NASAL APPLICATOR

Abstract

A nasal applicator for nasally applying medicinal active ingredients, comprising a dispensing pin which is introduced into a nostril, a active ingredient store arranged in an applicator housing, and a dispensing metering device. A transmitting device is designed so as to be engageable and disengageable between an actuation button and the dispensing metering device such that when the transmitting device is disengaged, the actuation button is moved in the open passage without a transmission to the dispensing metering device. A movement sensor is provided for detecting movements of the operating button, and a coupling switch is provided for engaging the transmitting device depending on a signal of the movement sensor. To generate a consistent spray pattern, the dispensing metering device comprises a pretensioning mechanism which can be tensioned or released to actuate a metering conveyor with a defined pretensioning force, wherein the engaged transmitting device can tension or release the pretensioning mechanism.

Claims

1-20. (canceled)

21. A nasal applicator for nasal administration of medicinal active ingredients, comprising: an active ingredient store arranged in an applicator housing; a dispensing pin which is configured to be introduced into a nostril; and a dispensing meter for a metered dispensing of the active ingredient from an active ingredient container via the dispensing pin, wherein an actuating button movable by hand is provided at a side of the applicator housing and is actuated transversely to a longitudinal direction of the applicator housing to actuate the dispensing meter whose actuation adjustment path is transmitted to the dispensing meter by a transmitter, wherein the transmitter is configured couplable and decouplable so that, with a decoupled transmitter, the actuating button is movable in free travel without transmission to the dispensing meter, and wherein a motion sensor is provided for detecting movements of the actuating button and a coupling switch is provided for coupling the transmitter in dependence on a signal of the motion sensor.

22. The nasal applicator in accordance with claim 21, wherein the coupling switch is released by a control apparatus in dependence on at least one further control parameter selected from the group consisting of an administered dose, a permitted maximum dose, an identification code individual to the patient, a release code, a time switching code, or an RFID signal.

23. The nasal applicator in accordance with claim 21, wherein the coupling switch is configured as working in dependence on the motion sensor such that the transmitter is only coupled when the actuating button is moved back into a starting position after a predetermined number of button actuations and/or release strokes, so that the actuation adjustment path of the actuating button is transmitted to the dispensing meter in a further button stroke.

24. The nasal applicator in accordance with claim 21, wherein the coupling switch has an interval timer for a temporally only limited coupling of the transmitter.

25. The nasal applicator in accordance with claim 21, wherein the coupling switch has a metering stroke circuit for coupling the transmitter for only one metering stroke and/or only an actuation of the dispensing meter.

26. The nasal applicator in accordance with claim 23, wherein the coupling switch and/or the motion sensor has/have a response threshold that leaves small deflections of the actuating button from its starting position out of consideration and only instigates a coupling of the transmitter on an exceeding of the response threshold.

27. The nasal applicator in accordance with claim 23, wherein the predetermined number of button actuations and/or release strokes is a first, free travel button stroke.

28. The nasal applicator in accordance with claim 21, wherein a mechanical blocking apparatus is provided for blocking the actuating button in an unactuated position; and wherein the mechanical blocking apparatus has a movable unblocking button for unblocking the mechanical blocking apparatus and releasing the actuating button.

29. The nasal applicator in accordance with claim 21, wherein the medicinal active ingredients are analgesics.

30. A nasal applicator for nasal administration of medicinal active ingredients, comprising: an active ingredient store arranged in an applicator housing; a dispensing pin which is configured to be introduced into a nostril; and a dispensing meter for a metered dispensing of the active ingredient from an active ingredient container via the dispensing pin, wherein an actuating button movable by hand is movably supported at the applicator housing to be movable relative to the housing and relative to the ingredient container to actuate the dispensing meter whose actuation adjustment path is transmitted to the dispensing meter by a transmitter which is supported movable relative to the applicator housing, the actuating button and the ingredient container, wherein the transmitter is configured couplable and decouplable so that, with a decoupled transmitter, the actuating button is movable in free travel without transmission to the dispensing meter, and wherein a motion sensor is provided for detecting movements of the actuating button and a coupling switch is provided for coupling the transmitter in dependence on a signal of the motion sensor.

