Nebulizer
10124125 ยท 2018-11-13
Assignee
Inventors
- Alexander Bach (Essen, DE)
- Jens Besseler (Bingen am Rhein, DE)
- Holger Holakovsky (Witten, DE)
- Manuel Daelman (Welver, DE)
- Gilbert WUTTKE (Ingelheim am Rhein, DE)
Cpc classification
A61M15/009
HUMAN NECESSITIES
A61M11/006
HUMAN NECESSITIES
B05B11/109
PERFORMING OPERATIONS; TRANSPORTING
International classification
Abstract
A nebulizer includes an insertable container and a securing mechanism for holding the container in the nebulizer such that the container can move back and forth but cannot be separated. The securing mechanism is formed by a metal unitary part. The securing mechanism forms a transportation lock for holding the container unmovable in the housing in a delivery state of the nebulizer. The securing mechanism forms a cage which encompasses the container.
Claims
1. A nebulizer (1) for a fluid (2), comprising: an insertable container (3) containing the fluid (2); a housing for receiving the container (3), wherein the container (3) is moveable back and forth along a longitudinal axis within the housing during conveying of the fluid (2), pressure generation and/or nebulization, where the housing includes a housing part (18); and a cage operating as a securing element (35) for holding the container (3), the cage including a plurality of holding and/or locking elements (36, 37), each having a proximal end coupled directly or indirectly to the housing part (18), an arm extending substantially parallel to the longitudinal axis, and a gripper element (36a, 37a, 37b) spaced away from the proximal end, the plurality of holding and/or locking elements (36, 37) being disposed annularly about a lower edge (41) the container (3), wherein respective lengths of the respective arms of the plurality of holding and/or locking elements (36, 37) are of a sufficient length such that the container (3): (i) is moveable back and forth along the longitudinal axis when the respective gripper elements (36a, 37a, 37b) of the holding and/or locking elements (36, 37) are not engaged with the lower edge (41) of the container (3) but the container (3) remains inseparable from the housing part (18); and (ii) is not moveable back and forth along the longitudinal axis when the respective gripper elements (36a, 37a, 37b) of the holding and/or locking elements (36, 37) are engaged with the lower edge (41) of the container (3).
2. The nebulizer according to claim 1, wherein: the nebulizer includes a nozzle; the housing includes a first housing part and the housing part is a second housing part releasably coupled to the first housing part in a longitudinal orientation and direction along the longitudinal axis; the container includes a closure part having a first end located within the container and extending toward a second end at which a fluid outlet for the liquid is located, the fluid outlet being closed by a first closure located at the first end of the closure part in a delivery state of the nebulizer; the nebulizer includes a conveying element for conveying the liquid from the container through the closure part and the fluid outlet towards the nozzle; and the cage operates in the delivery state of the nebulizer and an activated state of the nebulizer, and where in the activated state the cage operates such that: (i) the container is inseparable from the second housing part even when the first and second housing parts are separated, and (ii) the container is movable in the longitudinal direction along the longitudinal axis within the cage, wherein: the delivery state: (i) is a state in which an end of the conveying element is disposed through the second end and within the closure part and through the fluid outlet of the container, but not piercing the first closure at the first end of the closure part, and (ii) is a state in which the nebulizer is shipped or delivered to the user, and the activated state is a state in which the end of the conveying element advances through the first closure and into communication with the liquid within the container such that the first closure and the fluid outlet are opened inside the nebulizer before or during first use of the nebulizer.
3. The nebulizer according to claim 1, wherein the holding and/or locking elements (36, 37) include holding elements (36) in which the gripper elements (36a) thereof engage the lower edge (41) of the container (3) from only one longitudinal direction, and include locking elements (37) in which the gripper elements (37a) thereof engage the lower edge (41) of the container (3) from only another direction, opposing the one longitudinal direction, such that when both the gripper elements (36a) of the holding elements (36) and the gripper elements (37a) of the locking elements (37) simultaneously engage the lower edge (41) of the container (3), the container (3) is not moveable back and forth along the longitudinal axis.
4. The nebulizer according to claim 3, wherein the locking elements (37) operate to pivot and/or flex with respect to the respective proximal ends thereof, in order to transition from a state in which both the gripper elements (36a) of the holding elements (36) and the gripper elements (37a) of the locking elements (37) simultaneously engage the lower edge (41) of the container (3), to a state in which the gripper elements (37a) of the locking elements (37) do not engage the lower edge (41) of the container (3), thereby releasing the container (3) and permitting the container to move back and forth along the longitudinal axis.
