巴西专利BR112015004233B1 inhaler

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法律状态

优先权

专利摘要:
INHALER. An inhaler comprising a reservoir (2) of an inhalable composition. A valve element (11) moved by a flexible diaphragm (14) and ordered to a position where it closes a composition flow path from a reservoir. A first airflow path (16) is partially defined by one side of the diaphragm and a second airflow path (17) is partially defined by the opposite side of the diaphragm. Each flow path has an outlet (19f, 21) opening at one outlet end and the second flow path has an inlet (20) upstream of the outlet end. The airflow paths (16, 17) are arranged so that suction at the outlet end causes a reduction in pressure in the first airflow path relative to the pressure in the second airflow path, creating a differential of pressure through the diaphragm (14) that moves the valve element (11) against the stress force to open the composition flow path.
公开号:BR112015004233B1
申请号:R112015004233-3
申请日:2013-08-27
公开日:2020-10-27
发明作者:Alex Hearn；Iain McDerment
申请人:Kind Consumer Limited；
IPC主号:

专利说明:

[001] The present invention relates to an inhaler, specifically a device operated by breathing.
[002] Various types of breathing operated devices are known in the art. In addition, there is a selected amount that includes a means of using inhalation energy and the action of pressure to create an actuation trigger. For example, US 6,581,590 describes an actuator mechanism formed by a suction tube that communicates the nozzle with a diaphragm member and provides air to the user. This works on the basis of a single air flow and operates a locking mechanism, where air enters the device when the container actuator slides out of the diaphragm member. In addition, US 6318,366 provides a supply valve and diaphragm for a pneumatically operated gas demand device. In addition, WO 2006 / 079.751 describes a trigger mechanism that releases drugs for inhalation that can deliver chemical formulation in a cake.
[003] These devices operate an on / off configuration by means of which the prescribed breathing activation system distributes a defined bolt when firing at a given flow rate and will shut down as soon as the bolt has been emitted.
[004] WO 2011 / 015.826 describes an inhaler that is specifically designed for use as a simulated cigarette and nicotine delivery system, as well as ready-to-use drugs and pharmaceutical agents. This is provided with a breathing operated valve comprising a deformable tube which is closed by clamping by a valve element carried on a reed. This reed is ordered closed by a spring. The reed is surrounded by a flexible diaphragm. An airflow path is defined above the flexible diaphragm. This has air inlet holes that allow air to enter the air flow path above the diaphragm part along the simulated cigarette. This air then flows along the top of the diaphragm before exiting through an outlet opening at the end of the simulated cigarette which, in use, is drawn in by a user. Since the inlet is smaller than the outlet, this suction reduces the pressure in the space above the diaphragm. This causes the vane, and thereby the valve element, to be raised against the action of the spring, thereby opening the flow path of the composition to allow the composition to exit the simulated cigarette for inhalation.
[005] This reed system is highly efficient as a compact breathing operated valve specifically for use in an inhaler. However, it has now been refined to provide enhanced operation.
[006] An important aspect in the design of a simulated cigarette is to make the experience of using the simulated cigarette as similar as possible to the real smoking experience. When a user sniffs a cigarette, it uses a considerably lower flow rate, compared, for example, with the suction needed to open an inhaler primarily designed for medicinal purposes, such as an asthma inhaler. This can be in the range of 1 L / m compared to a dry powder inhaler which may require as much as 60 L / m of flow for deposition in the lung.
[007] It is desirable to have a valve operated by breathing that opens to a suction force as close as possible to the suction force by the user to smoke a cigarette. In practice, it is desirable to obtain a valve trigger at the lowest possible inhalation flow to ensure a consistent feeling of aspiration during the inhalation cycle. With larger trigger points, greater suction is required and this leads to a more binary mode of mechanism and a “trigger on / off” aspect of the valve trigger. This should also be done within the limits of the space available inside an inhaler that is the same size as a cigarette.
[008] According to the present invention, there are provided: an inhaler comprising a reservoir of an inhalable composition; a housing containing the reservoir and having an outlet end; a composition flow path for the composition flow from the reservoir and out of a composition outlet at the outlet end of the housing; a valve element requested by a requesting force to a position where it closes the composition flow path; a flexible diaphragm arranged to move the valve element; and a first airflow path partially defined by one side of the diaphragm, and a second airflow path defined by the opposite side of the diaphragm, each flow path having an outlet opening at the outlet end and the second flow path having an inlet upstream of the outlet end, where airflow paths are arranged so that suction from the outlet end causes a reduction in pressure in the first airflow path in relation to the pressure differential across the diaphragm that move the diaphragm and thus move the valve element against the request force to open the composition flow path.
[009] Thus, the present invention provides two flow paths that are arranged so that the pressure change on opposite sides of the diaphragm is intensified when suction is applied. The sensitivity of the breath operated valve is considerably enhanced compared to WO 2011 / 015.826, where there is only a single airflow path through the top of the diaphragm. Under the diaphragm in WO 2011 / 015.826, the only outlet is the composite outlet. Therefore, as the diaphragm moves upward, the space below it expands, causing a pressure drop. This works effectively as a brake on opening the valve. Because there is a second flow path, there is no fixed volume of gas to be expanded, thereby removing the brake and intensifying the valve's sensitivity. The mechanism can be sensitized to the user's breathing, calibrating the inhalation energy to the amount of formulation distributed, thus creating a device that a user can control and, thus, easily adjust the formulation in multiple doses.
[0010] Preferably, the pressure in the second air flow path will remain substantially atmospheric when suction is applied to the outlet ends.
[0011] Preferably, the second air flow path is configured so that there is no pressure increase in the second air flow path when suction is applied to the outlet end.
