巴西专利BR112012002718B1 inhaler

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专利摘要:
INHALER An inhaler is described comprising a reservoir (5) of an inhalable composition with an outlet (11) at one end (8) through which the inhalable composition is discharged. A non-metered breath activated valve (7) is provided between the end (8) and the a reservoir (5), the breath activated valve (7) comprising one. flow path (13) extending from the reservoir (5) to the outlet end (8). At least a portion of the flow path is a deformable tube (14). A clamping element (21) grips the deformable tube (14) to close, when no suction force is applied to the device, and releases the tube (14) to open the flow path, when suction is applied to the outlet (11) , to provide uninterrupted flow from the reservoir (5) to the outlet (11).
公开号:BR112012002718B1
申请号:R112012002718-2
申请日:2010-08-06
公开日:2021-01-19
发明作者:Alex Hearn；Iain McDerment
申请人:Kind Consumer Limited；
IPC主号:

专利说明:

The invention was specifically designed for a simulated cigarette device with a general shaped cigarette body. However, the invention concerns an outlet valve development for such a device, which has broader applications in the field of inhalers, for example, medical inhalers for delivery of oral medication such as asthma inhalers.
In the field of cigarette substitutions, there are numerous proposals for creating a simulated cigarette. Such a device has numerous advantages over traditional nicotine replacement therapies, such as plasters and gum, in which it replicates the physical act of smoking, which is psychologically important for a smoker, and can also deliver nicotine as a dose that more accurately replicates the pharmacokinetic effects of a cigarette that persistent smokers desire. Thus, a smoker can obtain the familiar "dose" of a cigarette, instead of having to deal with the slow release of a patch or gum that does not produce a dose like this that leads to unpredictable dosages and low craving scores and termination rates.
A simulated cigarette has an inhalable composition reservoir and an outlet valve that can be triggered, for example, by pushing a button or biting on the end of a cigarette. However, a preferred mechanism for opening the valve is to provide a breathing activated valve, as this ensures that the cigarette will only dispense when the user sucks on the device as in a normal cigarette.
WO 02/4 783 discloses a medication dispenser with a valve arrangement suitable for dispensing a metered dose. This takes the form of a flexible tube that is wrapped around a valve element and has a pair of folds. The portion of the tube between the folds is capable of holding a metered dose of the drug to be dispensed. When a user sucks the dispenser, the valve element moves, opening the fold downstream in order to dispense the metered dose. Upon exhalation, the valve moves in the opposite direction, closing the fold downstream and opening the fold upstream to allow the portion of the tube between the folds to be refilled with the medicine. This arrangement allows a user to inhale only a metered dose, no matter how long he sucks on the device.
US 4,393,884 discloses such a device that has a large resilient "tongue" with a flow path passing through it. This tongue is predisposed to a first position in which it is out of alignment with the cigarette outlet and can be sucked into a second position in which it aligns with the cigarette outlet to provide a flow path from the reservoir to the outlet. Such a device is difficult to seal in the first position. It will also require considerable force in order to suck the tongue into an open position against the action of a retaining spring, and the relatively large mass of the tongue means that it will be difficult for it to return to the closed position, meaning that dispensing will continue after suction. be interrupted.
US 6,889,687 discloses an additional example of a simulated cigarette with a breathing activated valve. This reveals countless examples. One of these has a pair of magnets, one of which is retained by a flexible membrane that allows the magnet to be separated when suction is applied to a device. This opens a flow path for the reservoir. However, the mechanism is reasonably complex, has a tortuous flow path that is likely to prevent delivery of the reservoir composition, and is of a "binary" nature in the sense that the valve is both open and closed. It does not provide the user with the ability to regulate the amount of flow, varying the degree of suction. A second example is a spring-loaded plunger that moves axially to open a passage in a central rod. An axially movable piston like this is undesirable in practice, since it has been observed that the level of suction required to overcome the force predisposed by spring is too high to be applicable in practice. Also, the flow path in the open position is outside the stem, into the plunger and back into the stem, so that it is again a bit tortuous. The third example is based on a magnetic interface where the force on it is overcome by a system of pallets that rotate around the axis of the device, thereby moving along a surface of flesh to pull the magnetic element of the valve out of its headquarters. Again, this presents problems of complexity, lack of control and a circuitous flow path.
WO 09/00 82, which is our previous request, discloses two different breathing-activated devices. The first of these has a pair of rotating pallet systems around an axis perpendicular to the main axis of the device to align a hole with the outlet hole of the reservoir, allowing dispensing. The second of these has a pair of hinged flaps that are sucked against the action of return springs in order to open the flow path. Although this solves some of the problems, in that it provides a simple mechanism and an axial flow path, the force required as suction to fire the device is relatively large and the user, as a result, can exercise less control over the system to release a variable dose, small or large, according to the admission of inhalation.
The present invention aims to provide an improved breathing operated valve for an inhaler and, in particular, a simulated cigarette.
According to the present invention, an inhaler is provided comprising: a reservoir of an inhalable composition; an outlet at one end through which the inhalable composition is discharged; and a non-metered breath activated valve between the end and the reservoir, the breath activated valve comprising a flow path extending from the reservoir to the outlet end, at least a portion of the flow path being a deformable tube, and a clamping element that clamps the deformable tube to close, when no suction force is applied to the device, and releases the tube to open the flow path, when suction is applied at the outlet, to provide uninterrupted flow from the reservoir to the outlet .