5. The nebulizer according to claim 1, wherein cage comprises an opening means for opening a venting hole (34) of the container (3).
6. The nebulizer according to claim 1, wherein the cage operates such that a transition from a state in which the container (3) is not moveable back and forth along the longitudinal axis when the respective gripper elements (36a, 37a, 37b) of the holding and/or locking elements (36, 37) are engaged with the lower edge (41) of the container (3), to a state when the container (3) is moveable back and forth along the longitudinal axis when the respective gripper elements (36a, 37a, 37b) of the holding and/or locking elements (36, 37) are not engaged with the lower edge (41) of the container (3) automatically when completely closing the housing.
7. The nebulizer according to claim 1, wherein the housing part (18) is replaceable together with the container (3), wherein the container (3) is inseparable from the housing part (18).
8. The nebulizer according to claim 1, wherein the cage is located in the housing part (18).
9. The nebulizer according to claim 1, wherein the container (3) is inseparable from the housing part (18) due to a corrugation (45) of the container (3).
10. The nebulizer according to claim 1, wherein the nebulizer (1) is constructed as an inhaler for medical aerosol treatment.
11. The nebulizer according to claim 1, wherein cage comprises a metal stamping part.
12. The nebulizer according to claim 1, wherein the cage consists of a single, unitary part.
13. A housing part for a nebulizer (1), comprising a housing part (18) for receiving the container (3), wherein the container (3) is moveable back and forth along a longitudinal axis within the housing during conveying of the fluid (2), pressure generation and/or nebulization, where the housing includes a housing part (18); and a cage operating as a securing element (35) for holding the container (3), the cage including a plurality of holding and/or locking elements (36, 37), each having a proximal end coupled directly or indirectly to the housing part (18), an arm extending substantially parallel to the longitudinal axis, and a gripper element (36a, 37a, 37b) spaced away from the proximal end, the plurality of holding and/or locking elements (36, 37) being disposed annularly about a lower edge (41) the container (3), wherein respective lengths of the respective arms of the plurality of holding and/or locking elements (36, 37) are of a sufficient length such that the container (3): (i) is moveable back and forth along the longitudinal axis when the respective gripper elements (36a, 37a, 37b) of the holding and/or locking elements (36, 37) are not engaged with the lower edge (41) of the container (3) but the container (3) remains inseparable from the housing part (18); and (ii) is not moveable back and forth along the longitudinal axis when the respective gripper elements (36a, 37a, 37b) of the holding and/or locking elements (36, 37) are engaged with the lower edge (41) of the container (3).
14. The housing part according to claim 13, wherein cage comprises a metal stamping part.
15. The housing part according to claim 13, wherein cage is produced from sheet material by cutting and bending.
16. The housing part according to claim 13, wherein the cage consists of a single, unitary part.
17. The housing part according to claim 13, wherein the cage encompasses an end or bottom portion of the container (3).
18. The housing part according to claim 13, wherein the container (3) is inseparable from the housing part (18) due to a corrugation (45) of the container (3).
19. The housing part according to claim 13, wherein the holding and/or locking elements (36, 37) include holding elements (36) in which the gripper elements (36a) thereof engage the lower edge (41) of the container (3) from only one longitudinal direction, and include locking elements (37) in which the gripper elements (37a) thereof engage the lower edge (41) of the container (3) from only another direction, opposing the one longitudinal direction, such that when both the gripper elements (36a) of the holding elements (36) and the gripper elements (37a) of the locking elements (37) simultaneously engage the lower edge (41) of the container (3), the container (3) is not moveable back and forth along the longitudinal axis.
20. The housing part according to claim 19, wherein the holding and/or locking elements (36, 37) extend at least axially or in the direction of the movement of the container (3).
21. The housing part according to claim 19, wherein the locking elements (37) operate to pivot and/or flex with respect to the respective proximal ends thereof, in order to transition from a state in which both the gripper elements (36a) of the holding elements (36) and the gripper elements (37a) of the locking elements (37) simultaneously engage the lower edge (41) of the container (3), to a state in which the gripper elements (37a) of the locking elements (37) do not engage the lower edge (41) of the container (3), thereby releasing the container (3) and permitting the container to move back and forth along the longitudinal axis.
