• 专利附录
  • 专利说明
  • 权利要求
  • 类似技术
  • 同族专利
  • 引用文献
  • 法律状态
  • 优先权
    • 专利摘要:
    INHALER An inhaler comprising a source of inhalable composition. An outlet flow path (14) is provided for the composition of the source for a composition outlet at an outlet end of the inhaler. Means (12, 13, 14) are provided to generate a composition flow from the source along the outflow path and out through the composition outlet when suction is applied to the outlet end. A pair of air vents (21) at the outlet end are arranged on opposite sides of the composition outlet, through which air is sucked in by the respective air jets when suction is applied to the outlet end. The composition and air vents are arranged so that, in use, the pair of air jets collide on the composition plume.
    公开号:BR112015004230B1
    申请号:R112015004230-9
    申请日:2013-08-27
    公开日:2020-10-27
    发明作者:Alex Hearn
    申请人:Kind Consumer Limited；
    IPC主号:
    专利说明:

    [001] The present invention relates to an inhaler. More specifically, the invention concerns an inhaler for a simulated cigarette, that is, an inhaler that has the size and general shape of a cigarette. However, the invention can also be applied to other types of inhalers, such as those that dispense asthma medication or other forms of medication.
    [002] Many of these inhalers are known. In general, the inhaler has a single hole in the outlet end that is placed in the user's mouth. The user then aspires from the outlet end to trigger the flow of composition into his mouth. At the same time, air is sucked through the outlet port to the user's mouth.
    [003] An example is in WO 2006 / 079.751 which describes a trigger mechanism that releases drugs for inhalation, which can deliver liquid formulation in a cake, so that it is necessary to distribute the entire dose of the reservoir to the user with a high flow rate formulation emitted that empties the reservoir almost completely.
    [004] Some examples tried to use turbulent flow to accelerate particles for the respiratory cycle. US 6,234,169, for example, requires a conduit between a chamber that uses the Coanda effect so that the air that enters via the orifice travels to the reservoir to aspirate medicine from the reservoir.
    [005] Other examples sought to vary the performance of the device, but changing characteristics of its mechanism to influence the resistance of the device to the user's breathing. For example, WO 2008 / 151,796 discloses an aerosol inhaler having a mouthpiece and an air supply opening, which fires a reservoir for fluid flow. This inhaler has a flow resistance of at least 60 kPa12s / m3. This is achieved through an insert in the nozzle to define an increase in flow resistance and / or guide an air flow entering through at least one air supply opening. Contrary to the present invention, the main aspect is to increase the flow resistance of the device, so that the flow resistance is at least 60 kPa1 / 2s / m3. This is significantly greater in terms of suction resistance than previous inhalers similar to the present type. Such an inhaler is considered a development in traditional metered dose inhalers, since a device that distributes greater than normal resistance will deliver a rapid formulation bolus at a high inhalation rate by the user, accelerating the flow emitted to the bottom of the lung when inspiration is taken.
    [006] For a simulated cigarette device, it is necessary to have very different characteristics of inhalation rate. Specifically, the duration of the flow, instead of an emitted cake, should aim to be as smooth and gradual as possible. For a pressurized metered dose inhaler (pMDI), inspiration levels can be as high as 60 1 / m, but for simulated cigarette devices it needs to be closer to 1- 2 1 / m.
    [007] In the field of simulated cigarettes, there are a number of devices currently on the market. ONE of them is the Nicorette ™ inhaler. This is provided with a nicotine-containing cartridge placed in a housing. The user then aspirates over one end of the housing, thereby aspirating air through the opposite end creating a flow of air that carries the nicotine which is then inhaled. In this way, air and nicotine-containing composition are inhaled through a single orifice.
    [008] The second type of device is the electronic cigarette. In this case, aspiration over the outlet end of the electronic cigarette decreases the internal pressure that triggers the operation of a heater to vaporize nicotine into the air stream, so that it is inhaled through the outlet end.
    [009] A variety of other simulated cigarettes are known in the art previously, none having dealt with the adaptation of such devices to the desired characteristics.
