Integration of ultrasonic sensor in plunger stopper of injection device

Abstract

The invention relates to integration of an ultrasonic sensor in a plunger stopper of an injection device. In particular to an injection device (102) comprising: a medicament reservoir (103); a plug (105) comprising a rigid core (125) and an ultrasound probe (122) arranged in the housing, the ultrasound probe configured to transmit an emitted ultrasound signal through the rigid core in a longitudinal direction of the rigid core into the medicament reservoir and to receive an ultrasound signal generated by a reflection of the emitted ultrasound signal, the reflections include at least reflections from the distal end of the medicament reservoir; a control component (124a) configured to be electrically coupled with the ultrasound probe and to process the ultrasound signal to generate injection device data; and an antenna (124c) configured to be electrically coupled with the control component and to transmit the injection device data to an external computing device (104).

Description

[0001] This invention application is a divisional application based on an invention patent application with application date of November 12, 2018, application number 201880073149.9 (international application number PCT / EP2018 / 080886) and name “Integration of Ultrasonic Sensor in the Plunger Plug of Injection Device”. Background Art

[0002] The electronic injection device allows the patient to safely administer medication without constant supervision by medical personnel, while also transmitting treatment data to medical personnel. The electronic injection device may include a medication reservoir such as a cartridge or syringe, a sensor, electronic components, a drive system, and an energy supply. The sensor may be integrated into the plunger stopper to determine the plunger position inside the cartridge or syringe. Further, the sensor may include an ultrasonic transmit / receive sensor.

[0003] The plug is typically made of a material that dampens the transmission of ultrasonic signals (e.g., an elastic material such as butyl rubber). The strong ultrasonic signals that can be transmitted through the elastic material require high energy. The consumption of high energy may be a problem with battery capacity. Further, the thickness of the rubber layer in front of the ultrasonic transmit / receive sensor needs to be very thin and its variability is limited. Conventional rubber molding processes may lack the required precision, and thin rubber walls may not be stable enough to withstand the manufacturing process.

[0004] Some known mechanical ventricular assist devices have been disclosed in PCT International Publication No. WO 2017 / 155672 published on September 14, 2017, and U.S. Patent Publication No. US 2017 / 0014535A1 published on January 19, 2017, and US2015 / 0174342 A1 published on June 25, 2015. These documents disclose ultrasound probes integrated into different medical devices so that the surface of the probe is in direct contact with a fluid (e.g., a drug or a patient's blood). The contact of fluids with the surface of an ultrasound probe system presents chemical and medical challenges. Common complications of fluid contact with the surface of an ultrasound probe include chemical interactions and fluid contamination. Summary of the invention

[0005] Implementations of the present disclosure include mechanisms and systems configured to measure the amount of medication in an injection device. In some implementations, an electronic injection device includes: a plug including a rigid core made of at least one of a cyclic olefin copolymer (COC) and a cyclic olefin polymer (COP) and an ultrasonic probe, the ultrasonic probe configured to transmit an emitted ultrasonic signal through the rigid core along a longitudinal direction of the rigid core into a medication reservoir and receive an ultrasonic signal generated by reflection of the emitted ultrasonic signal, the reflection including at least a reflection from a distal end of the medication reservoir; a control component configured to electrically couple with the ultrasonic probe and process the ultrasonic signal to generate injection device data; and an antenna configured to electrically couple with the control component and transmit the injection device data to an external computing device.

[0006] In some implementations, the ultrasonic signal is in a frequency range of about 2 MHz to about 12 MHz. The ultrasonic probe is attached to the inner wall of the closed end of the plug. The ultrasonic probe is coupled to the inner wall of the closed end of the plug by at least one of a mechanical press fit and a coupling agent. The ultrasonic probe is molded into the inner wall of the closed end of the plug. The ultrasonic probe is a predetermined distance from the outer wall of the plug so as to detect the amount of medicine in the cartridge included in the injection device. The injection device may include an energy source configured to provide energy to the ultrasonic probe and the control component. The injection device data includes an electrical signal associated with the amount of medicine in the cartridge included in the injection device. A portion of the rigid core between the ultrasonic probe and the medicine reservoir has a thickness of about 0.1 mm to about 4 mm. After dispensing a portion of the medicine, the ultrasonic probe transmits the ultrasonic signal.

[0007] According to another aspect of the present invention, a drug injection system includes: an injection device and an external computing device. The injection device includes: a plug, the plug includes a rigid core and an ultrasonic probe, the rigid core is made of at least one of a cyclic olefin copolymer (COC) and a cyclic olefin polymer (COP), the ultrasonic probe is configured to transmit the emitted ultrasonic signal through the rigid core along the longitudinal direction of the rigid core into the drug reservoir and receive an ultrasonic signal generated by the reflection of the emitted ultrasonic signal, the reflection at least includes a reflection from the far end of the drug reservoir; a control component, the control component is configured to be electrically coupled to the ultrasonic probe and process the ultrasonic signal to generate injection device data; and an antenna, the antenna is configured to be electrically coupled to the control component and transmit the injection device data. The external computing device is configured to receive, process and display the injection device data.

