Method for evaluating a pumping operation and liquid dispenser and evaluation unit using the method

Abstract

A pump dispenser is known, in particular for dispensing medicinal liquids. Depending on the application area, it may be very important to reliably detect the normality of the operation in order to provide feedback to the user or a third party about this. For this purpose, a method for evaluating a pumping operation is proposed, which is applied to a pump dispenser (10), which has two subunits (12, 14) that can be moved manually relative to each other and has a pump (20), which has a pump chamber that can be reduced from a first, non-operated end position to an operated second end position by the movement of the subunits (12, 14). In order to reliably detect the operated second end position, the force with which the subunits (12, 14) are manually moved toward each other is detected during the movement of the subunits (12, 14) relative to each other. The time curve of the detected force is evaluated as follows: a force increase that is unique to the reaching of the operated second end position is detected. Depending on whether a force increase unique to reaching the actuated second end position is detected, a signal unique to the result is output haptically, acoustically and / or visually via an output device and / or is transmitted via a wireless interface to an external display device.

Description

Technical Field

[0001] The present invention relates to the field of pump dispensers for discharging liquids, in particular the field of pump dispensers filled with medicinal liquids in the medical field. For such pump dispensers, it is provided that by manually actuating the pump of the pump dispenser, the liquid can be discharged from a liquid reservoir through an outlet, for example in the form of an atomized jet, a non-atomized jet or in the form of individual droplets. Background Art

[0002] Pump dispensers are used by the user to administer a medicinal liquid, for example, via the nasal or oral route and in particular also sublingually, i.e., under the tongue. In particular with unpleasant or smelly medicinal liquids, there is the risk that the user does not carry out a complete discharge, but instead ends the actuation too early. As a result, an insufficient amount of medicinal liquid is discharged. Summary of the invention

[0003] The object of the present invention is to provide a method and a device for carrying out the method which reduce or prevent the risk of incomplete discharge.

[0004] According to the invention, a method for evaluating the pumping operation on a pump dispenser for discharging liquids, in particular medicinal liquids, is proposed, which method is applied when using a pump dispenser, which has two subunits that can be moved manually relative to each other and which has a pump, which has a pump chamber that can be reduced by the movement of the subunits from a first, non-actuated end position to a second, actuated end position. Preferably, the medicinal liquid reaches the pump from a liquid reservoir preferably with a size between 20 ml and 1000 ml and from there further to the discharge opening. The liquid stored in the liquid reservoir can be in particular a drug, in particular a drug with a pharmaceutically active substance, but in particular an allergen extract.

[0005] The two subunits mentioned can in particular be a base with a liquid reservoir on the one hand and an actuation unit with an actuation button and a discharge opening on the other hand, the two subunits being pressed against each other during the discharge process, wherein the pump is actuated by compression of the subunits. Many pump dispensers are provided for use with one hand by gripping their liquid reservoir with one hand and pressing the actuation button with one finger of the hand, usually the index finger.

[0006] The outlet opening can be arranged in particular on the side of the actuation unit so that the outlet direction encloses an angle of >0°, preferably between 60° and 120°, with the actuation direction of the actuation unit. In order to better guide the outlet opening to the application site, a design can be advantageous in which a freely protruding applicator tube is provided, at the distal end of which the outlet opening is arranged.

[0007] The actuation unit can also be provided in particular for a sublingual applicator. In this case, a curved applicator tube tip is preferably provided on the end of the applicator tube protruding laterally from the actuation unit.

[0008] The pump can in particular be a piston pump which is designed as a piston pump having a pump cylinder and a pump piston which can be moved in the pump cylinder. The pump cylinder and the pump piston together define a pump chamber, wherein preferably valves which open and close depending on the pressure are provided on the input side and the output side of the pump chamber. If the subunits are moved towards each other, the inlet valve closes, the outlet valve opens, and the movement of the pump piston in the pump cylinder associated with the movement of the subunits discharges the liquid, which is conveyed to the discharge opening via the outlet valve and discharged there. In the return stroke, the outlet valve closes, the inlet valve opens, and the liquid is sucked from the liquid reservoir into the pump chamber.

[0009] However, in addition to piston pumps, other pumps can also be used, which can be acted upon by force for pumping in one direction up to an end position and which return to their starting position during the return stroke, such as bellows pumps.

[0010] In order to detect the actuated second end position, according to the invention, during the movement of the subunits relative to one another, the force with which the subunits are manually moved toward one another is detected by means of a force sensor. This force is applied by the user, in particular between his hand holding one of the subunits and the finger, in particular the index finger, pressing the other subunit against it.

[0011] A force sensor in the sense of the present invention is a sensor which reflects the applied force in the form of an analog force value, i.e. a numerical value which is higher the higher the force applied by the user. In contrast, a simple switch is not a force sensor in the sense of the present invention. However, such sensors are also force sensors in the sense of the present invention which reflect measured values ​​which can be directly attributed to the applied force, thus pressure sensors or displacement sensors coupled with a restoring spring force are also such sensors.

[0012] The force sensor can preferably be in particular an FSR sensor (Force Sensitive Resistor) or be designed as a piezoelectric sensor. These sensors provide analog sensor values ​​in the form of a variable resistance or a voltage.

