METHOD FOR EVALUATING A PUMP ACTUATION, AND FLUID DISPENSER AND EVALUATION UNIT WHICH USE THIS METHOD

Abstract

A method for evaluating the pump actuation for a pump dispenser that comprises two sub-units which can be moved manually towards one another and a pump which has a pump chamber that can be made smaller by moving the sub-units from a first end position into an actuated second end position. The force with which the sub-units are moved towards one another is detected by a force sensor during movement of the sub-units. The curve over time of the detected force is evaluated such that an increase in force is identified which is characteristic for reaching the actuated second end position. Depending on whether the increase in force was detected, a signal which is characteristic for the result is haptically, acoustically and/or visually output and/or transmitted via a wireless interface to an external display apparatus, by means of an output device.

Claims

1. A method for evaluating a pump actuation on a pump dispenser for discharging a fluid comprising: providing the pump dispenser with two sub-units , which can be moved manually relative to one another, and 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; detecting the actuated second end position, wherein a force with which the sub-units are manually moved towards one another is detected by a force sensor during movement of the sub-units towards one another; wherein a course of the detected force over time is evaluated in such a way that a force increase characteristic of reaching the actuated second end position is identified; and depending on whether the force increase characteristic of reaching the actuated second end position has been detected, at least one of the following: outputting a signal characteristic of a result haptically; outputting the signal characteristic of the result acoustically; outputting the signal characteristic of the result visually; and sending the signal characteristic of the result via a wireless interface to an external display device by an output device.

2. The method as claimed in claim 1, further including: storing data detected by the force sensor in a memory in such a way that the course of the detected force over time is determined ; wherein an evaluation used to determine whether the force increase characteristic of reaching the actuated second end position has occurred is performed taking the course of the detected force over time into account.

3. The method as claimed in claim 2, wherein: the evaluation is performed using a processor which has an operating mode as well as a power-saving sleep mode; the force sensor is connected to the processor in such a way that the processor in the sleep mode switches into the operating mode once a predetermined limit value is exceeded; and subsequently, in the operating mode, values detected by the force sensor are stored in the memory and repeatedly analyzed by the processor to identify the force increase characteristic of reaching the actuated second end position.

4. The method as claimed in claim 1, further including at least one of the following: the evaluation of the force over time is performed using a smoothed graph of the force over time; the evaluation of the force over time is performed in such a way that a slope of the force over time is evaluated, wherein an increase in the slope is interpreted as an indicator for reaching the actuated second end position; and the evaluation of the force over time is 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 at least one of different strengths and different speeds, wherein the reaching of the actuated second end position, the time of reaching the actuated second end position, or both the reaching of the actuated second end position and the time of reaching the actuated second end position are identified in different ways for the at least two categories.

5. The method as claimed in claim 1, including at least one of the following: the outputting or sending of the signal characteristic is performed in such a way that after a start of the actuation a first signal is output, which ends as soon as the force increase characteristic of reaching the actuated second end position is detected, as soon as a course of the force over time or a force value characteristic of an end of the actuation has been measured, or both as soon as the force increase characteristic of reaching the actuated second end position is detected and as soon as the course of the force over time or the force value characteristic of the end of the actuation has been measured; the outputting or sending of the signal characteristic is performed in such a way that a second signal is output when the force increase characteristic of reaching the actuated second end position has been detected; and the outputting or sending of the signal characteristic is performed in such a way that a third signal is output as soon as a course of the force over time or the force value characteristic of the end of actuation has been measured.

6. The method as claimed in claim 1, wherein: at least one of measurement data and data for detecting the force increase, detected by the force sensor, are sent to an external display device via a wireless interface.