[0008] In some implementations, the external computing device includes one of a mobile device, a smart watch, a tablet computer, and a laptop computer. The ultrasonic signal is in a frequency range of about 2 MHz to about 12 MHz. The ultrasonic probe is attached to the inner wall of the closed end of the plug. The ultrasonic probe is coupled to the inner wall of the closed end of the plug by at least one of mechanical press-fit and a coupling agent. The ultrasonic probe is molded into the inner wall of the closed end of the plug. The ultrasonic probe is a predetermined distance from the outer wall of the plug so as to detect the amount of medicine in the cartridge included in the injection device. The drug injection system may further include an energy source configured to provide energy to the ultrasonic probe and the control component. The injection device data includes an electrical signal associated with the amount of medicine in the cartridge included in the injection device.

[0009] According to another aspect of the present invention, a method for detecting the amount of medicine in an injection device includes: generating a trigger associated with the operation of the injection device; in response to generating the trigger, transmitting an emitted ultrasonic signal through an ultrasonic probe, the ultrasonic signal being directed to a medicine reservoir included in the injection device, the medicine reservoir being separated from the ultrasonic probe by a rigid portion of a plug, the rigid portion of the plug being made of at least one of a cyclic olefin copolymer (COC) and a cyclic olefin polymer (COP); and receiving, by the ultrasonic probe, an ultrasonic signal generated by reflection of the emitted ultrasonic signal, the reflection including at least a reflection from a distal end of the medicine reservoir; processing the ultrasonic signal to generate injection device data; and transmitting the injection device data to an external computing device, the external computing device being configured to receive, process and display the injection device data.

[0010] 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.

[0011] Specifically, the present invention includes the following items:

[0012] 1. An injection device (102), comprising: a drug reservoir (103); a plug (105, 200a, 200b, 200c), the plug comprising a rigid core (125) and an ultrasonic probe (122) arranged in a housing (121), the rigid core being made of at least one of cyclic olefin copolymer (COC) or cyclic olefin polymer (COP), the ultrasonic probe (122) being configured to transmit an ultrasonic signal along a longitudinal direction (202) of the rigid core (125) through the rigid core (125). 25) transmits to the drug reservoir (103) and receives an ultrasonic signal generated by reflection of the emitted ultrasonic signal, the reflection including at least a reflection from the distal end of the drug reservoir (103); a control component (124a), the control component being configured to be electrically coupled to the ultrasonic probe (122) and to process the ultrasonic signal to generate injection device data; and an antenna (124c), the antenna being configured to be electrically coupled to the control component (124a) and to transmit the injection device data to an external computing device (104).

[0013] 2. An injection device (102) according to item 1, wherein the ultrasonic signal is in a frequency range of about 2 MHz to about 12 MHz.

[0014] 3. An injection device (102) according to item 1, wherein the ultrasonic probe (122) is attached to the inner wall of the closed end (204) of the stopper (105, 200a, 200b, 200c).

[0015] 4. An injection device (102) according to item 3, wherein the ultrasonic probe (122) is coupled to the inner wall of the closed end (204) of the plug (105, 200a, 200b, 200c) by at least one of mechanical press-fitting or a coupling agent.

[0016] 5. An injection device (102) according to item 1, wherein the ultrasonic probe (122) is molded into the inner wall of the closed end (204) of the stopper (105, 200a, 200b, 200c).

[0017] 6. An injection device (102) according to item 1, wherein the injection device data comprises an electrical signal associated with the amount of medicament in the medicament reservoir (103), such as a cartridge.

[0018] 7. An injection device (102) according to claim 1, wherein a portion of the rigid core (125) between the ultrasound probe (122) and the drug reservoir (103) has a thickness of about 0.1 mm to about 4 mm.

[0019] 8. A drug injection system (100), comprising: an injection device (102) according to item 1; and an external computing device (104), the external computing device being configured to receive and process the injection device data and to display information related to the processed injection device data.

[0020] 9. The drug injection system (100) according to item 8, wherein the external computing device (104) comprises one of a mobile device, a smart watch, a tablet computer and a laptop computer.

[0021] 10. The drug injection system (100) according to item 8, wherein the ultrasonic probe (122) is attached to the inner wall of the closed end (204) of the stopper (105, 200a, 200b, 200c).

[0022] 11. A drug injection system (100) according to item 10, wherein the ultrasonic probe (122) is coupled to the inner wall of the closed end (204) of the plug (105, 200a, 200b, 200c) by at least one of mechanical press-fitting or a coupling agent.

[0023] 12. The drug injection system (100) according to item 8, wherein the ultrasonic probe (122) is molded into the inner wall of the closed end (204) of the stopper (105, 200a, 200b, 200c).

[0024] 13. The drug injection system (100) according to item 8, comprising an energy source (123), wherein the energy source is configured to provide energy to the ultrasound probe (122) and the control component (124a).

[0025] 14. A drug injection system (100) according to item 8, wherein the injection device data comprises an electrical signal associated with the amount of drug in the drug reservoir (103), such as a cartridge.

