Patent Application
20230129079
The invention relates to the field of pump dispensers for discharging fluid, in particular pump dispensers in the medical field, which are filled with a pharmaceutical fluid. In such pump dispensers, it is provided that by manual actuation of a pump of the pump dispenser, fluid can be discharged from a fluid reservoir through a discharge opening, for example in the form of an atomized spray, an unatomized jet, or in the form of individual drops.
Pump dispensers are used by users to apply pharmaceutical fluids, for example by nasal or oral route and in particular also sublingually, i.e. under the tongue. Particularly in the case of pharmaceutical fluids with an unpleasant taste or odor, there is a risk that the user will not perform a complete discharge, but instead will terminate the actuation too early. The result is an insufficient amount of pharmaceutical fluid discharged.
The problem addressed by the invention is to provide a method and devices for carrying out the method which reduces or prevents the risk of incomplete discharge.
According to the invention, a method for evaluating a pump actuation on a pump dispenser for discharging a fluid, in particular a pharmaceutical fluid, is proposed for this purpose, which is used when a pump dispenser is used which has two sub-units, which can be moved manually relative to one another, and which has a pump having a pump chamber that can be made smaller by moving the sub-units from an unactuated first end position into an actuated second end position. The preferably pharmaceutical fluid passes from the fluid reservoir, which is preferably between 20 ml and 1000 ml in size, to the pump and from there on to a discharge opening. The fluid stored in the fluid reservoir can be, in particular, a pharmaceutical, in particular containing pharmaceutically active substances, but in particular allergen extracts.
Said two sub-units, which may in particular be a base with a fluid reservoir on the one hand and an actuating unit with an actuating pusher and a discharge opening on the other hand, are pressed towards one another in the course of the discharge, wherein the pump is actuated by pressing the sub-units together. Many pump dispensers are designed for one-handed operation by grasping their fluid reservoir with the hand and pressing down an actuating pusher with one finger of the hand, usually the index finger.
The discharge opening can be provided in particular laterally on the actuating unit so that a discharge direction forms an angle > 0° with the actuating direction of the actuating unit, preferably between 60° and 120°. For a better approach of the discharge opening towards the application site, a design in which a freely projecting applicator tube is provided, at the distal end of which the discharge opening is arranged, can be advantageous.
In particular, the actuating unit can also be provided for the sublingual applicator. In this case, an angled applicator tube tip is preferably provided at the end of the applicator tube projecting laterally from the actuating unit.
The pump can be, in particular, a piston pump, which is designed as a piston pump with a pump cylinder and a pump piston displaceable therein. The pump cylinder and the pump piston jointly delimit the pump chamber, wherein pressure-dependent opening and closing valves are preferably provided on the inlet side and outlet side of the pump chamber. When the sub-units are moved towards one another, 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 sub-units displaces fluid, which is conveyed through the outlet valve to the discharge opening and is discharged here. On the return stroke, the outlet valve closes, the inlet valve opens, and fluid is drawn from the fluid reservoir into the pump chamber.
In addition to piston pumps, however, other types of pumps can also be used, which, for the purpose of pumping in one direction, can be pressurized to an end position and which return to their starting position on the return stroke. These include, for example, bellows pumps.
To detect the actuated second end position, in accordance with the invention the force with which the sub-units are manually moved towards one another is detected by means of a force sensor during the movement of the sub-units towards one another. This force is the force applied by the user, in particular between their hand grasping one sub-unit and the finger, in particular the index finger, pressing down on the other sub-unit.
A force sensor in the sense of the invention is a sensor that returns the applied force in the form of an analog force value, i.e., a value that is all the higher, the higher the force applied by the user. Accordingly, a simple switch is not a force sensor in the sense of the invention. However, sensors which return a measured value directly traceable to the applied force are also force sensors in the sense of the invention, so in particular also a pressure sensor or a displacement sensor coupled to a resetting spring force.
The force sensor can preferably be an FSR sensor (Force Sensitive Resistor) or a piezo sensor. These provide analog sensor values in the form of variable resistances or voltages.
The force sensor is preferably assigned a resetting spring force, which, when the actuating force ceases, presses the surfaces of the evaluation unit acting on the force sensor back into an initial position. In particular, the force sensor is preferably decoupled from one of the surfaces acting on it in the initial position due to the spring force, for example by a narrow gap, so that the force sensor reliably supplies a zero signal in this initial position.
