Device and method for detecting operating operations executable by a medical device

Abstract

To provide an apparatus and a method for reliable detection of actuation actions performed with a medical device.SOLUTION: An apparatus (2) including a detector unit is disclosed, the detector unit including a detector configured to detect an actuation action executable via the detector unit on an actuation button (11) of a medical device (1) for causing the medical device to expel at least part of a medicament contained in the medical device. The detector is configured to detect the actuation action on the basis of detection of a force and / or contact applied to the detector unit as part of the actuation action. The device further includes a motorized unit connected to the detector and configured to store and / or provide information related to the detected actuation action. Furthermore, a compliant method and a computer program for controlling the method are disclosed.SELECTED DRAWING: Figure 1

Description

[Technical field]

[0001] The present invention relates to an apparatus and a method for detecting actuation actions executable on a medical device for causing 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 injecting themselves with a dose of insulin, for example, once or several times per day. For example, a prefilled disposable insulin pen can be used as the injection device. Alternatively, a reusable pen may also be used. A reusable pen allows replacing an empty drug cartridge with a new one. Either pen 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 injection device. The dose can be manually selected with an insulin pen by turning the amount knob and observing the actual dose through a dose window or indicator on the insulin pen. The dose is then injected by inserting the needle into the appropriate skin area and pressing the insulin pen's actuator button.

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

[0004] Patent Document 1 discloses a method and an electronic module for monitoring the operation of a drug delivery device. The electronic device is releasably disposed in the vicinity of the drug delivery device and is used to detect a measurable auditory or vibration signal generated in response to an action occurring within the drug delivery device. Information related to or representing the measurement signal is then stored.

[0005] However, the measurement of such auditory signals (e.g., the sounds generated when setting a dosage or discharging) may not be sufficiently reliable in a noisy environment. The same holds for detecting vibration signals in a mobile environment.

Prior Art Documents

Patent Documents

[0006]

Patent Document 1

Summary of the Invention

Problems to be Solved by the Invention

[0007] Thus, it is an object of the present invention, in particular, to provide a reliable detection device and method for the operating actions performed by a medical device. Similarly, a computer program for controlling such a method is also required.

Means for Solving the Problems

[0008] An apparatus according to a first aspect of the present invention is disclosed. The apparatus includes a detector configured to detect an operating action executable via an operating button of a medical device through a detector unit to cause at least a part of a drug contained in the medical device to be discharged from the medical device. It includes a detector. Among them, the detector is configured to detect an operating operation based on the detection of force and / or a touch applied to the detection unit as part of the operating operation. The device further includes an electronic unit connected to the detector and configured to store and / or provide information related to the detected operating operation.

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

[0010] Similarly, it will be considered to disclose an apparatus configured to execute the method according to the second aspect of the present invention.

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

[0012] According to a fourth aspect of the present invention, furthermore, there is disclosed a computer-readable medium having stored therein the 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 a medium that is removably installed or fixedly installed in a device or apparatus. Non-limiting examples of such computer-readable media 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. The computer-readable medium is understood to be readable by a computer, such as a processor.

[0013] The functions and embodiments of the present invention (showing further functions) are described below, and it is understood that they are equally applicable to all aspects of the present invention. These single functions / embodiments are exemplary and non-limiting, and each is considered combinable with the apparatus, method, computer program and computer-readable medium of the present invention as described above, independently of the other disclosed functions / embodiments. Nevertheless, these functions / embodiments should also be considered disclosed in all possible combinations with each other and with the apparatus, method, computer program and computer-readable medium of the present invention as described above.

[0014] A medical device is configured to discharge a medicament (also often referred to as a "drug", non-limiting examples of which include substances that, when absorbed into a living organism, change normal bodily functions; substances used to treat, cure, prevent, or diagnose a disease, or otherwise enhance the physical or mental health of a living organism; or pharmaceutical formulations containing at least one pharmaceutically active compound). The discharged drug or medicament may be, for example, 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 discharged medicament can be administered, for example, at least partially (e.g., completely) into the body of a living organism (e.g., a human or an animal) using, for example, injection or infusion. Non-limiting examples of medical devices are, as a result, injection devices (such as injection pens) or infusion devices (such as infusion pumps). Among them, the injection process can be distinguished, for example, from the infusion process, especially based on the time taken by each process (e.g., the injection process may have a significantly shorter duration (e.g., 5 minutes or less) compared to the infusion process). The administration of the medicament can be performed, for example, by a physical entity (a person or a machine) using a medical device. The person performing the administration of the medicament may then be another person, for example, a patient receiving the medicament, or a healthcare professional such as a doctor or a nurse. An example of a medicament to be administered using a medical device is insulin.