7. A pump dispenser (10) for discharging a fluid comprising: a fluid reservoir for receiving the fluid prior to discharge and at least one discharge opening through which the fluid can be discharged into an environment; an actuating pusher which is displaceable relative to the fluid reservoir; 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 reducing a size of the pump chamber, and wherein a first wall of the walls of the pump chamber is provided stationary relative to the fluid reservoir and a second wall of the walls of the pump chamber is displaceable relative to the first wall by manual actuation of the actuating pusher; and an evaluation unit for identifying when the actuated second end position has been reached; the evaluation unit having a force sensor which measures a force applied by a user between the actuating pusher and the second wall or between a retaining surface on the fluid reservoir and the first wall; the evaluation unit having 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 at least one of the following: (a) the evaluation unit having an output device which, depending on a force evaluation, at least one of the following: outputs a signal characteristic of a result of the force evaluation as a haptic signal; outputs the signal characteristic of the result of the force evaluation as an acoustic signal; and outputs the signal characteristic of the result of the force evaluation as a visual signal; and (b) the evaluation unit having a wireless interface which, as a function of the force evaluation, can send the signal characteristic of the result of the force evaluation to an external display device.

8. An evaluation unit system for a pump dispenser for discharging a fluid comprising: an evaluation unit configured for tool-free attachment to the pump dispenser which has a fluid reservoir for receiving the fluid prior to discharge, at least one discharge opening through which the fluid can be discharged into an environment, and an actuating pusher, wherein the pump dispenser further has a 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; evaluation unit being designed to identify when the actuated second end position has been reached; the evaluation unit being: designed to be attached to the fluid reservoir and having a fastening region for stationary contact with the fluid reservoir (46) and a retaining surface for manual gripping of the evaluation unit, wherein the evaluation unit further has a force sensor for detecting the force applied by a user between the retaining surface and the fastening region, or designed to be attached to the actuating pusher and having a fastening region for stationary contact with the actuating pusher and an actuating surface for manually pressing down the evaluation unit, wherein the evaluation unit further has a force sensor which detects a force applied by a user between the actuating surface and the fastening region; the evaluation unit having 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 identified; and at least one of the following: (a) the evaluation unit having an output device, which, as a function of a force evaluation, at least one of the following: outputs a signal characteristic of a result of the force evaluation as a signal; outputs the signal characteristic of the result of the force evaluation as an acoustic signal; and outputs the signal characteristic of the result of the force evaluation as a visual signal; and (b) the evaluation unit having a wireless interface, which, as the function of the force evaluation, can send the signal characteristic of the result of the force evaluation to an external display device.

9. The evaluation unit system as claimed in claim 8, wherein: the evaluation unit is designed to be attached to the fluid reservoir; the evaluation unit has a housing with a casing wall into which the fluid reservoir of the pump dispenser can be inserted and an outside of which forms the retaining surface; and the fastening region of the evaluation unit is provided inside the casing wall and is configured to come into contact there with the inserted pump dispenser.

10. The evaluation unit systemas claimed in claim 9, wherein: the fastening region is 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 retaining element is elastically deflected and thereby produces a retaining force.

11. A set comprising a pump dispenser and the evaluation unit system as claimed in claim 8; whereinthe pump dispenser has a fluid reservoir and an actuating pusher movable relative to the fluid reservoir; and wherein the evaluation unit is attached to the fluid reservoir or to the actuating pusher of the pump dispenser.

12. The pump dispenser as claimed in claim 7, wherein: the pump dispenser has an actuating unit which comprises the actuating pusher and the discharge opening and which as a whole is displaceable in an actuation direction relative to the fluid reservoir for actuating the pump.

13. The pump dispenser as claimed in claim 7, including at least one of the following: the fluid reservoir is filled with a pharmaceutical fluid; he fluid reservoir has a volume between 20 ml and 1000 ml; and the pump is designed as a piston pump with a pump cylinder and a pump piston displaceable therein, which together delimit the pump chamber.

14. The pump dispenser as claimed in claim 7, including at least one of the following: the force sensor is designed as an FSR sensor (Force Sensitive Resistor) or as a piezo sensor; a spring is associated with the force sensor and spaces the components acting on the force sensor from one another in such a way that one of the components loses contact with the force sensor; the evaluation unit comprises at least one further sensor; the evaluation unit comprises an energy source in the form of a battery; and the evaluation unit comprises a radio interface.