[0013] Preferably, a restoring spring force is assigned to the force sensor, which presses the surface of the evaluation unit acting on the force sensor back into the initial position when the actuating force is removed. Particularly preferably, the force sensor is decoupled from one of the surfaces acting on it in the initial position, for example by a narrow gap, under the influence of the spring force, so that the force sensor reliably supplies a zero signal in this initial position.

[0014] According to the invention, the force sensor value reported by the force sensor is evaluated in such a way that a force increase that is unique to the reaching of the actuated second end position is detected. How this can be achieved is explained below. As a result of the evaluation, it is detected whether a unique force increase should be recorded, which is caused by the pump having reached its end position, in particular by the pump piston having entered its lowest end position in the pump cylinder. It has been shown that the result of the user unintentionally reaching this end position is that actuation is performed with a stronger and recognizable actuating force.

[0015] Depending on whether a force increase that is unique to the reaching of the actuated second end position is detected, a signal unique to the result is preferably subsequently outputted by the output device in a tactile, acoustic and / or visual manner. The output is preferably carried out on the pump dispenser itself or on an evaluation unit fastened thereto. The tactile signal is, for example, a vibration signal. The visual signal can be generated in particular by a display or an LED, wherein different signals with different colors or flashing sequences can be distinguished, if necessary. The acoustic signal can be composed in particular of one or more different signal tones.

[0016] In the simplest case, if a characteristic change curve of the force for the reaching of the second manipulated stroke end position is identified, a signal is output as positive feedback. This can be, for example, a green flashing or a vibration of an LED. As an alternative or in addition, it can be provided that if a characteristic change curve of the force for the second manipulated stroke end position is not identified after the start of discharge is detected, a signal is output as negative feedback, wherein the triggering of this signal can be the end of a predefined time interval from the start of manipulation. As an alternative, a drop in the force sensor value can be identified as a cancellation of the manipulation force. The LED can display a negative result, for example, by flashing red light of the LED.

[0017] Furthermore, a signal can also be output during the actuation in order to signal the user that the start of the actuation has been detected, in particular when the force sensor value exceeds a predefined minimum value. As soon as a force increase that is unique to the reaching of the actuated second end position is detected and / or as soon as the interruption of the actuation is detected, such a signal is terminated and a positive or negative feedback is output accordingly as a signal.

[0018] The signaling notification, in particular direct signaling notification on the pump dispenser or on an evaluation unit attached thereto, is considered as a preferred use of the evaluation result. However, it can be provided instead or preferably in addition that the evaluation result is sent to an external display device via a wireless interface. The wireless interface can be one of the common interfaces such as WLAN, Bluetooth, NFC, 3G, 4G or 5G, wherein Bluetooth 4.x or 5.x is preferred. The external display device is preferably a mobile phone or a smart watch.

[0019] The external display device can reflect the evaluation results according to the display conditions described above. In addition, the results can be stored and / or forwarded to an external server for evaluation by a third party. The results can also be used by a training program to show the user the correct use of the pump dispenser.

[0020] In the simplest case, the evaluation of reaching the actuated second end position can be performed in that the processor evaluates the respective current force value without taking into account previously detected force values. Thus, for example, the exceeding of a previously defined threshold value can be interpreted as an indicator of a force increase when reaching the second end position. However, this procedure is problematic because it is difficult to find an absolute threshold value that occurs equally during rapid and slow actuation.

[0021] It is therefore advantageous if the data detected by the force sensor are stored in a memory in such a way that a time profile of the detected force is generated thereby. For example, the force sensor can be queried at a frequency of 500 Hz from the start of the detection of the actuation and the force values ​​are stored in a memory. This generates a time profile of the force values.

[0022] Therefore, preferably an evaluation is performed taking into account this temporal profile, which is used to determine whether a force increase occurs that is unique to reaching the actuated second end position. This evaluation allows for greater reliability in distinguishing between reaching or not reaching the second end position.

[0023] The evaluation of the detected force-time curve is preferably performed in such a way that the slope of the corresponding image is taken into account for detecting the second terminal position. In particular, the slope of the force with respect to time can be evaluated. Here, the rise of the slope, i.e. the rise of the first derivative of the force with respect to time, can be interpreted as an indicator for reaching the second terminal position. In particular, a quotient consisting of the slope, i.e. the force rise within a defined duration and the force value can be formed. This quotient indicates the slope relative to the previously achieved force level. This quotient can be compared with a limit value, and the exceeding of this limit value can be interpreted as reaching the second terminal position. The corresponding limit value can be found out by experiment. In particular, the limit value itself is not constant, but changes with time, i.e. decreases. Therefore, in the simplest case, it can decrease linearly. The limit value can also be reset according to the arrival of a predefined force value.

[0024] The force is preferably evaluated over time by means of a smoothed image of the force over time. High frequencies are thus eliminated in the manner of a low-pass filter. Such high frequencies can arise in particular due to friction on the surfaces of the pump dispenser that slide along one another.

[0025] The force can also be evaluated in terms of time in such a way that the manipulation is classified into one of at least two categories by means of the force detected by the force sensor, the at least two categories being assigned to manipulations of different strengths and / or different speeds. This classification can be carried out in particular within a short first time period of the manipulation, for example within the first 0.5 seconds or less. The classification allows the identification of whether the manipulated second end position has been reached and, if necessary, when this has occurred, in different ways for at least two categories. These different ways can be reflected in different limit values ​​for the analysis. However, they can also be different in principle. Thus, for example, a relatively high manipulation force very early may lead to an evaluation in which the arrival of the second end position is assumed to be given, since the user can no longer prevent the arrival of the end position in practice anyway. Then only the corresponding moment is determined, wherein different rules can be taken into account to determine the moment than in the case of slow or normal manipulation.

