System for monitoring the dispensing of an administrable substance, protecting element and dispensing device

A system, a detection device, a method, a use, and a computer program product for monitoring an actual or simulated preparation, performing, and/or post-processing of a dispensing—referred to as dispensing process below—of an administrable, preferably pharmaceutical, substance, with a dispensing device for dispensing the substance, whereby the dispensing device has at least one sound generator, which is designed in the dispensing process to generate at least one sound event, specific to a property or change in state of the dispensing device, in an acoustic signal, and with a detection device for checking the acoustic signal for the at least one sound event, in order to make possible a detection of the property or change in state of the dispensing device.

BACKGROUND OF THE INVENTION

Field of the Invention

This invention relates to the monitoring of an actual or simulated preparation, performing, and/or post-processing of a dispensing of an administrable, preferably pharmaceutical, substance.

This invention relates in particular to the monitoring of the dispensing of an administrable substance in connection with operational monitoring of a dispensing device or in connection with the determination of so-called patient compliance, also called compliance or adherence.

In the case of operational monitoring, the process of an actual or simulated dispensing of an administrable or pharmaceutical substance is monitored with respect to indicators, which do or do not indicate a proper or complete operation, in particular administration.

To determine patient compliance, the extent to which and/or the intervals at which a medication is taken is/are monitored. The result of the monitoring, in particular, i.e., information on an actual administration or medication, can subsequently be checked to ascertain whether the latter corresponds to a preset value, which can be present in the form of, for example, a physician's prescription, or whether it deviates therefrom.

Based on the results of the operational monitoring or the determined patient compliance, measures can automatically be introduced. Such measures are introduced in particular when it is determined that there is a malfunction—it can be by technical defect or operating error—or that the administration of medicines deviates from this preset value.

Both results of operational monitoring and the determined patient compliance can be used as measures to inform or to alert a user (patient) or third party, such as a medical practitioner or a medical system.

Description of the Related Art

U.S. Pat. No. 7,002,476 B2 relates to a medicine-dispensing device that is coupled to a transceiver for wireless control, which transceiver accesses a set of control data from a server. A set of instructions is downloaded in order to instruct a user via the transceiver on how to use the dispensed medication.

In order to safeguard the medication, an audible or visible indication can be given after time elapses.

U.S. Pat. No. 7,093,736 B2 relates to an arrangement with a blister, which can be moved between two positions. An alert is given when a cycle period has ended. An alert unit is set back when the blister is accessed for the purpose of removing the medicine. To this end, a special device with a mechanism and a sensor system is proposed, which is designed to monitor access to the blister.

SUMMARY OF THE INVENTION

The object of this invention is to simplify or to improve the monitoring of the actual or simulated dispensing of an administrable substance.

This object is achieved by a system, a detection device, a method, a protecting element and a dispensing device as described herein.

A first aspect of this invention relates to a system for preferably acoustic monitoring of an actual or simulated preparation, performing, and/or post-processing of a dispensing of an administrable, preferably pharmaceutical, substance. This actual or simulated preparation, performing, and/or post-processing of a dispensing are combined below under the term “dispensing process”.

The system according to the proposed solution has, on the one hand, a dispensing device for dispensing the substance, and, on the other hand, a detection device for checking an acoustic signal.

In terms of this invention, the term “dispensing device” is defined as a device that is designed for dispensing the substance for the purpose of administration. The dispensing device is preferably a device for dispensing one or more doses or portions of the substance, which (in each case) are suitable for complete and/or direct administration to a patient because of their amount, their volume, and/or their form.

Thus, the term “dispensing device” comprises, on the one hand, packages such as blisters or containers such as reservoirs, from which the pharmaceutical or other administrable substance can be removed for the purpose of administration. In this case, the substance can be removed in particular manually in discrete individual doses, for example as capsules or tablets, or in the form of powders or granulates. Additional examples of dispensing devices are injection systems, such as autoinjectors and syringes, sprays, inhalers, or dispensers for liquids, creams or gels.

In terms of this invention, the term “actual dispensing” is defined as that the latter leads or is to lead to the administration of the substance. In this case, this can be the injection of an injection solution, the nebulizing of an inhalable substance, or the removal from a package of a substance that can be handled manually.

In terms of this invention, the term “simulated dispensing” is defined as in this case the operation of a dispensing device for administrable substances for testing or training, without this operation leading to or being able to lead to an administration of the substance, or wherein the substance is a placebo. The operation is carried out, however, in the same way or similarly to the operation of a dispensing device for actual dispensing or administration. What is meant in this case is in particular the preparation and operation of a dispensing device that contains a placebo, for example a placebo inhaler for inhalation training or a placebo autoinjector for injection training.

When hereinafter only “dispensing” is meant, this comprises the actual dispensing, the simulated dispensing, or a combination of simulated and actual dispensing unless something else is explicitly described or is obvious from the context.

“Administrable” is preferably a substance when it is suitable and intended for direct application to a patient (human or animal) or for direct ingestion by a patient and/or is present in a dosage form and amount that is usual for personal, medical, or clinical use.

The dispensing device according to the proposed solution has at least one sound generator. In terms of this invention, a structure that is designed to generate or to trigger a sound event in the acoustic signal is referred to as a “sound generator.”

In this case, the sound generator can be set up especially for the purpose of sound generation or can be formed by a structure that is used for another primary purpose, but which generates or triggers a sound event when used. The sound generator can be arranged in one or more pieces and in one or more positions of the dispensing device and/or packaging of the latter.

A sound generator preferably consists of at least two parts or sections that correspond to one another and that produce or trigger the sound event in the case of relative movement to one another or separation.

In terms of this invention, the generation of a sound wave and the generated sound wave are referred to collectively as a “sound event.” For the sake of clarity, the term “sound event” thus combines the process of exciting an acoustic oscillation and the result of the propagating sound wave produced in this way, since the latter do not directly correspond to one another.

The sound event can extend over a limited chronological tracing. The sound event is preferably an acoustic pulse, impulse, and/or of a temporary nature. The sound event is preferably short, for example shorter than 10, 5 or 2 seconds. It can also be shorter than 1 or 0.5 second.

The sound event generates or is preferably a sound wave with frequencies that are preferably audible and/or can be converted by commercially available microphones into electrical signals, for example between 100 Hz and 20 kHz. Alternatively or in addition, the sound event can generate or be ultrasound, for example between 20 and 200 kHz.

The sound event can be a noise or a tone. For example, the sound event is a clicking, clacking, popping, hissing, buzzing, or beeping.

In terms of this invention, an “acoustic signal” is a sound wave or information corresponding thereto, for example a corresponding electric current or a corresponding electric voltage, a spectrum, or a digital pendant of the sound wave. The acoustic signal can thus be present both as a sound wave and converted in the form of electric current and/or voltage and/or digitized as digital data, wherein the more electric current and/or voltage and/or data correspond to the sound waves or represent the latter. It is not necessary, but preferable, that the acoustic signal is present and processed electrically and/or digitally in the form of digital data, data streams, audio samples or the like.

The acoustic signal has the sound event. This can be done by having the acoustic signal be imprinted by the sound event. It is thus possible for the acoustic signal to be a chronological tracing of a sound wave that the sound event has in the form of a section or onto which the sound event is superimposed in the form of a sound wave. Alternatively or in addition, the acoustic signal is information that corresponds to this sound wave, which information comprises the information originating from the sound event.

The sound event is specific to a property or change in state of the dispensing device. In this way, the sound event preferably makes possible a (clear) identification of the dispensing device or the substance and/or an assignment of the dispensing device to a group or class of dispensing devices or substances. The possible identification of the substance is in this case a property of the dispensing device, since the latter has the substance or is designed for this purpose. Alternatively or in addition, because of specificity, the sound event can make it possible to detect a change in state in the form of a triggering, an actuation, an unlocking, a securing, a substance ejection, or a packing or unpacking.

A sound event is specific to the property or change in state of the dispensing device when the sound event can be different from other sound waves from other sources, and thus the sound event makes possible an assignment or identification.

The term “specific” thus means that the sound event is different from other sound events or can be identified independently of other sound events, preferably so that the sound event can be assigned to the property or change in state of the dispensing device and consequently, by means of the detection of the sound event, the dispensing device, property, or change in state of the dispensing device and/or the substance, or a group or class thereof can be identified. This comprises in particular the detection or differentiation of an event, such as a preparation, dispensing, and/or triggering.

For example, the same type of dispensing devices can be designed by various sound generators to generate different sound events in the case of different substances, in order to differentiate the substances in the case of otherwise identical dispensing devices. In this way, the respective sound event is specific to the substance.

Alternatively or in addition, differently-designed dispensing devices can have sound generators for generating the identical sound event, in order to be able to identify the same substance despite differently-designed dispensing devices.

Also, dispensing devices of the same design or class can have sound generators for generating the same sound event in order to detect the same design or class and/or to generate different sound events in order to be able to distinguish dispensing devices of the same design or class from one another.

The sound generator is designed to generate at least one sound event in the case of the preparation, performing, and/or post-processing of a dispensing of the substance. The generation preferably takes place as a byproduct in the dispensing process.

In terms of this invention, the term “dispensing process” in general combines: the preparation, performing, and/or post-processing of the actual or simulated dispensing of the substance. What are meant in this case are preferably only necessary steps, i.e., those that are absolutely necessary for the dispensing of the substance with proper use of the dispensing device. Such absolutely necessary steps can be for preparing the removal of a packaging or a protective part; for implementing a triggering, without which the dispensing could not be carried out; and/or for post-processing a removal of the dispensing device from the patient and/or a measure that is necessary for reuse.

Preferably, the—or in any case a—sound event is produced in the case of direct dispensing or as a step that directly accompanies the dispensing of the substance. The sound generator is thus designed to generate the sound event in the case of the direct dispensing or a step that directly accompanies the dispensing of the substance. Examples here are the triggering of the dispensing or the phase in which the substance leaves the dispensing device. There can be multiple sound events, however, wherein not all sound events have to be generated with the direct dispensing or a step that directly accompanies the dispensing of the substance.

Also, the system according to the proposed solution has a detection device for checking the acoustic signal in the at least one sound event. Because of this check, the property or change in state of the dispensing device can be detected or assigned, or this is carried out by the detection device.

In particular, the detection device detects or distinguishes the dispensing device, property, or change in state of the dispensing device and/or substance by checking the acoustic signal in the at least one sound event.

In other words, the detection device is thus designed to check and to detect the acoustic signal in the sound event that originates from the dispensing device and that is produced by the sound generator, whether the acoustic signal has the sound event that is specific to the dispensing device, property, or change in state of the dispensing device and/or substance.