By clamping a deformable tube, the present invention has numerous advantages. The clamping mechanism is simple, since all that is required is a mobile component to clamp the tube, which does not have to be complex. In addition, since the flow path is along an open tube, there is no need for a tortuous flow, which may otherwise be required to flow around an unseat valve component, such as those in US 6,889. 687. The non-metered valve that allows uninterrupted flow allows a user to regulate the dose he receives from the inhaler, since he will continue to dispense, as long as the user sucks.
The tight tube arrangement serves well for an unmeasured dosage. Also, although the device can be provided with the clamping element that effectively opens "suddenly" to provide a "binary" device that is both open and closed, the deformable tube is well suited for a device in which the degree of opening of the tube is proportional to the intensity of the suction. An outlet valve like this, which is operable by breathing, and of varying resistance according to the inhalation profile, is actuated, allowing the user to self-titrate the inhaled dose in a continuous manner. This has applications primarily for stop smoking inhaler devices, where users wish to self-label their nicotine dose in a way that suits their needs, but also in another area such as pain management, diabetes, asthma and COPD where self-administered doses are preferable. through the oral route.
The tube can be clamped in several places, but it is preferably clamped in one place, since it is all that is needed to perform its function. The flow path is preferably substantially straight to ensure smooth flow.
As mentioned earlier, the inhaler can be a drug delivery inhaler for any inhalable pharmaceutical composition.
However, the inhaler is preferably a simulated cigarette device with a general shaped cigarette body. In this case, the inhalable composition preferably includes nicotine, or a nicotine derivative, or its salt. On the other hand, it can be a simulated cigarette that mimics the physical act of smoking without requiring nicotine in the composition. Alternatively, the composition may include analgesics, anti-inflammatories, bronchodilators, antispasmodics, retrovirals or opiates controlled by the patient.
The clamping element can be formed from any suitable device that can release the deformable tube when suction is applied at the outlet. This can, for example, be a combination of an electronic flow sensor and a solenoid to move the clamping element. However, preferably, the clamping element is a mechanical element that moves by a pressure differential caused when suction is applied at the outlet.
The mechanical element can take the form of the pair of pallets of the second example of WO 09/00 82, where it is clamped between the pallets in the closed position and is released as the pallets pivot in the direction of the air flow.
However, preferably, the clamping element is an elongated pallet that is pivotally mounted at one end and extends longitudinally inside the inhaler, the pallet being pivotable between a first position, in which the tube is closed, and a second position, in which it releases the tube to provide the flow path. There may be a single palette that presses the deformable tube against a fixed part of the inhaler, or there may be a pair of such palettes between which the tube is pressed.
Preferably, each and every palette is predisposed to the closed position and the inhaler has a second flow path that creates a pressure differential across the palette that overcomes the predisposition force.
Each and every pallet can be exposed to an air flow, in such a way that, as a user sucks on the outlet, the flow through air collides on an external surface of the pallet to move it inward.
However, preferably, each and every palette is supported by a flexible membrane. This flexible membrane creates a chamber in which the pallet is housed and which is opened at the outlet, but is otherwise sealed, with the face of the membrane on the opposite side of the pallet being opened to atmospheric pressure. When a user sucks at the outlet, he creates negative pressure inside the chamber to move the pallet and the membrane flexes to allow this movement. This provides a very efficient mechanism for transporting the suction force to the pallet.
Preferably, the deformable tube is a nozzle which is also provided integrally with an outlet orifice, which is the narrowest part of the flow path.
In this case, preferably, the nozzle has an annular edge that protrudes at its end upstream which is adjusted at one end downstream of the flow path.
Examples of inhalers according to the present invention will now be described with reference to the accompanying drawings, in which:
Figure 1 is a section through a perspective view of a first inhaler in a closed position;
Figure 2 is a similar view in the open position;
Figure 3 is an exploded perspective view of the inhaler of Figures 1 and 2;
Figure 4 is a cross section through a perspective view of a second inhaler in the closed position;
The figure is a similar view in the open position; and
Figure 6 is a perspective view of the outlet end of the second example shown with the outer housing removed to show the tightened mechanism; and
Figure 7 is a cross section of an alternative arrangement of deformable tubular element.
The present invention relates to an improvement of the outlet valve for a breath activated cigarette and only this aspect of the invention will be specifically described here. For details of the construction of the remainder of the cigarette device and its refill mechanism, reference is made to WO 09/00 78.
The first example of an inhaler according to the present invention is shown in figures 1 to 3.
The device has a housing 1 consisting of a main chassis 2 and a closing element 3, as shown in figure 1. This is held in place by the seal 4. Within the housing, there is a reservoir containing the inhalable composition. This is preferably pressurized, but it can also work with a non-pressurized reservoir in combination with a Venturi nozzle to generate greater suction force in the reservoir, or a non-pressurized reservoir containing a substance that is prone to evaporate at room temperature.
It can be refillable as described in WO 09/00 82 through the filling valve 6, or the device can be a disposable device, or it can be arranged so that the reservoir is a replaceable component.
The breath activated valve 7 is positioned between an outlet end 8 and the reservoir. The breath-activated valve is arranged so that when a user sucks on the outlet end 8, the breath-activated valve 7 opens to allow the inhalable composition of the reservoir to be inhaled.
The housing at the outlet end has two holes. The first of these is the suction port 9 which communicates with a chamber, as will be described in more detail below, and the second is an outlet port 11 from which the dispensable inhalable composition is also described in more detail below. As shown by figure 3, the outlet orifice 11 is provided in a separate component 12.
