Inhaler authorization device and inhaler including such a device

Abstract

The inhaler (100) has an actuator (118) configured to interact with the container (110) to selectively release a substance for inhalation. A controller (112) is provided and configured to switch the inhaler between a locked state and an unlocked state. A motion sensor (114) is attached to the inhaler. The controller (112) is configured to store a predefined motion sequence, and when the predefined motion sequence is detected by the motion sensor, the controller is configured to switch the inhaler from the locked state to the unlocked state.

Description

[Technical field]

[0001] The present disclosure relates to the field of inhalers, and more particularly, to the field of devices for authorizing the use of an inhaler to dispense medication to an authorized user. [Background technology]

[0002] In general, an inhaler is a device configured to generate a dose of an aerosolized substance for entrainment into the mouth or nose of a user, typically with an inhalation action. Typically, but not exclusively, the inhaler is a medical inhaler, i.e., an inhaler configured to dispense an aerosolized drug for the treatment of various conditions, such as asthma or COPD. Other types of therapeutic inhalers are available, for example those containing alternative drugs and natural ingredients, but the key principle is that a therapeutic inhaler provides a benefit to the human or animal body.

[0003] Inhalers come in many forms, such as dry powder inhalers (DPIs) and pressurized metered dose inhalers (pMDIs). In the past, such inhalers have included a reservoir for medicament and an actuator / dispensing mechanism capable of releasing a dose of medicament for inhalation by a user.

[0004] More recently, technology has been introduced into inhalers to increase both their effectiveness and usability: for example, motorized actuation has become more common, as have electronic features such as dose counters.

[0005] It is desirable to prevent unauthorized use of inhalers. For example, unauthorized access to medication by children is highly undesirable. Inhalers may also contain controlled substances, such as opioids, that are susceptible to misuse.

[0006] WO 2019 / 157208 describes an electronic metered dose inhaler (MDI) system. A security feature verifies the user using an associated mobile app to verify the user's identity. The app and the inhaler communicate wirelessly. The inhaler contains an accelerometer that verifies that the inhaler has been properly shaken (and the contents properly agitated) before medication dispensing is permitted. The system relies on the presence of a mobile device with the appropriate app installed, battery status, and communication with the mobile device.

[0007] WO 2011 / 114355 describes an MDI with a locking means for locking an actuator. The actuator can be unlocked upon shaking the device, allowing the MDI to deliver homogenized medicament. The device is intended to ensure that the contents are properly homogenized prior to administration.

[0008] WO 2020 / 102229 describes a device in which actuation of the canister can be blocked until the solution has been properly shaken. An accelerometer determines how vigorously the device has been shaken. Summary of the Invention

[0009] This disclosure includes, without limitation, the following provisions.

[0010] Clause 1: An inhaler for delivering a therapeutic substance, comprising: an actuator configured to interact with a container to selectively release the therapeutic substance for inhalation; and a controller configured to switch the inhaler between a locked state in which release of the substance from the container is prevented or permitted within at least one locked constraint, and an unlocked state in which release of the substance from the container is permitted or permitted within at least one unlocked constraint that is less restrictive than the at least one locked constraint. The inhaler further comprises a motion sensor attached to the inhaler. The controller is configured to store a predefined motion sequence. Furthermore, when the predefined motion sequence is detected by the motion sensor, the controller is configured to switch the inhaler from the locked state to the unlocked state.

[0011] Advantageously, one or more embodiments of the present disclosure may provide a method for enabling user input for security purposes that does not require external devices or complex equipment such as a keyboard or fingerprint scanner.

[0012] Clause 2: The inhaler of clause 1, wherein the motion sensor is configured to sense motion in at least two directions, where "directions" means along different axes that are at an angle to each other, rather than forward and reverse along the same axis.

[0013] Clause 3: An inhaler as described in clause 2, wherein the motion sensor is configured to sense motion in three directions.

[0014] Clause 4: An inhaler described in any one of clauses 1 to 3, having a user-accessible configuration mode in which the user moves the inhaler in a pre-defined motion sequence that is detected by a motion sensor and recorded and stored by the controller.