[0016] A medical device can be, for example, a disposable device designed for a limited number of injection processes and subsequent disposal. The medical device can be pre-filled, for example, to be discarded (as a disposable device) after injecting all or substantially all of the plurality of drugs contained therein and can be non-refillable. Similarly well, the medical device may be equipped with a replaceable container containing the drug to be injected. The medical device can be, for example, an injection pen device having an injection needle at one end and an activation button at the other end. The activation button may protrude from the medical device (e.g., from one end thereof) so that it can be activated by being pressed by the user.

[0017] The activation operation of discharging at least a part of the drug into the medical device may be, for example, applying an activation force to the activation button.

[0018] The medical device can be, for example, a mechanical device (e.g., a purely mechanical device), which discharges at least a part of the drug contained therein if an activation force is applied to the activation button of the medical device. The activation force may be guided, for example, to a piston of a drug container (which may directly contain the drug or may contain a cartridge containing the drug), and a part of the drug may be discharged through the needle of the medical device.

[0019] Alternatively, the medical device can be, for example, at least partially an electronic device, where applying an activation force (which may be less than, for example, the activation force applied to a mechanical medical device) to the activation button will, for example, trigger the discharge of at least a part of the drug by an electric pump.

[0020] The activation operation is performed, for example, by a human or non-human user of the medical device, such as by a patient who is to receive the drug contained in the medical device or by a medical practitioner. The activation operation can be applied, for example, with a finger or thumb of a human user.

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

[0022] The detector unit may be, for example, the detector unit itself. Similarly well, the detector unit may include further elements. For example, the detector unit is a housing that at least partially surrounds the detector or includes it. The detector unit may further include, for example, a part that relays the operating force applied to the operating button via the detector unit. The part of the detector unit may be connected to the detector in order to enable the detector to detect the operating operation applied to the operating button via the detector unit. The detector unit needs to be strong enough, for example, to relay the operating force applied to the operating button via the detector unit.

[0023] The detector is configured to detect the force applied to the detector unit as part of the operating operation and / or the operating operation resulting from the detection of a touch.

[0024] As an example, when a force is applied to an activation button through a detector unit as part of an activation operation (e.g., an activation force), the actuator moves downward or inward, and as a result, closes an electrical switch. The detector may form part of the detector unit (e.g., a housing or base that supports the detector from below), or include an actuator (e.g., a snap element or pin) that protrudes therefrom. The actuator may be covered with a membrane that is part of the detector unit, for example, to prevent external contamination within the detector unit. The electrical switch may include a return element (e.g., such as a spring) that reopens the switch when the force is no longer applied, for example.

[0025] As another example, the detector may be a piezoelectric sensor included in the detector unit (e.g., a housing or a base that supports the detector from below) such that at least one of its surfaces receives a force that directly or indirectly (e.g., through a membrane of the detector unit) forms part of an activation operation (e.g., an activation force), and as a result, can detect it.

[0026] As a further example, the detector may be a pressure sensor included in the detection unit (which may be a sealed housing, for example), such that deformation of the detector unit (or movement of a part of the detector unit) in response to a force that forms part of an activation operation (e.g., an activation force) generates a pressure difference in the detector unit, and as a result, enables the detector to detect the activation force.

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

[0028] The detection of the actuating operation may have a binary nature such that it is detected only if, for example, the actuating operation is performed or not performed. Among them, The actuating operation is assumed to exist, for example, if its force component exceeds a predetermined threshold and / or if its touch component lasts longer than a predetermined time.

[0029] The electric unit is connected to the detector, for example, by a wired connection and is configured to store and / or provide information regarding the detected actuating operation. Among them, the information may be provided to the user of the medical device, for example, visually, auditorily, tactilely, or using vibration, and / or may be provided to an electronic device such as a mobile phone or a computer.

[0030] The electric unit may be, for example, an electric circuit. In a relatively simple embodiment, when the actuating operation is detected, the timer is activated and then causes and / or generates a display regarding the detected actuating operation for a predetermined time (e.g., turns on the LED). As time passes, the display stops (e.g., the LED goes out). In a more complex embodiment, the electric unit may include a processor and optionally further functional units such as a wireless communication module or a display module.

[0031] According to an embodiment of the present invention, as a result, instead of acoustic and vibration detection of operations performed by a medical device, generally, a force applied to an operating button of the device via a detector unit that is even more robust, and / or detection of an operating action caused by a touch is performed. Since the force and / or touch must be performed by the user of the medical device as part of the operating action anyway, no additional handling process is required. Information regarding the detected operating action is then provided to, for example, the user of the medical device and / or another entity, regarding the operating action, to the user and / or another entity. In this way, for example, the current situation and / or the course of the application method performed by the medical device can be displayed. This assists the user and / or other entities regarding the handling of the medical device and contributes to the safety of the product.

[0032] According to an embodiment of the invention, the force acts directly on the detector, or acts via at least a part of the detector unit, or is detected by the detector. This is because the detector responds to the movement and / or deformation of at least a part of the detector unit generated by the force.