22. The housing part according to claim 13, wherein the housing part includes a first housing part and a second housing part releasably coupled to the first housing part in a longitudinal orientation and direction along the longitudinal axis; the container includes a closure part having a first end located within the container and extending toward a second end at which a fluid outlet for the liquid is located, the fluid outlet being closed by a first closure located at the first end of the closure part in a delivery state of the nebulizer; the nebulizer includes a conveying element for conveying the liquid from the container through the closure part and the fluid outlet towards the nozzle; and the cage operates in the delivery state of the nebulizer and an activated state of the nebulizer, and where in the activated state the cage operates such that: (i) the container is inseparable from the second housing part even when the first and second housing parts are separated, and (ii) the container is movable in the longitudinal direction along the longitudinal axis within the cage, wherein: the delivery state: (i) is a state in which an end of the conveying element is disposed through the second end and within the closure part and through the fluid outlet of the container, but not piercing the first closure at the first end of the closure part, and (ii) is a state in which the nebulizer is shipped or delivered to the user, and the activated state is a state in which the end of the conveying element advances through the first closure and into communication with the liquid within the container such that the first closure and the fluid outlet are opened inside the nebulizer before or during first use of the nebulizer.
23. The housing part according to claim 13, wherein cage comprises an opening means for opening a venting hole (34) of the container (3).
Description
(1) Further advantages, features, characteristics and aspects of the present invention will become apparent from the claims and the following description of preferred embodiments with reference to the drawings. It shows:
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(15) In the Figures, the same reference numerals have been used for identical or similar parts, resulting in corresponding or comparable properties and advantages, even if the associated description is not repeated.
(16)
(17) When the fluid 2, preferably a liquid, more particularly a pharmaceutical composition, is nebulized, an aerosol 14 (
(18) Usually the inhaling is done at least once a day, more particularly several times a day, preferably at set intervals, depending on the complaint or illness from which the patient is suffering.
(19) The nebulizer 1 is provided with or comprises an insertable container 3 containing the fluid 2. The container 3 thus forms a reservoir for the fluid 2 which is to be nebulized. Preferably, the container 3 contains an amount of fluid 2 or active substance which is sufficient to provide up to 200 dosage units, for example, i.e. to allow up to 200 sprays or applications. A typical container 3, as disclosed in WO 96/06011 A1, holds e.g. a volume of about 2 to 10 ml.
(20) The container 3 is substantially cylindrical or cartridge-shaped and once the nebulizer 1 has been opened the container can be inserted therein from below and changed if desired. It is preferably of rigid construction, the fluid 2 in particular being held in a collapsible bag 4 in the container 3.
(21) The nebulizer 1 comprises preferably a pressure generator 5 for conveying and nebulizing the fluid 2, particularly in a preset and optionally adjustable dosage amount. The pressure generator 5 comprises preferably a holder 6 for the container 3, an associated drive spring 7, only partly shown, a locking element 8 which can be manually operated to release the spring 7, a conveying element, such as a conveying tube 9, a non-return valve 10, a pressure chamber 11 and/or an nozzle 12 for nebulizing the fluid 2 into a mouthpiece 13. The container 3 is fixed or held in the nebulizer 1 via the holder 6 such that the conveying tube 9 penetrates into the container 3. The holder 6 may be constructed so that the container 3 can be exchanged.
(22) As the drive spring 7 is axially tensioned the holder 6 with the container 3 and the conveying tube 9 is moved downwards in the drawings and fluid 2 is sucked out of the container 3 into the pressure chamber 11 of the pressure generator 5 through the non-return valve 10 (conveying of the fluid 2, suction stroke). Then, the nebulizer 1 is in the so-called activated or tensioned state.
(23) During the subsequent relaxation after actuation of the locking element 8 the fluid 2 in the pressure chamber 11 is put under pressure as the conveying tube 9 with its now closed non-return valve 10 is moved back upwards by the relaxation of the drive spring 7 and now acts as a pressing ram or piston (pressure generation and/or nebulization). This pressure forces the fluid 2 through the nozzle 12, whereupon it is nebulized into the aerosol 14, as shown in
(24) Generally, the nebulizer 1 operates with a spring pressure of 5 to 200 MPa, preferably 10 to 100 MPa on the fluid 2, with a volume of fluid 2 delivered per stroke of 10 to 50 l, preferably 10 to 20 l, most preferably about 15 l. The fluid 2 is converted into or nebulized as aerosol 14 the droplets of which have an aerodynamic diameter of up to 20 m, preferably 3 to 10 m. Preferably, the generated jet spray has an angle of 20 to 160, preferably 80 to 100. These values also apply to the nebulizer 1 according to the teaching of the present invention as particularly preferred values.
(25) A user (not shown) can inhale the aerosol 14, while an air supply can be sucked into the mouthpiece 13 through at least one air supply opening 15.