[0015] Clause 5: An inhaler as described in clause 4, wherein in order to record the predefined motion sequence, the user must move the inhaler in the predefined motion sequence at least twice.

[0016] Clause 6: An inhaler as described in clause 4 or 5, wherein the controller is configured to evaluate the input predefined motion sequence against at least one predefined criterion, and wherein the input predefined motion sequence is rejected if it does not satisfy the at least one predefined criterion.

[0017] Clause 7: An inhaler as described in clause 6, wherein the at least one predetermined criterion includes at least two-dimensional motion.

[0018] Clause 8: An inhaler as described in clause 7, wherein at least one predetermined criterion includes three-dimensional motion.

[0019] Clause 9: An inhaler according to any one of clauses 1 to 8, wherein the predetermined motion sequence includes one or more of: a minimum number of direction reversals in each direction, a minimum duration, not exceeding a maximum duration, or varying in a specific manner over time. By "varying in a specific manner over time" it is meant that the speed of movement of the inhaler and / or the time interval between movements are included in the motion sensing.

[0020] Clause 10: An inhaler as described in any one of clauses 1 to 9, wherein in the locked state, release of the substance from the container is prevented and in the unlocked state, release of the substance from the container is permitted.

[0021] Clause 11: An inhaler as described in any one of clauses 1 to 9, wherein in the locked state, release of substance from the container is prevented and in the unlocked state, release of substance from the container is permitted within at least one unlocked constraint.

[0022] Clause 12: An inhaler described in any one of clauses 1 to 9, wherein in the locked state, release of substance from the container is prevented within at least one locked constraint, and in the unlocked state, release of substance from the container is permitted within at least one unlocked constraint that is less restrictive than the at least one locked constraint.

[0023] Clause 13: An inhaler described in any one of clauses 1 to 12, wherein the actuator is powered to selectively release the substance for inhalation and the controller electronically controls the actuator when switching between a locked state and an unlocked state.

[0024] Clause 14: An inhaler as described in any one of clauses 1 to 12, comprising a lock configured to prevent actuation of an actuator that selectively releases a substance for inhalation, and wherein the controller electronically controls the lock when switching between a locked state and an unlocked state.

[0025] Clause 15: A method of using an inhaler for delivering a therapeutic substance, comprising providing an inhaler including an actuator configured to interact with a container to selectively release a therapeutic substance for inhalation, and a controller configured to switch the inhaler between a locked state in which release of the substance from the container is prevented or permitted within at least one locked constraint, and an unlocked state in which release of the substance from the container is permitted or permitted within at least one unlocked constraint that is less restrictive than the at least one locked constraint. The inhaler further includes a motion sensor attached to the inhaler. The controller is configured to store a predefined motion sequence. The method includes moving the inhaler through the motion sequence, determining by the controller whether the motion sequence matches the predefined motion sequence, and switching the inhaler from the locked state to the unlocked state if the motion sequence matches the predefined motion sequence.

[0026] Clause 16: A method of using an inhaler to deliver a therapeutic substance, comprising providing an inhaler including an actuator configured to interact with a container to selectively release a therapeutic substance for inhalation, and a controller configured to switch the inhaler between a locked state in which release of the substance from the container is prevented or permitted within at least one locked constraint, and an unlocked state in which release of the substance from the container is permitted or permitted within at least one unlocked constraint that is less restrictive than the at least one locked constraint. The inhaler further includes a motion sensor attached to the inhaler. The controller is configured to store a predefined motion sequence. The method includes moving the inhaler in a motion sequence, recording the motion sequence using the controller, storing the motion sequence as a predefined motion sequence, and switching the inhaler from the locked state to the unlocked state when the inhaler moves in the predefined motion sequence.

[0027] Clause 17: A method of using the inhaler described in clause 16, comprising evaluating the input motion sequence against at least one predetermined criterion, and rejecting the input motion sequence if the input motion sequence does not satisfy the at least one predetermined criterion.

[0028] Clause 18: A method of using the inhaler described in clause 17, comprising moving the inhaler a second time through the motion sequence, recording the second motion sequence using the controller, evaluating the inputted second motion sequence against the inputted first motion sequence, and rejecting the inputted first motion sequence and the inputted second motion sequence if the inputted first motion sequence and the inputted second motion sequence do not match.