[0012] The open area in the second air flow path at its upstream end is preferably larger than its open area at the outlet end. This will cause the pressure in the second flow path to increase when suction is applied by generating a greater pressure drop through the opening at the outlet end.
[0013] The first flow path may have an opening at its end of a smaller amount than the opening at the outlet end. Preferably, however, the first flow path is a dead-end flow path other than the opening at the outlet end. In this way, suction at the outlet end will simply suck air out of the first airflow path.
[0014] The composition flow path can be arranged on the same side of the diaphragm as the first air flow path. In this case, the valve element would effectively have to “act around” the composition flow path and be requested back towards the composition flow path. Preferably, the composition flow path is on the same side of the diaphragm as the second flow path. This provides for a simpler construction of the valve element.
[0015] Although the inhaler was specifically designed to be a simulated cigarette, it has broader applications as an inhaler, for example, for dispensing medication, particularly in a situation where a small trigger force is required. This is specifically advantageous when delivering medications or vaccines that require rapid delivery and compliance compared to traditional inhalers, for example, B2- adrenergic agonists, opioid classes, including synthetic and non-synthetic, hormones or neurotransmitters and not limited to anticholinergics, corticosteroids , cannabinoids, PDE4 inhibitors, LTD4 antagonists, EGFR inhibitors, dopamine agonists, antihistamines, PAF antagonists and PI3 inhibitors or antiviral LTD4 antagonists, antibiotics, antigens or therapeutic proteins.
[0016] An example of an inhaler according to the present invention will now be described with reference to the accompanying drawings, in which: figure 1 is an exploded perspective view of an inhaler; figure 2 is a schematic axial cross section through the outlet end of the inhaler in the plane containing an air flow path and with the vane removed for clarity; figure 3 is a perspective view of the outlet end of the inhaler with the cover, vane and diaphragm removed to show the air flow paths; figure 4 is a perspective view of the outlet end of the inhaler; figure 5 is a plan view of the inhaler; figure 6 is a complete cross section of the inhaler; and figure 6A is a cross section through line 6A-6A in figure 6.
[0017] The present invention relates to an improvement of the outlet valve for an inhaler, as described in WO 2011 / 015.826. For further details of the device and its refill mechanism, reference is made to WO 2009 / 001.078.
[0018] As shown in figure 1, the device comprises a housing 1 that is largely divided into two parts. The distal part is a reservoir 2 and the proximal part is the valve mechanism operated by breathing 3. At the distal end 4 there is a refill valve 5 that allows the reservoir to be loaded. The reservoir can contain a wick 6, as described in PCT / GB 2011 / 000.285. At the opposite end is the outlet end 5 which will be described in more detail below.
[0019] As best seen in figure 6, the reservoir has a portion 8 adjacent to the distal end 4 that occupies substantially the entire cross section of the inhaler at this point. A second portion 9 which is closest to the outlet end 7 occupies a relatively small portion of the cross section of the inhaler, because, as shown in figure 6, this part of the anti-collision inhaler also accommodates the valve mechanism described below and provides space for the air flow paths also described below.
[0020] As can be seen in figures 1 and 3, this second portion 9 of the reservoir is part of the same molding as the housing 1 and runs along the bottom of the inhaler.
[0021] An elastomeric insert 10 in the form of an open tube at both ends is inserted at the distal end, but forms an outflow path at the proximal end of the inlet path, as shown in figure 6. This insert 10 is normally clamped closed by a valve element 11 which is descendedly requested by a spring 11. This clamped closed valve mechanism is described in more detail in WO 2011 / 015.825.
[0022] The valve element 11 is part of a reed 13 that extends along most of the outlet end of the inhaler. The vane 13 is surrounded by a diaphragm 14 that extends across the entire lower face of the vane 13, except for the orifice through which the valve element 11 protrudes. This valve element is sealed around its periphery to the surrounding housing. At the distal end of the diaphragm 14, there is a twist 15 that provides a certain degree of freedom for the reed 13 to move up and down. The opposite end of the reed 13 is integral with a surrounding frame that is loaded into the housing so that there is a direct connection between the frame and reed to provide a joint around which the reed pivots.
[0023] A mechanism for opening the valve element 11 against the action of the spring 12 will now be described.
[0024] This is achieved by the first 16 and the second 17 air flow paths. The first air flow path 16 is above diaphragm 14, with the top of the flow path being formed by the part of housing 18 which is fixed to housing 1 once the valve elements are in place. The first airflow path is essentially provided by an outlet port 19 of the first airflow path that leads to the space occupied by the vane 13 above diaphragm 14. This flow path has no other holes.
[0025] The second air flow path 17 is below diaphragm 14 and is defined by a pair of inlet holes 20 of the second air flow path (only one shown in figure 2). In the present example, the second airflow path is actually defined by two separate paths that extend from the inlet holes 20 along the passages 17 that are defined by the housing 1, on the bottom surface, and the diaphragm 11 on its surface and extending along the second portion 9 of the reservoir to the outlet end, ending in a pair of outlet holes 21 of the second airflow path, which are smaller than the corresponding inlet holes 20. The flow through the second air flow path is illustrated by the arrows at the bottom of figure 2 and in figure 3. Deflectors 22 are provided along the second air flow path 17 to increase the flow resistance in this path.
[0026] As a user aspirates the outlet end 7, air is sucked out of the outlet port of the first air flow path 15, thereby reducing the pressure in the first air flow path 16. At the same time, air is sucked through the inlet holes 20 of the second air flow path. The combination of reduced pressure above the vane and the prevention of significant pressure reduction below the vane causes the vane to move upwards, deforming the diaphragm and raising the valve element against the action of the spring 12. When a user interrupts the suction on the outlet end, the pressure above and below the diaphragm is equalized and the spring 12 resumes valve element 11 to a position where it closes insert 10 by clamping.

