Drug delivery device with sensing system

Abstract

A drug delivery device is provided with dose delivery sensing capability. A dose button includes a support and a cover that at least partially encloses an electronics assembly including a sensor for detecting rotation of a component during dose delivery to determine a dose of drug delivered. The electronics assembly includes a controller for receiving signals from the sensor. The drug delivery device can be configured to communicate dose delivery information to an external device.

Description

[0001] This application is a divisional application of the invention patent application filed on February 20, 2020, with application number 202080017076.9 and titled "Drug Delivery Device with Sensing System". Background Technology

[0002] Patients with various illnesses often need to self-administer medications. To enable convenient and accurate self-administration, various devices widely known as pen injectors or injection pens have been developed. Typically, these injection pens are equipped with a barrel containing a piston and holding multiple doses of liquid medication. A drive member can move distally to advance the piston in the barrel, thereby dispensing the contained medication from an outlet at the distal end of the barrel, usually through a needle.

[0003] In disposable or pre-filled pens, once the pen has been used and the drug supply in the cartridge has been depleted, the user discards the entire pen and begins using a new replacement pen. In reusable pens, once the pen has been used and the drug supply in the cartridge has been depleted, the pen is disassembled to allow replacement of the used cartridge with a new cartridge, and then the pen is reassembled for subsequent use.

[0004] Many injection pens and other drug delivery devices utilize mechanical systems in which components rotate and / or translate relative to each other in a manner proportional to the dose delivered by the device. Systems have been developed to measure the relative motion of the components of a drug delivery device in order to assess the delivered dose. However, systems integrated into devices or modules face challenges in high-volume manufacturing and repeatable accuracy throughout the product's lifecycle. Adequate drug administration requires accurate dosage delivery by the drug delivery device. Many injection pens and other drug delivery devices do not include the ability to automatically detect and record the amount of drug delivered during an injection event. Without automated systems, patients must manually record the dose and time of each injection.

[0005] The inventors have recognized the need for a device capable of automatically detecting the dose delivered by a drug delivery device during an injection event, and / or overcoming one or more of these and other disadvantages of the prior art. Summary of the Invention

[0006] This invention relates to an electronic dosing detection system for a drug delivery device, located in the proximal portion of the drug delivery device. The dosing detection system is operable to detect data used to determine the dosage of drug delivered by the drug delivery device.

[0007] In one embodiment, a drug delivery device is provided, including a housing, an outlet, and a dosage button axially translatable relative to the housing to activate a dosage dispensing mode in which drug is dispensed from the outlet. The dosage button includes a support and a cover connected to the support. The drug delivery device also includes a compartment defined between the support and the cover, a tubular body rotatable relative to the housing during the dosage dispensing mode, and electronic components. The electronic components include a sensor configured to sense rotation of the tubular body and a controller configured to receive signals from the sensor. At least a portion of the electronic components is located within the compartment.

[0008] In one embodiment, a method of assembling a drug delivery device includes providing a housing, providing an outlet, and coupling a tubular body to the housing. The tubular body is configured to rotate relative to the housing during a dose dispensing mode in which drug is dispensed from the outlet. The method further includes forming a dose button having a cover and a support by at least partially encapsulating electronic components between a cover and a support and attaching the cover to the support. The electronic components have a sensor configured to sense rotation of the tubular body. The method further includes configuring the dose button to be axially translatable relative to the housing. Axial translation of the dose button relative to the housing initiates a dose dispensing mode. Attached Figure Description

[0009] Additional embodiments of the present disclosure, along with their features and advantages, will become more apparent from the description herein in conjunction with the accompanying drawings. The components in the drawings are not necessarily drawn to scale. Furthermore, in the drawings, the same reference numerals denote corresponding parts in different views.

[0010] Figure 1 This is a perspective view of a drug delivery device with a dose detection system according to one aspect of this disclosure.

[0011] Figure 2 yes Figure 1 A partially exploded perspective view of a drug delivery device shows a dosing button with a support and a cover, wherein the cover is shown to be separate from the support.

[0012] Figure 3 yes Figure 1 A partially exploded side view of the drug delivery device shows components of the dose detection system.

[0013] Figure 4 yes Figure 1 A cross-sectional view of a drug delivery device.

[0014] Figure 5 yes Figure 1 A partial cross-sectional view of the proximal end of the drug delivery device, showing the various components of the dose detection system.

[0015] Figure 6 yes Figure 1 A bottom view of a portion of the dosage button, showing the printed circuit board held inside the dosage button cover.

[0016] Figure 7 yes Figure 6 An exploded view of the dosing button cover shown.

[0017] Figure 8 This is a perspective view of the flange component of the dosage detection system in a drug delivery device.

[0018] Figure 9 yes Figure 8 Top view of the flange component.

[0019] Figure 10 This is a perspective view of the dosage button support.

[0020] Figure 11 yes Figure 10 Top view of the dosage button support. Detailed Implementation

[0021] To facilitate an understanding of the principles of this disclosure, reference will now be made to the embodiments shown in the accompanying drawings, and these embodiments will be described using precise language. However, it should be understood that this is not intended to limit the scope of the invention.

[0022] This disclosure relates to a sensing system for a drug delivery device. In one aspect, the sensing system is used to sense relative rotational motion between a dose setting component and an actuator component of the drug delivery device to determine the dose delivered by the drug delivery device. The sensed relative rotational motion is related to the delivered dose. As an illustration, the drug delivery device is described as being in the form of an injection pen. However, the drug delivery device can be any device for setting and delivering a drug dose, such as an injection pen, infusion pump, and syringe. The drug can be of any type that can be delivered by such a drug delivery device.

[0023] The device described herein may also include, for example, a drug within a reservoir or tube 20. In another embodiment, the system may include one or more devices including device 10 and a drug. The term “drug / pharmaceutical” refers to one or more therapeutic agents, including but not limited to insulin, insulin analogs such as lispro insulin or glargine insulin, insulin derivatives, glucagon-like peptide-1 (GLP-1) receptor agonists such as dulaglutide or liraglutide, glucagon, glucagon analogs, glucagon derivatives, gastric inhibitory peptides (GIPs), GIP analogs, GIP derivatives, gastric acid regulator analogs, gastric acid regulator derivatives, therapeutic antibodies, and any therapeutic agent capable of being delivered via the aforementioned device. The drug used in the device may be formulated with one or more excipients. The device is operated by a patient, caregiver, or healthcare professional in a manner generally described above to deliver the drug to a person.

[0024] An exemplary drug delivery device 10 in Figure 1-4 The image shows an injection pen configured to inject medication into a patient via a needle. Device 10 includes a body 11, which may include an elongated pen-shaped housing 12, the housing 12 including a distal portion 14 and a proximal portion 16. The distal portion 14 may be accommodated within an injection pen cap 18. (Reference) Figure 4 The distal portion 14 may include a tubing 20 configured to hold medication to be dispensed through the outlet 21 of the housing during a dispensing operation. The outlet 21 of the distal portion 14 may be equipped with an injection needle 24. In some embodiments, the injection needle is removable from the housing, while some embodiments include a needle attached to the tubing unit. In some embodiments, the injection needle is replaced with a new injection needle after each use.

