MXPA97003812A

MXPA97003812A - Device indicating the dose, to be provided on an inhala

Info

Publication number: MXPA97003812A
Application number: MXPA/A/1997/003812A
Authority: MX
Inventors: Lindahl Janeric; Wetterlin Kjell
Original assignee: Astra Ab
Priority date: 1994-11-29
Filing date: 1997-05-23
Publication date: 1997-08-01

Abstract

A device is described indicating the dose, to be provided with an inhaler, preferably a dry powder inhaler, operated by respiration, designed to contain multiple doses of a medicament containing an active substance, the inhaler has operating means that they comprise a maneuvering element for loading a dose of the medicament into a dosage unit and providing the dose in a position for inhalation, wherein the device indicating the dose is provided as a separate unit to be placed on the element of inhalation. maneuvering the inhaler and because it comprises a first element to be provided on and around the external wall surface of the operating element of the inhaler, a second element provided on and around the external surface of the first element, the second element is rotatable in relation to to the first element, means of interruption provided on the first and second elements that limit the length d of the relative movement between the elements and recording / indication for recording the movement of the maneuvering element and by feeding a dose to the inhalation channel when the inhaler is activated for inhalation, the recording / indication means are provided as parts of the first and second elements

Description

DEVICE INDICATING THE DOSE, TO BE PROVIDED ON AN INHALER FIELD OF THE INVENTION The present invention relates to a device indicating the dose, proposed to be provided in an inhaler, preferably a dry powder inhaler, operated by breathing, designed for multiple doses of a medicament containing an active substance , the inhaler has means of operation comprising a maneuvering element for loading a dose of the medicament into a dosage unit and providing the dose in a position for inhalation as described in the first part of claim 1.

BACKGROUND OF THE INVENTION [0002] Nowadays, most of the multi-dose inhalers used for the treatment of diseases in the bronchial area do not have a device that indicates the dose or have a device that indicates only when the storage compartment is empty. Thus, there is a great need among the users of such inhalers, patients also as treatment doctors and especially among parents who have children who use these dry powder inhalers, that the inhalers must be provided with a device indicating the dose, that - indicate each dose as well as the number of doses supplied from the storage of the medication in order to have the possibility to see how many doses are left in the inhaler. This could also be used to determine REF: 24648 how many doses have been delivered during a certain period of time in order to establish the correct therapy form.

Description of the Prior Art In the multi-dose, dry-breathing, dry powder inhaler, of the type described schematically in EP-A-0 069715 and EP-A-0 237 507 and sold under the trademark Turbohaler®, a device that indicates the dose has been integrated into the construction. This device indicating the dose indicates when 20 doses of the medication remain in the storage chamber of the inhaler and when there is nothing left of the medication for inhalation. This indicating device is described in EP-A-0 258 238. For this type of inhaler a device has also been constructed that indicates the dose, which indicates every 25a. dose until only 20 doses remain and one indication of each 5a. dose after this. Such a device can be seen in WO SE93 / 00389. The known devices are all more or less inaccurate and do not provide a system indicating the dose in which each dose fed is indicated and / or recorded. In addition, all known metering devices provided in such inhalers are not only complicated to produce themselves but also make the production of the orifices of the inhalers more complicated. Such devices are also expensive and take up a lot of space inside the inhalers.

Brief description of the invention The present invention relates to a device that indicates the dose, which solves the problems mentioned above. According to the invention, a device indicating the dose is provided, which is provided as a separate unit to be placed on the maneuvering element of the inhaler. The device indicating the dose comprises a first element to be provided on and around the maneuvering element, a second element provided on and around the external surface of the first element, the second element is rotatable in relation to the first element, means of interruption provided on the first and second elements that limit the length of relative movement between the elements and recording / indication means for recording the movement of the maneuvering element and by this feeding a dose to the inhalation channel when the inhaler is activated for the inhalation, the recording / indication means are provided with parts of the first and second elements as described in the characterizing part of claim 1. Since each rotation of the operating element and thereby the dosage unit, will make move a dose in the dosage unit from the position where the dosing unit is loaded to a position in the inhalation channel ready for inhalation, the construction of the means indicating the dose as described in the claim 1 will match and indicate each dose activated for inhalation. Thus, the device is easy to manufacture, to be mounted on the maneuvering element of the inhaler and to be used by the patient.