[0026] 15. A method for detecting a drug amount in an injection device (102), the method comprising: generating a trigger associated with an operation of the injection device (102); in response to generating the trigger, transmitting an ultrasonic signal emitted by an ultrasonic probe (122) disposed in a housing (121), the ultrasonic signal being directed to a drug reservoir (103) included in the injection device (102), the drug reservoir (103) being separated from the ultrasonic probe (122) by a rigid portion of a plug (105, 200a, 200b, 200c), the plug The rigid portion of (105, 200a, 200b, 200c) is made of at least one of cyclic olefin copolymer (COC) and cyclic olefin polymer (COP); receiving an ultrasonic signal generated by reflection of the emitted ultrasonic signal by the ultrasonic probe (122), the reflection at least including reflection from the distal end of the drug reservoir (103); processing the ultrasonic signal to generate injection device data including the amount of drug in the drug reservoir (103); and transmitting the injection device data to an external computing device (104), the external computing device being configured to

[0027] The injection device data is received and processed and information related to the processed injection device data is displayed. BRIEF DESCRIPTION OF THE DRAWINGS

[0028] 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.

[0029] Figures 1A to 1C is an exploded view of an example of an apparatus according to the present disclosure.

[0030] FIG. 2A to FIG. 2C is a block diagram of an example system architecture in which implementations of the present disclosure may be performed.

[0031] Figure 3 is a flow chart illustrating an example process that may be performed to carry out operations of the present disclosure.

[0032] Figure 4 is a schematic illustration of an example computer system that can be used to perform implementations of the present disclosure.

[0033] Like reference numerals in the various drawings represent like elements. DETAILED DESCRIPTION

[0034] Implementations of the present disclosure generally relate to mechanisms and systems configured for measuring the amount of medication within an injection device. More particularly, implementations of the present disclosure relate to a technique for determining the volume of a medication reservoir using a radio frequency (RF) signal.

[0035] Traditional elastic materials (such as butyl rubber) used for plunger plugs affect the transmission of ultrasonic signals. As described in further detail herein, the implementation of the present disclosure solves this challenge. For example, according to the implementation described herein, the plunger plug may include an ultrasonic probe embedded in a rigid material. The composition and configuration of the plunger plug provide multiple advantages. For example, the features of the plunger plug optimize the functionality and robust performance of the ultrasonic probe. The configuration of the plunger plug is associated with minimal energy consumption. The plunger plug may include a miniaturized ultrasonic probe that has minimal impact on the overall geometry and size of the plunger plug. The low dependence of the ultrasonic signal amplitude on the thickness and thickness variation of the plunger plug can facilitate the production process. Further, the plunger plug and the ultrasonic probe can be manufactured as separate elements (e.g., assembled before or after the main container filling / finishing operation). Separate manufacturing can avoid problems associated with heat treatment of sensitive electronic components in the ultrasonic probe (such as the sterilization process required for components used in the aseptic manufacturing process). Separate manufacturing can avoid problems associated with complex plunger plug manufacturing processes (such as embedding electronic components as part of the plug forming process).

[0036] Figures 1A to 1C An example system 100 is shown that can be used to perform implementations of the present disclosure. For example, the example system 100 can be used for transmission and reception of ultrasound signals to determine the amount of medication within an injection device 102. The example system 100 includes one or more injection devices 102, an external device 104, a network 106, and a server system 108.

[0037] Figures 1A to 1C An exploded view of the injection device 102 and a close-up view of a cross section of the plunger stopper 105 are depicted. The injection device 102 may be a pre-filled disposable injection pen, or the injection device 102 may be a reusable injection pen. For example, the injection device 102 may be configured to communicate with the external device 104 and transmit injection device data to the external device 104; the data may be, for example, operational data (e.g., the date and time when the injection device 102 is started and sensor measurements) and corresponding treatment data (e.g., the amount of medication within the injection device 102). In some implementations, the injection device 102 may be associated with an identifier that is used by the external device 104 to uniquely identify the injection device 102.

[0038] The injection device 102 may include a housing 110 (e.g., a cartridge holder of the injection device 102) and a needle assembly 115. The housing 110 may contain a medicament reservoir 103 (a primary container system of a cartridge with a closure), a plunger stopper 105, an electronic module 107, a plunger rod 118, a plunger head 109, a bearing 111, a dose knob 112, a dose window 114, and an injection button 120. The housing 110 may be molded from a medical grade plastic material. The medicament reservoir 103 may be molded from a glass material such as borosilicate, or may be made from a medical grade plastic material such as a polymer, including cyclic olefin copolymer (COC) or cyclic olefin polymer (COP). The medicament reservoir 103 may have a tubular (cylindrical) shape.

[0039] The medicament reservoir 103 can be configured to hold a fluid medicament. The medicament can include a pharmaceutical formulation containing at least one pharmaceutically active compound. The medicament can include an insulin analog, an insulin derivative, an analgesic, a hormone, a beta agonist, a corticosteroid, or a combination of any of the above-mentioned drugs. The medicament reservoir 103 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 103 can be provided with a pair of ends, one end having a pierceable membrane, the membrane receiving the inward end of the needle 113 in a liquid-tight sealed engagement, and the other end can be displaced by the stopper 105.