[0025] Piston 26 may be located within reservoir 20. The drug delivery device may include an injection mechanism located in the proximal portion 16, operable to advance piston 26 toward the outlet of reservoir 20 during a dosing operation, thereby forcing the contained drug through the needle tip. The injection mechanism may include a drive member 28, exemplary in the form of a screw / threaded rod, axially movable relative to housing 12 to advance piston 26 through reservoir 20.

[0026] The device may include a dose setting assembly connected to the housing 12 for setting the dose dispensed by the device 10. For example... Figure 3 and Figure 4 As best shown in the illustrated embodiment, the dose setting assembly includes a dose setting threaded rod 32 and a flange member / flange 38. The dose setting threaded rod 32 is in the form of a screw element that can be manipulated to move helically relative to the housing 12 about a rotational longitudinal axis AA during dose setting and dose dispensing (i.e., simultaneous axial and rotational movement). Figure 3 and Figure 4 The initial or zero-dose position is shown with the dose-setting threaded rod 32 fully screwed into the housing 12. The dose-setting threaded rod 32 is operable to be screwed out of the housing 12 proximally until it reaches a fully extended position corresponding to the maximum dose that the device 10 can deliver in a single injection. The extended position can be any position between the position corresponding to an incremental extended position (e.g., a dose setting of 0.5 or 1 unit) and the fully extended position corresponding to the maximum dose that the device 10 can deliver in a single injection, and is screwed into the housing 12 distally until it reaches an initial or zero position corresponding to the minimum dose that the device 10 can deliver in a single injection.

[0027] refer to Figure 3 and 4 The dose setting threaded rod 32 includes a helical threaded outer surface that engages with a corresponding threaded inner surface 13 of the housing 12 to allow the dose setting threaded rod 32 to move helically (i.e., simultaneously rotate and translate). The dose setting threaded rod 32 also includes a helical threaded inner surface that engages with the sleeve 34 of the device 10. Figure 4 The sleeve 34 has an internal thread that engages with the external thread of the drive member 28. When the sleeve 34 moves axially, this internal thread drives the drive member 28 to move the piston 26 axially. The outer surface of the dose setting threaded rod 32 includes dose indicator markings, such as numbers visible through the dose window 36, to indicate the set dose to the user.

[0028] As described above, in some embodiments, the dose setting assembly further includes a tubular flange member 38, which is coupled to the proximal end of the opening of the dose setting threaded rod 32 and is axially and rotatably locked to the dose setting threaded rod 32 by a protrusion 40 received in the opening 41 of the dose setting threaded rod 32. The protrusion 40 of the flange member 38 is as follows: Figure 3 , Figure 8 and Figure 9 As shown, the opening 41 of the dose setting threaded rod 32 is as follows: Figure 3 As shown in the image.

[0029] like Figure 3 and Figure 4 As shown, the delivery device 10 may include an actuator assembly having an engagement / clamping device 52 and a dose button 30. The engagement 52 is housed within a dose-setting threaded rod 32, and the engagement 52 includes an axially extending shank 54 at its proximal end. The dose button 30 of the actuator assembly is located at the proximal end of the dose-setting threaded rod 32 and the flange member 38. The dose button 30 includes a support 42 and a cap or cover 56. As will be discussed, the support 42 and the cover 56 encapsulate electronic components for storing and / or transmitting data related to the dose delivered by the drug delivery device.

[0030] The support 42 of the dosage button can be connected to the handle 54 of the connector 52, for example by interference fit or ultrasonic welding, so as to axially and rotatably fix the dosage button 30 and the connector 52 together.

[0031] In some embodiments, a portion of the connector may pass through the inner cavity 39 of the flange member 38. The inner cavity 39 of the flange member is as follows: Figure 8 and Figure 9 As best shown. In some embodiments, the cavity 39 can be used to help the coupling 52 be centered and positioned.

[0032] The proximal surface 60 of the dosage button 30 can be used as a push / press surface against which force can be manually applied, i.e., by the user directly pushing the actuator assembly (dosage button 30 and connector 52) in a distal direction. A biasing member 68, exemplarily a spring, can be disposed between the distal surface 70 of the support member 42 and the proximal surface 72 of the tubular flange member 38. Figure 8 and 9 This pushes the support 42 of the actuation assembly and the flange member 38 of the dose setting assembly axially away from each other. The user can press the dose button 30 to initiate the dose dispensing operation. In some embodiments, the bias member 68 abuts against the proximal surface 72 and may surround the raised collar 37 of the flange member 38.

[0033] The delivery device 10 can operate in a dose setting mode and a dose dispensing mode. In the dose setting mode, the dose button 30 is rotated relative to the housing 12 to set the desired dose to be delivered by the device 10. In some embodiments, rotating the dose button 30 in one direction relative to the housing 12 causes the dose button 30 to be axially translated proximally relative to the housing 12, and rotating the dose button 30 in the opposite direction relative to the housing 12 causes the dose button 30 to be axially translated distally relative to the housing. In some embodiments, clockwise rotation of the dose button moves the dose button 30 distally, counterclockwise rotation moves the dose button proximally, and vice versa.

[0034] In some embodiments, rotating the dose button 30 to axially translate it in the proximal direction increases the set dose, and rotating the dose button 30 to axially translate it in the distal direction decreases the set dose. The dose button 30 can be adjusted in predetermined rotation increments corresponding to the minimum increment of the set dose during dose setting operation. For example, one increment or "click" may equal half or one unit of the drug.

[0035] In some embodiments, the set dose can be made visible to the user via the dial gauge markings shown in the dose setting window 36. During dose setting mode, the actuator assembly, including the dose button 30 and the engagement 52, moves axially and rotates together with the dose setting assembly, including the flange member 38 and the dose setting threaded rod 32.

[0036] Because the dose setting threaded rod 32 is threadedly connected to the housing 12, the dose setting threaded rod 32 and the flange member 38 are rotatably fixed to each other and rotate and move proximally during dose setting. During this dose setting movement, the dose button 30 is moved through the flange member 38 and the coupling 52 ( Figure 4 The complementary keyway structure 74 is fixed in rotation relative to the flange member 38 and the dose setting threaded rod 32, and the flange member 38 and the coupling 52 are pressed together by the biasing member 68. During dose setting, the dose setting threaded rod 32, the flange member 38, the coupling 52, and the dose button 30 move together from the “start” position to the “end” position relative to the housing 12 in a helical manner (i.e., simultaneous rotation and axial translation). This rotation and translation relative to the housing is proportional to the dose set by the operation of the drug delivery device 10.

[0037] Once the desired dose is set, the device 10 is manipulated to allow the injection needle 24 to properly pierce, for example, the user's skin. A dose dispensing operation mode is activated in response to a distal axial force applied to the proximal surface 60 of the dose button 30. This axial force is applied directly to the dose button 30 by the user. This causes the actuator assembly (dose button 30 and connector 52) to move axially distally relative to the housing 12.