The device indicating the dose is hereby constructed as a unit to be placed on the maneuvering element of the operating means of an inhaler of the aforementioned type. If preferred, this can be removably mounted to be removed after the inhaler has been emptied and placed on a new inhaler. The device according to the invention provides a device which is exact and which coincides and indicates each dose moved to its position for inhalation in the inhalation channel. It is constructed in a way which makes it flexible in its construction as it can be easily modified to different demands and requirements, easy to manufacture and easy to use. The two main parts of the device, the first and second elements are preferably formed as cylinders. A viewing hole for displaying the number of the actual dose placed in the inhalation channel is provided on the second element. The interrupting means preferably comprise projections and holes provided on the external surface of the first element and on the internal surface of the second element respectively and arranged to coact with each other when the operation operating means of the inhaler is activated for inhalation. The recording / indication means could be either mechanical or electronic. The mechanical recording / indicating means could have different constructions. In one embodiment, the device comprises a number wheel (or wheel with numbers) and a gear wheel provided in the second cylinder and a drive arm provided on the inner wall of the first cylinder, the drive arm pushes the teeth of the gear wheel one step, to rotate the number wheel by this, in order to move a new digit to the display position in the viewing hole of the second cylinder when the maneuvering element and thereby the first cylinder are rotated. It could also comprise a digital tape provided on at least one roller having a gear wheel provided in the first cylinder and a driving arm provided on the inner wall of the second cylinder, the driving arm pushes the teeth of the gear wheel one step , to rotate the roller with the digital tape by this, in order to move a new digit to the display position in the viewing hole in the second cylinder when the maneuvering element and thereby the first cylinder are rotated. Another possible modification of a mechanical recording / indicating device comprises a digital disk (or disc with numbers) having a driving wheel with tiers and a driving arm provided on the inner wall of the first cylinder, the driving arm pushes the tiers of the wheel will drive one step, to rotate the digital disk by this in order to move a new digit to the display position in the viewing hole in the second cylinder, when the maneuvering element and thereby the first cylinder are rotated .

In this embodiment, a guide path along which the digits are provided and because a disk with holes is provided adjacent to the digital disk, thereby providing an amplification device in the hole of the disk with holes and moving along the guide path when the cylinders move one in relation to the other. The recording / indicating device could also comprise a gear wheel that is fixed to the first cylinder and an internal and external numerical disk that are provided with teeth, whereby the teeth of the gear wheel coact with the teeth of the internal numerical disk and move relative to the inner disk, whereby a new digit is moved to the display position in the viewing hole when the maneuvering element and thereby the first cylinder is rotated. At present the internal and external discs are preferably provided with internal and external numerical discs with hundreds and tens digits and the unit digits in order to make it possible to register 199 doses. In the modality that includes an electronic recording / indication device, the means for indicating the number of the dose positioned in the inhalation consists of a circuit board comprising a microphone, a battery, a microprocessor and a microswitch. In this mode the microphone detects a click sound which is created when the maneuvering element is rotated, in which the first cylinder is provided with a projection which activates the microswitch when the cylinder is rotated and in which the impulse of Microphone sound and microswitch pulse activate the microprocessor which will display a new digit in the display hole. Indications, preferably as marks, are provided in the housing and the maneuvering element of the inhaler or the first element of the recording / indicating device, to be used to indicate whether the maneuvering element and by this the first element have been rotated. to your retention limits when the inhaler has been activated for inhalation. The recording / indicating device according to the invention is proposed to be used in connection with an inhaler. It is proposed to be placed on the inhaler, which is preferably a multi-dose inhaler, powered by breathing, of dry powder, more preferably of the type sold under the trademark Turbuhaler®.