(26) Preferably, the nebulizer 1 can be manually activated or tensioned. The nebulizer 1 comprises preferably an upper housing part 16 and an inner part 17 which is rotatable relative thereto (
(27) The housing part 18 can be rotated relative to the upper housing part 16, carrying with it the part 17b of the inner part 17. As a result the drive spring 7 is tensioned in the axial direction by means of a gear or transmission (not shown) acting on the holder 6. During tensioning the container 3 is moved axially downwards until the container 3 assumes an end position as shown in
(28) The housing part 18 preferably forms a cap-like lower housing part and fits around or over a lower free end portion of the container 3. As the drive spring 7 is tensioned the container 3 moves with its end portion (further) into the housing part 18 or towards the end face thereof, while an aeration means, such as an axially acting spring 20 arranged in the housing part 18, comes in contact with base 21 of the container 3 and pierces the container 3 or a base seal thereon with a piercing element 22 when the container 3 makes contact with it for the first time, to allow air in or aeration.
(29) The nebulizer 1 may comprise a monitoring device 23 which counts the actuations of the nebulizer 1, preferably by detecting the rotation of the inner part 17 relative to the upper part 16 of the housing. Preferably, the monitoring device 23 blocks the actuation or use of the nebulizer 1, e.g. blocks the actuation of the locking element 8, when a certain number of actuations or discharged doses has been reached or exceeded.
(30) A preferred construction and mode of the inhaler or nebulizer 1 will now be described in more detail with reference to
(31)
(32) The container 3 is already mounted or pre-installed in the nebulizer 1 in the delivery state, as shown in
(33) The container 3 comprises a fluid outlet 24 for outputting the fluid 2 to be dispensed. In particular, the fluid outlet 24 allows a fluidic connection between the container 3 or its bag 4 on one hand and the nebulizer 1, its pressure generator 5 or the conveying element on the other hand.
(34) The fluid outlet 24 has an inner closure 25 that is preferably formed by a septum, a membrane, a plastic seal or the like and/or is provided inside the container 3. Optionally, a second or outer closure 26 can be provided.
(35) Preferably, the closures 25 and 26 are designed such that successive opening is possible by means of one common element, in particular the conveying element or conveying tube 9 or the like, and/or by piercing.
(36) In the preferred embodiment, the first closure 25 and second closure 26 are arranged one after the other and/or spaced in axial direction or direction of the stroke movement of the container 3 or with respect to the main outlet direction of the fluid 2.
(37) Generally, the container 3, fluid outlet 24 or closures 25 or 26 are opened in particular by means of a conveying element, such as the conveying tube 9, or the like and/or by piercing or in any other suitable manner. In particular, the opening is achieved by moving the container 3 relative to the nebulizer 1 or conveying element or tube 9 or the like and/or by movement in longitudinal or axial direction.
(38) Preferably, the first or inner closure 25 is formed or supported by a closure part 27 extending from the outlet or head end of the container 3 into the container 3 or bag 4. The second or outer closure 26 is preferably located adjacent to the head or axial end of the container 3 and/or held or connected to a flange 28, which can be formed by the closure part 27 or any other suitable part. However, other constructional solutions are possible.
(39) In the delivery state according to
(40) In particular, the container 3 is attached to or held by or secured in the housing part 18, in particular by a transportation lock 29, which is preferably arranged within or at the housing part 18. The transportation lock 29 holds the container 3 preferably temporarily, in particular before attaching the housing part 18 to the nebulizer 1 and/or in the delivery state. In particular, the transportation lock 29 holds the container 3 fixed during the fluidic connection of container 3 and/or during the mechanic connection of container 3, here with holder 6. Preferably, the transportation lock 29 holds the container 3 fixed during opening, in particular piercing, the container 3.
(41) In the delivery state, in which the nebulizer 1 can be shipped or delivered to the user or is still packed, the nebulizer 1 or the housing part 18 is preferably secured, in particular by means of a securing member 30, such that the container 3 and/or housing part 18 are held sufficiently spaced from the nebulizer 1 or upper housing part 16 and/or prevented from being completely inserted or pushed on the conveying element or tube 9, the housing or inner housing part 17 or the like and/or such that (complete) opening of the container 3, namely of the first closure 25, is prevented.
(42) In the shown embodiment, the securing member 30 is preferably mounted between the housing part 18 and the upper housing part 16 and preferably engages with or between the housing parts 16 and 18, so that the housing part or lower part 18 is axially secured or is kept or held sufficiently away or spaced from the upper housing part 16 to be able to hold the (still) closed container 3 or first closure 25 away from the conveying tube 9.