[0026] It is considered disadvantageous that the evaluation unit must be switched on before being operated by the user in order to evaluate the operating force. Preferably, the corresponding evaluation unit is always active instead. In order to achieve a low current demand despite this, it is considered advantageous to perform the evaluation using a processor, which has a normal operating mode and a static mode that saves power relative to this. Until the pump dispenser is operated, the processor is in static mode. In this static mode, the force value of the force sensor is monitored by the processor to see if it exceeds a predetermined limit value, which is particularly predetermined by a voltage level or a resistance level. At the same time, components of the processor that are not needed for this purpose can be turned off. If the limit value is exceeded, the processor is switched to an operating mode.

[0027] In this operating mode then reached, the values ​​detected by the force sensor are digitized by means of an analog-to-digital converter and stored in a memory and then preferably repeatedly analyzed by the processor to see whether a force increase unique to the reaching of the actuated second end position can be detected. This operating mode has a significantly higher energy requirement than the stationary mode. However, since the stay in the operating mode is only brief, this is not very important. As soon as the discharge process is finished, either after reaching the actuated second end position or after not reaching the second end position and after the associated signaling, the processor can switch back to the stationary mode.

[0028] In addition to the force sensor described, other sensors, thus in particular position sensors or acceleration sensors, can be provided in the evaluation unit for carrying out the method. In the method described, the sensor values ​​of the sensors can be used in addition, for example, to detect an upcoming use of the pump dispenser and / or to monitor whether a prescribed vibration of the pump dispenser is occurring in a regular manner. The sensor values ​​of these sensors or values ​​derived therefrom can be used to influence the emitted signal of the output device and / or be forwarded wirelessly to a display device.

[0029] In addition to the described method, the invention also relates to a system in which the described method is used.

[0030] Therefore, the present invention also relates in particular to a pump dispenser for discharging liquid, in particular for discharging medicinal liquid. This pump dispenser has a liquid reservoir for receiving liquid before discharging and at least one discharge port, through which the liquid can be discharged into the environment. In addition, the pump dispenser has an operating button and a pump with a pump chamber, wherein the operating button can be moved relative to the liquid reservoir, wherein the walls of the pump chamber can move relative to each other between a first end position that is not operated and a second end position that is operated in order to reduce the pump chamber, and wherein the first wall of the pump chamber is fixedly arranged relative to the liquid reservoir, and the second wall of the pump chamber can be moved relative to the first wall by manually operating the operating button. The wall mentioned here can be a wall formed by a pump cylinder and a pump piston of the pump in particular. It can also be related to the mutually opposite walls of a bellows pump.

[0031] The pump dispenser additionally has an evaluation unit, which is used to identify the manipulated second end position and utilize this identification by means of the described method. For this purpose, the evaluation unit has an electronic component, which is preferably powered by a battery. The electronic component also includes a force sensor in the sense explained above, which measures the force applied by the user between the manipulation button and the second wall, such as the pump piston, or between the holding surface on the liquid reservoir and the first wall, such as the pump cylinder. The evaluation unit also has a processor, which evaluates the force detected by the force sensor, so that it can identify the unique force rise for the arrival of the manipulated second end position. The evaluation unit additionally preferably has an output device, which outputs a signal unique to the result of the force evaluation as a tactile, acoustic and / or visible signal according to the force evaluation. In this case, it can particularly involve a vibration device or an LED. As a supplement to the output device or as an alternative thereof when necessary, the evaluation unit has a wireless interface, which can send a signal unique to the result of the force evaluation to an external display device according to the force evaluation, so that it can be used or forwarded in the above sense.

[0032] The described evaluation unit can be fixedly integrated into the pump dispenser, so that it cannot be separated from the components of the pump dispenser, in particular the pump, without tools. This may be expedient for devices with a replaceable or refillable liquid reservoir.

[0033] However, it is preferred that the evaluation unit, which is also included in the invention, is used for a pump dispenser for dispensing liquids, in particular for dispensing medicinal liquids, and that the evaluation unit is designed to be mounted on the pump dispenser without tools. In this case, the corresponding pump dispenser has a liquid reservoir for receiving the liquid before dispensing, at least one discharge opening and an actuation button, and a pump, wherein the liquid can be discharged into the surroundings via the discharge opening, and the actuation button can be moved relative to the liquid reservoir, and the pump can be actuated by moving the actuation button relative to the liquid reservoir between a first, non-actuated end position and a second, actuated end position.

[0034] The evaluation unit, which can be mounted on the pump dispenser without tools, is designed to detect the reaching of the actuated second end position by means of the above-described method. The evaluation unit is preferably mounted on the pump dispenser by means of a clamping or snap-in mechanism. The mounting is preferably carried out in such a way that the force sensor of the evaluation unit is arranged between an actuation surface of the evaluation unit and an actuation surface on the pump dispenser which is displaced with respect to actuation and is only indirectly actuated.