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

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

[0035] The apparatus may be considered for fixedly attaching to the medical device, for example, only if it can be removed from at least a part of the medical device and / or destruction of at least a part of the apparatus. The apparatus may be considered for removably attaching to the medical device if it can be removed from the medical device without destroying the medical device and the apparatus, for example, in a way that the apparatus can then be reattached to the medical device or another medical device. Non-limiting examples of the attachment unit are form closure, fit closure, screw coupling, or components enabling a Velcro-like coupling between the apparatus and the medical device. For example, the attachment unit may be configured to engage or at least partially surround a medical device, such as one or more arms, clips or rings. ing, or components enabling a Velcro-like coupling between the apparatus and the medical device. For example, the attachment unit may be configured to engage or at least partially surround a medical device, such as one or more arms, clips or rings. Thus, the apparatus can be a module for attaching to the medical device, for example, after the manufacture of the medical device is completed (or, for example, during the last manufacturing step). The apparatus can be attached to the medical device by, for example, a user of the medical device. The apparatus may, for example, have pre-stored information regarding the medical device to which it can be attached (e.g., therein

[0036] Thus, the apparatus can be a module for attaching to the medical device, for example, after the manufacture of the medical device is completed (or, for example, during the last manufacturing step). The apparatus can be attached to the medical device by, for example, a user of the medical device. The apparatus may, for example, have pre-stored information regarding the medical device to which it can be attached (e.g., therein It may include (such as the type of drug contained and / or the amount of drug contained therein). The device can be designed, for example, to be attachable only to a specific medical device and in such a way that attachment to other medical devices (such as to a medical device containing another drug) is impossible. This can be achieved, for example, by a different design of the attachment unit of the medical device to which the device can be attached and / or the parts. For example, devices for different medical devices can be provided with different protrusions in the attachment unit that cooperate with the thread grooves of the part of the medical device to which the device is to be attached. The attachment of the device may be possible only when the protrusions of the device match the thread grooves on the medical device.

[0037] The attachment unit can be adapted, for example, by a form closure, a fit closure or a screw coupling to fit at least part of the outer periphery of the medical device. The part of the medical device can be, for example, at least part of the actuation button, such as its upper end, or at least part of the dose selector (such as a ring-shaped dose knob that rotates around the longitudinal axis of the medical device to select the dose), or at least part of the housing of the medical device (such as the part of the housing below the dose selector of the medical device).

[0038] The housing of the detector unit can be connected to the attachment unit or integrally formed therewith, for example. For example, the housing may have a cylindrical or conical body, where the lower part of the housing forms an attachment unit with an opening at the lower end to be placed on top of the actuation button, and the upper part of the housing forms at least part of the detector unit. As a result, the detector unit can be arranged, for example, 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, a touch sensor.

[0040] According to an embodiment of the invention, the information related to the detected operating operation is information related to the time point at which the operating operation is detected. The time point can be displayed, for example, via a display element of the device, for the user to view when the medical device was last used, and as a result, for example, to prevent early reuse of the medical device if the user has forgotten that they have already used the medical device.

[0041] According to an embodiment of the invention, the information related to the detected operating operation is a description of the time point at which the operating operation is detected, or a description of the elapsed time since the operating operation was detected, or information as to whether a predetermined elapsed time has already elapsed or not since the predetermined operating operation was detected.

[0042] According to an embodiment of the device as described in the first aspect of the invention, the electric unit is configured to determine the length of the time interval during which the operating operation is applied, and store and / or provide information regarding the determined length of the time interval, and / or store and / or provide information related to the detected operating operation that depends on the determined length of the time interval. The length of the time interval can indicate, for example, the type of operation performed on the medical device. For example, a time interval having a length exceeding a predetermined threshold (e.g., 2 or 5 seconds) can indicate that the medical device is being used for injection / infusion, while a time interval having a length below a predefined threshold can indicate that a priming operation is being performed, for example, on the medical device. In the latter case, for example, no information regarding the detected operating operation is stored and / or provided. Priming (or commissioning) of the medical device can be performed, for example, when the device is used for the first time or after a change of the drug container. In a priming operation only a relatively small number of units of the drug are discharged.

[0043] According to an embodiment of the device according to the first aspect of the invention, the electric unit further optionally includes a providing unit configured to provide information related to an operating operation detected, for example, auditorily, tactilely, by vibration, or by transfer to a different electronic device of the medical 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). Among them, for example, different colors can carry different information. As an example, red can be indicated if the elapsed time since the last detected operating operation is below a predetermined threshold, while green can be indicated if the elapsed time since the last detected operating operation exceeds the predetermined threshold. Therefore, 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, when the user has forgotten that they used the medical device just a little while ago.