BRIEF DESCRIPTION OF THE DRAWINGS The device indicating the dose, according to the present invention, will now be described by way of example with reference to the accompanying drawings, in which Figures 1 and 2 are elevation views of a first preferred embodiment of The invention, Figure 3 is an elevation view of a second preferred embodiment of the invention, Figures 4 and 5 are elevational views of a third preferred embodiment of the invention, Figures 6 and 7 are elevational views of a fourth Preferred embodiment of the invention, Figures 8 and 9 are elevational views of a fifth preferred embodiment of the invention, Figure 10 shows an inhaler of the preferred type and a device indicating the dose, according to the invention.

DETAILED DESCRIPTION OF THE INVENTION The device according to the invention is proposed to be used in connection with an inhaler, for example the multi-dose inhaler, of dry powder, operated by breathing, registered and sold under the name Turbohaler®. The indicating device could naturally be modified within the scope of the appended claims for use with any dry powder inhaler, which, when activated, places a dose of the medicament in an inhalation channel. The preferred inhaler is provided with operating means comprising a maneuvering element A, shown in FIG. 10 only, which, when rotated by the user, moves a dosing unit from a loading position, in which a predetermined dose of the medicament is dosed to the dosage unit and an inhalation position where the dose is placed in the inhalation channel, is released and transported via the inhalation air through the channel to a nozzle and to the user. The rotation of the maneuvering element and by this the dosing unit is carried out in two directions, each rotation is limited by holding means. The Turbuhaler® and its function is described in EP-A-0 069 715 and EP-A-0 237 507, see also figure 10. In order to protect the inhaler from moisture and contamination, it is provided with a cover (not shown). The main construction of the device indicating the dose according to the invention will be seen in figures 1 to 9 and comprises a first element in the form of a cylinder 1 having a lower plate. This first element or cylinder is adapted to fit over the maneuvering element A of the inhaler and follows the movement of the maneuvering element when it is rotated. The first cylinder could be applied to the operating element A by snap-fitting or any other method such as bolting, by using a bayonet fitting or by using any kind of male-female connection, that is, by providing bolts on a part, which are joined with corresponding holes in the other part. On the external surface of the first cylinder projections 3 are provided. A second element 2 is provided and has the form of a second cylinder. The internal diameter of the second cylinder is only slightly larger than the outer diameter of the outer surface of the first cylinder in order to be provided around the external surface of the first cylinder 1, by which the second cylinder is movable tangentially and in relation to the first cylinder 1. Holes 4 are provided, which are preferably oblong, on the walls of the second cylinder 2. When the second cylinder is placed on the first cylinder, the projections 3 will enter the oblong holes 4. The holes 4 allow the projections 3 move a predetermined trajectory when the cylinders move one in relation to the other, in order to limit the movement. The second cylinder could be loaded by spring in relation to the first cylinder. In order to prevent the accidental rotation of the operating element in the modalities that have mechanical dose indicating devices and by this a record of a dose fed when the inhaler cover is unscrewed and screwed from the main body of the inhaler, a fixing ring 9 can be connected to the first cylinder 1. This fixing ring 9 is pressed downwards by the cover when it is screwed on the inhaler, thereby preventing the first 1 and second cylinders 2 from moving one on the other. relationship to the other. In the first embodiment, the mechanical dose indicating means are provided within the second cylinder, as can be seen in figures 1 and 2. A driving arm 5 is provided in the bottom of the first cylinder 1. A registration unit and indication 7 with a numerical wheel 7a is provided in the second cylinder 2. A display window 8 is also provided in the second cylinder, in which the numbers of the number wheel are shown. When the cylinders 1 and 2 move one in relation to the other, the driving arm 5 coact with a gear wheel 6 provided on the number wheel 7, which rotates the wheel one step and a new number corresponding to the number of doses placed in the inhalation channel is shown through the viewing window 8.