    [0010] For example, US 4,635,651 describes a self-propelled cigarette substitute, but does not take into account the precise mechanics of inhalation indicators.
    [0011] DE 4,030,257 describes a simulated cigarette to dispense nicotine with a valve activated by breathing. In this case, a circular disc is connected via an axial rod to the outlet valve for the source of materials to be inhaled. When the user inhales, air is sucked into the device through holes upstream of the plate and is sucked around the edge of the plate. However, there is no reference to how the pressure drop and resistance to flow would be controlled.
    [0012] FR 2,873,584 also provides a device that includes a pressurized formulation, a space and a discharge nozzle that aims to distribute particles smaller than 2 microns. However, there is no consideration of adequate discharge mechanics and adaptable to users' inhalation.
    [0013] A recent simulated cigarette design is described in our previous application WO 2011 / 015.825 and WO 2011 / 107.737. This document describes a simulated cigarette that has a pressurized reservoir, the outlet of which is closed by a deformable tube clamped by a valve member. The valve member is part of a reed supported on a membrane. When the user aspirates through the cigarette end, air is sucked out of the chamber above the membrane at a rate faster than the rate at which the element enters via a number of smaller inlet holes, so that the pressure above the membrane is reduced and valve is raised. At the outlet end of the device, the inhalable composition flows through a composition flow path below the membrane and there is a separate air stream coming from the chamber above the membrane. The nature of the valve design means that the flow paths must necessarily maintain their positional relationship with one orifice above the other.
    [0014] An important factor in the distribution of compositions from an inhaler is ensuring that the user's inspiration mechanics closely resemble traditional cigarette inhalation to be an effective substitute. This means that the pressure drop and the suction resistance must be designed to optimize performance. Another factor is the fact that the particle size of the distributed composition can be relatively smaller, well defined and easily able to be controlled to ensure that the particle size of the composition that is distributed is of an optimum size for absorption at the desired distribution site, ( be it the oral cavity, lungs etc.) and in the desired concentration.
    [0015] The present invention aims to provide an inhaler with intensified composition distribution.
    [0016] In accordance with the present invention, an inhaler is provided comprising a source of inhalable composition, an outflow path from the source composition to a composition outlet, at an outlet end of the inhaler, means for generating a composition flow from the source along the outlet flow path and out through the composition outlet when suction is applied to the outlet end; and a pair of air vents at the outlet end arranged on opposite sides of the composition outlet, through which air is sucked into the respective air jets when suction is applied to the outlet end, the composition and air vents being arranged in so that, in use, the pair of air jets collide with the plume of the composition.
    [0017] The air jets create turbulence inside the composition plume, thus breaking any larger particle of composition inside the plume. As a result, a more uniform and generally smaller particle size is obtained. In addition, the present invention allows a simple way to adjust the particle size, which can be done simply by changing the relative spacing of the three outlets. The present invention thus provides an inhaler that can mimic pressure drop, aspiration resistance and optimized droplet sizing for a simulated cigarette device to enhance sensory performance and increase the pharmacokinetic effect.
    [0018] The invention thus provides significant advantages over the device described in WO 2011 / 015.286 which does not address the problem of controlling the particle size and performance operated by breathing, since the arrangement of the exit orifices is dictated by the way the valve operates.
    [0019] In addition, the provision of a pair of air vents provides a benefit over the single air outlet of WO 2011 / 015.826, in which the presence of an air outlet on one side only of the composition outlet causes deflection of the feather of the composition. This deflection will vary, depending on the amount of suction applied, so that an accurate plume distribution becomes difficult. With an air jet on each side of the plume of the composition it ensures that the forces exerted on the plume by the air jets are balanced, thus ensuring that positive effects of breaking the composition are obtained without the unwanted deflection of the plume.