An outlet path 13 is defined between the reservoir and the outlet port 11.
A portion of the outlet path 13 is provided by the deformable tubular element 14. This tubular element moves between the closed position shown in figure 1 and the open position shown in figure 2 by a mechanism that will now be described.
This mechanism comprises a pivot-mounted palette 1 and a membrane 16. The pivot-mounted palette has a pivot 17 at the closest end to the outlet end 8 and a central reinforcement rib 18 arranged along its length and tapering outwardly. the output end. Around this midpoint, the pallet 1 is provided with a recess 19 to receive a spring that predisposes it to the closed position shown in figure 1. Below the recess 19 is a claw 21 with a triangular cross section that is configured to apply the force provided by the pallet 1 on the deformable tube 14 over a narrow area. The pallet 1 is supported by the diaphragm 16 which is sealed in the housing at its ends 22, 23. This seals the chamber except in the suction port 9.
The bottom side 24 of the membrane 16 is open to atmospheric pressure since there is a leakage path through the housing 1 that is not shown in the drawings, since it extends around the exit path 1 and, therefore, is not shown in the plane of figures 1 and 2.
When a user sucks the outlet end 8 with the device in the configuration shown in figure 1, the suction is communicated through the suction port 9 to the chamber through the holes 2 thereby lowering the pressure in this chamber. This causes the pallet 1 to be raised against the action of the spring to the position shown in figure 2, deforming the diaphragm in the configuration shown in figure 2 and lifting the claw 21 to allow the deformable tube to open, thereby allowing the composition inhalation of the reservoir along the outlet path 13 through the deformable tube 14, exit through the outlet orifice 11. The degree of suction applied by the user will determine the extent to which the pallet 1 moves and, therefore, the amount of composition that the user receives. As soon as a user interrupts the suction, the atmospheric pressure will return to the chamber through the suction orifice 9 and the spring will return the pallet to the position of figure 1, thus closing the tube 14 by the clamp.
A second example of an inhaler is shown in figures 4 to 6. It is also provided with a deformable tube 14, a reservoir and outlet end 8, but the mechanism is slightly different. In the closed position of figure 4, the deformable tube is clamped between a pair of claws 30 in a spring clamp 31. This clamp 31 is predisposed to the first position shown in figure 4. The inhaler has an outlet orifice 32 that completes a flow path of the reservoir through the deformable tube 14 through the outlet orifice 32, and a plurality of suction orifices 33 that provide suction for an inner chamber 34. In this example, there is a pair of pivot-mounted palettes 3 extending longitudinally along the opposite sides of the device. Each of the pallets is connected to an L-shaped support 36, one of which is shown in figure 6. This L-shaped support extends to the respective claw 30 and effectively reaches the opposite side of the deformable tube 14 for reasons described below.
The housing 1 is provided with a pair of inlet holes 37, one for each pallet. As a user sucks on the outlet end 8, the suction force through the suction holes 34 draws air through the inlet holes 37 into the chamber 34 thereby applying internal pressure to the blades 3. Due to the internal pressure, the pallets pivot inwards to the position shown in the figure. The L-shaped supports 36 mean that the downward movement of the upper palette 3 moves the lower jaw 30 downward and the upward movement of the lower palette 3 moves the upper jaw 30 downward, thus opening the deformable tube 14 as shown in figure to dispense inhalable composition. When the suction force is removed, the pressure differential through the blades 3 is removed and the resilience of the spring clip 31 resets the claws 30 to the position shown in figure 4.
An alternative arrangement of a deformable tubular element will now be described with reference to figure 7.
Palette 1, membrane 16 and other components are roughly the same as described with reference to the previous example. The main difference in this example is the configuration of the deformable tubular element 14 'and these differences are all those that will be described below.
Essentially, the orifice 11 that was previously in a separate component has now been integrated into the tubular element 14 'as orifice 11'. This has some additional benefits. First, by replacing the two components with a single component, the overall space required for the exit path has been reduced. This allows other elements such as palette 1 and membrane 16 to be increased in size. This, in turn, increases the sensitivity of the device, since it is more efficient at converting small breathing forces into a movement that opens the flow path. This is important for users who may have impaired lung function. Second, by eliminating the requirement for a seal between the tubular element 14 and the plate with the orifice 11, the fabrication of the device can be simplified.
Furthermore, this eliminates the potential for leakage at this interface.
Also, the way in which the orifice plate 14 'is sealed in the outlet path 13 at this upstream end has also been modified. At its upstream end, the tubular element 14 'is provided with an annular edge projecting outwardly 40. This fits at the downstream end of the 1st outlet path 13. This provides a safer sealing arrangement than connecting the tubular element 14 at the place. As a result, the new nozzle design can contain a pressurized formulation without leaking for a much longer period, and thus increase the stability of the formulation in the device, as well as retain greater capacity for a longer period.
The tubular element 14 'can have different thicknesses in the particular parts. For example, circumferential stresses will be maximum on the nozzle walls immediately downstream of flange 40. However, for the middle section of the tubular element 14 'where the claw 21 is sealing the tubular element, the material may be of reduced thickness to allow for an action 2 easier grip.
Preferably, the tubular member 14 'has a Shore hardness margin between A and 80A, more preferably 30A to 40A. In its thickest part, the wall can be 0.14 mm thick and, in its thinnest part, it can be 0.18 mm thick. In order to produce the optimal performance for the aerosol to reach the pulmonary system by inhalation, the exit orifice 11 is preferably between 0.1 mm and 0.1 mm wide, but preferably 0.2 to 0.3 mm and more preferably 0 , 2 mm wide. The internal channel in the tubular element 14 'away from the outlet 11 is preferably between 0.2 mm and 0.6 mm wide, preferably between 0.3 mm and 0.4 mm and more preferably 0.4 mm.