A second embodiment of the device indicating the dose will be seen in Figure 3. In this embodiment, the main construction of the device corresponds to the construction described in relation to the first embodiment. The first and second cylinders are provided in the same manner, but the indicating unit is provided as a tape with digits placed on the first cylinder 1. A driving arm 10 is provided on the inner wall of the second cylinder 2 and coact with a gears 11. Gear wheel 11 is provided on a roller on which the numerical tape - at its end is provided. The other end of the number band 12 is provided on a second roller 11a. A guide element 11b is provided between the two rollers 11 and 11b as can be seen in figure 3. When the cylinders move one relative to the other during the rotation of the operating element A, the driving arm 10 causes the gears to move of the wheel 11 and the tape moves one step forward. A display window 13 is provided on the wall of the second cylinder 2 where the digits of the tape, corresponding to the number of the dose are shown. In Figures 4 and 5 a third embodiment of the invention is shown. The main construction of the device that indicates the dose according to this modality corresponds to the construction described in relation to the first modality. A driving arm 15 is provided in the lower plate of the first cylinder 1. The lower plate of the first cylinder 1 is provided with a shaft projecting from the first cylinder 2. The indicating means comprises a driving wheel 14 with tiers 14a and a hole 14b , a numerical disk 16 having a projection 16b, a disk with holes 18, an amplification device 17 and a cover disk 19. The number wheel 16 has a spiral guide path 16a, along which are provided the digits When the device indicating the dose according to this embodiment is mounted, the driving wheel 14 is placed on the axis of the first cylinder, in such a way that the driving arm 15 coactuates with the teeth 14a. The digital disk 16 is provided with the projection 16b projecting to the hole 14b of the driving wheel. The disk with holes 18 is placed adjacent to the numerical disk 16 and the amplification device 17 is placed in the hole 18a of the disk with holes. The cover disk 19 is provided with a viewing hole 19a in which the amplification device 17 is placed. A transparent bottom plate 20 is placed in the second cylinder and the first and second cylinders are joined together in the manner mentioned above. When the maneuvering element A of the inhaler is rotated, the driving arm 15 of the first cylinder causes the driving wheel 14 to move one step, in order to move the digital disk by a step. The amplification device 17 is provided on the spirally formed path 16a of the digital disk, where the digits are placed and when the cylinders move one relative to the other a new digit will enter the area of the amplification device 17 and can be seen through the viewing hole 19a in the cover disc 19 and the transparent bottom plate 20. Figures 6 and 7 describe a further embodiment of the invention, wherein the main construction of the device indicating the dose is the same as in the modalities described above. As can be seen in Figure 6, the lower plate of the first cylinder 1 is provided with the protruding shaft. The means for indicating and recording the doses comprises a gear wheel 24, an internal numerical disk 23 and an external numerical disk 22 having a lower part with an annular hole 22b. The gear wheel 24 is mounted in the hole in the bottom plate of the first cylinder. The internal numerical disc 23 is mounted on the protruding shaft and is provided with teeth which coact with the gear wheel 24. The external numerical disk 22 is provided with teeth 22a and is mounted on the second cylinder in such a way that a driving arm 21 provided on the second cylinder coactuates with the teeth of the external numerical disk 22. The digits are provide on the bottom of the number discs in a manner which will be described below. The number of the fed dose is shown through a viewing window 25a in the lower plate 25 of the second cylinder 2. The relative movement between the first cylinder and the second cylinder is transmitted via the driving arm (21) to the external numerical disk (22) The gear wheel (24) transmits the movement to the internal numerical disk (23). Due to the marking of the discs, a high quantity of doses can be registered and indicated. The digits are provided along the periphery of the bottom of each digital ring. When assembled together, the inner disk 23 will be placed inside the outer disk and the digits of the inner disk 23 will be seen in the annular hole 22b of the lower part of the outer ring 22. In the preferred embodiment, the outer disk has a marking from 0 - 9 in one half of the disc and a score of 0 - 9 in the other half. The internal numerical disk (23) has the dialing of 00-19. When the 10th dose is activated and moved to the position for inhalation, the second 0 on the external numerical disk will be displayed in a display window (25a) in the bottom plate. At the same time a tooth is affected on the inner side of the external numerical disc (22) by the gear wheel (24) to rotate by this the internal disk (23) from 00 to 91. In doses 11 to 19, only the external disk is affected. In the number of doses 20, a 0 will be displayed on the external disk and at the same time a tooth on the inner surface of the disk will rotate the internal disk 22 from 01 to 02. A fifth embodiment of the present invention will be seen in the figures 8 and 9. This embodiment describes a device that indicates the dose in which the recording and indication means are electronic. This device provides a certain record of other parameters as well, such as for example a record of the time intervals between activation of the maneuvering element. The main parts of the device are the same as those described above, for example a first cylinder 1 constructed to be placed on the maneuvering element of an inhaler and a second cylinder 2 provided around the first cylinder and movable relative thereto. The movement is limited by the projections 3 on the outer surface of the first cylinder and by the oblong holes 4 in the walls of the second cylinder.