15. The pump dispenser as claimed in claim 12, including at least one of the following: the discharge opening is provided laterally on the actuating unit so that a discharge direction forms an angle > 0° with the actuation direction; and the actuating unit has an applicator tube, at a distal end of which the discharge opening is provided.

16. The set as claimed in claim 11, wherein: the pump dispenser has an actuating unit which comprises the actuating pusher and the discharge opening and which as a whole is displaceable in an actuation direction relative to the fluid reservoir for actuating the pump.

17. The set as claimed in claim 16, including at least one of the following: the discharge opening is provided laterally on the actuating unit so that a discharge direction forms an angle > 0° with the actuation direction; and the actuating unit has an applicator tube, at a distal end of which the discharge opening is provided.

18. The set as claimed in claim 11, including at least one of the following: the fluid reservoir is filled with a pharmaceutical fluid; the fluid reservoir has a volume between 20 ml and 1000 ml; and the pump is designed as a piston pump with a pump cylinder and a pump piston displaceable therein, which together delimit a pump chamber.

19. The evaluation unit as claimed in claim 8, including at least one of the following: the force sensor is designed as an FSR sensor (Force Sensitive Resistor) or as a piezo sensor; a spring is associated with the force sensor and spaces components acting on the force sensor from one another in such a way that one of the components loses contact with the force sensor; the evaluation unit comprises at least one further sensor; the evaluation unit comprises an energy source in the form of a battery; and the evaluation unit comprises a radio interface.

20. The method as claimed in claim 6, including at least one of the following: the external display device can indicate to a user whether the actuated second end position was achieved with the last discharge; and the display device sends at least one of the detected measurement data and data for detecting or not detecting the force increase characteristic of reaching the actuated second end position to an external server.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0042] 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.

[0043] FIGS. 1A and 1B show a pump dispenser, which in the present example is designed as a pump dispenser for sublingual application of a pharmaceutical fluid.

[0044] FIG. 2 shows the dispenser of FIGS. 1A and 1B supplemented by an evaluation unit coupled without the use of tools.

[0045] FIG. 3 shows the individual components of the evaluation unit of FIG. 2.

[0046] FIGS. 4A to 4C illustrate the use of the pump dispenser with the evaluation unit attached.

[0047] FIGS. 5A to 5C show force-time courses for different types of actuation.

[0048] FIG. 6 shows an alternative embodiment of an evaluation unit attached to the pump dispenser of FIGS. 1A and 1B.

DETAILED DESCRIPTION OF THE EXEMPLARY EMBODIMENTS

[0049] FIGS. 1A and 1B show a pump dispenser 10 of a design known per se. The pump dispenser 10 comprises a fluid reservoir 46 in which a pharmaceutical fluid is stored prior to discharge. For the discharge of this fluid, the pump dispenser 10 has a pump 20 and a discharge opening 38. With regard to the intended discharge of fluid under the tongue of the user, the discharge opening 38 is provided in the illustrated pump dispenser 10 at the distal end of a laterally freely projecting applicator tube 34, which in the specific embodiment has a radial tube portion 34A and an applicator tube tip 34B bending downwards therefrom.

[0050] 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.

[0051] To monitor this, the evaluation unit 50 is provided, which is shown in sectional view in FIG. 2 and the individual components of which can be taken from the exploded view in FIG. 3. The evaluation unit comprises a housing formed from two components 52, 54, wherein the component 54 forms a base and the component 52 forms a casing wall which surrounds a receiving space. This receiving space is delimited at its lower end by a cup-like component forming a fastening region 56, into which the fluid reservoir 46 is inserted to form a clamping connection. Internal ribs 56A of the component are deflected outwardly when the fluid reservoir 46 is inserted, thereby causing a clamping stress. A circuit board 60 is provided below the cup-like component, with a force sensor 64 in the manner of an FSR sensor being provided on the upper side of said circuit board. This sensor is surrounded by a compression spring 58, which, in the fully relaxed state, lifts the cup-like component in such a way that it loses contact with the force sensor 64. A processor 62 and a radio module 63 are provided on the underside of the circuit board 60 for communication with a cell phone 100 and indirectly with a server 102. Furthermore, a battery 66 and a vibration signal generator 68 are connected to contacts on the underside of the circuit board 60.