[0040] By turning the dose knob 112, a dose of the contained medicament can be discharged from the injection device 102. The selected dose is displayed by the dose window 114, 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 the selected dose displayed in the dose window 114 can be, for example, 30 IU. Turning the dose knob 112 can cause a mechanical click to provide acoustic feedback to the user. The numbers displayed in the dose window 114 can be printed on a sleeve, which is contained in the housing 110 and mechanically interacts with the plunger head 109, which is fixed to the end of the plunger rod 118 and pushes the plunger stopper 105 of the medicament reservoir 103. In some implementations, the selected dose can be displayed in different ways, such as with an electronic display (e.g., the dose window 114 can be in the form of an electronic display). The bearing 111 can provide a secure installation to one or both ends of the plunger rod 118. The plunger head 109 (eg, the rear end of the plunger) may be configured to expel a portion of the fluid by moving the plunger stopper 105 contained within the medicament reservoir 103 such that the position of the plunger stopper 105 is correlated to the amount of fluid within the injection device 102 .

[0041] The plunger stopper 105 may include an electronic module 107, a housing 125, a set of elastic rings 126a, 126b, a sealing plug 127a, a bearing 128 and a filler 129. One or more features of the plunger stopper 105 may be configured to optimize the operation of the electronic module 107. For example, the housing 125 may be formed of a rigid material that optimizes the transmission of ultrasonic signals through the housing 125 (e.g., minimizing relative attenuation to less than about 10%), as shown in Table 1. Therefore, the housing 125 is sometimes referred to as a rigid core. The rigid material of the housing 125 may include a medical grade plastic material, such as COC or COP (e.g., ). Table 1 includes the relative attenuation measurements of the exponential decay of the reflections generated by the shoulder of the cartridge and the needle pierceable end of the medicament reservoir 103. The results of Table 1 were generated using piezoelectric elements of different diameters embedded in elastic or rigid materials of various thicknesses. The results of Table 1 show the dependence of the ultrasonic signal amplitude on the thickness of the plunger stopper for butyl rubber and the dependence of the ultrasonic signal amplitude on the thickness of the plunger stopper for cycloolefin polymer COP The ultrasonic signal amplitude has a low dependence on the plunger stopper thickness (eg, less than 5%).

[0042] Table 1

[0043]

[0044] In some implementations, the thickness of the housing 125 at the closed end can be selected to maintain a specific distance between the electronic module 107 and the drug reservoir 103. The distance can be selected based on one or more features of the electronic module 107 (e.g., the near field of the ultrasound probe 122). For example, the thickness of the housing 125 at the closed end can be in the range of about 0.1 mm to about 1.6 mm. The preferred thickness of the housing 125 is between 0.8 mm and 1.3 mm, a range that provides mechanical stability during processing (e.g., transportation, storage, supply on a filling line, and insertion into a cartridge) to achieve manufacturability of the stopper shell and prevent attenuation of the ultrasonic signal. For example, for rubber molding, the thickness can be about 0.3 mm, while for injection molding of COC or COP, the thickness can be less than 0.1 mm.

[0045] For an ultrasonic frequency of 2.8 MHz, the thickness of the housing 125 at the closed end may preferably be about 1 mm. In some implementations, the thickness of the sidewalls of the housing 125 may be determined primarily by the manufacturability of the housing and mechanical stability during handling (e.g., shipping, storage, feeding on a filling line, and insertion into a cartridge). In some implementations, the thickness of the sidewalls of the housing 125 may be selected to withstand the forces applied during insertion of the stopper housing into the cartridge and the dispensing forces applied by the plunger head during administration of the medicament.

[0046] The resilient rings 126a, 126b may provide a secure fit of the housing 125 within the medicament reservoir 103 by preventing radial displacement of the housing 125. The bearing 128 may provide a secure fit to the end of the plunger stopper 105 proximate the plunger head 109. The filler 129 ( Figure 1A and Figure 1C ) or filling layers 129a, 129b ( Figure 1B ) can be configured to hold the electronic module 107 in a secure position within the plunger plug 105. The sealing plug 127a ( Figure 1A and Figure 1B ) or sealing film 127b ( Figure 1C ) can optionally be mounted on top of the electronic module 107 and can provide a liquid-tight seal to protect the electronic module 107 from moisture or liquid damage. The sealing plug 127a can be made of materials such as medical grade thermoplastic elastomers, rubber elastomers, and combinations thereof. The plunger stopper 105 can have a sufficient length so that the plunger stopper 105 will not be torn or twisted when engaged by the plunger head 109. Reference FIG. 2A to FIG. 2C Further details regarding the plunger stopper 105 are provided.

[0047] The needle assembly 115 includes a needle 113 that can be attached to the housing 110. The needle 113 can be covered by an inner needle cap 116 and an outer needle cap 117, which can in turn be covered by a cap 118. When the needle 113 is inserted into the patient's subcutaneous or intramuscular area, the injection button 120 is pushed, and the dose of the medicament displayed in the display window 114 can be discharged from the injection device 102. When the needle 113 of the injection device 102 remains inserted into the patient's body for a few seconds after the injection button 120 is pushed, a high percentage (e.g., about 100%) of the dose is injected into the patient's body. 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 112 is used.