[0044] Similarly well, the information related to the detected operating operation can be transmitted to the electronic device, for example, wirelessly (such as optical or wireless transmission like Bluetooth transmission) or by wired transmission. In the latter case, the electric unit of the device can include an interface for a cable to be connected, such as a Universal Serial Bus (USB) interface. The electronic device can be, for example, a mobile phone or a computer, where, for example, a log regarding the operations performed on the medical device can be maintained.

[0045] Among them, the electronic device can be, for example, in the form of a logbook or an archive It can be configured to store information and / or use information for monitoring the use of a medical device (e.g., issue a warning if improper handling of the medical device is detected), and / or use information to determine, optionally together with a proposal of the time point at which a dosage should be applied, the next type of drug to be administered and / or a dosage proposal. In an example embodiment, such information can be returned to the device and optionally displayed to the user of the device.

[0046] An electronic device can be, for example, a blood glucose monitoring system that can at least identify an individual pattern of blood glucose changes and help plan meals, activities, and when to take or administer medications during the day, or at least perform it (e.g., via an application that can be installed on the electronic device to enhance its functionality, such as a mobile phone application available on the Internet or via it).

[0047] A blood glucose monitoring system can include, for example, a blood glucose meter for measuring the blood glucose level of a patient using a medical device, or receive information regarding this blood glucose level from the blood glucose meter (e.g., regularly or irregularly). The blood glucose meter measures the blood glucose level based on, for example, a drop of blood placed on a disposable test strip having an interface with a digital meter.

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

[0049] In addition to the information related to the detected operating action, further information can be provided in the device (or its providing unit). Non-limiting examples of such information are the type of drug contained in the medical device and / or the original or current amount, the expiration date of the drug contained in the medical device, the second Information regarding the time point of a certain operating operation (or the elapsed time since the first detected operating operation), and the time point since the reset executed by the electric unit. At least a part of this information may be pre-stored in the device, for example, and / or programmed into the device by the user via a wireless or wired interface, or via the user interface of the device (in the simplest case, there may be only buttons, for example).

[0050] According to an embodiment of the device described in the first aspect of the invention, the device further includes a dosage determination unit configured to determine the dosage of a selected drug before the operating operation is applied, where the dosage determination unit is connected to the electric unit, and here, the electric unit is further configured to store and / or provide information related to the determined dosage, and / or store information related to the detected operating operation depending on the determined dosage. For example, if the determined dosage is below a predetermined threshold, the operating operation may be classified only as a priming operation, and no information regarding the detected operating operation and / or the determined dosage may be stored and / or provided.

[0051] The dosage determination unit may be configured to determine the dosage by sensing, for example, the sound generated when the dosage selector of a medical device is operated (for example, the sound caused by the mechanical elements of the medical device moving relative to each other during the selection of the dosage), or by sensing the movement of the dosage selector. The movement may include rotational movement, linear movement, or a combination of rotational and linear movement, such as helical movement. In the case of an injection pen, the movement may be rotational or helical movement. The rotational component of the movement may be determined, for example, in some cases, based on a toothed disk fixed to the dosage selector and cooperating with an optical barrier, or a ratchet disk fixed to the dosage selector and cooperating with an electric switch.

[0052] According to an embodiment of the device described in the first aspect of the invention, the electric unit may be further configured to provide information that enables identification, positioning, or detection of a medical device. The information may be provided, for example, in response to the reception of a triggering signal (e.g., a radio wave signal or an auditory signal such as a whistle), or under the control of the electric unit periodically, for example.

[0053] These and further concepts of the invention will become clear and be elucidated with reference to the detailed description presented hereinafter.

Brief Description of the Drawings

[0054]

Figure 1

Figure 2

Figure 3

Figure 4

Modes for Carrying Out the Invention

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

[0056] Native integration of such additional functions into injection / injector products raises costs, so it is generally preferred to provide such functions based on additional add-on modules.

[0057] Such add-on modules based on the complexity and criticality of the injection / injector device are It is advantageous to be provided without requiring structural changes to be added to the infusion / injection device.

[0058] Moreover, it is advantageous (e.g., cost - advantageous) that the add - on module can be easily and quickly attached to the infusion / injection device (at the end of the final manufacturing process or as a single step, if the add - on module is attached to the infusion / injection device) with only minor changes to the manufacturing line of the infusion / injection device, or, even in the case of a small number, can be assembled by hand (e.g., by the user of the infusion / injection device itself).

[0059] Embodiments of the present invention enable the addition of easily and cost - efficient functions (e.g., supported by a power source such as a battery) to medical devices. These functions can be, for example: - Display the time from the last application or until the next application (e.g., optically or audibly), - Remind of time (e.g., optically or audibly, or using vibration), - Indicate usability (e.g., optically or audibly, or using vibration), and / or, - Enable identification (e.g., wireless ID tag, RFID), and may include one or more of the above.