The “detection or assignment” of the property or change in state can in principle be or comprise an individual identification of a specific dispensing device or substance or the detection of a dispensing device or substance of a specific group or a type of dispensing devices or substances. The detection of the property of the dispensing device can thus be the detection of the dispensing device as such, but can also consist in that an event is detected with the dispensing device, such as, for example, a direct dispensing, by which conversely, in any case, a dispensing device or group or class thereof and/or substances and in addition a specific state or a specific change in state is/are also detected. By checking the acoustic signal for the at least one sound event, a sound event is preferably detected only when it originates from the dispensing process.

In terms of this invention, a “detection device” is thus first a device that is set up to analyze acoustic signals. It can have, for example, a processor, in particular a signal processor, or other analysis means for processing and evaluating audio signals in order to carry out this range of functions. Also, the detection device is set up specifically for checking. This means that the detection device is suitable optionally based on additional information to distinguish different sound events in the acoustic signal or to detect specific sound events or to distinguish from other sound events.

In order to be able to detect the sound event, the detection device preferably has corresponding information in the form of a sound event pattern. The sound event pattern can also be a signature of the sound event. With this sound event pattern, the detection device can compare the acoustic signal and detect when the sound event appears in the acoustic signal.

The system according to the proposed solution makes it possible in an advantageous way to monitor the dispensing process for dispensing the substance by examining the acoustic signal. It can thus be readily possible to check whether the correct substance is administered and/or whether administration is carried out at all and optionally whether it is carried out correctly, i.e., as specified.

In this case, the detection device can be produced in an especially simple and effective way by a Smartphone or another, in particular portable, device with a microphone and a processor. Specific hardware or expensive implementation of electronics in the dispensing device can thus be avoided. The detection device can have one or more (software) module(s), which can carry out the functions of the detection device.

Also, the check of the acoustic signal and the detection of the sound event make possible many applications that can be implemented by the detection device or made possible externally or in some other way. In one example, the detected or performed dispensing processes are reconciled to a preset value or used in another way to check a provided or preset medication. Alternatively or in addition, the check or the result of the check is used to detect malfunctions or incorrect applications of the dispensing device and optionally to prompt troubleshooting such as error signaling.

For the generation of the specific sound event, in many cases it is sufficient in an advantageous way to modify known dispensing devices not at all, only slightly, or only for certain of the many provided sound events or sound generators specifically for sound generation, so that in the case of the dispensing process, the specific sound event(s) is/are generated.

As a result, the system according to the proposed solution is to be implemented reliably, quickly, easily and with for the most part existing hardware in an unforeseen way and allows universal use, namely especially advantageously in connection with the monitoring of patient compliance (compliance/adherence), operational monitoring, and/or application monitoring.

Another aspect of this invention relates to the detection device for detection of a dispensing process of a preferably pharmaceutical substance that is carried out with a dispensing device of the system by examining an acoustic signal that is generated by a sound generator of the dispensing device for one or more sound events that are specific to the dispensing device and/or the substance.

Another, also independently achievable aspect of this invention relates to a method for monitoring an actual or simulated dispensing of an administrable, preferably pharmaceutical, substance with a dispensing device. In particular, this aspect relates to the detection of dispensing. In this case, an acoustic signal is checked to detect or distinguish the dispensing device, property, or change in state of the dispensing device and/or substance in a sound event that can be generated in a dispensing process comprising the preparation, performing, and/or post-processing of the dispensing with a sound generator of the dispensing device.

Another, also independently achievable aspect of this invention relates to a use of a mobile terminal device for detection of the actual or simulated dispensing of the administrable, preferably pharmaceutical, substance that is carried out with the dispensing device, wherein the mobile terminal device is used to pick up an acoustic signal and to examine it for a sound event that can be generated by the dispensing device during the dispensing process and that is specific to the dispensing device, property, or change in state of the dispensing device and/or the substance.

Another, also independently achievable aspect of this invention relates to a computer program product that has program code means, which, when they are implemented, for example on a processor, implement the method according to the proposed solution for detection. In particular, this is a preferred non-volatile computer-readable storage medium that has instructions, in particular in the form of code, which, when they are implemented on a processor, implement or effect the steps of the method according to the proposed solution.

Another, also independently achievable aspect of this invention relates to a protecting element for a dispensing device for dispensing an administrable, preferably pharmaceutical, substance. Preferably, the protecting element is configured cap-like and/or in the form of a cover or lid. The protecting element has or forms a sound generator which is designed to generate, upon an actual or simulated preparation of a dispensing of the substance, at least one reproducible sound event in an acoustic signal, the sound event being specific to a property and/or change in state of a dispensing device.

The protecting element is preferably configured to generate the sound event upon removing the protecting element from a main body of a dispensing device, wherein the generated sound event is independent of the speed, force and/or other external parameters used for removing the protecting element from the main body. This is conducive to the generation of a reproducible sound event and to a reliable detection of the sound event.

The protecting element preferably has a first part and a second part that are moveable relative to each other between an initial position and an activation position, preferably wherein the initial position and the activation position are different positions of the protecting element. This supports the generation of a reproducible sound event.

The sound generator is preferably configured to generate the sound event after movement of the protecting element from the initial position to the activation position and/or upon return of the protecting element from the activation position to the initial position. This is conducive to a reproducible generation of the sound event.

Another, also independently achievable aspect of this invention relates to a dispensing device for dispensing an administrable substance. The dispensing device has a main body and a protecting element, in particular as configured as described above.

Another, also independently achievable aspect of this invention relates to a system having the dispensing device.

In terms of this invention, substances that are suitable for ingestion by or other administration in a human or animal body are referred to as “administrable substances,” which substances can be present in particular in the form of liquids or suspensions—for example, for aerosol formation or injection-tablets, capsules, powders, or granulates.

This invention relates quite preferably to the administration of pharmaceutical substances in the form of medicines, but is not in principle limited thereto. Thus, it is not ruled out that this invention or aspects of the latter can also be advantageous independently of the administration of medicines. In terms of this invention, the term “administrable substance” therefore also comprises, in addition to pharmaceutical agents, substances that can be administered and are not strictly pharmaceutical.

In terms of this invention, “pharmaceutical” substances are pharmaceutical agents or medicines that have an active ingredient for healing or for preventing human or animal diseases. Preferably, in terms of this invention, dietary supplements, in a dosage form that corresponds to that of pharmaceutical agents, are also regarded as being among pharmaceutical substances. Alternatively or in addition, the substance can be cosmetic.

Additional advantages, aspects and properties of the present invention follow from the claims and from the subsequent description of the preferred embodiments with reference to the accompanying drawings.

DETAILED DESCRIPTION OF THE INVENTION

In the Figures, the same or similar parts are identified with the same or similar reference numbers and may have similar advantages, properties, and actions, even if a description is not repeated. Furthermore, reference is made to the definitions and statements that are cited in the parts of the general description.

FIG.1shows a system1according to the proposed solution for acoustic monitoring of a preparation, performing, and/or post-processing of a dispensing of an administrable, preferably pharmaceutical, substance2.

The system1has a dispensing device3for dispensing the substance2. The dispensing device3in turn has a sound generator4for generating at least one sound event5that is specific to a property or change in state of the dispensing device3in an acoustic signal6in the case of the preparation, performing, and/or post-processing of a dispensing of the substance2.

The preparation, performing, and/or post-processing is/are also referred to below as a dispensing process. However, the phase in which the substance2leaves the dispensing system3is called (direct) dispensing.

Also, the system1preferably has a detection device7for checking the acoustic signal6for the at least one sound event5A-5E in order to make possible a detection of the property or change in state of the dispensing device3. The detection device7is preferably designed for detecting or distinguishing the dispensing device3, property, or change in state of the dispensing device3and/or substance2by checking the acoustic signal6for the at least one sound event5.

In the example according toFIG.1, the dispensing device3is a so-called autoinjector. In principle, the invention, as it is explained in more detail below based on this autoinjector, can however, be applied in a corresponding way to other dispensing devices3.

FIG.2Ashows a view of the dispensing device3, which is present by way of example in the form of an autoinjector, whileFIG.2Bshows a partial section of the dispensing device3fromFIG.2A.

The dispensing device3has, as indicated in section according toFIG.2B, at least one administrable dose of the substance2, here a carpule3A that is filled with the substance2and with an injection needle3B.

The dispensing device3can be triggered, whereupon the substance2is administered. To this end, the carpule3A with the injection needle3B is moved in a sudden manner from the dispensing device3in order to penetrate into the tissue of a patient and to inject the contents of the carpule3A, i.e., the substance2, by means of the injection needle3B.

To trigger the dispensing, an actuator3C is provided at the dispensing device3. In this illustrative example, the actuator3C is a tube section or a sleeve that is pushed into the dispensing device3for triggering when the dispensing device3is attached to the patient and in this way brings about the triggering process, which causes the carpule3A to move and the substance2to be administered. In the case of other dispensing devices3, the actuator3C can also be implemented differently, however.

The triggering is prevented by a protecting element3D in the initial state of the dispensing device3. The protecting element3D in this example is a cap, which prevents the triggering and/or dispensing of the substance2.

Alternatively or in addition, however, other protecting elements3D can also be provided, which prevent the dispensing or triggering in an initial state of the dispensing device3. The protecting element3D can be unlocked in order to make possible the subsequent triggering and/or dispensing. In the illustrative example, the protecting element3D in the form of the cap is removed, and only when or as soon as the protecting element3D is removed can the triggering take place.

It is preferred that the protecting element3D of the dispensing device3has or forms the—or one of the—sound generator(s)4A. In this case, the protecting element3D can keep the substance3from being dispensed in an initial state and with generation of the sound event5A can be transferred into an enabling state for enabling the dispensing of the substance2.

The protecting element3D together with the part of the dispensing system3on which the protecting element3D is arranged in the initial state (locked, pushed-on cap) forms the sound generator4A here. In the illustrative example, the cap forms the sound generator4A in such a way that it forms a cylinder-piston unit with the other dispensing device3, by which when removing or opening the cap, an underpressure is generated in a hollow space that is formed by the cap. With complete removal or opening (enabling state), ambient air flows into this hollow space, by which the plop noise known for the opening or removal of a cap is generated.

The sound generator4A is preferably a structure that is not required for the dispensing process or the dispensing, not directly involved in the dispensing, and/or specifically designed or modified for the generation of the sound event5A.

In this example, the sound generator4A is a structure of the dispensing device3that is specific to or modified for sound generation, which device is designed to generate a sound event5A that is specific to the dispensing device3, property, or change in state of the dispensing device3and/or the substance2.

In this example, the sound generator4A has surface structures3E and counter-structures3F or is formed in this way, which structures are designed optionally for the dispensing process and specifically for this purpose to generate or to modify the sound during operation, i.e., the sound event5A that is produced by the sound generator4A in a way that is specific to the dispensing device3, property, or change in state of the dispensing device3and/or the substance2.