The recording and indicating means are provided as parts on a circuit board 26 and on a battery 27, a microphone 28, a microprocessor 29, a microswitch 30, a screen 31 and a registration selector 33. The lower plate of the first cylinder is provided with a projection 32 and the lower plate of the second cylinder is provided with a display window 35 and a hole 34 for the registration selector 33. When the maneuvering element of the inhaler moves to the position where the dose is fed to the dosing unit, a clicking sound is created in the maneuvering element. This clicking sound is recorded by the microphone 28. When the operating element A and thus the dosing unit are moved to the position for inhalation, the micro-switch 30 is affected by the projection 32 of the first cylinder. The sound pulse of the microphone 28 and the electrical pulse of the microswitch 30 must be recorded by the microprocessor 29 before the indication of the dose is shown on the screen 31. The electronic recording and indication device provides the possibility to record different data , such as the number of doses taken from the inhaler or the number of remaining doses, also as the time from the last dose or the total amount of doses taken during a specific period of time, for example a week or a similar period. The register selector 33 makes it possible to switch between different registers in the microprocessor, which gives the doctor and the patient the possibility of a more complete record of the patient's compliance in order to optimize the treatment. It is possible to provide separate sets to restore different records to their initial positions. In order to facilitate for the user of the inhaler, the grinding element and consequently the dosing unit and the priper elßnepto of the recording / indication device have been rotated by the trajectory required to move a charged dose to its position in the inhalation channel, indications could be provided. Such indications are preferably provided as marks on the outer surface of the housing and the maneuvering element of the inhaler or on the housing of the inhaler and the first element of the recording / indicating device. The indications are provided by this to indicate the limits of retention in the rotation in both directions.

Possible modifications The device indicating the dose according to the present invention could of course be modified within the scope of the appended claims. In the preferred embodiments, the first and second elements are cylinders formed, but could have any other appropriate shape. The different parts of the device according to the invention are preferably made of plastics or composite materials, but any other material could be used. As already mentioned above, the device is designed to be used in connection with a multi-dose inhaler, powered by breathing, of dry powder, of the kind sold under the trademark Turbuhaler®, but could be easily modified within the scope of the claims to be used with any other dry powder inhaler having a maneuvering unit, which is rotated when the inhaler is activated for inhalation.

It is noted that in relation to this date, the best method known by the applicant to carry out the aforementioned invention, is the conventional one for the manufacture of the objects referred to therein.

Having described the invention as above, property is claimed as contained in the following