[0060] The module / device according to embodiments of the present invention can be attached to a medical device, for example, in one or more forms: - The attachment can be permanent (i.e., non - detachable) as an additional manufacturing step during the manufacture of the medical device and / or the module. For example, the module can be attached to the medical device by clicking on a dose knob or an operating button of the medical device, or via a snap / latch mechanism, enabling cost - efficient automated assembly or hand assembly. - The attachment can be permanent for each medical device and can be performed by the user of the medical device. - The attachment is releasable (e.g., only temporary). The module can, therefore, be movable from one medical device to another, for example, and as a result, be reusable, providing cost savings to the user; can be attached.

[0061] The module / device according to an embodiment of the invention can include, for example, one or more of the following components: - A power unit, - A housing with an attachment unit (standardized) for attachment to a medical device, - A functional unit optionally provided with an integrated switch or sensor, - Optionally, an indicator / actuator / signal generator, - Optionally, a transmitter, - Optionally, a receiver, can be included.

[0062] The functional unit can be flexible in its functionality and can include, for example, one or more of: - A timer optionally provided with a programmed interface, - An indicator function (e.g., a key finder, etc.) that enables detection / positioning of a medical device, optionally combined with an external transmitter or external activation, - An RFID unit and / or a storage medium, can be included.

[0063] The indicator / actuator / signal generator can function, for example, in one or more of the following ways: - Optionally, via, for example, an LED, - Audibly (e.g., a speech generator or a voice signal), - Using oscillation, for example, by vibration, - Via, for example, a data set including at least one or more of an expiration date, a manufacturing date, a display of drug type, an active ingredient of the drug, a serial number, can function.

[0064] The embodiments of the present invention are described below with reference to an insulin injection device, where a module (as an embodiment of the device described in the present invention) can be attached or is attached. The present invention, however, is not limited to such applications, and may equally well be developed for injection / infusion devices that discharge other drugs, or other types of medical devices.

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

[0066] The injection device of Figure 1 is a reusable injection pen that includes a housing 10 and an insulin container 14 to which a needle 15 can be fixed. Insulin container 14 actually contains insulin and, when empty, can be replaced with a new cartridge, including a cartridge (not shown in Figure 1) that makes injection device 1 reusable. 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 discharged from injection device 1 can be selected by rotating dose knob (dose selector) 12, and the selected dose is thus displayed, for example, in a plurality of international units (IU) via dose window 13, where 1 IU is biologically equivalent to about 45.5 μg of pure crystalline insulin (1 / 22 mg). An example of the selected dose displayed in dose window 13 can be, for example, 30 IU as shown in Figure 1.

[0068] Rotating the dose knob 12 can cause a mechanical clicking sound to provide auditory feedback to the user. The numbers displayed in the dose window 13 are printed on a sleeve that is contained within the housing 10 and mechanically interacts with a piston within the insulin container 14 (and the cartridge contained therein). When the needle 15 is inserted into the patient's skin portion, subsequently, the activation button (injection button) 11 is pushed inward, for example, by the thumb of the user of the injection device, and the insulin dose displayed in the display window 13 is discharged from the injection device 1. The needle 15 of the injection device 1 remains in the skin portion for a certain period of time after the injection button 11 is pushed, and 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 described 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 cartridge conversion), it may be necessary to perform a so-called "prime shot" to remove air from the insulin container 14 and the cartridge within the needle 15, for example, by selecting 2 units of insulin and then pressing the activation button 11 while holding the injection device 1 with the upward-facing needle 15.

[0071] In FIG. 1, further, a module 2 is shown, which can be attached to the activation button 11 of the injection device 1, for example, by clicking it onto the activation button 11 or pressing it, to achieve a form closure or a fit closure. Similarly, the module 2 can be screwed onto or adhered onto the activation button 11.

[0072] This can be carried out, for example, by a user of the injection device 1 and can lead to either a fixed or releasable connection between the module 2 and the injection device 1. As already described above, the module 2 can also be well attached (fixedly or irreleasably) to the injection device 1 during the manufacture of the injection device 1. The module 2 includes a detector unit having a detector for detecting an operating action carried out on the operating button 11, and an electric unit for storing or providing information related to this detected operating action.

[0073] Attaching the module 2 onto the operating button 11 has the significance that the operating action can only be applied to the operating button 11 via the module 2, so that the module 2 can be fixed without the need for modification of the injection device 1 and a robust detection of the operating action can be carried out.

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

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

[0076] At the upper part of the circular protrusion 200 of the housing 20, an electric circuit 22 is located. The electric circuit 22 may be attached to the housing 20, for example, by an adhesive. However, equally well, no specific attachment will be able to be carried out so as to enable the removal of the electric circuit 22 from the module 2, for example, for modifying the electric circuit 22. The electric circuit 22 may be formed on a printed circuit board that may have, for example, one or more wiring layers. At the uppermost part of the electric circuit 22, a light-emitting diode (LED) 220 is located under the control of the electric circuit 22.