According to the invention, the force sensor values reported by the force sensor are evaluated in such a way that a force increase characteristic of reaching the actuated second end position is detected. The way in which this can be achieved will be explained later. The result of the evaluation is that it is recognized whether the characteristic force increase in question was detected, which results from the fact that the pump has reached its end position, in particular that the pump piston has moved into the pump cylinder to its lowest end position. It has been shown that the reaching of this end position by the user unintentionally leads to actuation with a stronger and identifiable actuating force.
Depending on whether the force increase characteristic of reaching the actuated second end position has been detected, a signal characteristic of the result is preferably then output haptically, acoustically and/or visually by an output device. The output preferably takes place on the pump dispenser itself or on an evaluation unit attached to it. A haptic signal is, for example, a vibration signal. A 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. An acoustic signal can in particular consist of one or more different signal tones.
In the simplest case, a signal is output as positive feedback when the characteristic course of the force for reaching the second actuated stroke end position has been detected. This could be, for example, a green illumination of an LED or a vibration. Alternatively or additionally, it can be provided that a signal is output as negative feedback if no characteristic progression of the force for the second actuated stroke end position is detected after detection of the start of discharge, wherein the trigger for this signal can be the expiry of a predefined time period from the start of actuation. Alternatively, a drop in the force sensor value can be detected as a discontinuation of the actuation force. An LED could indicate the negative result, for example, by lighting up red.
Furthermore, it is also possible to output a signal already during actuation to indicate to the user that the start of actuation has been detected, in particular when the force sensor value has exceeded a predetermined minimum. Such a signal ends as soon as the force increase characteristic of reaching the actuated second end position is detected and/or as soon as the termination of the actuation is detected, and a positive or a negative feedback is output as a signal accordingly.
Signaling, in particular direct signaling at the pump dispenser or at an evaluation unit attached thereto, is regarded as the preferred use of the result of the evaluation. However, it may instead or preferably additionally be provided that the result of the evaluation is sent to an external display device via a wireless interface. The wireless interface may 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 cell phone or a smart watch.
The external display device can reproduce the result of the evaluation according to the display described above. It can also store the results and/or pass them on to external servers for evaluation by third parties. The results can also be used by a training program, with which the correct use of the pump dispenser is made clear to the user.
In the simplest case, the evaluation for identifying the reaching of the actuated second end position can be performed by a processor evaluating the current force value without taking into account the previously detected force values. For example, exceeding a previously defined threshold value can be interpreted as an indication of the force increase when the second end position is reached. However, such an approach is problematic because it is difficult to find an absolute threshold value that occurs equally for fast and slow actuation.
It is therefore advantageous if the data detected by the force sensor are stored in a memory in such a way that the course of the detected force over time results from this. For example, the force sensor could be interrogated at a frequency of 500 Hz from the detection of the start of actuation and the force values stored in a memory. This results in the course of the force value over time.
The evaluation used to determine whether a force increase characteristic of reaching the actuated second end position has occurred is therefore preferably performed taking this course over time into account. Such an evaluation allows a higher reliability in the distinction of reaching or not reaching the second end position.
The evaluation of the course of the detected force over time is preferably performed in such a way that the slope of the corresponding graph is used to detect the second end position. In particular, the slope of the force over time can be evaluated. Here, an increase in the slope, i.e., the first derivative of the force over time, can be interpreted as an indicator for reaching the second end position. In particular, a quotient can be formed from the slope, i.e. the force increase over a defined period of time, and the force value. This indicates the slope relative to the previously reached force level. This quotient can be compared with a limit value and exceeding this limit value can be interpreted as reaching the second end position. The corresponding limit value can be determined by tests. In particular, the limit value itself is also not constant, but variable over time, namely is descending. Thus, in the simplest case, it can decrease linearly. It is also possible to reset the limit value depending on whether predefined force values are reached.
The evaluation of the force over time is preferably performed using a smoothed graph of the force over time. This eliminates high frequencies in the manner of a low-pass filter. Such frequencies can result in particular from friction on surfaces of the pump dispenser that slide along one another.
The evaluation of the force over time can also be performed in such a way that the force detected by the force sensor is used to categorize the actuation into one of at least two categories that are assigned to actuations of different strengths and/or speeds. In particular, this categorization can take place in a short first period of the actuation, for example within the first 0.5 seconds or less. The categorization allows the identification of whether the second actuated end position has been reached and, if so, when this occurred, to be performed in different ways for the at least two categories. These different ways can be reflected in different limit values used for the analysis. However, they can also be fundamentally different. For example, a comparatively high actuating force at a very early stage can lead to an analysis in which the reaching of the second end position is assumed to be given, since the user can no longer prevent the end position from being reached in practice anyway. Only the corresponding time is then determined, wherein other rules can be used to determine this than for slow or normal actuation.