[0038] Axial movement of the actuator assembly compresses the bias member 68 and reduces or closes the gap between the dose button 30 and the tubular flange member 38. This relative axial movement separates the complementary keyway structure 74 on the coupling 52 and the flange member 38, thereby disengaging the dose button 30 from rotational engagement with the flange member 38 and the dose setting threaded rod 32. Specifically, the dose setting threaded rod 32 is disengaged from the dose button 30 in rotational terms to allow backward / reverse drive of the dose setting threaded rod 32 relative to the dose button 30 and the housing 12. Furthermore, when the dose setting threaded rod 32 and the flange member 38 are freely rotating relative to the housing 12, rotation of the dose button 30 relative to the housing 12 is prevented by the user pressing the dose button 30 to engage it.

[0039] As the dose button 30 and connector 52 continue to be inserted axially without rotating relative to the housing 12, the dose setting threaded rod 32 screws back into the housing 12 as it rotates relative to the dose button 30. A dose marker indicating the remaining injection volume is visible through window 36. As the dose setting threaded rod 32 is screwed distally downward to advance the sleeve 34, the drive member 28 is advanced distally to push the piston 26 through the reservoir 20 and through the needle 24 to expel the drug.

[0040] During the dosage dispensing operation, when the dosage setting threaded rod 32 is screwed back into the housing 12, the amount of drug dispensed from the drug delivery device is proportional to the amount of rotational movement of the dosage setting threaded rod 32 relative to the housing 12. In some embodiments, because the dosage button 30 is fixed in rotation relative to the housing 12 during the dosage dispensing mode, the amount of drug dispensed from the drug delivery device when the dosage setting threaded rod 32 is screwed back into the housing 12 can be considered proportional to the amount of rotational movement of the dosage setting threaded rod 32 relative to the dosage button 30. The injection is completed when the internal thread of the dosage setting threaded rod 32 reaches the distal end of the corresponding external thread of the sleeve 34. Figure 4 Device 10 is then set back to the ready state or zero-dose position, such as... Figure 2 and Figure 4 As shown.

[0041] As described above, during dose delivery, the delivered dose can be derived based on the amount of rotation of the dose setting assembly (flange member 38 and dose setting threaded rod 32) relative to the actuator assembly (engager 52 and dose button 30). This rotation can be determined by detecting incremental movement of the dose setting assembly, which is "counted" as the dose setting assembly rotates during dose delivery.

[0042] A further description of the design and operation of an exemplary delivery device 10 can be found in U.S. Patent No. 7,291,132, entitled “Drug Dispensing Device with Triple Threads for Mechanical Advantage,” the entire disclosure of which is incorporated herein by reference. Another example of a delivery device is an autoinjector device, found in U.S. Patent No. 8,734,394, entitled “Autoinjection Device with Delay Mechanism Including Dual-Functional Bias Member,” which is incorporated herein by reference in its entirety. Such a device can be modified to have one or more of the various sensor systems described herein to determine the amount of drug delivered from the drug delivery device based on sensing relative rotation within the drug delivery device. Another example of a delivery device is a reusable pen device, found in U.S. Patent No. 7,195,616, entitled “Drug Injector Device with Resettable Drive Assembly,” which is incorporated herein by reference in its entirety. Such a device can be modified to have one or more of the various sensor systems described herein to determine the amount of drug delivered from the drug delivery device based on sensing relative rotation within the drug delivery device.

[0043] This document describes a dose detection system operable to determine the delivered dose based on the relative rotation between a dose setting member and a device body. The dose detection system utilizes a dose setting and / or delivery member, such as a flange member 38, a threaded rod 32, or a combination of both, as an integral unit connected to the device body and rotatable relative to the device body about a rotation axis during dose delivery. The element under test (DUT) is attached to the dose setting member and is fixed thereto in terms of rotation. An actuator is attached to the device body and remains non-rotating relative to the device body during dose delivery. Therefore, during dose delivery, the DUT rotates relative to the actuator in a manner related to the delivered dose.

[0044] In some embodiments, the dose detection system includes a rotary sensor attached to an actuator assembly and a test element, the test element including surface features circumferentially spaced apart about a rotation axis of the test element.

[0045] In some embodiments, the dose detection system may include a sensor and a measured component attached to a component of the drug delivery device. The term "attachment" includes any manner in which a component is positioned to a member of the drug delivery device or to another component such that they are operable as described herein. For example, a sensor may be attached to a component by being directly positioned on, housed within, integral with, or otherwise connected to the component. Connections may include, for example, connections formed by friction engagement, keyway construction, snap-fit ​​or press-fit, acoustic welding, or adhesive.

[0046] The term "direct attachment" describes an attachment in which two parts or one part is physically / concretely fixed together, without any intermediate components other than the attachment component. The attachment component may include fasteners, adapters, or other parts of the fastening system, such as a compressible membrane inserted between the two parts to facilitate attachment. "Direct attachment" differs from attachment where parts / components are connected via one or more intermediate functional components.

[0047] The term "fixed" is used to indicate that the indicated movement either can or cannot occur. For example, if the first and second components need to rotate together, then the two components are "fixed in terms of rotation." In another respect, a component may be "fixed" relative to another component functionally rather than structurally. For example, one component may press against another component, such that the frictional engagement between the two components fixes them together in terms of rotation, whereas without the pressing of the first component, the two components might not be fixed together.

[0048] Various sensor arrangements are considered here. Typically, a sensor device includes a sensor and a measured part. The term "sensor" refers to any component capable of detecting the relative position or movement of the measured part. The sensor can be used with associated electronic components to operate it. A "measured part" is any component that the sensor can detect the position and / or movement of relative to the sensor. In a dosing detection system, the measured part rotates relative to the sensor, and the sensor can detect the rotational movement of the measured part. The sensor may include one or more sensing elements, and the measured part may include one or more sensing elements. The sensor detects the movement of the measured part and provides an output representing the movement of the measured part.

[0049] Illustratively, the dose detection system includes electronic components suitable for operation of the sensor device as described herein. The drug delivery device may include a controller operatively connected to the sensor to receive output from the sensor. The controller begins receiving a generated signal from the sensor indicating a count from first to last to obtain a total count for determining the total displacement (e.g., angular displacement). In the case of detecting angular movement of the dose setting component, the controller may be configured to receive data indicating the angular movement of the dose setting component, which can be used to determine the dose delivered by the operation of the drug delivery device from the output. The controller may be configured to determine the dose delivered by the operation of the drug delivery device from the output. The controller may include conventional components such as a processor, power supply, memory, microcontroller, etc. Alternatively, at least some components may be provided separately, for example via a computer, smartphone, or other device. A means is then provided to operatively connect an external controller component to the sensor at the appropriate time, for example via a wired or wireless connection.