[0077] The electrical circuit 22 is connected to the poles of a battery 23 (e.g., a coin-type battery), which is located below the electrical circuit 22 and is connected to the poles of the battery 23 (e.g., a coin cell) located at least partially within the circular protrusion 200 via contacts not shown in FIG. 2 (e.g., one or more contacts (first pole) that contact the battery 23 on its side and one or more contacts (second pole) that contact the battery 23 at its top). As a result, the electrical wiring 22 receives power from the battery 23. The battery 23 can be held, for example, by the circular protrusion 200 (e.g., a battery holder with included contacts that can be attached to or formed at the bottom of the electrical circuit 22) and can be removed for replacement, for example, by pulling it downward from the circular protrusion 200.

[0078] On the top of the electrical circuit 22, a contact area 211 is formed, which is connected to the electrical circuit 22 as discussed with reference to FIG. 3 below. The module 2 further includes a snap disk 210, which has an electrically conductive portion 2100 on its lower surface, and when a downward force is applied to the snap disk 210, the snap disk 210 deforms and the electrically conductive portion 2100 is arranged with respect to the contact area 211 such that these contact areas 211 come into contact with the contact area 211 so that they are electrically connected as a result. The snap disk 210 and the contact area 211 thus form an electrical switch 21, which functions as a detector for the force applied to the snap disk 210. The reset force for this electrical switch 21 is such that when the downward force is no longer applied to the snap disk 210, the snap disk 210 returns to its previous position by the method provided by the snap disk 210. The snap disk 210 is designed to be at least partially transparent so that the light emitted by the LED 220 can be recognized through the snap disk 210. For this purpose, the snap disk 210 can be, for example, a circular or ring-shaped transparent portion. In FIG. 2, such a circular transparent area 2101 is shown in the snap disk 210.

[0079] Below the circular protrusion 200 of the housing 20, the module 2 forms a circular space for absorbing at least a part of the operating button 11 of the injection device 1. This space may be used at least partially and also at the lower part of the battery 23. The radius of this circular space is such that the needle 2 can be attached to the operating button 11 and remains firmly stationary on the operating button 11, while, for example, when the injection device 11 is replaced with another injection device without destroying the module 2 and the operating button 11 and the module 2 is to be reused, it is releasable from the operating button 11 and is adapted to the outer radius of the operating button 11.

[0080] The size of the example for the module 2 in FIG. 2 is 10.67 mm in total height, the circular protrusion at the upper part of the housing is 3 mm in height, and the circular protrusion at the lower part of the housing is 5.4 mm in height. The total diameter of the module 2 can be, for example, 17 mm, and the inner diameter of the circular protrusion 200 can be, for example, 11 mm.

[0081] Functionally, the upper part of the housing 20 provided with the electric switch 21, the electric circuit 22, the battery 23 and the circular protrusion 200 forms a detector unit. The operating operation (corresponding to the operating force in the embodiment of the present invention) can act on the operating button 11 of the injection device 1 only through this detector unit and is detected by the switch 21 that functions as a detector. When the battery 23 does not contact the operating button 11 (different from the example shown in FIG. 2), the detector unit may be assumed to include only the upper part of the housing 20 provided with the electric switch 21, the electric circuit 22 and the circular protrusion 200 because these components relay the operating force to the operating button 11.

[0082] Switch 21 is configured to detect the actuation movement based on the direction of the force provided to the detector unit as part of the actuation movement. In particular, when desiring to cause the discharge of a selected dose of the medicament contained in the injection device 1, the actuation force is first applied to the snap disk 210, which is then pushed downward to come into contact with the contact area 211. The actuation force is then relayed via the electrical circuit 22 and the battery 23 to the circular protrusion 200, and then via the circular protrusion 200 to the actuation button 11, which is its actual destination.

[0083] For the arrangement of the components shown in FIG. 2, it will be readily apparent to those skilled in the art that there are a plurality of options. For example, in order to avoid having to apply, inter alia, to the actuation button 11 via the electrical circuit 22 (and the battery 23 shown in FIG. 2), which might cause damage to these components, the contact area 211 might, for example, not be formed on the top of the electrical circuit 22, but could be formed on a separate parent plate to which the snap disk 210 is connected. This parent plate could then, for example, be such that the actuation force applied to this parent plate is then only relayed to the outer area of the electrical circuit 22, so that damage to the components in the inner area of the electrical circuit 22 can be avoided, and it can only come into contact with the electrical circuit 22 in its outer area (i.e., in the vicinity of the housing 20).

[0084] Equally well, of course, other types of electrical switches may be used. For example, instead of the snap disk 210, a rigid plate or cap (e.g., convex or concave) may be used, attached to the top of the housing 20, and may comprise a central opening through which the actuator of an electrical switch (e.g., a key switch) protrudes, where The length of the path that the actuator needs to move downward to close the electrical switch is selected such that when the top of the actuator is aligned with the top surface of the plate, the switch closes, and at this position, and also on the plate, when further force is applied, only the reset force of the switch (e.g., generated by a reset spring) acts on the component to which the switch is attached. When an operating force is applied through this plate, then the actuator of the electrical switch is pushed inward and the electrical switch closes. Further, applying the operating force then channels the operating force relayed to the operating button 11 through the housing 20 and its protrusion 200 and without passing through the electrical circuit 22 and the battery 23.