[0052] 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.

[0053] FIGS. 4A to 4C explain how the force is detected during actuation.

[0054] 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.

[0055] 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 FIGS. 4A to 4C illustrate this by means of the solid line in each case.

[0056] In a first actuation phase, towards the end of which the state of FIG. 4A is reached, the force sensor value increases. This is the phase before discharge, in which the gaps between individual components of the pump dispenser and also to the evaluation unit are initially compressed. Towards the end of this first actuation phase, the fluid is discharged.

[0057] FIG. 4B illustrates that the actuation force increases only slightly during fluid discharge. This increase is primarily due to the increasingly tensioned spring of the pump 20. FIG. 4B shows the pump dispenser 10 at the end of the fluid discharge phase. The pump piston has now reached its end position defined by the geometry of the pump chamber.

[0058] FIG. 4C illustrates that a further force increase now follows, while the relative position of the sub-units of the pump dispenser changes only slightly. This is due to the deformability of the components, but no longer leads to fluid discharge. The user can notice the end of the fluid discharge as well as the increasing force.

[0059] 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 FIGS. 4A to 4C.

[0060] With reference to FIGS. 5A to 5C, it will be explained how the evaluation can be performed by the processor 62. Here, FIG. 5A shows the force-time course corresponding to FIGS. 4A to 4C. The graphs of FIGS. 5B and 5C each show actuations with varying degrees of force.

[0061] The evaluation is performed as follows:

[0062] FIG. 5A, similarly to FIGS. 4A to 4C, shows the force-time course determined by means of the force sensor with a solid line. By means of the processor 62 this course is smoothed, for example by means of the moving average method. The correspondingly smoothed course is illustrated in the figures with a dotted line.

[0063] 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.

[0064] 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 FIG. 5A, the limit value is exceeded at time tE. As an alternative to a decrease over time, the limit value can also be adjusted in steps when an associated force value is reached in each case.

[0065] The described method allows the correct interpretation of the force course as they result from slow and normal actuation according to FIGS. 5A and 5B.

[0066] However, it has been shown that very powerful actuations, as shown in FIG. 5C, cannot always be analyzed very well with this method, since here the force does not increase over time after reaching the actuated end position to the same extent as with normal or slow actuation.

[0067] 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.

[0068] FIG. 6 illustrates in schematic form an alternative design of an evaluation unit 70. This is intended to be placed on the actuating unit 30 and the actuating pusher 32 there. It comprises similar components to the evaluation unit 50, namely a housing 71 which has an upper actuating surface 73 instead of the retaining surface 53. The housing 71 has a lateral surface which has a recess in the region of the applicator tube 34. At the lower end of the lateral surface, a detent cam is provided for coupling to the actuating unit 30, in this case to its sliding ring 31. Within the housing 71, the fastening region 76 is provided for stationary contact with the actuating pusher 32. Furthermore, similarly to the evaluation unit 50, a circuit board 80 is provided here, equipped with a force sensor 84, a microprocessor 82, a radio module 83 and a battery 86. An LED 88 is provided as an output device instead of the vibration signal generator 68. By way of example for both evaluation units 50, 70, the evaluation unit 70 further comprises a position and acceleration sensor 87, by means of which the vertical orientation of the dispenser during actuation and/or the proper shaking before actuation can be detected.

[0069] 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 FIGS. 4A to 4C and 5A to 5C. Deviating from the description in this regard, the present design preferably provides that the start of the actuation and thus of the evaluation is already signaled, for example by the LED radiating yellow. If the second actuated end position of the pump 20 is then not detected, for example for 1 second, the color changes to red. If, on the other hand, the second actuated end position is reached and thus a complete proper discharge is detected, the color changes to green.