Device and method for detecting operation executable in medical device

Abstract

To provide a detector configured to detect executable operation via a detector unit with respect to an actuation button 11 of a medical device 1 in order to cause the medical device to discharge at least a part of medicines included in the medical device, and a device including the detector unit.SOLUTION: A detector is configured to detect operation on the basis of detection of a force applied to and / or contact with a detector unit as a part of the operation. A module 2 further includes an electric unit connected to the detector and configured to store information related to the detected operation, and / or provide the information. Further disclosed is a complied method and a computer program for controlling the method.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] The present invention relates to an apparatus and a method for detecting actuation actions executable by a medical device to cause the medical device to expel a drug contained therein. The invention further relates to a computer program for controlling such a method. [Background technology]

[0002] There are a variety of diseases that require regular treatment by injection or infusion of a drug with a medical device that delivers this drug. As an example, type 1 and type 2 diabetes can be treated by the patient themselves injecting insulin doses, for example, once or several times per day. For example, a prefilled disposable insulin pen can be used as an injection device. Alternatively, a reusable pen may also be used. A reusable pen allows the empty drug cartridge to be replaced with a new one. Both pens may come with a set of disposable needles that are replaced before each use. The insulin dose to be injected is then delivered, for example, to the syringe used. The dose can be manually selected with an insulin pen by turning the amount knob and observing the actual dose through the dose window or display on the insulin pen. The dose is then injected by inserting the needle into the appropriate skin area and pressing the insulin pen's activation button.

[0003] It would be desirable to provide a medical device for drug injection with functionality beyond basic drug injection functions, such as functionality to monitor use and / or prevent mishandling of the medical device (e.g., untimely reuse), which requires detection of actuation actions performed on the medical device.

[0004] US Patent No. 5,949,999 discloses a method and electronic module for monitoring the operation of a medication delivery device. The electronic device is releasably placed in the vicinity of the medication delivery device and is used to detect measurable acoustic or vibration signals generated in response to actions occurring within the medication delivery device. Information relating to or representative of the measured signals is then stored.

[0005] However, measuring such auditory signals (e.g., the sound made when dialing or expelling a dose) may not be reliable enough in noisy environments. The same holds for detecting vibration signals in mobile environments. [Prior art documents] [Patent documents]

[0006] [Patent Document 1] WO No. 2007 / 107564 A1 Summary of the Invention [Problem to be solved by the invention]

[0007] It is thus, among other things, an object of the present invention to provide an apparatus and method for reliable detection of actuation actions performed on a medical device. There is also a need for a computer program for controlling such a method. [Means for solving the problem]

[0008] According to a first aspect of the present invention, a device is disclosed, the device comprising a detector unit including a detector configured to detect an actuation action executable via the detector unit on an actuation button of a medical device to expel at least a portion of a drug contained in the medical device into the medical device. The device includes a touchpad, wherein the detector is configured to detect an actuation action based on force detection and / or a touch applied to the detection unit as part of the actuation action. The device further includes an electronic unit coupled to the detector and configured to store and / or provide information related to the detected actuation action.

[0009] A method according to a second aspect of the present invention is disclosed. The method includes detecting, with a detector, an actuation action executable via a detector unit including a detector for an actuation button of the medical device to cause the medical device to expel at least a portion of a drug contained in the medical device, wherein the detector is configured to detect the actuation action based on a force and / or touch applied to the detector unit as part of the actuation action. The method further includes storing and / or providing information related to the detected actuation action.

[0010] Likewise, an apparatus configured to carry out the method according to the second aspect of the invention will be considered to be disclosed.

[0011] According to a third aspect of the present invention, there is further disclosed a computer program comprising executable instructions, when said computer program is executed on a processor, to cause the processor to control the steps of the method according to the second aspect of the present invention. The computer program may for example be storable or encoded on a computer-readable medium. The computer program may for example represent, at least in part, the software and / or firmware of the processor. The processor may for example be part of an electronic unit of a device.

[0012] According to a fourth aspect of the present invention, there is further disclosed a computer-readable medium having stored thereon a computer program according to the third aspect of the present invention. The computer-readable medium may be embodied, for example, as an electrical, magnetic, electromagnetic, optical, or other storage medium, and may be erasable or permanently installed in an apparatus or device. Non-limiting examples of such a computer-readable medium are random access memory (RAM) or read-only memory (ROM). The computer-readable medium may be, for example, a tangible medium, such as a tangible storage medium. A computer-readable medium is understood to be readable by a computer, for example, a processor.

[0013] Below, features and embodiments of the present invention (showing additional features) are described, which are understood to apply equally to all aspects of the present invention. These single features / embodiments are exemplary and non-limiting, and are considered to be combinable with the apparatus, methods, computer programs, and computer-readable media of the present invention as described above, independently of each other disclosed feature / embodiment. Nevertheless, these features / embodiments should also be considered to be disclosed in all possible combinations with each other and with the apparatus, methods, computer programs, and computer-readable media of the present invention as described above.

[0014] The medical device is configured to deliver a pharmaceutical agent (non-limiting examples of pharmaceutical agents, also often referred to as "drugs," include substances that, when absorbed into an organism's body, alter normal bodily function; substances used to treat, cure, prevent, or diagnose disease, or otherwise enhance the physical or mental well-being of an organism; or pharmaceutically active formulations containing at least one pharmaceutically active compound). The delivered drug or agent may, for example, be in a solid (e.g., powder), liquid, or gaseous state, or may include a mixture of components in a solid, liquid, and / or gaseous state, such as an aerosol.