[0035] In a first preferred structural form, it is provided that the evaluation unit is constructed to be placed on a liquid reservoir and has a fixed area for being fixedly abutted against the liquid reservoir or a fixed coupling surface for this purpose and a holding surface for manually grabbing the evaluation unit. The evaluation unit also has the described force sensor, which detects the force applied by the user between the holding surface and the fixed area in this case. Therefore, in such a design, it is provided that the user no longer holds the liquid reservoir itself in the area of ​​the holding surface in order to press the two subunits of the pump dispenser toward each other, but instead holds the holding surface of the evaluation unit. If another subunit of the pump dispenser, in particular the mentioned operating unit with an operating button, is now pressed downward, this force also acts between the holding surface of the evaluation unit and the fixed area and can be detected there by means of a force sensor. The fixing region is that section of the evaluation unit which bears directly against the liquid reservoir or against a surface which is fixed in position relative to the liquid reservoir and which is able to exert a force acting in the direction of the other subunit on the subunit of the liquid reservoir. In a particularly preferred embodiment, the fixing region is not only a bearing surface for applying force to the liquid reservoir, but also a retaining device which is coupled to the subunit of the liquid reservoir in such a way that the liquid reservoir is held sufficiently fixedly on the retaining device so that it cannot be separated from the fixing region even in an inverted position.

[0036] Particularly preferably, the evaluation unit designed to be placed on the liquid reservoir has a housing with a circumferential wall into which the liquid reservoir of the pump dispenser can be inserted and whose outer side forms the retaining surface. The fastening area of ​​the evaluation unit is preferably arranged inside the circumferential wall and there contacts the inserted pump dispenser.

[0037] The fastening region is preferably provided with at least one elastically deflectable retaining element and is designed for receiving the pump dispenser in such a way that when the pump dispenser is inserted into the fastening region, the at least one retaining element is elastically deflected and thus brings about a retaining force. In particular, the fastening region can be formed by a fastening cup having a plurality of elastically deflectable retaining elements distributed in the circumferential direction, for example in the form of inwardly directed ribs on a surrounding annular wall of the fastening cup.

[0038] In a second structural form as an alternative, the evaluation unit is arranged on another subunit. The evaluation unit is constructed to be placed on an operating button or a subunit of the operating button and has a fixed area for abutting against the operating button in a fixed position and an operating surface for manually pressing the evaluation unit in this case. Also as in the first structural form shown, the fixing is preferably carried out by means of clamping or snap connection. The evaluation unit also has a force sensor in the sense described at the beginning, which detects the force applied by the user between the operating surface and the fixed area in this case. In this alternative design, it is stipulated that the user no longer directly presses the operating button arranged on the pump dispenser so that the two subunits of the pump dispenser are pressed toward each other, but instead presses the operating surface of the evaluation unit. If the operating surface is pressed relative to another subunit of the pump dispenser, this force also acts on the operating surface of the evaluation unit on the one hand and the operating button of the pump dispenser on the other hand and the fixed area abutting thereon and can be detected there by means of a force sensor.

[0039] Regardless of whether the evaluation unit is arranged on the liquid reservoir or on the operating unit, the evaluation unit: has a processor that evaluates the force detected by the force sensor to identify a force increase that is unique to the reaching of the second manipulated end position; and has an output device that outputs a signal unique to the result of the force evaluation as a tactile, acoustic and / or visible signal based on the force evaluation; and / or has a wireless interface that can send a signal unique to the result of the force evaluation based on the force evaluation to an external display device.

[0040] The evaluation unit for tool-free mounting allows easy coupling to a pump dispenser and to be decoupled from the pump dispenser again when the liquid reservoir is emptied and the evaluation unit is to be mounted on a new pump dispenser.

[0041] The aforementioned evaluation unit, which can be mounted without tools, is intended for use with a pump dispenser and can also be provided as part of a kit consisting of pump dispenser and evaluation unit. BRIEF DESCRIPTION OF THE DRAWINGS

[0042] Further advantages and aspects of the invention are derived from the claims and the following description of preferred exemplary embodiments of the invention, which are explained below with reference to the drawings.

[0043] Figure 1A and 1B A pump dispenser is shown which in this embodiment is configured as a pump dispenser for sublingual administration of a medicinal liquid.

[0044] Figure 2 Shows Figure 1A and 1B A distributor which is supplemented by an evaluation unit that can be connected without tools.

[0045] Figure 3 Shows Figure 2 The various components of the evaluation unit.

[0046] Figures 4A to 4C The use of a pump dispenser with an installed evaluation unit is described.

[0047] Figures 5A to 5C Force-time curves for different types of actuation are shown.

[0048] Figure 6 Shown is placed in Figure 1A and 1B An alternative design of an evaluation unit on a pump dispenser. DETAILED DESCRIPTION

[0049] Figure 1A and 1BA pump dispenser 10 of a known structural form is shown. The pump dispenser 10 comprises a liquid reservoir 46 in which a medicinal liquid is stored before discharge. In order to discharge this liquid, the pump dispenser 10 has a pump 20 and a discharge port 38. In the pump dispenser 10 shown, the discharge port 38 is arranged on the distal end of the applicator tube 34 protruding freely laterally, taking into account the prescribed discharge of the liquid under the tongue of the user, and the applicator tube has a radial tube section 34A and an applicator tube tip 34B bent downward from the tube section in a specific design.