Claims

Claims 1. A device indicating the dose to be provided on an inhaler, preferably a dry powder inhaler, operated by breathing, designed to contain multiple doses of a medicament containing an active substance, the inhaler has operating means that they comprise a maneuvering element for loading a dose of the medication into a dosage unit and providing the dose in a position for inhalation, characterized in that the device indicating the dose is provided as a separate unit to be placed on the operating element of the device. inhaler and because it comprises a first element to be provided on and around the external wall surface of the inhaler maneuvering element, a second element provided on and around the outer surface of the first element, the second element is rotatable in relation to the first element, means of interruption provided on the first and second elements which limit the length of relative movement between the elements, and recording / indication means for recording the movement of the maneuvering element and by this feeding a dose to the inhalation channel when the inhaler is activated for inhalation, the means of Registration / inhalation are provided as parts of the first and second elements.
2. The device indicating the dose according to claim 1, characterized in that the first and second elements are cylinders formed and that the second cylinder is provided with a viewing hole.
3. The device indicating the dose according to claim 1, characterized in that the interrupting means are provided as projections on the outer surface of the first cylinder and holes on the internal surface of the second cylinder, the projections and the orifices are arranged to coact when the operating means of the inhaler are activated for inhalation.
4. The device indicating the dose according to claim 1, characterized in that the means for recording and indicating the dose are mechanical.
5. The device indicating the dose according to claim 1, characterized in that the means for recording and indicating the dose are electronic.
6. The device indicating the dose according to claim 4, characterized in that the means for indicating the dose fed comprises a number wheel having a gear wheel provided in the second cylinder and a driving arm provided on the internal wall of the first cylinder, the driving arm pushes the teeth of the gear wheel by one step, to thereby rotate the number wheel in order to move a new digit to the display position in the viewing hole of the second cylinder when the maneuvering element and by this the first cylinder is rotated.
7. The device indicating the dose according to claim 4, characterized in that the means for indicating the dose fed comprise a digital tape provided on at least one roller having a gear wheel provided in the first cylinder and a driving arm provided on the inner wall of the second cylinder, the driving arm drives the teeth of the gear wheel by one step, to thereby rotate the roller with the digital tape, in order to move a new digit to the display position in the opening hole of the second cylinder, when the maneuvering element and by this the first cylinder are rotated.
8. The device indicating the dose according to claim 4, characterized in that the means for indicating the dose comprise a digital disk having a driving wheel with steps and a driving arm provided on the inner wall of the first cylinder, the driving arm pushes the steps of the driving wheel by a step, to rotate by this the numerical disk, in order to move a new digit to the viewing position in the viewing hole in the second cylinder when the maneuvering element and by this The first cylinder is rotated.
9. The device indicating the dose according to claim 8, characterized in that the digital disk is provided with a guiding path along which the digits are provided and because a disk with holes is provided adjacent to the digital disk, by which an amplification device is provided in the orifice of the disk with holes and moves along the guide path when the cylinders move one in relation to the other.
10. The device indicating the dose according to claim 4, characterized in that the means for indicating the dose fed comprises a gear wheel that is fixed to the first cylinder and an internal numerical disk and an external numerical disk provided with teeth, whereby the teeth of the gear wheel coact with the teeth of the internal numerical disk and move in relation to the external disk, whereby a new digit will move to the position of display in the exhibition hole when the maneuvering element and by this The first cylinder is rotated.
11. The device indicating the dose according to claim 10, characterized in that the internal and external numerical discs are provided with hundreds and tens digits and the units digits, in order to make it possible to register 199 doses.
12. The device indicating the dose according to claim 5, characterized in that the means for indicating the number of the dose, positioned in the inhalation channel, consist of a circuit board comprising a microphone, a battery, a microprocessor and a microprocessor. microswitch.
13. The device indicating the dose according to claim 12, characterized in that the microphone detects a clicking sound which is created when the operating element is rotated, because the first cylinder is provided with a projection which activates the microswitch when the cylinder is rotated and because the sound impulse of the microphone and the impulse of the microswitch activates the microprocessor which will show a new digit in the display hole.
14. The device indicating the dose according to any of the preceding claims, characterized in that indications are provided in the housing and the maneuvering element or the first inhaler element indicates whether the operating means have been moved to their retention limits when the inhaler has been activated for inhalation.
15. The use according to claim 14, characterized in that the inhaler is a multi-dose inhaler, powered by breathing, of dry powder.
16. The use according to claim 15, characterized in that the inhaler is a Turbuhaler®.
17. The device indicating the dose according to any of claims 1 to 14, characterized in that it is used with an inhaler adapted for the treatment of diseases in the bronchial area.