[0015] The ejected drug may, for example, at least partially (e.g., completely) administer the substance into, for example, the body of a living organism (e.g., a human or animal) (e.g., by means of injection or infusion). Non-limiting examples of medical devices are, therefore, injection devices (such as injection pens) or infusion devices (such as infusion pumps). Therein, an injection process may be distinguished from an infusion process, for example, based, inter alia, on the time each process takes (e.g., an injection process may be of significantly smaller duration (e.g., 5 minutes or less) compared to an infusion process). The administration of the drug may, for example, be performed by an entity (person or machine) with a medical device. The person performing the administration of the drug may then be another person, for example, the patient receiving the drug, or a medical professional such as a doctor or nurse. An example of a drug to be administered with a medical device is insulin.

[0016] The medical device may be, for example, a disposable device designed for a limited number of injection processes and subsequent disposal. The medical device may, for example, be prefilled and non-refillable so that it is discarded after injecting all or substantially all of the multiple medications contained therein (as a disposable device). Equally well, the medical device may be equipped with a replaceable container containing the medication to be injected. The medical device may, for example, be an injection pen device with an injection needle at one end and an activation button at the other end. The activation button may, for example, protrude from the medical device (e.g., from one end thereof) so that it can be activated by the user by pressing it.

[0017] The actuation action that expels at least a portion of the agent into the medical device may, for example, involve applying an actuation force to an actuation button.

[0018] The medical device may, for example, be a mechanical device (e.g., a purely mechanical device) that expels at least a portion of a drug contained therein if an actuation force is applied to an actuation button of the medical device. The actuation force may, for example, be directed to a piston in a drug container (which may directly contain the drug or may include a cartridge containing the drug) and cause a portion of the drug to be expelled through a needle in the medical device.

[0019] Alternatively, the medical device may be, for example, an at least partially electronic device, where application of an actuation force to an actuation button (which may, for example, be less than the actuation force applied to a mechanical medical device) triggers the ejection of at least a portion of the medication, for example, with an electric pump.

[0020] The actuation action may be performed, for example, by a human or non-human user of the medical device, for example, by a patient to receive a medication contained in the medical device, or by a medical professional. The actuation action may, for example, be applied by the finger or thumb of a human user.

[0021] According to an embodiment of the invention, the actuation action is detected by a detector included in the detector unit. For this purpose, the detector unit is arranged relative to the actuation button in such a way that the actuation action has to be carried out at least partially on the actuation button via the detector unit. The detector unit may, for example, be placed at least partially on top of the actuation button or may, for example, be formed in an upper part of the actuation button itself. Instead of a surface of the actuation button, then, for example, at least a part of the surface of the detector unit becomes the surface on which the actuation force has to be applied.

[0022] The detector unit may, for example, be the detector unit itself. Equally well, the detector unit may include further elements. For example, the detector unit may be or include a housing that at least partially surrounds the detector. The detector unit may further include, for example, a part that relays the actuation force applied to the actuation button via the detector unit. Portions of the detector unit may be tethered to the detector to enable the detector to detect actuation actions applied to the actuation button via the detector unit. The detector unit, for example, needs to be robust enough to relay actuation forces applied to the actuation button via the detector unit.

[0023] The detector is configured to detect an actuation action resulting from detecting a force and / or a touch applied to the detector unit as part of the actuation action.

[0024] By way of example, the detector may be an electric switch with an actuator (e.g., a snap element or pin) forming part of or protruding from the detector unit (e.g., a housing or base supporting the detector from below) in such a way that when force is applied to the activation button via the detector unit as part of the activation action (e.g., an activation force), the actuator moves downwards or inwards, thereby closing the electric switch. The actuator may be covered by a membrane that is part of the detector unit, for example, to prevent external contamination within the detector unit. The electric switch may, for example, include a return element (e.g., such as a spring) that causes the switch to open again when force is no longer applied.

[0025] As another example, the detector may be a piezoelectric sensor that has at least one of its surfaces included in the detector unit (e.g., in a housing or a base supporting the detector from below) in such a way that it can receive, directly or indirectly (e.g., via a membrane of the detector unit), a force that forms part of the actuation movement (e.g., an actuation force) and thereby detect it.

[0026] As a further example, the detector may be a pressure sensor contained in the detection unit (which may be, for example, a sealed housing) in such a way that deformation of the detector unit (or movement of a part of the detector unit) in response to a force forming part of the actuation action (e.g., an actuation force) generates a pressure differential in the detector unit, thereby enabling the detector to detect the actuation force.

[0027] As a further example, the detector may be a touch sensor, e.g., electrical, or thermal, or possibly a touch sensor, to name just a few. The touch sensor may, for example, be a detector unit, or it may be arranged at the location of the detector unit in such a way that it must be touched when an actuation operation is to be performed. For example, when an actuation operation applies an actuation force, the touch sensor may be arranged at the detection unit to which the actuation force is applied.

[0028] The detection of the actuation action may be of a binary nature, such that it is detected only if the actuation action has been performed or not performed, for example. An actuation action is assumed to be present, for example, if the force component exceeds a predetermined threshold and / or if the touch component lasts longer than a predetermined time duration.

[0029] The electric unit is coupled to the detector, for example by a wired connection, and is configured to store and / or provide information about the detected actuation, whereby the information may be provided, for example, visually, audibly, tactilely or by means of vibration, to a user of the medical device and / or to an electronic device, for example a mobile phone or a computer.