In the example, the protecting element3D (an inside wall of the cap) has a surface structure3E that interacts with a counter-structure3F of the dispensing device3in such a way that during unlocking, here, i.e., removing or opening the cap, a sound event5A is generated or changed. The surface structure3E with the counter-structure3F forms the sound generator4A or a part thereof.

Here, by way of example, ribs, beads, or grooves that engage in one another are provided. When the cap is removed, these lead to an oscillation of the protecting element3D or the housing of the dispensing device3and consequently to a sound wave as a sound event5A that is produced by this oscillation and that corresponds to the latter.

This sound wave, produced by the modified structure, precedes the plop noise in the example and may partially overlap the latter.

In this way or a similar way, a specific sound event5A can be brought about by a specific or modified structure, and various sound events5A can be brought about by various possible configurations of the surface structures and counter-structures3E,3F, even when the dispensing device3can be identical relative to its design that relates to the dispensing.

In any case, it is not necessary, however, that the sound generator(s)4A has/have a modified structure in order to generate the specific sound event5A. It can be sufficient, in particular for identification of a group or class of dispensing devices3or for the identification of a dispensing herewith, to monitor or to detect sound events5A that accompany the dispensing process, without an existing dispensing device3being modified for this purpose. Sound generators4A are then the existing structures that generate sound in the case of the dispensing process. The sound events5A can be specific enough for a detection, in particular in the case of more complex dispensing devices3.

The sound generator4A,4B can thus be either a structure of the dispensing device3that is already existing or prepared or necessary for the dispensing of the substance2or it can be specifically formed or modified for this purpose.

The sound generator(s)4A is or are preferably designed so that the sound event5A or the sound events5A in the dispensing process is or are generated necessarily and in a reproducible manner.

In the illustrative example, this is achieved in such a way that the sound generator4A that made the protecting element3D must be unlocked (removed) before triggering can take place, by which the sound event5A is generated.

The necessary generation of the sound event5A can also be implemented in some other way, however. For example, a triggering mechanism can form a sound generator4B, so that the sound event5B is necessarily generated with the triggering (cf.FIG.1).

For the sound generator4B of the triggering mechanism and additional or different sound generators4A,4B, the features and properties that are explained in connection with the sound generator4A of the protecting element3D correspondingly apply unless otherwise described or the contrary follows from the context.

In principle, the sound generator4A,4B can be based on various measures for sound generation. In particular, the sound generator4A,4B can be or can have a ratchet, flapper, vibrating bell, rattle, whistle or structure for generating a reproducible plopping, clacking, clicking, screeching, clattering, grinding, rattling, hissing, squeaking, buzzing, whistling or can be or can have oscillations caused by a stick-slip effect.

For example, because of the movable parts, which move along on a sound generator4B in the form of a ratchet, produced by the triggering, the dispensing device3can generate a clattering as a sound event5B. In a corresponding way, another specific sound event5B can be produced by or during performing the dispensing of the substance2with another sound generator4B.

In one aspect of this invention, the dispensing device3has at least two different sound generators4A,4B. These are preferably designed such that in various phases of the dispensing process that follow one another in time, a first sound event5A and, preferably chronologically spaced, a second-preferably different from the first-sound event5B are generated.

In one aspect of this invention, the dispensing device3has multiple sound generators4A,4B or a sequence system with multiple sound generators4A,4B for generating a sequence of at least or more than two sound events5A,5B that (necessarily) follow one another in time during the course of the dispensing process. In this way, the acoustic signal6is imprinted by the sequence.

A sequence system can first consist of two or more sound generators4A,4B or have the latter. Also, it is preferable that the sequence system or the dispensing device3is coupled to the latter in such a way that the sound generators4A,4B during the dispensing process generate sound events5A,5B in a specific sequence. In this case, the sequence system is not necessarily a separate system, but rather it can also be produced by the design of the dispensing device3or by its components.

In the illustrative example, the dispensing device3is designed so that first, a first sound event5A is generated with the first sound generator4A of the protecting element3D, before a subsequent second sound event5B is or can be generated by the second sound generator4B of the triggering mechanism, which then form such a sequence. The dispensing device3in this case implements the sequence system by design. Alternatively, however, a sequence system can also be a separate component. Furthermore, there are also other possibilities to generate a sequence with more than two sound events5A,5B or to provide sound generators4A,4B for this purpose in the case of the dispensing device3.

In another aspect, the system1preferably has multiple dispensing devices3, which are distinguished relative to the substance2and the sound generator4A,4B and otherwise are designed identically or similarly. In this way, the same acoustic signal6can be generated by dispensing devices3with the same properties relative to the substance2. Furthermore, different sound generators4A,4B or acoustic signals6can be generated by dispensing devices3with various properties relative to the substance2. This makes possible the differentiation of various substances2themselves in the case of otherwise at least essentially identical dispensing devices3.

It is preferred that the sound generator(s)4A,4B generate(s) the sound event(s)5A,5B in the dispensing process necessarily and in a reproducible manner in a specific sequence. Here, this is ensured for the first sound event5A in such a way that the protecting element3D has to be removed or unlocked before the dispensing of the substance2can be carried out. Moreover, this is ensured for the second sound event5B in such a way that the second sound event5B is produced by the triggering of the dispensing as such a one; the dispensing of the substance2thus necessarily accompanies the generation of the second sound event5B by the second sound generator4B. There are, however, also other possibilities for implementing such necessary and reproducible sequences of sound events5A,5B in the dispensing process.

An also independently achievable aspect of this invention relates to the detection of a dispensing of an administrable, preferably pharmaceutical, substance2that is carried out or simulated with a dispensing device3. In this case, an acoustic signal6is examined for a sound event5A in the acoustic signal6that is specific to the dispensing device3, property, or change in state of the dispensing device3and/or the substance2.

The sound event5A,5B for which the acoustic signal6is examined is specific to or characteristic of the dispensing device3, property, or change in state of the dispensing device3and/or substance2and in particular of the preparation, performing, and/or post-processing of the dispensing of the substance2or the dispensing process of the substance2by means of the dispensing device3. The sound event5A,5B is preferably generated in this dispensing process. The sound event5A,5B is preferably specific to or characteristic of the dispensing process or a step in the latter.

By examining the acoustic signal6for the at least one sound event5A,5B, the dispensing device3, property, or change in state of the dispensing device3and/or the substance2can consequently be detected or distinguished. This includes the detection or differentiation of groups or classes of dispensing devices3or substances2.

An example of the detection of the dispensing device3, property, or change in state of the dispensing device3, and/or the substance2by checking the acoustic signal6for the at least one sound event5A,5B is explained in more detail below based onFIG.1.

In a Phase I, the dispensing device3is prepared for triggering by the dispensing device3being unlocked with the protecting element3D. This preparation or unlocking of the protecting element3D, in this example the removal of the cap, generates a first sound event5A. In the illustrative example, the protecting element3D is provided to this end with the sound generator4A, which is designed and set up to generate the sound event5A during unlocking (removal of the cap).

The sound event5A is represented in the acoustic signal6by (indicated) acoustic oscillations. The sound event5A moves into the acoustic signal6in such a way that the sound generator4A generates a sound wave, which forms a part of the acoustic signal6.

In the illustrative example, the dispensing device3has the protecting element3D as a first sound generator4A, which element is preferably designed cap-like and generates a plop noise during unlocking, i.e., in the case of the preparation of the dispensing of the substance2. As already previously explained, the protecting element3D can be especially set up or modified optionally and preferably for generating a specific sound event5A, here a modified plop noise.

In Phase II according toFIG.1, the dispensing device3is triggered, which in turn leads to a sound event5B, which is represented in the acoustic signal6by indicated acoustic oscillations. In this example, the dispensing device3that is designed as an autoinjector is triggered by attaching to a patient with the actuator3C or in another way. The triggering and/or direct dispensing of the substance2in this case produces the sound event5B.

For generating the second sound event4B, the dispensing device3has a second sound generator4B, which is implemented here by the triggering mechanism of the dispensing device3. This triggering mechanism generates a clacking, followed by a softer continuous noise and an optional clacking at the end of the injection process.

In its chronological tracing, the acoustic signal6therefore contains multiple different sound events5, which in this example originate, on the one hand, from the preparation and, on the other hand, from the performing of the (direct) dispensing of the substance2with the dispensing device3.

The acoustic signal6can also have other sound events5A,5B, however, which do not originate from the dispensing system3or from other steps. The latter can be ignored and/or discarded and/or identified as features for exclusion.

The acoustic signal6is picked up and processed by the detection device7. The detection device7can be implemented and is advantageous in the system1as well as independently of the system1and other parts of the system1. It therefore represents a separate aspect of this invention.

The detection device7is designed to detect the property or change in state of the dispensing device3or the dispensing device3and/or substance2in such a way that the acoustic signal6is examined by the detection device7for one or more sound events5A,5B that is/are generated by at least one sound generator4of the dispensing device2and is/are specific to the property or change in state of the dispensing device3or to the dispensing device3and/or the substance2.

The detection device7determines the property or change in state of the dispensing device3or the dispensing device3and/or substance2preferably in the case of detecting at least one sound event5A,5B in the acoustic signal6based on the detected sound event5A,5B.

The detection device7preferably has a microphone8, via which the acoustic signal6is picked up with the sound events5A,5B.

Furthermore, the detection device7preferably has a processor9for administering the acoustic signal6. In particular, the processor9is a signal processor—also called a digital signal processor (DSP)—or it has such a one. In this case, this is a processor9or a part thereof with computing structures that are especially suitable or are designed to process audio signals. The use of a signal processor has proven especially advantageous since the latter especially efficiently and effectively processes the acoustic signal6, in particular when it continuously monitors a continuous acoustic signal6.

The detection device7preferably digitizes the acoustic signal6and processes it digitally. The detection device7can to this end have an analog-digital converter (ADC) in order to convert an acoustic signal6, which is converted by the microphone8into analog electrical signals6, into a digital acoustic signal6. In principle, however, an analog processing is also possible.

The detection device7detects or distinguishes the dispensing device3and/or the substance2by preferably continuous checking of the acoustic signal6for the at least one sound event5A,5B. It is thus preferred that the signal6is checked without interruption over an extended period in order to identify sound events5A,5B in the acoustic signal6.

The detection device7can optionally have an output device10for outputting a result of the checking of the acoustic signal6or for signaling the detection or differentiation or a characteristic value of this. The output device10can be or have a display, a loudspeaker, and/or another user interface.

In another aspect of this invention, the detection device7has an interface11for producing a data link12, for example to a database13. The database13can form part of the system1or be provided separately therefrom as an external database13.

The detection device7is especially preferably designed for detecting or distinguishing at least two preferably different sound events5A,5B that in each case are specific to the dispensing device3and/or the substance2. This is done by checking the acoustic signal6for these sound events5A,5B.