31. The nasal applicator in accordance with claim 30, wherein the coupling switch is released by a control apparatus in dependence on at least one further control parameter selected from the group consisting of an administered dose, a permitted maximum dose, an identification code individual to the patient, a release code, a time switching code, and an RFID signal.

32. The nasal applicator in accordance with claim 30, wherein the coupling switch has an interval timer for a temporally only limited coupling of the transmitter.

33. The nasal applicator in accordance with claim 30, wherein the coupling switch has a metering stroke circuit for coupling the transmitter for only one metering stroke and/or only an actuation of the dispensing meter.

34. The nasal applicator in accordance with claim 30, wherein the medicinal active ingredients are analgesics.

35. The nasal applicator in accordance with claim 30, wherein the coupling switch is configured as working in dependence on the motion sensor such that the transmitter is only coupled when the actuating button is moved back into a starting position after a predetermined number of button actuations and/or release strokes, so that the actuation adjustment path of the actuating button is transmitted to the dispensing meter in a further button stroke.

36. A nasal applicator for nasal administration of medicinal active ingredients, comprising: an active ingredient store arranged in an applicator housing; a dispensing pin which is configured to be introduced into a nostril; and a dispensing meter for a metered dispensing of the active ingredient from an active ingredient container via the dispensing pin, wherein an actuating button movable by hand is movably supported at the applicator housing to be movable relative to the housing and relative to the ingredient container to actuate the dispensing meter whose actuation adjustment path is transmitted to the dispensing meter by a transmitter, wherein the dispensing meter has a loadable and releasable preload mechanism for actuating a metering conveyor with a defined preload force, and wherein the preload mechanism is designed as loadable by the transmitter against a retainer which is releasable by the transmitter so that the preload mechanism is loadable as well as releasable by the transmitter.

37. The nasal applicator in accordance with claim 36, wherein the medicinal active ingredients are analgesics.

38. The nasal applicator in accordance with claim 36, wherein the preload mechanism has a toggle lever that is stretchable by the transmitter and loads a spring device against the retainer.

39. The nasal applicator in accordance with claim 38, wherein the transmitter is coupled to the toggle lever in an articulated manner.

Description

BRIEF DESCRIPTION OF THE FIGURES

[0036] The present invention will be explained in more detail in the following with reference to a preferred embodiment and to associated drawings.

[0037] FIG. 1 shows a schematic representation of a nasal applicator in accordance with an advantageous embodiment of the invention in a starting position.

[0038] FIG. 2 shows a schematic representation of the nasal application that shows the interaction with an RFID arm band.

[0039] FIG. 3 shows a sectional, schematic representation of the actuation mechanism for actuating the active ingredient cartridge in a sectional view of the nasal applicator, with the transmitter to be actuated by the actuating button being shown in a decoupled starting position and with the preload apparatus being unloaded.

[0040] FIG. 4 shows a schematic sectional view of the actuation mechanism similar to FIG. 3, with the actuating button being depressed in the free travel in an activation or wake-up mode and having actuated a motion sensor.

[0041] FIG. 5 shows a schematic sectional view of the actuation mechanism similar to FIGS. 3 and 4, with the actuating button being prior to a second actuation stroke and the transmitter having been traveled into its coupling position so that, on a further depression of the actuating button, the spring mechanism of the preload apparatus is loadable.

[0042] FIG. 6 shows a schematic sectional view of the actuation mechanism similar to FIGS. 3 to 5, with the transmitter still being in its coupling position and with the toggling lever mechanism having loaded the preload apparatus by a further depression of the actuating button, with the transmitter just triggering the retainer of the preload apparatus.

[0043] FIG. 7 shows a schematic sectional view of the actuation mechanism similar to FIGS. 3 to 6, with the retainer of the preload apparatus having been triggered and the transmitter having again been brought into a decoupled position.