It is considered disadvantageous if the evaluation unit for evaluating the actuating force has to be switched on before actuation by the user. Preferably, the corresponding evaluation unit is always active instead. In order to nevertheless achieve a low power requirement, it is considered advantageous if the evaluation is performed using a processor which has a normal operating mode as well as a power-saving sleep mode. Until the pump dispenser is actuated, the processor is in sleep mode. In this mode, the processor monitors whether the force value of the force sensor exceeds a predefined limit value, in particular predefined by a voltage or resistance level. Parts of the processor not required for this can be switched off in the meantime. If the limit value is exceeded, the processor switches to operating mode.
In this operating mode, which is then reached, the values detected by the force sensor are digitized by means of an A/D converter and stored in the memory and then analyzed, preferably repeatedly, by the processor to identify whether the force increase characteristic of reaching the actuated second end position can be detected. This operating mode has a considerably higher energy requirement than the sleep mode. However, due to the only short stay in the operating mode, this is not very significant. As soon as a discharge process has been completed, either after the second actuated end position has been reached or after it has not been reached and after the associated signaling, the processor can switch back to the sleep mode.
In addition to the force sensor described, other sensors can be provided in the evaluation unit used to carry out the method, in particular position sensors or acceleration sensors. Their sensor values can be used as a supplement in the method described, for example to identify an upcoming use of the pump dispenser and/or to monitor whether an intended shaking of the pump dispenser has taken place properly. Sensor values of these sensors or values derived therefrom can be used to influence output signals of the dispensing device and/or can be forwarded wirelessly to a display device.
In addition to the method described, the invention also relates to systems in which the described method is used.
In particular, the invention also relates to a pump dispenser for discharging a fluid, in particular for discharging a pharmaceutical fluid. Such a pump dispenser has a fluid reservoir for receiving the fluid prior to discharge and at least one discharge opening through which fluid can be discharged into an environment. It further has an actuating pusher, which is displaceable relative to the fluid reservoir, and a pump having a pump chamber, wherein walls of the pump chamber are movable relative to one another between an unactuated first end position and an actuated second end position for the purpose of reducing the size of the pump chamber, and wherein a first wall of the pump chamber is provided stationary relative to the fluid reservoir and a second wall of the pump chamber is displaceable relative to the first wall by manual actuation of the actuating pusher. In particular, said walls may be walls formed by a pump cylinder and a pump piston of the pump. They can also be opposite walls of a bellows pump.
In addition, the pump dispenser has an evaluation unit for identifying when the second actuated end position has been reached and for using this identification by means of the method described. For this purpose, the evaluation unit has electronic components which are preferably powered by a battery. This also includes a force sensor in the sense explained above, which measures the force applied by a user between the actuating pusher and the second wall, for example the pump piston, or between a retaining surface on the fluid reservoir and the first wall, for example the pump cylinder. The evaluation unit further has a processor, which evaluates the force detected by the force sensor so that a force increase characteristic of reaching the actuated second end position can be detected. In addition, the evaluation unit preferably has an output device, which, depending on the force evaluation, outputs a signal characteristic of the result of the force evaluation as a haptic, acoustic and/or visual signal. In particular, this can be a vibration device or an LED. In addition or, if necessary, also as an alternative to the output device, the evaluation unit has a wireless interface, which, as a function of the force evaluation, can send a signal characteristic of the result of the force evaluation to an external display device in order to allow it to be used or forwarded in the sense described above.
The evaluation unit described can be permanently integrated in the pump dispenser so that it cannot be separated from its components, in particular from the pump, without the use of tools. This can be useful for dispensers with exchangeable or refillable fluid reservoirs.
However, it is preferred to use an evaluation unit for a pump dispenser for discharging a fluid, in particular for discharging a pharmaceutical fluid, which is also included by the invention and which is provided for tool-free attachment to a pump dispenser. In this case, the corresponding pump dispenser comprises the fluid reservoir for receiving the fluid prior to discharge, the at least one discharge opening through which fluid can be discharged into an environment, and an actuating pusher which is displaceable relative to the fluid reservoir, as well as the pump which is actuatable by displacement of the actuating pusher relative to the fluid reservoir between an unactuated first end position and an actuated second end position.
