PHARMACEUTICAL PREPARATION DISPENSING DEVICE

Abstract

The dispensing device makes it possible to dispense pharmaceutical preparations, for example in liquid form. It comprises a system for detecting agitation of the dispensing device, comprising: - agitation detection means (12), configured to detect whether sufficient agitation of the dispensing device has been carried out by a user, - warning means (14), controlled by the agitation detection means (12) and configured to warn the user that sufficient agitation of the dispensing device has been carried out.

Description

To this end, the invention relates in particular to a device for dispensing pharmaceutical preparations, for example in liquid form, comprising a system for detecting agitation of the dispensing device, comprising: - agitation detection means, configured to detect whether sufficient agitation of the dispensing device has been carried out by a user, and - warning means, controlled by the agitation detection means and configured to warn the user that sufficient agitation of the dispensing device has been achieved. Thus, thanks to this dispensing device, it can be detected whether the mixture contained in the dispensing device is in the intended conditions of use when it is dispensed, for example by presenting satisfactory homogeneity and fluidity, through the detection and warning of sufficient agitation of the dispensing device. The user can thus ensure that the agitation of the dispensing device carried out is sufficient before its use and obtain confirmation or repeat its agitation according to the information indicated by the warning means. It is understood that sufficient agitation of the distribution device can be revealed by certain parameters such as the density of the suspended particles, the viscosity of the liquid, its thixotropic character or even the particle size. These parameters can be defined beforehand, depending in particular on the nature of the mixture contained in the distribution device or the distribution device itself. Thus, depending on the parameters retained, it is possible to adapt criteria to consider that the agitation is sufficient. Among the other advantages of the dispensing device, it should be noted that even in the event of an accidental failure of the agitation detection system occurring during the life of the dispensing device, the user would already have acquired a certain habit and would therefore be repeatedly encouraged to adopt good practices in the use of the dispensing device. Advantageously, the dispensing device is accompanied by instructions for use and allows monitoring and control of proper compliance with the rules of use listed in the instructions, thus preventing risks linked to poor distribution of the liquid. The dispensing device may further comprise one or more of the following features, taken alone or in combination. - The agitation detection means comprise a sensor, configured to provide a characteristic quantity of agitation of the dispensing device, and means for processing the information provided by the sensor, these information processing means being configured to control the warning means. The characteristic quantity makes it possible to evaluate the agitation of the dispensing device according to the parameters retained, this may be for example an acceleration, a force or even a molecular concentration. Thus, criteria making it possible to evaluate the sufficiency of agitation will be chosen from this characteristic quantity. For example, a criterion may be the intensity of the characteristic quantity or even its frequency or its speed.These criteria are predefined and the characteristic quantity is evaluated according to these criteria by the information processing means, which are preferably electronic means such as a microcontroller equipped with suitable software, in the form of an electronic chip, in order to determine whether the agitation is sufficient. After processing the information, these processing means can send a positive or negative order to the warning means. - The agitation detection means are arranged to measure an acceleration of the dispensing device. Indeed, acceleration is a characteristic quantity which makes it possible to measure the agitation of the dispensing device. Preferably, it is measured by an accelerometer, for example sold in the form of a microelectromechanical system (called "MEMS"), which has a predetermined measurement range, expressed in gravitational (g), and a number of axes along which the acceleration is measured. The accelerometer may have a preferred axis, for example the vertical, so that only agitations along this direction will be taken into account, or preferably, have three axes X, Y and Z, thus describing the entire space. - The agitation detection means detect sufficient agitation when the characteristic quantity exceeds a predetermined threshold, for example an acceleration of the dispensing device of at least 3 g (gravitational). The threshold is adjustable according to the need and requirements of the type of dispensing device or the nature of the mixture it contains. Preferably, the threshold is chosen to be high enough so that low agitation, for example shaking during transport, cannot trigger the warning means and to ensure that the mixture is well agitated, while being low enough to take into account different types of users such as children, the elderly or disabled and to ensure detection as soon as the mixture is sufficiently agitated. - The agitation detection means detect sufficient agitation of the dispensing device when the predetermined threshold is exceeded a minimum number of times, for example more than three times, preferably more than five times. The number of times the threshold is exceeded can be chosen according to the need and requirements of the type of dispensing device or the nature of the mixture it contains. This number makes it possible to improve the monitoring of the agitation of the dispensing device and makes it possible to ensure that the agitation is actually sufficient to homogenize or fluidify the mixture. Thus, it must be high enough to obtain satisfactory agitation and remain reasonable, taking into account the effort and time required. Advantageously, the threshold