[0085] Similarly well, of course, other types of detectors may also be arranged, for example, a touch sensor arranged on, in, or below a plate (or cap) placed on the top of the housing 20; or a pressure sensor arranged within the housing 20 and responsive to a change in pressure occurring at the top of the housing 20 when force is applied to a flexible membrane or a moving member attached to the top of the housing 20 (assuming that the housing 20 is otherwise tight and this can be achieved, for example, by replacing the protrusion 200 with a hard plate), etc.

[0086] In module 2 of FIG. 2, the electrical circuit 22 is connected to the switch 21, in particular to its contact area 211, and provides information regarding the operating operation detected when the switch 21 is closed. In the embodiment of FIG. 2, the electrical switch 22 provides a timer when the switch 21 closes and the LED 220 lights up for a predetermined time. The lighting of the LED 220, as a result, indicates to the user of the injection device 1 that a predetermined time since the last operating operation has not yet elapsed, and as a result, for example, if the user has forgotten that they have just used the injection device 1 recently, it can prevent, for example, premature reuse of the injection device 1.

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

[0088] The electric circuit is monostable and includes a timer element U1 (e.g., TLC555 of Texas Instruments, which is a low-output variant of the NE555 timer, etc.), and executes a plurality of vibrators at its core. X1 and X2 are referred to as battery contacts connected to one pole of the battery 23 (supply voltage potential Vcc). These two contacts can be, for example, the lateral contact battery 23. X3 is a battery contact connected to the other pole of the battery 23 (ground potential GND), which can be arranged, for example, at the top of the battery 23. The battery 23 may be a coin-type cell battery such as CR1025.

[0089] In the circuit diagram 300, S1 represents the electric switch 21 in FIG. 2, and V1 means the LED 220 in FIG. 2. Further, R1, R2, R3, and R4 are resistors, and C1, C2, and C3 are capacitors.

[0090] The electric circuit in FIG. 3 functions as follows. When the switch S1 is closed, the LED V1 lights up and emits light. After a predetermined time governed by the values of R3 and C3 (T = R * C), the LED V1 goes out again.

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

[0092] As described above, the continuation of the predetermined time since the last operating operation has not yet passed. This display is merely an example of an additional functionality that can be added to the injection device described in the embodiments of the present invention. Similarly, well, Module 2 may be modified to carry other information. For example, the time point of the last detected operating operation (or the circumstances of the detected operating operation) can be displayed to the user, for example, optically (via a display panel integrated within Module 2), or aurally (e.g., via the generation of speech or sound). This display can be executed in response to the user's request that can be implemented by the user, for example, by pressing a button. Similarly, well, information regarding the detected operating operation (e.g., the last detected operating operation, or the circumstances of the last detected operating operation) can be stored in the memory of Module 2 and / or supplied to an electronic device via a wired or wireless connection. Module 2 may also be equipped with a key finder function.

[0093] The electrical circuit 23 of Module 2 also includes a processor (e.g., a microprocessor, etc.) that controls the functions of Module 2. This processor can store and / or provide information related to the operating operation detected by a detector such as an electrical switch (e.g., Switch 21) or other types of detectors.

[0094] Figure 4 is a flowchart 400 of an embodiment of the method described in the present invention. This method can be at least partially controlled and / or executed by, for example, the processor of Module 2. A computer program with instructions operable to cause the processor to execute this can be stored in a computer-readable medium, which may be, for example, a tangible storage medium. At step 401, an operating operation is detected, and at step 402, information related to the detected operating operation is stored and / or provided.

[0095] Module 2 of FIG. 2 may further be equipped with further components that can measure the dosage dialed in with the dosage knob 12 (see FIG. 1). This component may, for example, be formed or attached to the lower part of module 2 and may include a rotatable member attached to the dosage knob 12 such that its rotation relative to module 2 can be sensed. Information regarding this sensed rotation can then be converted by the electrical circuit 22 (or the processor of module 2) into information regarding the selected dosage, and information regarding the detected actuation operation, etc. can be stored and / or provided. Alternatively, an auditory sensor may be used in module 2 to determine the selected dosage based on the clicking sound formed by the injection device 1 when dialing in the dosage.

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

[0097] In an example embodiment, the dosage knob 12 can rotate relative to the housing 10 during dosage dialing, however, no rotational movement is performed relative to the dosage dial sleeve. During dosage injection, the dosage dial sleeve rotates. As a result, the relative rotational movement between the dosage dial sleeve and the dosage knob can be detected during dosage injection. Since module 2 can be fixed to the dosage knob 12, it can detect the relative movement.