(43) In the preferred embodiment, the securing member 30 is at least substantially hollow and/or cylindrical and is disposed axially between the (lower) housing part 18 and the upper housing part 16. To activate the nebulizer 1 or prepare it for use, i.e. to push the housing part 18 fully on in the axial direction and thereby open the container 3, the securing member 30 first has to be removed or released or opened. In the shown preferred embodiment, the securing member 30 is constructed in the manner of a banderole or the like, made of plastics, for example, and/or can be manually opened, removed or destroyed. The securing member 30 may alternatively or simultaneously form or constitute a seal of origin. However, other embodiments of the securing member 30 are also possible, e.g. in the form of a security tag or the like.
(44) Preferably, the container 3 and/or housing part 18 are held positively or in a form-fit or interlocking manner in the delivery state. This is achieved in the preferred embodiment in particular by means of the transportation lock 29 acting between the container 3 and the housing part 18, and the securing member 30 acting between the housing part 18 and the housing of the nebulizer 1 or the upper housing part 16 or the like. However, the transportation lock 29 or securing member 30 could also act directly between the container 3 on one hand and the nebulizer 1, its housing, the upper housing part 16, the inner housing part 17 or the holder 6 on the other hand.
(45) In the non-activated position, the housing part 18 is preferably secured so that it cannot be lost and, in particular, cannot be released. Then, the housing or lower part 18 of the nebulizer 1 can no longer be detached from the nebulizer 1 after it has been (partially) axially pushed on for the first time, i.e. the nebulizer 1 cannot be opened any longer, with the result that that the container 3 cannot be changed, i.e. cannot be removed again.
(46) In order to secure the housing part 18, it is preferably held or latched positively or in an interlocking or form-fit manner. Preferably, the housing part 18 is secured by means of at least one latching lug 31, protrusion, nose or the like which engages in an associated latching recess 32 in the housing part 18 or the like and, thereby, secures the housing part 18 against axial removal by interlocking engagement. In the present embodiment, the latching lug 31 may be formed by or at a latching arm 33 which can preferably flex. Thus, a ratchet-like means for securing the housing part 18 to the nebulizer 1 or its housing or the upper housing part 16 is formed. However, other constructional solutions are also possible.
(47) Once the security member 30 has been removed a user (not shown) can push the housing part 18 fully on in the axial direction and thereby open the container 3, i.e. first closure 25, by inserting the conveying element or conveying tube 9.
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(49) During this tensioning process the holder 6 is moved together with the conveying tube 9 axially towards or into the housing part 18, thus bringing the holder 6 into (complete) engagement with the container 3 and preferably also moving or pressing the container 3 against the piercing element 22 in the region of the base of the housing part 18 and thereby piercing or opening a venting hole 34 in the container base 21.
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(51) The nebulizer 1 is activated after the removal of the securing member 30 and (total) axial pushing on of the housing part 18 and can be used in the same way as the nebulizer 1 shown in
(52) As preferably the container 3 cannot then be removed, especially because the nebulizer 1 cannot be opened and the housing part 18 cannot be removed again, undesirable replacement of the container 3 by the user and in particular undesirable interim or subsequent opening of the nebulizer 1 by the user can be prevented.
(53) To prevent unwanted opening of the container 3, particularly of the first closure 25, in the delivery state of the nebulizer 1, preferably the transportation lock 29 is provided. By frictional, forcible or interlocking engagement, for example, the transportation lock 29 prevents the container 3 from undesirably moving axially in the nebulizer 1, e.g. during transportation, in the event of accidental dropping of the nebulizer 1 or the like.
(54) Preferably, the opening of the transportation lock 29 occurs automatically when closing the nebulizer 1 or its housing completely, i.e. when snapping or pushing on the housing part 18 completely towards the upper housing part 16. During this (axial or telescopic) closing movement, the transportation lock 29 is opened and the container 3 released in axial direction preferably only in a last part of the movement and/or just little before the final completely closed position is reached or just when the final completely closed position is reached.
(55) The closing movement of the nebulizer 1 opens the transportation lock 29 preferably automatically. In particular, the transportation lock 29 is opened by the direct or indirect interaction with or actuation by the housing of the nebulizer 1, the inner part 17 or its lower part 17b, a holding ring 38 bearing the spring 7 or the like. Preferably, the container 3 and/or first closure 25 are opened as well as the transportation lock 29 by means of a common actuation, here the closing movement of the nebulizer 1 or its housing or bottom part 18.