[0050] According to one aspect, the electronic component includes a sensor device comprising one or more sensors operatively communicating with a processor for receiving signals representing sensed rotation from the sensors. An exemplary electronic component 76 is described in... Figure 5-7 As shown, it may include a sensor 86 and a printed circuit board (PCB) 77 having multiple electronic components. The PCB may be a flexible PCB. The circuit board of the electronic component 76 may include a microcontroller unit as a controller, the microcontroller unit including at least one processing core and internal memory. The electronic component may include a power source 79, such as a battery, illustratively a coin cell battery, for powering the component. The controller of the electronic component 76 may include control logic circuitry operable to perform the operations described herein, including detecting angular movement of the dose setting component and / or detecting the dose delivered by the drug delivery device 10 based on the detected rotation of the dose setting component relative to the actuator assembly during dose setting and / or dose delivery. Many or all of the components of the electronic component may be contained in a compartment 85 within the dose button 30. In some embodiments, the compartment 85 may be defined between the proximal surface 71 of the support 42 of the dose button and the distal surface 81 of the cover 56 of the dose button. Figure 5 In the illustrated embodiment, the electronic component 76 is permanently integrated into the dosage button 30 of the delivery device. In other embodiments, the electronic component is provided as a module that can be removably attached to the actuator assembly of the drug delivery device.

[0051] Figure 6 A bottom view of the electronic component 76 held within the cover 56 is shown. Figure 7 An exploded view of electronic component 76 is shown. (As shown) Figure 6 and Figure 7 As shown, electronic component 76 may include a printed circuit board (PCB) 77 and a sensor 86 having a contact surface 111. (As...) Figure 7 As shown, electronic component 76 may also include battery 79 and battery compartment 87. Other sensors described herein, such as magnetic sensors, may not include contact surfaces and operate in a non-contact manner.

[0052] In some embodiments, at least a portion of the sensor 86 extends out of the compartment 85 of the dosage button 30. For example... Figure 10 and Figure 11As best shown, the proximal surface 71 of the support 42 of the dose button 30 may include one or more openings (shown as a first opening 45a and a second opening 45b) through which the sensor 86 may extend axially. In some embodiments, during the assembly of the drug delivery device, the contact surface 111 of the sensor 86 extends axially through either of the openings 45a, 45b of the support 42. This allows the contact surface 111 of the sensor to interact with components outside the compartment 85 of the dose button 30. In some embodiments, while only one opening in the support 42 (e.g., the first opening 45a) is required to accommodate the sensor, a second opening 45b may be provided, for example, for symmetry of the support component. This facilitates the fabrication of the component and / or the assembly of the component with the drug delivery device, as it allows the sensor to be positioned in either opening according to the angular orientation of the support 42. When the sensor lacks a contact surface, the sensor may be positioned above the openings 45a, 45b without any sensor portion extending through the opening, or with portions extending through the opening but not configured to engage the measured component.

[0053] The controller of electronic component 76 can be used to store the total angular motion used to determine dose delivery and / or detected dose delivery in local memory (e.g., internal flash memory or onboard EEPROM (Electrically Erasable Programmable Read-Only Memory)). The controller can also be operated to wirelessly transmit signals representing the total count, total angular motion, and / or detected dose to an external device, such as a user's portable device or a remote server. For example, the transmission can be performed via Bluetooth Low Energy (BLE) or other suitable short-range or long-range wireless communication protocols. Illustratively, the BLE control logic and the controller are integrated on the same circuitry.

[0054] As discussed, according to one aspect, the dosage detection system includes detecting the relative rotational motion between two components of a drug delivery device. Since the degree of rotation has a known relationship with the amount of drug delivered, the sensor is configured to detect the amount of angular motion from the start to the end of the dose injection. For example, in some embodiments, the relationship of the injection pen is that an 18° angular displacement of the dose setting component corresponds to one dose unit; however, other angular relationships are also suitable, such as 9°, 10°, 15°, 20°, 24°, or 36°, which may be used for one unit or half a unit. The sensor system is operable to determine the total angular displacement of the dose setting component during dose delivery. Therefore, if the angular displacement is 90°, then 5 dose units have been delivered.

[0055] As the injection proceeds, angular displacement is determined by counting dose increments. For example, the sensing system can use a repetitive pattern of the measured element, such that each repetition indicates a predetermined angular rotation. Conveniently, this pattern can be established such that each repetition corresponds to a minimum dose increment that can be set using a drug delivery device.

[0056] Dosage detection system components can be permanently or detachably attached to the drug delivery device. In some embodiments, at least some dosage detection system components are provided as modules that are removably attached to the drug delivery device. In other embodiments, dosage detection system components are permanently attached to the drug delivery device.

[0057] In some embodiments, the sensor can detect the relative rotation of the tested component, which is rotatably fixed to the dose setting threaded rod 32, during dose delivery, thereby determining the amount of medication delivered by the drug delivery device. In one illustrative embodiment, a rotary sensor is attached to and rotatably fixed to an actuator assembly. During dose delivery, the actuator assembly does not rotate relative to the device housing.

[0058] In some embodiments, the test component is attached and rotationally secured to a dose-setting threaded rod 32, which rotates relative to the dose button 30 and the device housing 12 during dose delivery. In some embodiments described herein, the test component includes an annular structure having a plurality of protrusions arranged circumferentially relative to each other and extending proximally. The shape and size of the protrusions are designed to deflect / bend the movable element of a rotary sensor. An exemplary embodiment of such a test component is a tubular flange member 38, such as... Figure 3 , Figure 5 , Figure 8 and Figure 9 As best shown herein. The embodiments described herein may be provided as modules that are removably attached to or integrated within the dosage button of the delivery device.

[0059] During dose delivery, the dose setting threaded rod 32 rotates freely relative to the dose button 30. In an exemplary embodiment, the electronic component 76 is fixed to the dose button 30 in terms of rotation and does not rotate during dose delivery.

[0060] like Figure 2 , Figure 3 and Figure 5As shown, the dosage button 30 includes a cover 56 connected to a support 42. Electronic components 76 may be at least partially housed within a compartment 85 defined between the cover 56 and the support. In some embodiments, the cover and support have corresponding keyway structures that engage with each other to join the cover and support together. For example, in some embodiments, the cover 56 may be connected to the support 42 via one or more snaps 57 located on the cover 56 and corresponding to one or more protrusions 43 on the support. Figure 5 and Figure 6 As shown, the latch 57 on the cover 56 can extend radially inward from the inner peripheral sidewall 73. (As...) Figure 5 , Figure 10 and Figure 11 As shown, the protrusion 43 on the support member 42 can point radially outward from the outer peripheral sidewall 75 of the support member 42. The protrusion 43 can form a triangular ramp shape.

[0061] The latch 57 on the cover 56 is configured to latch onto and engage with the protrusion 43 on the support member to attach the cover to the support member. In some embodiments, the protrusion on the support member includes a continuous annular protrusion surrounding the outer peripheral sidewall of the support member. The cover 56 may be attached to the support member 42 by friction engagement, interference fit, or any other suitable fit. In some embodiments, the cover 56 is permanently secured to the support member 42 during assembly, for example by ultrasonic welding, adhesive, or other suitable securing methods.