[0044] As FIG. 1 shows, the nasal applicator 1 can comprise an elongate, approximately cylindrical applicator housing 2 from which a dispensing pin 3 projects at the front face for introduction into a nasal cavity. The housing 2 can form a hand part for gripping the nasal applicator 1 and/or can form a receiving chamber 12 in its interior and can replaceably receive an active ingredient container 13 therein that is connectable to the dispensing pin 3 of the nasal applicator 1. To be able to change the active ingredient container 13, the housing 2 can, for example, be opened by a cover 28, the active ingredient container 13 can be inserted and the cover 28 can then be closed again.

[0045] The active ingredient container 13 together with the dispensing pin 3 can advantageously form a nasal spray cartridge or active ingredient cartridge known per se in which the active ingredient container 13 can be pressed onto the dispensing pin 3 to dispense the active ingredient by this stroke movement or compression movement. As FIG. 1 shows, the total active ingredient cartridge can be inserted into the applicator housing 2 when the cover 28 is removed. Said cover 28 is here pushed over the dispensing pin 3 and holds its fins tight when the cover 28 is closed again. The active ingredient container 13 is displaceably received in the applicator housing 2 so that the function of the active ingredient cartridge is maintained.

[0046] The discharge of the active ingredient from the inserted active ingredient container 13 advantageously takes place by a discharge actuator 26 that can, for example, be provided between the dispensing pin 3 and the active ingredient container 13 by means of which the active ingredient is propelled out of the active ingredient container 13. The active ingredient can here be conveyed via a cannula 16 that extends in the active ingredient container 13 via a pump 29 from where the active ingredient is further conveyed through a line 17 through the nasal pin 3 and is dispensed at the front face opening of the dispensing pin 3. As previously explained, said pump 29 can be integrated into the preconfigured active ingredient cartridge comprising the active ingredient container 13 and the dispensing pin 3.

[0047] To meter the active ingredient amount, said dispensing meter 40 in the form of the active ingredient cartridge in accordance with FIG. 1 can be actuated by an actuating button 9 at the housing 2.

[0048] Said actuating button 9 can, for example, be an actuation lever that is arranged at the peripheral side at the applicator housing 2 and that can be pressed into or moved toward the housing in the radial direction. Such an actuation adjustment movement of the actuating button 9 is transmitted to the dispensing meter via a transmitter 4, with in particular the active ingredient container 13 being able to be axially displaced in the longitudinal direction of the applicator housing 2 onto the dispensing pin 3 to hereby carry out a metering stroke. As FIG. 1 indicates, the movement of the transmitter 4 can be indirectly transmitted to the dispensing meter 40, in particular by means of a lever mechanism that implements the adjustment movement by a lever ratio. Such a lever mechanism 5 can comprise a toggle lever 6 that is supported at the applicator housing 2 and that can be stretched by a movement of the transmitter 4. This stretching movement of the toggle lever 6 can in turn be converted into a loading movement of a preload apparatus 10 that can, for example, have a spring device 11 in the form of a mechanical spring such as a spiral spring. Said preload apparatus 10 can then be triggered to actuate the dispensing meter in said manner.

[0049] The design of the actuation mechanism and said actuation via the preload apparatus 10 will be explained in more detail in the following with reference to FIGS. 3 to 7. As FIG. 3 shows, said transmitter 4 can be movably supported transversely to the longitudinal axis of the applicator housing 2 to be able to be moved by said actuating button 9. Said transmitter 4, that can, for example, form a rod-shaped, elongate element, can in particular be connected in an articulated manner to said toggle lever 6, for example in the region of its hinged joint.

[0050] Another end section of the transmitter 4 can extend in the region of the actuating button 9, with the actuating button 9 being able to have a cut-out 14 into which the transmitter 4 can travel to give the actuation button 9 a free-wheel or a free travel with respect to the transmitter 4.

[0051] On the other hand, the actuation button 9 can have an engagement contour 15 in proximity to said cut-out 14 at which engagement contour the transmitter 4 can be supported to take up and implement an adjustment movement of the actuation button 9. As in particular FIG. 5 shows, said engagement contour 15 can form an abutment and/or can have a support surface at which the transmitter 4 can be supported in the direction of its desired direction of movement. Said engagement contour 15 can in particular extend approximately transversely to the predetermined direction of movement of the actuation button 9.