[0050] The outlet 38 is arranged on an actuating unit 30 which can be pressed in a vertical direction relative to a liquid reservoir 46 and a base 40 connected thereto, wherein the actuating unit 30 is guided by a sliding ring 31 which slides on a sliding surface 41 of the base 40. The pressing is carried out in the following manner: the user grasps the liquid reservoir 46 with his hand in the region of the holding surface 48 and / or the base 40 and applies a force downwards to the actuating unit 30 with his index finger on the actuating button 32 of the actuating unit 30. The pump 20 is thereby actuated, the pump cylinder of the pump being clamped between the body of the liquid reservoir 46 and the base 40, and the piston unit having a pump outlet channel which protrudes upwards from the pump cylinder being clamped into the outlet channel 36 of the actuating unit. By pressing the actuating unit 30 relative to the liquid reservoir 46, the piston unit is pressed into the pump cylinder and the liquid contained in the pump chamber defined thereby is conveyed to the outlet. In this case, a prescribed dispensing quantity is only achieved when the actuating unit 30 is pressed into its mechanically predefined end position.

[0051] In order to monitor the discharge volume, the evaluation unit 50 is provided. Figure 2 The diagram is shown in cross-section and its individual components can be seen from Figure 3The evaluation unit comprises a housing formed by two components 52 and 54, wherein the component 54 forms the bottom and the component 52 forms the peripheral side wall surrounding the receiving space. This receiving space is limited at its lower end by a cup-shaped component forming a fixing area 56, into which the liquid reservoir 46 is pushed when a clamping connection is formed. The ribs 56A on the inner side of the component deflect outward when the liquid reservoir 46 is pushed in and thus cause clamping stress. A circuit board 60 is arranged below the cup-shaped component, on the upper side of which a force sensor 64 in the form of an FSR sensor is arranged. The force sensor is surrounded by a pressure spring 58, which lifts the cup-shaped component in a completely relaxed state so that it loses contact with the force sensor 64. A processor 62 and a radio module 63 for communicating with the mobile phone 100 and indirectly with the server 102 are arranged on the lower side of the circuit board 60. Furthermore, a battery 66 and a vibration signal generator 68 are connected to contacts on the bottom side of the printed circuit board 60 .

[0052] The pump dispenser 10 supplemented with the evaluation unit 50 can be operated by the user in a virtually unchanged manner. However, the user now no longer directly grips the holding surface 48 of the liquid reservoir 46 with his hand, but rather the holding surface 53 of the evaluation unit 50. If the user then presses the actuation button 32, a corresponding force also acts on the force sensor 64 taking into account the elastic force of the spring 58, so that a corresponding force sensor value is available to the processor 62.

[0053] Figures 4A to 4C The detection of forces during manipulation is explained.

[0054] Prior to use, the processor 62 is in a power saving mode until the force sensor value of the force sensor 64 exceeds the value zero for the first time. This occurs when the value zero is exceeded as soon as the spring 58 is compressed during actuation such that the force sensor 64 is contacted by the fastening region 56 and loaded with force.

[0055] At this point in time, the processor 62 switches to its operating mode and in this operating mode stores the force sensor values ​​of the force sensor 64 at a predetermined frequency, for example 500 Hz. From this point in time, the corresponding values ​​are stored in the memory of the evaluation unit 50. Figures 4A to 4C The diagram shown on the right illustrates this using the corresponding solid lines.

[0056] At the end of the first maneuvering phase Figure 4AIn the first actuation phase, the force sensor value increases. This is the phase before discharge, in which the gaps between the individual components of the pump dispenser and relative to the evaluation unit are first squeezed together. At the end of this first actuation phase, the liquid is discharged.

[0057] Figure 4B Show, during discharge liquid, described actuation force only slightly increases.This increase is mainly due to the increasingly tightened spring of pump 20 and causes. Figure 4B The pump dispenser 10 is shown at the end of the liquid discharge phase. The pump piston has now reached its end position defined by the geometry of the pump chamber.

[0058] Figure 4C It is shown that now, following a further increase in force, the relative positions of the subunits of the pump dispenser only change slightly. This is due to the deformability of the components, but no longer leads to liquid discharge. The user can notice the end of the liquid discharge and the increased force.

[0059] However, he pays particular attention to the vibrations generated by the vibration signal generator 68, because the processor 62 has been based on the FIG. 4A to FIG. 4C It is determined from the curve shown in FIG that the actuated second travel end position has been reached.

[0060] Will be aided by FIG. 5A to FIG. 5C To explain how the evaluation can be performed by the processor 62. Here, Figure 5A Shows the corresponding Figures 4A to 4C Force-time-variation curve. Figure 5B and 5C The graphs show more powerful manipulations to varying degrees.

[0061] The evaluation was conducted as follows:

[0062] Just like Figures 4A to 4C Same, Figure 5A The force-time curve determined by means of the force sensor is shown by a solid line. This curve is smoothed by means of a processor 62, for example by means of a smoothed average method. The corresponding smoothed curve is represented by a dotted line in the figure.

[0063] This smoothed variation curve is mainly used for further analysis. In this case, one possible method provides that the processor uses the already existing smoothed measured values ​​in such a way that at the current time t2, the processor checks the time interval I1 that has already passed since this time, for example here for the time t1, and the time interval I2 that is in the future at that time. For two time intervals of defined time length, average force values ​​are determined, which are referred to here as F1 and F2. The difference in the average force values ​​is referred to here as ΔF. From the force difference ΔF and one of the two values ​​F1 and F2 or their sum, a quotient, i.e., for example ΔF / F1, is formed, which indicates, as it were, to what extent the curve of the measured values ​​rises in the time interval I2 relative to the preceding time interval I1.