Preferably, the detection device7has an analysis device15for examining the different sound events5A,5B, detected in checking, for a predetermined sequence or order, or forms such an analysis device10.

The detection device7is preferably designed to output a result14via the output device10when the determined order of various sound events5A,5B that is specific to or characteristic of the dispensing process has been detected by the detection device7or analysis device or to output an error, when an order, amount, or number of different sound events5A,5B that deviates therefrom has been detected.

Especially preferably, the detection device7is designed to distinguish between different sound events5A,5B of the same, similar or different dispensing devices3.

For detection, the detection device7can be designed for comparison of the acoustic signal6with one or more sound event patterns17A,17B.

Sound event patterns17A,17B can be present as so-called audio samples, which have information relative to sound events5A,5B. In this case, these are segments of an acoustic signal6that (in each case) have one or more sound events5A,5B that took place in the past, were forecast, simulated or in another way suitable for comparison to the signal6. Sound event patterns17A,17B are similar in particular to the sound events5for which the acoustic signal6is to be examined or correspond to the latter. Alternatively or in addition, these are one or more sound events5A,5B representing information or information derived therefrom, such as processed, compressed, or aggregated sound events5. These include spectra and/or statistical information on sound events5.

The sound event pattern(s)17A,17B can have assignment means. With these assignment means, an assignment of the sound event pattern17A,17B or the sound event5A,5B that corresponds thereto to the dispensing device3, the property, and/or the change in state of the dispensing device3or substance2can be carried out. The sound event pattern17A,17B or assignment means is thus preferably designed for this purpose or contains information relative to the assignment. The assignment can be carried out by the detection device7. It is sufficient when the assignment means are related, linked, and/or (logically) associated with the respective sound event patterns17A,17B, so that the sound event patterns17A,17B have the assignment means.

The detection device7preferably has one or more of the sound event patterns17A,17B. Alternatively or in addition, one or more of the sound event patterns17A,17B is/are stored in the database13and can be accessed from the latter by the detection device7.

The sound event pattern(s)17A,17B is/are used to detect corresponding sound events5A,5B in the signal6. To this end, the detection device7compares the sound event pattern17A,17B to the signal6. When a sound event5A,5B can be detected in the signal6by means of a sound event pattern17A,17B, this can be recorded as a result14.

When multiple sound events5A,5B are detected in the signal6by means of the same sound event patterns17A,17B, the latter can be recorded as one or more results14.

When multiple sound events5A,5B are detected in the signal6by means of multiple sound event patterns17A,17B, the latter can be recorded as one or more results14.

The results14can be output by the detection device7via the output device10, further processed, and/or conveyed.

The detection device7preferably has a correlation module16for generating a correlation of the acoustic signal6with one or more sound event patterns17A,17B. The correlation can be done continuously and/or by a mathematical folding in the time range or multiplication in the frequency range, the latter preferably based on a (Fourier-) transformed signal6. The correlation is a preferred method for comparison of the sound event pattern17A,17B to the signal6.

The detection device7is preferably designed to output a result14when it detects that the acoustic signal6is impressed by a sequence of sound events5A,5B that follow one another in time, which sequence corresponds to the course of steps of the dispensing process, and which sequence thus has corresponding sound events5A,5B. Alternatively or in addition, the detection device7preferably is designed to output an error when it detects that the acoustic signal6is not impressed by a sequence of sound events5A,5B that follow one another in time, which sequence corresponds to the course of steps of the dispensing process, and which sequence thus has corresponding sound events5A,5B. In this way, the function and/or medication can advantageously be ensured or can be improved relative to the reliability.

The detection device7preferably detects dispensing processes with the dispensing system3or by the substance2. This can be carried out by detection of the dispensing system3or by the substance2or based on this detection.

The detection device7can have a counter that counts the number of dispensing cycles or dispensing processes with the dispensing device3.

Alternatively or in addition, the detection device7is designed for comparison of detected dispensing processes to a preset value. On this basis, optionally additional measures can be automatically set up, for example a signaling or transmission of information.

Further processing of the results14can preferably be carried out by the detection device7or externally, so that patient compliance (compliance/adherence) can be supported or controlled. To this end, based on one or more results14, information or warnings can be output. Alternatively or in addition, one or more results14or indicators derived therefrom can be forwarded, for example to a medical practitioner, a medical system, or the like.

Another, also independently achievable aspect of this invention relates to the use of a mobile terminal device, preferably a Smartphone, a tablet computer, and/or wearable devices, in particular a Smartwatch or fitness arm band, as a detection device7or for detection of dispensing, performed with a dispensing device3, of an administrable, preferably pharmaceutical, substance2or the detection of a simulation of such dispensing.

In this case, the mobile terminal device is used in order to pick up the acoustic signal6and to examine it for a (characteristic) sound event5A,5B that is generated by the dispensing device3during the preparation, performing, or post-processing of the dispensing of the substance2and that is specific to the dispensing device3, property, or change in state of the dispensing device3and/or the substance2, or the dispensing process.

In an also independently achievable aspect, this invention also relates to a computer program product that has program code means that, when they are implemented, perform the method according to the proposed solution. In particular, the computer program product is a computer-readable-preferably non-volatile-storage medium, having instructions that, when they are implemented on a processor9, effect the method according to the proposed solution or an implementation of the steps of the method according to the proposed solution. This can be a storage device of the detection device or a storage device that is separate therefrom.

The invention was explained based on the preferred example of a dispensing device3in the form of an autoinjector. However, additional dispensing systems3, sound generators4A,4B, and/or sound events5A,5B are possible, so that below, additional examples based onFIGS.4to7are explained.

FIG.4shows a secondary packaging18. This is present in the example as a covering box. The secondary packaging18can be separated by means of a tear flap19or along one or more predetermined scoring lines20. In this case, the secondary packaging generates a sound event5C. The tear flap19or predetermined scoring lines20therefore form a sound generator4C.

The sound generator4C is preferably designed to generate a sound event5C that is specific to or characteristic of the dispensing device3, the property, or change in state of the latter, or the substance2.

The specificity of the sound event5C, i.e., the suitability of the sound event5C for distinguishing the packaged dispensing device3from other dispensing devices3, can be improved in such a way that the sound generator4C is changed/modified compared to the usual tear flaps19or predetermined scoring lines20.

It is thus possible to provide a specific or particular, preferably irregular fluting or toothing, for example a fluting or toothing at variable distances—in particular periodic—of individual flutes or teeth or groups thereof, as indicated in the illustrative example, which leads to the specific sound event5C.

FIG.5shows a primary packaging21, in which the dispensing device3is directly arranged. In the illustrative example, the primary packaging21is a blister that has a receptacle22, into which the dispensing device3is inserted and is enclosed by means of a film23by reversible edge-side adhesive24.

The film23can be pulled off for removal from the dispensing device3. The film23in this case forms a sound generator4D. In this respect, the film23generates a specific noise as a sound event5D during the removal from the receptacle22.

In general, the structure of the sound generator4D-here, i.e., that of the blister, the receptacle22, the film23and/or the adhesive24—is preferably designed such that over the course of the process that generates the sound event5D, here the tearing, the generation of the sound event5D is variable in such a way that the sound event5D that can be generated or is generated is or will be changed or modified accordingly throughout. In this way, the sound event5D can be especially specific or characteristic.

Alternatively or in addition, the sound event5D can contain and transport identification information. Consequently, a detection or differentiation can be carried out in an especially reliable manner by means of the identification information. Corresponding measures are also possible in the case of other sound generators4A-4D. This can also be achieved by a sound generator4A-4D, which generates a variable sound event5A-5D, so that by the variability or changing, in particular modulation, data are integrated into the sound event5A-5D.

In the described way and not limited to the concrete embodiment, the sound generator4A-4D can thus be designed to acoustically modulate identification information or other information that preferably pertains to the dispensing device3and/or substance2in the sound event5A-5D. This leads to a type of melody or chord progression or progression of various noises, by which the identification information or other information is converted from the structure of the sound generator4A-4D into the sound event5A-5D. In the example fromFIG.4or else in general, this can be carried out by a toothing or topography that is varied over the course of the tear flap19or predetermined scoring lines20or other surface structure3E or counter-structure3F.

Based on the modulated sound event5D, the detection device7can then implement a detection or differentiation of the dispensing device3, property, or change in state of the dispensing device3and/or the substance2, and namely especially in a reliable, specific, and/or differentiated manner.

In this way-preferably by the detection device7-asound event pattern17A,17B can be compared to the acoustic signal6, which corresponds to the sound event5D with the modulated (identification) information. When the sound event5D with the (identification) information is subsequently detected, the dispensing device3, the property, the change in state of the latter, and/or the substance2is or will be detected or makes this possible.

Alternatively or in addition, multiple sound event patterns17A,17B can be provided for various modulated parts of the sound event5D and can be used to differentiate the various modulated parts of the sound event5D. The results14or series of results14can then be used for demodulation of the (identification) information.

The (identification) information can thus be recovered from the sound event5D and can be used for especially reliable, individual, and/or differentiated detection or differentiation of the dispensing device3, property, or change in state of the dispensing device3and/or the substance2.

Preferably, the detection device7is correspondingly designed to demodulate information that is modulated onto a sound event5D, in order to prepare an improved detection or differentiation of the dispensing device3, property, or change in state of the dispensing device3and/or of the substance2. To this end, the detection device7preferably has a demodulator for demodulation of the acoustic signal6for the purpose of recovering (identification) information that is modulated to this signal6or to one or more sound events5A-5D in the signal6.

In another, also independently achievable aspect, the dispensing device3can have a device3G for changing sound events5A-D. In the illustrative example according toFIG.5, the device3G is a grip part or other device3G that can be applied to the dispensing device3or its packaging. The device3G can be applied subsequently to the dispensing device3. In particular, it can be plugged in.

The device3G changes the property of one or more sound generators4of the dispensing device3in such a way that the sound generator(s)4generate(s) sound events5A-D that can be distinguished with and without the device3G or with different devices3G or is/are designed for this purpose. In particular, sound events5A-D are modified in such a way that a natural resonant frequency or a resonant element of the dispensing device3or packaging, a damping or general oscillating properties of the dispensing device3are changed.

With the device3G for changing sound events5A-D, it is possible to individualize sound events5A-D. In this way, dispensing devices3can subsequently also be made distinguishable from one another. Thus, for example, with different devices3G, otherwise identical dispensing systems3can be made distinguishable with respect to different substances2.

FIG.6shows a series of sound events5A-D in the signal6in three Phases I, II, and III that follow one another chronologically.

In the first Phase I, the signal6in a first time span t1has the sound event5C, which is produced by the sound generator4C of the secondary packaging18.