[0030] The electric unit may be, for example, an electric circuit. In a relatively simple embodiment, the electric circuit may be configured such that when an actuation movement is detected, a timer is started, and thereafter an indication regarding the detected actuation movement is triggered and / or generated for a predetermined time (e.g., LE D) after which the display stops (e.g. the LED goes out). In more complex embodiments, the power unit may include a processor and possibly further functional units, e.g. a wireless communication module or a display module.

[0031] According to an embodiment of the present invention, instead of acoustic or vibration detection of operations performed on the medical device, detection of actuation actions resulting from force and / or touch applied to the device's activation button is typically performed via an even more robust detector unit. Since the force and / or touch must be performed by the user of the medical device as part of the actuation action anyway, no additional handling process is required. Information about the detected actuation action can then be provided to, for example, the user of the medical device and / or another entity, which can then present the user and / or another entity with information about the actuation action. In this way, for example, the current status and / or history of an application procedure performed on the medical device can be displayed. This assists the user and / or other entities in handling the medical device and contributes to product safety.

[0032] According to embodiments of the invention, the force acts directly on the detector, or acts through at least a part of the detector unit, or is detected by the detector, since the detector responds to a movement and / or deformation of at least a part of the detector unit caused by the force.

[0033] The force may, for example, act directly on an actuator (e.g., a snap element or pin) of an electric switch which forms part of the detector unit, or which protrudes therefrom, or which may act directly on a piezoelectric sensor. Equally well, the force may act on an electric switch, or on a piezoelectric sensor via a membrane of the detector unit. Equally well, the force may be relayed to a sensor (e.g., an electrical or optical switch, or a piezoelectric sensor) via a part or component of the detector unit which is movably attached to the detector unit. Force may also be detected based on deformation of the detector unit, which may cause a change in pressure in the (sealed) detector unit which can be detected by a pressure sensor within or coupled to the detector unit.

[0034] According to an embodiment of the apparatus according to the first aspect of the invention, the apparatus comprises an attachment unit for fixedly or releasably attaching the apparatus to a medical device.

[0035] A device may be considered fixedly attached to a medical device, for example, only if it can be removed without destroying at least a portion of the medical device and / or at least a portion of the device. A device may be considered releasably attached to a medical device, for example, if it can be removed from the medical device without destroying the medical device and the device, for example, in a manner that allows the device to be subsequently reattached to the medical device or another medical device. Non-limiting examples of attachment units include form closures, fit closures, screw couplings, etc. or Velcro-like coupling between the device and the medical device. For example, the mounting unit may be configured to engage or at least partially surround a medical device, such as one or more arms, clips, or rings.

[0036] In this way, the apparatus may be, for example, a module that is attached to a medical device after the manufacture of the medical device is completed (or, for example, during the final manufacturing process). The apparatus may be attached to a medical device, for example, by a user of the medical device. The apparatus may, for example, contain pre-stored information (e.g., The device may include various specifications (such as the type of drug contained therein and / or the amount of drug contained therein). The device may, for example, be designed in such a way that it can only be attached to a specific medical device and that attachment of other medical devices (e.g., to medical devices containing different drugs) is not possible. This may, for example, be achieved by different designs of the mounting unit and / or part of the medical device to which the device can be attached. For example, devices for different medical devices may have different protrusions on the mounting unit that cooperate with threads on the part of the medical device to which the device is to be attached. Attachment of the device may only be possible if the protrusions on the device match the threads on the medical device.

[0037] The mounting unit may be adapted to circumferentially fit at least a portion of the medical device, for example, by a form closure, a fitted closure, or a screw coupling. The portion of the medical device may be, for example, at least a portion of an activation button, e.g., an upper end thereof, or at least a portion of a dose selector (e.g., a ring-shaped dose knob that rotates around the longitudinal axis of the medical device to select a dose), or at least a portion of a housing of the medical device (e.g., a portion of the housing at the bottom of a dose selector of the medical device).

[0038] The housing of the detector unit may, for example, be connected to or integrally formed with the mounting unit. For example, the housing may have a cylindrical or conical shape, where a lower part of the housing forms the mounting unit with an opening at the lower end to be placed, for example, over the activation button, and an upper part of the housing forms at least part of the detector unit. The detector unit may then, for example, be placed in the opening at the upper end of the housing in such a way that it is at least partially covered by the housing or by a membrane attached to the housing.

[0039] According to an embodiment of the invention, the detector is one of an electrical switch, a piezoelectric sensor, an optical sensor, a pressure sensor, and a touch sensor.

[0040] According to an embodiment of the invention, the information related to the detected activation action is information related to the time point at which the activation action is detected, which time point may be displayed, for example, via a display element of the device, in order to indicate to the user when the medical device was last used and thus prevent premature reuse of the medical device, for example, if the user forgets that they have already used the medical device.

[0041] According to an embodiment of the invention, the information related to the detected actuation action is a representation of the time at which the actuation action is detected, or a representation of the elapsed time since the actuation action was detected, or information on whether a predetermined elapsed time has already elapsed or not since the predetermined actuation action was detected.