[0029] Clause 19: The method of clause 17 or 18, wherein the at least one predetermined criterion comprises at least two-dimensional motion.

[0030] Clause 20: The method of clause 19, wherein the at least one predetermined criterion includes three-dimensional motion.

[0031] Clause 21: A method according to any one of clauses 16 to 20, wherein the predetermined motion sequence includes one or more of: a minimum number of direction reversals in each direction, a minimum duration, not exceeding a maximum duration, or changing in a particular manner over time. [Brief description of the drawings]

[0032] Embodiments of the present disclosure will now be described with reference to the following drawings. [Figure 1] FIG. 1 is a schematic diagram of a first inhaler according to the present disclosure. [Figure 2a] FIG. 2 is a flow diagram of a setup sequence according to the present disclosure. [Figure 2b] FIG. 2 is a flow diagram of a usage sequence according to the present disclosure. [Diagram 3] 1A-1D show side and front views of an inhaler illustrating the axis referred to in the present disclosure. [Figure 4a] 13A-13C are schematic diagrams of motion sequences, and schematic diagrams of motion in positive and negative Z directions. [Figure 4b] FIG. 1 is a schematic diagram of a motion sequence, showing motion in positive and negative X, Y, and Z directions. [Figure 4c] FIG. 13 is a schematic diagram of a motion sequence, showing a figure-of-eight motion. [Figure 4d] FIG. 1 is a schematic diagram of a motion sequence, showing a motion in the pattern of a person's initials. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0033] Description of the First Embodiment composition 1, a pressurized metered dose inhaler (pMDI) 100 includes a body 102 having a canister receiving portion 104, and a mouthpiece 106 having an exit orifice 108. The body 102 in this embodiment is constructed from a molded plastic material, although other materials are possible.

[0034] The body 102 of the pMDI 100 includes a pressurized canister (ie, container) 110 , a controller 112 , a movement sensor 114 , a locking mechanism (eg, lock) 116 , an actuator 118 , and a user display 119 .

[0035] The canister 110 contains a pressurized medication (i.e., therapeutic substance) and propellant, and includes a metering valve 120 that provides selective fluid communication between a valve outlet 122 and the interior of the canister 110. The metering valve 120 has a closed state in which no communication is allowed, and an open state in which a predetermined amount of medication is released into the valve outlet 122.

[0036] The controller 112 may include a memory, a processor, an input / output module, and a power source (eg, a battery).

[0037] The motion sensor 114 may be a three-axis accelerometer configured to detect motion in three Cartesian axes (X, Y, Z as shown in FIG. 3) of the pMDI 100.

[0038] The actuator 118 may be configured to interact with the container 110 to selectively release the therapeutic substance for inhalation. In one or more embodiments, the actuator 118 is configured to receive the valve 120 and selectively release a dose of the therapeutic substance from within the container 110. The locking mechanism 116 is positioned between the container 110 and the actuator 118 and configured to allow or prevent actuation of the valve 120 to release a dose of the therapeutic substance into the orifice 108. Any suitable technique may be utilized to selectively release the dose. In one or more embodiments, the actuator 118 may be powered to selectively release the therapeutic substance for inhalation. In one or more embodiments, the controller 112 may be configured to electronically control the actuator 118 when switching between a locked state and an unlocked state.

[0039] The user display 119 in this embodiment is a small screen that can display short messages to the user.

[0040] The controller 112 communicates with the motion sensor 114, the locking mechanism 116 (e.g., lock), and the user display 119. The controller 112 is configured to receive motion input from the motion sensor 114, analyze the motion input, and switch the locking mechanism 116 from a locked state to an unlocked state depending on the output of the analysis. The controller 112 is also configured to control messages provided via the display 119. In the locked state, release of the substance from the container 110 is prevented or permitted within at least one locked constraint. For example, in one or more embodiments, the locked constraint can include a dosing protocol, where the locking mechanism 116 is not switched from the locked state to the unlocked state unless a sufficient period of time has passed since the last dose was administered. Furthermore, in the unlocked state, release of the substance from the container is permitted or permitted within at least one unlocked constraint that is less restrictive than the at least one locked constraint. For example, in one or more embodiments, the unlocked constraint can include a timeout feature that must be used for a specific period of time when the inhaler is unlocked. use

[0041] 2a, there is shown one embodiment of a method for setting up / configuring a pMDI 100. In step S200, an authorized user receives the pMDI 100. At this stage, the lock / unlock protocol controlled by the controller 112 is disabled.