In Phase II, after a down time t2in which the primary packaging21is removed, in a time span t3, the signal6has the first sound event5A, which originates from the unlocking of the dispensing device3by means of the protecting element3D.

In Phase III, after another down time t4, in which the dispensing system3is moved to the dispensing point, in a time span t5, the signal6has the second sound event5B, which originates from the sound generator4B of the actuator3C.

The signal can be checked by the detection device7for detecting or distinguishing the dispensing device3, property, or change in state of the dispensing device3and/or the substance2by examining the acoustic signal6for at least one of the sound events5A-D.

It is thus possible for the check to be limited to the second sound event5B, which is detected in Phase III. This sound event5B can be specific or characteristic enough in particular to detect the dispensing device3as belonging to a group and/or to detect a dispensing of the substance2with this dispensing device3.

Alternatively, the signal6can be checked for at least two sound events5A-D. When a check is performed for the first sound event5A and the second sound event5B, and both sound events5A,5B in Phases II and III are detected, then, in addition to the findings from the detection of only the second sound event5B, it is possible to detect that the dispensing device3has been prepared for dispensing, namely by removing the protective part3D.

When the check is performed for the sound event5C that originates from the sound generator4C of the secondary packaging, it can be detected alternatively or in addition whether the dispensing system3has been removed from the secondary packaging18as expected.

When the check is performed for the sound event5D that originates from the sound generator4D of the primary packaging21, it can be detected alternatively or in addition whether the dispensing system3has been removed from the primary packaging21as expected. This is not the case in the example.

The signal6is preferably checked for at least two, especially preferably at least or exactly three sound events5A,5B,5C/5D, namely the unpacking, the unlocking and the triggering. Thus, when all sound events5A,5B,5C/5D in the signal6are detected (by the detection device7), it can be inferred that a properly-prepared originally-packaged dispensing device3has been triggered, and a direct dispensing, optionally dispensing with which substance2, has taken place.

Preferably, the series of the sound events5A-5D is checked (by the detection device7). Furthermore, it can thus be detected (by the detection device7) whether the dispensing process is completed in the planned series.

Alternatively or in addition, as explained above, the dispensing device3, property, or change in state of the dispensing device3and/or the substance2can be identified.

In another example,FIG.7shows a dispensing device3in the form of a cylinder with a sound generator4E in the form of an accessory device25, which in the illustrative example can be plugged into the dispensing device3or can be applied in a preferably reversible manner to the latter in some other way.

The sound generator4is formed here by a spring arm26in combination with a fluting of a closure27of the dispensing device3. When opening the dispensing device3, the spring arm generates a specific or characteristic clattering as a sound event5E. The fluting can be designed for modulation of the sound event5E.

In one aspect of this invention, a sound generator4A-4E generates a sound event5A-5D or is designed for this purpose, which corresponds to a manufacturer or is specific to a manufacturer. The corresponding sound event pattern17A,17B accordingly thus preferably has an assignment means, which identifies or assigns the manufacturer. In this way, a manufacturer identification of the dispensing device3or substance2can be made. Also, in any case, an affiliation of the dispensing device3or the substance2with a manufacturer can be detected. This information can be used in general to verify or to preclude detection of the dispensing system3.

In one aspect of this invention, a sound generator4A-4E generates a sound event5A-5D or is designed for this purpose, which corresponds to an active ingredient concentration or is specific to an active ingredient concentration. Accordingly, a sound event pattern17A,17B that corresponds to the sound event4A-4E preferably has an assignment means, which makes possible an identification or assignment of the active ingredient concentration. In this way, an active ingredient concentration of the substance2can be detected. On this basis, in particular together with the counting result, medication compliance can subsequently be determined.

In another aspect of this invention, the detection(s) or differentiation(s) of the dispensing device(s)3and/or the substance(s)2are counted or the detection device7is designed for this purpose. In particular, direct dispensing of the substance2, dispensing processes or direct dispensing with a determined—or a type of—dispensing device(s)3are counted. The result of this is referred to as the counting result. In this case, this can be a count or amount or a size without reference or with a time reference, such as detections or differentiations or dispensing processes per time span or (average) time spans between dispensing processes.

In another aspect of this invention, the detection device7is designed to generate, to store one or more results14or information for medication compliance that is derived therefrom in a database and/or on an application device for automatic dispensing or for adapting an automatic dispensing of the substance2, or to forward to other substances2. This can, but does not have to, be done based on the counting or counting result.

In another aspect of this invention, the sound generator4A-4E is an electroacoustic transducer, such as a piezo element, loudspeaker or the like, or has such a one. The electroacoustic transducer can be excited and/or activated in or causally by one step of the dispensing process in order to generate specific, as necessary also complex, sound events5A-5E. In particular, it is possible with the electroacoustic transducer also to modulate complex data or data packets with reliability in the sound event5A-5E.

In another aspect of this invention, the sound generator4A-4E is a piezo element or other element for generating ultrasound, or it has such a one. A sound event5A-5E in the ultrasound range makes possible or facilitates the detection based on the fundamental specificity of such sound events5A-5E. Unlike sound events5A-5E, ultrasound is generated less often by accident in the audible range and is contained at lower amplitude in ambient noise, thus facilitating detection.

In another aspect of this invention, the dispensing device3has as a sound generator4A-4E a housing part that is preferably modifiable or designed specifically for the sound generation or amplification.

In another aspect of this invention, the sound generator4has one or more elastic elements such as pins, spring arms, elastic structures or spring-loaded structures. The latter are preferably designed by interaction with another part for generating the sound event5A-5E. In particular, they interact with the surface structure3D or counter-structure3E in the dispensing process, forming the sound event5A-5E. For example, one or more elastic elements is or are provided in or on a cap, or in general in or on a closure for a supply receptacle, in particular a medication reservoir.

In another aspect of this invention, a blister is provided as a sound generator4A-4E. The latter, for example, can generate the sound event5A-5E—for example corresponding to an active ingredient concentration or the like—by a modified blister film or a system that is coupled to the blister in the case of the removal of the content of a blister.

In another aspect of this invention, the sound event5A-5E is used to identify a specific phase or a specific sequence of events in the dispensing process.

In other aspects of this invention, the detection device7is designed specifically to detect one or more of the described, specific sound events5A-5E. To this end, the detection device7can use a corresponding specific sound event pattern17A,17B. Preferably based on the sound event pattern17A,17B, the detection device7automatically assigns corresponding information pertaining to the things to which the sound events5A-5E are specific. Alternatively or in addition, the detection device7can have a microphone, which converts specific frequency ranges into electric currents or voltages, in particular audible frequencies and/or ultrasound.

In other aspects of this invention, the sound generator4A-4E generates a continuous, preferably constant or single-frequency, sound wave. In this case, the sound event5A-5E can consist in modifying this sound wave, in particular relative to frequency and/or amplitude.

In the following, a third embodiment of the dispensing device3according to the proposed solution will be discussed, in particular with reference toFIGS.8to13. If not indicated otherwise or obvious from the context, all previous explanations with regard to the system1and the dispensing device3also apply to the third embodiment of the dispensing device3.

The dispensing device preferably has a longitudinal or main axis A. Terms referring to an axis, such as “axial”, “radial” or the like, preferably relate to the axis A. For example, an “axial” direction or movement is a direction or movement which is parallel to the axis A and a “radial” direction or movement is a direction or movement which is radial to the axis A.

The dispensing device3according to the third embodiment is preferably essentially configured identically to the dispensing device3according to the first embodiment which is shown inFIG.2. The dispensing device3according to the third embodiment preferably only differs from the dispensing device3according to the first embodiment in the construction of the protecting element3D.

The dispensing device3preferably has a main body3H and a protecting element3D.

The protecting element3D preferably forms a lid and/or cover of the dispensing device3, in particular for covering an axial end of the main body3H. Particularly preferably, the protecting element3D is or forms a cap.

The protecting element3D is preferably detachable from and/or attachable to the main body3H. Preferably, the protecting element3D can be or is reversibly held on the main body3H, in particular an axial end thereof, preferably by a latching and/or snapping mechanism.

The protecting element3D can be covered by an additional cap or cover which is not shown in the Figures.

The protecting element3D and/or dispensing device7is/are preferably designed for single use and/or is/are a disposable product.

The protecting element3D preferably has or forms a sound generator4A. The sound generator4A of the dispensing device3according to the third embodiment is preferably similar to the sound generator4A of the dispensing device3according to the first embodiment, wherein differences will be described hereinafter.

Preferably, all parts of the sound generator4A are comprised by and/or integrated in the protecting element3D. The protecting element3D preferably completely comprises the sound generator4A. The main body3H does preferably not comprise the sound generator4A or parts thereof.

The sound generator4A is designed to generate, upon an actual or simulated preparation of a dispensing of the substance2, at least one reproducible sound event5A in an acoustic signal6, the sound event5A being specific to a property and/or change in state of the dispensing device3.

The protecting element3D is preferably configured to keep the substance2from being dispensed in an initial state of the dispensing device3. The dispensing device3can preferably be transferred to an enabling state for enabling the dispensing of the substance2, wherein the sound event5A is generated upon transferring the dispensing device3to the enabling state.

Different states of the dispensing device3are shown inFIG.8.FIG.8Adepicts the initial state,FIG.8Cdepicts the enabling state andFIG.8Bdepicts an intermediate state which is adopted upon transferring the dispensing device3from the initial state to the enabling state.

The initial state is in particular the state in which the protecting element3D, in particular the cap, is attached to the main body3H of the dispensing device3and thus covers the main body3H and/or prevents dispensing of the substance2. The enabling state is in particular the state in which the protecting element3D or cap has been removed from the main body3H and thus dispensing of the substance2is enabled.

The protecting element3D and/or the dispensing device3is/are preferably configured to generate the sound event5A upon transferring the protecting element3D and/or dispensing device3from the initial state to the enabling state. In particular, the protecting element3D and/or dispensing device3is/are configured to generate the sound event5A upon removing the protecting element3D from the main body3H.

The generated sound event5A is preferably independent of the speed, force and/or other external parameters used for transferring the protecting element3D or dispensing device3to the enabling state, in particular for removing the protecting element3D from the main body3H. In other words, the generated sound event5A does not depend on the manner in which a user (not shown) removes the protecting element3D or cap from the main body3H, but the generated sound event5A is always the same, regardless of for example whether the user removes the protecting element3D slowly or quickly. This is in particular achieved by the construction of the protecting element3D and/or an internal mechanism of the protecting element3D having or forming the sound generator4A and is conducive to the reproducible generation of the sound event5A.

The protecting element3D can preferably be positioned in different positions, as apparent fromFIG.8. In particular, the protecting element3D has an activation position.