[0042] According to an embodiment of the device according to the first aspect of the invention, the electric unit is configured to determine the length of the time interval for applying the actuation action and to store and / or provide information about the determined length of the time interval and / or to store and / or provide information related to the detected actuation action depending on the determined length of the time interval. The length of the time interval may, for example, indicate the type of action performed on the medical device. For example, a time interval with a length above a predefined threshold (e.g., 2 or 5 seconds) may indicate that the medical device is used for injection / infusion, while a time interval with a length below a predefined threshold may indicate that a priming action is, for example, performed on the medical device. In the latter case, for example, no information about the detected actuation action is stored and / or provided. Priming (or commissioning) of the medical device may, for example, be performed when using the device for the first time or after changing the drug container. In a priming action Only a relatively small number of units of the drug are excreted.

[0043] According to an embodiment of the device according to the first aspect of the invention, the electric unit further includes a providing unit configured to provide information related to the detected actuation, optionally audibly, tactilely, by vibration, or by transferring the medical device to a different electronic device. The information can be displayed, for example, via a display panel or via one or more light sources, such as light-emitting diodes (LEDs). Different colors can convey different information. For example, red can be displayed if the time elapsed since the last detected actuation is below a predetermined threshold, while green can be displayed if the time elapsed since the last detected actuation exceeds the predetermined threshold. Thus, red can indicate that the medical device should not be used, while green indicates that the medical device can be used again. This can prevent premature reuse of the medical device, for example, if the user forgets that they have already used the medical device just a short time ago.

[0044] Equally well, information relating to the detected actuation activity may be transmitted to the electronic device, for example wirelessly (for example optical or radio transmission, such as Bluetooth transmission) or by means of a signal. The data may be transmitted via a wired transmission. In the latter case, the electronic unit of the device may include an interface for a cable to be connected, such as a Universal Serial Bus (USB) interface. The electronic device may be, for example, a mobile phone or a computer, where, for example, a log may be maintained regarding the operations performed on the medical device.

[0045] Therein, the electronic device may store, for example, a logbook or archive. The device may be configured to store the information and / or use the information to monitor use of the medical device (e.g., issue an alert if improper handling of the medical device is detected) and / or use the information to determine a suggestion for the next type and / or dose of medication to be administered, optionally together with a suggestion for when the dose should be applied. In an example embodiment, such information may be returned to the device and optionally displayed to a user of the device.

[0046] The electronic device may be, or at least implement (e.g., via an application (such as a mobile phone application available on or via the Internet) that can at least reveal personal patterns of blood glucose changes and help plan meals, activities, and when to take or administer medications throughout the day) a blood glucose monitoring system to enhance its functionality.

[0047] A blood glucose monitoring system may include, for example, a blood glucose meter for measuring a patient's blood glucose level using a medical device, or may receive information about this blood glucose level from a blood glucose meter (e.g., regularly or irregularly). The blood glucose meter measures blood glucose levels based on, for example, a drop of blood placed on a disposable test strip that interfaces with a digital meter.

[0048] The provision of information regarding detected operating activity may be triggered by the user (e.g., by pressing a button on the device) or automatically, e.g., in response to the detected operating activity, or based on regular or irregular criteria that may be defined by the user of the device.

[0049] In addition to information related to the detected actuation, further information may be provided by the device (or its delivery unit). Non-limiting examples of such information include the type and / or original or current amount of medication contained in the medical device, the expiration date of the medication contained in the medical device, the number of times the medication was detected for the medical device (potentially after a reset operation performed on the power unit), and the number of times the medication was detected for the medical device. Information about the time of an actuation (or the time elapsed since the first detected actuation) and the time since a reset was performed on the electric unit. At least part of this information may, for example, be pre-stored in the device and / or may be programmed into the device by the user via a wireless or wired interface or via a user interface of the device (which in the simplest case could, for example, be just a button).

[0050] According to an embodiment of the device according to the first aspect of the invention, the device further comprises a dose determination unit configured to determine a dose of the selected drug before the actuation action is applied, wherein the dose determination unit is coupled to the electric unit, wherein the electric unit is further configured to store and / or provide information related to the determined dose and / or to store information related to the detected actuation action depending on the determined dose. For example, if the determined dose is below a predetermined threshold, the actuation action may be classified only as a priming operation, and no information related to the detected actuation action and / or the determined dose may be stored and / or provided.

[0051] The dose determination unit may be configured to determine the dose, for example, by sensing the sound made when the dose selector of the medical device is operated (e.g., a sound caused by mechanical elements of the medical device moving relative to one another during dose selection), or by sensing the movement of the dose selector. The movement may comprise a rotational movement, a linear movement, or a combination of rotational and linear movement, such as a spiral movement. In the case of an injection pen, the movement may be a rotational or a spiral movement. The rotational component of the movement may be determined, for example, on the basis of a toothed disk, possibly fixed to the dose selector and cooperating with a light barrier, or a ratchet disk, possibly fixed to the dose selector, and cooperating with an electric switch.

[0052] According to an embodiment of the apparatus according to the first aspect of the invention, the electric unit may further be configured to provide information enabling the medical device to be identified, located or detected, for example in response to receipt of a triggering signal (e.g., a radio signal or an acoustic signal such as a whistle) or under the control of the electric unit, for example, periodically.