must be exceeded during a given time interval in order to be able to consider that the agitation is sufficient.The given time interval is for example chosen to be less than 30 seconds, preferably less than 10 seconds. This ensures that the mixture does not have sufficient time to return to its resting state and that unintentional agitation, for example shaking during transport, cannot trigger the warning means. The given time interval can be chosen according to the need and requirements of the type of dispensing device or the nature of the mixture it contains. - The dispensing device comprises activation means, configured to activate the agitation detection means, comprising for example a switch actuated directly by the user, switch means actuated when a protective cap of the dispensing device is opened, such as a mechanical or magnetic contactor or a brightness detector, or contact detection means arranged on a surface of the dispensing device capable of being handled by the user, such as a finger rest surface of the dispensing device. The installation of the activation means has the advantage of only activating the agitation detection means when necessary, thereby saving energy and extending the service life of the agitation detection system.Thus, activation can be performed either actively, allowing the user to take control and activate the agitation detection means only when needed, or passively, thus enabling the agitation detection means to be activated during a necessary step in the method of using the dispensing device, such as opening a cap or even picking up the dispensing device. In the case of passive activation, it will be noted that the . Detection triggering is fully automated and requires no additional effort from the user. - The dispensing device includes a locking mechanism for blocking the dispensing of liquid (for example by preventing the removal of a protective cap) in cases where insufficient or no stirring has been detected by the stirring detection means, or when the stirring detection means are deactivated. In other words, use of the dispensing device would only be possible after sufficient stirring has been carried out. This is particularly advantageous in the case of users who do not read the instructions for use or read them incorrectly, because they can no longer avoid or forget to carry out stirring, or ignore the warning means. Thus, the locking mechanism increases safety in the use of the dispensing device and requires compliance with the information indicated by the warning means.In one example, the locking mechanism is a magnetically operated pin that can, for example, prevent activation of a product dispensing pump. - The dispensing device comprises inclination detection means, for example an inclinometer, configured to detect a satisfactory inclination of the dispensing device relative to a vertical direction, the satisfactory inclination being predefined quantitatively, for example greater than 30°, these inclination detection means also controlling the warning means, the inclination detection means preferably being arranged in a non-visible manner. Indeed, for ophthalmic or auricular mixtures, it frequently happens that the user does not sufficiently tilt the dispensing device when dispensing the mixture. However, the delivered dose can depend considerably on the angle of inclination of the dispensing device relative to the vertical, thus a lack of inclination can influence the quantity of mixture delivered and generate an underdose or an overdose.The satisfactory angle of inclination may be predetermined according to the nature of the mixture. It will be noted that the warning means advantageously make it possible to warn the user of a good and / or bad inclination. It will also be noted that it is possible to connect the inclination detection means to a locking mechanism which would prevent the delivery of the mixture when the angle of inclination is not satisfactory. Preferably, the inclination detection means comprise information processing means which may be the same as those included in the agitation detection means. - The dispensing device comprises means for putting the agitation detection means and / or the tilt detection means into standby mode, activated for example after a period of non-agitation of the dispensing device or when a protective cap is fitted to the dispensing device. Putting the agitation detection means or the tilt detection means into standby mode makes it possible to reduce their energy consumption and extend their service life. - The agitation detection means are arranged in a non-visible manner on the dispensing device. Preferably, they are arranged in empty spaces of the nozzle, under a protective casing of a reservoir of the dispensing device or even integrated into plastic components during overmolding or on the surface during molding or in rework after molding. Although the agitation detection means are generally autonomous, they can also be incorporated into an existing electronic system of the dispensing device so as to pool different elements such as the support or the power supply. In addition to aesthetic or protection reasons, the fact that the agitation detection means are arranged in a non-visible manner makes it possible not to clutter the exterior of the dispensing device. - The agitation detection means are arranged in a visible manner on the dispensing device, for example around the protective casing of the dispensing device or in a ring around the tip. Thus, it is easy to integrate them into existing dispensing devices, optionally after manufacture, without having to modify the interior of the dispensing device which is often more complex and less accessible. - The agitation detection means are arranged on a support card, for example attached to the dispensing device by snap-fastening, welding, crimping, riveting or even gluing, overmolded in a component of the dispensing device, or even constituted by an element of the dispensing device on which the detection means, or even other electronic components, are fixed, for example by welding. - The warning means include an optical warning device, such as an LED (light-emitting diode) or a display, an audible or vibrating indicator. For example, the use of one