权利要求:
Claims (13)
[0001]
1. Inhaler, characterized by the fact that it comprises: a reservoir of an inhalable composition; an outlet at one end through which the inhalable composition is discharged; and a non-metered breath activated valve between the end and the reservoir, the breath activated valve comprising a flow path extending from the reservoir to the outlet end, at least a portion of the flow path being a deformable tube, and a clamping element that clamps the deformable tube to close when no suction force is applied to the device and releases the tube to open the flow path when suction is applied at the outlet, to provide uninterrupted flow from the reservoir to the outlet.
[0002]
2. Inhaler according to claim 1, characterized by the fact that the inhaler is a simulated cigarette device with a body with a general cigarette shape.
[0003]
Inhaler according to claim 2, characterized in that the inhalable composition includes nicotine, or a nicotine derivative, or its salt.
[0004]
4. Inhaler, according to claim 1 or claim 2, characterized by the fact that the clamping device is configured in such a way that the degree of opening of the tube is proportional to the intensity of the suction.
[0005]
5. Inhaler, according to any of the preceding claims, characterized by the fact that the clamping element is a mechanical element that moves by a pressure differential caused when suction is applied at the outlet.
[0006]
6. Inhaler, according to the claim, characterized by the fact that the clamping element is an elongated pallet that is pivoted at one end and extends longitudinally inside the inhaler, the pallet being pivotable between a first position, in which the tube is closed, and a second position, in which it releases the tube to provide the flow path.
[0007]
7. Inhaler, according to claim 6, characterized by the fact that there is a single palette that presses the deformable tube against a fixed part of the inhaler.
[0008]
8. Inhaler, according to claim 6 or claim 7, characterized by the fact that each and every palette is predisposed to the closed position and the inhaler has a second flow path that creates a pressure differential through the palette that overcomes the predisposition force.
[0009]
Inhaler according to any one of claims 6 to 8, characterized by the fact that each and every palette is supported by a flexible membrane, in which the flexible membrane creates a chamber in which the palette is housed and which is opened to the outlet, but is otherwise sealed, with the face of the membrane on the side opposite the pallet being opened to atmospheric pressure.
[0010]
10. Inhaler according to any one of the preceding claims, characterized by the fact that the deformable tube is a nozzle which is also provided integrally with an outlet orifice, which is the narrowest part of the flow path.
[0011]
11. Inhaler, according to the claim, characterized by the fact that the nozzle has an annular edge that protrudes at its end upstream that adjusts at one end downstream of the flow path.
[0012]
12. Inhaler, according to any of the preceding claims, characterized by the fact that the path is substantially straight.
[0013]
13. Inhaler according to any of the preceding claims, characterized by the fact that the tube is clamped in one place.