[0053] These and further aspects of the invention will become apparent and elucidated with reference to the detailed description presented hereinafter. [Brief explanation of the drawings]

[0054] [Figure 1] 1 shows an exploded view of an injection device and an embodiment of an apparatus according to the present invention. [Figure 2] 1 shows a cross-sectional view of an embodiment of a device according to the present invention. [Figure 3] 1 shows an embodiment of a wiring circuit of an electric unit of a device according to the present invention. [Figure 4] 1 shows a flow chart of an embodiment of a method according to the present invention. DETAILED DESCRIPTION OF THE INVENTION

[0055] Embodiments of the present invention address, among other things, the need for an enhancement of a purely mechanical, single-use or multi-use / reusable syringe / injector (such as an insulin injection pen) that includes additional functionality, such as ease-of-use indicators, warning functions, or patient-specific treatment functions, and does not provide a power source.

[0056] Because native integration of such additional functionality into injection / infusion products increases costs, it is generally preferable to provide such functionality based on additional add-on modules.

[0057] Such add-on modules based on the complexity and criticality of the infusion / injection device may include: Advantageously, this is provided without requiring structural modifications to be made to the infusion / injection device.

[0058] Furthermore, it is advantageous (e.g., cost-effective) that the add-on modules can be easily and quickly attached to the injection / injection device with only minor modifications to the injection / injection device's manufacturing line (if the add-on modules are attached to the injection / injection device as the last or one of the final manufacturing steps), or even in small numbers, assembled by hand (e.g., by the user of the injection / injection device itself).

[0059] Embodiments of the present invention allow for the easy and cost-effective addition of functionality (e.g., supported by a power source such as a battery) to medical devices. These functionality may include, for example: - displaying (e.g. optically or audibly) the time since the last application or until the next application, - reminding the time (for example optically or audibly or by means of vibration), -Indicating availability (e.g. optically, audibly, or by vibration), and / or -allowing recognition (e.g. radio frequency identification tags, RFID), may include one or more of:

[0060] The modules / apparatus according to embodiments of the present invention may be provided, for example, in a medical device, in one or more of the following forms: The attachment may be permanent (fixed, i.e., non-releasable) as an additional manufacturing step during manufacturing of the medical device and / or module. For example, the module may attach to the medical device by clicking a dose knob or activation button on the medical device, or via a snap / latch mechanism, allowing for cost-effective automated or manual assembly. - The attachment can be permanent (fixed) for each medical device and can be performed by the user of the medical device. - the attachment is releasable (e.g. only temporarily). The module can therefore be, for example, movable from medical device to medical device and is therefore reusable, resulting in cost savings for the user; can be attached.

[0061] A module / device according to an embodiment of the present invention may comprise, for example, one or more of the following components: -power unit, a housing with a (standardized) attachment unit for attachment to the medical device; - functional units possibly with integrated switches or sensors, - possibly indicators / actuators / signal generators, - possibly a transmitter, - possibly a receiver, may include:

[0062] A functional unit may be flexible in its functionality and may, for example, include one or more of: a timer, possibly with a programmable interface; - indicator functions (e.g. key finder, etc.) that allow to find / locate the medical device, possibly combined with an external transmitter or external activation, - an RFID unit and / or a storage medium, may include:

[0063] The indicator / actuator / signal generator may, for example, be actuated in one or more of the following ways: Possibly via, for example, an LED acoustically (e.g., speech generator or voice signal); - by means of oscillation, e.g. by vibration, via a data set that includes, for example, at least one of the following: expiration date, date of manufacture, indication of drug type, active ingredient of the drug, serial number; It can function by:

[0064] In the following, embodiments of the invention are described with reference to insulin injection devices, in which modules (as embodiments of the apparatus according to the invention) are attachable or attached, but the invention is not limited to such applications and may equally well be deployed in injection / infusion devices delivering other drugs, or other types of medical devices.

[0065] Figure 1 is an exploded view of an injection device 1 and a module 2. The injection pen 1 may represent, for example, an Applicant's ClikSTAR® insulin injection pen.

[0066] The injection device of Figure 1 is a reusable injection pen comprising a housing 10 and an insulin container 14 to which a needle 15 can be secured. The insulin container 14 includes a cartridge (not shown in Figure 1) that actually contains the insulin and that, when empty, can be replaced with a new cartridge, making the injection device 1 reusable. The needle 15 is protected by an inner needle cap 16 and an outer needle cap 17, which in turn can be covered by a cap 18.

[0067] The insulin dose to be expelled from the injection device 1 can be selected by rotating the dose knob (dose selector) 12, and the selected dose is then displayed via the dose window 13, for example, in multiples of international units (IU), where 1 IU is bioequivalent to approximately 45.5 μg of pure crystalline insulin (1 / 22 mg). An example of a selected dose displayed in the dose window 13 could be, for example, 30 IU, as shown in FIG. 1.

[0068] Rotating the dose knob 12 may cause a mechanical click to cause auditory feedback to the user. The numbers displayed in the dose window 13 are printed on a sleeve contained within the housing 10 and which mechanically interacts with a piston in the insulin 14 container (and cartridge contained therein). When the needle 15 is inserted into the patient's skin area, and then the activation button (injection button) 11 is pressed inward, for example by the thumb of the injection device user, the insulin dose displayed in the display window 13 is expelled from the injection device 1. When the needle 15 of the injection device 1 remains in the skin area for a certain period of time after the injection button 11 is pressed, a high percentage (or almost all) of the dose is actually injected into the patient's body.

[0069] The injection device 1 can be used for several injection processes: As mentioned above, the empty insulin cartridge (located in the insulin container 14) can be replaced with a new one.