[0062] like Figure 8 and Figure 9 As shown, the tubular flange member 38 may include a plurality of axially oriented teeth 102, which may be circumferentially spaced at equal intervals about a rotation axis and may be arranged in relation to an equivalent dose unit or incremental dose unit. In this exemplary embodiment, the tubular flange member 38 includes 20 teeth 102, which are circumferentially spaced at equal intervals from each other in the rotational direction, such that the helical spacing between two adjacent teeth corresponds to an 18° rotation. Therefore, for Figure 8 The tubular flange member 38, with an 18° rotation, can be used to represent one dose unit or half a dose unit. It should be understood that in other embodiments, different total numbers of teeth can be used to produce other angular relationships, for example, 9°, 10°, 15°, 18°, 20°, 24°, or 36° can be used for one unit or 0.5 units.

[0063] The recess 124 may be defined between each pair of adjacent teeth 102. Each tooth 102 may have an approximately triangular profile and each tooth has a surface 120 against which the sensor's contact surface 111 may slide.

[0064] In some embodiments, a sensor for detecting rotation of a tubular flange member includes a movable element having a contact portion capable of abutting against a toothed part of the tubular flange member and being spring-biased such that the contact surface is configured to abut against and slide on the toothed part during dose delivery as the flange member rotates relative to the actuator assembly. The sensor responds to movement of the contact portion on the toothed part and generates a signal corresponding to the flange member. A controller responds to the signal generated by the sensor to determine a dose count used to determine the delivered dose based on the detected rotation of the flange member relative to the actuator assembly during dose delivery.

[0065] The contact surface can be biased against a physical / structural feature of the tubular flange member to ensure proper contact between the contact surface and the physical feature during rotation. In one embodiment, the movable element is an elastic member, a portion of which is attached to the actuator at a location offset from the contact surface. In one example, the movable element is a driven member comprising a beam attached to the actuator at one end and having a contact surface at the other end. The beam is bent to push the contact surface in the direction of the surface feature. Alternatively, the movable element can be biased in any of a variety of other ways. In addition to using an elastic beam, biasing can also be provided, for example, by using a spring member. Such a spring member can include, for example, a compression spring, a tension spring, or a torsion coil spring. In other embodiments, the movable element can be biased against a surface feature of the element under test by a separate elastic member or spring member supported on the movable element.

[0066] Figure 5 An exemplary embodiment of a sensor 86 is depicted, having a contact surface 111 that interacts with the teeth 102 of a tubular flange member 38. When the flange member 38 rotates relative to a dose button 30 during delivery, the teeth 102 of the flange member contact and slide against the contact surface 111 of the sensor 86, causing the contact surface 111 to move in an oscillating manner. The movement of the contact surface 111 can be a combination of axial and lateral movements as the contact surface 111 slides into and out of a recess 124 defined between the teeth 102 of the flange member 38. The sensor 86 can be configured to track the movement of the contact surface 111 and associate that movement with an output signal sent to a controller. In one embodiment, the sensor includes a switch defining the contact surface 111 that oscillates as it slides against a protrusion during rotation of the tubular member relative to the dose button, to change the state of the switch between an on and off state during dose dispensing modes.

[0067] As an alternative to the toothed elements on the tubular flange member, the surface features interacting with the sensor can include anything the sensor can detect. Sensor arrangements can be based on a variety of sensed properties, including, for example, tactile, optical, electrical, and magnetic properties. In the illustrative embodiment shown in the figures, the surface features are physical characteristics that allow the detection of incremental motion as the dose setting component rotates relative to the actuator assembly. In alternative embodiments, the sensor can be a piezoelectric sensor, a magnetic sensor such as a Hall effect sensor, wherein the toothed elements have magnetism or discernible magnetism, a capacitive or inductive sensor including toothed elements with metallic properties, an accelerometer for detecting vibrations of, for example, a ratchet mechanism or other pawl mechanism (where the vibrations can be associated with rotational motion), an optical sensor such as a reflective sensor, a discontinuity sensor, or an optical encoder, or any other sensor suitable for sensing rotation of the first component relative to the second component.

[0068] In some embodiments, when a user presses axially on the surface 60 of the dosage button 30, the dosage button 30 advances distally relative to the housing 12, compressing the spring 68. Continued distal pressing of the dosage button 30 causes the dosage setting threaded rod 32 to move helically relative to the housing 12. As a result, the dosage setting threaded rod 32 and the flange member 38 are driven to rotate by the axial pressing of the dosage button 30. In some embodiments, the dosage detection system is operable for dosage detection only when the dosage button is pressed.

[0069] In some embodiments, the electronic components may include a clock or timer to determine the elapsed time between counts triggered by a rotary sensor from a surface feature of the element under test. This can be used to indicate that a dose has been administered when the controller has not detected any counts after a period of time.

[0070] In some embodiments, a single sensing system may be used for dose detection sensing and wake-up activation. For example, when the sensor initially senses rotation of the element under test, the controller is configured to allow the electronics to be woken up or activated to a higher or full-power state. The wake-up feature is configured to allow electrical energy to be transferred from a power source (shown as a battery) to power the electronics used for dose sensing, so as to minimize unintentional power loss or use when a dose dispensing event does not occur. In other embodiments, a separate wake-up switch may be provided and arranged within the dose button housing, and triggered when the dose button is in its distal position. After the electronics are activated, the controller begins to receive signals generated from the rotary sensor, indicating a total count from the first count to the last count, to determine the total angular displacement and thus the amount of medication delivered.

[0071] In some embodiments, the electronic component may have a controller configured to receive an output signal from a rotary sensor. The controller of the electronic component may be programmed to convert the intermediate signal into a regulated digital signal, which may be a single step / square wave with a predetermined width representing a predetermined time. In some embodiments, output signals smaller than a predetermined level may be filtered out and ignored.

[0072] In one aspect, the user can receive digital feedback regarding the remaining medication level in the delivery device. When the medication level in the delivery device decreases, the user can receive an alert from the delivery device and / or from an external device, notifying them of the reduced medication level. For example, the user can receive the alert from a portable device, such as via an app, text message, or SMS. The alert can be visual, auditory, tactile (e.g., vibration), or any combination thereof.

[0073] In some embodiments, users may be advised to refill their medication and / or, for reusable medication delivery devices, to replace the (original) tubing with a new tubing. In some embodiments, a refill request may be automatically sent to the pharmacy when a decrease in medication level is detected.

[0074] Determining drug levels can be implemented in different ways. In some embodiments, an external device stores a record of the remaining drug level in the drug delivery device. The drug delivery device can communicate with the external device, informing it of the dose delivered from each drug delivery event. The drug delivery device can determine this dose information from the aforementioned sensors. The external device can then calculate and store the amount of drug remaining after each drug delivery event. For example, the external device can subtract the delivered dose from the most recent / last known amount of remaining drug.

[0075] In some embodiments, information regarding the amount of drug remaining in the drug delivery device may be calculated and / or stored by the drug delivery device itself. The drug delivery device may then transfer the remaining amount of drug in the drug delivery device to an external device.