The protecting element3D is preferably configured to automatically, immediately and/or necessarily generate the sound event5A after reaching the activation position, particularly wherein the generated sound event5A is independent of the manner in which the protecting element3D is manipulated, for example whether the protecting element3D is removed from the main body3H slowly or quickly.

Preferably, the sound event5A can only be generated if the protecting element3D is being positioned in the activation position (before generation of the sound event5A). In other words, positioning the protecting element3D in the activation position is preferably a necessary condition without which the sound event5A cannot be generated.

The activation position is preferably a position which has to be reached to enable generation of the sound event5A. Preferably, the activation position is a defined position of the protecting element3D which is defined or determined by the construction of the protecting element3D.

A “manipulation” of the protecting element3D and/or dispensing device3is preferably any action, in particular by a user, by which the position and/or state of the protecting element3D and/or the dispensing device3are changed. In particular, manipulation of the protecting element3D includes or means a process of removing the protecting element3D from the main body3H and/or moving different parts of the protecting element3D relative to one another.

The protecting element3D preferably has a drive element27. The drive element27is preferably a spring, in particular a tension spring. Preferably, the drive element27is, in particular completely, arranged within the protecting element3D or on the inside thereof.

The drive element27is preferably configured to be activated, in particular tensioned, by manipulating the protecting element3D such that the activation position is reached, in particular by positioning or moving the protecting element3D towards or in the actuation position.

Further, the drive element27is preferably configured to automatically, immediately and/or necessarily cause the generation of the sound event5A after the protecting element3D has reached the activation position.

The protecting element3D preferably has a first part28and a second part29. The first part28is preferably configured as a cap and the second part29is preferably configured as a sleeve which is in particular arranged or arrangeable within the cap, particularly coaxially with the cap. In particular, the first and second part28,29are at least essentially cylindrical.

The first and second part28,29are moveable relative to each other between an initial position and the activation position. The terms “initial position” and“activation position“denote different positions of the protecting element3D and, thus, in particular different positions of the first and second part28,29relative to each other.

The initial position of the protecting element3D is depicted inFIGS.11A and12Aand the activation position is depicted inFIGS.11B and12B.

In the initial position, the second part29is preferably completely inserted into the first part28. The initial position is preferably a resting position in which the protecting element3D is held or pre-tensioned and/or into which the protecting element3D returns when no external forces act on the protecting element3D and/or drive the parts28,29apart or prevent a moving of the parts28,29relative to each other.

The activation position is in particular a position in which the first and second part28,29have been moved relative to each other, in particular moved apart, with regard to the initial position. In the illustrative example, the activation position is a position in which the second part29has (partly) been moved out of the first part28and/or juts out of the first part28.

The initial position and the activation position are preferably different axial and/or rotational positions of the first and second part28,29relative to each other.

The activation position is preferably defined or determined by the construction or configuration of the first part28and the second part29, as explained in more detail below.

It is noted that the “initial state” of the dispensing device3and the “initial position” of the protecting element3D are not the same but are distinguished from each other. InFIG.8A, the protecting element3D is shown in the initial position in the dispensing device3is shown in the initial state. However, inFIG.8B, the first and second part28,29of the protecting element3D have been moved relative to each other, so that the protecting element3D is not in the initial position. InFIG.8C, the protecting element3D is again in the initial position (as described later), whereas the protecting element3D has been completely removed from the main body3H and, thus, the dispensing device3is in the enabling state.

The drive element27is configured to hold and/or pre-tension the protecting element3D or first and second part28,29in the initial position. The drive element27is preferably configured to be tensioned by moving the first and second sound part28,29apart. Preferably, the drive element27is arranged and/or tensioned between the first part28and the second part29. Further preferably, the drive element27is engaged with and/or attached to the first part28and/or the second part29.

The first and second part28,29are preferably linearly moveable relative to each other. As an alternative or addition, the first and second part28,29are rotatable relative to each other, at least to a certain degree and/or in a certain range. In the illustrated example, the first and second part28,29are both linearly moveable and—in a limited range—rotatable to each other, as explained in more detail below.

The second part29preferably has or is formed by several elements, in particular a sleeve element29A and a fitting element29B. In principle, the second part29could also be formed by only one piece. However, the two-piece construction with the sleeve element29A and the fitting element29B has proven advantageous for manufacturing and assembling the protecting element3D or second part29.

The sleeve element29A is preferably configured as a sleeve and/or essentially cylindrical. The fitting element29B is preferably inserted into and/or arranged coaxially with the sleeve element29A. In particular, the sleeve element29A has recesses which are configured for receiving or holding the fitting element29B.

The sleeve element29A and the fitting element29B preferably form a unit, in particular wherein the sleeve element29A and fitting element29B are not movable and/or moved relative to another during use of the dispensing device3and/or protecting element3D. In other words, the sleeve element29A and fitting element29B are preferably in a fixed position relative to each other. This can be achieved for example by fixedly attaching the sleeve element29A and fitting element29B to each other, for example by a latching mechanism and/or by providing a permanent connection between the sleeve element29A and the fitting element29B, for example by gluing, welding or the like.

The protecting element3D preferably has a latching mechanism and/or stop for preventing the second part29from being detached or removed from the first part28and/or for preventing relative movement of the first and second part28,29beyond the activation position.

The latching mechanism or stop preferably has or is formed by a pawl or an engagement hook30, which is in particular arranged on the first part28and an engagement element31corresponding to and/or configured to engage with the engagement hook30, preferably wherein the engagement element31is arranged on the second part29, in particular the fitting element29B.

The pawl or engagement hook30is preferably formed by a flexible arm which is in particular arranged and/or cut out from a cylindrical and/or peripheral wall of the first part28. The engagement element31is preferably formed by a radially protruding element of the second part29or fitting element29B, which is in particular arranged on an axial end of the second part29or fitting element29B.

Particularly preferably, the latching mechanism or stop has or is formed by two engagement hooks30and two engagement elements31which are each arranged on radially opposing sides of the first part28or second part29.

The latching mechanism or stop can be configured to reversibly hold the second part29or to irreversibly or inseparably connect the second part29to the first part28, so that the second part29cannot be removed or detached from the first part28(without destroying the protecting element3D, i.e. the first and/or second part28,29).

The sound generator4A is preferably configured to generate the sound event5A purely mechanically. In particular, the sound generator4A and/or protecting element3D comprises first and second sound generating elements32A,32B which are configured to (reproducibly) generate the sound event5A.

In particular, the sound generator4A is a ratchet and/or the sound event5A is generated by the sound generating elements32A,32B by moving the sound generating elements32A,32B relative to each other. Preferably, the first sound generating element32A comprises a rib surface structure or corrugated surface structure. The corresponding, second sound generating element32B preferably has or is formed by a projection. By moving the projection over the rib structure or corrugated structure, a ratchet sound is generated.

Preferably, the first part28has or forms the first sound generating element32A and the second part29has or forms the second sound generating element32B. The first sound generating element32A is preferably arranged on an inner wall of the first part28and the second sound generating element32B is preferably arranged on an outer wall of the second part29, in particular the sleeve element29A.

The first sound generating element32A is preferably attachable to the first part28, detachable from the first part28and/or exchangeable. Preferably, the first sound generating element32A is reversibly held or holdable on the first part28, for example by a latching mechanism or the like. In this way, different protecting elements3D and/or dispensing devices3can be provided with different sound generating elements32A or different sound generators4A, so that the sound generator4A can be adapted to the substance2of the dispensing device3and so that the sound event5A is specific for the substance2.

Preferably, the sound generator4A has or is formed by two identical pairs of corresponding sound generating elements32A,32B.

The protecting element3D and/or sound generator4A is preferably configured to generate the sound event5A, preferably only and/or exclusively, after movement of the protecting element3D from the initial position into the activation position and/or upon return of the protecting element3D from the activation position to the initial position.

It is noted, that expressions as “return from the activation position to the initial position” or “movement from the activation position to the initial position” or the like do not necessarily mean that the protecting element3D is actually again in the initial position at the end of the return or movement, respectively. In other words, the initial position does not need to be reached again but it is sufficient that the return or movement is essentially towards or in the direction of the initial position, in particular at least essentially opposite the movement from the initial position to the activation position, even without the protecting element3D finally ending up in the initial position. Thus, movements starting from the activation positions which do not reach or end up in the initial position are preferably also included by expressions as “return from the activation position to the initial position” or “movement from the activation position to the initial position” or the like.

In the illustrative example, reaching the initial position at the end of the return from the activation position requires or includes a rotation back to the initial position, as explained in more detail below. In particular, this rotation, which preferably occurs after generation of the sound event5A, can be omitted.

The protecting element3D is depicted in the initial position inFIGS.11A and12Aand in the activation position inFIGS.11B and12B.

The protecting element3D or the parts28,29is/are preferably movable or moved from the initial position to the activation position by, in particular axially, moving apart the first part28and the second part29. Moving apart the first and second part28,29preferably occurs automatically in a process of removing the protecting element3D from the main body3H, as in particular depicted inFIGS.8A and8B.

A “process of removing” the protecting element3D is in particular a process by which or at the end of which the protecting element3D is removed from the main body3H. A process of removing the protecting element3D preferably includes several positions of the protecting element3D and/or states of the dispensing device3. The actual removing of the protecting element3D from the main body3H preferably occurs only at the end and/or as a final step of the process, as will become clearer hereinafter.

The dispensing device3is preferably configured to move the protecting element3D into the activation position upon a process of removing the protecting element3D and/or the first part28from the main body3H.

In particular, the dispensing device3or main body3H, in particular a preferably at least essentially cylindrical needle protection34arranged within the main body3H and/or (radially) surrounding the injection needle3B, is configured to hold the second part29in a fixed position relative to the main body3H upon a process of removing the protecting element3D and/or the first part28from the main body3H, while the protecting element3D is moved from the initial position to the activation position by moving the first part28relative to the second part29and/or the main body3H, in particular moving the first part28away from the main body3H.

The process of removing the protecting element3D from the main body3H thus preferably involves a step in which the first part28is already moved away from the main body3H while the second part29has not yet moved relative to the main body3H. This is in particular shown inFIG.8B.

The dispensing device3preferably has a detent33for engaging with the protecting element3D, in particular the second part29, particularly preferably the fitting element29B. The detent33is preferably configured for holding, at least temporarily, the second part29in a fixed position relative to the main body3H upon the process of removing the protecting element3D from the main body3H.

The detent33is preferably arranged on a flexible arm which is in particular arranged on an inner wall of the main body3H, in particular the needle protection34.

The second part29, in particular the fitting element29B, preferably has an undercut35for engagement with the detent33. The undercut35is preferably configured as a notch which in particular circumferentially runs around the second part29or fitting element29B

The detent33and/or flexible arm is preferably configured to release the second part29from the detent33when the protecting element3D and/or first part28has reached the activation position and the protecting element3D and/or first part28is (subsequently) further moved away from the main body3H. The force by which the second part29is held by the stop or engagement hook30is preferably larger than the force by which the second part29is held with the detent33, so that the engagement between the detent33and the second part29is released when the protecting element3D is already in the activation position and then further moved away from the main body3H.