[0070] Before using the injection device 1 for the first time (or after converting the cartridge), it may be necessary to perform a so-called "prime shot" to remove air from the cartridge in the insulin container 14 and needle 15 while holding the injection device 1 with the needle 15 facing upwards by pressing the activation button 11, for example by selecting two units of insulin.

[0071] In FIG. 1, furthermore, a module 2 is shown, which may be, for example, a foam closure or can be attached to the activation button 11 of the injection device 1, for example by clicking it onto the activation button 11 or by pressing it to achieve a fitting closure. Equally well, the module 2 can be screwed onto the activation button 11 or glued onto it.

[0072] This can be performed, for example, by the user of the injection device 1 and can lead to either a fixed or a releasable connection between the module 2 and the injection device 1. As already mentioned above, the module 2 can equally well be attached (fixedly or non-releasably) to the injection device 1 during the manufacture of the injection device 1. The module 2 comprises a detector unit with a detector for detecting an actuation action performed on the actuation button 11, and an electronic unit for storing or providing information related to this detected actuation action.

[0073] Mounting the module 2 on the activation button 11 has the advantage that the activation action can only be applied to the activation button 11 via the module 2, so that the module 2 can be fixed without requiring any modifications to the injection device 1 and robust detection of the activation action can be performed.

[0074] FIG. 2 is a cross-sectional view through the center of the embodiment of module 2 of FIG. 1 when attached to the activation button 11 of the injection device 1.

[0075] The module 2 includes a housing 20 that is cylindrical in shape with an inner projection 200. The housing 20 may be made of aluminum, for example.

[0076] At the top of the circular protrusion 200 of the housing 20 is located the electrical circuit 22. The electrical circuit 22 may be attached to the housing 20, for example, by adhesive. However, equally well, any special attachment would not be feasible that would allow the electrical circuit 22 to be removed from the module 2, for example, to modify the electrical circuit 22. The electrical circuit 22 may be formed, for example, on a printed circuit board, which may have one or more wiring layers. At the top of the electrical circuit 22 is located a light-emitting diode (LED) 220 under the control of the electrical circuit 22.

[0077] The electrical circuit 22 is connected to the poles of the battery 23 (e.g., a coin cell) located below the electrical circuit 22 and at least partially connected to the poles of the battery 23 (e.g., a coin cell) located within the circular projection 200 via contacts not shown in FIG. 2 (e.g., one or more contacts (first poles) contacting the battery 23 at its sides and one or more contacts (second poles) contacting the battery 23 at its top). The electrical wiring 22 is thereby powered by the battery 23. The battery 23 may be held in the circular projection 200 (e.g., a battery holder with included contacts that may be attached to or formed at the bottom of the electrical circuit 22) and may be removed for replacement, for example, by pulling it downward from the circular projection 200.

[0078] At the top of the electrical circuit 22, a contact area 211 is formed, which is coupled to the electrical circuit 22, as will be discussed with reference to Figure 3 below. The module 2 further includes a snap disk 210, which has an electrically conductive portion 2100 on its underside, and which is positioned relative to the contact area 211 in such a way that when a downward force is applied to the snap disk 210, the snap disk 210 deforms and the electrically conductive portion 2100 comes into contact with the contact area 211 so that these contact areas 211 are thereby electrically connected. The snap disk 210 and the contact area 211 thus form an electrical switch 21, which acts as a detector for the force applied to the snap disk 210. A reset force on this electrical switch 21 is applied in such a way that when a downward force is no longer applied to the snap disk 210, the snap disk 210 returns to its previous position. The LED 220 is provided by a snap disc 210. The snap disc 210 is designed to be at least partially transparent so that the light emitted by the LED 220 can be seen through the snap disc 210. For this purpose, the snap disc 210 can be, for example, a circular or ring-shaped transparent portion. In FIG. 2, such a circular transparent area 2101 is shown on the snap disc 210.

[0079] Below the circular protrusion 200 of the housing 20, the module 2 forms a circular space to accommodate at least part of the activation button 11 of the injection device 1. This space may also be used, at least in part, for the lower part of the battery 23. The radius of this circular space is adapted to the outer radius of the activation button 11 in such a way that the needle 2 can be attached to and rest firmly on the activation button 11, while still being releasable from the activation button 11 without destroying the module 2 and the activation button 11, for example if the injection device 11 is replaced with another injection device but the module 2 is to be reused.

[0080] 2 has an overall height of 10.67 mm, the circular protrusion on the top of the housing is 3 mm high, and the circular protrusion on the bottom of the housing is 5.4 mm high. The overall diameter of module 2 can be, for example, 17 mm, and the inner diameter of circular protrusion 200 can be, for example, 11 mm.

[0081] Functionally, the upper part of the housing 20 with the electric switch 21, the electric circuit 22, the battery 23 and the circular protrusion 200 forms a detector unit. An actuation action (which in this embodiment of the invention corresponds to an actuation force) can only be exerted on the actuation button 11 of the injection device 1 via this detector unit and is detected by the switch 21, which functions as a detector. In the case where the battery 23 does not contact the actuation button 11 (unlike the example shown in Figure 2), the detector unit can be considered to include only the upper part of the housing 20 with the electric switch 21, the electric circuit 22 and the circular protrusion 200, since these components relay the actuation force to the actuation button 11.