[0076] In some embodiments, tracking the amount of medication remaining in a drug delivery device can be used for patient adherence to medication regimens. Users, caregivers, healthcare providers, insurers, and / or companies that create the medication may wish to monitor whether users are taking their medication at the prescribed amount and / or time. In some embodiments, this information can be used in conjunction with other devices to improve patient care. For example, the drug delivery device can be used in conjunction with a blood glucose meter. The dose delivered to the patient can be paired with glucose level information to determine information such as drug efficacy and the effectiveness of the patient's treatment regimen. This information may help improve patient care by suggesting possible ways to improve the patient's lifestyle.

[0077] According to one aspect, the drug delivery device can have the ability to help the user locate the device. The inventors have recognized that users may sometimes have difficulty finding their drug delivery device, especially if it is portable and can be used in different locations. The inventors have recognized the need for device location aids to help users locate the device.

[0078] In some embodiments, the location of the drug delivery device is tracked by one or more portable devices. For example, the drug delivery device may be configured to communicate with one or more portable devices or other external devices such as a remote server. The communication may be one-way or two-way.

[0079] In some embodiments, the drug delivery device periodically advertises information such as a unique identifier. A portable device can periodically scan the drug delivery device, and if the advertised drug delivery device is within communication range of the portable device, the portable device will receive communication from the drug delivery device. The portable device may have a built-in GPS or other location identification capability, and can then associate the location with each received communication. Specifically, if the communication protocol between the drug delivery device and the portable device is a short-range communication protocol (e.g., Bluetooth), the portable device can designate its own current location or a radius around its own current location as the location of the drug delivery device. In some embodiments, when the portable device no longer receives communication from the drug delivery device, indicating that the drug delivery device may have moved out of communication range, the portable device stores the most recent / last known location of the drug delivery device, which could be the time when the portable device most recently received communication from the drug delivery device. This most recent known location can be presented to the user to help the user determine the location of the drug delivery device.

[0080] In some embodiments, when the portable device enters the communication range of the drug delivery device, it can alert the user that the drug delivery device is nearby. This can be used to help the user physically locate the drug delivery device.

[0081] In some embodiments, when the portable device senses that the medication delivery device is no longer within communication range of the portable device (e.g., the portable device has not received an advertisement from the medication delivery device within a anticipated period of time), the portable device can alert the user that the medication delivery device is no longer nearby, or at least no longer close to the portable device itself. This feature can help users avoid forgetting to bring their medication delivery device when leaving a location.

[0082] In some embodiments, multiple portable devices can cooperate to help locate a drug delivery device. For example, a group of portable devices can be configured to periodically scan for drug delivery devices. When one of the portable devices locates a drug delivery device (e.g., by sensing that the drug delivery device is within communication range), the portable device can transmit the identity and / or location of the found drug delivery device to the other portable devices. This can be used, for example, in a home environment where each family member has their own portable device.

[0083] In some embodiments, the drug delivery device may include a built-in speaker. To help a user locate the drug delivery device, the user can trigger the speaker to emit a sound. In some embodiments, the user can use a portable device to trigger the speaker to emit a sound.

[0084] In some embodiments, the drug delivery device itself may have a built-in GPS or other location identification capabilities. The drug delivery device may transmit its location to a portable device or other external device, such as directly to a remote server.

[0085] According to one aspect, the date of first use of the drug delivery device is tracked, as well as the time in some embodiments.

[0086] One example use case for this functionality is determining the expiration date of a medication. For instance, in some embodiments, the medication delivery device can communicate with an external device that is first turned on, connected, or otherwise activated by the user. The external device can check whether the medication has expired, for example, by looking up the medication delivery device's identifier in an expiration date database.

[0087] Another example use case for this type of functionality is assisting with supply chain management. Knowing when a specific drug delivery device is first activated can provide manufacturers with important supply chain information, such as how long it takes for the device to reach and be used by a user after the manufacturer has already released it for sale. When an external device communicates its first use, it can also convey its specific identification number, allowing manufacturers to associate the information with known devices and store it in a database. Information can be categorized by device type, geographical location, etc.

[0088] In some embodiments, the time elapsed since the first use of the drug delivery device can be monitored. For certain types of drugs and drug delivery devices, the drug in the delivery device expires after a certain period of time following the first use of the device to deliver a certain amount of drug. This is particularly relevant for multi-dosage type drug delivery devices. Thus, the drug delivery device can detect when the user has first activated the device to deliver the drug. In some embodiments, the device can then start an internal timer to count down and warn the user that the drug has expired when the timer reaches a predetermined time. Examples of alarms include turning on, off, or flashing lights and / or using a light of a certain color, audible sounds, vibrations, or any combination thereof. In some embodiments, the drug delivery device can prevent the user from activating the device. This can be achieved with physical and / or electrical locks, making delivery impossible. In some embodiments, when the drug delivery device detects that the user has first activated the device to deliver the drug, the drug delivery device can communicate to an external device that the first delivery has occurred. The external device can then start a drug expiration countdown. When the countdown is complete, the external device can send a warning to the user and / or communicate to the drug delivery device that the drug has expired.

[0089] According to one aspect, the temperature of the drug can be monitored. The drug temperature can be monitored directly or indirectly. An example of direct measurement includes placing a temperature sensor in actual contact with the drug. An example of indirect measurement includes using a temperature sensor to measure the temperature of an area or component near the drug to approximate the actual temperature of the drug. For example, in one embodiment, the temperature sensor is located on a printed circuit board of the drug delivery device. Another example of indirect measurement includes directly measuring the temperature of materials within the drug delivery device that behave similarly to the actual drug when exposed to various temperature environments.

[0090] Temperature measurements may be performed periodically. Information related to the measured temperatures can be stored in the drug delivery device and transmitted to an external device either on each measurement, in batches, or in any combination thereof.

[0091] When a drug delivery device senses that the measured temperature is outside an acceptable temperature range, referred to here as a "temperature offset," various responses may occur. In some embodiments, the drug delivery device may directly alert the user and / or transmit the information to one or more external devices, which may then alert the user. When a temperature offset is detected, the alarm may occur in real time or upon the user's next use of the drug delivery device. In some embodiments, when a temperature offset is detected, the drug delivery device may store the time and / or date of the temperature offset along with the measured temperature and / or transmit it to an external device.

[0092] According to one aspect, the drug delivery device and / or external programs communicating with the drug delivery device, such as portable device applications, may include security features for controlling wireless communication between the drug delivery device and the external device. In some embodiments, the drug delivery device includes a binding management feature that prevents unauthorized access to the drug delivery device by a third party. In this binding management feature, the user has paired their drug delivery device with the user's portable device, which may be running an application specifically for the drug delivery device. If a different portable device attempts to connect to the drug delivery device, the user may receive a notification that a third party is attempting to connect to the drug delivery device. The user can grant or deny permission for the third party to connect to the drug delivery device. In some embodiments, this setting may be "remembered" by the application and / or the drug delivery device to avoid repeated notifications. In some embodiments, the application may be configured to include a menu that allows the user to change past authorization settings, such as granting access to previously denied third-party portable devices or denying access to previously approved third-party portable devices.

[0093] According to one aspect, if a drug delivery device is recalled, an external device or the drug delivery device itself can notify the user. In some embodiments, the drug delivery device broadcasts its unique identifier to an external device that can communicate with a remote server having a database that associates recall information with the identifier. The drug delivery device can also communicate directly with the remote server itself.