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同族专利:

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GB201106397D0|2011-06-01|

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RU2012108573A|2013-09-20|

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GB2476612B|2012-02-08|

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法律状态:
2020-07-28| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]|

2020-11-24| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|

2021-01-19| B16A| Patent or certificate of addition of invention granted|Free format text: PRAZO DE VALIDADE: 10 (DEZ) ANOS CONTADOS A PARTIR DE 19/01/2021, OBSERVADAS AS CONDICOES LEGAIS. |

2021-06-22| B16C| Correction of notification of the grant|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 06/08/2010, OBSERVADAS AS CONDICOES LEGAIS. PATENTE CONCEDIDA CONFORME ADI 5.529/DF, QUE DETERMINA A ALTERACAO DO PRAZO DE CONCESSAO |

优先权:

申请号 | 申请日 | 专利标题

GB0913942.9|2009-08-07|

GB0913942A|GB0913942D0|2009-08-07|2009-08-07|An inhaler|

GBGB1000403.4A|GB201000403D0|2010-01-11|2010-01-11|An inhaler|

GB10000403.4|2010-01-11|

GB1000403.4|2010-01-11|

GBGB1002024.6A|GB201002024D0|2009-08-07|2010-02-08|An inhaler|

GB1002024.6|2010-02-08|

PCT/GB2010/001487|WO2011015825A1|2009-08-07|2010-08-06|An inhaler|

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