[0082] The switch 21 is configured to detect an actuation action based on the direction of a force provided to the detector unit as part of the actuation action. In particular, when one wishes to cause the expulsion of a selected dose of medication contained in the injection device 1, an actuation force is first applied to the snap disc 210, which is then pushed downwards into contact with the contact area 211. The actuation force is then relayed via the electric circuit 22 and the battery 23 to the circular projection 200 and then via the circular projection 200 to its actual destination, the actuation button 11.

[0083] It will be readily apparent to those skilled in the art that there are several options for the arrangement of components shown in Fig. 2. For example, to avoid having to apply, inter alia, to the actuation button 11 via the electric circuit 22 (and the battery 23 shown in Fig. 2), which might cause damage to these components, the contact area 211 might not be formed, for example, on top of the electric circuit 22, but could also be formed on a separate mother plate to which the snap disk 210 is coupled. This mother plate could therefore only contact the electric circuit 22 in its outer region (i.e., in the vicinity of the housing 20), so that, for example, actuation forces applied to this mother plate could then be relayed only to the outer region of the electric circuit 22, thereby avoiding damage to components in the inner region of the electric circuit 22.

[0084] Of course, other types of electrical switches may be used equally well. For example, instead of snap disk 210, a rigid plate or cap (e.g., convex or concave) may be used, attached to the top of housing 20 and provided with a central opening through which the actuator of an electrical switch (e.g., a key switch) projects, where The length of the path the actuator must move downward to close the electric switch is selected so that the switch closes when the top of the actuator and the top of the plate surface are aligned, and so that in this position, and when further force is applied to the plate, only the reset force of the switch (e.g., generated by a reset spring) acts on the component to which the switch is mounted. When applying an actuation force through this plate, the actuator of the electric switch is then pushed inward and the electric switch is closed. Further application of the actuation force then leads to an actuation force that is relayed to the actuation button 11 through the housing 20 and its projection 200 and not through the electrical circuit 22 and battery 23.

[0085] Of course, other types of detectors may equally well be arranged, such as a touch sensor located on, in, or under a plate (or cap) placed on top of the housing 20; or a pressure sensor located within the housing 20 and responding to changes in pressure occurring at the top of the housing 20 when force is applied to a flexible membrane or moving member attached to the top of the housing 20 (assuming the housing 20 is otherwise tight, which can be achieved, for example, by replacing the protrusion 200 with a rigid plate).

[0086] In module 2 of Figure 2, electrical circuit 22 is coupled to switch 21, in particular to its contact area 211, and provides information regarding the actuation detected when switch 21 is closed. In the embodiment of Figure 2, electrical switch 22 provides a timer whereby switch 21 closes and LED 220 lights up for a predetermined time. The illumination of LED 220 is thereby to indicate to the user of injection device 1 that a predetermined time has not yet elapsed since the last actuation, thereby preventing, for example, premature reuse of injection device 1 if the user forgets that they have already used injection device 1 recently.

[0087] FIG. 3 shows a circuit diagram 300 for the electrical circuit 22 of module 2 of FIG.

[0088] The electrical circuit is a monostable with timer element U1 (e.g., a Texas Instruments TLC555, a low-power variant of the NE555 timer), running multiple vibrators at its core. X1 and X2 refer to battery contacts connected to one pole of battery 23 (supply voltage potential Vcc). These two contacts may be, for example, lateral contacts of battery 23. X3 is a battery contact connected to the other pole of battery 23 (ground potential GND), which may be located, for example, on top of battery 23. Battery 23 may be, for example, a coin cell battery such as a CR1025.

[0089] In the circuit diagram 300, S1 represents the electrical switch 21 of Figure 2, and V1 refers to the LED 220 of Figure 2. Furthermore, R1, R2, R3 and R4 are resistors, and C1, C2 and C3 are capacitors.

[0090] The electrical circuit in Figure 3 works as follows: When switch S1 is closed, LED V1 turns on and emits light. After a certain time, governed by the values ​​of R3 and C3 (T=R*C), LED V1 turns off again.

[0091] For example, the predetermined time may be set to 15 minutes. LED V1 will light up for 15 minutes after the last use of injection device 1 and in this way remind the user that injection device 1 has already been used.

[0092] As described above, the predetermined duration since the last activation has not yet expired. is just one example of additional functionality that can be added to an injection device according to an embodiment of the present invention. Module 2 may equally well be modified to carry other information. For example, the time of the last detected actuation (or the history of the detected actuation) may be displayed to the user, for example, optically (via a display integrated into mall 2) or audibly (e.g., via a spoken or toned sound). This display may be performed in response to a user request, which may be performed by the user, for example, by pressing a button. Similarly, information regarding the detected actuation (e.g., the last detected actuation or the history of the last detected actuation) may be stored in module 2's memory and / or provided to an electronic device via a wired or wireless connection. Module 2 may also be equipped with a key finder function.

[0093] The electrical circuitry 23 of module 2 also includes a processor (e.g., a microprocessor, etc.) that controls the function of module 2. The processor may store and / or provide information related to actuation detected by a detector, such as, for example, an electrical switch (e.g., switch 21) or other type of detector.

[0094] 4 is a flowchart 400 of an embodiment of a method according to the present invention. The method may be controlled and / or performed, at least in part, by a processor, for example, of module 2. A computer program with instructions operable to cause the processor to execute the method may be stored on a computer-readable medium, which may be, for example, a tangible storage medium. In step 401, an actuation action is detected, and in step 402, information related to the detected actuation action is stored and / or provided.