Preferably, the drive element27is configured to be activated, in particular tensioned, upon movement of the protecting element3D or the parts28,29from the initial position to the activation position.

The protecting element3D is preferably configured to return into the initial position when or after the protecting element3D has been moved from the initial position into the activation position. However, a return into the initial position is not necessary, as explained above. Preferably, the sound event5A is generated after the activation position has been reached and/or during moving or return of the protecting element3D or parts28,29, especially to the initial position.

The movement from the activation position to the initial position preferably takes place automatically and/or immediately after the activation position has been reached. In particular, the drive element27is configured to drive the return of the protecting element3D from the activation position to the initial position. As explained before, the drive element27is preferably activated or tensioned by moving from the initial position into the activation position, so that the return from the activation position to the initial position is caused or driven by the elastic restoring force of the tensioned spring or drive element27. In other words, the movement from the activation position to the initial position preferably takes place purely mechanically.

The protecting element3D is preferably configured so that no sound or sound event5A is generated upon movement of the protecting element3D from the initial position to the activation position and/or that the sound event5A is (only) generated after movement from the initial position the activation position, in particular upon movement of the protecting element3D from the activation position to the initial position. In other words, the protecting element3D and/or sound generator4A is preferably configured so that the sound generating elements32A,32B do not interact or contact each other upon movement from the initial position into the activation position and/or that the sound generating elements32A,32B (only) interact or contact each other after movement from the initial position the activation position, in particular upon movement from the activation position to the initial position so that the sound event5A is generated.

The non-interaction of the sound generating elements32A,32B upon movement from the initial position towards the activation position is also conducive to an easy operation of the dispensing device, in particular for a smooth removal of the protecting element3D from the main body3H. Namely, upon removal of the protecting element3D from the main body3H, a considerable force is already needed for working against the spring tension of the drive element27, which force would be further increased through interaction of the sound generating elements32A,32B upon movement from the initial position towards the activation position. Thus, the non-interaction of the sound generating elements32A,32B is advantageous for an easy operation, in particular for keeping the force needed for removal of the protecting element3D at an acceptable level.

The protecting element3D preferably has a guiding which is configured so that upon movement of the protecting element3D from the initial position into the activation position, the sound generating elements32A,32B do not interact, and so that upon movement of the protecting element3D from the activation position to the initial position, the sound generating elements32A,32B interact and generate the sound event5A.

The guiding is preferably configured to rotate the second part29when and/or (immediately) after the activation position is reached. Thus, upon movement from the initial position to the activation position, the second part29is preferably arranged in a different rotational position relative to the first part28than upon movement from the activation position back to the initial position. By the rotation, it is in particular achieved that the sound generating elements32A,32B do not interact or contact each other upon movement from the initial position to the activation position and/or that the sound generating elements32A,32B (only) interact or contact each other and thus generate the sound event5A upon movement from the activation position to the initial position.

The guiding is preferably configured to ensure that the sound event5A is only generated after the activation position has been reached.

The guiding preferably has or is formed by several guiding elements, in particular a first guiding element36A, a second guiding element36B, a third guiding element36C and/or a fourth guiding element36D.

The first, second, third and/or fourth guiding element(s)36A-36D is/are preferably (each) configured as a jut or protrusion.

Preferably, the protecting element3D comprises two identical guidings which are arranged on radially opposing sides of the protecting element3D.

The first part28preferably has the first guiding element36A. The first guiding element36A is preferably arranged on and/or projects from an inner, in particular cylindrical, wall of the first part28, as in particular shown inFIG.10. Preferably, the first guiding element36A extends axially and/or is elongated.

The first guiding element36A is preferably at least essentially in the form of quadrilateral, wherein two sides of the guiding element36A run parallel to the axis A and the other two sides are slanted with respect to the axis A. Particularly preferably, the first guiding element36A is at least essentially in the form a parallelogram.

The second part29preferably has the second, third, fourth and/or fifth guiding element36B to36I. The second, third and/or fourth guiding element(s)36B-36D is/are preferably arranged on and/or project(s) from an outer, in particular cylindrical, wall of the second part29, as in particularly shown inFIG.10.

The second guiding element36B is preferably configured to contact the first guiding element36A and/or to slide along the first guiding element36A.

The second guiding element36B is preferably at least essentially in the form of a quadrilateral. The second guiding element36B preferably has two slides running parallel to the axis A and two slides which are slanted with respect to the axis L. Particularly preferably, the first guiding element36is in the form of a parallelogram or rhombus.

The second guiding element36B is preferably configured to run around the first guiding element36A upon moving the protecting element3D from the initial position to the activation position and back to the initial position.

The second guiding element36B is preferably arranged at a free end of a flexible arm37of the second part29. The arm37is preferably configured to be at least essentially circumferentially deflected upon movement of the protection element3D from the initial position into the activation position and/or to flip back before and/or upon movement of the protecting element3D from the activation position to the initial position.

The arm37is preferably formed in one piece with the second part29, in particular the sleeve element29A. In particular, the arm37is formed by axial cutouts of the cylindrical wall of the sleeve element29A.

The fourth guiding element36D is preferably configured as axially running rail. The fourth guiding element36D is preferably configured to limit a rotation of the second part29relative to the first part28, in particular by contacting the engagement hook30.

The functionality of the guiding is explained in the following in particular with reference toFIGS.11to13.

InFIGS.11A and12A, the protecting element3D is shown in the initial position. InFIGS.11B and12B, the protecting element3D is shown in the activation position.FIG.13shows a bottom view of the protecting element3D in the initial position.

In the initial position, the sound generating elements32A,32B are offset from each other in the circumferential direction, as in particular visible inFIG.13. Further, the engagement hook30contacts the fourth guiding element36D, preferably so that a rotation of the second part29in clockwise direction inFIG.13is prevented.

As can be seen inFIGS.12A and13A, the first and second guiding elements36A,36B overlap in axial direction, so that the slanted sides of the first and second guiding elements36A,36B come into contact when the protecting element3D is moved from the initial position towards the activation position.

As a rotation of the second part29in clockwise direction inFIG.13is prevented by the engagement hook30and the guiding elements36A36B overlap in axial direction, the flexible arm37with the second guiding element36B is forced to bend or deflect, in particular in circumferential direction, upon further movement of the protecting element3D towards the activation position when the guiding elements36A,36B come into contact.

The deflection of the arm37preferably builds up a restoring force in the arm37and/or presses the second guide element36B, in particular an axial side thereof, against the first guide element36A, in particular an axial side thereof.

Upon further moving the first and second parts28,29apart, the activation position is reached. The activation position is in particular the position in which the second guide element36B has reached the axial end of the first guide element36A, as shown in particular inFIG.12B. In particular, the activation position is a reversal point of the protecting element3D and/or the position in which the second part29is caused to rotate and/or to move or slide back to the initial position in a different rotational position and/or along a different path and/or on a different axial side of the first guide element36A than on the way from the initial position to the activation position.

In the activation position, the engagement hook30preferably engages the engaging element31.

When or immediately after the activation position is reached, the restoring force of the bent or deflected arm37preferably causes the arm37to move or flip back into its rest position, i.e. the position in which the arm37is in the initial position of the protecting element3D. By this, the second guide element36B is moved relative to the first guide element36A, in particular so that the second guide element36B passes the corner at the end of the first guide element36A and/or slanted edges of the guide elements36A,36B contact each other.

The spring or drive element27is preferably tensioned upon movement of the protection element3D from the initial position to the activation position, as shown inFIGS.11A and11B.

Thus, the drive element27preferably causes or drives a movement of the second part29back towards the initial position when or immediately after the activation position has been reached or passed.

Upon return from the activation position to the initial position, the second guide element36B preferably slides along the first guide element36A, in particular on the axial side opposite to the axial side along which the second guide element36B has slid upon movement from the initial position to activation position.

The movement of the second guide element36B along the first guide element36A upon movement from the activation position to the initial position preferably involves a rotation of the second part29relative to the first part28, in particular in the anti-clockwise direction inFIG.13. This is in particular effected by the slanted edge of the first guide element36A and the circumferential movement of the second guide element36B which is caused thereby. By this rotation, the rotational position of the first and second part28,29relative to each other is changed in such a way that the sound generating elements32A,32B of the sound generator4A interact and generate the sound event5A upon movement from the activation position the initial position.

The third guide element36C is preferably slanted with respect to the axis A and/or the first guide element36A, so that towards the end of the movement from the activation position to the initial position, a rotation of the second part29back into the initial position is effected by the interaction between the first guide element36A and the third guide element36C.

To summarize, removing the protecting element3D from the main body3H and/or generating the sound event5A preferably goes as follows:

In the beginning, the protecting element3D, in particular in the form of a cap, is attached to the main body3H. In this position, the protecting element3D is an initial position and the detent33engages the second part29.

For removing the protecting element3D from the main body3H, a user (not shown) pulls the first part28away from the main body3H, in particular in axial direction. By this, the first and second part28,29are moved relative to each other, while the second part29is held by the detent33and, thus, it does not move relative to the main body3H. By the relative movement of the first and second part28,29, the drive element27is preferably tensioned.

Upon this movement, the second guide element36B preferably slides along the first guide element36A, in particular wherein the flexible arm37deflects, in particular circumferentially or upwards inFIGS.11and12.

The user preferably moves the first part28away from the main body3H until the activation position is reached.

When the activation position is reached or passed, the arm37preferably flips back so that the second guide element36B is moved around the first guide element36A and/or on the opposite side of the guide element36A, inFIG.12the lower side of the guide element36A.

Further, the second part29is released from the detent33when or shortly after the activation position is reached. This leads to a quick movement of the protecting element3D towards the initial position, in particular driven by the drive element27.

Further, the second part29has been rotated in the anti-clockwise direction inFIG.13upon reaching or passing the activation position, in particular by the arm37flipping back. By this rotation, the second part29is brought into a rotation position relative to the first part28that makes possible an interaction of the sound generating elements32A,32B.

By the quick movement from the activation position to the initial position, the sound event5A is generated by the sound generating elements32A,32B that slide along each other.

Towards the end of the movement back to the initial position, the third guide element36C preferably contacts the first guide element36A and thereby causes a rotation (in particular clockwise inFIG.13) of the second part29back into the initial position. This is, however, not mandatory.