[0064] This quotient, here exemplarily ΔF / F1, is compared with a limit value. In this case, the limit value is usually a time-varying limit value which decreases over time, in the simplest case linearly, from the start of the manual application of force. If the quotient is above the limit value, this is interpreted as reaching the actuated second end position. Figure 5A In the case of an operation, the limit value is exceeded at time t E. As an alternative to a decrease over time, the limit value can also be adjusted in stages when the assigned force value is reached.

[0065] The described method allows correct interpretation of Figure 5A and 5B The same force curve is obtained during slow and normal operation.

[0066] However, it has been shown that very powerful manipulations (e.g. Figure 5C ) cannot always be analyzed well with this approach, since here the forces no longer increase over time to the same extent after reaching the actuated end position as in normal or slow actuation.

[0067] The method described is therefore supplemented with the following procedure: if an immediate and significant increase in the measured force is recorded after the start of the manipulation, i.e., for example, a predetermined force value FS is reached or exceeded within a short time interval tS, or an early strong slope of the curve is determined by means of another calculation, this is an indicator for very powerful and / or fast manipulation. In such manipulations, in practice, it should no longer be prevented that the second end position is reached by the user. Therefore, it becomes clear within a short time interval tS that the second end position is reached in accordance with the specification. In this case, the time of reaching the manipulated second end position is no longer determined based on the evaluation of the slope as described above, but based on the reaching of a limit force FG that exceeds the force value FS. If the measured force value exceeds this limit force FG, this is a sufficiently accurate indicator for reaching the second end position.

[0068] Figure 6 A schematic diagram illustrates an alternative structural mode of the evaluation unit 70. This evaluation unit is configured to be placed on the operating unit 30 and the operating button 32 there. The evaluation unit includes a component similar to the evaluation unit 50, namely a housing 71, which has an operating surface 73 on the upper side to replace the holding surface 53. The housing 71 has a peripheral side, which has a recess in the area of ​​the applicator tube 34. A locking lug for coupling to the operating unit 30, in the current case, is provided at the lower end of the peripheral side. The fixing area 76 is provided inside the housing 71, which is used to abut against the operating button 32 in a fixed position. In addition, a circuit board 80 is provided here similarly to the evaluation unit 50, and the circuit board is equipped with a force sensor 84, a microprocessor 82, a radio module 83 and a battery 86. As an output device, an LED 88 is provided instead of the vibration signal generator 68. Furthermore, for both evaluation units 50 , 70 it is exemplified that the evaluation unit 70 has a position and acceleration sensor 87 , by means of which the vertical orientation of the dispenser during actuation and / or a vibration in accordance with regulations before actuation can be detected.

[0069] The force sensor 84 detects the actuation force just like the force sensor 64. Therefore, in principle the same force-time curve also occurs, as in Figures 4A to 4C and Figures 5A to 5C. In contrast to this description, in the present embodiment it is preferably provided that the start of the actuation and thus the start of the evaluation is signaled, for example by the LED emitting yellow light. If then, for example, the actuated second end position of the pump 20 is not detected within 1 second, the color changes to red. If, on the other hand, the actuated second end position is reached and therefore a completely normal discharge is detected, the color changes to green.

Claims

1. A method for evaluating a pumping operation on a pump dispenser (10) for dispensing a liquid, the method having the following characteristics: a. The method is applied to a pump dispenser (10), which has two subunits (12, 14) that can be manually moved relative to each other and has a pump (20), which has a pump chamber that can be reduced from a first, non-actuated end position to an actuated second end position by the movement of the subunits (12, 14), and b. in order to detect the actuated second end position, during the movement of the subunits (12, 14) relative to one another, detecting a force by means of a force sensor (64, 84), with which the subunits (12, 14) are manually moved toward one another, and c. evaluating the detected force profile over time in such a way that a force increase which is unique to reaching the actuated second end position is detected, and d. depending on whether a force increase which is unique to the reaching of the actuated second end position has been detected, outputting a signal which is unique to this result in a haptic, acoustic and / or visual manner via an output device and / or transmitting it via a wireless interface to an external display device, e. storing the data detected by the force sensor (64, 84) in a memory so that a time curve of the detected force is obtained therefrom, and f. An evaluation is performed taking into account the detected temporal profile, which is used to determine whether a force increase occurs which is unique to the reaching of the actuated second end position.

2. The method according to claim 1, It is characterized in that The pump dispenser is configured to discharge a medicinal liquid.

3. The method according to claim 1, Features The following additional features: a. The evaluation is performed using a processor (62, 82) having an operating mode and a quiescent mode relative to the operating mode for power saving, and b. the force sensor (64, 84) is connected to the processor in such a way that the processor (62, 82) switches to the operating mode in the idle mode after exceeding a predetermined limit value, and c. In the operating mode, the values ​​detected by the force sensor (64, 84) are subsequently stored in a memory and repeatedly evaluated by the processor (62, 82) in order to detect a force increase that is unique to the reaching of the actuated second end position.

4. The method according to any one of claims 1 to 3, Features At least one of the following additional features: a. evaluating the force with respect to time based on a smoothed image of the force with respect to time, and / or b. The force is evaluated with respect to time in such a way that the manipulation is classified into one of at least two categories depending on the force detected by the force sensor, the at least two categories being assigned to manipulations of different strengths and / or speeds, wherein the recognition of the reaching of the manipulated second end position and / or the recognition of the time of reaching the manipulated second end position are carried out in different ways for the at least two categories.