[0095] The module 2 of Fig. 2 may furthermore be equipped with a further component capable of measuring the dose dialed in by the dose knob 12 (see Fig. 1). This component may, for example, be formed on or attached to the lower part of the module 2 and may include a rotatable member attached to the dose knob 12 so that its rotation relative to the module 2 can be sensed. Information about this sensed rotation may then be converted by the electrical circuitry 22 (or a processor in the module 2) into information about the selected dose and may be stored and / or provided as information about detected actuation actions, etc. Alternatively, an auditory sensor may be used in the module 2 to determine the selected dose based on the clicking sound produced by the injection device 1 when dialing in the dose.

[0096] Rotation can be measured relative to another part of the knob 12, or relative to a part of the injection device 1, for example relative to the housing 10, or relative to the dose dial sleeve visible through the dosing window 13. By measuring the relative movement, it is possible to distinguish whether a dialed dose or an injected dose is being measured. In an example embodiment, the dose knob 12 can rotate relative to the housing 10 during dialing of the dose, however, it cannot rotate relative to the housing 10 during injection of the dose. As a result, the dialed dose can be measured.

[0097] In the example embodiment, the dose knob 12 may rotate relative to the housing 10 during dose dialing, but no rotational movement is performed relative to the dose dial sleeve. During dose injection, the dose dial sleeve rotates. As a result, relative rotational movement between the dose dial sleeve and the dose knob can be detected during dose injection. Module 2 may be secured to the dose knob 12 so that it can detect the relative movement.

[0098] The invention has been described above using embodiments that should be understood as non-limiting examples only, and it should be pointed out that there are alternatives and modifications that will be obvious to those skilled in the art and that can be made without departing from the scope and spirit of the appended claims.

Claims

1. An apparatus (2) comprising: a detector unit (20, 21, 22, 23) comprising a detector (21) configured to detect an actuation action executable via the detector unit (20, 21, 22, 23) on an actuation button (11) of the medical device (1) for expelling at least a portion of a drug contained in the medical device (1) into the medical device (1), wherein the detector (21) is configured to detect the actuation action based on detection of a force and / or a contact applied to the detector unit (20, 21, 22, 23) as part of the actuation action; and an electric unit (22) connected to said detector and adapted to store and / or provide information related to said detected actuation; The above device (2).

2. 2. The device (2) of claim 1, wherein the detector (21) responds to movement and / or deformation of at least a part of the detector unit (20, 21, 22, 23) caused by the force, so that the force acts directly on the detector (21) or via a part of the detector unit (20, 21, 22, 23) or is detected by the detector (21).

3. 3. The apparatus (2) according to claim 1 or 2, comprising an attachment unit for fixedly or releasably attaching the apparatus (2) to the medical device (1).

4. 4. The apparatus (2) according to claim 3, wherein the mounting unit is adapted to fit over the periphery of at least a portion of the medical device (1), in particular over a portion of the actuation button (11).

5. 5. The device (2) according to claim 3 or 4, wherein the housing (20) of the detector unit (20, 21, 22, 23) is connected to or integrally formed with the mounting unit.

6. The device (2) according to any one of claims 1 to 5, wherein the detector (21) is one of an electrical switch, a piezoelectric sensor, an optical sensor, a pressure sensor and a touch sensor.

7. The device (2) according to any one of claims 1 to 6, wherein the information relating to the detected actuation action is information relating to the time at which the actuation action is detected.

8. 8. The device (2) according to any one of claims 1 to 7, wherein the information relating to the detected actuation is an indication of the time at which the actuation is detected, or an indication of the time that has elapsed since the actuation was detected, or information as to whether a predefined time has already elapsed since the actuation was detected.

9. 9. The device (2) according to any one of claims 1 to 8, wherein the electric unit (22) is configured to determine the length of the time interval between the application of the actuating action and to store and / or provide information related to the determined length of the time interval and / or to store and / or provide information related to the actuating action depending on the determined length of the time interval.

10. The device (2) according to any one of claims 1 to 9, wherein the electric unit (22) and a providing unit (220) configured to provide information about the information related to the detected actuation action optically, audibly, tactilely, by vibration, or by transmission to an electronic device different from the medical device (1).

11. 11. The device (2) according to any one of claims 1 to 10, further comprising a dose determination unit configured to determine a dose of the selected drug before the actuation action is applied, wherein the dose determination unit is connected to the electric unit (22), and wherein the electric unit (22) is further configured to store and / or provide information related to the determined dose and / or to store and / or provide information related to the detected actuation action that is dependent on the determined dose.

12. 12. The apparatus (2) according to claim 11, wherein the dose determination unit is configured to determine the dose by sensing a sound generated when a dose selector (12) of the medical device (1) is operated or by sensing the movement of the dose selector (12).

13. 13. The apparatus (2) according to any one of claims 1 to 12, wherein the electric unit (22) is further configured to provide information that allows identifying, locating or finding the medical device (1).

14. A method (400) comprising: a step (401) of detecting, by a detector unit (20, 21, 22, 23), an actuation action executable via the detector (21) on an actuation button (11) of the medical device (1) for expelling at least a portion of a drug contained in the medical device (1) into the medical device (1), wherein the detector (21) is configured to detect the actuation action based on detection of a force and / or a contact applied to the detector unit (20, 21, 22, 23) as part of the actuation action; and - storing and / or providing information related to the detected actuation action (402); The above method comprising:

15. 15. A computer program comprising operable instructions that, when executed on a processor, cause the processor to control steps (401, 402) of the method (400) of claim 14.

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