(56)
(57) Preferably, in the non-activated state, i.e. when the housing part 18 has not been pushed on fully, the nebulizer 1 may be locked to prevent tensioning of the pressure generator 5, i.e. in particular to prevent rotation of the inner part 17 relative to the upper housing part 16. This may be important when the nebulizer 1 is supplied in the delivery state with the pressure generator 5 not under tension. Accordingly, the inhaler 1 may have a barrier, so that the inner part 17 can only be rotated relative to the upper housing part 16 when the housing part 18 has been pushed fully on. Alternatively or additionally, the securing member 30 may block not only pushing on of the bottom part 18 in the delivery state, but also any rotation of the inner part 17 until the securing member 30 has been opened, released or removed.
(58) In the following, a first embodiment of the inhaler or nebulizer 1 according to the present invention will be described in detail with reference to
(59)
(60) The nebulizer 1 or its housing comprises a securing means 35 for holding the container 3 such that the container 3 is moveable back and forth for the conveying of the fluid 2, pressure generation and/or nebulization, but is inseparable from the housing or housing part 18, and/or such that the container 3 is unmoveably held in the delivery state of the nebulizer 1.
(61) The securing means 35 is located or arranged preferably at or in the housing part 18 as shown in
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(63) Preferably, the securing means 35 comprises or consists of a metal and/or stamping part and/or consists of a single, unitary part as shown in
(64) Preferably, the securing means 35 is made of steel, in particular spring steel.
(65) Preferably, the securing means 35 is produced from sheet material by cutting, stamping or the like and/or by bending.
(66) Preferably, the securing means 35 or the part forms a cage, in particular, encompasses the container 3 or an end portion thereof.
(67) Preferably, the securing means 35 comprises holding elements 36 and/or locking elements 37. The elements 36 and 37 are preferably designed like arms, fingers leaves or the like. In particular, the elements 36, 37 are alternately distributed over a circumference of the container 3 and/or extend at least essentially axially or in the direction of the back and forth movement of the container 3.
(68) Preferably, the elements 36 and 37 are held by or connected with a base 38 of the securing means 35.
(69) Preferably, the securing means 35 or base 38 comprises or holds the piercing element 22 for piercing the container 3, i.e. opening the container base 21 or its venting hole 34 in the activated and tensioned state, i.e. when the container 3 reaches its lower end position. In the shown embodiment, the piercing element 22 is formed by a respective bending of a spring portion 39 of the securing means 35 or its base 38. The spring portion 39 can support or facilitate the (complete or final) connection of the container 3 to holder 6.
(70) The securing means 35 or base 38 comprises preferably at least one or multiple fixing portions 40 for fixing the securing means 35 at or in the nebulizer 1 or housing or housing part 18. In particular, the fixing portions 40 may fix the securing means 35 when the securing means 35 is pressed into the housing part 18 by cooperating with the side wall of the housing part 18.
(71) However, it is also possible to overmold the securing means 35, its base 38, the fixing portions 40 or the like. Moreover, the securing means 35 could be connected with the housing part 18 or the like in any other suitable manner.
(72) Preferably, the securing means 35 does not only prevent the separation of the container 3 from the nebulizer 1, its housing or housing part 18, but also forms the transportation lock 29 for holding the container 3 unmovable in the housing in the delivery state of the nebulizer 1.
(73) In the shown embodiment, the container end or edge 41 is caught between end portions 36a and 37a of the elements 36 and 37. The holding elements 36 grip or extend over the edge 41 and the locking elements 37 or its end portions 37a grip or extend under the edge 41 or container base 21 so that the edge 41 and container 3 are securely held preventing any axial movement of the container 3 relative to the securing means 35 and relative to the associated housing part 18 in this state, i.e. with locked securing means 35/transportation lock 29.
(74) The holding element 36 and the locking elements 37 are distributed alternatingly around the container 3 or edge 41.
(75) Preferably, the end portions 36a of the holding elements 36 end in a first radial plane and the end portions 37a of the locking elements 37 end in another, second radial plane, wherein the two planes are axially offset to hold the edge 41 in between and/or wherein the second plane is located axially between the first plane and the lower end position of the container 3 or the lower end of the housing part 18 or the piercing element 22. Additionally or alternatively, the end portions 36a end on another radius (outer radius) than the end portions 37a and/or are axially spaced therefrom.
(76) The end portions 36a and/or 37a are preferably form like claws or the like and/or extend preferably radially inwardly.
(77) Preferably, the elements 36 and/or 37 can flex with its free ends radially outwardly.