[0048] The injection device 102 can be used for several injection processes until the medicament reservoir 103 is emptied or the injection device 102 reaches an expiration date (e.g., 28 days after the first use). Before the first use of the injection device 102, it may be necessary to perform a priming operation to bring the plunger head 109 or the bearing 111 into contact with the stopper and remove air from the medicament reservoir 103 and the needle 113. For example, the priming operation may include selecting two units of medicament and pressing the injection button 120 while holding the needle 113 of the injection device 102 upward. The pulse generated by selecting two units of medicament or pressing the injection button 120 may start the operation of the electronic module 107 and / or the communication between the injection device 102 and the external device 104.

[0049] The electronic module 107 may be configured to perform and / or assist one or more functions (e.g., the discharge of a medicament) of the injection device 102. The electronic module 107 may be molded, assembled, or welded within the plunger stopper 105 of the injection device 102. The electronic module 107 may include a housing 121, an ultrasound probe 122, a battery 123, and / or auxiliary components 124. The auxiliary components 124 may include a control component 124a, a sensor 124b, and an antenna 124c.

[0050] The housing 121 may be an airtight closed structure configured to fit within a cavity formed in the plunger stopper 105. The housing 121 enables all components of the electronic module 107 to be inserted into the plunger stopper 105 simultaneously. The housing 121 may be made of a rigid material including a medical grade plastic material such as COC or COP. In some implementations, the thickness of the housing 121 and the thickness of the bottom layer 125 of the plunger stopper 105 may be selected to be substantially equal to or greater than the near field length of the ultrasound probe 122. For example, the thickness of the housing 121 and the thickness of the bottom layer 125 of the plunger stopper 105 may be greater than approximately 1 mm.

[0051] The ultrasonic probe 122 may be one or more low-power single-element ultrasonic transducers (including piezoelectric elements). The ultrasonic probe 122 may be powered by a battery 123 to generate ultrasonic signals and detect reflections of the ultrasonic signals. The diameter of the ultrasonic probe 122 may be proportional to the intensity of the ultrasonic signal generated, so that increasing the diameter of the ultrasonic probe 122 increases the intensity of the ultrasonic signal generated (see Table 1). The ultrasonic probe 122 may have a diameter of about 4 mm to about 8 mm. The ultrasonic probe 122 may be configured to generate a non-invasive ultrasonic signal with a frequency of 2 to 12 MHz. In some implementations, a plurality of ultrasonic probes 122 may be used, each with a specific frequency, so that the frequency of the ultrasonic signal may be changed based on a pre-measured volume of the drug to increase the accuracy of the measurement result. The ultrasonic signal may be directed to the drug reservoir 103. The reflection of the ultrasonic signal is associated with the amount of drug in the drug reservoir 103. The reflection of the ultrasonic signal indicates the reflection generated by each material transition region (including the boundary of the drug reservoir 103) through which the ultrasonic signal passes. The ultrasonic probe 122 may transmit an ultrasonic signal to the control component 124a to determine the volume of the medicine. For example, when the stopper moves from a first position to a second position, the position of the stopper in the cartridge is determined by estimating the change in flight time. The displacement (the difference between the first position and the second position) may be related to the volume of the medicine dispensed, and therefore to the dose dispensed. The sensor 124b may include one or more of a temperature sensor, a humidity sensor, an air quality sensor, a light intensity sensor, or other environmental sensors. The sensor 124b may be powered by a battery 123 to generate sensor data and transmit the sensor data to the control component 124a.

[0052] The coupling of the ultrasound probe to the plug shell can be accomplished by form fit and mechanical pressure between the ultrasound probe and the plug shell. As another method, a coupling agent such as a liquid or semi-liquid material (e.g., silicone oil or silicone gel of different viscosities, wax, hydrocarbon, paraffin, etc.) can be used to fill the space between the plug shell and the ultrasound probe. In some implementations, an adhesive or glue can be used to create a strong bond between the ultrasound probe and the plug shell.

[0053] The control component 124a can be an ultra-low power (μW) platform chip and can be configured to control the operation of the electronic module 107. For example, the control component 124 can control when the battery 123 powers the ultrasound probe, the sensor 124b, and the antenna 124c. The control component 124 can obtain energy from the battery 123 to process the ultrasound signal and the sensor data to generate the injection device data. The injection device data may include the amount of fluid in the drug reservoir 103, other environmental values ​​measured by the sensor 124b, and an identifier of the injection device 102. The control component 124 can transmit the injection device data to the antenna 124c, which can transmit the injection device data to the external device 104. The antenna 124c can be a radio frequency (RF) antenna, a Bluetooth antenna, a millimeter wave antenna, or any other type of antenna configured for short-range communication within the communication field 130. The communication field 130 can enable communication between the injection device 102 and the external device 104.

[0054] The external device 104 may communicate with the injection device 102 via the communication field 130, and may communicate with one or more of the server devices 108 via the network 106. In some implementations, the external device 104 may include any suitable type of computing device, such as a desktop computer, a laptop computer, a handheld computer, a tablet computer, a personal digital assistant (PDA), a cellular phone, a network appliance, a camera, a smart phone, an Enhanced General Packet Radio Service (EGPRS) mobile phone, a media player, a navigation device, an email device, a game console, or a suitable combination of any two or more of these devices, or other data processing devices.