[0052] Said engagement contour 15 can advantageously form a shoulder whose one limb serves the guidance of the transmitter 4 and whose other limb serves the support in the desired direction of movement.

[0053] To be able to move the transmitter 4 to and fro between its decoupled starting position shown in FIG. 3 in which the transmitter 4 can move in free travel into the receiving pocket 14 of the actuation button 9 and the coupled active position or transmitter position such as FIGS. 5 and 6 show and in which the transmitter 4 is in engagement with the actuation lever 9, an adjustment actuator 18 can be provided, for example in the form of an electromagnet or of another suitable actuator that is actuable by external energy and that can be controlled by a control apparatus 7.

[0054] The transmitter 4 can in particular be brought from its decoupled position into its coupled position in that the actuation button 9 is depressed or actuated once. Such an initially free-travel movement of the actuation button 9 is detected by a motion sensor 19 that can likewise be arranged in the applicator housing 2. Such a motion sensor 19 can be of different designs; it can, for example, work contactlessly. In this respect, different work principles are possible such as a light barrier and the like. A motion sensor 19 that works in a tactile manner can, however, advantageously also be provided that moves into contact with the actuation button 9 when the actuation button 9 is depressed.

[0055] If the motion sensor 19 indicates a movement of the actuation button 9, said adjustment actuator 18 can move the transmitter 4 into the coupled position as is shown by FIG. 5. However, before the adjustment actuator 18 is actually actuated, further operating parameters can be queried before the system in total is actually activated. The adjustment signal of the motion sensor 19 can in particular initially only be used to query dosage data and patient data such as an identification code, personal permitted dose and the like via the previously named electronic control apparatus 7.

[0056] This electronic control apparatus 7 can advantageously likewise be accommodated in the interior of the housing 2 and comprises a patient data store 8 from which the electronic control apparatus 7 can read out individually predefinable control data such as a maximum dosage, single dose or daily dose for a respective patient. Said control apparatus 7 and said patient data store 8 can, for example, be formed by a microcontroller and by associated circuit modules such as a storage element, with the patient data store 8 being able to be attached, for example, to the replaceable active ingredient container 13 or to the applicator housing 2 or being able to be connected to a store module attached thereto.

[0057] The control apparatus 7 can block the coupling of the transmitter 4 or can take it out of operation, for example when a maximum dose has been reached or when a release code is not present. To detect the actual dispensed amount, the nasal applicator 1 comprises a dose detection device that can, for example, be integrated into the control apparatus 7 and that counts the actuations of the dispensing pin and/or determines the length of the actuations.

[0058] Alternatively or additionally, as FIG. 2 illustrates, the nasal applicator 1 or its control apparatus 7 can also communicate with an RFID element 20 that the patient wears on his body, for example by means of an arm band or of a different body fastening means 25. Control data individual to the patient, for example relating to the permitted maximum dose, can on the one hand, be stored in said RFID element 20 and/or a release code that releases the nasal applicator 1 at all or unlocks said blocking apparatus 6. The control apparatus 7 can, for this purpose, communicate with said RFID element 20 by means of an RFID transmission/reception device 21 if the nasal applicator is close enough to the patient.

[0059] If the data query of the control apparatus 7 shows that the nasal applicator can be released, the coupling switch 22 can instigate the coupling of the transmitter 4. As FIG. 4 shows, this is initially not yet possible if the actuation button 9 is not yet completely depressed or is still in the first free-travel actuation stroke. If, however, as FIG. 5 shows, the actuating button is released after the initialization of the system so that it can travel back into its starting position, which can be assisted by a spring device 30, said coupling switch 22 can move the transmitter 4 into its coupling position. More precisely, the adjustment actuator 18 in the form of the electromagnet can pivot the transmitter 4 in its engagement position in which the transmitter 4 contacts the step-shaped engagement contour 15 of the actuation button 9, cf. FIG. 5. If the actuation button 9 is then actuated or depressed, the front-face end of the transmitter 4 moves toward the flank of the engagement contour 15 extending transversely to the direction of actuation so that the transmitter 4 is heldby the actuation force on the actuation button 9with friction engagement and/or with shape matching in the coupling position. The adjustment actuator 18 can here already be moved back again in a time-switched or also path-controlled mannerfor example by a signal of the motion sensor 19although FIG. 6 does not show this.