    [0020] Although it is preferable to have only two air vents, it is also possible to have additional vents. These additional outlets could be provided singularly, since with three or more outlets, the ability of one outlet to create significant deflection of the plume is greatly reduced. However, preferably, if additional air outlets are present, they will be present in at least one additional opposite pair. If the air coming from the air vents leaves the inhaler in a direction parallel to the direction of the plume, there will be a certain degree of interference in the air jet and the composition plume as these will diverge when moving away from the inhaler. Preferably, however, the air outlets are angled towards the composition outlet, so that the air jets converge towards the composition plume. This enhances the ability of the air jets to break up the larger particles within the plume of the composition. In addition, this provides an additional degree of "adaptation" of the device, in that the angle can be adjusted to retain the desired particle size at the composition output.
    [0021] The means for generating the composition flow from the source along the outlet flow path and outward through the composition outlet, like a composition plume when suction is applied, can take various forms. For example, the composition could be exposed to an airflow path through the cigarette, the throughflow of air dragging part of the composition. Alternatively, there may be a battery operated heater inside the cigarette that is fired when suction is applied to vaporize an amount of nicotine. Preferably, however, the source of inhalable composition is a pressurized reservoir and the means for generating a flow of the composition is a breathing operated valve. In this case, the pair of air outlets can be associated with air flow passages that are independent of the actuated mechanism. Preferably, however, the pair of air outlets is associated with air flow paths that, at least partially, operate the breath-operated valve.
    [0022] Taking the air outlets as part of the actuation mechanism of a valve operated by breathing provides additional possibilities to adapt the simulated cigarette. By changing the sizes of the air outlets, the pressure differential applied to the breathing valve can be varied. In this way, the suction force required to operate the breath operated valve can be adapted simply by changing the size of the air vents.
    [0023] Another benefit of having a valve operated by breathing and that is opened, at least partially, by the flow through a pair of air vents separated from the flow path of the outlet for the composition is the fact of the composition rate dispensed (essentially determined by the reservoir pressure and minimum composition outlet area) to be independent of the air flow through the air outlets. This allows the suction pressure at which the valve is triggered and the suction resistance to be adjusted (by varying the size of the air outlets) regardless of the amount of composition that is dispensed. This allows air outlet holes to remain relatively small to provide the necessary pressure drop and suction resistance. However, this also allows for a relatively large composition output, ideal for producing the required amount of composition. In this way, prior art compromises with a single hole are avoided.
    [0024] Preferably, the breath-operated valve comprises a valve element requested by a request force for a position in which it closes to the outflow path for the composition; a flexible diaphragm arranged to move the valve element; a first flow path partially defined by one side of the diaphragm and a second flow path partially defined by the opposite side of the diaphragm, each flow path having an opening at the outlet end, where the air flow paths are arranged so that suction at the outlet end causes a pressure reduction in the first airflow path and a relative increase in pressure in the second airflow path, creating a pressure differential across the diaphragm, which moves the diaphragm and thus moves the valve element against the request force to open the outlet flow path for the composition at the outlet end of the second air flow path.
    [0025] The air vents can simply be taken from the closed chambers inside the inhaler. Preferably, however, the air outlets are associated with one or more air inlets spaced from the outlet and so that there is a flow path through the air inlets to the air outlets. By varying the size of the air inlets and outlets, the suction resistance experienced by the user can be varied.
    [0026] 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 distributing drugs or vaccines that require rapid distribution 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 and kinase antagonists PI3 inhibitors or LTD4 antiviral antagonists, antibiotics, antigens or therapeutic proteins.
    [0027] 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; figure 6A is a cross section through line 6A-6A in figure 6; and figure 7 is a schematic flow tester.
    [0028] 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.
    [0029] As shown in figure 1, the device comprises a housing 1 which is roughly 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.
    [0030] 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.
    [0031] 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.
    [0032] 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 forced downwardly by a spring 11. This clamped closed valve mechanism is described in more detail in WO 2011 / 015.825.
    [0033] 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 sprain 15 that provides a certain degree of freedom for the reed 13 to move up and down. The vane and its frame are both made of a flexible plastic material, while the diaphragm is a more transparent flexible material. There is a direct connection between the material of the tongue and the material of the frame, so that it is the material of the tongue that acts as the joint, rather than the material of the membrane. The opposite end of the reed 13 is integral with a surrounding frame which is loaded into the housing, so that there is a direct connection between the frame and the reed to provide a joint around which the reed pivots.