[0055] The external device 104 may include a transceiver 132, a processor 134, and a display 136. The transceiver 132 may be configured to transmit a signal to activate and / or power the injection device 102 and to receive a signal from the injection device 102. The transceiver 132 may be configured to autonomously transmit a signal to the injection device 102 at a preset frequency during a preset time interval. The processor 134 may be configured to process data transmitted by the injection device 102. The external device 104 may be configured to enable a user to interact with the display 136 (e.g., through a graphical user interface) to initiate communication between the external device 102 and the injection device 102 (e.g., generate a trigger signal to initiate treatment and select a dose of medication). The display 136 may be configured to display data received from the injection device 102 and processed by the external processor 132.

[0056] In some implementations, the server device 108 includes at least one server 138 and at least one data storage 140. In the example of FIG. 1 , the server device 108 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) via the network 106 to support monitoring the use of the injection device 102. In some implementations, a user (e.g., a patient or a health care provider) can access the application services to analyze past and current data associated with the use of the injection device 102. 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.

[0057] FIG. 2A to FIG. 2C Examples of plugs 200a, 200b, 200c that may be used in implementations of the present disclosure are shown. For example, the plugs 200a, 200b, 200c may be reference Figures 1A to 1C An example of a plunger stopper 105 is described. The example stoppers 200a, 200b, 200c can be configured to optimize the transmission of RF signals to and from the ultrasound probe 122 across the closed end 204 of the housing 125 in a longitudinal direction 202 aligned with the axial direction of the drug reservoir 103. Further, the ultrasound probe 122 can be attached to the inner wall of the closed end 204 of the stoppers 200a, 200b, 200c.

[0058] For example, the housing 125 can be formed of a rigid material that optimizes the transmission of ultrasonic signals through the housing 125. The housing 125 can have a cylindrical shape or a flat conical shape having a closed end 204 and an open end 206. The diameter of the housing 125 is adapted to the inner diameter of the drug reservoir 103, such as a standard cartridge with a nominal fill volume of 3 mL or 1.5 mL, and the diameter of the housing is adapted to accommodate the positioning of the sealing ring in the interface between the housing 125 and the drug reservoir 103. Therefore, the outer diameter of the housing 125 is typically smaller than the inner diameter of the drug reservoir 103. In the example shown, the housing 125 is circumferentially surrounded by a set of elastic rings 126a, 126b. The elastic rings 126a, 126b may have a diameter between approximately 0.8 mm and 2 mm. For example, as Figure 2A As shown, both elastic rings 126a, 126b may have equal diameters of approximately 1 mm, 1.5 mm, or 2 mm. Figure 2B and Figure 2C As shown, the elastic ring 126a may have a diameter of approximately 1.5 mm or 2 mm, which may be larger than the diameter of the elastic ring 126b (eg, approximately 1 mm).

[0059] Sealing plug 127a( Figure 2A and 2B ) or sealing film 127b ( Figure 2C ) can be configured to seal the open end 206 of the housing 125 to protect the ultrasound probe 122 from moisture and gas contamination. The sealing plug 127a ( Figure 2A and Figure 2B ) can be configured to fit or be welded within the open end 206 of the housing 125. The fit can be a form fit, a positive fit, a snap-fit, a force closure, a closure link, an adhesive, or any combination thereof. The sealing plug 127a can be made of the same material as the housing 125 or a different material (e.g., an elastomeric material) to seal the open end 206 of the housing 125. The sealing membrane 127b ( Figure 2C ) may be a sealing film including one or more protective layers. The protective layer of the sealing film 127b may include a ceramic layer, a polymer layer, and a silicon oxide coating. The sealing film 127b may have a thickness of about 50 μm to about 100 μm, such as about 86 μm. The sealing film 127b may be attached to the open end 206 of the housing 125 using an adhesive or an attachment feature.

[0060] Figure 3 It is shown that, for example, reference Figures 1A to 1C and FIG. 2A to FIG. 2CFlowchart of an example process 300 performed by a device and system described herein. Process 300 begins with receiving a trigger signal (302). The trigger signal may include a start operation on an injection device having an ultrasound probe inserted in a rigid plunger stopper. The start operation may be initiated by a user of the injection device or a user of an external device in communication with the injection device. An example of a start 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 keeping the needle of the injection device facing upward. Another example of a start operation performed with the injection device may include pressing a start button of the injection device configured as an electrical switch. In some implementations, the trigger signal may include an interrogation signal generated by an external device. The interrogation signal may be automatically generated by the external device based on one or more conditions. The conditions may include a transmission frequency, a transmission time, and / or a time interval. For example, a medicament treatment may be scheduled to be performed within a specific time interval, during which the external device may generate an interrogation signal at a given frequency. The signal may be generated by the external device in response to a user input on the external device. For example, a user may interact with the external device to initiate a medicament dispensing service. The trigger signal may include at least one of a mechanical signal, an acoustic signal, and an electrical signal. The trigger signal may include a command to generate an ultrasonic signal.

[0061] In response to receiving the trigger signal, an ultrasonic signal can be generated by an ultrasonic probe located in a rigid plunger stopper of the injection device (304). In some implementations, the frequency of the transmitted ultrasonic signal can be selected based on the length of the medication reservoir or the pre-measured or expected volume of the medication. For example, an ultrasonic signal with a low frequency (e.g., 2 MHz) can be used for a large volume of medication, while an ultrasonic signal with a high frequency (e.g., 10 MHz) can be used for a small volume of medication. The transmitted ultrasonic signal is transmitted toward the closed end of the stopper formed of a rigid material in a direction parallel to the longitudinal center axis of the stopper and the injection device. The transmission of the transmitted ultrasonic signal can include transmission through the rigid material of the stopper and transmission through the medication stored in the medication reservoir.