[0060] If the actuation button 9 is further depressed with a coupled position of the transmitter 4, the transmitter 4 moves in accordance with the adjustment movement of the actuating button 9 transversely to the longitudinal direction of the applicator housing 2. The toggle lever 6 is accordingly stretched, cf. for comparison FIGS. 5 and 6.

[0061] This stretching movement of the toggle lever 6 loads the spring device 11 of the preload apparatus 10 that is still held back by the retainer 31 via the loader 23 so that the cartridge is not yet actuated. Said retainer 31 can here be arranged in the further travel path of the transmitter 4 so that on a complete depression or actuation of the actuation button 9 in an end section of the movement of the transmitter 4, said transmitter 4 triggers the retainer 31, cf. for comparison FIGS. 5, 6 and 7. The retainer 31 can in particularin rough termsextend transversely to the direction of movement of the transmitter 4 and/or in the longitudinal direction of the applicator housing 2 so that the transmitter 4 presses against the retainer 31 in the end section of its adjustment movement and entrains it. The retainer 31 is hereby triggered. The shape matching to a retaining nose 32 at which the retainer 31 is otherwise held back in the active direction of the spring device 11 can release, for example. The retainer 31 can, for example, also be held in a spring-preloaded manner at said retaining nose 32 so that it can only trigger through the adjustment force of the transmitter 4.

[0062] If the retainer 31 triggers, as FIG. 7 shows, the spring device 11 of the preload apparatus 10 can spring out due to its loading force and can hereby actuate the dispensing meter; more precisely, it can move the active ingredient container 13 of the cartridge toward the dispensing pin 3, whereby a metering stroke is carried out.

[0063] The triggering retainer 31 can advantageously simultaneously move the transmitter 4 back into its decoupled position on the adjustment movement of the sprint 11 if it has not already itself returned into this decoupled position. The retainer 31 can, for example, have a returning nose 33 that acts on the transmitter 4 transversely to its adjustment movement or comes into engagement with the transmitter 4 on a movement of the retainer 31 in the direction of the spring force of the spring device 11, whereby the transmitter 4 is moved back into its decoupled position.

[0064] Such a return movement of the transmitter 4 can also be assisted and/or triggered and/or effected by a separate return spring 34, cf. FIG. 7.

[0065] On a release of the actuating button 9, the system as a whole moves back into its starting position again as is shown in FIG. 3.

[0066] To further protect the applicator from an imprudent actuation by small children, for example, alternatively or additionally to the aforesaid RFID release device, a mechanical actuation block 24 can optionally also be provided that blocks the actuation button 9 in its starting position and has to be released first to enable a depression of the actuation button 9. Such an actuation block 24 or child security lock can, for example, comprise one or more transverse latches 27 at the applicator housing 2 that are adjustable transversely to the plane of movement of the actuation button 9, for example by depressible unblocking buttons or unblocking jaws that can project laterally out of the applicator housing 2, cf. FIG. 1.

[0067] The described nasal applicator can in particular be used to administer high-strength opioid analgesics, with the nasal applicator generally also being able to be used, for example, for dispensing other medication that are administered under the control of the patient himself/herself. They can in particular be substances that are sensibly administered under at least one of the following conditions: a) The disease or complaints/symptoms to be treated have a sudden onset and cannot be predicted with sufficient accuracy (for example migraine attacks, nausea/vomiting, blood sugar fluctuations, epileptic fits, extreme blood pressure fluctuations); b) The medication used for treating the above-named symptoms are absorbed fast over the nasal mucous membrane and effect a fast improvement of the complaints; c) The medication used for treating the symptoms named under a) have a certain risk potential or have strong side effects, i.e. their application must be regulated within certain limits (for example, the so-called triptans can act fast and reliably on migraine attacks, but result in serious circulatory disorders on an overdose); d) The medication used for treating the symptoms named under a) can lead to dependence/addiction (examples: opioids, anticonvulsants) so that an access control or a patient identification has to take place as part of a patient-controlled application.