(78) For example, the ends of the end portions 36a may be inclined such that the container 3 may be inserted into or connected with the securing means 35 by a respective axial force so that the holding elements 36 flex outwardly to allow passing of edge 41. However, the holding elements 36 can be flexed outwardly also by a suitable tool (not shown) or the like when the container 3 is inserted, in particular with its edge 41, into the securing means 35.
(79) Preferably, the holding elements 36 prevent separation of the container 3 from the securing means 35 and, thus, from the associated housing part 18 or the like.
(80) The locking elements 37 or its end portions 37a can be flexed radially outwardly in order to open the axial holding or transportation lock 29 (this will be explained in detail with reference to
(81) In the present embodiment, the locking elements 37 comprise actuation portions 37b (preferably formed at the free ends and/or between adjacent end portions 37a). Preferably, the actuation portions 37b form axial extensions which may be radially offset. The actuation portion 37b cooperate with an associated control member 42 or multiple control members 42 of the nebulizer 1 such that the locking elements 37 are flexed radially outwardly when (completely) closing the housing to open the transportation lock 29 (here primarily formed by the locking elements 37 or its end portions 37a).
(82)
(83)
(84) The control member 42 is preferably formed as an axial protrusion. It can be formed by or at a ring 43 or any other bearing means of the nebulizer 1 for counter-bearing the drive spring 7 in the inner part 17 or by or at any other suitable component if the nebulizer such as the inner part 17.
(85) The control member 42 may be formed like an axial protruding ring or shoulder or ridge which extends along the ring 43.
(86) The control member 42 may additionally secure the holding elements 36 against axial opening when the housing is completely closed as schematically shown in
(87)
(88) In the present embodiment, the securing means 35 has multiple functions. It holds the container 3 (in the activated state/with completely closed housing) such that it can move back and forth, in particular during conveying of the fluid 2, during pressure generation and/or during nebulization, wherein the container 3 is inseparable from the housing or the housing part 18. Further, the securing means 35 forms the transportation lock 29 and/or holds the container 3 unmovable in the delivery state of the nebulizer 1. Additionally or alternatively, the securing means 35 comprises an opening means, here the piercing element 22, for opening the venting hole 34 of the container 3.
(89) Preferably, the securing means 35 forms a cage which cannot be separated from the container 3 after connecting it with the container 3.
(90) The transportation lock 29 and the locking elements 37 are kept opened during the normal use of the nebulizer 1, in particular as long as the housing is (completely) closed. When the housing is opened, i.e. the housing part 18 is detached, the control member 42 may disengage from the actuation portions 37b so that the locking element 37 can close or flex inwardly again. Then, the locking elements 37 may grip with its end portions 37a over the edge 41 of the container 3 such that an additional lock is formed which prevents that the container 3 can be separated from the securing means 35/housing part 18.
(91) The securing means 35 prevents separation of the container 3 from the housing part 18. Therefore, the container 3 can be replaced or exchanged only together with the housing part 18 if the housing part 18 can be detached from the nebulizer 1 or inner part 17 at all. However, it is also possible that the nebulizer 1 cannot be opened. Then, the container 3 cannot be replaced.
(92) In the following, a second embodiment of the nebulizer 1 and the securing means 35 will be described with reference to
(93)
(94) In the second embodiment, the securing means 35 is arranged or located at or within the non-detachable part of the housing of the nebulizer 1, in particular at or in the upper housing part 16 or inner part 17. In particular, the securing means 35 is located or mounted at or within the ring 43 or any other suitable component preferably at the lower end of the inner part 17. In the shown embodiment, the securing means 35 is arranged at least primarily between the ring 43 and the container 3. However, other constructional solutions are possible.
(95)
(96) The securing means 35 or securing ring formed by the ring portion 44 and the associated holding elements 36 in the shown embodiment comprises preferably fixing portions 40 for fixing the securing means 35 or securing ring at the nebulizer 1, its housing or inner part 17, in particular at the ring 43 counter-bearing the drive spring 7. The fixing portions 40 extend preferably in axial direction from the ring portion 44 and are angled radially outwardly at its free ends so that a form-fit engagement is possible with ring 43 (ring 43 is axially held between the ring portion 44 and the free ends of the fixing portions 40 in the preferred embodiment). Thus, the securing means 35 or securing ring can be securely fixed at the ring 43. However, other constructional solutions are possible as well.
(97) It has to be noted that the securing means 35 or securing ring comprises or consists of a metal and/or stamping part and/or a single unitary part as already described with respect to the first embodiment.