[0098] The invention has been described above using embodiments that should be understood as illustrative only, and not in a limiting sense. In particular, it will be pointed out that there are also methods of exchange and modifications that are obvious to those skilled in the art and that can be carried out without departing from the scope and spirit of the appended claims.

Claims

1. An apparatus, comprising: a housing, a mounting unit for attaching the apparatus to a part of a medical device, a user-operable user interface surface for the operation of a user when the apparatus is attached to a movable member of the medical device, a functional unit including a sensor configured to obtain information related to the operation of the user, wherein the medical device is configured to discharge a drug, wherein the mounting unit is configured to fixedly attach or releasably attach the apparatus to a movable member of the medical device, wherein the functional unit is disposed within the housing such that when the apparatus is attached to the movable member of the medical device by the mounting unit, the sensor is disposed between the user interface surface and the movable member, the above apparatus.

2. The apparatus is configured to provide:[[]] a display at the time when the operation of the user is detected; a display of the elapsed time since the operation of the user was detected; or information as to whether a predefined time since the operation of the user was detected has already elapsed The apparatus according to claim 1, configured to obtain information related thereto.

3. The apparatus according to claim 1, wherein the information obtained is related to the relative movement between members during the operation of the medical device.

4. The apparatus according to claim 1, further comprising a signal unit configured to provide a signal to the user based on an evaluation of the obtained information related to the operation of the user.

5. The apparatus according to claim 2, wherein the functional unit includes a storage unit configured to store the obtained information.

6. The apparatus according to claim 1, further comprising a communication unit operably connected to the functional unit and configured to establish a connection with an external device, and when the connection is established, the apparatus is configured to wirelessly transmit the obtained information to the external device.

7. The apparatus according to claim 6, configured to transmit a signal via Bluetooth.

8. The apparatus according to claim 4, wherein the signal unit is configured to output an optical signal.

9. The apparatus according to claim 8, wherein the signal unit is configured to provide optical signals of different colors.

10. The apparatus according to claim 8, wherein the signal unit is an LED or includes an LED.

11. The device according to claim 3, configured to determine the dose discharged from the medical device based on relative movement during the dose setting operation.

12. The device according to claim 1, configured to detect relative movement between members for a dose discharging operation performed by a medical device.

13. The device according to claim 2, configured to determine the dose discharged from the medical device based on relative movement between members during the dose setting operation, and information regarding the start and end of the user's operation is used to provide information regarding the discharged dose.

14. The device according to claim 12, wherein one of the members is a dose knob or sleeve of the medical device.

15. The attachment unit is configured to engage or at least partially surround a movable member of the medical device by one or more arms, clips or rings, or the attachment unit is configured to engage the device housing of the medical device, the device according to claim 1.

16. The device according to claim 1, having a recess configured to receive a movable member of the medical device.

17. The device according to claim 4, including a light transmissive portion for transmitting a signal to the user.

18. The device according to claim 17, wherein the light transmissive portion is circular.

19. The device according to claim 18, wherein the light transmissive portion is provided on a curved portion of the outer surface of the device.

20. The user interface surface is configured to cause the medical device to discharge a dose of the medicament from the medical device in response to the user's operation after the discharged dose has been selected, the device according to claim 1.

21. The device includes a power source, the power source is disposed within the housing, the power source is disposed on a side of the electronic component substrate away from the light transmissive portion, and the electronic component is disposed within the housing, the device according to claim 17. Claim 21

22. The user interface surface is provided at the proximal end of the device, the proximal end of the user interface surface is offset proximally from the light transmissive portion, and the attachment unit is distal to the user interface surface and the signal unit, the device according to claim 19.

23. A system for discharging a medicament from a medical device, the system comprising - a medical device containing the medicament, the medical device being an injection pen; and - The device according to claim 1, comprising the above system.

24. A module for releasably attaching to a medical device, the medical device including a dose selector for selecting a dose of a drug in the medical device and an actuation button configured to move relative to the dose selector to cause at least a portion of the dose of the drug to be discharged from the medical device, the module including a sensor configured to detect an actuation operation of the medical device, the actuation operation causing the actuation button to move relative to the dose selector when applied to the actuation button by a user through a user interface surface of the module, and causing at least a portion of the dose of the drug in the medical device to be discharged; and an electric unit configured to store and / or provide information related to the actuation operation detected by and connected to the sensor, a sensor disposed between the user interface surface and the dose selector when the module is attached to the medical device, comprising the above module.

25. A system for discharging a drug from a medical device, the system including a medical device containing a drug, the medical device being an injection pen, the medical device including a dose selector for selecting a dose of the drug in the medical device and an actuation button configured to move relative to the dose selector to cause at least a portion of the dose of the drug to be discharged from the medical device; and the module according to claim 24, comprising the above system.

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