5. The method according to any one of claims 1 to 3, It is characterized in that The force is evaluated over time in such a way that the slope of the force is evaluated over time, wherein an increase in the slope is interpreted as an indicator of reaching the second end position.

6. The method according to claim 5, It is characterized in that The quotient of the slope and the force value is compared with a limit value, and the exceeding of this limit value is interpreted as reaching the second end position.

7. The method according to claim 6, It is characterized in that The limit value is time-dependent and force-dependent and decreases over time.

8. The method according to any one of claims 1 to 3, Features At least one of the following additional features: a. the signal is transmitted in such a way that a first signal is output after the start of the actuation and ends as soon as a force increase unique to the reaching of the actuated second end position is detected and / or as soon as a force curve or force value unique to the end of the actuation is measured, and / or b. the signal is transmitted in such a way that a second signal is output when a force increase which is unique to reaching the actuated second end position is detected, and / or c. The signal is transmitted in such a way that a third signal is output as soon as a force curve or a force value which is unique to the end of the actuation is measured.

9. The method according to any one of claims 1 to 3, Features The following additional features: a. The method provides that the measurement data detected by means of the force sensor (64, 84) and / or the data for detecting the force increase are transmitted to an external display device (100) via a wireless interface (63, 83).

10. The method according to claim 9, Features At least one of the following additional characteristics: a. displaying to the user on the external display device (100) whether the actuated second end position was reached during the last discharge, and / or b. The display device transmits the detected measurement data and / or data about the detection or non-detection of a force increase that is unique to the reaching of the actuated second end position to an external server (102).

11. A pump dispenser (10) for discharging a liquid, having the following characteristics: a. The pump dispenser (10) has a liquid reservoir (46) for receiving the liquid before discharge and has at least one discharge opening (38) through which the liquid can be discharged into the surrounding environment, and b. the pump dispenser (10) having an operating button (32) which is movable relative to the liquid reservoir (46), c. the pump dispenser (10) having a pump (20) with a pump chamber, wherein the walls of the pump chamber are movable relative to one another between a first, non-actuated end position and a second, actuated end position for the purpose of reducing the pump chamber, and wherein the first wall of the pump chamber is arranged fixed in position relative to the liquid reservoir (46), and the second wall of the pump chamber is movable relative to the first wall by manual actuation of the actuation button (32), and d. The pump dispenser (10) has an evaluation unit (50, 70) for detecting the reaching of the actuated second end position by means of a method according to any one of claims 1 to 10, wherein the evaluation unit (50, 70) has a force sensor (64, 84) which measures the force applied by the user between the actuation button (32) and the second wall or between the holding surface (48) on the liquid reservoir (46) and the first wall, and the evaluation unit (50, 70) has a processor (62, 82) which evaluates the force detected by the force sensor (64, 84) in order to detect a force increase which is unique to the reaching of the actuated second end position, and - The evaluation unit (50, 70) has an output device (68, 88), which outputs a signal unique to the result of the force evaluation as a tactile, acoustic and / or visual signal based on the force evaluation, and / or the evaluation unit (50, 70) has a wireless interface (63, 83), which can send a signal unique to the result of the force evaluation to an external display device (100) based on the force evaluation.

12. The pump dispenser (10) according to claim 11, It is characterized in that The pump dispenser is configured to discharge a medicinal liquid.

13. The pump dispenser (10) according to claim 11, Features Additional features: a. The pump dispenser (10) has an operating unit (30), which includes the operating button (32) and the discharge port (38), and the operating unit as a whole can be moved along an operating direction relative to the liquid reservoir (46) for the purpose of operating the pump (20).

14. The pump dispenser (10) according to claim 13, Features At least one of the following additional features: a. the discharge port (38) is arranged laterally on the operating unit (30) so that the discharge direction and the operating direction form an angle of >0°, and / or b. The manipulation unit (30) has an applicator tube (34), at the distal end of which the discharge opening (38) is arranged, wherein the pump dispenser (10) is provided for the sublingual discharge of liquids.

15. The pump dispenser (10) according to claim 13, It is characterized in that The discharge opening (38) is arranged laterally on the actuation unit (30) such that the discharge direction encloses an angle between 60° and 120° with the actuation direction.

16. The pump dispenser (10) according to any one of claims 11 to 15, having at least one of the following additional features: a. The liquid reservoir (46) is filled with a medicinal liquid, and / or b. The liquid reservoir (46) has a volume between 20 ml and 1000 ml, and / or c. The pump (20) is configured as a piston pump having a pump cylinder and a pump piston movable in the pump cylinder, wherein the pump cylinder and the pump piston jointly define a pump chamber, wherein valves that open and close according to pressure are arranged on the input side and the output side of the pump chamber.

17. The pump dispenser (10) according to any one of claims 11 to 15, having at least one of the following additional features: a. The force sensor (64, 84) is constructed as a FSR sensor (Force Sensitive Resistor) or a piezoelectric sensor, and / or b. A spring (58, 78) is assigned to the force sensor (64, 84), which, in a relaxed state, separates components acting on the force sensor (64, 84) from each other in such a way that one of the components loses contact with the force sensor (64, 84), and / or c. The evaluation unit (50, 70) comprises at least one acceleration and / or position sensor, and / or d. The evaluation unit (50, 70) comprises an energy source (66, 86) in the form of a battery, and / or e. The wireless interface (63, 83) is a radio interface.