(98) The holding elements 36 of the securing means 35 or securing ring cooperate preferably with engagement means formed on or by the container 3 such that the container 3 is moveable back and forth but is inseparable from the housing or nebulizer 1, and/or such that the transportation lock 29 is formed and/or that the container 3 is (axially) unmoveably held in the delivery state of the nebulizer 1.
(99) In the shown embodiment, the container 3 comprises at least one, here two radial shoulders, protrusions or corrugations 45 as engagement means. The corrugations 45 form preferably ring-like ribs or the like on the outer periphery of the container 3 and/or are axially spaced, in particular such that the holding elements 36 can engage in between the corrugations 45.
(100) The engagement means or corrugations 45 are preferably arranged or formed on the container 3 such that the holding elements 36 engagein particular in between the two corrugations 45 as schematically shown in
(101) In particular, the upper corrugation 45 prevents that the container 3 can be detached from the nebulizer 1 because the holding elements 36 cannot overcome or move over this corrugation 45. Thus, the securing means 35 prevent replacement of the container 3 at all. In the opposite direction, the lower corrugation 45 forms an obstacle or resistance for the holding elements 36 so that the container 3 is secured against further insertion in the delivery state, i.e. this corrugation 45 forms together with the securing means 35 or its holding elements 36 the transportation lock 29). However, this obstacle or resistance can be overcome, i.e. the transportation lock 29 can be opened, by a sufficiently high force, e.g. by manually closing the housing or manually inserting the container 3, because the holding element 36 can flex radially outwardly so that the lower corrugation 45 can pass and the container 3 can be inserted further, i.e. can move upwardly in
(102) The corrugations 45 can differ in axial or circumferential location, form, radial extension, inclination, dimension or the like as required or desired, in particular to realize a secure holding of the container 3 in the delivery state, wherein the force is not too high which has to be overcome when the container 3 is further inserted and opened.
(103)
(104)
(105) Generally, it should be pointed out that in the proposed nebulizer 1 the container 3 can preferably be inserted, in the nebulizer 1. Consequently, the container 3 is preferably a separate component. However, the container 3 may theoretically be formed directly by the nebulizer 1 or part of the nebulizer 1 or may otherwise be integrated in the nebulizer 1.
(106) As already mentioned, individual features, aspects and/or principles of the embodiments described may also be combined with one another as desired and may be used particularly in the nebulizer according to
(107) Unlike freestanding equipment or the like the proposed nebulizer 1 is preferably designed to be portable and in particular is a mobile hand operated device.
(108) The proposed solution may, however, be used not only in the nebulizers 1 specifically described here but also in other nebulizers or inhalers, e.g. powder inhalers or so-called metered dose inhalers.
(109) Preferably, the fluid 2 is a liquid, as already mentioned, especially an aqueous pharmaceutical formulation. However, it may also be some other pharmaceutical formulation, a suspension or the like.
(110) According to an alternative embodiment the fluid 2 may also comprise particles or powder. In this case, instead of the expulsion nozzle 12, some other kind of supply device may be provided, especially an expulsion opening (not shown) or a supply channel (not shown) for supplying the fluid to or powder or the like into the mouthpiece 13. The optional air supply opening 15 then serves to supply ambient air preferably in parallel so as to general or allow an airflow with a sufficient volume for breathing in or inhaling through the mouthpiece 13.
(111) If necessary the fluid 2 may also be atomized by means of a propellant gas.
(112) Preferred ingredients and/or formulations of the preferably medicinal fluid 2 are listed in particular in WO 2009/047173 A2 which is incorporated herewith by reference. As already stated, these may be aqueous or non-aqueous solutions, mixtures, formulations containing ethanol or free from solvent, or the like.
LIST OF REFERENCE NUMERALS
(113) 1 nebulizer 2 fluid 3 container 4 bag 5 pressure generator 6 holder 7 drive spring 8 locking element 9 conveying tube 10 non-return valve 11 pressure chamber 12 nozzle 13 mouthpiece 14 aerosol 15 air supply opening 16 upper housing part 17 inner part 17a upper part of the inner part 17b lower part of the inner part 18 housing part (lower part) 19 retaining element 20 spring 21 container base 22 piercing element 23 monitoring device 24 fluid outlet 25 first closure 26 second closure 27 closure part 28 flange 29 transportation lock 30 securing member 31 latching lug 32 latching recess 33 latching arm 34 venting hole 35 securing means 36 holding element 36a end portion 37 locking element 37a end portion 37b actuation portion 38 base 39 spring portion 40 fixing portion 41 edge 42 control member 43 ring 44 ring portion 45 corrugation