is not limited to such cleavage fragments. Antibody fragments that can be used in the present disclosure include, for example, Fab fragments, F(ab')2 fragments, scFv (single-chain Fv) fragments, linear antibodies, monospecific or multispecific antibody fragments (e.g., bispecific, trispecific, tetraspecific and multispecific antibodies (e.g., diabodies, triabodies, tetrabodies)), monovalent or multivalent antibody fragments (e.g., bivalent, trivalent, tetravalent and multivalent antibodies), minibodies, chelated recombinant antibodies, triabodies or diabodies, intracellular antibodies, nanobodies, small modular immunopharmaceuticals (SMIPs), binding domain immunoglobulin fusion proteins, camelized antibodies and antibodies containing VHH. Additional examples of antigen-binding antibody fragments are known in the art.

[0095] The term "complementarity determining region" or "CDR" refers to short polypeptide sequences within the variable region 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 region of both heavy and light chain polypeptides that are not CDR sequences and are primarily responsible for maintaining the correct positioning of the CDR sequences to allow antigen binding. Although the framework region itself is typically not directly involved in antigen binding, as known in the art, certain residues within the framework region of certain antibodies may be directly involved in antigen binding or may affect the ability of one or more amino acids in the CDR to interact with the antigen.

[0096] Examples of antibodies are anti-PCSK-9 mAb (eg, Alirocumab), anti-IL-6 mAb (eg, Sarilumab), and anti-IL-4 mAb (eg, Dupilumab).

[0097] Pharmaceutically acceptable salts of any API described herein are also contemplated for use in a drug or medicament in a drug delivery device. Pharmaceutically acceptable salts are, for example, acid addition salts and basic salts.

[0098] Those skilled in the art will appreciate that modifications (additions and / or removals) may be made to the various components / components of the APIs, formulations, apparatuses, methods, systems and embodiments described herein without departing from the full scope and spirit of the present disclosure, and that the present invention encompasses such modifications and any and all equivalents thereof.

[0099] Many implementations of the present disclosure have been described. However, it should be understood that various modifications may be made without departing from the spirit and scope of the present disclosure. Therefore, other implementations are within the scope of the appended claims.

Claims

1. An injection device, comprising: a reservoir comprising a wall defining a proximal end, a distal end, and a sidewall; a housing including said reservoir; a plunger rod configured to be movable within the reservoir in a direction from the distal end to the proximal end; and A resonant assembly comprising a plurality of resonators attached to a wall of the housing and aligned along a longitudinal axis of the injection device, the resonant assembly being configured to resonate at a resonant frequency that is dependent on a position of the plunger rod within the reservoir.

2. The injection device of claim 1 , wherein the resonant assembly comprises a magnet attached to the plunger rod and a plurality of resonators attached to the sidewall and configured to change their respective resonant frequencies based on at least one of a linear position and an angular position relative to the magnet, the plurality of resonators comprising a plurality of metamaterials that provide different responses based on a distance of the plunger rod.

3. The injection device of claim 1 , wherein the resonant assembly comprises a mechanical linkage attached to the plunger rod and a strain sensitive resonator attached to the sidewall, the strain sensitive resonator being configured to change its resonant frequency based on at least one of a linear position and an angular position relative to the mechanical linkage.

4. The injection device of claim 3, wherein the mechanical linkage comprises at least one of a spring, an eccentric element, and an eccentric disc.

5. The injection device of claim 1 , wherein the resonant assembly comprises a mechanical linkage attached to the plunger rod and an oscillator attached to the sidewall, the oscillator being configured to change its resonant frequency based on at least one of a linear position and an angular position relative to the mechanical linkage.

6. The injection device of claim 5, wherein the mechanical linkage comprises a beam attached to a cantilever of the oscillator through a diaphragm.

7. The injection device according to any one of claims 1 to 6, wherein the resonant component comprises a multi-slot patch resonator, the multi-slot patch resonator being configured to generate a signal comprising at least one of an identifier of the injection device and a medication type.

8. The injection device according to any one of claims 1 to 6, further comprising an antenna configured to transmit a signal generated based on the resonant frequency of the resonant component to an external device and / or receive an interrogation signal from an external device.

9. The injection device of claim 8, wherein the interrogation signal comprises a plurality of interrogation signals.

10. The injection device of claim 9, wherein the plurality of interrogation signals are received at regular time intervals.

11. The injection device according to claim 9, wherein: In response to receiving the plurality of interrogation signals, the resonant assembly generates a plurality of detection signals such that a frequency shift between two of the plurality of detection signals is correlated to the amount of medicament within the reservoir.

12. The injection device of claim 8, wherein the interrogation signal is generated in response to a trigger signal transmitted by the injection device.

13. An injection device according to any one of claims 1 to 6, wherein the position of the plunger rod is indicative of the amount of medicament within the reservoir.

14. A drug injection system, comprising: An external device, the external device comprising: a transmitter configured to generate an interrogation signal, a receiver configured to receive a radio frequency signal, and one or more processors configured to process the radio frequency signals and generate resulting data to be displayed by the external device; and An injection device as claimed in any preceding claim.

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