The evaluation unit, which can be attached to this pump dispenser without the use of tools, is designed to identify when the second actuated end position has been reached by means of the method described above. The evaluation unit is preferably attached to the pump dispenser via a clamping or snap-action mechanism. The attachment is preferably performed in such a way that the force sensor of the evaluation unit is arranged between an actuating surface of the evaluation unit and an actuating surface on the pump dispenser which is replaced thereby with regard to handling and is only indirectly actuated.
In a first preferred design, the evaluation unit is designed to be attached to the fluid reservoir and has a fastening region for stationary contact with the fluid reservoir or a coupling surface stationary for this purpose, as well as a retaining surface for manual gripping of the evaluation unit. The evaluation unit further has the described force sensor, which in this case detects the force applied by a user between the retaining surface and the fastening region. Accordingly, in such a design, it is envisaged that the user no longer grips around the fluid reservoir itself in the region of the retaining surface in order to press the two sub-units of the pump dispenser towards one another, but instead grips the retaining surface of the evaluation unit. If the other sub-unit of the pump dispenser, in particular said actuating unit with actuating pusher, is now pressed down, this force also acts between the retaining surface of the evaluation unit and the fastening region and can be detected there by means of the force sensor. The fastening region is that portion of the evaluation unit which is in direct contact with the fluid reservoir or a surface fixed thereto and which is capable of exerting a force acting in the direction of the other sub-unit on the sub-unit of the fluid reservoir. In particularly preferred embodiments, the fastening region is not only a contact surface for applying force to the fluid reservoir, but a retaining device that is coupled to the fluid reservoir sub-unit in such a way that the fluid reservoir is held thereon sufficiently firmly that it does not separate from the fastening region even in an overhead position.
In particular, an evaluation unit designed to be attached to the fluid reservoir preferably has a housing with a casing wall into which the fluid reservoir of the pump dispenser can be inserted and the outer side of which forms the retaining surface. The fastening region of the evaluation unit is preferably provided here inside the casing wall and comes into contact there with the inserted pump dispenser.
The fastening region is preferably provided with at least one elastically deflectable retaining element and is designed to receive 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 thereby produces a retaining force. In particular, the fastening region can be formed by a fastening cup that has a plurality of elastically deflectable retaining elements distributed circumferentially, for example in the form of inwardly pointing ribs on a circumferential ring wall of the fastening cup.
In an alternative second design, the evaluation unit is provided on the other sub-unit. The evaluation unit is thus designed to be attached to the actuating pusher or the actuating pusher sub-unit and in this case has a fastening region for stationary contact with the actuating pusher and an actuating surface for manually pressing down the evaluation unit. As with the first design presented, fastening is achieved here preferably by means of a clamping or snap-action connection. The evaluation unit also has a force sensor in the sense described at the outset, which in this case detects the force applied by a user between the actuating surface and the fastening region. In this alternative design, it is envisaged that the user no longer directly depresses the actuating pusher provided on the pump dispenser in order to press the two sub-units of the pump dispenser towards one another, but instead depresses the actuating surface of the evaluation unit. If the actuating surface is now pressed down against the other part unit of the pump dispenser, this force also acts between the actuating surface of the evaluation unit on the one hand and the actuating pusher of the pump dispenser and the fastening region adjacent thereto on the other hand and can be detected there by means of the force sensor.
Irrespective of whether the evaluation unit is attached to the fluid reservoir or to the actuating unit, it has a processor, which evaluates the force detected by the force sensor so that a force increase characteristic of reaching the actuated second end position is detected, and it has an output device, which, as a function of the force evaluation, outputs a signal characteristic of the result of the force evaluation as a haptic, acoustic and/or visual signal and/or via a wireless interface, which, as a function of the force evaluation, can send a signal characteristic of the result of the force evaluation to an external display device.
An evaluation unit for tool-free attachment allows the unit to be easily coupled to and decoupled from a pump dispenser when the fluid reservoir is emptied and the evaluation unit is to be attached to a new pump dispenser.
The aforementioned evaluation unit, which can be attached without the use of tools, is intended to be used together with a pump dispenser and can also be offered as part of a set consisting of a pump dispenser and an evaluation unit.
Further advantages and aspects of the invention will become apparent from the claims and from the following description of preferred exemplary embodiments of the invention, which are explained below with reference to the figures.