[0042] In step S202, the user activates the inhaler by pressing a power on control (not shown), such as a button.

[0043] At step S204 a user accessible configuration mode is activated and the user is prompted by the display 119 to record a movement sequence. In response to the prompt, at step S206 the user moves the inhaler in at least one direction in a desired sequence. With reference to Figure 3, the Cartesian coordinates of the pMDI 100 are shown. Figures 4a and 4b show two examples of simple movement patterns involving back and forth motion in at least one direction. Figure 4a shows a simple three step movement in only the positive and negative Z directions and Figure 4b shows a simple three step movement in the positive and negative X, Y and Z directions.

[0044] Figures 4c and 4d show more complex movements including simultaneous (i.e., in two or three dimensional space) movements in at least two directions. Figure 4c shows a motion sequence in the form of a "figure eight" motion path 200 in the ZY plane. Figure 4d shows a motion sequence in the form of a motion path 202 in the ZY plane describing the user's initials "jb". It will be appreciated that the user may choose to enter one or more of the following non-exhaustive list of motion paths and combinations thereof: ● Symbol ●Character ●Photos

[0045] Similar to recording a motion sequence in three-dimensional space, the controller 112 can also record the timing of the sequence. For example, a user can add one or more of the following time-dependent characteristics to a motion sequence: ● Adjusting frequency ●Suspended Change in speed - A predetermined rhythm (for example, one that matches a memorized song)

[0046] In step S208, the controller 112 is configured to determine whether the motion sequence satisfies at least one predetermined criterion to provide the predetermined motion sequence. The criterion may include at least one of the following: • The motion sequence is sufficiently complex, e.g. ○ Includes motion in at least two directions (X, Y, Z), ○ Contains the minimum number of direction reversals on each axis, ○ It is of minimum duration, or ○Do not exceed the maximum duration. The motion sequence is sufficient to agitate and / or homogenize the contents. For example, the motion sequence may include a predetermined number of reversals in the Z direction.

[0047] Moving to step S210, if the motion sequence meets the predetermined criteria in step S208, the controller 112 provides an indication to the user via the display 119 that the user should repeat the sequence. If the motion sequence does not meet the criteria, the controller 112 requests that the user input a new sequence, i.e., the input motion sequence is rejected.

[0048] In one or more embodiments, the controller 112 may require the user to move the inhaler in the predefined motion sequence at least twice to record the predefined motion sequence. For example, in step S210, the user repeats the motion sequence a second time and thereafter. The controller 112 may record the second motion sequence. In step S212, the controller 112 may be configured to determine whether the motion sequence has been successfully repeated. In one or more embodiments, the controller 112 may be configured to determine whether the motion sequence has been successfully repeated if the first input motion matches the second input motion. If the first input motion and the second input motion do not match, the controller 112 may be configured to reject the first input motion sequence and the second input motion sequence. If the first input motion and the second input motion match, in step S214, the predefined motion sequence is stored and the user is informed of the successful input via the display 119.

[0049] Referring to Figure 2b, one embodiment of a method of use of the pMDI 100 is shown. In step S300, the user moves the inhaler 100 in a motion sequence. In step S302, the controller 112 checks the motion sequence against the stored predefined motion sequences from Figure 2a. If the input motion sequence matches the stored predefined motion sequence, in step S304 the inhaler 100 is switched from a locked state to an unlocked state by the controller 112 and the inhaler can be used. If not, the user is presented with an error message and returns to step S300 to try again.

[0050] In step S306, the device is activated, which is detected by the controller 112, and in step S308, the device is locked once again. Variations

[0051] The following variations on the embodiments described herein are within the scope of the present disclosure.