The protecting element3D, in particular the guiding, can also have a securing device for preventing a contact and/or interaction between the sound generating elements32A,32B upon movement from the initial position to the activation position, for example a respective guiding element, a stop, a latching element or the like. In particular, this securing device is configured to prevent a rotation (in particular in anti-clockwise direction inFIG.13) of the second part29relative to the first part28upon movement from the initial position to the activation position. The securing element is preferably provided to ensure that the second guide element36B slides along the correct side of the first guide element36A, as described above, upon movement from the initial position to the activation position. In this way, incorrect operation by a user can be prevented. In particular, it can be prevented that the parts28,29are rotated relative to each other when the protecting element3D is removed from the main body3H, which could potentially happen when the protecting element3D is slightly twisted at the beginning of the movement from the initial position to the activation position.

The securing device is preferably arranged on the first and/or second part28,29. Preferably, the securing device is configured to contact, at least in the initial position and/or upon movement from the initial position to the activation position, one of the guiding elements36A-36D, in particular the first guiding element36A or the fourth guiding element36D.

The protecting element3D preferably has a damping device for controlling, damping and/or reducing the speed and/or acceleration of the movement of the protecting element3D from the activation position to the initial position.

The damping device can for example be realized by a reinforcement of parts of the protecting element3D, in particular the sound generating elements32A,32B, so that the pressure by which the sound generating elements32A,32B, are pressed against each other as increased.

Other possible solutions are a cylinder-piston arrangement realizing a damping and/or a regulation of air escaping from the protecting element3D in order to realize a pneumatic break which damps the movement from the activation position to the initial position.

As an alternative or in addition, it is also conceivable to change the exact design of this sound generating elements and/or the spring forces, for example of the drive element27and/or the flexible arm37, and/or to provide an additional spring or tensioning device.

A further embodiment of the protecting element3D and/or sound generator4A is shown inFIG.14.

Whereas the sound generator4A of the protecting element3D according toFIGS.8to13preferably works purely mechanically, the sound generator4A of the embodiment shown inFIG.14preferably works electronically.

The explanations with regard to the protecting element3according to the embodiment shown inFIGS.8to13preferably also apply to the protecting element according to the embodiment shown inFIG.14, unless indicated otherwise or obvious from the context.

In particular, the protecting element3D forms a lid and/or cover of the dispensing device3, in particular in the form of a cap. Further, the protecting element3D preferably has or forms the sound generator4A.

The protecting element3D preferably has a housing38, in particular in the form of a cap, preferably wherein in the sound generator4A is arranged inside the housing38or integrated into the housing38. The housing38can have or be formed by several parts.

The protecting element3D and/or sound generator4A preferably has a switch39, an electronic module or electronics40, a battery41, and/or an electroacoustic transducer42.

The sound generator4A and/or electroacoustic transducer42is preferably configured to generate the sound event5A. The battery41is preferably configured to supply the electronics40and/or transducer42with (electrical) energy.

The switch39is preferably configured to be actuated upon removing the protecting element3D from the main body3H, in particular the needle protection34. Preferably, the switch39is a biased switch.

Preferably, the protecting element3D has a, preferably spring-loaded, pin43arranged between the main body3H or needle protection34and the switch39. When the protecting element3D is attached to the main body3H of the dispensing device3, the pin43preferably contacts the switch39and/or the needle protection34or another part of the main body3H. However, other solutions are also possible here. In particular, the pin43can be omitted.

It is in particular possible that the switch39or an actuation element thereof is configured to be pressed down by the main body3H and/or pin43when the protecting element3D is attached to the main body3H and/or that the switch39is actuated by moving apart the main body3H and protecting element3D.

The switch39is preferably functionally coupled with the electronic module or electronics40. The electronics40are preferably configured to control the electroacoustic transducer42such that the sound event5A is generated upon actuation of the switch39.

The electronics40preferably have or form a control and/or processor for controlling the electroacoustic transducer42.

The switch39, electronics40, battery41and/or electroacoustic transducer42are preferably arranged and/or mounted on and/or coupled via a printed circuit board44. The electroacoustic transducer42is preferably arranged on a side of the printed circuit board44which is opposite the main body3H when the protecting element3D is attached to the main body3H.

The electroacoustic transducer42preferably has or is formed by a piezo transducer or piezoelectric transducer.

The transducer42is preferably configured to generate a sound event5A having a frequency of more than 2 kHz and/or less than 40 kHz, in particular a frequency of about 4 kHz and/or harmonics or whole multiples thereof, for example 8 kHz, 12 kHz, 16 kHz and/or 20 KHz. It is particularly preferred that the sound event5A has only frequencies in the ultrasonic range and/or frequencies of more than 16 kHz. Particularly preferably, the sound event has a frequency of about 20 kHz. This has proven advantageous because on the one side, these frequencies cannot be detected by humans and thus do not constitute acoustic harassments of humans. On the other hand, it is preferably easier to detect an ultrasonic sound event5A in the acoustic signal6because there are less background noises in the ultrasonic range.

The electronics40can also be configured for generating multiple and/or different sound events5A with the transducer42. Different sound events can differ for example in length, frequency, speed, loudness, spectral range, sequence of tones and/or frequencies or the like. In this way, the protecting element3D and/or sound generator4A and/or sound event5A can be adapted to or made specific for different dispensing devices3, in particular the substance2which is to be dispensed with the dispensing device3.

The various aspects of this invention that are explained in the general part, in the embodiments, and in the claims can in each case be implemented individually as well as in combination and can be advantageous, even when not every possible advantageous combination is explained separately.

Additional aspects of this invention are:

1. System for monitoring an actual or simulated preparation, performing, and/or post-processing of a dispensing—referred to below as dispensing process—of an administrable, preferably pharmaceutical, substance, having:a dispensing device for dispensing the substance, wherein the dispensing device has at least one sound generator, which is designed to generate in the dispensing process at least one sound event in an acoustic signal, in an acoustic signal, the sound event being specific to a property or change in state of the dispensing device, anda detection device for checking the acoustic signal for the at least one sound event in order to make possible a detection of the property or change in state of the dispensing device.

2. System according to Aspect1, characterized in that the sound generator(s) is/are designed so that the sound event or the sound events in the dispensing process is or are generated necessarily and in a reproducible manner.

3. System according to one of the preceding aspects, characterized in that the sound generator is a structure that is not required for the dispensing process and/or is specifically designed for the generation of the sound event.

4. System according to one of the preceding aspects, characterized in that the sound generator is or has a ratchet, flapper, vibrating bell, rattle, whistle or structure for generating a reproducible plopping, clacking, clicking, screeching, clattering, grinding, rattling, hissing, squeaking, buzzing, whistling or is or has oscillations caused in particular by a stick-slip effect.

5. System according to one of the preceding aspects, characterized in that a protecting element of the dispensing device has or forms the sound generator, wherein the protecting element keeps the substance from being dispensed in an initial state and with generation of the sound event can be transferred into an enabling state for enabling the dispensing of the substance.

6. System according to one of the preceding aspects, characterized in that the sound generator is set up for generating in the acoustic signal a sequence of more than two sound events that are separated from one another and that follow one another in time in the course of the dispensing process.

7. System according to one of the preceding aspects, characterized in that the dispensing device has at least two different sound generators, which are designed so that in different phases of the dispensing process, which phases follow one another in time, a first sound event and a second sound event-preferably different from the first—are generated.

8. System according to one of the preceding aspects, characterized in that the detection device for detecting the property or change in state of the dispensing device by checking the acoustic signal is designed for the at least one sound event.

9. System according to Aspect8, characterized in that the detection device is designed to compare the acoustic signal to one or more sound event pattern(s) and in this way to detect the at least one sound event in the acoustic signal, wherein sound event patterns are previously known information that corresponds to the sound events, that is similar to the sound events, or is derived therefrom.

10. System according to Aspect9, characterized in that the detection device has a correlation module for generating a correlation of the acoustic signal with one or more sound event patterns.

11. System according to one of Aspects8to10, characterized in that the detection device is designed to determine the property or change in state of the dispensing device when at least one sound event is detected in the acoustic signal based on the detected sound event.

12. System according to one of the preceding aspects, characterized in that the detection device is designed to distinguish between different sound events of the same, similar, or different dispensing devices.

13. System according to one of the preceding aspects, characterized in that the detection device has an output device for outputting a result of the checking of the acoustic signal, preferably wherein the detection device is designed for signaling with the output device the detection or for outputting the property or change in state of the dispensing device or a characteristic value of said change.

14. System according to one of the preceding aspects, characterized in that the detection device has or forms an analysis device for examining multiple sound events, detected in the check, for a predetermined sequence or order.

15. System according to one of the preceding aspects, characterized in that the detection device is designed to output a result, when it detects that the acoustic signal has a sequence of sound events that follow one another in time and that correspond to the course of steps of the dispensing process, or to output an error, when it detects that the acoustic signal does not have any sequence of sound events that follow one another in time and that correspond to the course of steps of the dispensing process.

16. System according to one of the preceding aspects, characterized in that the system has multiple dispensing devices, which are distinguished relative to the substance and the sound generator and are otherwise designed identically or similarly, so that the identical sound event or acoustic signal can be generated by the identical or similar dispensing devices with the same properties relative to the substance, and different sound events or acoustic signals can be generated by the identical or similar dispensing devices with different properties relative to the substance.

17. System according to one of the preceding aspects, characterized in that a part of the dispensing device—preferably a packaging, a primary packaging, a secondary packaging, a cap, a shell, a protective system, a mechanism, a stop, a pressure generator, an unlocking system, a triggering system, a flow path, and/or a dispensing device for ejecting the substance—has or forms the sound generator.

18. Detection device for checking an acoustic signal for a sound event that is generated by a sound generator of a dispensing device of a system according to one of the preceding aspects and is specific to a property or change in state of the dispensing device, sound event for detection of a dispensing process, carried out with the dispensing device, of the administrable, preferably pharmaceutical, substance.

19. Method for monitoring an actual or simulated preparation, performing, and/or post-processing of a dispensing-referred to as dispensing process below—of an administrable, preferably pharmaceutical, substance, wherein an acoustic signal is examined for a sound event that is specific to a property or change in state of the dispensing device, which sound event can be generated in the case of the dispensing process.

20. Use of a mobile terminal device, preferably a Smartphone, a tablet computer, and/or wearable devices, in particular a Smartwatch or a fitness arm band, for checking an acoustic signal for at least one sound event that is specific to a property or change in state of a dispensing device, which sound event can be generated in the case of an actual or simulated preparation, performing, and/or post-processing of a dispensing-referred to as dispensing process below—of an administrable, preferably pharmaceutical, substance, with a sound generator of the dispensing system, in order to make possible a detection of a property or change in state of the dispensing device.

21. Computer program product that has program code means, which, when they are implemented, perform a method according to Aspect19, in particular a computer-readable—preferably non-volatile-storage medium that has instructions, which, when they are implemented on a processor, implement the method according to Aspect19.

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