or more LEDs capable of emitting two colors will alert the user of good or bad shaking. Preferably, this light is visible regardless of where the dispensing device is held or its orientation. The LED(s) can, for example, be placed around the tip of the device, thus avoiding being hidden by the user's fingers. - The operation of the agitation detection means is independent of the quantity of mixture in the dispensing device. Thus, agitation detection can be carried out in an identical manner and according to the same criteria throughout the duration of use of the dispensing device. - The dispensing device comprises means for detecting the closing of the dispensing device. Thus, it is possible to detect a failure to close the dispensing device, or even a poor closure, and therefore risks of contamination or evaporation of the mixture contained in a reservoir or in a volume downstream of a valve. These means are advantageously configured to detect the end of use of the dispensing device and / or the presence of a protective cap. The detection of the end of use of the dispensing device can be carried out using possible means for activating the agitation detection means which would be in a non-activated configuration, for example when there is no pressure from the user or when a switch is closed. The detection of the end of use of the dispensing device can also be carried out by an absence of agitation or tilting for a predefined period.Where appropriate, warning means are provided to alert the user of an oversight or incorrect closing of the dispensing device. The invention will be better understood by reading the attached figures, which are provided as examples and are not limiting in nature, in which: - figure 1 is a schematic view in longitudinal section of a part of a distribution device according to one embodiment, - Figure 2 is a schematic longitudinal sectional view of a dispensing device illustrating different positions of the agitation detection system, - Figure 3 is a schematic view of an activation locking mechanism usable on the dispensing device of Figure 1, and - Figure 4 is a diagram illustrating the operation of a distribution device such as that of Figure 1. A device for dispensing a pharmaceutical preparation, for example in liquid form, as shown in FIG. 1, comprises for example a nasal tip 10, according to one embodiment. The nasal tip 10 comprises a detection system stirring of the distribution device, comprising - agitation detection means 12, configured to detect whether sufficient agitation of the dispensing device has been carried out by a user, - warning means 14, controlled by the agitation detection means 12 and configured to warn the user that sufficient agitation of the dispensing device has been carried out. The agitation detection means 12 comprise a sensor 16, configured to provide a characteristic quantity of agitation of the dispensing device. In this example, the agitation detection means 12 are arranged to measure an acceleration of the dispensing device, by means of an acceleration sensor or accelerometer 16. Thus sufficient agitation is detected when the characteristic quantity, namely the acceleration of the dispensing device recorded by the accelerometer 16, exceeds a predetermined threshold, for example 3 g (gravitational).More specifically, the agitation detection means 12 detect sufficient agitation of the dispensing device when the predetermined threshold is exceeded a minimum number of times during a given time interval, for example more than three times, preferably more than five times, for example 5 exceedances of the 3 g threshold during a time interval of less than 30 seconds, for example less than 10 seconds. As shown in Figure 1, the accelerometer 16 is placed here on a support card 20, for example an electronic card, of cylindrical shape, arranged inside an annular skirt 22 of the nasal tip 10. Thus, the agitation detection means 12 are arranged in a non-visible manner on the dispensing device. Alternatively, they can be arranged at one of the locations indicated by the rectangles 24a, 24b and 24c of Figure 2. They could also be arranged in a visible manner on the dispensing device, for example by replacing a ring 26 around the nasal tip 10 of the dispensing device. The agitation detection means 12 also comprise means 18 for processing the information provided by the sensor 16, which here comprise a microcontroller 18. These processing means 18 are configured to control the warning means 14 to warn the user that sufficient agitation of the dispensing device has been carried out, after having analyzed the information provided by the sensor 16, for example an accelerometer. The microcontroller 18 can be integrated, as shown in FIG. 1, into the electronic card 20 on which is also arranged the accelerometer 16. Other electronic components can also be integrated into the electronic card 20 to provide other functions, for example an inclinometer. In this particularly advantageous case, the dispensing device comprises inclination detection means, the inclinometer, configured to detect a satisfactory inclination of the dispensing device relative to a vertical direction, the satisfactory inclination being predefined quantitatively, for example greater than 30°. These inclination detection means also control the warning means 14. They are advantageously arranged in a non-visible manner on the dispensing device. The inclinometer can be connected to the microcontroller 18 which thus makes it possible to process both the information provided by the accelerometer 16 and by the inclinometer. In Figure 1, the warning means 14 are LEDs which make it possible to indicate whether the agitation is sufficient or not by displaying, for example, the color green or red. The LED(s) may be surrounded by a transparent ring which circumferentially diffuses the light emitted by these LEDs, placed for example at location 26. The warning means 14 may also be a display, in the form of a screen displaying a message, an audible or even vibrating warning device. In addition, the nasal tip 10 may comprise activation means, configured to activate the agitation detection means 12, which comprise for example: a switch actuated directly by the user, which may for example be located