18. An evaluation unit (50, 70) for a pump dispenser for dispensing a liquid, the evaluation unit having the following characteristics: a. The evaluation unit (50, 70) is configured to be mounted on a pump dispenser (10) without tools, the pump dispenser having: a liquid reservoir (46) for receiving liquid before discharge; at least one discharge opening (38) through which the liquid can be discharged into the surrounding environment; and an operating button (32) that can be moved relative to the liquid reservoir (46), wherein the pump dispenser (10) also has a pump (20) that can be operated by moving the operating button (32) relative to the liquid reservoir (46) between a first, non-operated end position and a second, operated end position, and b. The evaluation unit (50, 70) is configured to detect the reaching of the manipulated second end position by means of the method according to any one of claims 1 to 10, wherein the evaluation unit (50) is designed to be placed on a liquid reservoir (46) and has a fastening area (56) for a fixed position abutment against the liquid reservoir (46) and has a holding surface (53) for manually holding the evaluation unit (50), wherein the evaluation unit also has a force sensor (64) which detects a force applied by a user between the holding surface (53) and the fastening area (56), or The evaluation unit (70) is designed to be placed on an operating button (32) and has a fastening area (76) for abutting against the operating button (32) in a fixed position and has an operating surface (73) for manually pressing the evaluation unit (70), wherein the evaluation unit (70) also has a force sensor (84) which detects a force applied by a user between the operating surface (73) and the fastening area (76), and The evaluation unit (50, 70) has a processor (62, 82) which evaluates the force detected by the force sensor (64, 84) in order to detect a force increase which is unique to the reaching of the actuated second end position, and The evaluation unit (50, 70) has an output device (68, 88), which outputs a signal unique to the result of the force evaluation as a tactile, acoustic and / or visual signal based on the force evaluation, and / or the evaluation unit has a wireless interface (63, 83), which can send a signal unique to the result of the force evaluation based on the force evaluation to an external display device (100).

19. The evaluation unit (50, 70) according to claim 18, It is characterized in that The pump dispenser is configured to discharge a medicinal liquid.

20. The evaluation unit (50) according to claim 18, having the following additional features: a. The evaluation unit (50) is configured to be placed on the liquid reservoir (46), and b. The evaluation unit has a housing (51) having a peripheral side wall (52) into which the liquid reservoir (46) of the pump dispenser (10) can be inserted and whose outer side forms the retaining surface (53), and c. The fastening region (56) of the evaluation unit is arranged within the circumferential side wall (52) and is in contact there with the inserted pump dispenser (10).

21. The evaluation unit (50) according to claim 20, having the following further feature: d. The fixing area (56) is provided with at least one elastically deflectable retaining element (56A) and is constructed in such a way as to receive the pump dispenser (10) so that when the pump dispenser (10) is pushed into the fixing area (56), the retaining element (56A) is elastically deflected and thereby generates a retaining force.

22. The evaluation unit (50, 70) according to any one of claims 18 to 21, having at least one of the following further features: a. The force sensor (64, 84) is constructed as a FSR sensor (Force Sensitive Resistor) or a piezoelectric sensor, and / or b. A spring (58, 78) is assigned to the force sensor (64, 84), which, in a relaxed state, separates components acting on the force sensor (64, 84) from each other in such a way that one of the components loses contact with the force sensor (64, 84), and / or c. The evaluation unit (50, 70) comprises at least one acceleration and / or position sensor, and / or d. The evaluation unit (50, 70) comprises an energy source (66, 86) in the form of a battery, and / or e. The wireless interface (63, 83) is a radio interface.

23. A kit consisting of a pump dispenser and an evaluation unit having the following features: a. The kit comprises a pump dispenser (10) having a liquid reservoir (46) and an operating button (32) movable relative to the liquid reservoir (46), and b. The kit comprises an evaluation unit (50, 70) according to any one of claims 18 to 22, which is intended to be placed on a liquid reservoir (46) or an operating button (32) of the pump dispenser (10).

24. The kit according to claim 23, Features Additional features: a. The pump dispenser (10) has an operating unit (30), which includes the operating button (32) and the discharge port (38), and the operating unit as a whole can be moved along an operating direction relative to the liquid reservoir (46) for the purpose of operating the pump (20).

25. The kit according to claim 24, Features At least one of the following additional features: a. the discharge port (38) is arranged laterally on the operating unit (30) so that the discharge direction and the operating direction form an angle of >0°, and / or b. The manipulation unit (30) has an applicator tube (34), at the distal end of which the discharge opening (38) is arranged, wherein the pump dispenser (10) is provided for the sublingual discharge of liquids.

26. The kit according to claim 24, It is characterized in that The discharge opening (38) is arranged laterally on the actuation unit (30) such that the discharge direction encloses an angle between 60° and 120° with the actuation direction.

27. A kit according to any one of claims 23 to 26, having at least one of the following additional features: a. The liquid reservoir (46) is filled with a medicinal liquid, and / or b. The liquid reservoir (46) has a volume between 20 ml and 1000 ml, and / or c. The pump (20) is configured as a piston pump having a pump cylinder and a pump piston movable in the pump cylinder, wherein the pump cylinder and the pump piston jointly define a pump chamber, wherein valves that open and close according to pressure are arranged on the input side and the output side of the pump chamber.

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