[0062] The reflected ultrasonic signal is received by the ultrasonic probe (306). The reflected ultrasonic signal may include reflections from the rigid material of the stopper, reflections from the medicament stored in the medicament reservoir, and reflections from the distal end of the medicament reservoir. The terms "distal", "distally", and "distal end" refer to the end of the injection device toward which the needle is disposed and which also includes the shoulder region of the cartridge or syringe. The terms "proximal", "proximally", and "proximal end" refer to the opposite end of the injection device toward which the injection button or dose knob is disposed. One or more features of the reflected ultrasonic signal may indicate the amount of medicament contained by the medicament reservoir and the presence of bubbles. For example, reflections from the medicament stored in the medicament reservoir and reflections from the distal end (e.g., the needle pierceable end) of the medicament reservoir indicate the amount of medicament contained by the medicament reservoir.

[0063] In response to receiving the reflected ultrasound signal, an electrical signal may be generated by the ultrasound probe (308). The electrical signal may be used by the processor to generate injection device data (310). The injection device data may include the electrical signal, a unique identifier of the injection device, sensor measurements (e.g., medication temperature), internal clock measurements (e.g., a reception timestamp of the ultrasound signal), location, and / or situation-specific data of the injection device.

[0064] The injection device data is transmitted to an external device to analyze one or more parameters associated with the administration of the medicament and the operating condition of the injection device (312). The injection device data can be transmitted using radio frequency (RF) communication, Bluetooth communication, millimeter wave communication, or any other suitable type of short-range communication. The injection device data can be processed by a processor of the external device to generate result data (314). In response to obtaining the result data, the result data can be stored for future reference and displayed by a graphical user interface of the external device (316). In some implementations, process 300 is performed before the medicament is expelled by the injection device, and the process is repeated after the medicament is expelled by the injection device.

[0065] Figure 4A schematic diagram of an example 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 (e.g., server device 108 of FIG. 1 ). 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.

[0066] 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.

[0067] 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.

[0068] 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.

[0069] 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.

[0070] 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.

[0071] 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.

[0072] 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.

[0073] 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.

[0074] The present invention further includes the following:

[0075] 1. A drug injection system (100), comprising:

[0076] an electronic module (107) configured to be coupled to the injection device (102), the electronic module (107) comprising

[0077] a probe (122) configured to measure usage data of the injection device (102) when the electronic module (107) is coupled to the injection device, the usage data comprising (i) a dose size of an administered dose of a drug from the injection device (102), and (ii) a date and time of administration of the dose of the drug; and

[0078] an antenna (124c), the antenna (124c) being configured to transmit the usage data of the electronic module (107) to the outside; and

[0079] An electronic device (104) comprising

[0080] a transceiver (132) configured to communicate with the antenna (124c) of the electronic module (107) and receive usage data from the electronic module (107); and

[0081] A graphical user interface (136) is configured to (i) allow a user to interact with the graphical user interface (136), and (ii) display usage data to monitor usage of the injection device (102).

[0082] 2. The drug injection system (100) according to item 1, comprising an injection device (102) configured to administer a dose of the drug.

[0083] 3. The drug injection system (100) according to item 2, wherein the injection device (102) comprises a drug reservoir (103) containing the drug.

[0084] 4. A drug injection system (100) according to any one of items 1-3, wherein the electronic device (104) is configured to initiate communication between the electronic module (107) and the electronic device (104) in response to interaction between a user and a graphical user interface (136) of the electronic device (104).

[0085] 5. The drug injection system (100) according to any one of items 1 to 3, wherein the injection device (102) is associated with an identifier, and the electronic device (104) uses the identifier to uniquely identify the injection device (102).

[0086] 6. The drug injection system (100) according to any one of items 1 to 3, wherein the probe (122) is an ultrasonic probe (122) positioned within a plunger stopper (105) of the injection device (102).

[0087] 7. An electronic device (104) for monitoring an injection device (102), the electronic device (104) comprising:

[0088] a graphical user interface (136) configured to allow a user to interact with the graphical user interface (136) to initiate communication between the electronic device (104) and an electronic module (107) of the injection device (102), the electronic module (107) being configured to measure usage data of the injection device (102); and

[0089] a transceiver (132) configured to communicate with the electronic module (107) and receive usage data of the injection device (102), the usage data comprising (i) one or more dates on which a drug was injected by the injection device (102), and (ii) one or more discharged doses for each of the one or more dates,

[0090] The graphical user interface (136) is configured to display the usage data to monitor usage of the injection device (102).

[0091] 8. The electronic device (104) according to item 7, wherein the electronic device comprises a handheld computer or a mobile phone.

[0092] 9. The electronic device (104) according to item 7, wherein the transceiver is configured to communicate with an electronic module (107) for the injection device (102) using a Bluetooth connection.