The discharge opening 38 is provided on an actuating unit 30, which can be pressed down in a vertical direction relative to the fluid reservoir 46 and a base 40 connected thereto, wherein the actuating unit 30 is guided by a sliding ring 31 sliding on a sliding surface 41 of the base 40. Pressing down is performed as intended by the user grasping the fluid reservoir 46 with their hand in the region of the retaining surface 48 and/or the base 40 and by applying downward force to the actuating unit 30 at its actuating pusher 32 with their index finger. This actuates a pump 20, the pump cylinder of which is clamped between the bottle body of the fluid reservoir 46 and the base 40, while a piston unit projecting upwardly from the pump cylinder with a pump outlet channel is inserted in a clamping manner into a discharge channel 36 of the actuating unit. By pressing down the actuating unit 30 relative to the fluid reservoir 46, the piston unit is pressed into the pump cylinder and the fluid contained in the pump chamber defined thereby is conveyed to the discharge opening. The intended discharge volume is achieved only when the actuating unit 30 is pressed into its mechanically predetermined end position.
To monitor this, the evaluation unit 50 is provided, which is shown in sectional view in
The pump dispenser 10 supplemented by the evaluation unit 50 can be operated by the user in an almost unchanged manner. However, the user’s hand no longer directly grips the retaining surface 48 of the fluid reservoir 46, but the retaining surface 53 of the evaluation unit 50. If the user then presses the actuating pusher 32, the corresponding force also acts on the force sensor 64, taking into account the spring force of the spring 58, so that the corresponding force sensor values are available to the processor 62.
Prior to use, the processor 62 is in a low-power mode, in which it remains until the first time the force sensor value of the force sensor 64 exceeds zero. This occurs as soon as, upon actuation, the spring 58 is compressed to the point where the force sensor 64 is contacted by the mounting portion 56 and force is applied by the latter.
At this time, the processor 62 changes to its operating mode and stores the force sensor values of the force sensor 64 in this mode at a predetermined frequency, for example 500 Hz. The corresponding values are stored in the memory of the evaluation unit 50 from this point on. The graphs shown on the right in
In a first actuation phase, towards the end of which the state of
In particular, however, the user notices a vibration generated by the vibration signal generator 68 because the processor 62 has detected that the second actuated stroke end position has been reached based on the course shown in
With reference to
The evaluation is performed as follows:
This smoothed course is used primarily for further analysis. One possible method is for the processor to use the smoothed measured values already available in such a way that at a current time t2 it examines for time points in the past, by way of example here for time t1, in each case a time interval I1 lying back from this time and a time interval I2 lying in the future. For both intervals of defined time length, a mean force value is determined, said values being called F1 and F2 here. The difference of the mean force values is called ΔF here. On the basis of the force difference ΔF and one of the two values F1 and F2 or their sum, a quotient is formed, for example ΔF/F1, which indicates, as it were, how strongly the course of the measured values in the interval I2 increases in relation to the previous interval I1.
This quotient, in the present case by way of example ΔF/F1, is compared with a limit value. The limit value is usually a time-variable limit value which, starting from the beginning of the manual force application, decreases over time, in the simplest case linearly. If the quotient is above the limit value, this is interpreted as reaching the second actuated end position. In the case of the actuation of
The described method allows the correct interpretation of the force course as they result from slow and normal actuation according to
However, it has been shown that very powerful actuations, as shown in
The described method is therefore supplemented by the following approach: If an immediate clear increase in the measured force is detected after the start of actuation, for example a reaching or exceeding of a predefined force value FS within a short time period tS, or if an early strong slope of the graph is determined by means of another type of calculation, this is an indicator of a very forceful and/or fast actuation. With such an actuation, the reaching of the second end position by the user can no longer be prevented in practice. Thus, it becomes clear already within the short time period tS that the second end position is properly reached. In this case, the time of reaching the second actuated end position is no longer determined on the basis of an evaluation of the gradient as described above, but on the basis of reaching a limit force FG which is above the force value FS. If the measured force value exceeds this limit force FG, this is a sufficiently accurate indicator that the second end position has been reached.
The force sensor 84 detects the actuation force in the same way as the force sensor 64. In principle, therefore, an identical force-time course is also produced, as illustrated in
| Number | Date | Country | Kind |
|---|---|---|---|
| 20169402.3 | Apr 2020 | EP | regional |
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/EP2021/059233 | 4/8/2021 | WO |