on the outer wall of the annular skirt 22; switch means actuated when a protective cap of the dispensing device is opened, such as a mechanical or magnetic contactor or a brightness detector; or contact detection means arranged on a surface of the dispensing device capable of being manipulated by the user, such as a finger rest surface 23 of the dispensing device extending transversely to the annular skirt 22, as shown in FIG. 1. The nasal tip 10 may also comprise means for putting the agitation detection means 12 and / or tilt detection means on standby, activated for example after a period of non-agitation of the dispensing device or when a protective cap is attached to the dispensing device. These standby means may also be integrated into the electronic card 20. The nasal tip 10 may also include a locking mechanism 30 for blocking the dispensing of liquid, for example by preventing the removal of a protective cap or by blocking the activation means of the dispensing device, in cases where insufficient or no agitation has been detected by the agitation detection means 12, or when the agitation detection means 12 are deactivated. Figure 3 shows an example of such a locking mechanism 30, comprising two hooks 32a and 32b. One of the hooks, for example hook 32b, has a rotation axis 34, fixedly mounted on the dispensing device so that hook 32b can rotate relative to this axis 34. The other hook, for example hook 32a, is securely connected to another element of the dispensing device, for example a protective cap of the nasal tip 10.The hooks 32a and 32b each have a co-operating surface, for example in an “L” shape, arranged so that they can block a movement of the cap in a defined direction when the hooks 32a and 32b are in a locking position indicated by the letter A. In the case of Figure 3, the upward movement of the cap is blocked when the hooks 32a and 32b are in the locking position A where the hook 32b is held by a spring 39. To unlock the movement of the cap, a rotation of the hook 32b is necessary to move the hooks 32a and 32b into an unlocking position indicated by the letter B, where the hook 32a is free to perform an upward movement.The movement of the hook 32b can be carried out for example by means of a magnetic control system 36 which comprises a solenoid 38 and a magnet 40, the solenoid 38 being powered so as to move the hook 32b away from the hook 32a by causing the hook 32b to rotate. When the magnetic control system 36 stops operating, the hook 32b is returned to the locking position A by the spring 39. The power supply system of the solenoid 38 can be common with that of one or more of the components of the electronic card 20 such as the agitation detection means 12, the warning means 14 and / or the inclinometer. Part of the operation of the dispensing device such as that comprising the nasal nozzle 10 will now be described, with reference to FIG. 4. When the user begins to use the dispensing device, the agitation detection system is first activated during a step 46, either actively by the user via a switch, or passively upon opening a protective cap or upon picking up the dispensing device. During this step 46, the accelerometer 16 is activated. Once the agitation detection system is activated, the warning means 14 transmit a negative signal to the user during a step 48, for example by displaying the message “No ready" or by emitting a red light. Simultaneously with this step 48, a time counter located in the processing means 18 is started, during a step 50. Step 50 is followed by a test step 52 on the number of times the agitation detection means 12 detect the exceeding of the acceleration threshold of 3g during a given time interval. If in a predefined time interval t=T 1, for example less than 30 seconds, the agitation detection means 12 detect at least five times the exceeding of the threshold of 3 g in the case of an acceleration measurement, then we move on to a step 54 during which the warning means 14 transmit a positive signal to the user, for example by displaying the message “Ready” or by emitting a green light or by producing an audible signal or even by unlocking the protective cap if it was previously blocked by the locking mechanism 30.In this case, the user can then dispense the pharmaceutical preparation under satisfactory conditions of use for a predefined duration t=T2, for example more than 60 seconds. At the end of the duration t=T2, a step 56 is passed during which the warning means provide a negative signal. At the end of a predefined duration t=T3 elapsing after T2, for example more than 10 seconds, a step 58 can then be passed during which any standby means are activated, thus deactivating the agitation detection system and / or activating the locking mechanism to block the use of the dispensing device.Furthermore, at the end of test 52, if after activation of the agitation detection means 12, and during the period T1, the agitation detection means 12 do not detect the exceeding of the threshold of 3g five times, which is predetermined as being insufficient agitation, then we go directly to step 56 during which the warning means 14 provide a negative signal, without going through step 54 authorizing distribution. At the end of the standby step 58, we can return to step 46 of activation of the agitation detection system. It is understood that thanks to the dispensing device or the operation described above, satisfactory agitation of the pharmaceutical preparation which is dispensed is guaranteed. The invention is not limited to the examples presented above and other embodiments will become clear to those skilled in the art. In particular, it is understood that such a dispensing device could be used for any type of dispensing, for example in the form of drops, spray, jet, mist, to dispense an ophthalmic, nasal, oral or even auricular preparation, in combination with various dispensing means such as a non-return sealing membrane, a valve with aerosol, a pump, or even a simple tip equipped with a distribution channel connected to the reservoir. A distribution device according to the invention in the form of a syringe, or any other similar device intended for parenteral injection, can also be provided with agitation detection means and warning means.