[0093] 10. The electronic device (104) according to any one of clauses 7-9, wherein the usage data comprises one or more remaining amounts of the drug in the injection device (102) for each of the one or more dates.

[0094] 11. The electronic device (104) according to any one of items 7-9, wherein the usage data has been measured using an ultrasound probe (122) of the injection module (107).

[0095] 12. The electronic device (104) according to any one of items 7 to 9, wherein the electronic module (107) is inside the plunger stopper (105) of the injection device (102).

[0096] 13. An electronic module (107) for an injection device (102), the electronic module (107) comprising:

[0097] a probe (122) configured to measure usage data of the injection device (102), the usage data comprising (i) a dose size of a dose administered by the injection device (102), and (ii) a date and time of the administered dose;

[0098] an antenna (124c) configured to transmit the usage data to an electronic device (104) external to the electronic module (107) to present the usage data on a graphical user interface of the electronic device (104); and

[0099] A battery (123), wherein the battery (123) is configured to provide energy to the probe (122) and the antenna (124c).

[0100] 14. An electronic module (107) according to item 13, wherein the antenna (124c) is configured to initiate communication between the electronic module (107) and the electronic device (104) in response to user interaction with a graphical user interface (136) of the electronic device (104).

[0101] 15. The electronic module (107) according to item 13 or item 14, wherein the injection device (102) is associated with an identifier and the electronic device (104) uses the identifier to uniquely identify the injection device (102).

[0102] 16. An electronic module (107) according to item 13 or item 14, wherein the electronic module (107) is inside the plunger stopper (105) of the injection device (102).

[0103] 17. The electronic module (107) according to item 16, wherein the probe (122) is an ultrasound probe (122) arranged in the plunger stopper (105) of the injection device (102).

[0104] 18. A method of monitoring use of an injection device (102), the method comprising:

[0105] receiving, by the transceiver (132) of the electronic device (104), usage data of the injection device (102), the usage data of the injection device (102) having been measured by the electronic module (107) and comprising (i) one or more dates on which the drug was injected by the injection device (102), and (ii) one or more discharged doses for each of the one or more dates; and

[0106] Administration data for monitoring use of the injection device (102) is presented via a graphical user interface (136) of the electronic device (104).

[0107] 19. A method according to clause 18, comprising interacting with a graphical user interface (136) of the electronic device (104) to initiate communication between the electronic device (104) and the electronic module (107) before receiving the usage data.

[0108] 20. A method according to clause 18 or clause 19, comprising measuring the usage data using a probe (122) of the electronic module (107).

[0109] 21. The method according to item 20, wherein the probe (122) is arranged in a plunger stopper (105) of the injection device (102).

Claims

1. A drug injection system (100), comprising: an electronic module (107) configured to be coupled to the injection device (102), the electronic module (107) comprising a probe (122) configured to measure usage data of the injection device (102) when the electronic module (107) is coupled to the injection device, the usage data comprising (i) a dose size of an administered dose of a drug from the injection device (102), and (ii) the date and time of administration of the dose of said drug; and an antenna (124c), the antenna (124c) being configured to transmit the usage data of the electronic module (107) to the outside; and An electronic device (104) comprising a transceiver (132) configured to communicate with the antenna (124c) of the electronic module (107) and receive usage data from the electronic module (107); and A graphical user interface (136) is configured to (i) allow a user to interact with the graphical user interface (136), and (ii) display usage data to monitor usage of the injection device (102).

2. The drug injection system (100) of claim 1, comprising an injection device (102) configured to administer a dose of the drug.

3. The drug injection system (100) according to claim 2, wherein the injection device (102) comprises a drug reservoir (103) containing the drug.

4. A drug injection system (100) according to any one of claims 1-3, wherein the electronic device (104) is configured to initiate communication between the electronic module (107) and the electronic device (104) in response to interaction between a user and a graphical user interface (136) of the electronic device (104).

5. The drug injection system (100) according to any one of claims 1-3, wherein the injection device (102) is associated with an identifier, and the electronic device (104) uses the identifier to uniquely identify the injection device (102).

6. The drug injection system (100) according to any one of claims 1-3, wherein the probe (122) is an ultrasonic probe (122) positioned within a plunger stopper (105) of the injection device (102).

7. An electronic device (104) for monitoring an injection device (102), the electronic device (104) comprising: a graphical user interface (136) configured to allow a user to interact with the graphical user interface (136) to initiate communication between the electronic device (104) and an electronic module (107) of the injection device (102), the electronic module (107) being configured to measure usage data of the injection device (102); and a transceiver (132) configured to communicate with the electronic module (107) and receive usage data of the injection device (102), the usage data comprising (i) one or more dates on which a drug was injected by the injection device (102), and (ii) one or more discharged doses for each of the one or more dates, The graphical user interface (136) is configured to display the usage data to monitor usage of the injection device (102).

8. The electronic device (104) of claim 7, wherein the electronic device comprises a handheld computer or a mobile phone.

9. The electronic device (104) of claim 7, wherein the transceiver is configured to communicate with an electronic module (107) for the injection device (102) using a Bluetooth connection.

10. The electronic device (104) according to any one of claims 7-9, wherein the usage data comprises one or more remaining amounts of the drug in the injection device (102) for each of the one or more dates.

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