    [0034] A mechanism for opening the valve element 11 against the action of the spring 12 will now be described.
    [0035] 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.
    [0036] The second air flow path 17 is below the 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, which are defined by the housing 1, on the bottom surface, and the diaphragm 11 in its upper 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.
    [0037] 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 in which it closes insert 10 by clamping.
    [0038] As shown in figures 1, 2 and 4, the outlet end 7 in the part containing the insert 10 and the outlet holes 21 of the airflow path have a concave configuration 23. As a result, the outlet holes 21 are inclined towards the insert 10. By inhalation, the air coming out of the outlet holes 21 is inclined towards the composition plume emerging from the insert 10, so that the air quickly collides with the composition thus creating greater turbulence and reducing the average particle size of the composition.
    [0039] For traditional tobacco cigarettes, the international standards ISO 6565 and 7210 govern the testing and methodologies of aspiration resistance and pressure drop of tobacco cigarettes. This is an important measure for product quality specifications and to combine with mechanical smoke analytical determinations.
    [0040] Figure 7 is a general diagram for a test method under these standards, and shows a flow tester that allows an evaluation of the pressure drop through the inhaler device at different flows. The pressure drop is applied using a vacuum pump 30 under the control of a variable restrictor 31 and is measured by using a suitable pressure gauge 32, zeroing the measurement before testing to compensate for changes in atmospheric pressure. The flow is measured from the top of a float 33 and a flow tube 34. Each inhalation is measured according to ISO 7210: 1997.
    [0041] The size of the air jets influences the suction resistance of inhalation, so it was found to be a direct correlation with the pressure drop measured through the air outlet holes under ISO 7210 against the diameter of the outlet holes. the second airflow path. For example, with two holes in these air holes, each having a diameter of 0.45 mm, the suction resistance tested through 100 devices was 2.8 kPa. When the orifices have a diameter of 0.40 mm, an average pressure drop of 3.7 kPa is obtained, and when they have a diameter of 0.33 mm an average pressure drop of 5.2 kPa is obtained. And for the invention that an average pressure drop is in the range between 2 kPa and 4 kPa for the optimum performance characteristics for a smoker in an aerated simulated cigarette. This allows for a selected adaptation of the device to fit the particular formulation intensity, for example, a device of greater strength will be tailored for a formulation of greater intensity.
    [0042] Our copending order GB 1,215,273 describes formulations suitable for the composition. A device with greater suction resistance, with double air jets of 0.38 mm in diameter, can be paired with a formulation of nicotine of greater intensity, for example, 0.084% by weight. This is similar to conventional tobacco cigarettes, since cigarettes with a higher nicotine content are correlated with greater resistance to aspiration. In this way, the inhaler can provide a method and mechanism for adapting the pressure drop through air jets to particular formulation intensities, to distribute expanded product ranges and greater consumer acceptance.
    权利要求:
    Claims (15)
    [0001]
    1. Inhaler (1) comprising a source of inhalable composition (2), an outflow path (10) for the composition of the source to a composition outlet, at an outlet end of the inhaler, means for generating a flow of composition of the source along the outlet flow path and out of the composition outlet when suction is applied to the outlet end; characterized by the fact that it comprises a pair of air outlets (21) at the outlet end arranged on opposite sides of the composition outlet, through which air is sucked into the respective air jets when suction is applied to the outlet end, the outlets composition and air (21) being arranged so that, in use, the pair of air jets collide with the plume of the composition.
    [0002]
    2. Inhaler (1) according to claim 1, characterized by the fact that there are only two air outlets (21).
    [0003]
    Inhaler (1) according to claim 1, characterized in that additional outlets (21) are present in at least one additional opposite pair.
    [0004]
    Inhaler (1) according to any one of claims 1 to 3, characterized in that the air outlets (21) are angled towards the composition outlet, so that the air jets converge towards the composition plume.