[0052] The user display 119 may be a simple light, a complex display, or may be provided on a separate device (e.g., a mobile device such as a mobile phone) that communicates with the inhaler 100, for example, via Bluetooth®.

[0053] A "master" sequence may be stored within the controller 112, allowing the inhaler 100 to be reset if the user forgets its motion sequence.

[0054] The inhaler 100 may be configured to allow a certain number of doses, or doses per period (e.g., hour or day) without having to be unlocked. For example, one dose per hour may be allowed, after which the inhaler 100 is locked and can only be unlocked by the motion sequence described above.

[0055] The inhaler 100 may be equipped with a "time-out" feature that locks out after a predetermined period of time (e.g., one minute) if not used, step S308. The time-out may be overridden by a single use, a predetermined number of uses, or may allow unlimited multiple doses within a predetermined period of time.

[0056] The inhaler 100 can be inhibited from use when the integrated dose counter reaches a predetermined limit, for example if the maximum dose is about to be exceeded, or if the dose counter indicates that the canister is depleted.

[0057] The inhaler 100 can communicate the motion sequence to a mobile device where it can be visualized as a reminder to the user (similar to Figs. 4c and 4d).

[0058] The present disclosure may be implemented in types of inhalers other than pressurized metered dose inhalers (pMDIs).

[0059] Instead of the locking mechanism 116, the inhaler 100 may be equipped with an electronically controlled actuation mechanism that can only be activated when unlocked (ie, electronically locked) by the correct motion sequence.

[0060] All references and publications cited herein are expressly incorporated by reference in their entirety into this disclosure, except to the extent that they may directly contradict this disclosure. Although specific embodiments have been illustrated and described herein, those skilled in the art will appreciate that the specific embodiments illustrated and described may be substituted with various alternative and / or equivalent implementations without departing from the scope of the present disclosure. It is understood that the present disclosure is not intended to be unduly limited by the exemplary embodiments and examples described herein, and that such examples and embodiments are presented by way of example only, with the scope of the present disclosure intended to be limited only by the claims set forth herein.

Claims

1. 1. An inhaler for delivering a therapeutic substance, comprising: an actuator configured to interact with the container to selectively release the therapeutic substance for inhalation; The inhaler a locked state in which release of the substance from the container is prevented or allowed within at least one locked constraint; an unlocked state in which release of the substance from the container is permitted or permitted within at least one unlocked constraint that is less restrictive than the at least one locked constraint; a controller configured to switch between a motion sensor attached to the inhaler; Equipped with the controller is configured to store a predetermined motion sequence; The inhaler, wherein the controller is configured to switch the inhaler from the locked state to the unlocked state when the predetermined motion sequence is detected by the motion sensor.

2. 1. A method of using an inhaler to deliver a therapeutic substance, comprising: an actuator configured to interact with the container to selectively release the therapeutic substance for inhalation; The inhaler a locked state in which release of the substance from the container is prevented or allowed within at least one locked constraint; an unlocked state in which release of the substance from the container is permitted or permitted within at least one unlocked constraint that is less restrictive than the at least one locked constraint; a controller configured to switch between a motion sensor attached to the inhaler; To provide an inhaler comprising: the controller configured to store a predetermined motion sequence; moving the inhaler through a motion sequence; determining, by the controller, whether the motion sequence matches the predetermined motion sequence; switching the inhaler from the locked state to the unlocked state if the motion sequence matches the predetermined motion sequence; A method comprising:

3. 1. A method of using an inhaler to deliver a therapeutic substance, comprising: an actuator configured to interact with the container to selectively release the therapeutic substance for inhalation; The inhaler a locked state in which release of the substance from the container is prevented or allowed within at least one locked constraint; an unlocked state in which release of the substance from the container is permitted or permitted within at least one unlocked constraint that is less restrictive than the at least one locked constraint; a controller configured to switch between a motion sensor attached to the inhaler; To provide an inhaler comprising: the controller configured to store a predetermined motion sequence; moving the inhaler through a motion sequence; recording the motion sequence using the controller; storing the motion sequence as a predetermined motion sequence; switching the inhaler from the locked state to the unlocked state when the inhaler moves through the predetermined motion sequence; A method comprising:

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