[0094] In some embodiments, an external device, such as a portable device, warns a user that the medication delivery device and / or the medication within the device has been recalled and should not be used. The alert can take various forms, including messages displayed via an application running on the portable device, via text message, via SMS, via email, or any combination thereof.

[0095] In some embodiments, a remote server and / or an intermediate external device such as a portable device may instruct the drug delivery device to display a warning, notifying the user that the drug delivery device and / or the drug have been recalled and should not be used. In some embodiments, the drug delivery device may activate physical and / or electrical locks to prevent the device from being used.

[0096] According to one aspect, medication delivery devices can be used to detect failure to administer a dose according to a user's prescription. For example, if a user accidentally takes two doses of medication at the same time, or too close together, the external device or the medication delivery device itself will notify the user of the error. As other examples, a user may accidentally or intuitively skip a dose, or may have used an incorrect dose.

[0097] Detecting these types of errors may give the user an opportunity to take remedial action. External devices can provide the user with suggestions for remedial action, notify the user's healthcare provider, connect the user to the healthcare provider, or any combination thereof.

[0098] In some embodiments, such errors can be monitored because the drug delivery device can detect drug delivery and the delivered dosage. The drug delivery device can transmit this information to an external device.

[0099] The external delivery device or the drug delivery device itself can then determine whether the administration is appropriate. In some embodiments, the external device or the drug delivery device itself can compare the actual administration time and dose with the expected administration. If the actual administration does not match the expected administration, the external device and / or the drug delivery device can notify the user, for example, that they missed a dose, took too much or too little, or any combination thereof. In one illustrative embodiment, the drug delivery device transmits the dose and delivery time to the portable device. The portable device then communicates with a remote server to determine whether the actual administration matches the expected prescription regimen. If the actual administration does not match the expected regimen, the portable device warns the user of an administration error. In the event of a missed dose, the remote server can communicate with the portable device to notify it that the dose should have been administered. If the portable device does not receive information from the drug delivery device indicating that a dose has been administered, the portable device can send an alert to the user reminding them to take their medication.

[0100] The device shown is a reusable pen-shaped drug delivery device, typically specified as one that is manually operated by a user to selectively set the dosage, which is then injected. This type of injection device is well-known, and the description of the device is merely illustrative, as the sensing system can be adapted to various configurations of drug delivery devices, including pen-shaped drug delivery devices of different configurations, injection devices of different shapes, and infusion pump devices. The drug can be of any type that can be delivered by this drug delivery device. The device is intended to be illustrative and not limiting, as the sensing system described further below can be used in other devices with different configurations.

[0101] In order to clarify the usage of the expression and to inform the public hereby, the expression " ， ,……and <n> "at least one of" or "< / n> ， ，…… <n> "or a combination thereof" or "< / n> ， , ... and / or <n>"As defined by the applicant in the broadest sense, unless the applicant expressly states otherwise, it refers to one or more elements / components selected from the group consisting of A, B, ... and N, and not any other implied definition above and below. In other words, these phrases mean any combination of one or more of elements / components A, B, ... or N, including any single element or a combination of that element with one or more other elements, which may also include additional elements not listed."

[0102] While several embodiments have been described, it will be apparent to those skilled in the art that many more embodiments and implementations are possible. Therefore, the embodiments described herein are examples, not the only possible embodiments and implementations. Furthermore, the advantages described above are not necessarily the only advantages, and it is not necessarily expected that all described advantages will be achieved through every embodiment.

[0103] This disclosure describes several aspects, including but not limited to the following:

[0104] 1. A drug delivery device comprising: a housing; an outlet; a dosage button axially translatable relative to the housing to activate a dosage dispensing mode in which drug is dispensed from the outlet, the dosage button including a support and a cover connected to the support; a compartment defined between the support and the cover; a tubular body rotatable relative to the housing during the dosage dispensing mode; and an electronic component including a sensor configured to sense rotation of the tubular body and a controller configured to receive a signal from the sensor, wherein at least a portion of the electronic component is located within the compartment.

[0105] 2. The drug delivery device according to aspect 1, wherein during the dose dispensing mode, the tubular body rotates relative to the dose button, and a sensor is configured to sense the rotation of the tubular body relative to the dose button.

[0106] 3. The drug delivery device according to any one of aspects 1-2, wherein the dosage button is rotatable relative to the housing during the dosage setting mode and rotates together with the tubular body during the dosage setting mode.

[0107] 4. The drug delivery device according to any one of aspects 1-3, wherein the support includes an opening through which at least a portion of the sensor extends.

[0108] 5. The drug delivery device according to aspect 4, wherein the opening is located on the proximal surface of the support member.

[0109] 6. The drug delivery device according to any one of aspects 1-5, wherein the support includes a plurality of radially outwardly extending protrusions that engage with a cover to attach the cover to the support.

[0110] 7. The drug delivery device according to any one of aspects 1-6 further includes a rotatable threaded rod that rotates relative to the housing during a dose setting mode, wherein the degree / degree of rotation of the threaded rod during the dose setting mode determines the amount of drug dispensed from the outlet during the dose dispensing mode, and the tubular body is fixed to the rotatable threaded rod in terms of rotation.

[0111] 8. The drug delivery device according to aspect 7, wherein during the dose setting mode, the dose button rotates together with the rotatable threaded rod and the tubular body, and during the dose dispensing mode, the rotatable threaded rod and the tubular body rotate relative to the dose button.

[0112] 9. The drug delivery device according to any one of aspects 1-8, wherein the sensor includes a switch.

[0113] 10. The drug delivery device according to aspect 9, wherein the tubular body includes a plurality of protrusions and recesses, and during dose dispensing mode, as the tubular body rotates relative to the dose button, a switch slides against the protrusions.

[0114] 11. The drug delivery device according to aspect 10, wherein the plurality of protrusions are arranged in a circular pattern and equidistant from each other.

[0115] 12. The drug delivery device according to aspect 8, wherein the sensor includes a Hall effect sensor.

[0116] 13. The drug delivery device according to aspect 8, wherein the sensor includes an accelerometer.

[0117] 14. The drug delivery device according to aspect 8 further includes a connector having complementary keyway structures with the tubular body, the keyway structures connecting a dose button to the tubular body during a dose setting mode such that the dose button and the tubular body rotate together during the dose setting mode, wherein the keyway structure of the connector separates from the keyway structure of the tubular body during a dose dispensing mode to disengage the dose button from the tubular body, thereby allowing the tubular body to rotate relative to the dose button.

[0118] 15. The drug delivery device according to aspect 14, wherein at least a portion of the connector passes through a tubular body.

[0119] 16. The drug delivery device according to any one of aspects 1-15, wherein the support and the cover have complementary interlocking features that engage the support and the cover together.