    [0005]
    Inhaler (1) according to any one of claims 1 to 4, characterized in that the source of the inhalable composition is a pressurized reservoir (2), and the means for generating the flow of the composition is a breathing-operated valve (11) .
    [0006]
    6. Inhaler (1) according to claim 5, characterized in that the pair of air outlets (21) is associated with air flow paths (16, 17) that, at least partially, operate the breathing-operated valve .
    [0007]
    7. Inhaler (1) according to claim 6, characterized in that the breath-operated valve comprises a valve element (11) requested by a requesting force (12) for a position in which it closes the flow path of output for the composition; a flexible diaphragm (14) arranged to move the valve element; a first airflow path (17) partially defined by one side of the diaphragm and a second airflow path (16) partially defined by the opposite side of the diaphragm, each flow path having an opening at the outlet end, where the airflow paths are arranged so that suction at the outlet end causes reducing pressure in the first airflow path and a relative increase in pressure in the second airflow path, creating a pressure differential across the diaphragm ( 14) which moves the diaphragm and thereby moves the valve element against the force of to open the outlet flow path to the composition, where the pair of air outlets (21) provide the opening at the outlet end of the second air flow path (17).
    [0008]
    Inhaler (1) according to any one of claims 5 to 7, characterized in that the air outlets are associated with one or more air inlets (20) spaced from the outlet end so that there is a flow path through the air inlets to the air outlets.
    [0009]
    Inhaler (1) according to any one of claims 1 to 8, characterized by the fact that, through normal inhalation, the flow through all air outlets totals about 0.5 1 / m to 60 1 / m, preferably 1.0 l / m to 5 l / m, more preferably 1.5 l / m.
    [0010]
    Inhaler (1) according to any one of claims 1 to 9, characterized in that the outlet diameter of the composition outlet is 0.1 mm to 1.0 mm, preferably 0.2 mm, and the diameter each pair of outlets is 0.1 mm to 1.2 mm, preferably 0.4 mm.
    [0011]
    Inhaler (1) according to any one of claims 1 to 10, characterized in that the ratio between the cross-sectional area of the outlet of the composition outlet nozzle and the total cross-sectional area of the air outlets is between 16: 1 and 1: 1 and preferably between 4: 1 and 1: 1.
    [0012]
    Inhaler (1) according to any one of claims 1 to 11, characterized in that the total outlet area of the cross section of the composition outlet is from 0.008 mm2 to 0.8 mm2, preferably 0.07 mm2 to 0 , 2 mm2, and the total cross-sectional area of the air outlets is 0.14 mm2 to 1.0 mm2, and because the ratio of the two areas is 2: 1 to 8: 1, resulting in a droplet size 5 microns as a D50, preferably 0 to 3 microns and, more preferably, 0.6 microns.
    [0013]
    13. Inhaler (1) according to any one of claims 1 to 12, characterized by the fact that the pressure drop through the air outlet holes measured by ISO 6565 and ISO 7210 with two air jets is 0.5 to 4 kPa .
    [0014]
    14. Inhaler (1) according to claim 13, characterized by the fact that the pressure drop through the air outlet holes measured by ISO 6565 and 7210 with two air jets is 2 - 4 kPa.
    [0015]
    Inhaler (1) according to any one of claims 1 to 14, characterized by the fact that the pressure drop through the air outlet holes measured by ISO 6565 and ISO 7210 with air vents of 1 mm in diameter is 3 kPa at 4kPa.
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    US10441734B2|2019-10-15|
    PH12015500684A1|2015-05-18|
    IL237465D0|2015-04-30|
    HK1211186A1|2016-05-20|
    BR112015004230A2|2017-08-08|
    AU2013308231A1|2015-04-09|
    ZA201502014B|2016-07-27|
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    TW201410279A|2014-03-16|
    EP2890258A1|2015-07-08|
    AU2013308231B2|2016-04-14|
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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|
    GB1215282.3|2012-08-28|
    PCT/GB2013/052240|WO2014033439A1|2012-08-28|2013-08-27|A breath operated inhaler with plume impiging air jets|
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