Claims

CLAIMS 1. Device for dispensing pharmaceutical preparation, for example in liquid form, characterized in that it comprises a system for detecting agitation of the dispensing device, comprising: - agitation detection means (12), configured to detect whether sufficient agitation of the dispensing device has been carried out by a user, - warning means (14), controlled by the agitation detection means and configured to warn the user that sufficient agitation of the dispensing device has been carried out, - activation means (12), configured to activate the agitation detection means, comprising for example, a switch actuated directly by the user, switch means actuated when a protective cap of the dispensing device is opened, such as a mechanical or magnetic contactor or a brightness detector, or contact detection means arranged on a surface of the dispensing device capable of being manipulated by the user, such as a finger rest surface of the dispensing device.

2. Dispensing device according to claim 1, in which the agitation detection means (12) comprise a sensor (16), configured to provide a quantity characteristic of agitation of the dispensing device, and means for processing the information (18) provided by the sensor (16), these information processing means (18) being configured to control the warning means (14).

3. Dispensing device according to any one of the preceding claims, wherein the agitation detection means (12) are arranged to measure an acceleration of the dispensing device.

4. Dispensing device according to claim 2, in which the agitation detection means (12) detect sufficient agitation when the characteristic quantity exceeds a predetermined threshold, for example an acceleration of the dispensing device of at least 3 g (gravitational).

5. Dispensing device according to the preceding claim, in which the agitation detection means (12) detect sufficient agitation of the dispensing device when the predetermined threshold is exceeded a minimum number of times during a given time interval, for example more than three times, preferably more than five times. for a time interval of less than 30 seconds, preferably less than 10 seconds.

6. A dispensing device according to any preceding claim, comprising a locking mechanism (30) for blocking the dispensing of liquid (e.g. by preventing the removal of a protective cap) in cases where insufficient or no agitation has been detected by the agitation detection means (12), or when the agitation detection means (12) are deactivated.

7. Dispensing device according to any one of the preceding claims, further comprising inclination detection means, for example an inclinometer, configured to detect a satisfactory inclination of the dispensing device with respect to a vertical direction, the satisfactory inclination being predefined quantitatively, for example greater than 30°, these inclination detection means also controlling the warning means (14), the inclination detection means preferably being arranged in a non-visible manner.

8. Dispensing device according to any one of the preceding claims, comprising means for putting the agitation detection means (12) and / or tilt detection means into standby mode, activated for example after a period of non-agitation of the dispensing device or when a protective cap is fitted to the dispensing device.

9. Dispensing device according to any one of the preceding claims, in which the agitation detection means (12) are arranged in a non-visible manner on the dispensing device.

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