权利要求:
Claims (7)
[0001]
1. Inhaler, characterized by the fact that it comprises a reservoir (2) of an inhalable composition; a housing (1) containing the reservoir (2) and having an outlet end; a composition flow path (10) for the composition flow from the reservoir (2) and out of a composition outlet at the outlet end (5) of the housing (1); a valve element (11) requested by a requesting force to a position where it closes the composition flow path; a flexible diaphragm (14) arranged to move the valve element; and a first air flow path (16) partially defined by one side of the diaphragm (14), a second air flow (17) partially defined by the opposite side of the diaphragm, each flow path having an opening (19, 21) at the outlet end and the second flow path having an inlet (20) upstream of the outlet end, where the air flow paths (16, 17) are arranged so that suction at the outlet end causes a reduction pressure in the first air flow path (16) in relation to the pressure in the second air flow path (17), creating a pressure differential across the diaphragm (14) which moves the diaphragm and thus moves the valve (11) against the request force to open the composition flow path (10).
[0002]
2. Inhaler according to claim 1, characterized in that the pressure in the second air flow path (17) remains the same as atmospheric when suction is applied to the outlet ends (5).
[0003]
3. Inhaler according to claim 1 or 2, characterized in that the second air flow path (17) is configured so that there is no increase in pressure in the second air flow path when suction is applied at the outlet end (15).
[0004]
Inhaler according to any one of claims 1 to 3, characterized in that the open area of the second airflow path at its inlet (20) is larger than its open area at the inlet end (21).
[0005]
Inhaler according to any one of claims 1 to 4, characterized in that the first airflow path (16) is closed, except for the opening (19) at the outlet end (21).
[0006]
Inhaler according to any one of claims 1 to 5, characterized in that the composition flow path (10) is on the same side of the diaphragm (14) as the second flow path (17).
[0007]
Inhaler according to any one of claims 1 to 6, characterized by the fact that deflectors (22) are provided in the second air flow path (17) to increase the resistance to flow through it.

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同族专利:

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引用文献:

公开号 | 申请日 | 公开日 | 申请人 | 专利标题

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法律状态:
2018-11-21| B06F| Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]|

2019-10-08| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]|

2020-07-14| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|

2020-10-27| B16A| Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 27/08/2013, OBSERVADAS AS CONDICOES LEGAIS. |

优先权:

申请号 | 申请日 | 专利标题

GBGB1215282.3A|GB201215282D0|2012-08-28|2012-08-28|An inhaler|

GB201215278A|GB201215278D0|2012-08-28|2012-08-28|An inhaler|

GB1215282.3|2012-08-28|

GB1215278.1|2012-08-28|

PCT/GB2013/052239|WO2014033438A1|2012-08-28|2013-08-27|An inhaler|

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