[0120] 17. A method of assembling a drug delivery device, comprising: providing a housing; providing an outlet; connecting a tubular body to the housing, the tubular body being configured to rotate relative to the housing during a dose dispensing mode in which a drug is dispensed from the outlet; forming a dose button having a cover and a support by at least partially encapsulating electronic components between a cover and a support and attaching the cover to the support, the electronic components having a sensor configured to sense rotation of the tubular body; and configuring the dose button to translate axially relative to the housing, wherein the axial translation of the dose button relative to the housing initiates a dose dispensing mode.

[0121] 18. The method according to aspect 17 further includes inserting the sensor at least partially through an opening in the support to allow the sensor to interact with the tubular body.

[0122] 19. The method according to any one of aspects 17-18 further includes connecting the tubular body to the rotatable threaded rod to fix the tubular body to the rotatable threaded rod in a rotational manner, and configuring the rotatable threaded rod to be rotatable relative to the housing during a dose setting mode, wherein the degree of rotation of the threaded rod during the dose setting mode determines the amount of drug dispensed from the outlet during the dose dispensing mode.

[0123] 20. The method according to any one of aspects 17-19 further includes configuring the tubular body to rotate relative to the dose button during dose dispensing mode, and configuring a sensor to sense the rotation of the tubular body relative to the dose button.

[0124] 21. The method according to any one of aspects 17-20 further includes configuring the dose button to be rotatable relative to the housing during dose setting mode and to be rotatable together with the tubular body during dose setting mode.

[0125] 22. The method according to aspect 19 further includes configuring the dose button to rotate together with the rotatable threaded rod and the tubular body during dose setting mode, and configuring the rotatable threaded rod and the tubular body to rotate relative to the dose button during dose dispensing mode.

[0126] 23. The method according to any one of aspects 17-22 further includes providing a switch for the sensor.

[0127] 24. The method according to aspect 23 further includes providing a plurality of protrusions and notches for the tubular body, wherein during dose dispensing mode, as the tubular body rotates relative to the dose button, a switch slides against the protrusions.

[0128] 25. The method according to aspect 23 further includes inserting a connector at least partially through the tubular body, the connector and the tubular body having complementary keyway structures that engage a dose button to the tubular body during a dose setting mode, such that the dose button and the tubular body rotate together during the dose setting mode, wherein during a dose dispensing mode, the keyway structure of the connector separates from the keyway structure of the tubular body to disengage the dose button from the tubular body, thereby allowing the tubular body to rotate relative to the dose button.< / n>

Claims

1. A drug delivery device, comprising: case; exit; Support components; A cover, which is coupled to a support to define a compartment located between the support and the cover; A tubular body that rotates relative to the housing during dose dispensing mode, the tubular body comprising a plurality of protrusions and notches; and An electronic component including a sensor and a controller configured to receive signals from the sensor, the sensor including a switch configured to sense rotation of the tubular body by changing its state between an open and closed state as the switch slides against a protrusion during a dose dispensing mode, while the tubular body rotates relative to the housing, wherein at least a portion of the electronic component is positioned within a compartment.

2. The drug delivery device according to claim 1, wherein, During the dose dispensing mode, the tubular body rotates relative to the electronic components, and the sensor is configured to sense the rotation of the tubular body relative to the electronic components.

3. The drug delivery device according to claim 1, wherein, The support can rotate relative to the housing during the dose setting mode, and rotates together with the tubular body during the dose setting mode.

4. The drug delivery device according to claim 1, wherein, The support includes a first opening and a second opening located on a proximal surface of the support, each of the first opening and the second opening being configured to receive at least a portion of a sensor, the portion of the sensor extending axially through only one of the first opening and the second opening.

5. The drug delivery device according to claim 1, wherein, The support includes a plurality of radially outwardly extending protrusions that engage with the cover to attach the cover to the support.

6. The drug delivery device according to claim 1, further comprising a rotatable threaded rod that rotates relative to the housing during the dosage setting mode, wherein, The degree of rotation of the threaded rod during dose setting mode determines the amount of drug dispensed from the outlet during dose dispensing mode, and the tubular body is fixed to the rotatable threaded rod in terms of rotation.

7. The drug delivery device according to claim 6, wherein, During dose setting mode, the support rotates together with the rotatable threaded rod and tubular body, while during dose dispensing mode, the rotatable threaded rod and tubular body rotate relative to the support.

8. The drug delivery device according to claim 1, wherein, The plurality of protrusions are arranged in a circular pattern and are equidistant from each other.

9. The drug delivery device of claim 1, further comprising a connector having complementary keyway structures with the tubular body, the keyway structures connecting the support to the tubular body during a dose setting mode, such that the support and the tubular body rotate together during the dose setting mode, wherein, During the dose dispensing mode, the keyway structure of the connector separates from the keyway structure of the tubular body to disengage the support from the tubular body, thereby allowing the tubular body to rotate relative to the support.

10. The drug delivery device according to claim 9, wherein, At least a portion of the connector passes through a tubular body.

11. The drug delivery device according to claim 1, wherein, The support and the cover have complementary interlocking features that engage the support and the cover together.

12. The drug delivery device according to claim 1, wherein, The casing also includes a reservoir for holding the drug.

13. A method for assembling a drug delivery device, comprising: Provide housing; Provide export; A tubular body is attached to the housing, the tubular body being configured to rotate relative to the housing during a dose dispensing pattern in which the drug is dispensed from the outlet, the tubular body including a plurality of protrusions and notches; and The electronic components are at least partially encapsulated between a cover and a support, with the cover attached to the support. The electronic components have a sensor including a switch configured to sense rotation of the tubular body by changing its state between an open and closed state as the switch slides against a protrusion during a dose dispensing mode, while the tubular body rotates relative to the housing.

14. The method according to claim 13, wherein, The support defines a first opening and a second opening, each opening configured to receive at least a portion of a sensor, and the method further includes inserting at least partially the portion of the sensor into only one of the first and second openings in the support to allow the sensor to interact with the tubular body.

15. The method of claim 13, further comprising coupling the tubular body to the rotatable threaded rod to secure the tubular body to the rotatable threaded rod in rotation, and configuring the rotatable threaded rod to be rotatable relative to the housing during a dose setting mode, wherein, The degree of rotation of the threaded rod during dose setting mode determines the amount of drug dispensed from the outlet during dose dispensing mode.

16. The method of claim 13, further comprising configuring the tubular body to rotate relative to the support during dose dispensing mode, and configuring a sensor to sense the rotation of the tubular body relative to the support.

17. The method of claim 13, further comprising configuring the support member to be rotatable relative to the housing during dose setting mode and to be rotatable together with the tubular body during dose setting mode.

18. The method of claim 15, further comprising configuring the support member to rotate together with the rotatable threaded rod and the tubular body during a dose setting mode, and configuring the rotatable threaded rod and the tubular body to rotate relative to the support member during a dose dispensing mode.

19. The method of claim 13, further comprising attaching a connector to a support and at least partially inserting the connector through a tubular body, the connector and the tubular body having complementary keyway structures that connect the support to the tubular body during a dose setting mode, such that the support and the tubular body rotate together during the dose setting mode, wherein, During the dose dispensing mode, the keyway structure of the connector separates from the keyway structure of the tubular body to disengage the support from the tubular body, thereby allowing the tubular body to rotate relative to the support.

Images